[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2022 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          
          
          Title 42

Public Health


________________________

Parts 1 to 399

                         Revised as of October 1, 2022

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2022
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register.

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 42:
          Chapter I--Public Health Service, Department of 
          Health and Human Services                                  3
          Chapters II-III [Reserved]
  Finding Aids:
      Table of CFR Titles and Chapters........................     947
      Alphabetical List of Agencies Appearing in the CFR......     967
      List of CFR Sections Affected...........................     977

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 42 CFR 2.1 refers to 
                       title 42, part 2, section 
                       1.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, October 1, 2022), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
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instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
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previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not dropped in error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
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This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
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CFR INDEXES AND TABULAR GUIDES

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alphabetical list of agencies publishing in the CFR are also included in 
this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.

[[Page vii]]

    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
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the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

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INQUIRIES

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    The eCFR is a regularly updated, unofficial editorial compilation of 
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available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register
    October 1, 2022







[[Page ix]]



                               THIS TITLE

    Title 42--Public Health is composed of five volumes. The parts in 
these volumes are arranged in the following order: Parts 1-399, parts 
400-413, parts 414-429, parts 430-481, and part 482 to end. The first 
volume (parts 1-399) contains current regulations issued under chapter 
I--Public Health Service (HHS). The second, third, and fourth volumes 
(parts 400-413, parts 414-429, and parts 430-481) include regulations 
issued under chapter IV--Centers for Medicare & Medicaid Services (HHS) 
and the fifth volume (part 482 to end) contains the remaining 
regulations in chapter IV and the regulations issued under chapter V by 
the Office of Inspector General-Health Care (HHS). The contents of these 
volumes represent all current regulations codified under this title of 
the CFR as of October 1, 2022.

    For this volume, Michele Bugenhagen was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                   (This book contains parts 1 to 399)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Public Health Service, Department of Health and 
  Human Services............................................           2
chapters ii-iii [Reserved]

[[Page 3]]



    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 67 FR 
36549, May 24, 2002.

                    SUBCHAPTER A--GENERAL PROVISIONS
Part                                                                Page
2               Confidentiality of substance use disorder 
                    patient records.........................           9
2a              Protection of identity--research subjects...          32
3               Patient safety organizations and patient 
                    safety work product.....................          38
4               National Library of Medicine................          69
5               Designation of health professional(s) 
                    shortage areas..........................          72
6               Federal tort claims act coverage of certain 
                    grantees and individuals................          89
7               Distribution of reference biological 
                    standards and biological preparations...          92
8               Medication assisted treatment for opioid use 
                    disorders...............................          93
9               Standards of care for chimpanzees held in 
                    the federally supported sanctuary system         118
10              340B Drug Pricing Program...................         132
11              Clinical trials registration and results 
                    information submission..................         136
                         SUBCHAPTER B--PERSONNEL
21              Commissioned officers.......................         170
22              Personnel other than commissioned officers..         180
23              National Health Service Corps...............         181

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24              Senior Biomedical Research and Biomedical 
                    Product Assessment Service..............         186
               SUBCHAPTER C--MEDICAL CARE AND EXAMINATIONS
31              Medical care for certain personnel of the 
                    Coast Guard, National Ocean Survey, 
                    Public Health Service, and former 
                    Lighthouse Service......................         190
34              Medical examination of aliens...............         195
35              Hospital and station management.............         203
37              Specifications for medical examinations of 
                    coal miners.............................         212
38              Disaster assistance for crisis counseling 
                    and training............................         238
                          SUBCHAPTER D--GRANTS
50              Policies of general applicability...........         243
51              Requirements applicable to the protection 
                    and advocacy for individuals with mental 
                    illness program.........................         262
51a             Project grants for maternal and child health         274
51b             Project grants for preventive health 
                    services................................         277
51c             Grants for community health services........         283
51d             Mental health and substance abuse emergency 
                    response procedures.....................         299
51e-51g

[Reserved]

52              Grants for research projects................         303
52a             National Institutes of Health center grants.         307
52b             National Institutes of Health construction 
                    grants..................................         313
52c             Minority Biomedical Research Support Program         321
52d             National Cancer Institute Clinical Cancer 
                    Education Program.......................         323
52e             National Heart, Lung, and Blood Institute 
                    grants for prevention and control 
                    projects................................         326
52h             Scientific peer review of research grant 
                    applications and research and 
                    development contract projects...........         329
52i             National Institute on Minority Health and 
                    Health Disparities Research Endowment 
                    Programs................................         335
53              Grants, loans and loan guarantees for 
                    construction and modernization of 
                    hospitals and medical facilities........         340
54              Charitable Choice regulations applicable to 
                    States receiving Substance Abuse 
                    Prevention and Treatment block grants 
                    and/or Projects for Assistance in 
                    Transition from Homelessness grants.....         348

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54a             Charitable Choice regulations applicable to 
                    States, local governments and religious 
                    organizations receiving discretionary 
                    funding under Title V of the Public 
                    Health Service Act, 42 U.S.C. 290aa, et 
                    seq., for substance abuse prevention and 
                    treatment services......................         352
55a             Program grants for Black Lung clinics.......         356
56              Grants for migrant health services..........         359
57              Grants for construction of teaching 
                    facilities, educational improvements, 
                    scholarships and student loans..........         378
58              Grants for training of public health and 
                    allied health personnel.................         421
59              Grants for family planning services.........         421
59a             National Library of Medicine grants.........         431
            SUBCHAPTER E--FELLOWSHIPS, INTERNSHIPS, TRAINING
61              Fellowships.................................         436
62              National Health Service Corps Scholarship 
                    and Loan Repayment Programs.............         441
63              Traineeships................................         459
63a             National Institutes of Health training 
                    grants..................................         462
64              National Library of Medicine training grants         466
64a             Obligated service for mental health 
                    traineeships............................         468
65              National Institute of Environmental Health 
                    Sciences hazardous waste worker training         472
65a             National Institute of Environmental Health 
                    Sciences hazardous substances basic 
                    research and training grants............         475
66              National Research Service Awards............         479
67              Agency for Health Care Policy and Research 
                    grants and contracts....................         486
68              National Institutes of Health (NIH) Loan 
                    Repayment Programs (LRPs)...............         495
68b             National Institutes of Health (NIH) 
                    Undergraduate Scholarship Program 
                    Regarding Professions Needed by National 
                    Research Institutes (UGSP)..............         504
             SUBCHAPTER F--QUARANTINE, INSPECTION, LICENSING
70              Interstate quarantine.......................         509
71              Foreign quarantine..........................         519
72

[Reserved]

73              Select agents and toxins....................         554

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75              Standards for the accreditation of 
                    educational programs for and the 
                    credentialing of radiologic personnel...         578
   SUBCHAPTER G--OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED 
                               ACTIVITIES
80

[Reserved]

81              Guidelines for determining probability of 
                    causation under the energy employees 
                    occupational illness compensation 
                    program act of 2000.....................         591
82              Methods for conducting dose reconstruction 
                    under the Energy Employees Occupational 
                    Illness Compensation Program Act of 2000         598
83              Procedures for designating classes of 
                    employees as members of the special 
                    exposure cohort under the Energy 
                    Employees Occupational Illness 
                    Compensation Program Act of 2000........         609
84              Approval of respiratory protective devices..         620
85              Requests for health hazard evaluations......         689
85a             Occupational safety and health 
                    investigations of places of employment..         694
86              Grants for education programs in 
                    occupational safety and health..........         699
87              National Institute for Occupational Safety 
                    and Health Research and demonstration 
                    grants..................................         707
88              World Trade Center Health Program...........         709
SUBCHAPTER H--HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS 
                   SUBSTANCES RELEASES AND FACILITIES
90              Administrative functions, practices, and 
                    procedures..............................         727
93              Public health service policies on research 
                    misconduct..............................         731
                         SUBCHAPTER I [RESERVED]
                         SUBCHAPTER J--VACCINES
100             Vaccine injury compensation.................         760
110             Countermeasures injury compensation program.         769
               SUBCHAPTER K--HEALTH RESOURCES DEVELOPMENT
121             Organ Procurement and Transplantation 
                    Network.................................         801
124             Medical facility construction and 
                    modernization...........................         812

[[Page 7]]

125-129

[Reserved]

                  SUBCHAPTER L--COMPASSIONATE PAYMENTS
131-135

[Reserved]

  SUBCHAPTER M--INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
136             Indian health...............................         849
136a            Indian health...............................         886
137             Tribal self-governance......................         893
138-199

[Reserved]

[[Page 9]]



                     SUBCHAPTER A_GENERAL PROVISIONS





PART 2_CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS--
Table of Contents



                         Subpart A_Introduction

Sec.
2.1 Statutory authority for confidentiality of substance use disorder 
          patient records.
2.2 Purpose and effect.
2.3 Criminal penalty for violation.
2.4 Reports of violations.

                      Subpart B_General Provisions

2.11 Definitions.
2.12 Applicability.
2.13 Confidentiality restrictions and safeguards.
2.14 Minor patients.
2.15 Incompetent and deceased patients.
2.16 Security for records.
2.17 Undercover agents and informants.
2.18 Restrictions on the use of identification cards.
2.19 Disposition of records by discontinued programs.
2.20 Relationship to state laws.
2.21 Relationship to federal statutes protecting research subjects 
          against compulsory disclosure of their identity.
2.22 Notice to patients of federal confidentiality requirements.
2.23 Patient access and restrictions on use.

               Subpart C_Disclosures with Patient Consent

2.31 Consent requirements.
2.32 Prohibition on re-disclosure.
2.33 Disclosures permitted with written consent.
2.34 Disclosures to prevent multiple enrollments.
2.35 Disclosures to elements of the criminal justice system which have 
          referred patients.
2.36 Disclosures to prescription drug monitoring programs.

              Subpart D_Disclosures without Patient Consent

2.51 Medical emergencies.
2.52 Research.
2.53 Audit and evaluation.

          Subpart E_Court Orders Authorizing Disclosure and Use

2.61 Legal effect of order.
2.62 Order not applicable to records disclosed without consent to 
          researchers, auditors and evaluators.
2.63 Confidential communications.
2.64 Procedures and criteria for orders authorizing disclosures for 
          noncriminal purposes.
2.65 Procedures and criteria for orders authorizing disclosure and use 
          of records to criminally investigate or prosecute patients.
2.66 Procedures and criteria for orders authorizing disclosure and use 
          of records to investigate or prosecute a part 2 program or the 
          person holding the records.
2.67 Orders authorizing the use of undercover agents and informants to 
          criminally investigate employees or agents of a part 2 
          program.

    Authority: 42 U.S.C. 290dd-2.

    Source: 82 FR 6115, Jan. 18, 2017, unless otherwise noted.



                         Subpart A_Introduction



Sec.  2.1  Statutory authority for confidentiality of substance use disorder 
patient records.

    Title 42, United States Code, Section 290dd-2(g) authorizes the 
Secretary to prescribe regulations. Such regulations may contain such 
definitions, and may provide for such safeguards and procedures, 
including procedures and criteria for the issuance and scope of orders, 
as in the judgment of the Secretary are necessary or proper to 
effectuate the purposes of this statute, to prevent circumvention or 
evasion thereof, or to facilitate compliance therewith.



Sec.  2.2  Purpose and effect.

    (a) Purpose. Pursuant to 42 U.S.C. 290dd-2(g), the regulations in 
this part impose restrictions upon the disclosure and use of substance 
use disorder patient records which are maintained in connection with the 
performance of any part 2 program. The regulations in this part include 
the following subparts:
    (1) Subpart B of this part: General Provisions, including 
definitions, applicability, and general restrictions;

[[Page 10]]

    (2) Subpart C of this part: Disclosures with Patient Consent, 
including disclosures which require patient consent and the consent form 
requirements;
    (3) Subpart D of this part: Disclosures without Patient Consent, 
including disclosures which do not require patient consent or an 
authorizing court order; and
    (4) Subpart E of this part: Court Orders Authorizing Disclosure and 
Use, including disclosures and uses of patient records which may be made 
with an authorizing court order and the procedures and criteria for the 
entry and scope of those orders.
    (b) Effect. (1) The regulations in this part prohibit the disclosure 
and use of patient records unless certain circumstances exist. If any 
circumstance exists under which disclosure is permitted, that 
circumstance acts to remove the prohibition on disclosure but it does 
not compel disclosure. Thus, the regulations do not require disclosure 
under any circumstances.
    (2) The regulations in this part are not intended to direct the 
manner in which substantive functions such as research, treatment, and 
evaluation are carried out. They are intended to ensure that a patient 
receiving treatment for a substance use disorder in a part 2 program is 
not made more vulnerable by reason of the availability of their patient 
record than an individual with a substance use disorder who does not 
seek treatment.
    (3) Because there is a criminal penalty for violating the 
regulations, they are to be construed strictly in favor of the potential 
violator in the same manner as a criminal statute (see M. Kraus & 
Brothers v. United States, 327 U.S. 614, 621-22, 66 S. Ct. 705, 707-08 
(1946)).



Sec.  2.3  Criminal penalty for violation.

    Under 42 U.S.C. 290dd-2(f), any person who violates any provision of 
this section or any regulation issued pursuant to this section shall be 
fined in accordance with Title 18 of the U.S. Code.



Sec.  2.4  Reports of violations.

    (a) The report of any violation of the regulations in this part may 
be directed to the United States Attorney for the judicial district in 
which the violation occurs.
    (b) The report of any violation of the regulations in this part by 
an opioid treatment program may be directed to the United States 
Attorney for the judicial district in which the violation occurs as well 
as to the Substance Abuse and Mental Health Services Administration 
(SAMHSA) office responsible for opioid treatment program oversight.



                      Subpart B_General Provisions



Sec.  2.11  Definitions.

    For purposes of the regulations in this part:
    Central registry means an organization which obtains from two or 
more member programs patient identifying information about individuals 
applying for withdrawal management or maintenance treatment for the 
purpose of avoiding an individual's concurrent enrollment in more than 
one treatment program.
    Diagnosis means any reference to an individual's substance use 
disorder or to a condition which is identified as having been caused by 
that substance use disorder which is made for the purpose of treatment 
or referral for treatment.
    Disclose means to communicate any information identifying a patient 
as being or having been diagnosed with a substance use disorder, having 
or having had a substance use disorder, or being or having been referred 
for treatment of a substance use disorder either directly, by reference 
to publicly available information, or through verification of such 
identification by another person.
    Federally assisted--see Sec.  2.12(b).
    Informant means an individual:
    (1) Who is a patient or employee of a part 2 program or who becomes 
a patient or employee of a part 2 program at the request of a law 
enforcement agency or official; and
    (2) Who at the request of a law enforcement agency or official 
observes one or more patients or employees of the part 2 program for the 
purpose of reporting the information obtained to the law enforcement 
agency or official.
    Maintenance treatment means long-term pharmacotherapy for 
individuals

[[Page 11]]

with substance use disorders that reduces the pathological pursuit of 
reward and/or relief and supports remission of substance use disorder-
related symptoms.
    Member program means a withdrawal management or maintenance 
treatment program which reports patient identifying information to a 
central registry and which is in the same state as that central registry 
or is in a state that participates in data sharing with the central 
registry of the program in question.
    Minor, as used in the regulations in this part, means an individual 
who has not attained the age of majority specified in the applicable 
state law, or if no age of majority is specified in the applicable state 
law, the age of 18 years.
    Part 2 program means a federally assisted program (federally 
assisted as defined in Sec.  2.12(b) and program as defined in this 
section). See Sec.  2.12(e)(1) for examples.
    Part 2 program director means:
    (1) In the case of a part 2 program that is an individual, that 
individual.
    (2) In the case of a part 2 program that is an entity, the 
individual designated as director or managing director, or individual 
otherwise vested with authority to act as chief executive officer of the 
part 2 program.
    Patient means any individual who has applied for or been given 
diagnosis, treatment, or referral for treatment for a substance use 
disorder at a part 2 program. Patient includes any individual who, after 
arrest on a criminal charge, is identified as an individual with a 
substance use disorder in order to determine that individual's 
eligibility to participate in a part 2 program. This definition includes 
both current and former patients.
    Patient identifying information means the name, address, social 
security number, fingerprints, photograph, or similar information by 
which the identity of a patient, as defined in this section, can be 
determined with reasonable accuracy either directly or by reference to 
other information. The term does not include a number assigned to a 
patient by a part 2 program, for internal use only by the part 2 
program, if that number does not consist of or contain numbers (such as 
a social security, or driver's license number) that could be used to 
identify a patient with reasonable accuracy from sources external to the 
part 2 program.
    Person means an individual, partnership, corporation, federal, state 
or local government agency, or any other legal entity, (also referred to 
as ``individual or entity'').
    Program means:
    (1) An individual or entity (other than a general medical facility) 
who holds itself out as providing, and provides, substance use disorder 
diagnosis, treatment, or referral for treatment; or
    (2) An identified unit within a general medical facility that holds 
itself out as providing, and provides, substance use disorder diagnosis, 
treatment, or referral for treatment; or
    (3) Medical personnel or other staff in a general medical facility 
whose primary function is the provision of substance use disorder 
diagnosis, treatment, or referral for treatment and who are identified 
as such providers.
    Qualified service organization means an individual or entity who:
    (1) Provides services to a part 2 program, such as data processing, 
bill collecting, dosage preparation, laboratory analyses, or legal, 
accounting, population health management, medical staffing, or other 
professional services, or services to prevent or treat child abuse or 
neglect, including training on nutrition and child care and individual 
and group therapy, and
    (2) Has entered into a written agreement with a part 2 program under 
which that individual or entity:
    (i) Acknowledges that in receiving, storing, processing, or 
otherwise dealing with any patient records from the part 2 program, it 
is fully bound by the regulations in this part; and
    (ii) If necessary, will resist in judicial proceedings any efforts 
to obtain access to patient identifying information related to substance 
use disorder diagnosis, treatment, or referral for treatment except as 
permitted by the regulations in this part.
    Records means any information, whether recorded or not, created by, 
received, or acquired by a part 2 program relating to a patient (e.g., 
diagnosis, treatment and referral for treatment information, billing 
information,

[[Page 12]]

emails, voice mails, and texts), provided, however, that information 
conveyed orally by a part 2 program to a non-part 2 provider for 
treatment purposes with the consent of the patient does not become a 
record subject to this Part in the possession of the non-part 2 provider 
merely because that information is reduced to writing by that non-part 2 
provider. Records otherwise transmitted by a part 2 program to a non-
part 2 provider retain their characteristic as records in the hands of 
the non-part 2 provider, but may be segregated by that provider. For the 
purpose of the regulations in this part, records include both paper and 
electronic records.
    Substance use disorder means a cluster of cognitive, behavioral, and 
physiological symptoms indicating that the individual continues using 
the substance despite significant substance-related problems such as 
impaired control, social impairment, risky use, and pharmacological 
tolerance and withdrawal. For the purposes of the regulations in this 
part, this definition does not include tobacco or caffeine use.
    Third-party payer means an individual or entity who pays and/or 
agrees to pay for diagnosis or treatment furnished to a patient on the 
basis of a contractual relationship with the patient or a member of the 
patient's family or on the basis of the patient's eligibility for 
federal, state, or local governmental benefits.
    Treating provider relationship means that, regardless of whether 
there has been an actual in-person encounter:
    (1) A patient is, agrees to, or is legally required to be diagnosed, 
evaluated, and/or treated, or agrees to accept consultation, for any 
condition by an individual or entity, and;
    (2) The individual or entity undertakes or agrees to undertake 
diagnosis, evaluation, and/or treatment of the patient, or consultation 
with the patient, for any condition.
    Treatment means the care of a patient suffering from a substance use 
disorder, a condition which is identified as having been caused by the 
substance use disorder, or both, in order to reduce or eliminate the 
adverse effects upon the patient.
    Undercover agent means any federal, state, or local law enforcement 
agency or official who enrolls in or becomes an employee of a part 2 
program for the purpose of investigating a suspected violation of law or 
who pursues that purpose after enrolling or becoming employed for other 
purposes.
    Withdrawal management means the use of pharmacotherapies to treat or 
attenuate the problematic signs and symptoms arising when heavy and/or 
prolonged substance use is reduced or discontinued.

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43036, July 15, 2020]



Sec.  2.12  Applicability.

    (a) General-- (1) Restrictions on disclosure. The restrictions on 
disclosure in the regulations in this part apply to any records which:
    (i) Would identify a patient as having or having had a substance use 
disorder either directly, by reference to publicly available 
information, or through verification of such identification by another 
person; and
    (ii) Contain drug abuse information obtained by a federally assisted 
drug abuse program after March 20, 1972 (part 2 program), or contain 
alcohol abuse information obtained by a federally assisted alcohol abuse 
program after May 13, 1974 (part 2 program); or if obtained before the 
pertinent date, is maintained by a part 2 program after that date as 
part of an ongoing treatment episode which extends past that date; for 
the purpose of treating a substance use disorder, making a diagnosis for 
that treatment, or making a referral for that treatment.
    (2) Restriction on use. The restriction on use of information to 
initiate or substantiate any criminal charges against a patient or to 
conduct any criminal investigation of a patient (42 U.S.C. 290dd-2(c)) 
applies to any information, whether or not recorded, which is drug abuse 
information obtained by a federally assisted drug abuse program after 
March 20, 1972 (part 2 program), or is alcohol abuse information 
obtained by a federally assisted alcohol abuse program after May 13, 
1974 (part 2 program); or if obtained before the pertinent date, is 
maintained by a part 2 program after that date as part of an

[[Page 13]]

ongoing treatment episode which extends past that date; for the purpose 
of treating a substance use disorder, making a diagnosis for the 
treatment, or making a referral for the treatment.
    (b) Federal assistance. A program is considered to be federally 
assisted if:
    (1) It is conducted in whole or in part, whether directly or by 
contract or otherwise by any department or agency of the United States 
(but see paragraphs (c)(1) and (2) of this section relating to the 
Department of Veterans Affairs and the Armed Forces);
    (2) It is being carried out under a license, certification, 
registration, or other authorization granted by any department or agency 
of the United States including but not limited to:
    (i) Participating provider in the Medicare program;
    (ii) Authorization to conduct maintenance treatment or withdrawal 
management; or
    (iii) Registration to dispense a substance under the Controlled 
Substances Act to the extent the controlled substance is used in the 
treatment of substance use disorders;
    (3) It is supported by funds provided by any department or agency of 
the United States by being:
    (i) A recipient of federal financial assistance in any form, 
including financial assistance which does not directly pay for the 
substance use disorder diagnosis, treatment, or referral for treatment; 
or
    (ii) Conducted by a state or local government unit which, through 
general or special revenue sharing or other forms of assistance, 
receives federal funds which could be (but are not necessarily) spent 
for the substance use disorder program; or
    (4) It is assisted by the Internal Revenue Service of the Department 
of the Treasury through the allowance of income tax deductions for 
contributions to the program or through the granting of tax exempt 
status to the program.
    (c) Exceptions-- (1) Department of Veterans Affairs. These 
regulations do not apply to information on substance use disorder 
patients maintained in connection with the Department of Veterans 
Affairs' provision of hospital care, nursing home care, domiciliary 
care, and medical services under Title 38, U.S.C. Those records are 
governed by 38 U.S.C. 7332 and regulations issued under that authority 
by the Secretary of Veterans Affairs.
    (2) Armed Forces. The regulations in this part apply to any 
information described in paragraph (a) of this section which was 
obtained by any component of the Armed Forces during a period when the 
patient was subject to the Uniform Code of Military Justice except:
    (i) Any interchange of that information within the Armed Forces; and
    (ii) Any interchange of that information between the Armed Forces 
and those components of the Department of Veterans Affairs furnishing 
health care to veterans.
    (3) Communication within a part 2 program or between a part 2 
program and an entity having direct administrative control over that 
part 2 program. The restrictions on disclosure in the regulations in 
this part do not apply to communications of information between or among 
personnel having a need for the information in connection with their 
duties that arise out of the provision of diagnosis, treatment, or 
referral for treatment of patients with substance use disorders if the 
communications are:
    (i) Within a part 2 program; or
    (ii) Between a part 2 program and an entity that has direct 
administrative control over the program.
    (4) Qualified service organizations. The restrictions on disclosure 
in the regulations in this part do not apply to communications between a 
part 2 program and a qualified service organization of information 
needed by the qualified service organization to provide services to the 
program.
    (5) Crimes on part 2 program premises or against part 2 program 
personnel. The restrictions on disclosure and use in the regulations in 
this part do not apply to communications from part 2 program personnel 
to law enforcement agencies or officials which:
    (i) Are directly related to a patient's commission of a crime on the 
premises of the part 2 program or against part 2 program personnel or to 
a threat to commit such a crime; and
    (ii) Are limited to the circumstances of the incident, including the 
patient

[[Page 14]]

status of the individual committing or threatening to commit the crime, 
that individual's name and address, and that individual's last known 
whereabouts.
    (6) Reports of suspected child abuse and neglect. The restrictions 
on disclosure and use in the regulations in this part do not apply to 
the reporting under state law of incidents of suspected child abuse and 
neglect to the appropriate state or local authorities. However, the 
restrictions continue to apply to the original substance use disorder 
patient records maintained by the part 2 program including their 
disclosure and use for civil or criminal proceedings which may arise out 
of the report of suspected child abuse and neglect.
    (d) Applicability to recipients of information-- (1) Restriction on 
use of information. The restriction on the use of any information 
subject to the regulations in this part to initiate or substantiate any 
criminal charges against a patient or to conduct any criminal 
investigation of a patient applies to any person who obtains that 
information from a part 2 program, regardless of the status of the 
person obtaining the information or whether the information was obtained 
in accordance with the regulations in this part. This restriction on use 
bars, among other things, the introduction of that information as 
evidence in a criminal proceeding and any other use of the information 
to investigate or prosecute a patient with respect to a suspected crime. 
Information obtained by undercover agents or informants (see Sec.  2.17) 
or through patient access (see Sec.  2.23) is subject to the restriction 
on use.
    (2) Restrictions on disclosures--(i) Third-party payers, 
administrative entities, and others. The restrictions on disclosure in 
the regulations in this part apply to:
    (A) Third-party payers with regard to records disclosed to them by 
part 2 programs or under Sec.  2.31(a)(4)(i)(A);
    (B) Entities having direct administrative control over part 2 
programs with regard to information that is subject to the regulations 
in this part communicated to them by the part 2 program under paragraph 
(c)(3) of this section; and
    (C) Individuals or entities who receive patient records directly 
from a part 2 program or other lawful holder of patient identifying 
information and who are notified of the prohibition on re-disclosure in 
accordance with Sec.  2.32.
    (ii) Notwithstanding paragraph (d)(2)(i)(C) of this section, a non-
part 2 treating provider may record information about a substance use 
disorder (SUD) and its treatment that identifies a patient. This is 
permitted and does not constitute a record that has been re-disclosed 
under part 2, provided that any SUD records received from a part 2 
program or other lawful holder are segregated or segmented. The act of 
recording information about a SUD and its treatment does not by itself 
render a medical record which is created by a non-part 2 treating 
provider subject to the restrictions of this part 2.
    (e) Explanation of applicability--(1) Coverage. These regulations 
cover any information (including information on referral and intake) 
about patients receiving diagnosis, treatment, or referral for treatment 
for a substance use disorder created by a part 2 program. Coverage 
includes, but is not limited to, those treatment or rehabilitation 
programs, employee assistance programs, programs within general 
hospitals, school-based programs, and private practitioners who hold 
themselves out as providing, and provide substance use disorder 
diagnosis, treatment, or referral for treatment. However, the 
regulations in this part would not apply, for example, to emergency room 
personnel who refer a patient to the intensive care unit for an apparent 
overdose, unless the primary function of such personnel is the provision 
of substance use disorder diagnosis, treatment, or referral for 
treatment and they are identified as providing such services or the 
emergency room has promoted itself to the community as a provider of 
such services.
    (2) Federal assistance to program required. If a patient's substance 
use disorder diagnosis, treatment, or referral for treatment is not 
provided by a part 2 program, that patient's record is not covered by 
the regulations in this part. Thus, it is possible for an individual 
patient to benefit from federal support

[[Page 15]]

and not be covered by the confidentiality regulations because the 
program in which the patient is enrolled is not federally assisted as 
defined in paragraph (b) of this section. For example, if a federal 
court placed an individual in a private for-profit program and made a 
payment to the program on behalf of that individual, that patient's 
record would not be covered by the regulations in this part unless the 
program itself received federal assistance as defined by paragraph (b) 
of this section.
    (3) Information to which restrictions are applicable. Whether a 
restriction applies to the use or disclosure of a record affects the 
type of records which may be disclosed. The restrictions on disclosure 
apply to any part 2-covered records which would identify a specified 
patient as having or having had a substance use disorder. The 
restriction on use of part 2 records to bring criminal charges against a 
patient for a crime applies to any records obtained by the part 2 
program for the purpose of diagnosis, treatment, or referral for 
treatment of patients with substance use disorders. (Restrictions on use 
and disclosure apply to recipients of part 2 records under paragraph (d) 
of this section.)
    (4) How type of diagnosis affects coverage. These regulations cover 
any record reflecting a diagnosis identifying a patient as having or 
having had a substance use disorder which is initially prepared by a 
part 2 provider in connection with the treatment or referral for 
treatment of a patient with a substance use disorder. A diagnosis 
prepared by a part 2 provider for the purpose of treatment or referral 
for treatment, but which is not so used, is covered by the regulations 
in this part. The following are not covered by the regulations in this 
part:
    (i) Diagnosis which is made solely for the purpose of providing 
evidence for use by law enforcement agencies or officials; or
    (ii) A diagnosis of drug overdose or alcohol intoxication which 
clearly shows that the individual involved does not have a substance use 
disorder (e.g., involuntary ingestion of alcohol or drugs or reaction to 
a prescribed dosage of one or more drugs).

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43036, July 15, 2020]



Sec.  2.13  Confidentiality restrictions and safeguards.

    (a) General. The patient records subject to the regulations in this 
part may be disclosed or used only as permitted by the regulations in 
this part and may not otherwise be disclosed or used in any civil, 
criminal, administrative, or legislative proceedings conducted by any 
federal, state, or local authority. Any disclosure made under the 
regulations in this part must be limited to that information which is 
necessary to carry out the purpose of the disclosure.
    (b) Unconditional compliance required. The restrictions on 
disclosure and use in the regulations in this part apply whether or not 
the part 2 program or other lawful holder of the patient identifying 
information believes that the person seeking the information already has 
it, has other means of obtaining it, is a law enforcement agency or 
official or other government official, has obtained a subpoena, or 
asserts any other justification for a disclosure or use which is not 
permitted by the regulations in this part.
    (c) Acknowledging the presence of patients: Responding to requests. 
(1) The presence of an identified patient in a health care facility or 
component of a health care facility which is publicly identified as a 
place where only substance use disorder diagnosis, treatment, or 
referral for treatment is provided may be acknowledged only if the 
patient's written consent is obtained in accordance with subpart C of 
this part or if an authorizing court order is entered in accordance with 
subpart E of this part. The regulations permit acknowledgement of the 
presence of an identified patient in a health care facility or part of a 
health care facility if the health care facility is not publicly 
identified as only a substance use disorder diagnosis, treatment, or 
referral for treatment facility, and if the acknowledgement does not 
reveal that the patient has a substance use disorder.
    (2) Any answer to a request for a disclosure of patient records 
which is not

[[Page 16]]

permissible under the regulations in this part must be made in a way 
that will not affirmatively reveal that an identified individual has 
been, or is being, diagnosed or treated for a substance use disorder. An 
inquiring party may be provided a copy of the regulations in this part 
and advised that they restrict the disclosure of substance use disorder 
patient records, but may not be told affirmatively that the regulations 
restrict the disclosure of the records of an identified patient.
    (d) List of disclosures. Upon request, patients who have consented 
to disclose their patient identifying information using a general 
designation pursuant to Sec.  2.31(a)(4)(ii)(B) must be provided a list 
of entities to which their information has been disclosed pursuant to 
the general designation.
    (1) Under this paragraph (d), patient requests:
    (i) Must be made in writing; and
    (ii) Are limited to disclosures made within the past two years;
    (2) Under this paragraph (d), the entity named on the consent form 
that discloses information pursuant to a patient's general designation 
(the entity that serves as an intermediary, as described in Sec.  
2.31(a)(4)(ii)(B)) must:
    (i) Respond in 30 or fewer days of receipt of the written request; 
and
    (ii) Provide, for each disclosure, the name(s) of the entity(-ies) 
to which the disclosure was made, the date of the disclosure, and a 
brief description of the patient identifying information disclosed.
    (3) The part 2 program is not responsible for compliance with this 
paragraph (d); the entity that serves as an intermediary, as described 
in Sec.  2.31(a)(4)(ii)(B), is responsible for compliance with the 
requirement.

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43037, July 15, 2020]



Sec.  2.14  Minor patients.

    (a) State law not requiring parental consent to treatment. If a 
minor patient acting alone has the legal capacity under the applicable 
state law to apply for and obtain substance use disorder treatment, any 
written consent for disclosure authorized under subpart C of this part 
may be given only by the minor patient. This restriction includes, but 
is not limited to, any disclosure of patient identifying information to 
the parent or guardian of a minor patient for the purpose of obtaining 
financial reimbursement. These regulations do not prohibit a part 2 
program from refusing to provide treatment until the minor patient 
consents to the disclosure necessary to obtain reimbursement, but 
refusal to provide treatment may be prohibited under a state or local 
law requiring the program to furnish the service irrespective of ability 
to pay.
    (b) State law requiring parental consent to treatment. (1) Where 
state law requires consent of a parent, guardian, or other individual 
for a minor to obtain treatment for a substance use disorder, any 
written consent for disclosure authorized under subpart C of this part 
must be given by both the minor and their parent, guardian, or other 
individual authorized under state law to act in the minor's behalf.
    (2) Where state law requires parental consent to treatment, the fact 
of a minor's application for treatment may be communicated to the 
minor's parent, guardian, or other individual authorized under state law 
to act in the minor's behalf only if:
    (i) The minor has given written consent to the disclosure in 
accordance with subpart C of this part; or
    (ii) The minor lacks the capacity to make a rational choice 
regarding such consent as judged by the part 2 program director under 
paragraph (c) of this section.
    (c) Minor applicant for services lacks capacity for rational choice. 
Facts relevant to reducing a substantial threat to the life or physical 
well-being of the minor applicant or any other individual may be 
disclosed to the parent, guardian, or other individual authorized under 
state law to act in the minor's behalf if the part 2 program director 
judges that:
    (1) A minor applicant for services lacks capacity because of extreme 
youthor mental or physical condition to make a rational decision on 
whether to consent to a disclosure under subpart C of this part to their 
parent, guardian, or other individual authorized under state law to act 
in the minor's behalf; and

[[Page 17]]

    (2) The minor applicant's situation poses a substantial threat to 
the life or physical well-being of the minor applicant or any other 
individual which may be reduced by communicating relevant facts to the 
minor's parent, guardian, or other individual authorized under state law 
to act in the minor's behalf.



Sec.  2.15  Incompetent and deceased patients.

    (a) Incompetent patients other than minors--(1) Adjudication of 
incompetence. In the case of a patient who has been adjudicated as 
lacking the capacity, for any reason other than insufficient age, to 
manage their own affairs, any consent which is required under the 
regulations in this part may be given by the guardian or other 
individual authorized under state law to act in the patient's behalf.
    (2) No adjudication of incompetency. In the case of a patient, other 
than a minor or one who has been adjudicated incompetent, that for any 
period suffers from a medical condition that prevents knowing or 
effective action on their own behalf, the part 2 program director may 
exercise the right of the patient to consent to a disclosure under 
subpart C of this part for the sole purpose of obtaining payment for 
services from a third-party payer.
    (b) Deceased patients--(1) Vital statistics. These regulations do 
not restrict the disclosure of patient identifying information relating 
to the cause of death of a patient under laws requiring the collection 
of death or other vital statistics or permitting inquiry into the cause 
of death.
    (2) Consent by personal representative. Any other disclosure of 
information identifying a deceased patient as having a substance use 
disorder is subject to the regulations in this part. If a written 
consent to the disclosure is required, that consent may be given by an 
executor, administrator, or other personal representative appointed 
under applicable state law. If there is no such applicable state law 
appointment, the consent may be given by the patient's spouse or, if 
none, by any responsible member of the patient's family.

[82 FR 6115, Jan. 18, 2017, as amended at 83 FR 251, Jan. 3, 2018]



Sec.  2.16  Security for records.

    (a) The part 2 program or other lawful holder of patient identifying 
information must have in place formal policies and procedures to 
reasonably protect against unauthorized uses and disclosures of patient 
identifying information and to protect against reasonably anticipated 
threats or hazards to the security of patient identifying information. 
These formal policies and procedures must address:
    (1) Paper records, including:
    (i) Transferring and removing such records;
    (ii) Destroying such records, including sanitizing the hard copy 
media associated with the paper printouts, to render the patient 
identifying information non-retrievable;
    (iii) Maintaining such records in a secure room, locked file 
cabinet, safe, or other similar container, or storage facility when not 
in use;
    (iv) Using and accessing workstations, secure rooms, locked file 
cabinets, safes, or other similar containers, and storage facilities 
that use or store such information; and
    (v) Rendering patient identifying information non-identifiable in a 
manner that creates a very low risk of re-identification (e.g., removing 
direct identifiers).
    (2) Electronic records, including:
    (i) Creating, receiving, maintaining, and transmitting such records;
    (ii) Destroying such records, including sanitizing the electronic 
media on which such records are stored, to render the patient 
identifying information non-retrievable;
    (iii) Using and accessing electronic records or other electronic 
media containing patient identifying information; and
    (iv) Rendering the patient identifying information non-identifiable 
in a manner that creates a very low risk of re-identification (e.g., 
removing direct identifiers).
    (b) [Reserved]

[[Page 18]]



Sec.  2.17  Undercover agents and informants.

    (a) Restrictions on placement. Except as specifically authorized by 
a court order granted under Sec.  2.67, no part 2 program may knowingly 
employ, or enroll as a patient, any undercover agent or informant.
    (b) Restriction on use of information. No information obtained by an 
undercover agent or informant, whether or not that undercover agent or 
informant is placed in a part 2 program pursuant to an authorizing court 
order, may be used to criminally investigate or prosecute any patient.



Sec.  2.18  Restrictions on the use of identification cards.

    No person may require any patient to carry in their immediate 
possession while away from the part 2 program premises any card or other 
object which would identify the patient as having a substance use 
disorder. This section does not prohibit a person from requiring 
patients to use or carry cards or other identification objects on the 
premises of a part 2 program.



Sec.  2.19  Disposition of records by discontinued programs.

    (a) General. If a part 2 program discontinues operations or is taken 
over or acquired by another program, it must remove patient identifying 
information from its records or destroy its records, including 
sanitizing any associated hard copy or electronic media, to render the 
patient identifying information non-retrievable in a manner consistent 
with the policies and procedures established under Sec.  2.16, unless:
    (1) The patient who is the subject of the records gives written 
consent (meeting the requirements of Sec.  2.31) to a transfer of the 
records to the acquiring program or to any other program designated in 
the consent (the manner of obtaining this consent must minimize the 
likelihood of a disclosure of patient identifying information to a third 
party); or
    (2) There is a legal requirement that the records be kept for a 
period specified by law which does not expire until after the 
discontinuation or acquisition of the part 2 program.
    (b) Special procedure where retention period required by law. If 
paragraph (a)(2) of this section applies:
    (1) Records, which are paper, must be:
    (i) Sealed in envelopes or other containers labeled as follows: 
``Records of [insert name of program] required to be maintained under 
[insert citation to statute, regulation, court order or other legal 
authority requiring that records be kept] until a date not later than 
[insert appropriate date]'';
    (A) All hard copy media from which the paper records were produced, 
such as printer and facsimile ribbons, drums, etc., must be sanitized to 
render the data non-retrievable; and
    (B) [Reserved]
    (ii) Held under the restrictions of the regulations in this part by 
a responsible person who must, as soon as practicable after the end of 
the required retention period specified on the label, destroy the 
records and sanitize any associated hard copy media to render the 
patient identifying information non-retrievable in a manner consistent 
with the discontinued program's or acquiring program's policies and 
procedures established under Sec.  2.16.
    (2) Records, which are electronic, must be:
    (i) Transferred to a portable electronic device with implemented 
encryption to encrypt the data at rest so that there is a low 
probability of assigning meaning without the use of a confidential 
process or key and implemented access controls for the confidential 
process or key; or
    (ii) Transferred, along with a backup copy, to separate electronic 
media, so that both the records and the backup copy have implemented 
encryption to encrypt the data at rest so that there is a low 
probability of assigning meaning without the use of a confidential 
process or key and implemented access controls for the confidential 
process or key; and
    (iii) Within one year of the discontinuation or acquisition of the 
program, all electronic media on which the patient records or patient 
identifying information resided prior to being transferred to the device 
specified in (i) above or the original and backup electronic media 
specified in

[[Page 19]]

(ii) above, including email and other electronic communications, must be 
sanitized to render the patient identifying information non-retrievable 
in a manner consistent with the discontinued program's or acquiring 
program's policies and procedures established under Sec.  2.16; and
    (iv) The portable electronic device or the original and backup 
electronic media must be:
    (A) Sealed in a container along with any equipment needed to read or 
access the information, and labeled as follows: ``Records of [insert 
name of program] required to be maintained under [insert citation to 
statute, regulation, court order or other legal authority requiring that 
records be kept] until a date not later than [insert appropriate 
date];'' and
    (B) Held under the restrictions of the regulations in this part by a 
responsible person who must store the container in a manner that will 
protect the information (e.g., climate controlled environment); and
    (v) The responsible person must be included on the access control 
list and be provided a means for decrypting the data. The responsible 
person must store the decryption tools on a device or at a location 
separate from the data they are used to encrypt or decrypt; and
    (vi) As soon as practicable after the end of the required retention 
period specified on the label, the portable electronic device or the 
original and backup electronic media must be sanitized to render the 
patient identifying information non-retrievable consistent with the 
policies established under Sec.  2.16.



Sec.  2.20  Relationship to state laws.

    The statute authorizing the regulations in this part (42 U.S.C. 
290dd-2) does not preempt the field of law which they cover to the 
exclusion of all state laws in that field. If a disclosure permitted 
under the regulations in this part is prohibited under state law, 
neither the regulations in this part nor the authorizing statute may be 
construed to authorize any violation of that state law. However, no 
state law may either authorize or compel any disclosure prohibited by 
the regulations in this part.



Sec.  2.21  Relationship to federal statutes protecting research subjects 
against compulsory disclosure of their identity.

    (a) Research privilege description. There may be concurrent coverage 
of patient identifying information by the regulations in this part and 
by administrative action taken under section 502(c) of the Controlled 
Substances Act (21 U.S.C. 872(c) and the implementing regulations at 21 
CFR part 1316); or section 301(d) of the Public Health Service Act (42 
U.S.C. 241(d) and the implementing regulations at 42 CFR part 2a). These 
research privilege statutes confer on the Secretary of Health and Human 
Services and on the Attorney General, respectively, the power to 
authorize researchers conducting certain types of research to withhold 
from all persons not connected with the research the names and other 
identifying information concerning individuals who are the subjects of 
the research.
    (b) Effect of concurrent coverage. These regulations restrict the 
disclosure and use of information about patients, while administrative 
action taken under the research privilege statutes and implementing 
regulations protects a person engaged in applicable research from being 
compelled to disclose any identifying characteristics of the individuals 
who are the subjects of that research. The issuance under subpart E of 
this part of a court order authorizing a disclosure of information about 
a patient does not affect an exercise of authority under these research 
privilege statutes.



Sec.  2.22  Notice to patients of federal confidentiality requirements.

    (a) Notice required. At the time of admission to a part 2 program 
or, in the case that a patient does not have capacity upon admission to 
understand his or her medical status, as soon thereafter as the patient 
attains such capacity, each part 2 program shall:
    (1) Communicate to the patient that federal law and regulations 
protect the confidentiality of substance use disorder patient records; 
and

[[Page 20]]

    (2) Give to the patient a summary in writing of the federal law and 
regulations.
    (b) Required elements of written summary. The written summary of the 
federal law and regulations must include:
    (1) A general description of the limited circumstances under which a 
part 2 program may acknowledge that an individual is present or disclose 
outside the part 2 program information identifying a patient as having 
or having had a substance use disorder;
    (2) A statement that violation of the federal law and regulations by 
a part 2 program is a crime and that suspected violations may be 
reported to appropriate authorities consistent with Sec.  2.4, along 
with contact information;
    (3) A statement that information related to a patient's commission 
of a crime on the premises of the part 2 program or against personnel of 
the part 2 program is not protected;
    (4) A statement that reports of suspected child abuse and neglect 
made under state law to appropriate state or local authorities are not 
protected; and
    (5) A citation to the federal law and regulations.
    (c) Program options. The part 2 program must devise a notice to 
comply with the requirement to provide the patient with a summary in 
writing of the federal law and regulations. In this written summary, the 
part 2 program also may include information concerning state law and any 
of the part 2 program's policies that are not inconsistent with state 
and federal law on the subject of confidentiality of substance use 
disorder patient records.



Sec.  2.23  Patient access and restrictions on use.

    (a) Patient access not prohibited. These regulations do not prohibit 
a part 2 program from giving a patient access to their own records, 
including the opportunity to inspect and copy any records that the part 
2 program maintains about the patient. The part 2 program is not 
required to obtain a patient's written consent or other authorization 
under the regulations in this part in order to provide such access to 
the patient.
    (b) Restriction on use of information. Information obtained by 
patient access to his or her patient record is subject to the 
restriction on use of this information to initiate or substantiate any 
criminal charges against the patient or to conduct any criminal 
investigation of the patient as provided for under Sec.  2.12(d)(1).



               Subpart C_Disclosures With Patient Consent



Sec.  2.31  Consent requirements.

    (a) Required elements for written consent. A written consent to a 
disclosure under the regulations in this part may be paper or electronic 
and must include:
    (1) The name of the patient.
    (2) The specific name(s) or general designation(s) of the part 2 
program(s), entity(ies), or individual(s) permitted to make the 
disclosure.
    (3) How much and what kind of information is to be disclosed, 
including an explicit description of the substance use disorder 
information that may be disclosed.
    (4)(i) General requirement for designating recipients. The name(s) 
of the individual(s) or the name(s) of the entity(-ies) to which a 
disclosure is to be made.
    (ii) Special instructions for entities that facilitate the exchange 
of health information and research institutions. Notwithstanding 
paragraph (a)(4)(i) of this section, if the recipient entity facilitates 
the exchange of health information or is a research institution, a 
written consent must include the name(s) of the entity(-ies) and
    (A) The name(s) of individual or entity participant(s); or
    (B) A general designation of an individual or entity participant(s) 
or class of participants that must be limited to a participant(s) who 
has a treating provider relationship with the patient whose information 
is being disclosed. When using a general designation, a statement must 
be included on the consent form that the patient (or other individual 
authorized to sign in lieu of the patient), confirms their understanding 
that, upon their request and consistent with this part, they must be 
provided a list of entities to which their information has been 
disclosed

[[Page 21]]

pursuant to the general designation (see Sec.  2.13(d)).
    (5) The purpose of the disclosure. In accordance with Sec.  2.13(a), 
the disclosure must be limited to that information which is necessary to 
carry out the stated purpose.
    (6) A statement that the consent is subject to revocation at any 
time except to the extent that the part 2 program or other lawful holder 
of patient identifying information that is permitted to make the 
disclosure has already acted in reliance on it. Acting in reliance 
includes the provision of treatment services in reliance on a valid 
consent to disclose information to a third-party payer
    (7) The date, event, or condition upon which the consent will expire 
if not revoked before. This date, event, or condition must ensure that 
the consent will last no longer than reasonably necessary to serve the 
purpose for which it is provided.
    (8) The signature of the patient and, when required for a patient 
who is a minor, the signature of an individual authorized to give 
consent under Sec.  2.14; or, when required for a patient who is 
incompetent or deceased, the signature of an individual authorized to 
sign under Sec.  2.15. Electronic signatures are permitted to the extent 
that they are not prohibited by any applicable law.
    (9) The date on which the consent is signed.
    (b) Expired, deficient, or false consent. A disclosure may not be 
made on the basis of a consent which:
    (1) Has expired;
    (2) On its face substantially fails to conform to any of the 
requirements set forth in paragraph (a) of this section;
    (3) Is known to have been revoked; or
    (4) Is known, or through reasonable diligence could be known, by the 
individual or entity holding the records to be materially false.

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43037, July 15, 2020]



Sec.  2.32  Prohibition on re-disclosure.

    (a) Notice to accompany disclosure. Each disclosure made with the 
patient's written consent must be accompanied by one of the following 
written statements:
    (1) This record which has been disclosed to you is protected by 
federal confidentiality rules (42 CFR part 2). The federal rules 
prohibit you from making any further disclosure of this record unless 
further disclosure is expressly permitted by the written consent of the 
individual whose information is being disclosed in this record or, is 
otherwise permitted by 42 CFR part 2. A general authorization for the 
release of medical or other information is NOT sufficient for this 
purpose (see Sec.  2.31). The federal rules restrict any use of the 
information to investigate or prosecute with regard to a crime any 
patient with a substance use disorder, except as provided at Sec. Sec.  
2.12(c)(5) and 2.65; or
    (2) 42 CFR part 2 prohibits unauthorized disclosure of these 
records.
    (b) [Reserved]

[83 FR 251, Jan. 3, 2018, as amended at 85 FR 43037, July 15, 2020]



Sec.  2.33  Disclosures permitted with written consent.

    (a) If a patient consents to a disclosure of their records under 
Sec.  [thinsp]2.31, a part 2 program may disclose those records in 
accordance with that consent to any person or category of persons 
identified or generally designated in the consent, except that 
disclosures to central registries and in connection with criminal 
justice referrals must meet the requirements of Sec. Sec.  [thinsp]2.34 
and 2.35, respectively.
    (b) If a patient consents to a disclosure of their records under 
Sec.  2.31 for payment or health care operations activities, a lawful 
holder who receives such records under the terms of the written consent 
may further disclose those records as may be necessary for its 
contractors, subcontractors, or legal representatives to carry out 
payment and/or health care operations on behalf of such lawful holder. 
In accordance with Sec.  2.13(a), disclosures under this section must be 
limited to that information which is necessary to carry out the stated 
purpose of the disclosure. Examples of permissible payment or health 
care operations activities under this section include:
    (1) Billing, claims management, collections activities, obtaining 
payment under a contract for reinsurance,

[[Page 22]]

claims filing, and/or related health care data processing;
    (2) Clinical professional support services (e.g., quality assessment 
and improvement initiatives; utilization review and management 
services);
    (3) Patient safety activities;
    (4) Activities pertaining to:
    (i) The training of student trainees and health care professionals;
    (ii) The assessment of practitioner competencies;
    (iii) The assessment of provider or health plan performance; and/or
    (iv) Training of non-health care professionals;
    (5) Accreditation, certification, licensing, or credentialing 
activities;
    (6) Underwriting, enrollment, premium rating, and other activities 
related to the creation, renewal, or replacement of a contract of health 
insurance or health benefits, and/or ceding, securing, or placing a 
contract for reinsurance of risk relating to claims for health care;
    (7) Third-party liability coverage;
    (8) Activities related to addressing fraud, waste and/or abuse;
    (9) Conducting or arranging for medical review, legal services, and/
or auditing functions;
    (10) Business planning and development, such as conducting cost 
management and planning-related analyses related to managing and 
operating, including formulary development and administration, 
development or improvement of methods of payment or coverage policies;
    (11) Business management and general administrative activities, 
including management activities relating to implementation of and 
compliance with the requirements of this or other statutes or 
regulations;
    (12) Customer services, including the provision of data analyses for 
policy holders, plan sponsors, or other customers;
    (13) Resolution of internal grievances;
    (14) The sale, transfer, merger, consolidation, or dissolution of an 
organization;
    (15) Determinations of eligibility or coverage (e.g., coordination 
of benefit services or the determination of cost sharing amounts), and 
adjudication or subrogation of health benefit claims;
    (16) Risk adjusting amounts due based on enrollee health status and 
demographic characteristics;
    (17) Review of health care services with respect to medical 
necessity, coverage under a health plan, appropriateness of care, or 
justification of charges;
    (18) Care coordination and/or case management services in support of 
payment or health care operations; and/or
    (19) Other payment/health care operations activities not expressly 
prohibited in this provision.
    (c) Lawful holders who wish to disclose patient identifying 
information pursuant to paragraph (b) of this section must have in place 
a written contract or comparable legal instrument with the contractor or 
voluntary legal representative, which provides that the contractor, 
subcontractor, or voluntary legal representative is fully bound by the 
provisions of part 2 upon receipt of the patient identifying 
information. In making any such disclosures, the lawful holder must 
furnish such recipients with the notice required under Sec.  
[thinsp]2.32; require such recipients to implement appropriate 
safeguards to prevent unauthorized uses and disclosures; and require 
such recipients to report any unauthorized uses, disclosures, or 
breaches of patient identifying information to the lawful holder. The 
lawful holder may only disclose information to the contractor or 
subcontractor or voluntary legal representative that is necessary for 
the contractor or subcontractor or voluntary legal representative to 
perform its duties under the contract or comparable legal instrument. 
Contracts may not permit a contractor or subcontractor or voluntary 
legal representative to re-disclose information to a third party unless 
that third party is a contract agent of the contractor or subcontractor, 
helping them provide services described in the contract, and only as 
long as the agent only further discloses the information back to the 
contractor or lawful holder from which the information originated.

[83 FR 251, Jan. 3, 2018, as amended at 85 FR 43037, July 15, 2020]

[[Page 23]]



Sec.  2.34  Disclosures to prevent multiple enrollments.

    (a) Restrictions on disclosure. A part 2 program, as defined in 
Sec.  2.11, may disclose patient records to a central registry or to any 
withdrawal management or maintenance treatment program not more than 200 
miles away for the purpose of preventing the multiple enrollment of a 
patient only if:
    (1) The disclosure is made when:
    (i) The patient is accepted for treatment;
    (ii) The type or dosage of the drug is changed; or
    (iii) The treatment is interrupted, resumed or terminated.
    (2) The disclosure is limited to:
    (i) Patient identifying information;
    (ii) Type and dosage of the drug; and
    (iii) Relevant dates.
    (3) The disclosure is made with the patient's written consent 
meeting the requirements of Sec.  2.31, except that:
    (i) The consent must list the name and address of each central 
registry and each known withdrawal management or maintenance treatment 
program to which a disclosure will be made; and
    (ii) The consent may authorize a disclosure to any withdrawal 
management or maintenance treatment program established within 200 miles 
of the program, but does not need to individually name all programs.
    (b) Use of information limited to prevention of multiple 
enrollments. A central registry and any withdrawal management or 
maintenance treatment program to which information is disclosed to 
prevent multiple enrollments may not re-disclose or use patient 
identifying information for any purpose other than the prevention of 
multiple enrollments or to ensure appropriate coordinated care with a 
treating provider that is not a part 2 program unless authorized by a 
court order under subpart E of this part.
    (c) Permitted disclosure by a central registry to prevent a multiple 
enrollment. When a member program asks a central registry if an 
identified patient is enrolled in another member program and the 
registry determines that the patient is so enrolled, the registry may 
disclose:
    (1) The name, address, and telephone number of the member program(s) 
in which the patient is already enrolled to the inquiring member 
program; and
    (2) The name, address, and telephone number of the inquiring member 
program to the member program(s) in which the patient is already 
enrolled. The member programs may communicate as necessary to verify 
that no error has been made and to prevent or eliminate any multiple 
enrollments.
    (d) Permitted disclosure by a central registry to a non-member 
treating provider, to prevent a multiple enrollment. When, for the 
purpose of preventing multiple program enrollments or duplicative 
prescriptions, or to inform prescriber decision making regarding 
prescribing of opioid medication(s) or other prescribed substances, a 
provider with a treating provider relationship that is not a member 
program asks a central registry if an identified patient is enrolled in 
a member program, the registry may disclose:
    (1) The name, address, and telephone number of the member program(s) 
in which the patient is enrolled;
    (2) Type and dosage of any medication for substance use disorder 
being administered or prescribed to the patient by the member 
program(s); and
    (3) Relevant dates of any such administration or prescription. The 
central registry and non-member program treating prescriber may 
communicate as necessary to verify that no error has been made and to 
prevent or eliminate any multiple enrollments or improper prescribing.
    (e) Permitted disclosure by a withdrawal management or maintenance 
treatment program to prevent a multiple enrollment. A withdrawal 
management or maintenance treatment program which has received a 
disclosure under this section and has determined that the patient is 
already enrolled may communicate as necessary with the program making 
the disclosure to verify that no error has been made and to prevent or 
eliminate any multiple enrollments.

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43038, July 15, 2020]

[[Page 24]]



Sec.  2.35  Disclosures to elements of the criminal justice system 
which have referred patients.

    (a) A part 2 program may disclose information about a patient to 
those individuals within the criminal justice system who have made 
participation in the part 2 program a condition of the disposition of 
any criminal proceedings against the patient or of the patient's parole 
or other release from custody if:
    (1) The disclosure is made only to those individuals within the 
criminal justice system who have a need for the information in 
connection with their duty to monitor the patient's progress (e.g., a 
prosecuting attorney who is withholding charges against the patient, a 
court granting pretrial or post-trial release, probation or parole 
officers responsible for supervision of the patient); and
    (2) The patient has signed a written consent meeting the 
requirements of Sec.  [thinsp]2.31 (except paragraph (a)(6) of this 
section which is inconsistent with the revocation provisions of 
paragraph (c) of this section) and the requirements of paragraphs (b) 
and (c) of this section.
    (b) Duration of consent. The written consent must state the period 
during which it remains in effect. This period must be reasonable, 
taking into account:
    (1) The anticipated length of the treatment;
    (2) The type of criminal proceeding involved, the need for the 
information in connection with the final disposition of that proceeding, 
and when the final disposition will occur; and
    (3) Such other factors as the part 2 program, the patient, and the 
individual(s) within the criminal justice system who will receive the 
disclosure consider pertinent.
    (c) Revocation of consent. The written consent must state that it is 
revocable upon the passage of a specified amount of time or the 
occurrence of a specified, ascertainable event. The time or occurrence 
upon which consent becomes revocable may be no later than the final 
disposition of the conditional release or other action in connection 
with which consent was given.
    (d) Restrictions on re-disclosure and use. An individual within the 
criminal justice system who receives patient information under this 
section may re-disclose and use it only to carry out that individual's 
official duties with regard to the patient's conditional release or 
other action in connection with which the consent was given.

[82 FR 6115, Jan. 18, 2017, as amended at 83 FR 251, Jan. 3, 2018]



Sec.  2.36  Disclosures to prescription drug monitoring programs.

    A part 2 program or other lawful holder is permitted to report any 
SUD medication prescribed or dispensed by the part 2 program to the 
applicable state prescription drug monitoring program if required by 
applicable state law. A part 2 program or other lawful holder must 
obtain patient consent to a disclosure of records to a prescription drug 
monitoring program under Sec.  2.31 prior to reporting of such 
information.

[85 FR 43038, July 15, 2020]



              Subpart D_Disclosures Without Patient Consent



Sec.  2.51  Medical emergencies.

    (a) General rule. Under the procedures required by paragraph (c) of 
this section, patient identifying information may be disclosed to 
medical personnel to the extent necessary to:
    (1) Meet a bona fide medical emergency in which the patient's prior 
written consent cannot be obtained; or
    (2) Meet a bona fide medical emergency in which a part 2 program is 
closed and unable to provide services or obtain the prior written 
consent of the patient, during a temporary state of emergency declared 
by a state or federal authority as the result of a natural or major 
disaster, until such time that the part 2 program resumes operations.
    (b) Special rule. Patient identifying information may be disclosed 
to medical personnel of the Food and Drug Administration (FDA) who 
assert a reason to believe that the health of any individual may be 
threatened by an error in the manufacture, labeling, or sale of a 
product under FDA jurisdiction, and that the information will be used 
for the exclusive purpose of notifying patients or their physicians of 
potential dangers.

[[Page 25]]

    (c) Procedures. Immediately following disclosure, the part 2 program 
shall document, in writing, the disclosure in the patient's records, 
including:
    (1) The name of the medical personnel to whom disclosure was made 
and their affiliation with any health care facility;
    (2) The name of the individual making the disclosure;
    (3) The date and time of the disclosure; and
    (4) The nature of the emergency (or error, if the report was to 
FDA).

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43038, July 15, 2020]



Sec.  2.52  Research.

    (a) Notwithstanding other provisions of this part, including 
paragraph (b)(2) of this section, patient identifying information may be 
disclosed for the purposes of the recipient conducting scientific 
research if:
    (1) The individual designated as director or managing director, or 
individual otherwise vested with authority to act as chief executive 
officer or their designee, of a part 2 program or other lawful holder of 
part 2 data, makes a determination that the recipient of the patient 
identifying information is:
    (i) A HIPAA-covered entity or business associate that has obtained 
and documented authorization from the patient, or a waiver or alteration 
of authorization, consistent with the HIPAA Privacy Rule at 45 CFR 
164.508 or 164.512(i), as applicable;
    (ii) Subject to the HHS regulations regarding the protection of 
human subjects (45 CFR part 46), and provides documentation either that 
the researcher is in compliance with the requirements of 45 CFR part 46, 
including the requirements related to informed consent or a waiver of 
consent (45 CFR 46.111 and 46.116) or that the research qualifies for 
exemption under the HHS regulations (45 CFR 46.104) or any successor 
regulations;
    (iii) Subject to the FDA regulations regarding the protection of 
human subjects (21 CFR parts 50 and 56) and provides documentation that 
the research is in compliance with the requirements of the FDA 
regulations, including the requirements related to informed consent or 
an exception to, or waiver of, consent (21 CFR part 50) and any 
successor regulations; or
    (iv) Any combination of a HIPAA covered entity or business 
associate, and/or subject to the HHS regulations regarding the 
protection of human subjects, and/or subject to the FDA regulations 
regarding the protection of human subjects; and has met the requirements 
of paragraph (a)(1)(i), (ii) (iii), and/or (iv) of this section, as 
applicable.
    (2) The part 2 program or other lawful holder of part 2 data is a 
HIPAA covered entity or business associate, and the disclosure is made 
in accordance with the HIPAA Privacy Rule requirements at 45 CFR 
164.512(i).
    (3) If neither paragraph (a)(1) or (2) of this section apply to the 
receiving or disclosing party, this section does not apply.
    (b) Any individual or entity conducting scientific research using 
patient identifying information obtained under paragraph (a) of this 
section:
    (1) Is fully bound by the regulations in this part and, if 
necessary, will resist in judicial proceedings any efforts to obtain 
access to patient records except as permitted by the regulations in this 
part.
    (2) Must not re-disclose patient identifying information except back 
to the individual or entity from whom that patient identifying 
information was obtained or as permitted under paragraph (c) of this 
section.
    (3) May include part 2 data in research reports only in aggregate 
form in which patient identifying information has been rendered non-
identifiable such that the information cannot be re-identified and serve 
as an unauthorized means to identify a patient, directly or indirectly, 
as having or having had a substance use disorder.
    (4) Must maintain and destroy patient identifying information in 
accordance with the security policies and procedures established under 
Sec.  2.16.
    (5) Must retain records in compliance with applicable federal, 
state, and local record retention laws.

[[Page 26]]

    (c) Data linkages--(1) Researchers. Any individual or entity 
conducting scientific research using patient identifying information 
obtained under paragraph (a) of this section that requests linkages to 
data sets from a data repository(-ies) holding patient identifying 
information must:
    (i) Have the request reviewed and approved by an Institutional 
Review Board (IRB) registered with the Department of Health and Human 
Services, Office for Human Research Protections in accordance with 45 
CFR part 46 to ensure that patient privacy is considered and the need 
for identifiable data is justified. Upon request, the researcher may be 
required to provide evidence of the IRB approval of the research project 
that contains the data linkage component.
    (ii) Ensure that patient identifying information obtained under 
paragraph (a) of this section is not provided to law enforcement 
agencies or officials.
    (2) Data repositories. For purposes of this section, a data 
repository is fully bound by the provisions of part 2 upon receipt of 
the patient identifying data and must:
    (i) After providing the researcher with the linked data, destroy or 
delete the linked data from its records, including sanitizing any 
associated hard copy or electronic media, to render the patient 
identifying information non-retrievable in a manner consistent with the 
policies and procedures established under Sec.  2.16 Security for 
records.
    (ii) Ensure that patient identifying information obtained under 
paragraph (a) of this section is not provided to law enforcement 
agencies or officials.
    (2) Except as provided in paragraph (c) of this section, a 
researcher may not redisclose patient identifying information for data 
linkages purposes.

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43038, July 15, 2020]



Sec.  2.53  Audit and evaluation.

    (a) Records not copied or removed. If patient records are not 
downloaded, copied or removed from the premises of a part 2 program or 
other lawful holder, or forwarded electronically to another electronic 
system or device, patient identifying information, as defined in Sec.  
2.11, may be disclosed in the course of a review of records on the 
premises of a part 2 program or other lawful holder to any individual or 
entity who agrees in writing to comply with the limitations on re-
disclosure and use in paragraph (f) of this section and who:
    (1) Performs the audit or evaluation on behalf of:
    (i) Any federal, state, or local governmental agency that provides 
financial assistance to a part 2 program or other lawful holder, or is 
authorized by law to regulate the activities of the part 2 program or 
other lawful holder;
    (ii) Any individual or entity which provides financial assistance to 
the part 2 program or other lawful holder, which is a third-party payer 
covering patients in the part 2 program, or which is a quality 
improvement organization performing a QIO review, or the contractors, 
subcontractors, or legal representatives of such individual, entity, or 
quality improvement organization.
    (iii) An entity with direct administrative control over the part 2 
program or lawful holder.
    (2) Is determined by the part 2 program or other lawful holder to be 
qualified to conduct an audit or evaluation of the part 2 program or 
other lawful holder.
    (b) Copying, removing, downloading, or forwarding patient records. 
Records containing patient identifying information, as defined in Sec.  
2.11, may be copied or removed from the premises of a part 2 program or 
other lawful holder or downloaded or forwarded to another electronic 
system or device from the part 2 program's or other lawful holder's 
electronic records by any individual or entity who:
    (1) Agrees in writing to:
    (i) Maintain and destroy the patient identifying information in a 
manner consistent with the policies and procedures established under 
Sec.  2.16;
    (ii) Retain records in compliance with applicable federal, state, 
and local record retention laws; and
    (iii) Comply with the limitations on disclosure and use in paragraph 
(f) of this section; and
    (2) Performs the audit or evaluation on behalf of:

[[Page 27]]

    (i) Any federal, state, or local governmental agency that provides 
financial assistance to the part 2 program or other lawful holder, or is 
authorized by law to regulate the activities of the part 2 program or 
other lawful holder; or
    (ii) Any individual or entity which provides financial assistance to 
the part 2 program or other lawful holder, which is a third-party payer 
covering patients in the part 2 program, or which is a quality 
improvement organization performing a QIO review, or the contractors, 
subcontractors, or legal representatives of such individual, entity, or 
quality improvement organization.
    (iii) An entity with direct administrative control over the part 2 
program or lawful holder.
    (c) Activities included. Audits and evaluations under this section 
may include, but are not limited to:
    (1) Activities undertaken by a federal, state, or local governmental 
agency, or a third-party payer entity, in order to:
    (i) Identify actions the agency or third-party payer entity can 
make, such as changes to its policies or procedures, to improve care and 
outcomes for patients with SUDs who are treated by part 2 programs;
    (ii) Ensure that resources are managed effectively to care for 
patients; or
    (iii) Determine the need for adjustments to payment policies to 
enhance care or coverage for patients with SUD.
    (2) Reviews of appropriateness of medical care, medical necessity, 
and utilization of services.
    (d) Quality assurance entities included. Entities conducting audits 
or evaluations in accordance with paragraphs (a) and (b) of this section 
may include accreditation or similar types of organizations focused on 
quality assurance.
    (e) Medicare, Medicaid, Children's Health Insurance Program (CHIP), 
or related audit or evaluation. (1) Patient identifying information, as 
defined in Sec.  2.11, may be disclosed under paragraph (e) of this 
section to any individual or entity for the purpose of conducting a 
Medicare, Medicaid, or CHIP audit or evaluation, including an audit or 
evaluation necessary to meet the requirements for a Centers for Medicare 
& Medicaid Services (CMS)-regulated accountable care organization (CMS-
regulated ACO) or similar CMS-regulated organization (including a CMS-
regulated Qualified Entity (QE)), if the individual or entity agrees in 
writing to comply with the following:
    (i) Maintain and destroy the patient identifying information in a 
manner consistent with the policies and procedures established under 
Sec.  2.16;
    (ii) Retain records in compliance with applicable federal, state, 
and local record retention laws; and
    (iii) Comply with the limitations on disclosure and use in paragraph 
(f) of this section.
    (2) A Medicare, Medicaid, or CHIP audit or evaluation under this 
section includes a civil or administrative investigation of a part 2 
program by any federal, state, or local government agency with oversight 
responsibilities for Medicare, Medicaid, or CHIP and includes 
administrative enforcement, against the part 2 program by the government 
agency, of any remedy authorized by law to be imposed as a result of the 
findings of the investigation.
    (3) An audit or evaluation necessary to meet the requirements for a 
CMS-regulated ACO or similar CMS-regulated organization (including a 
CMS-regulated QE) must be conducted in accordance with the following:
    (i) A CMS-regulated ACO or similar CMS-regulated organization 
(including a CMS-regulated QE) must:
    (A) Have in place administrative and/or clinical systems; and
    (B) Have in place a leadership and management structure, including a 
governing body and chief executive officer with responsibility for 
oversight of the organization's management and for ensuring compliance 
with and adherence to the terms and conditions of the Participation 
Agreement or similar documentation with CMS; and
    (ii) A CMS-regulated ACO or similar CMS-regulated organization 
(including a CMS-regulated QE) must have a signed Participation 
Agreement or similar documentation with CMS, which provides that the 
CMS-regulated ACO or similar CMS-regulated organization (including a 
CMS-regulated QE):
    (A) Is subject to periodic evaluations by CMS or its agents, or is 
required by

[[Page 28]]

CMS to evaluate participants in the CMS-regulated ACO or similar CMS-
regulated organization (including a CMS-regulated QE) relative to CMS-
defined or approved quality and/or cost measures;
    (B) Must designate an executive who has the authority to legally 
bind the organization to ensure compliance with 42 U.S.C. 290dd-2 and 
this part and the terms and conditions of the Participation Agreement in 
order to receive patient identifying information from CMS or its agents;
    (C) Agrees to comply with all applicable provisions of 42 U.S.C. 
290dd-2 and this part;
    (D) Must ensure that any audit or evaluation involving patient 
identifying information occurs in a confidential and controlled setting 
approved by the designated executive;
    (E) Must ensure that any communications or reports or other 
documents resulting from an audit or evaluation under this section do 
not allow for the direct or indirect identification (e.g., through the 
use of codes) of a patient as having or having had a substance use 
disorder; and
    (F) Must establish policies and procedures to protect the 
confidentiality of the patient identifying information consistent with 
this part, the terms and conditions of the Participation Agreement, and 
the requirements set forth in paragraph (e)(1) of this section.
    (4) Program, as defined in Sec.  2.11, includes an employee of, or 
provider of medical services under the program when the employee or 
provider is the subject of a civil investigation or administrative 
remedy, as those terms are used in paragraph (e)(2) of this section.
    (5) If a disclosure to an individual or entity is authorized under 
this section for a Medicare, Medicaid, or CHIP audit or evaluation, 
including a civil investigation or administrative remedy, as those terms 
are used in paragraph (e)(2) of this section, the individual or entity 
may further disclose the patient identifying information that is 
received for such purposes to its contractor(s), subcontractor(s), or 
legal representative(s), to carry out the audit or evaluation, and a 
quality improvement organization which obtains such information under 
paragraph (a) or (b) of this section may disclose the information to 
that individual or entity (or, to such individual's or entity's 
contractors, subcontractors, or legal representatives, but only for the 
purposes of this section).
    (6) The provisions of this paragraph do not authorize the part 2 
program, the federal, state, or local government agency, or any other 
individual or entity to disclose or use patient identifying information 
obtained during the audit or evaluation for any purposes other than 
those necessary to complete the audit or evaluation as specified in 
paragraph (e) of this section.
    (f) Limitations on disclosure and use. Except as provided in 
paragraph (e) of this section, patient identifying information disclosed 
under this section may be disclosed only back to the part 2 program or 
other lawful holder from which it was obtained and may be used only to 
carry out an audit or evaluation purpose or to investigate or prosecute 
criminal or other activities, as authorized by a court order entered 
under Sec.  [thinsp]2.66.
    (g) Audits and evaluations mandated by statute or regulation. 
Patient identifying information may be disclosed to federal, state, or 
local government agencies, and the contractors, subcontractors, and 
legal representatives of such agencies, in the course of conducting 
audits or evaluations mandated by statute or regulation, if those audits 
or evaluations cannot be carried out using deidentified information.

[82 FR 6115, Jan. 18, 2017, as amended at 83 FR 252, Jan. 3, 2018; 85 FR 
43039, July 15, 2020]



          Subpart E_Court Orders Authorizing Disclosure and Use



Sec.  2.61  Legal effect of order.

    (a) Effect. An order of a court of competent jurisdiction entered 
under this subpart is a unique kind of court order. Its only purpose is 
to authorize a disclosure or use of patient information which would 
otherwise be prohibited by 42 U.S.C. 290dd-2 and the regulations in this 
part. Such an order does not compel disclosure. A subpoena or a similar 
legal mandate must be issued in order to compel disclosure. This mandate

[[Page 29]]

may be entered at the same time as and accompany an authorizing court 
order entered under the regulations in this part.
    (b) Examples. (1) A person holding records subject to the 
regulations in this part receives a subpoena for those records. The 
person may not disclose the records in response to the subpoena unless a 
court of competent jurisdiction enters an authorizing order under the 
regulations in this part.
    (2) An authorizing court order is entered under the regulations in 
this part, but the person holding the records does not want to make the 
disclosure. If there is no subpoena or other compulsory process or a 
subpoena for the records has expired or been quashed, that person may 
refuse to make the disclosure. Upon the entry of a valid subpoena or 
other compulsory process the person holding the records must disclose, 
unless there is a valid legal defense to the process other than the 
confidentiality restrictions of the regulations in this part.



Sec.  2.62  Order not applicable to records disclosed without consent 
to researchers, auditors and evaluators.

    A court order under the regulations in this part may not authorize 
qualified personnel, who have received patient identifying information 
without consent for the purpose of conducting research, audit or 
evaluation, to disclose that information or use it to conduct any 
criminal investigation or prosecution of a patient. However, a court 
order under Sec.  2.66 may authorize disclosure and use of records to 
investigate or prosecute qualified personnel holding the records.



Sec.  2.63  Confidential communications.

    (a) A court order under the regulations in this part may authorize 
disclosure of confidential communications made by a patient to a part 2 
program in the course of diagnosis, treatment, or referral for treatment 
only if:
    (1) The disclosure is necessary to protect against an existing 
threat to life or of serious bodily injury, including circumstances 
which constitute suspected child abuse and neglect and verbal threats 
against third parties;
    (2) The disclosure is necessary in connection with investigation or 
prosecution of an extremely serious crime, such as one which directly 
threatens loss of life or serious bodily injury, including homicide, 
rape, kidnapping, armed robbery, assault with a deadly weapon, or child 
abuse and neglect; or
    (3) The disclosure is in connection with litigation or an 
administrative proceeding in which the patient offers testimony or other 
evidence pertaining to the content of the confidential communications.
    (b) [Reserved]

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 80632, Dec. 14, 2020]



Sec.  2.64  Procedures and criteria for orders authorizing disclosures 
for noncriminal purposes.

    (a) Application. An order authorizing the disclosure of patient 
records for purposes other than criminal investigation or prosecution 
may be applied for by any person having a legally recognized interest in 
the disclosure which is sought. The application may be filed separately 
or as part of a pending civil action in which the applicant asserts that 
the patient records are needed to provide evidence. An application must 
use a fictitious name, such as John Doe, to refer to any patient and may 
not contain or otherwise disclose any patient identifying information 
unless the patient is the applicant or has given written consent 
(meeting the requirements of the regulations in this part) to disclosure 
or the court has ordered the record of the proceeding sealed from public 
scrutiny.
    (b) Notice. The patient and the person holding the records from whom 
disclosure is sought must be provided:
    (1) Adequate notice in a manner which does not disclose patient 
identifying information to other persons; and
    (2) An opportunity to file a written response to the application, or 
to appear in person, for the limited purpose of providing evidence on 
the statutory and regulatory criteria for the issuance of the court 
order as described in Sec.  2.64(d).
    (c) Review of evidence: Conduct of hearing. Any oral argument, 
review of evidence, or hearing on the application must be held in the 
judge's chambers

[[Page 30]]

or in some manner which ensures that patient identifying information is 
not disclosed to anyone other than a party to the proceeding, the 
patient, or the person holding the record, unless the patient requests 
an open hearing in a manner which meets the written consent requirements 
of the regulations in this part. The proceeding may include an 
examination by the judge of the patient records referred to in the 
application.
    (d) Criteria for entry of order. An order under this section may be 
entered only if the court determines that good cause exists. To make 
this determination the court must find that:
    (1) Other ways of obtaining the information are not available or 
would not be effective; and
    (2) The public interest and need for the disclosure outweigh the 
potential injury to the patient, the physician-patient relationship and 
the treatment services.
    (e) Content of order. An order authorizing a disclosure must:
    (1) Limit disclosure to those parts of the patient's record which 
are essential to fulfill the objective of the order;
    (2) Limit disclosure to those persons whose need for information is 
the basis for the order; and
    (3) Include such other measures as are necessary to limit disclosure 
for the protection of the patient, the physician-patient relationship 
and the treatment services; for example, sealing from public scrutiny 
the record of any proceeding for which disclosure of a patient's record 
has been ordered.



Sec.  2.65  Procedures and criteria for orders authorizing disclosure 
and use of records to criminally investigate or prosecute patients.

    (a) Application. An order authorizing the disclosure or use of 
patient records to investigate or prosecute a patient in connection with 
a criminal proceeding may be applied for by the person holding the 
records or by any law enforcement or prosecutorial officials who are 
responsible for conducting investigative or prosecutorial activities 
with respect to the enforcement of criminal laws. The application may be 
filed separately, as part of an application for a subpoena or other 
compulsory process, or in a pending criminal action. An application must 
use a fictitious name such as John Doe, to refer to any patient and may 
not contain or otherwise disclose patient identifying information unless 
the court has ordered the record of the proceeding sealed from public 
scrutiny.
    (b) Notice and hearing. Unless an order under Sec.  2.66 is sought 
in addition to an order under this section, the person holding the 
records must be provided:
    (1) Adequate notice (in a manner which will not disclose patient 
identifying information to other persons) of an application by a law 
enforcement agency or official;
    (2) An opportunity to appear and be heard for the limited purpose of 
providing evidence on the statutory and regulatory criteria for the 
issuance of the court order as described in Sec.  2.65(d); and
    (3) An opportunity to be represented by counsel independent of 
counsel for an applicant who is a law enforcement agency or official.
    (c) Review of evidence: Conduct of hearings. Any oral argument, 
review of evidence, or hearing on the application shall be held in the 
judge's chambers or in some other manner which ensures that patient 
identifying information is not disclosed to anyone other than a party to 
the proceedings, the patient, or the person holding the records. The 
proceeding may include an examination by the judge of the patient 
records referred to in the application.
    (d) Criteria. A court may authorize the disclosure and use of 
patient records for the purpose of conducting a criminal investigation 
or prosecution of a patient only if the court finds that all of the 
following criteria are met:
    (1) The crime involved is extremely serious, such as one which 
causes or directly threatens loss of life or serious bodily injury 
including homicide, rape, kidnapping, armed robbery, assault with a 
deadly weapon, and child abuse and neglect.
    (2) There is a reasonable likelihood that the records will disclose 
information of substantial value in the investigation or prosecution.

[[Page 31]]

    (3) Other ways of obtaining the information are not available or 
would not be effective.
    (4) The potential injury to the patient, to the physician-patient 
relationship and to the ability of the part 2 program to provide 
services to other patients is outweighed by the public interest and the 
need for the disclosure.
    (5) If the applicant is a law enforcement agency or official, that:
    (i) The person holding the records has been afforded the opportunity 
to be represented by independent counsel; and
    (ii) Any person holding the records which is an entity within 
federal, state, or local government has in fact been represented by 
counsel independent of the applicant.
    (e) Content of order. Any order authorizing a disclosure or use of 
patient records under this section must:
    (1) Limit disclosure and use to those parts of the patient's record 
which are essential to fulfill the objective of the order;
    (2) Limit disclosure to those law enforcement and prosecutorial 
officials who are responsible for, or are conducting, the investigation 
or prosecution, and limit their use of the records to investigation and 
prosecution of the extremely serious crime or suspected crime specified 
in the application; and
    (3) Include such other measures as are necessary to limit disclosure 
and use to the fulfillment of only that public interest and need found 
by the court.



Sec.  2.66  Procedures and criteria for orders authorizing disclosure 
and use of records to investigate or prosecute a part 2 program 
or the person holding the records.

    (a) Application. (1) An order authorizing the disclosure or use of 
patient records to investigate or prosecute a part 2 program or the 
person holding the records (or employees or agents of that part 2 
program or person holding the records) in connection with a criminal or 
administrative matter may be applied for by any administrative, 
regulatory, supervisory, investigative, law enforcement, or 
prosecutorial agency having jurisdiction over the program's or person's 
activities.
    (2) The application may be filed separately or as part of a pending 
civil or criminal action against a part 2 program or the person holding 
the records (or agents or employees of the part 2 program or person 
holding the records) in which the applicant asserts that the patient 
records are needed to provide material evidence. The application must 
use a fictitious name, such as John Doe, to refer to any patient and may 
not contain or otherwise disclose any patient identifying information 
unless the court has ordered the record of the proceeding sealed from 
public scrutiny or the patient has provided written consent (meeting the 
requirements of Sec.  2.31) to that disclosure.
    (b) Notice not required. An application under this section may, in 
the discretion of the court, be granted without notice. Although no 
express notice is required to the part 2 program, to the person holding 
the records, or to any patient whose records are to be disclosed, upon 
implementation of an order so granted any of the above persons must be 
afforded an opportunity to seek revocation or amendment of that order, 
limited to the presentation of evidence on the statutory and regulatory 
criteria for the issuance of the court order in accordance with Sec.  
2.66(c).
    (c) Requirements for order. An order under this section must be 
entered in accordance with, and comply with the requirements of, 
paragraphs (d) and (e) of Sec.  2.64.
    (d) Limitations on disclosure and use of patient identifying 
information. (1) An order entered under this section must require the 
deletion of patient identifying information from any documents made 
available to the public.
    (2) No information obtained under this section may be used to 
conduct any investigation or prosecution of a patient in connection with 
a criminal matter, or be used as the basis for an application for an 
order under Sec.  2.65.



Sec.  2.67  Orders authorizing the use of undercover agents and informants 
to investigate employees or agents of a part 2 program in connection 
with a criminal matter.

    (a) Application. A court order authorizing the placement of an 
undercover agent or informant in a part 2 program

[[Page 32]]

as an employee or patient may be applied for by any law enforcement or 
prosecutorial agency which has reason to believe that employees or 
agents of the part 2 program are engaged in criminal misconduct.
    (b) Notice. The part 2 program director must be given adequate 
notice of the application and an opportunity to appear and be heard (for 
the limited purpose of providing evidence on the statutory and 
regulatory criteria for the issuance of the court order in accordance 
with Sec.  2.67(c)), unless the application asserts that:
    (1) The part 2 program director is involved in the suspected 
criminal activities to be investigated by the undercover agent or 
informant; or
    (2) The part 2 program director will intentionally or 
unintentionally disclose the proposed placement of an undercover agent 
or informant to the employees or agents of the program who are suspected 
of criminal activities.
    (c) Criteria. An order under this section may be entered only if the 
court determines that good cause exists. To make this determination the 
court must find all of the following:
    (1) There is reason to believe that an employee or agent of the part 
2 program is engaged in criminal activity;
    (2) Other ways of obtaining evidence of the suspected criminal 
activity are not available or would not be effective; and
    (3) The public interest and need for the placement of an undercover 
agent or informant in the part 2 program outweigh the potential injury 
to patients of the part 2 program, physician-patient relationships and 
the treatment services.
    (d) Content of order. An order authorizing the placement of an 
undercover agent or informant in a part 2 program must:
    (1) Specifically authorize the placement of an undercover agent or 
an informant;
    (2) Limit the total period of the placement to twelve months, 
starting on the date that the undercover agent or informant is placed on 
site within the program. The placement of an undercover agent or 
informant must end after 12 months, unless a new court order is issued 
to extend the period of placement;
    (3) Prohibit the undercover agent or informant from disclosing any 
patient identifying information obtained from the placement except as 
necessary to investigate or prosecute employees or agents of the part 2 
program in connection with the suspected criminal activity; and
    (4) Include any other measures which are appropriate to limit any 
potential disruption of the part 2 program by the placement and any 
potential for a real or apparent breach of patient confidentiality; for 
example, sealing from public scrutiny the record of any proceeding for 
which disclosure of a patient's record has been ordered.
    (e) Limitation on use of information. No information obtained by an 
undercover agent or informant placed in a part 2 program under this 
section may be used to investigate or prosecute any patient in 
connection with a criminal matter or as the basis for an application for 
an order under Sec.  2.65.

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43039, July 15, 2020]



PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents



Sec.
2a.1 Applicability.
2a.2 Definitions.
2a.3 Application; coordination.
2a.4 Contents of application; in general.
2a.5 Contents of application; research projects in which drugs will be 
          administered.
2a.6 Issuance of Confidentiality Certificates; single project 
          limitation.
2a.7 Effect of Confidentiality Certificate.
2a.8 Termination.

    Authority: Sec. 3(a), Pub. L. 91-513 as amended by sec. 122(b), Pub. 
L. 93-282; 84 Stat. 1241 (42 U.S.C. 242a(a)), as amended by 88 Stat. 
132.

    Source: 44 FR 20384, Apr. 4, 1979, unless otherwise noted.



Sec.  2a.1  Applicability.

    (a) Section 303(a) of the Public Health Service Act (42 U.S.C. 
242a(a)) provides that ``[t]he Secretary [of Health and Human Services] 
may authorize persons engaged in research on mental health, including 
research on the use and effect of alcohol and other

[[Page 33]]

psychoactive drugs, to protect the privacy of individuals who are the 
subject of such research by withholding from all persons not connected 
with the conduct of such research the names or other identifying 
characteristics of such individuals. Persons so authorized to protect 
the privacy of such individuals may not be compelled in any Federal, 
State, or local civil, criminal, administrative, legislative, or other 
proceedings to identify such individuals.'' The regulations in this part 
establish procedures under which any person engaged in research on 
mental health including research on the use and effect of alcohol and 
other psychoactive drugs (whether or not the research is federally 
funded) may, subject to the exceptions set forth in paragraph (b) of 
this section, apply for such an authorization of confidentiality.
    (b) These regulations do not apply to:
    (1) Authorizations of confidentiality for research requiring an 
Investigational New Drug exemption under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new 
drugs, such as methadone, requiring continuation of long-term studies, 
records, and reports. Attention is called to 21 CFR 291.505(g) relating 
to authorizations of confidentiality for patient records maintained by 
methadone treatment programs.
    (2) Authorizations of confidentiality for research which are related 
to law enforcement activities or otherwise within the purview of the 
Attorney General's authority to issue authorizations of confidentiality 
pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C. 
872(c)) and 21 CFR 1316.21.
    (c) The Secretary's regulations on confidentiality of alcohol and 
drug abuse patient records (42 CFR part 2) and the regulations of this 
part may, in some instances, concurrently cover the same transaction. As 
explained in 42 CFR 2.24 and 2.24-1, 42 CFR part 2 restricts voluntary 
disclosures of information from applicable patient records while a 
Confidentiality Certificate issued pursuant to the regulations of this 
part protects a person engaged in applicable research from being 
compelled to disclose identifying characteristics of individuals who are 
the subject of such research.



Sec.  2a.2  Definitions.

    (a) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (b) Person means any individual, corporation, government, or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    (c) Research means systematic study directed toward new or fuller 
knowledge and understanding of the subject studied. The term includes, 
but is not limited to, behavioral science studies, surveys, evaluations, 
and clinical investigations.
    (d) Drug has the meaning given that term by section 201(g)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
    (e) Controlled drug means a drug which is included in schedule I, 
II, III, IV, or V of part B of the Controlled Substances Act (21 U.S.C. 
811-812).
    (f) Administer refers to the direct application of a drug to the 
body of a human research subject, whether such application be by 
injection, inhalation, ingestion, or any other means, by (1) a qualified 
person engaged in research (or, in his or her presence, by his or her 
authorized agent), or (2) a research subject in accordance with 
instructions of a qualified person engaged in research, whether or not 
in the presence of a qualified person engaged in research.
    (g) Identifying characteristics refers to the name, address, any 
identifying number, fingerprints, voiceprints, photographs or any other 
item or combination of data about a research subject which could 
reasonably lead directly or indirectly by reference to other information 
to identification of that research subject.
    (h) Psychoactive drug means, in addition to alcohol, any drug which 
has as its principal action an effect on thought, mood, or behavior.



Sec.  2a.3  Application; coordination.

    (a) Any person engaged in (or who intends to engage in) the research 
to

[[Page 34]]

which this part applies, who desires authorization to withhold the names 
and other identifying characteristics of individuals who are the subject 
of such research from any person or authority not connected with the 
conduct of such research may apply to the Office of the Director, 
National Institute on Drug Abuse, the Office of the Director, National 
Institute of Mental Health, or the Office of the Director, National 
Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville, 
Maryland 20857 for an authorization of confidentiality.
    (b) If there is uncertainty with regard to which Institute is 
appropriate or if the research project falls within the purview of more 
than one Institute, an application need be submitted only to one 
Institute. Persons who are uncertain with regard to the applicability of 
these regulations to a particular type of research may apply for an 
authorization of confidentiality under the regulations of this part to 
one of the Institutes. Requests which are within the scope of the 
authorities described in Sec.  2a.1(b) will be forwarded to the 
appropriate agency for consideration and the person will be advised 
accordingly.
    (c) An application may accompany, precede, or follow the sumission 
of a request for DHHS grant or contract assistance, though it is not 
necessary to request DHHS grant or contract assistance in order to apply 
for a Confidentiality Certificate. If a person has previously submitted 
any information required in this part in connection with a DHHS grant or 
contract, he or she may substitute a copy of information thus submitted, 
if the information is current and accurate. If a person requests a 
Confidentiality Certificate at the same time he or she submits an 
application for DHHS grant or contract assistance, the application for a 
Confidentiality Certificate may refer to the pertinent section(s) of the 
DHHS grant or contract application which provide(s) the information 
required to be submitted under this part. (See Sec. Sec.  2a.4 and 
2a.5.)
    (d) A separate application is required for each research project for 
which an authorization of confidentiality is requested.



Sec.  2a.4  Contents of application; in general.

    In addition to any other pertinent information which the Secretary 
may require, each application for an authorization of confidentiality 
for a research project shall contain:
    (a) The name and address of the individual primarily responsible for 
the conduct of the research and the sponsor or institution with which he 
or she is affiliated, if any. Any application from a person affiliated 
with an institution will be considered only if it contains or is 
accompanied by documentation of institutional approval. This 
documentation may consist of a written statement signed by a responsible 
official of the institution or of a copy of or reference to a valid 
certification submitted in accordance with 45 CFR part 46.
    (b) The location of the research project and a description of the 
facilities available for conducting the research, including the name and 
address of any hospital, institution, or clinical laboratory facility to 
be utilized in connection with the research.
    (c) The names, addresses, and summaries of the scientific or other 
appropriate training and experience of all personnel having major 
responsibilities in the research project and the training and experience 
requirements for major positions not yet filled.
    (d) An outline of the research protocol for the project including a 
clear and concise statement of the purpose and rationale of the research 
project and the general research methods to be used.
    (e) The date on which research will begin or has begun and the 
estimated date for completion of the project.
    (f) A specific request, signed by the individual primarily 
responsible for the conduct of the research, for authority to withhold 
the names and other identifying characteristics of the research subjects 
and the reasons supporting such request.
    (g) An assurance (1) From persons making application for a 
Confidentiality Certificate for a research project for which DHHS grant 
or contract support is received or sought that

[[Page 35]]

they will comply with all the requirements of 45 CFR part 46, 
``Protection of Human Subjects,'' or
    (2) From all other persons making application that they will comply 
with the informed consent requirements of 45 CFR 46.103(c) and document 
legally effective informed consent in a manner consistent with the 
principles stated in 45 CFR 46.110, if it is determined by the 
Secretary, on the basis of information submitted by the person making 
application, that subjects will be placed at risk. If a modification of 
paragraphs (a) or (b) of 45 CFR 46.110 is to be used, as permitted under 
paragraph (c) of that section, the applicant will describe the proposed 
modification and submit it for approval by the Secretary.
    (h) An assurance that if an authorization of confidentiality is 
given it will not be represented as an endorsement of the research 
project by the Secretary or used to coerce individuals to participate in 
the research project.
    (i) An assurance that any person who is authorized by the Secretary 
to protect the privacy of research subjects will use that authority to 
refuse to disclose identifying characteristics of research subjects in 
any Federal, State, or local civil, criminal, administrative, 
legislative, or other proceedings to compel disclosure of the 
identifying characteristics of research subjects.
    (j) An assurance that all research subjects who participate in the 
project during the period the Confidentiality Certificate is in effect 
will be informed that:
    (1) A Confidentiality Certificate has been issued;
    (2) The persons authorized by the Confidentiality Certificate to 
protect the identity of research subjects may not be compelled to 
identify research subjects in any civil, criminal, administrative, 
legislative, or other proceedings whether Federal, State, or local;
    (3) If any of the following conditions exist the Confidentiality 
Certificate does not authorize any person to which it applies to refuse 
to reveal identifying information concerning research subjects:
    (i) The subject consents in writing to disclosure of identifying 
information,
    (ii) Release is required by the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of 
Federal Regulations), or
    (iii) Authorized personnel of DHHS request identifying information 
for audit or program evaluation of a research project funded by DHHS or 
for investigation of DHHS grantees or contractors and their employees or 
agents carrying out such a project. (See Sec.  2a.7(b));
    (4) The Confidentiality Certificate does not govern the voluntary 
disclosure of identifying characteristics of research subjects;
    (5) The Confidentiality Certificate does not represent an 
endorsement of the research project by the Secretary.
    (k) An assurance that all research subjects who enter the project 
after the termination of the Confidentiality Certificate will be 
informed that the authorization of confidentiality has ended and that 
the persons authorized to protect the identity of research subjects by 
the Confidentiality Certificate may not rely on the Certificate to 
refuse to disclose identifying characteristics of research subjects who 
were not participants in the project during the period the Certificate 
was in effect. (See Sec.  2a.8(c)).



Sec.  2a.5  Contents of application; research projects in which drugs 
will be administered.

    (a) In addition to the information required by Sec.  2a.4 and any 
other pertinent information which the Secretary may require, each 
application for an authorization of confidentiality for a research 
project which involves the administering of a drug shall contain:
    (1) Identification of the drugs to be administered in the research 
project and a description of the methods for such administration, which 
shall include a statement of the dosages to be administered to the 
research subjects;
    (2) Evidence that individuals who administer drugs are authorized to 
do so under applicable Federal and State law; and
    (3) In the case of a controlled drug, a copy of the Drug Enforcement 
Administration Certificate of Registration

[[Page 36]]

(BND Form 223) under which the research project will be conducted.
    (b) An application for an authorization of confidentiality with 
respect to a research project which involves the administering of a 
controlled drug may include a request for exemption of persons engaged 
in the research from State or Federal prosecution for possession, 
distribution, and dispensing of controlled drugs as authorized under 
section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 
21 CFR 1316.22. If the request is in such form, and is supported by such 
information, as is required by 21 CFR 1316.22, the Secretary will 
forward it, together with his or her recommendation that such request be 
approved or disapproved, for the consideration of the Administrator of 
the Drug Enforcement Administration.



Sec.  2a.6  Issuance of Confidentiality Certificates; 
single project limitation.

    (a) In reviewing the information provided in the application for a 
Confidentiality Certificate, the Secretary will take into account:
    (1) The scientific or other appropriate training and experience of 
all personnel having major responsibilities in the research project;
    (2) Whether the project constitutes bona fide ``research'' which is 
within the scope of the regulations of this part; and
    (3) Such other factors as he or she may consider necessary and 
appropriate. All applications for Confidentiality Certificates shall be 
evaluated by the Secretary through such officers and employees of the 
Department and such experts or consultants engaged for this purpose as 
he or she determines to be appropriate.
    (b) After consideration and evaluation of an application for an 
authorization of confidentiality, the Secretary will either issue a 
Confidentiality Certificate or a letter denying a Confidentiality 
Certificate, which will set forth the reasons for such denial, or will 
request additional information from the person making application. The 
Confidentiality Certificate will include:
    (1) The name and address of the person making application;
    (2) The name and address of the individual primarily responsible for 
conducting the research, if such individual is not the person making 
application;
    (3) The location of the research project;
    (4) A brief description of the research project;
    (5) A statement that the Certificate does not represent an 
endorsement of the research project by the Secretary;
    (6) The Drug Enforcement Administration registration number for the 
project, if any; and
    (7) The date or event upon which the Confidentiality Certificate 
becomes effective, which shall not be before the later of either the 
commencement of the research project or the date of issuance of the 
Certificate, and the date or event upon which the Certificate will 
expire.
    (c) A Confidentiality Certificate is not transferable and is 
effective only with respect to the names and other identifying 
characteristics of those individuals who are the subjects of the single 
research project specified in the Confidentiality Certificate. The 
recipient of a Confidentiality Certificate shall, within 15 days of any 
completion or discontinuance of the research project which occurs prior 
to the expiration date set forth in the Certificate, provide written 
notification to the Director of the Institute to which application was 
made. If the recipient determines that the research project will not be 
completed by the expiration date set forth in the Confidentiality 
Certificate he or she may submit a written request for an extension of 
the expiration date which shall include a justification for such 
extension and a revised estimate of the date for completion of the 
project. Upon approval of such a request, the Secretary will issue an 
amended Confidentiality Certificate.
    (d) The protection afforded by a Confidentiality Certificate does 
not extend to significant changes in the research project as it is 
described in the application for such Certificate (e.g., changes in the 
personnel having major responsibilities in the research project, major 
changes in the scope or direction of the research protocol, or changes 
in the

[[Page 37]]

drugs to be administered and the persons who will administer them). The 
recipient of a Confidentiality Certificate shall notify the Director of 
the Institute to which application was made of any proposal for such a 
significant change by submitting an amended application for a 
Confidentiality Certificate in the same form and manner as an original 
application. On the basis of such application and other pertinent 
information the Secretary will either:
    (1) Approve the amended application and issue an amended 
Confidentiality Certificate together with a Notice of Cancellation 
terminating original the Confidentiality Certificate in accordance with 
Sec.  2a.8; or
    (2) Disapprove the amended application and notify the applicant in 
writing that adoption of the proposed significant changes will result in 
the issuance of a Notice of Cancellation terminating the original 
Confidentiality Certificate in accordance with Sec.  2a.8.



Sec.  2a.7  Effect of Confidentiality Certificate.

    (a) A Confidentiality Certificate authorizes the withholding of the 
names and other identifying characteristics of individuals who 
participate as subjects in the research project specified in the 
Certificate while the Certificate is in effect. The authorization 
applies to all persons who, in the performance of their duties in 
connection with the research project, have access to information which 
would identify the subjects of the research. Persons so authorized may 
not, at any time, be compelled in any Federal, State, or local civil, 
criminal, administrative, legislative, or other proceedings to identify 
the research subjects encompassed by the Certificate, except in those 
circumstances specified in paragraph (b) of this section.
    (b) A Confidentiality Certificate granted under this part does not 
authorize any person to refuse to reveal the name or other identifying 
characteristics of any research subject in the following circumstances:
    (1) The subject (or, if he or she is legally incompetent, his or her 
guardian) consents, in writing, to the disclosure of such information,
    (2) Authorized personnel of DHHS request such information for audit 
or program evaluation of a research project funded by DHHS or for 
investigation of DHHS grantees or contractors and their employees or 
agents carrying out such a project. (See 45 CFR 5.71 for confidentiality 
standards imposed on such DHHS personnel), or
    (3) Release of such information is required by the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated 
thereunder (title 21, Code of Federal Regulations).
    (c) Neither a Confidentiality Certificate nor the regulations of 
this part govern the voluntary disclosure of identifying characteristics 
of research subjects.



Sec.  2a.8  Termination.

    (a) A Confidentiality Certificate is in effect from the date of its 
issuance until the effective date of its termination. The effective date 
of termination shall be the earlier of:
    (1) The expiration date set forth in the Confidentiality 
Certificate; or
    (2) Ten days from the date of mailing a Notice of Cancellation to 
the applicant, pursuant to a determination by the Secretary that the 
research project has been completed or discontinued or that retention of 
the Confidentiality Certificate is otherwise no longer necessary or 
desirable.
    (b) A Notice of Cancellation shall include: an identification of the 
Confidentiality Certificate to which it applies; the effective date of 
its termination; and the grounds for cancellation. Upon receipt of a 
Notice of Cancellation the applicant shall return the Confidentiality 
Certificate to the Secretary.
    (c) Any termination of a Confidentiality Certificate pursuant to 
this section is operative only with respect to the names and other 
identifying characteristics of individuals who begin their participation 
as research subjects after the effective date of such termination. (See 
Sec.  2a.4(k) requiring researchers to notify subjects who enter the 
project after the termination of the Confidentiality Certificate of 
termination of the Certificate). The protection afforded by a 
Confidentiality Certificate is permanent with respect to

[[Page 38]]

subjects who participated in research during any time the authorization 
was in effect.



PART 3_PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT--
Table of Contents



                      Subpart A_General Provisions

Sec.
3.10 Purpose.
3.20 Definitions.

            Subpart B_PSO Requirements and Agency Procedures

3.102 Process and requirements for initial and continued listing of 
          PSOs.
3.104 Secretarial actions.
3.106 Security requirements.
3.108 Correction of deficiencies, revocation, and voluntary 
          relinquishment.
3.110 Assessment of PSO compliance.
3.112 Submissions and forms.

 Subpart C_Confidentiality and Privilege Protections of Patient Safety 
                              Work Product

3.204 Privilege of patient safety work product.
3.206 Confidentiality of patient safety work product.
3.208 Continued protection of patient safety work product.
3.210 Required disclosure of patient safety work product to the 
          Secretary.
3.212 Nonidentification of patient safety work product.

                      Subpart D_Enforcement Program

3.304 Principles for achieving compliance.
3.306 Complaints to the Secretary.
3.308 Compliance reviews.
3.310 Responsibilities of respondents.
3.312 Secretarial action regarding complaints and compliance reviews.
3.314 Investigational subpoenas and inquiries.
3.402 Basis for a civil money penalty.
3.404 Amount of a civil money penalty.
3.408 Factors considered in determining the amount of a civil money 
          penalty.
3.414 Limitations.
3.416 Authority to settle.
3.418 Exclusivity of penalty.
3.420 Notice of proposed determination.
3.422 Failure to request a hearing.
3.424 Collection of penalty.
3.426 Notification of the public and other agencies.
3.504 Hearings before an ALJ.
3.506 Rights of the parties.
3.508 Authority of the ALJ.
3.510 Ex parte contacts.
3.512 Prehearing conferences.
3.514 Authority to settle.
3.516 Discovery.
3.518 Exchange of witness lists, witness statements, and exhibits.
3.520 Subpoenas for attendance at hearing.
3.522 Fees.
3.524 Form, filing, and service of papers.
3.526 Computation of time.
3.528 Motions.
3.530 Sanctions.
3.532 Collateral estoppel.
3.534 The hearing.
3.538 Witnesses.
3.540 Evidence.
3.542 The record.
3.544 Post hearing briefs.
3.546 ALJ's decision.
3.548 Appeal of the ALJ's decision.
3.550 Stay of the Secretary's decision.
3.552 Harmless error.

    Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.

    Source: 73 FR 70796, Nov. 21, 2008, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  3.10  Purpose.

    The purpose of this part is to implement the Patient Safety and 
Quality Improvement Act of 2005 (Pub. L. 109-41), which amended Title IX 
of the Public Health Service Act (42 U.S.C. 299 et seq.) by adding 
sections 921 through 926, 42 U.S.C. 299b-21 through 299b-26.



Sec.  3.20  Definitions.

    As used in this part, the terms listed alphabetically below have the 
meanings set forth as follows:
    Affiliated provider means, with respect to a provider, a legally 
separate provider that is the parent organization of the provider, is 
under common ownership, management, or control with the provider, or is 
owned, managed, or controlled by the provider.
    AHRQ stands for the Agency for Healthcare Research and Quality in 
HHS.
    ALJ stands for an Administrative Law Judge of HHS.
    Board means the members of the HHS Departmental Appeals Board, in 
the Office of the Secretary, which issues decisions in panels of three.
    Bona fide contract means:
    (1) A written contract between a provider and a PSO that is executed 
in

[[Page 39]]

good faith by officials authorized to execute such contract; or
    (2) A written agreement (such as a memorandum of understanding or 
equivalent recording of mutual commitments) between a Federal, State, 
local, or Tribal provider and a Federal, State, local, or Tribal PSO 
that is executed in good faith by officials authorized to execute such 
agreement.
    Complainant means a person who files a complaint with the Secretary 
pursuant to Sec.  3.306.
    Component organization means an entity that:
    (1) Is a unit or division of a legal entity (including a 
corporation, partnership, or a Federal, State, local or Tribal agency or 
organization); or
    (2) Is owned, managed, or controlled by one or more legally separate 
parent organizations.
    Component PSO means a PSO listed by the Secretary that is a 
component organization.
    Confidentiality provisions means for purposes of subparts C and D, 
any requirement or prohibition concerning confidentiality established by 
sections 921 and 922(b)-(d), (g) and (i) of the Public Health Service 
Act, 42 U.S.C. 299b-21, 299b-22(b)-(d), (g) and (i) and the provisions, 
at Sec. Sec.  3.206 and 3.208, that implement the statutory prohibition 
on disclosure of identifiable patient safety work product.
    Disclosure means the release, transfer, provision of access to, or 
divulging in any other manner of patient safety work product by:
    (1) An entity or natural person holding the patient safety work 
product to another legally separate entity or natural person, other than 
a workforce member of, or a health care provider holding privileges 
with, the entity holding the patient safety work product; or
    (2) A component PSO to another entity or natural person outside the 
component PSO and within the legal entity of which the component PSO is 
a part.
    Entity means any organization or organizational unit, regardless of 
whether the organization is public, private, for-profit, or not-for-
profit.
    Group health plan means an employee welfare benefit plan (as defined 
in section 3(1) of the Employee Retirement Income Security Act of 1974 
(ERISA)) to the extent that the plan provides medical care (as defined 
in paragraph (2) of section 2791(a) of the Public Health Service Act, 
including items and services paid for as medical care) to employees or 
their dependents (as defined under the terms of the plan) directly or 
through insurance, reimbursement, or otherwise.
    Health insurance issuer means an insurance company, insurance 
service, or insurance organization (including a health maintenance 
organization, as defined in 42 U.S.C. 300gg-91(b)(3)) which is licensed 
to engage in the business of insurance in a State and which is subject 
to State law which regulates insurance (within the meaning of 29 U.S.C. 
1144(b)(2)). This term does not include a group health plan.
    Health maintenance organization means:
    (1) A Federally qualified health maintenance organization (HMO) (as 
defined in 42 U.S.C. 300e(a));
    (2) An organization recognized under State law as a health 
maintenance organization; or
    (3) A similar organization regulated under State law for solvency in 
the same manner and to the same extent as such a health maintenance 
organization.
    HHS stands for the United States Department of Health and Human 
Services.
    HIPAA Privacy Rule means the regulations promulgated under section 
264(c) of the Health Insurance Portability and Accountability Act of 
1996 (HIPAA), at 45 CFR part 160 and subparts A and E of part 164.
    Identifiable patient safety work product means patient safety work 
product that:
    (1) Is presented in a form and manner that allows the identification 
of any provider that is a subject of the work product, or any providers 
that participate in, or are responsible for, activities that are a 
subject of the work product;
    (2) Constitutes individually identifiable health information as that 
term is defined in the HIPAA Privacy Rule at 45 CFR 160.103; or

[[Page 40]]

    (3) Is presented in a form and manner that allows the identification 
of an individual who in good faith reported information directly to a 
PSO or to a provider with the intention of having the information 
reported to a PSO (``reporter'').
    Nonidentifiable patient safety work product means patient safety 
work product that is not identifiable patient safety work product in 
accordance with the nonidentification standards set forth at Sec.  
3.212.
    OCR stands for the Office for Civil Rights in HHS.
    Parent organization means an organization that: owns a controlling 
interest or a majority interest in a component organization; has the 
authority to control or manage agenda setting, project management, or 
day-to-day operations; or the authority to review and override decisions 
of a component organization. The component organization may be a 
provider.
    Patient Safety Act means the Patient Safety and Quality Improvement 
Act of 2005 (Pub. L. 109-41), which amended Title IX of the Public 
Health Service Act (42 U.S.C. 299 et seq.) by inserting a new Part C, 
sections 921 through 926, which are codified at 42 U.S.C. 299b-21 
through 299b-26.
    Patient safety activities means the following activities carried out 
by or on behalf of a PSO or a provider:
    (1) Efforts to improve patient safety and the quality of health care 
delivery;
    (2) The collection and analysis of patient safety work product;
    (3) The development and dissemination of information with respect to 
improving patient safety, such as recommendations, protocols, or 
information regarding best practices;
    (4) The utilization of patient safety work product for the purposes 
of encouraging a culture of safety and of providing feedback and 
assistance to effectively minimize patient risk;
    (5) The maintenance of procedures to preserve confidentiality with 
respect to patient safety work product;
    (6) The provision of appropriate security measures with respect to 
patient safety work product;
    (7) The utilization of qualified staff; and
    (8) Activities related to the operation of a patient safety 
evaluation system and to the provision of feedback to participants in a 
patient safety evaluation system.
    Patient safety evaluation system means the collection, management, 
or analysis of information for reporting to or by a PSO.
    Patient safety organization (PSO) means a private or public entity 
or component thereof that is listed as a PSO by the Secretary in 
accordance with subpart B. A health insurance issuer or a component 
organization of a health insurance issuer may not be a PSO. See also the 
exclusions in Sec.  3.102 of this part.
    Patient safety work product:
    (1) Except as provided in paragraph (2) of this definition, patient 
safety work product means any data, reports, records, memoranda, 
analyses (such as root cause analyses), or written or oral statements 
(or copies of any of this material)
    (i) Which could improve patient safety, health care quality, or 
health care outcomes; and
    (A) Which are assembled or developed by a provider for reporting to 
a PSO and are reported to a PSO, which includes information that is 
documented as within a patient safety evaluation system for reporting to 
a PSO, and such documentation includes the date the information entered 
the patient safety evaluation system; or
    (B) Are developed by a PSO for the conduct of patient safety 
activities; or
    (ii) Which identify or constitute the deliberations or analysis of, 
or identify the fact of reporting pursuant to, a patient safety 
evaluation system.
    (2)(i) Patient safety work product does not include a patient's 
medical record, billing and discharge information, or any other original 
patient or provider information; nor does it include information that is 
collected, maintained, or developed separately, or exists separately, 
from a patient safety evaluation system. Such separate information or a 
copy thereof reported to a PSO shall not by reason of its reporting be 
considered patient safety work product.
    (ii) Patient safety work product assembled or developed by a 
provider for

[[Page 41]]

reporting to a PSO may be removed from a patient safety evaluation 
system and no longer considered patient safety work product if:
    (A) The information has not yet been reported to a PSO; and
    (B) The provider documents the act and date of removal of such 
information from the patient safety evaluation system.
    (iii) Nothing in this part shall be construed to limit information 
that is not patient safety work product from being:
    (A) Discovered or admitted in a criminal, civil or administrative 
proceeding;
    (B) Reported to a Federal, State, local or Tribal governmental 
agency for public health or health oversight purposes; or
    (C) Maintained as part of a provider's recordkeeping obligation 
under Federal, State, local or Tribal law.
    Person means a natural person, trust or estate, partnership, 
corporation, professional association or corporation, or other entity, 
public or private.
    Provider means:
    (1) An individual or entity licensed or otherwise authorized under 
State law to provide health care services, including--
    (i) A hospital, nursing facility, comprehensive outpatient 
rehabilitation facility, home health agency, hospice program, renal 
dialysis facility, ambulatory surgical center, pharmacy, physician or 
health care practitioner's office (includes a group practice), long term 
care facility, behavior health residential treatment facility, clinical 
laboratory, or health center; or
    (ii) A physician, physician assistant, registered nurse, nurse 
practitioner, clinical nurse specialist, certified registered nurse 
anesthetist, certified nurse midwife, psychologist, certified social 
worker, registered dietitian or nutrition professional, physical or 
occupational therapist, pharmacist, or other individual health care 
practitioner;
    (2) Agencies, organizations, and individuals within Federal, State, 
local, or Tribal governments that deliver health care, organizations 
engaged as contractors by the Federal, State, local, or Tribal 
governments to deliver health care, and individual health care 
practitioners employed or engaged as contractors by the Federal State, 
local, or Tribal governments to deliver health care; or
    (3) A parent organization of one or more entities described in 
paragraph (1)(i) of this definition or a Federal, State, local, or 
Tribal government unit that manages or controls one or more entities 
described in paragraphs (1)(i) or (2) of this definition.
    Research has the same meaning as the term is defined in the HIPAA 
Privacy Rule at 45 CFR 164.501.
    Respondent means a provider, PSO, or responsible person who is the 
subject of a complaint or a compliance review.
    Responsible person means a person, other than a provider or a PSO, 
who has possession or custody of identifiable patient safety work 
product and is subject to the confidentiality provisions.
    Workforce means employees, volunteers, trainees, contractors, or 
other persons whose conduct, in the performance of work for a provider, 
PSO or responsible person, is under the direct control of such provider, 
PSO or responsible person, whether or not they are paid by the provider, 
PSO or responsible person.



            Subpart B_PSO Requirements and Agency Procedures



Sec.  3.102  Process and requirements for initial 
and continued listing of PSOs.

    (a) Eligibility and process for initial and continued listing--(1) 
Submission of certification. Any entity, except as specified in 
paragraph (a)(2) of this section, may request from the Secretary an 
initial or continued listing as a PSO by submitting a completed 
certification form that meets the requirements of this section, in 
accordance with Sec.  3.112. An individual with authority to make 
commitments on behalf of the entity seeking listing will be required to 
submit contact information for the entity and:
    (i) Attest that the entity is not subject to any exclusion in 
paragraph (a)(2) of this section;

[[Page 42]]

    (ii) Provide certifications that the entity meets each requirement 
for PSOs in paragraph (b) of this section;
    (iii) If the entity is a component of another organization, provide 
the additional certifications that the entity meets the requirements of 
paragraph (c)(1)(i) of this section;
    (iv) If the entity is a component of an excluded entity described in 
paragraph (a)(2)(ii), provide the additional certifications and 
information required by paragraph (c)(1)(ii) of this section;
    (v) Attest that the entity has disclosed if the Secretary has ever 
delisted this entity (under its current name or any other) or refused to 
list the entity or whether any of its officials or senior managers held 
comparable positions of responsibility in an entity that was denied 
listing or delisted and, if any of these circumstances apply, submit 
with its certifications and related disclosures, the name of the entity 
or entities that the Secretary declined to list or delisted;
    (vi) Attest that the PSO will promptly notify the Secretary during 
its period of listing if it can no longer comply with any of its 
attestations and the applicable requirements in Sec. Sec.  3.102(b) and 
3.102(c) or if there have been any changes in the accuracy of the 
information submitted for listing, along with the pertinent changes; and
    (vii) Provide other information that the Secretary determines to be 
necessary to make the requested listing determination.
    (2) Exclusion of certain entities. The following types of entities 
may not seek listing as a PSO:
    (i) A health insurance issuer; a unit or division of a health 
insurance issuer; or an entity that is owned, managed, or controlled by 
a health insurance issuer;
    (ii)(A) An entity that accredits or licenses health care providers;
    (B) An entity that oversees or enforces statutory or regulatory 
requirements governing the delivery of health care services;
    (C) An agent of an entity that oversees or enforces statutory or 
regulatory requirements governing the delivery of health care services; 
or
    (D) An entity that operates a Federal, state, local or Tribal 
patient safety reporting system to which health care providers (other 
than members of the entity's workforce or health care providers holding 
privileges with the entity) are required to report information by law or 
regulation.
    (iii) A component of an entity listed in paragraph (a)(2)(ii) may 
seek listing as a component PSO subject to the requirements and 
restrictions of paragraph (c)(1)(ii) of this section.
    (3) Submission of certification for continued listing. To facilitate 
a timely Secretarial determination regarding acceptance of its 
certification for continued listing, a PSO must submit the required 
certification no later than 75 days before the expiration of a PSO's 
three-year period of listing.
    (b) Fifteen general PSO certification requirements. The 
certifications submitted to the Secretary in accordance with paragraph 
(a)(1)(ii) of this section must conform to the following 15 
requirements:
    (1) Required certification regarding eight patient safety 
activities--(i) Initial listing. An entity seeking initial listing as a 
PSO must certify that it has written policies and procedures in place to 
perform each of the eight patient safety activities, defined in Sec.  
3.20. With respect to paragraphs (5) and (6) in the definition of 
patient safety activities regarding confidentiality and security, the 
policies and procedures must include and provide for:
    (A) Compliance with the confidentiality provisions of subpart C of 
this part and with appropriate security measures as required by Sec.  
3.106 of this subpart.
    (B) Notification of each provider that submitted patient safety work 
product or data as described in Sec.  3.108(b)(2) to the entity if the 
submitted work product or data was subject to an unauthorized disclosure 
or its security was breached.
    (ii) Continued Listing. A PSO seeking continued listing must certify 
that it is performing, and will continue to perform, each of the patient 
safety activities defined in Sec.  3.20, and is and will continue to 
comply with the requirements of paragraphs (b)(1)(i)(A) and (B) of this 
section.
    (2) Required certification regarding seven PSO criteria--(i) Initial 
Listing. In its initial certification submission, an

[[Page 43]]

entity must also certify that, if listed as a PSO, it will comply with 
the seven requirements in paragraphs (b)(2)(i)(A) through (G) of this 
section.
    (A) The mission and primary activity of the PSO must be to conduct 
activities that are to improve patient safety and the quality of health 
care delivery.
    (B) The PSO must have appropriately qualified workforce members, 
including licensed or certified medical professionals.
    (C) The PSO, within the 24-month period that begins on the date of 
its initial listing as a PSO, and within each sequential 24-month period 
thereafter, must have 2 bona fide contracts, each of a reasonable period 
of time, each with a different provider for the purpose of receiving and 
reviewing patient safety work product.
    (D) The PSO is not a health insurance issuer, and is not a component 
of a health insurance issuer.
    (E) The PSO must make disclosures to the Secretary as required under 
Sec.  3.102(d), in accordance with Sec.  3.112 of this subpart.
    (F) To the extent practical and appropriate, the PSO must collect 
patient safety work product from providers in a standardized manner that 
permits valid comparisons of similar cases among similar providers.
    (G) The PSO must utilize patient safety work product for the purpose 
of providing direct feedback and assistance to providers to effectively 
minimize patient risk.
    (ii) Continued Listing. A PSO seeking continued listing must certify 
that it is complying with, and will continue to comply with, the 
requirements of paragraphs (b)(2)(i)(A) through (G) of this section.
    (iii) Compliance with the criterion for collecting patient safety 
work product in a standardized manner to the extent practical and 
appropriate. With respect to paragraph (b)(2)(i)(F) of this section, the 
Secretary will assess compliance by a PSO in the following manner.
    (A) A PSO seeking continued listing must:
    (1) Certify that the PSO is using the Secretary's published guidance 
for common formats and definitions in its collection of patient safety 
work product (option (I));
    (2) Certify that the PSO is using an alternative system of formats 
and definitions that permits valid comparisons of similar cases among 
similar providers (option (II)); or
    (3) Provide a clear explanation for why it is not practical or 
appropriate for the PSO to comply with options (I) or (II) at this time.
    (B) The Secretary will consider a PSO to be in compliance if the 
entity complies with option (I), satisfactorily demonstrates that option 
(II) permits valid comparisons of similar cases among similar providers, 
or satisfactorily demonstrates that it is not practical or appropriate 
for the PSO to comply with options (I) or (II) at this time.
    (c) Additional certifications required of component organizations--
(1) Requirements when seeking listing--(i) Requirements that all 
component organizations must meet. In addition to meeting the 15 general 
PSO certification requirements of paragraph (b) of this section, an 
entity seeking initial listing that is a component of another 
organization must certify that it will comply with the requirements of 
paragraph (c)(2) of this section. A component PSO seeking continued 
listing must certify that it is complying with, and will continue to 
comply with, the requirements of this same paragraph (c)(2). At initial 
and continued listing, a component entity must attach to its 
certifications for listing contact information for its parent 
organization(s).
    (ii) Additional requirements and limitations applicable to 
components of entities that are excluded from listing. In addition to 
the requirements under paragraph (c)(1)(i) of this section, a component 
of an organization excluded from listing under paragraph (a)(2)(ii) of 
this section must submit the additional certifications and specified 
information for initial and continued listing and comply with paragraph 
(c)(4) of this section.
    (2) Required component certifications--(i) Separation of patient 
safety work product. A component PSO must maintain patient safety work 
product separately from the rest of the parent organization(s) of which 
it is a part, and establish appropriate security measures

[[Page 44]]

to maintain the confidentiality of patient safety work product. The 
information system in which the component PSO maintains patient safety 
work product must not permit unauthorized access by one or more 
individuals in, or by units of, the rest of the parent organization(s) 
of which it is a part.
    (ii) Nondisclosure of patient safety work product. A component PSO 
must require that members of its workforce and any other contractor 
staff not make unauthorized disclosures of patient safety work product 
to the rest of the parent organization(s) of which it is a part.
    (iii) No conflict of interest. The pursuit of the mission of a 
component PSO must not create a conflict of interest with the rest of 
the parent organization(s) of which it is a part.
    (3) Written agreements for assisting a component PSO in the conduct 
of patient safety activities. Notwithstanding the requirements of 
paragraph (c)(2) of this section, a component PSO may provide access to 
identifiable patient safety work product to one or more individuals in, 
or to one or more units of, the rest of the parent organization(s) of 
which it is a part, if the component PSO enters into a written agreement 
with such individuals or units which requires that:
    (i) The component PSO will only provide access to identifiable 
patient safety work product to enable such individuals or units to 
assist the component PSO in its conduct of patient safety activities, 
and
    (ii) Such individuals or units that receive access to identifiable 
patient safety work product pursuant to such written agreement will only 
use or disclose such information as specified by the component PSO to 
assist the component PSO in its conduct of patient safety activities, 
will take appropriate security measures to prevent unauthorized 
disclosures and will comply with the other certifications the component 
has made pursuant to paragraph (c)(2) of this section regarding 
unauthorized disclosures and conducting the mission of the PSO without 
creating conflicts of interest.
    (4) Required attestations, information and operational limitations 
for components of entities excluded from listing. A component 
organization of an entity that is subject to the restrictions of 
paragraph (a)(2)(ii) of this section must:
    (i) Submit the following information with its certifications for 
listing:
    (A) A statement describing its parent organization's role, and the 
scope of the parent organization's authority, with respect to any of the 
following that apply: Accreditation or licensure of health care 
providers, oversight or enforcement of statutory or regulatory 
requirements governing the delivery of health care services, serving as 
an agent of such a regulatory oversight or enforcement authority, or 
administering a public mandatory patient safety reporting system;
    (B) An attestation that the parent organization has no policies or 
procedures that would require or induce providers to report patient 
safety work product to their component organization once listed as a PSO 
and that the component PSO will notify the Secretary within 5 calendar 
days of the date on which the component organization has knowledge of 
the adoption by the parent organization of such policies or procedures, 
and an acknowledgment that the adoption of such policies or procedures 
by the parent organization during the component PSO's period of listing 
will result in the Secretary initiating an expedited revocation process 
in accordance with Sec.  3.108(e); and
    (C) An attestation that the component organization will prominently 
post notification on its Web site and publish in any promotional 
materials for dissemination to providers, a summary of the information 
that is required by paragraph (c)(4)(i)(A) of this section.
    (ii) Comply with the following requirements during its period of 
listing:
    (A) The component organization may not share staff with its parent 
organization(s).
    (B) The component organization may enter into a written agreement 
pursuant to paragraph (c)(3) but such agreements are limited to units or 
individuals of the parent organization(s) whose responsibilities do not 
involve the activities specified in the restrictions in paragraph 
(a)(2)(ii) of this section.

[[Page 45]]

    (d) Required notifications. Upon listing, PSOs must meet the 
following notification requirements:
    (1) Notification regarding PSO compliance with the minimum contract 
requirement. No later than 45 calendar days prior to the last day of the 
pertinent 24-month assessment period, specified in paragraph 
(b)(2)(iii)(C) of this section, the Secretary must receive from a PSO a 
certification that states whether it has met the requirement of that 
paragraph regarding two bona fide contracts, submitted in accordance 
with Sec.  3.112 of this subpart.
    (2) Notification regarding a PSO's relationships with its 
contracting providers--(i) Requirement. A PSO must file a disclosure 
statement regarding a provider with which it has a contract that 
provides the confidentiality and privilege protections of the Patient 
Safety Act (hereinafter referred to as a Patient Safety Act contract) if 
the PSO has any other relationships with this provider that are 
described in paragraphs (d)(2)(i)(A) through (D) of this section. The 
PSO must disclose all such relationships. A disclosure statement is not 
required if all of its other relationships with the provider are limited 
to Patient Safety Act contracts.
    (A) The provider and PSO have current contractual relationships, 
other than those arising from any Patient Safety Act contracts, 
including formal contracts or agreements that impose obligations on the 
PSO.
    (B) The provider and PSO have current financial relationships other 
than those arising from any Patient Safety Act contracts. A financial 
relationship may include any direct or indirect ownership or investment 
relationship between the PSO and the contracting provider, shared or 
common financial interests or direct or indirect compensation 
arrangements whether in cash or in-kind.
    (C) The PSO and provider have current reporting relationships other 
than those arising from any Patient Safety Act contracts, by which the 
provider has access to information regarding the work and operation of 
the PSO that is not available to other contracting providers.
    (D) Taking into account all relationships that the PSO has with the 
provider, the PSO is not independently managed or controlled, or the PSO 
does not operate independently from, the contracting provider.
    (ii) Content. A PSO must submit to the Secretary the required 
attestation form for disclosures with the information specified below in 
accordance with Sec.  3.112 and this section. The substantive 
information that must be included with each submission has two required 
parts:
    (A) The Required Disclosures. The first part of the substantive 
information must provide a succinct list of obligations between the PSO 
and the contracting provider apart from their Patient Safety Act 
contract(s) that create, or contain, any of the types of relationships 
that must be disclosed based upon the requirements of paragraphs 
(d)(2)(i)(A) through (D) of this section. Each reportable obligation or 
discrete set of obligations that the PSO has with this contracting 
provider should be listed only once; noting the specific aspects of the 
obligation(s) that reflect contractual or financial relationships, 
involve access to information that is not available to other providers, 
or affect the independence of PSO operations, management, or control.
    (B) An Explanatory Narrative. The second required part of the 
substantive information must provide a brief explanatory narrative 
succinctly describing: The policies and procedures that the PSO has in 
place to ensure adherence to objectivity and professionally recognized 
analytic standards in the assessments it undertakes; and any other 
policies or procedures, or agreements with this provider, that the PSO 
has in place to ensure that it can fairly and accurately perform patient 
safety activities.
    (iii) Deadlines for submission. The Secretary must receive a 
disclosure statement within 45 days of the date on which a PSO enters a 
contract with a provider if the circumstances described in any of the 
paragraphs (d)(2)(i)(A) through (D) of this section are met on the date 
the contract is entered. During the contract period, if these 
circumstances subsequently arise, the Secretary must receive a 
disclosure statement from the PSO within 45 days

[[Page 46]]

of the date that any disclosure requirement in paragraph (d)(2)(i) of 
this section first applies.



Sec.  3.104  Secretarial actions.

    (a) Actions in response to certification submissions for initial and 
continued listing as a PSO. (1) In response to an initial or continued 
certification submission by an entity, pursuant to the requirements of 
Sec.  3.102 of this subpart, the Secretary may--
    (i) Accept the certification submission and list the entity as a 
PSO, or maintain the listing of a PSO, if the Secretary determines that 
the entity meets the applicable requirements of the Patient Safety Act 
and this subpart;
    (ii) Deny acceptance of a certification submission and, in the case 
of a currently listed PSO, remove the entity from the list if the entity 
does not meet the applicable requirements of the Patient Safety Act and 
this subpart; or
    (iii) Condition the listing of an entity or the continued listing of 
a PSO, following a determination made pursuant to paragraph (c) of this 
section or a determination after review of the pertinent history of an 
entity that has been delisted or refused listing and its officials and 
senior managers.
    (2) Basis for determination. In making a determination regarding 
listing, the Secretary will consider the certification submission; any 
prior actions by the Secretary regarding the entity or PSO including 
delisting; any history of or current non-compliance by the entity or the 
PSO or its officials or senior managers with statutory or regulatory 
requirements or requests from the Secretary; the relationships of the 
entity or PSO with providers; and any findings made by the Secretary in 
accordance with paragraph (c) of this section.
    (3) Notification. The Secretary will notify in writing each entity 
of action taken on its certification submission for initial or continued 
listing. The Secretary will provide reasons when an entity's 
certification is conditionally accepted and the entity is conditionally 
listed, when an entity's certification is not accepted and the entity is 
not listed, or when acceptance of its certification is revoked and the 
entity is delisted.
    (b) Actions regarding PSO compliance with the minimum contract 
requirement. After the date on which the Secretary, under Sec.  
3.102(d)(1) of this subpart, must receive notification regarding 
compliance of a PSO with the minimum contract requirement--
    (1) If the PSO has met the minimum contract requirement, the 
Secretary will acknowledge in writing receipt of the notification and 
add information to the list established pursuant to paragraph (d) of 
this section stating that the PSO has certified that it has met the 
requirement.
    (2) If the PSO states that it has not yet met the minimum contract 
requirement by the date specified in Sec.  3.102(d)(1), or if notice is 
not received by that date, the Secretary will issue to the PSO a notice 
of a preliminary finding of deficiency as specified in Sec.  3.108(a)(2) 
and establish a period for correction that extends until midnight of the 
last day of the PSO's applicable 24-month period of assessment. 
Thereafter, if the requirement has not been met, the Secretary will 
provide the PSO a written notice of proposed revocation and delisting in 
accordance with Sec.  3.108(a)(3).
    (c) Actions regarding required disclosures by PSOs of relationships 
with contracting providers. The Secretary will review and make findings 
regarding each disclosure statement submitted by a PSO, pursuant to 
Sec.  3.102(d)(2), regarding its relationships with contracting 
provider(s), determine whether such findings warrant action regarding 
the listing of the PSO in accordance with paragraph (c)(2) of this 
section, and make the findings public.
    (1) Basis of findings regarding PSO disclosure statements. In 
reviewing disclosure statements, submitted pursuant to Sec.  3.102(d)(2) 
of this subpart, the Secretary will consider the disclosed 
relationship(s) between the PSO and the contracting provider and the 
statements and material submitted by the PSO describing the policies and 
procedures that the PSO has in place to determine whether the PSO can 
fairly and accurately perform the required patient safety activities.

[[Page 47]]

    (2) Determination by the Secretary. Based on the Secretary's review 
and findings, he may choose to take any of the following actions:
    (i) For an entity seeking an initial or continued listing, the 
Secretary may list or continue the listing of an entity without 
conditions, list the entity subject to conditions, or deny the entity's 
certification for initial or continued listing; or
    (ii) For a listed PSO, the Secretary may determine that the entity 
will remain listed without conditions, continue the entity's listing 
subject to conditions, or remove the entity from the list of PSOs.
    (3) Release of disclosure statements and Secretarial findings. (i) 
Subject to paragraph (c)(3)(ii) of this section, the Secretary will make 
disclosure statements available to the public along with related 
findings that are made available in accordance with paragraph (c) of 
this section.
    (ii) The Secretary may withhold information that is exempt from 
public disclosure under the Freedom of Information Act, e.g., trade 
secrets or confidential commercial information that are subject to the 
restrictions of 18 U.S.C. 1905.
    (d) Maintaining a list of PSOs. The Secretary will compile and 
maintain a publicly available list of entities whose certifications as 
PSOs have been accepted. The list will include contact information for 
each entity, a copy of all certification forms and disclosure statements 
submitted by each entity in accordance with paragraph (c)(3)(ii) of this 
section, the effective date of the PSO's listing, and information on 
whether a PSO has certified that it has met the two contract 
requirement. The list also will include a copy of the Secretary's 
findings regarding each disclosure statement submitted by an entity, 
information describing any related conditions that have been placed by 
the Secretary on the listing of an entity as a PSO, and other 
information that this Subpart states may be made public. AHRQ may 
maintain a PSO website (or a comparable future form of public notice) 
and may post the list on this website.
    (e) Three-year period of listing. (1) The three-year period of 
listing of a PSO will automatically expire at midnight of the last day 
of this period, unless the listing had been revoked or relinquished 
earlier in accordance with Sec.  3.108 of this subpart, or if, prior to 
this automatic expiration, the PSO seeks a new three-year listing, in 
accordance with Sec.  3.102, and the Secretary accepts the PSO's 
certification for a new three-year listing, in accordance with Sec.  
3.104(a).
    (2) The Secretary plans to send a written notice of imminent 
expiration to a PSO at least 60 calendar days prior to the date on which 
its three-year period of listing expires if the Secretary has not yet 
received a certification for continued listing. The Secretary plans to 
indicate, on the AHRQ PSO website, the PSOs from whom certifications for 
continued listing have not been timely received.
    (f) Effective dates of Secretarial actions. Unless otherwise stated, 
the effective date of each action by the Secretary pursuant to this 
subpart will be specified in the written notice of such action that is 
sent to the entity. When the Secretary sends a notice that addresses 
acceptance or revocation of an entity's certifications or voluntary 
relinquishment by an entity of its status as a PSO, the notice will 
specify the effective date and time of listing or delisting.



Sec.  3.106  Security requirements.

    (a) Application. A PSO must secure patient safety work product in 
conformance with the security requirements of paragraph (b) of this 
section. These requirements must be met at all times and at any location 
at which the PSO, its workforce members, or its contractors receive, 
access, or handle patient safety work product. Handling patient safety 
work product includes its processing, development, use, maintenance, 
storage, removal, disclosure, transmission and destruction.
    (b) Security framework. A PSO must have written policies and 
procedures that address each of the considerations specified in this 
subsection. In addressing the framework that follows, the PSO may 
develop appropriate and scalable security standards, policies, and 
procedures that are suitable for the size and complexity of its 
organization.

[[Page 48]]

    (1) Security management. A PSO must address:
    (i) Maintenance and effective implementation of written policies and 
procedures that conform to the requirements of this section to protect 
the confidentiality, integrity, and availability of the patient safety 
work product that is received, accessed, or handled; and to monitor and 
improve the effectiveness of such policies and procedures, and
    (ii) Training of the PSO workforce and PSO contractors who receive, 
access, or handle patient safety work product regarding the requirements 
of the Patient Safety Act, this Part, and the PSO's policies and 
procedures regarding the confidentiality and security of patient safety 
work product.
    (2) Distinguishing patient safety work product. A PSO must address:
    (i) Maintenance of the security of patient safety work product, 
whether in electronic or other media, through either physical separation 
from non-patient safety work product, or if co-located with non-patient 
safety work product, by making patient safety work product 
distinguishable so that the appropriate form and level of security can 
be applied and maintained;
    (ii) Protection of the media, whether in electronic, paper, or other 
media or format, that contain patient safety work product, limiting 
access to authorized users, and sanitizing and destroying such media 
before their disposal or release for reuse; and
    (iii) Physical and environmental protection, to control and limit 
physical and virtual access to places and equipment where patient safety 
work product is received, accessed, or handled.
    (3) Security control and monitoring. A PSO must address:
    (i) Identification of those authorized to receive, access, or handle 
patient safety work product and an audit capacity to detect unlawful, 
unauthorized, or inappropriate receipt, access, or handling of patient 
safety work product, and
    (ii) Methods to prevent unauthorized receipt, access, or handling of 
patient safety work product.
    (4) Security assessment. A PSO must address:
    (i) Periodic assessments of security risks and controls to establish 
if its controls are effective, to correct any deficiency identified, and 
to reduce or eliminate any vulnerabilities.
    (ii) System and communications protection, to monitor, control, and 
protect PSO receipt, access, or handling of patient safety work product 
with particular attention to the transmission of patient safety work 
product to and from providers, other PSOs, contractors or any other 
responsible persons.



Sec.  3.108  Correction of deficiencies, revocation, 
and voluntary relinquishment.

    (a) Process for correction of a deficiency and revocation--(1) 
Circumstances leading to revocation. The Secretary may revoke his 
acceptance of an entity's certification (``revocation'') and delist the 
entity as a PSO if he determines--
    (i) The PSO is not fulfilling the certifications made to the 
Secretary as required by Sec.  3.102;
    (ii) The PSO has not met the two contract requirement, as required 
by Sec.  3.102(d)(1);
    (iii) Based on a PSO's disclosures made pursuant to Sec.  
3.102(d)(2) , that the entity cannot fairly and accurately perform the 
patient safety activities of a PSO with a public finding to that effect; 
or
    (iv) The PSO is not in compliance with any other provision of the 
Patient Safety Act or this part.
    (2) Notice of preliminary finding of deficiency and establishment of 
an opportunity for correction of a deficiency. (i) Except as provided by 
paragraph (e) of this section, if the Secretary determines that a PSO is 
not in compliance with its obligations under the Patient Safety Act or 
this subpart, the Secretary must send a PSO written notice of the 
preliminary finding of deficiency. The notice must state the actions or 
inactions that encompass the deficiency finding, outline the evidence 
that the deficiency exists, specify the possible and/or required 
corrective actions that must be taken, and establish a date by which the 
deficiency must be corrected. The Secretary may specify in the notice 
the form of documentation required to demonstrate that the deficiency 
has been corrected.

[[Page 49]]

    (ii) The notice of a preliminary finding of deficiency is presumed 
received five days after it is sent, absent evidence of the actual 
receipt date. If a PSO does not submit evidence to the Secretary within 
14 calendar days of actual or constructive receipt of such notice, 
whichever is longer, which demonstrates that the preliminary finding is 
factually incorrect, the preliminary finding will be the basis for a 
finding of deficiency.
    (3) Determination of correction of a deficiency. (i) Unless the 
Secretary specifies another date, the Secretary must receive 
documentation to demonstrate that the PSO has corrected any deficiency 
cited in the preliminary finding of deficiency no later than five 
calendar days following the last day of the correction period that is 
specified by the Secretary in such notice.
    (ii) In making a determination regarding the correction of any 
deficiency, the Secretary will consider the documentation submitted by 
the PSO, any assessments under Sec.  3.110, recommendations of program 
staff, and any other information available regarding the PSO that the 
Secretary deems appropriate and relevant to the PSO's implementation of 
the terms of its certification.
    (iii) After completing his review, the Secretary may make one of the 
following determinations:
    (A) The action(s) taken by the PSO have corrected any deficiency, in 
which case the Secretary will withdraw the notice of deficiency and so 
notify the PSO;
    (B) The PSO has acted in good faith to correct the deficiency, but 
the Secretary finds an additional period of time is necessary to achieve 
full compliance and/or the required corrective action specified in the 
notice of a preliminary finding of deficiency needs to be modified in 
light of the experience of the PSO in attempting to implement the 
corrective action, in which case the Secretary will extend the period 
for correction and/or modify the specific corrective action required; or
    (C) The PSO has not completed the corrective action because it has 
not acted with reasonable diligence or speed to ensure that the 
corrective action was completed within the allotted time, in which case 
the Secretary will issue to the PSO a notice of proposed revocation and 
delisting.
    (iv) When the Secretary issues a written notice of proposed 
revocation and delisting, the notice will specify the deficiencies that 
have not been timely corrected and will detail the manner in which the 
PSO may exercise its opportunity to be heard in writing to respond to 
the deficiencies specified in the notice.
    (4) Opportunity to be heard in writing following a notice of 
proposed revocation and delisting. The Secretary will afford a PSO an 
opportunity to be heard in writing, as specified in paragraph (a)(4)(i) 
of this section, to provide a substantive response to the deficiency 
finding(s) set forth in the notice of proposed revocation and delisting.
    (i) The notice of proposed revocation and delisting is presumed 
received five days after it is sent, absent evidence of actual receipt. 
The Secretary will provide a PSO with a period of time, beginning with 
the date of receipt of the notice of proposed revocation and delisting 
of which there is evidence, or the presumed date of receipt if there is 
no evidence of earlier receipt, and ending at midnight 30 calendar days 
thereafter, during which the PSO may submit a substantive response to 
the deficiency findings in writing.
    (ii) The Secretary will provide to the PSO any rules of procedure 
governing the form or transmission of the written response to the notice 
of proposed revocation and delisting. Such rules may also be posted on 
the AHRQ PSO Web site or published in the Federal Register.
    (iii) If a PSO does not submit a written response to the deficiency 
finding(s) within 30 calendar days of receipt of the notice of proposed 
revocation and delisting, the notice of proposed revocation becomes 
final as a matter of law and the basis for Secretarial action under 
paragraph (b)(1) of this section.
    (5) The Secretary's decision regarding revocation. The Secretary 
will review the entire administrative record pertaining to a notice of 
proposed revocation and delisting and any written materials submitted by 
the PSO under paragraph (a)(4) of this section. The

[[Page 50]]

Secretary may affirm, reverse, or modify the notice of proposed 
revocation and delisting and will make a determination with respect to 
the continued listing of the PSO.
    (b) Revocation of the Secretary's acceptance of a PSO's 
certifications--(1) Establishing the date and time of revocation and 
delisting. When the Secretary concludes, in accordance with a decision 
made under paragraphs (a)(5), (e)(3)(iii) or (e)(3)(iv)(C) of this 
section, that revocation of the acceptance of a PSO's certification is 
warranted for its failure to comply with requirements of the Patient 
Safety Act or of this Part, the Secretary will establish the effective 
time and date for such prompt revocation and removal of the entity from 
the list of PSOs, so notify the PSO in writing, and provide the relevant 
public notice required by Sec.  3.108(d) of this subpart.
    (2) Required notification of providers and status of data. (i) Upon 
being notified of the Secretary's action pursuant to paragraph (b)(1) of 
this section, the former PSO will take all reasonable actions to notify 
each provider, whose patient safety work product it collected or 
analyzed, of the Secretary's action(s) and the following statutory 
information: Confidentiality and privilege protections that applied to 
patient safety work product while the former PSO was listed continue to 
apply after the entity is removed from listing. Data submitted by 
providers to the former PSO for 30 calendar days following the date and 
time on which the entity was removed from the list of PSOs pursuant to 
paragraph (b)(1) of this section will have the same status as data 
submitted while the entity was still listed.
    (ii) Within 15 days of being notified of the Secretary's action 
pursuant to paragraph (b)(1) of this section, the former PSO shall 
submit to the Secretary confirmation that it has taken the actions in 
paragraph (b)(2)(i) of this section.
    (3) Disposition of patient safety work product and data. Within 90 
days following the effective date of revocation and delisting pursuant 
to paragraph (b)(1) of this section, the former PSO will take one or 
more of the following measures in regard to patient safety work product 
and data described in paragraph (b)(2)(i) of this section:
    (i) Transfer such patient safety work product or data, with the 
approval of the source from which it was received, to a PSO that has 
agreed to receive such patient safety work product or data;
    (ii) Return such work product or data to the source from which it 
was submitted; or
    (iii) If returning such patient safety work product or data to its 
source is not practicable, destroy such patient safety work product or 
data.
    (c) Voluntary relinquishment--(1) Circumstances constituting 
voluntary relinquishment. A PSO will be considered to have voluntarily 
relinquished its status as a PSO if the Secretary accepts a notification 
from a PSO that it wishes to relinquish voluntarily its listing as a 
PSO.
    (2) Notification of voluntary relinquishment. A PSO's notification 
of voluntary relinquishment to the Secretary must include the following:
    (i) An attestation that all reasonable efforts have been made, or 
will have been made by a PSO within 15 calendar days of this statement, 
to notify the sources from which it received patient safety work product 
of the PSO's intention to cease PSO operations and activities, to 
relinquish voluntarily its status as a PSO, to request that these other 
entities cease reporting or submitting any further information to the 
PSO as soon as possible, and inform them that any information reported 
after the effective date and time of delisting that the Secretary sets 
pursuant to paragraph (c)(3) of this section will not be protected as 
patient safety work product under the Patient Safety Act.
    (ii) An attestation that the entity has established a plan, or 
within 15 calendar days of this statement, will have made all reasonable 
efforts to establish a plan, in consultation with the sources from which 
it received patient safety work product, that provides for the 
disposition of the patient safety work product held by the PSO 
consistent with, to the extent practicable, the statutory options for 
disposition of patient safety work product as set out in paragraph 
(b)(3) of this section; and

[[Page 51]]

    (iii) Appropriate contact information for further communications 
from the Secretary.
    (3) Response to notification of voluntary relinquishment. (i) After 
a PSO provides the notification required by paragraph (c)(2) of this 
section, the Secretary will respond in writing to the entity indicating 
whether the proposed voluntary relinquishment of its PSO status is 
accepted. If the voluntary relinquishment is accepted, the Secretary's 
response will indicate an effective date and time for the entity's 
removal from the list of PSOs and will provide public notice of the 
voluntary relinquishment and the effective date and time of the 
delisting, in accordance with Sec.  3.108(d) of this subpart.
    (ii) If the Secretary receives a notification of voluntary 
relinquishment during or immediately after revocation proceedings for 
cause under paragraphs (a)(4) and (a)(5) of this section, the Secretary, 
as a matter of discretion, may accept voluntary relinquishment in 
accordance with the preceding paragraph or decide not to accept the 
entity's proposed voluntary relinquishment and proceed with the 
revocation for cause and delisting pursuant to paragraph (b)(1) of this 
section.
    (4) Non-applicability of certain procedures and requirements. (i) A 
decision by the Secretary to accept a request by a PSO to relinquish 
voluntarily its status as a PSO pursuant to paragraph (c)(2) of this 
section does not constitute a determination of a deficiency in PSO 
compliance with the Patient Safety Act or with this Subpart.
    (ii) The procedures and requirements of Sec.  3.108(a) of this 
subpart regarding deficiencies including the opportunity to correct 
deficiencies and to be heard in writing, and the procedures and 
requirements of Sec.  3.108(b) are not applicable to determinations of 
the Secretary made pursuant to this subsection.
    (d) Public notice of delisting regarding removal from listing. If 
the Secretary removes an entity from the list of PSOs following 
revocation of acceptance of the entity's certification pursuant to Sec.  
3.108(b)(1), voluntary relinquishment pursuant to Sec.  3.108(c)(3), or 
expiration of an entity's period of listing pursuant to Sec.  
3.104(e)(1), the Secretary will promptly publish in the Federal Register 
and on the AHRQ PSO website, or in a comparable future form of public 
notice, a notice of the actions taken and the effective dates.
    (e) Expedited revocation and delisting--(1) Basis for expedited 
revocation. Notwithstanding any other provision of this section, the 
Secretary may use the expedited revocation process described in 
paragraph (e)(3) of this section if he determines--
    (i) The PSO is not in compliance with this part because it is or is 
about to become an entity described in Sec.  3.102(a)(2).
    (ii) The parent organization of the PSO is an entity described in 
Sec.  3.102(a)(2) and requires or induces health care providers to 
report patient safety work product to its component PSO; or
    (iii) The circumstances for revocation in paragraph (a)(1) of this 
section exist, and the Secretary has determined that there would be 
serious adverse consequences if the PSO were to remain listed.
    (2) Applicable provisions. If the Secretary uses the expedited 
revocation process described in paragraph (e)(3) of this section, the 
procedures in paragraphs (a)(2) through (5) of this section shall not 
apply and paragraph (a)(1) and paragraphs (b) and (d) of this section 
shall apply.
    (3) Expedited revocation process. (i) The Secretary must send the 
PSO a written notice of deficiency that:
    (A) Identifies the evidence that the circumstances for revocation 
and delisting under paragraph (a)(1) of this section exist, and any 
corrective action that the PSO must take if the Secretary determines 
that corrective action may resolve the matter so that the entity would 
not be delisted; and
    (B) Provides an opportunity for the PSO to respond in writing to 
correct the facts or the legal bases for delisting found in the notice, 
and to offer any other grounds for its not being delisted.
    (ii) The notice of deficiency will be presumed to be received five 
days after it is sent, absent evidence of the actual receipt date.

[[Page 52]]

    (iii) If the PSO does not submit a written response to the Secretary 
within 14 calendar days of actual or constructive receipt of such 
notice, whichever is longer, the Secretary may revoke his acceptance of 
the PSO's certifications and remove the entity from the list of PSOs.
    (iv) If the PSO responds in writing within the required 14-day time 
period, the Secretary may take any of the following actions:
    (A) Withdraw the notice of deficiency;
    (B) Provide the PSO with more time to resolve the matter to the 
Secretary's satisfaction; or
    (C) Revoke his acceptance of the PSO's certifications and remove the 
entity from the list of PSOs.



Sec.  3.110  Assessment of PSO compliance.

    The Secretary may request information or conduct announced or 
unannounced reviews of, or site visits to, PSOs, to assess or verify PSO 
compliance with the requirements of this subpart and for these purposes 
will be allowed to inspect the physical or virtual sites maintained or 
controlled by the PSO. The Secretary will be allowed to inspect and/or 
be given or sent copies of any PSO records deemed necessary and 
requested by the Secretary to implement the provisions of this subpart. 
Such PSO records may include patient safety work product in accordance 
with Sec.  3.206(d) of this part.



Sec.  3.112  Submissions and forms.

    (a) Forms referred to in this subpart may be obtained on the PSO Web 
site (http://www.pso.ahrq.gov) maintained for the Secretary by AHRQ or a 
successor agency or on successor publication technology or by requesting 
them in writing by e-mail at [email protected], or by mail from the 
Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540 
Gaither Road, Rockville, MD 20850. A form (including any required 
attachments) must be submitted in accordance with the accompanying 
instructions.
    (b) Information submitted to AHRQ in writing, but not required to be 
on or attached to a form, and requests for information from AHRQ, may be 
submitted by mail or other delivery to the Agency for Healthcare 
Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville, 
MD 20850, by facsimile at (301) 427-1341, or by e-mail at 
[email protected].
    (c) If a submission to the Secretary is incomplete or additional 
information is needed to allow a determination to be made under this 
subpart, the submitter will be notified if any additional information is 
required.



 Subpart C_Confidentiality and Privilege Protections of Patient Safety 
                              Work Product



Sec.  3.204  Privilege of patient safety work product.

    (a) Privilege. Notwithstanding any other provision of Federal, 
State, local, or Tribal law and subject to paragraph (b) of this section 
and Sec.  3.208 of this subpart, patient safety work product shall be 
privileged and shall not be:
    (1) Subject to a Federal, State, local, or Tribal civil, criminal, 
or administrative subpoena or order, including in a Federal, State, 
local, or Tribal civil or administrative disciplinary proceeding against 
a provider;
    (2) Subject to discovery in connection with a Federal, State, local, 
or Tribal civil, criminal, or administrative proceeding, including in a 
Federal, State, local, or Tribal civil or administrative disciplinary 
proceeding against a provider;
    (3) Subject to disclosure pursuant to section 552 of Title 5, United 
States Code (commonly known as the Freedom of Information Act) or any 
other similar Federal, State, local, or Tribal law;
    (4) Admitted as evidence in any Federal, State, local, or Tribal 
governmental civil proceeding, criminal proceeding, administrative 
rulemaking proceeding, or administrative adjudicatory proceeding, 
including any such proceeding against a provider; or
    (5) Admitted in a professional disciplinary proceeding of a 
professional disciplinary body established or specifically authorized 
under State law.
    (b) Exceptions to privilege. Privilege shall not apply to (and shall 
not be construed to prohibit) one or more of the following disclosures:

[[Page 53]]

    (1) Disclosure of relevant patient safety work product for use in a 
criminal proceeding, subject to the conditions at Sec.  3.206(b)(1) of 
this subpart.
    (2) Disclosure to the extent required to permit equitable relief 
subject to the conditions at Sec.  3.206(b)(2) of this subpart.
    (3) Disclosure pursuant to provider authorizations subject to the 
conditions at Sec.  3.206(b)(3) of this subpart.
    (4) Disclosure of non-identifiable patient safety work product 
subject to the conditions at Sec.  3.206(b)(5) of this subpart.
    (c) Implementation and enforcement by the Secretary. Privilege shall 
not apply to (and shall not be construed to prohibit) disclosures of 
relevant patient safety work product to or by the Secretary if such 
patient safety work product is needed to investigate or determine 
compliance, or to seek or impose civil money penalties, with respect to 
this part or the HIPAA Privacy Rule, or to make or support decisions 
with respect to listing of a PSO.



Sec.  3.206  Confidentiality of patient safety work product.

    (a) Confidentiality. Subject to paragraphs (b) through (e) of this 
section, and Sec. Sec.  3.208 and 3.210 of this subpart, patient safety 
work product shall be confidential and shall not be disclosed.
    (b) Exceptions to confidentiality. The confidentiality provisions 
shall not apply to (and shall not be construed to prohibit) one or more 
of the following disclosures:
    (1) Disclosure in criminal proceedings. Disclosure of relevant 
patient safety work product for use in a criminal proceeding, but only 
after a court makes an in-camera determination that:
    (i) Such patient safety work product contains evidence of a criminal 
act;
    (ii) Such patient safety work product is material to the proceeding; 
and
    (iii) Such patient safety work product is not reasonably available 
from any other source.
    (2) Disclosure to permit equitable relief for reporters. Disclosure 
of patient safety work product to the extent required to permit 
equitable relief under section 922 (f)(4)(A) of the Public Health 
Service Act, provided the court or administrative tribunal has issued a 
protective order to protect the confidentiality of the patient safety 
work product in the course of the proceeding.
    (3) Disclosure authorized by identified providers. (i) Disclosure of 
identifiable patient safety work product consistent with a valid 
authorization if such authorization is obtained from each provider 
identified in such work product prior to disclosure. A valid 
authorization must:
    (A) Be in writing and signed by the provider from whom authorization 
is sought; and
    (B) Contain sufficient detail to fairly inform the provider of the 
nature and scope of the disclosures being authorized;
    (ii) A valid authorization must be retained by the disclosing entity 
for six years from the date of the last disclosure made in reliance on 
the authorization and made available to the Secretary upon request.
    (4) Disclosure for patient safety activities--(i) Disclosure between 
a provider and a PSO. Disclosure of patient safety work product for 
patient safety activities by a provider to a PSO or by a PSO to that 
disclosing provider.
    (ii) Disclosure to a contractor of a provider or a PSO. A provider 
or a PSO may disclose patient safety work product for patient safety 
activities to an entity with which it has contracted to undertake 
patient safety activities on its behalf. A contractor receiving patient 
safety work product for patient safety activities may not further 
disclose patient safety work product, except to the provider or PSO with 
which it is contracted.
    (iii) Disclosure among affiliated providers. Disclosure of patient 
safety work product for patient safety activities by a provider to an 
affiliated provider.
    (iv) Disclosure to another PSO or provider. Disclosure of patient 
safety work product for patient safety activities by a PSO to another 
PSO or to another provider that has reported to the PSO, or, except as 
otherwise permitted in paragraph (b)(4)(iii) of this section, by a 
provider to another provider, provided:

[[Page 54]]

    (A) The following direct identifiers of any providers and of 
affiliated organizations, corporate parents, subsidiaries, practice 
partners, employers, members of the workforce, or household members of 
such providers are removed:
    (1) Names;
    (2) Postal address information, other than town or city, State and 
zip code;
    (3) Telephone numbers;
    (4) Fax numbers;
    (5) Electronic mail addresses;
    (6) Social security numbers or taxpayer identification numbers;
    (7) Provider or practitioner credentialing or DEA numbers;
    (8) National provider identification number;
    (9) Certificate/license numbers;
    (10) Web Universal Resource Locators (URLs);
    (11) Internet Protocol (IP) address numbers;
    (12) Biometric identifiers, including finger and voice prints; and
    (13) Full face photographic images and any comparable images; and
    (B) With respect to any individually identifiable health information 
in such patient safety work product, the direct identifiers listed at 45 
CFR 164.514(e)(2) have been removed.
    (5) Disclosure of nonidentifiable patient safety work product. 
Disclosure of nonidentifiable patient safety work product when patient 
safety work product meets the standard for nonidentification in 
accordance with Sec.  3.212 of this subpart.
    (6) Disclosure for research. (i) Disclosure of patient safety work 
product to persons carrying out research, evaluation or demonstration 
projects authorized, funded, certified, or otherwise sanctioned by rule 
or other means by the Secretary, for the purpose of conducting research.
    (ii) If the patient safety work product disclosed pursuant to 
paragraph (b)(6)(i) of this section is by a HIPAA covered entity as 
defined at 45 CFR 160.103 and contains protected health information as 
defined by the HIPAA Privacy Rule at 45 CFR 160.103, such patient safety 
work product may only be disclosed under this exception in the same 
manner as would be permitted under the HIPAA Privacy Rule.
    (7) Disclosure to the Food and Drug Administration (FDA) and 
entities required to report to FDA. (i) Disclosure by a provider of 
patient safety work product concerning an FDA-regulated product or 
activity to the FDA, an entity required to report to the FDA concerning 
the quality, safety, or effectiveness of an FDA-regulated product or 
activity, or a contractor acting on behalf of FDA or such entity for 
these purposes.
    (ii) Any person permitted to receive patient safety work product 
pursuant to paragraph (b)(7)(i) of this section may only further 
disclose such patient safety work product for the purpose of evaluating 
the quality, safety, or effectiveness of that product or activity to 
another such person or the disclosing provider.
    (8) Voluntary disclosure to an accrediting body. (i) Voluntary 
disclosure by a provider of patient safety work product to an 
accrediting body that accredits that provider, provided, with respect to 
any identified provider other than the provider making the disclosure:
    (A) The provider agrees to the disclosure; or
    (B) The identifiers at Sec.  3.206(b)(4)(iv)(A) are removed.
    (ii) An accrediting body may not further disclose patient safety 
work product it receives pursuant to paragraph (b)(8)(i) of this 
section.
    (iii) An accrediting body may not take an accrediting action against 
a provider based on a good faith participation of the provider in the 
collection, development, reporting, or maintenance of patient safety 
work product in accordance with this Part. An accrediting body may not 
require a provider to reveal its communications with any PSO.
    (9) Disclosure for business operations. (i) Disclosure of patient 
safety work product by a provider or a PSO for business operations to 
attorneys, accountants, and other professionals. Such contractors may 
not further disclose patient safety work product, except to the entity 
from which they received the information.
    (ii) Disclosure of patient safety work product for such other 
business operations that the Secretary may prescribe by regulation as 
consistent with the goals of this part.

[[Page 55]]

    (10) Disclosure to law enforcement. (i) Disclosure of patient safety 
work product to an appropriate law enforcement authority relating to an 
event that either constitutes the commission of a crime, or for which 
the disclosing person reasonably believes constitutes the commission of 
a crime, provided that the disclosing person believes, reasonably under 
the circumstances, that the patient safety work product that is 
disclosed is necessary for criminal law enforcement purposes.
    (ii) Law enforcement personnel receiving patient safety work product 
pursuant to paragraph (b)(10)(i) of this section only may disclose that 
patient safety work product to other law enforcement authorities as 
needed for law enforcement activities related to the event that gave 
rise to the disclosure under paragraph (b)(10)(i) of this section.
    (c) Safe harbor. A provider or responsible person, but not a PSO, is 
not considered to have violated the requirements of this subpart if a 
member of its workforce discloses patient safety work product, provided 
that the disclosure does not include materials, including oral 
statements, that:
    (1) Assess the quality of care of an identifiable provider; or
    (2) Describe or pertain to one or more actions or failures to act by 
an identifiable provider.
    (d) Implementation and enforcement by the Secretary. The 
confidentiality provisions shall not apply to (and shall not be 
construed to prohibit) disclosures of relevant patient safety work 
product to or by the Secretary if such patient safety work product is 
needed to investigate or determine compliance or to seek or impose civil 
money penalties, with respect to this part or the HIPAA Privacy Rule, or 
to make or support decisions with respect to listing of a PSO.
    (e) No limitation on authority to limit or delegate disclosure or 
use. Nothing in subpart C of this part shall be construed to limit the 
authority of any person to enter into a contract requiring greater 
confidentiality or delegating authority to make a disclosure or use in 
accordance with this subpart.



Sec.  3.208  Continued protection of patient safety work product.

    (a) Except as provided in paragraph (b) of this section, patient 
safety work product disclosed in accordance with this subpart, or 
disclosed impermissibly, shall continue to be privileged and 
confidential.
    (b)(1) Patient safety work product disclosed for use in a criminal 
proceeding pursuant to section 922(c)(1)(A) of the Public Health Service 
Act, 42 U.S.C. 299b-22(c)(1)(A), and/or pursuant to Sec.  3.206(b)(1) of 
this subpart continues to be privileged, but is no longer confidential.
    (2) Non-identifiable patient safety work product that is disclosed 
is no longer privileged or confidential and not subject to the 
regulations under this part.
    (3) Paragraph (b) of this section applies only to the specific 
patient safety work product disclosed.



Sec.  3.210  Required disclosure of patient safety work product 
to the Secretary.

    Notwithstanding any other provision in this part, providers, PSOs, 
and responsible persons must disclose patient safety work product upon 
request by the Secretary when the Secretary determines such patient 
safety work product is needed to investigate or determine compliance or 
to seek or impose civil money penalties, with respect to this part or 
the HIPAA Privacy Rule, or to make or support decisions with respect to 
listing of a PSO.



Sec.  3.212  Nonidentification of patient safety work product.

    (a) Patient safety work product is nonidentifiable with respect to a 
particular identified provider or a particular identified reporter if:
    (1) A person with appropriate knowledge of and experience with 
generally accepted statistical and scientific principles and methods for 
rendering information not individually identifiable:
    (i) Applying such principles and methods, determines that the risk 
is very small that the information could be used, alone or in 
combination with other reasonably available information, by an 
anticipated recipient to

[[Page 56]]

identify an identified provider or reporter; and
    (ii) Documents the methods and results of the analysis that justify 
such determination; or
    (2)(i) The following identifiers of such provider or reporter and of 
affiliated organizations, corporate parents, subsidiaries, practice 
partners, employers, members of the workforce, or household members of 
such providers or reporters are removed:
    (A) The direct identifiers listed at Sec.  3.206(b)(4)(iv)(A)(1) 
through (13) of this subpart;
    (B) Geographic subdivisions smaller than a State, including street 
address, city, county, precinct, zip code and equivalent geocodes, 
except for the initial three digits of a zip code if, according to the 
current publicly available data from the Bureau of the Census, the 
geographic unit formed by combining all zip codes with the same three 
initial digits contains more than 20,000 people;
    (C) All elements of dates (except year) for dates directly related 
to a patient safety incident or event; and
    (D) Any other unique identifying number, characteristic, or code 
except as permitted for re-identification; and
    (ii) The provider, PSO or responsible person making the disclosure 
does not have actual knowledge that the information could be used, alone 
or in combination with other information that is reasonably available to 
the intended recipient, to identify the particular provider or reporter.
    (3) Re-identification. A provider, PSO, or responsible person may 
assign a code or other means of record identification to allow 
information made nonidentifiable under this section to be re-identified 
by such provider, PSO, or responsible person, provided that:
    (i) The code or other means of record identification is not derived 
from or related to information about the provider or reporter and is not 
otherwise capable of being translated so as to identify the provider or 
reporter; and
    (ii) The provider, PSO, or responsible person does not use or 
disclose the code or other means of record identification for any other 
purpose, and does not disclose the mechanism for re-identification.
    (b) Patient safety work product is non-identifiable with respect to 
a particular patient only if the individually identifiable health 
information regarding that patient is de-identified in accordance with 
the HIPAA Privacy Rule standard and implementation specifications for 
the de-identification at 45 CFR 164.514(a) through (c).



                      Subpart D_Enforcement Program



Sec.  3.304  Principles for achieving compliance.

    (a) Cooperation. The Secretary will, to the extent practicable, seek 
the cooperation of providers, PSOs, and responsible persons in obtaining 
compliance with the applicable confidentiality provisions.
    (b) Assistance. The Secretary may provide technical assistance to 
providers, PSOs, and responsible persons to help them comply voluntarily 
with the applicable confidentiality provisions.



Sec.  3.306  Complaints to the Secretary.

    (a) Right to file a complaint. A person who believes that patient 
safety work product has been disclosed in violation of the 
confidentiality provisions may file a complaint with the Secretary.
    (b) Requirements for filing complaints. Complaints under this 
section must meet the following requirements:
    (1) A complaint must be filed in writing, either on paper or 
electronically.
    (2) A complaint must name the person that is the subject of the 
complaint and describe the act(s) believed to be in violation of the 
applicable confidentiality provision(s).
    (3) A complaint must be filed within 180 days of when the 
complainant knew or should have known that the act complained of 
occurred, unless this time limit is waived by the Secretary for good 
cause shown.
    (4) The Secretary may prescribe additional procedures for the filing 
of complaints, as well as the place and manner of filing, by notice in 
the Federal Register.
    (c) Investigation. The Secretary may investigate complaints filed 
under this section. Such investigation may include a review of the 
pertinent policies,

[[Page 57]]

procedures, or practices of the respondent and of the circumstances 
regarding any alleged violation. At the time of initial written 
communication with the respondent about the complaint, the Secretary 
will describe the act(s) that are the basis of the complaint.



Sec.  3.308  Compliance reviews.

    The Secretary may conduct compliance reviews to determine whether a 
respondent is complying with the applicable confidentiality provisions.



Sec.  3.310  Responsibilities of respondents.

    (a) Provide records and compliance reports. A respondent must keep 
such records and submit such compliance reports, in such time and manner 
and containing such information, as the Secretary may determine to be 
necessary to enable the Secretary to ascertain whether the respondent 
has complied or is complying with the applicable confidentiality 
provisions.
    (b) Cooperate with complaint investigations and compliance reviews. 
A respondent must cooperate with the Secretary, if the Secretary 
undertakes an investigation or compliance review of the policies, 
procedures, or practices of the respondent to determine whether it is 
complying with the applicable confidentiality provisions.
    (c) Permit access to information. (1) A respondent must permit 
access by the Secretary during normal business hours to its facilities, 
books, records, accounts, and other sources of information, including 
patient safety work product, that are pertinent to ascertaining 
compliance with the applicable confidentiality provisions. If the 
Secretary determines that exigent circumstances exist, such as when 
documents may be hidden or destroyed, a respondent must permit access by 
the Secretary at any time and without notice.
    (2) If any information required of a respondent under this section 
is in the exclusive possession of any other agency, institution, or 
person, and the other agency, institution, or person fails or refuses to 
furnish the information, the respondent must so certify and set forth 
what efforts it has made to obtain the information.



Sec.  3.312  Secretarial action regarding complaints and compliance reviews.

    (a) Resolution when noncompliance is indicated. (1) If an 
investigation of a complaint pursuant to Sec.  3.306 of this subpart or 
a compliance review pursuant to Sec.  3.308 of this subpart indicates 
noncompliance, the Secretary may attempt to reach a resolution of the 
matter satisfactory to the Secretary by informal means. Informal means 
may include demonstrated compliance or a completed corrective action 
plan or other agreement.
    (2) If the matter is resolved by informal means, the Secretary will 
so inform the respondent and, if the matter arose from a complaint, the 
complainant, in writing.
    (3) If the matter is not resolved by informal means, the Secretary 
will--
    (i) So inform the respondent and provide the respondent an 
opportunity to submit written evidence of any mitigating factors. The 
respondent must submit any evidence to the Secretary within 30 days 
(computed in the same manner as prescribed under Sec.  3.526 of this 
subpart) of receipt of such notification; and
    (ii) If, following action pursuant to paragraph (a)(3)(i) of this 
section, the Secretary decides that a civil money penalty should be 
imposed, inform the respondent of such finding in a notice of proposed 
determination in accordance with Sec.  3.420 of this subpart.
    (b) Resolution when no violation is found. If, after an 
investigation pursuant to Sec.  3.306 of this subpart or a compliance 
review pursuant to Sec.  3.308 of this subpart, the Secretary determines 
that further action is not warranted, the Secretary will so inform the 
respondent and, if the matter arose from a complaint, the complainant, 
in writing.
    (c) Uses and disclosures of information obtained. (1) Identifiable 
patient safety work product obtained by the Secretary in connection with 
an investigation or compliance review under this subpart will not be 
disclosed by the Secretary, except in accordance with Sec.  3.206(d) of 
this subpart, or if otherwise permitted by this part or the Patient 
Safety Act.

[[Page 58]]

    (2) Except as provided for in paragraph (c)(1) of this section, 
information, including testimony and other evidence, obtained by the 
Secretary in connection with an investigation or compliance review under 
this subpart may be used by HHS in any of its activities and may be used 
or offered into evidence in any administrative or judicial proceeding.



Sec.  3.314  Investigational subpoenas and inquiries.

    (a) The Secretary may issue subpoenas in accordance with 42 U.S.C. 
405(d) and (e), and 1320a-7a(j), to require the attendance and testimony 
of witnesses and the production of any other evidence including patient 
safety work product during an investigation or compliance review 
pursuant to this part.
    (1) A subpoena issued under this paragraph must--
    (i) State the name of the person (including the entity, if 
applicable) to whom the subpoena is addressed;
    (ii) State the statutory authority for the subpoena;
    (iii) Indicate the date, time, and place that the testimony will 
take place;
    (iv) Include a reasonably specific description of any documents or 
items required to be produced; and
    (v) If the subpoena is addressed to an entity, describe with 
reasonable particularity the subject matter on which testimony is 
required. In that event, the entity must designate one or more natural 
persons who will testify on its behalf, and must state as to each such 
person that person's name and address and the matters on which he or she 
will testify. The designated person must testify as to matters known or 
reasonably available to the entity.
    (2) A subpoena under this section must be served by--
    (i) Delivering a copy to the natural person named in the subpoena or 
to the entity named in the subpoena at its last principal place of 
business; or
    (ii) Registered or certified mail addressed to the natural person at 
his or her last known dwelling place or to the entity at its last known 
principal place of business.
    (3) A verified return by the natural person serving the subpoena 
setting forth the manner of service or, in the case of service by 
registered or certified mail, the signed return post office receipt, 
constitutes proof of service.
    (4) Witnesses are entitled to the same fees and mileage as witnesses 
in the district courts of the United States (28 U.S.C. 1821 and 1825). 
Fees need not be paid at the time the subpoena is served.
    (5) A subpoena under this section is enforceable through the 
district court of the United States for the district where the 
subpoenaed natural person resides or is found or where the entity 
transacts business.
    (b) Investigational inquiries are non-public investigational 
proceedings conducted by the Secretary.
    (1) Testimony at investigational inquiries will be taken under oath 
or affirmation.
    (2) Attendance of non-witnesses is discretionary with the Secretary, 
except that a witness is entitled to be accompanied, represented, and 
advised by an attorney.
    (3) Representatives of the Secretary are entitled to attend and ask 
questions.
    (4) A witness will have the opportunity to clarify his or her 
answers on the record following questioning by the Secretary.
    (5) Any claim of privilege must be asserted by the witness on the 
record.
    (6) Objections must be asserted on the record. Errors of any kind 
that might be corrected if promptly presented will be deemed to be 
waived unless reasonable objection is made at the investigational 
inquiry. Except where the objection is on the grounds of privilege, the 
question will be answered on the record, subject to objection.
    (7) If a witness refuses to answer any question not privileged or to 
produce requested documents or items, or engages in conduct likely to 
delay or obstruct the investigational inquiry, the Secretary may seek 
enforcement of the subpoena under paragraph (a)(5) of this section.
    (8) The proceedings will be recorded and transcribed. The witness is 
entitled

[[Page 59]]

to a copy of the transcript, upon payment of prescribed costs, except 
that, for good cause, the witness may be limited to inspection of the 
official transcript of his or her testimony.
    (9)(i) The transcript will be submitted to the witness for 
signature.
    (A) Where the witness will be provided a copy of the transcript, the 
transcript will be submitted to the witness for signature. The witness 
may submit to the Secretary written proposed corrections to the 
transcript, with such corrections attached to the transcript. If the 
witness does not return a signed copy of the transcript or proposed 
corrections within 30 days (computed in the same manner as prescribed 
under Sec.  3.526 of this part) of its being submitted to him or her for 
signature, the witness will be deemed to have agreed that the transcript 
is true and accurate.
    (B) Where, as provided in paragraph (b)(8) of this section, the 
witness is limited to inspecting the transcript, the witness will have 
the opportunity at the time of inspection to propose corrections to the 
transcript, with corrections attached to the transcript. The witness 
will also have the opportunity to sign the transcript. If the witness 
does not sign the transcript or offer corrections within 30 days 
(computed in the same manner as prescribed under Sec.  3.526 of this 
part) of receipt of notice of the opportunity to inspect the transcript, 
the witness will be deemed to have agreed that the transcript is true 
and accurate.
    (ii) The Secretary's proposed corrections to the record of 
transcript will be attached to the transcript.



Sec.  3.402  Basis for a civil money penalty.

    (a) General rule. A person who discloses identifiable patient safety 
work product in knowing or reckless violation of the confidentiality 
provisions shall be subject to a civil money penalty for each act 
constituting such violation.
    (b) Violation attributed to a principal. A principal is 
independently liable, in accordance with the federal common law of 
agency, for a civil money penalty based on the act of the principal's 
agent, including a workforce member, acting within the scope of the 
agency if such act could give rise to a civil money penalty in 
accordance with Sec.  3.402(a) of this subpart.



Sec.  3.404  Amount of a civil money penalty.

    (a) The amount of a civil money penalty will be determined in 
accordance with paragraph (b) of this section and Sec.  3.408.
    (b) The Secretary may impose a civil monetary penalty in the amount 
of not more than $11,000. This amount has been updated and will be 
updated annually, in accordance with the Federal Civil Monetary penalty 
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 
2015 (section 701 of Pub. L. 114-74). The amount, as updated, is 
published at 45 CFR part 102.

[81 FR 61560, Sept. 6, 2016]



Sec.  3.408  Factors considered in determining the amount 
of a civil money penalty.

    In determining the amount of any civil money penalty, the Secretary 
may consider as aggravating or mitigating factors, as appropriate, any 
of the following:
    (a) The nature of the violation.
    (b) The circumstances, including the consequences, of the violation, 
including:
    (1) The time period during which the violation(s) occurred; and
    (2) Whether the violation caused physical or financial harm or 
reputational damage;
    (c) The degree of culpability of the respondent, including:
    (1) Whether the violation was intentional; and
    (2) Whether the violation was beyond the direct control of the 
respondent.
    (d) Any history of prior compliance with the Patient Safety Act, 
including violations, by the respondent, including:
    (1) Whether the current violation is the same or similar to prior 
violation(s);
    (2) Whether and to what extent the respondent has attempted to 
correct previous violations;

[[Page 60]]

    (3) How the respondent has responded to technical assistance from 
the Secretary provided in the context of a compliance effort; and
    (4) How the respondent has responded to prior complaints.
    (e) The financial condition of the respondent, including:
    (1) Whether the respondent had financial difficulties that affected 
its ability to comply;
    (2) Whether the imposition of a civil money penalty would jeopardize 
the ability of the respondent to continue to provide health care or 
patient safety activities; and
    (3) The size of the respondent.
    (f) Such other matters as justice may require.



Sec.  3.414  Limitations.

    No action under this subpart may be entertained unless commenced by 
the Secretary, in accordance with Sec.  3.420 of this subpart, within 6 
years from the date of the occurrence of the violation.



Sec.  3.416  Authority to settle.

    Nothing in this subpart limits the authority of the Secretary to 
settle any issue or case or to compromise any penalty.



Sec.  3.418  Exclusivity of penalty.

    (a) Except as otherwise provided by paragraph (b) of this section, a 
penalty imposed under this part is in addition to any other penalty 
prescribed by law.
    (b) Civil money penalties shall not be imposed both under this part 
and under the HIPAA Privacy Rule (45 CFR parts 160 and 164).



Sec.  3.420  Notice of proposed determination.

    (a) If a penalty is proposed in accordance with this part, the 
Secretary must deliver, or send by certified mail with return receipt 
requested, to the respondent, written notice of the Secretary's intent 
to impose a penalty. This notice of proposed determination must include:
    (1) Reference to the statutory basis for the penalty;
    (2) A description of the findings of fact regarding the violations 
with respect to which the penalty is proposed;
    (3) The reason(s) why the violation(s) subject(s) the respondent to 
a penalty;
    (4) The amount of the proposed penalty;
    (5) Any factors described in Sec.  3.408 of this subpart that were 
considered in determining the amount of the proposed penalty; and
    (6) Instructions for responding to the notice, including a statement 
of the respondent's right to a hearing, a statement that failure to 
request a hearing within 60 days permits the imposition of the proposed 
penalty without the right to a hearing under Sec.  3.504 of this subpart 
or a right of appeal under Sec.  3.548 of this subpart, and the address 
to which the hearing request must be sent.
    (b) The respondent may request a hearing before an ALJ on the 
proposed penalty by filing a request in accordance with Sec.  3.504 of 
this subpart.



Sec.  3.422  Failure to request a hearing.

    If the respondent does not request a hearing within the time 
prescribed by Sec.  3.504 of this subpart and the matter is not settled 
pursuant to Sec.  3.416 of this subpart, the Secretary may impose the 
proposed penalty or any lesser penalty permitted by sections 921 through 
926 of the Public Health Service Act, 42 U.S.C. 299b-21 through 299b-26. 
The Secretary will notify the respondent by certified mail, return 
receipt requested, of any penalty that has been imposed and of the means 
by which the respondent may satisfy the penalty, and the penalty is 
final on receipt of the notice. The respondent has no right to appeal a 
penalty under Sec.  3.548 of this subpart with respect to which the 
respondent has not timely requested a hearing.



Sec.  3.424  Collection of penalty.

    (a) Once a determination of the Secretary to impose a penalty has 
become final, the penalty will be collected by the Secretary, subject to 
the first sentence of 42 U.S.C. 1320a-7a(f).
    (b) The penalty may be recovered in a civil action brought in the 
United States district court for the district where the respondent 
resides, is found, or is located.
    (c) The amount of a penalty, when finally determined, or the amount

[[Page 61]]

agreed upon in compromise, may be deducted from any sum then or later 
owing by the United States, or by a State agency, to the respondent.
    (d) Matters that were raised or that could have been raised in a 
hearing before an ALJ, or in an appeal under 42 U.S.C. 1320a-7a(e), may 
not be raised as a defense in a civil action by the United States to 
collect a penalty under this part.



Sec.  3.426  Notification of the public and other agencies.

    Whenever a proposed penalty becomes final, the Secretary will 
notify, in such manner as the Secretary deems appropriate, the public 
and the following organizations and entities thereof and the reason it 
was imposed: The appropriate State or local medical or professional 
organization, the appropriate State agency or agencies administering or 
supervising the administration of State health care programs (as defined 
in 42 U.S.C. 1320a-7(h)), the appropriate utilization and quality 
control peer review organization, and the appropriate State or local 
licensing agency or organization (including the agency specified in 42 
U.S.C. 1395aa(a), 1396a(a)(33)).



Sec.  3.504  Hearings before an ALJ.

    (a) A respondent may request a hearing before an ALJ. The parties to 
the hearing proceeding consist of--
    (1) The respondent; and
    (2) The officer(s) or employee(s) of HHS to whom the enforcement 
authority involved has been delegated.
    (b) The request for a hearing must be made in writing signed by the 
respondent or by the respondent's attorney and sent by certified mail, 
return receipt requested, to the address specified in the notice of 
proposed determination. The request for a hearing must be mailed within 
60 days after notice of the proposed determination is received by the 
respondent. For purposes of this section, the respondent's date of 
receipt of the notice of proposed determination is presumed to be 5 days 
after the date of the notice unless the respondent makes a reasonable 
showing to the contrary to the ALJ.
    (c) The request for a hearing must clearly and directly admit, deny, 
or explain each of the findings of fact contained in the notice of 
proposed determination with regard to which the respondent has any 
knowledge. If the respondent has no knowledge of a particular finding of 
fact and so states, the finding shall be deemed denied. The request for 
a hearing must also state the circumstances or arguments that the 
respondent alleges constitute the grounds for any defense and the 
factual and legal basis for opposing the penalty.
    (d) The ALJ must dismiss a hearing request where--
    (1) On motion of the Secretary, the ALJ determines that the 
respondent's hearing request is not timely filed as required by 
paragraph (b) or does not meet the requirements of paragraph (c) of this 
section;
    (2) The respondent withdraws the request for a hearing;
    (3) The respondent abandons the request for a hearing; or
    (4) The respondent's hearing request fails to raise any issue that 
may properly be addressed in a hearing.



Sec.  3.506  Rights of the parties.

    (a) Except as otherwise limited by this subpart, each party may--
    (1) Be accompanied, represented, and advised by an attorney;
    (2) Participate in any conference held by the ALJ;
    (3) Conduct discovery of documents as permitted by this subpart;
    (4) Agree to stipulations of fact or law that will be made part of 
the record;
    (5) Present evidence relevant to the issues at the hearing;
    (6) Present and cross-examine witnesses;
    (7) Present oral arguments at the hearing as permitted by the ALJ; 
and
    (8) Submit written briefs and proposed findings of fact and 
conclusions of law after the hearing.
    (b) A party may appear in person or by a representative. Natural 
persons who appear as an attorney or other representative must conform 
to the standards of conduct and ethics required of practitioners before 
the courts of the United States.
    (c) Fees for any services performed on behalf of a party by an 
attorney are

[[Page 62]]

not subject to the provisions of 42 U.S.C. 406, which authorizes the 
Secretary to specify or limit their fees.



Sec.  3.508  Authority of the ALJ.

    (a) The ALJ must conduct a fair and impartial hearing, avoid delay, 
maintain order, and ensure that a record of the proceeding is made.
    (b) The ALJ may--
    (1) Set and change the date, time and place of the hearing upon 
reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences to identify or simplify the issues, or to 
consider other matters that may aid in the expeditious disposition of 
the proceeding;
    (4) Administer oaths and affirmations;
    (5) Issue subpoenas requiring the attendance of witnesses at 
hearings and the production of documents at or in relation to hearings;
    (6) Rule on motions and other procedural matters;
    (7) Regulate the scope and timing of documentary discovery as 
permitted by this subpart;
    (8) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;
    (9) Examine witnesses;
    (10) Receive, rule on, exclude, or limit evidence;
    (11) Upon motion of a party, take official notice of facts;
    (12) Conduct any conference, argument or hearing in person or, upon 
agreement of the parties, by telephone; and
    (13) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact. A 
summary judgment decision constitutes a hearing on the record for the 
purposes of this subpart.
    (c) The ALJ--
    (1) May not find invalid or refuse to follow Federal statutes, 
regulations, or Secretarial delegations of authority and must give 
deference to published guidance to the extent not inconsistent with 
statute or regulation;
    (2) May not enter an order in the nature of a directed verdict;
    (3) May not compel settlement negotiations; or
    (4) May not enjoin any act of the Secretary.



Sec.  3.510  Ex parte contacts.

    No party or person (except employees of the ALJ's office) may 
communicate in any way with the ALJ on any matter at issue in a case, 
unless on notice and opportunity for both parties to participate. This 
provision does not prohibit a party or person from inquiring about the 
status of a case or asking routine questions concerning administrative 
functions or procedures.



Sec.  3.512  Prehearing conferences.

    (a) The ALJ must schedule at least one prehearing conference, and 
may schedule additional prehearing conferences as appropriate, upon 
reasonable notice, which may not be less than 14 business days, to the 
parties.
    (b) The ALJ may use prehearing conferences to discuss the 
following--
    (1) Simplification of the issues;
    (2) The necessity or desirability of amendments to the pleadings, 
including the need for a more definite statement;
    (3) Stipulations and admissions of fact or as to the contents and 
authenticity of documents;
    (4) Whether the parties can agree to submission of the case on a 
stipulated record;
    (5) Whether a party chooses to waive appearance at an oral hearing 
and to submit only documentary evidence (subject to the objection of the 
other party) and written argument;
    (6) Limitation of the number of witnesses;
    (7) Scheduling dates for the exchange of witness lists and of 
proposed exhibits;
    (8) Discovery of documents as permitted by this subpart;
    (9) The time and place for the hearing;
    (10) The potential for the settlement of the case by the parties; 
and
    (11) Other matters as may tend to encourage the fair, just and 
expeditious disposition of the proceedings, including the protection of 
confidentiality of

[[Page 63]]

identifiable patient safety work product that may be submitted into 
evidence or otherwise used in the proceeding, if appropriate.
    (c) The ALJ must issue an order containing the matters agreed upon 
by the parties or ordered by the ALJ at a prehearing conference.



Sec.  3.514  Authority to settle.

    The Secretary has exclusive authority to settle any issue or case 
without the consent of the ALJ.



Sec.  3.516  Discovery.

    (a) A party may make a request to another party for production of 
documents for inspection and copying that are relevant and material to 
the issues before the ALJ.
    (b) For the purpose of this section, the term ``documents'' includes 
information, reports, answers, records, accounts, papers and other data 
and documentary evidence. Nothing contained in this section may be 
interpreted to require the creation of a document, except that requested 
data stored in an electronic data storage system must be produced in a 
form accessible to the requesting party.
    (c) Requests for documents, requests for admissions, written 
interrogatories, depositions and any forms of discovery, other than 
those permitted under paragraph (a) of this section, are not authorized.
    (d) This section may not be construed to require the disclosure of 
interview reports or statements obtained by any party, or on behalf of 
any party, of persons who will not be called as witnesses by that party, 
or analyses and summaries prepared in conjunction with the investigation 
or litigation of the case, or any otherwise privileged documents.
    (e)(1) When a request for production of documents has been received, 
within 30 days the party receiving that request must either fully 
respond to the request, or state that the request is being objected to 
and the reasons for that objection. If objection is made to part of an 
item or category, the part must be specified. Upon receiving any 
objections, the party seeking production may then, within 30 days or any 
other time frame set by the ALJ, file a motion for an order compelling 
discovery. The party receiving a request for production may also file a 
motion for protective order any time before the date the production is 
due.
    (2) The ALJ may grant a motion for protective order or deny a motion 
for an order compelling discovery if the ALJ finds that the discovery 
sought--
    (i) Is irrelevant;
    (ii) Is unduly costly or burdensome;
    (iii) Will unduly delay the proceeding; or
    (iv) Seeks privileged information.
    (3) The ALJ may extend any of the time frames set forth in paragraph 
(e)(1) of this section.
    (4) The burden of showing that discovery should be allowed is on the 
party seeking discovery.



Sec.  3.518  Exchange of witness lists, witness statements, and exhibits.

    (a) The parties must exchange witness lists, copies of prior written 
statements of proposed witnesses, and copies of proposed hearing 
exhibits, including copies of any written statements that the party 
intends to offer in lieu of live testimony in accordance with Sec.  
3.538, not more than 60, and not less than 15, days before the scheduled 
hearing.
    (b)(1) If, at any time, a party objects to the proposed admission of 
evidence not exchanged in accordance with paragraph (a) of this section, 
the ALJ must determine whether the failure to comply with paragraph (a) 
of this section should result in the exclusion of that evidence.
    (2) Unless the ALJ finds that extraordinary circumstances justified 
the failure timely to exchange the information listed under paragraph 
(a) of this section, the ALJ must exclude from the party's case-in-
chief--
    (i) The testimony of any witness whose name does not appear on the 
witness list; and
    (ii) Any exhibit not provided to the opposing party as specified in 
paragraph (a) of this section.
    (3) If the ALJ finds that extraordinary circumstances existed, the 
ALJ must then determine whether the admission of that evidence would 
cause substantial prejudice to the objecting party.

[[Page 64]]

    (i) If the ALJ finds that there is no substantial prejudice, the 
evidence may be admitted.
    (ii) If the ALJ finds that there is substantial prejudice, the ALJ 
may exclude the evidence, or, if he or she does not exclude the 
evidence, must postpone the hearing for such time as is necessary for 
the objecting party to prepare and respond to the evidence, unless the 
objecting party waives postponement.
    (c) Unless the other party objects within a reasonable period of 
time before the hearing, documents exchanged in accordance with 
paragraph (a) of this section will be deemed to be authentic for the 
purpose of admissibility at the hearing.



Sec.  3.520  Subpoenas for attendance at hearing.

    (a) A party wishing to procure the appearance and testimony of any 
person at the hearing may make a motion requesting the ALJ to issue a 
subpoena if the appearance and testimony are reasonably necessary for 
the presentation of a party's case.
    (b) A subpoena requiring the attendance of a person in accordance 
with paragraph (a) of this section may also require the person (whether 
or not the person is a party) to produce relevant and material evidence 
at or before the hearing.
    (c) When a subpoena is served by a respondent on a particular 
employee or official or particular office of HHS, the Secretary may 
comply by designating any knowledgeable HHS representative to appear and 
testify.
    (d) A party seeking a subpoena must file a written motion not less 
than 30 days before the date fixed for the hearing, unless otherwise 
allowed by the ALJ for good cause shown. That motion must--
    (1) Specify any evidence to be produced;
    (2) Designate the witnesses; and
    (3) Describe the address and location with sufficient particularity 
to permit those witnesses to be found.
    (e) The subpoena must specify the time and place at which the 
witness is to appear and any evidence the witness is to produce.
    (f) Within 15 days after the written motion requesting issuance of a 
subpoena is served, any party may file an opposition or other response.
    (g) If the motion requesting issuance of a subpoena is granted, the 
party seeking the subpoena must serve it by delivery to the person 
named, or by certified mail addressed to that person at the person's 
last dwelling place or principal place of business.
    (h) The person to whom the subpoena is directed may file with the 
ALJ a motion to quash the subpoena within 10 days after service.
    (i) The exclusive remedy for contumacy by, or refusal to obey a 
subpoena duly served upon, any person is specified in 42 U.S.C. 405(e).



Sec.  3.522  Fees.

    The party requesting a subpoena must pay the cost of the fees and 
mileage of any witness subpoenaed in the amounts that would be payable 
to a witness in a proceeding in United States District Court. A check 
for witness fees and mileage must accompany the subpoena when served, 
except that, when a subpoena is issued on behalf of the Secretary, a 
check for witness fees and mileage need not accompany the subpoena.



Sec.  3.524  Form, filing, and service of papers.

    (a) Forms. (1) Unless the ALJ directs the parties to do otherwise, 
documents filed with the ALJ must include an original and two copies.
    (2) Every pleading and paper filed in the proceeding must contain a 
caption setting forth the title of the action, the case number, and a 
designation of the paper, such as motion to quash subpoena.
    (3) Every pleading and paper must be signed by and must contain the 
address and telephone number of the party or the person on whose behalf 
the paper was filed, or his or her representative.
    (4) Papers are considered filed when they are mailed.
    (b) Service. A party filing a document with the ALJ or the Board 
must, at the time of filing, serve a copy of the document on the other 
party. Service upon any party of any document must be made by delivering 
a copy, or placing a

[[Page 65]]

copy of the document in the United States mail, postage prepaid and 
addressed, or with a private delivery service, to the party's last known 
address. When a party is represented by an attorney, service must be 
made upon the attorney in lieu of the party.
    (c) Proof of service. A certificate of the natural person serving 
the document by personal delivery or by mail, setting forth the manner 
of service, constitutes proof of service.



Sec.  3.526  Computation of time.

    (a) In computing any period of time under this subpart or in an 
order issued thereunder, the time begins with the day following the act, 
event or default, and includes the last day of the period unless it is a 
Saturday, Sunday, or legal holiday observed by the Federal Government, 
in which event it includes the next business day.
    (b) When the period of time allowed is less than 7 days, 
intermediate Saturdays, Sundays, and legal holidays observed by the 
Federal Government must be excluded from the computation.
    (c) Where a document has been served or issued by placing it in the 
mail, an additional 5 days must be added to the time permitted for any 
response. This paragraph does not apply to requests for hearing under 
Sec.  3.504.



Sec.  3.528  Motions.

    (a) An application to the ALJ for an order or ruling must be by 
motion. Motions must state the relief sought, the authority relied upon 
and the facts alleged, and must be filed with the ALJ and served on all 
other parties.
    (b) Except for motions made during a prehearing conference or at the 
hearing, all motions must be in writing. The ALJ may require that oral 
motions be reduced to writing.
    (c) Within 10 days after a written motion is served, or such other 
time as may be fixed by the ALJ, any party may file a response to the 
motion.
    (d) The ALJ may not grant a written motion before the time for 
filing responses has expired, except upon consent of the parties or 
following a hearing on the motion, but may overrule or deny the motion 
without awaiting a response.
    (e) The ALJ must make a reasonable effort to dispose of all 
outstanding motions before the beginning of the hearing.



Sec.  3.530  Sanctions.

    The ALJ may sanction a person, including any party or attorney, for 
failing to comply with an order or procedure, for failing to defend an 
action or for other misconduct that interferes with the speedy, orderly 
or fair conduct of the hearing. The sanctions must reasonably relate to 
the severity and nature of the failure or misconduct. The sanctions may 
include--
    (a) In the case of refusal to provide or permit discovery under the 
terms of this part, drawing negative factual inferences or treating the 
refusal as an admission by deeming the matter, or certain facts, to be 
established;
    (b) Prohibiting a party from introducing certain evidence or 
otherwise supporting a particular claim or defense;
    (c) Striking pleadings, in whole or in part;
    (d) Staying the proceedings;
    (e) Dismissal of the action;
    (f) Entering a decision by default;
    (g) Ordering the party or attorney to pay the attorney's fees and 
other costs caused by the failure or misconduct; and
    (h) Refusing to consider any motion or other action that is not 
filed in a timely manner.



Sec.  3.532  Collateral estoppel.

    When a final determination that the respondent violated a 
confidentiality provision has been rendered in any proceeding in which 
the respondent was a party and had an opportunity to be heard, the 
respondent is bound by that determination in any proceeding under this 
part.



Sec.  3.534  The hearing.

    (a) The ALJ must conduct a hearing on the record in order to 
determine whether the respondent should be found liable under this part.
    (b)(1) The respondent has the burden of going forward and the burden 
of persuasion with respect to any challenge to the amount of a proposed 
penalty pursuant to Sec. Sec.  3.404 and 3.408, including

[[Page 66]]

any factors raised as mitigating factors.
    (2) The Secretary has the burden of going forward and the burden of 
persuasion with respect to all other issues, including issues of 
liability and the existence of any factors considered as aggravating 
factors in determining the amount of the proposed penalty.
    (3) The burden of persuasion will be judged by a preponderance of 
the evidence.
    (c) The hearing must be open to the public unless otherwise ordered 
by the ALJ for good cause shown, which may be that identifiable patient 
safety work product has been introduced into evidence or is expected to 
be introduced into evidence.
    (d)(1) Subject to the 15-day rule under Sec.  3.518(a) and the 
admissibility of evidence under Sec.  3.540, either party may introduce, 
during its case in chief, items or information that arose or became 
known after the date of the issuance of the notice of proposed 
determination or the request for hearing, as applicable. Such items and 
information may not be admitted into evidence, if introduced--
    (i) By the Secretary, unless they are material and relevant to the 
acts or omissions with respect to which the penalty is proposed in the 
notice of proposed determination pursuant to Sec.  3.420 of this part, 
including circumstances that may increase penalties; or
    (ii) By the respondent, unless they are material and relevant to an 
admission, denial or explanation of a finding of fact in the notice of 
proposed determination under Sec.  3.420 of this part, or to a specific 
circumstance or argument expressly stated in the request for hearing 
under Sec.  3.504, including circumstances that may reduce penalties.
    (2) After both parties have presented their cases, evidence may be 
admitted in rebuttal even if not previously exchanged in accordance with 
Sec.  3.518.



Sec.  3.538  Witnesses.

    (a) Except as provided in paragraph (b) of this section, testimony 
at the hearing must be given orally by witnesses under oath or 
affirmation.
    (b) At the discretion of the ALJ, testimony of witnesses other than 
the testimony of expert witnesses may be admitted in the form of a 
written statement. The ALJ may, at his or her discretion, admit prior 
sworn testimony of experts that has been subject to adverse examination, 
such as a deposition or trial testimony. Any such written statement must 
be provided to the other party, along with the last known address of the 
witness, in a manner that allows sufficient time for the other party to 
subpoena the witness for cross-examination at the hearing. Prior written 
statements of witnesses proposed to testify at the hearing must be 
exchanged as provided in Sec.  3.518.
    (c) The ALJ must exercise reasonable control over the mode and order 
of interrogating witnesses and presenting evidence so as to:
    (1) Make the interrogation and presentation effective for the 
ascertainment of the truth;
    (2) Avoid repetition or needless consumption of time; and
    (3) Protect witnesses from harassment or undue embarrassment.
    (d) The ALJ must permit the parties to conduct cross-examination of 
witnesses as may be required for a full and true disclosure of the 
facts.
    (e) The ALJ may order witnesses excluded so that they cannot hear 
the testimony of other witnesses, except that the ALJ may not order to 
be excluded--
    (1) A party who is a natural person;
    (2) In the case of a party that is not a natural person, the officer 
or employee of the party appearing for the entity pro se or designated 
as the party's representative; or
    (3) A natural person whose presence is shown by a party to be 
essential to the presentation of its case, including a person engaged in 
assisting the attorney for the Secretary.



Sec.  3.540  Evidence.

    (a) The ALJ must determine the admissibility of evidence.
    (b) Except as provided in this subpart, the ALJ is not bound by the 
Federal Rules of Evidence. However, the ALJ may apply the Federal Rules 
of Evidence where appropriate, for example, to exclude unreliable 
evidence.
    (c) The ALJ must exclude irrelevant or immaterial evidence.

[[Page 67]]

    (d) Although relevant, evidence may be excluded if its probative 
value is substantially outweighed by the danger of unfair prejudice, 
confusion of the issues, or by considerations of undue delay or needless 
presentation of cumulative evidence.
    (e) Although relevant, evidence must be excluded if it is privileged 
under Federal law.
    (f) Evidence concerning offers of compromise or settlement is 
inadmissible to the extent provided in Rule 408 of the Federal Rules of 
Evidence.
    (g) Evidence of crimes, wrongs, or acts other than those at issue in 
the instant case is admissible in order to show motive, opportunity, 
intent, knowledge, preparation, identity, lack of mistake, or existence 
of a scheme. This evidence is admissible regardless of whether the 
crimes, wrongs, or acts occurred during the statute of limitations 
period applicable to the acts or omissions that constitute the basis for 
liability in the case and regardless of whether they were referenced in 
the Secretary's notice of proposed determination under Sec.  3.420.
    (h) The ALJ must permit the parties to introduce rebuttal witnesses 
and evidence.
    (i) All documents and other evidence offered or taken for the record 
must be open to examination by both parties, unless otherwise ordered by 
the ALJ for good cause shown.



Sec.  3.542  The record.

    (a) The hearing must be recorded and transcribed. Transcripts may be 
obtained following the hearing from the ALJ. A party that requests a 
transcript of hearing proceedings must pay the cost of preparing the 
transcript unless, for good cause shown by the party, the payment is 
waived by the ALJ or the Board, as appropriate.
    (b) The transcript of the testimony, exhibits, and other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for decision by the ALJ and the 
Secretary.
    (c) The record may be inspected and copied (upon payment of a 
reasonable fee) by any person, unless otherwise ordered by the ALJ for 
good cause shown, which may include the presence in the record of 
identifiable patient safety work product.
    (d) For good cause, which may include the presence in the record of 
identifiable patient safety work product, the ALJ may order appropriate 
redactions made to the record.



Sec.  3.544  Post hearing briefs.

    The ALJ may require the parties to file post-hearing briefs. In any 
event, any party may file a post-hearing brief. The ALJ must fix the 
time for filing the briefs. The time for filing may not exceed 60 days 
from the date the parties receive the transcript of the hearing or, if 
applicable, the stipulated record. The briefs may be accompanied by 
proposed findings of fact and conclusions of law. The ALJ may permit the 
parties to file reply briefs.



Sec.  3.546  ALJ's decision.

    (a) The ALJ must issue a decision, based only on the record, which 
must contain findings of fact and conclusions of law.
    (b) The ALJ may affirm, increase, or reduce the penalties imposed by 
the Secretary.
    (c) The ALJ must issue the decision to both parties within 60 days 
after the time for submission of post-hearing briefs and reply briefs, 
if permitted, has expired. If the ALJ fails to meet the deadline 
contained in this paragraph, he or she must notify the parties of the 
reason for the delay and set a new deadline.
    (d) Unless the decision of the ALJ is timely appealed as provided 
for in Sec.  3.548, the decision of the ALJ will be final and binding on 
the parties 60 days from the date of service of the ALJ's decision.



Sec.  3.548  Appeal of the ALJ's decision.

    (a) Any party may appeal the decision of the ALJ to the Board by 
filing a notice of appeal with the Board within 30 days of the date of 
service of the ALJ decision. The Board may extend the initial 30 day 
period for a period of time not to exceed 30 days if a party files with 
the Board a request for an extension within the initial 30 day period 
and shows good cause.
    (b) If a party files a timely notice of appeal with the Board, the 
ALJ must

[[Page 68]]

forward the record of the proceeding to the Board.
    (c) A notice of appeal must be accompanied by a written brief 
specifying exceptions to the initial decision and reasons supporting the 
exceptions. Any party may file a brief in opposition to the exceptions, 
which may raise any relevant issue not addressed in the exceptions, 
within 30 days of receiving the notice of appeal and the accompanying 
brief. The Board may permit the parties to file reply briefs.
    (d) There is no right to appear personally before the Board or to 
appeal to the Board any interlocutory ruling by the ALJ.
    (e) The Board may not consider any issue not raised in the parties' 
briefs, nor any issue in the briefs that could have been raised before 
the ALJ but was not.
    (f) If any party demonstrates to the satisfaction of the Board that 
additional evidence not presented at such hearing is relevant and 
material and that there were reasonable grounds for the failure to 
adduce such evidence at the hearing, the Board may remand the matter to 
the ALJ for consideration of such additional evidence.
    (g) The Board may decline to review the case, or may affirm, 
increase, reduce, reverse or remand any penalty determined by the ALJ.
    (h) The standard of review on a disputed issue of fact is whether 
the initial decision of the ALJ is supported by substantial evidence on 
the whole record. The standard of review on a disputed issue of law is 
whether the decision is erroneous.
    (i) Within 60 days after the time for submission of briefs and reply 
briefs, if permitted, has expired, the Board must serve on each party to 
the appeal a copy of the Board's decision and a statement describing the 
right of any respondent who is penalized to seek judicial review.
    (j)(1) The Board's decision under paragraph (i) of this section, 
including a decision to decline review of the initial decision, becomes 
the final decision of the Secretary 60 days after the date of service of 
the Board's decision, except with respect to a decision to remand to the 
ALJ or if reconsideration is requested under this paragraph.
    (2) The Board will reconsider its decision only if it determines 
that the decision contains a clear error of fact or error of law. New 
evidence will not be a basis for reconsideration unless the party 
demonstrates that the evidence is newly discovered and was not 
previously available.
    (3) A party may file a motion for reconsideration with the Board 
before the date the decision becomes final under paragraph (j)(1) of 
this section. A motion for reconsideration must be accompanied by a 
written brief specifying any alleged error of fact or law and, if the 
party is relying on additional evidence, explaining why the evidence was 
not previously available. Any party may file a brief in opposition 
within 15 days of receiving the motion for reconsideration and the 
accompanying brief unless this time limit is extended by the Board for 
good cause shown. Reply briefs are not permitted.
    (4) The Board must rule on the motion for reconsideration not later 
than 30 days from the date the opposition brief is due. If the Board 
denies the motion, the decision issued under paragraph (i) of this 
section becomes the final decision of the Secretary on the date of 
service of the ruling. If the Board grants the motion, the Board will 
issue a reconsidered decision, after such procedures as the Board 
determines necessary to address the effect of any error. The Board's 
decision on reconsideration becomes the final decision of the Secretary 
on the date of service of the decision, except with respect to a 
decision to remand to the ALJ.
    (5) If service of a ruling or decision issued under this section is 
by mail, the date of service will be deemed to be 5 days from the date 
of mailing.
    (k)(1) A respondent's petition for judicial review must be filed 
within 60 days of the date on which the decision of the Board becomes 
the final decision of the Secretary under paragraph (j) of this section.
    (2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for 
judicial review filed in any U.S. Court of Appeals challenging the final 
decision of the Secretary must be sent by certified mail, return receipt 
requested, to

[[Page 69]]

the General Counsel of HHS. The petition copy must be a copy showing 
that it has been time-stamped by the clerk of the court when the 
original was filed with the court.
    (3) If the General Counsel of HHS received two or more petitions 
within 10 days after the final decision of the Secretary, the General 
Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation 
of any petitions that were received within the 10 day period.



Sec.  3.550  Stay of the Secretary's decision.

    (a) Pending judicial review, the respondent may file a request for 
stay of the effective date of any penalty with the ALJ. The request must 
be accompanied by a copy of the notice of appeal filed with the Federal 
court. The filing of the request automatically stays the effective date 
of the penalty until such time as the ALJ rules upon the request.
    (b) The ALJ may not grant a respondent's request for stay of any 
penalty unless the respondent posts a bond or provides other adequate 
security.
    (c) The ALJ must rule upon a respondent's request for stay within 10 
days of receipt.



Sec.  3.552  Harmless error.

    No error in either the admission or the exclusion of evidence, and 
no error or defect in any ruling or order or in any act done or omitted 
by the ALJ or by any of the parties is ground for vacating, modifying or 
otherwise disturbing an otherwise appropriate ruling or order or act, 
unless refusal to take such action appears to the ALJ or the Board 
inconsistent with substantial justice. The ALJ and the Board at every 
stage of the proceeding must disregard any error or defect in the 
proceeding that does not affect the substantial rights of the parties.



PART 4_NATIONAL LIBRARY OF MEDICINE--Table of Contents



Sec.
4.1 Programs to which these regulations apply.
4.2 Definitions.
4.3 Purpose of the Library.
4.4 Use of Library facilities.
4.5 Use of materials from the collections.
4.6 Reference, bibliographic, reproduction, and consultation services.
4.7 Fees.
4.8 Publication of the Library and information about the Library.

    Authority: 42 U.S.C. 216, 286.

    Source: 56 FR 29188, June 26, 1991, unless otherwise noted.



Sec.  4.1  Programs to which these regulations apply.

    (a) The regulations of this part govern access to the National 
Library of Medicine's facilities and library collections and the 
availability of its bibliographic, reproduction, reference, and related 
services. These functions are performed by the Library directly for the 
benefit of the general public and health-sciences professionals as 
required by sections 465(b) (3)-(6) of the Act (42 U.S.C. 286(b) (3)-
(6)).
    (b) The regulations of this part do not apply to:
    (1) The Library's internal functions relating to the acquisition and 
preservation of materials and the organization of these materials as 
required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1) 
and (2)).
    (2) The availability of ``records'' under the Freedom of Information 
Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are 
covered in 45 CFR parts 5 and 5b.
    (3) Federal assistance for medical libraries and other purposes 
which are authorized by sections 469-477 of the Act (42 U.S.C. 286b to 
286b-8). (See parts 59a, 61 and 64 of this chapter.)
    (4) The availability of facilities, collections, and related 
services of Regional Medical Libraries established or maintained under 
the authority in section 475 of the Act (42 U.S.C. 286b-6). (See part 
59a, subpart B of this chapter.)



Sec.  4.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Collections means all books, periodicals, prints, audiovisual 
materials, films, videotapes, recordings, manuscripts, and other 
resource materials of the library. It does not include data processing 
tapes or programs used solely for internal processing activities to

[[Page 70]]

generate reference materials, nor does it include ``records'' of the 
Library as defined in 45 CFR 5.5. Records of the Library are available 
in accordance with the regulations under the Freedom of Information Act 
and Privacy Act of 1974. (See 45 CFR parts 5 and 5b.)
    Director means the Director of the National Library of Medicine or 
the Director's delegate.
    Health-sciences professional means any person engaged in: (1) The 
administration of health activities; (2) the provision of health 
services; or (3) research, teaching, or education concerned with the 
advancement of medicine or other sciences related to health or 
improvement of the public health.
    Historical collection means: (1) Materials in the collections 
published or printed prior to 1914; (2) manuscripts and prints; (3) the 
archival film collection; and (4) other materials of the collections 
which, because of age, or unique or unusual value, require special 
handling, storage, or protection for their preservation, as determined 
by the Director.
    Library means the National Library of Medicine, established by 
section 465 of the Act (42 U.S.C. 286).
    Regional Medical Library means a medical library established or 
maintained as a regional medical library under section 475 of the Act 
(42 U.S.C. 286b-6).



Sec.  4.3  Purpose of the Library.

    The purpose of the Library is to assist the advancement of medical 
and related sciences and aid the dissemination and exchange of 
scientific and other information important to the progress of medicine 
and the public health. The Library acquires and maintains library 
materials pertinent to medicine, including audiovisual materials; 
compiles, publishes, and disseminates catalogs, indices, and 
bibliographies of these materials, as appropriate; makes available 
materials, through loan or otherwise; provides reference and other 
assistance to research; and engages in other activities in furtherance 
of this purpose.



Sec.  4.4  Use of Library facilities.

    (a) General. The Library facilities are available to any person 
seeking to make use of the collections. The Director may prescribe 
reasonable rules to assure the most effective use of facilities by 
health-sciences professionals and to protect the collections from misuse 
or damage. These rules must be consistent with the regulations in this 
part and applicable Department regulations and policies on 
nondiscrimination.
    (b) Reading rooms. Public reading rooms are available for obtaining 
and reading materials from the collections. The Director may prescribe 
reasonable rules designed to provide adequate reading space and orderly 
conditions and procedures.
    (c) Study rooms. Upon request a limited number of study rooms may be 
made available to individuals requiring extensive use of Library 
materials. Requests for study rooms shall be addressed in writing to the 
Director. The Director shall give priority, in the following order, for 
study room use to:
    (1) Persons engaged in ``special scientific projects'' under section 
473 of the Act (42 U.S.C. 286b-4),
    (2) Health-sciences professionals, and
    (3) The general public.



Sec.  4.5  Use of materials from the collections.

    (a) Unrestricted materials. Except as otherwise provided in this 
section, materials from the collections are generally available to any 
interested person only in facilities provided by the Library for this 
purpose. The Director may prescribe additional reasonable rules to 
assure the most effective use of the Library's resources by health-
sciences professionals and to protect the collections from misuse or 
damage. The rules must be consistent with the regulations in this part 
and applicable Department regulations and policies on nondiscrimination. 
Materials in the collections are available upon each request which 
assures, to the Director's satisfaction, that the materials will be 
safeguarded from misuse, damage, loss, or misappropriation, and will be 
returned promptly after use or upon request of the Library.
    (b) Restricted materials--(1) Historical collection. Materials from 
the historical

[[Page 71]]

collection are available only as the Director may permit to assure their 
maximum preservation and protection. Copies of these materials may be 
made available in the form of microfilm and other copies, for which 
reasonable fees may be charged.
    (2) Gifts. Materials in the collections are available only in 
accordance with any limitations imposed as a condition of the 
acquisition of those materials, whether the acquisition was by gift or 
purchase.
    (c) Loans--(1) General. Requests for loans of materials must assure 
the Library that (i) the materials will be safeguarded from misuse, 
damage, loss, or misappropriation and (ii) the materials will be 
returned promptly after use or upon request of the Library. The Library 
may provide copies in lieu of original materials, which need not be 
returned unless otherwise stated at the time of the loan.
    (2) Loans of audiovisual materials. Audiovisual materials are 
available for loan under the same general terms as printed materials.
    (3) Loans to other libraries. Upon request materials or copies are 
available for use through libraries of public or private agencies or 
institutions. The requesting library must assure that it has first 
exhausted its own collection resources, those of other local libraries 
in the geographic area, and those of the Regional Medical Library 
network (including Regional and Resource Libraries) before making a 
request for a loan.
    (4) Loans to health-sciences professionals. The Director may make 
loans of materials directly to health-sciences professionals. An 
individual wishing a loan of library materials must assure to the 
satisfaction of the Director that the individual is geographically 
isolated, in terms of distance or available transportation, from medical 
literature resources likely to contain the desired material.

(Approved by the Office of Management and Budget under control number 
0925-0276)



Sec.  4.6  Reference, bibliographic, reproduction, and consultation services.

    (a) General. To the extent resources permit, the Library will make 
available, upon request, reference, bibliographic, reproduction, and 
consultation services. Priority will be given to requests from health-
sciences professionals for services not reasonably available through 
local or regional libraries.
    (b) Specialized bibliographic services. The Director may provide 
bibliographies on individually selected medical or scientific topics 
upon request where it is consistent with the Library's purpose. The 
Director may publish and make available for general distribution by the 
Library, bibliographic searches determined to be of general interest. 
The Library may also produce and distribute a limited number of 
bibliographies on topics of general interest to public or nonprofit 
health-related professional societies, research organizations, and other 
group users. These bibliographies may be produced on a regularly 
recurring or intermittent basis under contract between the Library and 
public or nonprofit agencies, when determined in each case by the 
Director to be necessary to assure more effective distribution of the 
bibliographic information.
    (c) Information retrieval system computer tapes. To the extent 
Library resources permit and in order to further the Library's purpose, 
the Director may make available upon request by agencies, organizations, 
and institutions copies of all or part of the Library's magnetic tapes.



Sec.  4.7  Fees.

    The Director may charge reasonable fees for any service provided by 
the Library under this part, in accordance with a schedule available at 
the Library upon request, which are designed to recover all or a portion 
of the cost to the Library of providing the service.



Sec.  4.8  Publication of the Library and information about the Library.

    Lists of bibliographies, Library publications sold by the Government 
Printing Office, necessary application forms, and other information 
concerning the organization, operation, functions, and services of the 
Library, are available from the National Library of Medicine, Bethesda, 
Maryland 20894.

[[Page 72]]



PART 5_DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS--Table of Contents



Sec.
5.1 Purpose.
5.2 Definitions.
5.3 Procedures for designation of health professional(s) shortage areas.
5.4 Notification and publication of designations and withdrawals.

Appendix A to Part 5--Criteria for Designation of Areas having Shortages 
          of Primary Medical Care Professional(s)
Appendix B to Part 5--Criteria for Designation of Areas having Shortages 
          of Dental Professional(s)
Appendix C to Part 5--Criteria for Designation of Areas Having Shortages 
          of Mental Health Professionals
Appendix D to Part 5--Criteria for Designation of Areas having Shortages 
          of Vision Care Professional(s)
Appendix E to Part 5--Criteria for Designation of Areas having Shortages 
          of Podiatric Professional(s)
Appendix F to Part 5--Criteria for Designation of Areas having Shortages 
          of Pharmacy Professional(s)
Appendix G to Part 5--Criteria for Designation of Areas having Shortages 
          of Veterinary Professional(s)

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690 
(42 U.S.C. 216); sec. 332 of the Public Health Service Act, 90 Stat. 
2270-2272 (42 U.S.C. 254e).

    Source: 45 FR 76000, Nov. 17, 1980, unless otherwise noted.



Sec.  5.1  Purpose.

    These regulations establish criteria and procedures for the 
designation of geographic areas, population groups, medical facilities, 
and other public facilities, in the States, as health professional(s) 
shortage areas.



Sec.  5.2  Definitions.

    Act means the Public Health Service Act, as amended.
    Health professional(s) shortage area means any of the following 
which the Secretary determines has a shortage of health professional(s): 
(1) An urban or rural area (which need not conform to the geographic 
boundaries of a political subdivision and which is a rational area for 
the delivery of health services); (2) a population group; or (3) a 
public or nonprofit private medical facility.
    Health service area means a health service area whose boundaries 
have been designated by the Secretary, under section 1511 of the Act, 
for purposes of health planning activities.
    Health systems agency or HSA means the health systems agency 
designated, under section 1515 of the Act, to carry out health planning 
activities for a specific health service area.
    Medical facility means a facility for the delivery of health 
services and includes: (1) A community health center, public health 
center, outpatient medical facility, or community mental health center; 
(2) a hospital, State mental hospital, facility for long-term care, or 
rehabilitation facility; (3) a migrant health center or an Indian Health 
service facility; (4) a facility for delivery of health services to 
inmates in a U.S. penal or correctional institution (under section 323 
of the Act) or a State correctional institution; (5) a Public Health 
Service medical facility (used in connection with the delivery of health 
services under section 320, 321, 322, 324, 325, or 326 of the Act); or 
(6) any other Federal medical facility.
    Metropolitan area means an area which has been designated by the 
Office of Management and Budget as a standard metropolitan statistical 
area (SMSA). All other areas are ``non-metropolitan areas.''
    Poverty level means the povery level as defined by the Bureau of the 
Census, using the poverty index adopted by a Federal Interagency 
Committee in 1969, and updated each year to reflect changes in the 
Consumer Price Index.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department to whom the authority 
involved has been delegated.
    State includes, in addition to the several States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, 
the Virgin Islands, Guam, American Samoa, and the Trust Territory of the 
Pacific Islands.
    State health planning and development agency or SHPDA means a State 
health planning and development agency designated under section 1521 of 
the Act.

[[Page 73]]



Sec.  5.3  Procedures for designation of health professional(s) shortage areas.

    (a) Using data available to the Department from national, State, and 
local sources and based upon the criteria in the appendices to this 
part, the Department will annually prepare listings (by State and health 
service area) of currently designated health professional(s) shortage 
areas and potentially designatable areas, together with appropriate 
related data available to the Department. Relevant portions of this 
material will then be forwarded to each health systems agency, State 
health planning and development agency, and Governor, who will be asked 
to review the listings for their State, correct any errors of which they 
are aware, and offer their recommendations, if any, within 90 days, as 
to which geographic areas, population groups, and facilities in areas 
under their jurisdiction should be designated. An information copy of 
these listings will also be made available, upon request, to interested 
parties for their use in providing comments or recommendations to the 
Secretary and/or to the appropriate HSA, SHPDA, or Governor.
    (b) In addition, any agency or individual may request the Secretary 
to designate (or withdraw the designation of) a particular geographic 
area, population group, or facility as a health professional(s) shortage 
area. Each request will be forwarded by the Secretary to the appropriate 
HSA, SHPDA, and Governor, who will be asked to review it and offer their 
recommendations, if any, within 30 days. An information copy will also 
be made available to other interested parties, upon request, for their 
use in providing comments or recommendations to the Secretary and/or to 
the appropriate HSA, SHPDA, or Governor.
    (c) In each case where the designation of a public facility 
(including a Federal medical facility) is under consideration, the 
Secretary will give written notice of the proposed designation to the 
chief administrative officer of the facility, who will be asked to 
review it and offer their recommendations, if any, within 30 days.
    (d) After review of the available information and consideration of 
the comments and recommendations submitted, the Secretary will designate 
health professional(s) shortage areas and withdraw the designation of 
any areas which have been determined no longer to have a shortage of 
health professional(s).



Sec.  5.4  Notification and publication of designations and withdrawals.

    (a) The Secretary will give written notice of the designation (or 
withdrawal of designation) of a health professional(s) shortage area, 
not later than 60 days from the date of the designation (or withdrawal 
of designation), to:
    (1) The Governor of each State in which the area, population group, 
medical facility, or other public facility so designated is in whole or 
in part located;
    (2) Each HSA for a health service area which includes all or any 
part of the area, population group, medical facility, or other public 
facility so designated;
    (3) The SHPDA for each State in which the area, population group, 
medical facility, or other public facility so designated is in whole or 
in part located; and
    (4) Appropriate public or nonprofit private entities which are 
located in or which have a demonstrated interest in the area so 
designated.
    (b) The Secretary will periodically publish updated lists of 
designated health professional(s) shortage areas in the Federal 
Register, by type of professional(s) shortage. An updated list of areas 
for each type of professional(s) shortage will be published at least 
once annually.
    (c) The effective date of the designation of an area shall be the 
date of the notification letter to the individual or agency which 
requested the designation, or the date of publication in the Federal 
Register, whichever comes first.
    (d) Once an area is listed in the Federal Register as a designated 
health professional(s) shortage area, the effective date of any later 
withdrawal of the area's designation shall be the date when notification 
of the withdrawal, or an updated list of designated areas

[[Page 74]]

which does not include it, is published in the Federal Register.



  Sec. Appendix A to Part 5--Criteria for Designation of Areas Having 
            Shortages of Primary Medical Care Professional(s)

                        Part I--Geographic Areas

                               A. Criteria

    A geographic area will be designated as having a shortage of primary 
medical care manpower if the following three criteria are met:
    1. The area is a rational area for the delivery of primary medical 
care services.
    2. One of the following conditions prevails within the area:
    (a) The area has population to full-time-equivalent primary care 
physician ratio of at least 3,500:1.
    (b) The area has a population to full-time-equivalent primary care 
physician ratio of less than 3,500:1 but greater than 3,000:1 and has 
usually high needs for primary care services or insufficient capacity of 
existing primary care providers.
    3. Primary medical care manpower in contiguous areas are 
overutilized, excessively distant, or inaccessible to the population of 
the area under consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Primary Medical Care Services.
    (a) The following areas will be considered rational areas for the 
delivery of primary medical care services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 30 minutes travel time of each other.
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market or 
transportation patterns, distinctive population characteristics or other 
factors, has limited access to contiguous area resources, as measured 
generally by a travel time greater than 30 minutes to such resources.
    (iii) Established neighborhoods and communities within metropolitan 
areas which display a strong self-identity (as indicated by a 
homogeneous socioeconomic or demographic structure and/or a tradition of 
interaction or interdependency), have limited interaction with 
contiguous areas, and which, in general, have a minimum population of 
20,000.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 30 minutes travel time:
    (i) Under normal conditions with primary roads available: 20 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 15 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
25 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 30 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, with 
the following adjustments, where appropriate:
    (a) Adjustments to the population for the differing health service 
requirements of various age-sex population groups will be computed using 
the table below of visit rates for 12 age-sex population cohorts. The 
total expected visit rate will first be obtained by multiplying each of 
the 12 visit rates in the table by the size of the area population 
within that particular age-sex cohort and adding the resultant 12 visit 
figures together. This total expected visit rate will then be divided by 
the U.S. average per capita visit rate of 5.1, to obtain the adjusted 
population for the area.

----------------------------------------------------------------------------------------------------------------
                                                                                    Age groups
                                                                 -----------------------------------------------
                               Sex                                 Under                                  65 and
                                                                     5     5-14    15-24   25-44   45-64   over
----------------------------------------------------------------------------------------------------------------
Male............................................................     7.3     3.6     3.3     3.6     4.7     6.4
Female..........................................................     6.4     3.2     5.5     6.4     6.5     6.8
----------------------------------------------------------------------------------------------------------------

    (b) The effect of transient populations on the need of an area for 
primary care professional(s) will be taken into account as follows:
    (i) Seasonal residents, i.e., those who maintain a residence in the 
area but inhabit it for only 2 to 8 months per year, may be included but 
must be weighted in proportion to the fraction of the year they are 
present in the area.
    (ii) Other tourists (non-resident) may be included in an area's 
population but only with a weight of 0.25, using the following formula: 
Effective tourist contribution to population = 0.25 x (fraction of year 
tourists are present in area) x (average daily number of tourists during 
portion of year that tourists are present).
    (iii) Migratory workers and their families may be included in an 
area's population, using the following formula: Effective migrant 
contribution to population = (fraction of year migrants are present in 
area) x (average daily number of migrants during portion of year that 
migrants are present).
    3. Counting of Primary Care Practitioners.

[[Page 75]]

    (a) All non-Federal doctors of medicine (M.D.) and doctors of 
osteopathy (D.O.) providing direct patient care who practice principally 
in one of the four primary care specialities--general or family 
practice, general internal medicine, pediatrics, and obstetrics and 
gynecology--will be counted. Those physicians engaged solely in 
administration, research, and teaching will be excluded. Adjustments for 
the following factors will be made in computing the number of full-time-
equivalent (FTE) primary care physicians:
    (i) Interns and residents will be counted as 0.1 full-time 
equivalent (FTE) physicians.
    (ii) Graduates of foreign medical schools who are not citizens or 
lawful permanent residents of the United States will be excluded from 
physician counts.
    (iii) Those graduates of foreign medical schools who are citizens or 
lawful permanent residents of the United States, but do not have 
unrestricted licenses to practice medicine, will be counted as 0.5 FTE 
physicians.
    (b) Practitioners who are semi-retired, who operate a reduced 
practice due to infirmity or other limiting conditions, or who provide 
patient care services to the residents of the area only on a part-time 
basis will be discounted through the use of full-time equivalency 
figures. A 40-hour work week will be used as the standard for 
determining full-time equivalents in these cases. For practitioners 
working less than a 40-hour week, every four (4) hours (or \1/2\ day) 
spent providing patient care, in either ambulatory or inpatient 
settings, will be counted as 0.1 FTE (with numbers obtained for FTE's 
rounded to the nearest 0.1 FTE), and each physician providing patient 
care 40 or more hours a week will be counted as 1.0 FTE physician. (For 
cases where data are available only for the number of hours providing 
patient care in office settings, equivalencies will be provided in 
guidelines.)
    (c) In some cases, physicians located within an area may not be 
accessible to the population of the area under consideration. Allowances 
for physicians with restricted practices can be made, on a case-by-case 
basis. However, where only a portion of the population of the area 
cannot access existing primary care resources in the area, a population 
group designation may be more appropriate (see part II of this 
appendix).
    (d) Hospital staff physicians involved exclusively in inpatient care 
will be excluded. The number of full-time equivalent physicians 
practicing in organized outpatient departments and primary care clinics 
will be included, but those in emergency rooms will be excluded.
    (e) Physicians who are suspended under provisions of the Medicare-
Medicaid Anti-Fraud and Abuse Act for a period of eighteen months or 
more will be excluded.
    4. Determination of Unusually High Needs for Primary Medical Care 
Services.
    An area will be considered as having unusually high needs for 
primary health care services if at least one of the following criteria 
is met:
    (a) The area has more than 100 births per year per 1,000 women aged 
15-44.
    (b) The area has more than 20 infant deaths per 1,000 live births.
    (c) More than 20% of the population (or of all households) have 
incomes below the poverty level.
    5. Determination of Insufficient Capacity of Existing Primary Care 
Providers.
    An area's existing primary care providers will be considered to have 
insufficient capacity if at least two of the following criteria are met:
    (a) More than 8,000 office or outpatient visits per year per FTE 
primary care physician serving the area.
    (b) Unusually long waits for appointments for routine medical 
services (i.e., more than 7 days for established patients and 14 days 
for new patients).
    (c) Excessive average waiting time at primary care providers (longer 
than one hour where patients have appointments or two hours where 
patients are treated on a first-come, first-served basis).
    (d) Evidence of excessive use of emergency room facilities for 
routine primary care.
    (e) A substantial proportion (2/3 or more) of the area's physicians 
do not accept new patients.
    (f) Abnormally low utilization of health services, as indicated by 
an average of 2.0 or less office visits per year on the part of the 
area's population.
    6. Contiguous Area Considerations.
    Primary care professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant, 
overutilized or inaccessible to the population of the area under 
consideration if one of the following conditions prevails in each 
contiguous area:
    (a) Primary care professional(s) in the contiguous area are more 
than 30 minutes travel time from the population center(s) of the area 
being considered for designation (measured in accordance with paragraph 
B.1(b) of this part).
    (b) The contiguous area population-to-full-time-equivalent primary 
care physician ratio is in excess of 2000:1, indicating that 
practitioners in the contiguous area cannot be expected to help 
alleviate the shortage situation in the area being considered for 
designation.
    (c) Primary care professional(s) in the contiguous area are 
inaccessible to the population of the area under consideration because 
of specified access barriers, such as:
    (i) Significant differences between the demographic (or socio-
economic) characteristics of the area under consideration and those of 
the contiguous area, indicating that

[[Page 76]]

the population of the area under consideration may be effectively 
isolated from nearby resources. This isolation could be indicated, for 
example, by an unusually high proportion of non-English-speaking 
persons.
    (ii) A lack of economic access to contiguous area resources, as 
indicated particularly where a very high proportion of the population of 
the area under consideration is poor (i.e., where more than 20 percent 
of the population or the households have incomes below the poverty 
level), and Medicaid-covered or public primary care services are not 
available in the contiguous area.
    C. Determination of Degree of Shortage.
    Designated areas will be assigned to degree-of-shortage groups, 
based on the ratio (R) of population to number of full-time equivalent 
primary care physicians and the presence or absence of unusually high 
needs for primary health care services, according to the following 
table:

------------------------------------------------------------------------
                                    High needs not        High needs
                                       indicated           indicated
------------------------------------------------------------------------
Group 1.........................  No physicians.....  No physicians; or
                                                       R=5,00
                                                       0
Group 2.........................  R=5,000  5,000R<
                                                       l=4,000
Group 3.........................  5,000R<  4,000R<
                                   l=4,000.            l=3,500
Group 4.........................  4,000R<  3,500R<
                                   l=3,500.            l=3,000
------------------------------------------------------------------------

    D. Determination of size of primary care physician shortage. Size of 
Shortage (in number of FTE primary care physicians needed) will be 
computed using the following formulas:
    (1) For areas without unusually high need or insufficient capacity:
Primary care physician shortage = area population / 3,500 - number of 
          FTE primary care physicians
    (2) For areas with unusually high need or insufficient capacity:
Primary care physician shortage = area population / 3,000 - number of 
          FTE primary care physicians

                       Part II--Population Groups

    A. Criteria.
    1. In general, specific population groups within particular 
geographic areas will be designated as having a shortage of primary 
medical care professional(s) if the following three criteria are met:
    (a) The area in which they reside is rational for the delivery of 
primary medical care services, as defined in paragraph B.1 of part I of 
this appendix.
    (b) Access barriers prevent the population group from use of the 
area's primary medical care providers. Such barriers may be economic, 
linguistic, cultural, or architectural, or could involve refusal of some 
providers to accept certain types of patients or to accept Medicaid 
reimbursement.
    (c) The ratio of the number of persons in the population group to 
the number of primary care physicians practicing in the area and serving 
the population group is at least 3,000:1.
    2. Indians and Alaska Natives will be considered for designation as 
having shortages of primary care professional(s) as follows:
    (a) Groups of members of Indian tribes (as defined in section 4(d) 
of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are 
automatically designated.
    (b) Other groups of Indians or Alaska Natives (as defined in section 
4(c) of Pub. L. 94-437) will be designated if the general criteria in 
paragraph A are met.
    B. Determination of Degree of Shortage.
    Each designated population group will be assigned to a degree-of-
shortage group, based on the ratio (R) of the group's population to the 
number of primary care physicians serving it, as follows:

Group 1--No physicians or R5,000.
Group 2--5,000R=4,000.
Group 3--4,000R=3,500.
Group 4--3,500R=3,000.

    Population groups which have received ``automatic'' designation will 
be assigned to degree-of-shortage group 4 if no information on the ratio 
of the number of persons in the group to the number of FTE primary care 
physicians serving them is provided.
    C. Determination of size of primary care physician shortage. Size of 
shortage (in number of primary care physicians needed) will be computed 
as follows:
    Primary care physician shortage = number of persons in population 
group/3,000-number of FTE primary care physicians

                          Part III--Facilities

    A. Federal and State Correctional Institutions.
    1. Criteria.
    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of primary medical care professional(s) if both the following 
criteria are met:
    (a) The institution has at least 250 inmates.
    (b) The ratio of the number of internees per year to the number of 
FTE primary care physicians serving the institution is at least 1,000:1.
    Here the number of internees is defined as follows:
    (i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not indicate 
that intake medical examinations are routinely performed upon entry, 
then--Number of internees = average number of inmates.
    (ii) If the average length-of-stay is specified as one year or more, 
and intake medical examinations are routinely performed upon entry, 
then--Number of internees = average

[[Page 77]]

number of inmates + (0.3) x number of new inmates per year.
    (iii) If the average length-of-stay is specified as less than one 
year, and intake examinations are routinely performed upon entry, then--
Number of internees = average number of inmates + (0.2) x (1 + ALOS/2) x 
number of new inmates per year where ALOS = average length-of-stay (in 
fraction of year). (The number of FTE primary care physicians is 
computed as in part I, section B, paragraph 3 above.)
    2. Determination of Degree of Shortage.
    Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of 
internees to primary care physicians, as follows:
    Group 1--Institutions with 500 or more inmates and no physicians.
    Group 2--Other institutions with no physicians and institutions with 
R greater than (or equal to) 2,000:1.
    Group 3--Institutions with R greater than (or equal to) 1,000:1 but 
less than 2,000:1.
    B. Public or Non-Profit Medical Facilities.
    1. Criteria.
    Public or non-profit private medical facilities will be designated 
as having a shortage of primary medical care professional(s) if:
    (a) the facility is providing primary medical care services to an 
area or population group designated as having a primary care 
professional(s) shortage; and
    (b) the facility has insufficient capacity to meet the primary care 
needs of that area or population group.
    2. Methodology
    In determining whether public or nonprofit private medical 
facilities meet the criteria established by paragraph B.1 of this Part, 
the following methodology will be used:
    (a) Provision of Services to a Designated Area or Population Group.
    A facility will be considered to be providing services to a 
designated area or population group if either:
    (i) A majority of the facility's primary care services are being 
provided to residents of designated primary care professional(s) 
shortage areas or to population groups designated as having a shortage 
of primary care professional(s); or
    (ii) The population within a designated primary care shortage area 
or population group has reasonable access to primary care services 
provided at the facility. Reasonable access will be assumed if the area 
within which the population resides lies within 30 minutes travel time 
of the facility and non-physical barriers (relating to demographic and 
socioeconomic characteristics of the population) do not prevent the 
population from receiving care at the facility.
    Migrant health centers (as defined in section 319(a)(1) of the Act) 
which are located in areas with designated migrant population groups and 
Indian Health Service facilities are assumed to be meeting this 
requirement.
    (b) Insufficient capacity to meet primary care needs.
    A facility will be considered to have insufficient capacity to meet 
the primary care needs of the area or population it serves if at least 
two of the following conditions exist at the facility:
    (i) There are more than 8,000 outpatient visits per year per FTE 
primary care physician on the staff of the facility. (Here the number of 
FTE primary care physicians is computed as in Part I, Section B, 
paragraph 3 above.)
    (ii) There is excessive usage of emergency room facilities for 
routine primary care.
    (iii) Waiting time for appointments is more than 7 days for 
established patients or more than 14 days for new patients, for routine 
health services.
    (iv) Waiting time at the facility is longer than 1 hour where 
patients have appointments or 2 hours where patients are treated on a 
first-come, first-served basis.
    3. Determination of Degree of Shortage.
    Each designated medical facility will be assigned to the same 
degree-of-shortage group as the designated area or population group 
which it serves.

[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8737, Mar. 2, 1989; 57 
FR 2480, Jan. 22, 1992]



  Sec. Appendix B to Part 5--Criteria for Designation of Areas Having 
                   Shortages of Dental Professional(s)

                        Part I--Geographic Areas

                               A. Criteria

    A geographic area will be designated as having a dental manpower 
shortage if the following three criteria are met:
    1. The area is a rational area for the delivery of dental services.
    2. One of the following conditions prevails in the area:
    (a) The area has a population to full-time-equivalent dentist ratio 
of less than 5,000:1 or
    (b) The area has a population to full-time-equivalent dentist ratio 
of less than 5,000:1 but greater than 4,000:1 and has unusually high 
needs for dental services or insufficient capacity of existing dental 
providers.
    3. Dental manpower in contiguous areas are over utilized, 
excessively distant, or inaccessible to the population of the area under 
consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Area for the Delivery of Dental Services.

[[Page 78]]

    (a) The following areas will be considered rational areas for the 
delivery of dental health services:
    (i) A county, or a group of several contiguous counties whose 
population centers are within 40 minutes travel time of each other.
    (ii) A portion of a county (or an area made up of portions of more 
than one county) whose population, because of topography, market or 
transportation patterns, distinctive population characteristics, or 
other factors, has limited access to contiguous area resources, as 
measured generally by a travel time of greater than 40 minutes to such 
resources.
    (iii) Established neighborhoods and communities within metropolitan 
areas which display a strong self-identity (as indicated by a homogenous 
socioeconomic or demographic structure and/or a traditional of 
interaction or intradependency), have limited interaction with 
contiguous areas, and which, in general, have a minimum population of 
20,000.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count use will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, with 
the following adjustments:
    (a) Seasonal residents, i.e., those who maintain a residence in the 
area but inhabit it for only 2 to 8 months per year, may be included but 
must be weighted in proportion to the fraction of the year they are 
present in the area.
    (b) Migratory workers and their families may be included in an 
area's population using the following formula: Effective migrant 
contribution to population = (fraction of year migrants are present in 
area) x (average daily number of migrants during portion of year that 
migrants are present).
    3. Counting of Dental Practitioners.
    (a) All non-Federal dentists providing patient care will be counted, 
except in those areas where it is shown that specialists (those dentists 
not in general practice or pedodontics) are serving a larger area and 
are not addressing the general dental care needs of the area under 
consideration.
    (b) Full-time equivalent (FTE) figures will be used to reflect 
productivity differences among dental practices based on the age of the 
dentists, the number of auxiliaries employed, and the number of hours 
worked per week. In general, the number of FTE dentists will be computed 
using weights obtained from the matrix in Table 1, which is based on the 
productivity of dentists at various ages, with different numbers of 
auxiliaries, as compared with the average productivity of all dentists. 
For the purposes of these determinations, an auxiliary is defined as any 
non-dentist staff employed by the dentist to assist in operation of the 
practice.

     Table 1--Equivalency Weights, by Age and Number of Auxiliaries
------------------------------------------------------------------------
                                            <55    55-59   60-64   65 +
------------------------------------------------------------------------
No auxiliaries..........................     0.8     0.7     0.6     0.5
One auxiliary...........................     1.0     0.9     0.8     0.7
Two auxiliaries.........................     1.2     1.0     1.0     0.8
Three auxiliaries.......................     1.4     1.2     1.0     1.0
Four or more auxiliaries................     1.5     1.5     1.3     1.2
------------------------------------------------------------------------

    If information on the number of auxiliaries employed by the dentist 
is not available, Table 2 will be used to compute the number of full-
time equivalent dentists.

                  Table 2--Equivalency Weights, by Age
------------------------------------------------------------------------
                                            55     55-59   60-64   65 +
------------------------------------------------------------------------
Equivalency weights.....................     1.2     0.9     0.8     0.6
------------------------------------------------------------------------

    The number of FTE dentists within a particular age group (or age/
auxiliary group) will be obtained by multiplying the number of dentists 
within that group by its corresponding equivalency weight. The total 
supply of FTE dentists within an area is then computed as the sum of 
those dentists within each age (or age/auxiliary) group.
    (c) The equivalency weights specified in tables 1 and 2 assume that 
dentists within a particular group are working full-time (40 hours per 
week). Where appropriate data are available, adjusted equivalency 
figures for dentists who are semi-retired, who operate a reduced 
practice due to infirmity or other limiting conditions, or who are 
available to the population of an area only on a part-time basis will be 
used to reflect the reduced availability of these dentists. In computing 
these equivalency figures, every 4 hours (or \1/2\ day) spent in the 
dental practice will be counted as 0.1 FTE except that each dentist 
working more than 40 hours a week will be counted as 1.0. The count 
obtained for a particular age group of dentists will then be multiplied 
by the appropriate equivalency weight from table 1 or 2 to obtain a 
full-time equivalent figure for dentists within that particular age or 
age/auxiliary category.
    4. Determination of Unusually High Needs for Dental Services.

[[Page 79]]

    An area will be considered as having unusually high needs for dental 
services if at least one of the following criteria is met:
    (a) More than 20% of the population (or of all households) has 
incomes below the poverty level.
    (b) The majority of the area's population does not have a 
fluoridated water supply.
    5. Determination of Insufficient Capacity of Existing Dental Care 
Providers.
    An area's existing dental care providers will be considered to have 
insufficient capacity if at least two of the following criteria are met:
    (a) More than 5,000 visits per year per FTE dentist serving the 
area.
    (b) Unusually long waits for appointments for routine dental 
services (i.e., more than 6 weeks).
    (c) A substantial proportion (\2/3\ or more) of the area's dentists 
do not accept new patients.
    6. Contiguous Area Considerations.
    Dental professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant, 
overutilized or inaccessible to the population of the area under 
consideration if one of the following conditions prevails in each 
contiguous area:
    (a) Dental professional(s) in the contiguous area are more than 40 
minutes travel time from the center of the area being considered for 
designation (measured in accordance with Paragraph B.1.(b) of this 
part).
    (b) Contiguous area population-to-(FTE) dentist ratios are in excess 
of 3,000:1, indicating that resources in contiguous areas cannot be 
expected to help alleviate the shortage situation in the area being 
considered for designation.
    (c) Dental professional(s) in the contiguous area are inaccessible 
to the population of the area under consideration because of specified 
access barriers, such as:
    (i) Significant differences between the demographic (or 
socioeconomic) characteristics of the area under consideration and those 
of the contiguous area, indicating that the population of the area under 
consideration may be effectively isolated from nearby resources. Such 
isolation could be indicated, for example, by an unusually high 
proportion of non-English-speaking persons.
    (ii) A lack of economic access to contiguous area resources, 
particularly where a very high proportion of the population of the area 
under consideration is poor (i.e., where more than 20 percent of the 
population or of the households have incomes below the poverty level) 
and Medicaid-covered or public dental services are not available in the 
contiguous area.
    C. Determination of Degree of Shortage.
    The degree of shortage of a given geographic area, designated as 
having a shortage of dental professional(s), will be determined using 
the following procedure:
    Designated areas will be assigned to degree-of-shortage groups, 
based on the ratio (R) of population to number of full-time-equivalent 
dentists and the presence or absence of unusually high needs for dental 
services, or insufficient capacity of existing dental care providers 
according to the following table:

------------------------------------------------------------------------
                                     High needs or
                                     insufficient        High needs or
                                     capacity not        insufficient
                                       indicated      capacity indicated
------------------------------------------------------------------------
Group 1.........................  No dentists.......  No dentists or
                                                       R=8,00
                                                       0.
Group 2.........................  R=8,000  8,000R<
                                                       l=6,000.
Group 3.........................  8,000R<  6,000R<
                                   l=6,000.            l=5,000.
Group 4.........................  6,000R<  5,000R<
                                   l=5,000.            l=4,000.
------------------------------------------------------------------------

    D. Determination of size of dental shortage. Size of Dental Shortage 
(in number of FTE dental practitioners needed) will be computed using 
the following formulas:
    (1) For areas without unusually high need:
Dental shortage = area population/5,000-number of FTE dental 
practitioners
    (2) For areas with unusually high need:
Dental shortage = area population/4,000-number of FTE dental 
practitioners

                       Part II--Population Groups

    A. Criteria.
    1. In general, specified population groups within particular 
geographic areas will be designated as having a shortage of dental care 
professional(s) if the following three criteria are met:
    a. The area in which they reside is rational for the delivery of 
dental care services, as defined in paragraph B.1 of part I of this 
appendix.
    b. Access barriers prevent the population group from use of the 
area's dental providers.
    c. The ratio (R) of the number of persons in the population group to 
the number of dentists practicing in the area and serving the population 
group is at least 4,000:1.
    2. Indians and Alaska Natives will be considered for designation as 
having shortages of dental professional(s) as follows:
    (a) Groups of members of Indian tribes (as defined in section 4(d) 
of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are 
automatically designated.
    (b) Other groups of Indians or Alaska Natives (as defined in section 
4(c) of Pub. L. 94-437) will be designated if the general criteria in 
paragraph 1 are met.
    B. Determination of Degree of Shortage.
    Each designated population group will be assigned to a degree-of-
shortage group as follows:

Group 1--No dentists or R=8,000.
Group 2--8,000R=6,000.
Group 3--6,000R=5,000.

[[Page 80]]

Group 4--5,000R=4,000.

Population groups which have received ``automatic'' designation will be 
assigned to degree-of-shortage group 4 unless information on the ratio 
of the number of persons in the group to the number of FTE dentists 
serving them is provided.
    C. Determination of size of dental shortage. Size of dental shortage 
will be computed as follows:
Dental shortage = number of persons in population group/4,000-number of 
FTE dental practitioners

                          Part III--Facilities

    A. Federal and State Correctional Institutions.
    1. Criteria
    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of dental professional(s) if both the following criteria are 
met:
    (a) The institution has at least 250 inmates.
    (b) The ratio of the number of internees per year to the number of 
FTE dentists serving the institution is at least 1,500:1.
    Here the number of internees is defined as follows:
    (i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not indicate 
that intake dental examinations are routinely performed by dentists upon 
entry, then--Number of internees = average number of inmates.
    (ii) If the average length-of-stay is specified as one year or more, 
and intake dental examinations are routinely performed upon entry, 
then--Number of internees = average number of inmates + number of new 
inmates per year.
    (iii) If the average length-of-stay is specified as less than one 
year, and intake dental examinations are routinely performed upon entry, 
then--Number of internees = average number of inmates + \1/3\ x (1 + 2 x 
ALOS) x number of new inmates per year where ALOS = average length-of-
stay (in fraction of year).

(The number of FTE dentists is computed as in part I, section B, 
paragraph 3 above.)

    2. Determination of Degree of Shortage.
    Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of 
internees to dentists, as follows:
    Group 1--Institutions with 500 or more inmates and no dentists.
    Group 2--Other institutions with no dentists and institutions with R 
greater than (or equal to) 3,000:1.
    Group 3--Institutions with R greater than (or equal to) 1,500:1 but 
less than 3,000:1.

    B. Public or Non-Profit Private Dental Facilities.
    1. Criteria.
    Public or nonprofit private facilties providing general dental care 
services will be designated as having a shortage of dental 
professional(s) if both of the following criteria are met:
    (a) The facility is providing general dental care services to an 
area or population group designated as having a dental professional(s) 
shortage; and
    (b) The facility has insufficent capacity to meet the dental care 
needs of that area or population group.
    2. Methodology.
    In determining whether public or nonprofit private facilities meet 
the criteria established by paragraph B.1. of this part, the following 
methodology will be used:
    (a) Provision of Services to a Designated Area or Population Group.
    A facility will be considered to be providing services to an area or 
population group if either:
    (i) A majority of the facility's dental care services are being 
provided to residents of designated dental professional(s) shortage 
areas or to population groups designated as having a shortage of dental 
professional(s); or
    (ii) The population within a designated dental shortage area or 
population group has reasonable access to dental services provided at 
the facility. Reasonable access will be assumed if the population lies 
within 40 minutes travel time of the facility and non-physical barriers 
(relating to demographic and socioeconomic characteristics of the 
population) do not prevent the population from receiving care at the 
facility.
    Migrant health centers (as defined in section 319(a)(1) of the Act) 
which are located in areas with designated migrant population groups and 
Indian Health Service facilities are assumed to be meeting this 
requirement.
    (b) Insufficient Capacity To Meet Dental Care Needs.
    A facility will be considered to have insufficient capacity to meet 
the dental care needs of a designated area or population group if either 
of the following conditions exists at the facility.
    (i) There are more than 5,000 outpatient visits per year per FTE 
dentist on the staff of the facility. (Here the number of FTE dentists 
is computed as in part I, section B, paragraph 3 above.)
    (ii) Waiting time for appointments is more than 6 weeks for routine 
dental services.
    3. Determination of Degree of Shortage.
    Each designated dental facility will be assigned to the same degree-
of-shortage group as the designated area or population group which it 
serves.

[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8738, Mar. 2, 1989; 57 
FR 2480, Jan. 22, 1992]

[[Page 81]]



  Sec. Appendix C to Part 5--Criteria for Designation of Areas Having 
                Shortages of Mental Health Professionals

                        Part I--Geographic Areas

    A. Criteria. A geographic area will be designated as having a 
shortage of mental health professionals if the following four criteria 
are met:
    1. The area is a rational area for the delivery of mental health 
services.
    2. One of the following conditions prevails within the area:
    (a) The area has--
    (i) A population-to-core-mental-health-professional ratio greater 
than or equal to 6,000:1 and a population-to-psychiatrist ratio greater 
than or equal to 20,000:1, or
    (ii) A population-to-core-professional ratio greater than or equal 
to 9,000:1, or
    (iii) A population-to-psychiatrist ratio greater than or equal to 
30,000:1;
    (b) The area has unusually high needs for mental health services, 
and has--
    (i) A population-to-core-mental-health-professional ratio greater 
than or equal to 4,500:1 and
    A population-to-psychiatrist ratio greater than or equal to 
15,000:1, or
    (ii) A population-to-core-professional ratio greater than or equal 
to 6,000:1, or
    (iii) A population-to-psychiatrist ratio greater than or equal to 
20,000:1;
    3. Mental health professionals in contiguous areas are overutilized, 
excessively distant or inaccessible to residents of the area under 
consideration.

    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Mental Health Services.
    (a) The following areas will be considered rational areas for the 
delivery of mental health services:
    (i) An established mental health catchment area, as designated in 
the State Mental Health Plan under the general criteria set forth in 
section 238 of the Community Mental Health Centers Act.
    (ii) A portion of an established mental health catchment area whose 
population, because of topography, market and/or transportation patterns 
or other factors, has limited access to mental health resources in the 
rest of the catchment area, as measured generally by a travel time of 
greater than 40 minutes to these resources.
    (iii) A county or metropolitan area which contains more than one 
mental health catchment area, where data are unavailable by individual 
catchment area.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions.
    3. Counting of mental health professionals. (a) All non-Federal core 
mental health professionals (as defined below) providing mental health 
patient care (direct or other, including consultation and supervision) 
in ambulatory or other short-term care settings to residents of the area 
will be counted. Data on each type of core professional should be 
presented separately, in terms of the number of full-time-equivalent 
(FTE) practitioners of each type represented.
    (b) Definitions:
    (i) Core mental health professionals or core professionals includes 
those psychiatrists, clinical psychologists, clinical social workers, 
psychiatric nurse specialists, and marriage and family therapists who 
meet the definitions below.
    (ii) Psychiatrist means a doctor of medicine (M.D.) or doctor of 
osteopathy (D.O.) who
    (A) Is certified as a psychiatrist or child psychiatrist by the 
American Medical Specialities Board of Psychiatry and Neurology or by 
the American Osteopathic Board of Neurology and Psychiatry, or, if not 
certified, is ``broad-eligible'' (i.e., has successfully completed an 
accredited program of graduate medical or osteopathic education in 
psychiatry or child psychiatry); and
    (B) Practices patient care psychiatry or child psychiatry, and is 
licensed to do so, if required by the State of practice.
    (iii) Clinical psychologist means an individual (normally with a 
doctorate in psychology) who is practicing as a clinical or counseling 
psychologist and is licensed or certified to do so by the State of 
practice; or, if licensure or certification is not required in the State 
of practice, an individual with a doctorate in psychology and two years 
of supervised clinical or counseling experience. (School psychologists 
are not included.)
    (iv) Clinical social worker means an individual who--
    (A) Is certified as a clinical social worker by the American Board 
of Examiners in Clinical Social Work, or is listed on the National

[[Page 82]]

Association of Social Workers' Clinical Register, or has a master's 
degree in social work and two years of supervised clinical experience; 
and
    (B) Is licensed to practice as a social worker, if required by the 
State of practice.
    (v) Psychiatric nurse specialist means a registered nurse (R.N.) 
who--
    (A) Is certified by the American Nurses Association as a psychiatric 
and mental health clinical nurse specialist, or has a master's degree in 
nursing with a specialization in psychiatric/mental health and two years 
of supervised clinical experience; and
    (B) Is licensed to practice as a psychiatric or mental health nurse 
specialist, if required by the State of practice.
    (vi) Marriage and family therapist means an individual (normally 
with a master's or doctoral degree in marital and family therapy and at 
least two years of supervised clinical experience) who is practicing as 
a marital and family therapist and is licensed or certified to do so by 
the State of practice; or, if licensure or certification is not required 
by the State of practice, is eligible for clinical membership in the 
American Association for Marriage and Family Therapy.
    (c) Practitioners who provide patient care to the population of an 
area only on a part-time basis (whether because they maintain another 
office elsewhere, spend some of their time providing services in a 
facility, are semi-retired, or operate a reduced practice for other 
reasons), will be counted on a partial basis through the use of full-
time-equivalency calculations based on a 40-hour week. Every 4 hours (or 
\1/2\ day) spent providing patient care services in ambulatory or 
inpatient settings will be counted as 0.1 FTE, and each practitioner 
providing patient care for 40 or more hours per week as 1.0 FTE. Hours 
spent on research, teaching, vocational or educational counseling, and 
social services unrelated to mental health will be excluded; if a 
practitioner is located wholly or partially outside the service area, 
only those services actually provided within the area are to be counted.
    (d) In some cases, practitioners located within an area may not be 
accessible to the general population of the area under consideration. 
Practitioners working in restricted facilities will be included on an 
FTE basis based on time spent outside the facility. Examples of 
restricted facilities include correctional institutions, youth detention 
facilities, residential treatment centers for emotionally disturbed or 
mentally retarded children, school systems, and inpatient units of State 
or county mental hospitals.
    (e) In cases where there are mental health facilities or 
institutions providing both inpatient and outpatient services, only 
those FTEs providing mental health services in outpatient units or other 
short-term care units will be counted.
    (f) Adjustments for the following factors will also be made in 
computing the number of FTE providers:
    (i) Practitioners in residency programs will be counted as 0.5 FTE.
    (ii) Graduates of foreign schools who are not citizens or lawful 
permanent residents of the United States will be excluded from counts.
    (iii) Those graduates of foreign schools who are citizens or lawful 
permanent residents of the United States, and practice in certain 
settings, but do not have unrestricted licenses to practice, will be 
counted on a full-time-equivalency basis up to a maximum of 0.5 FTE.
    (g) Practitioners suspended for a period of 18 months or more under 
provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act will not be 
counted.
    4. Determination of unusually high needs for mental health services. 
An area will be considered to have unusually high needs for mental 
health services if one of the following criteria is met:
    (a) 20 percent of the population (or of all households) in the area 
have incomes below the poverty level.
    (b) The youth ratio, defined as the ratio of the number of children 
under 18 to the number of adults of ages 18 to 64, exceeds 0.6.
    (c) The elderly ratio, defined as the ratio of the number of persons 
aged 65 and over to the number of adults of ages 18 to 64, exceeds 0.25.
    (d) A high prevalence of alcoholism in the population, as indicated 
by prevalence data showing the area's alcoholism rates to be in the 
worst quartile of the nation, region, or State.
    (e) A high degree of substance abuse in the area, as indicated by 
prevalence data showing the area's substance abuse to be in the worst 
quartile of the nation, region, or State.
    5. Contiguous area considerations. Mental health professionals in 
areas contiguous to an area being considered for designation will be 
considered excessively distant, overutilized or inaccessible to the 
population of the area under consideration if one of the following 
conditions prevails in each contiguous area:
    (a) Core mental health professionals in the contiguous area are more 
than 40 minutes travel time from the closest population center of the 
area being considered for designation (measured in accordance with 
paragraph B.1(b) of this part).
    (b) The population-to-core-mental-health-professional ratio in the 
contiguous area is in excess of 3,000:1 and the population-to-
psychiatrist ratio there is in excess of 10,000:1, indicating that core 
mental health professionals in the contiguous areas are overutilized and 
cannot be expected to help alleviate the shortage situation in the area 
for

[[Page 83]]

which designation is being considered. (If data on core mental health 
professionals other than psychiatrists are not available for the 
contiguous area, a population-to-psychiatrist ratio there in excess of 
20,000:1 may be used to demonstrate overutilization.)
    (c) Mental health professionals in contiguous areas are inaccessible 
to the population of the requested area due to geographic, cultural, 
language or other barriers or because of residency restrictions of 
programs or facilities providing such professionals.
    C. Determination of degree of shortage. Designated areas will be 
assigned to degree-of-shortage groups according to the following table, 
depending on the ratio (RC) of population to number of FTE 
core-mental-health-service providers (FTEC); the ratio 
(RP) of population to number of FTE psychiatrists 
(FTEP); and the presence or absence of high needs:

                        High Needs Not Indicated

Group 1--FTEC = 0 and FTEP = 0
Group 2--RC gte * 6,000:1 and FTEP = 0
Group 3--RC gte 6,000:1 and RP gte 20,000
Group 4(a)--For psychiatrist placements only: All other areas with 
FTEP = 0 or RP gte 30,000
Group 4(b)--For other mental health practitioner placements: All other 
areas with RC gte 9,000:1.

    * Note: ``gte'' means ``greater than or equal to''.

                          High Needs Indicated

Group 1--FTEC = 0 and FTEP = 0
Group 2--RC gte 4,500:1 and FTEP = 0
Group 3--RC gte 4,500:1 and RP gte 15,000
Group 4(a)--For psychiatrist placements only: All other areas with 
FTEP = 0 or RP gte 20,000
Group 4(b)--For other mental health practitioner placements: All other 
areas with RC gte 6,000:1.
    D. Determination of Size of Shortage. Size of Shortage (in number of 
FTE professionals needed) will be computed using the following formulas:
    (1) For areas without unusually high need:

Core professional shortage = area population/6,000-number of FTE core 
professionals
Psychiatrist shortage = area population/20,000-number of FTE 
psychiatrists

    (2) For areas with unusually high need:

Core professional shortage = area population/4,500-number of FTE core 
professionals
Psychiatrist shortage = area population/15,000-number of FTE 
psychiatrists

                       Part II--Population Groups

    A. Criteria. Population groups within particular rational mental 
health service areas will be designated as having a mental health 
professional shortage if the following criteria are met:
    1. Access barriers prevent the population group from using those 
core mental health professionals which are present in the area; and
    2. One of the following conditions prevails:
    (a) The ratio of the number of persons in the population group to 
the number of FTE core mental health professionals serving the 
population group is greater than or equal to 4,500:1 and the ratio of 
the number of persons in the population group to the number of FTE 
psychiatrists serving the population group is greater than or equal to 
15,000:1; or,
    (b) The ratio of the number of persons in the population group to 
the number of FTE core mental health professionals serving the 
population group is greater than or equal to 6,000:1; or,
    (c) The ratio of the number of persons in the population group to 
the number of FTE psychiatrists serving the population group is greater 
than or equal to 20,000:1.
    B. Determination of degree of shortage. Designated population groups 
will be assigned to the same degree-of-shortage groups defined in part 
I.C of this appendix for areas with unusually high needs for mental 
health services, using the computed ratio (RC) of the number 
of persons in the population group to the number of FTE core mental 
health service providers (FTEC) serving the population group, 
and the ration (RP) of the number of persons in the 
population group to the number of FTE psychiatrists (FTEP) 
serving the population group.
    C. Determination of size of shortage. Size of shortage will be 
computed as follows:
Core professional shortage = number of persons in population group/
4,500-number of FTE core professionals
Psychiatrist shortage = number of persons in population group/15,000-
number of FTE psychiatrists

                          Part III--Facilities

             A. Federal and State Correctional Institutions

                              1. Criteria.

    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of psychiatric manpower if both of the following criteria are 
met:
    (a) The institution has more than 250 inmates, and
    (b) The ratio of the number of internees per year to the number of 
FTE psychiatrists serving the institution is at least 1,000:1.
    Here the number of internees is defined as follows:
    (i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not

[[Page 84]]

indicate that intake psychiatric examinations are routinely performed 
upon entry, then--
    Number of internees=average number of inmates
    (ii) If the average length-of-stay is specified as one year or more, 
and the intake psychiatric examinations are routinely performed upon 
entry, then--
    Number internees=average number of inmates+number of new inmates per 
year
    (iii) If the average length-of-stay is specified as less than one 
year, and intake psychiatric examinations are routinely performed upon 
entry, then--
    Number of internees=average number of inmates+\1/
3\x[1+(2xALOS)]xnumber of new inmates per year
    where ALOS=average length-of-stay (in fraction of year) (The number 
of FTE psychiatrists is computed as in Part I, Section B, paragraph 3 
above.)

                 2. Determination of Degree of Shortage.

    Designated correctional institutions will be assigned to degree-of-
shortage groups, based on the number of inmates and/or the ration (R) of 
internees to FTE psychiatrists, as follows:
    Group 1--Institutions with 500 or more inmates and no psychiatrist.
    Group 2--Other institutions with no psychiatrists and institutions 
with R greater than (or equal to) 3,000:1.
    Group 3--Institutions with R greater than (or equal to) 2,000:1 but 
less than 3,000:1.

    B. State and County Mental Hospitals.
    1. Criteria.
    A State or county hospital will be designated as having a shortage 
of psychiatric professional(s) if both of the following criteria are 
met:
    (a) The mental hospital has an average daily inpatient census of at 
least 100; and
    (b) The number of workload units per FTE psychiatrists available at 
the hospital exceeds 300, where workload units are calculated using the 
following formula:
    Total workload units = average daily inpatient census + 2 x (number 
of inpatient admissions per year) + 0.5 x (number of admissions to day 
care and outpatient services per year).
    2. Determination of Degree of Shortage.
    State or county mental hospitals will be assigned to degree-of-
shortage groups, based on the ratio (R) of workload units to number of 
FTE psychiatrists, as follows:

    Group 1--No psychiatrists, or R1,800.
    Group 2--1,800R1,200.
    Group 3--1,200R600.
    Group 4--600R300.

    C. Community Mental Health Centers and Other Public or Nonprofit 
Private Facilities.
    1. Criteria.
    A community mental health center (CMHC), authorized by Pub. L. 94-
63, or other public or nonprofit private facility providing mental 
health services to an area or population group, may be designated as 
having a shortage of psychiatric professional(s) if the facility is 
providing (or is responsible for providing) mental health services to an 
area or population group designated as having a mental health 
professional(s) shortage, and the facility has insufficient capacity to 
meet the psychiatric needs of the area or population group.
    2. Methodology.
    In determining whether CMHCs or other public or nonprofit private 
facilities meet the criteria established in paragraph C.1 of this Part, 
the following methodology will be used.
    (a) Provision of Services to a Designated Area or Population Group.
    The facility will be considered to be providing services to a 
designated area or population group if either:
    (i) A majority of the facility's mental health services are being 
provided to residents of designated mental health professional(s) 
shortage areas or to population groups designated as having a shortage 
of mental health professional(s); or
    (ii) The population within a designated psychiatric shortage area or 
population group has reasonable access to mental health services 
provided at the facility. Such reasonable access will be assumed if the 
population lies within 40 minutes travel time of the facility and 
nonphysical barriers (relating to demographic and socioeconomic 
characteristics of the population) do not prevent the population from 
receiving care at the facility.
    (b) Responsibility for Provision of Services.
    This condition will be considered to be met if the facility, by 
Federal or State statute, administrative action, or contractual 
agreement, has been given responsibility for providing and/or 
coordinating mental health services for the area or population group, 
consistent with applicable State plans.
    (c) Insufficient capacity to meet mental health service needs. A 
facility will be considered to have insufficient capacity to meet the 
mental health service needs of the area or population it serves if:
    (i) There are more than 1,000 patient visits per year per FTE core 
mental health professional on staff of the facility, or
    (ii) There are more than 3,000 patient visits per year per FTE 
psychiatrist on staff of the facility, or
    (iii) No psychiatrists are on the staff and this facility is the 
only facility providing (or responsible for providing) mental health 
services to the designated area or population.
    3. Determination of Degree-of-Shortage.

[[Page 85]]

    Each designated facility will be assigned to the same degree-of-
shortage group as the designated area or population group which it 
serves.

[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8738, Mar. 2, 1989; 57 
FR 2477, Jan. 22, 1992]



  Sec. Appendix D to Part 5--Criteria for Designation of Areas Having 
                Shortages of Vision Care Professional(s)

                        Part I--Geographic Areas

    A. Criteria.
    A geographic area will be designated as having a shortage of vision 
care professional(s) if the following three criteria are met:
    1. The area is a rational area for the delivery of vision care 
services.
    2. The estimated number of optometric visits supplied by vision care 
professional(s) in the area is less than the estimated requirements of 
the area's population for these visits, and the computed shortage is at 
least 1,500 optometric visits.
    3. Vision care professional(s) in contiguous areas are excessively 
distant, overutilized, or inaccessible to the population of the area 
under consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Vision Care Services.
    (a) The following areas will be considered rational areas for the 
delivery of vision care services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 40 minutes travel time of each other;
    (ii) A portion of a county (or an area made up of portions of more 
than one county) whose population, because of topography, market or 
transportation patterns, or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 40 minutes to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Determination of Estimated Requirement for Optometric Visits.
    The number of optometric visits required by an area's population 
will be estimated by multiplying each of the following visit rates by 
the size of the population within that particular age group and then 
adding the figures obtained together.

----------------------------------------------------------------------------------------------------------------
                                              Annual number of optometric visits required per person, by age
                                         -----------------------------------------------------------------------
                   Age                                                                                  60 and
                                           Under 20      20-29       30-39       40-49       50-59       over
----------------------------------------------------------------------------------------------------------------
Number of visits........................        0.11        0.20        0.24        0.35        0.41        0.48
----------------------------------------------------------------------------------------------------------------

    For geographic areas where the age distribution of the population is 
not known, it will be assumed that the percentage distribution, by age 
groups, for the area is the same as the distribution for the county of 
which it is a part.
    (3) Determination of Estimated Supply of Optometric Visits.
    The estimated supply of optometric services will be determined by 
use of the following formula:

Optometric visits supplied = 3,000 x (number of optometrists under 65)
Optometric visits supplied + 2,000 x (number of optometrists 65 and 
          over)
Optometric visits supplied + 1,500 x (number of ophthamologists)

    (4) Determination of Size of Shortage.
    Size of shortage (in number of optometric visits) will be computed 
as follows:
    Optometric visit shortage = visits required - visits supplied
    (5) Contiguous Area Considerations.
    Vision care professional(s) in area contiguous to an area being 
considered for designation will be considered execessively distant, 
overutilized or inaccessible to the population of the area if one of the 
following conditions prevails in each contiguous area:
    (a) Vision care professional(s) in the contiguous area are more than 
40 minutes travel time from the center of the area being considered for 
designation (measured in accordance with paragraph B.1(b) of this part).
    (b) The estimated requirement for vision care services in the 
contiguous area exceeds the estimated supply of such services there, 
based on the requirements and supply calculations previously described.

[[Page 86]]

    (c) Vision care professional(s) in the contiguous area are 
inaccessible to the population of the area because of specified access 
barriers (such as economic or cultural barriers).
    C. Determination of Degree-of-Shortage.
    Designated areas (and population groups) will be assigned to degree-
of-shortage groups, based on the ratio of optometric visits supplied to 
optometric visits required for the area (or group), as follows:

    Group 1--Areas (or groups) with no optometric visits being supplied 
(i.e., with no optometrists or ophthalmologists).
    Group 2--Areas (or groups) where the ratio of optometric visits 
supplied to optometric visits required is less than 0.5.
    Group 3--Areas (or groups) where the ratio of optometric visits 
supplied to optometric visits required is between 0.5 and 1.0.

                       Part II--Population Groups

    A. Criteria.
    Population groups within particular geographic areas will be 
designated if both the following criteria are met:
    (1) Members of the population group do not have access to vision 
care resources within the area (or in contiguous areas) because of non-
physical access barriers (such as economic or cultural barriers).
    (2) The estimated number of optometric visits supplied to the 
population group (as determined under paragraph B.3 of part I of this 
Appendix) is less than the estimated number of visits required by that 
group (as determined under paragraph B.2 of part I of this Appendix), 
and the computed shortage is at least 1,500 optometric visits.
    B. Determination of Degree of Shortage.
    The degree of shortage of a given population group will be 
determined in the same way as described for areas in paragraph C of part 
I of this appendix.



  Sec. Appendix E to Part 5--Criteria for Designation of Areas Having 
                 Shortages of Podiatric Professional(s)

                        Part I--Geographic Areas

    A. Criteria.
    A geographic area will be designated as having a shortage of 
podiatric professional(s) if the following three criteria are met:
    1. The area is a rational area for the delivery of podiatric 
services.
    2. The area's ratio of population to foot care practitioners is at 
least 28,000:1, and the computed podiatrist shortage to meet this ratio 
is at least 0.5.
    3. Podiatric professional(s) in contiguous areas are overutilized, 
excessively distant, or inaccessible to the population of the area under 
consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this Part, the following methodology will be used:
    1. Rational Areas for the Delivery of Podiatric Services.
    (a) The following areas will be considered rational areas for the 
delivery of podiatric services:
    (i) A county or a group of contiguous counties whose population 
centers are within 40 minutes travel time of each other.
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market and/or 
transportation patterns or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 40 minutes from its population center to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the area 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, 
adjusted by the following formula to take into account the differing 
utilization rates of podiatric services by different age groups within 
the population:

Adjusted population = total population x (1 + 2.2 x (percent of 
          population 65 and over) - 0.44 x (percent of population under 
          17)).

    3. Counting of Foot Care Practitioners.
    (a) All podiatrists providing patient care will be counted. However, 
in order to take into account productivity differences in podiatric 
practices associated with the age of the podiatrists, the following 
formula will be utilized:

Number of FTE podiatrists = 1.0 x (podiatrists under age 55)
 + .8 x (podiatrists age 55 and over)

    (b) In order to take into account the fact that orthopedic surgeons 
and general and family practitioners devote a percentage of their time 
to foot care, the total available foot care practitioners will be 
computed as follows:

Number of foot care practitioners = number of FTE podiatrists
 + .15 x (number of orthopedic surgeons)

[[Page 87]]

 + .02 x (number of general and family practioners).

    4. Determination of Size of Shortage.
    Size of shortage (in number of FTE podiatrists) will be computed as 
follows:

Podiatrist shortage = adjusted population / 28,000 - number of FTE foot 
          care practitioners.

    5. Contiguous Area Considerations.
    Podiatric professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant, 
overutilized or inaccessible to the population of the area under 
consideration if one of the following conditions prevails in each 
contiguous area:
    (a) Podiatric professional(s) in the contiguous area are more than 
40 minutes travel time from the center of the area being considered for 
designation.
    (b) The population-to-foot care practitioner ratio in the contiguous 
areas is in excess of 20,000:1, indicating that contiguous area 
podiatric professional(s) cannot be expected to help alleviate the 
shortage situation in the area for which designation is requested.
    (c) Podiatric professional(s) in the contiguous area are 
inaccessible to the population of the area under consideration because 
of specified access barriers (such as economic or cultural barriers).
    C. Determination of Degree of Shortage.
    Designated areas will be assigned to groups, based on the ratio (R) 
of adjusted population to number of foot care practitioners, as follows:

Group 1 Areas with no foot care practitioners, and areas with R 
50,000 and no podiatrists.
Group 2 Other areas with R 50,000.
Group 3 Areas with 50,000 R 28,000.



  Sec. Appendix F to Part 5--Criteria for Designation of Areas Having 
                  Shortages of Pharmacy Professional(s)

                        Part I--Geographic Areas

    A. Criteria.
    A geographic area will be designated as having a shortage of 
pharmacy professional(s) if the following three criteria are met:
    1. The area is a rational area for the delivery of pharmacy 
services.
    2. The number of pharmacists serving the area is less than the 
estimated requirement for pharmacists in the area, and the computed 
pharmacist shortage is at least 0.5.
    3. Pharmacists in contiguous areas are overutilized or excessively 
distant from the population of the area under consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this Part, the following methodology will be used:
    1. Rational Areas for the Delivery of Pharmacy Services.
    (a) The following areas will be considered rational areas for the 
delivery of pharmacy services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 30 minutes travel time of each other; and
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market or 
transportation patterns or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 30 minutes to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 30 minutes travel time:
    (i) Under normal conditions with primary roads available: 20 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 15 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
25 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the area 
corresponding to 30 minutes travel time.
    2. Counting of Pharmacists.
    All active pharmacists within the area will be counted, except those 
engaged in teaching, administration, or pharmaceutical research.
    3. Determination of Estimated Requirement for Pharmacists.
    (a) Basic estimate. The basic estimated requirement for pharmacists 
will be calculated as follows:

Basic pharmacist requirement = .15 x (resident civilian population/
          1,000) + .035 x (total number of physicians engaged in patient 
          care in the area).

    (b) Adjusted estimate. For areas with less than 20,000 persons, the 
following adjustment is made to the basic estimate to compensate for the 
lower expected productivity of small practices.

Estimated pharmacist requirement = (2 - population/20,000) x basic 
          pharmacist requirement.

    4. Size of Shortage Computation.
    The size of the shortage will be computed as follows:

Pharmacist shortage = estimated pharmacist requirement - number of 
          pharmacists available.

    5. Contiguous Area Considerations.

[[Page 88]]

    Pharmacists in areas contiguous to an area being considered for 
designation will be considered excessively distant or overutilized if 
either:
    (a) Pharmacy professional(s) in contiguous areas are more than 30 
minutes travel time from the center of the area under consideration, or
    (b) The number of pharmacists in each contiguous area is less than 
or equal to the estimated requirement for pharmacists for that 
contiguous area (as computed above).
    C. Determination of Degree-of-Shortage.
    Designated areas will be assigned to degree-of-shortage groups, 
based on the proportion of the estimated requirement for pharmacists 
which is currently available in the area, as follows:

    Group 1--Areas with no pharmacists.
    Group 2--Areas where the ratio of available pharmacists to 
pharmacists required is less than 0.5.
    Group 3--Areas where the ratio of available pharmacists to 
pharmacists required is between 0.5 and 1.0.



  Sec. Appendix G to Part 5--Criteria for Designation of Areas Having 
                 Shortages of Veterinary Professional(s)

                        Part I--Geographic Areas

    A. Criteria for Food Animal Veterinary Shortage.
    A geographic area will be designated as having a shortage of food 
animal veterinary professional(s) if the following three criteria are 
met:
    1. The area is a rational area for the delivery of veterinary 
services.
    2. The ratio of veterinary livestock units to food animal 
veterinarians in the area is at least 10,000:1, and the computed food 
animal veterinarian shortage to meet this ratio is at least 0.5.
    3. Food animal veterinarians in contiguous areas are overutilized or 
excessively distant from the population of the area under consideration.
    B. Criteria for Companion Animal Veterinary Shortage.
    A geographic area will be designated as having a shortage of 
companion animal veterinary professional(s) if the following three 
criteria are met:
    1. The area is a rational area for the delivery of veterinary 
services.
    2. The ratio of resident civilian population to number of companion 
animal veterinarians in the area is at least 30,000:1 and the computed 
companion animal veterinary shortage to meet this ratio is at least 0.5.
    3. Companion animal veterinarians in contiguous areas are 
overutilized or excessively distant from the population of the area 
under consideration.
    C. Methodology.
    In determining whether an area meets the criteria established by 
paragraphs A and B of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Veterinary Services.
    (a) The following areas will be considered rational areas for the 
delivery of veterinary services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 40 minutes travel time of each other.
    (ii) A portion of a county (or an area made up of portions of more 
than one county) which, because of topography, market and/or 
transportation patterns or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 40 minutes to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    2. Determination of Number of Veterinary Livestock Units (VLU) 
Requiring Care.
    Since various types of food animals require varying amounts of 
veterinary care, each type of animal has been assigned a weight 
indicating the amount of veterinary care it requires relative to that 
required by a milk cow. Those weights are used to compute the number of 
``Veterinary Livestock Units'' (VLU) for which veterinary care is 
required.
    The VLU is computed as follows:

Veterinary Livestock Units (VLU) = (number of milk cows)
 + .2 x (number of other cattle and calves)
 + .05 x (number of hogs and pigs)
 + .05 x (number of sheep)
 + .002 x (number of poultry).

    3. Counting of Food Animal Veterinarians.
    The number of food animal veterinarians is determined by weighting 
the number of veterinarians within each of several practice categories 
according to the average fraction of practice time in that category 
which is devoted to food animal veterinary care, as follows:

Number of Food Animal Veterinarians = (number of veterinarians in large 
animal practice, exclusively)
 + (number of veterinarians in bovine practice, exclusively)
 + (number of veterinarians in poultry practice, exclusively)
 + .75 x (mixed practice veterinarians with greater than 50% of practice 
in large animal care)

[[Page 89]]

 + .5 x (mixed practice veterinarians with approximately 50% of practice 
in large animal care)
 + .25 x (mixed practice veterinarians with less than 50% of practice in 
large animal care).

    4. Counting of Companion Animal Veterinarians (that is, those who 
provide services for dogs, cats, horses, and any other animals 
maintained as companions to the owner rather than as food animals).
    The number of full-time equivalent companion animal veterinarians is 
determined by weighting the number of veterinarians within each of 
several practice categories by the average portion of their practice 
which is devoted to companion animal care by the practitioners within 
that category, as follows:

Number of Companion Animal Veterinarians = (number of veterinarians in 
large animal practice, exclusively)
 + (number of veterinarians in equine practice, exclusively)
 + .75 x (mixed practice veterinarians with greater than 50% of practice 
in small animal care)
 + .5 x (mixed practice veterinarians with approximately 50% of practice 
in small animal care)
 + .25 x (mixed practice veterinarians with less than 50% of practice in 
small animal care).

    5. Size of Shortage Computation.
    The size of shortage will be computed as follows:
    (a) Food animal veterinarian shortage = (VLU/10,000)-(number of food 
animal veterinarians).
    (b) Companion animal veterinarian shortage = (resident civilian 
pop./30,000)-(number of companion animal veterinarians).
    6. Contiguous Area Considerations.
    Veterinary professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant from 
the population of the area or overutilized if one of the following 
conditions prevails in each contiguous area:
    (a) Veterinary professional(s) in the contiguous area are more than 
60 minutes travel time from the center of the area being considered for 
designation (measured in accordance with paragraph C.1.(b) of this 
part).
    (b) In the case of food animal veterinary professional(s), the VLU-
to-food animal veterinarian ratio in the contiguous area is in excess of 
5,000:1.
    (c) In the case of companion animal veterinary professional(s), the 
population-to-companion animal veterinarian ratio in the contiguous area 
is in excess of 15,000:1.
    C. Determination of Degree-of-Shortage.
    Designated areas will be assigned to degree-of-shortage groups as 
follows:

    Group 1--Areas with a food animal veterinarian shortage and no 
veterinarians.
    Group 2--Areas (not included above) with a food animal veterinarian 
shortage and no food animal veterinarians.
    Group 3--All other food animal veterinarian shortage areas.
    Group 4--All companion animal shortage areas (not included above) 
having no veterinarians.
    Group 5--All other companion animal shortage areas.



PART 6_FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS--
Table of Contents



Sec.
6.1 Applicability.
6.2 Definitions.
6.3 Eligible entities.
6.4 Covered individuals.
6.5 Deeming process for eligible entities.
6.6 Covered acts and omissions.

    Authority: Sections 215 and 224 of the Public Health Service Act, 42 
U.S.C. 216 and 233.

    Source: 60 FR 22532, May 8, 1995, unless otherwise noted.



Sec.  6.1  Applicability.

    This part applies to entities and individuals whose acts and 
omissions related to the performance of medical, surgical, dental, or 
related functions are covered by the Federal Tort Claims Act (28 U.S.C. 
1346(b) and 2671-2680) in accordance with the provisions of section 
224(g) of the Public Health Service Act (42 U.S.C. 233(g)).



Sec.  6.2  Definitions.

    Act means the Public Health Service Act, as amended.
    Attorney General means the Attorney General of the United States and 
any other officer or employee of the Department of Justice to whom the 
authority involved has been delegated.
    Covered entity means an entity described in Sec.  6.3 which has been 
deemed by the Secretary, in accordance with Sec.  6.5, to be covered by 
this part.
    Covered individual means an individual described in Sec.  6.4.
    Effective date as used in Sec.  6.5 and Sec.  6.6 refers to the date 
of the Secretary's determination that an entity is a covered entity.
    Secretary means the Secretary of Health and Human Services (HHS) and

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any other officer or employee of the Department of HHS to whom the 
authority involved has been delegated.
    Subrecipient means an entity which receives a grant or a contract 
from a covered entity to provide a full range of health services on 
behalf of the covered entity.



Sec.  6.3  Eligible entities.

    (a) Grantees. Entities eligible for coverage under this part are 
public and nonprofit private entities receiving Federal funds under any 
of the following grant programs:
    (1) Section 329 of the Act (relating to grants for migrant health 
centers);
    (2) Section 330 of the Act (relating to grants for community health 
centers);
    (3) Section 340 of the Act (relating to grants for health services 
for the homeless); and
    (4) Section 340A of the Act (relating to grants for health services 
for residents of public housing).
    (b) Subrecipients. Entities that are subrecipients of grant funds 
described in paragraph (a) of this section are eligible for coverage 
only if they provide a full range of health care services on behalf of 
an eligible grantee and only for those services carried out under the 
grant funded project.



Sec.  6.4  Covered individuals.

    (a) Officers and employees of a covered entity are eligible for 
coverage under this part.
    (b) Contractors of a covered entity who are physicians or other 
licensed or certified health care practitioners are eligible for 
coverage under this part if they meet the requirements of section 
224(g)(5) of the Act.
    (c) An individual physician or other licensed or certified health 
care practitioner who is an officer, employee, or contractor of a 
covered entity will not be covered for acts or omissions occurring after 
receipt by the entity employing such individual of notice of a final 
determination by the Attorney General that he or she is no longer 
covered by this part, in accordance with section 224(i) of the Act.



Sec.  6.5  Deeming process for eligible entities.

    Eligible entities will be covered by this part only on and after the 
effective date of a determination by the Secretary that they meet the 
requirements of section 224(h) of the Act. In making such determination, 
the Secretary will receive such assurances and conduct such 
investigations as he or she deems necessary.



Sec.  6.6  Covered acts and omissions.

    (a) Only acts and omissions occurring on and after the effective 
date of the Secretary's determination under Sec.  6.5 and before the 
later date specified in section 224(g)(3) of the Act are covered by this 
part.
    (b) Only claims for damage for personal injury, including death, 
resulting from the performance of medical, surgical, dental, or related 
functions are covered by this part.
    (c) With respect to covered individuals, only acts and omissions 
within the scope of their employment (or contract for services) are 
covered. If a covered individual is providing services which are not on 
behalf of the covered entity, such as on a volunteer basis or on behalf 
of a third-party (except as described in paragraph (d) of this section), 
whether for pay or otherwise, acts and omissions which are related to 
such services are not covered.
    (d) Only acts and omissions related to the grant-supported activity 
of entities are covered. Acts and omissions related to services provided 
to individuals who are not patients of a covered entity will be covered 
only if the Secretary determines that:
    (1) The provision of the services to such individuals benefits 
patients of the entity and general populations that could be served by 
the entity through community-wide intervention efforts within the 
communities served by such entity;
    (2) The provision of the services to such individuals facilitates 
the provision of services to patients of the entity; or
    (3) Such services are otherwise required to be provided to such 
individuals under an employment contract or similar arrangement between 
the entity and the covered individual.

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    (e) Examples. The following are examples of situations within the 
scope of paragraph (d) of this section:
    (1) A community health center deemed to be a covered entity 
establishes a school-based or school-linked health program as part of 
its grant supported activity. Even though the students treated are not 
necessarily registered patients of the center, the center and its health 
care practitioners will be covered for services provided, if the 
Secretary makes the determination in paragraph (d)(1) of this section.
    (2) A migrant health center requires its physicians to obtain staff 
privileges at a community hospital. As a condition of obtaining such 
privileges, and thus being able to admit the center's patients to the 
hospital, the physicians must agree to provide occasional coverage of 
the hospital's emergency room. The Secretary would be authorized to 
determine that this coverage is necessary to facilitate the provision of 
services to the grantee's patients, and that it would therefore be 
covered by paragraph (d)(2) of this section.
    (3) A homeless health services grantee makes arrangements with local 
community providers for after-hours coverage of its patients. The 
grantee's physicians are required by their employment contracts to 
provide periodic cross-coverage for patients of these providers, in 
order to make this arrangement feasible. The Secretary may determine 
that the arrangement is within the scope of paragraph (d)(3) of this 
section.
    (4) For the specific activities described in this paragraph (e)(4), 
when carried out by an entity (and its eligible personnel) that has been 
covered under paragraph (c) of this section, the Department has 
determined that coverage is provided under paragraph (d) of this 
section, without the need for specific application for an additional 
coverage determination under paragraph (d) of this section, if the 
activity or arrangement in question fits squarely within these 
descriptions; otherwise, the health center should seek a particularized 
determination of coverage.
    (i) Community-Wide Interventions. (A) School-Based Clinics: Health 
center staff provide primary and preventive health care services at a 
facility located in a school or on school grounds. The health center has 
a written affiliation agreement with the school.
    (B) School-Linked Clinics: Health center staff provide primary and 
preventive health care services, at a site not located on school 
grounds, to students of one or more schools. The health center has a 
written affiliation agreement with each school.
    (C) Health Fairs: On behalf of the health center, health center 
staff conduct or participate in an event to attract community members 
for purposes of performing health assessments. Such events may be held 
in the health center, outside on its grounds, or elsewhere in the 
community.
    (D) Immunization Campaigns: On behalf of the health center, health 
center staff conduct or participate in an event to immunize individuals 
against infectious illnesses. The event may be held at the health 
center, schools, or elsewhere in the community.
    (E) Migrant Camp Outreach: Health center staff travel to a migrant 
farmworker residence camp to conduct intake screening to determine those 
in need of clinic services (which may mean health care is provided at 
the time of such intake activity or during subsequent clinic staff 
visits to the camp).
    (F) Homeless Outreach: Health center staff travel to a shelter for 
homeless persons, or a street location where homeless persons 
congregate, to conduct intake screening to determine those in need of 
clinic services (which may mean health care is provided at the time of 
such intake activity or during subsequent clinic staff visits to that 
location).
    (ii) Hospital-Related Activities. Periodic hospital call or hospital 
emergency room coverage is required by the hospital as a condition for 
obtaining hospital admitting privileges. There must also be 
documentation for the particular health care provider that this coverage 
is a condition of employment at the health center.
    (iii) Coverage-Related Activities. As part of a health center's 
arrangement with local community providers for after-hours coverage of 
its patients, the health center's providers are required by their 
employment contract

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to provide periodic or occasional cross-coverage for patients of these 
providers.
    (iv) Coverage in Certain Individual Emergencies. A health center 
provider is providing or undertaking to provide covered services to a 
health center patient within the approved scope of project of the 
center, or to an individual who is not a patient of the health center 
under the conditions set forth in this rule, when the provider is then 
asked, called upon, or undertakes, at or near that location and as the 
result of a non-health center patient's emergency situation, to 
temporarily treat or assist in treating that non-health center patient. 
In addition to any other documentation required for the original 
services, the health center must have documentation (such as employee 
manual provisions, health center bylaws, or an employee contract) that 
the provision of individual emergency treatment, when the practitioner 
is already providing or undertaking to provide covered services, is a 
condition of employment at the health center.

[60 FR 22532, May 8, 1995; 60 FR 36073, July 13, 1995; 78 FR 58204, 
Sept. 23, 2013]



PART 7_DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS 
AND BIOLOGICAL PREPARATIONS--Table of Contents



Sec.
7.1 Applicability.
7.2 Establishment of a user charge.
7.3 Definitions.
7.4 Schedule of charges.
7.5 Payment procedures.
7.6 Exemptions.

    Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title 
V of the Independent Offices Appropriations Act of 1952 (31 U.S.C. 
9701); and secs. 301(a) and 352 of the Public Health Service Act, as 
amended (42 U.S.C. 241(a) and 263).

    Source: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.



Sec.  7.1  Applicability.

    The provisions of this part are applicable to private entities 
requesting from the Centers for Disease Control and Prevention (CDC) 
reference biological Standards and Biological preparations for use in 
their laboratories.

[78 FR 43820, July 22, 2013]



Sec.  7.2  Establishment of a user charge.

    Except as otherwise provided in Sec.  7.6, a user charge shall be 
imposed to cover the cost to CDC of producing and distributing reference 
biological standards and biological preparations.



Sec.  7.3  Definitions.

    Biological standards means a uniform and stable reference biological 
substance which allows measurements of relative potency to be made and 
described in a common currency of international and national units of 
activity.
    Biological preparations means a reference biological substance which 
may be used for a purpose similar to that of a standard, but which has 
been established without a full collaborative study, or where a 
collaborative study has shown that it is not appropriate to establish 
the preparation as an international standard.



Sec.  7.4  Schedule of charges.

    The charges imposed in Sec.  7.2 are based on the amount published 
in CDC's price list of available products. These changes will reflect 
direct costs (such as salaries and equipment), indirect costs (such as 
rent, telephone service, and a proportionate share of management and 
administrative costs), and the cost of particular ingredients. Charges 
may vary over time and between different biological standards or 
biological preparations, depending upon the cost of ingredients and the 
complexity of production. An up-to-date schedule of charges is available 
from the Division of Scientific Resources, Centers for Disease Control, 
1600 Clifton Road NE., MS C-17, Atlanta, Georgia, 30333 or 404-639-3466.

[78 FR 43820, July 22, 2013]



Sec.  7.5  Payment procedures.

    An up-to-date fee schedule and instructions for terms of payment are 
available from the Division of Scientific Resources, Centers for Disease 
Control and Prevention, 1600 Clifton Road, MS C-17, Atlanta, Georgia 
30333 or 404-639-3466. Any changes in the fee

[[Page 93]]

schedule will be published in the Federal Register. The fee must be paid 
in U.S. dollars at the time that the requester requests the biological 
reference standard or biological preparation.

[78 FR 43820, July 22, 2013]



Sec.  7.6  Exemptions.

    State and local health departments, governmental institutions (e.g., 
State hospitals and universities), the World Health Organization, and 
ministries of health of foreign governments may be exempted from paying 
user charges, when using biological standards or biological preparations 
for public health purposes.



PART 8_MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS--
Table of Contents



                      Subpart A_General Provisions

Sec.
8.1 Scope.
8.2 Definitions.

          Subpart B_Accreditation of Opioid Treatment Programs

8.3 Application for approval as an accreditation body.
8.4 Accreditation body responsibilities.
8.5 Periodic evaluation of accreditation bodies.
8.6 Withdrawal of approval of accreditation bodies.

  Subpart C_Certification and Treatment Standards for Opioid Treatment 
                                Programs

8.11 Opioid treatment program certification.
8.12 Federal opioid treatment standards.
8.13 Revocation of accreditation and accreditation body approval.
8.14 Suspension or revocation of certification.
8.15 Forms.

Subpart D_Procedures for Review of Suspension or Proposed Revocation of 
    OTP Certification, and of Adverse Action Regarding Withdrawal of 
                    Approval of an Accreditation Body

8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing official's response.
8.26 Preparation of the review file and written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written communications by reviewing official and 
          calculation of deadlines.
8.31 Authority and responsibilities of the reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative action; exhaustion of 
          administrative remedies.

Subpart E [Reserved]

    Subpart F_Authorization To Increase Patient Limit to 275 Patients

8.610 Which practitioners are eligible for a patient limit of 275?
8.615 What constitutes a qualified practice setting?
8.620 What is the process to request a patient limit of 275?
8.625 How will a Request for Patient Limit Increase be processed?
8.630 What must practitioners do in order to maintain their approval to 
          treat up to 275 patients?
8.635 What are the reporting requirements for practitioners whose 
          Request for Patient Limit Increase is approved?
8.640 What is the process for renewing a practitioner's Request for 
          Patient Limit Increase approval?
8.645 What are the responsibilities of practitioners who do not submit a 
          renewal Request for Patient Limit Increase, or whose renewal 
          request is denied?
8.650 Can SAMHSA's approval of a practitioner's Request for Patient 
          Limit Increase be suspended or revoked?
8.655 Can a practitioner request to temporarily treat up to 275 patients 
          in emergency situations?

    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-
23, 300x-27(a), 300y-11.

    Source: 66 FR 4090, Jan. 17, 2001, unless otherwise noted.

    Editorial Note: Nomenclature changes to part appear at 81 FR 44736, 
July 8, 2016.



                      Subpart A_General Provisions



Sec.  8.1  Scope.

    (a) Subparts A through C of this part establish the procedures by 
which the

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Secretary of Health and Human Services (the Secretary) will determine 
whether a practitioner is qualified under section 303(g) of the 
Controlled Substances Act (CSA) (21 U.S.C. 823(g)) to dispense opioid 
drugs in the treatment of opioid use disorders. The regulations also 
establish the Secretary's standards regarding the appropriate quantities 
of opioid drugs that may be provided for unsupervised use by individuals 
undergoing such treatment (21 U.S.C. 823(g)(1)). Under these 
regulations, a practitioner who intends to dispense opioid drugs in the 
treatment of opioid use disorder must first obtain from the Secretary 
or, by delegation, from the Administrator, Substance Abuse and Mental 
Health Services Administration (SAMHSA), a certification that the 
practitioner is qualified under the Secretary's standards and will 
comply with such standards. Eligibility for certification will depend 
upon the practitioner obtaining accreditation from an accreditation body 
that has been approved by SAMHSA. These regulations establish the 
procedures whereby an entity can apply to become an approved 
accreditation body. This part also establishes requirements and general 
standards for accreditation bodies to ensure that practitioners are 
consistently evaluated for compliance with the Secretary's standards for 
treatment of opioid use disorder with an opioid agonist treatment 
medication.
    (b) The regulations in subpart F of this part establish the 
procedures and requirements that practitioners who are authorized to 
treat up to 100 patients pursuant to a waiver obtained under section 
303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in order to 
treat up to 275 patients with medications covered under section 
303(g)(2)(C) of the CSA.

[81 FR 44736, July 8, 2016]



Sec.  8.2  Definitions.

    The following definitions apply to this part:
    Accreditation body means a body that has been approved by SAMHSA in 
this part to accredit opioid treatment programs using opioid agonist 
treatment medications.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body, as 
described in Sec.  8.3(b).
    Accreditation elements mean the elements or standards that are 
developed and adopted by an accreditation body and approved by SAMHSA.
    Accreditation survey means an onsite review and evaluation of an 
opioid treatment program by an accreditation body for the purpose of 
determining compliance with the Federal opioid treatment standards 
described in Sec.  8.12.
    Accredited opioid treatment program means an opioid treatment 
program that is the subject of a current, valid accreditation from an 
accreditation body approved by SAMHSA under Sec.  8.3(d).
    Additional Credentialing means board certification in addiction 
medicine or addiction psychiatry by the American Board of Addiction 
Medicine, the American Board of Medical Specialties, or the American 
Osteopathic Association or certification by the American Board of 
Addiction Medicine, or the American Society of Addiction Medicine.
    Approval term means the 3 year period in which a practitioner is 
approved to treat up to 275 patients that commences when a 
practitioner's Request for Patient Limit Increase is approved in 
accordance with Sec.  8.625.
    Behavioral health services means any non-pharmacological 
intervention carried out in a therapeutic context at an individual, 
family, or group level. Interventions may include structured, 
professionally administered interventions (e.g., cognitive behavior 
therapy or insight oriented psychotherapy) delivered in person, 
interventions delivered remotely via telemedicine shown in clinical 
trials to facilitate medication-assisted treatment (MAT) outcomes, or 
non-professional interventions.
    Certification means the process by which SAMHSA determines that an 
opioid treatment program is qualified

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to provide opioid treatment under the Federal opioid treatment 
standards.
    Certification application means the application filed by an opioid 
treatment program for purposes of obtaining certification from SAMHSA, 
as described in Sec.  8.11(b).
    Certified opioid treatment program means an opioid treatment program 
that is the subject of a current, valid certification under Sec.  8.11.
    Comprehensive maintenance treatment is maintenance treatment 
provided in conjunction with a comprehensive range of appropriate 
medical and rehabilitative services.
    Covered medications means the drugs or combinations of drugs that 
are covered under 21 U.S.C. 823(g)(2)(C).
    Detoxification treatment means the dispensing of an opioid agonist 
treatment medication in decreasing doses to an individual to alleviate 
adverse physical or psychological effects incident to withdrawal from 
the continuous or sustained use of an opioid drug and as a method of 
bringing the individual to a drug-free state within such period.
    Dispense means to deliver a controlled substance to an ultimate user 
by, or pursuant to, the lawful order of, a practitioner, including the 
prescribing and administering of a controlled substance.
    Diversion control plan means a set of documented procedures that 
reduce the possibility that controlled substances will be transferred or 
used illicitly.
    Emergency situation means that an existing State, tribal, or local 
system for substance use disorder services is overwhelmed or unable to 
meet the existing need for medication-assisted treatment as a direct 
consequence of a clear precipitating event. This precipitating event 
must have an abrupt onset, such as practitioner incapacity; natural or 
human-caused disaster; an outbreak associated with drug use; and result 
in significant death, injury, exposure to life-threatening 
circumstances, hardship, suffering, loss of property, or loss of 
community infrastructure.
    Federal opioid treatment standards means the standards established 
by the Secretary in Sec.  8.12 that are used to determine whether an 
opioid treatment program is qualified to engage in e opioid treatment. 
The Federal opioid treatment standards established in Sec.  8.12 also 
include the standards established by the Secretary regarding the 
quantities of opioid drugs which may be provided for unsupervised use.
    For-cause inspection means an inspection of an opioid treatment 
program by the Secretary, or by an accreditation body, that may be 
operating in violation of Federal opioid treatment standards, may be 
providing substandard treatment, or may be serving as a possible source 
of diverted medications.
    Interim maintenance treatment means maintenance treatment provided 
in an opioid treatment program in conjunction with appropriate medical 
services while a patient is awaiting transfer to a program that provides 
comprehensive maintenance treatment.
    Long-term detoxification treatment means detoxification treatment 
for a period more than 30 days but not in excess of 180 days.
    Maintenance treatment means the dispensing of an opioid agonist 
treatment medication at stable dosage levels for a period in excess of 
21 days in the treatment of an individual for opioid use disorder.
    Medical director means a physician, licensed to practice medicine in 
the jurisdiction in which the opioid treatment program is located, who 
assumes responsibility for administering all medical services performed 
by the program, either by performing them directly or by delegating 
specific responsibility to authorized program physicians and healthcare 
professionals functioning under the medical director's direct 
supervision.
    Medical and rehabilitative services means services such as medical 
evaluations, counseling, and rehabilitative and other social programs 
(e.g., vocational and educational guidance, employment placement), that 
are intended to help patients in opioid treatment programs become and/or 
remain productive members of society.
    Medication-Assisted Treatment (MAT) means the use of medication in 
combination with behavioral health services to provide an individualized 
approach to the treatment of substance use disorder, including opioid 
use disorder.

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    Medication unit means a facility established as part of, but 
geographically separate from, an opioid treatment program from which 
licensed private practitioners or community pharmacists dispense or 
administer an opioid agonist treatment medication or collect samples for 
drug testing or analysis.
    Nationally recognized evidence-based guidelines means a document 
produced by a national or international medical professional 
association, public health agency, such as the World Health 
Organization, or governmental body with the aim of assuring the 
appropriate use of evidence to guide individual diagnostic and 
therapeutic clinical decisions.
    Opioid agonist treatment medication means any opioid agonist drug 
that is approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opioid use disorder.
    Opioid dependence means repeated self-administration that usually 
results in opioid tolerance, withdrawal symptoms, and compulsive drug-
taking. Dependence may occur with or without the physiological symptoms 
of tolerance and withdrawal.
    Opioid drug means any drug having an addiction-forming or addiction-
sustaining liability similar to morphine or being capable of conversion 
into a drug having such addiction-forming or addiction-sustaining 
liability.
    Opioid treatment program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment medication registered under 21 U.S.C. 823(g)(1).
    Opioid treatment program certification means the process by which 
SAMHSA determines that an opioid treatment program is qualified to 
provide opioid treatment under the Federal opioid treatment standards 
described in Sec.  8.12.
    Opioid use disorder means a cluster of cognitive, behavioral, and 
physiological symptoms in which the individual continues use of opioids 
despite significant opioid-induced problems.
    Opioid use disorder treatment means the dispensing of an opioid 
agonist treatment medication, along with a comprehensive range of 
medical and rehabilitative services, when clinically necessary, to an 
individual to alleviate the adverse medical, psychological, or physical 
effects incident to an opioid use disorder. This term includes a range 
of services including detoxification treatment, short-term 
detoxification treatment, long-term detoxification treatment, 
maintenance treatment, comprehensive maintenance treatment, and interim 
maintenance treatment.
    Patient for purposes of subparts B through E of this part, means any 
individual who receives maintenance or detoxification treatment in an 
opioid treatment program. For purposes of subpart F of this part, 
patient means any individual who is dispensed or prescribed covered 
medications by a practitioner.
    Patient limit means the maximum number of individual patients that a 
practitioner may dispense or prescribe covered medications to at any one 
time.
    Practitioner means a physician who is appropriately licensed by the 
State to dispense covered medications and who possesses a waiver under 
21 U.S.C. 823(g)(2).
    Practitioner incapacity means the inability of a practitioner as a 
result of an involuntary event to physically or mentally perform the 
tasks and duties required to provide medication-assisted treatment in 
accordance with nationally recognized evidence-based guidelines.
    Program sponsor means the person named in the application for 
certification described in Sec.  8.11(b) as responsible for the 
operation of the opioid treatment program and who assumes responsibility 
for all its employees, including any practitioners, agents, or other 
persons providing medical, rehabilitative, or counseling services at the 
program or any of its medication units. The program sponsor need not be 
a licensed physician but shall employ a licensed physician for the 
position of medical director.
    Short-term detoxification treatment means detoxification treatment 
for a period not in excess of 30 days.

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    State Authority is the agency designated by the Governor or other 
appropriate official designated by the Governor to exercise the 
responsibility and authority within the State or Territory for governing 
the treatment of opioid use disorder with an opioid drug.
    Treatment plan means a plan that outlines for each patient 
attainable short-term treatment goals that are mutually acceptable to 
the patient and the opioid treatment program and which specifies the 
services to be provided and the frequency and schedule for their 
provision.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 44736, July 8, 2016; 81 
FR 62404, Sept. 9, 2016]



          Subpart B_Accreditation of Opioid Treatment Programs

    Source: 81 FR 44738, July 8, 2016, unless otherwise noted.



Sec.  8.3  Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State 
governmental entities, or political subdivisions thereof, capable of 
meeting the requirements of this part may apply for approval as an 
accreditation body.
    (b) Application for initial approval. Electronic copies of an 
accreditation body application form [SMA-167] shall be submitted to: 
http://buprenorphine.samhsa.gov/pls/bwns/waiver. Accreditation body 
applications shall include the following information and supporting 
documentation:
    (1) Name, address, and telephone number of the applicant and a 
responsible official for the accreditation body. The application shall 
be signed by the responsible official;
    (2) Evidence of the nonprofit status of the applicant (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a State governmental entity or 
political subdivision;
    (3) A set of the accreditation elements or standards and a detailed 
discussion showing how the proposed accreditation elements or standards 
will ensure that each OTP surveyed by the applicant is qualified to meet 
or is meeting each of the Federal opioid treatment standards set forth 
in Sec.  8.12;
    (4) A detailed description of the applicant's decisionmaking 
process, including:
    (i) Procedures for initiating and performing onsite accreditation 
surveys of OTPs;
    (ii) Procedures for assessing OTP personnel qualifications;
    (iii) Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs during 
the accreditation process, including a request for a complete history of 
prior accreditation activities and a statement that all information and 
data submitted in the application for accreditation is true and 
accurate, and that no material fact has been omitted;
    (iv) Policies and procedures for notifying OTPs and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTPs;
    (v) Policies and procedures for suspending or revoking an OTP's 
accreditation;
    (vi) Policies and procedures that will ensure processing of 
applications for accreditation and applications for renewal of 
accreditation within a timeframe approved by SAMHSA; and
    (vii) A description of the applicant's appeals process to allow OTPs 
to contest adverse accreditation decisions.
    (5) Policies and procedures established by the accreditation body to 
avoid conflicts of interest, or the appearance of conflicts of interest, 
by the applicant's board members, commissioners, professional personnel, 
consultants, administrative personnel, and other representatives;
    (6) A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician on the applicant's staff;
    (7) A description of the applicant's training policies;
    (8) Fee schedules, with supporting cost data;
    (9) Satisfactory assurances that the body will comply with the 
requirements of Sec.  8.4, including a contingency

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plan for investigating complaints under Sec.  8.4(e);
    (10) Policies and procedures established to protect confidential 
information the applicant will collect or receive in its role as an 
accreditation body; and
    (11) Any other information SAMHSA may require.
    (c) Application for renewal of approval. An accreditation body that 
intends to continue to serve as an accreditation body beyond its current 
term shall apply to SAMHSA for renewal, or notify SAMHSA of its 
intention not to apply for renewal, in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of an 
accreditation body's term of approval, the body shall inform SAMHSA in 
writing of its intent to seek renewal.
    (2) SAMHSA will notify the applicant of the relevant information, 
materials, and supporting documentation required under paragraph (b) of 
this section that the applicant shall submit as part of the renewal 
procedure.
    (3) At least 3 months before the date of expiration of the 
accreditation body's term of approval, the applicant shall furnish to 
SAMHSA three copies of a renewal application containing the information, 
materials, and supporting documentation requested by SAMHSA under 
paragraph (c)(2) of this section.
    (4) An accreditation body that does not intend to renew its approval 
shall so notify SAMHSA at least 9 months before the expiration of the 
body's term of approval.
    (d) Rulings on applications for initial approval or renewal of 
approval. (1) SAMHSA will grant an application for initial approval or 
an application for renewal of approval if it determines the applicant 
substantially meets the accreditation body requirements of this subpart.
    (2) If SAMHSA determines that the applicant does not substantially 
meet the requirements set forth in this subpart. SAMHSA will notify the 
applicant of the deficiencies in the application and request that the 
applicant resolve such deficiencies within 90 days of receipt of the 
notice. If the deficiencies are resolved to the satisfaction of SAMHSA 
within the 90-day time period, the body will be approved as an 
accreditation body. If the deficiencies have not been resolved to the 
satisfaction of SAMHSA within the 90-day time period, the application 
for approval as an accreditation body will be denied.
    (3) If SAMHSA does not reach a final decision on a renewal 
application before the expiration of an accreditation body's term of 
approval, the approval will be deemed extended until SAMHSA reaches a 
final decision, unless an accreditation body does not rectify 
deficiencies in the application within the specified time period, as 
required in paragraph (d)(2) of this section.
    (e) Relinquishment of approval. An accreditation body that intends 
to relinquish its accreditation approval before expiration of the body's 
term of approval shall submit a letter of such intent to SAMHSA, at the 
address in paragraph (b) of this section, at least 9 months before 
relinquishing such approval.
    (f) Notification. An accreditation body that does not apply for 
renewal of approval, or is denied such approval by SAMHSA, relinquishes 
its accreditation approval before expiration of its term of approval, or 
has its approval withdrawn, shall:
    (1) Transfer copies of records and other related information as 
required by SAMHSA to a location, including another accreditation body, 
and according to a schedule approved by SAMHSA; and
    (2) Notify, in a manner and time period approved by SAMHSA, all OTPs 
accredited or seeking accreditation by the body that the body will no 
longer have approval to provide accreditation services.
    (g) Term of approval. An accreditation body's term of approval is 
for a period not to exceed 5 years.
    (h) State accreditation bodies. State governmental entities, 
including political subdivisions thereof, may establish organizational 
units that may act as accreditation bodies, provided such units meet the 
requirements of this section, are approved by SAMHSA under this section, 
and have taken appropriate measures to prevent actual

[[Page 99]]

or apparent conflicts of interest, including cases in which State or 
Federal funds are used to support opioid treatment services.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 44737, July 8, 2016]



Sec.  8.4  Accreditation body responsibilities.

    (a) Accreditation surveys and for cause inspections. (1) 
Accreditation bodies shall conduct routine accreditation surveys for 
initial, renewal, and continued accreditation of each OTP at least every 
3 years.
    (2) Accreditation bodies must agree to conduct for-cause inspections 
upon the request of SAMHSA.
    (3) Accreditation decisions shall be fully consistent with the 
policies and procedures submitted as part of the approved accreditation 
body application.
    (b) Response to noncompliant programs. (1) If an accreditation body 
receives or discovers information that suggests that an OTP is not 
meeting Federal opioid treatment standards, or if survey of the OTP by 
the accreditation body otherwise demonstrates one or more deficiencies 
in the OTP, the accreditation body shall as appropriate either require 
and monitor corrective action or shall suspend or revoke accreditation 
of the OTP, as appropriate based on the significance of the 
deficiencies.
    (i) Accreditation bodies shall either not accredit or shall revoke 
the accreditation of any OTP that substantially fails to meet the 
Federal opioid treatment standards.
    (ii) Accreditation bodies shall notify SAMHSA as soon as possible 
but in no case longer than 48 hours after becoming aware of any practice 
or condition in an OTP that may pose a serious risk to public health or 
safety or patient care.
    (iii) If an accreditation body determines that an OTP is 
substantially meeting the Federal opioid treatment standards, but is not 
meeting one or more accreditation elements, the accreditation body shall 
determine the necessary corrective measures to be taken by the OTP, 
establish a schedule for implementation of such measures, and notify the 
OTP in writing that it must implement such measures within the specified 
schedule in order to ensure continued accreditation. The accreditation 
body shall verify that the necessary steps are taken by the OTP within 
the schedule specified and that all accreditation elements are being 
substantially met or will be substantially met.
    (2) Nothing in this part shall prevent accreditation bodies from 
granting accreditation, contingent on promised programmatic or 
performance changes, to OTPs with less substantial violations. Such 
accreditation shall not exceed 12 months. OTPs that have been granted 
such accreditation must have their accreditation revoked if they fail to 
make changes to receive unconditional accreditation upon resurvey or 
reinspection.
    (c) Recordkeeping. (1) Accreditation bodies shall maintain records 
of their accreditation activities for at least 5 years from the creation 
of the record. Such records must contain sufficient detail to support 
each accreditation decision made by the accreditation body.
    (2) Accreditation bodies shall establish procedures to protect 
confidential information collected or received in their role as 
accreditation bodies that are consistent with, and that are designed to 
ensure compliance with, all Federal and State laws, including 42 CFR 
part 2.
    (i) Information collected or received for the purpose of carrying 
out accreditation body responsibilities shall not be used for any other 
purpose or disclosed, other than to SAMHSA or its duly designated 
representatives, unless otherwise required by law or with the consent of 
the OTP.
    (ii) Nonpublic information that SAMHSA shares with the accreditation 
body concerning an OTP shall not be further disclosed except with the 
written permission of SAMHSA.
    (d) Reporting. (1) Accreditation bodies shall provide to SAMHSA any 
documents and information requested by SAMHSA within 5 days of receipt 
of the request.
    (2) Accreditation bodies shall make a summary of the results of each 
accreditation survey available to SAMHSA upon request. Such summaries 
shall contain sufficient detail to justify the accreditation action 
taken.

[[Page 100]]

    (3) Accreditation bodies shall provide SAMHSA upon request a list of 
each OTP surveyed and the identity of all individuals involved in the 
conduct and reporting of survey results.
    (4) Accreditation bodies shall submit to SAMHSA the name of each OTP 
for which the accreditation body accredits conditionally, denies, 
suspends, or revokes accreditation, and the basis for the action, within 
48 hours of the action.
    (5) Notwithstanding any reports made to SAMHSA under paragraphs 
(d)(1) through (d)(4) of this section, each accreditation body shall 
submit to SAMHSA semiannually, on January 15 and July 15 of each 
calendar year, a report consisting of a summary of the results of each 
accreditation survey conducted in the past year. The summary shall 
contain sufficient detail to justify each accreditation action taken.
    (6) All reporting requirements listed in this section shall be 
provided to SAMHSA at the address specified in Sec.  8.3(b).
    (e) Complaint response. Accreditation bodies shall have policies and 
procedures to respond to complaints from SAMHSA, patients, facility 
staff, and others, within a reasonable period of time but not more than 
5 days of the receipt of the complaint. Accreditation bodies shall also 
agree to notify SAMHSA within 48 hours of receipt of a complaint and 
keep SAMHSA informed of all aspects of the response to the complaint.
    (f) Modifications of accreditation elements. Accreditation bodies 
shall obtain SAMHSA's authorization prior to making any substantive 
(i.e., noneditorial) change in accreditation elements.
    (g) Conflicts of interest. The accreditation body shall maintain and 
apply policies and procedures that SAMHSA has approved in accordance 
with Sec.  8.3 to reduce the possibility of actual conflict of interest, 
or the appearance of a conflict of interest, on the part of individuals 
who act on behalf of the accreditation body. Individuals who participate 
in accreditation surveys or otherwise participate in the accreditation 
decision or an appeal of the accreditation decision, as well as their 
spouses and minor children, shall not have a financial interest in the 
OTP that is the subject of the accreditation survey or decision.
    (h) Accreditation teams. (1) An accreditation body survey team shall 
consist of healthcare professionals with expertise in drug abuse 
treatment and, in particular, opioid treatment. The accreditation body 
shall consider factors such as the size of the OTP, the anticipated 
number of problems, and the OTP's accreditation history, in determining 
the composition of the team. At a minimum, survey teams shall consist of 
at least two healthcare professionals whose combined expertise includes:
    (i) The dispensing and administration of drugs subject to control 
under the Controlled Substances Act (21 U.S.C. 801 et seq.);
    (ii) Medical issues relating to the dosing and administration of 
opioid agonist treatment medications for the treatment of opioid use 
disorder;
    (iii) Psychosocial counseling of individuals undergoing opioid 
treatment; and
    (iv) Organizational and administrative issues associated with opioid 
treatment programs.
    (2) Members of the accreditation team must be able to recuse 
themselves at any time from any survey in which either they or the OTP 
believes there is an actual conflict of interest or the appearance of a 
conflict of interest.
    (i) Accreditation fees. Fees charged to OTPs for accreditation shall 
be reasonable. SAMHSA generally will find fees to be reasonable if the 
fees are limited to recovering costs to the accreditation body, 
including overhead incurred. Accreditation body activities that are not 
related to accreditation functions are not recoverable through fees 
established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different OTPs.
    (2) At SAMHSA's request, accreditation bodies shall provide to 
SAMHSA financial records or other materials, in a manner specified by 
SAMHSA, to assist in assessing the reasonableness of accreditation body 
fees.

[[Page 101]]



Sec.  8.5  Periodic evaluation of accreditation bodies.

    SAMHSA will evaluate periodically the performance of accreditation 
bodies primarily by inspecting a selected sample of the OTPs accredited 
by the accrediting body and by evaluating the accreditation body's 
reports of surveys conducted, to determine whether the OTPs surveyed and 
accredited by the accreditation body are in compliance with the Federal 
opioid treatment standards. The evaluation will include a determination 
of whether there are major deficiencies in the accreditation body's 
performance that, if not corrected, would warrant withdrawal of the 
approval of the accreditation body under Sec.  8.6.



Sec.  8.6  Withdrawal of approval of accreditation bodies.

    If SAMHSA determines that an accreditation body is not in 
substantial compliance with this subpart, SAMHSA shall take appropriate 
action as follows:
    (a) Major deficiencies. If SAMHSA determines that the accreditation 
body has a major deficiency, such as commission of fraud, material false 
statement, failure to perform a major accreditation function 
satisfactorily, or significant noncompliance with the requirements of 
this subpart, SAMHSA shall withdraw approval of that accreditation body.
    (1) In the event of a major deficiency, SAMHSA shall notify the 
accreditation body of the agency's action and the grounds on which the 
approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
each OTP that has been accredited or is seeking accreditation that the 
accreditation body's approval has been withdrawn. Such notification 
shall be made within a time period and in a manner approved by SAMHSA.
    (b) Minor deficiencies. If SAMHSA determines that the accreditation 
body has minor deficiencies in the performance of an accreditation 
function, that are less serious or more limited than the types of 
deficiencies described in paragraph (a) of this section, SAMHSA will 
notify the body that it has 90 days to submit to SAMHSA a plan of 
corrective action. The plan must include a summary of corrective actions 
and a schedule for their implementation. SAMHSA may place the body on 
probationary status for a period of time determined by SAMHSA, or may 
withdraw approval of the body if corrective action is not taken.
    (1) If SAMHSA places an accreditation body on probationary status, 
the body shall notify all OTPs that have been accredited, or that are 
seeking accreditation, of the accreditation body's probationary status 
within a time period and in a manner approved by SAMHSA.
    (2) Probationary status will remain in effect until such time as the 
body can demonstrate to the satisfaction of SAMHSA that it has 
successfully implemented or is implementing the corrective action plan 
within the established schedule, and the corrective actions taken have 
substantially eliminated all identified problems.
    (3) If SAMHSA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, SAMHSA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all OTPs that have been accredited, or are seeking accreditation, of the 
accreditation body's loss of SAMHSA approval within a time period and in 
a manner approved by SAMHSA.
    (c) Reapplication. (1) An accreditation body that has had its 
approval withdrawn may submit a new application for approval if the body 
can provide information to SAMHSA to establish that the problems that 
were grounds for withdrawal of approval have been resolved.
    (2) If SAMHSA determines that the new application demonstrates that 
the body satisfactorily has addressed the causes of its previous 
unacceptable performance, SAMHSA may reinstate approval of the 
accreditation body.
    (3) SAMHSA may request additional information or establish 
additional conditions that must be met before SAMHSA approves the 
reapplication.

[[Page 102]]

    (4) SAMHSA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud, 
material false statement, or willful disregard of public health.
    (d) Hearings. An opportunity to challenge an adverse action taken 
regarding withdrawal of approval of an accreditation body shall be 
addressed through the relevant procedures set forth in subpart C of this 
part, except that the procedures in Sec.  8.28 for expedited review of 
an immediate suspension would not apply to an accreditation body that 
has been notified under paragraph (a) or (b) of this section of the 
withdrawal of its approval.



  Subpart C_Certification and Treatment Standards for Opioid Treatment 
                                Programs

    Source: Redesignated at 81 FR 44737, July 8, 2016, unless otherwise 
noted.



Sec.  8.11  Opioid treatment program certification.

    (a) General. (1) An OTP must be the subject of a current, valid 
certification from SAMHSA to be considered qualified by the Secretary 
under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 
823(g)(1)) to dispense opioid drugs in the treatment of opioid use 
disorder. An OTP must be determined to be qualified under section 
303(g)(1) of the Controlled Substances Act, and must be determined to be 
qualified by the Attorney General under section 303(g)(1), to be 
registered by the Attorney General to dispense opioid agonist treatment 
medications to individuals for treatment of opioid use disorder.
    (2) To obtain certification from SAMHSA, an OTP must meet the 
Federal opioid treatment standards in Sec.  8.12, must be the subject of 
a current, valid accreditation by an accreditation body or other entity 
designated by SAMHSA, and must comply with any other conditions for 
certification established by SAMHSA.
    (3) Certification shall be granted for a term not to exceed 3 years, 
except that certification may be extended during the third year if an 
application for accreditation is pending.
    (b) Application for certification. Three copies of an application 
for certification must be submitted by the OTP to the address identified 
in Sec.  8.3(b). SAMHSA will consider and accept the electronic 
submission of these materials when electronic submission systems are 
developed and available. The application for certification shall 
include:
    (1) A description of the current accreditation status of the OTP;
    (2) A description of the organizational structure of the OTP;
    (3) The names of the persons responsible for the OTP;
    (4) The addresses of the OTP and of each medication unit or other 
facility under the control of the OTP;
    (5) The sources of funding for the OTP and the name and address of 
each governmental entity that provides such funding; and
    (6) A statement that the OTP will comply with the conditions of 
certification set forth in paragraph (f) of this section.
    (7) The application shall be signed by the program sponsor who shall 
certify that the information submitted in the application is truthful 
and accurate.
    (c) Action on application. (1) Following SAMHSA's receipt of an 
application for certification of an OTP, and after consultation with the 
appropriate State authority regarding the qualifications of the 
applicant, SAMHSA may grant the application for certification, or renew 
an existing certification, if SAMHSA determines that the OTP has 
satisfied the requirements for certification or renewal of 
certification.
    (2) SAMHSA may deny the application if SAMHSA determines that:
    (i) The application for certification is deficient in any respect;
    (ii) The OTP will not be operated in accordance with the Federal 
opioid treatment standards established under Sec.  8.12;
    (iii) The OTP will not permit an inspection or a survey to proceed, 
or will not permit in a timely manner access to relevant records or 
information; or
    (iv) The OTP has made misrepresentations in obtaining accreditation 
or in applying for certification.
    (3) Within 5 days after it reaches a final determination that an OTP 
meets

[[Page 103]]

the requirements for certification, SAMHSA will notify the Drug 
Enforcement Administration (DEA) that the OTP has been determined to be 
qualified to provide opioid treatment under section 303(g)(1) of the 
Controlled Substances Act.
    (d) Transitional certification. OTPs that before May 18, 2001 were 
the subject of a current, valid approval by FDA under 21 CFR, part 291 
(contained in the 21 CFR parts 200 to 299 edition, revised as of July 1, 
2000), are deemed to be the subject of a current valid certification for 
purposes of paragraph (a)(11) of this section. Such ``transitional 
certification'' will expire on August 17, 2001 unless the OTP submits 
the information required by paragraph (b) of this section to SAMHSA on 
or before August 17, 2001. In addition to this application, OTPs must 
certify with a written statement signed by the program sponsor, that 
they will apply for accreditation within 90 days of the date SAMHSA 
approves the second accreditation body. Transitional certification, in 
that case, will expire on May 19, 2003. SAMHSA may extend the 
transitional certification of an OTP for up to one additional year 
provided the OTP demonstrates that it has applied for accreditation, 
that an accreditation survey has taken place or is scheduled to take 
place, and that an accreditation decision is expected within a 
reasonable period of time (e.g., within 90 days from the date of 
survey). Transitional certification under this section may be suspended 
or revoked in accordance with Sec.  8.14.
    (e) Provisional certification. (1) OTPs that have no current 
certification from SAMHSA, but have applied for accreditation with an 
accreditation body, are eligible to receive a provisional certification 
for up to 1 year. To receive a provisional certification, an OTP shall 
submit the information required by paragraph (b) of this section to 
SAMHSA along with a statement identifying the accreditation body to 
which the OTP has applied for accreditation, the date on which the OTP 
applied for accreditation, the dates of any accreditation surveys that 
have taken place or are expected to take place, and the expected 
schedule for completing the accreditation process. A provisional 
certification for up to 1 year will be granted, following receipt of the 
information described in this paragraph, unless SAMHSA determines that 
patient health would be adversely affected by the granting of 
provisional certification.
    (2) An extension of provisional certification may be granted in 
extraordinary circumstances or otherwise to protect public health. To 
apply for a 90-day extension of provisional certification, an OTP shall 
submit to SAMHSA a statement explaining its efforts to obtain 
accreditation and a schedule for obtaining accreditation as 
expeditiously as possible.
    (f) Conditions for certification. (1) OTPs shall comply with all 
pertinent State laws and regulations. Nothing in this part is intended 
to limit the authority of State and, as appropriate, local governmental 
entities to regulate the use of opioid drugs in the treatment of opioid 
use disorder. The provisions of this section requiring compliance with 
requirements imposed by State law, or the submission of applications or 
reports required by the State authority, do not apply to OTPs operated 
directly by the Department of Veterans Affairs, the Indian Health 
Service, or any other department or agency of the United States. Federal 
agencies operating OTPs have agreed to cooperate voluntarily with State 
agencies by granting permission on an informal basis for designated 
State representatives to visit Federal OTPs and by furnishing a copy of 
Federal reports to the State authority, including the reports required 
under this section.
    (2) OTPs shall allow, in accordance with Federal controlled 
substances laws and Federal confidentiality laws, inspections and 
surveys by duly authorized employees of SAMHSA, by accreditation bodies, 
by the DEA, and by authorized employees of any relevant State or Federal 
governmental authority.
    (3) Disclosure of patient records maintained by an OTP is governed 
by the provisions of 42 CFR part 2, and every program must comply with 
that part. Records on the receipt, storage, and distribution of opioid 
agonist treatment medications are also subject to inspection under 
Federal controlled

[[Page 104]]

substances laws and under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.). Federally-sponsored treatment programs are subject 
to applicable Federal confidentiality statutes.
    (4) A treatment program or medication unit or any part thereof, 
including any facility or any individual, shall permit a duly authorized 
employee of SAMHSA to have access to and to copy all records on the use 
of opioid drugs in accordance with the provisions of 42 CFR part 2.
    (5) OTPs shall notify SAMHSA within 3 weeks of any replacement or 
other change in the status of the program sponsor or medical director.
    (6) OTPs shall comply with all regulations enforced by the DEA under 
21 CFR chapter II, and must be registered by the DEA before 
administering or dispensing opioid agonist treatment medications.
    (7) OTPs must operate in accordance with Federal opioid treatment 
standards and approved accreditation elements.
    (g) Conditions for interim maintenance treatment program approval. 
(1) Before a public or nonprofit private OTP may provide interim 
maintenance treatment, the program must receive the approval of both 
SAMHSA and the chief public health officer of the State in which the OTP 
operates.
    (2) Before SAMHSA may grant such approval, the OTP must provide 
SAMHSA with documentation from the chief public health officer of the 
State in which the OTP operates demonstrating that:
    (i) Such officer does not object to the providing of interim 
maintenance treatment in the State;
    (ii) The OTP seeking to provide such treatment is unable to place 
patients in a public or nonprofit private comprehensive treatment 
program within a reasonable geographic area within 14 days of the time 
patients seek admission to such programs;
    (iii) The authorization of the OTP to provide interim maintenance 
treatment will not otherwise reduce the capacity of comprehensive 
maintenance treatment programs in the State to admit individuals 
(relative to the date on which such officer so certifies); and
    (iv) The State certifies that each individual enrolled in interim 
maintenance treatment will be transferred to a comprehensive maintenance 
treatment program no later than 120 days from the date on which each 
individual first requested treatment, as provided in section 1923 of the 
Public Health Service Act (21 U.S.C. 300x-23).
    (3) SAMHSA will provide notice to the OTP denying or approving the 
request to provide interim maintenance treatment. The OTP shall not 
provide such treatment until it has received such notice from SAMHSA.
    (h) Exemptions. An OTP may, at the time of application for 
certification or any time thereafter, request from SAMHSA exemption from 
the regulatory requirements set forth under this section and Sec.  8.12. 
An example of a case in which an exemption might be granted would be for 
a private practitioner who wishes to treat a limited number of patients 
in a non-metropolitan area with few physicians and no rehabilitative 
services geographically accessible and requests exemption from some of 
the staffing and service standards. The OTP shall support the rationale 
for the exemption with thorough documentation, to be supplied in an 
appendix to the initial application for certification or in a separate 
submission. SAMHSA will approve or deny such exemptions at the time of 
application, or any time thereafter, if appropriate. SAMHSA shall 
consult with the appropriate State authority prior to taking action on 
an exemption request.
    (i) Medication units, long-term care facilities and hospitals. (1) 
Certified OTPs may establish medication units that are authorized to 
dispense opioid agonist treatment medications for observed ingestion. 
Before establishing a medication unit, a certified OTP must notify 
SAMHSA by submitting form SMA-162. The OTP must also comply with the 
provisions of 21 CFR part 1300 before establishing a medication unit. 
Medication units shall comply with all pertinent state laws and 
regulations.
    (2) Certification as an OTP under this part will not be required for 
the maintenance or detoxification treatment of a patient who is admitted 
to a hospital or long-term care facility for the treatment of medical 
conditions other than

[[Page 105]]

opioid use disorder and who requires maintenance or detoxification 
treatment during the period of his or her stay in that hospital or long-
term care facility. The terms ``hospital'' and ``long-term care 
facility'' as used in this section are to have the meaning that is 
assigned under the law of the State in which the treatment is being 
provided. Nothing in this section is intended to relieve hospitals and 
long-term care facilities from the obligation to obtain registration 
from the Attorney General, as appropriate, under section 303(g) of the 
Controlled Substances Act.

[66 FR 4090, Jan. 17, 2001, as amended at 66 FR 15347, Mar. 19, 2001]



Sec.  8.12  Federal opioid treatment standards.

    (a) General. OTPs must provide treatment in accordance with the 
standards in this section and must comply with these standards as a 
condition of certification.
    (b) Administrative and organizational structure. An OTP's 
organizational structure and facilities shall be adequate to ensure 
quality patient care and to meet the requirements of all pertinent 
Federal, State, and local laws and regulations. At a minimum, each OTP 
shall formally designate a program sponsor and medical director. The 
program sponsor shall agree on behalf of the OTP to adhere to all 
requirements set forth in this part and any regulations regarding the 
use of opioid agonist treatment medications in the treatment of opioid 
use disorder which may be promulgated in the future. The medical 
director shall assume responsibility for administering all medical 
services performed by the OTP. In addition, the medical director shall 
be responsible for ensuring that the OTP is in compliance with all 
applicable Federal, State, and local laws and regulations.
    (c) Continuous quality improvement. (1) An OTP must maintain current 
quality assurance and quality control plans that include, among other 
things, annual reviews of program policies and procedures and ongoing 
assessment of patient outcomes.
    (2) An OTP must maintain a current ``Diversion Control Plan'' or 
``DCP'' as part of its quality assurance program that contains specific 
measures to reduce the possibility of diversion of controlled substances 
from legitimate treatment use and that assigns specific responsibility 
to the medical and administrative staff of the OTP for carrying out the 
diversion control measures and functions described in the DCP.
    (d) Staff credentials. Each person engaged in the treatment of 
opioid use disorder must have sufficient education, training, and 
experience, or any combination thereof, to enable that person to perform 
the assigned functions. All physicians, nurses, and other licensed 
professional care providers, including addiction counselors, must comply 
with the credentialing requirements of their respective professions.
    (e) Patient admission criteria--(1) Maintenance treatment. An OTP 
shall maintain current procedures designed to ensure that patients are 
admitted to maintenance treatment by qualified personnel who have 
determined, using accepted medical criteria such as those listed in the 
Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), that 
the person is currently addicted to an opioid drug, and that the person 
became addicted at least 1 year before admission for treatment. In 
addition, a program physician shall ensure that each patient voluntarily 
chooses maintenance treatment and that all relevant facts concerning the 
use of the opioid drug are clearly and adequately explained to the 
patient, and that each patient provides informed written consent to 
treatment.
    (2) Maintenance treatment for persons under age 18. A person under 
18 years of age is required to have had two documented unsuccessful 
attempts at short-term detoxification or drug-free treatment within a 
12-month period to be eligible for maintenance treatment. No person 
under 18 years of age may be admitted to maintenance treatment unless a 
parent, legal guardian, or responsible adult designated by the relevant 
State authority consents in writing to such treatment.
    (3) Maintenance treatment admission exceptions. If clinically 
appropriate, the

[[Page 106]]

program physician may waive the requirement of a 1-year history of 
addiction under paragraph (e)(1) of this section, for patients released 
from penal institutions (within 6 months after release), for pregnant 
patients (program physician must certify pregnancy), and for previously 
treated patients (up to 2 years after discharge).
    (4) Detoxification treatment. An OTP shall maintain current 
procedures that are designed to ensure that patients are admitted to 
short- or long-term detoxification treatment by qualified personnel, 
such as a program physician, who determines that such treatment is 
appropriate for the specific patient by applying established diagnostic 
criteria. Patients with two or more unsuccessful detoxification episodes 
within a 12-month period must be assessed by the OTP physician for other 
forms of treatment. A program shall not admit a patient for more than 
two detoxification treatment episodes in one year.
    (f) Required services--(1) General. OTPs shall provide adequate 
medical, counseling, vocational, educational, and other assessment and 
treatment services. These services must be available at the primary 
facility, except where the program sponsor has entered into a formal, 
documented agreement with a private or public agency, organization, 
practitioner, or institution to provide these services to patients 
enrolled in the OTP. The program sponsor, in any event, must be able to 
document that these services are fully and reasonably available to 
patients.
    (2) Initial medical examination services. OTPs shall require each 
patient to undergo a complete, fully documented physical evaluation by a 
program physician or a primary care physician, or an authorized 
healthcare professional under the supervision of a program physician, 
before admission to the OTP. The full medical examination, including the 
results of serology and other tests, must be completed within 14 days 
following admission.
    (3) Special services for pregnant patients. OTPs must maintain 
current policies and procedures that reflect the special needs of 
patients who are pregnant. Prenatal care and other gender specific 
services or pregnant patients must be provided either by the OTP or by 
referral to appropriate healthcare providers.
    (4) Initial and periodic assessment services. Each patient accepted 
for treatment at an OTP shall be assessed initially and periodically by 
qualified personnel to determine the most appropriate combination of 
services and treatment. The initial assessment must include preparation 
of a treatment plan that includes the patient's short-term goals and the 
tasks the patient must perform to complete the short-term goals; the 
patient's requirements for education, vocational rehabilitation, and 
employment; and the medical, psychosocial, economic, legal, or other 
supportive services that a patient needs. The treatment plan also must 
identify the frequency with which these services are to be provided. The 
plan must be reviewed and updated to reflect that patient's personal 
history, his or her current needs for medical, social, and psychological 
services, and his or her current needs for education, vocational 
rehabilitation, and employment services.
    (5) Counseling services. (i) OTPs must provide adequate substance 
abuse counseling to each patient as clinically necessary. This 
counseling shall be provided by a program counselor, qualified by 
education, training, or experience to assess the psychological and 
sociological background of patients, to contribute to the appropriate 
treatment plan for the patient and to monitor patient progress.
    (ii) OTPs must provide counseling on preventing exposure to, and the 
transmission of, human immunodeficiency virus (HIV) disease for each 
patient admitted or readmitted to maintenance or detoxification 
treatment.
    (iii) OTPs must provide directly, or through referral to adequate 
and reasonably accessible community resources, vocational 
rehabilitation, education, and employment services for patients who 
either request such services or who have been determined by the program 
staff to be in need of such services.
    (6) Drug abuse testing services. OTPs must provide adequate testing 
or analysis for drugs of abuse, including at least eight random drug 
abuse tests per

[[Page 107]]

year, per patient in maintenance treatment, in accordance with generally 
accepted clinical practice. For patients in short-term detoxification 
treatment, the OTP shall perform at least one initial drug abuse test. 
For patients receiving long-term detoxification treatment, the program 
shall perform initial and monthly random tests on each patient.
    (g) Recordkeeping and patient confidentiality. (1) OTPs shall 
establish and maintain a recordkeeping system that is adequate to 
document and monitor patient care. This system is required to comply 
with all Federal and State reporting requirements relevant to opioid 
drugs approved for use in treatment of opioid use disorder. All records 
are required to be kept confidential in accordance with all applicable 
Federal and State requirements.
    (2) OTPs shall include, as an essential part of the recordkeeping 
system, documentation in each patient's record that the OTP made a good 
faith effort to review whether or not the patient is enrolled any other 
OTP. A patient enrolled in an OTP shall not be permitted to obtain 
treatment in any other OTP except in exceptional circumstances. If the 
medical director or program physician of the OTP in which the patient is 
enrolled determines that such exceptional circumstances exist, the 
patient may be granted permission to seek treatment at another OTP, 
provided the justification for finding exceptional circumstances is 
noted in the patient's record both at the OTP in which the patient is 
enrolled and at the OTP that will provide the treatment.
    (h) Medication administration, dispensing, and use. (1) OTPs must 
ensure that opioid agonist treatment medications are administered or 
dispensed only by a practitioner licensed under the appropriate State 
law and registered under the appropriate State and Federal laws to 
administer or dispense opioid drugs, or by an agent of such a 
practitioner, supervised by and under the order of the licensed 
practitioner. This agent is required to be a pharmacist, registered 
nurse, or licensed practical nurse, or any other healthcare professional 
authorized by Federal and State law to administer or dispense opioid 
drugs.
    (2) OTPs shall use only those opioid agonist treatment medications 
that are approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opioid use disorder. In addition, OTPs who are fully 
compliant with the protocol of an investigational use of a drug and 
other conditions set forth in the application may administer a drug that 
has been authorized by the Food and Drug Administration under an 
investigational new drug application under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act for investigational use in the treatment of 
opioid use disorder. Currently the following opioid agonist treatment 
medications will be considered to be approved by the Food and Drug 
Administration for use in the treatment of opioid use disorder:
    (i) Methadone;
    (ii) Levomethadyl acetate (LAAM); and
    (iii) Buprenorphine and buprenorphine combination products that have 
been approved for use in the treatment of opioid use disorder.
    (3) OTPs shall maintain current procedures that are adequate to 
ensure that the following dosage form and initial dosing requirements 
are met:
    (i) Methadone shall be administered or dispensed only in oral form 
and shall be formulated in such a way as to reduce its potential for 
parenteral abuse.
    (ii) For each new patient enrolled in a program, the initial dose of 
methadone shall not exceed 30 milligrams and the total dose for the 
first day shall not exceed 40 milligrams, unless the program physician 
documents in the patient's record that 40 milligrams did not suppress 
opioid abstinence symptoms.
    (4) OTPs shall maintain current procedures adequate to ensure that 
each opioid agonist treatment medication used by the program is 
administered and dispensed in accordance with its approved product 
labeling. Dosing and administration decisions shall be made by a program 
physician familiar with the most up-to-date product labeling. These 
procedures must ensure that any significant deviations from the approved 
labeling, including deviations

[[Page 108]]

with regard to dose, frequency, or the conditions of use described in 
the approved labeling, are specifically documented in the patient's 
record.
    (i) Unsupervised or ``take-home'' use. To limit the potential for 
diversion of opioid agonist treatment medications to the illicit market, 
opioid agonist treatment medications dispensed to patients for 
unsupervised use shall be subject to the following requirements.
    (1) Any patient in comprehensive maintenance treatment may receive a 
single take-home dose for a day that the clinic is closed for business, 
including Sundays and State and Federal holidays.
    (2) Treatment program decisions on dispensing opioid treatment 
medications to patients for unsupervised use beyond that set forth in 
paragraph (i)(1) of this section, shall be determined by the medical 
director. In determining which patients may be permitted unsupervised 
use, the medical director shall consider the following take-home 
criteria in determining whether a patient is responsible in handling 
opioid drugs for unsupervised use.
    (i) Absence of recent abuse of drugs (opioid or nonnarcotic), 
including alcohol;
    (ii) Regularity of clinic attendance;
    (iii) Absence of serious behavioral problems at the clinic;
    (iv) Absence of known recent criminal activity, e.g., drug dealing;
    (v) Stability of the patient's home environment and social 
relationships;
    (vi) Length of time in comprehensive maintenance treatment;
    (vii) Assurance that take-home medication can be safely stored 
within the patient's home; and
    (viii) Whether the rehabilitative benefit the patient derived from 
decreasing the frequency of clinic attendance outweighs the potential 
risks of diversion.
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi) 
of this section apply. The dispensing restrictions set forth in 
paragraphs (i)(3)(i) through (vi) of this section do not apply to 
buprenorphine and buprenorphine products listed under paragraph 
(h)(2)(iii) of this section.
    (i) During the first 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is limited to a single 
dose each week and the patient shall ingest all other doses under 
appropriate supervision as provided for under the regulations in this 
subpart.
    (ii) In the second 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) are two doses per 
week.
    (iii) In the third 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) are three doses per 
week.
    (iv) In the remaining months of the first year, a patient may be 
given a maximum 6-day supply of take-home medication.
    (v) After 1 year of continuous treatment, a patient may be given a 
maximum 2-week supply of take-home medication.
    (vi) After 2 years of continuous treatment, a patient may be given a 
maximum one-month supply of take-home medication, but must make monthly 
visits.
    (4) No medications shall be dispensed to patients in short-term 
detoxification treatment or interim maintenance treatment for 
unsupervised or take-home use.
    (5) OTPs must maintain current procedures adequate to identify the 
theft or diversion of take-home medications, including labeling 
containers with the OTP's name, address, and telephone number. Programs 
also must ensure that take-home supplies are packaged in a manner that 
is designed to reduce the risk of accidental ingestion, including child-
proof containers (see Poison Prevention Packaging Act, Public Law 91-601 
(15 U.S.C. 1471 et seq.)).
    (j) Interim maintenance treatment. (1) The program sponsor of a 
public or nonprofit private OTP may place an individual, who is eligible 
for admission to comprehensive maintenance treatment, in interim 
maintenance treatment if the individual cannot be placed

[[Page 109]]

in a public or nonprofit private comprehensive program within a 
reasonable geographic area and within 14 days of the individual's 
application for admission to comprehensive maintenance treatment. An 
initial and at least two other urine screens shall be taken from interim 
patients during the maximum of 120 days permitted for such treatment. A 
program shall establish and follow reasonable criteria for establishing 
priorities for transferring patients from interim maintenance to 
comprehensive maintenance treatment. These transfer criteria shall be in 
writing and shall include, at a minimum, a preference for pregnant women 
in admitting patients to interim maintenance and in transferring 
patients from interim maintenance to comprehensive maintenance 
treatment. Interim maintenance shall be provided in a manner consistent 
with all applicable Federal and State laws, including sections 1923, 
1927(a), and 1976 of the Public Health Service Act (21 U.S.C. 300x-23, 
300x-27(a), and 300y-11).
    (2) The program shall notify the State health officer when a patient 
begins interim maintenance treatment, when a patient leaves interim 
maintenance treatment, and before the date of mandatory transfer to a 
comprehensive program, and shall document such notifications.
    (3) SAMHSA may revoke the interim maintenance authorization for 
programs that fail to comply with the provisions of this paragraph (j). 
Likewise, SAMHSA will consider revoking the interim maintenance 
authorization of a program if the State in which the program operates is 
not in compliance with the provisions of Sec.  8.11(g).
    (4) All requirements for comprehensive maintenance treatment apply 
to interim maintenance treatment with the following exceptions:
    (i) The opioid agonist treatment medication is required to be 
administered daily under observation;
    (ii) Unsupervised or ``take-home'' use is not allowed;
    (iii) An initial treatment plan and periodic treatment plan 
evaluations are not required;
    (iv) A primary counselor is not required to be assigned to the 
patient;
    (v) Interim maintenance cannot be provided for longer than 120 days 
in any 12-month period; and
    (vi) Rehabilitative, education, and other counseling services 
described in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this 
section are not required to be provided to the patient.

[66 FR 4090, Jan. 17, 2001, as amended at 68 FR 27939, May 22, 2003; 77 
FR 72761, Dec. 6, 2012; 80 FR 34838, June 18, 2015]



Sec.  8.13  Revocation of accreditation and accreditation body approval.

    (a) SAMHSA action following revocation of accreditation. If an 
accreditation body revokes an OTP's accreditation, SAMHSA may conduct an 
investigation into the reasons for the revocation. Following such 
investigation, SAMHSA may determine that the OTP's certification should 
no longer be in effect, at which time SAMHSA will initiate procedures to 
revoke the facility's certification in accordance with Sec.  8.14. 
Alternatively, SAMHSA may determine that another action or combination 
of actions would better serve the public health, including the 
establishment and implementation of a corrective plan of action that 
will permit the certification to continue in effect while the OTP seeks 
reaccreditation.
    (b) Accreditation body approval. (1) If SAMHSA withdraws the 
approval of an accreditation body under Sec.  8.6, the certifications of 
OTPs accredited by such body shall remain in effect for a period of 1 
year after the date of withdrawal of approval of the accreditation body, 
unless SAMHSA determines that to protect public health or safety, or 
because the accreditation body fraudulently accredited treatment 
programs, the certifications of some or all of the programs should be 
revoked or suspended or that a shorter time period should be established 
for the certifications to remain in effect. SAMHSA may extend the time 
in which a certification remains in effect under this paragraph on a 
case-by-case basis.
    (2) Within 1 year from the date of withdrawal of approval of an 
accreditation body, or within any shorter period of time established by 
SAMHSA, OTPs currently accredited by the accreditation body must obtain 
accreditation from another accreditation body.

[[Page 110]]

SAMHSA may extend the time period for obtaining reaccreditation on a 
case-by-case basis.



Sec.  8.14  Suspension or revocation of certification.

    (a) Revocation. Except as provided in paragraph (b) of this section, 
SAMHSA may revoke the certification of an OTP if SAMHSA finds, after 
providing the program sponsor with notice and an opportunity for a 
hearing in accordance with subpart C of this part, that the program 
sponsor, or any employee of the OTP:
    (1) Has been found guilty of misrepresentation in obtaining the 
certification;
    (2) Has failed to comply with the Federal opioid treatment standards 
in any respect;
    (3) Has failed to comply with reasonable requests from SAMHSA or 
from an accreditation body for records, information, reports, or 
materials that are necessary to determine the continued eligibility of 
the OTP for certification or continued compliance with the Federal 
opioid treatment standards; or
    (4) Has refused a reasonable request of a duly designated SAMHSA 
inspector, Drug Enforcement Administration (DEA) Inspector, State 
Inspector, or accreditation body representative for permission to 
inspect the program or the program's operations or its records.
    (b) Suspension. Whenever SAMHSA has reason to believe that 
revocation may be required and that immediate action is necessary to 
protect public health or safety, SAMHSA may immediately suspend the 
certification of an OTP before holding a hearing under subpart C of this 
part. SAMHSA may immediately suspend as well as propose revocation of 
the certification of an OTP before holding a hearing under subpart C of 
this part if SAMHSA makes a finding described in paragraph (a) of this 
section and also determines that:
    (1) The failure to comply with the Federal opioid treatment 
standards presents an imminent danger to the public health or safety;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the failure to comply with the 
Federal opioid treatment standards was intentional or was associated 
with fraud.
    (c) Written notification. In the event that SAMHSA suspends the 
certification of an OTP in accordance with paragraph (b) of this section 
or proposes to revoke the certification of an OTP in accordance with 
paragraph (a) of this section, SAMHSA shall promptly provide the sponsor 
of the OTP with written notice of the suspension or proposed revocation 
by facsimile transmission, personal service, commercial overnight 
delivery service, or certified mail, return receipt requested. Such 
notice shall state the reasons for the action and shall state that the 
OTP may seek review of the action in accordance with the procedures in 
subpart C of this part.
    (d)(1) If SAMHSA suspends certification in accordance with paragraph 
(b) of this section:
    (i) SAMHSA will immediately notify DEA that the OTP's registration 
should be suspended under 21 U.S.C. 824(d); and
    (ii) SAMHSA will provide an opportunity for a hearing under subpart 
C of this part.
    (2) Suspension of certification under paragraph (b) of this section 
shall remain in effect until the agency determines that:
    (i) The basis for the suspension cannot be substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The OTP's certification shall be revoked.



Sec.  8.15  Forms.

    (a) SMA-162--Application for Certification to Use Opioid Agonist 
Treatment Medications for Opioid Treatment.
    (b) SMA-163--Application for Becoming an Accreditation Body under 
Sec.  8.3.

[[Page 111]]



Subpart D_Procedures for Review of Suspension or Proposed Revocation of 
    OTP Certification, and of Adverse Action Regarding Withdrawal of 
                    Approval of an Accreditation Body

    Source: Redesignated at 81 FR 44737, July 8, 2016, unless otherwise 
noted.



Sec.  8.21  Applicability.

    The procedures in this subpart apply when:
    (a) SAMHSA has notified an OTP in writing that its certification 
under the regulations in subpart B of this part has been suspended or 
that SAMHSA proposes to revoke the certification; and
    (b) The OTP has, within 30 days of the date of the notification or 
within 3 days of the date of the notification when seeking an expedited 
review of a suspension, requested in writing an opportunity for a review 
of the suspension or proposed revocation.
    (c) SAMHSA has notified an accreditation body of an adverse action 
taken regarding withdrawal of approval of the accreditation body under 
the regulations in subpart A of this part; and
    (d) The accreditation body has, within 30 days of the date of the 
notification, requested in writing an opportunity for a review of the 
adverse action.



Sec.  8.22  Definitions.

    The following definitions apply to this subpart C.
    (a) Appellant means:
    (1) The treatment program which has been notified of its suspension 
or proposed revocation of its certification under the regulations of 
this part and has requested a review of the suspension or proposed 
revocation, or
    (2) The accreditation body which has been notified of adverse action 
regarding withdrawal of approval under the regulations of this subpart 
and has requested a review of the adverse action.
    (b) Respondent means SAMHSA.
    (c) Reviewing official means the person or persons designated by the 
Secretary who will review the suspension or proposed revocation. The 
reviewing official may be assisted by one or more HHS officers or 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.



Sec.  8.23  Limitation on issues subject to review.

    The scope of review shall be limited to the facts relevant to any 
suspension, or proposed revocation, or adverse action, the necessary 
interpretations of the facts the regulations, in the subpart, and other 
relevant law.



Sec.  8.24  Specifying who represents the parties.

    The appellant's request for review shall specify the name, address, 
and phone number of the appellant's representative. In its first written 
submission to the reviewing official, the respondent shall specify the 
name, address, and phone number of the respondent's representative.



Sec.  8.25  Informal review and the reviewing official's response.

    (a) Request for review. Within 30 days of the date of the notice of 
the suspension or proposed revocation, the appellant must submit a 
written request to the reviewing official seeking review, unless some 
other time period is agreed to by the parties. A copy must also be sent 
to the respondent. The request for review must include a copy of the 
notice of suspension, proposed revocation, or adverse action, a brief 
statement of why the decision to suspend, propose revocation, or take an 
adverse action is incorrect, and the appellant's request for an oral 
presentation, if desired.
    (b) Acknowledgment. Within 5 days after receiving the request for 
review, the reviewing official will send an acknowledgment and advise 
the appellant of the next steps. The reviewing official will also send a 
copy of the acknowledgment to the respondent.



Sec.  8.26  Preparation of the review file and written arguments.

    The appellant and the respondent each participate in developing the 
file

[[Page 112]]

for the reviewing official and in submitting written arguments. The 
procedures for development of the review file and submission of written 
argument are:
    (a) Appellant's documents and brief. Within 30 days after receiving 
the acknowledgment of the request for review, the appellant shall submit 
to the reviewing official the following (with a copy to the respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation of 
appellant's certification or to take adverse action regarding withdrawal 
of approval of the accreditation body is incorrect (appellant's brief).
    (b) Respondent's documents and brief. Within 30 days after receiving 
a copy of the acknowledgment of the request for review, the respondent 
shall submit to the reviewing official the following (with a copy to the 
appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification, or approval as 
an accreditation body, tabbed and organized chronologically, and 
accompanied by an index identifying each document. Only essential 
documents should be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension, proposed revocation, or 
adverse action (respondent's brief).
    (c) Reply briefs. Within 10 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive documentation. The reviewing official may take any 
appropriate steps to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.
    (f) Discovery. The use of interrogatories, depositions, and other 
forms of discovery shall not be allowed.



Sec.  8.27  Opportunity for oral presentation.

    (a) Electing oral presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decisionmaking process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide for 
an oral presentation at the official's own initiative or at the request 
of the respondent.
    (b) Presiding official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral presentation.
    (c) Preliminary conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the hearing 
altogether; scheduling the hearing; and any other matter that will 
assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding official 
may, at the presiding official's discretion, produce a written document 
summarizing the conference or transcribe the conference, either of which 
will be made a part of the record.
    (d) Time and place of oral presentation. The presiding official will 
attempt to schedule the oral presentation within 45 days of the date 
appellant's request for review is received or within 15 days of 
submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.

[[Page 113]]

    (e) Conduct of the oral presentation--(1) General. The presiding 
official is responsible for conducting the oral presentation. The 
presiding official may be assisted by one or more HHS officers or 
employees or consultants in conducting the oral presentation and 
reviewing the evidence. While the oral presentation will be kept as 
informal as possible, the presiding official may take all necessary 
steps to ensure an orderly proceeding.
    (2) Burden of proof/standard of proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend, propose revocation, or take adverse action is 
appropriate. The appellant, however, has a responsibility to respond to 
the respondent's allegations with evidence and argument to show that the 
respondent is incorrect.
    (3) Admission of evidence. The rules of evidence do not apply and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. Each 
party may make an opening and closing statement, may present witnesses 
as agreed upon in the pre-hearing conference or otherwise, and may 
question the opposing party's witnesses. Since the parties have ample 
opportunity to prepare the review file, a party may introduce additional 
documentation during the oral presentation only with the permission of 
the presiding official. The presiding official may question witnesses 
directly and take such other steps necessary to ensure an effective and 
efficient consideration of the evidence, including setting time 
limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing the 
motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of justice or making of false statements. 
Obstruction of justice or the making of false statements by a witness or 
any other person may be the basis for a criminal prosecution under 18 
U.S.C. 1001 or 1505.
    (g) Post-hearing procedures. At the presiding official's discretion, 
the presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may 
submit comments on any major prejudicial errors in the transcript.



Sec.  8.28  Expedited procedures for review of immediate suspension.

    (a) Applicability. When the Secretary notifies a treatment program 
in writing that its certification has been immediately suspended, the 
appellant may request an expedited review of the suspension and any 
proposed revocation. The appellant must submit this request in writing 
to the reviewing official within 10 days of the date the OTP received 
notice of the suspension. The request for review must include a copy of 
the suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is incorrect, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing official's response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review file and briefs. Within 10 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, tabbed, indexed, and organized chronologically; and

[[Page 114]]

    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official in accordance 
with Sec.  8.27(a), the presiding official will attempt to schedule the 
oral presentation within 20 to 30 days of the date of appellant's 
request for review at a time and place determined by the presiding 
official following consultation with the parties. The presiding official 
may hold a pre-hearing conference in accordance with Sec.  8.27(c) and 
will conduct the oral presentation in accordance with the procedures of 
Sec. Sec.  8.27(e), (f), and (g).
    (e) Written decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7 to 10 days of the date of 
the oral presentation or within 3 days of the date on which the 
transcript is received or the date of the last submission by either 
party, whichever is later. All other provisions set forth in Sec.  8.33 
apply.
    (f) Transmission of written communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be sent by facsimile transmission, personal 
service, or commercial overnight delivery service.



Sec.  8.29  Ex parte communications.

    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notice to the other party.



Sec.  8.30  Transmission of written communications by reviewing official 
and calculation of deadlines.

    (a) Timely review. Because of the importance of a timely review, the 
reviewing official should normally transmit written communications to 
either party by facsimile transmission, personal service, or commercial 
overnight delivery service, or certified mail, return receipt requested, 
in which case the date of transmission or day following mailing will be 
considered the date of receipt. In the case of communications sent by 
regular mail, the date of receipt will be considered 3 days after the 
date of mailing.
    (b) Due date. In counting days, include Saturdays, Sundays, and 
holidays. However, if a due date falls on a Saturday, Sunday, or Federal 
holiday, then the due date is the next Federal working day.



Sec.  8.31  Authority and responsibilities of the reviewing official.

    In addition to any other authority specified in this subpart C, the 
reviewing official and the presiding official, with respect to those 
authorities involving the oral presentation, shall have the authority to 
issue orders; examine witnesses; take all steps necessary for the 
conduct of an orderly hearing; rule on requests and motions; grant 
extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify these procedures in a specific case, usually 
with notice to the parties; reconsider a decision of the reviewing 
official where a party promptly alleges a clear error of fact or law; 
and to take any other action necessary to resolve disputes in accordance 
with the objectives of the procedures in this subpart.



Sec.  8.32  Administrative record.

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.



Sec.  8.33  Written decision.

    (a) Issuance of decision. The reviewing official shall issue a 
written decision upholding or denying the suspension, proposed 
revocation, or adverse action. The decision will set forth the reasons 
for the decision and describe the basis

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for that decision in the record. Furthermore, the reviewing official may 
remand the matter to the respondent for such further action as the 
reviewing official deems appropriate.
    (b) Date of decision. The reviewing official will attempt to issue 
the decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of the 
date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public notice and communications to the Drug Enforcement 
Administration (DEA). (1) If the suspension and proposed revocation of 
OTP certification are upheld, the revocation of certification will 
become effective immediately and the public will be notified by 
publication of a notice in the Federal Register. SAMHSA will notify DEA 
within 5 days that the OTP's registration should be revoked.
    (2) If the suspension and proposed revocation of OTP certification 
are denied, the revocation will not take effect and the suspension will 
be lifted immediately. Public notice will be given by publication in the 
Federal Register. SAMHSA will notify DEA within 5 days that the OTP's 
registration should be restored, if applicable.



Sec.  8.34  Court review of final administrative action; 
exhaustion of administrative remedies.

    Before any legal action is filed in court challenging the 
suspension, proposed revocation, or adverse action, respondent shall 
exhaust administrative remedies provided under this subpart, unless 
otherwise provided by Federal law. The reviewing official's decision, 
under Sec.  8.28(e) or Sec.  8.33(a), constitutes final agency action as 
of the date of the decision.

Subpart E [Reserved]



    Subpart F_Authorization To Increase Patient Limit to 275 Patients

    Source: 81 FR 44738, July 8, 2016, unless otherwise noted.



Sec.  8.610  Which practitioners are eligible for a patient limit of 275?

    The total number of patients that a practitioner may dispense or 
prescribe covered medications to at any one time for purposes of 21 
U.S.C. 823(g)(2)(B)(iii) is 275 if:
    (a) The practitioner possesses a current waiver to treat up to 100 
patients under section 303(g)(2) of the Controlled Substances Act (21 
U.S.C. 823(g)(2)) and has maintained the waiver in accordance with 
applicable statutory requirements without interruption for at least one 
year since the practitioner's notification of intent (NOI) under section 
303(g)(2)(B) to treat up to 100 patients was approved;
    (b) The practitioner:
    (1) Holds additional credentialing as defined in Sec.  8.2; or
    (2) Provides medication-assisted treatment (MAT) utilizing covered 
medications in a qualified practice setting as defined in Sec.  8.615;
    (c) The practitioner has not had his or her enrollment and billing 
privileges in the Medicare program revoked under Sec.  424.535 of this 
title; and
    (d) The practitioner has not been found to have violated the 
Controlled Substances Act pursuant to 21 U.S.C. 824(a).



Sec.  8.615  What constitutes a qualified practice setting?

    A qualified practice setting is a practice setting that:
    (a) Provides professional coverage for patient medical emergencies 
during hours when the practitioner's practice is closed;
    (b) Provides access to case-management services for patients 
including referral and follow-up services for programs that provide, or 
financially support, the provision of services such as medical, 
behavioral, social, housing, employment, educational, or other related 
services;
    (c) Uses health information technology (health IT) systems such as

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electronic health records, if otherwise required to use these systems in 
the practice setting. Health IT means the electronic systems that health 
care professionals and patients use to store, share, and analyze health 
information;
    (d) Is registered for their State prescription drug monitoring 
program (PDMP) where operational and in accordance with Federal and 
State law. PDMP means a statewide electronic database that collects 
designated data on substances dispensed in the State. For practitioners 
providing care in their capacity as employees or contractors of a 
Federal government agency, participation in a PDMP is required only when 
such participation is not restricted based on their State of licensure 
and is in accordance with Federal statutes and regulations;
    (e) Accepts third-party payment for costs in providing health 
services, including written billing, credit, and collection policies and 
procedures, or Federal health benefits.



Sec.  8.620  What is the process to request a patient limit of 275?

    In order for a practitioner to receive approval for a patient limit 
of 275, a practitioner must meet all of the requirements specified in 
Sec.  8.610 and submit a Request for Patient Limit Increase to SAMHSA 
that includes all of the following:
    (a) Completed Request for Patient Limit Increase form;
    (b) Statement certifying that the practitioner:
    (1) Will adhere to nationally recognized evidence-based guidelines 
for the treatment of patients with opioid use disorders;
    (2) Will provide patients with necessary behavioral health services 
as defined in Sec.  8.2 or through an established formal agreement with 
another entity to provide behavioral health services;
    (3) Will provide appropriate releases of information, in accordance 
with Federal and State laws and regulations, including the Health 
Information Portability and Accountability Act Privacy Rule (45 CFR part 
160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if 
applicable, to permit the coordination of care with behavioral health, 
medical, and other service practitioners;
    (4) Will use patient data to inform the improvement of outcomes;
    (5) Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from legitimate treatment use;
    (6) Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency situation that would 
impact a patient's access to care as defined in Sec.  8.2; and
    (7) Will notify all patients above the 100 patient level, in the 
event that the request for the higher patient limit is not renewed or 
the renewal request is denied, that the practitioner will no longer be 
able to provide MAT services using buprenorphine to them and make every 
effort to transfer patients to other addiction treatment;
    (c) Any additional documentation to demonstrate compliance with 
Sec.  8.610 as requested by SAMHSA.



Sec.  8.625  How will a Request for Patient Limit Increase be processed?

    (a) Not later than 45 days after the date on which SAMHSA receives a 
practitioner's Request for Patient Limit Increase as described in Sec.  
8.620, or renewal Request for Patient Limit Increase as described in 
Sec.  8.640, SAMHSA shall approve or deny the request.
    (1) A practitioner's Request for Patient Limit Increase will be 
approved if the practitioner satisfies all applicable requirements under 
Sec. Sec.  8.610 and 8.620. SAMHSA will thereafter notify the 
practitioner who requested the patient limit increase, and the Drug 
Enforcement Administration (DEA), that the practitioner has been 
approved to treat up to 275 patients using covered medications. A 
practitioner's approval to treat up to 275 patients under this section 
will extend for a term not to exceed 3 years.
    (2) SAMHSA may deny a practitioner's Request for Patient Limit 
Increase if SAMHSA determines that:
    (i) The Request for Patient Limit Increase is deficient in any 
respect; or
    (ii) The practitioner has knowingly submitted false statements or 
made

[[Page 117]]

misrepresentations of fact in the practitioner's Request for Patient 
Limit Increase.
    (b) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal), SAMHSA shall notify the practitioner of the 
reasons for the denial.
    (c) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal) based solely on deficiencies that can be resolved, 
and the deficiencies are resolved to the satisfaction of SAMHSA in a 
manner and time period approved by SAMHSA, the practitioner's Request 
for Patient Limit Increase will be approved. If the deficiencies have 
not been resolved to the satisfaction of SAMHSA within the designated 
time period, the Request for Patient Limit Increase may be denied.



Sec.  8.630  What must practitioners do in order to maintain their approval 
to treat up to 275 patients?

    (a) A practitioner whose Request for Patient Limit Increase is 
approved in accordance with Sec.  8.625 shall maintain all eligibility 
requirements specified in Sec.  8.610, and all attestations made in 
accordance with Sec.  8.620(b), during the practitioner's 3-year 
approval term. Failure to do so may result in SAMHSA withdrawing its 
approval of a practitioner's Request for Patient Limit Increase.
    (b) All practitioners whose Request for Patient Limit Increase has 
been approved under Sec.  8.625 must provide reports to SAMHSA as 
specified in Sec.  8.635.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 66196, Sept. 27, 2016]



Sec.  8.635  What are the reporting requirements for practitioners 
whose Request for Patient Limit Increase is approved?

    (a) General. All practitioners whose Request for Patient Limit 
Increase is approved under Sec.  8.625 must submit to SAMHSA annually a 
report along with documentation and data, as requested by SAMHSA, to 
demonstrate compliance with applicable provisions in Sec. Sec.  8.610, 
8.620, and 8.630.
    (b) Schedule. The report must be submitted within 30 days following 
the anniversary date of a practitioner's Request for Patient Limit 
Increase approval under Sec.  8.625, and during this period on an annual 
basis thereafter or on another annual schedule as determined by SAMHSA.
    (c) Content of the Annual Report. The report shall include 
information concerning the following, as further detailed in report form 
instructions issued by the Secretary:
    (1) The annual caseload of patients by month.
    (2) Numbers of patients provided behavioral health services and 
referred to behavioral health services.
    (3) Features of the practitioner's diversion control plan.
    (d) Discrepancies. SAMHSA may check reports from practitioners 
prescribing under the higher patient limit against other data sources to 
the extent allowable under applicable law. If discrepancies between 
reported information and other data are identified, SAMHSA may require 
additional documentation from the practitioner.
    (e) Noncompliance. Failure to submit reports under this section, or 
deficient reports, may be deemed a failure to satisfy the requirements 
for a patient limit increase, and may result in the withdrawal of 
SAMHSA's approval of the practitioner's Request for Patient Limit 
Increase.

[81 FR 66196, Sept. 27, 2016]



Sec.  8.640  What is the process for renewing a practitioner's 
Request for Patient Limit Increase approval?

    (a) Practitioners who intend to continue to treat up to 275 patients 
beyond their current 3 year approval term must submit a renewal Request 
for Patient Limit Increase in accordance with the procedures outlined 
under Sec.  8.620 at least 90 days before the expiration of their 
approval term.
    (b) If SAMHSA does not reach a final decision on a renewal Request 
for Patient Limit Increase before the expiration of a practitioner's 
approval term, the practitioner's existing approval term will be deemed 
extended until SAMHSA reaches a final decision.

[[Page 118]]



Sec.  8.645  What are the responsibilities of practitioners who do not submit 
a renewal Request for Patient Limit Increase, 
or whose renewal request is denied?

    Practitioners who are approved to treat up to 275 patients in 
accordance with Sec.  8.625, but who do not renew their Request for 
Patient Limit Increase, or whose renewal request is denied, shall 
notify, under Sec.  8.620(b)(7) in a time period specified by SAMHSA, 
all patients affected above the 100 patient limit, that the practitioner 
will no longer be able to provide MAT services using covered medications 
and make every effort to transfer patients to other addiction treatment.



Sec.  8.650  Can SAMHSA's approval of a practitioner's 
Request for Patient Limit Increase be suspended or revoked?

    (a) SAMHSA, at any time during a practitioner's 3 year approval 
term, may suspend or revoke its approval of a practitioner's Request for 
Patient Limit Increase under Sec.  8.625 if it is determined that:
    (1) Immediate action is necessary to protect public health or 
safety;
    (2) The practitioner made misrepresentations in the practitioner's 
Request for Patient Limit Increase;
    (3) The practitioner no longer satisfies the requirements of this 
subpart; or
    (4) The practitioner has been found to have violated the CSA 
pursuant to 21 U.S.C. 824(a).
    (b) [Reserved]



Sec.  8.655  Can a practitioner request to temporarily treat 
up to 275 patients in emergency situations?

    (a) Practitioners with a current waiver to prescribe up to 100 
patients and who are not otherwise eligible to treat up to 275 patients 
under Sec.  8.610 may request a temporary increase to treat up to 275 
patients in order to address emergency situations as defined in Sec.  
8.2 if the practitioner provides information and documentation that:
    (1) Describes the emergency situation in sufficient detail so as to 
allow a determination to be made regarding whether the situation 
qualifies as an emergency situation as defined in Sec.  8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit;
    (2) Identifies a period of time, not longer than 6 months, in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and
    (3) Describes an explicit and feasible plan to meet the public and 
individual health needs of the impacted persons once the practitioner's 
approval to treat up to 275 patients expires.
    (b) Prior to taking action on a practitioner's request under this 
section, SAMHSA shall consult, to the extent practicable, with the 
appropriate governmental authorities in order to determine whether the 
emergency situation that a practitioner describes justifies an immediate 
increase in the higher patient limit.
    (c) If SAMHSA determines that a practitioner's request under this 
section should be granted, SAMHSA will notify the practitioner that his 
or her request has been approved. The period of such approval shall not 
exceed six months.
    (d) If a practitioner wishes to receive an extension of the approval 
period granted under this section, he or she must submit a request to 
SAMHSA at least 30 days before the expiration of the six month period, 
and certify that the emergency situation as defined in Sec.  8.2 
necessitating an increased patient limit continues. Prior to taking 
action on a practitioner's extension request under this section, SAMHSA 
shall consult, to the extent practicable, with the appropriate 
governmental authorities in order to determine whether the emergency 
situation that a practitioner describes justifies an extension of an 
increase in the higher patient limit.
    (e) Except as provided in this section and Sec.  8.650, requirements 
in other sections under subpart F of this part do not apply to 
practitioners receiving waivers in this section.



PART 9_STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY SUPPORTED 
SANCTUARY SYSTEM--Table of Contents



Sec.
9.1 Applicability and purpose.

[[Page 119]]

9.2 Definitions.
9.3 Sanctuary policies and responsibilities.
9.4 Physical facility policies and design.
9.5 Chimpanzee ownership, fees, and studies.
9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia.
9.7 Reproduction.
9.8 Animal records.
9.9 Facility staffing.
9.10 Occupational Health and Safety Program (OHSP) and biosafety 
          requirements.
9.11 Animal transport.
9.12 Compliance with the Standards of Care, USDA and PHS policies and 
          regulations.
9.13 Other federal laws, regulations, and statutes that apply to this 
          part.

    Authority: 42 U.S.C. 216, 287a-3a.

    Source: 73 FR 60423, Oct. 10, 2008, unless otherwise noted.



Sec.  9.1  Applicability and purpose.

    (a) General. The standards of care set forth in this part apply to 
the chimpanzee sanctuaries that are contracted (or subcontracted) to the 
Federal Government to operate the federally supported chimpanzee 
sanctuary system authorized by section 481C of the Public Health Service 
(PHS) Act, as amended (42 U.S.C. 287a-3a).
    (b) What is the purpose of the federally supported chimpanzee 
sanctuary system and the authority for establishing these standards of 
care regulation? The Chimpanzee Health Improvement, Maintenance, and 
Protection Act (Pub. L. 106-551, referred to as the ``CHIMP Act'' or 
``Chimpanzee Retirement Act'') was enacted by Congress to provide for 
the establishment and operation of a sanctuary system to provide 
lifetime care for chimpanzees that have been used, or were bred or 
purchased for use, in research conducted or supported by the agencies of 
the Federal Government, and that are determined to be no longer needed 
for such research. The CHIMP Act also mandates that standards of care 
for chimpanzees in the sanctuary shall be developed to ensure the well-
being of chimpanzees and the health and safety of the chimpanzees.
    (c) To what chimpanzee sanctuaries do the standards of care in this 
part apply? The standards of care set forth in this part apply to only 
those sanctuaries that are contracted or subcontracted to the Federal 
Government to operate the federally supported chimpanzee sanctuary 
system.



Sec.  9.2  Definitions.

    As used in this part:
    Adequate veterinary care means a program directed by a veterinarian 
qualified through training and/or experience to provide professional 
medical care to the chimpanzees within the Sanctuary and with the 
appropriate authority to provide this care. The program also provides 
guidance to all caregivers on all matters relating to the health and 
well-being of the chimpanzees.
    American Zoo and Aquarium Association (AZA) means the professional 
society composed of individuals with various backgrounds and interests 
that are devoted to advancing the knowledge and understanding of zoo 
animals and the management of zoos in the United States.
    American Zoo and Aquarium Association (AZA) Accreditation Standards 
are those standards developed by the AZA that are used to review, 
evaluate, and accredit zoos or zoological gardens. These standards cover 
a variety of areas including facilities, policies and procedures, 
training, staff qualifications, medical and animal care, husbandry and 
well-being procedures, and conservation, along with other specific 
areas.
    Animal Care and Use Committee means the Institutional Animal Care 
and Use Committee established under section 13(b) of the Animal Welfare 
Act of 1985 and the Health Research Extension Act of 1985. For the 
purpose of these Standards of Care, it shall consist of at least five 
(5) members including the Chairperson, a Doctor of Veterinary Medicine 
(D.V.M. or V.M.D.) knowledgeable in nonhuman primate care and diseases 
and with delegated program responsibility, a member not affiliated with 
the Sanctuary, a scientist, and a member of the animal protection 
community. The requirement that a member of the ACUC must be from an 
animal protection organization is unique to this part and is not 
required under the Animal Welfare Regulations or the Public Health 
Service Policy on the Humane Care and Use of Laboratory Animals. This 
Committee must be established if research as defined by the Animal 
Welfare Act Regulations and the Public

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Health Service Policy (research, teaching, testing, exhibition) is to be 
conducted at the sanctuary.
    Animal protection organization means a nonprofit organization whose 
primary mission is protection of animals through positive advocacy and 
action.
    Animal Resource Manager (or Animal Resource Supervisor) means the 
individual employee responsible for managing the nonprofessional staff 
providing care for the chimpanzees at the sanctuary. This individual may 
perform other duties as assigned by the Sanctuary Contractor.
    Animal Welfare Act/Regulations means the Act of August 24, 1966 
(Pub. L. 89-544, commonly known as the Laboratory Animal Welfare Act), 
as amended by the Act of December 24, 1970 (Pub. L. 91-579, the Animal 
Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-279, the 
Animal Welfare Act of 1976), and the Act of December 23, 1985 (Pub. L. 
99-198, the Food Security Act of 1985), and as may be subsequently 
amended, and the United States Department of Agriculture (USDA) 
regulations implementing the Animal Welfare Act in title 9, chapter 1, 
subchapter A of the CFR.
    Animal Welfare Assurance means the documentation from an institution 
assuring compliance with the PHS Policy on Humane Care and Use of 
Laboratory Animals. This policy is administered by the Office of 
Laboratory Animal Welfare (OLAW), National Institutes of Health.
    Association for Assessment and Accreditation of Laboratory Animal 
Care, International (AAALAC) means the nonprofit organization that is 
recognized in the United States and abroad as being the body responsible 
for the accreditation of laboratory animal programs.
    Behaviorist means a person hired by the sanctuary to administer or 
oversee the enrichment and behavioral program for the chimpanzees at the 
sanctuary. This individual must be qualified through training or 
experience.
    Biosafety Officer means the individual responsible for establishing 
and monitoring workplace safety procedures designed to minimize or 
prevent injury or loss due to biohazards in accordance with policies 
established by the sanctuary administration.
    Board of Directors (BOD) means the individuals selected by the 
Contractor to govern the nonprofit institution responsible for operating 
the federally supported chimpanzee Sanctuary system. The board members 
must meet the qualifications and criteria stated in the CHIMP Act.
    Chair of the Board of Directors means the individual chosen by the 
BOD or other legally empowered entity to carry out such action, who is 
responsible for chairing meetings and acting on behalf of the board. 
This individual reports directly to the Board.
    Chief Executive Officer (CEO) means the principal person responsible 
for overall accomplishment of the mission of the chimpanzee sanctuary.
    CHIMP Act means the Chimpanzee Health Improvement, Maintenance, and 
Protection Act of December 20, 2000 (Pub. L. 106-551) commonly known as 
the ``CHIMP Act'' or ``Chimpanzee Retirement Act,'' and any future 
amendments.
    Chimpanzee means a member of Pan troglodytes. It excludes the pygmy 
chimpanzee (Pan paniscus or bonobo).
    Chimpanzee caregivers (caregivers) mean all sanctuary technical and 
husbandry staff providing long-term care and services for the 
chimpanzees.
    Contractor/Primary Contractor/Sanctuary Contractor means the 
nonprofit entity awarded a contract by the Federal Government to 
establish and operate the chimpanzee sanctuary system.
    Euthanasia means the humane death of a chimpanzee accomplished by a 
method that produces rapid unconsciousness and subsequent death without 
evidence of pain or distress. The method must be consistent with the 
recommendations of the American Veterinary Medical Association Panel on 
Euthanasia.
    Exhibition means exhibiting chimpanzees to the public for 
compensation. This definition excludes limited viewing for educational 
purposes that are not disruptive to the chimpanzees.
    Facility director means the individual responsible for directing the 
overall activities at the Sanctuary site.
    Facility Veterinarian means a person who has graduated from a 
veterinary school accredited by the American Veterinary Medical 
Association (AVMA)

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Council on Education, or who has a certificate issued by the AVMA's 
Education Commission for Foreign Veterinary Graduates; has training and/
or experience in the care and management of nonhuman primates; and has 
direct or delegated authority for activities involving chimpanzees at 
the federally funded chimpanzee sanctuary.
    Federal Acquisition Regulations (FAR) means the codified rules 
applicable to contracts, specifically those sections of the FAR (48 CFR 
chapter 1, part 52) that are applicable to contracts between the Federal 
Government and a contractor (in this case a private, nonprofit entity 
under contract to operate the chimpanzee sanctuary system).
    Federal agency means an executive agency as such term is defined in 
section 105 of title 5, United States Code, and refers to the agency 
from which the research facility receives a Federal award for projects 
involving animals.
    Federally owned chimpanzees mean chimpanzees that have been 
purchased by, bred by, or donated to a federal agency for use in 
biomedical/behavioral research. Chimpanzees whose ownership was 
subsequently transferred from Federal ownership via written transfer 
agreements are no longer federally owned.
    Guide means The Guide for the Care and Use of Laboratory Animals, 
published by the National Academy of Sciences, Institute for Laboratory 
Animal Research of the National Research Council, 1996, International 
Standard Book Number 0-309-05377-3.
    Housing facility means any land, premises, shed, barn, building, 
trailer, or other structure or area housing intended to house 
chimpanzees.
    Indoor housing facility refers to any structure or enclosure (for 
example, cages, pens, rooms) for maintaining animals in a controlled 
environment that provides for normal physiological and behavioral needs.
    Interstate air transport live animals (IATA) regulations means those 
regulations and standards covering the air transportation of nonhuman 
primates developed and implemented by the International Air 
Transportation Association.
    Invasive research (studies) utilizes those procedures that cause 
more than momentary pain, distress, fear, discomfort, injury, or other 
negative modalities to a chimpanzee. Any procedure that enters or 
exposes a body cavity is considered to be invasive. Sanctuary 
chimpanzees may not be used in invasive research. This definition 
excludes any invasive procedure that is a part of veterinary, medical, 
or surgical care that is performed by or under the direction of the 
Sanctuary Veterinarian using acceptable veterinary practices. Some 
examples of invasive studies are:
    (1) Experimental exposure to a substance that may be detrimental to 
a chimpanzee's health (e.g., infectious disease, radiation). This does 
not include accidental exposures to infectious diseases transmitted from 
cage mates or from radiation or other exposures at the time of regularly 
scheduled or necessary veterinary examinations and treatments;
    (2) Any invasion of a body cavity;
    (3) Surgery and surgical implantation of devices that are not a part 
of a veterinary medical treatment or colony management purposes.
    (4) Behavioral studies that cause distress or discomfort, such as 
induction of a fear response;
    (5) Testing of any drug;
    (6) Purposeful manipulation of social groups or the removal from 
their social group or addition of individuals in order to conduct 
behavioral research (for example, on aggression). Creation and 
refinement of social groups will be necessary when the animals arrive at 
the Sanctuary and this should take place only when necessary in regards 
to colony management and should not be driven by independently initiated 
research studies;
    (7) Restraint unless it is in conjunction with the annual exam or 
clinical care; and
    (8) Darting or anesthesia induction other than at annual exam or in 
the case of an emergency in which the chimpanzee's well-being is at 
stake.
    National Primate Research Center (NPRC) means those centers 
supported by the Office of Research Infrastructure Programs (ORIP) 
within the Division of Program Coordination, Planning and Strategic 
Initiatives (DPCPSI), National Institutes of

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Health, Department of Health and Human Services, as national resources 
for providing high-quality nonhuman primate research resources and 
facilities. As of 2015, there were seven such centers.
    National Research Council means the component of the National 
Academy of Sciences that advises the Federal Government on matters 
related to science, research, and research resources.
    Nonfederally owned chimpanzees mean chimpanzees that have not been 
purchased by, bred by, or donated to the Federal Government for use in 
federally supported research projects. In accordance with the CHIMP Act, 
chimpanzees owned on the date of passage of the CHIMP Act by a National 
Primate Research Center may enter the sanctuary system without requiring 
the NPRC to pay a fee. Offspring born in the sanctuary is owned by the 
Sanctuary Contractor.
    Noninvasive research (studies) means the use of procedures that 
depend upon close observation of chimpanzee behavior or on medical 
information collected during the course of normal veterinary care. These 
procedures do not require removal of the chimpanzees from their social 
group or environment, or require a separate anesthetic or sedation event 
to collect data or record observations. Some examples of noninvasive 
studies are:
    (1) Visual observation;
    (2) Behavioral studies designed to improve the establishment and 
maintenance of social groups. These activities may cause stress as a 
result of novel interactions between chimpanzees and caregivers, but 
they are not considered invasive as long as they are intended to 
maximize the well-being of the chimpanzees;
    (3) Medical examinations as deemed necessary to oversee the health 
of the chimpanzees, in the least invasive manner possible. Collection of 
samples routinely obtained during a physical examination for processing 
during this time is also considered noninvasive since a separate event 
is not required;
    (4) Administration and evaluation of environmental enrichment used 
to promote the psychological well-being of the chimpanzees; and
    (5) Actions taken to provide essential medical treatment to an 
individual chimpanzee exhibiting symptoms of illness. This applies only 
to serious illness that cannot be treated while the chimpanzee remains 
within the colony.
    Outdoor housing facility (area) means corrals, Primadomes (a 
prefabricated outdoor housing unit), fenced open areas, or similar 
structures or areas for maintaining chimpanzees with access to adequate 
protection from the extremes of environmental elements and harsh weather 
conditions.
    Outdoor ranging area means an area that allows chimpanzees greater 
ranging space than corrals or other outdoor housing area and includes a 
variety of vegetation, shrubbery, grasses and trees, thereby providing 
for a fairly unrestricted natural setting for the chimpanzees to engage 
in species-appropriate activities. The area is secured by an outer 
perimeter barrier.
    Project Officer means the individual designated by the Federal 
Government to represent the contracting officer and interests of the 
federal agency, within defined areas, in monitoring and overseeing the 
chimpanzee sanctuary system contract.
    Sanctuary Chimpanzee Care Committee (SCCC) or similar designated 
committee means the group of individuals designated by the CEO of the 
sanctuary that reviews and monitors adherence to the policies, 
procedures, and regulations at the sanctuary.
    Sanctuary Contractor means the nonprofit, private entities selected 
by ORIP/DPCPSI/NIH to develop and operate the chimpanzee sanctuary 
system. This contractor is also known as the ``primary contractor'' for 
the sanctuary system.
    Sanctuary Director means the individual who provides day-to-day 
direction and oversight to the employees responsible for performing the 
daily tasks at the facility.
    Sanctuary or federally supported chimpanzee sanctuary system means 
the sanctuary or sanctuary system established by the Federal Government 
through contracting with a private, nonprofit entity, for the purpose of 
carrying out the provisions of the CHIMP

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Act of 2000. The system includes a primary Contractor and may include 
additional subcontractors as required. This sanctuary system is 
supported primarily from funds allocated by ORIP/DPCPSI/NIH/HHS with 
some matching funds from the nonprofit contractor.
    Secretary means the Secretary of Health and Human Services or his/
her designee.
    Subcontractor means a private, nonprofit entity selected by the 
primary contractor to provide additional sanctuary services.
    Surplus chimpanzees means chimpanzees that are no longer needed in 
research and that were used, or were bred or purchased for use, in 
research conducted or supported by the Federal Government.
    USDA licensed intermediate handler/carrier means any person, 
including a department, agency, or instrumentality of the United States 
or of any State or local government, who is engaged in any business in 
which it receives custody of animals in connection with their 
transportation in commerce and who is licensed by the USDA.
    Zoonotic disease(s) means diseases that are transmissible from 
chimpanzees to humans.

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]



Sec.  9.3  Sanctuary policies and responsibilities.

    (a) What are the policies and responsibilities governing the 
sanctuary system? It will be the policies and responsibilities of the 
sanctuary system to:
    (1) Appoint a Board of Directors (BOD) responsible for the overall 
governance and direction of the Sanctuary. The BOD shall designate the 
Chief Executive Officer (CEO), who is responsible for the management and 
oversight of the daily operations of the sanctuary and the performance 
of other delegated tasks. Subcontractors, if applicable, shall be 
governed by the policies that are developed by the Board of Directors of 
the primary contractor.
    (2) Direct the BOD to:
    (i) Ensure that chimpanzees accepted into the sanctuary are not 
discharged;
    (ii) Develop guidelines for accepting chimpanzees not owned by the 
Federal Government into the sanctuary if the conditions are met as 
outlined in 42 U.S.C. 287;
    (iii) Ensure that the Board of Directors of the primary contractor 
consists of no more than thirteen (13) individuals, and that the 
conditions governing the terms of the Board members are in compliance 
with the CHIMP Act;
    (iv) Include individuals with the following expertise and experience 
as set forth in the CHIMP Act;
    (A) At least one veterinarian who is qualified in veterinary care of 
nonhuman primates. These qualifications may be met through postdoctoral 
training, experience, or both;
    (B) Individual(s) with expertise and experience in zoological 
science and with knowledge in behavioral primatology;
    (C) Individual(s) with experience in the animal protection field;
    (D) Individual(s) with experience and expertise in the field of 
business and management of nonprofit organizations;
    (E) Individual(s) knowledgeable and experienced in accrediting 
programs of animal care;
    (F) Individual(s) with experience and expertise in containing 
biohazards;
    (v) Ensure that a member of the Board of Directors serves as the 
Chair of the Board of Directors, who may be elected or appointed by the 
Board from among the individuals identified in paragraphs (a) (1) (iv) 
(A) through (F) of this section;
    (vi) Ensure that no member of the board shall have been fined for, 
or signed a consent decree for, any violation of the Animal Welfare Act;
    (vii) Create a safe and species-appropriate physical and social 
environment for the lifetime care of chimpanzees;
    (viii) Comply with all applicable provisions of the animal welfare 
regulations and other federal, state and local laws, regulations, and 
policies;
    (ix) Achieve accreditations from appropriate accrediting bodies 
within a reasonable time frame mutually agreed upon by the Contractor 
and ORIP/DPCPSI;
    (x) Prohibit any invasive research on the resident chimpanzees, but 
permit

[[Page 124]]

noninvasive studies (Definitions for the terms invasive and non-invasive 
are set forth in Sec.  9.2 of this part.);
    (xi) Prohibit exhibition of chimpanzees in the sanctuary (This 
policy does not prohibit educational activities that may involve limited 
viewing of chimpanzees in their environment and that are designed to 
promote an understanding of chimpanzee behavior, well-being, or 
importance to the ecological system that does not adversely affect the 
chimpanzees' routine.);
    (xii) Staff the organization with people with appropriate 
experience; and
    (xiii) Authorize the establishment of a Sanctuary Chimpanzee Care 
Committee (SCCC) that is appointed by and reports to the CEO or 
President of the company or corporationThe SCCC is responsible for 
overseeing the chimpanzee care program and operations to ensure the 
health and well-being of the chimpanzees and the occupational safety of 
the staff are being addressed. The Committee must consist of no fewer 
than five people who must include:
    (A) A chair (person) knowledgeable of the needs of chimpanzees;
    (B) A veterinarian with chimpanzee care experience;
    (C) A behaviorist with experience in chimpanzee behavior;
    (D) A member of the chimpanzee care staff; and
    (E) Member or members from the community, including at least one 
with affiliation or employment with an animal protection organization as 
defined in Sec.  9.2 of this part.
    (F) The SCCC will:
    (1) Oversee and evaluate the chimpanzee care and socialization 
program;
    (2) Review and approve proposed education programs. No program 
should be approved that might interfere with the chimpanzees' well-being 
or routine activities;
    (3) Conduct a formal review of the program on a semiannual basis and 
submit reports to the Sanctuary Director. The reports must be available 
for review by the USDA and NIH representatives during site visits;
    (4) Establish a mechanism for receipt and review of concerns 
involving the care of chimpanzees and resolving such concerns;
    (5) Review all noninvasive study proposals. The SCCC membership may 
require additional qualified individuals to perform the functions of an 
Animal Care and Use Committee (ACUC) if and when the need arises. The 
contractor may establish a separate ACUC. The ACUC must be established 
in accordance with the applicable provisions of the Animal Welfare Act 
regulations, the Public Health Service Policy on Humane Care and Use of 
Laboratory Animals, and these standards of care;
    (6) Review all euthanasia events. Euthanasia events performed for 
medical or humane reasons must be based upon sound professional 
veterinary judgment that conforms to current veterinary medical 
practices and must be in the best interest of the chimpanzee. Euthanasia 
performed for emergency reasons without advance review by the SCCC shall 
be reviewed by the SCCC as soon as possible after the event to ensure 
compliance with established policy;
    (7) Establish procedures to prevent any reproduction in the colony 
through appropriate permanent birth control, preferably by vasectomy of 
all sexually mature male chimpanzees in the sanctuary; and
    (8) Develop procedures for maintaining chimpanzees that are 
seropositive for or harboring infectious agents or previously have been 
exposed to infectious agents (whether experimentally induced or 
naturally occurring) that will allow them to be accepted by the 
sanctuary and properly housed. The procedures must be submitted to NCRR/
NIH for approval.
    (b) Who is responsible for developing or revising sanctuary 
policies? (1) The Sanctuary Contractor is responsible for developing, 
revising, and implementing policies affecting the sanctuary.
    (2) The federal agency (ORIP/DPCPSI/NIH) designated by the Secretary 
must concur with any changes that substantially change existing 
policies. The Secretary, or designee, will determine if a policy change 
will have a substantial impact upon current policy after consultation 
with the Sanctuary Contractor.

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]

[[Page 125]]


    Editorial Note: At 85 FR 54273, Sept. 1, 2020, Sec.  9.3 was 
amended, however, the amendment could not be incorporated because 
paragraph (a)(8) does not exist.



Sec.  9.4  Physical facility policies and design.

    (a) What standards apply to the facility design and physical plant? 
The chimpanzee sanctuary facility must be designed to provide sufficient 
space and variety of natural or artificial objects to accommodate 
natural activities of chimpanzees while restricting their movement and 
range to the defined area. Daily observation of chimpanzees within the 
enclosures is required and shall be accomplished with minimal 
disturbance to the chimpanzees. The facility design and physical plant 
should be in accordance with the recommendation of The Guide for the 
Care and Use of Laboratory Animals (Guide), where applicable. The Guide 
is published by the National Research Council, 1996, International 
Standard Book Number 0-309-05377-3. The Guide is incorporated by 
reference in this section. The Director of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain a copy of the publication from the National 
Academy Press, 2101 Constitution Avenue, NW., Lockbox 285, Washington, 
DC 20055; or you may order it electronically via the Internet at http://
www.nap.edu; or view it online at http://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at NIH, ORIP/DPCPSI, One Democracy 
Plaza, 6701 Democracy Boulevard, Bethesda, MD 20817-4874, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (1) The facility design and physical plant consist of the following 
components: Indoor design features; outdoor design features; 
construction and construction materials; physical barriers; shelter; 
service support space, including storage areas for food, supplies, and 
equipment; personnel and administrative support space; quarantine and 
isolation facilities; treatment area; heating, ventilation, and air 
conditioning (HVAC); food preparation area; and animal waste treatment.
    (2) A housing system shall include indoor and outdoor enclosures 
that must be kept in good repair to prevent escape and injury to the 
chimpanzees, promote physical comfort, facilitate sanitation and 
servicing, and address the psychological well-being and social needs of 
the chimpanzees. Chimpanzees must be able to retreat from areas where 
they feel threatened or agitated by close human encounters or encounters 
with other chimpanzees.
    (3) Indoor areas shall have special areas for social introductions 
and medical treatment. Quarantine and isolation facilities are required 
for the sanctuary. These facilities must be designed to prevent the 
spread of undesirable agents from quarantine and isolation rooms to 
other parts of the facility.
    (4) Outdoor areas must provide sufficient ranging space and either 
natural or artificial structures that chimpanzees can use for shelter or 
nesting areas to sleep, rest, or seek refuge from rain, direct sun, 
wind, and extreme temperatures.
    (5) Animal waste from the Sanctuary must be properly treated to 
remove known hazardous agents before discharging it into the environment 
in accordance with currently acceptable and effective waste treatment 
procedures, including current industry standards and Federal laws, 
regulations or guidelines, as applicable.
    (6) An area for treatment of and performing veterinary clinical 
procedures on chimpanzees must be provided at each Sanctuary site. This 
area must be constructed and provisioned to perform emergency 
procedures, including minor surgery and emergency surgical procedures, 
complete physical examinations, and facilities for extended care of 
medical conditions as needed.
    (b) What security measures are required for the sanctuary? The 
sanctuary must provide adequate security against unauthorized entry, 
sabotage, malicious damage, and theft of chimpanzees and property and 
must minimize any chance of escape by a chimpanzee. The security staff 
must have training and/

[[Page 126]]

or experience in methods and equipment designed to detect possible 
security breaches and the ability to respond to security events in a 
timely and effective manner. Perimeter containment shall be used to 
protect the compound housing the chimpanzees consistent with the 
recommendations of the Guide (incorporated by reference, see paragraph 
(a) of this section).
    (c) Is the sanctuary required to develop disaster and escaped animal 
contingency plans? The sanctuary facility must prepare disaster and 
escaped animal contingency plans outlining simple and easy to follow 
plans for dealing with natural and man-made disasters and steps to be 
taken in case a chimpanzee escapes from the compound. The Sanctuary also 
must provide adequate security against unauthorized entry, sabotage, 
malicious damage, and theft of chimpanzees and property and must 
minimize any chance of escape by a chimpanzee. Primary barriers must be 
constructed to prevent escape of chimpanzees and secondary or perimeter 
barriers must prevent entry of unauthorized persons into the facility, 
consistent with the recommendations of the Guide (incorporated by 
reference, see paragraph (a) of this section).

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]



Sec.  9.5  Chimpanzee ownership, fees, and studies.

    (a) Who owns the chimpanzees in the federally supported sanctuary? 
The Federal Government retains ownership of chimpanzees owned by the 
Federal Government at the time they enter the sanctuary system. Non-
federally owned or supported chimpanzees will be owned by the sanctuary. 
The chimpanzees shall continue to be maintained in the sanctuary 
throughout their lifetime and shall not be discharged from the sanctuary 
except as specifically indicated in the CHIMP Act.
    (b) Is there a charge for placing chimpanzees in the sanctuary? No 
fees shall be charged by the Sanctuary Contractor for federally owned or 
supported chimpanzees entering the sanctuary. Chimpanzees that were 
owned by a NPRC when the CHIMP Act became effective are also admitted 
without payment of fees. Fees for maintenance of the chimpanzees alluded 
to above are provided for in the contract between the Federal Government 
and the Sanctuary Contractor.
    (c) May the sanctuary agree to accept chimpanzees that are not owned 
by the Federal Government? The sanctuary may accept chimpanzees that are 
not owned by the Federal Government subject to the following conditions:
    (1) Ownership of the chimpanzee must be transferred to the 
sanctuary;
    (2) Fees for these chimpanzees may be levied based on a range of 
considerations that include most importantly, the well-being of the 
chimpanzee and, secondarily, factors that include (but are not limited 
to) the resources available to support the chimpanzee; the health, age, 
and social history of the chimpanzee; and other relevant factors 
affecting the cost of caring for the chimpanzee. While chimpanzees not 
owned or supported by the Federal Government may be admitted to the 
sanctuary, federal funds may not be used for their support unless 
authorized by the Secretary or an authorized designee;
    (3) Available space exists in the sanctuary; and
    (4) An agreement exists between the sanctuary system and the ORIP/
DPCPSI/NIH documenting that the chimpanzee may be brought into the 
sanctuary.
    (d) What additional conditions apply when nongovernmental owned 
chimpanzees transfer to the chimpanzee sanctuary? The following 
additional conditions apply when nongovernmental owned chimpanzees 
transfer to the chimpanzee sanctuary:
    (1) Chimpanzees transferred to the sanctuary sites must be 
permanently incapable of reproduction, for example, by vasectomy, tubal 
ligation, or another reliable procedure;
    (2) Complete histories must accompany each chimpanzee. Any 
chimpanzee missing documentation for any period of research or other use 
may not be transferred to the Sanctuary without the concurrent 
authorization of the Sanctuary Contractor's Board of Directors and the 
ORIP/DPCPSI/NIH; the records may be created and retained in electronic 
form; and

[[Page 127]]

    (3) Appropriate screening of each chimpanzee must be performed to 
assess the likelihood of the chimpanzee being a health or safety threat 
to the care staff and/or other chimpanzees.
    (e) What are the criteria for acceptance and the fees for admission 
into the sanctuary for nongovernmental owned chimpanzees? The chimpanzee 
Sanctuary Contractor, in conjunction with ORIP/DPCPSI/NIH , must 
establish criteria and a fee system for acceptance of nongovernmental 
owned chimpanzees. Funds collected for this purpose must be accounted 
for and used to help defray the expenses incurred in operating the 
sanctuary.
    (f) Under what circumstances might a chimpanzee from the sanctuary 
be returned to research at a United States research facility? In 
December 2007, the CHIMP Act was amended by the ``Chimp Haven is Home 
Act,'' which terminated the authority for the removal of chimpanzees 
from the sanctuary system for research purposes.

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]



Sec.  9.6  Animal care, well-being, husbandry, veterinary care, and euthanasia.

    (a) What are the requirements for promoting the well-being of 
sanctuary chimpanzees? The goal of chimpanzee housing and management in 
the sanctuary is to promote the chimpanzees' well-being.
    (b) What are the provisions for daily chimpanzee husbandry and care? 
Adequate and proper care for chimpanzees in the sanctuary must be 
provided with respect to physical environment, housing and husbandry, 
behavioral management, and population management and control. Specific 
requirements include the following:
    (1) Chimpanzees must have access to food, water, and bedding at all 
times, unless medical or behavioral conditions dictate otherwise. 
Husbandry procedures shall represent current policies and practices and 
conform to standards set by a nationally recognized accrediting 
association in accordance with the Guide (incorporated by reference, see 
paragraph (a) of Sec.  9.4).
    (2) Indoor primary enclosures must be cleaned as often as required 
to maintain a clean and healthy environment, with a minimum of once 
daily. Outdoor enclosures must be monitored daily and cleaned on a 
routine basis. Outdoor ranging areas will not require a routine cleaning 
schedule but must be monitored for excessive accumulation of waste or 
other unhealthy conditions. Housing areas shall provide sufficient space 
for chimpanzees to perform species-typical behavior and expression. 
Examples of such activities include but are not limited to natural 
movements, climbing, swinging, resting, running, group interactions, 
sleeping, etc. Feeding and watering implements must be sanitized at 
intervals required to maintain them in a sanitary condition, in 
accordance with the Guide (incorporated by reference, see paragraph (a) 
of Sec.  9.4).
    (3) The federally supported chimpanzee sanctuary must employ a 
behavioral scientist knowledgeable in primate behavior and socialization 
requirements. This individual shall provide primary leadership in 
developing, implementing, and monitoring the chimpanzee behavioral 
guidelines for the sanctuary. Enrichment techniques used shall be 
currently accepted practices. The sanctuary must provide for the 
expertise to plan, administer, and evaluate the effectiveness of the 
well-being program.
    (4) Many chimpanzees can be trained through positive reinforcement 
to cooperate with a variety of veterinary and chimpanzee care 
procedures. Efforts must be made to develop or maintain this capability 
for chimpanzees housed in the sanctuary to the extent possible. Trainers 
must use currently acceptable practices that do not include physical 
punishment.
    (c) What are the requirements for an adequate veterinary care and 
animal health program? The sanctuary staff must provide sufficient 
resources of personnel, equipment, supplies, and facilities to enable 
the provision of adequate veterinary care as set forth in the Guide 
(incorporated by reference, see paragraph (b) of Sec.  9.4). For 
additional guidance see the American College of Laboratory Animal 
Medicine document, ``The Provision of Adequate Veterinary Care,'' 
available on the Internet at http://www.aclam.org.

[[Page 128]]

    (1) If the sanctuary houses chimpanzees with infectious diseases, it 
must have a veterinarian knowledgeable in the infectious diseases and 
care of chimpanzees. The Facility Veterinarian is responsible for 
establishing and implementing a health monitoring system specifically 
designed to meet the health requirements of chimpanzees in the 
sanctuary. Routine observation and the prevention of disease, metabolic 
conditions, abnormal behavior and injury must be a priority focus of the 
Facility Veterinarian and staff.
    (2) Newly received chimpanzees must be quarantined for a period for 
physiological, psychological, and nutritional stabilization before their 
introduction to the rest of the group. The stabilization period must be 
lengthened appropriately if the chimpanzee has a significant medical 
problem or if abnormal medical findings are detected during the 
quarantine period. If the chimpanzee has not been given a complete 
physical examination within six months, an examination must be conducted 
during the stabilization period.
    (3) The sanctuary must implement appropriate methods for disease 
surveillance and diagnosis of diseases, which may include the following:
    (4) Tuberculin (TB) tests must be negative for two (2) consecutive 
tests before the chimpanzee is released from quarantine. Any chimpanzee 
that is suspected of harboring the TB organism, or that is diagnosed 
with TB will be isolated and treated until determined by the Facility 
Veterinarian to be of no health risk to other chimpanzees or humans. The 
Facility Veterinarian may recommend euthanasia in those cases that do 
not respond to therapy and in which the chimpanzee consequently 
experiences undue pain and suffering that cannot be alleviated. The 
procedures noted under Sec.  9.6 (d) must be observed if euthanasia is 
necessary.
    (5) Fecal samples must be checked for parasites and parasitic ova.
    (6) A complete blood count and serum chemical panel must be 
obtained.
    (7) Additional serum for banking and/or testing shall be obtained as 
appropriate by the Facility Veterinarian and is considered beneficial 
for chimpanzee health.
    (8) If the donating facility did not test for the appropriate 
viruses, the sanctuary must perform a viral panel and serology for the 
various chronic hepatitis viruses and HIV.
    (9) Additional tests or procedures that are deemed beneficial to the 
chimpanzees' health may be required by the Facility Veterinarian.
    (10) Chimpanzees are susceptible to many of the vaccine preventable 
diseases of human childhood. Appropriate vaccines must be considered and 
administered if deemed necessary, at the discretion of the Facility 
Veterinarian, to protect the chimpanzees in the sanctuary. Methods of 
disease prevention, diagnosis, and therapy must comply with those 
currently accepted in veterinary medical practice. Arrangements with 
diagnostic laboratories must be established before chimpanzees arrive at 
the sanctuary.
    (11) The sanctuary must minimize the use of physical and chemical 
restraint. Chimpanzees in the sanctuary shall be trained to permit 
certain procedures with minimal or no restraint. Such procedures may 
include injections, dosing or other treatments, and cage-side health 
observations. However, chemical sedation sometimes may be appropriate 
for certain necessary medical interventions or for the safety of the 
chimpanzee and caregivers. If physical restraint measures are necessary, 
due consideration must be given to the temporary or permanent effects 
upon the chimpanzee and human and animal safety concerns.
    (12) Methods used to relieve pain must be documented in the 
chimpanzee medical or surgical records. These records will be available 
for review by USDA and NIH representatives. The Facility Veterinarian 
must ensure that pain management is current and in accordance with 
acceptable veterinary medical practices.
    (13) Chimpanzees must be cared for by qualified personnel on a daily 
basis, including weekends and holidays, to safeguard their well-being. 
Emergency veterinary care must also be available during these times. 
Notification procedures must be documented in the form of operating 
procedures.

[[Page 129]]

    (d) Under what circumstances is euthanasia permitted? As stated in 
section 481C(d)(2)(I) of the Public Health Service Act, as added by 
section 2 of the CHIMP Act, none of the chimpanzees may be subjected to 
euthanasia except when it is in the best interest of the chimpanzee 
involved as determined by the SCCC and the Facility Veterinarian. 
Therefore, euthanasia for medical or humane reasons is permitted. 
Euthanasia may be permitted for reasons of health or quality of life of 
the individual chimpanzee, including for disease, in connection with 
trauma, complications of aging, or for other humane reasons. The 
sanctuary must establish a policy on euthanasia that will provide 
conditions that must be met before euthanasia is permitted and guidance 
for performing euthanasia.
    (1) Methods of euthanasia will be consistent with the most recent 
report of the American Veterinary Medical Association Panel on 
Euthanasia (2002), unless more reliable data becomes available. When 
euthanasia is performed, the veterinarian will determine the appropriate 
agent, and it will be administered only by properly trained personnel 
under the direction of the Facility Veterinarian. The decision to 
perform euthanasia will be made by the veterinarian in consultation with 
the Facility Director or Deputy Director.
    (2) The SCCC will participate in the decision in nonmedical 
emergencies. All euthanasia decisions must be reviewed by the SCCC, 
preferably prior to euthanasia. In emergencies, where euthanasia has to 
be performed immediately by the Facility Veterinarian, the circumstances 
and the decision by the Facility Veterinarian will be presented at the 
next scheduled or special meeting of the SCCC. The ORIP/DPCPSI Project 
Officer must be notified of the euthanasia event within 72 hours by 
electronic or telephonic means. Euthanasia of individual chimpanzees may 
negatively affect the care staff and appropriate counseling and 
psychological support shall be considered.

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]



Sec.  9.7  Reproduction.

    Chimpanzee reproduction is prohibited in the sanctuary. Therefore, 
all males must be sterilized by vasectomy before acceptance into the 
system, or, as a temporary measure, housed apart from females until they 
are sterilized. Vasectomies are advisable because they are minimally 
invasive and because effectiveness of the vasectomy may be validated 
through laboratory testing for semen. Seminal collection techniques must 
be carefully evaluated to avoid painful stimuli. Other proven methods of 
birth control may be used under special conditions deemed appropriate by 
the Facility Veterinarian and SCCC. The Facility Veterinarian must 
determine the appropriate test(s) to use to validate sterility. A 
veterinarian experienced in performing vasectomies in chimpanzees should 
perform the operation. Documentation must accompany each male accepted 
to the sanctuary system attesting to the fact that the male has been 
vasectomized and laboratory tests confirm that a segment of the Vas 
Deferens has been removed, or that the test used is reliable and is 
negative for sperm. The sanctuary must have a contingency plan for 
handling accidental births that includes the length of time the 
offspring is expected to remain with the mother.



Sec.  9.8  Animal records.

    (a) What records must be maintained for chimpanzees in the sanctuary 
and how are they managed? (1) Contractors and Subcontractors operating 
the federal chimpanzee sanctuary system must maintain appropriate 
records to allow for accountability and disposition of chimpanzees under 
their care as required by the USDA Animal Welfare Regulations (9 CFR 
2.35). The records may be created and retained in electronic form.
    (2) The animal records currently required by the USDA Animal Welfare 
Regulations are also required for these standards. Chimpanzees must be 
individually and permanently identifiable.
    (3) Retrievable records must be maintained for a minimum of three 
years beyond the disposition or death of each chimpanzee in accordance 
with the Animal Welfare Regulations section 2.35(f) (9 CFR 2.35(f)). 
Original records

[[Page 130]]

or a copy must be transferred if the chimpanzee moves to a different 
facility. The records must include standard information, including 
permanent individual identification, research use(s), reproductive 
status (past and present), a summary or copy of the medical and 
behavioral history, the sire's identification number (if available), the 
dam's identification number, birth date, sex, and date acquired by the 
sanctuary. The disposition date must also be noted, if applicable, 
including whether the chimpanzee died or was transferred to another site 
in the federal sanctuary system. The records may be created and retained 
in electronic form.
    (4) The contractor and any subcontractor(s) operating the federally 
supported chimpanzee sanctuary must provide special, quarterly, and 
annual progress reports to the designated Federal officials as 
identified in the contract. The annual report must also contain a 
statement that certifies the sanctuary is in full compliance with these 
standards of care regulation.
    (b) What are the rules governing the disposition of necropsy 
records? The CHIMP Act requires that necropsy records from chimpanzees 
previously used in federally funded research projects be made available 
on a reasonable basis to investigators engaged in biomedical or 
behavioral research. In order to comply with this provision, the 
contractor for the sanctuary system must devise a plan that will allow 
interested parties to contact the sanctuary and receive necropsy records 
when they become available. Records may be provided free of charge but 
requesters may be required to pay for packaging and shipping costs. The 
records may be created and retained in electronic form.



Sec.  9.9  Facility staffing.

    How many personnel are required to staff the chimpanzee sanctuary 
and what qualifications and training must the staff possess? (a) The 
professional, managerial, and support staff must be sufficient to 
support the scope and diversity of the activities and chimpanzee 
population of the sanctuary. The level of staffing shall be adequate to 
ensure that the chimpanzees receive appropriate health care, are well 
cared for, and the administrative and fiscal operations are sound and in 
keeping with current practices required by ORIP/DPCPSI/NIH ;
    (b) There must be a sufficient number of appropriately trained 
animal care and technical personnel to provide appropriate care to the 
chimpanzees at all times, including evenings, weekends, and holidays. 
The number of animal care staff to chimpanzee ratio shall be adjusted as 
experience is gained during the operation of the sanctuary. Sufficiently 
trained staff also must be available to maintain adequate behavioral 
enrichment;
    (c) The Facility Director must be a person with experience in 
chimpanzee care and socialization techniques. In addition, the Director 
must have management and administrative experience;
    (d) The Biosafety Officer must have experience in developing and 
monitoring biohazards and dealing with biosafety issues related to 
captive nonhuman primates. Experience in these areas dealing 
specifically with chimpanzees is desirable;
    (e) The remaining staff, which may include part-time, full-time, or 
contractor Facility Veterinarian(s) and Behaviorist(s), must possess the 
skills, knowledge, and/or experience required to perform their duties, 
as elaborated within the regulation.

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]



Sec.  9.10  Occupational Health and Safety Program (OHSP) 
and biosafety requirements.

    (a) How are employee Occupational Health and Safety Program risks 
and concerns addressed? The sanctuary shall assure that an Occupational 
Health and Safety Program (OHSP) is developed and implemented in 
accordance with current veterinary medical practices and the guidelines 
and standards found in the Guide (incorporated by reference, see 
paragraph (a) of section 9.4);
    (b) How are biosafety concerns addressed? The sanctuary shall 
institute and administer an effective biosafety program that addresses 
the biosafety hazards at that particular site. The

[[Page 131]]

program shall include identifying biohazards, outlining practices and 
procedures to be followed, providing personal safety equipment or 
protective clothing and equipment, and establishing a description of the 
facility requirements for working with hazardous agents or materials. 
Policies and procedures must be implemented to avoid exposure to 
environmental and animal hazards. Biosafety must be included in the 
training program for all Sanctuary employees. In establishing a program, 
the Sanctuary must use current accepted practices and publications 
prepared by the CDC, NIH, and professional societies specializing in 
biosafety. The input and guidance of personnel trained or experienced in 
biosafety are essential. Complete records of both clinical and 
experimental agent exposure must accompany each chimpanzee sent to the 
sanctuary. The donating facility must also provide recent testing (for 
example, serology, virus culture, histology) so that the sanctuary staff 
is fully aware of the health condition of the arriving chimpanzee. The 
records may be created and retained in electronic form.



Sec.  9.11  Animal transport.

    The transportation of chimpanzees by surface or air must be in 
accordance with the requirements set forth in the Animal Welfare Act and 
Regulations and the International Air Transport Association (IATA) Live 
Animal Regulations and guidelines, as applicable.



Sec.  9.12  Compliance with the Standards of Care, and USDA and PHS policies 
and regulations.

    (a) How will compliance with the standards set forth in this part be 
monitored and what are the consequences of noncompliance with the 
standards? The federally supported chimpanzee sanctuary must comply with 
the standards of care set forth in this part and include a statement in 
the Annual Progress Report certifying compliance with these standards of 
care in accordance with the terms of the current contract between ORIP/
DPCPSI and the Sanctuary Contractor. A designated representative of the 
Secretary will monitor compliance. The responsibility to monitor 
compliance with the standards is delegated to ORIP/DPCPSI/NIH/HHS . The 
ORIP/DPCPSI/NIH Project Officer for this contract will conduct scheduled 
site visits at least one time annually (or more often if necessary) and 
review monthly and quarterly reports submitted to the Project and 
Contract Officer. Subcontractors are subjected to the same provisions. 
Failure to comply with the standards set forth in this part, or to 
correct deficiencies noted within the allowable time period, could 
result in termination of the contract by the Federal Government (HHS/
NIH), or allow the Secretary to correct the deficiencies according to 
the terms and conditions outlined in the contract. The Secretary may 
impose additional sanctions on the contractor up to, and including, 
authorizing assumption or reassignment of the management of the 
sanctuary contract.
    (b) To what type of outside review or inspection will the federally 
supported sanctuary be subjected? As noted in paragraph (a) of this 
section, the contractor for the sanctuary will be monitored on a 
regularly scheduled basis by representatives of ORIP/DPCPSI/NIH/HHS . 
The ORIP/DPCPSI representative will use facility site visits, reports, 
personal contact, and any other means as appropriate to ensure 
compliance with these standards. The contractor and subcontractors are 
required to obtain and maintain an Animal Welfare Assurance from NIH's 
Office of Laboratory Animal Welfare (OLAW) when chimpanzees are used for 
noninvasive studies as authorized in the CHIMP Act. In addition, the 
sanctuary must achieve accreditation by a nationally recognized animal 
program accrediting body (such as the AAALAC, the AZA, or similar 
recognized body) within a time frame to be determined by ORIP/DPCPSI/NIH 
. The federally supported sanctuary must comply with the requirements 
set forth in the Animal Welfare Regulations (9 CFR parts 1 through 3).

[73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020]



Sec.  9.13  Other federal laws, regulations, and statutes 
that apply to the sanctuary.

    (a) Animal Welfare Act (7 U.S.C. 2131-2159).

[[Page 132]]

    (b) Animal Welfare Regulations, 9 CFR, subchapter A, parts 1 and 2; 
part 3, subpart D--Specifications for the Humane Handling, Care, 
Treatment, and Transport of Nonhuman Primates.



PART 10_340B DRUG PRICING PROGRAM--Table of Contents



                      Subpart A_General Provisions

Sec.
10.1 Purpose.
10.2 Summary of 340B Drug Pricing Program.
10.3 Definitions.

                      Subpart B_340B Ceiling Price

10.10 Ceiling price for a covered outpatient drug.
10.11 Manufacturer civil monetary penalties.

               Subpart C_Administrative Dispute Resolution

10.20 Administrative Dispute Resolution Panel.
10.21 Claims.
10.22 Information requests.
10.23 Conduct of the ADR proceeding.
10.24 Final agency decision.

    Authority: Sec. 340B of the Public Health Service Act (42 U.S.C. 
256b) (PHSA), as amended.

    Source: 82 FR 1229, Jan. 5, 2017, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  10.1  Purpose.

    This part implements section 340B of the Public Health Service Act 
(PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.''



Sec.  10.2  Summary of 340B Drug Pricing Program.

    Section 340B of the PHSA instructs the Secretary of Health and Human 
Services to enter into agreements with manufacturers of covered 
outpatient drugs under which the amount to be paid to manufacturers by 
certain statutorily-defined covered entities does not exceed the 340B 
ceiling price.



Sec.  10.3  Definitions.

    For the purposes of this part, the following definitions apply:
    Administrative Dispute Resolution (ADR) Process means a process used 
to resolve the following types of claims, including any issues that 
assist the 340B ADR Panel in resolving claims:
    (1) Claims by covered entities that may have been overcharged for 
covered outpatient drugs purchased from manufacturers; and
    (2) Claims by manufacturers of 340B drugs, after a manufacturer has 
conducted an audit of a covered entity (pursuant to section 
340B(a)(5)(C) of the Act), that a covered entity may have violated the 
prohibitions against duplicate discounts or diversion.
    Administrative Dispute Resolution Panel (340B ADR Panel) means a 
decision-making body within the Department that, acting on an express, 
written delegation of authority from the Secretary of HHS, reviews and 
makes a precedential and binding decision for a claim brought under the 
ADR Process.
    Average Manufacturer Price (AMP) has the meaning set forth in 
section 1927(k)(1) of the Social Security Act, as implemented in 42 CFR 
447.504.
    Ceiling price means the maximum statutory price established under 
section 340B(a)(1) of the PHSA and this section.
    Claim means a written allegation filed by or on behalf of a covered 
entity or by a manufacturer for resolution under the ADR Process.
    CMS is the Centers for Medicare & Medicaid Services.
    Consolidated claim means a claim resulting from combining multiple 
manufacturers' claims against the same covered entity;
    Covered entity means an entity that is listed within section 
340B(a)(4) of the PHSA, meets the requirements under section 340B(a)(5) 
of the PHSA, and is registered and listed in the 340B database.
    Covered outpatient drug has the meaning set forth in section 1927(k) 
of the Social Security Act.
    Joint claim means a claim resulting from combining multiple covered 
entities' (or their membership organizations' or associations') claims 
against the same manufacturer for the same drug or drugs.
    Manufacturer has the meaning set forth in section 1927(k) of the 
Social

[[Page 133]]

Security Act, as implemented in 42 CFR 447.502.
    National Drug Code (NDC) has the meaning set forth in 42 CFR 
447.502.
    Pharmaceutical Pricing Agreement (PPA) means an agreement described 
in section 340B(a)(1) of the PHSA.
    Quarter refers to a calendar quarter unless otherwise specified.
    Secretary means the Secretary of the Department of Health and Human 
Services and any other officer of employee of the Department of Health 
and Human Services to whom the authority involved has been delegated.

[82 FR 1229, Jan. 5, 2017, as amended at 85 FR 80644, Dec. 14, 2020]



                      Subpart B_340B Ceiling Price



Sec.  10.10  Ceiling price for a covered outpatient drug.

    A manufacturer is required to calculate the 340B ceiling price for 
each covered outpatient drug, by National Drug Code (NDC) on a quarterly 
basis.
    (a) Calculation of 340B ceiling price. The 340B ceiling price for a 
covered outpatient drug is equal to the Average Manufacturer Price (AMP) 
from the preceding calendar quarter for the smallest unit of measure 
minus the Unit Rebate Amount (URA) and will be calculated using six 
decimal places. HRSA will publish the 340B ceiling price rounded to two 
decimal places.
    (b) Exception. When the ceiling price calculation in paragraph (a) 
of this section results in an amount less than $0.01 the ceiling price 
will be $0.01.
    (c) New drug price estimation. A manufacturer must estimate the 340B 
ceiling price for a new covered outpatient drug as of the date the drug 
is first available for sale. That estimation should be calculated as 
wholesale acquisition cost minus the appropriate rebate percentage until 
an AMP is available, which should occur no later than the 4th quarter 
that the drug is available for sale. Manufacturers are required to 
calculate the actual 340B ceiling price as described in paragraph (a) of 
this section and offer to refund or credit the covered entity the 
difference between the estimated 340B ceiling price and the actual 340B 
ceiling price within 120 days of the determination by the manufacturer 
that an overcharge occurred.



Sec.  10.11  Manufacturer civil monetary penalties.

    (a) General. Any manufacturer with a pharmaceutical pricing 
agreement that knowingly and intentionally charges a covered entity more 
than the ceiling price, as defined in Sec.  10.10, for a covered 
outpatient drug, may be subject to a civil monetary penalty not to 
exceed $5,000 for each instance of overcharging, as defined in paragraph 
(b) of this section. This penalty will be imposed pursuant to the 
applicable procedures at 42 CFR part 1003. Any civil monetary penalty 
assessed will be in addition to repayment for an instance of 
overcharging as required by section 340B(d)(1)(B)(ii) of the PHSA.
    (b) Instance of overcharging. An instance of overcharging is any 
order for a covered outpatient drug, by NDC, which results in a covered 
entity paying more than the ceiling price, as defined in Sec.  10.10, 
for that covered outpatient drug.
    (1) Each order for an NDC will constitute a single instance, 
regardless of the number of units of each NDC ordered. This includes any 
order placed directly with a manufacturer or through a wholesaler, 
authorized distributor, or agent.
    (2) Manufacturers have an obligation to ensure that the 340B 
discount is provided through distribution arrangements made by the 
manufacturer.
    (3) An instance of overcharging is considered at the NDC level and 
may not be offset by other discounts provided on any other NDC or 
discounts provided on the same NDC on other transactions, orders, or 
purchases.
    (4) An instance of overcharging may occur at the time of initial 
purchase or when subsequent ceiling price recalculations due to pricing 
data submitted to CMS or new drug price estimations as defined in Sec.  
10.10(c) result in a covered entity paying more than the ceiling price 
due to failure or refusal to refund or credit a covered entity.



               Subpart C_Administrative Dispute Resolution

    Source: 85 FR 80644, Dec. 14, 2020, unless otherwise noted.

[[Page 134]]



Sec.  10.20  Administrative Dispute Resolution Panel.

    The Secretary shall establish a 340B Administrative Dispute 
Resolution Board (Board) consisting of at least six members appointed by 
the Secretary with equal numbers from the Health Resources and Service 
Administration (HRSA), the Centers for Medicare & Medicaid Services 
(CMS), and the Office of the General Counsel (OGC) from which 
Administrative Dispute Resolution Panels (340B ADR Panel) of three 
members shall be selected by the HRSA Administrator (to review claims 
and, pursuant to authority expressly delegated through this rule by the 
Secretary, and to make precedential and binding final agency decisions 
regarding claims filed by covered entities and manufacturers). There 
shall also be one ex-officio, non-voting member chosen from the staff of 
the HRSA Office of Pharmacy Affairs (OPA). HRSA and CMS Board members 
shall have relevant expertise and experience in drug pricing or drug 
distribution. OGC Board members shall have expertise and experience in 
handling complex litigation.
    (a) Members of the 340B ADR Panel. (1) For each case, the HRSA 
Administrator shall:
    (i) Select from the Board three voting members, one from each of the 
three HHS operating or staff divisions involved (i.e., CMS, HRSA, OGC) 
to form a 340B ADR Panel.
    (ii) Remove an individual from a 340B ADR Panel for cause; and
    (iii) Appoint replacement members from the Board should an 
individual be unable to complete his or her duties on a 340B ADR Panel.
    (2) No member of a 340B ADR Panel may have a conflict of interest, 
as defined in paragraph (b) of this section.
    (b) Conflicts of interest. All individuals who serve on a 340B ADR 
Panel will be screened for conflicts of interest prior to reviewing a 
claim. Conflicts of interest may include:
    (1) Financial interest in a party involved, a subsidiary of a party 
involved, or in the claim before a 340B ADR Panel;
    (2) Family or close relation to a party involved; and
    (3) Current or former business or employment relation to a party.
    (c) Duties of the 340B ADR Panel. The 340B ADR Panel will adjudicate 
each claim using the procedures described Sec. Sec.  10.21, 10.22, 
10.23, and 10.24.
    (1) Review and evaluate documents and other information submitted by 
covered entities and manufacturers;
    (2) Request additional information or clarification of an issue from 
any or all parties to make a final agency decision;
    (3) When necessary, evaluate a claim in a separate session from the 
parties involved;
    (4) Consult with OPA and the parties, as appropriate and necessary, 
regarding any inquiries or concerns while reviewing a claim; and
    (5) Issue a final agency decision on each claim and submit the 
written decision to the parties, and to HRSA for appropriate action.



Sec.  10.21  Claims.

    (a) Initiating an action. Any covered entity or manufacturer may 
initiate an action for monetary damages or equitable relief against a 
manufacturer or covered entity, as the case may be, by filing a written 
petition for relief with HRSA and mailing a copy of the petition with 
any attachments to the General Counsel or other senior official of the 
opposing party at its principal place of business by certified mail, 
return receipt requested, within three days of filing the claim. The 
petition should satisfy the pleading requirements of Rules 8, 10, and 11 
of the Federal Rules of Civil Procedure, including setting forth the 
factual basis for invoking the 340B ADR Panel's jurisdiction. A claim 
must include all of the requirements in paragraph (d) of this section. 
Additional information to substantiate a claim may be submitted.
    (b) 340B ADR Panel's jurisdiction. The 340B ADR Panel shall have 
jurisdiction to entertain any petition where the damages sought exceed 
$25,000 or where the equitable relief sought will likely have a value of 
more than $25,000 during the twelve-month period after the 340B ADR 
Panel's final agency decision, provided the petition asserts claims of 
the type set forth below.

[[Page 135]]

    (c) Claims permitted. The ADR process is limited to the following:
    (1) Claims by a covered entity that it has been overcharged by a 
manufacturer for a covered outpatient drug, including claims that a 
manufacturer has limited the covered entity's ability to purchase 
covered outpatient drugs at or below the 340B ceiling price; and
    (2) Claims by a manufacturer, after it has conducted an audit of a 
covered entity pursuant to section 340B(a)(5)(C) of the PHSA, that the 
covered entity has violated section 340B(a)(5)(A) of the PHSA regarding 
the duplicate discount prohibition, or section 340B(a)(5)(B) of the PHSA 
regarding the diversion prohibition, including claims that an individual 
does not qualify as a patient for 340B Program purposes and claims that 
a covered entity is not eligible for the 340B Program.
    (d) Limitation of actions. (1) A covered entity or manufacturer must 
file a written claim for administrative dispute resolution with HRSA 
within 3 years of the date of the alleged violation. Any file, document, 
or record associated with the claim that is the subject of the ADR 
process must be maintained by the covered entity and manufacturer until 
the final agency decision is issued by the 340B ADR Panel.
    (2) Notwithstanding Rules 8 and 10 of the Federal Rules of Civil 
Procedure, a covered entity filing a claim described in paragraph (c)(1) 
of this section must provide documents sufficient to demonstrate its 
claim that it has been overcharged by a manufacturer, along with any 
such other documentation as may be requested by the 340B ADR Panel.
    (3) Notwithstanding Rules 8 and 10 of the Federal Rules of Civil 
Procedure, a manufacturer filing a claim under paragraph (c)(2) of this 
section must provide documents sufficient to demonstrate its claim that 
a covered entity has violated the prohibition on diversion or duplicate 
discount, along with any such documentation as may be requested by the 
340B ADR Panel.
    (e) Combining claims. (1) Two or more covered entities may jointly 
file claims of overcharges by the same manufacturer for the same drug or 
drugs if each covered entity that could file a claim against the 
manufacturer consents to the jointly filed claim, including submission 
of the required documentation, described in paragraph (d) of this 
section.
    (2) An association or organization may file claims of overcharges by 
the same manufacturer for the same drug or drugs on behalf of multiple 
covered entities if each covered entity represented could file a claim 
against the manufacturer, is a member of the association or 
organization, meets the requirements described in paragraph (d) of this 
section, including submission of the required documentation, and each 
covered entity has agreed to representation by the association or 
organization on its behalf.
    (3) A manufacturer or manufacturers may request to consolidate 
claims brought by more than one manufacturer against the same covered 
entity if each manufacturer could individually file a claim against the 
covered entity, consents to the filing of the consolidated claim, meets 
the requirements described in paragraph (d) of this section for that 
claim, and the 340B ADR Panel determines that such consolidation is 
appropriate and consistent with the goals of fairness and economy of 
sources. The 340B ADR Panel will not permit consolidated claims filed on 
behalf of manufacturers by associations or organizations representing 
their interests.
    (4) Joinder, consolidation, and other third-party practice not 
referenced in this paragraph (e) shall be governed by the Federal Rules 
of Civil Procedure, as relevant, unless the parties and 340B ADR Panel 
agree otherwise.
    (f) Responding to a submitted claim. Upon receipt of service of 
petition, the respondent must file with the 340B ADR Panel a written 
response to the Petition as set forth in Rule 12 or 56. The 340B ADR 
Panel may issue additional instructions as may be necessary or desirable 
governing the conduct of ADR proceedings, including instructions 
pertaining to deadlines for submission of additional information. If an 
opposing party does not respond to the petition, the 340B ADR Panel may 
enter a final agency decision by default in favor of the Petitioner. In 
a proceeding for damages, the Petitioner must still introduce evidence 
sufficient

[[Page 136]]

to support its claim for damages even though the merits have been 
resolved through default.



Sec.  10.22  Information requests.

    (a) Discovery. The 340B ADR Panel may permit a covered entity 
limited discovery to obtain such information and documents as may be 
relevant to demonstrate the merits of a claim. Such discovery shall be 
governed, to the extent applicable, by the Federal Rules of Civil 
Procedure.
    (b) 340B ADR Panel information requests. Taking into account any 
party's request for further information, the 340B ADR Panel may request 
additional information from either party.
    (c) Failure to respond to information requests. If the 340B ADR 
Panel finds that a party has failed to respond or fully respond to an 
information request, the 340B ADR Panel make take the following actions, 
including:
    (1) Holding facts to have been established in the proceeding;
    (2) Precluding a party from presenting or contesting a particular 
issue;
    (3) Excluding evidence; or
    (4) Judgment in the proceeding or dismissal of proceeding.



Sec.  10.23  Conduct of the ADR proceeding.

    (a) The 340B ADR Panel will determine, in its own discretion, the 
most efficient and practical form of the ADR proceeding. Unless the 
matter is resolved through a motion to dismiss or summary judgment under 
Rule 56, the 340B ADR Panel shall conduct an evidentiary hearing when 
there are material facts in dispute. The ADR proceeding may be conducted 
by video conference, in-person, or through other means.
    (b) The 340B ADR Panel will determine the proper course of conduct 
in an ADR proceeding. Unless the parties agree otherwise and the 340B 
ADR Panel concurs, the Federal Rules of Civil Procedure, to the extent 
applicable, shall govern the proceedings.
    (c) Unless the parties agree otherwise and the 340B ADR Panel 
concurs, the Federal Rules of Evidence shall apply to the proceedings.
    (d) The 340B ADR Panel may issue additional instructions or guidance 
as may be necessary or desirable governing the conduct of ADR 
proceedings.



Sec.  10.24  Final agency decision.

    (a) The 340B ADR Panel will review the evidence submitted by the 
parties and determine if the preponderance of the evidence supports the 
conclusion that a violation as described in Sec.  10.21(c)(1) or (2) has 
occurred.
    (b) The 340B ADR Panel will prepare an agency decision based on its 
review and evaluation of the evidence submitted by the parties, 
including documents provided as required in Sec.  10.21(d), information 
requests in support of a claim, and responses to a claim.
    (c) The agency decision will represent the decision of a majority of 
the 340B ADR Panel's findings regarding the claim and discuss the 
findings supporting the decision.
    (d) The agency decision constitutes a final agency decision that is 
precedential and binding on the parties involved unless invalidated by 
an order of a court of competent jurisdiction.
    (e) The 340B ADR Panel will submit the final agency decision to all 
parties, and to HRSA for appropriate action regarding refunds, 
penalties, removal, or referral to appropriate Federal authorities.



PART 11_CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION--
Table of Contents



                      Subpart A_General Provisions

Sec.
11.2 What is the purpose of this part?
11.4 To whom does this part apply?
11.6 What are the requirements for the submission of truthful 
          information?
11.8 In what format must clinical trial information be submitted?
11.10 What definitions apply to this part?

                         Subpart B_Registration

11.20 Who must submit clinical trial registration information?
11.22 Which applicable clinical trials must be registered?
11.24 When must clinical trial registration information be submitted?

[[Page 137]]

11.28 What constitutes clinical trial registration information?
11.35 By when will the NIH Director post clinical trial registration 
          information submitted under Sec.  11.28?

                Subpart C_Results Information Submission

11.40 Who must submit clinical trial results information?
11.42 For which applicable clinical trials must clinical trial results 
          information be submitted?
11.44 When must clinical trial results information be submitted for 
          applicable clinical trials subject to Sec.  11.42?
11.48 What constitutes clinical trial results information?
11.52 By when will the NIH Director post submitted clinical trial 
          results information?
11.54 What are the procedures for requesting a waiver of the 
          requirements for clinical trial results information 
          submission?

      Subpart D_Additional Submission of Clinical Trial Information

11.60 What requirements apply to the voluntary submission of clinical 
          trial information for clinical trials of FDA-regulated drug 
          products (including biological products) and device products?
11.62 What requirements apply to applicable clinical trials for which 
          submission of clinical trial information has been determined 
          by the Director to be necessary to protect the public health?
11.64 When must clinical trial information submitted to 
          ClinicalTrials.gov be updated or corrected?

        Subpart E_Potential Legal Consequences of Non-Compliance

11.66 What are potential legal consequences of not complying with the 
          requirements of this part?

    Authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 
U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b).

    Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  11.2  What is the purpose of this part?

    This part implements section 402(j) of the Public Health Service Act 
(42 U.S.C. 282(j)) by providing requirements and procedures for the 
submission of clinical trial information for certain applicable clinical 
trials and other clinical trials to the Director of the National 
Institutes of Health (NIH) to be made publicly available via 
ClinicalTrials.gov, the Internet-accessible clinical trial registry and 
results data bank established by the National Library of Medicine (NLM) 
at https://clinicaltrials.gov.



Sec.  11.4  To whom does this part apply?

    (a) This part applies to the responsible party for an applicable 
clinical trial that is required to be registered under Sec.  11.22, a 
clinical trial for which clinical trial registration information or 
clinical trial results information is submitted voluntarily in 
accordance with Sec.  11.60, or an applicable clinical trial that is 
required by the Director to have clinical trial information submitted to 
protect the public health under Sec.  11.62.
    (b) The responsible party must communicate the identity and contact 
information of the responsible party to the Director by submitting the 
Responsible Party, by Official Title and Responsible Party Contact 
Information data elements under Sec.  11.28(a)(2)(iii)(B) and 
(a)(2)(iv)(F) as part of the clinical trial information submitted at the 
time of registration. Changes must be communicated to the Director by 
updating information in accordance with Sec.  11.64(a).
    (c) Determination of responsible party. For purposes of this part, 
each applicable clinical trial or other clinical trial must have one 
responsible party. With respect to a clinical trial, the sponsor of the 
clinical trial will be considered the responsible party unless and until 
a principal investigator has been designated the responsible party, in 
accordance with paragraph (c)(2) of this section. With respect to a 
pediatric postmarket surveillance of a device product that is not a 
clinical trial, the responsible party is the entity that the U.S. Food 
and Drug Adminstration (FDA), under section 522 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 3601), orders to conduct the pediatric 
postmarket surveillance of a device product.
    (1) Determination of sponsor. For purposes of this part, each 
applicable clinical trial or other clinical trial must have one sponsor.

[[Page 138]]

    (i) When an applicable clinical trial or other clinical trial is 
conducted under an investigational new drug application (IND) or 
investigational device exemption (IDE), the IND or IDE holder will be 
considered the sponsor.
    (ii) When an applicable clinical trial or other clinical trial is 
not conducted under an IND or IDE, the single person or entity who 
initiates the trial, by preparing and/or planning the trial, and who has 
authority and control over the trial, will be considered the sponsor.
    (2) Designation of a principal investigator as the responsible 
party.
    (i) The sponsor may designate a principal investigator as the 
responsible party if such principal investigator meets all of the 
following requirements:
    (A) Is responsible for conducting the trial;
    (B) Has access to and control over the data from the trial;
    (C) Has the right to publish the results of the trial; and
    (D) Has the ability to meet all of the requirements for submitting 
and updating clinical trial information as specified in this part.
    (ii) With regard to an applicable clinical trial or other clinical 
trial, a designation by the sponsor under paragraph (c)(2)(i) of this 
section shall consist of the sponsor obtaining from the principal 
investigator an acknowledgment of the principal investigator's 
responsibilities under this part as responsible party, and the principal 
investigator acknowledging the designation as responsible party to the 
Director in the format specified at https://prsinfo.clinicaltrials.gov.
    (3) Withdrawal of the designation of a principal investigator as the 
responsible party.
    In the event that a principal investigator who has been designated 
the responsible party no longer meets or is no longer able to meet all 
the requirements for being so designated under paragraph (c)(2)(i) of 
this section, the sponsor must withdraw the designation in the format 
specified at https://prsinfo.clinicaltrials.gov, at which time the 
sponsor will be considered the responsible party unless and until the 
sponsor makes a new designation in accordance with paragraph (c)(2) of 
this section.



Sec.  11.6  What are the requirements for the submission 
of truthful information?

    The clinical trial information submitted by a responsible party 
under this part shall not be false or misleading in any particular. A 
responsible party who submits false and/or misleading information is 
subject to civil monetary penalties and/or other civil or criminal 
remedies available under U.S. law.



Sec.  11.8  In what format must clinical trial information be submitted?

    Information submitted under this part must be submitted 
electronically to ClinicalTrials.gov, in the format specified at https:/
/prsinfo.clinicaltrials.gov.



Sec.  11.10  What definitions apply to this part?

    (a) The following definitions apply to terms used in this part:
    Adverse event means any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign (for example, abnormal 
physical exam or laboratory finding), symptom, or disease, temporally 
associated with the subject's participation in the research, whether or 
not considered related to the subject's participation in the research. 
See also the definition of ``serious adverse event.''
    Applicable clinical trial means an applicable device clinical trial 
or an applicable drug clinical trial. Expanded access use under section 
561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) is 
not an applicable clinical trial.
    Applicable device clinical trial means:
    (1) A prospective clinical study of health outcomes comparing an 
intervention with a device product subject to section 510(k), 515, or 
520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 
U.S.C. 360e, 21 U.S.C. 360j(m)) against a control in human subjects 
(other than a small clinical trial to determine the feasibility of a 
device product, or a clinical trial to test prototype device products 
where the primary outcome measure

[[Page 139]]

relates to feasibility and not to health outcomes);
    (2) A pediatric postmarket surveillance of a device product as 
required under section 522 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 3601); or
    (3) A clinical trial of a combination product with a device primary 
mode of action under 21 CFR part 3, provided that it meets all other 
criteria of the definition under this part.
    Applicable drug clinical trial means a controlled clinical 
investigation, other than a phase 1 clinical investigation, of a drug 
product subject to section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) or a biological product subject to section 351 of 
the Public Health Service Act (42 U.S.C. 262), where ``clinical 
investigation'' has the meaning given in 21 CFR 312.3 and ``phase 1'' 
has the meaning given in 21 CFR 312.21. A clinical trial of a 
combination product with a drug primary mode of action under 21 CFR part 
3 is also an applicable drug clinical trial, provided that it meets all 
other criteria of the definition under this part.
    Approved drug means a drug product that is approved for any use 
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) or a biological product licensed for any use under section 351 of 
the Public Health Service Act (42 U.S.C. 262).
    Approved or cleared device means a device product that is cleared 
for any use under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C 360(k)) or approved for any use under sections 515 or 
520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e, 
360j(m)).
    Arm means a pre-specified group or subgroup of human subject(s) in a 
clinical trial assigned to receive specific intervention(s) (or no 
intervention) according to a protocol.
    Clinical study means research according to a protocol involving one 
or more human subjects to evaluate biomedical or health-related 
outcomes, including interventional studies and observational studies.
    Clinical trial means a clinical investigation or a clinical study in 
which human subject(s) are prospectively assigned, according to a 
protocol, to one or more interventions (or no intervention) to evaluate 
the effect(s) of the intervention(s) on biomedical or health-related 
outcomes.
    Clinical trial information means the data elements, including 
clinical trial registration information and clinical trial results 
information, that the responsible party is required to submit to 
ClinicalTrials.gov, as specified in section 402(j) of the Public Health 
Service Act (42 U.S.C. 282(j)) and this part.
    Clinical trial registration information means the data elements that 
the responsible party is required to submit to ClinicalTrials.gov, as 
specified in section 402(j)(2)(A)(ii) of the Public Health Service Act 
(42 U.S.C. 282(j)(2)(A)(ii)) or Sec.  11.28, as applicable.
    Clinical trial results information means the data elements that the 
responsible party is required to submit to ClinicalTrials.gov, as 
specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health 
Service Act (42 U.S.C. 282(j)(3)(C) and (I)) or Sec.  11.48, as 
applicable. If a responsible party submits clinical trial results 
information voluntarily for a clinical trial, clinical trial results 
information also means Sec.  11.60(b)(2)(i)(B) or Sec.  
11.60(c)(2)(i)(B), as applicable.
    Comparison group means a grouping of human subjects in a clinical 
trial that is or may be used in analyzing the results data collected 
during the clinical trial.
    Completion date means, for a clinical trial, including an applicable 
clinical trial, the date that the final subject was examined or received 
an intervention for the purposes of final collection of data for the 
primary outcome, whether the clinical trial concluded according to the 
pre-specified protocol or was terminated. In the case of clinical trials 
with more than one primary outcome measure with different completion 
dates, this term refers to the date on which data collection is 
completed for all of the primary outcomes. For a pediatric postmarket 
surveillance of a device product that is not a clinical trial, 
completion date means the date on which the final report of the 
pediatric postmarket surveillance of the device product is submitted to 
FDA. For purposes of this part, completion

[[Page 140]]

date is referred to as ``primary completion date.''
    Control or controlled means, with respect to a clinical trial, that 
data collected on human subjects in the clinical trial will be compared 
to concurrently collected data or to non-concurrently collected data 
(e.g., historical controls, including a human subject's own baseline 
data), as reflected in the pre-specified primary or secondary outcome 
measures. For purposes of this part, all clinical trials with one or 
more arms and pre-specified outcome measure(s) are controlled.
    Device means a device as defined in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
    Director means the NIH Director or any official of NIH to whom the 
NIH Director delegates authorities granted in section 402(j) of the 
Public Health Service Act (42 U.S.C. 282(j)).
    Drug means a drug as defined in section 201(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(g)) or a biological product as 
defined in section 351 of the Public Health Service Act (42 U.S.C. 262).
    Enroll or enrolled means a human subject's, or their legally 
authorized representative's, agreement to participate in a clinical 
trial following completion of the informed consent process, as required 
in 21 CFR part 50 and/or 45 CFR part 46, as applicable. For the purposes 
of this part, potential subjects who are screened for the purpose of 
determining eligibility for a trial, but do not participate in the 
trial, are not considered enrolled, unless otherwise specified by the 
protocol.
    Human subjects protection review board means an institutional review 
board (IRB) as defined in 21 CFR 50.3 or 45 CFR 46.102, as applicable, 
that is responsible for assuring the protection of the rights, safety, 
and well-being of human subjects involved in a clinical trial and is 
adequately constituted to provide assurance of that protection. An IRB 
may also be known as an ``independent ethics committee.''
    Interventional means, with respect to a clinical study or a clinical 
investigation, that participants are assigned prospectively to an 
intervention or interventions according to a protocol to evaluate the 
effect of the intervention(s) on biomedical or other health-related 
outcomes.
    Investigational Device Exemption (IDE) has the meaning given in 21 
CFR part 812.
    Investigational New Drug Application (IND) has the meaning given in 
21 CFR 312.3.
    NCT number means the unique identification code assigned to each 
record in ClinicalTrials.gov, including a record for an applicable 
clinical trial, a clinical trial, or an expanded access program.
    Ongoing means, with respect to a clinical trial of a drug product 
(including a biological product) or a device product and to a date, that 
one or more human subjects is enrolled in the clinical trial, and the 
date is before the primary completion date of the clinical trial. With 
respect to a pediatric postmarket surveillance of a device product, 
ongoing means a date between the date on which FDA approves the plan for 
conducting the surveillance and the date on which the final report is 
submitted to FDA.
    Outcome measure means a pre-specified measurement that will be used 
to determine the effect of an experimental variable on the human 
subject(s) in a clinical trial. See also the definitions of ``primary 
outcome measure'' and ``secondary outcome measure.''
    Pediatric postmarket surveillance of a device product means the 
active, systematic, scientifically valid collection, analysis, and 
interpretation of data or other information conducted under section 522 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a 
marketed device product that is expected to have significant use in 
patients who are 21 years of age or younger at the time of diagnosis or 
treatment. A pediatric postmarket surveillance of a device product may 
be, but is not always, a clinical trial.
    Primary completion date means, for purposes of this part, 
``completion date.'' See the definition of ``completion date.''
    Primary outcome measure means the outcome measure(s) of greatest 
importance specified in the protocol, usually

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the one(s) used in the power calculation. Most clinical trials have one 
primary outcome measure, but a clinical trial may have more than one. 
For purposes of this part, ``primary outcome'' has the same meaning as 
primary outcome measure.
    Principal investigator means the individual who is responsible for 
the overall scientific and technical direction of the study.
    Protocol means the written description of the clinical trial, 
including objective(s), design, and methods. It may also include 
relevant scientific background and statistical considerations.
    Responsible party means, with respect to a clinical trial, the 
sponsor of the clinical trial, as defined in 21 CFR 50.3; or the 
principal investigator of such clinical trial if so designated by a 
sponsor, grantee, contractor, or awardee, so long as the principal 
investigator is responsible for conducting the trial, has access to and 
control over the data from the clinical trial, has the right to publish 
the results of the trial, and has the ability to meet all of the 
requirements under this part for the submission of clinical trial 
information. For a pediatric postmarket surveillance of a device product 
that is not a clinical trial, the responsible party is the entity who 
FDA orders to conduct the pediatric postmarket surveillance of the 
device product.
    Secondary outcome measure means an outcome measure that is of lesser 
importance than a primary outcome measure, but is part of a pre-
specified analysis plan for evaluating the effects of the intervention 
or interventions under investigation in a clinical trial and is not 
specified as an exploratory or other measure. A clinical trial may have 
more than one secondary outcome measure. For purposes of this part, 
``secondary outcome'' has the same meaning as secondary outcome measure.
    Secretary means the Secretary of Health and Human Services or any 
other official(s) to whom the Secretary delegates the authority 
contained in section 402(j) of the Public Health Service Act (42 U.S.C. 
282(j)).
    Serious adverse event means an adverse event that results in any of 
the following outcomes: Death, a life-threatening adverse event as 
defined in 21 CFR 312.32, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions, 
or a congenital anomaly/birth defect. Important medical events that may 
not result in death, be life-threatening, or require hospitalization may 
be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the human subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of a substance use disorder.
    Sponsor means either a ``sponsor'' or ``sponsor-investigator,'' as 
each is defined in 21 CFR 50.3.
    Study completion date means, for a clinical trial, the date the 
final subject was examined or received an intervention for purposes of 
final collection of data for the primary and secondary outcome measures 
and adverse events (e.g., last subject's last visit), whether the 
clinical trial concluded according to the pre-specified protocol or was 
terminated.
    U.S. FDA-regulated device product means, for purposes of this part, 
a device product subject to section 510(k), 515, 520(m), or 522 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 
21 U.S.C. 360j(m), 21 U.S.C. 360l).
    U.S. FDA-regulated drug product means, for purposes of this part, a 
drug product subject to section 505 of the Federal Food, Drug, and 
Cosmetic Act or a biological product subject to section 351 of the 
Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
    (b) The following definitions apply to data elements of clinical 
trial information referenced in this part, unless otherwise specified:
    (1) Brief Title means a short title of the clinical trial written in 
language intended for the lay public, including any acronym or 
abbreviation used publicly to identify the clinical trial.

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    (2) Official Title means the title of the clinical trial, 
corresponding to the title of the protocol.
    (3) Brief Summary means a short description of the clinical trial, 
including a brief statement of the clinical trial's hypothesis, written 
in language intended for the lay public.
    (4) Primary Purpose means the main objective of the intervention(s) 
being evaluated by the clinical trial.
    (5) Study Design means a description of the manner in which the 
clinical trial will be conducted, including the following information:
    (i) Interventional Study Model. The strategy for assigning 
interventions to human subjects.
    (ii) Number of Arms. The number of arms in the clinical trial. For a 
trial with multiple periods or phases that have different numbers of 
arms, it means the maximum number of arms during all periods or phases.
    (iii) Arm Information. A description of each arm of the clinical 
trial that indicates its role in the clinical trial, provides an 
informative title, and, if necessary, additional descriptive information 
(including which interventions are administered in each arm) to 
differentiate each arm from other arms in the clinical trial.
    (iv) Allocation. The method by which human subjects are assigned to 
arms in a clinical trial.
    (v) Masking. The party or parties, if any, involved in the clinical 
trial who are prevented from having knowledge of the interventions 
assigned to individual human subjects.
    (6) Study Phase means, for a clinical trial of a drug product 
(including a biological product), the numerical phase of such clinical 
trial, consistent with terminology in 21 CFR 312.21, such as phase 2 or 
phase 3, and in 21 CFR 312.85 for phase 4 studies.
    (7) Study Type means the nature of the investigation or 
investigational use for which clinical trial information is being 
submitted, e.g., interventional, observational.
    (8) Pediatric Postmarket Surveillance of a Device Product means a 
clinical trial or study that includes a U.S. FDA-regulated device 
product as an intervention and is a pediatric postmarket surveillance of 
a device product ordered under section 522 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 369l).
    (9) Primary Disease or Condition Being Studied in the Trial, or the 
Focus of the Study means the name(s) of the disease(s) or condition(s) 
studied in the clinical trial, or the focus of the clinical trial. Use, 
if available, appropriate descriptors from NLM's Medical Subject 
Headings (MeSH)-controlled vocabulary thesaurus or terms from another 
vocabulary, such as the Systematized Nomenclature of Medicine--Clinical 
Terms (SNOMED CT), that has been mapped to MeSH within the Unified 
Medical Language System (UMLS) Metathesaurus.
    (10) Intervention Name(s) means a brief descriptive name used to 
refer to the intervention(s) studied in each arm of the clinical trial. 
A non-proprietary name of the intervention must be used, if available. 
If a non-proprietary name is not available, a brief descriptive name or 
identifier must be used.
    (11) Other Intervention Name(s) means other current and former 
name(s) or alias(es), if any, different from the Intervention Name(s), 
that the sponsor has used publicly to identify the intervention(s), 
including, but not limited to, past or present names such as brand 
name(s), or serial numbers.
    (12) Intervention Description means details that can be made public 
about the intervention, other than the Intervention Name(s) and Other 
Intervention Name(s), sufficient to distinguish the intervention from 
other, similar interventions studied in the same or another clinical 
trial. For example, interventions involving drugs may include dosage 
form, dosage, frequency, and duration.
    (13) Intervention Type means, for each intervention studied in the 
clinical trial, the general type of intervention, e.g., drug, 
biological/vaccine, or, device.
    (14) Device Product Not Approved or Cleared by U.S. FDA means that 
at least one device product studied in the clinical trial has not been 
previously approved or cleared by FDA for one or more uses.
    (15) Product Manufactured in and Exported from the U.S. means that 
any drug product (including a biological product) or device product 
studied in

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the clinical trial is manufactured in the United States or one of its 
territories and exported for study in a clinical trial in another 
country.
    (16) Study Start Date means the estimated date on which the clinical 
trial will be open for recruitment of human subjects, or the actual date 
on which the first human subject was enrolled.
    (17) Primary Completion Date means the estimated or actual primary 
completion date. If an estimated primary completion date is used, the 
responsible party must update the Primary Completion Date data element 
once the clinical trial has reached the primary completion date to 
reflect the actual primary completion date.
    (18) Enrollment means the estimated total number of human subjects 
to be enrolled (target number) or the actual total number of human 
subjects that are enrolled in the clinical trial. Once the trial has 
reached the primary completion date, the responsible party must update 
the Enrollment data element to reflect the actual number of human 
subjects enrolled in the clinical trial.
    (19) Primary Outcome Measure Information means a description of each 
primary outcome measure, to include the following information:
    (i) Name of the specific primary outcome measure;
    (ii) Description of the metric used to characterize the specific 
primary outcome measure; and
    (iii) Time point(s) at which the measurement is assessed for the 
specific metric used.
    (20) Secondary Outcome Measure Information means a description of 
each secondary outcome measure, to include the following information:
    (i) Name of the specific secondary outcome measure;
    (ii) Description of the metric used to characterize the specific 
secondary outcome measure; and
    (iii) Time point(s) at which the measurement is assessed for the 
specific metric used.
    (21) Eligibility Criteria means a limited list of criteria for 
selection of human subjects to participate in the clinical trial, 
provided in terms of inclusion and exclusion criteria and suitable for 
assisting potential human subjects in identifying clinical trials of 
interest.
    (22) Sex/Gender means the sex and, if applicable, gender of the 
human subjects who may participate in the clinical trial.
    (23) Age Limits means the minimum and maximum age of human subjects 
who may participate in the clinical trial, provided in relevant units of 
time.
    (24) Accepts Healthy Volunteers means that human subjects who do not 
have a disease or condition, or related conditions or symptoms, under 
study in the clinical trial are permitted to participate in the clinical 
trial.
    (25) Overall Recruitment Status means the recruitment status for the 
clinical trial as a whole, based on the status of the individual sites. 
If at least one facility in a multi-site clinical trial has an 
individual site status of ``recruiting,'' then the overall recruitment 
status for the trial must be ``recruiting.''
    (26) Why Study Stopped means, for a clinical trial that is suspended 
or terminated or withdrawn prior to its planned completion as 
anticipated by the protocol, a brief explanation of the reason(s) why 
the clinical trial was stopped.
    (27) Individual Site Status means the recruitment status of each 
participating facility in a clinical trial.
    (28) Availability of Expanded Access means, for an applicable drug 
clinical trial of a drug product (including a biological product) that 
is not an approved drug product (including a biological product), and 
for which the responsible party is both the manufacturer of the drug 
product (including a biological product) and the sponsor of the 
applicable clinical trial:
    (i) An indication of whether there is expanded access to the 
investigational drug product (including a biological product) under 
section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb) for those individuals who do not qualify for enrollment in the 
applicable clinical trial, under one or more of the following types of 
expanded access programs: for individual patients, including for 
emergency use, as specified in 21 CFR 312.310; for intermediate-size 
patient populations, as specified in 21 CFR 312.315; or under a

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treatment IND or treatment protocol, as specified in 21 CFR 312.320; and
    (ii) If expanded access is available under section 561 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb), the NCT number 
of the expanded access record.
    (29) Name of the Sponsor means the name of the entity or individual 
who is the sponsor of the clinical trial, as defined in this part.
    (30) Responsible Party, by Official Title means an:
    (i) Indication of whether the responsible party is the sponsor of 
the clinical trial, as that term is defined in 21 CFR 50.3; the sponsor-
investigator, as that term is defined in 21 CFR 50.3; or a principal 
investigator designated pursuant to this part; and
    (ii) Either:
    (A) The official name of the entity, if the responsible party is an 
entity; or
    (B) The official title and primary organizational affiliation of the 
individual, if the responsible party is an individual.
    (31) Facility Information means, for each participating facility in 
a clinical trial, the following information:
    (i) Facility Name, meaning the full name of the organization where 
the clinical trial is being conducted;
    (ii) Facility Location, including city, state, country and zip code 
for U.S. locations (including territories of the United States) and city 
and country for locations in other countries; and
    (iii) Either:
    (A) For each facility participating in a clinical trial, Facility 
Contact, including the name or title, telephone number, and email 
address of a person to whom questions concerning the trial and 
enrollment at that site can be addressed; or
    (B) Central Contact Person, including the name or title, toll-free 
telephone number, and email address of a person to whom questions 
concerning enrollment at any location of the trial can be addressed.
    (32) Unique Protocol Identification Number means any unique 
identifier assigned to the protocol by the sponsor.
    (33) Secondary ID means:
    (i) Any identifier(s) other than the organization's unique protocol 
identifier or NCT number that is assigned to the clinical trial, 
including any unique clinical trial identifiers assigned by other 
publicly available clinical trial registries. If the clinical trial is 
funded in whole or in part by a U.S. Federal Government agency, the 
complete grant or contract number must be submitted as a Secondary ID.
    (ii) A description of the type of Secondary ID.
    (34) U.S. Food and Drug Administration IND or IDE Number means an 
indication of whether there is an IND or IDE for the clinical trial and, 
if so, each of the following elements:
    (i) Name or abbreviation of the FDA center with whom the IND or IDE 
is filed;
    (ii) IND or IDE number assigned by the FDA center; and
    (iii) For an IND, the IND serial number, as defined in 21 CFR 
312.23(e), if any, assigned to the clinical trial.
    (35) Human Subjects Protection Review Board Status means information 
to indicate whether a clinical trial has been reviewed and approved by a 
human subjects protection review board or whether such review is not 
required per applicable law (e.g., 21 CFR part 56, 45 CFR part 46, or 
other applicable regulation). Human Subjects Protection Review Board 
Status must be listed as ``approved'' if at least one human subjects 
protection review board has approved the clinical trial.
    (36) Record Verification Date means the date on which the 
responsible party last verified the clinical trial information in the 
entire ClinicalTrials.gov record for the clinical trial, even if no 
additional or updated information was submitted at that time.
    (37) Responsible Party Contact Information means administrative 
information to identify and allow communication with the responsible 
party by telephone, email, and regular mail or delivery service. 
Responsible Party Contact Information includes the name, official title, 
organizational affiliation, physical address, mailing address, phone 
number, and email address of the individual who is the responsible party 
or of a designated employee of the organization that is the responsible 
party.
    (38) Studies a U.S. FDA-regulated Device Product means that a 
clinical trial

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studies a device product subject to section 510(k), 515, or 520(m) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 
360e, 21 U.S.C. 360j(m)).
    (39) Studies a U.S. FDA-regulated Drug Product means a clinical 
trial studies a drug product (including a biological product) subject to 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
or section 351 of the Public Health Service Act (42 U.S.C. 262).
    (40) Post Prior to U.S. FDA Approval or Clearance means, for an 
applicable device clinical trial of a device product that has not been 
previously approved or cleared, the responsible party indicates to the 
Director that it is authorizing the Director, in accordance with Sec.  
11.35(b)(2)(ii), to publicly post its clinical trial registration 
information, which would otherwise be subject to delayed posting, as 
specified in Sec.  11.35(b)(2)(i), prior to the date of FDA approval or 
clearance of its device product.
    (41) Study Completion Date means the estimated or actual study 
completion date. Once the clinical trial has reached the study 
completion date, the responsible party must update the Study Completion 
Date data element to reflect the actual study completion date in 
accordance with Sec.  11.64(a)(1)(ii)(J) .



                         Subpart B_Registration



Sec.  11.20  Who must submit clinical trial registration information?

    The responsible party for an applicable clinical trial specified in 
Sec.  11.22 must submit clinical trial registration information for that 
clinical trial.



Sec.  11.22  Which applicable clinical trials must be registered?

    (a) General specification. (1) Any applicable clinical trial that is 
initiated after September 27, 2007, must be registered.
    (2) Any applicable clinical trial that is initiated on or before 
September 27, 2007, and is ongoing on December 26, 2007, must be 
registered.
    (3) Determining the date of initiation for an applicable clinical 
trial. An applicable clinical trial, other than a pediatric postmarket 
surveillance of a device product that is not a clinical trial, is 
considered to be initiated on the date on which the first human subject 
is enrolled. A pediatric postmarket surveillance of a device product 
that is not a clinical trial is considered to be initiated on the date 
on which FDA approves the plan for conducting the surveillance.
    (b) Determination of applicable clinical trial for a clinical trial 
or study initiated on or after January 18, 2017. A clinical trial or 
study that, at any point in time, meets the conditions listed in 
paragraph (b)(1) or (2) of this section will be considered to meet the 
definition of an applicable clinical trial.
    (1) Applicable device clinical trial. A clinical trial or study that 
meets the conditions listed in either paragraph (b)(1)(i) or (ii) of 
this section is an applicable device clinical trial:
    (i) The study is a pediatric postmarket surveillance of a device 
product as required by FDA under section 522 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 3601).
    (ii) The study is a clinical trial with one or more arms that meets 
all of the following criteria:
    (A) Study Type is interventional;
    (B) Primary Purpose of the clinical trial is other than a 
feasibility study;
    (C) The clinical trial Studies a U.S. FDA-regulated Device Product; 
and
    (D) One or more of the following applies:
    (1) At least one Facility Location is within the United States or 
one of its territories,
    (2) A device product under investigation is a Product Manufactured 
in and Exported from the U.S. or one of its territories for study in 
another country, or
    (3) The clinical trial has a U.S. Food and Drug Administration IDE 
Number.
    (2) Applicable drug clinical trial. A clinical trial with one or 
more arms that meets the following conditions is an applicable drug 
clinical trial:
    (i) Study Type is interventional;
    (ii) Study Phase is other than phase 1;
    (iii) The clinical trial Studies a U.S. FDA-regulated Drug Product; 
and
    (iv) One or more of the following applies:

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    (A) At least one Facility Location for the clinical trial is within 
the United States or one of its territories,
    (B) A drug product (including a biological product) under 
investigation is a Product Manufactured in and Exported from the U.S. or 
one of its territories for study in another country, or
    (C) The clinical trial has a U.S. Food and Drug Administration IND 
Number.



Sec.  11.24  When must clinical trial registration information be submitted?

    (a) General. Except as provided in paragraph (b) of this section, 
the responsible party for an applicable clinical trial for which 
submission of clinical trial registration information is required must 
submit the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) or Sec.  11.28(a), as applicable, not later than 
December 26, 2007, or 21 calendar days after the first human subject is 
enrolled, whichever date is later.
    (b) Exceptions:. (1) The responsible party for an applicable 
clinical trial that is a clinical trial and for which the submission of 
clinical trial registration information is required and that is not for 
a serious or life-threatening disease or condition must submit clinical 
trial registration information as specified in section 402(j)(2)(A)(ii) 
of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or Sec.  
11.28(a), as applicable, not later than September 27, 2008, or 21 
calendar days after the first human subject is enrolled, whichever date 
is later.
    (2) The responsible party for an applicable device clinical trial 
that is a pediatric postmarket surveillance of a device product and is 
not a clinical trial must submit clinical trial registration 
information, as specified in section 402(j)(2)(A)(ii) of the Public 
Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or Sec.  11.28(b), not 
later than December 26, 2007, or 21 calendar days after FDA approves the 
postmarket surveillance plan, whichever date is later.



Sec.  11.28  What constitutes clinical trial registration information?

    (a) For each applicable clinical trial that must be registered with 
ClinicalTrials.gov, other than a pediatric postmarket surveillance of a 
device product that is not a clinical trial, the responsible party must 
submit the following information:
    (1) For such applicable clinical trials that were initiated before 
January 18, 2017, the responsible party must submit the information 
specified in section 402(j)(2)(A)(ii) of the Public Health Service Act 
(42 U.S.C. 282(j)(2)(A)(ii)).
    (2) For such applicable clinical trials that are initiated on or 
after January 18, 2017, the responsible party must submit the data 
elements listed below:
    (i) Descriptive information:
    (A) Brief Title;
    (B) Official Title;
    (C) Brief Summary;
    (D) Primary Purpose;
    (E) Study Design;
    (F) Study Phase, for an applicable drug clinical trial;
    (G) Study Type;
    (H) Pediatric Postmarket Surveillance of a Device Product, for an 
applicable device clinical trial that is a Pediatric Postmarket 
Surveillance of a Device Product;
    (I) Primary Disease or Condition Being Studied in the Trial, or the 
Focus of the Study;
    (J) Intervention Name(s), for each intervention studied;
    (K) Other Intervention Name(s), for each intervention studied;
    (L) Intervention Description, for each intervention studied;
    (M) Intervention Type, for each intervention studied;
    (N) Studies a U.S. FDA-regulated Device Product;
    (O) Studies a U.S. FDA-regulated Drug Product;
    (P) Device Product Not Approved or Cleared by U.S. FDA, if any 
studied intervention is a device product;
    (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable 
device clinical trial that studies at least one device product not 
previously approved or cleared by the U.S. FDA;
    (R) Product Manufactured in and Exported from the U.S., if the entry 
for U.S. Food and Drug Administration

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IND or IDE Number in Sec.  11.28(a)(2)(iv)(C) indicates that there is no 
IND or IDE for the clinical trial, and the entry(ies) for Facility 
Information in Sec.  11.28(a)(2)(iii)(C) include no facility locations 
in the United States or its territories;
    (S) Study Start Date;
    (T) Primary Completion Date;
    (U) Study Completion Date;
    (V) Enrollment;
    (W) Primary Outcome Measure Information, for each primary outcome 
measure; and
    (X) Secondary Outcome Measure Information, for each secondary 
outcome measure.
    (ii) Recruitment information:
    (A) Eligibility Criteria;
    (B) Sex/Gender;
    (C) Age Limits;
    (D) Accepts Healthy Volunteers;
    (E) Overall Recruitment Status;
    (F) Why Study Stopped;
    (G) Individual Site Status; and
    (H) Availability of Expanded Access. If expanded access is available 
for an investigational drug product (including a biological product), an 
expanded access record must be submitted in accordance with Sec.  
11.28(c), unless an expanded access record was submitted previously in 
accordance with that provision.
    (iii) Location and contact information:
    (A) Name of the Sponsor;
    (B) Responsible Party, by Official Title; and
    (C) Facility Information.
    (iv) Administrative data:
    (A) Unique Protocol Identification Number;
    (B) Secondary ID;
    (C) U.S. Food and Drug Administration IND or IDE Number;
    (D) Human Subjects Protection Review Board Status;
    (E) Record Verification Date; and
    (F) Responsible Party Contact Information.
    (b) Pediatric postmarket surveillance of a device product that is 
not a clinical trial. For each pediatric postmarket surveillance of a 
device product that is not a clinical trial, the responsible party must 
submit the following information:
    (1) For such applicable device clinical trials that were initiated 
before January 18, 2017, the responsible party must submit the 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
    (2) For such applicable device clinical trials that are initiated on 
or after January 18, 2017, the responsible party must submit the data 
elements listed below:
    (i) Descriptive information:
    (A) Brief Title. A short title of the pediatric postmarket 
surveillance of a device product in language intended for the lay 
public. If an acronym or abbreviation is used to publicly identify the 
surveillance, it must be provided.
    (B) Official Title. The title of the pediatric postmarket 
surveillance of a device product, corresponding to the title of the 
protocol or the FDA-approved plan for conducting the surveillance
    (C) Brief Summary. A short description of the pediatric postmarket 
surveillance of a device product, including a brief statement of the 
hypothesis or objective, written in language intended for the lay 
public, and a general description of the surveillance design, including 
relevant population information
    (D) Study Type. The type of study being registered. In the case of a 
pediatric postmarket surveillance of a device product that is not a 
clinical trial, a study type of ``observational'' is required.
    (E) Pediatric Postmarket Surveillance of a Device Product. For a 
study that includes an FDA-regulated device product as an intervention 
and is a pediatric postmarket surveillance of a device product
    (F) Primary Disease or Condition Being Studied, or the Focus of the 
Study. The name(s) of the disease(s) or condition(s) being studied in 
the pediatric postmarket surveillance of a device product, or the focus 
of the surveillance study. Use, if available, appropriate descriptors 
fromNLM's MeSH-controlled vocabulary thesaurus or terms from another 
vocabulary, such as the SNOMED CT, that has been mapped to MeSH within 
the UMLS Metathesaurus.

[[Page 148]]

    (G) Intervention Name(s). A brief descriptive name used to refer to 
each intervention studied in the pediatric postmarket surveillance of a 
device product. A non-proprietary name of the intervention must be used, 
if available. If a non-proprietary name is not available, a brief 
descriptive name or identifier must be used.
    (H) Other Intervention Name(s). Any other current and former name(s) 
or alias(es), different from the Intervention Name(s), that the sponsor 
has used publicly to identify the intervention(s), including, but not 
limited to, past or present names such as brand name(s), or serial 
numbers
    (I) Intervention Description. Details that can be made public about 
each intervention, other than the Intervention Name(s) and Other 
Intervention Name(s), sufficient to distinguish the intervention from 
other, similar interventions studied in the same or another clinical 
trial or pediatric postmarket surveillance of a device product that is 
not a clinical trial
    (J) Intervention Type. For each intervention studied in the 
pediatric postmarket surveillance of a device product, the general type 
of intervention
    (K) Study Start Date. The date on which FDA approves the pediatric 
postmarket surveillance plan, as specified in 21 CFR 822.19(a).
    (L) Primary Completion Date. The estimated or actual date on which 
the final report of the pediatric postmarket surveillance of a device 
product is expected to be submitted to FDA. Once the final report has 
been submitted, this is the actual date on which the final report is 
submitted to FDA.
    (ii) Location and contact information:
    (A) Name of the Sponsor.
    (B) Responsible Party, by Official Title:
    (1) If the responsible party is an entity, the official name of the 
entity; or
    (2) If the responsible party is an individual, the official title 
and primary organizational affiliation of the individual.
    (C) Contact Information. The name or official title, toll-free 
telephone number, and email address of a person to whom questions 
concerning the pediatric postmarket surveillance of a device product can 
be addressed.
    (iii) Administrative data:
    (A) Unique Protocol Identification Number. The unique identifier 
assigned to the pediatric postmarket surveillance of a device product by 
the sponsor, if any.
    (B) Secondary ID: (1) Identifier(s) other than the organization's 
unique protocol identifier or NCT number that is assigned to the 
pediatric postmarket surveillance of a device product, if any, including 
any unique identifiers assigned by other publicly available clinical 
study registries. If the pediatric postmarket surveillance of a device 
product is funded in whole or in part by a U.S. Federal Government 
agency, the complete grant or contract number must be submitted as a 
Secondary ID.
    (2) For each secondary ID listed, a description of the type of 
secondary ID.
    (C) Human Subjects Protection Review Board Status. Information to 
indicate whether a pediatric postmarket surveillance of a device product 
has been reviewed and approved by a human subjects protection review 
board or whether such review is not required per applicable law (e.g., 
21 CFR part 56, 45 CFR part 46, or other applicable regulation). Human 
Subjects Protection Review Board Status must be listed as ``approved'' 
if at least one human subjects protection review board has approved the 
pediatric postmarket surveillance.
    (D) Record Verification Date. The date on which the responsible 
party last verified the clinical trial information in the entire 
ClinicalTrials.gov record for the pediatric postmarket surveillance of a 
device product, even if no additional or updated information was 
submitted at that time
    (E) Responsible Party Contact Information. Administrative 
information sufficient to identify and allow communication with the 
responsible party by telephone, email, and regular mail or delivery 
service. Responsible Party Contact Information includes the name, 
official title, organizational affiliation, physical address, mailing 
address, phone number, and email address of the individual who is the 
responsible party

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or of a designated employee of the organization that is the responsible 
party.
    (c) Expanded access record. If expanded access is available, as 
specified in 21 CFR 312.315 (for an intermediate-size patient 
population) or 21 CFR 312.320 (under a treatment IND or treatment 
protocol), for an investigational drug product (including a biological 
product) studied in an applicable drug clinical trial, and the data 
elements set forth in paragraphs (c)(1) through (4) of this section have 
not been submitted in an expanded access record for that investigational 
product, the responsible party, if both the manufacturer of the 
investigational product and the sponsor of the applicable clinical 
trial, must submit the clinical trial information specified in 
paragraphs (c)(1) through (4) of this section to ClinicalTrials.gov in 
the form of an expanded access record. If expanded access is available 
only as specified in 21 CFR 312.310 (for individual patients, including 
for emergency use) for an investigational drug product (including a 
biological product) studied in an applicable drug clinical trial, and 
the data elements set forth in paragraphs (c)(1)(i), (iii), (iv), (vi), 
(ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv), and (v) of this 
section have not been submitted in an expanded access record for that 
investigational product, the responsible party, if both the manufacturer 
of the investigational product and the sponsor of the applicable 
clinical trial, must submit the clinical trial information specified in 
those paragraphs to ClinicalTrials.gov in the form of an expanded access 
record.
    (1) Descriptive information:
    (i) Brief Title. A short title identifying the expanded access, 
written in language intended for the lay public. If an acronym or 
abbreviation is used publicly to identify the expanded access, it must 
be provided.
    (ii) Official Title. The title, if any, of the expanded access 
program corresponding to the title that has been submitted to FDA for 
that program
    (iii) Brief Summary. A short description of the availability of 
expanded access, including the procedure for requesting the 
investigational drug product (including a biological product).
    (iv) Study Type. The nature of the investigation or investigational 
use for which clinical trial information is being submitted, i.e., 
``expanded access''.
    (v) Primary Disease or Condition. The name(s) of the disease(s) or 
condition(s) for which expanded access to the investigational drug 
product (including a biological product) is available. Use, if 
available, appropriate descriptors from NLM's MeSH-controlled vocabulary 
thesaurus, or terms from another vocabulary, such as the SNOMED CT, that 
has been mapped to MeSH within the UMLS Metathesaurus.
    (vi) Intervention Name(s). A brief descriptive name used to refer to 
the investigational drug product (including a biological product) that 
is available through expanded access. A non-proprietary name of the 
intervention must be used, if available. If a non-proprietary name is 
not available, a brief descriptive name or identifier must be used.
    (vii) Other Intervention Name(s). Any other current and former 
name(s) or alias(es), different from the Intervention Name(s), that the 
sponsor has used publicly to identify the intervention, including, but 
not limited to, past or present names such as brand name(s), or serial 
numbers.
    (viii) Intervention Description. Details that can be made public 
about each intervention, other than the Intervention Name(s) or Other 
Intervention Name(s), sufficient to distinguish the intervention from 
other, similar interventions that are available through expanded access 
or in clinical trials.
    (ix) Intervention Type. For each investigational drug product 
(including a biological product) for which expanded access is available, 
the general type of intervention, e.g., drug.
    (x) Expanded Access Type. The type(s) of expanded access for which 
the investigational drug product (including a biological product) is 
available, as specified in Sec.  11.10(b)(28).
    (2) Recruitment information:
    (i) Eligibility Criteria. A limited list of criteria for determining 
who is eligible to receive the investigational drug product (including a 
biological product) through expanded access, provided

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in terms of inclusion and exclusion criteria and suitable for assisting 
potential patients in identifying investigational drug products 
(including biological products) of interest for which expanded access is 
available.
    (ii) Sex/Gender. The sex and gender (if applicable) of the patients 
for whom expanded access is available.
    (iii) Age Limits. The minimum and maximum age of patients for whom 
expanded access is available, provided in relevant units of time.
    (iv) Expanded Access Status. The status of availability of the 
investigational drug product (including a biological product) through 
expanded access.
    (3) Contact information:
    (i) Name of the Sponsor.
    (ii) Responsible Party, by Official Title. The official name of the 
entity.
    (iii) Contact Information. The name or official title, toll-free 
telephone number, and email address of a person to whom questions 
concerning expanded access can be addressed.
    (4) Administrative data:
    (i) Unique Protocol Identification Number. Any unique identifier 
assigned by the sponsor to refer to the availability of its 
investigational drug product (including a biological product) for 
expanded access use or to identify the expanded access record.
    (ii) Secondary ID: (A) Any identifier(s) other than the Unique 
Protocol Identification Number or the NCT number that is assigned to the 
expanded access record, including any unique identifiers assigned by 
other publicly available clinical trial or expanded access registries.
    (B) For each Secondary ID listed, a description of the type of 
Secondary ID.
    (iii) U.S. Food and Drug Administration IND Number. An indication of 
whether there is an IND and, if so, each of the following elements:
    (A) Name or abbreviation of the FDA center with whom the IND is 
filed (i.e., CDER or CBER), if applicable;
    (B) IND number (assigned by the FDA center) under which the 
investigational drug product (including a biological product) is being 
made available for expanded access, if applicable; and
    (C) IND serial number. as defined in 21 CFR 312.23(e), if any, 
assigned to the expanded access.
    (iv) Record Verification Date. The date on which the responsible 
party last verified the information in the expanded access record, even 
if no additional or updated information was submitted at that time.
    (v) Responsible Party Contact Information. Administrative 
information sufficient to identify and allow communication with the 
responsible party entering the clinical trial information into the 
expanded access record by telephone, email, and regular mail or delivery 
service. Responsible Party Contact Information includes the name, 
official title, organizational affiliation, physical address, mailing 
address, phone number, and email address of the individual who is the 
responsible party or of a designated employee of the organization that 
is the responsible party.



Sec.  11.35  By when will the NIH Director post clinical trial registration 
information submitted under Sec.  11.28?

    (a) Applicable drug clinical trial. The Director will post publicly 
on ClinicalTrials.gov the clinical trial registration information, 
except for certain administrative data, for an applicable drug clinical 
trial not later than 30 calendar days after the responsible party has 
submitted such information, as specified in Sec.  11.24.
    (b) Applicable device clinical trial. (1) For an applicable device 
clinical trial of a device product that was previously approved or 
cleared, the Director will post publicly on ClinicalTrials.gov the 
clinical trial registration information, except for certain 
administrative data, as soon as practicable, but not later than 30 
calendar days after clinical trial results information is required to be 
posted, as specified in Sec.  11.52.
    (2) For an applicable device clinical trial of a device product that 
has not been previously approved or cleared:
    (i) The Director will post publicly on ClinicalTrials.gov the 
clinical trial registration information, except for certain 
administrative data, not earlier than the date of FDA approval or 
clearance of the device product and not later than 30 calendar days 
after the

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date of such approval or clearance, except as otherwise provided in 
paragraph (b)(2)(ii) of this section.
    (ii) If, prior to the date of approval or clearance of the device 
product, the responsible party for an applicable clinical trial that is 
initiated on or after January 18, 2017, indicates to the Director, by 
submitting the Post Prior to U.S. FDA Approval or Clearance data element 
under Sec.  11.28(a)(2)(i)(Q), that it is authorizing the Director to 
publicly post its clinical trial registration information, which would 
otherwise be subject to delayed posting as specified in paragraph 
(b)(2)(i) of this section, prior to the date of FDA approval or 
clearance of its device product, the Director will publicly post the 
registration information, except for certain administrative data, as 
soon as practicable.



                Subpart C_Results Information Submission



Sec.  11.40  Who must submit clinical trial results information?

    The responsible party for an applicable clinical trial specified in 
Sec.  11.42 must submit clinical trial results information for that 
clinical trial.



Sec.  11.42  For which applicable clinical trials must clinical trial results 
information be submitted?

    (a) Applicable clinical trials for which the studied product is 
approved, licensed, or cleared by FDA. Unless a waiver of the 
requirement to submit clinical trial results information is granted in 
accordance with Sec.  11.54, clinical trial results information must be 
submitted for any applicable clinical trial for which the studied 
product is approved, licensed, or cleared by FDA for which submission of 
clinical trial registration information is required in accordance with 
the following:
    (1) If the primary completion date is before January 18, 2017, the 
responsible party must submit the clinical trial results information 
specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health 
Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)); or
    (2) If the primary completion date is on or after January 18, 2017, 
the responsible party must submit the clinical trial results information 
specified in Sec.  11.48.
    (b) Applicable clinical trials for which the studied product is not 
approved, licensed, or cleared by FDA. Unless a waiver of the 
requirement to submit clinical trial results information is granted in 
accordance with Sec.  11.54, clinical trial results information 
specified in Sec.  11.48 must be submitted for any applicable clinical 
trial with a primary completion date on or after January 18, 2017 for 
which clinical trial registration information is required to be 
submitted and for which the studied product is not approved, licensed, 
or cleared by FDA.



Sec.  11.44  When must clinical trial results information be submitted 
for applicable clinical trials subject to Sec.  11.42?

    (a) Standard submission deadline. In general, for applicable 
clinical trials subject to Sec.  11.42, clinical trial results 
information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the 
Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 
282(j)(3)(I)) or in Sec.  11.48, as applicable, must be submitted no 
later than 1 year after the primary completion date of the applicable 
clinical trial.
    (b) Delayed submission of results information with certification if 
seeking approval, licensure, or clearance of a new use--(1) General 
requirements. If, prior to the results information submission deadline 
specified under paragraph (a) of this section, the responsible party 
submits a certification that an applicable clinical trial involves an 
FDA-regulated drug product (including a biological product) or device 
product that previously has been approved, licensed, or cleared, for 
which the manufacturer is the sponsor of the applicable clinical trial 
and for which an application or premarket notification seeking approval, 
licensure, or clearance of the use being studied (which is not included 
in the labeling of the approved, licensed, or cleared drug product 
(including a biological product) or device product) has been filed or 
will be filed within 1 year with FDA, the deadline for submitting 
clinical trial results information, as specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public

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Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) 
or Sec.  11.48, as applicable, will be 30 calendar days after the 
earliest of the following events:
    (i) FDA approves, licenses, or clears the drug product (including a 
biological product) or device product for the use studied in the 
applicable clinical trial;
    (ii) FDA issues a letter that ends the regulatory review cycle for 
the application or submission but does not approve, license, or clear 
the drug product (including a biological product) or device product for 
the use studied in the applicable clinical trial; or
    (iii) The application or premarket notification seeking approval, 
licensure, or clearance of the new use is withdrawn without resubmission 
for not less than 210 calendar days.
    (2) Two-year limitation. Notwithstanding the deadlines specified in 
paragraph (b)(1) of this section, the responsible party must submit 
clinical trial results information specified in paragraph (b)(1) of this 
section not later than the date that is 2 years after the date that the 
certification was submitted, except to the extent that paragraph (d) of 
this section applies.
    (3) Additional requirements. If a responsible party who is both the 
manufacturer of the drug product (including a biological product) or 
device product studied in an applicable clinical trial and the sponsor 
of the applicable clinical trial submits a certification in accordance 
with paragraph (b)(1) of this section, that responsible party must 
submit such a certification for each applicable clinical trial that 
meets the following criteria:
    (i) The applicable clinical trial is required to be submitted in an 
application or premarket notification seeking approval, licensure, or 
clearance of a new use; and
    (ii) The applicable clinical trial studies the same drug product 
(including a biological product) or device product for the same use as 
studied in the applicable clinical trial for which the initial 
certification was submitted.
    (c) Delayed submission of results with certification if seeking 
initial approval, licensure, or clearance.--(1) General requirements. 
If, prior to the submission deadline specified under paragraph (a) of 
this section, a responsible party submits a certification that an 
applicable clinical trial studies an FDA-regulated drug product 
(including a biological product) or device product that was not 
approved, licensed, or cleared by FDA for any use before the primary 
completion date of the trial, and that the sponsor intends to continue 
with product development and is either seeking, or may at a future date 
seek, FDA approval, licensure, or clearance of the drug product 
(including a biological product) or device product under study, the 
deadline for submitting clinical trial results information, as specified 
in Sec.  11.48, will be 30 calendar days after the earlier of the date 
on which:
    (i) FDA approves, licenses, or clears the drug product (including a 
biological product) or device product for any use that is studied in the 
applicable clinical trial; or
    (ii) The marketing application or premarket notification is 
withdrawn without resubmission for not less than 210 calendar days.
    (2) Two-year limitation. Notwithstanding the deadlines established 
in paragraph (c)(1) of this section, the responsible party must submit 
clinical trial results information specified in paragraph (c)(1) of this 
section not later than 2 years after the date on which the certification 
was submitted, except to the extent that paragraph (d) of this section 
applies.
    (d) Submitting partial results information. (1) If clinical trial 
results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) 
of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 
282(j)(3)(I)) or Sec.  11.48, as applicable, has not been collected for 
a secondary outcome measure(s) or additional adverse event information 
by the primary completion date, the responsible party must submit the 
remaining required clinical trial results information for secondary 
outcome measure(s) or additional adverse event information for that 
clinical trial by the following deadlines:
    (i) For secondary outcome measure(s), by the later of:
    (A) One year after the date on which the final subject is examined 
or receives an intervention for the purposes

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of final collection of data for that secondary outcome measure, whether 
the clinical trial was concluded according to the pre-specified protocol 
or was terminated; or
    (B) If a certification to delay results information submission has 
been submitted under paragraph (b) or (c) of this section, the date on 
which results information for the primary outcome measures is due 
pursuant to paragraph (b) or (c) of this section.
    (ii) For additional adverse event information, by the later of:
    (A) One year after the date of data collection for additional 
adverse event information, whether the clinical trial was concluded 
according to the pre-specified protocol or was terminated; or
    (B) If a certification to delay results information submission has 
been submitted under paragraph (b) or (c) of this section, the date on 
which results information for the primary outcome measures is due 
pursuant to paragraph (b) or (c) of this section.
    (2) Except, if clinical trial results information was submitted for 
the primary outcome measure(s) prior to the effective date of these 
regulations but data collection for all of the secondary outcome 
measure(s) or additional adverse event information is not completed 
until on or after January 18, 2017, clinical trial results information 
for all primary and secondary outcome measures and adverse event 
information for the clinical trial must be submitted as specified in 
sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act 
(42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
    (3) For each submission of partial results information for a 
clinical trial, as specified in paragraph (d)(1) of this section:
    (i) If any amendments were made to the protocol and/or statistical 
analysis plan as described in Sec.  11.48(a)(5) since the previous 
submission of partial results information, the responsible party must 
submit a copy of the revised protocol and/or statistical analysis plan; 
and
    (ii) If information about certain agreements as described in Sec.  
11.48(a)(6)(ii) has changed since the previous submission of partial 
results information, the responsible party must submit information to 
reflect the new status of certain agreements between the principal 
investigator and the sponsor.
    (e) Extensions for good cause. (1) A responsible party may request 
an extension of the deadline for submitting clinical trial results 
information subject to paragraphs (e)(1)(i) and (ii) of this section or 
section 402(j)(3)(E)(vi) of the Public Health Service Act (42 U.S.C. 
282(j)(3)(E)(vi)), as applicable, and may request more than one 
extension for the same applicable clinical trial.
    (i) The responsible party must submit a request for an extension to 
ClinicalTrials.gov prior to the date on which clinical trial results 
information would otherwise be due in accordance with paragraph (a), 
(b), (c), (d), (e), or (f) of this section.
    (ii) A request for an extension must contain the following:
    (A) Description of the reason(s) why clinical trial results 
information cannot be provided according to the deadline, with 
sufficient detail to allow for the evaluation of the request; and
    (B) Estimate of the date on which the clinical trial results 
information will be submitted.
    (2) Decision and submission deadline. The Director will provide a 
response electronically to the responsible party indicating whether the 
requested extension demonstrates good cause and has been granted.
    (i) If the extension request is granted, the responsible party must 
submit clinical trial results information not later than the date of the 
deadline specified in the electronic response.
    (ii) If the extension request is denied, the responsible party must 
either appeal in accordance with paragraph (e)(3) of this section or 
submit clinical trial results information specified in Sec.  11.48 by 
the later of the submission deadline specified in paragraph (a), (b), 
(c), (d), (e), or (f) of this section, as applicable, or 30 calendar 
days after the date on which the electronic notice of the denial is sent 
to the responsible party.
    (3) Appealing a denied extension request. (i) A responsible party 
who seeks to appeal a denied extension request or

[[Page 154]]

the deadline specified in a granted extension must submit an appeal to 
the Director in the format specified at https://
prsinfo.clinicaltrials.gov/ not later than 30 calendar days after the 
date on which the electronic notification of the granting or denial of 
the request is sent to the responsible party.
    (ii) An appeal must contain an explanation of the reason(s) why the 
initial decision to deny the extension request or to grant the extension 
request with a shorter deadline than requested should be overturned or 
revised, with sufficient detail to allow for the evaluation of the 
appeal.
    (iii) The Director will provide an electronic notification to the 
responsible party indicating whether the requested extension has been 
granted upon appeal.
    (iv) If the Director grants the extension request upon appeal, the 
responsible party must submit clinical trial results information not 
later than the deadline specified in the electronic notification 
specified in paragraph (e)(3)(iii) of this section.
    (v) If the Director denies the appeal of a denied extension request, 
the responsible party must submit clinical trial results information by 
the later of the deadline specified in paragraph (a), (b), (c), (d), 
(e), or (f) of this section, or 30 calendar days after the electronic 
notification of the denial of the appeal, specified in paragraph 
(e)(3)(iii) of this section, is sent to the responsible party.
    (vi) If the Director denies an appeal of a denied deadline specified 
in a granted extension request, the responsible party must submit 
clinical trial results information by the later of the deadline 
specified in the notification granting the extension request, specified 
in paragraph (e)(2)(i) of this section, or 30 calendar days after the 
electronic notification denying the appeal, specified in paragraph 
(e)(3)(iii) of this section, is sent to the responsible party.
    (f) Pediatric postmarket surveillance of a device product that is 
not a clinical trial. For each pediatric postmarket surveillance of a 
device product that is not a clinical trial as defined in this part, the 
responsible party must submit clinical trial results information as 
specified in Sec.  11.48(b) or section 402(j)(C)(3) of the Public Health 
Service Act (42 U.S.C. 282(j)(C)(3)), as applicable, not later than 30 
calendar days after the date on which the final report of the approved 
pediatric postmarket surveillance of a device product, as specified in 
21 CFR 822.38, is submitted to FDA.



Sec.  11.48  What constitutes clinical trial results information?

    (a) For each applicable clinical trial, other than a pediatric 
postmarket surveillance of a device product that is not a clinical 
trial, for which clinical trial results information must be submitted 
under Sec.  11.42, the responsible party must provide the following:
    (1) Participant flow. Information for completing a table documenting 
the progress of human subjects through a clinical trial, by arm, 
including the number who started and completed the clinical trial. This 
information must include the following elements:
    (i) Participant Flow Arm Information. A brief description of each 
arm used for describing the flow of human subjects through the clinical 
trial, including a descriptive title used to identify each arm;
    (ii) Pre-assignment Information. A description of significant events 
in the clinical trial that occur after enrollment and prior to 
assignment of human subjects to an arm, if any; and
    (iii) Participant Data. The number of human subjects that started 
and completed the clinical trial, by arm. If assignment is based on a 
unit other than participants, also include a description of the unit of 
assignment and the number of units that started and completed the 
clinical trial, by arm.
    (2) Demographic and baseline characteristics. Information for 
completing a table of demographic and baseline measures and data 
collected by arm or comparison group and for the entire population of 
human subjects who participated in the clinical trial. This information 
must include the following elements:
    (i) Baseline Characteristics Arm/Group Information. A brief 
description of each arm or comparison group used for describing the 
demographic and baseline characteristics of the human subjects

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in the clinical trial, including a descriptive title used to identify 
each arm or comparison group.
    (ii) Baseline Analysis Population Information--(A) Overall Number of 
Baseline Participants. The total number of human subjects for whom 
baseline characteristics were measured, by arm or comparison group and 
overall.
    (B) Overall Number of Units Analyzed. If the analysis is based on a 
unit other than participants, a description of the unit of analysis and 
the number of units for which baseline measures were measured and 
analyzed, by arm or comparison group and overall.
    (C) Analysis Population Description. If the Overall Number of 
Baseline Participants (or units) differs from the number of human 
subjects (or units) assigned to the arm or comparison group and overall, 
a brief description of the reason(s) for the difference.
    (iii) Baseline Measure Information. A description of each baseline 
or demographic characteristic measured in the clinical trial, including 
age, sex/gender, race, ethnicity (if collected under the protocol), and 
any other measure(s) that were assessed at baseline and are used in the 
analysis of the primary outcome measure(s) in accordance with Sec.  
11.48(a)(3). The description of each measure must include the following 
elements:
    (A) Name and description of the measure, including any categories 
that are used to submit Baseline Measure Data.
    (B) Measure Type and Measure of Dispersion: For each baseline 
measure submitted, an indication of the type of data to be submitted and 
the associated measure of dispersion.
    (C) Unit of Measure. For each baseline measure for which data are 
collected, the unit of measure.
    (iv) Baseline Measure Data. The value(s) for each submitted baseline 
measure, by arm or comparison group and for the entire population of 
human subjects for whom baseline characteristics were measured.
    (v) Number of baseline participants (and units), by arm or 
comparison group and overall, if different from the Overall Number of 
Baseline Participants or Overall Number of Units Analyzed in Sec.  
11.48(a)(2)(ii)(A) and (B), respectively.
    (3) Outcomes and statistical analyses. Information for completing a 
table of data for each primary and secondary outcome measure by arm or 
comparison group, including the result(s) of scientifically appropriate 
statistical analyses that were performed on the outcome measure data, if 
any. This information must include the following elements:
    (i) Outcome Measure Arm/Group Information. A brief description of 
each arm or comparison group used for submitting an outcome measure for 
the clinical trial, including a descriptive title to identify each arm 
or comparison group.
    (ii) Analysis Population Information--(A) Number of Participants 
Analyzed. The number of human subjects for whom an outcome was measured 
and analyzed, by arm or comparison group.
    (B) Number of Units Analyzed. If the analysis is based on a unit 
other than participants, a description of the unit of analysis and the 
number of units for which an outcome was measured and analyzed, by arm 
or comparison group.
    (C) Analysis Population Description. If the Number of Participants 
Analyzed or Number of Units Analyzed differs from the number of human 
subjects or units assigned to the arm or comparison group, a brief 
description of the reason(s) for the difference.
    (iii) Outcome Measure Information. A description of each outcome 
measure, to include the following elements:
    (A) Name of the specific outcome measure, including the titles of 
any categories in which Outcome Measure Data in Sec.  11.48(a)(3)(iv) 
are aggregated.
    (B) Description of the metric used to characterize the specific 
outcome measure.
    (C) Time point(s) at which the measurement was assessed for the 
specific metric.
    (D) Outcome Measure Type. The type of outcome measure, whether 
primary, secondary, other pre-specified, or post-hoc.
    (E) Measure Type and Measure of Dispersion or Precision. For each 
outcome measure for which data are collected, the type of data submitted 
and the measure of dispersion or precision.

[[Page 156]]

    (F) Unit of Measure. For each outcome measure for which data are 
collected, the unit of measure.
    (iv) Outcome Measure Data. The measurement value(s) for each outcome 
measure for which data are collected, by arm or comparison group and by 
category (if specified).
    (v) Statistical Analyses. Result(s) of scientifically appropriate 
tests of the statistical significance of the primary and secondary 
outcome measures, if any.
    (A) A statistical analysis is required to be submitted if it is:
    (1) Pre-specified in the protocol and/or statistical analysis plan 
and was performed on the outcome measure data,
    (2) Made public by the sponsor or responsible party prior to the 
date on which clinical trial results information is submitted for the 
primary outcome measures(s) studied in the clinical trial to which the 
statistical analysis applies, or
    (3) Conducted on a primary outcome measure in response to a request 
made by FDA prior to the date on which clinical trial results 
information is submitted for the primary outcome measure(s) studied in 
the clinical trial to which the statistical analysis applies.
    (B) Information for each statistical analysis specified in paragraph 
(a)(3)(v)(A) of this section must include the following elements:
    (1) Statistical Analysis Overview: Identification of the arms or 
comparison groups compared in the statistical analysis; the type of 
statistical test conducted; and, for a non-inferiority or equivalence 
test, a description of the analysis that includes, at minimum, the power 
calculation and non-inferiority or equivalence margin.
    (2) One of the following, as applicable:
    (i) Statistical Test of Hypothesis: The p-value and the procedure 
used for the statistical analysis; or
    (ii) Method of Estimation: The estimation parameter, estimated 
value, and confidence interval (if calculated).
    (4) Adverse event information. (i) Information to describe the 
methods for collecting adverse events during an applicable clinical 
trial:
    (A) Time Frame. The specific period of time over which adverse event 
information was collected and for which information is submitted in 
paragraph (a)(4)(iii) of this section.
    (B) Adverse Event Reporting Description. If the adverse event 
information collected in the clinical trial is collected based on a 
different definition of adverse event and/or serious adverse event than 
defined in this part, a brief description of how those definitions 
differ.
    (C) Collection Approach. The type of approach taken to collect 
adverse event information, whether systematic or non-systematic.
    (ii) Information for completing three tables summarizing anticipated 
and unanticipated adverse events collected during an applicable clinical 
trial:
    (A) Table of all serious adverse events grouped by organ system, 
with the number and frequency of each event by arm or comparison group;
    (B) Table of all adverse events, other than serious adverse events, 
that exceed a frequency of 5 percent within any arm of the clinical 
trial, grouped by organ system, with the number and frequency of each 
event by arm or comparison group; and
    (C) Table of all-cause mortality, with the number and frequency of 
deaths due to any cause by arm or comparison group.
    (iii) Information for each table specified in paragraph (a)(4)(ii) 
of this section must include the following elements, unless otherwise 
specified:
    (A) Adverse Event Arm/Group Information. A brief description of each 
arm or comparison group used for submitting adverse event information 
from the clinical trial, including a descriptive title used to identify 
each arm or comparison group.
    (B) Total Number Affected. The overall number of human subjects 
affected, by arm or comparison group, by:
    (1) Serious adverse event(s);
    (2) Adverse event(s) other than serious adverse events that exceed a 
frequency of 5 percent within any arm of the clinical trial; and
    (3) Deaths due to any cause.
    (C) Total Number at Risk. The overall number of human subjects 
included in

[[Page 157]]

the assessment, by arm or comparison group, for:
    (1) Serious adverse events;
    (2) Adverse event(s) other than serious adverse events that exceed a 
frequency of 5 percent within any arm of the clinical trial; or
    (3) Deaths due to any cause.
    (D) Adverse Event Information. For the two tables described in 
paragraphs (a)(4)(ii)(A) and (B) of this section, a description of each 
type of serious adverse event and other adverse event that is not a 
serious adverse event and exceeds a frequency of 5 percent within any 
arm of the clinical trial, consisting of the following attributes:
    (1) Descriptive term for the adverse event; and
    (2) Organ system associated with the adverse event.
    (E) Adverse Event Data. For the two tables described in paragraphs 
(a)(4)(ii)(A) and (B) of this section and for each adverse event listed 
in accordance with paragraph (a)(4)(iii)(D) of this section:
    (1) Number of human subjects affected by such adverse event.
    (2) Number of human subjects at risk for such adverse event.
    (5) Protocol and statistical analysis plan. A copy of the protocol 
and the statistical analysis plan (if not included in the protocol), 
including all amendments that have been approved by a human subjects 
protection review board (if applicable) before the time of submission 
under this subsection and that apply to all clinical trial Facility 
Locations. The responsible party must include the Official Title (as 
defined in Sec.  11.10(b)(2)), NCT number (as defined in Sec.  11.10(a)) 
(if available), and date of the protocol and the statistical analysis 
plan on the cover page of each document. The responsible party may 
redact names, addresses, and other personally identifiable information, 
as well as any trade secret and/or confidential commercial information 
(as those terms are defined in the Freedom of Information Act (5 U.S.C. 
552) and the Trade Secrets Act (18 U.S.C. 1905)) contained in the 
protocol or statistical analysis plan prior to submission, unless such 
information is otherwise required to be submitted under this part. The 
protocol and statistical analysis plan must be submitted in a common 
electronic document format specified at https://
prsinfo.clinicaltrials.gov.
    (6) Administrative information--(i) Results Point of Contact. Point 
of contact for scientific information about the clinical trial results 
information, including the following:
    (A) Name or official title of the point of contact
    (B) Name of the affiliated organization, and
    (C) Telephone number and email address of the point of contact.
    (ii) Certain Agreements. An indication of whether the principal 
investigator is an employee of the sponsor and, if not, whether there 
exists any agreement (other than an agreement solely to comply with 
applicable provisions of law protecting the privacy of human subjects 
participating in the clinical trial) between the sponsor or its agent 
and the principal investigator that restricts in any manner the ability 
of the principal investigator, after the primary completion date of the 
clinical trial, to discuss the results of the clinical trial at a 
scientific meeting or any other public or private forum or to publish in 
a scientific or academic journal information concerning the results of 
the clinical trial
    (7) Additional clinical trial results information for applicable 
device clinical trials of unapproved or uncleared device products. (i) 
For an applicable device clinical trial of an unapproved or uncleared 
device product and for which clinical trial registration information has 
not been posted publicly on Clinical Trials.gov by the Director in 
accordance with Sec.  11.35(b)(2)(i), the responsible party must provide 
the following data elements, as the data elements are defined in Sec.  
11.10(b): Brief Title; Official Title; Brief Summary; Primary Purpose; 
Study Design; Study Type; Primary Disease or Condition Being Studied in 
the Trial, or the Focus of the Study; Intervention Name(s); Other 
Intervention Name(s); Intervention Description; Intervention Type; 
Device Product Not Approved or Cleared by U.S. FDA, if any studied 
intervention is a device product; Study Start Date; Primary Completion 
Date; Study Completion Date, Enrollment; Primary

[[Page 158]]

Outcome Measure Information; Secondary Outcome Measure Information; 
Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy 
Volunteers; Overall Recruitment Status; Why Study Stopped; Name of the 
Sponsor; Responsible Party, by Official Title; Facility Name and 
Facility Location, for each participating facility in a clinical trial; 
Unique Protocol Identification Number; Secondary ID; Human Subjects 
Protection Review Board Status; and Record Verification Date.
    (ii) The responsible party shall submit all the results information 
specified in paragraph (a)(7)(i) and must submit an affirmation that any 
information previously submitted to ClinicalTrials.gov for the data 
elements listed in paragraph (a)(7)(i) of this section have been updated 
in accordance with Sec.  11.64(a) and are to be included as clinical 
trial results information.
    (b) Pediatric postmarket surveillance of a device product that is 
not a clinical trial. For each pediatric postmarket surveillance of a 
device product that is not a clinical trial, the responsible party must 
submit a copy of any final report that is submitted to FDA as specified 
in 21 CFR 822.38. The responsible party may redact names, addresses, and 
other personally identifiable information or commercial confidential 
information contained in the final report prior to submission to NIH, 
unless such information is otherwise required to be submitted under this 
part. The final report must be in a common electronic document format 
specified at https://prsinfo.clinicaltrials.gov.



Sec.  11.52  By when will the NIH Director post submitted 
clinical trial results information?

    Except for clinical trial results information submitted under 
section 402(j)(4)(A) of the PHS Act and Sec.  11.60, the Director will 
post publicly clinical trial results information on ClinicalTrials.gov 
not later than 30 calendar days after the date of submission.



Sec.  11.54  What are the procedures for requesting and obtaining a waiver 
of the requirements for clinical trial results information submission?

    (a) Waiver request. (1) A responsible party for an applicable 
clinical trial with a primary completion date on or after January 18, 
2017 may request a waiver from any applicable requirement(s) of this 
subpart C by submitting a waiver request in the format specified at 
https://prsinfo.clinicaltrials.gov/ to the Secretary or delegate prior 
to the deadline specified in Sec.  11.44(a) for submitting clinical 
trial results information.
    (2) The waiver request must contain:
    (i) The NCT number, Brief Title, and Name of the Sponsor of the 
applicable clinical trial for which the waiver is requested;
    (ii) The specific requirement(s) of this subpart C for which the 
waiver is requested; and
    (iii) A description of the extraordinary circumstances that the 
responsible party believes justify the waiver and an explanation of why 
granting the request would be consistent with the protection of public 
health or in the interest of national security.
    (3) The responsible party will not be required to comply with the 
specified requirements of this subpart for which a waiver is granted.
    (4) The responsible party must comply with any requirements of this 
subpart for which a waiver is not granted or must submit an appeal as 
set forth in paragraph (b) of this section. The deadline for submitting 
any required clinical trial results information will be the later of the 
original submission deadline or 30 calendar days after the notification 
of the denial is sent to the responsible party.
    (b) Appealing a denied waiver request. (1) A responsible party for 
an applicable clinical trial with a primary completion date on or after 
January 18, 2017 may appeal a denied waiver request by submitting an 
appeal to the Secretary or delegate in the format specified at https://
prsinfo.clinicaltrials.gov/ not later than 30 calendar days after the 
date on which the electronic notification of the denial in paragraph 
(a)(4) of this section denying the request is sent to the responsible 
party.
    (2) The responsible party is not required to comply with any 
requirements of this subpart for which a waiver is granted upon appeal.

[[Page 159]]

    (3) The responsible party must submit clinical trial results 
information to comply with any requirements of this subpart that are not 
waived upon appeal by the later of the original submission deadline or 
30 calendar days after the notice of the denial upon appeal is sent to 
the responsible party.
    (c) If a waiver is granted under paragraph (a) or (b) of this 
section:
    (1) The Director will include a notation in the clinical trial 
record that specified elements of the requirements of this part have 
been waived.
    (2) The Secretary will notify, in writing, the appropriate 
committees of Congress and provide an explanation for why the waiver was 
granted, not later than 30 calendar days after any waiver is granted.
    (d) A responsible party for an applicable clinical trial with a 
primary completion date before January 18, 2017 may request a waiver 
from any applicable requirement(s) for clinical trial results 
information submission by submitting a waiver request, as specified in 
section 402(j)(3)(H) of the Public Health Service Act (42 U.S.C. 
282(j)(3)(H)).



      Subpart D_Additional Submission of Clinical Trial Information



Sec.  11.60  What requirements apply to the voluntary submission 
of clinical trial information for clinical trials of FDA-regulated 
drug products (including biological products) and device products?

    (a) If a responsible party voluntarily submits clinical trial 
information for a clinical trial described in paragraph (a)(1) of this 
section, the responsible party must meet the conditions specified in 
paragraph (a)(2) of this section.
    (1) The requirements of paragraph (a) of this section apply to a 
clinical trial that was initiated before January 18, 2017 and has a 
primary completion date before January 18, 2017, and that is either:
    (i) A clinical trial of an FDA-regulated drug product (including a 
biological product) or device product that is not an applicable clinical 
trial, or
    (ii) An applicable clinical trial that is not otherwise required to 
submit clinical trial registration information.
    (2) If the responsible party for a clinical trial described in 
paragraph (a)(1) of this section voluntarily submits clinical trial 
registration information and/or clinical trial results information, the 
responsible party must comply with the following requirements:
    (i) The responsible party must submit the information in paragraphs 
(b)(2)(i)(A), (B), or (C) of this section for the clinical trial being 
submitted voluntarily.
    (A) If the responsible party voluntarily registers a clinical trial, 
the responsible party must submit clinical trial registration 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
    (B) If the responsible party voluntarily submits clinical trial 
results information for a clinical trial for which the clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) has not been 
submitted, the responsible party must submit the clinical trial results 
information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the 
Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 
282(j)(3)(I)).
    (C) If the responsible party both voluntarily submits clinical trial 
registration information and voluntarily submits clinical trial results 
information, the responsible party must submit both clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and clinical 
trial results information specified in sections 402(j)(3)(C) and 
402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) 
and 42 U.S.C. 282(j)(3)(I)).
    (ii) If, on or after September 27, 2007, a manufacturer submits an 
application or premarket notification to FDA for approval, licensure, or 
clearance of a drug product (including a biological product) or device 
product under sections 505, 510(k), 515, or 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C 355, 360(k), 360e, 360j(m)) or section 
351 of the Public Health Service Act (42 U.S.C. 262) for the use studied 
in the clinical trial submitted under paragraph (a)(1) of this section, 
the responsible party specified in paragraph (a)(1)

[[Page 160]]

of this section must also submit the information specified in paragraph 
(a)(2)(iii) of this section by the deadline specified in paragraph 
(a)(2)(iv)(B) of this section for any applicable clinical trial that has 
not been submitted to ClinicalTrials.gov and that meets the following 
criteria:
    (A) The applicable clinical trial is required to be submitted to FDA 
under sections 505, 510(k), 515, or 520(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 
of the Public Health Service Act (42 U.S.C. 262) in an application or 
premarket notification for approval, licensure, or clearance to market 
the drug product (including a biological product) or device product for 
the use studied in the clinical trial specified in paragraph (a)(1) of 
this section; and
    (B) The manufacturer of the drug product (including a biological 
product) or device product studied in the applicable clinical trial is 
also the responsible party for the clinical trial specified in paragraph 
(a)(1) of this section.
    (iii) Information to be submitted for clinical trials described in 
paragraph (a)(2)(ii) of this section:
    (A) If the clinical trial information voluntarily submitted for a 
clinical trial described in paragraph (a)(1) of this section consists 
only of the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)), the information to be submitted in accordance with 
paragraph (a)(2)(ii) of this section must consist, at minimum, of the 
clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)).
    (B) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (a)(1) of this section consists of 
the clinical trial results information specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information to be 
submitted in accordance with paragraph (a)(2)(ii) of this section must 
consist of the clinical trial results information specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
    (C) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (a)(1) of this section consists of 
both the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) and the clinical trial results information specified 
in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service 
Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information 
to be submitted in accordance with paragraph (a)(2)(ii) of this section 
must consist of both the clinical trial registration information 
specified in section 402(j)(2)(A)(ii) of the Public Health Service Act 
(42 U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information 
specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health 
Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
    (iv) Submission deadlines:
    (A) Secondary outcome measure(s) and adverse event information for 
voluntarily submitted clinical trials, under paragraph (a) of this 
section:
    (1) If data collection for secondary outcome measure(s) for a 
voluntarily submitted clinical trial under paragraph (a) of this section 
is not completed by the primary completion date of the voluntarily 
submitted clinical trial, clinical trial results information for the 
secondary outcome measure(s) required in section 402(j)(3)(C) of the 
Public Health Service Act (42 U.S.C. 282(j)(3)(C)) must be submitted by 
the later of the date that the clinical trial results information is 
voluntarily submitted for the primary outcome measure(s) or 1 year after 
the date on which the final subject was examined or received an 
intervention for the purposes of final collection of data for the 
secondary outcome(s), whether the clinical trial was concluded according 
to the pre-specified protocol or was terminated.
    (2) If data collection for adverse event information continues after 
the primary completion date of the voluntarily submitted clinical trial, 
any adverse event information collected after

[[Page 161]]

the primary completion date and subject to the submission requirements 
in section 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 
282(j)(3)(I)) must be submitted by the later of the date that the 
clinical trial results information is voluntarily submitted for the 
primary outcome measure(s) or 1 year after the date of final collection 
of data for adverse event information, whether the clinical trial was 
concluded according to the pre-specified protocol or was terminated.
    (B) The clinical trial information specified in paragraph 
(a)(2)(iii) of this section must be submitted not later than the later 
of the date on which the application or premarket notification to FDA 
for approval, licensure, or clearance to market a drug product 
(including a biological product) or device product under section 351 of 
the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial 
specified under paragraph (a)(1) of this section is submitted to FDA or 
the date on which the clinical trial information specified in paragraph 
(a)(2)(i) of this section for the clinical trial specified under 
paragraph (a)(1) of this section is submitted to ClinicalTrials.gov.
    (b) If a responsible party voluntarily submits clinical trial 
information for a clinical trial described in paragraph (b)(1) of this 
section, the responsible party must meet the conditions specified in 
paragraph (b)(2) of this section.
    (1) The requirements of paragraph (b) of this section apply to a 
clinical trial that was initiated before January 18, 2017 and has a 
primary completion date on or after January 18, 2017, and that is 
either:
    (i) A clinical trial of an FDA-regulated drug product (including a 
biological product) or device product that is not an applicable clinical 
trial; or
    (ii) An applicable clinical trial that is not otherwise required to 
submit clinical trial registration information.
    (2) If the responsible party for a clinical trial described in 
paragraph (b)(1) of this section voluntarily submits clinical trial 
registration information and/or clinical trial results information, the 
responsible party must comply with the following requirements:
    (i) The responsible party must submit the information in paragraph 
(b)(2)(i)(A), (B), or (C) of this section for the clinical trial being 
submitted voluntarily.
    (A) If the responsible party voluntarily registers a clinical trial, 
the responsible party must submit clinical trial registration 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
    (B) If the responsible party voluntarily submits clinical trial 
results information for a clinical trial for which the clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) has not been 
submitted, the responsible party must submit the data elements specified 
in Sec.  11.48, as well as the data elements listed below, as those data 
elements are defined in Sec.  11.10(b) and apply to the clinical trial 
and the intervention(s) studied: Brief Title; Official Title; Brief 
Summary; Primary Purpose; Study Design; Study Phase, for a clinical 
trial of a drug product (including a biological product); Study Type; 
Pediatric Postmarket Surveillance of a Device Product; Primary Disease 
or Condition Being Studied in the Trial, or the Focus of the Study; 
Intervention Name(s), for each intervention studied; Other Intervention 
Name(s), for each intervention studied; Intervention Description, for 
each intervention studied; Intervention Type, for each intervention 
studied; Device Product Not Approved or Cleared by U.S. FDA, if any 
studied intervention is a device product; Product Manufactured in and 
Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; 
Studies a U.S. FDA-regulated Drug Product; Study Start Date; Primary 
Completion Date; Study Completion Date; Enrollment; Eligibility 
Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall 
Recruitment Status; Why Study Stopped; Availability of Expanded Access, 
if any studied intervention is an investigational drug product 
(including a biological product); Name of the Sponsor; Responsible 
Party, by Official Title; Facility Information, for

[[Page 162]]

each participating facility; Unique Protocol Identification Number; 
Secondary ID; U.S. Food and Drug Administration IND or IDE Number; Human 
Subjects Protection Review Board Status; Record Verification Date; and 
Responsible Party Contact Information.
    (C) If the responsible party both voluntarily submits clinical trial 
registration information and voluntarily submits clinical trial results 
information, the responsible party must submit both the clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical 
trial results information specified in Sec.  11.48.
    (ii) If, on or after September 27, 2007, a manufacturer submits an 
application or premarket notification to FDA for approval, licensure, or 
clearance of a drug product (including a biological product) or device 
product under section 505, 510(k), 515, or 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 
351 of the Public Health Service Act (42 U.S.C. 262) for the use studied 
in the clinical trial submitted under paragraph (b)(1) of this section, 
the responsible party specified in paragraph (b)(1) of this section must 
also submit the information specified in paragraph (b)(2)(iii) of this 
section by the deadline specified in paragraph (b)(2)(iv)(B) of this 
section for any applicable clinical trial that has not been submitted to 
ClinicalTrials.gov and that meets the following criteria:
    (A) The applicable clinical trial is required to be submitted to FDA 
under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) in an application or 
premarket notification for approval, licensure, or clearance to market 
the drug product (including a biological product) or device product for 
the use studied in the clinical trial specified in paragraph (b)(1) of 
this section; and
    (B) The manufacturer of the drug product (including a biological 
product) or device product studied in the applicable clinical trial is 
also the responsible party for the clinical trial specified in paragraph 
(b)(1) of this section.
    (iii) Information to be submitted for clinical trials described in 
paragraph (b)(2)(ii) of this section:
    (A) If the clinical trial information voluntarily submitted for a 
clinical trial described in paragraph (b)(1) of this section consists 
only of the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)), the information to be submitted in accordance with 
paragraph (b)(2)(ii) of this section must consist, at minimum, of the 
clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)).
    (B) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (b)(1) of this section consists of 
the clinical trial results information specified in Sec.  
11.60(b)(2)(i)(B), the information to be submitted in accordance with 
paragraph (b)(2)(ii) of this section must consist of the clinical trial 
results information specified in Sec.  11.60(b)(2)(i)(B).
    (C) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (b)(1) of this section consists of 
both the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) and the clinical trial results information specified 
in Sec.  11.48, the information to be submitted in accordance with 
paragraph (b)(2)(ii) of this section must consist of both the clinical 
trial registration information specified in section 402(j)(2)(A)(ii) of 
the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the 
clinical trial results information specified in Sec.  11.48.
    (iv) Submission deadlines:
    (A) Secondary outcome measure(s) and adverse event information for 
voluntarily submitted clinical trials, under paragraph (b) of this 
section:
    (1) If data collection for secondary outcome measure(s) for a 
voluntarily submitted clinical trial under paragraph (b) of this section 
is not completed by the primary completion date of the voluntarily 
submitted clinical

[[Page 163]]

trial, clinical trial results information for the secondary outcome 
measure(s) required in Sec.  11.48(a)(3) must be submitted by the later 
of the date that the clinical trial results information is voluntarily 
submitted for the primary outcome measure(s) or 1 year after the date on 
which the final subject was examined or received an intervention for the 
purposes of final collection of data for the secondary outcome(s), 
whether the clinical trial was concluded according to the pre-specified 
protocol or was terminated.
    (2) If data collection for adverse event information continues after 
the primary completion date of the voluntarily submitted clinical trial, 
any adverse event information collected after the primary completion 
date and subject to the submission requirements in Sec.  11.48(a)(4) 
must be submitted by the later of the date that the clinical trial 
results information is voluntarily submitted for the primary outcome 
measure(s) or 1 year after the date of final collection of data for 
adverse event information, whether the clinical trial was concluded 
according to the pre-specified protocol or was terminated.
    (B) The clinical trial information specified in paragraph 
(b)(2)(iii) of this section must be submitted not later than the later 
of the date on which the application or premarket notification to FDA 
for approval, licensure, or clearance to market a drug product 
(including a biological product) or device product under section 351 of 
the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial 
specified under paragraph (b)(1) of this section is submitted to FDA or 
the date on which the clinical trial information specified in paragraph 
(b)(2)(i) of this section for the clinical trial specified under 
paragraph (b)(1) of this section is submitted to ClinicalTrials.gov.
    (c) If a responsible party voluntarily submits clinical trial 
information for a clinical trial described in paragraph (c)(1) of this 
section, the responsible party must meet the conditions specified in 
paragraph (c)(2) of this section.
    (1) The requirements of paragraph (c) of this section apply to a 
clinical trial that was initiated on or after January 18, 2017 and has a 
primary completion date on or after January 18, 2017, and that is 
either:
    (i) A clinical trial of an FDA-regulated drug product (including a 
biological product) or device product that is not an applicable clinical 
trial; or
    (ii) An applicable clinical trial that is not otherwise required to 
submit clinical trial registration information.
    (2) If the responsible party for a clinical trial described in 
paragraph (c)(1) of this section voluntarily submits clinical trial 
registration information and/or clinical trial results information, the 
responsible party must comply with the following requirements:
    (i) The responsible party must submit the information in paragraph 
(c)(2)(i)(A), (B), or (C) of this section for the clinical trial being 
submitted voluntarily.
    (A) If the responsible party voluntarily registers a clinical trial, 
the responsible party must submit the clinical trial registration 
information specified in Sec.  11.28(a).
    (B) If the responsible party voluntarily submits clinical trial 
results information for a clinical trial for which the clinical trial 
registration information specified in Sec.  11.28(a) has not been 
submitted, the responsible party must submit the data elements specified 
in paragraph (b)(2)(i)(B) of this section.
    (C) If the responsible party both voluntarily submits clinical trial 
registration information and voluntarily submits clinical trial results 
information, the responsible party must submit both the clinical trial 
registration information specified in Sec.  11.28(a) and the clinical 
trial results information specified in Sec.  11.48.
    (ii) If, on or after September 27, 2007, a manufacturer submits an 
application or premarket notification to FDA for approval, licensure, or 
clearance of a drug product (including a biological product) or device 
product under section 505, 510(k), 515, or 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 
351 of the Public Health Service Act (42 U.S.C. 262) for the use studied 
in

[[Page 164]]

the clinical trial submitted under paragraph (c)(1) of this section, the 
responsible party specified in paragraph (c)(1) of this section must 
also submit the information specified in paragraph (c)(2)(iii) of this 
section by the deadline specified in paragraph (c)(2)(iv)(B) of this 
section for any applicable clinical trial that has not been submitted to 
ClinicalTrials.gov and that meets the following criteria:
    (A) The applicable clinical trial is required to be submitted to FDA 
under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) in an application or 
premarket notification for approval, licensure, or clearance to market 
the drug product (including a biological product) or device product for 
the use studied in the clinical trial specified in paragraph (c)(1) of 
this section; and
    (B) The manufacturer of the drug product (including a biological 
product) or device product studied in the applicable clinical trial is 
also the responsible party for the clinical trial specified in paragraph 
(c)(1) of this section.
    (iii) Information to be submitted for clinical trials described in 
paragraph (c)(2)(ii) of this section:
    (A) If the clinical trial information voluntarily submitted for a 
clinical trial described in paragraph (c)(1) of this section consists 
only of the clinical trial registration information specified in Sec.  
11.28(a), the information to be submitted in accordance with paragraph 
(c)(2)(ii) of this section must consist, at minimum, of the clinical 
trial registration information specified in Sec.  11.28(a).
    (B) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (c)(1) of this section consists of 
the clinical trial results information specified in Sec.  
11.60(c)(2)(i)(B), the information to be submitted in accordance with 
paragraph (c)(2)(ii) of this section must consist of the clinical trial 
results information specified in Sec.  11.60(c)(2)(i)(B).
    (C) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (c)(1) of this section consists of 
both the clinical trial registration information specified in Sec.  
11.28(a) and the clinical trial results information specified in Sec.  
11.48, the information to be submitted in accordance with paragraph 
(c)(2)(ii) of this section must consist of both the clinical trial 
registration information specified in Sec.  11.28(a) and the clinical 
trial results information specified in Sec.  11.48.
    (iv) Submission deadlines:
    (A) Secondary outcome measure(s) and adverse event information for 
voluntarily-submitted clinical trials, under paragraph (c) of this 
section:
    (1) If data collection for secondary outcome measure(s) for a 
voluntarily submitted clinical trial under paragraph (c) of this section 
is not completed by the primary completion date of the voluntarily 
submitted clinical trial, clinical trial results information for the 
secondary outcome measure(s) required in Sec.  11.48(a)(3) must be 
submitted by the later of the date that the clinical trial results 
information is voluntarily submitted for the primary outcome measure(s) 
or 1 year after the date on which the final subject was examined or 
received an intervention for the purposes of final collection of data 
for the secondary outcome(s), whether the clinical trial was concluded 
according to the pre-specified protocol or was terminated.
    (2) If data collection for adverse event information continues after 
the primary completion date of the voluntarily submitted clinical trial, 
any adverse event information collected after the primary completion 
date and subject to the submission requirements in Sec.  11.48(a)(4) 
must be submitted by the later of the date that the clinical trial 
results information is voluntarily submitted for the primary outcome 
measure(s) or 1 year after the date of final collection of data for 
adverse events information, whether the clinical trial was concluded 
according to the pre-specified protocol or was terminated.
    (B) The clinical trial information specified in paragraph 
(c)(2)(iii) of this section must be submitted not later than the later 
of the date on which the application or premarket notification to FDA 
for approval, licensure, or clearance to market a drug product 
(including a biological product) or device

[[Page 165]]

product under section 351 of the Public Health Service Act (42 U.S.C. 
262) or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use 
studied in the clinical trial specified under paragraph (c)(1) of this 
section is submitted to FDA or the date on which the clinical trial 
information specified in paragraph (c)(2)(i) of this section for the 
clinical trial specified under paragraph (c)(1) of this section is 
submitted to ClinicalTrials.gov.
    (v) All submissions of clinical trial information under paragraph 
(c) of this section are subject to the applicable update and corrections 
requirements specified in Sec.  11.64.
    (d) Statement to accompany applicable clinical trials submitted 
under paragraphs (a), (b), and (c) of this section. Each applicable 
clinical trial for which clinical trial information is submitted under 
paragraphs (a), (b), and (c) of this section and posted on 
ClinicalTrials.gov will include the statement ``This clinical trial 
information was submitted voluntarily under the applicable law and, 
therefore, certain submission deadlines may not apply. (That is, 
clinical trial information for this applicable clinical trial was 
submitted under section 402(j)(4)(A) of the Public Health Service Act 
and 42 CFR 11.60 and is not subject to the deadlines established by 
sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 
11.24 and 11.44.)''



Sec.  11.62  What requirements apply to applicable clinical trials 
for which submission of clinical trial information has been determined by 
the Director to be necessary to protect the public health?

    (a) A responsible party who receives notification that the Director 
has determined that posting of clinical trial information for an 
applicable clinical trial described in paragraph (b) of this section is 
necessary to protect the public health must submit clinical trial 
information as specified in paragraph (c) of this section.
    (b) An applicable clinical trial subject to this section must be 
either:
    (1) An applicable clinical trial of an approved, licensed, or 
cleared drug product (including a biological product) or device product 
that has a primary completion date on or after September 27, 1997; or
    (2) An applicable clinical trial that is subject to registration 
under Sec.  11.22(a) and studies a drug product (including a biological 
product) or device product that is unapproved, unlicensed, or uncleared, 
regardless of whether approval, licensure, or clearance was, is, or will 
be sought, and that is not otherwise subject to results information 
submission in accordance with the regulation.
    (c) Deadline for submission of clinical trial information:
    (1) General. Except as provided in paragraphs (c)(2) and (c)(3) of 
this section, a responsible party for an applicable clinical trial that 
is subject to this section must submit the clinical trial registration 
information specified in Sec.  11.28(a) and the clinical trial results 
information specified in Sec.  11.48(a) not later than 30 calendar days 
after the submission date specified in the notification described in 
paragraph (a) of this section.
    (2) Exception. If a responsible party submits a certification 
consistent with Sec.  11.44(b) or (c) not later than 30 calendar days 
after the submission date specified in the notification described in 
paragraph (a) of this section, the responsible party must submit the 
clinical trial results information specified in Sec.  11.48(a) not later 
than the deadline specified in Sec.  11.44(b) or (c), as applicable.
    (3) If a responsible party submitted clinical trial registration 
information describing the applicable clinical trial specified in the 
notification described in paragraph (a) of this section prior to the 
date on which the notification is sent to the responsible party, the 
responsible party must update such clinical trial information to reflect 
changes, if any, in the applicable clinical trial not later than 30 
calendar days after the submission date specified in the notification 
described in paragraph (a) of this section, irrespective of the deadline 
for updates specified in Sec.  11.64.

[[Page 166]]



Sec.  11.64  When must clinical trial information submitted to 
ClinicalTrials.gov be updated or corrected?

    (a) Updates. (1) Clinical trial registration information:
    (i) The responsible party for an applicable clinical trial for which 
clinical trial registration information was required to be submitted if 
the clinical trial was initiated before January 18, 2017, must submit 
updates in accordance with the following:
    (A) In general, changes to the clinical trial registration 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)) that was required at the time 
of submission must be updated not less than once every 12 months.
    (B) Overall Recruitment Status must be updated not later than 30 
calendar days after any change in overall recruitment status.
    (C) Primary Completion Date must be updated not later than 30 
calendar days after the clinical trial reaches its actual primary 
completion date.
    (ii) The responsible party for an applicable clinical trial, or for 
another clinical trial for which registration information was 
voluntarily submitted pursuant to Sec.  11.60(c), if the clinical trial 
was initiated on or after January 18, 2017, must submit updates in 
accordance with the following:
    (A) In general, changes to clinical trial registration information 
specified in Sec.  11.28 must be updated not less than once every 12 
months.
    (B) If the first human subject was not enrolled in the clinical 
trial at the time of registration, the Study Start Date data element 
must be updated not later than 30 calendar days after the first human 
subject is enrolled.
    (C) Intervention Name(s) must be updated to a non-proprietary name 
not later than 30 calendar days after a non-proprietary name is 
established for any intervention included in the Intervention Name(s) 
data element.
    (D) Availability of expanded access:
    (1) If expanded access to an investigational drug product (including 
a biological product) becomes available after an applicable clinical 
trial of that product has been registered, the responsible party, if 
both the manufacturer of the investigational drug product (including a 
biological product) and the sponsor of the applicable clinical trial, 
must, not later than 30 calendar days after expanded access becomes 
available, update the Availability of Expanded Access data element for 
that applicable clinical trial and, unless an expanded access record has 
already been created as required by Sec.  11.28(a)(2)(ii)(H), submit the 
data elements in accordance with Sec.  11.28(c) to create an expanded 
access record.
    (2) No later than 30 calendar days after the date on which the 
responsible party receives an NCT number for an expanded access record 
created as required by Sec.  11.28(a)(2)(ii)(H), the responsible party 
must update the Availability of Expanded Access data element by entering 
the NCT number in the clinical trial record for the applicable clinical 
trial.
    (E) Expanded access record:
    (1) Expanded Access Status, under Sec.  11.28(c)(2)(iv), must be 
updated not later than 30 calendar days after a change in the 
availability of expanded access to an investigational drug product 
(including a biological product) under section 561 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb).
    (2) Expanded Access Type, under Sec.  11.28(c)(1)(x), must be 
updated not later than 30 calendar days after a change in the type(s) of 
expanded access available for an investigational drug product (including 
a biological product) under section 561 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb).
    (F) Overall Recruitment Status must be updated not later than 30 
calendar days after any change in overall recruitment status. If, at any 
time, Overall Recruitment Status is changed to ``suspended,'' 
``terminated,'' or ``withdrawn,'' the responsible party must also submit 
the Why Study Stopped data element.
    (G) Individual Site Status must be updated not later than 30 
calendar days after a change in status for any individual site.
    (H) Human Subjects Protection Review Board Status must be updated 
not later than 30 calendar days after a change in status.

[[Page 167]]

    (I) Primary Completion Date must be updated not later than 30 
calendar days after the clinical trial reaches its actual primary 
completion date. At the time, the date is changed to ``actual,'' and the 
Enrollment data element specifying the actual number of participants 
enrolled must be submitted.
    (J) Study Completion Date must be updated not later than 30 calendar 
days after the clinical trial reaches its actual study completion date.
    (K) Responsible Party, by Official Title must be updated not later 
than 30 calendar days after a change in the responsible party or the 
official title of the responsible party.
    (L) Responsible Party Contact Information must be updated not later 
than 30 calendar days after a change in the responsible party or the 
contact information for the responsible party.
    (M) Device Product Not Approved or Cleared by U.S. FDA must be 
updated not later than 15 calendar days after a change in approval or 
clearance status has occurred.
    (N) Record Verification Date must be updated any time the 
responsible party reviews the complete set of submitted clinical trial 
information for accuracy and not less than every 12 months, even if no 
other updated information is submitted at that time.
    (O) If a protocol is amended in such a manner that changes are 
communicated to human subjects in the clinical trial, updates to any 
relevant clinical trial registration information data elements must be 
submitted not later than 30 calendar days after the protocol amendment 
is approved by a human subjects protection review board.
    (iii) In addition to the update requirements established in 
paragraphs (a)(1)(i) and (a)(1)(ii) of this section, clinical trial 
registration information must be updated at the time that clinical trial 
results information for that clinical trial is initially submitted.
    (A) If the clinical trial was initiated before January 18, 2017, a 
responsible party must submit updates to the clinical trial registration 
information described in Sec.  11.64(a)(1)(i).
    (B) If the clinical trial was initiated on or after January 18, 
2017, the responsible party must submit updates to the clinical trial 
registration information in accordance with Sec.  11.64(a)(1)(ii).
    (2) Clinical trial results information. The responsible party for an 
applicable clinical trial, or for another clinical trial for which 
results information was voluntarily submitted pursuant to Sec.  11.60(b) 
or (c), where the clinical trial has a Primary Completion Date on or 
after January 18, 2017, must submit updates in accordance with the 
following:
    (i) In general, changes to required clinical trial results 
information, other than the protocol and statistical analysis plan 
specified in Sec.  11.48(a)(5) and certain agreements specified in Sec.  
11.48(a)(6)(ii),must be updated not less than once every 12 months.
    (ii) For applicable device clinical trials of unapproved or 
uncleared device products, the responsible party must update the 
following data elements, as defined in Sec.  11.10(b), in accordance 
with the following:
    (A) Intervention Name(s) must be updated to a non-proprietary name 
not later than 30 calendar days after a non-proprietary name is 
established for any intervention included in the Intervention Name(s) 
data element.
    (B) Primary Completion Date must be updated not later than 30 
calendar days after the clinical trial reaches its actual primary 
completion date. At the time the date is changed to ``actual,'' the 
Enrollment data element specifying the actual number of participants 
enrolled must be submitted.
    (C) Study Completion Date must be updated not later than 30 calendar 
days after the clinical trial reaches its actual study completion date.
    (D) Overall Recruitment Status must be updated not later than 30 
calendar days after any change in overall recruitment status. If, at any 
time, Overall Recruitment Status is changed to ``suspended,'' 
``terminated,'' or ``withdrawn,'' the responsible party must also submit 
the Why Study Stopped data element.
    (E) Record Verification Date must be updated any time the 
responsible party reviews the complete set of submitted clinical trial 
information for accuracy and not less than every 12 months, even if no 
other updated information is submitted at that time.

[[Page 168]]

    (3) A responsible party's obligation to submit updates as specified 
in this section ends on the date on which all required clinical trial 
results information has been submitted as specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C)) and 42 U.S.C. 282(j)(3)(I)) or as specified in 
Sec.  11.48, as applicable, and corrections have been made or addressed 
in response to any electronic notice received under Sec.  11.64(b)(1). 
If no clinical trial results information is required to be submitted, a 
responsible party's obligation to submit updates to clinical trial 
registration information ends on the date on which all required clinical 
trial registration information has been submitted as specified in 
section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii) or Sec.  11.28, as applicable, and corrections have 
been made or addressed in response to any electronic notice received 
under Sec.  11.64(b)(1).
    (4) Public availability of updates. (i) Updates to clinical trial 
registration information and clinical trial results information will be 
posted in accordance with Sec.  11.35 and Sec.  11.52, respectively.
    (ii) The Director will retain prior clinical trial registration 
information and clinical trial results information and make it publicly 
available in accordance with Sec.  11.35 and Sec.  11.52, respectively, 
through ClinicalTrials.gov so that updates do not result in the removal 
of any information from the original submission or any preceding update.
    (b) Corrections--(1) Quality control. After clinical trial 
registration information has been submitted as specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) or Sec.  11.28, as applicable, or clinical trial 
results information has been submitted as specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or Sec.  11.48, as 
applicable, including the updates specified in paragraph (a) of this 
section, the Director may provide electronic notification to the 
responsible party of apparent errors, deficiencies, and/or 
inconsistencies in the submitted information identified during 
procedures for quality control review established by the Director, as 
specified at https://prsinfo.clinicaltrials.gov. The responsible party 
must correct or address all apparent errors, deficiencies, and/or 
inconsistencies identified in the notification not later than 15 
calendar days for clinical trial registration information, or 25 
calendar days for clinical trial results information, after the date of 
the electronic notification sent to the responsible party.
    (2) Other corrections. (i) A responsible party who becomes aware of 
errors, other than those specified in paragraph (b)(1) of this section, 
in any clinical trial information submitted under this part shall have 
not more than 15 calendar days for clinical trial registration 
information, or 25 calendar days for clinical trial results information, 
to correct or address such errors.
    (ii) A responsible party's obligation to correct or address errors 
as specified in paragraph (b)(2) of this section ends on the date on 
which all required clinical trial results information has been submitted 
as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public 
Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) 
or Sec.  11.48, as applicable, and corrections have been made or 
addressed in response to any electronic notice received under Sec.  
11.64(b)(1). If no clinical trial results information is required to be 
submitted, a responsible party's obligation to correct or address errors 
ends on the date on which all required clinical trial registration 
information has been submitted as specified in section 402(j)(2)(A)(ii) 
of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or Sec.  
11.28, as applicable, and corrections have been made or addressed in 
response to any electronic notice received under Sec.  11.64(b)(1).
    (3) Compliance with the quality control review process, including 
the requirements of this section, does not constitute a legal defense to 
enforcement pursuant to section 301(jj) of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 331(jj)), section 303(f)(3) of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 333(f)(3)), or any other Federal law.

[[Page 169]]



        Subpart E_Potential Legal Consequences of Non-Compliance



Sec.  11.66  What are potential legal consequences of not complying 
with the requirements of this part?

    (a) Civil or criminal judicial actions. Failure to comply with the 
requirements of this part, issued under section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)), is a prohibited act under one or 
more provisions of section 301(jj) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(jj)):
    (1) Failure to submit the certification required by section 
402(j)(5)(B) of the Public Health Service (42 U.S.C. 282(j)(5)(B)) that 
all applicable requirements of section 402(j) have been met, or 
knowingly submitting a false certification under section 402(j)(5)(B), 
is a prohibited act under section 301(jj)(1) of the Federal Food, Drug, 
and Cosmetic Act.
    (2) Failure to submit clinical trial information required under 
section 402(j) of the Public Health Service Act is a prohibited act 
under section 301(jj)(2) of the Federal Food, Drug, and Cosmetic Act.
    (3) Submission of clinical trial information under section 402(j) 
that is false or misleading in any particular is a prohibited act under 
section 301(jj)(3) of the Federal Food, Drug, and Cosmetic Act.
    (b) Civil monetary penalty actions. Any person who violates section 
301(jj) of the Federal Food, Drug, and Cosmetic Act is subject to civil 
monetary penalties under section 303(f)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333(f)(3)).
    (c) Grant funding actions. Under section 402(j)(5)(A) of the Public 
Health Service Act (42 U.S.C. 282(j)(5)(A)), if an applicable clinical 
trial is funded in whole or part by the Department of Health and Human 
Services, any required grant or progress report forms must include a 
certification that the responsible party has made all required 
registration and results submissions. If it is not verified that the 
required registration and results clinical trial information for each 
applicable clinical trial for which a grantee is the responsible party 
has been submitted, any remaining funding for a grant or funding for a 
future grant to such grantee will not be released. If the head of an HHS 
agency verifies that a grantee has not submitted such required clinical 
trial information, the agency head will provide notice to the grantee of 
the non-compliance and allow the grantee 30 days to correct the non-
compliance and submit the required clinical trial information.

[[Page 170]]



                         SUBCHAPTER B_PERSONNEL





PART 21_COMMISSIONED OFFICERS--Table of Contents



                          Subpart A_Definitions

Sec.
21.1 Meaning of terms.

                          Subpart B_Appointment

         Provisions Applicable Both to Regular and Reserve Corps

21.21 Meaning of terms.
21.22 Submission of application and evidence of qualifications.
21.23 False statements as disqualification.
21.24 Physical examinations.
21.25 Eligibility; junior assistant grade.
21.26 Eligibility; assistant grade.
21.27 Eligibility; senior assistant grade.
21.28 Age requirements, Regular Corps, senior assistant grade and below.
21.29 Eligibility; grades above senior assistant grade.
21.30 Determination of creditable years of educational and professional 
          training and experience.
21.31 Eligibility; all grades; academic and professional education and 
          professional training and experience.
21.32 Boards; appointment of; powers and duties.
21.33 General service.
21.34 Certification by candidate; requirement of new physical 
          examination.

               Provisions Applicable Only to Regular Corps

21.41 Professional examinations, holding of; subjects to be included.
21.42 Examinations; junior assistant, assistant, or senior assistant 
          grade.
21.43 Examination; full grade and above.
21.44 Clinical or other practical demonstration.
21.45 Rating values.
21.46 Merit roll.
21.47 Examination; anticipation of meeting qualifications.

               Provisions Applicable Only to Reserve Corps

21.51 Appointment of officers having specialized training or experience 
          in administration and management.
21.52 Waiver of entrance qualifications for original appointment in time 
          of war or national emergency.
21.53 Examination.
21.54 Students.
21.55 Appointment to higher grades; candidates exceptionally qualified 
          in specialized fields.
21.56 Reappointment.
21.57 Examination for reappointment.
21.58 Physical examination for reappointment.

       Subpart C_Involuntary Child and Spousal Support Allotments

21.70 Purpose.
21.71 Applicability and scope.
21.72 Definitions.
21.73 Policy.
21.74 Responsibilities.
21.75 Procedures.



                          Subpart A_Definitions

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216.



Sec.  21.1  Meaning of terms.

    As used in this part, the term:
    (a) Act means the Public Health Service Act, 58 Stat. 682, as now or 
hereafter amended.
    (b) Department means the Department of Health and Human Services.
    (c) Secretary means the Secretary of Health and Human Services.
    (d) Service means the Public Health Service.
    (e) Surgeon General means the Surgeon General of the Public Health 
Service.
    (f) Commissioned officer or officer, unless otherwise indicated, 
means either an officer of the Regular Corps or an officer of the 
Reserve Corps.

[21 FR 9806, Dec. 12, 1956]



                          Subpart B_Appointment

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216; sec. 
208, 58 Stat. 685, as amended; 42 U.S.C. 209.

    Source: 21 FR 9806, Dec. 12, 1956, unless otherwise noted.

         Provisions Applicable Both to Regular and Reserve Corps



Sec.  21.21  Meaning of terms.

    The terms approved school, approved college, approved postgraduate 
school, or

[[Page 171]]

approved training course means, except as otherwise provided by law:
    (a) A school, college, postgraduate school, or training course which 
has been accredited or approved by a professional body or bodies 
recognized by the Surgeon General for such purpose, or which, in the 
absence of such a body, meets generally accepted professional standards 
as determined by the Surgeon General, or
    (b) In the case of a candidate who is applying for appointment as a 
medical officer, any non-approved medical school provided that the 
candidate has passed examinations given by a professional body or bodies 
recognized by the Surgeon General for such purpose.

[24 FR 1790, Mar. 12, 1959]



Sec.  21.22  Submission of application and evidence of qualifications.

    (a) Application form. Every candidate for examination for 
appointment as an officer shall submit a written application on such 
form as may be prescribed by the Surgeon General.
    (b) Documentary evidence. The application shall be accompanied by 
such documentary evidence as may be required by the Surgeon General.



Sec.  21.23  False statements as disqualification.

    Willfully false statements shall be cause for rejection of the 
application or, as provided in subpart N of this part, for dismissal.



Sec.  21.24  Physical examinations.

    Every candidate for appointment as an officer shall undergo such 
physical examination as the Surgeon General may direct, and no candidate 
who is not found to be physically qualified shall be appointed as an 
officer.



Sec.  21.25  Eligibility; junior assistant grade.

    (a) Requirements; all candidates. Except as provided in Sec.  21.54, 
and as otherwise provided in this section, every candidate for 
examination for appointment in the grade of junior assistant:
    (1) Shall be a citizen of the United States;
    (2) Shall be at least 18 years of age; and
    (3) Shall have been granted an academic or professional degree from 
an approved school, college, or postgraduate school, and, unless the 
required professional training has been otherwise obtained from an 
approved school, college, or postgraduate school, shall have majored in 
the profession in which the examination is being held.
    (b) [Reserved]
    (c) Special requirement; therapists. Every candidate for examination 
for appointment as a therapist shall have received a certificate from an 
approved school of physical therapy or an approved school of 
occupational therapy.

[21 FR 9806, Dec. 12, 1956, as amended at 30 FR 9437, July 29, 1965]



Sec.  21.26  Eligibility; assistant grade.

    (a) Requirements; all candidates. Except as otherwise provided in 
this section every candidate for examination for appointment in the 
grade of assistant:
    (1) Shall meet the requirements for eligibility for examination for 
appointment in the grade of junior assistant;
    (2) Shall be at least 21 years of age; and
    (3) Shall have had at least 7 years of educational and professional 
training or experience subsequent to high school, except that a 
candidate who applies for examination for appointment in the Reserve 
Corps to serve as a medical or dental intern may be examined for such 
appointment upon the completion of 6 years of such education, training, 
or experience.
    (b) Additional requirements; dietitians. Every candidate for 
examination for appointment as a dietitian shall have successfully 
completed an approved training course for dietetic interns.



Sec.  21.27  Eligibility; senior assistant grade.

    Every candidate for examination for appointment in the grade of 
senior assistant shall meet the requirements for eligibility for 
examination for appointment in the grade of assistant and shall have 
completed at least 10 years of educational and professional training or 
experience subsequent to high school.

[[Page 172]]



Sec.  21.28  Age requirements, Regular Corps, senior assistant grade and below.

    No candidate for appointment to the Regular Corps, except in the 
nurse category, shall be appointed (a) after age 31 to the permanent 
junior assistant grade, (b) after age 34 to the permanent assistant 
grade, or (c) after age 37 to the permanent senior assistant grade: 
Provided, That the Surgeon General may waive these age limitations, 
subject to other provisions of law, in the case of any officer of the 
Reserve Corps who is recommended for appointment to the Regular Corps by 
the Chief of the Bureau to which he is assigned and who has been on 
continuous active duty for at least two years immediately preceding the 
date of such recommendation. The age limitations for candidates who have 
had prior active service in the Commissioned Corps of the Public Health 
Service shall be increased by the period of such service.

[27 FR 3886, Apr. 24, 1962]



Sec.  21.29  Eligibility; grades above senior assistant grade.

    Every candidate for examination for appointment in grades above that 
of senior assistant shall meet the requirements for eligibility for 
examination for appointment in the grade of senior assistant. Candidates 
for examination for appointment in the full, senior, or director grade 
shall have completed at least 7, 14, or 15 additional years, 
respectively, of postgraduate professional training for experience. When 
officers of the Service are unavailable for the performance of duties 
requiring highly specialized training and experience in special fields 
related to public health, the Surgeon General may specify that a 
candidate for appointment to the Regular Corps with such highly 
specialized training and experience shall be examined for appointment in 
the full or senior grade upon completion of at least 5 or 12 additional 
years, respectively, of postgraduate professional training or 
experience, except that the total number of such appointments during a 
fiscal year shall not exceed three.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]



Sec.  21.30  Determination of creditable years of educational 
and professional training and experience.

    The level of academic attainment, the number of calendar years and 
the quality of educational and professional training and experience 
shall be considered in determining the number of years of such training 
and experience with which each candidate for appointment may be 
credited.

[25 FR 5184, June 10, 1960]



Sec.  21.31  Eligibility; all grades; academic and professional education 
and professional training and experience.

    The Surgeon General is authorized, subject to the other provisions 
of this subpart to adopt additional standards by which the education, 
training, and experience required under this subpart, and evidence 
thereof, shall be of such specific kind and quality, pertinent to the 
particular profession concerned, as in his judgment are necessary to 
limit the examination to qualified candidates.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]



Sec.  21.32  Boards; appointment of; powers and duties.

    The Surgeon General shall from time to time appoint boards and 
subboards of officers to consider the qualifications of candidates for 
appointment as officers, and shall refer to such boards the applications 
of those candidates who are eligible for examination for appointment. 
Such boards and subboards shall consist of three or more officers, the 
majority of whom, so far as practicable, shall be of the same profession 
as the candidate. The Surgeon General shall prescribe the duties of 
boards and subboards in relation to the examination process not 
otherwise prescribed in this subpart.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]



Sec.  21.33  General service.

    Officers shall be appointed only to general service and shall be 
subject to change of station.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]

[[Page 173]]



Sec.  21.34  Certification by candidate; requirement of new 
physical examination.

    If a candidate for appointment in the Regular Corps or an officer of 
the Reserve Corps on inactive service has passed a physical examination 
within a period of one year from the date on which it is contemplated 
that he will be appointed or called to active duty, he shall, prior to 
being appointed or called to active duty, certify that to the best of 
his knowledge and belief he is free from all disease or injury not noted 
in his record at the time of his examination and that he is willing to 
serve in any climate. If a candidate for appointment in the Regular 
Corps, or an officer of the Reserve Corps on inactive service, has not 
passed a physical examination within a period of one year from the date 
on which it is contemplated that he will be appointed or called to 
active duty, he may, prior to being appointed or called to active duty, 
be required to undergo such physical examination as the Surgeon General 
may direct to determine his physical qualification for appointment or 
call to active duty in accordance with standards prescribed for original 
appointment, or he may be appointed or called to active duty after 
executing the certificate described in this section, but shall be 
physically examined to determine his physical qualification for 
continued active service in accordance with standards prescribed for 
original appointment within a period of 15 days after reporting for duty 
at his first station.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959. 
Redesignated at 25 FR 5184, June 10, 1960]

               Provisions Applicable Only to Regular Corps



Sec.  21.41  Professional examinations, holding of; subjects to be included.

    From time to time the Surgeon General may order examinations to be 
held in such professions or specialties within professions and for such 
grades as he deems necessary for the purpose of providing merit rolls of 
eligible candidates for appointment in the Regular Corps and shall, if a 
professional examination is to be required, prescribe the subjects 
relating to each profession or specialty within such profession in which 
candidates will be examined.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]



Sec.  21.42  Examinations; junior assistant, assistant, 
or senior assistant grade.

    The examination for appointment to the junior assistant, assistant, 
or senior assistant grade in the Regular Corps shall consist of (a) a 
written professional examination relating to the fundamentals of the 
candidate's profession or specialty within his profession and their 
relationship to the activities of the Service, and (b) an examination as 
to the candidate's general fitness, which shall include an oral 
interview, and a review and evaluation of the candidate's academic and 
professional education and professional training and experience, and may 
include other written tests to determine the candidate's fitness for 
appointment as an officer. If an applicant for appointment to any of 
these grades is an officer of the Reserve Corps who has been on active 
duty for not less than one year immediately preceding his application, 
the Surgeon General may direct that the officer be examined as provided 
in Sec.  21.43.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959; 25 
FR 11099, Nov. 23, 1960]



Sec.  21.43  Examination; full grade and above.

    The examination for appointment to the full, senior, or director 
grade in the Regular Corps shall consist of a review and evaluation of 
the candidate's academic and professional education and professional 
training and experience. The Surgeon General may, however, direct that 
the examination of a candidate for appointment to any such grade shall 
also include an oral interview, a written or oral professional 
examination, or both.



Sec.  21.44  Clinical or other practical demonstration.

    In the discretion of the Surgeon General a candidate for appointment 
to any grade up to and including the senior assistant grade in the 
Regular

[[Page 174]]

Corps may be required to perform successfully a clinical or other 
practical demonstration which, if required, shall constitute a part of 
the professional examination.



Sec.  21.45  Rating values.

    The examination of every candidate for appointment to any grade in 
the Regular Corps shall be rated by a board appointed pursuant to Sec.  
21.30 in accordance with such relative values for each part of the 
examination as are prescribed by the Surgeon General. No candidate who 
receives a final rating below 80 shall be appointed in the Regular 
Corps.



Sec.  21.46  Merit roll.

    Each board appointed pursuant to Sec.  21.30 to consider the 
qualifications of candidates for appointment as officers shall assign a 
numerical rating to each candidate for appointment in the Regular Corps 
who passes the examination, and shall submit a report to the Surgeon 
General of the ratings and the relative standing of all such candidates 
for each grade in each profession or specialty within a profession. The 
Surgeon General shall submit each such report with his recommendations 
to the Secretary, and, if approved by the Secretary, the report shall 
constitute a merit roll from which the Secretary shall, in accordance 
with relative standing, recommend available persons to the President for 
nomination as commissioned officers of the Regular Corps. A board may 
consider any newly discovered evidence relating to the physical, 
professional, or personal qualifications of any candidate examined for 
appointment. Upon recommendation of such board after review of such 
evidence, the Surgeon General, with the approval of the Secretary, may 
correct the rating of a candidate or may qualify or disqualify a 
candidate. The placing of a candidate's name on a merit roll shall give 
no assurance of an appointment. A merit roll shall expire when a new 
merit roll in the same profession or specialty within a profession and 
grade has been established, but no merit roll shall continue in effect 
longer than two years after its approval by the Secretary. Every 
candidate who has not been nominated by the President for appointment 
prior to the expiration of a merit roll on which his name appears, 
shall, unless he requests the opportunity to be reexamined, be rated 
with the next group of candidates of the same profession or specialty 
within a profession for appointment in the same grade and shall be given 
the same rating he had on the expired merit roll. If two candidates who 
were examined at the same time receive the same numerical rating the 
elder candidate shall assume relative standing on the merit roll over 
the younger candidate. If a candidate whose name is being transferred 
from an expired to a new merit roll has the same numerical rating as a 
candidate whose name is being placed on the new merit roll for the first 
time, the former shall assume relative standing on the merit roll over 
the latter. The name of a candidate may be removed from a merit roll in 
the event that he refuses an appointment when offered. No candidate's 
eligibility for appointment shall exceed two years unless he again 
becomes eligible as the result of another examination.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]



Sec.  21.47  Examination; anticipation of meeting qualifications.

    A potential candidate for appointment in any grade in the Regular 
Corps may be examined within a period of nine months prior to the date 
upon which it is anticipated that he will qualify for appointment under 
this subpart. Upon successful completion of the examination, his name 
will be entered on a merit roll. In the event that his name, in order of 
relative standing among all candidates, precedes that of fully qualified 
candidates, his name, for purpose of appointment, shall be passed over 
in favor of fully qualified candidates until such time as he becomes 
fully qualified, but in no event shall he otherwise lose his relative 
standing on the merit roll, except as provided in Sec.  21.46. If the 
candidate fails to qualify for appointment at the time that it was 
anticipated that he would qualify, his name shall be removed from the 
merit roll.

[[Page 175]]

               Provisions Applicable Only to Reserve Corps



Sec.  21.51  Appointment of officers having specialized training 
or experience in administration and management.

    The Surgeon General may recommend for original appointment in the 
Reserve Corps candidates who have specialized training or experience in 
administration and management relating to the functions of the Service. 
All such candidates shall be subject to the same eligibility 
requirements for original appointment as are applicable to other 
candidates, except that such a candidate may substitute experience in 
administration or management for the requirement of professional 
training or experience.



Sec.  21.52  Waiver of entrance qualifications for original appointment 
in time of war or national emergency.

    If, in time of war or national emergency proclaimed by the 
President, the Secretary determines that there is need for commissioned 
personnel to meet the needs of the Service, other than persons eligible 
for examination for original appointment under the eligibility 
requirements prescribed in this subpart, he may prescribe standards of 
eligibility for examination for the original appointment of officers in 
the Reserve Corps without regard to such eligibility requirements. Such 
standards shall, however, authorize the examination only of candidates 
with specialized experience in administration or management or 
candidates with training or experience in fields relating to public 
health. The permanent grade of an officer who becomes eligible for 
examination for appointment pursuant to such standards and who becomes 
eligible for appointment after passage of an examination shall be 
limited to the junior assistant or the assistant grade, except that, if 
upon examination a candidate is found to be exceptionally qualified for 
the performance of highly specialized duties with the Service pursuant 
to Sec.  21.55, he may be recommended for appointment to any grade up to 
and including the director grade.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]



Sec.  21.53  Examination.

    The examination of candidates for original appointment as officers 
to any grade in the Reserve Corps shall consist of a review and 
evaluation of their academic and other education and their training and 
experience. In the discretion of the Surgeon General the examination of 
any such candidate may include an oral interview, a written examination, 
or both.



Sec.  21.54  Students.

    A potential candidate for appointment in the Regular Corps who is 
pursuing a course of instruction which, upon completion, would qualify 
him under Sec.  21.25 or Sec.  21.26 for examination for appointment in 
the junior assistant or assistant grade may be examined for and 
appointed in the Reserve Corps in the junior assistant grade but shall 
not be called to extended active duty until the successful completion of 
such course of instruction, except that: (a) He may be called to active 
duty for purposes of training for periods not to exceed 120 days during 
any fiscal year, and (b) those students who have completed at least 3 
years of collegiate or professional study leading to the qualifying 
degree for appointment may be called to active duty for the purpose of 
completing the requirements of Sec.  21.25(a)(3). An appointment made 
under this subpart shall be terminated upon the officer's failure to 
continue a full-time course of study or failure to meet the requirements 
of Sec.  21.25(a)(3) within 18 months after entering on active duty.

[34 FR 706, Jan. 17, 1969]



Sec.  21.55  Appointment to higher grades; candidates exceptionally qualified 
in specialized fields.

    Any candidate eligible for examination for appointment in the grade 
of assistant pursuant to Sec.  21.26 who, upon examination for such 
purpose, is found

[[Page 176]]

exceptionally qualified for the performance of duties requiring highly 
specialized training or experience may be recommended for appointment in 
the Reserve Corps in any grade up to and including the director grade 
without regard to the additional years of postgraduate training or 
experience prescribed for grades above the assistant grade.



Sec.  21.56  Reappointment.

    An officer of the Reserve Corps, after being examined and found 
qualified for reappointment, may be recommended for reappointment to the 
same grade in the event that his commission expires before he becomes 
eligible for reappointment to a higher grade, or may be recommended for 
reappointment to a higher grade to be effective on or after the date on 
which he meets the qualifications prescribed in this subpart for 
original appointment to such higher grade.



Sec.  21.57  Examination for reappointment.

    The examination of an officer of the Reserve Corps on active duty 
who is being considered for reappointment in such corps shall consist of 
a review and evaluation of his record with the Service. The examination 
of an officer of the Reserve Corps on inactive duty who is being 
considered for reappointment in such corps shall consist of (a) a review 
and evaluation of his record with the Service while on active duty, if 
any, and (b) the record of his training or experience during the period 
of his inactive duty preceding such examination. In the discretion of 
the Surgeon General the examination for reappointment of an officer, 
whether on active or inactive duty, may include an oral interview.



Sec.  21.58  Physical examination for reappointment.

    Every officer of the Reserve Corps being considered for 
reappointment shall undergo such physical examination as the Surgeon 
General may direct. An officer on active duty may be recommended for 
reappointment unless he is found to have a physical disability which is 
determined to render him physically unfit to perform the duties of his 
office under section 402 of the Career Compensation Act of 1949, as 
amended. An officer may be recommended for promotion only if he meets 
the physical qualifications for original appointment. If an officer is 
not available to be physically examined because of circumstances which 
make it impracticable for the Service to require such examination, he 
may, in the discretion of the Surgeon General, be reappointed without 
such examination, but shall be examined as soon thereafter as 
practicable and his physical qualification or disqualification for 
continued or future active service shall be determined on the same basis 
as if the physical examination had been given prior to reappointment.



       Subpart C_Involuntary Child and Spousal Support Allotments

    Authority: 37 U.S.C. 101, 15 U.S.C. 1673, 42 U.S.C. 665.

    Source: 49 FR 7235, Feb. 24, 1984, unless otherwise noted.



Sec.  21.70  Purpose.

    Under references 37 U.S.C. 101, 15 U.S.C. 1673, and 42 U.S.C. 665, 
this subpart provides implementing policies governing involuntary child 
or child and spousal support allotments, assigns responsibilities, and 
prescribes procedures.



Sec.  21.71  Applicability and scope.

    (a) This subpart applies to officers in the Public Health Service 
Commissioned Corps. The term ``Public Health Service,'' hereinafter 
shall be referred to as Service.
    (b) Its provisions pertain to officers of the Service under a call 
or order to active duty for a period of six months or more.



Sec.  21.72  Definitions.

    (a) Child support. Periodic payments for the support and maintenance 
of a child or children, subject to and in accordance with State or local 
law. This includes, but is not limited to payments to provide for health 
care, education, recreation, clothing, or to meet

[[Page 177]]

other specific needs of such a child or children.
    (b) Spousal support. Periodic payments for the support and 
maintenance of a spouse or former spouse in accordance with State or 
local law. It includes, but is not limited to, separate maintenance, 
alimony pendente lite, and maintenance. Spousal support does not include 
any payment for transfer of property or its value by an individual to 
his or her spouse or former spouse in compliance with any community 
property settlement, equitable distribution of property, or other 
division of property between spouse or former spouse.
    (c) Notice. A court order, letter, or similar documentation issued 
by an authorized person, which provides notification that an officer has 
failed to make periodic support payments under a support order.
    (d) Support order. Any order providing for child or child and 
spousal support issued by a court of competent jurisdiction or by 
administrative procedures established under State law that affords 
substantially due process and is subject to judicial review. A court of 
competent jurisdiction includes Indian tribal courts within any State, 
territory, or possession of the United States and the District of 
Columbia.
    (e) Authorized person. (1) Any agent or attorney of any State having 
in effect a plan approved under part D of title IV of the Social 
Security Act (42 U.S.C. 651-665), who has the duty or authority to seek 
recovery of any amounts owed as child or child and spousal support 
(including, when authorized under a State plan, any official of a 
political subdivision); and (2) the court which has authority to issue 
an order against the officer for the support and maintenance of a child, 
or any agent of such court.
    (f) Active duty. Full-time duty in the Service, including full-time 
training duty.
    (g) Legal officer. Shall be an officer of the Service or employee of 
the Department who is a lawyer and who has substantial knowledge of the 
regulations, policies, and procedures relating to the implementation of 
section 172 of Pub. L. 97-248.



Sec.  21.73  Policy.

    (a) It is the policy of the Department of Health and Human Services 
to withhold allotments from pay and allowances of commissioned officers 
on active duty in the Service to make involuntary allotments from pay 
and allowances as payment of child, or child and spousal, support 
payments when the officer has failed to make periodic payments under a 
support order in a total amount equal to the support payable for two 
months or longer. Failure to make such payments shall be established by 
notice from an authorized person to the designated official of the 
Department. Such notice shall specify the name and address of the payee 
to whom the allotment is payable. The amount of the allotment shall be 
the amount necessary to comply with the support order including amounts 
for arrearages as well as for current support. However the amount of the 
allotment, when added to any other amounts withheld from the officer's 
pay pursuant to a support order, shall not exceed the limits for 
involuntary allotments from pay as prescribed in section 303 (b) and (c) 
of the Consumer Credit Protection Act, 15 U.S.C. 1673. An allotment 
under this Subpart shall be adjusted or discontinued upon notice from 
any authorized person.
    (b) Notwithstanding the above, no action shall be taken to withhold 
an allotment from the pay and allowances of any officer until such 
officer has had an opportunity to consult with a legal officer of the 
Department to discuss the legal and other factors involved with respect 
to the officer's support obligation and his or her failure to make 
payments. The Department shall exercise continuing good faith efforts to 
arrange such a consultation, but must begin to withhold allotments on 
the first end-of-month payday after 30 days have elapsed since notice of 
an opportunity to consult was sent to the officer.



Sec.  21.74  Responsibilities.

    (a) The General Counsel, Office of the Secretary, Department of 
Health and Human Services, shall be the Designated Official for the 
Department

[[Page 178]]

and shall provide guidance to the Service regarding administration of 
the provisions of these regulations.
    (b) The Commissioned Personnel Operations Division, Office of 
Personnel Management, Office of Management, Office of the Assistant 
Secretary for Health, shall implement the provisions of these 
regulations.



Sec.  21.75  Procedures.

    (a) Service of notice. (1) An authorized person shall serve on the 
designated official of the Department a signed notice including:
    (i) Full name of the officer;
    (ii) Social security number of the officer;
    (iii) Duty station location of the officer, if known;
    (iv) A statement that support payments are delinquent by an amount 
at least equal to the amount of support payable for two months;
    (v) A photocopy, along with any modifications, of the underlying 
support order;
    (vi) A statement of the amount of arrearages provided for in the 
court order and the amount which is to be applied each month toward 
liquidation of the arrearages, if applicable;
    (vii) The full name and address of the payee to whom the allotment 
will be payable;
    (viii) Any limitations on the duration of the support allotment.
    (2) The service of notice shall be accomplished by certified or 
registered mail, return receipt requested, or by personal service, upon 
the appropriate designated official of the Department. The designated 
official shall note the date and time of receipt on the notice.
    (3) Valid service is not accomplished until the notice is received 
in the office of the designated official.
    (4) If the order of a court or duly authorized administrative agency 
seeks collection of arrearages, the notice must state that the support 
allotment qualifies for the additional 5 percent in excess of the 
maximum percentage limitations found in 15 U.S.C. 1673. Supporting 
evidence must be submitted to the Department establishing that the 
support order is 12 or more weeks in arrears.
    (5) When the information submitted is not sufficient to identify the 
officer the notice shall be returned directly to the authorized person 
with an explanation of the deficiency. However, before returning the 
notice, an attempt should be made to inform the authorized person who 
caused the notice to be served that it will not be honored unless 
adequate information is supplied.
    (6) Upon proper service of notice of delinquent support payments and 
together with all required supplementary documents and information, the 
Service shall identify the officer from whom moneys are due and payable. 
The pay of the officer shall be reduced by the amount necessary to 
comply with the support order and liquidate arrearages if any, if 
provided by order of a court or duly authorized administrative agency. 
The maximum amount to be alloted under the provision together with any 
other moneys withheld from the officer for support pursuant to a court 
order may not exceed:
    (i) 50 percent of the officer's disposable earnings for any month 
when the officer asserts by affidavit or other acceptable evidence that 
he or she is supporting a spouse or dependent child or both, other than 
a party in the support order. When the officer submits evidence, copies 
shall be sent to the authorized person, together with notification that 
the officer's support claim will be honored. If the support claim is 
contested by the authorized person, the authorized person may refer it 
to the appropriate court or other authority for resolution. Pending 
resolution of a contested support claim, the allotment shall be made but 
the amount of such allotment may not exceed 50 percent of the officer's 
disposable earnings;
    (ii) 60 percent of the officer's disposable earnings for any month 
when the officer fails to assert by affidavit or other acceptable 
evidence, that he or she is supporting a spouse or dependent child or 
both;
    (iii) Regardless of the limitations above, an additional five 
percent of the officer's disposable earnings shall be withheld when it 
is stated in the notice that the officer is in arrears in an amount 
equivalent to 12 or more weeks' support.

[[Page 179]]

    (b) Disposable earnings. (1) The following moneys, as defined in the 
U.S. Public Health Service Commissioned Corps Personnel Manual, are 
subject to inclusion in computation of the officer's disposable 
earnings:
    (i) Basic pay;
    (ii) Basic allowances for quarters for officers with dependents and 
officers without dependents;
    (iii) Basic allowance for subsistence;
    (iv) Special pay for physicians, dentists, optometrists, and 
veterinarians;
    (v) Hazardous duty pay;
    (vi) Flying pay; and
    (vii) Family separation allowances (only for officers assigned 
outside the contiguous United States).
    (c) Exclusions. The following moneys are excluded from the 
computation of the officer's disposable earnings. Amounts due from or 
payable by the United States shall be offset by any amounts:
    (1) Owed by the officer to the United States.
    (2) Required by law to be deducted from the remuneration or other 
payment involved including but not limited to:
    (i) Amounts withheld from benefits payable under title II of the 
Social Security Act when the withholding is required by law;
    (ii) FICA.
    (3) Properly withheld for Federal and State income tax purposes if 
the withholding of the amounts is authorized or required by law and if 
amounts withheld are not greater than would be the case if the 
individual claimed all dependents to which he or she were entitled. The 
withholding of additional amounts pursuant to 26 U.S.C. 3402(i) may be 
permitted only when the officer presents evidence of a tax obligation 
which supports the additional withholding.
    (4) Deducted for the Servicemen's Group Life Insurance coverage.
    (5) Advances of pay that may be due and payable by the officer in 
the future.
    (d) Officer Notification. (1) As soon as possible, but not later 
than 30 calendar days after the date of receipt of notice, the 
Commissioned Personnel Operations Division shall send to the officer at 
his or her duty station, written notice:
    (i) That notice has been served, including a copy of the documents 
submitted;
    (ii) Of the maximum limitations set forth, with a request that the 
officer submit supporting affidavits or other documentation necessary 
for determining the applicable percentage limitation;
    (iii) That by submitting supporting affidavits or other necessary 
documentation, the officer consents to the disclosure of such 
information to the party requesting the support allotment;
    (iv) Of the amount of percentage that will be deducted if the 
officer fails to submit the documentation necessary to enable the 
designated official of the Service to respond to the legal process 
within the time limits set forth;
    (v) That a consultation with a legal officer is authorized and will 
be provided by the Department. The name, address, and telephone number 
of the legal officer will be provided;
    (vi) That the officer may waive the personal consultation with a 
legal officer; however if consultation is waived action will be taken to 
initiate the allotment by the first end-of-month payday after 
notification is received that the officer has waived his/her 
consultation;
    (vii) That the allotment will be initiated without the officer 
having received a personal consultation with a legal officer if the 
legal officer provides documentation that consultation could not be 
arranged even though good faith attempts to do so had been made; and
    (viii) Of the date that the allotment is scheduled to begin.
    (2) The Commissioned Personnel Operations Division shall inform the 
appropriate legal officer of the need for consultation with the officer 
and shall provide the legal officer with a copy of the notice and other 
legal documentation served on the designated official.
    (3) If possible, the Commissioned Personnel Operations Division 
shall provide the officer with the following:
    (i) A consultation in person with the appropriate legal officer to 
discuss the legal and other factors involved with

[[Page 180]]

the officer's support obligation and his/her failures to make payment;
    (ii) Copies of any other documents submitted with the notice.
    (4) The legal officer concerned will confirm in writing to the 
Commissioned Personnel Operations Division within 30 days of notice that 
the officer received a consultation concerning the officer's support 
obligation and the consequences of failure to make payments. The legal 
officer concerned must advise the Commissioned Personnel Operations 
Division of the inability to arrange such consultation and the status of 
continuing efforts to contact the officer.
    (e) Lack of money. (1) When notice is served and the identified 
officer is found not to be entitled to any moneys due from or payable by 
the Department of Health and Human Services, the Commissioned Personnel 
Operations Division shall return the notice to the authorized person, 
and advise in writing that no moneys are due from or payable by the 
Department of Health and Human Services to the named individual.
    (2) Where it appears that moneys are only temporarily exhausted or 
otherwise unavailable, the Commissioned Personnel Operations Division 
shall advise the authorized person in writing on a timely basis as to 
why, and for how long, the moneys will be unavailable.
    (3) In instances where the officer separates from active duty, the 
authorized person shall be informed in writing on a timely basis that 
the allotment is discontinued.
    (f) Effective date of allotment. Allotments shall be withheld 
beginning on the first end-of-month payday after the Commissioned 
Personnel Operations Division is notified that the officer has had a 
consultation with a legal officer, has waived his/her right to such 
consultation, or the legal officer has submitted documentation that a 
consultation with the officer could not be arranged after good faith 
attempts to do so were made by the legal officer. The Service shall not 
be required to vary its normal allotment payment cycle to comply with 
the notice.
    (g) Designated official. Department of Health and Human Services, 
General Counsel, Room 5362 North Building, 330 Independence Avenue, SW., 
Washington, DC 20201.

(Approved by the Office of Management and Budget under control number 
0937-0123)



PART 22_PERSONNEL OTHER THAN COMMISSIONED OFFICERS--Table of Contents



   Hansen's Disease Duty by Personnel Other Than Commissioned Officers

                           Special Consultants

Sec.
22.3 Appointment of special consultants.
22.5 Leave without pay while on detail.

    Authority: Sec. 208(e) of the Public Health Service Act, 42 U.S.C. 
210(e); E.O. 11140, 29 FR 1637.

   Hansen's Disease Duty by Personnel Other Than Commissioned Officers

                           Special Consultants



Sec.  22.3  Appointment of special consultants.

    (a) When the Public Health Service requires the services of 
consultants who cannot be obtained when needed through regular Civil 
Service appointment or under the compensation provisions of the 
Classification Act of 1949, special consultants to assist and advise in 
the operations of the Service may be appointed, subject to the 
provisions of the following paragraphs and in accordance with such 
instructions as may be issued from time to time by the Secretary of 
Health and Human Services.
    (b) Appointments, pursuant to the provisions of this section, may be 
made by those officials of the Service to whom authority has been 
delegated by the Secretary or his designee.
    (c) The per diem or other rates of compensation shall be fixed by 
the appointing officer in accordance with criteria established by the 
Surgeon General.

(Sec. 208(c), 58 Stat. 686, as amended; 42 U.S.C. 209(e); sec. 207(f), 
58 Stat. 686 as amended by 62 Stat. 40; 42 U.S.C. 209(f))

[21 FR 9821, Dec. 12, 1956, as amended at 31 FR 12939, Oct. 5, 1966]

[[Page 181]]



Sec.  22.5  Leave without pay while on detail.

    The Secretary or his delegate may, pursuant to section 214(d) of the 
Public Health Service Act, 42 U.S.C. 215(d), and with the consent of the 
officer or employee concerned, arrange, through agreements or otherwise, 
for a civilian officer or employee of the Public Health Service to be 
placed on leave without pay for the period of a detail to a State, a 
subdivision thereof, or a private non-profit institution and be paid by 
the non-Federal organization. Such an arrangement may be for a period of 
not to exceed 2 years, but may be extended for additional periods of not 
to exceed 2 years each.

(Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216)

[33 FR 18981, Dec. 20, 1968]



PART 23_NATIONAL HEALTH SERVICE CORPS--Table of Contents



     Subpart A_Assignment of National Health Service Corps Personnel

Sec.
23.1 To what entities does this regulation apply?
23.2 Definitions.
23.3 What entities are eligible to apply for assignment?
23.4 How must an entity apply for assignment?
23.5 What are the criteria for deciding which applications for 
          assignment will be approved?
23.6 What are the criteria for determining the entities to which 
          National Health Service Corps personnel will be assigned?
23.7 What must an entity agree to do before the assignment is made?
23.8 What operational requirements apply to an entity to which National 
          Health Service Corps personnel are assigned?
23.9 What must an entity to which National Health Service Corps 
          personnel are assigned (i.e., a National Health Service Corps 
          site) charge for the provision of health services by assigned 
          personnel?
23.10 Under what circumstances may a National Health Service Corps 
          site's reimbursement obligation to the Federal Government be 
          waived?
23.11 Under what circumstances may the Secretary sell equipment or other 
          property of the United States used by the National Health 
          Service Corps site?
23.12 Who will supervise and control the assigned personnel?
23.13 What nondiscrimination requirements apply to National Health 
          Service Corps sites?

    Authority: Secs. 333, 338E(c), and 338C(e)(1), Public Health Service 
Act. 90 Stat. 2272, as amended, 95 Stat. 905, 97 Stat. 1345 (42 U.S.C. 
254f et seq.), 95 Stat. 912 (42 U.S.C. 254p(c)), 95 Stat. 910 (42 U.S.C. 
254n(e)(1)).

    Source: 45 FR 12790, Feb. 27, 1980, unless otherwise noted.



     Subpart A_Assignment of National Health Service Corps Personnel



Sec.  23.1  To what entities does this regulation apply?

    This regulation applies to the assignment of National Health Service 
Corps personnel under section 333 et seq. of the Public Health Service 
Act (42 U.S.C. 254f) to provide health services in or to health manpower 
shortage areas as designated under section 332 of the Public Health 
Service Act (42 U.S.C. 254e).



Sec.  23.2  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Assigned National Health Service Corps personnel or Corps personnel 
means health personnel of the Regular and Reserve Corps of the Public 
Health Service Commissioned Corps and civilian personnel as designated 
by the Secretary including, but not limited to, physicians, dentists, 
nurses, and other health professions personnel who are assigned under 
section 333 of the Act and this regulation.
    Health manpower shortage area means the geographic area, the 
population group, the public or nonprofit private medical facility or 
any other public facility which has been determined by the Secretary to 
have a shortage of health manpower under section 332 of the Act and its 
implementing regulation (42 CFR part 5).
    National Health Service Corps site means the entity to which 
personnel have been assigned under section 333 of the Act and this 
regulation to provide health services in or to health manpower shortage 
area.
    Nonprofit private entity means as entity which may not lawfully hold 
or use

[[Page 182]]

any part of its net earnings to the benefit of any private shareholder 
or individual and which does not hold or use its net earnings for that 
purpose.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of that Department to whom the authority 
involved has been delegated.



Sec.  23.3  What entities are eligible to apply for assignment?

    Any public or nonprofit private entity which is located in a health 
manpower shortage area, or has a demonstrated interest in the shortage 
area, may apply for the assignment of National Health Service Corps 
personnel.



Sec.  23.4  How must an entity apply for assignment?

    (a) An application for the assignment of National Health Service 
Corps personnel must be submitted to the Secretary by an eligibe 
applicant in the form and at the time prescribed by the Secretary. \1\ 
The application must be signed by an individual authorized to act for 
the applicant and to assume on behalf of the applicant the obligations 
imposed by law, the Act, this regulation, and any additional conditions 
of assignment imposed under these authorities.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from Regional 
Offices of the Department of Health and Human Services at the addresses 
set forth at 45 CFR 5.31(b).
---------------------------------------------------------------------------

    (b) In addition to other pertinent information required by the 
Secretary, an application for the assignment of Corps personnel must 
include--
    (1) A description of the applicant's overall organizational 
structure;
    (2) A justification of the request for the assignment of personnel 
based upon the needs of the health manpower shortage area;
    (3) A description of the applicant's financial plan for operating 
the National Health Service Corps site including a proposed budget, 
sources of non-Federal support obtained, and the proposed expenditures 
for obtaining adequate support staff, equipment and supplies;
    (4) A list of the proposed fees and discounted fees to be charged 
for the provision of health services; and
    (5) If an entity wishes to request an interest free loan (not to 
exceed $50,000) under section 335(c) of the Act to assist the applicant 
in establishing the practice of the assigned National Health Service 
Corps personnel, a detailed justification of the amount requested must 
be included.
    (c) An application for assignment must include evidence that the 
applicant has provided a copy of the completed application for review to 
(1) each health systems agency designated under section 1515 of the Act 
for the health service area which includes all or part of the health 
manpower shortage area for which as assignment of National Health 
Service Corps personnel is sought or (2) if no health systems agency has 
been designated for such a health service area, to each State health 
planning and development agency designated under section 1521 of the Act 
for each State which includes all or part of the health manpower 
shortage area for which an assignment of National Health Service Corps 
personnel is sought.
    (d) If an application for assignment is filed by an applicant which 
had previously been assigned National Health Service Corps personnel 
under an agreement entered into under section 329 of the Act as in 
effect before October 1, 1977, or under section 334 of the Act, the 
applicant must provide the information the Secretary considers necessary 
to make the determinations required by section 333(a)(1)(D) of the Act.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec.  23.5  What are the criteria for deciding which applications 
for assignment will be approved?

    (a) In approving or disapproving an application for assignment of 
Corps personnel, the Secretary will consider, among other pertinent 
factors:
    (1) The applicant's ability and plans to meet the operational 
requirements in Sec.  23.8.
    (2) The administrative and managerial capability of the applicant.
    (3) The soundness of the applicant's financial plan for operating 
the National Health Service Corps site.

[[Page 183]]

    (4) The extent to which community resources will be used in 
operating the National Health Service Corps site.
    (5) Comments received from any designated health systems agency or 
any designated State health planning and development agency to which an 
application was submitted for review under Sec.  23.4(c).
    (6) Comments received from health professional societies serving the 
health manpower shortage area.
    (b) Special consideration for the assignment of Corps personnel will 
be given to the entity which is located in a health manpower shortage 
area over an entity which is not located in a health manpower shortage 
area but has a demonstrated interest in it.



Sec.  23.6  What are the criteria for determining the entities 
to which National Health Service Corps personnel will be assigned?

    (a) The Secretary may, upon approving an application for the 
assignment of personnel and after entering into an agreement with an 
applicant under Sec.  23.7, assign National Health Service Corps 
personnel to provide health services in or to a health manpower shortage 
area.
    (b) In assigning National Health Service Corps personnel to serve in 
a health manpower shortage area, the Secretary will seek to assign 
personnel who have those characteristics which will increase the 
probability of their remaining to serve in the health manpower shortage 
area upon completion of the period of assignment. In addition, the 
Secretary will apply a weighted-value system in which the first factor 
listed below is assigned the greatest weight and the second, and third 
factors are assigned lesser weights in descending order:
    (1) The need of the health manpower shortage area as determined by 
criteria established under section 332(b) of the Act.
    (2) The willingness of individuals, government agencies, or health 
entities within the health manpower shortage area to cooperate with the 
National Health Service Corps in providing effective health services.
    (3) The comments of health professional societies serving the health 
manpower shortage area.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec.  23.7  What must an entity agree to do before the assignment is made?

    (a) Requirements. To carry out the purposes of section 334 of the 
Act, each National Health Service Corps site must enter into an 
agreement with the Secretary under which the site agrees to:
    (1) Be responsible for charging for health services provided by 
assigned National Health Service Corps personnel;
    (2) Take reasonable action for the collection of the charges for 
those health services;
    (3) Reimburse the United States the sums required under section 334 
of the Act; and
    (4) Prepare and submit an annual report. The agreement will set 
forth the period of assignment (not to exceed 4 years), the number and 
type of Corps personnel to be assigned to the site, and other 
requirements which the Secretary determines necessary to carry out the 
purposes of the Act.
    (b) Termination. An agreement entered into under this section may be 
terminated by either party on 30-days written notice or modified by 
mutual consent consistent with section 333 of the Act.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec.  23.8  What operational requirements apply to an entity to which 
National Health Service Corps personnel are assigned?

    Each National Health Service Corps site must:
    (a) Operate a health care delivery system within a planned or 
existing community structure to assure:
    (1) The provision of high quality comprehensive health care;
    (2) To the extent feasible, full professional health care coverage 
for the health manpower shortage area;
    (3) Continuum of care; and
    (4) The availability and accessibility of secondary and tertiary 
health care

[[Page 184]]

(the two more sophisticated levels of health care beyond primary care);
    (b) Establish and maintain a patient record system;
    (c) Implement a system for maintaining the confidentiality of 
patient records;
    (d) Meet the requirements of applicable fire and safety codes;
    (e) Develop, to the extent feasible, linkages with other health care 
facilities for the provision of services which supplement or complement 
the services furnished by the assigned Corps personnel;
    (f) Operate a quality assurance system which meets the requirements 
of 42 CFR 51c.303(c) for the establishment and operation of a quality 
assurance system in a community health center; and
    (g) Establish basic data, cost accounting, and management 
information and reporting systems as prescribed by the Secretary.



Sec.  23.9  What must an entity to which National Health Service Corps 
personnel are assigned (i.e., a National Health Service Corps site) 
charge for the provision of health services by assigned personnel?

    (a) Except as provided in paragraph (b) of this section, individuals 
receiving services from assigned National Health Service Corps personnel 
must be charged on a fee-for-service or other basis at a rate which is 
computed to permit recovery of the value of the services and is approved 
by the Secretary.
    (b) In determining whether to approve fees to be charged for health 
services, the Secretary will consider: The costs to the National Health 
Service Corps of providing the health services; the costs to the health 
manpower shortage area for providing the services; and the charges for 
similar services by other practitioners or facilities in or nearby the 
health manpower shortage area. However, if assigned National Health 
Service Corps personnel are providing services within the framework of 
an established health services delivery system, the Secretary may 
approve the fees charged under that system without regard to the 
foregoing factors.
    (c)(1) No charge or a nominal charge will be made for health 
services provided by assigned National Health Service Corps personnel to 
individuals within the health manpower shortage area with annual incomes 
at or below the poverty guidelines updated periodically in the Federal 
Register by the U.S. Department of Health and Human Services under the 
authority of 42 U.S.C. 9902(2). However, no individual will be denied 
health services based upon inability to pay for the services. Any 
individual who has an annual income above the poverty guidelines but 
whose income does not exceed 200 percent of the poverty guidelines, will 
receive health services at a nominal charge. However, charges will be 
made for services to the extent that payment will be made by a third 
party which is authorized or under legal obligation to pay the charges.
    (2) The provisions of this paragraph also apply with respect to 
services provided by an individual who is fulfilling an NHSC scholarship 
obligation under section 753 or who received a special grant under 
section 755.

[45 FR 12790, Feb. 27, 1980, as amended at 85 FR 72908, Nov. 16, 2020]



Sec.  23.10  Under what circumstances may a National Health Service Corps 
site's reimbursement obligation to the Federal Government be waived?

    (a) The Secretary may waive in whole or in part the reimbursement 
requirements of section 334(a)(3) of the Act if he determines that:
    (1) The National Health Service Corps site is financially unable to 
meet the reimbursement requirements or that compliance with those 
requirements will unreasonably limit the ability of the site to 
adequately support the provision of services by assigned Corps 
personnel. In making these determinations, the Secretary will consider--
    (i) The costs necessary to adequately support the health services 
provided by the assigned National Health Service Corps personnel and the 
income and financial resources available to meet the costs;

[[Page 185]]

    (ii) The ability of the applicant to obtain credit from suppliers, 
lending institutions, private organizations and individuals;
    (iii) The need of the health manpower shortage area for health 
services; and
    (iv) The extent to which the National Health Service Corps site 
utilizes health professions personnel.
    (2) A significant percentage of the individuals who are located in 
the health manpower shortage area and are receiving the health services 
of the assigned National Health Service Corps personnel are elderly, 
living in poverty, or have other characteristics which indicate an 
inability to pay. For purposes of this section, ``elderly'' means 
persons 65 years or older and the ``CSA Income Poverty Guidelines'' will 
be used as the standard for determining whether individuals are living 
in poverty. Other characteristics indicating inability to pay include, 
but are not to be limited to, the ratio of unemployment in the health 
manpower shortage area and the area's cost-of-living index.
    (b) The Secretary may waive in whole or in part the reimbursement 
requirements of section 334(f)(1) of the Act if he or she determines 
that the National Health Service Corps site is a small health center (as 
defined by section 334(f)(5) of the Act) that needs all or part of the 
amount otherwise payable to--
    (1) Expand or improve its provision of health services;
    (2) Increase the number of individuals served;
    (3) Renovate or modernize facilities for its provision of health 
services;
    (4) Improve the administration of its health service programs; or
    (5) Establish a financial reserve to assure its ability to continue 
providing health services;
    (c) Where the Secretary determines that a National Health Service 
Corps site is eligible for a waiver under paragraph (a) (1) or (2) of 
this section. the Secretary may waive the application of the 
reimbursement requirements of section 334(a)(3) of the Act and apply the 
reimbursement requirements of section 334(f)(1) of the Act. The 
Secretary may waive in whole or in part the reimbursement requirements 
of section 334(f)(1) for such a site if he or she determines that the 
National Health Service Corps site meets the requirements of paragraph 
(a)(1) of this section. Funds retained by a National Health Service 
Corps site as a result of such waiver must be used for the purposes set 
forth in paragraphs (b) (1) through (5) of this section.
    (d) Requests for a prospective or retrospective waiver must be made 
at the time and in the manner and contain the documentation prescribed 
by the Secretary.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec.  23.11  Under what circumstances may the Secretary sell equipment 
or other property of the United States used by the National Health 
Service Corps site?

    (a) Upon expiration of the assignment of all Corps personnel to a 
health manpower shortage area, the Secretary may sell equipment and 
other property of the United States used by the assigned personnel. The 
equipment may be sold at the fair market value or less than the fair 
market value to any entity providing health services in or to a health 
manpower shortage area if the Secretary determines that an entity is 
unable to pay the fair market value. In determining whether an entity is 
financially unable to purchase equipment or property at fair market 
value, the Secretary will consider (1) the present financial resources 
of the entity available to purchase the equipment or property based upon 
its current liabilities, and (2) the entity's ability to obtain the 
funds necessary to purchase the equipment or property. However, the 
Secretary will not sell the equipment or property for less than fair 
market value to a profitmaking organization unless the organization 
gives reasonable assurance that it will use the equipment or property to 
provide health services in or to the health manpower shortage area.
    (b) The Secretary will give priority to sales to an entity providing 
reasonable assurance that it will use the equipment or property for the 
purpose of retaining within the health manpower shortage area National 
Health Service Corps personnel who have completed their assignments.

[[Page 186]]



Sec.  23.12  Who will supervise and control the assigned personnel?

    Assigned National Health Service Corps personnel will at all times 
remain under the direct supervision and control of the Secretary. 
Observance of institutional rules and regulations by the assigned 
personnel is a mere incident of the performance of their Federal 
functions and does not alter their direct professional and 
administrative responsibility to the Secretary.



Sec.  23.13  What nondiscrimination requirements apply to National Health 
Service Corps sites?

    National Health Service Corps sites are advised that in addition to 
complying with the terms and conditions of this regulation, the 
following laws and regulations are applicable--
    (a) Title VI of the Civil Rights Act of 1964 (43 U.S.C. 2000d et 
seq.) and its implementing regulations, 45 CFR part 80 (prohibiting 
discrimination in federally assisted programs on the grounds of race, 
color, or national origin); and
    (b) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) 
and its implementing regulations, 45 CFR part 84 (prohibiting 
discrimination in federally assisted programs on the basis of handicap).
    (c) The Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.) and 
its implementing regulations, 45 CFR part 91 (prohibiting 
nondiscrimination on the basis of age in HHS programs or activities 
receiving Federal financial assistance).

[45 FR 12790, Feb. 27, 1980, as amended at 49 FR 38109, Sept. 27, 1984]



PART 24_SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE--
Table of Contents



Sec.
24.1 Establishment, number of members, and purpose.
24.2 Allocation.
24.3 Policy board.
24.4 Eligibility.
24.5 Pay and compensation.
24.6 Performance appraisal system.
24.7 Inapplicability of provisions regarding appointments.
24.8 Removal from the Service.
24.9 Reporting.

    Authority: 42 U.S.C. 237; Pub. L. 114-255, div. A, title Ill, sec. 
3071, Dec. 19, 2016, 130 Stat. 1133; Section 228 of the Public Health 
Service Act; 5 U.S.C. 301.

    Source: 85 FR 21781, Apr. 20, 2020, unless otherwise noted.



Sec.  24.1  Establishment, number of members, and purpose.

    (a) There is established in the Public Health Service the Silvio O. 
Conte Senior Biomedical Research and Biomedical Product Assessment 
Service (SBRBPAS or Service) consisting of members the maximum number of 
which is prescribed by law. The purpose of the Service is to recruit and 
retain outstanding and qualified scientific and technical experts in the 
fields of biomedical research, clinical research evaluation, and 
biomedical product assessment.
    (b) The Secretary may not use the authority in paragraph (a) of this 
section to reduce the number of employees serving in any other 
employment system to offset the number of members within the Service.



Sec.  24.2  Allocation.

    (a) The Secretary shall determine the number of SBRBPAS slots to be 
allocated to each participating operating division, taking into account 
the need for such expertise within the operating division.
    (b) The SBRBPAS Policy Board may advise the Secretary regarding 
adjustments to the allocation of slots at any time.
    (c) SBRBPAS appointments shall be made judiciously in supporting the 
recruitment and retention of outstanding and qualified scientific and 
technical experts in the fields of biomedical research, clinical 
research evaluation, and biomedical product assessment.
    (d) The Secretary will ensure that SBRBPAS assignments are used 
primarily in support of high priority programs authorized by Congress 
and which directly support the goals and priorities of the Department in 
the areas of biomedical research, clinical research evaluation or 
biomedical product assessment.

[[Page 187]]



Sec.  24.3  Policy Board.

    The Secretary, or designee, may establish an SBRBPAS Policy Board to 
serve in an advisory capacity, recommending allocation of SBRBPAS slots 
among the participating operating divisions; assessing the 
administration of the SBRBPAS and ensuring consistent application of 
regulations, policies, and procedural guidelines; and recommending to 
the Secretary, or designee, changes to the Service as warranted. 
Membership will include representatives from the Office of the Assistant 
Secretary for Administration and representatives from the operating 
divisions which use the Service. The Secretary, or designee, shall 
determine the number of Board members; select the individual members, 
including the chairperson; and decide the length of service of each 
Board position.



Sec.  24.4  Eligibility.

    (a) No individual may be appointed to the SBRBPAS unless such 
individual:
    (1) Has earned a doctoral level degree in biomedicine or a related 
field, or a doctoral or master's level degree in engineering, 
bioinformatics, or a related or emerging field; and
    (2) Meets the qualification standards prescribed by the Office of 
Personnel Management for appointment to a position at GS-15 of the 
General Schedule.
    (b) Individuals eligible under paragraph (a) of this section shall 
be experts outstanding in the field of biomedical research, clinical 
research evaluation, or biomedical product assessment. The criteria in 
paragraphs (c) through (e) of this section are indicators that the 
individual is considered an expert outstanding in their respective 
field.
    (c) An individual will be considered an expert outstanding in 
biomedical research when the individual is actively engaged in original 
biomedical research, including behavioral research, and whose work in 
this area is considered by recognized experts or peers to be 
outstanding. One or more of the following achievements will indicate the 
individual has been recognized by experts or peers as outstanding:
    (1) Conducted original research that has been published in peer-
reviewed journals of high stature;
    (2) Received major prizes and awards (such as visiting 
professorships and named lectureships) in recognition of original 
contributions to research;
    (3) Received invitations to speak at or to chair major national or 
international meetings or symposia;
    (4) Been elected to membership in professional societies of high 
stature; or
    (5) Meet other criteria demonstrating sufficient rigor or 
accomplishment in a field that is relevant and necessary to the 
accomplishment of the agency's mission.
    (d) An individual will be considered an expert outstanding in 
Clinical Research Evaluation when the individual is actively engaged in 
clinical research evaluation and is considered by recognized experts or 
peers to be outstanding. One or more of the following achievements will 
indicate the individual has been recognized by experts or peers as 
outstanding:
    (1) Significant experience dealing with complex, precedent-setting 
evaluation issues, including those arising during product development, 
that involved significant scientific controversy, had far reaching 
implications for clinical research or resulted in a widespread economic 
effect in the health-care delivery system;
    (2) Taken an active role in the development of significant 
scientific or regulatory guidelines for clinical research evaluation;
    (3) Been the recipient of invitations to speak at or to chair major 
national or international meetings and symposia; or
    (4) Meet other criteria demonstrating sufficient rigor or 
accomplishment in a field that is relevant and necessary to the 
accomplishment of the agency's mission.
    (e) An individual will be considered an expert outstanding in 
biomedical product assessment when an individual is actively engaged in 
the development or assessment of biomedical products and whose work in 
this area is considered by recognized experts or peers to be 
outstanding. One or more of the following achievements will indicate the 
individual has been recognized by experts or peers as outstanding.

[[Page 188]]

    (1) Significant experience dealing with complex, precedent-setting 
evaluation, scientific policies or development issues (e.g., those 
associated with novel biomedical products, novel approaches to 
biomedical product-manufacturing, or use of novel evaluation methods);
    (2) Demonstrated cutting-edge expertise in a scientific or technical 
discipline critical to design, development, manufacturing, clinical 
performance assessment, or other technical aspects of effective 
oversight of biomedical products;
    (3) Played a leadership role in planning and conducting public 
meetings to seek public input and communicate regulatory scientific 
policies;
    (4) Been the recipient of invitations to speak at or to chair major 
national or international meetings and symposia; or
    (5) Meet other criteria demonstrating sufficient rigor or 
accomplishment in an activity or field that is relevant and necessary to 
the accomplishment of the agency's mission.



Sec.  24.5  Pay and compensation.

    The Service is an ungraded system, with a single flexible pay range 
to include all members.
    (a) Pay of SBRBPAS members is determined by the Secretary. A 
member's pay shall not be less than the minimum rate payable for GS-15 
of the General Schedule and shall not exceed the amount of annual 
compensation (excluding expenses) specified in section 102 of title 3 of 
the U.S. Code. Although the full pay range will be implemented, pay at 
the higher end of the range will be used only as needed to recognize 
individual scientific value and expertise as is necessary to recruit and 
retain exceptionally well-qualified scientists and technical experts.
    (b) The following factors will be used in setting pay for individual 
members:
    (1) Impact of the individual on the field of biomedical research, 
clinical research evaluation, or biomedical product assessment;
    (2) Recognition of the individual by his or her peers in the 
respective field;
    (3) Originality of the individual's ideas or work products;
    (4) Specific clinical or highly technical skills of the individuals 
which are of benefit to the agency and which are in addition to 
requirements of the basic scientific assignment;
    (5) The individual's earnings and monetary benefits; and
    (6) Other relevant factors.
    (c) Annual adjustments to pay rates may be made effective on the 
first day of the first pay period on or after January 1 of each calendar 
year. The rate of such adjustments will be at the discretion of the 
Secretary, or designee, except that the minimum rate payable in the 
SBRBPAS will be increased to the amount of the minimum rate of the GS-15 
of the General Schedule.
    (d) Other pay adjustments may be made by the Secretary or designee 
on an individual basis.
    (e) New appointees to the SBRBPAS, who are not covered by the Civil 
Service Retirement System, will be covered by the Federal Employees 
Retirement System.



Sec.  24.6  Performance appraisal system.

    The members of the Service shall be subject to a performance 
appraisal system that is designed to encourage excellence in performance 
and shall provide for periodic and systematic assessment of the 
performance of members.



Sec.  24.7  Inapplicability of provisions regarding appointments.

    (a) Appointments to the Service shall be made without regard to the 
provisions of title 5 of the U.S. Code regarding appointments.
    (b) Members of the Service shall not be covered by the following 
provisions of title 5 of the U.S. Code:
    (1) Subchapter I of chapter 35 (relating to retention preference in 
the event of reduction in force);
    (2) Chapter 43 (relating to performance appraisal and performance-
based actions);
    (3) Chapter 51 (relating to classification);
    (4) Subchapter III of chapter 53 (relating to General Schedule pay 
rates); and
    (5) Chapter 75 (relating to adverse actions).

[[Page 189]]



Sec.  24.8  Removal from the Service.

    (a) A member of the Service may be subject to disciplinary action, 
including removal from the Service, for substandard performance of duty 
as a member of the service, for misconduct, for reasons of national 
security or for other reasons as determined by the Secretary.
    (b) A member for whom disciplinary action is proposed is entitled 
to:
    (1) Written notice of the proposed action and the basis therefor;
    (2) A reasonable opportunity to answer the notice of proposed action 
both orally and in writing;
    (3) The right to be represented by an attorney or other 
representative in making such answer; and
    (4) A written decision on the proposal.
    (c) The decision may be made by an official with delegated authority 
to take such action, but in no case may the official be at a level below 
the head of the Operating Division where the member is assigned.
    (d) A member who is separated from the Service involuntarily and 
without cause and who, immediately prior to his appointment to the 
Service, was a career appointee in the civil service or the Senior 
Executive Service, may be appointed to a position in the competitive 
civil service at grade GS-15 of the General Schedule. Such an 
appointment may be made by the Secretary or his/her designee without 
regard to the provisions of title 5, U.S. Code regarding appointments in 
the civil service.
    (e) A member who is separated from the Service involuntarily and 
without cause and who, immediately prior to appointment to the Service, 
was not a career appointee in the civil service or the Senior Executive 
Service may be appointed to a position in the excepted civil service at 
grade GS-15 of the General Schedule for a period not to exceed two 
years.
    (f) There shall be no right to further review of the final decision 
on a disciplinary action. At his/her discretion, the Secretary may 
review an action taken under this section and may reduce, suspend, or 
overrule the action taken.
    (g) A member of the Service may be removed from the Service for such 
other reasons as may be prescribed by the Secretary.



Sec.  24.9  Reporting.

    (a) No later than May 1, 2020, and annually thereafter, each 
participating operating division shall submit to the Secretary a report 
of its implementation of the SBRBPAS authority in accordance with the 
Agency's policy requirements.
    (b) At his or her discretion, the Secretary may use the information 
provided in the report under paragraph (a) of this section to inform the 
work of the Policy Board, including allocation of SBRBPAS slots.

[[Page 190]]



               SUBCHAPTER C_MEDICAL CARE AND EXAMINATIONS





PART 31_MEDICAL CARE FOR CERTAIN PERSONNEL OF THE COAST GUARD, 
NATIONAL OCEAN SURVEY, PUBLIC HEALTH SERVICE, AND FORMER LIGHTHOUSE SERVICE--
Table of Contents



                               Definitions

Sec.
31.1 Meaning of terms.

 Provisions Applicable to Coast Guard, National Ocean Survey and Public 
                             Health Service

31.2 Persons entitled to treatment.
31.3 Use of Service facilities.
31.4 Use of other than Service facilities.
31.5 Application for treatment; active duty personnel.
31.6 Personnel absent without leave.
31.7 Continuance of medical relief after loss of status.
31.8 Retired personnel; extent of treatment.
31.9 Dependent members of families; treatment.
31.10 Dependent members of families; use of Service facilities.

     Provisions Applicable to Personnel of Former Lighthouse Service

31.11 Persons entitled to treatment.
31.12 Use of Service facilities.
31.13 Use of other than Service facilities.
31.14 Application for treatment; active duty personnel.
31.15 Continuance of medical relief after loss of status.
31.16 Retired personnel; extent of treatment.

    Source: 21 FR 9821, Dec. 12, 1956, unless otherwise noted.

                               Definitions



Sec.  31.1  Meaning of terms.

    As used in this part, the term:
    (a) Act means the Public Health Service Act, approved July 1, 1944, 
58 Stat. 682, as amended.
    (b) Service means the Public Health Service.
    (c) Surgeon General means the Surgeon General of the Public Health 
Service.
    (d) Medical relief station means a first-, second-, third-, or 
fourth-class station of the Service.
    (e) First-class stations means a hospital operated by the Service.
    (f) Second-class station means a medical relief facility, other than 
a hospital of the Service, under the charge of a commissioned officer.
    (g) Third-class station means a medical relief facility, other than 
a hospital of the Service, under the charge of a medical officer or 
employee of the Service other than a commissioned officer.
    (h) Fourth-class station means a medical relief facility designated 
by the Surgeon General, other than a first-, second-, or third-class 
station.
    (i) Designated physician means a physician holding an appointment to 
act regularly for the Service for a class or classes of specified 
beneficiaries at a place where there is no medical relief station.
    (j) Designated dentist means a dentist holding an appointment to 
perform dental service for the Service for a class or classes of 
specified beneficiaries.
    (k) Active duty means active duty status as distinguished from being 
on inactive status or retired and includes periods of authorized leave 
or liberty.
    (l) Dependent members of families in the case of male personnel 
means the lawful wife, the unmarried children (including stepchildren or 
adopted children) under 21 years of age, and the father or mother if in 
fact dependent upon such son for his or her chief support; and in the 
case of female personnel, the unmarried children (including stepchildren 
or adopted children) under 21 years of age if their father is dead or 
they are in fact dependent on such mother for their chief support, the 
father or mother if in fact dependent upon such daughter for his or her 
chief support, and the husband if in fact dependent upon such wife for 
his chief support: Provided, however, That in the case of members of the 
Women's Reserve of the Coast Guard the husbands of such members shall 
not be considered dependents.

(Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216)

[[Page 191]]

 Provisions Applicable to Coast Guard, National Ocean Survey and Public 
                             Health Service



Sec.  31.2  Persons entitled to treatment.

    To the extent and under the circumstances prescribed in Sec. Sec.  
31.2 to 31.10, the following persons shall be entitled to medical, 
surgical, and dental treatment and hospitalization by the Service:
    (a) Coast Guard. (1) Commissioned officers, chief warrant officers, 
warrant officers, cadets, and enlisted personnel of the Regular Coast 
Guard, including those on shore duty and those on detached duty, whether 
on active duty or retired;
    (2) Regular members of the Coast Guard Reserve when on active duty 
or when retired for disability;
    (3) Temporary members of the Coast Guard Reserve when on active duty 
or in case of physical injury incurred or sickness or disease contracted 
while performing active Coast Guard duty;
    (4) Members of the Women's Reserve of the Coast Guard when on active 
duty or when retired for disability;
    (5) Members of the Coast Guard Auxiliary in case of physical injury 
incurred or sickness or disease contracted while performing active Coast 
Guard duty.
    (b) National Ocean Survey. Commissioned officers, ships' officers, 
and members of the crews of vessels of the National Ocean Survey, 
including those on shore duty and those on detached duty whether on 
active duty or retired.
    (c) Public Health Service. (1) Commissioned officers of the Regular 
Corps of the Service, whether on active duty or retired;
    (2) Commissioned officers of the Reserve Corps of the Service when 
on active duty or when retired for disability.

(Sec. 326, 58 Stat. 697, as amended 42 U.S.C. 253)



Sec.  31.3  Use of Service facilities.

    Except as otherwise provided in Sec. Sec.  31.3 to 31.10, the 
persons specified in Sec.  31.2 shall be entitled to medical, surgical, 
and dental treatment and hospitalization only at medical relief stations 
and by designated physicians and designated dentists, and the cost of 
services procured elsewhere shall not be borne by the Service.

(Sec. 326, 58 Stat. 697, as amended 42 U.S.C. 253)



Sec.  31.4  Use of other than Service facilities.

    (a) When a person specified in Sec.  31.2 who is on active duty 
requires immediate medical, surgical, or dental treatment or 
hospitalization and the urgency of the situation does not permit 
treatment at a medical relief station or by a designated physician or 
designated dentist, an officer of the same service as the patient may 
arrange for treatment or hospitalization at the expense of the Service.
    (b) When the circumstances are such that an officer of the same 
service as the patient is not available to make the necessary 
arrangements, the treatment or hospitalization may be obtained by or on 
behalf of the patient at the expense of the Service.
    (c) In every case of treatment or hospitalization as defined in 
paragraph (b) of this section, the responsible superior officer of the 
patient shall be notified as promptly as possible and a full report 
shall be submitted by such officer to the Surgeon General through 
appropriate official channels. As soon as practicable, unless the 
interests of the patient or the Government require otherwise, treatment 
or hospitalization shall be continued at a medical relief station or by 
a designated physician or designated dentist or at another appropriate 
Federal medical facility.
    (d) When the necessary medical relief cannot be obtained from a 
medical relief station or a designated physician or designated dentist, 
preference shall be given to other Federal medical facilities when 
reasonably available and when conditions permit.
    (e) Vouchers on proper forms covering expenses for treatment or 
hospitalization under the circumstances specified in paragraphs (a) and 
(b) of this section shall be forwarded to the Surgeon General through 
appropriate official channels. Each such voucher shall be accompanied by 
or contain a statement of the facts necessitating the treatment or 
hospitalization. Unreasonable charges for emergency

[[Page 192]]

treatment or hospitalization will not be allowed.
    (f) Expenses for consultants or special services, or for dental 
treatment other than emergency measures to relieve pain, shall not be 
allowed except when authorized in advance by the headquarters of the 
Service or, in extraordinary cases, when subsequently approved by such 
headquarters upon receipt of report and satisfactory explanation as to 
the necessity and urgency therefor.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec.  31.5  Application for treatment; active duty personnel.

    (a) An applicant for medical relief who is on active duty shall 
furnish a certificate identifying him. Such certificate, in the case of 
Coast Guard personnel, shall be signed by an officer of the Coast Guard, 
and in the case of National Ocean Survey personnel, shall be signed by 
an officer of the National Ocean Survey. Commissioned officers of any of 
the services mentioned in Sec.  31.2 and officers in charge of units may 
sign their own certificates. In an emergency, the officer in charge of a 
medical relief station, or a designated physician or designated dentist, 
may accept other evidence of status satisfactory to him.
    (b) A temporary member of the Coast Guard Reserve except when on 
active duty or a member of the Coast Guard Auxiliary shall, when 
applying for medical relief, furnish a statement signed by a responsible 
superior officer setting forth the facts and circumstances giving rise 
to the need for medical relief. In emergencies, such statement shall be 
furnished promptly after the member has received the immediately 
required care and treatment. Such statement shall be presumptive 
evidence of the facts stated, but if investigation indicates that the 
injury, sickness, or disease was not incurred or contracted in the 
manner stated, further treatment may be denied.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec.  31.6  Personnel absent without leave.

    No member of any of the services enumerated in Sec.  31.2 shall be 
entitled when absent without leave to medical relief except at a medical 
relief station or by a designated physician or designated dentist.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec.  31.7  Continuance of medical relief after loss of status.

    If a member is separated from any of the services enumerated in 
Sec.  31.2, except persons specified in Sec.  31.2(a) (3) and (5) who 
shall be entitled to treatment after separation under the conditions set 
forth in such paragraphs, while undergoing treatment by the Service, his 
treatment shall be discontinued immediately unless the physician in 
charge determines that the condition of the patient does not permit 
interruption of treatment, in which case the treatment shall be 
discontinued as soon as practicable and the condition of the patient 
permits. At that time he shall be discharged from treatment and shall 
not thereafter be afforded medical relief by the Service by reason of 
his previous service.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec.  31.8  Retired personnel; extent of treatment.

    (a) A retired member of the Coast Guard, National Ocean Survey, or 
Public Health Service specified in Sec.  31.2 shall be entitled to 
medical, surgical, and dental treatment and hospitalization at medical 
relief stations of the first-, second-, and third-class, upon 
presentation of satisfactory evidence of his status.
    (b) Elective medical or surgical treatment requiring hospitalization 
shall be furnished only at hospitals operated by the Service.
    (c) Dental treatment shall be furnished to the extent of available 
facilities only at medical relief stations where full-time dental 
officers are on duty; at other medical relief stations the dental 
treatment shall be limited

[[Page 193]]

to emergency measures necessary to relieve pain.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec.  31.9  Dependent members of families; treatment.

    To the extent and under the circumstances prescribed in this part, 
the Service shall provide medical advice and outpatient treatment at 
first-, second-, and third-class medical relief stations and 
hospitalization at first-class stations to the dependent members of 
families of the following persons:
    (a) Coast Guard. Commissioned officers, chief warrant officers, 
warrant officers, cadets, and enlisted personnel of the Regular Coast 
Guard, including those on shore duty and those on detached duty, whether 
on active duty or retired; and regular members of the United States 
Coast Guard Reserve and members of the Women's Reserve of the Coast 
Guard, when on active duty or when retired for disability.
    (b) National Ocean Survey. Commissioned officers, ships' officers, 
and members of the crews of vessels of the United States National Ocean 
Survey, including those on shore duty and those on detached duty, 
whether on active duty or retired.
    (c) Public Health Service. Commissioned officers of the Regular 
Corps of the Service, whether on active duty or retired, and 
commissioned officers of the Reserve Corps of the Service when on active 
duty or when retired for disability.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec.  31.10  Dependent members of families; use of Service facilities.

    (a) A dependent member of the family of any person specified in 
Sec.  31.9 shall, upon presentation of satisfactory evidence of such 
status, be entitled to medical advice and out-patient treatment at 
first-, second-, and third-class medical relief stations and 
hospitalization at first-class stations if suitable accommodations are 
available therein and if the condition of the dependent is such as to 
require hospitalization, both as determined by the medical officer in 
charge.
    (b) Hospitalization at first-class stations shall be at a per diem 
cost to the officer, enlisted person, member of a crew or other person 
concerned. Such cost shall be at such uniform rate as may be prescribed 
from time to time by the President for the hospitalization of dependents 
of naval and Marine Corps personnel at any naval hospital.
    (c) Hospitalization at first-class stations and out-patient 
treatment at first-, second-, and third-class stations may include such 
services and supplies as, in the judgment of the medical officer in 
charge, are necessary for reasonable and adequate treatment.
    (d) Dental treatment shall be furnished to the extent of available 
facilities only at medical relief stations where full-time officers are 
on duty.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)

     Provisions Applicable to Personnel of Former Lighthouse Service



Sec.  31.11  Persons entitled to treatment.

    To the extent and under the circumstances prescribed in this part, 
the following persons shall be entitled to medical, surgical, and dental 
treatment and hospitalization by the Service: Lightkeepers, assistant 
lightkeepers, and officers and crews of vessels of the former Lighthouse 
Service, including any such persons who subsequent to June 30, 1939, 
have involuntarily been assigned to other civilian duty in the Coast 
Guard, who were entitled to medical relief at hospitals and other 
stations of the Service prior to July 1, 1944, and who are now or 
hereafter on active duty or who have been or may hereafter be retired 
under the provisions of section 6 of the act of June 20, 1918, as 
amended (33 U.S.C. 763).

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



Sec.  31.12  Use of Service facilities.

    Except as otherwise provided herein, the persons specified in Sec.  
31.11 shall be entitled to medical, surgical, and dental treatment and 
hospitalization only at medical relief stations and by designated 
physicians and designated dentists, and the cost of services procured

[[Page 194]]

elsewhere shall not be borne by the Service.

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



Sec.  31.13  Use of other than Service facilities.

    (a) When a person specified in Sec.  31.11 who is on active duty 
requires immediate medical, surgical, or dental treatment or 
hospitalization and the urgency of the situation does not permit 
treatment at a medical relief station or by a designated physician or 
designated dentist, an officer or other appropriate supervisory official 
of the Coast Guard may arrange for treatment or hospitalization.
    (b) In every such case of treatment or hospitalization, a full 
report thereof shall be submitted to the Surgeon General through Coast 
Guard headquarters. As soon as practicable, unless the interests of the 
patient or the Government require otherwise, treatment or 
hospitalization shall be continued at a medical relief station or by a 
designated physician or designated dentist or at another appropriate 
Federal medical facility.
    (c) When the necessary medical relief cannot be obtained from a 
medical relief station or a designated physician or designated dentist, 
preference shall be given to other Federal medical facilities when 
reasonably available and when conditions permit.
    (d) Vouchers on proper forms covering expenses for treatment or 
hospitalization under the circumstances specified in paragraph (a) of 
this section shall be forwarded to the Surgeon General through Coast 
Guard headquarters. Each such voucher shall be accompanied by or contain 
a statement of the facts necessitating the treatment or hospitalization. 
Unreasonable charges for emergency treatment or hospitalization will not 
be allowed.
    (e) Expenses for consultants or special services, or for dental 
treatment other than emergency measures to relieve pain, shall not be 
allowed except when authorized in advance by the headquarters of the 
Service or, in extraordinary cases, when subsequently approved by such 
headquarters upon receipt of report and satisfactory explanation as to 
the necessity and urgency therefor.

(Sec. 610(b), 58 Stat. 714 as amended; 33 U.S.C. 763c)



Sec.  31.14  Application for treatment; active duty personnel.

    An applicant for medical relief who is on active duty shall furnish 
a certificate identifying him. Such certificate shall be signed by an 
officer or other appropriate supervisory official of the Coast Guard. In 
an emergency, the officer in charge of a medical relief station, or a 
designated physician or designated dentist, may accept other evidence of 
status satisfactory to him.

(Sec. 610(b), 58 Stat. 714 as amended; 33 U.S.C. 763c)



Sec.  31.15  Continuance of medical relief after loss of status.

    If a person is separated while undergoing treatment by the Service, 
his treatment shall be discontinued immediately unless the physician or 
dentist in charge determines that the condition of the patient does not 
permit interruption of treatment, in which case the treatment shall be 
discontinued as soon as practicable and the condition of the patient 
permits. At that time he shall be discharged from treatment and shall 
not thereafter be afforded medical relief by the Service by reason of 
his previous service.

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



Sec.  31.16  Retired personnel; extent of treatment.

    (a) Any retired person specified in Sec.  31.11 shall be entitled to 
medical, surgical, and dental treatment and hospitalization at medical 
relief stations of the first, second, and third class, upon presentation 
of satisfactory evidence of his status.
    (b) Elective medical or surgical treatment requiring hospitalization 
shall be furnished only at hospitals operated by the Service.
    (c) Dental treatment shall be furnished to the extent of available 
facilities only at medical relief stations where full-time dental 
officers are on duty; at other medical relief stations the dental 
treatment shall be limited

[[Page 195]]

to emergency measures necessary to relieve pain.

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



PART 34_MEDICAL EXAMINATION OF ALIENS--Table of Contents



Sec.
34.1 Applicability.
34.2 Definitions.
34.3 Scope of examinations.
34.4 Medical notifications.
34.5 Postponement of medical examination.
34.6 Applicability of foreign quarantine regulations.
34.7 Medical and other care; death.
34.8 Reexamination; convening of review boards; expert witnesses; 
          reports.

    Authority: 42 U.S.C. 252; 8 U.S.C. 1182 and 1222.

    Source: 81 FR 4201, Jan. 26, 2016, unless otherwise noted.



Sec.  34.1  Applicability.

    The provisions of this part shall apply to the medical examination 
of:
    (a) Aliens applying for a visa at an embassy or consulate of the 
United States;
    (b) Aliens arriving in the United States;
    (c) Aliens required by DHS to have a medical examination in 
connection with the determination of their admissibility into the United 
States; and
    (d) Aliens applying for adjustment of status.



Sec.  34.2  Definitions.

    As used in this part, terms shall have the following meanings:
    (a) CDC. Centers for Disease Control and Prevention, Department of 
Health and Human Services, or an authorized representative acting on its 
behalf.
    (b) Communicable disease of public health significance. Any of the 
following diseases:
    (1) Communicable diseases as listed in a Presidential Executive 
Order, as provided under Section 361(b) of the Public Health Service 
Act. The current revised list of quarantinable communicable diseases is 
available at http://www.cdc.gov and http://www.archives.gov/federal-
register.
    (2) Communicable diseases that may pose a public health emergency of 
international concern if it meets one or more of the factors listed in 
Sec.  34.3(d) and for which the Director has determined a threat exists 
for importation into the United States, and such disease may potentially 
affect the health of the American public. The determination will be made 
consistent with criteria established in Annex 2 of the International 
Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the 
Fifty-Eighth World Health Assembly in 2005, and as entered into effect 
in the United States in July 2007, subject to the U.S. Government's 
reservation and understandings:
    (i) Any of the communicable diseases for which a single case 
requires notification to the World Health Organization (WHO) as an event 
that may constitute a public health emergency of international concern, 
or
    (ii) Any other communicable disease the occurrence of which requires 
notification to the WHO as an event that may constitute a public health 
emergency of international concern. HHS/CDC's determinations will be 
announced by notice in the Federal Register.
    (3) Gonorrhea.
    (4) Hansen's disease, infectious.
    (5) Syphilis, infectious.
    (6) Tuberculosis, active.
    (c) Civil surgeon. A physician designated by DHS to conduct medical 
examinations of aliens in the United States who are applying for 
adjustment of status to permanent residence or who are required by DHS 
to have a medical examination.
    (d) Class A medical notification. Medical notification of:
    (1) A communicable disease of public health significance;
    (2) A failure to present documentation of having received 
vaccination against ``vaccine-preventable diseases'' for an alien who 
seeks admission as an immigrant, or who seeks adjustment of status to 
one lawfully admitted for permanent residence, which shall include at 
least the following diseases: Mumps, measles, rubella, polio, tetanus 
and diphtheria toxoids, pertussis, Haemophilus influenza type B and 
hepatitis B, and any other vaccinations recommended by the Advisory 
Committee for Immunization Practices (ACIP) for

[[Page 196]]

which HHS/CDC determines, by applying criteria published in the Federal 
Register, there is a public health need at the time of immigration or 
adjustment of status. Provided, however, that in no case shall a Class A 
medical notification be issued for an adopted child who is 10 years of 
age or younger if, prior to the admission of the child, an adoptive 
parent or prospective adoptive parent of the child, who has sponsored 
the child for admission as an immediate relative, has executed an 
affidavit stating that the parent is aware of the vaccination 
requirement and will ensure that, within 30 days of the child's 
admission, or at the earliest time that is medically appropriate, the 
child will receive the vaccinations identified in the requirement.
    (3)(i) A current physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior; or
    (4) Drug abuse or addiction.
    (e) Class B medical notification. Medical notification of a physical 
or mental health condition, disease, or disability serious in degree or 
permanent in nature.
    (f) DHS. U.S. Department of Homeland Security.
    (g) Director. The Director of the Centers for Disease Control and 
Prevention or a designee as approved by the Director or Secretary of 
Health and Human Services.
    (h) Drug abuse. ``Current substance use disorder or substance-
induced disorder, mild'' as defined in the most recent edition of the 
Diagnostic and Statistical Manual for Mental Disorders (DSM) as 
published by the American Psychiatric Association, or by another 
authoritative source as determined by the Director, of a substance 
listed in Section 202 of the Controlled Substances Act, as amended (21 
U.S.C. 802).
    (i) Drug addiction. ``Current substance use disorder or substance-
induced disorder, moderate or severe'' as defined in the most recent 
edition of the Diagnostic and Statistical Manual for Mental Disorders 
(DSM), as published by the American Psychiatric Association, or by 
another authoritative source as determined by the Director, of a 
substance listed in Section 202 of the Controlled Substances Act, as 
amended (21 U.S.C. 802).
    (j) Medical examiner. A panel physician, civil surgeon, or other 
physician designated by the Director to perform medical examinations of 
aliens.
    (k) Medical hold document. A document issued to DHS by a quarantine 
officer of HHS at a port of entry which defers the inspection for 
admission until the cause of the medical hold is resolved.
    (l) Medical notification. A medical examination document issued to a 
U.S. consular authority or DHS by a medical examiner, certifying the 
presence or absence of:
    (1) A communicable disease of public health significance;
    (2) Documentation of having received vaccination against ``vaccine-
preventable diseases'' for an alien who seeks admission as an immigrant, 
or who seeks adjustment of status to one lawfully admitted for permanent 
residence, which shall include at least the following diseases: Mumps, 
measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, 
Haemophilus influenza type B and hepatitis B, and any other vaccinations 
recommended by the Advisory Committee for Immunization Practices (ACIP) 
for which HHS/CDC determines, based upon criteria published in the 
Federal Register, there is a public health need at the time of 
immigration or adjustment of status. Provided, however, that in no case 
shall a Class A medical notification be issued for an adopted child who 
is 10 years of age or younger if, prior to the admission of the child, 
an adoptive parent or prospective adoptive parent of the child, who has 
sponsored the child for admission as an immediate relative, has executed 
an affidavit stating that the parent is aware of the vaccination 
requirement and will ensure that, within 30 days of the child's 
admission, or at the earliest time that is medically appropriate, the 
child will

[[Page 197]]

receive the vaccinations identified in the requirement;
    (3)(i) A current physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (4) Drug abuse or addiction; or
    (5) Any other physical or mental condition, disease, or disability 
serious in degree or permanent in nature.
    (m) Medical officer. A physician or other medical professional 
assigned by the Director to conduct physical and mental examinations of 
aliens on behalf of HHS/CDC.
    (n) Mental disorder. A currently accepted psychiatric diagnosis, as 
defined by the current edition of the Diagnostic and Statistical Manual 
of Mental Disorders published by the American Psychiatric Association or 
by another authoritative source as determined by the Director.
    (o) Panel physician. A physician selected by a United States embassy 
or consulate to conduct medical examinations of aliens applying for 
visas.
    (p) Physical disorder. A currently accepted medical diagnosis, as 
defined by the current edition of the Manual of the International 
Classification of Diseases, Injuries, and Causes of Death published by 
the World Health Organization or by another authoritative source as 
determined by the Director.



Sec.  34.3  Scope of examinations.

    (a) General. In performing examinations, medical examiners shall 
consider those matters that relate to the following:
    (1) Communicable disease of public health significance;
    (2) Documentation of having received vaccination against ``vaccine-
preventable diseases'' for an alien who seeks admission as an immigrant, 
or who seeks adjustment of status to one lawfully admitted for permanent 
residence, which shall include at least the following diseases: Mumps, 
measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, 
Haemophilus influenza type B and hepatitis B, and any other vaccinations 
recommended by the Advisory Committee for Immunization Practices (ACIP) 
for which HHS/CDC determines there is a public health need at the time 
of immigration or adjustment of status.
    Provided, however, that in no case shall a Class A medical 
notification be issued for an adopted child who is 10 years of age or 
younger if, prior to the admission of the child, an adoptive parent or 
prospective adoptive parent of the child, who has sponsored the child 
for admission as an immediate relative, has executed an affidavit 
stating that the parent is aware of the vaccination requirement and will 
ensure that, within 30 days of the child's admission, or at the earliest 
time that is medically appropriate, the child will receive the 
vaccinations identified in the requirement;
    (3)(i) A current physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (4) Drug abuse or drug addiction; and
    (5) Any other physical or mental health condition, disease, or 
disability serious in degree or permanent in nature.
    (b) Scope of all medical examinations. (1) All medical examinations 
will include the following:
    (i) A general physical examination and medical history, evaluation 
for tuberculosis, and serologic testing for syphilis.
    (ii) A physical examination and medical history for diseases 
specified in Sec. Sec.  34.2(b)(1), and 34.2(b)(4) through 34.2(b)(10).
    (2) For the examining physician to reach a determination and 
conclusion about the presence or absence of a physical or mental 
abnormality, disease, or disability, the scope of the examination shall 
include any laboratory

[[Page 198]]

or additional studies that are deemed necessary, either as a result of 
the physical examination or pertinent information elicited from the 
alien's medical history or other relevant records.
    (c) Additional medical screening and testing for examinations 
performed outside the United States.
    (1) HHS/CDC may require additional medical screening and testing for 
medical examinations performed outside the United States for diseases 
specified in Sec. Sec.  34.2(b)(2) and 34.2(b)(3) by applying the risk-
based medical and epidemiologic factors in paragraph (d)(2) of this 
section.
    (2) Such examinations shall be conducted in a defined population in 
a geographic region or area outside the United States as determined by 
HHS/CDC.
    (3) Additional medical screening and testing shall include a medical 
interview, physical examination, laboratory testing, radiologic exam, or 
other diagnostic procedure, as determined by HHS/CDC.
    (4) Additional medical screening and testing will continue until 
HHS/CDC determines such screening and testing is no longer warranted 
based on factors such as the following: Results of disease outbreak 
investigations and response efforts; effectiveness of containment and 
control measures; and the status of an applicable determination of 
public health emergency of international concern declared by the 
Director General of the WHO.
    (5) HHS/CDC will directly provide medical examiners information 
pertaining to all applicable additional requirements for medical 
screening and testing, and will post these at the following Internet 
addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://
www.globalhealth.gov.
    (d) Risk-based approach. (1) HHS/CDC will use the medical and 
epidemiological factors listed in paragraph (d)(2) of this section to 
determine the following:
    (i) Whether a disease as specified in Sec.  34.2(b)(3)(ii) is a 
communicable disease of public health significance;
    (ii) Which diseases in Sec.  34.2(b)(2) and (3) merit additional 
screening and testing, and the geographic area in which HHS/CDC will 
require this screening.
    (2) Medical and epidemiological factors include the following: (i) 
The seriousness of the disease's public health impact;
    (ii) Whether the emergence of the disease was unusual or unexpected;
    (iii) The risk of the spread of the disease in the United States;
    (iv) The transmissibility and virulence of the disease;
    (v) The impact of the disease at the geographic location of medical 
screening; and
    (vi) Other specific pathogenic factors that would bear on a 
disease's ability to threaten the health security of the United States.
    (e) Persons subject to requirement for chest radiograph examination 
and serologic testing. (1) As provided in paragraph (e)(2) of this 
section, a chest radiograph examination and serologic testing for 
syphilis shall be required as part of the examination of the following:
    (i) Applicants for immigrant visas;
    (ii) Students, exchange visitors, and other applicants for non-
immigrant visas required by a U.S. consular authority to have a medical 
examination;
    (iii) Applicants outside the United States who apply for refugee 
status;
    (iv) Applicants in the United States who apply for adjustment of 
their status under the immigration statute and regulations.
    (v) Applicants required by DHS to have a medical examination in 
connection with determination of their admissibility into the United 
States.
    (2) Chest radiograph examination and serologic testing. Except as 
provided in paragraph (e)(2)(iv) of this section, applicants described 
in paragraph (e)(1) of this section shall be required to have the 
following:
    (i) For applicants 15 years of age and older, a chest radiograph 
examination;
    (ii) For applicants under 15 years of age, a chest radiograph 
examination if the applicant has symptoms of tuberculosis, a history of 
tuberculosis, or evidence of possible exposure to a transmissible 
tuberculosis case in a household or other enclosed environment for a 
prolonged period;
    (iii) For applicants 15 years of age and older, serologic testing 
for syphilis

[[Page 199]]

and other communicable diseases of public health significance as 
determined by the Director through technical instructions.
    (iv) Exceptions. Serologic testing for syphilis shall not be 
required if the alien is under the age of 15, unless there is reason to 
suspect infection with syphilis. An alien, regardless of age, in the 
United States, who applies for adjustment of status to lawful permanent 
resident, shall not be required to have a chest radiograph examination 
unless their tuberculin skin test, or an equivalent test for showing an 
immune response to Mycobacterium tuberculosis antigens, is positive. 
HHS/CDC may authorize exceptions to the requirement for a tuberculin 
skin test, an equivalent test for showing an immune response to 
Mycobacterium tuberculosis antigens, or chest radiograph examination for 
good cause, upon application approved by the Director.
    (3) Immune response to Mycobacterium tuberculosis antigens. (i) All 
aliens 2 years of age or older in the United States who apply for 
adjustment of status to permanent residents, under the immigration laws 
and regulations, or other aliens in the United States who are required 
by DHS to have a medical examination in connection with a determination 
of their admissibility, shall be required to have a tuberculin skin test 
or an equivalent test for showing an immune response to Mycobacterium 
tuberculosis antigens. Exceptions to this requirement may be authorized 
for good cause upon application approved by the Director. In the event 
of a positive test of immune response, a chest radiograph examination 
shall be required. If the chest radiograph is consistent with 
tuberculosis, the alien shall be referred to the local health authority 
for evaluation. Evidence of this evaluation shall be provided to the 
civil surgeon before a medical notification may be issued.
    (ii) Aliens in the United States less than 2 years of age shall be 
required to have a tuberculin skin test, or an equivalent, appropriate 
test to show an immune response to Mycobacterium tuberculosis antigens, 
if there is evidence of contact with a person known to have tuberculosis 
or other reason to suspect tuberculosis. In the event of a positive test 
of immune response, a chest radiograph examination shall be required. If 
the chest radiograph is consistent with tuberculosis, the alien shall be 
referred to the local health authority for evaluation. Evidence of this 
evaluation shall be provided to the civil surgeon before a medical 
notification may be issued.
    (iii) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to Mycobacterium 
tuberculosis antigens, and, if indicated, a chest radiograph.
    (iv) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to Mycobacterium 
tuberculosis antigens, and a chest radiograph, regardless of age, if he/
she has symptoms of tuberculosis, a history of tuberculosis, or evidence 
of possible exposure to a transmissible tuberculosis case in a household 
or other enclosed environment for a prolonged period, as determined by 
the Director.
    (4) Additional testing requirements. All applicants may be required 
to undergo additional testing for tuberculosis based on the medical 
evaluation.
    (5) How and where performed. All chest radiograph images used in 
medical examinations performed under the regulations to this part shall 
be large enough to encompass the entire chest.
    (6) Chest x-ray, laboratory, and treatment reports. The chest 
radiograph reading and serologic test results for syphilis shall be 
included in the medical notification. When the medical examiner's 
conclusions are based on a study of more than one chest x-ray image, the 
medical notification shall include at least a summary statement of 
findings of the earlier images, followed by a complete reading of the 
last image, and dates and details of any laboratory tests and treatment 
for tuberculosis.
    (f) Procedure for transmitting records. For aliens issued immigrant 
visas, the medical notification and chest radiograph images, if any, 
shall be placed in a separate envelope, which

[[Page 200]]

shall be sealed. When more than one chest radiograph image is used as a 
basis for the examiner's conclusions, all images shall be included. 
Records may be transmitted by other means, as approved by the Director.
    (g) Failure to present records. When a determination of 
admissibility is to be made at the U.S. port of entry, a medical hold 
document shall be issued pending completion of any necessary examination 
procedures. A medical hold document may be issued for aliens who:
    (1) Are not in possession of a valid medical notification, if 
required;
    (2) Have a medical notification which is incomplete;
    (3) Have a medical notification which is not written in English;
    (4) Are suspected to have an inadmissible medical condition.
    (h) The Secretary of Homeland Security, after consultation with the 
Secretary of State and the Secretary of Health and Human Services, may 
in emergency circumstances permit the medical examination of refugees to 
be completed in the United States.
    (i) All medical examinations shall be carried out in accordance with 
such technical instructions for physicians conducting the medical 
examination of aliens as may be issued by the Director. Copies of such 
technical instructions are available upon request to the Director, 
Division of Global Migration and Quarantine, Mailstop E03, HHS/CDC, 
Atlanta GA 30333.



Sec.  34.4  Medical notifications.

    (a) Medical examiners shall issue medical notifications of their 
findings of the presence or absence of Class A or Class B medical 
conditions. The presence of such condition must have been clearly 
established.
    (b) Class A medical notifications. (1) The medical examiner shall 
report his/her findings to the consular officer or DHS by Class A 
medical notification which lists the specific condition for which the 
alien may be inadmissible, if an alien is found to have:
    (i) A communicable disease of public health significance;
    (ii) A lack of documentation, or no waiver, for an alien who seeks 
admission as an immigrant, or who seeks adjustment of status to one 
lawfully admitted for permanent residence, of having received 
vaccination against vaccine-preventable diseases which shall include at 
least the following diseases: Mumps, measles, rubella, polio, tetanus 
and diphtheria toxoids, pertussis, Haemophilus influenza type B and 
hepatitis B, and any other vaccinations recommended by the Advisory 
Committee for Immunization Practices (ACIP) for which HHS/CDC 
determines, by applying criteria published in the Federal Register, 
there is a public health need at the time of immigration or adjustment 
of status. Provided however, that a Class A medical notification shall 
in no case be issued for an adopted child who is 10 years of age or 
younger if, prior to the admission of the child, an adoptive parent or 
prospective adoptive parent of the child, who has sponsored the child 
for admission as an immediate relative, has executed an affidavit 
stating that the parent is aware of the vaccination requirement and will 
ensure that, within 30 days of the child's admission, or at the earliest 
time that is medically appropriate, the child will receive the 
vaccinations identified in the requirement;
    (iii)(A) A current physical or mental disorder, and behavior 
associated with the disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others; or
    (B) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (iv) Drug abuse or drug addiction. Provided, however, that a Class A 
medical notification of a physical or mental disorder, and behavior 
associated with that disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others, shall in no 
case be issued with respect to an alien having only mental shortcomings 
due to ignorance, or suffering only from a condition attributable to 
remediable physical causes or of a temporary nature, caused by a toxin, 
medically prescribed drug, or disease.

[[Page 201]]

    (2) The medical notification shall state the nature and extent of 
the abnormality; the degree to which the alien is incapable of normal 
physical activity; and the extent to which the condition is remediable. 
The medical examiner shall indicate the likelihood, that because of the 
condition, the applicant will require extensive medical care or 
institutionalization.
    (c) Class B medical notifications. (1) If an alien is found to have 
a physical or mental abnormality, disease, or disability serious in 
degree or permanent in nature amounting to a substantial departure from 
normal well-being, the medical examiner shall report his/her findings to 
the consular or DHS officer by Class B medical notification which lists 
the specific conditions found by the medical examiner. Provided, 
however, that a Class B medical notification shall in no case be issued 
with respect to an alien having only mental shortcomings due to 
ignorance, or suffering only from a condition attributable to remediable 
physical causes or of a temporary nature, caused by a toxin, medically 
prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of 
the abnormality, the degree to which the alien is incapable of normal 
physical activity, and the extent to which the condition is remediable. 
The medical examiner shall indicate the likelihood, that because of the 
condition, the applicant will require extensive medical care or 
institutionalization.
    (d) Other medical notifications. If as a result of the medical 
examination, the medical examiner does not find a Class A or Class B 
condition in an alien, the medical examiner shall so indicate on the 
medical notification form and shall report his findings to the consular 
or DHS officer.



Sec.  34.5  Postponement of medical examination.

    Whenever, upon an examination, the medical examiner is unable to 
determine the physical or mental condition of an alien, completion of 
the medical examination shall be postponed for such observation and 
further examination of the alien as may be reasonably necessary to 
determine his/her physical or mental condition. The examination shall be 
postponed for aliens who have an acute infectious disease until the 
condition is resolved. The alien shall be referred for medical care as 
necessary.



Sec.  34.6  Applicability of foreign quarantine regulations.

    Aliens arriving at a port of the United States shall be subject to 
the applicable provisions of 42 CFR part 71, Foreign Quarantine, with 
respect to examination and quarantine measures.



Sec.  34.7  Medical and other care; death.

    (a) An alien detained by or in the custody of DHS may be provided 
medical, surgical, psychiatric, or dental care by HHS through 
interagency agreements under which DHS shall reimburse HHS. Aliens found 
to be in need of emergency care in the course of medical examination 
shall be treated to the extent deemed practical by the attending 
physician and if considered to be in need of further care, may be 
referred to DHS along with the physician's recommendations concerning 
such further care.
    (b) In case of the death of an alien, the body shall be delivered to 
the consular or immigration authority concerned. If such death occurs in 
the United States, or in a territory or possession thereof, public 
burial shall be provided upon request of DHS and subject to its 
agreement to pay the burial expenses. Autopsies shall not be performed 
unless approved by DHS.



Sec.  34.8  Reexamination; convening of review boards; 
expert witnesses; reports.

    (a) The Director shall convene a board of medical officers to 
reexamine an alien:
    (1) Upon the request of DHS for a reexamination by such a board; or
    (2) Upon an appeal to DHS by an alien who, having received a medical 
examination in connection with the determination of admissibility to the 
United States (including examination on arrival and adjustment of status 
as provided in the immigration laws and regulations) has been certified 
for a Class A condition.

[[Page 202]]

    (b) The board shall reexamine an alien certified as:
    (1) Having a communicable disease of public health significance;
    (2) Lacking documentation of having received vaccination against 
``vaccine-preventable diseases'' for an alien who seeks admission as an 
immigrant, or who seeks adjustment of status to one lawfully admitted 
for permanent residence, which shall include at least the following 
diseases: Mumps, measles, rubella, polio, tetanus and diphtheria 
toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and 
any other vaccinations recommended by the Advisory Committee for 
Immunization Practices (ACIP) for which HHS/CDC determines, by applying 
criteria published in the Federal Register, there is a public health 
need at the time of immigration or adjustment of status. Provided, 
however, that in no case shall a Class A medical notification be issued 
for an adopted child who is 10 years of age or younger if, prior to the 
admission of the child, an adoptive or prospective adoptive parent, who 
has sponsored the child for admission as an immediate relative, has 
executed an affidavit stating that the parent is aware of the 
vaccination requirement and will ensure that the child will be 
vaccinated within 30 days of the child's admission, or at the earliest 
time that is medically appropriate.
    (3)(i) Having a current physical or mental disorder and behavior 
associated with the disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others; or
    (ii) Having a history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior; or
    (iii) Having drug abuse or drug addiction;
    (c) The board shall consist of the following:
    (1) In circumstances covered by paragraph (b)(1) of this section, 
the board shall consist of at least one medical officer who is 
experienced in the diagnosis and treatment of the communicable disease 
for which the medical notification has been made;
    (2) In circumstances covered by paragraph (b)(2) of this section, 
the board shall consist of at least one medical officer who is 
experienced in the diagnosis and treatment of the vaccine-preventable 
disease for which the medical notification has been made;
    (3) In circumstances covered by paragraph (b)(3) of this section, 
the board shall consist of at least one medical officer who is 
experienced in the diagnosis and treatment of the physical or mental 
disorder, or substance-related disorder for which medical notification 
has been made.
    (d) The decision of the majority of the board shall prevail, 
provided that at least two medical officers concur in the judgment of 
the board.
    (e) Reexamination shall include:
    (1) Review of all records submitted by the alien, other witnesses, 
or the board;
    (2) Use of any laboratory or additional studies which are deemed 
clinically necessary as a result of the physical examination or 
pertinent information elicited from the alien's medical history;
    (3) Consideration of statements regarding the alien's physical or 
mental condition made by a physician after his/her examination of the 
alien; and
    (4) A physical or psychiatric examination of the alien performed by 
the board, at the board's discretion;
    (f) An alien who is to be reexamined shall be notified of the 
reexamination not less than 5 days prior thereto.
    (g) The alien, at his/her own cost and expense, may introduce as 
witnesses before the board such physicians or medical experts as the 
board may in its discretion permit; provided that the alien shall be 
permitted to introduce at least one expert medical witness. If any 
witnesses offered are not permitted by the board to testify (either 
orally or through written testimony), the record of the proceedings 
shall show the reason for the denial of permission.
    (h) Witnesses before the board shall be given a reasonable 
opportunity to review the medical notification and other records 
involved in the reexamination and to present all relevant and material 
evidence orally or in writing

[[Page 203]]

until such time as the reexamination is declared by the board to be 
closed. During the course of the reexamination the alien's attorney or 
representative shall be permitted to question the alien and he/she, or 
the alien, shall be permitted to question any witnesses offered in the 
alien's behalf or any witnesses called by the board. If the alien does 
not have an attorney or representative, the board shall assist the alien 
in the presentation of his/her case to the end that all of the material 
and relevant facts may be considered.
    (i) Any proceedings under this section may, at the board's 
discretion, be conducted based on the written record, including through 
written questions and testimony.
    (j) The findings and conclusions of the board shall be based on its 
medical examination of the alien, if any, and on the evidence presented 
and made a part of the record of its proceedings.
    (k) The board shall report its findings and conclusions to DHS, and 
shall also give prompt notice thereof to the alien if his/her 
reexamination has been based on his/her appeal. The board's report to 
DHS shall specifically affirm, modify, or reject the findings and 
conclusions of prior examining medical officers.
    (l) The board shall issue its medical notification in accordance 
with the applicable provisions of this part if it finds that an alien it 
has reexamined has a Class A or Class B condition.
    (m) If the board finds that an alien it has reexamined does not have 
a Class A or Class B condition, it shall issue its medical notification 
in accordance with the applicable provisions of this part.
    (n) After submission of its report, the board shall not be 
reconvened, nor shall a new board be convened, in connection with the 
same application for admission or for adjustment of status, except upon 
the express authorization of the Director.



PART 35_HOSPITAL AND STATION MANAGEMENT--Table of Contents



                            Subpart A_General

Sec.
35.1 Hospital and station rules.
35.2 Compliance with hospital rules.
35.3 Noncompliance; deprivation of privileges.
35.4 Noncompliance; discharge or transfer.
35.5 Entitlement to care after discharge or transfer by reason of 
          noncompliance.
35.6 Admissions; determination of eligibility for care.
35.7 Admissions; designation of person to be notified.
35.8 Safekeeping of money and effects; withdrawals.
35.9 Disposition of money and effects left by other than deceased 
          patients.
35.10 Destruction of effects dangerous to health.
35.11 Clinical records; confidential.
35.12 Solicitation of legal business prohibited.
35.13 Entry for negotiation of release or settlement.
35.14 Solicitation of legal business; negotiation of release or 
          settlement; assistance prohibited.
35.15 Consent to operative procedures.
35.16 Autopsies and other post-mortem operations.
35.17 Fees and charges for copying, certification, search of records and 
          related services.

                     Subpart B_Transfer of Patients

35.21 Authorization of transfer.
35.22 Attendants.

         Subpart C_Disposition of Articles Produced by Patients

35.31 Retention by patients.
35.32 Board of appraisers.
35.33 Sale; prices; deposit of proceeds.
35.34 Resale.
35.35 Unsalable articles.

      Subpart D_Disposal of Money and Effects of Deceased Patients

35.41 Inventory.
35.42 Notice upon death.
35.43 Delivery only upon filing claim; forms; procedure.
35.44 Delivery to legal representative; to other claimants if value is 
          $1,000 or less.
35.45 Disposition of effects; exceptions.
35.46 Conflicting claims.
35.47 Disposition of Government checks.
35.48 Deposit of unclaimed money; sale of unclaimed effects and deposit 
          of proceeds.
35.49 Sale of unclaimed effects; procedures.
35.50 Disposition of unsold effects.
35.51 Manner of delivery; costs, receipts.
35.52 Delivery of possession only; title unaffected.

[[Page 204]]

           Subpart E_Contributions for the Benefit of Patients

35.61 Applicability.
35.62 Acceptance of contributions.
35.63 Report of and accounting for contributions.
35.64 Donors.
35.65 Acceptable personal property.
35.66 Expenditure of cash contributions.

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216, sec. 
321, 53 Stat. 695, as amended; 42 U.S.C. 248, unless otherwise noted.

    Source: 21 FR 9830, Dec. 12, 1956, unless otherwise noted.



                            Subpart A_General



Sec.  35.1  Hospital and station rules.

    The officer in charge of a station or hospital of the Service is 
authorized to adopt such rules and issue such instructions, not 
inconsistent with the regulations in this part and other provisions of 
law, as he deems necessary for the efficient operation of the station or 
hospital and for the proper and humane care and treatment of all 
patients therein. All general rules governing the conduct and privileges 
of patients, and of members of the public while on the premises, shall 
be posted in prominent places.



Sec.  35.2  Compliance with hospital rules.

    All patients and visitors in stations and hospitals of the Service 
are expected to comply with the rules and instructions issued under the 
authority of the officer in charge.



Sec.  35.3  Noncompliance; deprivation of privileges.

    Any patient who wilfully fails or refuses to comply with rules or 
instructions of a hospital or station or with regulations of the 
Service, may, by the direction of the officer in charge, be deprived of 
recreational or other privileges accorded patients. Any visitor who 
wilfully fails or refuses to comply with any such rules, instructions, 
or regulations may, by direction of the officer in charge, be denied 
visiting privileges.



Sec.  35.4  Noncompliance; discharge or transfer.

    (a) If the officer in charge finds, upon investigation, that a 
patient other than a leprosy patient, by willful and persistent failure 
or refusal to comply with such rules, instructions, or regulations is 
seriously impeding the course of his own care and treatment, or that of 
other patients, he may (1) discharge the patient, or (2) if the patient 
is not a voluntary patient, arrange for his transfer to the custody of 
the authority responsible for his admission to the station or hospital. 
No patient shall be discharged or transferred on account of 
noncompliance if to do so would seriously endanger his life or health, 
nor shall any patient be discharged if his failure to comply is due, in 
the opinion of the officer in charge, to a mental disease or disorder.
    (b) If the discharge or transfer of a patient is likely to endanger 
the health of persons other than the patient or officers or employees of 
the station or hospital, the officer in charge shall give advance notice 
to appropriate State, county, or municipal authorities of the discharge 
or transfer.



Sec.  35.5  Entitlement to care after discharge or transfer 
by reason of noncompliance.

    No person otherwise entitled to care, treatment, or hospitalization 
at Service facilities, or in other facilities at the expense of the 
Service, shall be denied such care or treatment by reason of his prior 
discharge or transfer from any such facility under the provisions of 
Sec.  35.4.



Sec.  35.6  Admissions; determination of eligibility for care.

    Except as may otherwise be provided for specific classes of patients 
by the regulations of this chapter, the officer in charge of the station 
or hospital to which application is made is authorized to determine the 
eligibility of applicants, as beneficiaries of the Service, for care and 
for treatment. Such determinations shall be subject to review by the 
chief of the division of the Service responsible for administration of 
the station or hospital concerned upon referral made by the officer in 
charge in doubtful cases or upon appeal made by

[[Page 205]]

an applicant who has been denied care or treatment.



Sec.  35.7  Admissions; designation of person to be notified.

    Every in-patient, at the time of admission to the hospital or 
station or as soon thereafter as practicable, shall be requested to 
designate a person or persons to be notified in case of emergency.



Sec.  35.8  Safekeeping of money and effects; withdrawals.

    (a) A place for the safekeeping of money and effects of patients 
shall be provided at each station or hospital, and an itemized receipt 
therefor shall be furnished to the patient and to any other person who 
places money or effects therein for the benefit of the patient.
    (b) Money and effects may be withdrawn only by or on behalf of the 
patient, by his legally appointed representative authorized to receive 
or dispose of his property (including the money and effects in the 
custody of the station or hospital), or by a person who is authorized, 
under the law of the State in which the station or hospital is located, 
to receive or dispose of the patient's money and effects. In any case in 
which the officer in charge has had actual notice of the appointment of 
a legal representative, withdrawals may be made only by such 
representative or in accordance with his written directions. No delivery 
shall be made under this paragraph unless (1) the person receiving the 
money or effects shall sign an itemized receipt therefor, or (2) the 
delivery is witnessed by two persons. The provisions of this paragraph 
do not prohibit withdrawals made necessary by the provisions of this 
part for the disposition of money and effects left by patients on death 
or on departure from the station or hospital, or by the provisions of 
Sec.  35.10.



Sec.  35.9  Disposition of money and effects left by 
other than deceased patients.

    Money and effects left on the premises by a patient shall be 
forwarded promptly to him. If because his whereabouts are unknown his 
money and effects cannot be delivered to him within 120 days after his 
departure, his money shall be deposited into the Treasury and credited 
to the account entitled ``Money and Effects of Former Patients (PHS (T) 
name of patient),'' and his effects shall be held for him for six months 
and then sold in accordance with Sec.  35.49, and the proceeds deposited 
into the Treasury and credited to the above account.



Sec.  35.10  Destruction of effects dangerous to health.

    The officer in charge shall cause to be destroyed effects brought 
into or received in the station or hospital area by patients which, in 
the judgement of such officer, are dangerous as a source of disease to 
the health or life of patients or personnel of the station or hospital 
or visitors therein and cannot otherwise be safely disposed of or 
rendered harmless by disinfection or other means. The destruction of 
effects shall be witnessed by at least one officer or employee 
designated for that purpose by the officer in charge, and appropriate 
records of the destruction shall be maintained.



Sec.  35.11  Clinical records; confidential.

    A complete clinical record shall be maintained for each patient 
admitted to a station or hospital of the Service. Such records shall be 
confidential and shall not be disclosed except as may be provided 
elsewhere in regulations of the Service.



Sec.  35.12  Solicitation of legal business prohibited.

    The solicitation, directly or indirectly, of legal business or of a 
retainer or agreement authorizing an attorney to render legal services, 
is prohibited in all stations and hospitals of the Service.



Sec.  35.13  Entry for negotiation of release or settlement.

    (a) No person shall be permitted to enter a station or hospital of 
the Service for the purpose of negotiating a settlement or obtaining a 
general or special release or statement from any patient with reference 
to any illness or personal injury for which the patient is receiving 
care or treatment, or for the purpose of conferring with him as an

[[Page 206]]

attorney or representative of an attorney with reference to such illness 
or injury, unless the patient has signified his willingness to have such 
person enter for such purpose and, in the judgment of the officer in 
charge, the physical or mental condition of the patient will not thereby 
be impaired.
    (b) Any person entering a station or hospital for a purpose 
enumerated in paragraph (a) of this section shall register in the manner 
prescribed by the officer in charge, and shall furnish for the records 
of the station or hospital the name of each patient by whom he has been 
received for such a purpose.



Sec.  35.14  Solicitation of legal business; negotiation of release 
or settlement; assistance prohibited.

    All employees of the Service and all persons attached in any 
capacity to a station or hospital, including patients, are forbidden to 
communicate, directly or indirectly, with any person for the purpose of 
aiding in the solicitation of legal business or in the negotiation of a 
settlement or the obtaining of a general or special release or statement 
from any patient with reference to any illness or personal injury for 
which the patient is receiving care or treatment therein. No patient is 
prohibited by this section from communicating on his own behalf with an 
attorney of his choice or with other persons.



Sec.  35.15  Consent to operative procedures.

    Except in emergencies when the patient is physically or mentally 
incapable of consenting and the delay required to obtain the consent of 
his natural or legal guardian would seriously endanger the patient's 
health, no operative procedure shall be undertaken unless the patient 
or, in the case of a minor or incompetent, his natural or legal guardian 
gives his consent, nor shall any major operative procedure or the 
administration of a general anaesthetic be undertaken unless such 
consent has been obtained in writing. The consent or refusal of consent 
shall be made a part of the clinical record.



Sec.  35.16  Autopsies and other post-mortem operations.

    Autopsies, or other post-mortem operations, including removal of 
tissue for transplanting, may be performed on the body of a deceased 
patient only by direction of the officer in charge and only if consented 
to in writing by a person authorized under the law of the State in which 
the station or hospital is located to permit an autopsy or such other 
post-mortem operation under the circumstances of the particular death 
involved. Restrictions or limitations imposed by the person consenting 
thereto on the extent of the autopsy or other post-mortem operation 
shall be observed. Documents embodying consent shall be made a part of 
the clinical record.

[25 FR 6331, July 6, 1960]



Sec.  35.17  Fees and charges for copying, certification, 
search of records and related services.

    A prescribed fee, in accordance with the schedule in paragraph (c) 
of this section, shall be collected for each of the listed services.
    (a) Application for services. Any person requesting (1) a copy of a 
clinical record, clinical abstract, or other document containing 
clinical information; or (2) a certification of a clinical record or 
document; or (3) a search of clinical records, shall make written 
application therefor to the Public Health Service facility having 
custody of the subject matter involved. Such application shall state 
specifically the particular record or document requested, and the 
purpose for which such copy or document is desired to be used. The 
application shall be accompanied by a deposit in an amount equal to the 
prescribed charge for the service rendered. Where it is not known if a 
clinical record or other document is in existence, the application shall 
be accompanied by a minimum deposit of $2.50.
    (b) Authorization for disclosure. The furnishing of copies of PHS 
records containing confidential clinical information must comply with 
the requirements of part I, title 42, Code of Federal Regulations, 
governing authorization for the disclosure of such information.
    (c) Schedule of fees.

[[Page 207]]



(1) Photocopy reproduction of a clinical record or other
 document (through use of facility equipment):
  (a) Processing (searching, preparation of record and use of      $3.25
   equipment), first page.......................................
  (b) Each additional page......................................     .25
(2) Certification, per document.................................     .25
(3) Unsuccessful searching, per hour (minimum charge 1 hour)....    2.50
(4) Clinical abstracts, per request.............................    3.00
(5) Arranging commercial duplication of a clinical record, per       \1\
 request........................................................    0.50
(6) If the requested material is to be transmitted by registered
 mail, airmail, or special delivery mail, the postal fees
 therefor shall be added to the other fees provided above,
 unless the applicant has included proper postage or stamped
 return envelopes for this purpose.
 
\1\ The private concern which duplicates records for an applicant will
  make a separate charge therefor and will bill the applicant directly.

    (d) Waiver of fee. The prescribed fee may be waived, in the 
discretion of the medical officer in charge, under the following 
circumstances:
    (1) When the service or document is requested by another agency of 
the Federal Government for use in carrying out official Government 
business.
    (2) When a clinical record is requested for the purpose of providing 
continued medical care to a Service beneficiary by a non-Service 
physician, clinic, or hospital, in which case the record will be 
forwarded only to the physician, clinic, or hospital concerned.
    (3) When the service or document is requested by an attorney in the 
prosecution of a Service beneficiary's personal injury claim against a 
third person, involving the concurrent assertion of a government medical 
care claim under 42 U.S.C. 2651-2653. In such case, the service or 
document requested will be furnished only upon compliance with all 
additional requirements for the release of records in third party 
recovery cases, including the proper execution of form PHS-4686, 
Agreement to Assign Claim Upon Request.
    (4) When the service or document is requested by, and furnished to, 
a Member of Congress for official use.
    (5) When the service or document is requested by, and furnished to, 
a court in lieu of the personal court appearance of an employee of the 
Public Health Service.
    (6) When the service or document is required to be furnished free in 
accordance with a Federal statute or an Executive order.
    (7) When the furnishing of the service or document requested without 
charge would be an appropriate courtesy to a foreign country or 
international organization.

(Sec. 501, 65 Stat. 290; 31 U.S.C. 483(a); sec. 215, 58 Stat. 690, as 
amended; 42 U.S.C. 216)

[32 FR 6842, May 4, 1967]



                     Subpart B_Transfer of Patients



Sec.  35.21  Authorization of transfer.

    Except as otherwise provided by law or regulation with respect to 
certain classes of patients, the officer in charge of a station or 
hospital of the Service may provide, without any cost to the patient, 
for the transfer of the patient either from such station or hospital to 
another station or hospital of the Service or to any non-Service station 
or hospital at which the patient may be received, or from any non-
Service hospital at which he is receiving care or treatment as a patient 
of the Service to a station or hospital of the Service.



Sec.  35.22  Attendants.

    Patients shall be transferred by such means and accompanied by such 
medical, nursing, or other attendants as may be necessary to protect the 
health and safety of the patient and other persons likely to come into 
contact with him, including in the case of a prisoner such guards as may 
be necessary to assure his safekeeping. A female patient requiring the 
services of attendants shall be accompanied by at least one female 
attendant. Medical or nursing attendants shall be qualified to care for 
persons suffering from the type of disease or disorder with which the 
patient is afflicted and shall be provided with equipment and medicines 
necessary for the care of the patient.



         Subpart C_Disposition of Articles Produced by Patients



Sec.  35.31  Retention by patients.

    Subject to the rules of the station or hospital, patients may be 
accorded the privilege of retaining articles produced by them in the 
course of their curative treatment with the aid of materials furnished 
by the Service. Articles not

[[Page 208]]

retained by patients shall be disposed of as provided in this subpart. 
The provisions of this subpart do not apply to the products of 
industrial activities established for narcotic addicts.



Sec.  35.32  Board of appraisers.

    The officer in charge shall appoint, from the personnel of the 
station or hospital, a board of three persons to serve at his pleasure. 
The board shall provide for the sale of articles having commercial value 
and shall keep appropriate records of such articles and their 
disposition.



Sec.  35.33  Sale; prices; deposit of proceeds.

    The board shall determine and redetermine from time to time the 
prices at which articles are to be sold, and in doing so shall consider 
the cost of materials used, reasonable handling charges, and the fair 
market value of the articles. The sale price shall be indicated on each 
article by tag or other appropriate means, and a list of articles 
offered for sale and their respective sale prices shall be posted from 
time to time in the hospital or station area. In its discretion, the 
board may offer such articles for purchase by other patients or by 
charitable organizations before offering them for purchase to the 
general public. No article shall be sold or resold to any officer or 
employee of the Service. Moneys received from the sale of articles shall 
be deposited into the Treasury to the credit of the appropriation from 
which the materials for making such articles were purchased.



Sec.  35.34  Resale.

    No article purchased under the provisions of this subpart shall be 
resold in the hospital or station area at a price to exceed the sale 
price fixed by the board for such article.



Sec.  35.35  Unsalable articles.

    Articles having no commercial value shall be stored, destroyed, or 
otherwise disposed of as the officer in charge may direct.



      Subpart D_Disposal of Money and Effects of Deceased Patients



Sec.  35.41  Inventory.

    Promptly after the death of a patient in a station or hospital of 
the Service, an inventory of his money and effects left therein shall be 
made by two or more officers or employees of the Service designated for 
such purpose by the officer in charge.



Sec.  35.42  Notice upon death.

    The officer in charge shall notify in writing all persons known to 
him to whom delivery of the patient's money and effects might be made 
hereunder, and, in the case of an alien patient, a consul of the country 
of his apparent nationality. Each person so notified shall be requested 
to furnish information concerning (a) the existence or whereabouts of 
any persons to whom delivery of the deceased patient's money and effects 
may be made pursuant to these provisions, and (b) the permanent 
residence or home of the deceased.



Sec.  35.43  Delivery only upon filing claim; forms; procedure.

    (a) Delivery of the money and effects of a deceased patient shall be 
made only to a person who has filed a claim therefor on a form 
prescribed by the Surgeon General.
    (b) A claimant shall furnish, in addition to the information on the 
prescribed form, such additional information as the officer in charge 
may consider necessary to establish the identity of the claimant and the 
truth of his statements.
    (c) A person filing a claim as a legal representative shall be 
required to present letters of administration or a certificate of a 
court attesting his qualification or appointment.
    (d) If a claim is made after the money, or proceeds from the sale of 
the effects, of a deceased patient have been deposited in the Treasury, 
the claim shall be referred to the General Accounting Office. If the 
claim is for checks or evidences of indebtedness of the United States 
which have been trasnsmitted to the issuing agency pursuant to 
Sec. Sec.  35.47 and 35.48, the claimant shall be referred to such 
agency.

[[Page 209]]



Sec.  35.44  Delivery to legal representative; to other claimants 
if value is $1,000 or less.

    The money and effects of the deceased patient shall in all cases be 
delivered to the legal representative, if any, of his estate. If the 
value is $1,000 or less, and the officer in charge has neither notice 
nor other knowledge of the appointment or qualification of a legal 
representative, nor reason to believe that a legal representative will 
be appointed or qualified, he shall deliver all the money and effects, 
as soon as practicable after the expiration of 10 days from the sending 
of notices to one of the following in the indicated order of priority:
    (a) A person, if any, designated in writing by the patient to 
receive the same.
    (b) The patient's surviving spouse.
    (c) The patient's child or children in equal parts.
    (d) The patient's parent or parents in equal parts.
    (e) Any other person who would be entitled to receive the money and 
effects under the law of the patient's domicile: Provided, That delivery 
of such money and effects may be made immediately upon application by 
one of the persons specified above if the officer in charge has neither 
notice nor other knowledge that a person higher in the indicated order 
of priority exists.



Sec.  35.45  Disposition of effects; exceptions.

    Irrespective of the provisions of this subpart, the officer in 
charge may (a) release from among the effects of the deceased patient so 
much of the patient's clothing as may be necessary for use in 
preparation of his body for burial and (b) cause to be destroyed, or 
otherwise disposed of, such used toilet articles of the patient as 
appear to have no commercial or other value.



Sec.  35.46  Conflicting claims.

    In any case in which conflicting claims are filed or the officer in 
charge considers it to be in the interest of persons who may be 
ultimately entitled thereto, delivery may be withheld from all persons 
other than a duly qualified legal representative.



Sec.  35.47  Disposition of Government checks.

    Notwithstanding any other provisions of this subpart, immediately 
upon completion of the inventory, checks drawn on the Treasurer of the 
United States shall be sent by safe means to the department, agency, or 
establishment of the Government of the United States issuing such 
checks. The transmittal shall be accompanied by a statement of the 
reasons therefor and of all available information which may aid the 
issuing unit in the disposition of the check transmitted. Notice of the 
disposition of any checks, with identifying information, shall be given 
to the person or persons, if any, to which money and effects are 
delivered in accordance with Sec.  35.44.



Sec.  35.48  Deposit of unclaimed money; sale of unclaimed effects 
and deposit of proceeds.

    If, within 120 days after sending of notices no claim has been filed 
pursuant to the provisions of Sec.  35.43, the patient's money, 
consisting of all types of United States currency and coin, shall be 
deposited in the Treasury to the credit of the trust-fund account 
entitled ``Money and Effects of Deceased Patients, Public Health 
Service.'' If, within six months after the death of a patient, no claim 
has been filed pursuant to the provisions of Sec.  35.43, his effects 
(including foreign currency and coin but excluding Postal Savings 
Certificates and other evidences of indebtedness of the United States) 
shall be sold at public auction or by sealed bids to the highest bidder 
and the proceeds deposited to the credit of the trust-fund account 
entitled ``Money and Effects of Deceased Patients, Public Health 
Service.'' Postal Savings Certificates and other evidences of 
indebtedness of the United States shall be transmitted to the issuing 
department or agency with a statement of the occasion therefor.



Sec.  35.49  Sale of unclaimed effects; procedures.

    The following provisions shall govern the sale of effects:
    (a) Notice. Reasonable advance notice of proposed sales shall be 
posted at such prominent places in the station or

[[Page 210]]

hospital area as the officer in charge may designate. In addition, a 
notice shall be posted at the nearest post office, and notices shall be 
sent by mail to all known persons to whom delivery of money and effects 
of the patient may be made under the provisions of this subpart. The 
officer or employee who posts or sends notices of sales shall make an 
appropriate affidavit on a copy of the notice as to his action in that 
respect, including in his affidavit the names of persons to whom copies 
of the notices were mailed and the mailing dates. The copy of the notice 
on which the affidavit appears shall be retained in the files of the 
station or hospital.
    (b) Form and contents of notice. Notice of proposed sales shall be 
given on a form prescribed by the Surgeon General. The notice shall 
include: an inventory of the effects to be offered for sale; the names 
of the patients from whom the effects were received; the precise date, 
time, and place when and where the sale will be held; a statement that 
the articles will be available for inspection immediately prior to sale, 
if sold at public auction, or on a day and during the hours appointed 
for the inspection of articles if sold by sealed bid; a statement that 
the sale is to be held pursuant to the provisions of the regulations in 
this part, that, if the articles are to be sold by sealed bid, the right 
to reject all bids is reserved, and that, if otherwise authorized, 
delivery will be made of effects or proceeds of sales to persons filing 
claims prior to the sale of effects or prior to the transmittal of 
proceeds to the Surgeon General.
    (c) Time and place of sales. All sales shall be held at reasonable 
hours and at such places within the station or hospital area as the 
officer in charge may designate.
    (d) Who shall conduct sales. All sales shall be conducted by the 
officer in charge or by a responsible officer or employee designated by 
him.
    (e) Sale and delivery. All effects offered for sale shall be sold to 
the highest bidder and delivered to him immediately upon payment of the 
sale price in cash or by postal money order or certified check and 
execution of an appropriate receipt by the person to whom delivery is 
made.



Sec.  35.50  Disposition of unsold effects.

    The officer in charge shall dispose of effects offered for sale but 
remaining unsold in such manner as he considers to be proper, but, if 
practicable, such effects shall be used for the benefit of other 
patients of the Service.



Sec.  35.51  Manner of delivery; costs, receipts.

    (a) If a person entitled under this subpart to receive the money and 
effects of a patient is unable to take possession thereof at the station 
or hospital, they shall be sent to him at the expense of the United 
States in the most economical manner available. The records of the 
station or hospital shall show the names and addresses of persons to 
whom money or effects have been sent, the date of sending, the means 
used, an itemized list of the money or effects sent, and a statement by 
a witnessing officer or employee verifying the foregoing from his own 
observation.
    (b) If not delivered personally by an authorized officer or employee 
of the Service, money, evidences of indebtedness, and other valuable 
papers and documents shall be sent by registered mail (or other safe 
means).
    (c) Persons receiving the money and effects of a patient shall be 
required to execute an itemized receipt therefor.



Sec.  35.52  Delivery of possession only; title unaffected.

    Except for delivery of effects to purchasers at sales held in 
accordance with Sec.  35.49, delivery or deposit under this subpart of 
the money or effects, or the proceeds of a sale of the effects, of a 
deceased patient constitutes only a transfer of possession and is not 
intended to affect in any manner the title to such money, effects, or 
proceeds.



           Subpart E_Contributions for the Benefit of Patients

    Authority: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 
U.S.C. 216); sec. 321, 58 Stat. 695, as amended, 62 Stat. 1017 (42 
U.S.C. 248).

[[Page 211]]


    Source: 42 FR 60742, Nov. 29, 1977, unless otherwise noted.



Sec.  35.61  Applicability.

    This subpart sets forth the policies and procedures governing the 
acceptance and administration of contributions of money or property 
intended solely for the benefit of all patients in a ward or unit or a 
particular hospital or station of the Public Health Service, excluding 
outpatient clinics. Such contributions are distinguishable from (a) 
monies or other valuables belonging to specific patients which are 
accepted and held in custody for the convenience of the patient until 
such time as he or she wishes to withdraw them, and (b) gifts to the 
United States to support Public Health Service functions under section 
501 of the Public Health Service Act or other statutory provisions, 
which may be accepted and administered only in accordance with such 
statutory provisions or other applicable laws.



Sec.  35.62  Acceptance of contributions.

    (a) The officer in charge of a hospital or station or his delegate 
may accept contributions of money or personal property which are donated 
for the general benefit of all patients within the hospital or station 
(or a ward or unit thereof) without further specification or conditions 
as to use. Contributions tendered subject to conditions by the donor, 
such as expenditure or use only on behalf of certain patients or for 
specific purposes, may not be accepted.
    (b) Contribution of money or property shall be accepted in writing.



Sec.  35.63  Report of and accounting for contributions.

    (a) Contributions of money accepted pursuant to Sec.  35.62 
(hereinafter referred to as ``patient fund'') will be treated 
consistently with Federal deposit rules and as supplemented with 
appropriate procedures of the facility. This regulation is not intended 
to exclude contributions for the benefit of patients from proper 
accountability and control of funds and property.
    (b) Contributions of property accepted pursuant to Sec.  35.62 shall 
be recorded and accounted for in the same manner as other property of a 
similar kind maintained in the hospital or station, but with suitable 
identification so that it can be distinguished from government-owned 
property.



Sec.  35.64  Donors.

    Authorized contributions may be accepted from patients, employees 
and other individuals, and agencies and organizations.



Sec.  35.65  Acceptable personal property.

    Contributions of personal property which may be accepted pursuant to 
Sec.  35.62 include, but are not limited to, recreational equipment, 
furniture, radios and television sets. After its useful life, any cash 
proceeds realized upon disposition of such property shall be deposited 
to the credit of the patient fund and shall be available for expenditure 
pursuant to Sec.  35.66(c).



Sec.  35.66  Expenditure of cash contributions.

    (a) Officials authorized to accept contributions shall not maintain 
control over the actual obligation or expenditure of such monies.
    (b) Only those officers or employees specifically designated in 
writing by the officer in charge for such purpose may obligate and 
expend monies from the patient fund. The names of officials so 
designated shall be provided to the relevant fiscal control office.
    (c) Subject to availability of sufficient funds, monies in the 
patient fund may be expended for materials, services or activities which 
contribute to the well-being or morale of patients, including but not 
limited to provision of reading and entertainment materials, recreation 
activities, and, in appropriate cases, necessary financial support 
(including travel expenses, meals, and lodging) of relatives, guardians, 
or friends of patients to enable such persons to be available for the 
patient's comfort and support.
    (d) Officers in charge may issue such additional instructions, not 
inconsistent with this subpart, as may be necessary to implement its 
provisions.

[[Page 212]]



PART 37_SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF COAL MINERS--
Table of Contents



                 Subpart_Chest Radiographic Examinations

Sec.
37.1 Scope.
37.2 Definitions.
37.3 Chest radiographs required for miners.
37.4 Chest radiographic examinations conducted by the Secretary.
37.10 Standards incorporated by reference.
37.20 Miner identification document.

      Specifications for Performing Chest Radiographic Examinations

37.40 General provisions.
37.41 Chest radiograph specifications--film.
37.42 Chest radiograph specifications--digital radiography systems.
37.43 Approval of radiographic facilities that use film radiography 
          systems..
37.44 Approval of radiographic facilities that use digital radiography 
          systems.
37.45 Protection against radiation emitted by radiographic equipment.

  Specifications for Interpretation, Classification, and Submission of 
                            Chest Radiographs

37.50 Interpreting and classifying chest radiographs--film radiography 
          systems.
37.51 Interpreting and classifying chest radiographs--digital 
          radiography systems.
37.52 Proficiency in the use of systems for classifying the 
          pneumoconioses.
37.53 Method of obtaining definitive chest radiograph classifications.
37.54 Notification of abnormal radiographic findings.
37.60 Submitting required chest radiograph classification and miner 
          identification documents.

                   Review and Availability of Records

37.70 Review of classifications.
37.80 Availability of records for radiographs.

                       Subpart_Spirometry Testing

37.90 Scope.
37.91 Definitions.
37.92 Spirometry testing required for miners.
37.93 Approval of spirometry facilities.
37.94 Respiratory assessment form.
37.95 Specifications for performing spirometry tests.
37.96 Spirometry interpretations, reports, and submission.
37.97 Notification of spirometry results.
37.98 Standards incorporated by reference.

                      Subpart_General Requirements

37.100 Coal mine operator plan for medical examinations.
37.101 Approval of plans.
37.102 Transfer of affected miner to less dusty area.
37.103 Medical examination at miner's expense.

                            Subpart_Autopsies

37.200 Scope.
37.201 Definitions.
37.202 Payment for autopsy.
37.203 Autopsy specifications.
37.204 Procedure for obtaining payment.

    Authority: Sec. 203, 83 Stat. 763; 30 U.S.C. 843, unless otherwise 
noted.

    Source: 43 FR 33715, Aug. 1, 1978, unless otherwise noted.



                 Subpart_Chest Radiographic Examinations



Sec.  37.1  Scope.

    Under this subpart, coal mine operators are required to provide 
radiographic examinations to each current and new coal miner, using 
medical facilities approved by NIOSH in accordance with standards 
established in this subpart.

[79 FR 45118, Aug. 4, 2014]



Sec.  37.2  Definitions.

    Any term defined in the Federal Mine Safety and Health Act of 1977 
(30 U.S.C. 801 et seq., Pub. L. 95-164, as amended) and not defined 
below will have the meaning given it in the Act. As used in this 
subpart:
    Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 
801, et seq., Pub. L. 95-164, as amended).
    B Reader means a physician certified by NIOSH as able to classify 
chest radiographs using the ILO Classification system, pursuant to Sec.  
37.52(b).
    Chest radiograph means a single posteroanterior radiographic 
projection or radiograph of the chest at full inspiration recorded on 
either film or digital radiography systems.
    Convenient time and place means that an examination conducted 
pursuant to this part must be given at a reasonable hour in the locality 
in which the miner

[[Page 213]]

resides or a location that is equally accessible to the miner. For 
example, examinations at the mine during, immediately preceding, or 
immediately following work and a ``no appointment'' examination at a 
medical facility in a community easily accessible to the residences of a 
majority of the miners working at the mine will be considered of 
equivalent convenience for purposes of this definition.
    Digital radiography systems, as used in this context, include both 
Digital Radiography (DR) and Computed Radiography (CR) systems.
    (1) Computed radiography (CR) is the term for digital radiographic 
image acquisition systems that detect radiographic signals using a 
cassette-based photostimulable storage phosphor. Subsequently, the 
cassette is processed using a stimulating laser beam to convert the 
latent radiographic image to electronic signals which are then processed 
and stored so they can be displayed.
    (2) Digital radiography (DR) is the term used for digital 
radiographic image acquisition systems in which the radiographic signals 
received by the image detector are converted nearly instantaneously to 
electronic signals without movable cassettes.
    Facility means a facility or organization licensed to provide health 
care by the State or Territory in which services are provided, such as a 
hospital, a clinic, or other provider that performs medical 
examinations.
    ILO Classification means the classification of radiographs using the 
International Classification of Radiographs of Pneumoconioses, a system 
devised by an international committee of the International Labour Office 
(ILO), including a complete set of standard film radiographs or digital 
chest image files available from the ILO or other set of chest image 
files approved by NIOSH as equivalent. The ILO Classification is 
incorporated by reference into Sec. Sec.  37.50(a) and (c) and 37.51(b).
    MSHA means the Mine Safety and Health Administration, Department of 
Labor.
    Miner means any individual working in a coal or other mine.
    NIOSH means the National Institute for Occupational Safety and 
Health (NIOSH), located within the Centers for Disease Control and 
Prevention (CDC). Within NIOSH, the Respiratory Health Division (RHD), 
1095 Willowdale Road, Morgantown, WV 26505, is the organizational unit 
that has programmatic responsibility for the Coal Workers' Health 
Surveillance Program.
    NIOSH representative means employees of CDC/NIOSH and employees of 
CDC contractors.
    Operator means any owner, lessee, or other person who operates, 
controls, or supervises a coal or other mine or any independent 
contractor performing services or construction at such mine.
    Panel of B Readers means the group of physicians that are currently 
certified by NIOSH as B Readers and who classify or otherwise evaluate 
radiographs for the Coal Workers' Health Surveillance Program.
    Pre-placement physical examination means any medical examination 
that includes a chest radiographic examination given in accordance with 
the specifications of this Part to a person not previously employed by 
the same operator. Such examinations should be conducted consistent with 
applicable law, including the Americans with Disabilities Act of 1990, 
which provides that pre-placement examinations take place only after an 
offer of employment has been made and subject to certain restrictions 
(42 U.S.C. 12112(d)).
    Qualified medical physicist means an individual who is trained in 
evaluating the performance of radiographic equipment including radiation 
controls and facility quality assurance programs, and has the relevant 
current certification by a competent U.S. national board, or 
unrestricted license or approval from a U.S. State or territory.
    Radiographic technique chart means a table that specifies the types 
of cassette, intensifying screen, film or digital detector, grid, 
filter, and lists X-ray machine settings (timing, kVp, mA) that enables 
the radiographer to select the correct settings based on the body 
habitus or the thickness of the chest tissue.
    Radiologic technologist means an individual who has met the 
requirements for privileges to perform general radiographic procedures 
and for competence in using the equipment and software

[[Page 214]]

employed by the examining facility to obtain chest radiographs as 
specified by the State or Territory and examining facility in which such 
services are provided. Optimally, such an individual will have completed 
a formal training program in radiography leading to a certificate, an 
associate degree, or a bachelor's degree and participated in the 
voluntary initial certification and annual renewal of registration for 
radiologic technologists offered by the American Registry of Radiologic 
Technologists.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved may be delegated.
    Soft copy means the image of a coal miner's chest radiograph 
acquired using a digital radiography system, viewed at the full 
resolution of the image acquisition system using an electronic medical 
image display device.

[77 FR 56726, Sept. 13, 2012, as amended at 79 FR 45118, Aug. 4, 2014; 
81 FR 73279, Oct. 24, 2016]



Sec.  37.3  Chest radiographs required for miners.

    (a) Voluntary examinations. Every operator must provide to each 
miner who is employed in or at any of its coal mines and who was 
employed in coal mining prior to December 30, 1969, or who has completed 
the required examinations under paragraph (b) of this section an 
opportunity for a chest radiograph at no cost to the miner in accordance 
with this subpart:
    (1) NIOSH will notify the operator of each coal mine of a period 
within which the operator may provide examinations to each miner 
employed at its coal mine. The period must begin no sooner than 3.5 
years and end no later than 4.5 years subsequent to the ending date of 
the previous 6-month period specified for a coal mine either by the 
operator on an approved plan or by NIOSH if the operator did not submit 
an approved plan. Within the period specified for each mine, the 
operator may select a 6-month period within which to provide 
examinations in accordance with a plan approved under Sec.  37.101.
    (2) Within either the next or future period(s) specified to the 
operator for each of its coal mines, the operator of the coal mine may 
select a different 6-month period for each of its mines within which to 
offer examinations. In the event the operator does not submit an 
approved plan, NIOSH will specify a 6-month period to the operator 
within which miners must have the opportunity for examinations.
    (b) Mandatory examinations. Every operator must provide to each 
miner who begins working in or at an underground coal mine for the first 
time after December 30, 1969 or in or at a surface coal mine for the 
first time after August 1, 2014:
    (1) An initial chest radiograph, as soon as possible, but in no 
event later than 30 days after commencement of employment or within 30 
days of approval of a plan to provide chest radiographs. An initial 
chest radiograph given to a miner according to former regulations for 
this subpart prior to August 1, 2014 will also be considered as 
fulfilling this requirement.
    (2) A second chest radiograph, in accordance with this subpart, 3 
years following the initial examination if the miner is still engaged in 
coal mining. A second radiograph given to a miner according to former 
regulations under this subpart prior to August 1, 2014 will be 
considered as fulfilling this requirement.
    (3) A third chest radiograph 2 years following the second chest 
radiograph if the miner is still engaged in coal mining and if the 
second radiograph shows evidence of category 1 (1/0, 1/1, 1/2), category 
2 (2/1, 2/2, 2/3), category 3 (3/2, 3/3, 3/+) simple pneumoconiosis, or 
complicated pneumoconiosis (ILO Classification) or if the second 
spirometry examination specified in Sec.  37.92(b)(2) shows evidence of 
decreased lung function to the extent specified in Sec.  37.92(b)(3).
    (c) Notification. NIOSH will notify the miner when he or she is due 
to receive the second or third mandatory examination under paragraph (b) 
of this section. NIOSH will notify the coal mine operator when the miner 
is to be given a second examination.

[[Page 215]]

    (1) The operator will be notified of a miner's third examination 
only with the miner's written consent. The notice to the operator will 
not state the medical reason for the examination or that it is the third 
examination in the series.
    (2) If the miner is notified by NIOSH that the third mandatory 
examination is due and the operator is not so notified, availability of 
the radiographic examination under the NIOSH-approved operator's plan 
will constitute the operator's compliance with the requirement to 
provide a third mandatory examination even if the miner refuses to take 
the examination.
    (d) Availability of chest radiographs. The opportunity for chest 
radiographs to be made available by an operator for purposes of this 
subpart must be provided in accordance with a plan that has been 
submitted and approved in accordance with this part.

[81 FR 73280, Oct. 24, 2016]



Sec.  37.4  Chest radiographic examinations conducted by the Secretary.

    (a) The Secretary will give chest radiographs or make arrangements 
with an appropriate person, agency, or institution to give the chest 
radiographs and with A or B Readers to interpret the radiographs 
required under this subpart in the locality where the miner resides, at 
the mine, or at a medical facility easily accessible to a mining 
community or mining communities, under the following circumstances:
    (1) Where, in the judgment of the Secretary, due to the lack of 
adequate medical or other necessary facilities or personnel at the mine 
or in the locality where the miner resides, the required radiographic 
examination cannot be given.
    (2) Where the operator has not submitted an approvable plan.
    (3) Where, after commencement of an operator's program pursuant to 
an approved plan and after notice to the operator of his failure to 
follow the approved plan and, after allowing 15 calendar days to bring 
the program into compliance, the Secretary determines and notifies the 
operator in writing that the operator's program still fails to comply 
with the approved plan.
    (b) The operator of the mine must reimburse the Secretary or other 
person, agency, or institution as the Secretary may direct, for the cost 
of conducting each examination made in accordance with this section.
    (c) All examinations given or arranged by the Secretary will comply 
with the time requirements of Sec.  37.3. Whenever the Secretary gives 
or arranges for the examinations of miners at a time, a written notice 
of the arrangements will be sent to the operator who must post the 
notice on the mine bulletin board.

[81 FR 73281, Oct. 24, 2016]



Sec.  37.10  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this subpart, 
Subpart--Chest Radiographic Examinations, with the approval of the 
Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 
51. To enforce any edition other than that specified in this section, 
NIOSH must publish notice of change in the Federal Register and the 
material must be available to the public. All approved material is 
available for inspection at NIOSH, Respiratory Health Division, 1095 
Willowdale Road, Morgantown, WV 26505. To arrange for an inspection at 
NIOSH, call 304-285-5749. Copies are also available for inspection at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (b) American Association of Physicists in Medicine, Order 
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 
53705, http://www.aapm.org/pubs/reports:
    (1) AAPM On-Line Report No. 03, Assessment of Display Performance 
for Medical Imaging Systems, April 2005, into Sec.  37.51(d) and (e).
    (2) AAPM Report No. 14, Performance Specifications and Acceptance 
Testing for X-Ray Generators and Automatic Exposure Control Devices, 
Report of the Diagnostic X-Ray Imaging Committee Task Group on 
Performance Specifications and Acceptance Testing

[[Page 216]]

for X-Ray Generators and Automatic Exposure Control Devices, published 
by the American Institute of Physics for AAPM, January 1985, into 
Sec. Sec.  37.42(h) and 37.44(g).
    (3) AAPM Report No. 31, Standardized Methods for Measuring 
Diagnostic X-Ray Exposures, Report of Task Group 8, Diagnostic X-Ray 
Imaging Committee, published by the American Institute of Physics, July 
1990, into Sec.  37.44(g).
    (4) AAPM Report No. 74, Quality Control in Diagnostic Radiology, 
Report of Task Group 12, Diagnostic X-Ray Imaging Committee, published 
by Medical Physics Publishing for AAPM, July 2002, into Sec. Sec.  
37.42(h), 37.43(f), and 37.44(g).
    (5) AAPM Report No. 93, Acceptance Testing and Quality Control of 
Photostimulable Storage Phosphor Imaging Systems, October 2006, into 
Sec. Sec.  37.42(i) and 37.44(g).
    (6) AAPM Report No. 116, An Exposure Indicator for Digital 
Radiography, Report of AAPM Task Group 116, published by AAPM, July 
2009, into Sec.  37.44(g).
    (c) American College of Radiology, 1891 Preston White Dr., Reston, 
VA 20191, http://www.acr.org:
    (1) ACR Practice Guideline for Diagnostic Reference Levels in 
Medical X-Ray Imaging, Revised 2008 (Resolution 3), into Sec. Sec.  
37.42(i) and 37.44(g).
    (2) [Reserved]
    (d) International Labour Office, CH-1211 Geneva 22, Switzerland, 
http://www.ilo.org/publns:
    (1) Guidelines for the Use of the ILO International Classification 
of Radiographs of Pneumoconioses, Revised Edition 2011, into Sec. Sec.  
37.50(a), 37.50(c), and 37.51(b).
    (2) [Reserved]
    (e) National Council on Radiation Protection and Measurements, NCRP 
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095, 
Telephone (800) 229-2652, http://www.ncrppublications.org:
    (1) NCRP Report No. 102, Medical X-ray, Electron Beam, and Gamma-Ray 
Protection for Energies Up to 50 MeV (Equipment Design, Performance, and 
Use), issued June 30, 1989, into Sec.  37.45.
    (2) NCRP Report No. 105, Radiation Protection for Medical and Allied 
Health Personnel, issued October 30, 1989, into Sec.  37.45.
    (3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, into Sec.  37.45.
    (f) National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209, http://medical.nema.org:
    (1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 3: Information Object Definitions, 
copyright 2011, into Sec.  37.42(i).
    (2) DICOM Standard PS3.4-2011, Digital Imaging and Communications in 
Medicine (DICOM) standard, Part 4: Service Class Specifications, 
copyright 2011, into Sec.  37.42(i).
    (3) DICOM Standard PS 3.10-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 10: Media Storage and File Format for 
Media Interchange, copyright 2011, into Sec.  37.42(i).
    (4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 11: Media Storage Application 
Profiles, copyright 2011, into Sec.  37.42(i).
    (5) DICOM Standard PS 3.12-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media 
for Media Interchange, copyright 2011, into Sec. Sec.  37.42(i) and 
37.44(a).
    (6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display 
Function, copyright 2011, into Sec. Sec.  37.42(i)(5) and 37.51(d).
    (7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 16: Content Mapping Resource, 
copyright 2011, into Sec.  37.42(i).

[81 FR 73281, Oct. 24, 2016]



Sec.  37.20  Miner identification document.

    As part of the examination, a Miner Identification Document (CDC/
NIOSH (M)2.9) which includes an occupational history questionnaire must 
be completed for each miner at the facility where the examination is 
made (this

[[Page 217]]

document is required for both radiographic and spirometry examinations 
conducted pursuant to this part).

[81 FR 73282, Oct. 24, 2016]

      Specifications for Performing Chest Radiographic Examinations



Sec.  37.40  General provisions.

    (a) The chest radiographic examination must be given at a convenient 
time and place.
    (b) The chest radiographic examination consists of the chest 
radiograph, a completed Chest Radiograph Classification Form (CDC/NIOSH 
2.8), and a completed Miner Identification Document (CDC/NIOSH 2.9).
    (c) A radiographic examination must be made in a facility approved 
in accordance with Sec.  37.43 or Sec.  37.44. Chest radiographs of 
miners under this section must be performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.

[81 FR 73282, Oct. 24, 2016]



Sec.  37.41  Chest radiograph specifications--film.

    (a) Miners must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a dressing area and for 
those miners who wish to use one, the facility will provide a clean 
gown. Facilities must be heated to a comfortable temperature.
    (b) Every chest radiograph must be a single posteroanterior 
projection at full inspiration on a film being no less than 14 by 17 
inches and no greater than 16 by 17 inches. The film and cassette must 
be capable of being positioned both vertically and horizontally so that 
the chest radiograph will include both apices and costophrenic angles. 
If a miner is too large to permit the above requirements, then the 
projection must include both apices with minimum loss of the 
costophrenic angle.
    (c) Chest radiographs of miners under this section must be 
performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.
    (d) Radiographs must be made with a diagnostic X-ray machine with a 
maximum actual (not nominal) source (focal spot) of 2 mm, as measured in 
two orthogonal directions.
    (e) Except as provided in this paragraph (e), radiographs must be 
made with units having generators that comply with the following:
    (1) The generators of existing radiographic units acquired by the 
examining facility prior to July 27, 1973, must have a minimum rating of 
200 mA at 100 kVp;
    (2) Generators of units acquired subsequent to that date must have a 
minimum rating of 300 mA at 125 kVp.
    (f) Radiographs made with battery-powered mobile or portable 
equipment must be made with units having a minimum rating of 100 mA at 
110 kVp at 500 Hz, or of 200 mA at 110 kVp at 60 Hz.
    (g) Capacitor discharge and field emission units may be used if the 
model of such units is approved by NIOSH for quality, performance, and 
safety. NIOSH will consider such units for approval when listed by a 
facility seeking approval under Sec. Sec.  37.43 or 37.44.
    (h) Radiographs must be given only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The beam 
limiting device must provide rectangular collimation and must be of the 
type described in 21 CFR 1020.31(d), (e), (f), and (g). The use of such 
a device must be discernible from an examination of the radiograph.
    (i) To ensure high quality chest radiographs:
    (1) The maximum exposure time must not exceed 50 milliseconds except 
that with single phase units with a rating less than 300 mA at 125 kVp 
and subjects with chests over 28 cm posteroanterior, the exposure may be

[[Page 218]]

increased to not more than 100 milliseconds;
    (2) The source or focal spot to film distance must be at least 6 
feet;
    (3) Medium speed film and medium speed intensifying screens are 
recommended. However, any film-screen combination, the rated ``speed'' 
of which is at least 100 and does not exceed 300, that produces 
radiographs with spatial resolution, contrast, latitude and quantum 
mottle similar to those of systems designated as ``medium speed'' may be 
employed;
    (4) Film-screen contact shall be maintained and verified at 6 month 
or shorter intervals;
    (5) Intensifying screens shall be inspected at least once a month 
and cleaned when necessary by the method recommended by the 
manufacturer;
    (6) All intensifying screens in a cassette shall be of the same type 
and made by the same manufacturer;
    (7) A suitable grid or other means of reducing scattered radiation 
must be used;
    (8) The geometry of the radiographic system shall insure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the film surface and impinges on the center of the film;
    (9) A formal quality assurance program shall be established at each 
facility.
    (j) Radiographic processing:
    (1) Either automatic or manual film processing is acceptable. A 
constant time-temperature technique shall be meticulously employed for 
manual processing.
    (2) If mineral or other impurities in the processing water introduce 
difficulty in obtaining a high-quality radiograph, a suitable filter or 
purification system must be used.
    (k) Before the miner is advised that the examination is concluded, 
the radiograph must be processed and inspected and accepted for quality 
by the physician, or if the physician is not available, acceptance may 
be made by the radiologic technologist. In a case of a substandard 
radiograph, another must be immediately made. All substandard 
radiographs must be clearly marked as rejected and promptly sent to 
NIOSH for disposal.
    (l) An electric power supply shall be used which complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine.
    (m) A test object may be required on each radiograph for an 
objective evaluation of film quality at the discretion of NIOSH.
    (n)(1) Each radiograph made hereunder must be permanently and 
legibly marked with:
    (i) The name and address or NIOSH approval number of the facility at 
which it is made;
    (ii) The miner's Social Security number;
    (iii) The miner's date of birth; and
    (iv) The date of the radiograph.
    (2) No other identifying markings may be recorded on the radiograph.

[43 FR 33715, Aug. 1, 1978, as amended at 52 FR 7866, Mar. 13, 1987; 77 
FR 56729, Sept. 13, 2012]



Sec.  37.42  Chest radiograph specifications--digital radiography systems.

    (a) Miners must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a private dressing area 
and for those miners who wish to use one, the facility must provide a 
clean gown. Facilities must be heated to a comfortable temperature.
    (b) Every digital chest radiograph taken as required under this 
section must be a single posteroanterior projection at full inspiration 
on a digital detector with sensor area being no less than 1505 cm square 
centimeters with a minimum width of 35cm. The imaging plate must have a 
maximum pixel pitch of 200[micro]m, with a minimum bit depth of 10. 
Spatial resolution must be at least 2.5 line pairs per millimeter. The 
storage phosphor cassette or digital image detector must be positioned 
either vertically or horizontally so that the image includes the apices 
and costophrenic angles of both right and left lungs. If the detector 
cannot include the apices and costophrenic angles of both lungs as 
described, then two side-by-side images can be obtained that together 
include the apices and the costophrenic angles of both right and left 
lungs.
    (c) Chest radiographs of miners under this section must be 
performed:

[[Page 219]]

    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.
    (d) Radiographs must be made with a diagnostic X-ray machine with a 
maximum actual (not nominal) source (focal spot) of 2 mm, as measured in 
two orthogonal directions.
    (e) Radiographs must be made with units having generators which have 
a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage must be at 
least the minimum as recommended by the manufacturer for chest 
radiography.
    (f) An electric power supply must be used that complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine. If the manufacturer or installer of the radiographic equipment 
recommends equipment for control of electrical power fluctuations, such 
equipment must be used as recommended.
    (g) Radiographs must be obtained only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The beam 
limiting device must provide rectangular collimation. Electronic post-
image acquisition ``shutters'' available on some CR and DR systems that 
limit the size of the final image and that simulate collimator limits 
must not be used. The use and effect of the beam limiting device must be 
discernible on the resulting image.
    (h) Radiographic technique charts must be used that are developed 
specifically for the X-ray system and detector combinations used, 
indicating exposure parameters by anatomic measurements.
    (1) If automated exposure control devices are used, performance must 
be documented by a medical physicist utilizing the image capture systems 
and exposure parameters used at the facility for chest imaging, using 
methods recommended in AAPM Report No. 74, pages 17-18, and in AAPM 
Report No. 14, pages 61-62 (incorporated by reference, see Sec.  37.10).
    (2) Exposure parameters achieved during the evaluation of the 
automated exposure system must be recorded by the medical physicist in a 
written report or electronic file that is stored at the facility and 
available for inspection by NIOSH for a minimum of 5 years after the 
miner's examination.
    (i) To ensure high quality digital chest radiographs:
    (1) The maximum exposure time must not exceed 50 milliseconds except 
for subjects with chests over 28 centimeters posteroanterior, for whom 
the exposure time must not exceed 100 milliseconds;
    (2) The distance from source or focal spot to detector must be at 
least 70 inches (or 180 centimeters if measured in centimeters);
    (3) The exposure setting for chest images must be within the range 
of 100-300 equivalent exposure speeds and must comply with ACR Practice 
Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging, 
Section V--Diagnostic Reference Levels For Imaging With Ionizing 
Radiation and Section VII--Radiation Safety in Imaging (incorporated by 
reference, see Sec.  37.10). Radiation exposures should be periodically 
measured and patient radiation doses estimated by the medical physicist 
to assure doses are as low as reasonably achievable.
    (4) Digital radiography system performance, including resolution, 
modulation transfer function (MTF), image signal-to-noise and detective 
quantum efficiency must be evaluated and judged acceptable by a 
qualified medical physicist using the specifications in AAPM Report No. 
93, pages 1-68 (incorporated by reference, see Sec.  37.10). Image 
management software and settings for routine chest imaging must be used, 
including routine amplification of digital detector signal as well as 
standard image post-processing functions. Image or edge enhancement 
software functions must not be employed unless they are integral to the 
digital radiography system (not elective); in such cases, only the 
minimum image enhancement permitted by the system may be employed.

[[Page 220]]

    (5)(i) The image object, transmission and associated data storage, 
file format, and transmission of associated information must conform to 
the following components of the Digital Imaging and Communications in 
Medicine (DICOM) standard (incorporated by reference, see Sec.  37.10):
    (A) DICOM Standard PS 3.3-2011, Annex A--Composite Information 
Object Definitions, sections: Computed Radiography Image Information 
Object Definition; Digital X-Ray Image Information Object Definition; X-
Ray Radiation Dose SR Information Object Definition; and Grayscale 
Softcopy Presentation State Information Object Definition.
    (B) DICOM Standard PS3.4-2011, Annex B--Storage Service Class; Annex 
N--Softcopy Presentation State Storage SOP Classes; Annex O--Structured 
Reporting Storage SOP Classes.
    (C) DICOM Standard PS 3.10-2011.
    (D) DICOM Standard PS 3.11-2011
    (E) DICOM Standard PS 3.12-2011.
    (F) DICOM Standard PS 3.14-2011.
    (G) DICOM Standard PS 3.16-2011.
    (ii) Identification of each miner, chest image, facility, date and 
time of the examination must be encoded within the image information 
object, according to DICOM Standard PS 3.3-2011, Information Object 
Definitions, for the DICOM ``DX'' object. If data compression is 
performed, it must be lossless. Exposure parameters (kVp, mA, time, beam 
filtration, scatter reduction, radiation exposure) must be stored in the 
DX information object.
    (iii) Exposure parameters as defined in the DICOM Standard PS 3.16-
2011 must additionally be provided, when such parameters are available 
from the facility digital image acquisition system or recorded in a 
written report or electronic file and either transmitted to NIOSH or 
stored at the facility and available for inspection by NIOSH for 5 years 
after the examination.
    (6) A specific test object may be required on each radiograph for an 
objective evaluation of image quality at the discretion of NIOSH.
    (7) CR imaging plates must be inspected at least once a month and 
cleaned when necessary by the method recommended by the manufacturer;
    (8) A grid or air gap for reducing scattered radiation must be used; 
grids must not be used that cause Moir[eacute] interference patterns in 
either horizontal or vertical images.
    (9) The geometry of the radiographic system must ensure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the CR imaging plate, or DR detector and is correctly aligned to the 
grid;
    (10) Radiographs must not be made when the environmental 
temperatures and humidity in the facility are outside the manufacturer's 
recommended range of the CR and DR equipment to be used.
    (11) Before the miner is advised that the examination is concluded, 
the radiograph must be processed and inspected and accepted for quality 
by the physician, or if the physician is not available, acceptance may 
be made by the radiologic technologist. In a case of a substandard 
radiograph, another must be made immediately. Unacceptable digital image 
files must be fully deleted immediately or rendered permanently 
inaccessible in the event that permanent deletion is not technologically 
feasible.
    (j) The following are not authorized for use under this section:
    (1) Digital images derived from film screen chest radiographs (e.g., 
by scanning or digital photography); or
    (2) Images that were acquired using digital systems and then printed 
on transparencies for back-lighted display (e.g., using tradition view 
boxes).

[77 FR 56730, Sept. 13, 2012]



Sec.  37.43  Approval of radiographic facilities 
that use film radiography systems.

    (a) Facilities become eligible to participate in this program by 
demonstrating their ability to make high quality diagnostic chest 
radiographs by submitting to NIOSH six or more sample chest radiographs 
made and processed at the applicant facility and which are of acceptable 
quality to one or more individuals selected by NIOSH from the panel of B 
Readers. Applicants must also submit a radiograph of

[[Page 221]]

a plastic step-wedge object \1\ or other test object (available on loan 
from NIOSH) that was made and processed at the same time with the same 
technique as the radiographs submitted and processed at the facility for 
which approval is sought.
---------------------------------------------------------------------------

    \1\ The plastic step-wedge object is described in E. Dale Trout, 
John P. Kelley, A Phantom for the Evaluation of Techniques and Equipment 
Used for Roentgenography of the Chest, Amer J Roentgenol 
1973;117(4):771-776.
---------------------------------------------------------------------------

    (1) At least one chest radiograph and one test object radiograph 
must have been made with each unit to be used hereunder.
    (2) All radiographs must have been made within 15 calendar days 
prior to submission and must be marked to identify the facility where 
each radiograph was made, the X-ray machine used, and the date each was 
made.
    (3) The chest radiographs will be returned and may be the same 
radiographs submitted pursuant to Sec.  37.52(a)(2)(i).
    (b) Each radiographic facility submitting chest radiographs for 
approval under this section must complete and include a Radiographic 
Facility Certification Document (CDC 2.11) describing each unit to be 
used to make chest radiographs under the Act. The form must include:
    (1) The date of the last radiation safety inspection by an 
appropriate licensing agency or, if no such agency exists, by a 
qualified expert as defined in NCRP Report No. 102 (incorporated by 
reference, see Sec.  37.10);
    (2) The deficiencies found;
    (3) A statement that all the deficiencies have been corrected; and
    (4) The date of acquisition of the unit. To be acceptable, the 
radiation safety inspection must have been made within 1 year preceding 
the date of application.
    (c) Radiographs submitted with applications for approval under this 
section will be evaluated by one or more individuals selected by NIOSH 
from the panel of B Readers or by a qualified medical physicist or 
consultant. Applicants will be advised of any reasons for denial of 
approval.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may require a facility periodically to resubmit 
radiographs of a test object, sample radiographs, or a Radiographic 
Facility Certification Document for quality control purposes.
    (1) Approvals granted hereunder may be suspended or withdrawn by 
notice in writing when in the opinion of NIOSH the quality of 
radiographs or information submitted under this section warrants such 
action.
    (2) A copy of a notice withdrawing approval will be sent to each 
operator who has listed the facility as its facility for giving chest 
radiographs and must be displayed on the mine bulletin board adjacent to 
the operator's approved plan. The approved plan will be reevaluated by 
NIOSH in light of this change.
    (f) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56 (incorporated by reference, see Sec.  
37.10).
    (g) In conducting medical examinations pursuant to this part, 
physicians and radiographic facilities must maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, classifications, and images) 
consistent with applicable statutes and regulations governing the 
handling and protection of individually identifiable health information, 
including, as applicable, the HIPAA Privacy and Security Rules (45 CFR 
part 160 and 45 CFR part 164, subparts A, C, and E).

[81 FR 73282, Oct. 24, 2016]



Sec.  37.44  Approval of radiographic facilities that use 
digital radiography systems.

    (a) Facilities seeking approval must demonstrate the ability to make 
high quality digital chest radiographs by submitting to NIOSH digital 
radiographic image files of a test object (e.g., a plastic step-wedge or 
chest phantom which will be provided on

[[Page 222]]

loan from NIOSH) as well as digital radiographic image files from six or 
more sample chest radiographs that are of acceptable quality to one or 
more individuals selected by NIOSH from the panel of B Readers and a 
qualified medical physicist or consultant, both designated by NIOSH.
    (1) Image files must be submitted on standard portable media 
(compact or digital video disc) and formatted to meet specifications of 
the Digital Imaging and Communications in Medicine (DICOM) standard PS 
3.12-2011 (incorporated by reference, see Sec.  37.10). Applicants will 
be advised of any reasons for denial of approval.
    (2) All submitted images must be made within 60 days prior to the 
date of application using the same technique, equipment, and software as 
will be used by the facility under the requested approval. At least six 
chest radiographs and one test object radiograph must have been made 
with each digital radiographic unit to be used by the facility under the 
requested approval. The corresponding radiographic image files must be 
submitted on standard portable media (compact or digital video disc) and 
formatted to meet specifications of the current DICOM Standard PS 3.12-
2011.
    (3) Documentation must include the following: the identity of the 
facility where each radiograph was made; the X-ray machine used; and the 
model, version, and production date of each image acquisition software 
program and hardware component.
    (4) The submitted sample digital chest image files must include at 
least two taken with the detector in the vertical position and two in 
the horizontal position where the imaging system permits these 
positions, and at least two chest images must be from persons within the 
highest quartile of chest diameters (28 cm or greater).
    (b) Each radiographic facility submitting chest radiographic image 
files for approval under this section must complete and include an 
Radiographic Facility Certification Document (CDC 2.11) describing each 
system component, and the models and versions of image acquisition 
hardware and software to be used to make digital chest radiographs under 
the Act. The form must include:
    (1) A copy of a dated report signed by a qualified medical 
physicist, documenting the evaluation of radiation safety and 
performance characteristics specified in this section for each digital 
radiography system;
    (2) A copy of the report of the most recent radiation safety 
inspection by a licensing agency, if such agency exists;
    (3) A listing of all deficiencies noted in either of the reports;
    (4) A statement that all the listed deficiencies have been 
corrected; and
    (5) The names and relevant training and experience of facility 
personnel described in paragraphs (c), (e), and (f) of this section. To 
be acceptable, the report by the medical physicist and radiation safety 
inspection specified in this paragraph (b) must have been made within 1 
year prior to the date of submission of the application.
    (c) Facilities must maintain ongoing licensure and certification 
under relevant local, State, and Federal laws and regulations for all 
digital equipment and related processes covered under this part.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may periodically require a facility to resubmit 
radiographic image files of the NIOSH-supplied test object (e.g., step-
wedge or chest phantom), sample radiographs, or a Radiographic Facility 
Certification Document. Approvals granted to facilities under this 
section may be suspended or withdrawn by notice in writing when, in the 
opinion of NIOSH, deficiencies in the quality of radiographs or 
information submitted under this section warrant such action. A copy of 
a notice suspending or withdrawing approval will be sent to each 
operator that has listed the facility for its use under this part and 
must be displayed on the mine bulletin board adjacent to the operator's 
approved plan. The operator's approved plan may be reevaluated by NIOSH 
in response to such suspension or withdrawal.

[[Page 223]]

    (f) A qualified medical physicist who is familiar with the facility 
hardware and software systems for image acquisition, manipulation, 
display, and storage, must be on site or available as a consultant. The 
physicist must be trained in evaluating the performance of radiographic 
equipment and facility quality assurance programs, and must be licensed/
approved by a State or Territory of the United States or certified by a 
competent U.S. national board.
    (g) Facilities must document that testing performed by a qualified 
medical physicist has verified that performance of each image 
acquisition system for which approval is sought met initial 
specifications and standards of the equipment manufacturer and 
performance testing as required under paragraphs (c), (f), and (h) of 
this section.
    (h) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56, and AAPM Report No. 116, sections VIII, 
IX, and X (incorporated by reference, see Sec.  37.10).
    (1) Applications for facility approval must include a comprehensive 
assessment by a qualified medical physicist within 12 months prior to 
application addressing the performance of X-ray generators, automatic 
exposure controls, and image capture systems. The assessment must comply 
with the following guidelines: AAPM Report No. 93, pages 1-68; AAPM 
Report No. 74, pages 6-11; and AAPM Report No. 14, pages 1-96 
(incorporated by reference, see Sec.  37.10).
    (2) Radiographic technique charts must be used that are developed 
specifically for the radiography system and detector combinations used, 
indicating exposure parameters by anatomic measurements. If automated 
exposure control devices are used, calibration for chest imaging must be 
documented using the actual voltages and image capture systems.
    (i) Radiological exposures resulting from at least ten (randomly 
selected) digital chest images obtained at the facility must be 
monitored at least quarterly to detect and correct potential dose creep, 
using methods specified in AAPM Report No. 31 (incorporated by 
reference, see Sec.  37.10). Radiation exposures must be compared to a 
professionally accepted reference level published in the American 
College of Radiology (ACR) Practice Guideline for Diagnostic Reference 
Levels in Medical X-Ray Imaging, pages 1-6 (incorporated by reference, 
see Sec.  37.10).
    (ii) The medical physicist must conduct an annual assessment of 
measured or estimated radiation exposures, with specific recommended 
actions to minimize exposures during examinations performed under this 
part.
    (3) For each digital radiography device and system, performance must 
be monitored annually in accordance with the recommendations of AAPM 
Report No. 93 (incorporated by reference, see Sec.  37.10), except for 
the testing specifically excluded below. Documentation must be 
maintained on the completion of quality assurance testing, including the 
reproducibility of X-ray output, linearity and reproducibility of mA 
settings, accuracy and reproducibility of timer and kVp settings, 
accuracy of source-to-detector distance, and X-ray field focal spot 
size, selection, beam quality, congruence and collimation. For DR 
systems, the following tests listed in AAPM Report No. 93 are not 
required under this part:
    (i) Section 8.4.5: Laser beam function.
    (ii) Section 8.4.9: Erasure Thoroughness.
    (iii) Section 8.4.11: Imaging Plate (IP) Throughput.
    (4) Facilities must maintain documentation, available for inspection 
by NIOSH for 5 years, of the ongoing implementation of policies and 
procedures for monitoring and evaluating the effective management, 
safety, and proper performance of chest image acquisition, digitization, 
processing, compression, transmission, display, archiving, and retrieval 
functions of digital radiography devices and systems.
    (i) In conducting medical examinations pursuant to this part, 
physicians and radiographic facilities must maintain the results and 
analysis of these

[[Page 224]]

examinations (including any hard copies or digital files containing 
individual data, interpretations, and images) consistent with applicable 
statutes and regulations governing the handling and protection of 
individually identifiable health information, including, as applicable, 
the HIPAA Privacy and Security Rules (45 CFR part 160 and 45 CFR part 
164, subparts A, C, and E).

[81 FR 73282, Oct. 24, 2016]



Sec.  37.45  Protection against radiation emitted by radiographic equipment.

    Except as otherwise specified in Sec.  37.41 and Sec.  37.42, 
radiographic equipment, its use and the facilities (including mobile 
facilities) in which such equipment is used, must conform to applicable 
State or Territorial and Federal regulations. Where no applicable 
regulations exist, radiographic equipment, its use and the facilities 
(including mobile facilities) in which such equipment is used must 
conform to the recommendations in NCRP Report No. 102, NCRP Report No. 
105, and NCRP Report No. 147 (incorporated by reference, see Sec.  
37.10).

[77 FR 56733, Sept. 13, 2012]

  Specifications for Interpretation, Classification, and Submission of 
                            Chest Radiographs



Sec.  37.50  Interpreting and classifying chest radiographs--
film radiography systems.

    (a) Chest radiographs must be interpreted and classified in 
accordance with the Guidelines for the Use of the ILO International 
Classification of Radiographs of Pneumoconioses (incorporated by 
reference, see Sec.  37.10). Chest radiograph interpretations and 
classifications must be recorded on a paper or electronic Chest 
Radiograph Classification Form (CDC/NIOSH 2.8).
    (b) Radiographs must be interpreted and classified only by a 
physician who reads chest radiographs in the normal course of practice 
and who has demonstrated proficiency in classifying the pneumoconioses 
in accordance with Sec.  37.52.
    (1) Initial clinical interpretations and notification of findings 
other than pneumoconiosis under paragraph (a) of this section must be 
provided by a qualified physician who provides these services for the 
examining facility. This physician must have all required licensure and 
privileges, and must interpret chest radiographs in the normal course of 
practice.
    (2) [Reserved]
    (c) All interpreters, whenever interpreting chest radiographs made 
under the Act, must have immediately available for reference a complete 
set of the standard radiographs for use with the Guidelines for the Use 
of the ILO International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec.  37.10).
    (d) View boxes used for making interpretations must comply with the 
following:
    (1) Fluorescent lamps must be simultaneously replaced with new lamps 
at 6-month intervals;
    (2) All the fluorescent lamps in a panel of boxes must have 
identical manufacturer's ratings as to intensity and color;
    (3) The glass, internal reflective surfaces, and the lamps must be 
kept clean;
    (4) The unit must be so situated as to minimize front surface glare.

[81 FR 73284, Oct. 24, 2016]



Sec.  37.51  Interpreting and classifying chest radiographs--
digital radiography systems.

    (a) For each chest radiograph obtained at an approved facility using 
a digital radiography system, a qualified and licensed physician who 
reads chest radiographs in the normal course of practice must provide an 
initial clinical interpretation and notification, as specified in Sec.  
37.54, of any significant abnormal findings other than pneumoconiosis.
    (b) Chest radiographs must be classified for pneumoconiosis by 
physician readers (B Readers) who have demonstrated ongoing proficiency, 
as specified in Sec.  37.52(b), in classifying the pneumoconioses in a 
manner consistent with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec.  37.10). Chest radiograph 
classifications must be recorded on a paper or electronic

[[Page 225]]

Chest Radiograph Classification Form (CDC/NIOSH 2.8).
    (c) All B Readers, whenever classifying digitally-acquired chest 
radiographs made under the Act, must have immediately available for 
reference a complete set of NIOSH-approved standard digital chest 
radiographic images, including electronic images such as scanned images, 
provided for use with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec.  37.10).
    (1) Only NIOSH-approved standard digital (electronic) images may be 
used for classifying digital chest images for pneumoconiosis.
    (2) Modification of the appearance of the standard images using 
software tools is not permitted.
    (d) Viewing systems should enable readers to display the coal 
miner's chest image at the full resolution of the image acquisition 
system, side-by-side with the selected NIOSH-approved standard images 
for comparison.
    (1)(i) Image display devices must be flat panel monitors displaying 
at least 3 MP at 10 bit depth. Image displays and associated graphics 
cards must meet the calibration and other specifications of the Digital 
Imaging and Communications in Medicine (DICOM) standard PS 3.14-2011 
(incorporated by reference, see Sec.  37.10).
    (ii) Image displays and associated graphics cards must not deviate 
by more than 10 percent from the grayscale standard display function 
(GSDF) when assessed according to the AAPM On-Line Report No. 03, pages 
1-146 (incorporated by reference, see Sec.  37.10).
    (2) Display system luminance (maximum and ratio), relative noise, 
linearity, modulation transfer function (MTF), frequency, and glare 
should meet or exceed recommendations listed in AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec.  37.10). Viewing 
displays must have a maximum luminance of at least 171 cd/m2, a ratio of 
maximum luminance to minimum luminance of at least 250, and a glare 
ratio greater than 400. The contribution of ambient light reflected from 
the display surface, after light sources have been minimized, must be 
included in luminance measurements.
    (3) Displays must be situated so as to minimize front surface glare. 
Readers must minimize reflected light from ambient sources during the 
performance of classifications.
    (4) Measurements of the width and length of pleural shadows and the 
diameter of opacities must be taken using calibrated software measuring 
tools. If permitted by the viewing software, a record must be made of 
the presentation state(s), including any noise reduction and edge 
enhancement or restoration functions that were used in performing the 
classification, including any annotations and measurements.
    (e) Quality control procedures for devices used to display chest 
images for classification must comply with the recommendations of the 
American Association of Physicists in Medicine AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec.  37.10).
    (1) If automatic quality assurance systems are used, visual 
inspection must be performed using one or more test patterns recommended 
by the medical physicist every 6 months, or more frequently, to check 
for defects that automatic systems may not detect.
    (2) [Reserved]
    (f) Classification of CR and DR digitally-acquired chest radiographs 
under this part must be performed based on the viewing of images 
displayed as soft copies using the viewing workstations specified in 
this section. Classification of radiographs must not be based on the 
viewing of hard copy printed transparencies of images that were 
digitally-acquired.
    (g) The classification of chest radiographs based on digitized 
copies of chest radiographs that were originally acquired using film-
screen techniques is not permissible under this part.

[81 FR 73284, Oct. 24, 2016]



Sec.  37.52  Proficiency in the use of systems for classifying 
the pneumoconioses.

    (a) First or A Readers:

[[Page 226]]

    (1) Approval of a physician as an A Reader continues indefinitely if 
established prior to October 15, 2012.
    (2) Physicians who desire to become A Readers must demonstrate their 
proficiency in classifying the pneumoconioses by either:
    (i) Submitting to NIOSH from the physician's files six sample chest 
radiographs which are considered properly classified by one or more 
individuals selected by NIOSH from the panel of B Readers. The six 
radiographs must consist of two without pneumoconiosis, two with simple 
pneumoconiosis, and two with complicated pneumoconiosis (these may be 
the same radiographs submitted for facility approval pursuant to 
Sec. Sec.  37.43 and 37.44). The films will be returned to the 
physician. The classifications must be on the Chest Radiograph 
Classification Form (CDC/NIOSH 2.8); or
    (ii) Satisfactory completion, since June 11, 1970, of a course 
approved by NIOSH on the ILO International Classification of Radiographs 
of Pneumoconioses.
    (b) Final or B Readers:
    (1) Approval as a B Reader established prior to October 1, 1976, is 
hereby terminated.
    (2) Proficiency in evaluating chest radiographs for radiographic 
quality and in the use of the ILO Classification for interpreting chest 
radiographs for pneumoconiosis and other diseases must be demonstrated 
by those physicians who desire to be B Readers by taking and passing a 
specially-designed proficiency examination given on behalf of or by 
NIOSH at a time and place specified by NIOSH.
    (i) Each physician who desires to take the digital version of the 
examination will be provided a complete set of the current NIOSH-
approved standard reference digital radiographs.
    (ii) Physicians who qualify under this provision need not be 
qualified under paragraph (a) of this section.
    (c) Physicians who wish to participate in the program must 
familiarize themselves with the necessary components for attainment of 
reliable classification of chest radiographs for the pneumoconioses\2\ 
and apply using a Physician Application for Certification Form (CDC 
2.12(E)).
---------------------------------------------------------------------------

    \2\ NIOSH Safety and Health Topic, Chest Radiography: Radiographic 
Classification, http://www.cdc.gov/niosh/topics/chestradiography/
radiographic-classification.html.

[81 FR 73284, Oct. 24, 2016]



Sec.  37.53  Method of obtaining definitive chest radiograph classifications.

    (a) All chest radiographs which are first classified by an A or B 
Reader will be submitted by NIOSH to a B Reader qualified pursuant to 
Sec.  37.52.
    (1) If there is agreement between the two classifications, as 
described in paragraph (b) of this section, the result will be 
considered final and reported to MSHA for transmittal to the miner.
    (2) When agreement is lacking, NIOSH must obtain a third 
classification from the panel of B Readers.
    (i) If any two of the three classifications demonstrate agreement, 
the result must be considered the final determination.
    (ii) If agreement is lacking among the three classifications, NIOSH 
will obtain independent classifications from two additional B Readers 
selected from the panel, and the final determination will be the median 
category derived from the total of five classifications.
    (b) Two classifications are considered to be in agreement when:
    (1) They are derived from complete classifications recorded using 
approved paper or electronic versions of the Chest Radiograph 
Classification Form (CDC/NIOSH 2.8) and received by NIOSH; and
    (2) Both find either stage A, B, or C complicated pneumoconiosis; 
or,
    (3) For simple pneumoconiosis, are both in the same major category 
or are within one minor category (ILO Classification 12-point scale) of 
each other (subject to the exception in paragraph (b)(3)(ii) of this 
section).
    (i) The higher of the two classifications must be reported.
    (ii) The only exception to the one minor category principle is a 
reading sequence of 0/1, 1/0 or 1/0, 0/1, which are not considered 
agreement.

[81 FR 73285, Oct. 24, 2016]

[[Page 227]]



Sec.  37.54  Notification of abnormal radiographic findings.

    (a) Significant abnormal findings other than pneumoconiosis. The 
first physician to interpret the radiograph must communicate findings 
of, or findings suggesting, abnormality of cardiac shape or size, 
tuberculosis, lung cancer, or any other significant abnormal findings 
other than pneumoconiosis to the miner indicated on the Miner 
Identification Document or to the miner's designated physician. A notice 
of the communication must be submitted to NIOSH. When significant 
abnormal findings are reported, NIOSH will also notify the miner to 
contact his or her physician.
    (b) Significant changes or progression of disease. When NIOSH has 
more than one radiograph of a miner in its files and the most recent 
examination was found by the first physician to interpret the radiograph 
or subsequently by NIOSH B Readers to show an abnormality of cardiac 
shape or size, tuberculosis, cancer, complicated pneumoconiosis, and any 
other significant abnormal findings, NIOSH will arrange for a licensed 
physician to compare the most recent image to older images and NIOSH 
will inform the miner of any significant changes or progression of 
disease or other findings.
    (c) Notice of eligibility for part 90 transfer option. All final 
determinations of radiographic classifications providing evidence for 
development of pneumoconiosis will be reported to the miner or to the 
miner's designated physician by NIOSH. In addition, NIOSH will 
coordinate with MSHA to assure that such miners are notified of 
eligibility to transfer to a less dusty area, in accordance with section 
203 of the Act (see 30 CFR part 90 and Sec.  37.102).
    (d) Prompt dispatch of findings. NIOSH will make every reasonable 
effort to process the findings described in paragraph (c) of this 
section within 60 days of receipt of the information described in Sec.  
37.60 in a complete and acceptable form.
    (1) NIOSH will coordinate with MSHA to provide notice of eligibility 
for the part 90 transfer option within the same time frame.
    (2) The results of an examination may not be processed by NIOSH if 
the examination was made within 6 months of the date of a previous 
acceptable examination.

[81 FR 73285, Oct. 24, 2016]



Sec.  37.60  Submitting required chest radiograph classification 
and miner identification documents.

    (a) Each chest radiograph required to be made under this subpart, 
together with the completed Chest Radiograph Classification Form and the 
completed Miner Identification Document, must be submitted together for 
each miner to NIOSH within 14 calendar days after the radiographic 
examination is given. All submitted items become the property of NIOSH.
    (1) When the radiograph is digital, the image file for each 
radiograph, together with either hard copy or electronic versions of the 
completed Chest Radiograph Classification Form and the completed Miner 
Identification Document, must be submitted to NIOSH using the software 
and format specified by NIOSH either using portable electronic media, or 
a secure electronic file transfer.
    (2) NIOSH will notify the submitting facility when it has received 
the image files and forms from the examination. After this notification, 
the facility will permanently delete, or if this is not technologically 
feasible for the imaging system used, render permanently inaccessible 
all files and forms from its electronic and physical files.
    (b) If NIOSH deems any submission under paragraph (a) of this 
section inadequate, the operator will be notified of the deficiency. The 
operator must promptly make appropriate arrangements for the necessary 
reexamination at no expense to the miner.
    (c) Failure to comply with paragraph (a) or (b) of this section will 
be cause to revoke approval of a plan or any other approval as may be 
appropriate. An approval that has been revoked may be reinstated at the 
discretion of NIOSH after it receives satisfactory assurances and 
evidence that all deficiencies have been corrected and that effective 
controls have been instituted to prevent a recurrence.
    (d) Chest radiographs and other required documents must be submitted 
only for miners.

[[Page 228]]

    (e) If a miner refuses to participate in all phases of the 
examination prescribed in this subpart, no report need be made. If a 
miner refuses to participate in any phase of the examination prescribed 
in this subpart, all forms must be submitted with his or her name and 
the last four digits of the Social Security number on each. If any form 
cannot be completed because of the miner's refusal, it must be marked 
``Miner Refuses,'' and submitted to NIOSH. No submission will be made, 
however, without a completed Miner Identification Document (CDC/NIOSH 
2.9) containing the miner's name, address, last four digits of the 
Social Security number and place of employment.

[81 FR 73285, Oct. 24, 2016]

                   Review and Availability of Records



Sec.  37.70  Review of classifications.

    (a) Any miner who believes the classification for pneumoconiosis 
reported to him or her by MSHA is in error may file a written request 
with NIOSH that his or her radiograph be reevaluated.
    (1) If the classification was based on agreement between an A Reader 
and a B Reader, NIOSH will obtain one or more additional classifications 
by B Readers as necessary to obtain agreement in accordance with Sec.  
37.53, and MSHA must report the results to the miner together with 
notification from MSHA of any rights which may accrue to the miner in 
accordance with Sec.  37.102.
    (2) If the reported classification was based on agreement between 
two (or more) B Readers, the reading will be accepted as conclusive and 
the miner must be so informed by MSHA.
    (b) Any operator who is directed by MSHA to transfer a miner to a 
less dusty atmosphere based on the most recent examination may file a 
written request with NIOSH to review its findings. The standards set 
forth in paragraph (a) of this section apply and the operator and miner 
will be notified by MSHA whether the miner is entitled to the option to 
transfer.

[81 FR 73286, Oct. 24, 2016]



Sec.  37.80  Availability of records for radiographs.

    (a) Medical information and radiographs on miners will be released 
by NIOSH only with the written consent from the miner, or if the miner 
is deceased, written consent from the miner's widow or widower, next of 
kin, or legal representative.
    (b) To the extent authorized, original film radiographs will be made 
available for examination only at the NIOSH facility in Morgantown, WV.

[81 FR 73286, Oct. 24, 2016]



                       Subpart_Spirometry Testing

    Source: 79 FR 45119, Aug. 4, 2014, unless otherwise noted.



Sec.  37.90  Scope.

    Under this subpart, coal mine operators are required to provide 
spirometry testing to both current and newly employed coal miners, using 
medical facilities approved by NIOSH in accordance with standards 
established in this subpart.

[81 FR 73286, Oct. 24, 2016]



Sec.  37.91  Definitions.

    Definitions provided in Sec.  37.2 will have the same meaning in 
this subpart. Any term defined in the Federal Mine Safety and Health Act 
of 1977 (Pub. L. 95-164, as amended) and not defined in Sec.  37.2 or 
this section will have the meaning given it in the Act. As used in this 
subpart:
    ATS means American Thoracic Society.
    ERS means European Respiratory Society.
    FET means forced expiratory time, which is the time from the 
beginning of a forced exhalation (the back-extrapolated ``time zero'') 
maneuver to the end of expiration.
    FEV1 means forced expiratory volume in one second, which is the 
greatest volume of air that can be forcibly blown out within the first 
second, after full inspiration.
    FEV1/FVC means the ratio between the largest acceptable FEV1 and the 
largest acceptable FVC following the

[[Page 229]]

forced vital capacity maneuver. It is usually reported as a percentage.
    FEV6 means forced expiratory volume in six seconds, which is the 
greatest volume of air that can forcibly be blown out in six seconds, 
after full inspiration.
    FVC means forced vital capacity, which is the greatest volume of air 
that can forcibly be blown out after full inspiration.
    PEF means peak expiratory flow, which is the maximal airflow 
generated during a forced vital capacity maneuver.
    Spirometry test means a pulmonary function test that measures 
expiratory volume and airflow rates and may determine the presence and 
severity of lung function impairments, if such are present.

[81 FR 73286, Oct. 24, 2016]



Sec.  37.92  Spirometry testing required for miners.

    (a) Voluntary tests. Each operator must provide to all miners who 
are employed in or at any of its coal mines the opportunity to have a 
spirometry test and a respiratory assessment at no cost to the miner at 
least once every 5 years in accordance with this subpart. The tests will 
be available during a 6-month period that begins no less than 3.5 years 
and not more than 4.5 years from the end of the last 6-month period.
    (b) Mandatory tests. Every operator must provide to each miner who 
begins work in or at a coal mine for the first time on or after August 
1, 2014, spirometry testing and respiratory assessment at no cost to the 
miner in accordance with this subpart.
    (1) Initial spirometry testing and respiratory assessment will be 
provided to all miners who begin work in or at a coal mine for the first 
time on or after August 1, 2014 within the first 30 days of their 
employment or within 30 days of approval of a plan to provide spirometry 
testing.
    (2) A follow-up second spirometry test and respiratory assessment 
will be provided to the miner no later than 3 years after the initial 
spirometry if the miner is still engaged in coal mining.
    (3) A third spirometry test and respiratory assessment will be 
provided no later than 2 years after the tests in paragraphs Sec.  
37.3(b)(2) and paragraph (b)(2) of this section if the chest radiograph 
shows evidence of pneumoconiosis as defined in Sec.  37.3(b)(3) or if 
the second spirometry test results demonstrate a 15 percent or greater 
decline in the percent predicted FEV1 value since the initial (i.e., 
baseline) test.
    (i) Percent predicted FEV1 will be calculated according to 
prediction equations published in Spirometric Reference Values from a 
Sample of the General U.S. Population, American Journal of Respiratory 
and Critical Care Medicine, 159(1):179-187, January 1999 (incorporated 
by reference, see Sec.  37.98).
    (ii) A correction factor to Caucasian reference values will be 
applied when testing individuals of Asian descent as specified in the 
ATS Technical Standards: Spirometry in the Occupational Setting, p. 987 
(incorporated by reference, see Sec.  37.98).
    (c) Notification. NIOSH will notify the miner when he or she is due 
to receive the second or third mandatory test under paragraph (b) of 
this section. NIOSH will notify the coal mine operator when the miner is 
to perform a second spirometry test.
    (1) The operator will be notified of a miner's eligibility for a 
third test only with the miner's written consent. The notice to the 
operator will not state the medical reason for the test or that it is 
the third test in the series.
    (2) If the miner is notified by NIOSH that the third mandatory test 
is due and the operator is not so notified, availability of spirometry 
testing under the NIOSH-approved operator's plan will constitute the 
operator's compliance with the requirement to provide a third spirometry 
test even if the miner does not take the test.
    (d) Availability of spirometry testing. The opportunity for 
spirometry to be available for purposes of this subpart must be 
indicated in an operator's plan that has been submitted and approved in 
accordance with this subpart.

[81 FR 73286, Oct. 24, 2016]

[[Page 230]]



Sec.  37.93  Approval of spirometry facilities.

    (a) Application for facility approval. Facilities seeking approval 
to provide the spirometry testing specified under this subpart must have 
the ability to provide spirometry of high technical quality. Thus, 
NIOSH-approved facilities must meet the requirements specified in this 
subpart for the following activities: Training of technicians who 
perform the tests; conducting spirometry tests using equipment and 
procedures that meet required specifications; collecting the respiratory 
assessment form; transmitting data to NIOSH; and communicating with 
miners as required for scheduling, testing, and notification of results. 
Facilities seeking approval may apply to NIOSH using the Spirometry 
Facility Certification document (CDC/NIOSH 2.14).
    (b) Spirometry quality assurance. A spirometry quality assurance 
program must be in place to minimize the rate of invalid test results. 
This program must include all of the following components:
    (1) Instrument calibration checks. Testing personnel must fully 
comply with the 2005 ATS/ERS Standardisation of Spirometry guidelines 
for instrument calibration check procedures, pp. 322-323, including 
Table 3 (incorporated by reference, see Sec.  37.98).
    (i) For volume spirometers, calibration check procedures must 
include daily (day of testing) leak and volume accuracy checks. In 
addition, volume linearity checks must be performed according to the 
frequency established by the 2005 ATS/ERS guidelines.
    (ii) For flow-type spirometers, calibration must be checked daily by 
injecting 3 liters of air from a calibration syringe at 3 different 
speeds (fast, medium, slow). Flow linearity must be checked weekly as 
established by the 2005 ATS/ERS guidelines.
    (iii) Instrument calibration check records must be maintained by the 
facility and available for inspection by NIOSH, as deemed necessary.
    (2) Automated maneuver and test session quality checks. The 
spirometer software must automatically perform quality assurance checks 
on expiratory maneuvers during each spirometry testing session. Screen 
displayed error messages must alert the technician to maneuver 
acceptability and test session non-repeatability. Each spirometry test 
session must have the goal of obtaining 3 acceptable with 2 repeatable 
forced vital capacity maneuvers, as defined by the 2005 ATS/ERS 
Standardisation of Spirometry, p. 325 (incorporated by reference, see 
Sec.  37.98).
    (3) Ongoing monitoring of test quality. Facilities must submit 
spirometry results to NIOSH within 14 calendar days of testing as 
specified in Sec.  37.96(c) to permit NIOSH to monitor test quality and 
provide a results report to each miner. NIOSH may provide quality 
performance feedback to the appropriate technician(s) along with 
suggestions for improvement.
    (4) Quality assurance audits. NIOSH may periodically conduct audits 
to review tests submitted by approved facilities and assess the quality 
of spirometry provided. Such audits may include a review of all 
spirometry data obtained during a specified time period or review of 
spirometry test data collected over time on selected miners.
    (c) Noncompliance. If NIOSH determines that a facility is not 
compliant with the policies and procedures specified in this subpart, or 
determines as the result of a quality assurance audit as specified in 
this section that a facility is not performing spirometry of adequate 
quality, the facility will be notified of the deficiency. The facility 
must promptly make appropriate arrangements for the deficiency to be 
rectified.
    (d) Revocation of approval. If a facility fails to rectify 
deficiencies within 60 days of notification, NIOSH approval of the 
facility may be revoked. An approval which has been revoked may be 
reinstated at the discretion of NIOSH after it receives satisfactory 
assurances and evidence that all deficiencies have been corrected and 
that effective controls have been instituted by the facility to prevent 
a recurrence.
    (e) Maintenance of records. When conducting spirometry tests 
pursuant to this subpart, physicians and facilities must maintain the 
results and analyses of these tests (including any hard copies or 
digital files containing individual data, such as interpretations) in a 
manner consistent with applicable

[[Page 231]]

statutes and regulations governing the handling and protection of 
individually identifiable health information, including, as applicable, 
the HIPAA Privacy and Security Rules (45 CFR part 160 and 45 CFR part 
164, subparts A, C, and E).

[81 FR 73287, Oct. 24, 2016]



Sec.  37.94  Respiratory assessment form.

    As part of the spirometry testing and concurrent with it, personnel 
at the facility must complete a Respiratory Assessment Form (CDC/NIOSH 
2.13).

[81 FR 73287, Oct. 24, 2016]



Sec.  37.95  Specifications for performing spirometry tests.

    (a) Persons administering spirometry tests. Each person 
administering spirometry tests for the Coal Workers' Health Surveillance 
Program must successfully complete a NIOSH-approved spirometry training 
course and maintain a valid certificate by periodically completing 
NIOSH-approved spirometry refresher training courses, identified on the 
NIOSH Web site at http://www.cdc.gov/niosh/. A copy of the certificate 
of completion from a NIOSH-approved spirometry training or refresher 
course, with validation dates printed on the document, must be available 
for inspection. NIOSH will assign each person administering spirometry 
tests a unique identification number, which must be entered into the 
spirometry system computer whenever instrument quality assurance or 
miner testing is done or on the Spirometry Results Notification Form 
(CDC/NIOSH 2.15).
    (b) Spirometer specifications. Spirometry testing equipment must 
meet the 2005 ATS/ERS Standardisation of Spirometry specifications for 
spirometer accuracy and precision and real-time display size and 
content, pp. 331-333, including Table 2 on p. 322 and Table 6 on p. 332 
(incorporated by reference, see Sec.  37.98). Facilities must make 
available for inspection written verification from a third-party testing 
laboratory (not the manufacturer or distributor) that the model of 
spirometer being used has successfully passed its validation checks as 
required by the Standardization of Spirometry; 1994 Update protocol, 
Appendix B pp. 1126-1134, including Table C1 (incorporated by reference, 
see Sec.  37.98). Facilities may request such documentation from 
spirometer manufacturers. For each forced expiratory maneuver submitted 
for a miner under this part, the spirometry data file must retain a 
record of the parameters defined in the 2005 ATS/ERS Standardisation of 
Spirometry, p. 335 including Table 8 (incorporated by reference, see 
Sec.  37.98). Spirometers that provide electronic transfer of spirometry 
data results files must use the format, content, and data structure 
specified by the 2005 ATS/ERS Standardisation of Spirometry, p. 335, or 
a procedure for data transfer that is approved by NIOSH.
    (c) Spirometry procedures. Administration of spirometry must include 
the following:
    (1) Miner Identification Document. The Miner Identification Document 
(CDC/NIOSH (M)2.9), described in Sec.  37.20, must be completed for each 
miner at the facility where spirometry is performed.
    (2) Pre-test checklist. The Spirometry Pre-Test Checklist portion of 
the Spirometry Results Notification Form (CDC/NIOSH 2.15) must be 
completed prior to each spirometry session to identify possible 
contraindications to testing, or factors that might affect results.
    (3) Respiratory Assessment Form. A standardized Respiratory 
Assessment Form (CDC/NIOSH 2.13) must be completed at the initial 
spirometry and repeated at each spirometry testing procedure.
    (4) Collection of anthropometric and demographic information. The 
miner's standing height must be measured in stocking feet using a 
stadiometer (or equivalent device) each time the miner performs 
spirometry. The miner's weight must also be measured (in stocking feet). 
The miner's birth date, race, and ethnicity must also be recorded. These 
data will be entered into the spirometry system computer and transmitted 
with the spirometry data file or, if required under the facility's 
approval, on the Spirometry Results Notification Form (CDC/NIOSH 2.15).

[[Page 232]]

    (5) Test procedures. Spirometry will be conducted in accordance with 
test procedures defined in the 2005 ATS/ERS Standardisation of 
Spirometry, pp. 323-326, and the Standardisation of Lung Function 
Testing, Replies to Readers, pp. 1496-1498 (both incorporated by 
reference, see Sec.  37.98).
    (i) The technician must be able to view real-time testing display 
screens as specified in the 2005 ATS/ERS Standardisation of Spirometry, 
p. 322 (incorporated by reference, see Sec.  37.98).
    (ii) A miner will be tested in the standing position, but may be 
seated if he or she experiences lightheadedness or other signs or 
symptoms that raise a safety concern relating to the standing position 
during the spirometry test.
    (d) Records retention. On-site records of the results will include 
spirometry test reports and retention of all spirometry sessions, pre-
test checklists, and standardized respiratory assessment results in 
electronic or printed format until notification to delete or render the 
information inaccessible, as described in Sec.  37.100(b)(6)(ii), is 
received from NIOSH.

[81 FR 73287, Oct. 24, 2016]



Sec.  37.96  Spirometry interpretations, reports, and submission.

    (a) Interpretation of spirometry tests. Interpretations will be 
carried out by physicians or other qualified health care professionals 
with expertise in spirometry who have all required licensure and 
privileges to provide this service in their State or Territory. 
Interpretations must be carried out using procedures and criteria 
consistent with recommendations in the ATS Technical Standards: 
Spirometry in the Occupational Setting, pp. 987-990, and the ATS/ERS 
Interpretative Strategies for Lung Function Tests, p. 950, p. 956 
including Table 5, and p. 957 including Table 6 (both incorporated by 
reference, see Sec.  37.98).
    (b) Spirometry reports at NIOSH-approved spirometry facilities. (1) 
Spirometry test reports must contain the following:
    (i) The miner's age, height, gender, race, and weight;
    (ii) Numerical values (FVC, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, FET, 
and PEF) and volume-time and flow-volume spirograms for all recorded 
expiratory maneuvers; normal reference value set used; and the 
predicted, percent predicted, and lower limit of normal threshold 
values;
    (iii) Miner position during testing (standing or sitting);
    (iv) Dates of test and last calibration check;
    (v) Ambient temperature and barometric pressure (volume 
spirometers); and
    (vi) The technician's unique identification number.
    (2) NIOSH will notify the submitting facility when to permanently 
delete or, if this is not technologically feasible for the spirometry 
system used, render permanently inaccessible all files and forms 
associated with a miner's spirometry test from its electronic and 
physical files.
    (c) Submission of spirometry results. Facilities must submit results 
of spirometry tests electronically with content as specified in Sec.  
37.96(b), completed pre-test screening checklists (found in Spirometry 
Results Notification Form CDC/NIOSH 2.15), and completed Respiratory 
Assessment Form (CDC/NIOSH 2.13) within 14 calendar days of testing a 
miner.
    (1) Electronic spirometry test results. Submission of spirometry 
test results in the form of an electronic data file in a format approved 
by NIOSH is preferred. Facilities must utilize a secure internet data 
transfer site specified by NIOSH. Data submission must be performed as 
specified in the facility's approval. The transmitted spirometry data 
files must include a variable length record providing all parameters in 
the format, content, and data structure described by the 2005 ATS/ERS 
Standardisation of Spirometry, p. 335 including Table 8 (incorporated by 
reference, see Sec.  37.98), or an alternate data file that is approved 
by NIOSH.
    (2) Spirometry test results submitted using the Spirometry Results 
Notification form. If specified under a facility's approval, spirometry 
results may be provided using the Spirometry Results Notification Form 
(CDC/NIOSH 2.15). The form must be completed and submitted 
electronically, accompanied by image files in a format approved by NIOSH 
that documents the flow-volume and

[[Page 233]]

volume-time curves for each trial reported on the form. The method of 
electronic submission must be approved by NIOSH and carried out securely 
as specified for electronic data files in Sec.  37.96(c)(1).
    (d) Confidentiality of spirometry results. Individual medical 
information and spirometry results are considered protected health 
information under HIPAA and may only be released as specified by HIPAA 
or to NIOSH, as discussed in paragraph (d)(1) of this section, and 
maintained by the spirometry facility as specified in Sec.  37.93(e).
    (1) Personally identifiable information in the possession of NIOSH 
will be released only with the written consent of the miner or, if the 
miner is deceased, the written consent of the miner's next of kin or 
legal representative.
    (2) To provide on-site back-up and assure complete data transfer, 
facilities must retain the forms and results (in electronic or paper 
format) from a miner's test until instruction has been received from 
NIOSH to delete the associated files and forms or, if this is not 
technologically feasible, render the data permanently inaccessible.

[81 FR 73288, Oct. 24, 2016]



Sec.  37.97  Notification of spirometry results.

    (a) Findings must be communicated to the miner or, if requested by 
the miner, to the miner's designated physician. The health care 
professional at the NIOSH-approved facility must inform the miner if the 
spirometry shows abnormal results or if the respiratory assessment 
suggests he or she may benefit from the medical follow-up or a smoking 
cessation intervention.
    (b) NIOSH will notify the miner of his or her spirometry test 
results, a comparison between current and previously submitted 
spirometry tests (if available), and will advise the miner to contact a 
health care professional as appropriate based on the results.

[81 FR 73289, Oct. 24, 2016]



Sec.  37.98  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this subpart, 
Subpart--Spirometry Testing, with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any 
edition other than that specified in this section, NIOSH must publish 
notice of change in the Federal Register and the material must be 
available to the public. All approved material is available for 
inspection at NIOSH, Respiratory Health Division, 1095 Willowdale Road, 
Morgantown, WV 26505. To arrange for an inspection at NIOSH, call 304-
285-5749. Copies are also available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030 or go to http:/
/www.archives.gov/federal_register/code_of_federal_regulations/
ibv_locations.html.
    (b) American Journal of Respiratory and Critical Care Medicine, 
American Thoracic Society (ATS), 25 Broadway, 18th Floor, New York, NY 
10004. Phone: (800) 635-7181, extension 8065. Email: 
[email protected]. http://www.atsjournals.org/action/showHome:
    (1) Standardization of Spirometry; 1994 Update. Official Statement 
of the ATS, adopted November 11, 1994. American Journal of Respiratory 
and Critical Care Medicine 152(3):1107-1136, September 1995, into Sec.  
37.95(b). This ATS Official Statement is also available at http://
www.atsjournals.org/doi/pdf/10.1164/ajrccm.152.3.7663792.
    (2) Official American Thoracic Society Technical Standards: 
Spirometry in the Occupational Setting (``ATS Technical Standards: 
Spirometry in the Occupational Setting''). Redlich CA, Tarlo SM, 
Hankinson JL, Townsend MC, Eschenbacher WL, Von Essen SG, Sigsgaard T, 
and Weissman DN. American Journal of Respiratory and Critical Care 
Medicine 189(8):983-994, April 15, 2014, into Sec. Sec.  37.92(b) and 
37.96(a).
    (3) Spirometric Reference Values from a Sample of the General U.S. 
Population. Hankinson JL, Odencrantz JR, Fedan KB. American Journal of 
Respiratory and Critical Care Medicine, 159(1):179-187, January 1999, 
into Sec.  37.92(b).
    (c) European Respiratory Journal, 442 Glossop Road, Sheffield, S10 
2PX, UK.

[[Page 234]]

Phone: 44 114 267 28 60; Fax: 44 114 266 50 64. Email: [email protected]. 
http://erj.ersjournals.com/.
    (1) Standardisation of Spirometry (``2005 ATS/ERS Standardisation of 
Spirometry''). ATS/ERS Task Force: Standardization of Lung Function 
Testing. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, 
Coates A, Crapo R, Enright P, van der Grinten CPM, Gustafsson P, Jensen 
R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino 
R, Viegi G, and Wanger J. European Respiratory Journal 26(2):319-338, 
August 2005, into Sec. Sec.  37.93(b); 37.95(b) and (c); and 37.96(c). 
The ATS/ERS Standardisation of Spirometry is also available on the ATS 
Web site at https://www.thoracic.org/statements/resources/pfet/PFT2.pdf.
    (2) Interpretative Strategies for Lung Function Tests (``ATS/ERS 
Interpretative Strategies for Lung Function Tests''). ATS/ERS Task 
Force: Standardisation of Lung Function Testing. Pellegrino R, Viegi G, 
Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten 
CPM, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay 
R, Miller MR, Navajas D, Pedersen OF, and Wanger J. European Respiratory 
Journal 26(5):948-968, November 2005, into Sec.  37.96(a). The ATS/ERS 
Standardisation of Lung Function Testing is also available on the ATS 
Web site at http://www.thoracic.org/statements/resources/pft/pft5.pdf.
    (3) Standardisation of Lung Function Testing, the Authors' Replies 
to Readers' Comments (``Standardisation of Lung Function Testing, 
Replies to Readers''). Miller MR, Hankinson J, Brusasco V, Burgos F, 
Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, Jensen 
R, MacIntyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, and Wanger 
J. European Respiratory Journal 36(6):1496-1498, December 2010, into 
Sec.  37.95(c). The Standardisation of Lung Function Testing, Replies to 
Readers is also available on the ATS Web site at http://
www.thoracic.org/statements/resources/pft/clarification-12-2010.pdf.

[81 FR 73289, Oct. 24, 2016]



                      Subpart_General Requirements

    Source: 79 FR 45123, Aug. 4, 2014, unless otherwise noted.



Sec.  37.100  Coal mine operator plan for medical examinations.

    (a) Each coal mine operator must submit and receive NIOSH approval 
of a plan for the provision of chest radiographs, occupational 
histories, spirometry tests, and respiratory assessments of miners, 
using the appropriate forms provided by NIOSH.
    (1) During the transition from August 1, 2014 until the time when 
spirometry facilities are approved by NIOSH, any person becoming a coal 
mine operator on or after August 1, 2014, or any coal mine operator 
without an approved plan as of that date must submit a plan within 60 
days that provides for chest radiographs and occupational histories 
only.
    (2) Coal mine operators with previously approved plans for only 
chest radiographs and occupational histories, or with plans developed 
pursuant to paragraph (a)(1) of this section, will be notified by MSHA 
when the plans must be amended to include spirometry testing and 
respiratory assessments. Amendments must be submitted to NIOSH within 60 
days of MSHA's notification.
    (b) The coal mine operator's plan must include:
    (1) The name, address, and telephone number of the operator(s) 
submitting the plan;
    (2) The name, MSHA identification number for respirable dust 
measurements, and address of the mine included in the plan;
    (3) The proposed beginning and ending date of the 6-month period(s) 
for voluntary radiography exams and spirometry tests (see Sec. Sec.  
37.3(a) and 37.92(a)), the estimated number of miners to be given or 
offered examinations during the 6-month period under the plan, and a 
roster specifying the names and current home mailing addresses of each 
miner covered by the plan;
    (4) The name and location of the approved radiograph and spirometry 
facility or facilities, and the approximate date(s) and time(s) of day 
during which the radiograph examination and

[[Page 235]]

spirometry will be given to miners to enable a determination of whether 
the examinations will be conducted at a convenient time and place;
    (5) If a mobile medical examination facility is proposed to provide 
some or all of the surveillance tests specified in paragraph (a) of this 
section, the plan must provide that each miner be given adequate notice 
of the opportunity to have the examination and that no miner will have 
to wait for an examination more than 1 hour before or after his or her 
work shift. The plan must include:
    (i) The number of change houses at the mine.
    (ii) One or more alternate non-mobile approved medical examination 
facilities for the reexamination of miners and for the mandatory 
examination of miners when necessary (see Sec. Sec.  37.3(b) and 
37.92(b)), or an assurance that the mobile facility will return to the 
location(s) specified in the plan as frequently as necessary to provide 
for medical surveillance examinations in accordance with these 
regulations.
    (iii) The name and location of each change house at which 
examinations will be given. For mines with more than one change house, 
the examinations must be given at each change house or at a change house 
located at a convenient place for each miner.
    (6) Assurances that:
    (i) The operator will not solicit a physician's spirometric, 
radiographic or other findings concerning any miner employed by the 
operator;
    (ii) Instructions have been given to the person(s) giving the 
examinations that duplicate spirograms or copies of spirograms 
(including copies of electronic files) and radiographs or copies of 
radiographs (including, for digital radiographs, copies of electronic 
files) will not be made, and to the extent that it is technically 
feasible all related electronic files must be permanently deleted from 
the facility records or rendered permanently inaccessible following the 
confirmed transfer of such data to NIOSH, and that (except as may be 
necessary for the purpose of this part) the physician's spirometric, 
radiographic and other findings, as well as the occupational history and 
respiratory assessment information obtained from a miner will not be 
disclosed in a manner that would permit identification of the individual 
miner with his or her information; and
    (iii) The spirometry and radiographic examinations will be made at 
no charge to the miner.
    (c) Operators may provide for alternate spirometry or radiography 
facilities in plans submitted to NIOSH for approval.
    (d) The change of operators of any mine operating under a plan 
approved pursuant to Sec.  37.101(a) must not affect the plan of the 
operator which has transferred responsibility for the mine. Every plan 
is subject to revision in accordance with paragraph (e) of this section.
    (e) The operator must advise NIOSH of any change in its plan. Each 
change in an approved plan is subject to the same review and approval as 
the originally approved plan.
    (f) The operator must promptly display in a visible location on the 
bulletin board at the mine its proposed plan or proposed change in a 
NIOSH-approved plan when it is submitted to NIOSH. The proposed plan or 
change in a NIOSH-approved plan must remain posted in a visible location 
on the bulletin board until NIOSH either grants or denies approval at 
which time the approved plan or denial of approval must be permanently 
posted. In the case of an operator who does not have a bulletin board, 
such as an operator that is a contractor, the operator must otherwise 
notify its employees of the examination arrangements. Upon request, the 
contractor must show NIOSH written evidence that its employees have been 
notified.
    (g) Upon notification from NIOSH that sufficient time has elapsed 
since the previous period of examinations, the operator must resubmit a 
plan for each of its coal mines to NIOSH for approval for the next 
period of examinations (see Sec. Sec.  37.3(a)(2) and 37.92(a)). The 
plan must include the proposed beginning and ending dates of the next 
period of examinations and all information required by paragraph (b) of 
this section.

[81 FR 73289, Oct. 24, 2016]

[[Page 236]]



Sec.  37.101  Approval of plans.

    (a) If, after review of any plan submitted pursuant to this subpart, 
NIOSH determines that the action to be taken under the plan by the 
operator meets the specifications of this subpart and will effectively 
achieve its purpose, NIOSH will approve the plan and notify the operator 
submitting the plan of the approval. Approval may be conditioned upon 
such terms as the Secretary deems necessary to carry out the purpose of 
section 203 of the Act.
    (b) Where NIOSH has reason to believe that it will deny approval of 
a plan NIOSH will, prior to the denial, give notice in writing to the 
operator(s) of an opportunity to amend the plan. The notice must specify 
the ground(s) upon which approval is proposed to be denied.
    (c) If a plan is denied approval, NIOSH will advise the operator(s) 
in writing of the reasons for the denial and inform MSHA that the plan 
was denied.

[81 FR 73290, Oct. 24, 2016]



Sec.  37.102  Transfer of affected miner to less dusty area.

    (a) Any miner who, in the judgment of NIOSH, has evidence of the 
development of pneumoconiosis, must be afforded the option of 
transferring from his or her position to another position in an area of 
the mine where the concentration of respirable dust in the mine 
atmosphere is in compliance with the MSHA requirements in 30 CFR part 
90. A classification of one or more of the miner's chest radiographs as 
showing category 1 (\1/0\, \1/1\, \1/2\), category 2 (\2/1\, \2/2\, \2/
3\), or category 3 (\3/2\, \3/3\, 3/+) simple pneumoconiosis, or 
complicated pneumoconiosis (ILO Classification) will be accepted as such 
evidence. NIOSH will, at its discretion, also accept other medical 
examinations provided to NIOSH for review, such as computed tomography 
scans of the chest or lung biopsies, as evidence of the development of 
pneumoconiosis.
    (b) Any transfer under this section shall be in accordance with the 
procedures specified in 30 CFR part 90.

[81 FR 73290, Oct. 24, 2016]



Sec.  37.103  Medical examination at miner's expense.

    Any miner who wishes to obtain a medical examination at the miner's 
own expense at an approved spirometry or radiography facility and to 
have the complete examination submitted to NIOSH may do so, provided 
that the examination is made no sooner than 6 months after the most 
recent examination of the miner submitted to NIOSH. NIOSH will provide 
radiographic classification, evaluation of spirometry test results, and 
reporting of the results of examinations made at the miner's expense in 
the same manner as if they were submitted under an operator's plan. Any 
change in the miner's transfer rights under the Act that may result from 
this examination will be subject to the terms of Sec.  37.102.

[81 FR 73290, Oct. 24, 2016]



                            Subpart_Autopsies

    Authority: Sec. 508, 83 Stat. 803; 30 U.S.C. 957.

    Source: 36 FR 8870, May 14, 1971, unless otherwise noted.



Sec.  37.200  Scope.

    The provisions of this subpart set forth the conditions under which 
the Secretary will pay pathologists to obtain results of autopsies 
performed by them on miners.



 Sec.  37.201  Definitions.

    As used in this subpart:
    (a) Secretary means the Secretary of Health and Human Services.
    (b) Miner means any individual who during their life was employed in 
any coal mine.
    (c) Pathologist means:
    (1) A physician certified in anatomic pathology or pathology by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology,
    (2) A physician who possesses qualifications which are considered 
board-eligible by the American Board of Pathology or American 
Osteopathic Board of Pathology, or
    (3) An intern, resident, or other physician in a training program in 
pathology who performs the autopsy under

[[Page 237]]

the supervision of a pathologist as defined in paragraph (c) (1) or (2) 
of this section.
    (d) NIOSH means the National Institute for Occupational Safety and 
Health, located within the Centers for Disease Control and Prevention 
(CDC). Within NIOSH, the Respiratory Health Division (formerly called 
the Division of Respiratory Disease Studies and the Appalachian 
Laboratory for Occupational Safety and Health) is the organizational 
unit that has programmatic responsibility for the medical examination 
and surveillance program.

[86 FR 24338, May 6, 2021]



Sec.  37.202  Payment for autopsy.

    (a) NIOSH may, at its discretion, pay any pathologist who has 
received prior authorization for payment from NIOSH pursuant to Sec.  
37.204(a). Payment will only be provided with proof that legal consent 
for an autopsy as required by applicable law from the next of kin or 
other authorized person has been obtained, or that consent is not 
required, such as for a forensic autopsy. Payment may be provided to a 
pathologist who:
    (1) Performs an autopsy on a miner in accordance with this subpart; 
and
    (2) Submits the findings and other materials to NIOSH in accordance 
with this subpart within 180 calendar days after having performed the 
autopsy.
    (i) Types of chest radiographic images accepted for submission 
include a digital chest image (posteroanterior view) provided in an 
electronic format consistent with the DICOM standards described in Sec.  
37.42(c)(5), a chest computed tomography provided in an electronic 
format consistent with DICOM standards, or a good-quality copy or 
original of a film chest radiograph (posteroanterior view).
    (ii) More than one type of chest radiographic image may be 
submitted.
    (b) If payments are available, pathologists will be compensated in 
accordance with their ordinary, usual, or customary fees or at amounts 
determined through negotiation with NIOSH. To inform payment amounts, 
NIOSH may collect information about the fees charged by other 
pathologists with the same board certifications for the same services, 
in the same geographic area. NIOSH will additionally compensate a 
pathologist for the submission of chest radiographic images made of the 
subject of the autopsy within 5 years prior to their death together with 
copies of any interpretations made.
    (c) A pathologist (or the pathologist's employer, the organization 
in which the pathologist practices, or another entity receiving payment 
on behalf of or for services provided by the pathologist) who receives 
any other specific payment, fee, or reimbursement in connection with the 
autopsy from the miner's surviving spouse, family, estate, or any other 
Federal agency will not receive payment from NIOSH.

[86 FR 24339, May 6, 2021]



Sec.  37.203  Autopsy specifications.

    (a) Each autopsy for which a claim for payment is submitted pursuant 
to this subpart must be performed in a manner consistent with standard 
autopsy procedures such as those, for example, set forth in Autopsy 
Performance & Reporting, third edition (Kim A. Collins, ed., College of 
American Pathologists, 2017). Copies of this document may be borrowed 
from NIOSH.
    (b) Each autopsy must include:
    (1) Gross and microscopic examination of the lungs, pulmonary 
pleura, and tracheobronchial lymph nodes;
    (2) Weights of the heart and each lung (these and all other 
measurements required under this subparagraph must be in the metric 
system);
    (3) Circumference of each cardiac valve when opened;
    (4) Thickness of right and left ventricles; these measurements must 
be made perpendicular to the ventricular surface and must not include 
trabeculations or pericardial fat. The right ventricle must be measured 
at a point midway between the tricuspid valve and the apex, and the left 
ventricle must be measured directly above the insertion of the anterior 
papillary muscle;
    (5) Size, number, consistency, location, description and other 
relevant details of all lesions of the lungs;
    (6) Level of the diaphragm;
    (7) From each type of suspected pneumoconiotic lesion, 
representative

[[Page 238]]

microscopic slides stained with hematoxylin eosin or other appropriate 
stain, and one formalin fixed, paraffin-impregnated block of tissue; a 
minimum of three stained slides and three blocks of tissue corresponding 
to the three stained slides must be submitted. When no such lesion is 
recognized, similar material must be submitted from three separate areas 
of the lungs selected at random; a minimum of three stained slides and 
three formalin fixed, paraffin-impregnated blocks of tissue 
corresponding to the three stained slides must be submitted.
    (c) Needle biopsy techniques will not be accepted.

]86 FR 24339, May 6, 2021]



Sec.  37.204  Procedure for obtaining payment.

    (a) Prior to performing an autopsy, the pathologist must obtain 
written authorization from NIOSH and agreement regarding payment amount 
for services specified in Sec.  37.202(a) by submitting an Authorization 
for Payment of Autopsy (form CDC 2.19).
    (1) NIOSH will maintain up-to-date information about the 
availability of payments on its website.
    (2) After receiving a completed authorization request form, NIOSH 
will reply in writing with an authorization determination within 3 
working days.
    (b) After performance of an autopsy, each claim for payment under 
this subpart must be submitted to NIOSH and must include:
    (1) An invoice (in duplicate) on the pathologist's letterhead or 
billhead indicating the date of autopsy, the amount of the claim, and a 
signed statement that the pathologist (or the pathologist's employer, 
the organization in which the pathologist practices, or another entity 
receiving compensation on behalf of or for services provided by the 
pathologist) is not receiving any other specific compensation for the 
autopsy from the miner's surviving spouse or next-of-kin, the estate of 
the miner, or any other source.
    (2) Completed Consent, Release and History Form for Autopsy (CDC/
NIOSH (M)2.6). This form may be completed with the assistance of the 
pathologist, attending physician, family physician, or any other 
responsible person who can provide reliable information.
    (3) Report of autopsy:
    (i) The information, slides, and blocks of tissue required by this 
subpart.
    (ii) Clinical abstract of terminal illness and other data that the 
pathologist determines is relevant.
    (iii) Final summary, including final anatomical diagnoses, 
indicating presence or absence of simple and complicated pneumoconiosis, 
and correlation with clinical history if indicated.

[86 FR 24339, May 6, 2021]



PART 38_DISASTER ASSISTANCE FOR CRISIS COUNSELING AND TRAINING--
Table of Contents



Sec.
38.1 Purpose; coordination.
38.2 Definitions.
38.3 Assistance; procedures, limitations.
38.4 Contracts.
38.5 Grant assistance.
38.6 Nondiscrimination.
38.7 Nonliability.
38.8 Criminal and civil penalties.
38.9 Federal audits.

    Authority: Sec. 413, Pub. L. 93-288. The Disaster Relief Act of 
1974, 88 Stat. 157, 42 U.S.C. 5183, E.O. 11795, 39 FR 25939, as amended 
by E.O. 11910, 41 FR 15681.

    Source: 41 FR 52052, Nov. 26, 1976, unless otherwise noted.



Sec.  38.1  Purpose; coordination.

    (a) Purpose. This part establishes standards and procedures for the 
implementation of section 413 of Pub. L. 93-288, the Disaster Relief Act 
of 1974 (42 U.S.C. 5183) which authorizes the provision, either directly 
or through financial assistance to State or local agencies or private 
mental health organizations, of:
    (1) Professional counseling services to victims of a major disaster 
in order to relieve mental health problems caused or aggravated by such 
a major disaster or its aftermath; and
    (2) Training of disaster workers to provide or assist in providing 
those professional counseling services.
    (b) Coordination. The Secretary, acting through the National 
Institute of Mental Health, will, as provided in 24 CFR 2205.51, carry 
out section 413 of the

[[Page 239]]

Act and this part in coordination with and under the general policy 
guidance of, the Administrator of the Federal Disaster Assistance 
Administration. Contracts and grants awarded under this part are subject 
to all applicable provisions of the Act and the implementing regulations 
promulgated by the Administrator (24 CFR part 2205).



Sec.  38.2  Definitions.

    All terms not defined herein shall have the same meaning as given 
them in the Act. As used in this part:
    (a) Act means the Disaster Relief Act of 1974 (42 U.S.C. 5121, et 
seq.).
    (b) Administrator means the Administrator, Federal Disaster 
Assistance Administration (FDAA), Department of Housing and Urban 
Development, and any other person to whom he delegates the authority.
    (c) Contractor means any public agency or private mental health 
organization which, pursuant to this part, contracts with the Secretary 
to provide professional mental health crisis counseling services or to 
provide mental health training for disaster workers.
    (d) Crisis means the existence of any life situation resulting from 
a major disaster or its aftermath which so effects the emotional and 
mental equilibrium of a disaster victim that professional mental health 
counseling services should be provided to help preclude possible 
damaging physical or psychological effects.
    (e) Disaster workers means mental health specialists such as 
psychiatrists, psychologists, psychiatric nurses, social workers, or 
qualified agents thereof.
    (f) Federal Coordinating Officer means the person appointed by the 
Administrator to coordinate Federal assistance in a major disaster.
    (g) Governor means the chief executive of a State.
    (h) Grantee means any public agency or private nonprofit mental 
health organization which, pursuant to this part, is awarded a grant for 
the purpose of providing professional mental health crisis counseling 
services or mental health training for disaster workers.
    (i) Major disaster means any hurricane, tornado, storm, flood, high-
water, wind-driven water, tidal wave, tsunami, earthquake, volcanic 
eruption, landslide, mudslide, snowstorm, drought, fire, explosion, or 
other catastrophe in any part of the United States which, in the 
determination of the President, causes damage of sufficient severity and 
magnitude to warrant major disaster assistance under the Act above and 
beyond emergency services by the Federal Government, to supplement the 
efforts and available resources of the States, local governments, and 
disaster relief organizations, in alleviating the damage, loss, 
hardship, or suffering caused thereby.
    (j) Regional Director means a director of a regional office of the 
Federal Disaster Assistance Administration (FDAA).
    (k) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (l) State means any of the fifty States, the District of Columbia, 
Puerto Rico, the Virgin Islands, Guam, American Samoa, the Canal Zone, 
or the Trust Territory of the Pacific Islands.
    (m) State Coordinating Officer means the person appointed by the 
Governor to act in cooperation with the appointed Federal Coordinating 
Officer.
    (n) Training means the specific instruction which may be required to 
enable disaster workers to provide professional mental health crisis 
counseling to victims of a major disaster or its aftermath.



Sec.  38.3  Assistance; procedures, limitations.

    (a) Application. In order to obtain assistance under this part, the 
Governor or his State Coordinating Officer must, not later than 60 days 
following a major disaster declaration by the President, file with the 
appropriate Regional Director a request which includes:
    (1) An estimate of the number of disaster victims who may need 
professional mental health crisis counseling services and of the number 
of disaster workers who may need training in the provision of such 
services;

[[Page 240]]

    (2) Identification of the geographical areas in which the need 
exists;
    (3) An estimate of the period during which assistance under this 
part will be required and of the total funds which will be required to 
provide such assistance;
    (4) A description of the types of mental health problems caused or 
aggravated by the major disaster or its aftermath; and
    (5) Identification of the State and local agencies and private 
mental health organizations capable of providing professional mental 
health crisis counseling to disaster victims or training of disaster 
workers.
    (b) Review, approval. The Secretary, upon notification by the 
Administrator of a State request for assistance under this part, will 
conduct a review to determine the extent to which such assistance is 
needed to supplement assistance programs provided by State and local 
governments and private organizations and, on the basis of that review, 
prepare and submit a recommendation and report for consideration by the 
Administrator. Upon approval by the Administrator and his advancement of 
funds for carrying out the approved assistance, the Secretary may, 
within the limits of the funds advanced, provide the approved services 
either directly or through a grant or contract.
    (c) Eligibility for services. (1) In order to be eligible for the 
professional mental health crisis counseling services available under 
this part an individual must:
    (i) Have been located within the designated major disaster area or 
have been a resident of such area at the time of the major disaster or 
its aftermath; and
    (ii) Have a mental health problem which was caused or aggravated by 
the major disaster or its aftermath.
    (2) Disaster workers who are available on short notice to provide 
professional mental health crisis counseling services in a major 
disaster area are eligible for training under this part.
    (d) Time limitation. Contracts and grants awarded under this part 
will not continue beyond 180 days after the first day services are 
provided pursuant to such contracts and grants, except that upon the 
recommendation of the Secretary (1) the Regional Director may extend the 
180 day period for up to 30 days or (2) the Administrator may extend the 
180 day period for more than 30 days.



Sec.  38.4  Contracts.

    (a) Eligibility. Public agencies and private mental health 
organizations which are determined by the Secretary to be capable of 
providing the professional mental health crisis counseling services or 
mental health training of disaster workers needed as a result of a major 
disaster are eligible for the award of a contract under this part.
    (b) Use of local agencies. Preference will be given to the extent 
feasible and practicable, to those agencies and organizations which are 
located or do business primarily in the area affected by the major 
disaster.
    (c) General requirements. Contracts under this part shall be entered 
into and carried out in accordance with the provisions of chapters 1 and 
3 of title 41 of the Code of Federal Regulations and all other 
applicable laws and regulations.
    (d) Payments. The Secretary shall from time to time make payments to 
the contractor of all or a portion of the contract award, either by way 
of reimbursement for expenses incurred or in advance for expenses to be 
incurred, to the extent he determines such payments are necessary to 
promote prompt initiation and advancement of the services to be provided 
under the contract. All payments not expended by the contractor within 
the period of the contract shall be returned to the Secretary.
    (e) Reports. Contractors shall submit the following reports to the 
Secretary:
    (1) Progress reports, to be submitted at the end of the first 30 
days of the contract period and every 30 days therafter;
    (2) A final report to be submitted within 60 days of the date upon 
which the contract terminates; and
    (3) Such additional reports as the Secretary may prescribe including 
those which may be required to enable the Federal Coordinating Officer 
to carry out his functions.

[[Page 241]]



Sec.  38.5  Grant assistance.

    (a) Eligibility. Public agencies and private nonprofit mental health 
organizations which are determined by the Secretary to be capable of 
providing the professional mental health crisis counseling services or 
mental health training of disaster workers needed as a result of a major 
disaster are eligible for a grant award under this part.
    (b) Application. The application shall contain:
    (1) A proposed plan for the provision of the services for which 
grant assistance is requested;
    (2) A proposed budget for the expenditure of the requested grant 
funds; and
    (3) Such other pertinent information and assurances as the Secretary 
may require.
    (c) Grant awards. (1) Preference will be given, to the extent 
feasible and practicable, to those public and private nonprofit agencies 
and organizations which are located or do business primarily in the area 
affected by the major disaster.
    (2) Within the limits of the funds advanced by the Administrator, 
the amount of any grant award shall be determined on the basis of the 
Secretary's estimate of the sum necessary to carry out the grant 
purpose.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Other HHS regulations that apply. Several other regulations 
apply to grants under this grant. These include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

    (e) Expenditure of grant funds. Any funds granted pursuant to this 
part shall be expended solely for the purposes for which the funds were 
granted in accordance with the approved application and budget, the 
regulations of this part, the terms and the conditions of the award, and 
the applicable cost principles prescribed in 45 CFR part 75, subpart E.
    (f) Reports. In exceptional circumstances, a grantee may be required 
to submit special progress reports, in addition to those otherwise 
required, relating to the conduct and results of the approved grant.

[41 FR 52052, Nov. 26, 1976, as amended at 45 FR 57396, Aug. 28, 1980; 
49 FR 38109, Sept. 27, 1984; 81 FR 3006, Jan. 20, 2016]



Sec.  38.6  Nondiscrimination.

    Attention is called to the requirements of 24 CFR 2205.13 relating 
to nondiscrimination on the grounds of race. religion, sex, color, age, 
economic status, or national origin in the provision of disaster 
assistance.



Sec.  38.7  Nonliability.

    Attention is called to section 308 of the Act (42 U.S.C. 5148) which 
provides that the Federal Government shall not be liable for any claim 
based upon the exercise or performance of or the failure to exercise or 
perform a discretionary function or duty on the part of a Federal agency 
or an employee of the Federal Government in carrying out the provisions 
of the Act.



Sec.  38.8  Criminal and civil penalties.

    Attention is called to section 317 of the Act (42 U.S.C. 5157) which 
provides:

    (a) Any individual who fraudulently or willfully misstates any fact 
in connection with a request for assistance under this Act shall be 
fined not more than $10,000 or imprisoned for not more than one year or 
both for each violation.

[[Page 242]]

    (b) Any individual who knowingly violates any order or regulation 
under this Act shall be subject to a civil penalty of not more than 
$5,000 for each violation.
    (c) Whoever knowingly misapplies the proceeds of a loan or other 
cash benefit obtained under any section of this Act shall be subject to 
a fine in an amount equal to one and one half times the original 
principal amount of the loan or cash benefit.



Sec.  38.9  Federal audits.

    The Secretary, the Administrator, and the Comptroller General of the 
United States, or their duly authorized representatives shall have 
access to any books, documents, papers, and records that pertain to 
Federal funds, equipment, and supplies received under this part for the 
purpose of audit and examination.

[[Page 243]]



                           SUBCHAPTER D_GRANTS





PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents



Subpart A [Reserved]

Subpart B_Sterilization of Persons in Federally Assisted Family Planning 
                                Projects

Sec.
50.201 Applicability.
50.202 Definitions.
50.203 Sterilization of a mentally competent individual aged 21 or 
          older.
50.204 Informed consent requirement.
50.205 Consent form requirements.
50.206 Sterilization of a mentally incompetent individual or of an 
          institutionalized individual.
50.207 Sterilization by hysterectomy.
50.208 Program or project requirements.
50.209 Use of Federal financial assistance.
50.210 Review of regulation.

Appendix to Subpart B of Part 50--Required Consent Form

 Subpart C_Abortions and Related Medical Services in Federally Assisted 
                  Programs of the Public Health Service

50.301 Applicability.
50.302 Definitions.
50.303 General rule.
50.304 Life of the mother would be endangered.
50.305 [Reserved]
50.306 Rape and incest.
50.307 Documentation needed by programs or projects.
50.308 Drugs and devices and termination of ectopic pregnancies.
50.309 Recordkeeping requirements.
50.310 Confidentiality.

         Subpart D_Public Health Service Grant Appeals Procedure

50.401 What is the purpose of this subpart?
50.402 To what program do these regulations apply?
50.403 What is the policy basis for these procedures?
50.404 What disputes are covered by these procedures?
50.405 What is the structure of review committees?
50.406 What are the steps in the process?

               Subpart E_Maximum Allowable Cost for Drugs

50.501 Applicability.
50.502 Definitions.
50.503 Policy.
50.504 Allowable cost of drugs.

               Subpart F_Promoting Objectivity in Research

50.601 Purpose.
50.602 Applicability.
50.603 Definitions.
50.604 Responsibilities of Institutions regarding Investigator financial 
          conflicts of interest.
50.605 Management and reporting of financial conflicts of interest.
50.606 Remedies.
50.607 Other HHS regulations that apply.

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42 
U.S.C. 300a-4), unless otherwise noted.

    Source: 43 FR 52165, Nov. 8, 1978, unless otherwise noted.

Subpart A [Reserved]



Subpart B_Sterilization of Persons in Federally Assisted Family Planning 
                                Projects



Sec.  50.201  Applicability.

    The provisions of this subpart are applicable to programs or 
projects for health services which are supported in whole or in part by 
Federal financial assistance, whether by grant or contract, administered 
by the Public Health Service.



Sec.  50.202  Definitions.

    As used in this subpart:
    Arrange for means to make arrangements (other than mere referral of 
an individual to, or the mere making of an appointment for him or her 
with, another health care provider) for the performance of a medical 
procedure on an individual by a health care provider other than the 
program or project.
    Hysterectomy means a medical procedure or operation for the purpose 
of removing the uterus.
    Institutionalized individual means an individual who is (1) 
involuntarily confined or detained, under a civil or criminal statute, 
in a correctional or rehabilitative facility, including a mental 
hospital or other facility for

[[Page 244]]

the care and treatment of mental illness, or (2) confined, under a 
voluntary commitment, in a mental hospital or other facility for the 
care and treatment of mental illness.
    Mentally incompetent individual means an individual who has been 
declared mentally incompetent by a Federal, State, or local court of 
competent jurisdiction for any purpose unless he or she has been 
declared competent for purposes which include the ability to consent to 
sterilization.
    Public Health Service means the Office of the Assistant Secretary 
for Health, Health Resources and Services Administration, National 
Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse 
and Mental Health Administration and all of their constituent agencies.
    The Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    Sterilization means any medical procedure, treatment, or operation 
for the purpose of rendering an individual permanently incapable of 
reproducing.

[43 FR 52165, Nov. 8, 1978, as amended at 49 FR 38109, Sept. 27, 1984]



Sec.  50.203  Sterilization of a mentally competent individual 
aged 21 or older.

    Programs or projects to which this subpart applies shall perform or 
arrange for the performance of sterilization of an individual only if 
the following requirements have been met:
    (a) The individual is at least 21 years old at the time consent is 
obtained.
    (b) The individual is not a mentally incompetent individual.
    (c) The individual has voluntarily given his or her informed consent 
in accordance with the procedures of Sec.  50.204 of this subpart.
    (d) At least 30 days but not more than 180 days have passed between 
the date of informed consent and the date of the sterilization, except 
in the case of premature delivery or emergency abdominal surgery. An 
individual may consent to be sterilized at the time of premature 
delivery or emergency abdominal surgery, if at least 72 hours have 
passed after he or she gave informed consent to sterilization. In the 
case of premature delivery, the informed consent must have been given at 
least 30 days before the expected date of delivery.



Sec.  50.204  Informed consent requirement.

    Informed consent does not exist unless a consent form is completed 
voluntarily and in accordance with all the requirements of this section 
and Sec.  50.205 of this subpart.
    (a) A person who obtains informed consent for a sterilization 
procedure must offer to answer any questions the individual to be 
sterilized may have concerning the procedure, provide a copy of the 
consent form, and provide orally all of the following information or 
advice to the individual who is to be sterilized:
    (1) Advice that the individual is free to withhold or withdraw 
consent to the procedure any time before the sterilization without 
affecting his or her right to future care or treatment and without loss 
or withdrawal of any federally funded program benefits to which the 
individual might be otherwise entitled:
    (2) A description of available alternative methods of family 
planning and birth control;
    (3) Advice that the sterilization procedure is considered to be 
irreversible;
    (4) A thorough explanation of the specific sterilization procedure 
to be performed;
    (5) A full description of the discomforts and risks that may 
accompany or follow the performing of the procedure, including an 
explanation of the type and possible effects of any anesthetic to be 
used;
    (6) A full description of the benefits or advantages that may be 
expected as a result of the sterilization; and
    (7) Advice that the sterilization will not be performed for at least 
30 days except under the circumstances specified in Sec.  50.203(d) of 
this subpart.
    (b) An interpreter must be provided to assist the individual to be 
sterilized if he or she does not understand the language used on the 
consent form or the language used by the person obtaining the consent.

[[Page 245]]

    (c) Suitable arrangements must be made to insure that the 
information specified in paragraph (a) of this section is effectively 
communicated to any individual to be sterilized who is blind, deaf or 
otherwise handicapped.
    (d) A witness chosen by the individual to be sterilized may be 
present when consent is obtained.
    (e) Informed consent may not be obtained while the individual to be 
sterilized is:
    (1) In labor or childbirth;
    (2) Seeking to obtain or obtaining an abortion; or
    (3) Under the influence of alcohol or other substances that affect 
the individual's state of awareness.
    (f) Any requirement of State and local law for obtaining consent, 
except one of spousal consent, must be followed.



Sec.  50.205  Consent form requirements.

    (a) Required consent form. The consent form appended to this subpart 
or another consent form approved by the Secretary must be used.
    (b) Required signatures. The consent form must be signed and dated 
by:
    (1) The individual to be sterilized; and
    (2) The interpreter, if one is provided; and
    (3) The person who obtains the consent; and
    (4) The physician who will perform the sterilization procedure.
    (c) Required certifications. (1) The person obtaining the consent 
must certify by signing the consent form that:
    (i) Before the individual to be sterilized signed the consent form, 
he or she advised the individual to be sterilized that no Federal 
benefits may be withdrawn because of the decision not to be sterilized,
    (ii) He or she explained orally the requirements for informed 
consent as set forth on the consent form, and
    (iii) To the best of his or her knowledge and belief, the individual 
to be sterilized appeared mentally competent and knowingly and 
voluntarily consented to be sterilized.
    (2) The physician performing the sterilization must certify by 
signing the consent form, that:
    (i) Shortly before the performance of the sterilization, he or she 
advised the individual to be sterilized that no Federal benefits may be 
withdrawn because of the decision not to be sterilized,
    (ii) He or she explained orally the requirements for informed 
consent as set forth on the consent form, and
    (iii) To the best of his or her knowledge and belief, the individual 
to be sterilized appeared mentally competent and knowingly and 
voluntarily consented to be sterilized. Except in the case of premature 
delivery or emergency abdominal surgery, the physician must further 
certify that at least 30 days have passed between the date of the 
individual's signature on the consent form and the date upon which the 
sterilization was performed. If premature delivery occurs or emergency 
abdominal surgery is required within the 30-day period, the physician 
must certify that the sterilization was performed less than 30 days but 
not less than 72 hours after the date of the individual's signature on 
the consent form because of premature delivery or emergency abdominal 
surgery, as applicable. In the case of premature delivery, the physician 
must also state the expected date of delivery. In the case of emergency 
abdominal surgery, the physician must describe the emergency.
    (3) If an interpreter is provided, the interpreter must certify that 
he or she translated the information and advice presented orally, read 
the consent form and explained its contents and to the best of the 
interpreter's knowledge and belief, the individual to be sterilized 
understood what the interpreter told him or her.



Sec.  50.206  Sterilization of a mentally incompetent individual 
or of an institutionalized individual.

    Programs or projects to which this subpart applies shall not perform 
or arrange for the performance of a sterilization of any mentally 
incompetent individual or institutionalized individual.



Sec.  50.207  Sterilization by hysterectomy.

    (a) Programs or projects to which this subpart applies shall not 
perform or arrange for the performance of any

[[Page 246]]

hysterectomy solely for the purpose of rendering an individual 
permanently incapable of reproducing or where, if there is more than one 
purpose to the procedure, the hysterectomy would not be performed but 
for the purpose of rendering the individual permanently incapable of 
reproducing.
    (b) Except as provided in paragraph (c) of this section, programs or 
projects to which this subpart applies may perform or arrange for the 
performance of a hysterectomy not covered by paragraph (a) of this 
section only if:
    (1) The person who secures the authorization to perform the 
hysterectomy has informed the individual and her representative, if any, 
orally and in writing, that the hysterectomy will make her permanently 
incapable of reproducing; and
    (2) The individual or her representative, if any, has signed a 
written acknowledgment of receipt of that information.
    (c)(1) A program or project is not required to follow the procedures 
of paragraph (b) of this section if either of the following 
circumstances exists:
    (i) The individual is already sterile at the time of the 
hysterectomy.
    (ii) The individual requires a hysterectomy because of a life-
threatening emergency in which the physician determines that prior 
acknowledgment is not possible.
    (2) If the procedures of paragraph (b) of this section are not 
followed because one or more of the circumstances of paragraph (c)(1) 
exist, the physician who performs the hysterectomy must certify in 
writing:
    (i) That the woman was already sterile, stating the cause of that 
sterility; or
    (ii) That the hysterectomy was performed under a life-threatening 
emergency situation in which he or she determined prior acknowledgment 
was not possible. He or she must also include a description of the 
nature of the emergency.

[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]



Sec.  50.208  Program or project requirements.

    (a) A program or project must, with respect to any sterilization 
procedure or hysterectomy it performs or arranges, meet all requirements 
of this subpart.
    (b) The program or project shall maintain sufficient records and 
documentation to assure compliance with these regulations, and must 
retain such data for at least 3 years.
    (c) The program or project shall submit other reports as required 
and when requested by the Secretary.



Sec.  50.209  Use of Federal financial assistance.

    (a) Federal financial assistance adminstered by the Public Health 
Service may not be used for expenditures for sterilization procedures 
unless the consent form appended to this section or another form 
approved by the Secretary is used.
    (b) A program or project shall not use Federal financial assistance 
for any sterilization or hysterectomy without first receiving 
documentation showing that the requirements of this subpart have been 
met. Documentation includes consent forms, and as applicable, either 
acknowledgments of receipt of hysterectomy information or certification 
of an exception for hysterectomies.

[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]



Sec.  50.210  Review of regulation.

    The Secretary will request public comment on the operation of the 
provisions of this subpart not later than 3 years after their effective 
date.



      Sec. Appendix to Subpart B of Part 50--Required Consent Form

    Notice: YOUR DECISION AT ANY TIME NOT TO BE STERILIZED WILL NOT 
RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED BY 
PROGRAMS OR PROJECTS RECEIVING FEDERAL FUNDS.

                        Consent to Sterilization

    I have asked for and received information about sterilization from 
_______ (doctor or clinic). When I first asked for the information, I 
was told that the decision to be sterilized is completely up to me. I 
was told that I could decide not to be sterilized. If I decide not to be 
sterilized, my decision will not affect my right to future care or 
treatment. I

[[Page 247]]

will not lose any help or benefits from programs receiving Federal 
funds, such as A.F.D.C. or medicaid that I am now getting or for which I 
may become eligible.
    I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND 
NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME PREGNANT, 
BEAR CHILDREN OR FATHER CHILDREN.
    I was told about those temporary methods of birth control that are 
available and could be provided to me which will allow me to bear or 
father a child in the future. I have rejected these alternatives and 
chosen to be sterilized.
    I understand that I will be sterilized by an operation known as a 
_______. The discomforts, risks and benefits associated with the 
operation have been explained to me. All my questions have been answered 
to my satisfaction.
    I understand that the operation will not be done until at least 30 
days after I sign this form. I understand that I can change my mind at 
any time and that my decision at any time not to be sterilized will not 
result in the withholding of any benefits or medical services provided 
by federally funded programs.
    I am at least 21 years of age and was born on __ (day), __ (month), 
__ (year).
    I, _______, hereby consent of my own free will to be sterilized by 
_______ by a method called _______. My consent expires 180 days from the 
date of my signature below.
    I also consent to the release of this form and other medical records 
about the operation to:
    Representatives of the Department of Health and Human Services or
    Employees of programs or projects funded by that Department but only 
for determining if Federal laws were observed.
    I have received a copy of this form.

Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)

    You are requested to supply the following information, but it is not 
required:

                     Ethnicity and Race Designation

    Ethnicity:

[squ] Hispanic or Latino
[squ] Not Hispanic or Latino

    Race (mark one or more):

[squ] American Indian or Alaska Native
[squ] Asian
[squ] Black or African American
[squ] Native Hawaiian or Other Pacific Islander
[squ] White

                         Interpreter's Statement

    If an interpreter is provided to assist the individual to be 
sterilized:
    I have translated the information and advice presented orally to the 
individual to be sterilized by the person obtaining this consent. I have 
also read him/her the consent form in _______ language and explained its 
contents to him/her. To the best of my knowledge and belief he/she 
understood this explanation.

Interpreter_____________________________________________________________
Date____________________________________________________________________

                    State of Person Obtaining Consent

    Before _______ (name of individual), signed the consent form, I 
explained to him/her the nature of the sterilization operation _______, 
the fact that it is intended to be a final and irreversible procedure 
and the discomforts, risks and benefits associated with it.
    I counseled the individual to be sterilized that alternative methods 
of birth control are available which are temporary. I explained that 
sterilization is different because it is permanent.
    I informed the individual to be sterilized that his/her consent can 
be withdrawn at any time and that he/she will not lose any health 
services or any benefits provided by Federal funds.
    To the best of my knowledge and belief the individual to be 
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appears to 
understand the nature and consequence of the procedure.

Signature of person obtaining consent___________________________________
Date____________________________________________________________________
Facility________________________________________________________________
Address_________________________________________________________________

                          Physician's Statement

    Shortly before I performed a sterilization operation upon _______ 
(name of individual to be sterilized), on _____ (date of sterilization), 
_______ (operation), I explained to him/her the nature of the 
sterilization operation _______ (specify type of operation), the fact 
that it is intended to be a final and irreversible procedure and the 
discomforts, risks and benefits associated with it.
    I counseled the individual to be sterilized that alternative methods 
of birth control are available which are temporary. I explained that 
sterilization is different because it is permanent.
    I informed the individual to be sterilized that his/her consent can 
be withdrawn at any time and that he/she will not lose any health 
services or benefits provided by Federal funds.
    To the best of my knowledge and belief the individual to be 
sterilized is at least 21 years old and appears mentally competent. He/
She

[[Page 248]]

knowingly and voluntarily requested to be sterilized and appeared to 
understand the nature and consequences of the procedure.
    (Instructions for use of alternative final paragraphs: Use the first 
paragraph below except in the case of premature delivery or emergency 
abdominal surgery where the sterilization is performed less than 30 days 
after the date of the individual's signature on the consent form. In 
those cases, the second paragraph below must be used. Cross out the 
paragraph which is not used.)
    (1) At least 30 days have passed between the date of the 
individual's signature on this consent form and the date the 
sterilization was performed.
    (2) This sterilization was performed less than 30 days but more than 
72 hours after the date of the individual's signature on this consent 
form because of the following circumstances (check applicable box and 
fill in information requested):

[squ] Premature delivery
Individual's expected date of delivery:_________________________________
[squ] Emergency abdominal surgery:
(Describe circumstances):_______________________________________________

Physician_______________________________________________________________
Date____________________________________________________________________

                    Paperwork Reduction Act Statement

    A Federal agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
the currently valid OMB control number. Public reporting burden for this 
collection of information will vary; however, we estimate an average of 
one hour per response, including for reviewing instructions, gathering 
and maintaining the necessary data, and disclosing the information. Send 
any comment regarding the burden estimate or any other aspect of this 
collection of information to the OS Reports Clearance Officer, ASBTF/
Budget Room 503 HHH Building, 200 Independence Avenue, SW., Washington, 
DC 20201.
    Respondents should be informed that the collection of information 
requested on this form is authorized by 42 CFR part 50, subpart B, 
relating to the sterilization of persons in federally assisted public 
health programs. The purpose of requesting this information is to ensure 
that individuals requesting sterilization receive information regarding 
the risks, benefits and consequences, and to assure the voluntary and 
informed consent of all persons undergoing sterilization procedures in 
federally assisted public health programs. Although not required, 
respondents are requested to supply information on their race and 
ethnicity. Failure to provide the other information requested on this 
consent form, and to sign this consent form, may result in an inability 
to receive sterilization procedures funded through federally assisted 
public health programs.
    All information as to personal facts and circumstances obtained 
through this form will be held confidential, and not disclosed without 
the individual's consent, pursuant to any applicable confidentiality 
regulations.

[43 FR 52165, Nov. 8, 1978, as amended at 58 FR 33343, June 17, 1993; 68 
FR 12308, Mar. 14, 2003]



 Subpart C_Abortions and Related Medical Services in Federally Assisted 
                  Programs of the Public Health Service

    Authority: Sec. 118, Pub. L. 96-86, Oct. 12, 1979, unless otherwise 
noted.

    Source: 43 FR 4570, Feb. 2, 1978, unless otherwise noted.



Sec.  50.301  Applicability.

    The provisions of this subpart are applicable to programs or 
projects for health services which are supported in whole or in part by 
Federal financial assistance, whether by grant or contract, appropriated 
to the Department of Health and Human Services and administered by the 
Public Health Service.



Sec.  50.302  Definitions.

    As used in this subpart: (a) Law enforcement agency means an agency, 
or any part thereof, charged under applicable law with enforcement of 
the general penal statutes of the United States, or of any State or 
local jurisdiction.
    (b) Medical procedures performed upon a victim of rape or incest 
means any medical service, including an abortion, performed for the 
purpose of preventing or terminating a pregnancy arising out of an 
incident of rape or incest.
    (c) Physician means a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by the State in which he or 
she practices.
    (d) Public health service means: (1) An agency of the United States 
or of a State or local government, that provides health or medical 
services; and
    (2) A rural health clinic, as defined under section 1(d)(aa)(2) of 
Pub. L. 95-210, 91 Stat. 1485; except that any agency or facility whose 
principal function

[[Page 249]]

is the performance of abortions is specifically excluded from this 
definition.



Sec.  50.303  General rule.

    Federal financial participation is not available for the performance 
of an abortion in programs or projects to which this subpart applies 
except under circumstances described in Sec.  50.304 or Sec.  50.306.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec.  50.304  Life of the mother would be endangered.

    Federal financial participation is available in expenditures for an 
abortion when a physician has found, and so certified in writing to the 
program or project, that on the basis of his/her professional judgment, 
the life of the mother would be endangered if the fetus were carried to 
term. The certification must contain the name and address of the 
patient.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978]



Sec.  50.305  [Reserved]



Sec.  50.306  Rape and incest.

    Federal financial participation is available in expenditures for 
medical procedures performed upon a victim of rape or incest if the 
program or project has received signed documentation from a law 
enforcement agency or public health service stating:
    (a) That the person upon whom the medical procedure was performed 
was reported to have been the victim of an incident of rape or incest;
    (b) The date on which the incident occurred;
    (c) The date on which the report was made, which must have been 
within 60 days of the date on which the incident occurred;
    (d) The name and address of the victim and the name and address of 
the person making the report (if different from the victim); and
    (e) That the report included the signature of the person who 
reported the incident.

Federal financial participation is also available in expenditures for 
abortions for victims of rape or incest under the circumstances 
described in Sec.  50.304 without regard to the requirements of the 
preceding sentence.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec.  50.307  Documentation needed by programs or projects.

    Federal financial participation is unavailable for the performance 
of abortions or other medical procedures otherwise provided for under 
Sec. Sec.  50.304 and 50.306 if the program or project has paid without 
first having received the certifications and documentation specified in 
those sections.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec.  50.308  Drugs and devices and termination of ectopic pregnancies.

    Federal financial participation is available with respect to the 
cost of drugs or devices to prevent implantation of the fertilized ovum, 
and for medical procedures necessary for the termination of an ectopic 
pregnancy.



Sec.  50.309  Recordkeeping requirements.

    Programs or projects to which this subpart applies must maintain 
copies of the certifications and documentation specified in Sec. Sec.  
50.304 and 50.306 for three years pursuant to the retention and 
custodial requirements for records at 45 CFR 75.361 et seq.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979; 81 
FR 3006, Jan. 20, 2016]



Sec.  50.310  Confidentiality.

    Information in the records or in the possession of programs or 
projects which is acquired in connection with the requirements of this 
subpart may not be disclosed in a form which permits the identification 
of an individual without the individual's consent except as may be 
necessary for the health of the individual or as may be necessary for 
the Secretary to monitor the activities of those programs or projects. 
In any event, any disclosure shall be subject to appropriate safeguards 
which will minimize the likelihood of

[[Page 250]]

disclosures of personal information in identifiable form.



         Subpart D_Public Health Service Grant Appeals Procedure

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216); 45 CFR 16.3(c).

    Source: 54 FR 34770, Aug. 22, 1989, unless otherwise noted.



Sec.  50.401  What is the purpose of this subpart?

    This subpart establishes an informal procedure for the resolution of 
certain postaward grant and cooperative agreement disputes within the 
agencies and offices identified in Sec.  50.402.

[63 FR 66062, Dec. 1, 1998]



Sec.  50.402  To what program do these regulations apply?

    This subpart applies to all grant and cooperative agreement 
programs, except block grants, which are administered by the National 
Institutes of Health; The Centers for Disease Control and Prevention; 
the Agency for Toxic Substances and Disease Registry; the Food and Drug 
Administration; and the Office of Public Health and Science. For 
purposes of this subpart, these entities are hereinafter referred to as 
``agencies.''

[70 FR 76175, Dec. 23, 2005]



Sec.  50.403  What is the policy basis for these procedures?

    The Secretary of Health and Human Services has established a 
Departmental Appeals Board for the purpose of providing a fair and 
flexible process for the appeal of written final decisions involving 
certain grant and cooperative agreement programs administered by 
constituent agencies of the Department. The regulatory provision which 
establishes the circumstances under which the Board will accept an 
appeal (45 CFR 16.3) provides, among other things, that the appellant 
must have exhausted any preliminary appeal process required by 
regulation before a formal appeal to the Departmental Board will be 
allowed. This subpart provides such an informal preliminary procedure 
for resolution of disputes in order to preclude submission of cases to 
the Departmental Appeals Board before an agency identified in Sec.  
50.402 has had an opportunity to review decisions of its officials and 
to settle disputes with grantees.

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]



Sec.  50.404  What disputes are covered by these procedures?

    (a) These procedures are applicable to the following adverse 
determinations under discretionary project grants and cooperative 
agreements (both referred to in this subpart as grants) issued by the 
agencies identified at Sec.  50.402;
    (1) Termination, in whole or in part, of a grant for failure of the 
grantee to carry out its approved project in accordance with the 
applicable law and the terms and conditions of such assistance or for 
failure of the grantee otherwise to comply with any law, regulation, 
assurance, term, or condition applicable to the grant.
    (2) A determination that an expenditure not allowable under the 
grant has been charged to the grant or that the grantee has otherwise 
failed to discharge its obligation to account for grant funds.
    (3) A determination that a grant is void.
    (4) A denial of a noncompeting continuation award under the project 
period system of funding where the denial is for failure to comply with 
the terms of a previous award.
    (b) A determination subject to this subpart may not be reviewed by 
the review committee described in Sec.  50.405 unless an officer or 
employee of the agency has notified the grantee in writing of the 
adverse determination. The notification must set forth the reasons for 
the determination in sufficient detail to enable the grantee to respond 
and must inform the grantee of the opportunity for review under this 
subpart.

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]



Sec.  50.405  What is the structure of review committees?

    The head of the agency, or his or her designee, shall appoint review 
committees to review adverse determinations

[[Page 251]]

made by officials for programs under their jurisdiction. A minimum of 
three employees shall be appointed (one of whom shall be designated as 
chairperson) either on an ad hoc, case-by-case basis, or as regular 
members of review committees for such terms as may be designated. None 
of the members of the review committee reviewing any given appeal may be 
from the office of the responsible official whose adverse determination 
is being appealed (e.g., project officer, grants specialist, program 
manager, grants management officer).

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]



Sec.  50.406  What are the steps in the process?

    (a) A grantee with respect to whom an adverse determination 
described in Sec.  50.404(a) above has been made and who desires a 
review of that determination must submit a request for such review to 
the head of the appropriate agency or his or her designee no later than 
30 days after the written notification of the determination is received, 
except that if the grantee shows good cause why an extension of time 
should be granted, the head of the appropriate agency or his or her 
designee may grant an extension of time.
    (b) The request for review must include a copy of the adverse 
determination, must identify the issue(s) in dispute, and must contain a 
full statement of the grantee's position with respect to such issue(s) 
and the pertinent facts and reasons in support of the grantee's 
position. In addition to the required written statement, the grantee 
shall provide copies of any documents supporting its claim.
    (c) When a request for review has been filed under this subpart with 
respect to an adverse determination, no action may be taken by the 
awarding agency pursuant to such determination until the request has 
been disposed of, except that the filing of the request shall not affect 
any authority which the agency may have to suspend assistance or 
otherwise to withhold or defer payments under the grant during 
proceedings under this subpart. This paragraph does not require the 
awarding agency to provide continuation funding during the appeal 
process to a grantee whose noncompeting continuation award has been 
denied.
    (d) Upon receipt of a request for review, the head of the agency or 
his or her designee will make a decision as to whether the dispute is 
reviewable under this subpart and will promptly notify the grantee and 
the office responsible for the adverse determination of this decision. 
If the head of the agency or his or her designee determines that the 
dispute is reviewable, he or she will forward the matter to the review 
committee appointed under Sec.  50.405.
    (e) The agency involved will provide the review committee appointed 
under Sec.  50.405 with copies of all relevant background materials 
(including applications(s), award(s), summary statement(s), and 
correspondence) and any additional pertinent information available. 
These materials must be tabbed and organized chronologically and 
accompanied by an indexed list identifying each document.
    (f) The grantee shall be given an opportunity to provide the review 
committee with additional statements and documentation not provided in 
the request for review described in paragraph (b) of this section. This 
additional submission, which must be organized and indexed as indicated 
under paragraph (e) of this section, should provide only material that 
is relevant to the review committee's deliberation of the issues in the 
case.
    (g) The review committee may, at its discretion, invite the grantee 
and/or the agency staff to discuss the pertinent issues with the 
committee and to submit such additional information as the committee 
deems appropriate.
    (h) Based on its review, the review committee will prepare a written 
decision to be signed by the chairperson and each of the other committee 
members. The review committee shall send the written decision with a 
transmittal letter to the grantee and shall send a copy of both to the 
official responsible for the adverse determination. If the decision is 
adverse to the grantee's position, the transmittal letter must state the 
grantee's right to appeal to

[[Page 252]]

the Departmental Appeals Board under 45 CFR part 16.

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66063, Dec. 1, 1998]



               Subpart E_Maximum Allowable Cost for Drugs

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216).

    Source: 40 FR 34514, Aug. 15, 1975, unless otherwise noted.



Sec.  50.501  Applicability.

    This subpart is applicable to programs or projects for health 
services which are supported in whole or in part by Federal financial 
assistance, whether by grant or contract, administered by the Public 
Health Service. It applies to Federal funds and to non-Federal funds 
which are required to be expended as a condition to receiving Federal 
funds under such programs or projects.



Sec.  50.502  Definitions.

    As used in this subpart:
    (a) Public Health Service means the Office of the Assistant 
Secretary for Health, Health Resources and Services Administration, 
National Institutes of Health, Centers for Disease Control, Alcohol, 
Drug Abuse and Mental Health Administration, Food and Drug 
Administration, and all of their constituent agencies.
    (b) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (c) Program funds means (1) Federal funds provided through grant or 
contract to support a program or project covered by Sec.  50.501, and 
(2) any non-Federal funds that are required as a condition of such grant 
or contract to be expended to carry out such program or project.
    (d) Provider means one who furnishes medical or pharmaceutical 
services or supplies for which program funds may be expended under any 
of the programs or projects described in Sec.  50.501.
    (e) Acquisition cost means the price generally and currently paid by 
providers for a drug marketed or sold by a particular formulator or 
labeler in the package size of drug most frequently purchased by 
providers, as determined by the Secretary on the basis of drug price 
information furnished by the Department.

[40 FR 34514, Aug. 15, 1975, as amended at 49 FR 38109, Sept. 27, 1984]



Sec.  50.503  Policy.

    It is the policy of the Secretary that program funds which are 
utilized for the acquisition of drugs be expended in the most economical 
manner feasible. In furtherance of this policy, the Secretary has 
established, in 45 CFR part 19, a procedure for determining the Maximum 
Allowable Cost for drugs which are purchased with program funds.



Sec.  50.504  Allowable cost of drugs.

    (a) The maximum amount which may be expended from program funds for 
the acquisition of any drug shall be the lowest of
    (1) The maximum allowable cost (MAC) of the drug, if any, 
established in accordance with 45 CFR part 19, plus a dispensing fee 
determined by the Secretary in accordance with paragraph (b) of this 
section, to be reasonable;
    (2) The acquisition cost of the drug plus a dispensing fee 
determined by the Secretary, in accordance with paragraph (b) of this 
section, to be reasonable; or
    (3) The provider's usual and customary charge to the public for the 
drug; Provided, That the MAC established for any drug shall not apply to 
a brand of that drug prescribed for a patient which the prescriber has 
certified, in accordance with paragraph (c) of this section, is 
medically necessary for that patient; And Provided further, That where 
compensation for drug dispensing is included in other costs allowable 
under the applicable program statute and regulations, the terms and 
conditions of the grant or contract, and the applicable cost principles 
prescribed in 45 CFR part 75, subpart E, no separate dispensing fee will 
be recognized.
    (b) In determining whether a dispensing fee is reasonable, the 
Secretary will take into account:

[[Page 253]]

    (1) Cost components such as overhead, professional services, and 
profits,
    (2) Payment practices of third-party payment organizations, 
including other Federal programs such as titles XVIII and XIX of the 
Social Security Act; and
    (3) Any surveys by States, universities or others of costs of 
pharmacy operations and the fees charged in the particular area.
    (c) A certification by a prescriber, pursuant to paragraph (a) of 
this section, that a brand of drug is medically necessary for a 
particular patient shall be in the prescriber's own handwriting, in such 
form and manner as the Secretary may prescribe. An example of an 
acceptable certification is the notation ``brand necessary''. A 
procedure for checking a box on a form will not constitute an acceptable 
certification.

[40 FR 34514, Aug. 15, 1975, as amended at 81 FR 3006, Jan. 20, 2016]



               Subpart F_Promoting Objectivity in Research

    Authority: 42 U.S.C. 216, 289b-1, 299c-4; Sec. 219, Tit. II, Div. D, 
Pub. L. 111-117, 123 Stat. 3034.

    Source: 76 FR 53283, August 25, 2011, unless otherwise noted.



Sec.  50.601  Purpose.

    This subpart promotes objectivity in research by establishing 
standards that provide a reasonable expectation that the design, 
conduct, and reporting of research funded under Public Health Service 
(PHS) grants or cooperative agreements will be free from bias resulting 
from Investigator financial conflicts of interest.



Sec.  50.602  Applicability.

    This subpart is applicable to each Institution that is applying for, 
or that receives, PHS research funding by means of a grant or 
cooperative agreement and, through the implementation of this subpart by 
the Institution, to each Investigator who is planning to participate in, 
or is participating in, such research; provided, however, that this 
subpart does not apply to SBIR Program Phase I applications. In those 
few cases where an individual, rather than an Institution, is applying 
for, or receives, PHS research funding, PHS Awarding Components will 
make case-by-case determinations on the steps to be taken, consistent 
with this subpart, to provide a reasonable expectation that the design, 
conduct, and reporting of the research will be free from bias resulting 
from a financial conflict of interest of the individual.



Sec.  50.603  Definitions.

    As used in this subpart:
    Disclosure of significant financial interests means an 
Investigator's disclosure of significant financial interests to an 
Institution.
    Financial conflict of interest (FCOI) means a significant financial 
interest that could directly and significantly affect the design, 
conduct, or reporting of PHS-funded research.
    FCOI report means an Institution's report of a financial conflict of 
interest to a PHS Awarding Component.
    Financial interest means anything of monetary value, whether or not 
the value is readily ascertainable.
    HHS means the United States Department of Health and Human Services, 
and any components of the Department to which the authority involved may 
be delegated.
    Institution means any domestic or foreign, public or private, entity 
or organization (excluding a Federal agency) that is applying for, or 
that receives, PHS research funding.
    Institutional responsibilities means an Investigator's professional 
responsibilities on behalf of the Institution, and as defined by the 
Institution in its policy on financial conflicts of interest, which may 
include for example: activities such as research, research consultation, 
teaching, professional practice, institutional committee memberships, 
and service on panels such as Institutional Review Boards or Data and 
Safety Monitoring Boards.
    Investigator means the project director or principal Investigator 
and any other person, regardless of title or position, who is 
responsible for the design, conduct, or reporting of research funded by 
the PHS, or proposed for such funding, which may include, for example, 
collaborators or consultants.

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    Manage means taking action to address a financial conflict of 
interest, which can include reducing or eliminating the financial 
conflict of interest, to ensure, to the extent possible, that the 
design, conduct, and reporting of research will be free from bias.
    PD/PI means a project director or principal Investigator of a PHS-
funded research project; the PD/PI is included in the definitions of 
senior/key personnel and Investigator under this subpart.
    PHS means the Public Health Service of the U.S. Department of Health 
and Human Services, and any components of the PHS to which the authority 
involved may be delegated, including the National Institutes of Health 
(NIH).
    PHS Awarding Component means the organizational unit of the PHS that 
funds the research that is subject to this subpart.
    Public Health Service Act or PHS Act means the statute codified at 
42 U.S.C. 201 et seq.
    Research means a systematic investigation, study or experiment 
designed to develop or contribute to generalizable knowledge relating 
broadly to public health, including behavioral and social-sciences 
research. The term encompasses basic and applied research (e.g., a 
published article, book or book chapter) and product development (e.g., 
a diagnostic test or drug). As used in this subpart, the term includes 
any such activity for which research funding is available from a PHS 
Awarding Component through a grant or cooperative agreement, whether 
authorized under the PHS Act or other statutory authority, such as a 
research grant, career development award, center grant, individual 
fellowship award, infrastructure award, institutional training grant, 
program project, or research resources award.
    Senior/key personnel means the PD/PI and any other person identified 
as senior/key personnel by the Institution in the grant application, 
progress report, or any other report submitted to the PHS by the 
Institution under this subpart.
    Significant financial interest means:
    (1) A financial interest consisting of one or more of the following 
interests of the Investigator (and those of the Investigator's spouse 
and dependent children) that reasonably appears to be related to the 
Investigator's institutional responsibilities:
    (i) With regard to any publicly traded entity, a significant 
financial interest exists if the value of any remuneration received from 
the entity in the twelve months preceding the disclosure and the value 
of any equity interest in the entity as of the date of disclosure, when 
aggregated, exceeds $5,000. For purposes of this definition, 
remuneration includes salary and any payment for services not otherwise 
identified as salary (e.g., consulting fees, honoraria, paid 
authorship); equity interest includes any stock, stock option, or other 
ownership interest, as determined through reference to public prices or 
other reasonable measures of fair market value;
    (ii) With regard to any non-publicly traded entity, a significant 
financial interest exists if the value of any remuneration received from 
the entity in the twelve months preceding the disclosure, when 
aggregated, exceeds $5,000, or when the Investigator (or the 
Investigator's spouse or dependent children) holds any equity interest 
(e.g., stock, stock option, or other ownership interest); or
    (iii) Intellectual property rights and interests (e.g., patents, 
copyrights), upon receipt of income related to such rights and 
interests.
    (2) Investigators also must disclose the occurrence of any 
reimbursed or sponsored travel (i.e., that which is paid on behalf of 
the Investigator and not reimbursed to the Investigator so that the 
exact monetary value may not be readily available), related to their 
institutional responsibilities; provided, however, that this disclosure 
requirement does not apply to travel that is reimbursed or sponsored by 
a Federal, state, or local government agency, an Institution of higher 
education as defined at 20 U.S.C. 1001(a), an academic teaching 
hospital, a medical center, or a research institute that is affiliated 
with an Institution of higher education. The Institution's FCOI policy

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will specify the details of this disclosure, which will include, at a 
minimum, the purpose of the trip, the identity of the sponsor/organizer, 
the destination, and the duration. In accordance with the Institution's 
FCOI policy, the institutional official(s) will determine if further 
information is needed, including a determination or disclosure of 
monetary value, in order to determine whether the travel constitutes an 
FCOI with the PHS-funded research.
    (3) The term significant financial interest does not include the 
following types of financial interests: salary, royalties, or other 
remuneration paid by the Institution to the Investigator if the 
Investigator is currently employed or otherwise appointed by the 
Institution, including intellectual property rights assigned to the 
Institution and agreements to share in royalties related to such rights; 
any ownership interest in the Institution held by the Investigator, if 
the Institution is a commercial or for-profit organization; income from 
investment vehicles, such as mutual funds and retirement accounts, as 
long as the Investigator does not directly control the investment 
decisions made in these vehicles; income from seminars, lectures, or 
teaching engagements sponsored by a Federal, state, or local government 
agency, an Institution of higher education as defined at 20 U.S.C. 
1001(a), an academic teaching hospital, a medical center, or a research 
institute that is affiliated with an Institution of higher education; or 
income from service on advisory committees or review panels for a 
Federal, state, or local government agency, an Institution of higher 
education as defined at 20 U.S.C. 1001(a), an academic teaching 
hospital, a medical center, or a research institute that is affiliated 
with an Institution of higher education.
    Small Business Innovation Research (SBIR) Program means the 
extramural research program for small businesses that is established by 
the Awarding Components of the Public Health Service and certain other 
Federal agencies under Public Law 97-219, the Small Business Innovation 
Development Act, as amended. For purposes of this subpart, the term SBIR 
Program also includes the Small Business Technology Transfer (STTR) 
Program, which was established by Public Law 102-564.



Sec.  50.604  Responsibilities of Institutions regarding Investigator 
financial conflicts of interest.

    Each Institution shall:
    (a) Maintain an up-to-date, written, enforced policy on financial 
conflicts of interest that complies with this subpart, and make such 
policy available via a publicly accessible Web site. If the Institution 
does not have any current presence on a publicly accessible Web site 
(and only in those cases), the Institution shall make its written policy 
available to any requestor within five business days of a request. If, 
however, the Institution acquires a presence on a publicly accessible 
Web site during the time of the PHS award, the requirement to post the 
information on that Web site will apply within 30 calendar days. If an 
Institution maintains a policy on financial conflicts of interest that 
includes standards that are more stringent than this subpart (e.g., that 
require a more extensive disclosure of financial interests), the 
Institution shall adhere to its policy and shall provide FCOI reports 
regarding identified financial conflicts of interest to the PHS Awarding 
Component in accordance with the Institution's own standards and within 
the timeframe prescribed by this subpart.
    (b) Inform each Investigator of the Institution's policy on 
financial conflicts of interest, the Investigator's responsibilities 
regarding disclosure of significant financial interests, and of these 
regulations, and require each Investigator to complete training 
regarding the same prior to engaging in research related to any PHS-
funded grant and at least every four years, and immediately when any of 
the following circumstances apply:
    (1) The Institution revises its financial conflict of interest 
policies or procedures in any manner that affects the requirements of 
Investigators;
    (2) An Investigator is new to an Institution; or
    (3) An Institution finds that an Investigator is not in compliance 
with the Institution's financial conflict of interest policy or 
management plan.

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    (c) If the Institution carries out the PHS-funded research through a 
subrecipient (e.g., subcontractors or consortium members), the 
Institution (awardee Institution) must take reasonable steps to ensure 
that any subrecipient Investigator complies with this subpart by:
    (1) Incorporating as part of a written agreement with the 
subrecipient terms that establish whether the financial conflicts of 
interest policy of the awardee Institution or that of the subrecipient 
will apply to the subrecipient's Investigators.
    (i) If the subrecipient's Investigators must comply with the 
subrecipient's financial conflicts of interest policy, the subrecipient 
shall certify as part of the agreement referenced above that its policy 
complies with this subpart. If the subrecipient cannot provide such 
certification, the agreement shall state that subrecipient Investigators 
are subject to the financial conflicts of interest policy of the awardee 
Institution for disclosing significant financial interests that are 
directly related to the subrecipient's work for the awardee Institution;
    (ii) Additionally, if the subrecipient's Investigators must comply 
with the subrecipient's financial conflicts of interest policy, the 
agreement referenced above shall specify time period(s) for the 
subrecipient to report all identified financial conflicts of interest to 
the awardee Institution. Such time period(s) shall be sufficient to 
enable the awardee Institution to provide timely FCOI reports, as 
necessary, to the PHS as required by this subpart;
    (iii) Alternatively, if the subrecipient's Investigators must comply 
with the awardee Institution's financial conflicts of interest policy, 
the agreement referenced above shall specify time period(s) for the 
subrecipient to submit all Investigator disclosures of significant 
financial interests to the awardee Institution. Such time period(s) 
shall be sufficient to enable the awardee Institution to comply timely 
with its review, management, and reporting obligations under this 
subpart.
    (2) Providing FCOI reports to the PHS Awarding Component regarding 
all financial conflicts of interest of all subrecipient Investigators 
consistent with this subpart, i.e., prior to the expenditure of funds 
and within 60 days of any subsequently identified FCOI.
    (d) Designate an institutional official(s) to solicit and review 
disclosures of significant financial interests from each Investigator 
who is planning to participate in, or is participating in, the PHS-
funded research.
    (e)(1) Require that each Investigator who is planning to participate 
in the PHS-funded research disclose to the Institution's designated 
official(s) the Investigator's significant financial interests (and 
those of the Investigator's spouse and dependent children) no later than 
the time of application for PHS-funded research.
    (2) Require each Investigator who is participating in the PHS-funded 
research to submit an updated disclosure of significant financial 
interests at least annually, in accordance with the specific time period 
prescribed by the Institution, during the period of the award. Such 
disclosure shall include any information that was not disclosed 
initially to the Institution pursuant to paragraph (e)(1) of this 
section, or in a subsequent disclosure of significant financial 
interests (e.g., any financial conflict of interest identified on a PHS-
funded project that was transferred from another Institution), and shall 
include updated information regarding any previously disclosed 
significant financial interest (e.g., the updated value of a previously 
disclosed equity interest).
    (3) Require each Investigator who is participating in the PHS-funded 
research to submit an updated disclosure of significant financial 
interests within thirty days of discovering or acquiring (e.g., through 
purchase, marriage, or inheritance) a new significant financial 
interest.
    (f) Provide guidelines consistent with this subpart for the 
designated institutional official(s) to determine whether an 
Investigator's significant financial interest is related to PHS-funded 
research and, if so related, whether the significant financial interest 
is a financial conflict of interest. An Investigator's significant 
financial interest is related to PHS-funded research when the 
Institution, through its designated official(s), reasonably determines 
that

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the significant financial interest: could be affected by the PHS-funded 
research; or is in an entity whose financial interest could be affected 
by the research. The Institution may involve the Investigator in the 
designated official(s)'s determination of whether a significant 
financial interest is related to the PHS-funded research. A financial 
conflict of interest exists when the Institution, through its designated 
official(s), reasonably determines that the significant financial 
interest could directly and significantly affect the design, conduct, or 
reporting of the PHS-funded research.
    (g) Take such actions as necessary to manage financial conflicts of 
interest, including any financial conflicts of a subrecipient 
Investigator pursuant to paragraph (c) of this section. Management of an 
identified financial conflict of interest requires development and 
implementation of a management plan and, if necessary, a retrospective 
review and a mitigation report pursuant to Sec.  50.605(a).
    (h) Provide initial and ongoing FCOI reports to the PHS as required 
pursuant to Sec.  50.605(b).
    (i) Maintain records relating to all Investigator disclosures of 
financial interests and the Institution's review of, and response to, 
such disclosures (whether or not a disclosure resulted in the 
Institution's determination of a financial conflict of interest) and all 
actions under the Institution's policy or retrospective review, if 
applicable, for at least three years from the date the final 
expenditures report is submitted to the PHS or, where applicable, from 
other dates specified in 45 CFR 75.361 for different situations.
    (j) Establish adequate enforcement mechanisms and provide for 
employee sanctions or other administrative actions to ensure 
Investigator compliance as appropriate.
    (k) Certify, in each application for funding to which this subpart 
applies, that the Institution:
    (1) Has in effect at that Institution an up-to-date, written, and 
enforced administrative process to identify and manage financial 
conflicts of interest with respect to all research projects for which 
funding is sought or received from the PHS;
    (2) Shall promote and enforce Investigator compliance with this 
subpart's requirements including those pertaining to disclosure of 
significant financial interests;
    (3) Shall manage financial conflicts of interest and provide initial 
and ongoing FCOI reports to the PHS Awarding Component consistent with 
this subpart;
    (4) Agrees to make information available, promptly upon request, to 
the HHS relating to any Investigator disclosure of financial interests 
and the Institution's review of, and response to, such disclosure, 
whether or not the disclosure resulted in the Institution's 
determination of a financial conflict of interest; and
    (5) Shall fully comply with the requirements of this subpart.

[76 FR 53283, August 25, 2011, as amended at 81 FR 3006, Jan. 20, 2016]



Sec.  50.605  Management and reporting of financial conflicts of interest.

    (a) Management of financial conflicts of interest.
    (1) Prior to the Institution's expenditure of any funds under a PHS-
funded research project, the designated official(s) of an Institution 
shall, consistent with Sec.  50.604(f): review all Investigator 
disclosures of significant financial interests; determine whether any 
significant financial interests relate to PHS-funded research; determine 
whether a financial conflict of interest exists; and, if so, develop and 
implement a management plan that shall specify the actions that have 
been, and shall be, taken to manage such financial conflict of interest. 
Examples of conditions or restrictions that might be imposed to manage a 
financial conflict of interest include, but are not limited to:
    (i) Public disclosure of financial conflicts of interest (e.g., when 
presenting or publishing the research);
    (ii) For research projects involving human subjects research, 
disclosure of financial conflicts of interest directly to participants;
    (iii) Appointment of an independent monitor capable of taking 
measures to

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protect the design, conduct, and reporting of the research against bias 
resulting from the financial conflict of interest;
    (iv) Modification of the research plan;
    (v) Change of personnel or personnel responsibilities, or 
disqualification of personnel from participation in all or a portion of 
the research;
    (vi) Reduction or elimination of the financial interest (e.g., sale 
of an equity interest); or
    (vii) Severance of relationships that create financial conflicts.
    (2) Whenever, in the course of an ongoing PHS-funded research 
project, an Investigator who is new to participating in the research 
project discloses a significant financial interest or an existing 
Investigator discloses a new significant financial interest to the 
Institution, the designated official(s) of the Institution shall, within 
sixty days: review the disclosure of the significant financial interest; 
determine whether it is related to PHS-funded research; determine 
whether a financial conflict of interest exists; and, if so, implement, 
on at least an interim basis, a management plan that shall specify the 
actions that have been, and will be, taken to manage such financial 
conflict of interest. Depending on the nature of the significant 
financial interest, an Institution may determine that additional interim 
measures are necessary with regard to the Investigator's participation 
in the PHS-funded research project between the date of disclosure and 
the completion of the Institution's review.
    (3) Whenever an Institution identifies a significant financial 
interest that was not disclosed timely by an Investigator or, for 
whatever reason, was not previously reviewed by the Institution during 
an ongoing PHS-funded research project (e.g., was not timely reviewed or 
reported by a subrecipient), the designated official(s) shall, within 
sixty days: review the significant financial interest; determine whether 
it is related to PHS-funded research; determine whether a financial 
conflict of interest exists; and, if so:
    (i) Implement, on at least an interim basis, a management plan that 
shall specify the actions that have been, and will be, taken to manage 
such financial conflict of interest going forward;
    (ii)(A) In addition, whenever a financial conflict of interest is 
not identified or managed in a timely manner including failure by the 
Investigator to disclose a significant financial interest that is 
determined by the Institution to constitute a financial conflict of 
interest; failure by the Institution to review or manage such a 
financial conflict of interest; or failure by the Investigator to comply 
with a financial conflict of interest management plan, the Institution 
shall, within 120 days of the Institution's determination of 
noncompliance, complete a retrospective review of the Investigator's 
activities and the PHS-funded research project to determine whether any 
PHS-funded research, or portion thereof, conducted during the time 
period of the noncompliance, was biased in the design, conduct, or 
reporting of such research.
    (B) The Institution is required to document the retrospective 
review; such documentation shall include, but not necessarily be limited 
to, all of the following key elements:
    (1) Project number;
    (2) Project title;
    (3) PD/PI or contact PD/PI if a multiple PD/PI model is used;
    (4) Name of the Investigator with the FCOI;
    (5) Name of the entity with which the Investigator has a financial 
conflict of interest;
    (6) Reason(s) for the retrospective review;
    (7) Detailed methodology used for the retrospective review (e.g., 
methodology of the review process, composition of the review panel, 
documents reviewed);
    (8) Findings of the review; and
    (9) Conclusions of the review.
    (iii) Based on the results of the retrospective review, if 
appropriate, the Institution shall update the previously submitted FCOI 
report, specifying the actions that will be taken to manage the 
financial conflict of interest going forward. If bias is found, the 
Institution is required to notify the PHS Awarding Component promptly 
and submit a mitigation report to the PHS Awarding Component. The 
mitigation report must include, at a minimum, the key elements 
documented in the

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retrospective review above and a description of the impact of the bias 
on the research project and the Institution's plan of action or actions 
taken to eliminate or mitigate the effect of the bias (e.g., impact on 
the research project; extent of harm done, including any qualitative and 
quantitative data to support any actual or future harm; analysis of 
whether the research project is salvageable). Thereafter, the 
Institution will submit FCOI reports annually, as specified elsewhere in 
this subpart. Depending on the nature of the financial conflict of 
interest, an Institution may determine that additional interim measures 
are necessary with regard to the Investigator's participation in the 
PHS-funded research project between the date that the financial conflict 
of interest or the Investigator's noncompliance is determined and the 
completion of the Institution's retrospective review.
    (4) Whenever an Institution implements a management plan pursuant to 
this subpart, the Institution shall monitor Investigator compliance with 
the management plan on an ongoing basis until the completion of the PHS-
funded research project.
    (5)(i) Prior to the Institution's expenditure of any funds under a 
PHS-funded research project, the Institution shall ensure public 
accessibility, via a publicly accessible Web site or written response to 
any requestor within five business days of a request, of information 
concerning any significant financial interest disclosed to the 
Institution that meets the following three criteria:
    (A) The significant financial interest was disclosed and is still 
held by the senior/key personnel as defined by this subpart;
    (B) The Institution determines that the significant financial 
interest is related to the PHS-funded research; and
    (C) The Institution determines that the significant financial 
interest is a financial conflict of interest.
    (ii) The information that the Institution makes available via a 
publicly accessible Web site or written response to any requestor within 
five business days of a request, shall include, at a minimum, the 
following: the Investigator's name; the Investigator's title and role 
with respect to the research project; the name of the entity in which 
the significant financial interest is held; the nature of the 
significant financial interest; and the approximate dollar value of the 
significant financial interest (dollar ranges are permissible: $0-
$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 
by increments of $20,000; amounts above $100,000 by increments of 
$50,000), or a statement that the interest is one whose value cannot be 
readily determined through reference to public prices or other 
reasonable measures of fair market value.
    (iii) If the Institution uses a publicly accessible Web site for the 
purposes of this subsection, the information that the Institution posts 
shall be updated at least annually. In addition, the Institution shall 
update the Web site within sixty days of the Institution's receipt or 
identification of information concerning any additional significant 
financial interest of the senior/key personnel for the PHS-funded 
research project that was not previously disclosed, or upon the 
disclosure of a significant financial interest of senior/key personnel 
new to the PHS-funded research project, if the Institution determines 
that the significant financial interest is related to the PHS-funded 
research and is a financial conflict of interest. The Web site shall 
note that the information provided is current as of the date listed and 
is subject to updates, on at least an annual basis and within 60 days of 
the Institution's identification of a new financial conflict of 
interest. If the Institution responds to written requests for the 
purposes of this subsection, the Institution will note in its written 
response that the information provided is current as of the date of the 
correspondence and is subject to updates, on at least an annual basis 
and within 60 days of the Institution's identification of a new 
financial conflict of interest, which should be requested subsequently 
by the requestor.
    (iv) Information concerning the significant financial interests of 
an individual subject to paragraph (a)(5) of this section shall remain 
available, for responses to written requests or for posting via the 
Institution's publicly

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accessible Web site for at least three years from the date that the 
information was most recently updated.
    (6) In addition to the types of financial conflicts of interest as 
defined in this subpart that must be managed pursuant to this section, 
an Institution may require the management of other financial conflicts 
of interest in its policy on financial conflicts of interest, as the 
Institution deems appropriate.
    (b) Reporting of financial conflicts of interest.
    (1) Prior to the Institution's expenditure of any funds under a PHS-
funded research project, the Institution shall provide to the PHS 
Awarding Component an FCOI report regarding any Investigator's 
significant financial interest found by the Institution to be 
conflicting and ensure that the Institution has implemented a management 
plan in accordance with this subpart. In cases in which the Institution 
identifies a financial conflict of interest and eliminates it prior to 
the expenditure of PHS-awarded funds, the Institution shall not submit 
an FCOI report to the PHS Awarding Component.
    (2) For any significant financial interest that the Institution 
identifies as conflicting subsequent to the Institution's initial FCOI 
report during an ongoing PHS-funded research project (e.g., upon the 
participation of an Investigator who is new to the research project), 
the Institution shall provide to the PHS Awarding Component, within 
sixty days, an FCOI report regarding the financial conflict of interest 
and ensure that the Institution has implemented a management plan in 
accordance with this subpart. Pursuant to paragraph (a)(3)(ii) of this 
section, where such FCOI report involves a significant financial 
interest that was not disclosed timely by an Investigator or, for 
whatever reason, was not previously reviewed or managed by the 
Institution (e.g., was not timely reviewed or reported by a 
subrecipient), the Institution also is required to complete a 
retrospective review to determine whether any PHS-funded research, or 
portion thereof, conducted prior to the identification and management of 
the financial conflict of interest was biased in the design, conduct, or 
reporting of such research. Additionally, pursuant to paragraph 
(a)(3)(iii) of this section, if bias is found, the Institution is 
required to notify the PHS Awarding Component promptly and submit a 
mitigation report to the PHS Awarding Component.
    (3) Any FCOI report required under paragraphs (b)(1) or (b)(2) of 
this section shall include sufficient information to enable the PHS 
Awarding Component to understand the nature and extent of the financial 
conflict, and to assess the appropriateness of the Institution's 
management plan. Elements of the FCOI report shall include, but are not 
necessarily limited to the following:
    (i) Project number;
    (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used;
    (iii) Name of the Investigator with the financial conflict of 
interest;
    (iv) Name of the entity with which the Investigator has a financial 
conflict of interest;
    (v) Nature of the financial interest (e.g., equity, consulting fee, 
travel reimbursement, honorarium);
    (vi) Value of the financial interest (dollar ranges are permissible: 
$0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-
$100,000 by increments of $20,000; amounts above $100,000 by increments 
of $50,000), or a statement that the interest is one whose value cannot 
be readily determined through reference to public prices or other 
reasonable measures of fair market value;
    (vii) A description of how the financial interest relates to the 
PHS-funded research and the basis for the Institution's determination 
that the financial interest conflicts with such research; and
    (viii) A description of the key elements of the Institution's 
management plan, including:
    (A) Role and principal duties of the conflicted Investigator in the 
research project;
    (B) Conditions of the management plan;
    (C) How the management plan is designed to safeguard objectivity in 
the research project;
    (D) Confirmation of the Investigator's agreement to the management 
plan;

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    (E) How the management plan will be monitored to ensure Investigator 
compliance; and
    (F) Other information as needed.
    (4) For any financial conflict of interest previously reported by 
the Institution with regard to an ongoing PHS-funded research project, 
the Institution shall provide to the PHS Awarding Component an annual 
FCOI report that addresses the status of the financial conflict of 
interest and any changes to the management plan for the duration of the 
PHS-funded research project. The annual FCOI report shall specify 
whether the financial conflict is still being managed or explain why the 
financial conflict of interest no longer exists. The Institution shall 
provide annual FCOI reports to the PHS Awarding Component for the 
duration of the project period (including extensions with or without 
funds) in the time and manner specified by the PHS Awarding Component.
    (5) In addition to the types of financial conflicts of interest as 
defined in this subpart that must be reported pursuant to this section, 
an Institution may require the reporting of other financial conflicts of 
interest in its policy on financial conflicts of interest, as the 
Institution deems appropriate.



Sec.  50.606  Remedies.

    (a) If the failure of an Investigator to comply with an 
Institution's financial conflicts of interest policy or a financial 
conflict of interest management plan appears to have biased the design, 
conduct, or reporting of the PHS-funded research, the Institution shall 
promptly notify the PHS Awarding Component of the corrective action 
taken or to be taken. The PHS Awarding Component will consider the 
situation and, as necessary, take appropriate action, or refer the 
matter to the Institution for further action, which may include 
directions to the Institution on how to maintain appropriate objectivity 
in the PHS-funded research project. PHS may, for example, require 
Institutions employing such an Investigator to enforce any applicable 
corrective actions prior to a PHS award or when the transfer of a PHS 
grant(s) involves such an Investigator.
    (b) The PHS Awarding Component and/or HHS may inquire at any time 
before, during, or after award into any Investigator disclosure of 
financial interests and the Institution's review (including any 
retrospective review) of, and response to, such disclosure, regardless 
of whether the disclosure resulted in the Institution's determination of 
a financial conflict of interest. An Institution is required to submit, 
or permit on site review of, all records pertinent to compliance with 
this subpart. To the extent permitted by law, HHS will maintain the 
confidentiality of all records of financial interests. On the basis of 
its review of records or other information that may be available, the 
PHS Awarding Component may decide that a particular financial conflict 
of interest will bias the objectivity of the PHS-funded research to such 
an extent that further corrective action is needed or that the 
Institution has not managed the financial conflict of interest in 
accordance with this subpart. The PHS Awarding Component may determine 
that imposition of specific award conditions under 45 CFR 75.207, or 
suspension of funding or other enforcement action under 45 CFR 75.371, 
is necessary until the matter is resolved.
    (c) In any case in which the HHS determines that a PHS-funded 
project of clinical research whose purpose is to evaluate the safety or 
effectiveness of a drug, medical device, or treatment has been designed, 
conducted, or reported by an Investigator with a financial conflict of 
interest that was not managed or reported by the Institution as required 
by this subpart, the Institution shall require the Investigator involved 
to disclose the financial conflict of interest in each public 
presentation of the results of the research and to request an addendum 
to previously published presentations.

[76 FR 53283, August 25, 2011, as amended at 81 FR 3006, Jan. 20, 2016]



Sec.  50.607  Other HHS regulations that apply.

    Several other regulations and policies apply to this subpart. They 
include, but are not necessarily limited to:


[[Page 262]]


2 CFR part 376--Nonprocurement debarment and suspension (HHS)
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
          and Audit Requirements for HHS Awards
45 CFR part 79--Program fraud civil remedies

[76 FR 53283, August 25, 2011, as amended at 81 FR 3006, Jan. 20, 2016]



PART 51_REQUIREMENTS APPLICABLE TO THE PROTECTION AND ADVOCACY FOR INDIVIDUALS 
WITH MENTAL ILLNESS PROGRAM--Table of Contents



Sec.
51.1 Scope.
51.2 Definitions.

                      Subpart A_Basic Requirements

51.3 Formula for determining allotments.
51.4 Grants administration requirements.
51.5 Eligibility for allotment.
51.6 Use of allotments.
51.7 Eligibility for protection and advocacy services.
51.8 Annual reports.
51.9 [Reserved]
51.10 Remedial actions.
51.11-51.20 [Reserved]

             Subpart B_Program Administration and Priorities

51.21 Contracts for program operations.
51.22 Governing authority.
51.23 Advisory council.
51.24 Program priorities.
51.25 Grievance procedure.
51.26 Conflicts of interest.
51.27 Training.
51.28-51.30 [Reserved]

               Subpart C_Protection and Advocacy Services

51.31 Conduct of protection and advocacy activities.
51.32 Resolving disputes.
51.33-51.40 [Reserved]

         Subpart D_Access to Records, Facilities and Individuals

51.41 Access to records.
51.42 Access to facilities and residents.
51.43 Denial of delay or access.
51.44 [Reserved]
51.45 Confidentiality of protection and advocacy system records.
51.46 Disclosing information obtained from a provider of mental health 
          services.

    Authority: 42 U.S.C. 10801, et seq.

    Source: 62 FR 53564, Oct. 15, 1997, unless otherwise noted.



Sec.  51.1  Scope.

    The provisions of this part apply to recipients of Federal 
assistance under the Protection and Advocacy for Mentally Ill 
Individuals Act of 1986, as amended.



Sec.  51.2  Definitions.

    In addition to the definitions in section 102 of the Act, as 
amended, the following definitions apply:
    Abuse means any act or failure to act by an employee of a facility 
rendering care or treatment which was performed, or which was failed to 
be performed, knowingly, recklessly, or intentionally, and which caused, 
or may have caused, injury or death to an individual with mental 
illness, and includes but is not limited to acts such as: rape or sexual 
assault; striking; the use of excessive force when placing an individual 
with mental illness in bodily restrains; the use of bodily or chemical 
restraints which is not in compliance with Federal and State laws and 
regulations; verbal, nonverbal, mental and emotional harassment; and any 
other practice which is likely to cause immediate physical or 
psychological harm or result in long-term harm if such practices 
continue.
    Act means the Protection and Advocacy for Mentally Ill Individuals 
Act of 1986, as amended, also referred to as Protection and Advocacy for 
Individuals with Mental Illness Act.
    ADD means the Administration on Developmental Disabilities within 
the Administration for Children and Families, Department of Health and 
Human Services.
    Care or Treatment means services provided to prevent, identify, 
reduce or stabilize mental illness or emotional impairment such as 
mental health screening, evaluation, counseling, biomedical, behavioral 
and psychotherapies, supportive or other

[[Page 263]]

adjunctive therapies, medication supervision, special education and 
rehabilitation, even if only ``as needed'' or under a contractual 
arrangement.
    Center or CMHS means the Center for Mental Health Services, a 
component of the Substance Abuse and Mental Health Services 
Administration.
    Complaint includes, but is not limited to any report or 
communication, whether formal or informal, written or oral, received by 
the P&A system, including media accounts, newspaper articles, telephone 
calls (including anonymous calls) from any source alleging abuse or 
neglect of an individual with mental illness.
    Department or HHS means the U.S. Department of Health and Human 
Services.
    Designated Official is the State official or public or private 
entity empowered by the Governor or State legislature to be accountable 
for the proper use of funds by the P&A system.
    Director means the Director of the Center for Mental Health 
Services, Substance Abuse and Mental Health Services Administration, or 
his or her designee.
    Facility includes any public or private residential setting that 
provides overnight care accompanied by treatment services. Facilities 
include, but are not limited to the following: general and psychiatric 
hospitals, nursing homes, board and care homes, community housing, 
juvenile detention facilities, homeless shelters, and jails and prisons, 
including all general areas as well as special mental health or forensic 
units.
    Fiscal Year or FY means the Federal fiscal year (October 1-September 
30) unless otherwise specified.
    Full Investigation is based upon a complaint or a determination of 
probable cause and means the access to facilities, clients and records 
authorized under this part that is necessary for a P&A system to make a 
determination about whether an allegation of abuse or neglect is taking 
place or has taken place. Full investigations may be conducted 
independently or in cooperation with other agencies authorized to 
conduct similar investigations.
    Governor means the chief executive officer of the State, Territory 
or the District of Columbia, or his or her designee, who has been 
formally designated to act for the Governor in carrying out the 
requirements of the Act and this part.
    Individual with Mental Illness means an individual who has a 
significant mental illness or emotional impairment, as determined by a 
mental health professional qualified under the laws and regulations of 
the State and
    (1) Who is an inpatient or resident in a facility rendering care or 
treatment, even if the whereabouts of such impatient or resident is 
unknown;
    (2) Who is in the process of being admitted to a facility rendering 
care or treatment, including persons being transported to such a 
facility, or
    (3) Who is involuntarily confined in a detention facility, jail or 
prison.
    Legal Guardian, Conservator, and Legal Representative all mean an 
individual whose appointment is made and regularly reviewed by a State 
court or agency empowered under State law to appoint and review such 
officers, and having authority to consent to health/mental health care 
or treatment of an individual with mental illness. It does not include 
persons acting only as a representative payee, persons acting only to 
handle financial payments, attorneys or persons acting on behalf of an 
individual with mental illness only in individual legal matters, or 
officials responsible for the provision of health or mental health 
services to an individual with mental illness, or their designees.
    Neglect means a negligent act or omission by an individual 
responsible for providing services in a facility rendering care or 
treatment which caused or may have caused injury or death to an 
individual with mental illness or which placed an individual with mental 
illness at risk of injury or death, and includes, but is not limited to, 
acts or omissions such as failure to: establish or carry out an 
appropriate individual program or treatment plan (including a discharge 
plan); provide adequate nutrition, clothing, or health care; and the 
failure to provide a safe environment which also includes failure to 
maintain adequate numbers of appropriately trained staff.

[[Page 264]]

    Private Entity means a nonprofit or for-profit corporation, 
partnership or other nongovernmental organization.
    Probable cause means reasonable grounds for belief that an 
individual with mental illness has been, or may be at significant risk 
of being subject to abuse or neglect. The individual making such 
determination may base the decision on reasonable inferences drawn from 
his or her experience or training regarding similar incidents, 
conditions or problems that are usually associated with abuse or 
neglect.
    Program means activities carried out by the P&A system and operating 
as part of a P&A system to meet the requirements of the Act.
    Public Entity means an organizational unit of a State or local 
government or a quasi-governmental entity with one or more governmental 
powers.
    System means the organization or agency designated in a State to 
administer and operate a protection and advocacy program under Part C of 
the Developmental Disabilities Assistance and Bill of Rights Act (42 
U.S.C. 6041, 6042) and thereby eligible to administer a program for 
individuals with mental illness.



                      Subpart A_Basic Requirements



Sec.  51.3  Formula for determining allotments.

    The Secretary shall make allotments to eligible Systems from amounts 
apportioned each year under the Act on the basis of a formula prescribed 
by the Secretary in accordance with the requirements of sections 112 and 
113 of the Act (42 U.S.C. 10822 and 10823).



Sec.  51.4  Grants administration requirements.

    The following parts of titles 42 and 45 CFR apply to grants funded 
under this part.

42 CFR Part 50, Subpart D.
45 CFR Part 16--Procedures of the Departmental Grant Appeal Board.
45 CFR Part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.
45 CFR Part 76--Government-wide Debarment and Suspension 
(Nonprocurement) and Government-wide Requirements for Drug-Free 
Workplace.
45 CFR Part 80--Nondiscrimination under Programs Receiving Federal 
Assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964.
45 CFR Part 81--Practice and Procedure for Hearings under Part 80 of 
This Title.
45 CFR Part 84--Nondiscrimination on the Basis of Handicap in Programs 
and Activities Receiving or Benefiting from Federal Financial 
Assistance.
45 CFR Part 86--Nondiscrimination on the Basis of Sex in Education 
Programs and Activities Receiving Federal Financial Assistance.
45 CFR Part 91--Nondiscrimination on the Basis of Age in Education 
Programs and Activities Receiving Federal Financial Assistance from HHS.
45 CFR Part 93--New Restrictions on Lobbying.
45 CFR Part 1386, subpart A.

[62 FR 53564, Oct. 15, 1997, as amended at 81 FR 3006, Jan. 20, 2016]



Sec.  51.5  Eligibility for allotment.

    (a) Federal financial assistance for protection and advocacy 
activities for individuals with mental illness will be given only to a 
System that has been established under Part C of the Developmental 
Disabilities Assistance and Bill of Rights Act (42 U.S.C. 6041, et seq.) 
and designated in accordance with 45 CFR part 1386, subpart B.
    (b) The P&A system must meet the requirements of sections 105 and 
111 of the Act (42 U.S.C. 10805 and 10821) and that P&A system must be 
operational. Each system shall submit an application at the beginning of 
each PAIMI authorization period. This application shall contain at a 
minimum the program priorities and budget for the first year of the 
authorization period and the required assurances and certifications. 
Thereafter, the system shall submit yearly updates of the budget and 
program priorities for the upcoming fiscal year through its annual 
report.
    (c) Written assurances of compliance with sections 105 and 111 of 
the Act (42 U.S.C. 10805 and 10821) and other requirements of the Act 
and this part shall be submitted by the P&A system in the format 
designated by the Director. These assurances will remain in effect for 
the period specified in the application for funds unless changes occur 
within the State which affect the

[[Page 265]]

functioning of the P&A system, in which case an amendment will be 
required 30 days prior to the effective date of the change. The P&A 
system shall also provide the Department the name of the designated 
official.
    (d) The Governor's written assurance that the allotments made 
available under the Act will be used to supplement and not to supplant 
the level of non-Federal funds available in the State to protect and 
advocate the rights of individuals with mental illness shall be 
submitted by the P&A system. The Governor may provide this assurance 
along with the assurances provided to ADD under 45 CFR part 1386, as 
long as it can reasonably be construed as applying to the PAIMI program. 
Any future ``supplement and not supplant'' assurance shall explicitly 
refer to the PAIMI program.



Sec.  51.6  Use of allotments.

    (a) Allotments must be used to supplement and not to supplant the 
level of non-Federal funds available in the State to protect and 
advocate the rights of individuals with mental illness.
    (b) Allotments may not be used to support lobbying activities to 
influence proposed or pending Federal legislation or appropriations. 
This restriction does not affect the right of any P&A system, 
organization or individual to petition Congress or any other government 
body or official using other resources.
    (c) Allotments may not be used to produce or distribute written, 
audio or visual materials or publicity intended or designed to support 
or defeat any candidate for public office.
    (d) If an eligible P&A system is a public entity, that P&A system 
shall not be required by the State to obligate more than five percent of 
its annual allotment for State oversight administrative expenses under 
this grant such as costs of internal or external evaluations, monitoring 
or auditing. This restriction does not include:
    (1) Salaries, wages and benefits of program staff;
    (2) Costs associated with attending governing board or advisory 
council meetings; or
    (3) Expenses associated with the provision of training or technical 
assistance for staff, contractors, members of the governing board or 
advisory council.
    (e) No more than ten percent of each annual allotment may be used 
for providing technical assistance and training, including travel 
expenses for staff, contractors, or members of the governing board or 
advisory council as defined in Sec.  51.27.
    (f) Allotments may be used to pay the otherwise allowable costs 
incurred by a P&A system in bringing lawsuits in its own right to 
redress incidents of abuse or neglect, discrimination, and other rights 
violations impacting on individuals with mental illness and when it 
appears on behalf of named plaintiffs or a class of plaintiffs for such 
purposes.



Sec.  51.7  Eligibility for protection and advocacy services.

    In accordance with section 105(a)(1)(C) of the Act (42 U.S.C. 
10805(a)(1)(C)) and the priorities established by the P&A system 
governing authority, together with the advisory council, pursuant to 
section 105(c)(2)(B) of the Act (42 U.S.C. 10805(c)(2)(B)), allotments 
may be used:
    (a) To provide protection and advocacy services for:
    (1) Individuals with mental illness as defined in 42 U.S.C. 10802(4) 
and 10805(a), including persons who report matters which occurred while 
they were individuals with mental illness;
    (2) Persons who were individuals with mental illness who are 
residents of the State, but only with respect to matters which occur 
within 90 days after the date of the discharge of such individuals from 
a facility providing care or treatment; and
    (3) Individuals with mental illness in Federal facilities rendering 
care or treatment who request representation by the eligible P&A system. 
Representation may be requested by an individual with mental illness, or 
by a legal guardian, conservator or legal representative.
    (b) To provide representation of clients in civil commitment 
proceedings if the P&A system is acting on behalf of an eligible 
individual to obtain judicial review of his or her commitment

[[Page 266]]

in order to appeal or otherwise challenge acts or omissions which have 
subjected the individual to abuse or neglect or otherwise violated his 
or her rights. This restriction does not prevent a P&A system from 
representing clients in commitment or recommitment proceedings using 
other resources so long as this representation does not conflict with 
responsibilities under the Act.



Sec.  51.8  Annual reports.

    By January 1 of each year, a report shall be submitted, pursuant to 
section 105(a)(7) of the Act (42 U.S.C. 10805(a)(7)), to the Secretary 
which is in the format designated by the Secretary.

[62 FR 53564, Oct. 15, 1997]



Sec.  51.9  [Reserved]



Sec.  51.10  Remedial actions.

    Failure to submit an annual report in the designated format on time 
or to submit requested information and documentation, corrective action 
plans and ongoing implementation status reports in response to Federal 
review and monitoring activities or to satisfy any other requirement of 
the Act, this part, or other requirements, may be considered a breach of 
the terms and conditions of the grant award and may required remedial 
action, such as the suspension or termination of an active grant, 
withholding of payments or converting to a reimbursement method of 
payment. Any remedial actions shall be taken consistent with 45 CFR Part 
75 and 42 CFR Part 50, as appropriate.

[62 FR 53564, Oct. 15, 1997, as amended at 81 FR 3007, Jan. 20, 2016]



Sec. Sec.  51.11-51.20  [Reserved]



             Subpart B_Program Administration and Priorities



Sec.  51.21  Contracts for program operations.

    (a) An eligible P&A system should work cooperatively with existing 
advocacy agencies and groups and, where appropriate, consider entering 
into contracts for protection and advocacy services with organizations 
already working on behalf of individuals with metal illness. Special 
consideration should be given to contracting for the services of groups 
run by individuals who have received or are receiving mental health 
services or by family members of such individuals.
    (b) An eligible P&A system may contract for the operation of all or 
part of its program with another public or private nonprofit 
organization with demonstrated experience in working with individuals 
with mental illness provided that:
    (1) Any organization that will operate the full program meets the 
requirements of section 104(a)(1), 105 and 111 of the Act (42 U.S.C. 
10804(a)(1), 10805 and 10821) and has the capacity to perform protection 
and advocacy activities throughout the State;
    (2) The eligible P&A system institutes oversight and monitoring 
procedures which ensure that this system will be able to meet all 
applicable terms, conditions and obligations of the Federal grant;
    (3) The eligible P&A system and the contractor organization enter 
into a written agreement that includes at least the following:
    (i) A description of the protection and advocacy services to be 
provided;
    (ii) The type of personnel, their qualifications and training;
    (iii) The methods to be used;
    (iv) A timetable for performance;
    (v) A budget;
    (vi) Assurances that the contractor will meet all applicable terms 
and conditions of the grant;
    (vii) Assurances that the contractor has adequate management and 
fiscal systems in place, including insurance coverage, if appropriate:
    (viii) Assurances that the contractor's staff is trained to provide 
advocacy services to and conduct full investigations on behalf of 
individuals with mental illness; and
    (ix) Assurances that the contractor staff is trained to work with 
family members of clients served by the P&A system where the clients 
are:
    (A) Minors;
    (B) Legally competent and choose to involve the family member; or,
    (C) Legally incompetent and the legal guardians, conservators or 
other

[[Page 267]]

legal representatives are family members.



Sec.  51.22  Governing authority.

    (a) Each P&A system shall have a governing authority responsible for 
its planning, designing, implementing and functioning. It shall, jointly 
with the advisory council, annually establish program priorities and 
policies.
    (b) If the P&A system is organized with a multi-member governing 
board:
    (1) Each P&A system shall establish policies and procedures for the 
selection of its governing board members and for the board evaluation of 
the P&A system director. The terms of board members shall be staggered 
and for 4 years except that any member appointed to fill a vacancy for 
an unexpired term shall serve for the remainder of such term. A member 
who has been appointed for a term of 4 years may not be reappointed to 
the governing board during the 2-year period beginning on the date on 
which such 4-year term expired.
    (2) The board shall be composed of members who broadly represent or 
are knowledgeable about the needs of the clients served by the P&A 
system and shall include a significant representation of individuals 
with mental illness who are, or have been eligible for services, or have 
received or are receiving mental health services, and family members, 
guardians, advocates, or authorized representatives of such individuals.
    (3) If the governing authority is organized as a private nonprofit 
entity, the chairperson of the advisory council shall be a member of the 
governing board.
    (c) Continuing efforts shall be made to include members of racial 
and ethnic minority groups as board members.
    (d) Any member of the advisory council may also serve on the 
governing board.



Sec.  51.23  Advisory council.

    (a) Each P&A system shall establish an advisory council to:
    (1) Provide independent advice and recommendations to the system.
    (2) Work jointly with the governing authority in the development of 
policies and priorities.
    (3) Submit a section of the system's annual report as required under 
Sec.  51.8.
    (b) Members of the council shall include attorneys, mental health 
professionals, individuals from the public who are knowledgeable about 
mental illness, the advocacy needs of persons with mental illness and 
have demonstrated a substantial commitment to improving mental health 
services, a provider of mental health services, individuals who have 
received or are receiving mental health services and family members of 
such individuals. Continuing efforts shall be made to include members of 
racial and ethnic minority groups on the advisory council.
    (1) At least 60 percent of the membership of the advisory council 
shall be comprised of individuals who have received or are receiving 
mental health services or who are family members of such individuals. At 
least one family member shall be a primary care giver for an individual 
who is currently a minor child or youth who is receiving or has received 
mental health services;
    (2) The council shall be chaired by an individual who has received 
or is receiving mental health services or who is a family member of such 
an individual;
    (3) The advisory council shall meet no less than three times 
annually. The terms of council members shall be staggered and for 4 
years except that any member appointed to fill a vacancy for an 
unexpired term shall serve for the remainder of such term. A member who 
has been appointed for a term of 4 years may not be reappointed to the 
council during the 2-year period beginning on the date on which such 4-
year term expired.
    (c) Each P&A system shall provide its advisory council with reports, 
materials and fiscal data to enable review of existing program policies, 
priorities and performance outcomes. Such submissions shall be made at 
least annually and shall report expenditures for the past two fiscal 
years, as well as projected expenses for the next fiscal year, 
identified by budget category (e.g., salary and wages, contract for 
services, administrative expenses) including the amount allotted for 
training of each the advisory council, governing board and staff.

[[Page 268]]

    (d) Reimbursement of expenses. (1) Allotments may be used to pay for 
all or a part of the expenses incurred by members of the advisory 
council in order to participate in its activities. Expenses may include 
transportation costs, parking, meals, hotel costs, per diem expenses, 
stipends or subsistence allowances, and the cost of day care or child 
care (or its equivalent for the child's travel and subsistence expenses) 
for their dependents with mental illness or developmental disabilities.
    (2) Each P&A system shall establish its own policies and procedures 
for reimbursement of expenses of council members, taking into account 
the needs of individual council members, available resources, and 
applicable restrictions on use of grant funds, including the 
restrictions in Sec. Sec.  51.31(e) and 51.6(e).

[62 FR 53564, Oct. 15, 1997]



Sec.  51.24  Program priorities.

    (a) Program priorities and policies shall be established annually by 
the governing authority, jointly with the advisory council. Priorities 
shall specify short-term program goals and objectives, with measurable 
outcomes, to implement the established priorities. In developing 
priorities, consideration shall be given to, at a minimum, case 
selection criteria, the availability of staff and monetary resources, 
and special problems and cultural barriers faced by individuals with 
mental illness who are multiply handicapped or who are members of racial 
or ethnic minorities in obtaining protection of their rights. Systemic 
and legislative activities shall also be addressed in the development 
and implementation of program priorities.
    (b) Members of the public shall be given an opportunity, on an 
annual basis, to comment on the priorities established by, and the 
activities of, the P&A system. Procedures for public comment must 
provide for notice in a format accessible to individuals with mental 
illness, including such individuals who are in residential facilities, 
to family members and representatives of such individuals and to other 
individuals with disabilities. Procedures for public comment must 
provide for receipt of comments in writing or in person.



Sec.  51.25  Grievance procedure.

    (a) The P&A system shall establish procedures to address grievances 
from:
    (1) Clients or prospective clients of the P&A system to assure that 
individuals with mental illness have full access to the services of the 
program; and
    (2) Individuals who have received or are receiving mental health 
services in the State, family members of such individuals, or 
representatives of such individuals or family members to assure that the 
eligible P&A system is operating in compliance with the Act.
    (b) At a minimum, the grievance procedures shall provide for:
    (1) An appeal to the governing authority from any final staff review 
and/or determination; in cases where the governing authority is the 
director of the P&A system, the final review and/or determination shall 
be made by a superior of the governing authority, e.g., a supervisor, or 
by an independent entity, e.g., an appointed board or committee.
    (2) Reports, at least annually, to the governing authority and the 
advisory council describing the grievances received and processed and 
their resolution;
    (3) Identification of individuals responsible for review;
    (4) A timetable to ensure prompt notification concerning the 
grievance procedure to clients, prospective clients or persons denied 
representation, and to ensure prompt resolution;
    (5) A written response to the grievant; and
    (6) Protection of client confidentiality.

[62 FR 53564, Oct. 15, 1997]



Sec.  51.26  Conflicts of interest.

    The P&A system must develop appropriate policies and procedures to 
avoid actual or apparent conflict of interest involving clients, 
employees, contractors and subcontractors, and members of the governing 
authority and advisory council, particularly with respect to matters 
affecting client services, particular contracts and subcontracts,

[[Page 269]]

grievance review procedures, reimbursements and expenses, and the 
employment or termination of staff.



Sec.  51.27  Training.

    A P&A system shall provide training for program staff, and may also 
provide training for contractors, governing board and advisory council 
members to enhance the development and implementation of effective 
protection and advocacy services for individuals with mental illness, 
including at a minimum:
    (a)(1) Training of program staff to work with family members of 
clients served by the program where the individual with mental illness 
is:
    (i) A minor,
    (ii) Legally competent and chooses to involve the family member; or
    (iii) Legally incompetent and the legal guardian, conservator or 
other legal representative is a family member.
    (2) This training may be provided by individuals who have received 
or are receiving mental health services and family members of such 
individuals.
    (b) Training to enhance sensitivity to and understanding of 
individuals with mental illness who are members of racial or ethnic 
minorities and to develop strategies for outreach to those populations.
    (c) Training to conduct full investigations of abuse or neglect.



Sec. Sec.  51.28-51.30  [Reserved]



               Subpart C_Protection and Advocacy Services



Sec.  51.31  Conduct of protection and advocacy activities.

    (a) Consistent with State and Federal law and the canons of 
professional ethics, a P&A system may use any appropriate technique and 
pursue administrative, legal or other appropriate remedies to protect 
and advocate on behalf of individuals with mental illness to address 
abuse, neglect or other violations of rights.
    (b) A P&A system shall establish policies and procedures to guide 
and coordinate advocacy activities. The P&A system shall not implement a 
policy or practice restricting the remedies which may be sought on 
behalf of individuals with mental illness or compromising the authority 
of the P&A system to pursue such remedies through litigation, legal 
action or other forms of advocacy. However, this requirement does not 
prevent the P&A system from placing limitations on case or client 
acceptance criteria developed as part of the annual priorities. 
Prospective clients must be informed of any such limitations at the time 
they request service.
    (c) Wherever possible, the program should establish an ongoing 
presence in residential mental health care or treatment facilities, and 
relevant hospital units.
    (d) Program activities should be carried out in a manner which 
allows program staff to:
    (1) Interact regularly with those individuals who are current or 
potential recipients of protection and advocacy services;
    (2) Interact regularly with staff providing care or treatment;
    (3) Obtain information and review records; and
    (4) Communicate with family members, social and community service 
workers and others involved in providing care or treatment.
    (e) A P&A system may support or provide training, including related 
travel expenses, for individuals with mental illness, family members of 
such individuals, and other persons who are not program staff, 
contractors, or board or council members, to increase knowledge about 
protection and advocacy issues, to enhance leadership capabilities, or 
to promote Federal-State and intra-State cooperation on matter related 
to mental health system improvement. Decisions concerning the selection 
of individuals to receive such training shall be made in accordance with 
established policies, procedures and priorities of the P&A system.
    (f) A P&A system may monitor, evaluate and comment on the 
development and implementation of Federal, State and local laws, 
regulations, plans, budgets, levies, projects, policies and hearings 
affecting individuals with mental illness as a part of federally

[[Page 270]]

funded advocacy activities. A P&A system shall carry out systemic 
advocacy--those efforts to implement changes in policies and practices 
of systems that impact persons with mental illness.
    (g) Determination of ``probable cause'' may result from P&A system 
monitoring or other activities, including observation by P&A system 
personnel, and reviews of monitoring and other reports prepared by 
others whether pertaining to individuals with mental illness or to 
general conditions affecting their health or safety.
    (h) A P&A which is a public P&A system shall be free from hiring 
freezes, reductions in force, prohibitions on staff travel, or other 
policies imposed by the State to the extend that such policies would 
impact program staff or activities funded with Federal dollars and would 
prevent the P&A system from carrying out its mandates under the Act.
    (i) A P&A system may exercise its authority under State law where 
the authority exceeds the authority required by the Act. However, State 
law must not diminish the required authority of the Act.



Sec.  51.32  Resolving disputes.

    (a) Each P&A system is encouraged to develop and employ techniques 
such as those involving negotiation, conciliation and mediation to 
resolve disputes early in the protection and advocacy process.
    (b) Disputes should be resolved whenever possible through 
nonadversarial process involving negotiation, mediation and 
conciliation. Consistent with State and Federal laws and canons of 
professional responsibility, family members should be involved in this 
process, as appropriate, where the individual with mental illness is:
    (1) A minor,
    (2) Legally competent and chooses to involve the family member, or
    (3) Legally incompetent and the legal guardian, conservator or other 
legal representative is a family member or the legal guardian, 
conservator or other legal representative chose to involve the family 
member.
    (c) A P&A system must exhaust in a timely manner all administrative 
remedies, where appropriate, prior to initiating legal action in a 
Federal or State court.
    (d) Paragraph (c) of this section does not apply to any legal action 
instituted to prevent or eliminate imminent serious harm to an 
individual with mental illness nor does it apply in circumstances where 
administrative procedures do not exist. If in pursing administrative 
remedies, the P&A system determines that any matter with respect to an 
individual with mental illness with mental illness with not be resolved 
within a reasonable time, the P&A system may pursue alternative 
remedies, including initiating legal action.
    (e) A P&A system shall be held to the standard of exhaustion of 
remedies provided under State and Federal law. The Act imposes no 
additional burden respecting exhaustion of remedies.



Sec. Sec.  51.33-51.40  [Reserved]



         Subpart D_Access to Records, Facilities and Individuals



Sec.  51.41  Access to records.

    (a) Access to records shall be extended promptly to all authorized 
agents of a P&A system.
    (b) A P&A system shall have access to the records of any of the 
following individuals with mental illness:
    (1) An individual who is a client of the P&A system if authorized by 
that individual or the legal guardian, conservator or other legal 
representative.
    (2) An individual, including an individual who has died or whose 
whereabouts is unknown to whom all of the following conditions apply:
    (i) The individual, due to his or her mental or physical condition, 
is unable to authorize the P&A system to have access.
    (ii) The individual does not have a legal guardian, conservator or 
other legal representative, or the individual's guardian is the State or 
one of its political subdivisions; and
    (iii) A complaint or report has been received and the P&A system has 
determined that there is probable cause to believe that the individual 
has been or may be subject to abuse or neglect.

[[Page 271]]

    (3) An individual who has a legal guardian, conservator, or other 
legal representative, with respect to whom a complaint or report has 
been received by the P&A system and with respect to whom the P&A system 
has determined that there is probable cause to believe that the health 
or safety of the individual is in serious and immediate jeopardy, 
whenever all of the following conditions exists:
    (i) The P&A system has made a good faith effort to contact the 
representative upon prompt receipt of the representative's name and 
address;
    (ii) The P&A system has made a good faith effort to offer assistance 
to the representative to resolve the situation; and
    (iii) The representative has failed or refused to act on behalf of 
the individual.
    (c) Information and individual records, whether written or in 
another medium, draft or final, including handwritten notes, electronic 
files, photographs or video or audio tape records, which shall be 
available to the P&A system under the Act shall include, but not be 
limited to:
    (1) Information and individual records, obtained in the course of 
providing intake, assessment, evaluation, supportive and other services, 
including medical records, financial records, and reports prepared or 
received by a member of the staff of a facility or program rendering 
care or treatment. This includes records stored or maintained in 
locations other than the facility or program as long as the system has 
obtained appropriate consent consistent with section 105(a)(4) of the 
Act. The system shall request of facilities that in requesting records 
from service providers or other facilities on residents that they 
indicate in the release form the records may be subject to review by a 
system.
    (2) Reports prepared by an agency charged with investigating abuse 
neglect, or injury occurring at a facility rendering care or treatment, 
or by or for the facility itself, that describe any or all of the 
following:
    (i) Abuse, neglect, or injury occurring at the facility;
    (ii) The steps taken to investigate the incidents;
    (iii) Reports and records, including personnel records, prepared or 
maintained by the facility, in connection with such reports of 
incidents; or
    (iv) Supporting information that was relied upon in creating a 
report, including all information and records used or reviewed in 
preparing reports of abuse, neglect or injury such as records which 
describe persons who were interviewed, physical and documentary evidence 
that was reviewed, and the related investigative findings.
    (3) Discharge planning records.
    (4) Reports prepared by individuals and entities performing 
certification or licensure reviews, or by professional accreditation 
organizations, as well as related assessments prepared for the facility 
by its staff, contractors or related entities, except that nothing in 
this section is intended to preempt State law protecting records 
produced by medical care evaluation or peer review committees.
    (5) Professional, performance, building or other safety standards, 
demographic and statistical information relating to the facility.
    (d) A P&A system shall have reasonable access and authority to 
interview and examine all relevant records of any facility service 
recipient (consistent with the provisions of section 105(a)(4) of the 
Act) or employee.
    (e) A P&A system shall be permitted to inspect and copy records, 
subject to a reasonable charge to offset duplicating costs.



Sec.  51.42  Access to facilities and residents.

    (a) Access to facilities and residents shall be extended to all 
authorized agents of a P&A system.
    (b) A P&A system shall have reasonable unaccompanied access to 
public and private facilities and programs in the State which render 
care or treatment for individuals with mental illness, and to all areas 
of the facility which are used by residents or are accessible to 
residents. The P&A system shall have reasonable unaccompanied access to 
residents at all times necessary to conduct a full investigation of an 
incident of abuse or neglect. This authority shall include the 
opportunity

[[Page 272]]

to interview any facility service recipient, employee, or other persons, 
including the person thought to be the victim of such abuse, who might 
be reasonably believed by the system to have knowledge of the incident 
under investigation. Such access shall be afforded, upon request, by the 
P&A system when:
    (1) An incident is reported or a complaint is made to the P&A 
system;
    (2) The P&A system determines there is probable cause to believe 
that an incident has or may have occurred; or
    (3) The P&A system determines that there is or may be imminent 
danger of serious abuse or neglect of an individual with mental illness.
    (c) In addition to access as prescribed in paragraph (b) of this 
section, a P&A system shall have reasonable unaccompanied access to 
facilities including all area which are used by residents, are 
accessible to residents, and to programs and their residents at 
reasonable times, which at a minimum shall include normal working hours 
and visiting hours. Residents include adults or minors who have legal 
guardians or conservators. P&A activities shall be conducted so as to 
minimize interference with facility programs, respect residents' privacy 
interests, and honor a resident's request to terminate an interview. 
This access is for the purpose of:
    (1) Providing information and training on, and referral to programs 
addressing the needs of individuals with mental illness, and information 
and training about individual rights and the protection and advocacy 
services available from the P&A system, including the name, address, and 
telephone number of the P&A system.
    (2) Monitoring compliance with respect to the rights and safety of 
residents; and
    (3) Inspecting, viewing and photographing all areas of the facility 
which are used by residents or are accessible to residents.
    (d) Unaccompanied access to residents shall include the opportunity 
to meet and communicate privately with individuals regularly, both 
formally and informally, by telephone, mail and in person. Residents 
include minors or adults who have legal guardians or conservators.
    (e) The right of access specified in paragraph (c) of this section 
shall apply despite the existence of any State or local laws or 
regulations which restrict informal access to minors and adults with 
legal guardians or conservators. The system shall make very effort to 
ensure that the parents of minors or guardians of individuals in the 
care of a facility are informed that the system will be monitoring 
activities at the facility and may in the course of such monitoring have 
access to the minor or adult with a legal guardian. The system shall 
take no formal action on behalf of individuals with legal guardians or 
conservators, or initiate a formal attorney/client or advocate/client 
relationship without appropriate consent, except in emergency situations 
as described in Sec.  51.41(b)(3).
    (f) A P&A system providing representation to individuals with mental 
illness in Federal facilities shall have all the rights and authority 
accorded other representatives of residents of such facilities pursuant 
to State and Federal laws.



Sec.  51.43  Denial or delay of access.

    If a P&A system's access to facilities, programs, residents or 
records covered by the Act or this part is delayed or denied, the P&A 
system shall be provided promptly with a written statement of reasons, 
including, in the case of a denial for alleged lack of authorization, 
the name, address and telephone number of the legal guardian, 
conservator, or other legal representative of an individual with mental 
illness. Access to facilities, records or residents shall not be delayed 
or denied without the prompt provision of written statements of the 
reasons for the denial.



Sec.  51.44  [Reserved]



Sec.  51.45  Confidentiality of protection and advocacy system records.

    (a) Records maintained by the P&A system are the property of the P&A 
system which must protect them from loss, damage, tampering or use by 
unauthorized individuals. The P&A system must:

[[Page 273]]

    (1) Except as provided elsewhere in this section, keep confidential 
all records and information, including information contained in any 
automated electronic database pertaining to:
    (i) Clients to the same extent as is required under Federal or State 
laws for a provider of mental health services;
    (ii) Individuals who have been provided general information or 
technical assistance on a particular matter;
    (iii) Identity of individuals who report incidents of abuse or 
neglect or furnish information that forms the basis for a determination 
that probable cause exists; and
    (iv) Names of individuals who are residents and provide information 
for the record.
    (2) Have written policies governing access to, storage of, 
duplication and release of information from client records; and
    (3) Obtain written consent from the client, if competent, or from 
his or her legal representative, from individuals who have been provided 
general information or technical assistance on a particular matter and 
from individuals who furnish reports or information that forms the basis 
for a determination of probable cause, before releasing information to 
individuals not otherwise authorized to receive it.
    (b) Nothing in this subpart shall prevent the P&A system from. (1) 
Issuing a public report of the results of an investigation which 
maintains the confidentiality of the individuals listed in paragraph 
(a)(1) of this section or,
    (2) Reporting the results of an investigation which maintains the 
confidentiality of individual service recipients to responsible 
investigative or enforcement agencies should an investigation reveal 
information concerning the facility, its staff, or employees warranting 
possible sanctions or corrective action. this information may be 
reported to agencies responsible for facility licensing or 
accreditation, employee discipline, employee licensing or certification, 
or criminal prosecution.
    (c) For purposes of any periodic audit, report, or evaluation of the 
performance of the P&A system, the Secretary shall not require the P&A 
system to disclose the identity, or any other personally identifiable 
information, of any individual requesting assistance under a program. 
This requirement does not restrict access by the Department or other 
authorized Federal or State officials to client records or other records 
of the P&A system when deemed necessary for audit purposes and for 
monitoring P&A system compliance with applicable Federal or State laws 
and regulations. The purpose of obtaining such information is solely to 
determine that P&A systems are spending their grant funds awarded under 
the Act on serving individuals with mental illness. Officials that have 
access to such information must keep it confidential to the maximum 
extent permitted by law and regulations. If photostatic copies of 
materials are provided, then the destruction of such evidence is 
required once such reviews have been completed.
    (d) Subject to the restrictions and procedures set out in this 
section, implementing section 106 (a) and (b) of the Act (42 U.S.C. 
10806 (a) and (b)), this part does not limit access by a legal guardian, 
conservator, or other legal representative of an individual with mental 
illness, unless prohibited by State or Federal law, court order or the 
attorney-client privilege.



Sec.  51.46  Disclosing information obtained from a provider 
of mental health services.

    (a) Except as provided in paragraph (b) of this section, if a P&A 
system has access to records pursuant to section 105(a)(4) of the Act 
(42 U.S.C. 10805(a)(4)) which, under Federal or State law, are required 
to be maintained in a confidential manner by a provider of mental health 
services, it may not disclose information from such records to the 
individual who is the subject of the information if the mental health 
professional responsible for supervising the provision of mental health 
services to that individual has given the P&A system a written 
determination that disclosure of such information to the individual 
would be detrimental to the individual's health. The provider shall be 
responsible for giving any such written determination to the P&A system 
at the same time as

[[Page 274]]

access to the records containing the information is granted.
    (b)(1) If the disclosure of information has been denied under 
paragraph (a) of this section to an individual, the following 
individuals or the P&A system may select another mental health 
professional to review the information and to determine if disclosure of 
the information would be detrimental to the individual's health:
    (i) Such individual;
    (ii) The legal guardian, conservator or other legal representative 
of the individual; or
    (iii) An eligible P&A system, acting on behalf of an individual:
    (A) Whose legal guardian is the State; or
    (B) Whose legal guardian, conservator, or other legal representative 
has not, within a reasonable time after the denial of access to 
information under paragraph (a), selected a mental health professional 
to review the information.
    (2) If such mental health professional determines, based on 
professional judgment, that disclosure of the information would not be 
detrimental to the health of the individual, the P&A system may disclose 
such information to the individual.
    (c) The restriction in paragraph (b) of this section does not affect 
the P&A system's access to the records.



PART 51a_PROJECT GRANTS FOR MATERNAL AND CHILD HEALTH--Table of Contents



Sec.
51a.1 To which programs does this regulation apply?
51a.2 Definitions.
51a.3 Who is eligible to apply for Federal funding?
51a.4 How is application made for Federal funding?
51a.5 What criteria will DHHS use to decide which projects to fund?
51a.6 What confidentiality requirements must be met?
51a.7 What other DHHS regulations apply?
51a.8 What other conditions apply to these grants?

    Authority: Sec. 1102 of the Social Security Act, 49 Stat. 647 (42 
U.S.C. 1302); sec. 502(a), 502(b)(1)(A), and 506(a)(3) of the Social 
Security Act, 95 Stat. 819-20 (42 U.S.C. 702(a), 702(b)(1)(A) and 
706(a)(3)).

    Source: 51 FR 7727, Mar. 5, 1986, unless otherwise noted.



Sec.  51a.1  To which programs does this regulation apply?

    The regulation in this part applies to grants, contracts, and other 
arrangements under section 502(a) and 502(b)(1)(A) of the Social 
Security Act, as amended (42 U.S.C. 702(a) and 702(b)(1)(A)), the 
Maternal and Child Health (MCH) Federal Set-Aside project grant 
programs. Section 502(a) authorizes funding for special projects of 
regional and national significance (SPRANS), research and training 
projects with respect to maternal and child health and children with 
special health care needs (including early intervention training and 
services development); genetic disease testing, counseling and 
information programs; comprehensive hemophilia diagnostic and treatment 
centers; projects for screening and follow-up of newborns for sickle 
cell anemia and other genetic disorders; and special maternal and child 
health improvement projects. Section 502(b)(1)(A) authorizes funding for 
projects termed community integrated service system (CISS) projects for 
the development and expansion of: maternal and infant health home 
visiting; projects to increase the participation of obstetricians and 
pediatricians in title V and title XIX programs; integrated maternal and 
child health service systems; maternal and child health centers 
operating under the direction of not-for-profit hospitals; rural 
maternal and child health programs; and outpatient and community-based 
services programs for children with special health care needs.

[59 FR 36706, July 19, 1994]



Sec.  51a.2  Definitions.

    Act means the Social Security Act, as amended.
    Genetic diseases means inherited disorders caused by the 
transmission of certain aberrant genes from one generation to another.
    Hemophilia means a genetically transmitted bleeding disorder 
resulting from a deficiency of a plasma clotting factor.
    Institution of higher learning means any college or university 
accredited by

[[Page 275]]

a regionalized body or bodies approved for such purpose by the Secretary 
of Education, and any teaching hospital which has higher learning among 
its purposes and functions and which has a formal affiliation with an 
accredited school of medicine and a full-time academic medical staff 
holding faculty status in such school of medicine.
    Secretary means the Secretary of Health and Human Services or his or 
her designee.



Sec.  51a.3  Who is eligible to apply for Federal funding?

    (a) With the exception of training and research, as described in 
paragraph (b) of this section, any public or private entity, including 
an Indian tribe or tribal organization (as those terms are defined at 25 
U.S.C. 450b) is eligible to apply for federal funding under this Part.
    (b) Only public or nonprofit private institutions of higher learning 
may apply for training grants. Only public or nonprofit institutions of 
higher learning and public or private nonprofit agencies engaged in 
research or in programs relating to maternal and child health and/or 
services for children with special health care needs may apply for 
grants contracts or cooperative agreements for research in maternal and 
child health services or in services for children with special health 
care needs.

[59 FR 36706, July 19, 1994]



Sec.  51a.4  How is application made for Federal funding?

    An application for funding under the MCH Federal Set-Aside project 
grant programs must be submitted to the Secretary at such time and in 
such manner as the Secretary may prescribe. It must include a budget and 
narrative plan of the manner in which the project will meet each of the 
requirements prescribed by the Secretary. The plan must describe the 
project in sufficient detail to identify clearly the nature, need, and 
specific objectives of, and methodology for carrying out, the project.

(Approved by the Office of Management and Budget under control number 
0915-0050)

[59 FR 36706, July 19, 1994]



Sec.  51a.5  What criteria will DHHS use to decide which projects to fund?

    (a) The Secretary will determine the allocation of funds available 
under sections 502(a) and 502(b)(1)(A) of the Act for each of the 
activities described in Sec.  51a.1.
    (b) Within the limit of funds determined by the Secretary to be 
available for each of the activities described in Sec.  51a.1, the 
Secretary may award Federal funding for projects under this part to 
applicants which will, in his or her judgment, best promote the purpose 
of title V of the Social Security Act and address achievement of Healthy 
Children 2000 objectives, \1\ taking, the following factors into 
account:
---------------------------------------------------------------------------

    \1\ Healthy Children 2000: National Health Promotion and Disease 
Prevention Objectives Related to Mothers, Infants, Children, 
Adolescents, and Youth is a special compendium of health status goals 
and national health objectives affecting mothers, infants, children, 
adolescents, and youth originally published in Healthy People 2000 in 
September 1990. Potential applicants may obtain a copy of Healthy People 
2000 (Full Report: Stock No. 017-001-00474-0 or Healthy People 2000 
(Summary Report; Stock No. 017-001-00473-1) through the Superintendent 
of Documents, Government Printing Office Washington, DC 20402-9325, 
(telephone: 202 512-1800).
---------------------------------------------------------------------------

    (1) The extent to which the project will contribute to the 
advancement of maternal and child health and/or improvement of the 
health of children with special health care needs;
    (2) The extent to which the project is responsive to policy concerns 
applicable to MCH grants and to program objectives, requirements, 
priorities and/or review criteria for specific project categories, as 
published in program announcements or guidance materials.
    (3) The extent to which the estimated cost to the Government of the 
project is reasonable, considering the anticipated results;
    (4) The extent to which the project personnel are well qualified by 
training and/or experience for their roles in the project and the 
applicant organization has adequate facilities and personnel; and
    (5) The extent to which, insofar as practicable, the proposed 
activities, if well executed, are capable of attaining project 
objectives.

[[Page 276]]

    (c) For the following types of CISS projects, preference for funding 
will be given to qualified applicants in areas with a high infant 
mortality rate (relative to the latest average infant mortality rate in 
the United States or in the State in which the area is located):
    (1) Projects for the development and expansion of maternal and 
infant health home visiting;
    (2) Projects to increase the participation of obstetricians and 
pediatricians in title V and title XIX programs;
    (3) Integrated maternal and child health service systems;
    (4) Maternal and child health centers operating under the direction 
of not-for-profit hospitals;
    (5) Rural maternal and child health programs; and
    (6) Outpatient and community based services for children with 
special health care needs.

[59 FR 36706, July 19, 1994]



Sec.  51a.6  What confidentiality requirements must be met?

    All information as to personal facts and circumstances obtained by 
the project's staff about recipients of services shall be held 
confidential, and shall not be disclosed without the individual's 
consent except as may be otherwise required by applicable law or as may 
be necessary to provide for medical audits by the Secretary with 
appropriate safeguards for confidentiality of patient records. 
Otherwise, information may be disclosed only in summary, statistical, or 
other form which does not identify particular individuals.



Sec.  51a.7  What other DHHS regulations apply?

    (a) Several other DHHS regulations apply to awards under this part. 
These include, but are not limited to:

42 CFR part 50--Policies of general applicability:
    subpart B--Sterilization of persons in federally assisted family 
planning projects.
    subpart C--Abortions and related medical services in federally 
assisted programs of the Public Health Service.
    subpart E--Maximum allowable cost for drugs.

45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Service--
Effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under Part 80 of 
this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.
45 CFR part 93--New restrictions on lobbying.

    (b) In addition to the above regulations, the following apply to 
projects funded through grants:

42 CFR part 50--Policies of general applicability:
    subpart D--Public Health Service grant appeals procedure.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.

[59 FR 36707, July 19, 1994, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  51a.8  What other conditions apply to these grants?

    (a) Recipients of project grants will be required to submit such 
additional information to the Secretary on an annual basis as the 
Secretary determines, including:
    (1) the number of individuals served or trained, as appropriate 
under the project;
    (2) a copy of any evaluation conducted by the recipient; and
    (3) a list of Healthy Children 2000 objectives addressed by the 
project and data on how the project contributed toward meeting the 
objectives.
    (b) The Secretary may at the time of award of project grants under 
this Part impose additional conditions, including conditions governing 
the use of information or consent forms, when, in the Secretary's 
judgment, they are necessary to advance the approved program, the 
interest of public health, or the conservation of grant funds.

[[Page 277]]

    (c) Grant recipients of Healthy Tomorrows Partnership for Children 
Program, a Community Integrated Service System-funded initiative, must 
contribute non-Federal matching funds in years 2 through 5 of the 
project period equal to two times the amount of the Federal Grant Award 
or such lesser amount determined by the Secretary for good cause shown. 
Reimbursement for services provided to an individual under a State plan 
under Title XIX will not be deemed ``non-Federal matching funds'' for 
the purposes of this provision.

[59 FR 36707, July 19, 1994, as amended at 72 FR 3080, Jan. 24, 2007]



PART 51b_PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
51b.101 To which programs do these regulations apply?
51b.102 Definitions.
51b.103 What are the general application requirements?
51b.104 Can personnel, supplies, and related items be provided in lieu 
          of cash?
51b.105 Which other HHS regulations apply to these grants?
51b.106 What other conditions apply to these grants?
51b.107 Is participation in preventive health service programs required 
          by these regulations?

          Subpart B_Grants for Childhood Immunization Programs

51b.201 To which programs does this subpart apply?
51b.202 Definitions.
51b.203 Who is eligible for a grant under this subpart?
51b.204 What information is required in the application?
51b.205 How will grant applications be evaluated and the grants awarded?
51b.206 How can grant funds be used?

Subpart C [Reserved]

         Subpart D_Grants for Venereal Disease Control Programs

51b.401 To which programs does this subpart apply?
51b.402 Definitions.
51b.403 Who is eligible for a grant under this subpart?
51b.404 What are the confidentiality requirements?
51b.405 What information is required in the application?
51b.406 How will grant applications be evaluated and the grants awarded?
51b.407 How can grant funds be used?

Subpart E [Reserved]

 Subpart F_Grants for Research, Demonstrations, and Public Information 
    and Education for the Prevention and Control of Venereal Disease

51b.601 To which programs does this subpart apply?
51b.602 Who is eligible for a grant under this subpart?
51b.603 What are the confidentiality requirements?
51b.604 What information is required in the application?
51b.605 How will grant applications be evaluated and the grants awarded?
51b.606 How can grant funds be used?

    Authority: Secs. 317 and 318, Public Health Service Act, 92 Stat. 
3574 and 3582 (42 U.S.C. 247b, 247c); sec. 1743 Pub. L. 97-35, 95 Stat. 
763 (31 U.S.C. 1243 note).



                      Subpart A_General Provisions

    Source: 48 FR 4473, Feb. 1, 1983, unless otherwise noted.



Sec.  51b.101  To which programs do these regulations apply?

    The regulations in this part apply to grants for preventive health 
service programs authorized under section 317 (42 U.S.C. 247b) and for 
venereal disease prevention and control programs authorized under 
section 318 (42 U.S.C. 247c) of the Act.



Sec.  51b.102  Definitions.

    As used in these regulations:
    Act means the Public Health Service Act, as amended.
    Secretary means the Secretary of Health and Human Services (HHS) or 
any other officer or employee of that Department to whom the authority 
involved has been delegated.
    State means one of the 50 States, the District of Columbia, Guam, 
the Commonwealth of Puerto Rico, the Northern Mariana Islands, the 
Virgin Islands, American Samoa, and the Trust Territory of the Pacific 
Islands.

[[Page 278]]



Sec.  51b.103  What are the general application requirements?

    (a) The project application shall contain a full description of the 
program objectives, plans, and activities. With respect to programs 
authorized by section 317 of the Act only, the application shall also 
provide, as the Secretary may require:
    (1) The amount of Federal, State, and other funds obligated by the 
applicant in its latest annual accounting period for the provision of 
such program.
    (2) A description of the services provided by the applicant for this 
accounting period covered under paragraph (a)(1) of this section.
    (3) The amount of Federal funds needed by the applicant to continue 
providing these services.
    (4) A description of any proposed changes in the provision of the 
services, reasons and priorities, and the amount of Federal funds needed 
by the applicant to make the changes.
    (b) The application shall contain evidence satisfactory to the 
Secretary that it has been submitted, as appropriate, for action to the 
planning agency designated by the Secretary under title XV of the Act 
(42 CFR parts 122 and 123). These grants are subject to the 
intergovernmental review of Federal programs of Executive Order 12372.
    (c) The application shall contain assurances that no one will be 
denied services because of inability to pay, and that the services are 
provided in a manner which preserves human dignity and maximizes 
acceptance.



Sec.  51b.104  Can personnel, supplies, and related items 
be provided in lieu of cash?

    The Secretary may reduce a grant by the amount of the fair market 
value of any supplies (including vaccines and other preventive agents) 
or equipment furnished a grant recipient when furnished at the request 
of the recipient. The Secretary also may reduce a grant by the amount of 
the pay, allowances, travel expenses, and any other costs in connection 
with the detail of any officer or employee of the Government to the 
recipient when the detail is at the request of the recipient. The amount 
the grant is reduced shall be available for payment by the Secretary of 
the costs incurred in furnishing the supplies or equipment or in 
detailing personnel and shall be deemed to have been paid to the 
recipient.



Sec.  51b.105  Which other HHS regulations apply to these grants?

    Several other HHS regulations apply to grants under this part. These 
include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Debarment and suspension from eligibility for financial 
assistance
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[49 FR 38109, Sept. 27, 1984, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  51b.106  What other conditions apply to these grants?

    (a) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 2 to 
5 years.
    (b) For budgetary and funding purposes, the project period is 
generally divided into 12-month intervals called budget periods. A 
grantee must submit a separate application to have the support continued 
for each subsequent budget period after the initial award. Decisions 
regarding continuation awards and the funding level of such awards will 
be made after consideration of such factors as the grantee's progress 
and management practices

[[Page 279]]

and the availability of funds. In all cases, continuation awards require 
a determination by HHS that continued funding is in the best interest of 
the government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Any funds granted pursuant to this subpart shall be expended 
solely for the purposes for which the funds were granted in accordance 
with the approved application and budget, the regulations of this part, 
the terms and conditions of the award, and the applicable cost 
principles prescribed in 45 CFR part 75, subpart E.
    (e) The Secretary may, at the time of award, impose additional 
conditions, including conditions governing the use of information or 
consent forms, when, in the Secretary's judgment, they are necessary to 
advance the approved program, the interest of the public health, or the 
conservation of grant funds.

[48 FR 4473, Feb. 1, 1983, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  51b.107  Is participation in preventive health service programs 
required by these regulations?

    Nothing in these regulations shall be construed to require any State 
or political subdivision to have a preventive health service program 
which would require any person who objects to treatment to be treated 
under the program.



          Subpart B_Grants for Childhood Immunization Programs

    Source: 44 FR 40501, July 11, 1979, unless otherwise noted.



Sec.  51b.201  To which programs does this subpart apply?

    The regulations in this subpart apply to the award of grants under 
section 317 of the Act for programs to immunize children against vaccine 
preventable diseases.



Sec.  51b.202  Definitions.

    As used in this subpart:
    Childhood immunization program means a preventive health service 
program to immunize children against vaccine preventable diseases 
including poliomyelitis, measles, mumps, rubella, diphtheria, pertussis, 
and tetanus.



Sec.  51b.203  Who is eligible for a grant under this subpart?

    An applicant must be a State agency or an agency of a political 
subdivision of a State which has legal responsibility for disease 
control under the laws of a State.



Sec.  51b.204  What information is required in the application?

    (a) The initial application must cover the project period, and must 
include a description of the following:
    (1) The need for grant support.
    (2) The immediate (1 year budget period) and long-range (2-5 year 
project period) objectives of the project in specific and measurable 
terms.
    (3) Current immunization programs and the additional or intensified 
activities to be carried out to meet the objectives and priorities.
    (4) The following program elements should be included and described:
    (i) A plan to assure that children begin and complete their 
immunizations on schedule, including the use of a standard immunization 
record card, a provider-based tickler system (public and private) for 
the recall of children, and a hospital-based immunization education 
program for new mothers.
    (ii) Assessment of immunization status of school enterers, children 
attending licensed day-care centers, and children under 2 years of age 
and new enrollees under age 5 served in public clinics.
    (iii) A plan for surveillance of vaccine-preventable diseases that 
includes morbidity and mortality reporting as well as field and 
laboratory investigations.
    (iv) Procedures for prompt review of the data collected from the 
morbidity surveillance system to allow for immediate response to all 
occurrence of suspected diphtheria and polio cases upon notification and 
response to suspected measles cases within 48 hours.

[[Page 280]]

    (v) A system for monitoring vaccine-associated reactions including a 
mechanism for responding to persons with vaccine-related complaints.
    (vi) A plan to systematically immunize susceptible children at 
school entry through vigorous enforcement of school immunization laws.
    (5) The manner in which the applicant intends to evaluate the 
project.
    (b) An application for a continuation grant must be submitted for 
each funding period. This continuation application must include the 
following:
    (1) A budget and justification for the grant funds requested.
    (2) A summary of the progress achieved during the previous budget 
period.
    (3) A description of any changes in the information shown in the 
project application.

[48 FR 4474, Feb. 1, 1983]



Sec.  51b.205  How will grant applications be evaluated 
and the grants awarded?

    (a) Within the limits of funds available, the Secretary may award a 
grant to assist in meeting part of the cost of a childhood immunization 
program. Grants will be awarded to those applicants whose projects he 
determines will best promote the purposes of section 317 of the Act. 
Before awarding a grant to a local public entity of a State, the 
Secretary will consult with the State health authority.
    (b) Priorities for funding will be based on the following factors:
    (1) The relative extent of the problems which are caused by one or 
more of the vaccine preventable diseases in the area served by the 
applicant.
    (2) The extent to which the proposed program is designed to 
eliminate or reduce the problems.
    (3) The extent to which the proposed program will increase the 
immunization rates in population groups identified as having the lowest 
immunity levels.
    (4) The extent to which the grantee will cooperate with and use 
public and nonprofit private entities and volunteers.
    (5) The extent to which a strong commitment to the objectives of the 
program is reflected in the commitment of grantee resources to the 
program.

[44 FR 40501, July 11, 1979, as amended at 48 FR 4475, Feb. 1, 1983]



Sec.  51b.206  How can grant funds be used?

    Grant funds awarded under this subpart may be used to purchase 
supplies, materials, and equipment for childhood immunization programs. 
Grant funds also may be used to pay for salaries or wages and related 
expenses for personnel directly involved in the planning, organization, 
promotion, epidemiology, surveillance, and other program activities.

Subpart C [Reserved]



         Subpart D_Grants for Venereal Disease Control Programs

    Source: 48 FR 4475, Feb. 1, 1983, unless otherwise noted.



Sec.  51b.401  To which programs does this subpart apply?

    The regulations in this subpart apply to the award of project grants 
under section 318(c) of the Act for venereal disease prevention and 
control programs, and under section 318(b) of the Act with respect to 
public information and education activities which are integral to a 
balanced, comprehensive venereal disease control program.



Sec.  51b.402  Definitions.

    As used in this subpart:
    Venereal disease means gonorrhea, syphilis, or any other disease 
which can be sexually transmitted and which the Secretary determines is 
or may be amenable to control with assistance provided under this 
authority and which is of national significance.
    Venereal disease control program means a program designed to carry 
out activities or to provide services to systematically detect and 
prevent venereal disease as distinguished from those activities or 
services which are designed to diagnose or treat venereal disease 
patients or suspects.

[[Page 281]]



Sec.  51b.403  Who is eligible for a grant under this subpart?

    An applicant must be a State agency or a political subdivision of a 
State which has legal responsibility for disease control under the laws 
of the State.



Sec.  51b.404  What are the confidentiality requirements?

    All information obtained by program personnel in connection with the 
examination, care, and treatment of an individual in this program shall 
be held confidential. It shall not be disclosed without the individual's 
consent except as may be required by the law of a State or political 
subdivision of a State or as may be necessary to provide services to the 
individual. Information may be disclosed in summary, statistical, or 
other form, or for clinical or research purposes, but only if the 
disclosure does not identify particular individuals.



Sec.  51b.405  What information is required in the application?

    (a) The initial application must include a description of the 
following:
    (1) The nature and extent of the venereal disease problem in the 
area.
    (2) The need for project grant support.
    (3) The immediate (1-year budget period) and long-range (2-5 year 
project period) objectives of the project in specific and measurable 
terms.
    (4) The activities to be carried out to meet the objectives. The 
following program elements must be included and described:
    (i) Venereal disease surveillance.
    (ii) Casefinding and case followup.
    (iii) Interstate epidemiologic referral and followup.
    (iv) Public venereal disease information and education.
    (v) Professional (including appropriate allied health personnel) 
venereal disease education, training, and clinical skills improvement 
activities, including efforts to assure high quality clinical services 
in public venereal disease clinics.
    (5) At the option of the applicant, special studies or 
demonstrations to evaluate or test venereal disease prevention and 
control strategies and activities.
    (6) The manner in which the applicant intends to conduct and 
evaluate the project, including a system for analysis of morbidity data 
so that control activities can be efficiently evaluated and targeted.
    (7) The diagnostic and treatment services that will be provided.
    (8) A budget and justification for the grant funds requested. Since 
public information and education activities are authorized separately 
from other control program activities, funds requested for this purpose 
must be itemized and justified separately in the narrative part of the 
application.
    (b) An application for a continuation grant must be submitted for 
each funding period. This continuation application must include the 
following:
    (1) A budget and justification for the grant funds requested.
    (2) A summary of the progress achieved during the previous budget 
period.
    (3) A description of any changes in the information shown in the 
project application.



Sec.  51b.406  How will grant applications be evaluated and the grants awarded?

    (a) Within the limits of funds available, the Secretary may award a 
grant to assist in meeting the cost of a venereal disease control 
program. Before awarding a grant to a political subdivision of a State, 
the Secretary will consult with the State health authority.
    (b) Priorities for funding will be based on the following factors:
    (1) The relative extent of the venereal disease problem in the area 
served by the applicant.
    (2) The design of the venereal disease prevention and control 
program.
    (3) The general quality of the applicant's plan of operation and 
objectives in accordance with the requirements in these regulations. 
Emphasis will be placed on determining the extent to which services are 
coordinated among health care providers in the area served and 
integrated into a cohesive plan for delivery of service to groups having 
the highest incidence of venereal disease.

[[Page 282]]

    (4) The capacity of the applicant to make effective use of Federal 
funds.
    (5) The commitment of the applicant to the control of venereal 
disease as reflected in the commitment of applicant resources to the 
program.



Sec.  51b.407  How can grant funds be used?

    Grant funds awarded under this subpart may be used only for programs 
approved under section 318(c), and with respect to public information 
and education, those programs approved under section 318(b) of the Act. 
Unless specifically approved, grant funds shall not be used for 
performing diagnostic tests (other than gonorrhea screening tests), 
maintaining central registries, purchasing data processing equipment, or 
providing diagnostic and treatment facilities and services. The 
applicant must provide assurances, however, that these services will be 
available as needed as an adjunct to control program activities 
supported with grant funds. To obtain special approval for grant support 
of such activities, the grantee shall justify the exception to the 
satisfaction of the Secretary that funds for this purpose are necessary 
for the proper conduct of the program and are otherwise unavailable. 
Support of these services will generally be approved only in the 
following situations:
    (a) Special studies or demonstrations, (b) the support of 
developmental or start-up activity, or (c) the support of an essential 
service which will result in a savings to a detection or prevention 
activity supported by the grant. Unless otherwise approved, exceptions 
based on paragraphs (b) and (c) of this section are only allowed during 
one funding period. The grantee is expected to support these activities 
in subsequent funding periods.

Subpart E [Reserved]



 Subpart F_Grants for Research, Demonstrations, and Public Information 
    and Education for the Prevention and Control of Venereal Disease

    Source: 48 FR 4476, Feb. 1, 1983, unless otherwise noted.



Sec.  51b.601  To which programs does this subpart apply?

    The regulations in this subpart apply to the award of venereal 
disease control project grants for research, demonstrations, public 
information, and education activities which can be applied to achieve 
improvements in venereal disease prevention and control under section 
318(b) of the Act.



Sec.  51b.602  Who is eligible for a grant under this subpart?

    An applicant must be a State, political subdivision of any State, or 
any other public or nonprofit private entity.



Sec.  51b.603  What are the confidentiality requirements?

    All information obtained by program personnel in connection with the 
examination, care, and treatment of an individual in this program shall 
be held confidential. It shall not be disclosed without the individual's 
consent except as may be required by the law of a State, or political 
subdivision of a State, or as may be necessary to provide services to 
the individual. Information may be disclosed in summary, statistical, or 
other form, or for clinical or research purposes, but only if the 
disclosure does not identify particular individuals.



Sec.  51b.604  What information is required in the application?

    (a) The initial application must include a description of the 
following:
    (1) The setting and circumstances for which project grant support is 
being requested, including:
    (i) The immediate and long-range objectives of the project in 
specific and measurable terms.
    (ii) The activities which will be undertaken to accomplish the 
objectives, including the timing of these activities.
    (iii) The anticipated application of findings to the national 
venereal disease control effort.
    (iv) Any other information which will support the request for grant 
assistance.
    (2) The relationship between the planned activities and the project 
objectives. The application must describe

[[Page 283]]

in detail how the applicant intends to proceed, particularly if the 
project is unusually complex and several activities are interdependent 
or unprecedented.
    (3) A comprehensive and realistic plan which the applicant will use 
to evaluate the project. The plan must include periodic assessment of 
any possible impact, both positive and negative, that the proposed 
project might have upon the established venereal disease control program 
in the locality or localities in which the project will be undertaken.
    (b) An application for a continuation grant must be submitted for 
each funding period. This continuation application must include the 
following:
    (1) A budget and justification for the grant funds requested.
    (2) A summary of the progress achieved during the previous budget 
period.
    (3) A description of any changes in the information shown in the 
project application.



Sec.  51b.605  How will grant applications be evaluated and the grants awarded?

    (a) Within the limits of funds available, the Secretary may award a 
grant to assist in meeting the costs of special activities authorized 
under section 318(b) of the Act.
    (b) Grant applications will be reviewed and evaluated according to 
the following criteria:
    (1) Is there adequate evidence that the proposed project is needed 
and that the outcome has potential to directly benefit the national 
venereal disease control effort?
    (2) Are the project objectives specific, measurable, realistic, time 
phased, and related to promoting the purposes of section 318?
    (3) Is the method of operation logical and clearly related to 
project objectives, and does it describe how the applicant intends to 
proceed particularly with activities which are complex, interrelated, or 
unprecedented?
    (4) Does the method of operation include an assessment of any 
possible impact, both positive and negative, that the conduct of the 
proposed initiative might have upon the established venereal disease 
control program in the locality or localities in which the project will 
be undertaken?
    (5) Does the proposal include a comprehensive and realistic plan for 
the evaluation of the project, and specify the measures and instruments 
of measurement to be used?
    (6) Is the budget request reasonable and consistent with the 
intended use of grant funds?
    (7) If the applicant intends only to evaluate an existing disease 
prevention and control approach, are the objectives substantially 
different from those which could be met by routine program evaluation?



Sec.  51b.606  How can grant funds be used?

    (a) Grant funds may be used for the costs associated with planning, 
organizing, and conducting applied research, demonstrations, and public 
information and education programs.
    (b) Grant funds may also be used to reimburse individuals who agree 
to be participants in the applied research projects. This reimbursement, 
however, must be justified as necessary and reasonable. A schedule of 
reimbursements must be submitted with the application and approved as 
part of the program plan.
    (c) Grant funds may not be used to supplant funds supporting 
existing venereal disease control services provided by a State or 
locality.



PART 51c_GRANTS FOR COMMUNITY HEALTH SERVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
51c.101 Applicability.
51c.102 Definitions.
51c.103 Eligibility.
51c.104 Application.
51c.105 Accord with health planning.
51c.106 Amount of grant.
51c.107 Use of project funds.
51c.108 Grant payments.
51c.109 Nondiscrimination.
51c.110 Confidentiality.
51c.111 Publications and copyright.
51c.112 Grantee accountability.
51c.113 Applicability of 45 CFR part 75.

[[Page 284]]

  Subpart B_Grants for Planning and Developing Community Health Centers

51c.201 Applicability.
51c.202 Application.
51c.203 Project elements.
51c.204 Grant evaluation and award.

         Subpart C_Grants for Operating Community Health Centers

51c.301 Applicability.
51c.302 Application.
51c.303 Project elements.
51c.304 Governing board.
51c.305 Grant evaluation and award.

        Subpart D_Grants for Operating Community Health Projects

51c.401 Applicability.
51c.402 Application.
51c.403 Project elements.
51c.404 Grant evaluation and award.

      Subpart E_Acquisition and Modernization of Existing Buildings

51c.501 Applicability.
51c.502 Definitions.
51c.503 Application.
51c.504 Project elements.
51c.505 Determination of cost.
51c.506 Use of grant funds.
51c.507 Facility which has previously received Federal grant.

    Authority: Sec. 330, Public Health Service Act, 89 Stat. 342, (42 
U.S.C. 254b); sec. 215, Public Health Service Act, 58 Stat. 690, (42 
U.S.C. 216).

    Source: 41 FR 53205, Dec. 3, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  51c.101  Applicability.

    The regulations of this subpart are applicable to all project grants 
authorized by section 330 of the Public Health Service Act (42 U.S.C. 
254c).



Sec.  51c.102  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act.
    (b) Catchment area means the area served by a project funded under 
section 330 of the Act.
    (c)(1) Community health center or center means an entity which, 
through its staff and supporting resources or through contracts or 
cooperative arrangements with other public or private entities, provides 
for all residents of its catchment area:
    (i) Primary health services;
    (ii) As determined by the Secretary to be appropriate for particular 
centers, supplemental health services necessary for the adequate support 
of primary health services;
    (iii) Referral to providers of supplemental health services and 
payment, as determined by the Secretary to be appropriate and feasible, 
for their provision of such services;
    (iv) Environmental health services, as determined by the Secretary 
to be appropriate for particular centers; and
    (v) Information on the availability and proper use of health 
services.
    (2) For purposes of paragraph (c)(1) of this section, the provision 
of a given service by a center will be determined by the Secretary to be 
appropriate where:
    (i) There is a need, as determined by the Secretary, for the 
provision of such service in the catchment area; and
    (ii) The provision of such service by the center is feasible, taking 
into consideration the center's projected revenues, other resources, and 
grant support under this part.
    (d) Environmental health services means the detection and 
alleviation of unhealthful conditions of the environment of the 
catchment area, such as problems associated with water supply, sewage 
treatment, solid waste disposal, rodent and parasite infestation, and 
housing conditions. For the purposes of this part, the detection and 
alleviation of unhealthful conditions of the environment includes the 
notification of and making of arrangements with appropriate Federal, 
State, or local authorities responsible for correcting such conditions.
    (e) Medically underserved population means the population of an 
urban or rural area designated by the Secretary as an area with a 
shortage of personal health services or a population group designated by 
the Secretary as having a shortage of such services. Medically 
underserved areas will be designated by the Secretary and a list of 
those designated will be published in the Federal Register from time to 
time, taking into consideration the following factors, among others:

[[Page 285]]

    (1) Available health resources in relation to size of the area and 
its population, including appropriate ratios of primary care physicians 
in general or family practice, internal medicine, pediatrics, or 
obstetrics and gynecology to population;
    (2) Health indices for the population of the area, such as infant 
mortality rate;
    (3) Economic factors affecting the population's access to health 
services, such as percentage of the population with incomes below the 
poverty level; and
    (4) Demographic factors affecting the population's need and demand 
for health services, such as percentage of the population age 65 and 
over.
    (f) Nonprofit, as applied to any private agency, institution, or 
organization, means one which is a corporation or association, or is 
owned and operated by one or more corporations or associations, no part 
of the net earnings of which inures, or may lawfully inure, to the 
benefit of any private shareholder or individual.
    (g) Physician means a licensed doctor of medicine or doctor of 
osteopathy.
    (h) Primary health services means:
    (1) Diagnostic, treatment, consultative, referral, and other 
services rendered by physicians, and, where feasible, by physician's 
extenders, such as physicians' assistants, nurse clinicians, and nurse 
practitioners;
    (2) Diagnostic laboratory services and diagnostic radiologic 
services;
    (3) Preventive health services, including medical social services, 
nutritional assessment and referral, preventive health education, 
children's eye and ear examinations, prenatal and post-partum care, 
prenatal services, well child care (including periodic screening), 
immunizations, and voluntary family planning services;
    (4) Emergency medical services, including provision, through clearly 
defined arrangements, for access of users of the center to health care 
for medical emergencies during and after the center's regularly 
scheduled hours;
    (5) Transportation services as needed for adequate patient care, 
sufficient so that residents of the catchment area served by the center 
with special difficulties of access to services provided by the center 
receive such services; and
    (6) Preventive dental services provided by a licensed dentist or 
other qualified personnel, including (i) oral hygiene instruction; (ii) 
oral prophylaxis, as necessary; and (iii) topical application of 
fluorides, and the prescription of fluorides for systemic use when not 
available in the community water supply.
    (i) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (j) Supplemental health services means health services which are not 
included as primary health services and which are:
    (1) Inpatient and outpatient hospital services;
    (2) Home health services;
    (3) Extended care facility services;
    (4) Rehabilitative services (including physical and occupational 
therapy) and long-term physical medicine;
    (5) Mental health services, including services of psychiatrists, 
psychologists, and other appropriate mental health professionals;
    (6) Dental services other than those provided as primary health 
services;
    (7) Vision services, including routine eye and vision examinations 
and provision of eyeglasses, as appropriate and feasible;
    (8) Allied health services;
    (9) Pharmaceutical services, including the provision of prescription 
drugs;
    (10) Therapeutic radiologic services;
    (11) Public health services (including nutrition education and 
social services);
    (12) Ambulatory surgical services;
    (13) Health education services; and
    (14) Services, including the services of outreach workers, which 
promote and facilitate optimal use of primary health services and 
services referred to in the preceding subparagraphs of this paragraph 
and, if a substantial number of individuals in the population served by 
the center are of limited English-speaking ability, the services of 
outreach workers and other personnel fluent in the language or languages 
spoken by such individuals.

[[Page 286]]



Sec.  51c.103  Eligibility.

    Any public or nonprofit private entity is eligible to apply for a 
grant under this part.



Sec.  51c.104  Application.

    (a) An application for a grant under this part shall be submitted to 
the Secretary at such time and in such form and manner as the Secretary 
may prescribe.
    (b) The application shall contain a budget and narrative plan of the 
manner in which the applicant intends to conduct the project and carry 
out the requirements of this part. The application must describe how and 
the extent to which the project has met, or plans to meet, each of the 
requirements in subpart B (relating to grants for planning and 
developing community health centers), subpart C (relating to grants for 
the operation of community health centers), or subpart D (relating to 
grants for the operation of community health projects), as applicable. 
In addition, applications must include:
    (1) A statement of specific, measurable objectives and the methods 
to be used to assess the achievement of the objectives in specified time 
periods and at least on an annual basis.
    (2) The precise boundaries of the catchment area to be served by the 
applicant, including an identification of the medically underserved 
population or populations within the catchment area. In addition, the 
application shall include information sufficient to enable the Secretary 
to determine that the applicant's catchment area meets the following 
criteria:
    (i) The size of such area is such that the services to be provided 
by the applicant are available and accessible to the residents of the 
area promptly and as appropriate;
    (ii) The boundaries of such area conform, to the extent practicable, 
to relevant boundaries of political subdivisions, school districts, and 
areas served by Federal and State health and social service programs; 
and
    (iii) The boundaries of such area eliminate, to the extent possible, 
barriers resulting from the area's physical characteristics, its 
residential patterns, its economic and social groupings, and available 
transportation.
    (3) The results of an assessment of the need that the population 
served or proposed to be served has for the services to be provided by 
the project (or in the case of applications for planning and development 
projects, the methods to be used in assessing such need), utilizing, but 
not limited to, the factors set forth in Sec.  51c.102(e)(1)-(4).
    (4) Position descriptions for key personnel who will be utilized in 
carrying out the activities of the project and a statement indicating 
the need for the positions to be supported with grant funds to 
accomplish the objectives of the project.
    (5) Letters and other forms of evidence showing that efforts have 
been made to secure financial and professional assistance and support 
for the project within the proposed catchment area and the continuing 
involvement of the community in the development and operation of the 
project.
    (6) An assurance that an independent certified public accountant, or 
a public accountant licensed before December 31, 1970, will be engaged 
to certify that the system for the management and control of its 
financial assets will be in accord with sound financial management 
practices, including applicable Federal requirements.
    (7) A list of all services proposed to be provided by the project.
    (8) A list of services which are to be provided directly by the 
project through its own staff and resources and a description of any 
contractual or other arrangements (including copies of documents, where 
available) entered into, or planned for the provision of services.
    (9) The schedule of fees and/or payments and schedule of discounts 
for services provided by the project.
    (10) Evidence that all applicable requirements for review and/or 
approval of the application under title XV of the Act have been met.
    (11) An assurance that the project will be conducted in accordance 
with the applicable requirements of this part.
    (c) The application must be executed by an individual authorized to 
act for the applicant and to assume on behalf

[[Page 287]]

of the applicant the obligations imposed by the statute, the applicable 
regulations of this part, and any additional conditions of the grant.

(Sec. 330, Public Health Service Act, 89 Stat. 342, (42 U.S.C. 254c); 
sec. 215, Public Health Service Act, 58 Stat. 690, 67 Stat. 63 (42 
U.S.C. 216))

[41 FR 53205, Dec. 3, 1976, as amended at 48 FR 29201, June 24, 1983; 48 
FR 45558, Oct. 6, 1983]



Sec.  51c.105  Accord with health planning.

    A grant may be made under this part only if the applicable 
requirements of title XV of the Act relating to review and approval by 
the appropriate health planning agencies have been met.



Sec.  51c.106  Amount of grant.

    (a) The amount of any award under this part will be determined by 
the Secretary on the basis of his estimate of the sum necessary for a 
designated portion of direct project costs plus an additional amount for 
indirect costs, if any, which will be calculated by the Secretary 
either:
    (1) On the basis of the estimate of the actual indirect costs 
reasonably related to the project; or
    (2) On the basis of a percentage of all, or a portion of, the 
estimated direct costs of the project when there are reasonable 
assurances that the use of such percentage will not exceed the 
approximate actual indirect costs. Such award may include an estimated 
provisional amount for indirect costs or for designated direct costs 
(such as fringe benefit rates) subject to upward (within the limits of 
available funds) as well as downward adjustments to actual costs when 
the amount properly expended by the grantee for provisional items has 
been determined by the Secretary: Provided, however, That no grant shall 
be made for an amount in excess of the total cost found necessary by the 
Secretary to carry out the project.
    (i) In determining the percentage of project costs to be borne by 
the grantee, factors which the Secretary will take into consideration 
will include the following:
    (A) The ability of the grantee to finance its share of project costs 
from non-Federal sources;
    (B) The need in the area served by the project for the services to 
be provided; and
    (C) The extent to which the project will provide services in an 
innovative manner which the Secretary desires to stimulate in the 
interest of developing more effective health service delivery systems on 
a regional or national basis.
    (ii) At any time after approval of an application under this part, 
the Secretary may retroactively agree to a percentage of project costs 
to be borne by the grantee lower than that determined pursuant to 
paragraph (a)(2)(i) of this section where he finds that changed 
circumstances justify a smaller contribution.
    (iii) In determining the grantee's share of project costs, costs 
borne by Federal grant funds, or costs used to match other Federal 
grants, may not be included except as otherwise provided by law or 
regulations.
    (b) All grant awards shall be in writing, and shall set forth the 
amount of funds granted and the period for which support is recommended.
    (c) Neither the approval of any project nor any grant award shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application.



Sec.  51c.107  Use of project funds.

    (a) Any funds granted pursuant to this part, as well as other funds 
to be used in performance of the approved project, may be expended 
solely for carrying out the approved project in accordance with section 
330 of the Act, the applicable regulations of this part, the terms and 
conditions of the award, and the applicable cost principles prescribed 
in 45 CFR part 75, subpart E.
    (b) Project funds awarded under this part may be used for, but need 
not be limited to, the following:
    (1) The costs of acquiring and modernizing existing buildings 
(including the costs of amortizing the principal of, and paying interest 
on, loans), but only in accordance with subpart E of

[[Page 288]]

this part and as approved in the grant award;
    (2) The costs of obtaining technical assistance to develop and 
improve the management capability of the project, but only as approved 
by the Secretary;
    (3) The reimbursement of members of the grantee's governing board, 
if any, for reasonable expenses actually incurred by reason of their 
participation in board activities;
    (4) The reimbursement of governing board members for wages lost by 
reason of participation in the activities of such board if the member is 
from a family with an annual family income below $10,000 or if the 
member is a single person with an annual income below $7,000;
    (5) The cost of delivering health services, including services 
rendered on a prepaid capitation basis, to residents of the project's 
catchment area within the following limitations: grant funds may be used 
to pay the full cost of project services to individuals and families 
with annual incomes at or below those set forth in the poverty 
guidelines updated periodically in the Federal Register by the U.S. 
Department of Health and Human Services under the authority of 42 U.S.C. 
9902(2); and to pay the portion of the cost of services provided in 
accordance with the schedule of discounts which, under such schedule, is 
uncompensated; Provided, That (i) charges will be made to such 
individuals and families in accordance with Sec.  51c.303(f) of subpart 
C; (ii) reasonable effort shall be made to collect such charges under a 
billing and collections system; and (iii) the charge to grant funds 
shall exclude any amounts collected pursuant to paragraph (b)(5)(ii) of 
this section;
    (6) The cost of insurance for medical emergency and out-of-area 
coverage;
    (7) The cost of providing to the staff of the project training 
related to the provision of health services provided or to be provided 
by the project, and, to the staff and governing board, if any, training 
related to the management of an ambulatory care facility, consistent 
with the applicable requirements of 45 CFR part 75; and
    (8) The cost of developing and maintaining a reserve fund where 
required by State law for prepaid health care plans.
    (c) Prior approval by the Secretary of revisions of the budget and 
project plan is required whenever there is to be a significant change in 
the scope or nature of project activities.

[41 FR 53205, Dec. 3, 1976, as amended at 81 FR 3007, Jan. 20, 2016; 85 
FR 72908, Nov. 16, 2020]



Sec.  51c.108  Grant payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred, to the extent he 
determines such payments necessary to promote prompt initiation and 
advancement of the approved project.



Sec.  51c.109  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, (42 U.S.C. 2000d et seq.)) and in 
particular section 601 of such Act which provides that no person in the 
United States shall on the grounds of race, color, or national origin be 
excluded from participation, in be denied the benefits of, or be 
subjected to discrimination under any program or activity receiving 
Federal Financial assistance. A regulation implementing such title VI, 
which applies to grants made under this part, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80). In addition, no person shall, on the grounds 
of age, sex, creed, or marital status (unless otherwise medically 
indicated), be excluded from participation in, be denied the benefits 
of, or be subjected to discrimination under any program or activity so 
receiving Federal financial assistance.
    (b) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of his handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance.

[[Page 289]]



Sec.  51c.110  Confidentiality.

    All information as to personal facts and circumstances obtained by 
the project staff about recipients of services shall be held 
confidential, and shall not be divulged without the individual's consent 
except as may be required by law or as may be necessary to provide 
service to the individual or to provide for medical audits by the 
Secretary or his designee with appropriate safeguards for 
confidentiality of patient records. Otherwise, information may be 
disclosed only in summary, statistical, or other form which does not 
identify particular individuals.



Sec.  51c.111  Publications and copyright.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright without prior approval any 
publications, films, or similar materials developed or resulting from a 
project supported by a grant under this part, subject, however, to a 
royalty-free, nonexclusive, and irrevocable license or right in the 
Government to reproduce, translate, publish, use, disseminate, and 
dispose of such materials and to authorize others to do so.



Sec.  51c.112  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other funds, including funds derived 
from other grant awards. With respect to each approved project, the 
grantee shall account for the sum total of all amounts paid as well as 
other funds and in-kind contributions by presenting or otherwise making 
available evidence satisfactory to the Secretary of expenditure for 
direct and indirect costs meeting the requirements of this part: 
Provided, however, That when the amount awarded for indirect costs was 
based on a predetermined fixed-percentage of estimated direct costs, the 
amount allowed for indirect costs shall be computed on the basis of such 
predetermined fixed-percentage rates applied to the total, or a selected 
element thereof, of the reimbursable direct costs incurred.
    (b) Accounting for interest earned on grant funds. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the government of the 
political subdivisions of the State. All grantees other than a State, as 
defined, must return all interest earned on grant funds to the Federal 
Government.
    (c) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full account, as 
provided herein, as of the date of the termination of grant support. The 
Secretary may require other special and periodic accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project the 
total sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section;
    (ii) Any credits for earned interest pursuant to paragraph (b) of 
this section;
    (iii) Any other amounts due pursuant to 45 CFR 75.307, 75.371 
through 75.385, and 75.316-75.325.

[41 FR 53205, Dec. 3, 1976, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  51c.113  Applicability of 45 CFR part 75.

    The provisions of 45 CFR part 75, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part.

[81 FR 3007, Jan. 20, 2016]



  Subpart B_Grants for Planning and Developing Community Health Centers



Sec.  51c.201  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants

[[Page 290]]

awarded pursuant to section 330(c) of the Act for projects for planning 
and developing community health centers which will serve medically 
underserved populations.



Sec.  51c.202  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
51c.104 of subpart A, contain information sufficient to enable the 
Secretary to determine that the project for which the grant is sought 
will meet the requirements of Sec.  51c.203.



Sec.  51c.203  Project elements.

    A project for the planning and developing of a community health 
center supported under this subpart must:
    (a) Prepare an assessment of the need of the population proposed to 
be served by the community health center for the services set forth in 
Sec.  51c.102(c)(1) of subpart A, with special attention to the need of 
the medically underserved population for such services. Such assessment 
of need shall, at a minimum, consider the factors listed in Sec.  
51c.102(e)(1)-(4).
    (b) Design a community health center program for such population, 
based on such assessment, which indicates in detail how the proposed 
community health center will fulfill the needs identified in the 
assessment prepared pursuant to paragraph (a) of this section and how it 
will meet the requirements contained in subpart C of this part.
    (c) Develop a plan for the implementation of the program designed 
pursuant to paragraph (b) of this section. Such implementation plan 
shall provide for the time-phased recruitment and training of the 
personnel essential for the operation of a community health center and 
the gradual assumption of operational status of the project so that the 
project will, in the judgment of the Secretary, meet the requirements 
contained in subpart C of this part as of the end of the project period.
    (d) Implement the plan developed pursuant to paragraph (c) of this 
section in accordance with such paragraph.
    (e) Make efforts to secure, within the proposed catchment area of 
such center to the extent possible, financial and professional 
assistance and support for the project.
    (f) Initiate and encourage continuing community involvement in the 
development and operation of the project.
    (g) Establish standards and qualifications for personnel (including 
the project director).
    (h) Utilize, to the maximum extent feasible, other Federal, State, 
local, and private resources available for support of the project, prior 
to use of project funds under this subpart.



Sec.  51c.204  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 330(c) of the Act and the applicable regulations 
of this part, taking into account:
    (1) The degree to which the proposed project satisfactorily provides 
for the elements set forth in Sec.  51c.203;
    (2) The relative need of the population to be served for the 
services to be provided;
    (3) The administrative and management capability of the applicant;
    (4) The potential of the project for development of new and 
effective methods for health services delivery and management;
    (5) The soundness of the fiscal plan for assuring effective 
utilization of grant funds and maximizing non-grant revenue;
    (6) The extent to which community resources will be utilized in the 
project;
    (7) The extent to which grants approved under this part will provide 
for an appropriate distribution of resources throughout the country, 
taking into consideration the following factors;
    (i) The urban-rural area to be served;
    (ii) The nature of the organization applying; and
    (iii) The organizational structure for delivery of services;

[[Page 291]]

    (8) Whether the project's catchment area is exclusive of the area 
served by a community health center;
    (9) The degree to which the applicant intends to integrate services 
supported by a grant under this subpart with health services provided 
under other Federally assisted health services or reimbursement programs 
or projects.
    (b) The Secretary may:
    (1) Make no more than two grants under this subpart for the same 
project.
    (2) Make a grant under this subpart to an entity which has been 
awarded one or more grants under section 330(d)(1)(A) and/or section 
330(d)(1)(B) of the Act only if the grant under this subpart is for a 
new project.



         Subpart C_Grants for Operating Community Health Centers



Sec.  51c.301  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A, are applicable to grants awarded pursuant to section 
330(d)(1)(A) of the Act for the costs of operation of community health 
centers which serve medically underserved populations.



Sec.  51c.302  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
51c.104 of subpart A,
    (a) Be submitted by an entity which may be a co-applicant which the 
Secretary determines is a community health center, and
    (b) Contain information sufficient to enable the Secretary to 
determine that the center will meet the requirements of Sec.  51c.103.

[41 FR 53205, Dec. 3, 1976, as amended at 42 FR 60418, Nov. 25, 1977]



Sec.  51c.303  Project elements.

    A community health center supported under this subpart must:
    (a) Provide the health services of the center so that such services 
are available and accessible promptly, as appropriate, and in a manner 
which will assure continuity of service to the residents of the center's 
catchment area.
    (b) Implement a system for maintaining the confidentiality of 
patient records in accordance with the requirements of Sec.  51c.110 of 
subpart A.
    (c) Have an ongoing quality assurance program which provides for the 
following:
    (1) Organizational arrangements, including a focus of 
responsibility, to support the quality assurance program and the 
provision of high quality patient care;
    (2) Periodic assessment of the appropriateness of the utilization of 
services and the quality of services provided or proposed to be provided 
to individuals served by the center. Such assessments shall:
    (i) Be conducted by physicians or by other licensed health 
professionals under the supervision of physicians;
    (ii) Be based on the systematic collection and evaluation of patient 
records; and
    (iii) Identify and document the necessity for change in the 
provision of services by the center and result in the institution of 
such change, where indicated.
    (d) Develop management and control systems which are in accordance 
with sound financial management procedures, including the provision for 
an audit on an annual basis (unless waived for cause by the Secretary) 
by an independent certified public accountant or a public accountant 
licensed prior to December 31, 1970, to determine, at a minimum, the 
fiscal integrity of grant financial transactions and reports, and 
compliance with the regulations of this part and the terms and 
conditions of the grant.
    (e) Where the cost of care and services furnished by or through the 
project is to be reimbursed under title XIX or title XX of the Social 
Security Act, obtain or make every reasonable effort to obtain a written 
agreement with the title XIX or title XX State agency for such 
reimbursement.
    (f) Have prepared a schedule of fees or payments for the provision 
of its services designed to cover its reasonable costs of operation and 
a corresponding schedule of discounts adjusted on the basis of the 
patient's ability to pay. Provided, That such schedule of discounts 
shall provide for a full discount

[[Page 292]]

to individuals and families with annual incomes at or below those set 
forth in the poverty guidelines updated periodically in the Federal 
Register by the U.S. Department of Health and Human Services under the 
authority of 42 U.S.C. 9902(2); and for no discount to individuals and 
families with annual incomes greater than twice those set forth in such 
Guidelines, except that nominal fees for services may be collected from 
individuals with annual incomes at or below such levels where imposition 
of such fees is consistent with project goals.
    (g) Make every reasonable effort, including the establishment of 
systems for eligibility determination, billing, and collection, to:
    (1) Collect reimbursement for its costs in providing health services 
to persons who are entitled to insurance benefits under title XVIII of 
the Social Security Act, to medical assistance under a State plan 
approved under title XIX of such Act, to social services and family 
planning under title XX of such Act, or to assistance for medical 
expenses under any other public assistance program, grant program, or 
private health insurance or benefit program on the basis of the schedule 
of fees prepared pursuant to paragraph (f) of this section without 
application of any discounts, and
    (2) Secure from patients payments for services in accordance with 
the schedule of fees and discounts required by paragraph (f) of this 
section.
    (h) Have a governing board which meets the requirements of Sec.  
51c.304.
    (i) Have developed an overall plan and budget for the center that:
    (1) Provides for an annual operating budget and a three-year 
financial management plan which include all anticipated income and 
expenses related to items which would, under generally accepted 
accounting principles, be considered income and expense items;
    (2) Provides for a capital expenditures plan for at least a three-
year period (including the year to which the operating budget described 
in paragraph (i)(1) of this section is applicable) which includes and 
identifies in detail the anticipated sources of financing for, and the 
objective of, each anticipated expenditure in excess of $100,000 related 
to the acquisition of land, the improvement of land, buildings, and 
equipment and the replacement, modernization and expansion of buildings 
and equipment which would, under generally accepted accounting 
principles, be considered capital items;
    (3) Provides for plan review and updating at least annually; and
    (4) Is prepared under the direction of the governing board, by a 
committee consisting of representatives of the governing board, and 
administrative staff, and the medical staff, if any, of the center.
    (j) Establish basic statistical data, cost accounting, management 
information, and reporting or monitoring systems which shall enable the 
center to provide such statistics and other information as the Secretary 
may reasonably require relating to the center's costs of operation, 
patterns of utilization of services, and the availability, 
accessibility, and acceptability of its services and to make such 
reports to the Secretary in a timely manner with such frequency as the 
Secretary may reasonably require.
    (k) Review its catchment area annually to insure that the criteria 
set out in Sec.  51c.104(b)(2) of subpart A are met and, where such 
criteria are not met, revise its catchment area, with the approval of 
the Secretary, to conform to such criteria to the extent feasible.
    (l) In the case of a center which serves a population including a 
substantial proportion of individuals of limited English-speaking 
ability, have developed a plan and made arrangements responsive to the 
needs of such populations for providing services to the extent 
practicable in the language and cultural context most appropriate to 
such individuals, and have identified an individual on its staff who is 
fluent in both that language and in English and whose responsibilities 
include providing guidance to such individuals and to appropriate staff 
members with respect to cultural sensitivities and bridging linguistic 
and cultural differences. If more than one non-English language is 
spoken by such group or groups, an individual or individuals fluent in 
those languages and English shall be so identified.

[[Page 293]]

    (m) Be operated in a manner calculated to preserve human dignity and 
to maximize acceptability and effective utilization of services.
    (n) To the extent possible, coordinate and integrate project 
activities with the activities of other Federally funded, as well as 
State and local, health services delivery projects and programs serving 
the same population.
    (o) Establish means for evaluating progress toward the achievement 
of the specific objectives of the project.
    (p) Provide sufficient staff, qualified by training and experience, 
to carry out the activities of the center.
    (q) Assure that facilities utilized in the performance of the 
project meet applicable fire and life safety codes.
    (r) Utilize, to the maximum extent feasible, other Federal, State, 
and local, and private resources available for support of the project, 
prior to use of project funds under this part.
    (s) Provide for community participation through, for example, 
contributions of cash or services, loans of full-or part-time staff, 
equipment, space, materials, or facilities.
    (t) Where the center will provide services through contract or other 
cooperative arrangements with other providers of services, establish 
rates and methods of payment for health care. Such payments must be made 
pursuant to agreements, with a schedule of rates and payment procedures 
maintained by the project. The project must be prepared to substantiate 
that such rates are reasonable and necessary.
    (u) Operate in a manner such that no person shall be denied service 
by reason of his inability to pay therefor: Provided, however, That a 
charge for the provision of services will be made to the extent that a 
third party (including a Government agency) is authorized or is under 
legal obligation to pay such charges.
    (v) In addition to the above, projects which are supported with 
grant funds for the operation of a prepaid health care plan also must 
provide:
    (1) A marketing and enrollment plan, including market analysis, 
marketing strategy, and enrollment growth projections.
    (2) A plan that provides for funding on a capitation basis of such 
portion of the residents of the catchment area of the center, as the 
Secretary shall determine.
    (3) An assurance that services shall be available to all residents 
of the catchment area without regard to method of payment or health 
status.

[41 FR 53205, Dec. 3, 1976, as amended at 85 FR 72908, Nov. 16, 2020; 85 
FR 83830, Dec. 23, 2020; 86 FR 54396, Oct. 1, 2021]



Sec.  51c.304  Governing board.

    A governing board for the center shall be established by an 
applicant as follows:
    (a) Size. The board shall consist of at least 9 but not more than 25 
members, except that this requirement may be waived by the Secretary for 
good cause shown.
    (b) Composition. (1) A majority of the board members shall be 
individuals who are or will be served by the center and who, as a group, 
represent the individuals being or to be served in terms of demographic 
factors, such as race, ethnicity, sex.
    (2) No more than one-half of the remaining members of the board may 
be individuals who derive more than 10 percent of their annual income 
from the health care industry.
    (3) The remaining members of the board shall be representative of 
the community in which the center's catchment area is located and shall 
be selected for their expertise in community affairs, local government, 
finance and banking, legal affairs, trade unions, and other commercial 
and industrial concerns, or social service agencies within the 
community.
    (4) No member of the board shall be an employee of the center, or 
spouse or child, parent, brother or sister by blood or marriage of such 
an employee. The project director may be a non-voting, ex-officio member 
of the board.
    (c) Selection of members. The method of selection of all governing 
board members shall be prescribed in the by-laws or other internal 
governing rules of the center. Such by-laws or other rules must specify 
a process of selection of individuals on the governing board who 
represent the population served or to be served by the center so that 
such individuals, as a group, are representative of such population.

[[Page 294]]

Such process of selection in the by-laws or other rules is subject to 
approval by the Secretary.
    (d) Functions and responsibilities. (1) The governing board for the 
center shall have authority for the establishment of policy in the 
conduct of the center.
    (2) The governing board shall hold regularly scheduled meetings, at 
least once each month, for which minutes shall be kept.
    (3) The governing board shall have specific responsibility for:
    (i) Approval for the selection and dismissal of a project director 
or chief executive officer of the center;
    (ii) Establishing personnel policies and procedures, including 
selection and dismissal procedures, salary and benefit scales, employee 
grievance procedures, and equal opportunity practices;
    (iii) Adopting policy for financial management practices, including 
a system to assure accountability for center resources, approval of the 
annual project budget, center priorities, eligibility for services 
including criteria for partial payment schedules, and long-range 
financial planning;
    (iv) Evaluating center activities including services utilization 
patterns, productivity of the center, patient satisfaction, achievement 
of project objectives, and development of a process for hearing and 
resolving patient grievances;
    (v) Assuring that the center is operated in compliance with 
applicable Federal, State, and local laws and regulations; and
    (vi) Adopting health care policies including scope and availability 
of services, location and hours of services, and quality-of-care audit 
procedures.



Sec.  51c.305  Grant evaluation and award.

    Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 330(d)(1)(A) of the Act and the applicable 
regulations of this part, taking into consideration;
    (a) The extent to which the project would provide for the elements 
set forth in Sec.  51c.303;
    (b) The relative need of the population to be served for the 
services to be provided;
    (c) The potential of the center for the development of new and 
effective methods for health services delivery and management;
    (d) The soundness of the fiscal plan for assuring effective 
utilization of grant funds and maximizing non-grant revenue;
    (e) The administrative and management capability of the applicant;
    (f) The extent to which grants approved under this part will provide 
for an appropriate distribution of resources throughout the country, 
taking into consideration the following factors:
    (1) The urban-rural area to be served;
    (2) The nature of the organization applying;
    (3) The organizational structure for delivery of services;
    (g) The number of users of the center and the level of utilization 
of services in previous operational periods, if any;
    (h) Whether the center's catchment area is exclusive of the area 
served by another center;
    (i) The degree to which the applicant intends to integrate services 
supported by a grant under this subpart with health services provided 
under other Federally assisted health services or reimbursement programs 
or projects;
    (j) The extent to which community resources will be utilized by the 
project;
    (k) The extent to which the center will provide preventive health 
services so as to maintain and improve the health status of the 
population served; and
    (l) The extent to which center operations will emphasize direct 
health services, efficiency of operations and sound financial 
management.



        Subpart D_Grants for Operating Community Health Projects



Sec.  51c.401  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A are applicable to grants awarded pursuant to section 
330(d)(1)(B) of the Act for the costs of operation of projects

[[Page 295]]

which provide health services to medically underserved populations.



Sec.  51c.402  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
51c.104 of subpart A, contain information sufficient to enable the 
Secretary to determine that the project for which the grant is sought 
will meet the requirements of Sec.  51c.403 of this subpart.



Sec.  51c.403  Project elements.

    A project for the operation of a community health project supported 
under this subpart must:
    (a) Meet all of the requirements of Sec.  51c.303 of this part 
except for paragraph (h).
    (b) Provide those services enumerated in Sec.  51c.102(c)(1) of this 
part which the Secretary determines to be feasible and desirable and 
which are specified in the grant award.
    (c) Establish a governing board meeting the requirements of Sec.  
51c.304 by the end of the period of support under section 330(d)(1)(B) 
of the Act and this subpart.



Sec.  51c.404  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 330(d)(1)(B) of the Act and the applicable 
regulations of this part,
    (1) Where the project meets the requirements of Sec.  51c.403(a); 
and
    (2) Taking into consideration the following:
    (i) The degree to which the project would provide the services 
enumerated in Sec.  51c.102(c)(1) and the feasibility of its providing 
all of such enumerated services by the end of the period of support 
under section 330(d)(1)(B) of the Act and this subpart;
    (ii) Whether the project will have a governing board meeting the 
requirements of Sec.  51c.304 by the end of the period of support under 
section 330(d)(1)(B) of the Act and this subpart;
    (iii) The degree to which the applicant intends to integrate 
services supported by a grant under this subpart with health services 
provided under other Federally assisted health service or reimbursement 
programs or projects;
    (iv) The need of the population to be served for the services to be 
provided;
    (v) The potential of the project for the development of new and 
effective methods for health services delivery and management;
    (vi) The soundness of the fiscal plan for assuring effective 
utilization of grant funds and maximizing non-grant revenue;
    (vii) The administrative and management capacity of the applicant; 
and
    (viii) The extent to which community resources will be utilized in 
the project.
    (b) The Secretary may:
    (1) Make no more than two grants for the same entity under section 
330(d)(1)(B) of the Act;
    (2) Not make any grant under section 330(d)(1)(B) to an entity 
which, for the same project, has been awarded more than one grant under 
section 330(c) of the Act;
    (3) Not make a grant under section 330(d)(1)(B) to an entity which 
has been awarded a grant under section 330(d)(1)(A) of the Act.



      Subpart E_Acquisition and Modernization of Existing Buildings



Sec.  51c.501  Applicability.

    The regulations of this subpart, in addition to the regulations of 
the other applicable subparts of this part, are applicable to grants 
under section 330 of the Act for project costs which include the cost of 
acquisition and/or modernization of existing buildings (including the 
cost of amortizing the principal of, and paying the interest on, loans), 
except that, these regulations are not applicable to grants for project 
costs which include the costs of modernization of existing buildings if 
those costs can otherwise be supported under subparts B, C, or D of this 
part.

[43 FR 5352, Feb. 7, 1978]

[[Page 296]]



Sec.  51c.502  Definitions.

    (a) Equipment means nonexpendable personal property as defined in 45 
CFR 75.2.
    (b) Existing building means a completed or substantially completed 
structure, and may include the realty on which it is or is to be 
located.
    (c) Modernization means the alteration, repair, remodeling and/or 
renovation of a building (including the initial equipment thereof and 
improvements to the building's site) which, when completed, will render 
the building suitable for use by the project for which the grant is 
made.

[43 FR 5352, Feb. 7, 1978, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  51c.503  Application.

    (a) General requirements. An application for a grant under this part 
for a project under subparts B, C, or D which includes the acquisition 
and/or modernization of an existing building must include the following:
    (1) A legal description of the site and a drawing showing the 
location of the building;
    (2) A description of the architectural, structural, and other 
pertinent characteristics of the building sufficient to show that it is 
or that it will be, after alteration and renovation or after 
modernization, suitable for use by the project;
    (3) A detailed estimate of the cost of the proposed acquisition and/
or modernization;
    (4) A description of, and copies of any relevant documents 
concerning, any existing or proposed financing arrangements for the 
acquisition and/or modernization;
    (5) The proposed schedule for acquisition and/or modernization and 
occupancy;
    (6) An assessment of the environmental impact of the proposed 
acquisition and/or modernization as called for by section 102(2)(c) of 
the National Environmental Policy Act of 1969 (42 U.S.C. 4332(c)) and 
such information as may be necessary to comply with the National 
Historic Preservation Act of 1966 (16 U.S.C. 470(f));
    (7) Reasonable assurances that--
    (i) The applicant has or will obtain a fee simple or such other 
estate or interest in the site, including necessary easements and 
rights-of-way, sufficient to assure for a period of not less than 20 
years (in the case of interim facilities, for the period constituting 
the estimated useful life of such facilities) undisturbed use and 
possession for the purpose of the operation of the project;
    (ii) The building will be used for the purposes for which the grant 
is made;
    (iii) The building complies, or after alteration and renovation or 
after modernization will comply, with applicable State and local codes 
and with:
    (A) ``American National Standard Specifications for Making Buildings 
and Facilities Accessible to, and Usable by, the Physically 
Handicapped'' Number ANSI A117.1-1961 (R 1971), as modified by other 
standards prescribed by the Secretary or the Administrator of the 
General Services Administration. The applicant shall be responsible for 
conducting inspections to insure compliance with the specifications;
    (B) The applicable standards set forth in Life Safety Code 1973, 
NFPA No. 101, which is hereby incorporated by reference and made a part 
hereof. Copies of such document are available for examination at the 
Department's and Regional Offices' Information Centers listed in 45 CFR 
5.31 and may also be obtained from the National Fire Protection 
Association, 470 Atlantic Avenue, Boston, MA 02210 for $3.00 per copy.
    (iv) In the case of a public applicant with an approved project 
which involves the displacement of persons or businesses on or after 
January 2, 1971, whose real property has or will be taken, the applicant 
will comply with the provisions of the Uniform Relocation Assistance and 
Real Property Acquisition Policies Act of 1970 (Pub. L. 91-646) and the 
applicable regulations issued thereunder (45 CFR part 15);
    (v) Sufficient funds will be available to meet any portion of the 
cost of acquiring and/or modernizing the building not borne by the grant 
under this part;
    (vi) Sufficient funds will be available after acquisition and/or 
modernization of the building for effective use of the building for the 
purposes of the project;

[[Page 297]]

    (vii) The applicable requirements of the Flood Disaster Protection 
Act of 1973 have been met;
    (8) Such other information as the Secretary may reasonably require.
    (b) Requirement for acquisition grants. Except for a grant solely 
for amortization of principal and payment of interest on an existing 
loan, an application for a grant for a project which includes the 
acquisition of an existing building must include, in addition to the 
requirements of paragraph (a) of this section, evidence satisfactory to 
the Secretary that the applicant has explored other alternatives to the 
proposed acquisition (such as leasing facilities or acquiring other 
facilities in the project's catchment area) and that the proposed 
acquisition constitutes the soundest alternative from a financial and 
program standpoint.
    (c) Requirements for modernization grants. In addition to the 
requirements of paragraph (a) of this section, an application for a 
grant for a project which includes modernization of an existing building 
must include the following:
    (1) Plans and specifications for the proposed modernization which 
conform to the standards specified in Sec.  51c.503(a)(7)(iii);
    (2) Reasonable assurance that any laborer or mechanic employed by 
any contractor or subcontractor in the performance of work on the 
modernization project will be paid wages at rates not less than those 
prevailing on similar work in the locality as determined by the 
Secretary of Labor under the Davis-Bacon Act (40 U.S.C. 276a et seq.) 
and will receive compensation at a rate not less than one and one-half 
times his basic rate of pay for all hours worked in any workweek in 
excess of 8 hours in any calendar day; and
    (3) Copies of any construction and materials contracts already 
entered into for the proposed modernization.

[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]



Sec.  51c.504  Project elements.

    (a) General requirements. A grantee which has received a grant under 
section 330 of the Act for a project which includes the acquisition and/
or modernization of an existing building must:
    (1) Assurances. Comply with the assurances provided pursuant to this 
subpart.
    (2) Approval of estimated cost. Not enter into any contract for the 
acquisition and/or modernization funded under this subpart where the 
cost of such acquisition and/or modernization exceeds the estimates in 
the application, without the prior approval of the Secretary.
    (3) Non-default. Make every effort to prevent any default on any 
loan secured by the building and, in the event of a default, promptly 
notify the Secretary of the default and make every effort on a timely 
basis to cure the default.
    (b) Requirements for acquisition grants. In addition to the 
requirements of paragraph (a) of this section, a grantee which has 
received a grant under section 330 of the Act for a project which 
includes the acquisition of an existing building must:
    (1) Bona-fide sale. Acquire or, in the case of a grant solely for 
amortization of principal and payment of interest on an existing loan, 
have acquired the existing building pursuant to a bona-fide sale 
involving an actual cost to the applicant and resulting in additional or 
improved facilities for the purposes of the project.
    (2) Standards of construction and equipment. Except in the case of a 
grant solely for amortization of principal and payment of interest on an 
existing loan, obtain a determination by the Secretary that the facility 
conforms (or upon completion of any necessary alteration and renovation 
or modernization will conform) to the standards set forth in Sec.  
51c.503(a)(7)(iii) of this subpart before entering into a final or 
unconditional contract for the acquisition. Where the Secretary finds 
that exceptions to or modifications of any such standards would be 
consistent with the purposes of the Act and of the program, he may 
authorize such exceptions or modifications.
    (3) Financing. Where the grantee will obtain a loan secured by the 
building in order to acquire the building, obtain such financing at the 
lowest current rate prevailing in the area for comparable loans on 
comparable facilities.
    (c) Requirements for modernization grants. In addition to the 
requirements

[[Page 298]]

of paragraph (a) of this section, a grantee which has received a grant 
under section 330 of the Act for a project which includes the 
modernization of an existing building must:
    (1) Costs in excess of approved costs. Finance all costs in excess 
of the estimated costs approved in the application and submit to the 
Secretary for prior approval any changes that substantially alter the 
scope of the function, utilities, or safety of the facility.
    (2) Competitive bids. (i) Obtain the approval of the Secretary 
before the project is advertised or placed on the market for bidding; 
such approval must include a determination by the Secretary that the 
final plans and specifications conform to the standards set forth in 
Sec.  51c.503(a)(7)(iii) of these regulations.
    (ii) Except as otherwise provided by State or local law, contract 
for construction (including the purchase and installation of built-in 
equipment) on a lump sum fixed-price basis, and award contracts on the 
basis of competitive bidding obtained by public advertising with award 
of the contracts to the lowest responsive and responsible bidders. The 
provision for exceptions based on State and local law shall not be 
invoked to give local contractors or suppliers a percentage preference 
over non-local contractors bidding for the same contract. Such practices 
are precluded by this paragraph.
    (3) Construction contracts. (i) Include the following conditions and 
provisions in all construction contracts for the modernization project:
    (A) The provisions set forth in ``DHHS Requirements for Federally 
Assisted Construction Contracts Regarding Labor Standards and Equal 
Employment Opportunities,'' Form DHHS 514 (rev. 7/76) (issued by the 
Office of Grants Administration Policy, U.S. Department of Health and 
Human Services) pertaining to the Davis-Bacon Act, the Contract Work 
Hours Standards Act, and the Copeland Act (Anti-Kickback) Regulations, 
except in the case of contracts in the amount of $2,000 or less; and 
pertaining to Executive Order 11246, 30 FR 12319 (September 24, 1965), 
as amended, relating to nondiscrimination in construction contract 
employment, except in the case of contracts in the amount of $10,000 or 
less;
    (B) That the contractor shall furnish performance and payment bonds 
each of which shall be in the full amount of the contract price, and 
shall maintain, during the life of the contract, adequate fire, 
workmen's compensation, public liability, and property damage insurance: 
Provided, however, That in the case of a State or local unit of 
government which enters into a construction contract of less than 
$100,000, State or local provisions with respect to performance and 
payment bonds shall be deemed to meet the requirements of this 
paragraph; and
    (C) That the Secretary shall have access at all reasonable times to 
work wherever it is in preparation or progress, and the contractor shall 
provide proper facilities for such access and inspection.
    (ii) Executive Order 11246. Comply with the applicable requirements 
of Executive Order 11246, 30 FR 12319 (September 24, 1965) as amended, 
relating to nondiscrimination in construction contract employment, and 
the applicable rules, regulations, and procedures prescribed pursuant 
thereto.
    (4) Modernization supervision. Provide and maintain competent and 
adequate architectural or engineering supervision and inspection at the 
modernization site to insure that the completed work conforms with the 
plans and specifications.
    (5) Completion responsibility. Complete the modernization in 
accordance with the grant application and the approved plans and 
specifications.
    (6) Progress reports. Furnish progress reports and such other 
information concerning the modernization as the Secretary may require.
    (d) The Secretary may at any time approve exceptions to the 
provisions of this section where he finds that such exceptions are not 
inconsistent with section 330 of the Act, other requirements of law, or 
the purposes of the program.

[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]



Sec.  51c.505  Determination of cost.

    The cost of acquisition and/or modernization of existing buildings 
for

[[Page 299]]

which funds may be granted under this part will be determined by the 
Secretary, utilizing such documentation submitted by the applicant as 
the Secretary may prescribe (including the reports of such real estate 
appraisers as the Secretary may approve) and other relevant factors, 
taking into consideration only that portion of the existing building 
necessary for the operation of the approved project.

[41 FR 5700, Dec. 30, 1976]



Sec.  51c.506  Use of grant funds.

    Grant funds may be used to amortize the principal of or pay interest 
on a loan or mortgage on an existing building acquired under this part, 
including a building purchased by a grantee prior to the promulgation of 
this part, but only if the building is being used for the purposes of 
section 330 and complies with the applicable provisions of this subpart 
and only to the extent the Secretary finds such principal amounts and 
interest rates to be reasonable.

[41 FR 5700, Dec. 30, 1976]



Sec.  51c.507  Facility which has previously received Federal grant.

    No grant for the acquisition of a facility which has previously 
received a Federal grant for construction, acquisition, or equipment 
shall serve either to reduce or restrict the liability of the applicant 
or any other transferor or transferee from any obligation of 
accountability imposed by the Federal Government by reason of such prior 
grant.

[41 FR 5700, Dec. 30, 1976]



PART 51d_MENTAL HEALTH AND SUBSTANCE ABUSE EMERGENCY RESPONSE PROCEDURES--
Table of Contents



Sec.
51d.1 To what does this subpart apply?
51d.2 Definitions.
51d.3 Who is eligible for an award under this subpart?
51d.4 What information is required in the application?
51d.5 How is an emergency determined to exist?
51d.6 How will applications be evaluated and awarded?
51d.7 What are the limitations on how award funds may be used?
51d.8 Which other HHS regulations apply to these awards?
51d.9 What other conditions apply to these awards?
51d.10 What are the reporting requirements?

    Authority: 42 U.S.C. 290aa(m).

    Source: 66 FR 51877, Oct. 11, 2001, unless otherwise noted.



Sec.  51d.1  To what does this subpart apply?

    The regulations in this subpart apply to grants that enable public 
entities to respond to needs in local communities created by mental 
health or substance abuse emergencies, as authorized under section 
501(m) of the Public Health Service Act (42 U.S.C. 290aa(m)).



Sec.  51d.2  Definitions.

    As used in this part:
    Federally recognized Indian Tribal government means the governing 
body of any Indian tribe, band, nation, or other organized group or 
community, including any Native village as defined in, or established 
pursuant to, the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et 
seq.), which is recognized as eligible for the special programs and 
services provided by the United States to Indians because of their 
status as Indians;
    Immediate award means a short term award of up to $50,000, or such 
greater amount as determined by the Secretary on a case-by-case basis, 
to address the immediate needs resulting from a mental health or 
substance abuse emergency. Such funding may be provided for a period of 
up to 90 days.
    Intermediate award means an award intended to meet the more ongoing 
needs resulting from a mental health or substance abuse emergency than 
is possible under an Immediate award. Intermediate awards may fund up to 
one year of services, although in some exceptional circumstances, and to 
the extent that funding is available, such funding may be continued for 
an additional period of up to one year.
    Public entity means any State, any political subdivision of a State, 
any Federally recognized Indian tribal government or tribal 
organization.
    Secretary means the Secretary of Health and Human Services (HHS) or 
any other officer or employee of that

[[Page 300]]

Department to whom the authority involved has been delegated.
    State means one of the 50 States, the District of Columbia, Guam, 
the Commonwealth of Puerto Rico, the Northern Mariana Islands, the 
Virgin Islands, American Samoa, and the Trust Territory of the Pacific 
Islands.
    Tribal organization means the recognized governing body of any 
Indian tribe; any legally established organization of Indians which is 
controlled, sanctioned, or chartered by such governing body or which is 
democratically elected by the adult members of the Indian community to 
be served by such organization and which includes the maximum 
participation of Indians in all phases of its activities.

[66 FR 51877, Oct. 11, 2001, as amended at 67 FR 56931, Sept. 6, 2002]



Sec.  51d.3  Who is eligible for an award under this subpart?

    An applicant must be a public entity as defined by this subpart. 
Applicants are eligible for either or both Immediate and Intermediate 
awards.



Sec.  51d.4  What information is required in the application?

    (a) Application for Immediate awards: The application is to contain 
the following information:
    (1) A certification by the State's chief executive officer, or, for 
the purposes of a Federally recognized Indian tribal government, the 
principal elected official, or such officer's or official's designee, 
that a mental health or substance abuse emergency exists, as well as a 
written statement setting out the basis for the certification;
    (2) A brief program plan describing needs;
    (3) An estimate of the number of people to be served and the 
geographical area to be served;
    (4) A description of the types of services to be provided;
    (5) A budget justifying the amount of the request;
    (6) Required certifications; and
    (7) Such other pertinent information as the Secretary may require.
    (b) Application for Intermediate awards: The application is to be 
submitted on an OMB-approved application form and contain the following:
    (1) If the applicant has not applied previously for an Immediate 
award, a certification by the State's chief executive officer, or, for 
the purposes of a Federally recognized Indian tribal government, the 
principal elected official, or such officer's or official's designee, 
that a mental health or substance abuse emergency exists, as well as a 
written statement setting out the basis for the certification;
    (2) An application submission date within three months of the date 
of the event that precipitated the mental health or substance abuse 
emergency, as certified in accordance with 51d.4(a)(1) or (b)(1), except 
that upon the request of a State, the Secretary may provide a waiver of 
this application submission deadline if the Secretary determines there 
is good cause to justify the waiver;
    (3) A detailed and comprehensive assessment of need;
    (4) Demographics specific to the estimated number of people to be 
served;
    (5) A description of the services that were provided up to the date 
of the submission of the Intermediate award application;
    (6) The geographical area to be served;
    (7) A detailed implementation program plan and related time line, 
including a description of outreach to special population groups 
affected by the crisis;
    (8) A budget justifying the amount of the request for personnel, 
equipment, supplies, travel, training, data collection and any technical 
assistance required; the budget shall include an identification of the 
resources the applicant is able to commit to the project, if any, 
including any in-kind contributions;
    (9) Any information that has changed since an Immediate application 
was submitted, if one was submitted; and
    (10) such other pertinent information as the Secretary may require.
    (c) Signature on Award Applications. The application must be signed 
by an individual authorized to act for the applicant and to assume on 
behalf of the applicant the obligations imposed by the statute, all 
applicable regulations, and any additional conditions of the grant.

[[Page 301]]



Sec.  51d.5  How is an emergency determined to exist?

    (a) In making a decision as to whether a mental health or substance 
abuse emergency exists for purposes of section 501(m) of the PHS Act, 
the Secretary, using discretion, will consider all relevant factors, but 
at a minimum the following must exist:
    (1) Existing State, Tribal and local systems for mental health and/
or substance abuse services are overwhelmed or unable to meet the 
existing mental health or substance abuse needs of the local community 
at issue; and
    (2) This inability to meet the mental health and/or substance abuse 
service needs of a local community is the direct consequence of a clear 
precipitating event. This precipitating event must:
    (i) Have a sudden, rapid onset and a definite conclusion, such as:
    (A) A natural disaster (including, but not limited to, a hurricane, 
tornado, storm, flood, earthquake, fire, drought, or other natural 
catastrophe); or
    (B) A technological disaster (including, but not limited to, a 
chemical spill, a major industrial accident, or a transportation 
accident); or
    (C) A criminal act with significant casualties (including, but not 
limited to, a domestic act of terrorism, a hostage situation, or an 
incident of mass violence including school shootings and riots); and
    (ii) Result in significant:
    (A) Death,
    (B) Injury,
    (C) Exposure to life-threatening circumstances,
    (D) Hardship,
    (E) Suffering,
    (F) Loss of property, or
    (G) Loss of community infrastructure (e.g., loss of treatment 
facilities, staff, public transportation and/or utilities, or isolation 
from services); and
    (3) No other local, State, Tribal or Federal funding is available to 
adequately address the specific level of need resulting from the 
precipitating event and resulting emergency mental health and/or 
substance abuse service needs of the impacted community.
    (b) In making a determination that a mental health or substance 
abuse emergency exists, the Secretary will consider the certification 
and written statements provided in accordance with Sec.  51d.4(a)(1) or 
(b)(1), and other information independently available to the Secretary.
    (c) Once the Secretary determines that a mental health or substance 
abuse emergency exists, the Secretary may exercise discretion to make 
awards to enable public entities to respond to the emergency, within the 
limits of funds available.



Sec.  51d.6  How will applications be evaluated and awarded?

    (a) In assessing applications for funding, the Secretary will 
utilize the following criteria.
    (1) Documentation of Need. Applicant has demonstrated mental health 
and/or substance abuse needs directly resulting from the precipitating 
event. The precipitating event is clearly identified along with 
information regarding its impact. Applicant has identified any high risk 
groups or populations with special concerns that may impact the delivery 
of services (e.g., children, adolescents, older adults, ethnic and 
cultural groups, lower income populations). This documentation of need 
shall include the extent of physical, psychological and social problems 
observed, and a description of how the estimate of the number of people 
to be served was made. Applicant has clearly documented that no other 
local, State, Tribal or Federal funding sources are available to address 
the need.
    (2) Plan of Services. Applicant has a clear plan of services to 
address documented needs within a defined geographic area and in a 
specified time period. The plan of services is appropriate to the type 
of grant requested (e.g., Immediate or Intermediate) and specifically 
addresses the needs of any high risk groups or populations with special 
concerns identified in the assessment of need. The plan of services 
clearly identifies the following:
    (a) The types of services to be provided (e.g., outreach, crisis 
counseling, public education on stress management and crisis mental 
health, public education on substance abuse prevention, information and 
referral services, short term substance abuse or mental health 
prevention and/or treatment services);

[[Page 302]]

    (b) Strategies for targeting those identified as needing services, 
including high risk groups or populations with special concerns 
identified in the needs assessment;
    (c) Appropriate training to be provided to staff to assure that 
services are appropriate to the crisis situation and the plans for 
community recovery;
    (d) Quality control methods in place to assure appropriate services 
to the target population;
    (e) Staff support mechanisms that are available;
    (f) Plans for coordination of services with key local, State, Tribal 
and Federal partners involved in addressing the precipitating event 
(e.g., emergency management agencies, law enforcement, education 
agencies, public health agencies, and other agencies active in crisis 
response); and
    (g) An estimate of the length of time for which said services 
requiring Federal funding will be needed, and the manner in which long-
term cases will be referred for continued assistance after Federal funds 
have ended.
    (3) Organizational Capability. Applicant is a public entity with 
demonstrated organizational capacity to deliver services as described in 
the plan of services. The applicant should also have a demonstrated 
history of service delivery to the target population within the defined 
service area for the program. The budget submitted shall provide 
sufficient justification and demonstrate that it is consistent with the 
documentation of need and plan of services. This shall include a 
description of the facilities to be utilized, including plans for 
securing office space if necessary to the project.
    (b) In determining the appropriateness and necessity of funding, the 
Secretary may consult with other Federal agencies responsible for 
responding to crisis incidents, including the Readiness, Response and 
Recovery Directorate within the Federal Emergency Management Agency 
(FEMA), the Safe and Drug Free Schools Program within the U.S. 
Department of Education, the Office for Victims of Crime (OVC) within 
the U.S. Department of Justice, the National Transportation Safety Board 
(NTSB) within the U.S. Department of Transportation, the Emergency 
Response Program within the Environmental Protection Agency (EPA), the 
Bureau of Indian Affairs (BIA) within the U.S. Department of the 
Interior, the Animal and Plant Health Inspection Service within the U.S. 
Department of Agriculture, the Indian Health Service (IHS) within the 
U.S. Department of Health and Human Services, and other Federal agencies 
with jurisdiction over specific types of crisis response.



Sec.  51d.7  What are the limitations on how award funds may be used?

    Unallowable Expenses: The following expenses will not be reimbursed 
under section 501(m) of the PHS Act:
    (1) Major construction costs;
    (2) Childcare services, unless provided by the institution or entity 
providing mental health or substance abuse treatment and integral to the 
treatment program;
    (3) Services outside of the geographic area specified in the 
application, except to the extent that the precipitating event requires 
physical relocation of either affected parties or facilities;
    (4) Any mental health or substance abuse services not directly 
related to the mental health or substance abuse emergency;
    (5) Any expenses that supplant ongoing local, State, Tribal or 
Federal expenditures; and
    (6) Any other costs unallowable by Federal law or regulation.



Sec.  51d.8  Which other HHS regulations apply to these awards?

    Several other HHS regulations apply to grants under this part. These 
include, but are not limited to:

45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Debarment and suspension from eligibility for financial 
assistance
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department

[[Page 303]]

of Health and Human Services effectuation of title VI of the Civil 
Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefitting from Federal financial 
assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefitting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[66 FR 51877, Oct. 11, 2001, as amended at 67 FR 56931, Sept. 6, 2002; 
81 FR 3007, Jan. 20, 2016]



Sec.  51d.9  What other conditions apply to these awards?

    Award funding made under this authority is to be supplemental in 
nature. Consistent with the criteria in Sec.  51d.5 and the 
certification in Sec.  51d.4(a)(1), such funds will only be made 
available if no other local, State, Tribal or Federal source is 
available to adequately address the emergency mental health and/or 
substance abuse service needs of the impacted community.



Sec.  51d.10  What are the reporting requirements?

    (a) For immediate awards:
    (1) A mid-program report only if an Intermediate award application 
is being prepared and submitted. This report shall be included as part 
of the Intermediate award application,
    (2) Quarterly financial status reports of expenditures to date, due 
30 days following the end of the reporting period, as permitted by 45 
CFR 75.341,
    (3) A final program report, a financial status report, and a final 
voucher 90 days after the last day of Immediate award services, in 
accordance with CFR 75.342.
    (b) For intermediate awards:
    (1) Quarterly progress reports, due 30 days following the end of the 
reporting period, as permitted by CFR 75.342,
    (2) Quarterly financial status reports of expenditures to date, due 
30 days following the end of the reporting period, as permitted by 45 
CFR 75.341,
    (3) A final program report, to be submitted within 90 days after the 
end of the program services period, in accordance with CFR 75.342,
    (4) A financial status report, to be submitted within 90 days after 
the end of the program services period, in accordance with CFR 75.342,
    (5) Such additional reports as the Secretary may require.
    (c) The following shall be specifically addressed in final program 
reports:
    (1) Description of services provided,
    (2) Number of individuals assisted,
    (3) Amount of funding expended and for what purposes,
    (4) Personnel costs,
    (5) Training costs,
    (6) Technical consultation costs,
    (7) Equipment costs,
    (8) Travel and transportation costs, and
    (9) A narrative describing lessons learned and exemplary practices, 
and a description of the transition plan, for how services will be 
funded or provided when Federal funds have been exhausted.

[66 FR 51877, Oct. 11, 2001, as amended at 81 FR 3007, Jan. 20, 2016]

                        PARTS 51e	51g [RESERVED]



PART 52_GRANTS FOR RESEARCH PROJECTS--Table of Contents



Sec.
52.1 To which programs do these regulations apply?
52.2 Definitions.
52.3 Who is eligible to apply for a grant?
52.4 How to apply for a grant.
52.5 Evaluation and disposition of applications.
52.6 Grant awards.
52.7 Use of funds; changes.
52.8 Other HHS policies and regulations that apply.
52.9 Additional conditions.

    Authority: 42 U.S.C. 216.



Sec.  52.1  To which programs do these regulations apply?

    (a) General. The regulations of this party apply to all health-
related research project grants administered by

[[Page 304]]

the PHS or its components, except for grants for health services 
research, demonstration, and evaluation projects administered by the 
Agency for Health Care Policy and Research. These regulations do not 
apply to research grants that are not for the support of an identified 
research project (sometimes referred to as general research support 
grants), grants for the construction or operation of research 
facilities, grants for prevention or educational programs, demonstration 
grants, traineeships, training grants, or to the support of research 
training under the National Research Service Awards program.
    (b) Specific programs covered. From time to time the Secretary will 
publish a list of the research project grant programs covered by this 
part. The list is for informational purposes only and is not intended to 
restrict the statement of applicability in paragraph (a) of this 
section. In addition, information on particular research project grant 
programs, including applications and instructions, may be obtained from 
the component of the PHS that administers the program.

[61 FR 55105, Oct. 24, 1996.]



Sec.  52.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Grantee means the institution, organization, individual or other 
person designated in the grant award document as the responsible legal 
entity to whom a grant is awarded under this part. The term shall also 
mean the recipient of a cooperative agreement awarded under this part.
    HHS means the Department of Health and Human Services.
    Principal investigator means the individual(s) judged by the 
applicant organization to have the appropriate level of authority and 
responsibility to direct the project or program supported by the grant 
and who is or are responsible for the scientific and technical direction 
of the project.
    Project means the particular activity for which funding is sought 
under this part as described in the application for grant award.
    Public Health Service and PHS means the operating division of the 
Department that consists of the Agency for Health Care Policy and 
Research, the Centers for Disease Control and Prevention, the Food and 
Drug Administration, the Health Resources and Services Administration, 
the Indian Health Service, the National Institutes of Health, the Office 
of the Assistant Secretary for Health, the Substance Abuse and Mental 
Health Administration, and the Agency for Toxic Substances and Disease 
Registry.
    Research means a systematic investigation, study or experiment 
designed to contribute to general knowledge relating broadly to public 
health by establishing, discovering, developing, elucidating or 
confirming information about, or the underlying mechanisms relating to, 
the biological functions, diseases, or related matters to be studied.
    Secretary means the Secretary of HHS and any other officer or 
employee of the HHS to whom the authority involved may be delegated.

[61 FR 55105, Oct. 24, 1996, as amended at 74 FR 57921, Nov. 10, 2009]



Sec.  52.3  Who is eligible to apply for a grant?

    (a) Persons eligible. Any individual, corporation, public or private 
institution or agency, or other legal entity shall be eligible for a 
grant award, except:
    (1) An individual or entity which is otherwise ineligible for an 
award under applicable law or regulation;
    (2) Federal agencies or institutions, unless specifically authorized 
by law to receive the grant; or
    (3) Individuals, corporations, institutions, agencies, and other 
entities during the period they are debarred or suspended from 
eligibility for Federal financial assistance (see 45 CFR part 76).
    (b) Permissible activities within research projects. Any project 
found by the Secretary to be a research project within the meaning of 
this part shall be eligible for a grant award. Eligible projects may 
consist of laboratory, clinical, population, field, statistical, basic, 
applied or other types of investigations,

[[Page 305]]

studies or experiments, or combinations thereof, and may either be 
limited to one, or a particular aspect of a problem or subject, or may 
consist of two or more related problems or subjects for concurrent or 
consecutive investigation and involving multiple disciplines, facilities 
and resources.
    (c) Preferences. In the award of grants for international research 
relating to the development and evaluation of vaccines and treatments 
for AIDS under section 2315 of the Act, preference shall be given to:
    (1) Activities conducted by, or in cooperation with, the World 
Health Organization, and
    (2) With respect to activities in the Western Hemisphere, activities 
conducted by, or in cooperation with, the Pan American Health 
Organization or the World Health Organization.

[61 FR 55105, Oct. 24, 1996]



Sec.  52.4  How to apply for a grant.

    Each institution interested in applying for a grant under this part 
must submit an application at such time and in such form and manner as 
the Secretary may prescribe.

[61 FR 55105, Oct. 24, 1996]



Sec.  52.5  Evaluation and disposition of applications.

    (a) Evaluation. All applications filed in accordance with Sec.  52.4 
shall be evaluated by the Secretary through such officers and employees 
and such experts or consultants engaged for this purpose as the 
Secretary determines are specially qualified in the areas of research 
involved in the project, including review by an appropriate National 
Advisory Council or other body as may be required by law. The 
Secretary's evaluation shall take into account among other pertinent 
factors the scientific merit and significance of the project, the 
competency of the proposed staff in relation to the type of research 
involved, the feasibility of the project, the likelihood of its 
producing meaningful results, the proposed project period, and the 
adequacy of the applicant's resources available for the project and the 
amount of grant funds necessary for completion, and in the case of 
applications for support of research in emergency medical services, 
special consideration shall be given to applications for grants for 
research relating to the delivery of emergency medical services in rural 
areas.
    (b) Disposition. On the basis of the Secretary's evaluation of an 
application in accordance with paragraph (a) of this section and subject 
to approvals, recommendations or consultations by the appropriate 
National Advisory Council or other body as may be required by law, the 
Secretary will (1) approve, (2) defer because of either lack of funds or 
a need for further evaluation, or (3) disapprove support of the proposed 
project in whole or in part. With respect to approved projects, the 
Secretary will determine the project period (subject to extension as 
provided in Sec.  52.7(c)) during which the project may be supported. 
Any deferral and disapproval of an application will not preclude its 
reconsideration or a reapplication.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]



Sec.  52.6  Grant awards.

    (a) Within the limits of funds available for that purpose, the 
Secretary will award a grant to those applicants whose approved projects 
will in the Secretary's judgment best promote the purposes of the 
statute authorizing the grant and the regulations of this part. The date 
specified by the Secretary as the beginning of the project period shall 
be no later than 9 months following the date of any initial or new award 
statement unless the Secretary finds that because of the nature of a 
project or the grantee's particular circumstances earlier assurance of 
grant support is required to initiate the project. Any funds granted 
under this part shall be expended solely for the purposes for which the 
funds were granted in accordance with the approved application and 
budget, the regulations of this part, the terms and conditions of the 
award and the applicable cost principles prescribed in 45 CFR part 75, 
subpart E.
    (b) Evaluation of unapproved drug treatments for AIDS. Grants under 
section 2314 of the Act to support research relating to the evaluation 
of drug treatments for AIDS not approved by

[[Page 306]]

the Commissioner of Food and Drugs, shall be subject to appropriate 
scientific and ethical guidelines established by the Secretary for each 
project, pursuant to section 2314(c) of the Act. In order to receive a 
grant, the applicant must agree to comply with those guidelines.
    (c) Notice of grant award. (1) The notice of grant award specifies 
how long HHS intends to support the project without requiring the 
project to recompete for funds. This period, called the project period, 
will usually be for 1-5 years.
    (2) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit an application at the time and in the form and 
manner as the Secretary may prescribe to have support continued for each 
subsequent year.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Multiple or concurrent awards. Whenever a research project 
involves a number of different but related problems, activities or 
disciplines which require evaluation by different groups, or whenever 
support for a project could be more effectively administered by separate 
handling of separate aspects of the project, the Secretary may evaluate, 
approve, and make one or more awards pursuant to one or more 
applications. When making more than one award in response to a single 
application, the Secretary shall consult with the applicant 
organization(s), as appropriate.
    (e) Unobligated balances. The Secretary may permit unobligated grant 
funds remaining in the grant account at the close of a budget period to 
be carried forward for obligation during a subsequent budget period, 
provided a continuation award is made for that period and the 
Secretary's written approval is obtained.
    (f) Award for continuation of project under new grantee. The 
Secretary, upon application in accordance with the provisions of Sec.  
52.4 and without further action by a Council or other body, may make a 
grant to any institution or other person eligible under Sec.  52.3 for 
continuation of a currently supported project for which a grant was 
previously made to another institution or person, provided the Secretary 
finds that the change in the conduct of the project is consonant with 
the previous evaluation and approval of the project under Sec.  52.5.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 61 FR 55105, 
Oct. 24, 1996; 74 FR 57921, Nov. 10, 2009; 81 FR 3007, Jan. 20, 2016]



Sec.  52.7  Use of funds; changes.

    (a) Delegation of fiscal responsibility. The grantee may not in 
whole or in part delegate or transfer to another person responsibility 
for the use or expenditure of grant funds.
    (b) Changes in project. The permissible changes by the principal 
investigator in the approved project shall be limited to changes in 
methodology, approach or other aspects of the project to expedite 
achievement of the project's research objectives, including changes that 
grow out of the approved project and serve the best scientific strategy. 
If the grantee and the principal investigator are uncertain whether a 
change complies with this provision, the question must be referred to 
the Secretary for a final determination.
    (c) Changes in project period. The project period determined 
pursuant to Sec.  52.5(b) may be extended by the Secretary, with or 
without additional grant support, for such an additional period as the 
Secretary determines may be required to complete, or fulfill the 
purposes of, the approved project.

[45 FR 12240, Feb. 25, 1980]



Sec.  52.8  Other HHS regulations and policies that apply.

    Several other HHS policies and regulations apply to grants under 
this part. These include, but are not necessarily limited to:

37 CFR part 401--Rights to inventions made by nonprofit organizations 
and small business firms under government grants, contracts, and 
cooperative agreements
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science

[[Page 307]]

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectively in research for which PHS funding is sought
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research.

    Note: This policy is subject to changes, and interested persons 
should contact the Office of Research on Women's Health, NIH, Room 201, 
Building 1, MSC 0161, BETHESDA, MD 20892-0161 (301-402-1770; not a toll-
free number) to obtain references to the current version and any 
amendments.]

59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to changes, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (301-496-
9838; not a toll-free number) to obtain references to the current 
version and any amendments.]

``PHS Grants Policy Statement,'' DHHS Publication No. (OASH) 94-50,000 
(Rev.) April 1, 1994.

    Note: This policy is subject to changes, and interested persons 
should contact the Grants Policy Branch, OASH, Room 17A45, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857 (301-443-1874; not a 
toll-free number) to obtain references to the current version and any 
amendments.]

``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986).

    Note: This policy is subject to changes, and interested persons 
should contact the Office for Protection from Research Risks, NIH, Suite 
3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-
496-7005; not a toll-free number) to obtain references to the current 
version and any amendments.]

[61 FR 55106 Oct. 24, 1996, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  52.9  Additional conditions.

    The Secretary may with respect to any grant award or class of awards 
impose additional conditions prior to or at the time of any award when 
in the Secretary's judgment such conditions are necessary to assure or 
protect advancement of the approved project, the interests of the public 
health, or the conservation of grant funds.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]



PART 52a_NATIONAL INSTITUTES OF HEALTH CENTER GRANTS--Table of Contents



Sec.
52a.1 To which programs do these regulations apply?
52a.2 Definitions.
52a.3 Who is eligible to apply?
52a.4 What information must each application contain?
52a.5 How will NIH evaluate applications?
52a.6 Information about grant awards.
52a.7 For what purposes may a grantee spend grant funds?
52a.8 Other HHS regulations and policies that apply.
52a.9 Additional conditions.

    Authority: 42 U.S.C. 216, 284g, 285a-6(c)(1)(E), 285a-7(c)(1)(G), 
285b-4, 285c-5, 285c-8, 285d-6, 285e-2, 285e-3, 285e-10a, 285f-1, 285g-
5, 285g-7, 285g-9, 285m-3, 285o-2, 286a-7(c)(1)(G), 287c-32(c), 300cc-
16.

    Source: 57 FR 61006, Dec. 23, 1992, unless otherwise noted.



Sec.  52a.1  To which programs do these regulations apply?

    (a) The regulations of this part apply to grants by the National 
Institutes of Health and its organizational components to support the 
planning, establishment, expansion, and operation of research and 
demonstration and/or

[[Page 308]]

multipurpose centers in health fields described in this paragraph. 
Specifically, these regulations apply to:
    (1) National Institute of Mental Health centers of excellence with 
respect to research on autism, as authorized by section 409C of the Act 
(42 U.S.C. 284g);
    (2) National cancer research and demonstration centers (including 
payments for construction), as authorized by section 414 of the Act (42 
U.S.C. 285a-3);
    (3) National cancer research and demonstration centers with respect 
to breast cancer, as authorized by section 417 of the Act (42 U.S.C. 
285a-6);
    (4) National cancer and demonstration centers with respect to 
prostate cancer, as authorized by section 417A of the Act (42 U.S.C. 
285a-7);
    (5) National research and demonstration centers for heart, blood 
vessel, lung, and blood diseases, sickle cell anemia, blood resources, 
and pediatric cardiovascular diseases (including payments for 
construction), as authorized by section 422 of the Act (42 U.S.C. 485b-
4);
    (6) Research and training centers (including diabetes mellitus, and 
digestive, endocrine, metabolic, kidney and urologic diseases), as 
authorized by section 431 of the Act (42 U.S.C. 285c-5);
    (7) Research and training centers regarding nutritional disorders, 
as authorized by section 434 of the Act (42 U.S.C. 285c-8);
    (8) Multipurpose arthritis and musculoskeletal diseases centers 
(including payments for alteration, but not construction), as authorized 
by section 441 of the Act (42 U.S.C. 285d-6);
    (9) Alzheimer's disease centers, as authorized by section 445 of the 
Act (42 U.S.C. 285e-2);
    (10) Claude D. Peppers Older Americans Independence Centers, as 
authorized by section 445A of the Act (42 U.S.C. 285e-3);
    (11) Centers of excellence in Alzheimer's disease research and 
treatment, as authorized by section 445I of the Act (42 U.S.C. 285e-
10a);
    (12) Research centers regarding chronic fatigue syndrome, as 
authorized by section 447 of the Act (42 U.S.C. 285f-1);
    (13) Research centers with respect to contraception and infertility, 
as authorized by section 452A of the Act (42 U.S.C. 285g-5);
    (14) Child health research centers, as authorized by section 452C of 
the Act (42 U.S.C. 285g-7);
    (15) Fragile X research centers, as authorized by 452E of the Act 
(42 U.S.C. 285g-9);
    (16) Multipurpose deafness and other communication disorders 
centers, as authorized by section 464C of the Act (42 U.S.C. 285m-3);
    (17) National drug abuse research centers, as authorized by section 
464N of the Act (42 U.S.C. 285o-2);
    (18) Centers of excellence in biomedical and behavioral research 
training for individuals who are members of minority health disparity 
populations or other health disparity populations, as authorized by 
section 485F of the Act (42 U.S.C. 287c-32); and
    (19) Centers for acquired immunodeficiency syndrome (AIDS) research, 
as authorized by section 2316 of the Act (42 U.S.C. 300cc-16).
    (b) This part does not apply to:
    (1) Grants for construction (see 42 CFR part 52b), except as noted 
in paragraph (a) of this section;
    (2) Grants covered by 42 CFR part 52 (grants for research projects); 
or
    (3) Grants for general research support under section 301(a)(3) of 
the Act (42 U.S.C. 241(a)(3)).
    (c) This part also applies to cooperative agreements made to support 
the centers specified in paragraph (a) of this section. When a reference 
is made in this part to ``grants,'' the reference shall include 
``cooperative agreements.''

[61 FR 55108, Oct. 24, 1996, as amended at 68 FR 69621, Dec. 15, 2003]



Sec.  52a.2  Definitions.

    As used in this part:
    Act means the Public Health Services Act, as amended (42 U.S.C. 201 
et seq.).
    Center means:
    (a) For purposes of grants authorized by section 409C of the Act, a 
public or nonprofit private entity which provides for planning and 
conducting basic and clinical research into the cause, diagnosis, early 
detection, prevention, control, and treatment of autism, including the 
fields of developmental

[[Page 309]]

neurobiology, genetics, and psychopharmacology;
    (b) For purposes of grants authorized by section 414 of the Act, an 
agency or institution which provides for planning and conducting basic 
and clinical research into, training in, and demonstration of advanced 
diagnostic, control, prevention and treatment methods for cancer;
    (c) For purposes of grants authorized by section 417 of the Act, an 
agency or institution which provides for planning and conducting basic, 
clinical, epidemiological, psychological, prevention and treatment 
research and related activities on breast cancer;
    (d) For purposes of grants authorized by section 417A of the Act, an 
agency or institution which provides for planning and conducting basic, 
clinical, and epidemiological, psychosocial, prevention and control, 
treatment, research, and related activities on prostate cancer;
    (e) For purposes of grants authorized by section 422 of the Act, an 
agency or institution which provides for planning and basic and clinical 
research into, training in, and demonstration of, management of blood 
resources and advanced diagnostic, prevention, and treatment methods 
(including emergency services) for heart, blood vessel, lung, or blood 
diseases including sickle cell anemia;
    (f) For purposes of grants authorized by section 431 of the Act, a 
single institution or a consortium of cooperating institutions, which 
conducts research, training, information programs, epidemiological 
studies, data collection activities and development of model programs in 
diabetes mellitus and related endocrine and metabolic diseases;
    (g) For purposes of grants authorized by section 434 of the Act, a 
single institution or a consortium of cooperating institutions which 
conducts basic and clinical research, training, and information programs 
in nutritional disorders, including obesity;
    (h) For purposes of grants authorized by section 441 of the Act, a 
facility which conducts basic and clinical research into arthritis and 
musculosketal diseases; and orthopedic procedures, training, and 
information programs for the health community and the general public;
    (i) For purposes of grants authorized by section 445 of the Act, a 
public or private nonprofit entity (including university medical 
centers) which conducts basic and clinical research (including 
multidisciplinary research) into, training in, and demonstration of 
advanced diagnostic, prevention, and treatment methods for Alzheimer's 
disease;
    (j) For purposes of grants authorized by section 445A of the Act, a 
single public or private nonprofit institution or entity or a consortium 
of cooperating institutions or entities which conducts research into the 
aging processes and into the diagnosis and treatment of diseases, 
disorders, and complications related to aging, including menopause, 
which research includes research on such treatments, and on medical 
devices and other medical interventions regarding such diseases, 
disorders, and complications, that can assist individuals in avoiding 
institutionalization and prolonged hospitalization and in otherwise 
increasing the independence of the individuals.
    (k) For the purposes of section 445I of the Act, a single 
institution or consortium of cooperating institutions which conducts 
basic and clinical research on Alzheimer's disease.
    (l) For purposes of grants authorized by section 447 of the Act, a 
single institution or consortium of cooperating institutions which 
conducts basic and clinical research on chronic fatigue syndrome;
    (m) For purposes of grants authorized by section 452A of the Act, a 
single institution or consortium of cooperating institutions which 
conducts clinical and other applied research, training programs, 
continuing education programs, and information programs with respect to 
methods of contraception, and infertility;
    (n) For purposes of grants authorized by section 452C of the Act, an 
agency or institution which conducts research with respect to child 
health, and gives priority to the expeditious transfer of advances from 
basic science to clinical applications and improving the care of infants 
and children;

[[Page 310]]

    (o) For purposes of grants authorized by section 452E of the Act, a 
single institution or a consortium of cooperating institutions which 
conducts research for the purposes of improving the diagnosis and 
treatment of, and finding the cure for, fragile X;
    (p) For purposes of grants authorized by section 464C of the Act, a 
single institution or a consortium of cooperating institutions which 
conducts basic and clinical research into, training in, information and 
continuing education programs for the health community and the general 
public about, and demonstration of, advanced diagnostic, prevention, and 
treatment methods for disorders of hearing and other communication 
processes and complications resulting from these disorders;
    (q) For purposes of grants authorized by section 464N of the Act, 
institutions designated as National Drug Abuse Research Centers for 
interdisciplinary research relating to drug abuse and other biomedical, 
behavioral, and social issues related to drug abuse;
    (r) For purposes of grants authorized by section 485F of the Act, a 
biomedical or behavioral research institution or consortia that:
    (1) Have a significant number of members of minority health 
disparity populations or other health disparity populations enrolled as 
students in the institution (including individuals accepted for 
enrollment in the institution);
    (2) Have been effective in assisting such students of the 
institution to complete the program of education or training and receive 
the degree involved;
    (3) Have made significant efforts to recruit minority students to 
enroll in and graduate from the institution, which may include providing 
means-tested scholarships and other financial assistance as appropriate; 
and
    (4) Have made significant recruitment efforts to increase the number 
of minority or other members of health disparity populations serving in 
faculty or administrative positions at the institution; or
    (s) For the purposes of grants authorized in section 2316 of the 
Act, an entity for basic and clinical research into, and training in, 
advanced diagnostic, prevention, and treatment methods for acquired 
immunodeficiency syndrome (AIDS).
    Director means the Director of NIH or the organizational component 
authorized to award grants to support centers under this part.
    Grant(s) means, unless the context otherwise requires, an award of 
funds to support a center authorized under Sec.  52a.1. The term 
includes cooperative agreement(s).
    NIH means the National Institutes of Health and its organizational 
components that award grants.
    Nonprofit as applied to any agency or institution means an agency or 
institution which is a corporation or an association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    Project period means the period of time, from one to five years, 
specified in the notice of grant award that the NIH or the awarding 
component intends to support a proposed center without requiring the 
center to recompete for funds.

[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55108, Oct. 24, 1996; 
68 FR 69621, Dec. 15, 2003]



Sec.  52a.3  Who is eligible to apply?

    (a) Any public or private nonprofit agency, institution, or 
consortium of agencies is eligible to apply for a grant under sections 
409C, 414, 417, 417A, 422, 445, 445A, 445I, 447, 452A, and 2316 of the 
Act.
    (b) Any public or private nonprofit or for-profit agency, 
institution, or consortium of agencies is eligible to apply for a grant 
under sections 428, 431, 434, 441, 452C, 452E, 464C, 464J, 464N, and 
485F of the Act.
    (c) Any applicant under this part must be located in a State, the 
District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, or the successor States of the Trust Territory of 
the Pacific Islands (the Federated States of Micronesia, the Republic of 
the Marshall Islands, and the Republic of Palau).

[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996; 
68 FR 69622, Dec. 15, 2003]

[[Page 311]]



Sec.  52a.4  What information must each application contain?

    Each application under this part must include detailed information 
as to the following:
    (a) The personnel, facilities, and other resources available to the 
applicant with which to initiate and maintain the proposed center grants 
program;
    (b) Any research, training, demonstration, or information 
dissemination activities in which the applicant is currently engaged; 
the sources of funding for these activities; and the relevance of these 
activities to the proposed center grants program;
    (c) Proposed research, training, demonstration, and information 
dissemination activities;
    (d) The proposed organizational structure of the center and the 
relationship of the proposed center to the applicant organization(s);
    (e) The names and qualifications of the center director and key 
staff members who would be responsible for conducting the proposed 
activities;
    (f) Proposed methods for monitoring and evaluating individual 
activities and the overall center program;
    (g) Proposed methods for coordinating the center's activities, where 
appropriate, with similar efforts by other public and private 
organizations;
    (h) The availability of any community resources necessary to carry 
out proposed activities; and
    (i) Efforts to be made to generate and collect income from sources 
other than NIH to be used to further the purposes of the center program. 
NIH encourages these efforts. Income may include, but is not limited to, 
that generated from the sale or rental of products or services produced 
by grant-supported activities, such as laboratory tests, computer time, 
and payments received from patients or third parties, where appropriate 
(the disposition of grant-related income is governed by 45 CFR 75.307);
    (j) The proposed budget for the center and a justification for the 
amount of the grant funds requested; and
    (k) Any other information that the Director of the awarding 
institute may request.

(Approved under OMB Control Number 0925-0001)

[57 FR 61006, Dec. 23, 1992, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  52a.5  How will NIH evaluate applications?

    (a) NIH considers the following in evaluating Center grant 
applications:
    (1) The scientific and technical merit of the proposed program;
    (2) The qualifications and experience of the center director and 
other key personnel;
    (3) The statutory and program purposes to be accomplished;
    (4) The extent to which the various components of the proposed 
program would be coordinated into one multi-disciplinary effort within 
the center;
    (5) The extent to which the center's activities would be coordinated 
with similar efforts by other organizations;
    (6) The administrative and managerial capability of the applicant;
    (7) The reasonableness of the proposed budget in relation to the 
proposed program; and
    (8) Other factors which the awarding institute, center, or division 
considers appropriate in light of its particular statutory mission.
    (b) Where required by statute or NIH policy, applications are 
reviewed by appropriate national advisory councils or boards before 
awards are made. NIH grants may be awarded generally only after approval 
recommendations from both appropriate scientific peer review groups and 
national advisory councils or boards.



Sec.  52a.6  Information about grant awards.

    (a) The notice of grant award specifies how long NIH intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (b) Generally, the grant will initially be for one year, and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent

[[Page 312]]

year. Decisions regarding continuation awards and the funding level of 
such awards will be made after consideration of such factors as the 
grantee's progress and management practices, and the availability of 
funds. In all cases, continuation awards require a determination by the 
NIH that continued funding is in the best interest of the Federal 
Government.
    (c) Neither the approval of any application, nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.

(Approved under OMB Control Number 0925-0001)



Sec.  52a.7  For what purposes may a grantee spend grant funds?

    A grantee shall spend funds it receives under this part solely in 
accordance with the approved application and budget, the authorizing 
legislation, the regulations of this part, the terms and conditions of 
the award, and the applicable cost principles prescribed in 45 CFR part 
75, subpart E.

[61 FR 55109, Oct. 24, 1996, as amended at 81 FR 3007, Jan. 20, 2016]



Sec.  52a.8  Other HHS regulations and policies that apply.

    Several other regulations and policies apply to this part. These 
include, but are not necessarily limited to:

42 CFR part 50, Subpart A--Responsibilities of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, Subpart D--Public Health Service grant appeals 
procedures
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Research on Women's Health, NIH, Room 201, 
MSC 0161, BETHESDA, MD 20892-0601 (301-402-1770; not a toll-free number) 
to obtain references to the current version and any amendments.

59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSA 7010, BETHESDA, MD 20892-7010 (301-496-
9838; not a toll-free number) to obtain references to the current 
version and any amendments.

Public Health Service Policy on Humane Care and Use of Laboratory 
Animals, Office of Laboratory Animal Welfare, Office of Extramural 
Research, NIH (Revised September 1986).

    Note: This policy is subject to change, and interested persons 
should contact the Office of Laboratory Animal Welfare, Office of 
Extramural Research, NIH, Rockledge 1, 6705 Rockledge Drive, Bethesda, 
Maryland 20817, telephone 301-594-2382 (not a toll-free number) to 
obtain references to the current version and any amendments.

[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996; 
68 FR 69622, Dec. 15, 2003; 81 FR 3007, Jan. 20, 2016]



Sec.  52a.9  Additional conditions.

    The Director may, with respect to any grant award, impose additional 
conditions prior to or at the time of any award when in the Director's 
judgment the conditions are necessary to assure the carrying out of the 
purposes of the award, the interests of the public

[[Page 313]]

health, or the conservation of grant funds.

[61 FR 55110, Oct. 24, 1996]



PART 52b_NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS--Table of Contents



Sec.
52b.1 To what programs do these regulations apply?
52b.2 Definitions.
52b.3 Who is eligible to apply?
52b.4 How to apply.
52b.5 How will NIH evaluate applications?
52b.6 What is the rate of federal financial participation?
52b.7 How is the grantee obligated to use the facility?
52b.8 How will NIH monitor the use of facilities constructed with 
          federal funds?
52b.9 What is the right of the United States to recover federal funds 
          when facilities are not used for research or are transferred?
52b.10 What are the terms and conditions of awards?
52b.11 What are the requirements for acquisition and modernization of 
          existing facilities?
52b.12 What are the minimum requirements of construction and equipment?
52b.13 Additional conditions.
52b.14 Other federal laws, regulations, executive orders, and policies 
          that apply.

    Authority: 42 U.S.C. 216, 285a-2, 285a-3, 285b-3, 285b-4, 285d-6, 
285i, 285m-3, 285o-4, 287a-2, 287a-3, 300cc-41.

    Source: 64 FR 63722, Nov. 22, 1999, unless otherwise noted.



Sec.  52b.1  To what programs do these regulations apply?

    (a) General. Except as provided in paragraph (c) of this section, 
this part applies to all grants awarded by NIH and its components for 
construction of new buildings and the alteration, renovation, 
remodeling, improvement, expansion, and repair of existing buildings, 
including the provision of equipment necessary to make the building (or 
applicable part of the building) suitable for the purpose for which it 
was constructed.
    (b) Specific programs covered. From time to time the Director may 
publish a list of the construction grant programs covered by this part. 
The list is for informational purposes only and is not intended to 
restrict the statement of applicability in paragraph (a) of this 
section. In addition, information on particular construction grant 
programs, including applications and instructions, may be obtained from 
the component of NIH that administers the program.
    (c) Specific programs excluded. The regulations of this part do not 
apply to minor alterations, renovations, or repairs funded under a 
research project grant (see part 52 of this chapter) or alterations or 
renovations funded under an NIH center grant (see part 52a of this 
chapter).



Sec.  52b.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Construction means the construction of new buildings or the 
modernization of, or the completion of shell space in, existing 
buildings (including the installation of fixed equipment), but excluding 
the cost of land acquisition and off-site improvements.
    Construction grant means funds awarded for construction in 
accordance with the applicable provisions of the Act and this part.
    Director means the Director of NIH or the director of an NIH 
national research institute, center, or other component of NIH, 
authorized to award grants for construction under the applicable 
provisions of the Act, and any official to whom the authority involved 
is delegated.
    Federal share with respect to any construction project means the 
proportion, expressed as a percentage, of the cost of a project to be 
paid by a grant award under the Act.
    HHS, DHHS, and Department mean the Department of Health and Human 
Services.
    Institute means any national research institute, center, or other 
agency of the National Institutes of Health.
    Modernization means the alteration, renovation, remodeling, 
improvement, expansion, and/or repair of existing buildings and the 
provision of equipment necessary to make the building suitable for use 
for the purposes of the particular program.

[[Page 314]]

    NIH means the National Institutes of Health and its organizational 
components that award construction grants.
    Nonprofit as applied to any agency or institution means an agency or 
institution which is a corporation or an association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    Project means the particular construction activity which is 
supported by a grant under this part.
    Secretary means the Secretary of Health and Human Services and any 
official to whom the authority involved is delegated.



Sec.  52b.3  Who is eligible to apply?

    In order to be eligible for a construction grant under this part, 
the applicant must:
    (a) Be a public or private nonprofit agency or institution;
    (b) Be located in a state, the District of Columbia, Puerto Rico, 
the Virgin Islands, the Canal Zone, Guam, American Samoa, or the 
successor states of the Trust Territory of the Pacific Islands (the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau); and
    (c) Meet any additional eligibility criteria specified in the 
applicable provisions of the Act.



Sec.  52b.4  How to apply.

    Applications for construction grants under this part shall be made 
at the times and in the form and manner as the Secretary may prescribe.



Sec.  52b.5  How will NIH evaluate applications?

    (a) In evaluating and approving applications for construction grants 
under this part, the Director shall take into account, among other 
pertinent factors, the following:
    (1) The priority score assigned to the application by an NIH peer 
review group as described in paragraph (b) of this section;
    (2) The relevance of the project for which construction is proposed 
to the objectives and priorities of the particular program authorized by 
the Act;
    (3) The scientific merit of the research activities that will be 
carried out in the proposed facility;
    (4) The scientific or professional standing or reputation of the 
applicant and of its existing or proposed officers and research staff;
    (5) The availability, by affiliation or other association, of other 
scientific or health personnel and facilities to the extent necessary to 
carry out effectively the program proposed for the facility, including 
the adequacy of an acceptable biohazard control and containment program 
when warranted;
    (6) The need for the facility and its total effects on similar or 
related facilities in the locale, and the need for appropriate 
geographic distribution of similar facilities; and
    (7) The financial need of the applicant.
    (b) The priority score of the application shall be based, among 
other pertinent factors, on the following criteria:
    (1) The scientific merit of the total program and its component 
parts to be carried out in the facility;
    (2) The administrative and leadership capabilities of the 
applicant's officers and staff;
    (3) The organization of the applicant's research program and its 
relationship with the applicant's overall research programs;
    (4) The anticipated effect of the project on other relevant research 
programs and facilities in the geographic area, and nationwide;
    (5) The need for the project or additional space; and
    (6) The project cost and design.



Sec.  52b.6  What is the rate of federal financial participation?

    (a) Unless otherwise specified by statute, the rate of federal 
financial participation in a construction project supported by a grant 
under this part shall not be more than 50 percent of the necessary 
allowable costs of construction as determined by the Director, except 
that when the Director finds good cause for waiving this limitation, the 
amount of the construction grant may be more than 50 percent of the 
necessary allowable costs of construction.

[[Page 315]]

    (b) Subject to paragraph (a) of this section, the Director shall set 
the actual rate of federal financial participation in the necessary 
allowable costs of construction, taking into consideration the most 
effective use of available federal funds to further the purposes of the 
applicable provisions of the Act.



Sec.  52b.7  How is the grantee obligated to use the facility?

    (a) The grantee shall use the facility (or that portion of the 
facility supported by a grant under this part) for its originally 
authorized purpose so long as needed for that purpose, or other period 
prescribed by statute, unless the grantee obtains advance approval from 
the Director, in the form and manner as the Director may prescribe, to 
use the facility for another purpose. Use for other purposes shall be 
limited as prescribed in Sec.  52b.9(c)(2).
    (b) The Director, in determining whether to approve an alternative 
use of the facility, shall take into consideration the extent to which:
    (1) The facility will be used by the grantee or other owner for a 
purpose described in Sec.  52b.9(c)(2); or
    (2) There are reasonable assurances that alternative facilities not 
previously used for NIH supported research will be utilized to carry out 
the original purpose as prescribed in Sec.  52b.9(c)(1).
    (c) Sale or transfer. In the form and manner as the Director may 
prescribe, the grantee may request the Director's approval to sell the 
facility or transfer title to a third party eligible under Sec.  52b.3 
for continued use of the facility for an authorized purpose in 
accordance with paragraphs (a) and (b) of this section. If approval is 
permissible under the Act or other federal statute and is granted, the 
terms of the transfer shall provide that the transferee shall assume all 
the rights and obligations of the transferor set forth in 45 CFR part 
75, the regulations of this part, and the other terms and conditions of 
the grant.

[64 FR 63722, Nov. 22, 1999, as amended at 81 FR 3008, Jan. 20, 2016]



Sec.  52b.8  How will NIH monitor the use of facilities constructed 
with federal funds?

    NIH may monitor the use of each facility constructed with funds 
awarded under this part to ensure its continued use for the originally 
authorized research purpose, by means of reviewing periodic facility use 
certifications or reports, site visits, and other appropriate means.



Sec.  52b.9  What is the right of the United States to recover Federal funds 
when facilities are not used for research or are transferred?

    (a) If the grantee plans to cease using the facility for the 
particular biomedical research or training purposes for which it was 
constructed as required by Sec.  52b.7 (or alternate use authorized 
under Sec.  52b.7(a) or paragraph (c) of this section), or the grantee 
decides to sell or transfer title to an entity ineligible for a grant 
under Sec.  52b.3, the grantee shall request disposition instructions 
from NIH in the form and manner as the Director may prescribe. Those 
instructions shall provide for one of the following alternatives:
    (1) The facility may be sold and the grantee or transferee shall pay 
to the United States an amount computed by multiplying the federal share 
of the facility times the proceeds from the sale (after deducting the 
actual and reasonable selling and fix-up expenses, if any, from the 
sales proceeds). The sales procedures must provide for competition to 
the extent practicable, and be designed to provide the highest possible 
return;
    (2) The grantee may retain title and shall pay to the United States 
an amount computed by multiplying the current fair market value of the 
facility by the federal share of the facility; or
    (3) The grantee shall transfer the title to either the United States 
or to an eligible non-federal party approved by the Director. The 
grantee shall be entitled to be paid an amount computed by multiplying 
the current fair market value of the facility by the nonfederal share of 
the facility.
    (b) The grantee or transferor of a facility which is sold or 
transferred, or the owner of a facility the use of which

[[Page 316]]

has changed, as described in paragraph (a) of this section, shall report 
that action in writing to the Director not later than 10 days from the 
date on which the sale, transfer, or change occurs, in the form and 
manner as the Director may prescribe.
    (c) In lieu of disposition of a facility pursuant to the provisions 
of paragraph (a) of this section, the Director may, for good cause, 
supported by assurances provided by the grantee or transferee, approve 
one of the following alternatives:
    (1) Transfer of the remaining usage obligation to facilities of 
substantially comparable or greater value or utility, to carry out the 
biomedical research or training purpose for which the grant was awarded. 
In this event, the remaining usage obligation shall be released from the 
original facility constructed with grant funds and transferred to the 
new facility, and the grantee shall remain subject to all other 
requirements imposed under this part with respect to the new facility; 
or
    (2) Use the facility for as long as needed, in order of priority, 
for one of the following purposes:
    (i) For other health related activities consistent with the purposes 
of one or more of the activities of the awarding institute as authorized 
under title IV or other provisions of the Act;
    (ii) To provide training and instruction in the health fields for 
health professionals or health related information programs for the 
public; or
    (iii) Other health related purposes consistent with one or more of 
the purposes authorized under the Act.
    (d) The right of recovery of the United States set forth in 
paragraph (a) of this section shall not, prior to judgment, constitute a 
lien on any facility supported in whole or in part by a federal grant, 
including a construction grant under this part.
    (e) Any amount required to be paid to the United States under this 
section will be paid to the awarding institute for disposition as 
required by law.

(Approved by the Office of Management and Budget under Control Number 
0925-0424; expires November 30, 2001)



Sec.  52b.10  What are the terms and conditions of awards?

    In addition to any other requirement imposed by law or determined by 
the Director to be reasonably necessary to fulfill the purposes of the 
grant, each construction grant shall be subject to the terms and 
conditions and the grantee assurances required by this section, 
supported by such documentation as the Director may reasonably require. 
The Director may, by general policy or for good cause shown by an 
applicant, approve exceptions to these terms and conditions or 
assurances where the Director finds that the exceptions are consistent 
with the applicable provisions of the Act and the purposes of the 
particular program:
    (a) Title. The applicant must have a fee simple or other estate or 
interest in the site, including necessary easements and rights-of-way, 
sufficient to assure for the estimated useful life of the facility, as 
determined by the Director, undisturbed use and possession for the 
purpose of the construction and operation of the facility.
    (b) Plans and specifications. Approval by the Director of the final 
working drawings, specifications, and cost estimates must be obtained 
before the project is advertised or placed on the market for bidding. 
The approval must include a determination by the Director that the final 
plans and specifications conform to the minimum standards of 
construction and equipment as set forth in Sec.  52b.12.
    (c) Relocation assistance. An applicant with an approved project 
which involves the displacement of persons or businesses shall comply 
with the provisions of the Uniform Relocation Assistance and Real 
Property Acquisition Policies Act of 1970, as amended (42 U.S.C. 4601 et 
seq.) and the applicable regulations issued under that Act (45 CFR part 
15; 49 CFR part 24).
    (d) Approval of changes in estimated cost. Unless approved by the 
Director, the applicant shall not enter into any construction contracts 
for the project or a part of the project, the cost of which exceeds the 
estimated cost approved in the terms of an award for that portion of the 
work covered by the plans and specifications. Exceptions

[[Page 317]]

shall be requested in the form and manner as the Director may prescribe.
    (e) Completion responsibility. The applicant must construct the 
project, or cause it to be constructed, to final completion in 
accordance with the grant application, the terms and conditions of the 
award, and the approved plans and specifications.
    (f) Construction schedule inspection. Prior to the start of 
construction, the grantee shall submit an approved copy of the 
construction schedule (critical path method) to the Director in the form 
and manner as the Director may prescribe.
    (g) Construction management. The applicant must provide and maintain 
competent and adequate construction management services for inspection 
at the construction site to ensure that the completed work conforms with 
the approved plans and specifications. Construction management services 
shall include daily construction logs and monthly status reports which 
shall be maintained at the job site and shall be submitted to the 
Director at the times and in the form and manner as the Director may 
prescribe.
    (h) Nonfederal share. Sufficient funds must be available to meet the 
nonfederal share of the costs of constructing the facility.
    (i) Funds for operation. Sufficient funds must be available when 
construction is completed for effective use of the facility for the 
purposes for which it is being constructed.
    (j) Inspection. The Director and the Director's representatives 
shall have access at all reasonable times to all work areas and 
documents during any stage of construction and the contractor shall 
provide proper facilities for this access and inspection.
    (k) Accessibility to handicapped persons. The facility must be 
designed to comply with the Uniform Federal Accessibility Standards (41 
CFR part 101-19, subpart 101-19.6, Appendix A), as modified by other 
standards prescribed by the Director or the Administrator of General 
Services. The applicant shall conduct inspections to ensure compliance 
with these specifications by the contractor.
    (l) Notice of Federal Interest. The grantee shall record a Notice of 
Federal Interest in the appropriate official land records of the 
jurisdiction in which the property is located.
    (m) Title insurance. The grantee shall purchase a title insurance 
policy unless a legal opinion has been provided which certifies that the 
grantee institution has fee simple title to the site free and clear of 
all liens, easements, rights-of-way, and any other adverse interests 
which would encumber the project. The Director may waive this 
requirement upon a request from the grantee adequately documenting self-
insurance against the risks involved and containing such other 
information as the Director may prescribe.
    (n) Physical destruction insurance. At the time construction is 
completed or at the time of beneficial occupancy, whichever comes first, 
the grantee shall purchase an insurance policy which insures the 
facility for the full appraised value of the property using state 
certified appraisers. The insurance policy must protect the property 
from total and partial physical destruction. The insurance policy must 
be maintained throughout the period of federal interest. The Director 
may waive this requirement upon a written request from the grantee 
adequately documenting self-insurance against the risks involved and 
containing such other information as the Director may prescribe.

(Approved by the Office of Management and Budget under Control Number 
0925-0424; expires November 30, 2001)



Sec.  52b.11  What are the requirements for acquisition and modernization 
of existing facilities?

    Grant awards for the acquisition and modernization of existing 
facilities are permitted if authorized by the statutes authorizing the 
construction grant program and shall be subject to the requirements of 
this section.
    (a) Minimum standards of construction and equipment. A determination 
by the Director that the facility conforms (or upon completion of any 
necessary construction will conform) to the minimum standards of 
construction and equipment as set forth in Sec.  52b.12 shall be 
obtained before entering into a final

[[Page 318]]

or unconditional contract for the acquisition and/or modernization of 
facilities. Where the Director finds that exceptions to or modifications 
of these minimum standards would be consistent with the purposes of the 
applicable section of the Act under which the acquisition or 
modernization is supported, the Director may authorize the exceptions or 
modifications.
    (b) Estimated cost of acquisition and remodeling: suitability of 
facility. Each application for a project involving the acquisition of 
existing facilities shall include in the detailed estimates of the costs 
of the project, the cost of acquiring the facilities, and any cost of 
remodeling, renovating or altering the facilities to serve the purposes 
for which they are acquired. The application shall demonstrate to the 
satisfaction of the Director that the architectural, mechanical, 
electrical, plumbing, structural, and other pertinent features of the 
facility, as modified by any proposed expansion, remodeling, renovation, 
or alteration, will be suitable for the purposes of the applicable 
sections of the Act.
    (c) Bona fide sale. Grant awards for the acquisition of existing 
facilities shall be subject to the condition that the acquisition 
constitutes a bona fide sale involving an actual cost to the applicant 
and will result in additional or improved facilities for purposes of the 
applicable provisions of the Act.
    (d) Facility previously funded by a federal grant. No grant for the 
acquisition or modernization of a facility which has previously been 
funded in whole or in part by a federal grant for construction, 
acquisition, or equipment shall serve either to reduce or restrict the 
liability of the applicant or any other transferor or transferee from 
any obligation of accountability imposed by the Federal Government by 
reason of the prior grant.

(Approved by the Office of Management and Budget under Control Number 
0925-0424; expires November 30, 2001)



Sec.  52b.12  What are the minimum requirements of construction and equipment?

    (a) General. In addition to being subject to other laws, 
regulations, executive orders, and policies referred to in Sec.  52b.14, 
the standards set forth in this section have been determined by the 
Director to constitute minimum requirements of construction and 
equipment, including the expansion, remodeling, renovation, or 
alteration of existing buildings, and these standards, as may be 
amended, or any revisions or successors of these standards, shall apply 
to all projects for which federal assistance is requested under this 
part. The publications referenced in this section are hereby 
incorporated by reference and made a part of the regulations in this 
part.
    (b) Incorporation by reference. The Director of the Federal Register 
approves the incorporations by reference in paragraph (c) of this 
section in accordance with 5 U.S.C. 552(a)(1) and 1 CFR part 51. Copies 
may also be obtained from the organizations at the addresses listed in 
paragraph (c) of this section. Copies may be inspected at the National 
Cancer Institute, Executive Plaza North, Room 539, 6130 Executive 
Boulevard, Rockville, MD 20852 (telephone 301-496-8534; not a toll-free 
number); the National Center for Research Services, Building 31, Room 
3B11, 9000 Rockville Pike, Bethesda, MD 20892 (telephone 301-496-5793); 
not a toll-free number); and at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. The 
Director may for good cause shown, approve plans and specifications 
which contain deviations from the requirements prescribed in paragraph 
(c) of this section, if the Director is satisfied that the purposes of 
the requirements have been fulfilled. In addition to these requirements, 
each project shall meet the requirements of the applicable state and 
local codes and ordinances relating to construction.
    (c) Design and construction standards. The facility shall comply 
with the following mandatory design and construction standards:
    (1) ``Guidelines for Design and Construction of Hospital and Health 
Care

[[Page 319]]

Facilities'' (1996-97). American Institute of Architects Academy of 
Architecture for Health (AIA); available from AIA Rizzoli Catalogue 
Sales, 117 Post Street, San Francisco, CA 94108 (telephone 1-800-522-
6657, fax 415-984-0024).
    (2) 1995 ASHRAE Handbook: Heating, Ventilating, and Air Conditioning 
Applications (1995), Chapter 13, ``Laboratory Systems.'' American 
Society of Heating, Refrigerating and Air Conditioning Engineers, Inc., 
1791 Tullie Circle, NE, Atlanta, GA 30329 (telephone 404-636-8400).
    (3) ICBO ``Uniform Building Code,'' Volumes 1-3 (1997). 
International Conference of Building Officials (ICBO), 5360 South 
Workman Mill Road, Whittier, CA 90601-2298 (telephone 562-699-0541 or 
800-284-4406).
    (4) BOCA National Building Code (1996) 1998 Supplement, Building 
Officials and Code Administrators International, Inc. (BOCA), 4051 West 
Fossmoor Road, Country Club Hills, IL 60478-5795 (telephone 708-799-
4981; fax 708-799-4981).
    (5) ``Recommended Lateral Force Requirements and Commentary'' 
(1996). Structural Engineers Association of California; available from 
International Conference of Building Officials, 5360 South Workman Mill 
Road, Whittier, CA 90601-2298 (telephone 562-699-0541).
    (6) ``Prudent Practices in the Laboratory: Handling and Disposal of 
Chemicals'' (1995). National Research Council; available from National 
Academy Press, 8700 Spectrum Drive, Landover, MD 20785 (telephone 1-800-
624-6242).
    (7) The following material is available for purchase from the 
National Fire Protection Association (NFPA), 11 Tracy Drive, Avon, MA 
02322-9908 (telephone 617-770-3000 or 1-800-735-0100):
    (i) NFPA 45, ``Standard on Protection for Laboratories Using 
Chemicals'' (1996).
    (ii) NFPA 70, ``National Electric Code'' (1996).
    (iii) NFPA 99, Chapter 4, ``Gas and Vacuum Systems'' (1996).
    (iv) NFPA 101, ``Life Safety Code'' (1997).
    (v) NFPA ``Health Care Facilities Handbook'' (1996).
    (8) NSF Standard No. 49 for Class II (Laminar Flow) Biohazard 
Cabinetry (1992). National Sanitation Foundation (NSF), 3475 Plymouth 
Road, Box 1468, Ann Arbor, MI 48106 (telephone 734-769-9010).
    (9) ACGIH ``Industrial Ventilation: A Manual of Recommended 
Practice'' (1998). American Conference of Governmental Industrial 
Hygienists (ACGIH), 1330 Kemper Meadow Drive, Cincinnati, OH 45240-1634 
(telephone 513-742-2020).
    (10) AIHA ``Laboratory Ventilation Workbook'' (1994). American 
Industrial Hygiene Association (AIHA), 2700 Prosperity Avenue, Suite 
250, Fairfax, VA 22031 (telephone 703-849-8888).
    (11) The following material is available for purchase from the 
Southern Building Code Congress (SBCC), 900 Montclair Road, Birmingham, 
AL 35213-1206 (telephone 205-591-1853; fax 202-591-0075:
    (i) SBCC ``International Standard Plumbing Code'' (1997).
    (ii) SBCC ``Standard Building Code'' (1997).

[64 FR 63722, Nov. 22, 1999, as amended at 69 FR 18803, Apr. 9, 2004]



Sec.  52b.13  Additional conditions.

    The Director may with respect to any grant award impose additional 
conditions consistent with the regulations of this part prior to or at 
the time of any award when in the Director's judgment the conditions are 
necessary to assure or protect advancement of the approved project, the 
purposes of the applicable provisions of the Act, or the conservation of 
grant funds.



Sec.  52b.14  Other federal laws, regulations, executive orders, 
and policies that apply.

    Other federal laws, regulations, executive orders, and policies 
apply to grants under this part. These include, but are not necessarily 
limited to:
    (a) Laws.
    An Act to Provide for the Preservation of Historical and 
Archeological Data (and other purposes), as amended (16 U.S.C. 469 et 
seq.).

Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151 et seq.).
Earthquake Hazards Reduction Act of 1977, as amended (42 U.S.C. 7701 et 
seq.).

[[Page 320]]

Flood Disaster Protection Act of 1973, section 202, as amended (42 
U.S.C. 4106).
National Historic Preservation Act, section 106, as amended (16 U.S.C. 
470f).
Safe Drinking Water Act, as amended (42 U.S.C. 300f et seq.).

    (b) Regulations.

9 CFR part 3--Standards (Animal Welfare).
29 CFR 1910.1450--Occupational exposure to hazardous chemicals in 
laboratories.
36 CFR part 1190--Minimum guidelines and requirements for accessible 
design.
41 CFR part 101-19, subpart 101-19.6--Accommodations for the physically 
handicapped.
41 CFR part 101-19, subpart 101-19.6, Appendix A--Uniform Federal 
accessibility standards.
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science.
42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure.
45 CFR part 15--Uniform relocation assistance and real property 
acquisition for Federal and federally assisted programs.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 46--Protection of human subjects.
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this chapter.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefitting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.
45 CFR part 93--New restrictions on lobbying.
49 CFR part 24--Uniform relocation assistance and real property 
acquisition for Federal and federally assisted programs.

    (c) Executive orders.

Executive Order 11988, Floodplain Management (May 24, 1977)(3 CFR, 1977 
Comp., p. 117).
Executive Order 11990, Protection of Wetlands (May 24, 1977)(3 CFR, 1977 
Comp., p. 121).
Executive Order 12699, Seismic Safety of Federal and Federally Assisted 
or Regulated New Building Construction (January 5, 1990)(3 CFR, 1990 
Comp., p. 269).

    (d) Policies. (1) Design Policy and Guidelines (1996). Division of 
Engineering Services, National Institutes of Health (Note: To obtain 
copies of the policy, interested persons should contact the Division of 
Engineering Services, 9000 Rockville Pike, Building 13, Room 2E43, 
Bethesda, MD 20892 (telephone 301-496-6186; not a toll-free number) or 
visit the following site on the World Wide Web (http://des.od.nih/gov/
nihpol.html).).
    (2) NIH Guidelines on the Inclusion of Women and Minorities as 
Subjects in Clinical Research (1994) (Note: To obtain copies of the 
policy, interested persons should contact the Office of Research on 
Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-
0161 (telephone 301-402-1770; not a toll-free number).).
    (3) NIH Guidelines for Research Involving Recombinant DNA Molecules 
(1994) (Note: To obtain copies of the policy, interested persons should 
contact the Office of Recombinant DNA Activities, NIH, 6000 Executive 
Boulevard, Suite 323, MSC 7010, Bethesda, MD 20892-7010 (telephone 301-
496-9838; not a toll-free number).).
    (4) ``NIH Grants Policy Statement.'' NIH Pub. No. 99-80 (Oct. 1998) 
(Note: To obtain copies of the policy, interested persons should contact 
the Extramural Outreach and Information Resources Office (EOIRO), Office 
of Extramural Research, NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, 
Bethesda, MD 20892-7910 (telephone 301-435-0714; not a toll-free 
number). Information may also be obtained by contacting the EOIRO via 
its e-mail address ([email protected]) and by browsing the NIH 
Home Page site on the World Wide Web (http://www.nih.gov).).
    (5) ``Guide for the Care and Use of Laboratory Animals (1996). 
Institute of Laboratory Animal Resources, Commission on Life Sciences, 
National Research Council (Note: To obtain copies of the policy, 
interested persons should contact the Office for Protection from

[[Page 321]]

Research Risks, NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507, 
Rockville, MD 20852-7507 (telephone 301-496-7005; not a toll-free 
number).).
    (6) ``Public Health Service Policy on Humane Care and Use of 
Laboratory Animals.'' (Rev. Sept. 1986). Office for Protection from 
Research Risks, NIH (Note: To obtain copies of the policy, interested 
persons should contact the Office for Protection from Research Risks, 
NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD 
20852-7507 (telephone 301-496-7005; not a toll-free number).).
    (7) ``Biosafety in Microbiological and Biomedical Laboratories.'' 
DHHS Publication No. (CDC) 88-8395 (1993). Centers for Disease Control 
and Prevention (CDC) (Note: To obtain copies of the policy, interested 
persons should contact the Division of Safety, Occupational Safety and 
Health Branch, NIH, 13 South Drive, Room 3K04, MSC 5760, Bethesda, MD 
20892-5760 (telephone 301-496-2960; not a toll-free number).).
    (8) ``NIH Guidelines for the Laboratory Use of Chemical 
Carcinogens,'' DHHS Publication No. (NIH) 81-2385 (May 1981) (Note: To 
obtain copies of the policy, interested persons should contact the 
Division of Safety, Occupational Safety and Health Branch, NIH, 13 South 
Drive, Room 3K04, MSC 5760, Bethesda, MD 20892-5760 (telephone 301-496-
2960; not a toll-free number).).
    (9) ``NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects (March 6, 1998).'' NIH 
Guide for Grants and Contracts (Note: To obtain copies of the policy, 
interested persons should contact the Office of Extramural Research, 
NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20817-7910 
(telephone 301-435-0714; not a toll-free number). Information may also 
be obtained by browsing the NIH Home Page site on the World Wide Web 
(http://www.nih.gov).).

[64 FR 63722, Nov. 22, 1999, as amended at 81 FR 3008, Jan. 20, 2016]



PART 52c_MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM--Table of Contents



Sec.
52c.1 Applicability.
52c.2 Definitions.
52c.3 Eligibility.
52c.4 Application.
52c.5 Grant awards.
52c.6 Expenditure of grant funds.
52c.7 Other HHS regulations that apply.
52c.8 Additional conditions.

    Authority: 42 U.S.C. 216, 241(a)(3).

    Source: 45 FR 12246, Feb. 25, 1980, unless otherwise noted.



Sec.  52c.1  Applicability.

    The regulations in this part apply to grants (under the Minority 
Biomedical Research Support Program) awarded in accordance with section 
301(a)(3) of the Public Health Service (PHS) Act (42 U.S.C. 241(a)(3)) 
to increase the numbers of ethnic minority faculty, students, and 
investigators engaged in biomedical research, and to broaden the 
opportunities for participation in biomedical research of ethnic 
minority faculty, students, and investigators, by providing general 
support for biomedical research programs at eligible institutions.

[58 FR 61030, Nov. 19, 1993]



Sec.  52c.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Ethnic minorities includes but is not limited to such groups as 
Black Americans, Hispanic Americans, Asian/Pacific Islanders, and 
American Indians/Native Alaskans (Native Americans).
    HHS means the Department of Health and Human Services.
    Nonprofit as applied to any institution means an institution which 
is a corporation or association no part of the net earnings of which 
inures or may lawfully inure to the benefit of any private shareholder 
or individual.
    Program director means a single individual, designated in the grant 
application, who is scientifically trained and has research experience 
and who is responsible for the overall execution of the program 
supported under this part at the grantee institution.
    Secretary means the Secretary of Health and Human Services and any

[[Page 322]]

other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.

[58 FR 61030, Nov. 19, 1993]



Sec.  52c.3  Eligibility.

    To be eligible for a grant under this Program, an applicant must be:
    (a) One of the following:
    (1) A public or private nonprofit university, four year college, or 
other institution offering undergraduate, graduate, or health 
professional degrees, with a traditionally high (more than 50 percent) 
minority student enrollment;
    (2) A public or private nonprofit two year college with a 
traditionally high (more than 50 percent) minority student enrollment;
    (3) A public or private nonprofit university, four year college, or 
other institution offering undergraduate, graduate, or health 
professional degrees, with a student enrollment a significant proportion 
(but not necessarily more than 50 percent) of which is derived from 
ethnic minorities, provided the Secretary determines that said 
institution has a demonstrated commitment to the special encouragement 
of and assistance to ethnic minority faculty, students, and 
investigators; or
    (4) An Indian tribe which has a recognized governing body which 
performs substantial governmental functions, or an Alaska Regional 
Corporation as defined in the Alaska Native Claims Settlement Act (43 
U.S.C. 1601 et seq.), and
    (b) Located in a State, the District of Columbia, Puerto Rico, the 
Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor 
States of the Trust Territory of the Pacific Islands (the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau).

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030, 
Nov. 19, 1993]



Sec.  52c.4  Application.

    An institution interested in applying for a grant under this part 
must submit an application at the time and in the form and manner that 
the Secretary may prescribe.

[58 FR 61030, Nov. 19, 1993]



Sec.  52c.5  Grant awards.

    (a) Within the limits of funds available, and upon such 
recommendation as may be required by law, the Secretary shall award 
grants to those applications with proposed biomedical research programs 
which will, in the Secretary's judgment, best promote the purposes of 
this part, taking into consideration among other pertinent factors:
    (1) The benefits that can be expected to accrue to the national 
effort in biomedical research and in increasing the pool of biomedical 
researchers;
    (2) The institution's capability, from a scientific and technical 
standpoint, to engage in biomedical research;
    (3) The benefits that can be expected to accrue to the institution 
and its students;
    (4) The administrative and managerial capability and competence of 
the applicant;
    (5) The availability of the facilities and resources (including 
where necessary collaborative arrangements with other institutions) to 
engage in biomedical research;
    (6) The applicant's relative need for funding; and
    (7) The overall significance of the proposal in terms of numbers of 
ethnic minority persons benefited thereby.
    (b) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (c) Generally the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in

[[Page 323]]

any way to make any additional, supplemental, continuation, or other 
award with respect to any approved application or portion of an approved 
application.

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030, 
Nov. 19, 1993]



Sec.  52c.6  Expenditure of grant funds.

    (a) Any funds granted pursuant to this part shall be expended solely 
for the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the terms 
and conditions of the award, and the applicable cost principles 
prescribed by 45 CFR part 75, subpart E.
    (b) The Secretary may permit unobligated grant funds remaining in 
the grant account at the close of a budget period to be carried forward 
for obligation during a subsequent budget period, provided a 
continuation award is made for that period and the Secretary's written 
approval is obtained. The amount of any subsequent award will take into 
consideration unobligated grant funds remaining in the grant account.

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 45 FR 68392, 
Oct. 15, 1980; 81 FR 3008, Jan. 20, 2016]



Sec.  52c.7  Other HHS regulations that apply.

    Several other regulations and policies apply to grants under this 
part. These include, but are not necessarily limited to:

37 CFR part 401--Rights to inventions made by nonprofit organizations 
and small business firms under government grants, contracts, and 
cooperative agreements
42 CFR part 50, subpart A--Responsibilities of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals 
procedures
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs 
and activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying
51 FR 16958, or successor--NIH Guidelines for Research Involving 
Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986), or successor

[58 FR 61030, Nov. 19, 1993, as amended at 81 FR 3008, Jan. 20, 2016]



Sec.  52c.8  Additional conditions.

    The Secretary may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in the Secretary's 
judgment those conditions are necessary to assure or protect advancement 
of the approved program, the interests of the public health, or the 
conservation of grant funds.



PART 52d_NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM--
Table of Contents



Sec.
52d.1 Applicability.
52d.2 Definitions.
52d.3 Eligibility.
52d.4 Application.
52d.5 Program requirements.
52d.6 Grant awards.
52d.7 Expenditure of grant funds.
52d.8 Other HHS regulations that apply.
52d.9 Additional conditions.

    Authority: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 
U.S.C. 216); sec. 404(a)(4), 92 Stat. 3426 (42 U.S.C. 285).

    Source: 45 FR 12247, Feb. 25, 1980, unless otherwise noted.

[[Page 324]]



Sec.  52d.1  Applicability.

    The regulations in this part apply to grants under the Clinical 
Cancer Education Program authorized by section 404(a)(4) of the Public 
Health Service Act, to encourage planning and development of 
multidisciplinary educational programs aimed at achieving optimal care 
of cancer patients and to enable students in the health professions to 
acquire basic knowledge of neoplastic disease and the preventive 
measures and diagnostic and therapeutic skills necessary to the 
provision of such care.



Sec.  52d.2  Definitions.

    (a) Act means the Public Health Service Act, as amended.
    (b) Director, NCI, means the Director of the National Cancer 
Institute and any other officer or employee of said Institute to whom 
the authority involved has been delegated.
    (c) [Reserved]
    (d) Board means the National Cancer Advisory Board established by 
section 407 of the Act (42 U.S.C. 286b).
    (e) Affiliated teaching hospital means a hospital which, although 
not owned by such school, has a written agreement with a school of 
medicine, osteopathy, dentistry, or public health eligible for 
assistance under this part, providing for effective control by the 
school of the teaching in the hospital.
    (f) Specialized cancer institute means an institution which has as 
its primary mission the diagnosis, prevention, or treatment of cancer.

[45 FR 12247, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980, as amended at 
47 FR 53012, Nov. 24, 1982]



Sec.  52d.3  Eligibility.

    To be eligible for a grant under this part, an applicant must be:
    (a) A public or private school of medicine, osteopathy, dentistry, 
or public health, affiliated teaching hospital, or specialized cancer 
institute; and
    (b) Located in a State, the District of Columbia, Puerto Rico, the 
Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust 
Territory of the Pacific Islands.

[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]



Sec.  52d.4  Application.

    (a) Application for a grant under this subpart shall be made on an 
authorized form. \1\ Applicants shall submit completed forms, on or 
before the dates the Director, NCI, may prescribe.
---------------------------------------------------------------------------

    \1\ Applications and instructions are available from the Division of 
Cancer Research Resources and Centers, Education Branch, Westwood 
Building, 5333 Westbard Avenue, Bethesda, MD 20205.
---------------------------------------------------------------------------

    (b) [Reserved]
    (c) In addition to any other pertinent information that the 
Director, NCI, may require, each application shall set forth in detail:
    (1) A program plan defining the objectives of the proposed program 
and the means by which these objectives would be achieved, including 
descriptions of:
    (i) The general educational level (e.g., pre-doctoral, post-
doctoral) of the students to be involved in the program;
    (ii) The proposed course of study and its relation to the diagnosis, 
prevention, control, and treatment of cancer;
    (iii) The clinical experiences to be provided to the students;
    (iv) Multidisciplinary aspects of the program;
    (v) The particular schools or branches within the institution which 
would have responsibility for individual aspects of the program; and
    (vi) The teaching mechanisms to be employed, including specific 
discussion of those techniques which would be innovative.
    (2) The availability of personnel, facilities, and resources needed 
to carry out the program;
    (3) The names, qualifications, and proposed duties of the program 
director and any staff members who would be responsible for the program, 
including a description of those duties which would actually be carried 
out by the program director and those which would be shared with or 
assigned to others;
    (4) The names and qualifications of proposed members of a cancer 
education committee which would be established by the applicant to 
advise it on the planning, organization, operation and evaluation of the 
program

[[Page 325]]

and the specific duties which would be assigned to said committee;
    (5) Insofar as necessary, cooperative arrangements with other 
schools, hospitals, and institutions which would participate in the 
program;
    (6) The proposed project period, a detailed budget for the first 
budget period including a list of other anticipated sources of support 
and anticipated total needs for each of the succeeding budget periods of 
the requested project period, and a justification for the amount of 
grant funds requested;
    (7) Proposed methods for monitoring and evaluating the program; and
    (8) A description of how the education and training effort will be 
sustained upon expiration of the award.

[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]



Sec.  52d.5  Program requirements.

    (a) If the program is to be offered at the graduate level, it must 
be multidisciplinary in scope involving at least two or more clinical or 
preclinical sciences relating to cancer;
    (b) The cancer education committee provided for in the approved 
application must meet at least four times per year, and must be chaired 
by the program director.



Sec.  52d.6  Grant awards.

    (a) Within the limits of funds available, after consultation with 
the Board, the Director, NCI, may award grants to applicants with 
proposed programs which in the NCI Director's judgment best promote the 
purposes of this part, taking into consideration among other pertinent 
factors:
    (1) The relevance of the proposed program to the objectives of this 
part;
    (2) The extent to which the program would involve innovative 
teaching techniques;
    (3) The availability of adequate staff, facilities, and resources 
(including where necessary cooperative arrangements with other 
institutions or hospitals) to carry out the program;
    (4) The qualifications and experience of the program director;
    (5) The authority of the program director to ensure that the program 
is planned with multidisciplinary input and that multidisciplinary 
aspects of the program are carried out;
    (6) The extent to which the cancer education committee is broadly 
representative of the disciplines concerned with cancer care and 
teaching and is allowed to participate in the planning, organization, 
operation, and evaluation of the program;
    (7) If the program is to be offered at the pre-doctoral level, the 
extent to which its objectives are designed to aid students:
    (i) To acquire a basic understanding of fundamental principles of 
cancer biology, epidemiology, detection, diagnosis, prevention, 
treatment and control;
    (ii) To interest students in learning more about cancer; and
    (iii) To develop an appreciation of the need for a comprehensive 
multidisciplinary approach to the care of cancer patients;
    (8) The administrative and managerial capability of the applicant;
    (9) The reasonableness of the proposed budget in relation to the 
proposed program;
    (10) The adequacy of the methods for monitoring and evaluating the 
program on a continuing basis; and
    (11) The degree to which the application adequately provides for the 
requirements set forth in Sec.  52d.5.
    (b) The notice of grant award specifies how long HHS intends to 
support the program without requiring the program to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (c) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.

[[Page 326]]

    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.



Sec.  52d.7  Expenditure of grant funds.

    (a) Any funds granted pursuant to this part shall be expended solely 
for the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the terms 
and conditions of the awards, and the applicable cost principles 
prescribed by 45 CFR part 75, subpart E, except that grant funds may not 
be used for costs incurred in connection with activities which, prior to 
the grant, were part of the grantee's standard curriculum.
    (b) The Director, NCI, may permit unobligated grant funds remaining 
in the grant account at the close of a budget period to be carried 
forward for obligation during a subsequent budget period, provided a 
continuation award is made for that period and the NCI Director's 
written approval is obtained. The amount of any subsequent award will 
take into consideration unobligated grant funds remaining in the grant 
account.

[45 FR 12247, Feb. 25, 1980, as amended at 81 FR 3008, Jan. 20, 2016]



Sec.  52d.8  Other HHS regulations that apply.

    Several other regulations apply to grants under this subpart. These 
include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[49 FR 38111, Sept. 27, 1984, as amended at 81 FR 3008, Jan. 20, 2016]



Sec.  52d.9  Additional conditions.

    The Director, NCI, may with respect to any grant award impose 
additional conditions prior to or at the time of any award when in the 
NCI Director's judgment those conditions are necessary to assure or 
protect advancement of the approved program, the interests of the public 
health, or the conservation of grant funds.



PART 52e_NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION 
AND CONTROL PROJECTS--Table of Contents



Sec.
52e.1 To what programs do these regulations apply?
52e.2 Definitions.
52e.3 Who is eligible to apply?
52e.4 How to apply.
52e.5 What are the project requirements?
52e.6 How will NIH evaluate applications?
52e.7 What are the terms and conditions of awards?
52e.8 Other HHS regulations and policies that apply.
52e.9 Additional conditions.

    Authority: 42 U.S.C. 216, 285b-1.

    Source: 45 FR 12249, Feb. 25, 1980, unless otherwise noted.



Sec.  52e.1  To what programs do these regulations apply?

    (a) This part applies to grants under section 419 of the Act (42 
U.S.C. 285b-1) for projects to:
    (1) Demonstrate and evaluate the effectiveness of new techniques or 
procedures for the prevention and control of heart, blood vessel, lung, 
and blood diseases, with special consideration given to the prevention 
and control of these diseases in children, and in populations that are 
at increased risk with respect to such diseases;

[[Page 327]]

    (2) Develop and evaluate methods of educating health practitioners 
concerning the prevention and control of these diseases; and
    (3) Develop and evaluate methods of educating the public concerning 
the prevention and control of these diseases.
    (b) For purposes of this part, prevention and control projects shall 
include community-based and population-based programs carried out in 
cooperation with other Federal agencies, with public health agencies of 
State or local governments, with nonprofit private entities that are 
community-based health agencies, or with other appropriate public or 
nonprofit private entities.

[45 FR 12249, Feb. 25, 1980; 45 FR 20097, Mar. 27, 1980, as amended at 
58 FR 54298, Oct. 21, 1993; 59 FR 59372, Nov. 17, 1994]



Sec.  52e.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Council means the National Heart, Lung, and Blood Advisory Council, 
established under section 406 of the Act (42 U.S.C. 284a).
    Director means the Director of the National Heart, Lung, and Blood 
Institute and any official to whom the authority involved may be 
delegated.
    Emergency medical services means the services utilized in responding 
to the perceived individual need for immediate medical care in order to 
prevent loss of life or aggravation of physiological or psychological 
illness or injury.
    HHS means the Department of Health and Human Services.
    National program means the National Heart, Blood Vessel, Lung, and 
Blood Diseases and Blood Resources Program referred to in section 421 of 
the Act (42 U.S.C. 285b-3).
    Nonprofit as applied to any agency or institution means an agency or 
institution which is a corporation or an association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    PHS means the Public Health Service.

[58 FR 54298, Oct. 21, 1993]



Sec.  52e.3  Who is eligible to apply?

    To be eligible for a grant under this part, an applicant must be a 
public or nonprofit private agency or institution.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]



Sec.  52e.4  How to apply.

    (a) Application for a grant under this subpart shall be made on an 
authorized form. \2\ Applicants shall submit completed forms on or 
before the dates the Director may prescribe.
---------------------------------------------------------------------------

    \2\ Applications and instructions are available from the Division of 
Extramural Affairs, National Heart, Lung, and Blood Institute, National 
Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20205.
---------------------------------------------------------------------------

    (b) Each private institution which does not already have on file 
with the National Institutes of Health evidence of nonprofit status, 
must submit with its application acceptable proof of such status.
    (c) In addition to any other pertinent information that the Director 
may require each application shall set forth in detail:
    (1) The nature and purpose of the proposed project and the methods 
to be employed in carrying it out;
    (2) The relevance of the proposed project to the National Program;
    (3) The defined population to participate in the proposed project 
and the rationale for its selection;
    (4) With respect to applications relating to projects covered by 
Sec.  52e.1(a)(1), prior research findings on which the proposed project 
is based;
    (5) The personnel, facilities, and other resources, including 
community resources, available to carry out the proposed project;
    (6) Current activities of the applicant involving prevention or 
control of heart, blood vessel, lung, and blood diseases, the sources of 
funding for such activities, and the anticipated relationship of these 
activities to the proposed project;
    (7) The names and qualifications of the project director and key 
staff members who would be responsible for conducting the proposed 
project;
    (8) Proposed methods for monitoring and evaluating the project; and

[[Page 328]]

    (9) The proposed project period; a detailed budget for the first 
budget period, including a list of other anticipated sources of support 
and anticipated total needs for each of the succeeding budget periods of 
the requested project period; and a justification for the amount of 
grant funds requested.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]



Sec.  52e.5  What are the project requirements?

    (a) An approvable application must demonstrate to the satisfaction 
of the Director that:
    (1) With respect to applications relating to projects covered by 
Sec.  52e.1(a)(1), the techniques or procedures to be demonstrated and 
evaluated have been found safe and effective in the research setting 
and, based upon research findings, appear to have the potential for 
general applicability to the prevention, diagnosis, or treatment of 
heart, blood vessel, lung, or blood diseases;
    (2) With respect to applications relating to projects covered by 
Sec.  52e.1(a)(2) and Sec.  52e.1(a)(3), the project will include 
development and evaluation of one or more methods for educating health 
practitioners or the public concerning advances in the prevention, 
diagnosis, or treatment of such diseases; and
    (3) The nature of the project is such that its completion may be 
anticipated within the project period, or such other period as may be 
specified in the application.
    (b) The project must, in the judgment of the Director, be necessary 
for cooperation by the National Heart, Lung, and Blood Institute with 
one or more other Federal Health agencies, State, local or regional 
public health agencies, or nonprofit private health agencies in the 
diagnosis, prevention, or treatment of heart, blood vessel, lung or 
blood diseases.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, 54299, Oct. 21, 
1993]



Sec.  52e.6  How will NIH evaluate applications?

    (a) Within the limits of funds available, after consultation with 
the Council, the Director may award grants to applicants with proposed 
projects which in the Director's judgment will best promote the purposes 
of section 419 of the Act, taking into consideration among other 
pertinent factors:
    (1) The scientific and technical merit of the proposed project;
    (2) The significance of the project in relation to the goals of the 
National Program;
    (3) Whether the project appropriately emphasizes the prevention, 
diagnosis, or treatment of heart, blood vessel, lung, or blood diseases 
of children;
    (4) The qualifications and experience of the project director and 
other key personnel;
    (5) The administrative and managerial capability and fiscal 
responsibility of the applicant;
    (6) The reasonableness of the proposed budget in relation to the 
proposed project;
    (7) The adequacy of the methods proposed for monitoring and 
evaluating the proposed project; and
    (8) The degree to which the application adequately provides for the 
requirements set forth in Sec. Sec.  52e.5(a) and 52e.5(b).
    (b) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (c) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.

[[Page 329]]

    (e) Any funds granted under this part shall be expended solely for 
the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the 
terms, and conditions of the award, and the applicable cost principles 
prescribed in 45 CFR part 75, subpart E.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993; 
81 FR 3008, Jan. 20, 2016]



Sec.  52e.7  What are the terms and conditions of awards?

    (a) Any funds granted pursuant to this part shall be expended solely 
for the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the terms 
and conditions of the award, and the applicable cost principles 
prescribed by 45 CFR part 75, subpart E.
    (b) The Director may permit unobligated grant funds remaining in the 
grant account at the close of a budget period to be carried forward for 
obligation during a subsequent budget period, provided a continuation 
award is made for that period and the NHLBI Director's written approval 
is obtained. The amount of any subsequent award will take into 
consideration unobligated grant funds remaining in the grant account.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, 54299, Oct. 21, 
1993; 81 FR 3008, Jan. 20, 2016]



Sec.  52e.8  Other HHS regulations and policies that apply.

    Several other regulations apply to grants under this part. These 
include but are not necessarily limited to:

42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying
51 FR 16958 or successor--NIH Guidelines for Research Involving 
Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986), or successor
59 FR 14508 (as republished March 28, 1994), as may be amended, or its 
successor--NIH Guidelines on the Inclusion of Women and Minorities as 
Subjects in Clinical Research.

[58 FR 54298, Oct. 21, 1993, as amended at 59 FR 59372, Nov. 17, 1994; 
81 FR 3008, Jan. 20, 2016]



Sec.  52e.9  Additional conditions.

    The Director, may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in the Director's 
judgment those conditions are necessary to assure or protect advancement 
of the approved project, the interests of the public health, or the 
conservation of grant funds.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54299, Oct. 21, 1993]



PART 52h_SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 
AND DEVELOPMENT CONTRACT PROJECTS--Table of Contents



Sec.
52h.1 Applicability.
52h.2 Definitions.
52h.3 Establishment and operation of peer review groups.
52h.4 Composition of peer review groups.

[[Page 330]]

52h.5 Conflict of interest.
52h.6 Availability of information.
52h.7 What matters must be reviewed for grants?
52h.8 What are the review criteria for grants?
52h.9 What matters must be reviewed for unsolicited contract proposals?
52h.10 What matters must be reviewed for solicited contract proposals?
52h.11 What are the review criteria for contract projects and proposals?
52h.12 Other regulations that apply.

    Authority: 42 U.S.C. 216; 42 U.S.C. 282 (b)(6); 42 U.S.C. 284 
(c)(3); 42 U.S.C. 289a.

    Source: 69 FR 275, Jan. 5, 2004, unless otherwise noted.



Sec.  52h.1  Applicability.

    (a) This part applies to:
    (1) Applications of the National Institutes of Health for grants or 
cooperative agreements (a reference in this part to grants includes 
cooperative agreements) for biomedical and behavioral research; and
    (2) Biomedical and behavioral research and development contract 
project concepts and proposals for contract projects administered by the 
National Institutes of Health.
    (b) This part does not apply to applications for:
    (1) Continuation funding for budget periods within an approved 
project period;
    (2) Supplemental funding to meet increased administrative costs 
within a project period; or
    (3) Construction grants.



Sec.  52h.2  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act, as amended (42 U.S.C. 
201 et seq.).
    (b) Appearance of a conflict of interest means that a reviewer or 
close relative or professional associate of the reviewer has a financial 
or other interest in an application or proposal that is known to the 
reviewer or the government official managing the review and would cause 
a reasonable person to question the reviewer's impartiality if he or she 
were to participate in the review; the government official managing the 
review (the Scientific Review Administrator or equivalent) will evaluate 
the appearance of a conflict of interest and determine, in accordance 
with this subpart, whether or not the interest would likely bias the 
reviewer's evaluation of the application or proposal.
    (c) Awarding official means the Secretary of Health and Human 
Services and any other officer or employee of the Department of Health 
and Human Services to whom the authority involved has been delegated; 
except that, where the Act specifically authorizes another official to 
make awards in connection with a particular program, the awarding 
official shall mean that official and any other officer or employee of 
the Department of Health and Human Services to whom the authority 
involved has been delegated.
    (d) Budget period means the interval of time (usually 12 months) 
into which the project period is divided for budgetary and reporting 
purposes.
    (e) Close relative means a parent, spouse, domestic partner, or son 
or daughter.
    (f) Contract proposal means a written offer to enter into a contract 
that is submitted to the appropriate agency official by an individual or 
nonfederal organization which includes, at a minimum, a description of 
the nature, purpose, duration, and cost of the project, and the methods, 
personnel, and facilities to be utilized in carrying it out. A contract 
proposal may be unsolicited by the federal government or submitted in 
response to a request for proposals.
    (g) Development means the systematic use of knowledge gained from 
research to create useful materials, devices, systems, or methods.
    (h) DHHS means the Department of Health and Human Services.
    (i) Director means the Director of the National Institutes of Health 
and any other official or employee of the National Institutes of Health 
to whom the authority involved has been delegated.
    (j) Grant as used in this part, includes cooperative agreements.
    (k) Peer review group means a group of primarily nongovernment 
experts qualified by training and experience in particular scientific or 
technical fields, or as authorities knowledgeable in the various 
disciplines and fields related to the scientific areas under review, to

[[Page 331]]

give expert advice on the scientific and technical merit of grant 
applications or contract proposals, or the concept of contract projects, 
in accordance with this part.
    (l) Principal investigator has the same meaning as in 42 CFR part 
52.
    (m) Professional associate means any colleague, scientific mentor, 
or student with whom the peer reviewer is currently conducting research 
or other significant professional activities or with whom the member has 
conducted such activities within three years of the date of the review.
    (n) Project approach means the methodology to be followed and the 
resources needed in carrying out the project.
    (o) Project concept means the basic purpose, scope, and objectives 
of the project.
    (p) Project period has the same meaning as in 42 CFR part 52.
    (q) Real conflict of interest means a reviewer or a close relative 
or professional associate of the reviewer has a financial or other 
interest in an application or proposal that is known to the reviewer and 
is likely to bias the reviewer's evaluation of that application or 
proposal as determined by the government official managing the review 
(the Scientific Review Administrator, or equivalent), as acknowledged by 
the reviewer, or as prescribed by this part. A reviewer shall have a 
real conflict of interest if he/she or a close relative or professional 
associate of the reviewer:
    (1) Has received or could receive a direct financial benefit of any 
amount deriving from an application or proposal under review;
    (2) Apart from any direct financial benefit deriving from an 
application or proposal under review, has received or could receive a 
financial benefit from the applicant institution, offeror or principal 
investigator that in the aggregate exceeds $10,000 per year; this amount 
includes honoraria, fees, stock or other financial benefit, and 
additionally includes the current value of the reviewer's already 
existing stock holdings. The Director, NIH, may amend the dollar 
threshold periodically, as appropriate, after public notice and comment; 
or
    (3) Has any other interest in the application or proposal that is 
likely to bias the reviewer's evaluation of that application or 
proposal. Regardless of the level of financial involvement or other 
interest, if the reviewer feels unable to provide objective advice, he/
she must recuse him/herself from the review of the application or 
proposal at issue. The peer review system relies on the professionalism 
of each reviewer to identify to the designated government official any 
real or apparent conflicts of interest that are likely to bias the 
reviewer's evaluation of an application or proposal.
    (r) Request for proposals means a Government solicitation to 
prospective offerors, under procedures for negotiated contracts, to 
submit a proposal to fulfill specific agency requirements based on terms 
and conditions defined in the request for proposals. The request for 
proposals contains information sufficient to enable all offerors to 
prepare proposals, and is as complete as possible with respect to: 
nature of work to be performed; descriptions and specifications of items 
to be delivered; performance schedule; special requirements clauses, or 
other circumstances affecting the contract; format for cost proposals; 
and evaluation criteria by which the proposals will be evaluated.
    (s) Research has the same meaning as in 42 CFR part 52.
    (t) Research and development contract project means an identified, 
circumscribed activity, involving a single contract or two or more 
similar, related, or interdependent contracts, intended and designed to 
acquire new or fuller knowledge and understanding in the areas of 
biomedical or behavioral research and/or to use such knowledge and 
understanding to develop useful materials, devices, systems, or methods.
    (u) Scientific review group has the same meaning as peer review 
group, which is defined in paragraph (k) of this section.
    (v) Solicited contract proposal has the same meaning as the 
definition of offer in 48 CFR 2.101.
    (w) Unsolicited contract proposal has the same meaning as 
unsolicited proposal in 48 CFR 15.601.

[[Page 332]]



Sec.  52h.3  Establishment and operation of peer review groups.

    (a) To the extent applicable, the Federal Advisory Committee Act, as 
amended (5 U.S.C. appendix 2) and chapter 9 of the DHHS General 
Administration Manual \1\ shall govern the establishment and operation 
of peer review groups.
---------------------------------------------------------------------------

    \1\ The DHHS General Administration Manual is available for public 
inspection and copying at the Department's information centers listed in 
45 CFR 5.31 and may be purchased from the Superintendent of Documents, 
U.S. Government Printing Office, Washington, DC 20402.
---------------------------------------------------------------------------

    (b) Subject to Sec.  52h.5 and paragraph (a) of this section, the 
Director will adopt procedures for the conduct of reviews and the 
formulation of recommendations under Sec. Sec.  52h.7, 52h.9, and 
52h.10.



Sec.  52h.4  Composition of peer review groups.

    (a) To the extent applicable, the selection and appointment of 
members of peer review groups and their terms of service shall be 
governed by chapter 9 of the DHHS General Administration Manual.
    (b) Subject to paragraph (a) of this section, members will be 
selected based upon their training and experience in relevant scientific 
or technical fields, or upon their qualifications as authorities 
knowledgeable in the various disciplines and fields related to the 
scientific areas under review, taking into account, among other factors:
    (1) The level of formal scientific or technical education completed 
or experience acquired by the individual;
    (2) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of the research;
    (3) Recognition as reflected by awards and other honors received 
from scientific and professional organizations; and
    (4) The need for the group to have included within its membership 
experts from various areas of specialization within relevant scientific 
or technical fields, or authorities knowledgeable in the various 
disciplines and fields related to the scientific areas under review.
    (c) Except as otherwise provided by law, not more than one-fourth of 
the members of any peer review group to which this part applies may be 
officers or employees of the United States. Being a member of a 
scientific peer review group does not make an individual an officer or 
employee of the United States.



Sec.  52h.5  Conflict of interest.

    (a) This section applies only to conflicts of interest involving 
members of peer review groups. This section does not cover individuals 
serving on National Advisory Councils or Boards, Boards of Scientific 
Counselors, or Program Advisory Committees who, if not already officers 
or employees of the United States, are special Government employees and 
covered by title 18 of the United States Code, the Office of Government 
Ethics Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635), and Executive Order 11222, as amended. For 
those federal employees serving on peer review groups, in accordance 
with Sec.  52h.4, the requirements of title 18 of the United States 
Code, 5 CFR part 2635 and Executive Order 12674, as modified by 
Executive Order 12731, apply.
    (b) A reviewer with a real conflict of interest must recuse him/
herself from the review of the application or proposal, except as 
otherwise provided in this section.
    (1) A reviewer who is a salaried employee, whether full-time or 
part-time, of the applicant institution, offeror, or principal 
investigator, or is negotiating for employment, shall be considered to 
have a real conflict of interest with regard to an application/proposal 
from that organization or principal investigator, except that the 
Director may determine there is no real conflict of interest or an 
appearance of a conflict of interest where the components of a large or 
multicomponent organization are sufficiently independent to constitute, 
in effect, separate organizations, provided that the reviewer has no 
responsibilities at the institution that would significantly affect the 
other component.

[[Page 333]]

    (2) Where a reviewer's real conflict of interest is based upon the 
financial or other interest of a close relative or professional 
associate of the reviewer, that reviewer must recuse him/herself, unless 
the Director provides a waiver in accordance with paragraph (b)(4) of 
this section.
    (3) For contract proposal reviews, an individual with a real 
conflict of interest in a particular proposal(s) is generally not 
permitted to participate in the review of any proposals responding to 
the same request for proposals. However, if there is no other qualified 
reviewer available having that individual's expertise and that expertise 
is essential to ensure a competent and fair review, a waiver may be 
granted by the Director to permit that individual to serve as a reviewer 
of those proposals with which the reviewer has no conflict, while 
recusing him/herself from the review of any particular proposal(s) in 
which there is a conflict of interest.
    (4) The Director may waive any of the requirements in paragraph (b) 
of this section relating to a real conflict of interest if the Director 
determines that there are no other practical means for securing 
appropriate expert advice on a particular grant or cooperative agreement 
application, contract project, or contract proposal, and that the real 
conflict of interest is not so substantial as to be likely to affect the 
integrity of the advice to be provided by the reviewer.
    (c) Any appearance of a conflict of interest will result in recusal 
of the reviewer, unless the Director provides a waiver, determining that 
it would be difficult or impractical to carry out the review otherwise, 
and the integrity of the review process would not be impaired by the 
reviewer's participation.
    (d) When a peer review group meets regularly it is assumed that a 
relationship among individual reviewers in the group exists and that the 
group as a whole may not be objective about evaluating the work of one 
of its members. In such a case, a member's application or proposal shall 
be reviewed by another qualified review group to ensure that a competent 
and objective review is obtained.
    (e) When a member of a peer review group participates in or is 
present during the concept review of a contract proposal that occurs 
after release of the solicitation, as described under Sec.  52h.10(b), 
but before receipt of proposals, the member is not considered to have a 
real conflict of interest as described in paragraph (b) of this section, 
but is subject to paragraph (c) of this section concerning appearance of 
conflict of interest if the member is planning to respond to the 
solicitation. When the concept review occurs after receipt of proposals, 
paragraph (b) applies.
    (f) No member of a peer review group may participate in any review 
of a specific grant application or contract project for which the member 
has had or is expected to have any other responsibility or involvement 
(whether pre-award or post-award) as an officer or employee of the 
United States.
    (g) The Director may periodically issue guidance to the government 
officials responsible for managing reviews and reviewers on what 
interests would constitute a real conflict of interest or an appearance 
of a conflict of interest.



Sec.  52h.6  Availability of information.

    (a) Transcripts, minutes, and other documents made available to or 
prepared for or by a peer review group will be available for public 
inspection and copying to the extent provided by the Freedom of 
Information Act, as amended (5 U.S.C. 552), the Federal Advisory 
Committee Act, as amended (5 U.S.C. appendix 2), the Privacy Act of 
1974, as amended (5 U.S.C. 552a), and implementing DHHS regulations (45 
CFR parts 5, 5b).
    (b) Meetings of peer review groups reviewing grant applications or 
contract proposals are closed to the public in accordance with sections 
552b(c)(4) and 552b(c)(6) of the Government in the Sunshine Act, as 
amended (5 U.S.C. 552b(c)(4) and 552b(c)(6)) and section 10(d) of the 
Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). 
Documents made available to, or prepared for or by peer review groups 
that contain trade secrets or commercial or financial information 
obtained from a person that is privileged or confidential, and personal 
information concerning individuals associated with applications or 
proposals,

[[Page 334]]

the disclosure of which would constitute a clearly unwarranted invasion 
of personal privacy, are exempt from disclosure in accordance with the 
Freedom of Information Act, as amended (5 U.S.C. 552(b)(4) and 
552(b)(6)).
    (c) Meetings of peer review groups reviewing contract project 
concepts are open to the public in accordance with the provisions of the 
Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2) and the 
Government in the Sunshine Act, as amended (5 U.S.C. 552b).



Sec.  52h.7  What matters must be reviewed for grants?

    (a) Except as otherwise provided by law, no awarding official shall 
award a grant based upon an application covered by this part unless the 
application has been reviewed by a peer review group in accordance with 
the provisions of this part and the group has made recommendations 
concerning the scientific merit of that application. In addition, where 
under applicable law an awarding official is required to secure the 
approval or advice of a national council or board concerning an 
application, the application may not be considered by the council or 
board unless it has been reviewed by the appropriate peer review group, 
in accordance with the provisions of this part, and the group has made 
recommendations concerning the scientific merit of the application, 
except where the council or board is the peer review group.
    (b) Except to the extent otherwise provided by law, recommendations 
by peer review groups are advisory only and not binding on the awarding 
official or the national advisory council or board.



Sec.  52h.8  What are the review criteria for grants?

    In carrying out its review under Sec.  52h.7, the scientific peer 
review group shall assess the overall impact that the project could have 
on the research field involved, taking into account, among other 
pertinent factors:
    (a) The significance of the goals of the proposed research, from a 
scientific or technical standpoint;
    (b) The adequacy of the approach and methodology proposed to carry 
out the research;
    (c) The innovativeness and originality of the proposed research;
    (d) The qualifications and experience of the principal investigator 
and proposed staff;
    (e) The scientific environment and reasonable availability of 
resources necessary to the research;
    (f) The adequacy of plans to include both genders, minorities, 
children and special populations as appropriate for the scientific goals 
of the research;
    (g) The reasonableness of the proposed budget and duration in 
relation to the proposed research; and
    (h) The adequacy of the proposed protection for humans, animals, and 
the environment, to the extent they may be adversely affected by the 
project proposed in the application.



Sec.  52h.9  What matters must be reviewed for unsolicited contract proposals?

    (a) Except as otherwise provided by law, no awarding official shall 
award a contract based upon an unsolicited contract proposal covered by 
this part unless the proposal has been reviewed by a peer review group 
in accordance with the provisions of this part and the group has made 
recommendations concerning the scientific merit of that proposal.
    (b) Except to the extent otherwise provided by law, peer review 
group recommendations are advisory only and not binding on the awarding 
official.



Sec.  52h.10  What matters must be reviewed for solicited contract proposals?

    (a) Subject to paragraphs (b) and (c) of this section, no awarding 
official shall issue a request for contract proposals with respect to a 
contract project involving solicited contract proposals, unless the 
project concept has been reviewed by a peer review group or advisory 
council in accordance with this part and the group has made 
recommendations concerning the scientific merit of the concept.
    (b) The awarding official may delay carrying out the requirements 
for peer review of paragraph (a) of this section

[[Page 335]]

until after issuing a request for proposals if the official determines 
that the accomplishment of essential program objectives would otherwise 
be placed in jeopardy and any further delay clearly would not be in the 
best interest of the Government. The awarding official shall specify in 
writing the grounds on which this determination is based. Under these 
circumstances, the awarding official will not award a contract until 
peer review of the project concept and the proposals has been completed. 
The request for proposals shall state that the project concept will be 
reviewed by a peer review group and that no award will be made until the 
review is conducted and recommendations made based on that review.
    (c) The awarding official may determine that peer review of the 
project concept for behavioral or biomedical research and development 
contracts is not needed if one of the following circumstances applies: 
the solicitation is to re-compete or extend a project that is within the 
scope of a current project that has been peer reviewed, or there is a 
Congressional authorization or mandate to conduct specific contract 
projects. If a substantial amount of time has passed since the concept 
review, the awarding official shall determine whether peer review is 
required to ensure the continued scientific merit of the concept.
    (d) Except to the extent otherwise provided by law, the 
recommendations referred to in this section are advisory only and not 
binding on the awarding official.



Sec.  52h.11  What are the review criteria for contract projects and proposals?

    (a) In carrying out its review of a project concept under Sec.  
52h.10(a) or Sec.  52h.10(b), the peer review group shall take into 
account, among other pertinent factors:
    (1) The significance from a scientific or technical standpoint of 
the goals of the proposed research or development activity;
    (2) The availability of the technology and other resources necessary 
to achieve those goals;
    (3) The extent to which there are identified, practical uses for the 
anticipated results of the activity; and
    (4) Where the review includes the project approach, the adequacy of 
the methodology to be utilized in carrying out the activity.
    (b) In carrying out its review of unsolicited contract proposals 
under Sec.  52h.9, the peer review group shall take into account, among 
other pertinent factors, the criteria in Sec.  52h.8 which are relevant 
to the particular proposals.
    (c) In carrying out its review of solicited proposals under Sec.  
52h.10(a) or (b), the peer review group shall evaluate each proposal in 
accordance with the criteria set forth in the request for proposals.



Sec.  52h.12  Other regulations that apply.

    The regulations in this part are in addition to, and do not 
supersede other regulations concerning grant applications, contract 
projects, or contract proposals set forth elsewhere in this title, title 
45, or title 48 of the Code of Federal Regulations.



PART 52i_NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES 
RESEARCH ENDOWMENT PROGRAMS--Table of Contents



Sec.
52i.1 To what programs does this part apply?
52i.2 Definitions.
52i.3 Who is eligible to apply?
52i.4 Under what conditions may an eligible institution designate a 
          foundation as the recipient of a research endowment grant?
52i.5 How to apply for a grant.
52i.6 Evaluation and disposition of research endowment grant 
          applications.
52i.7 Grant Awards.
52i.8 When and for what purposes may a grantee spend the endowment fund 
          corpus?
52i.9 How much endowment fund income may a grantee spend and for what 
          purposes?
52i.10 How shall a grantee calculate the amount of endowment fund income 
          that it may withdraw and spend?
52i.11 What shall a grantee record and report?
52i.12 What happens if a grantee fails to administer the research 
          endowment grant in accordance with applicable regulations?

[[Page 336]]

52i.13 Other HHS policies and regulations that apply.
52i.14 Additional conditions.

     Authority: 42 U.S.C. 216, 285t-285t-1.

    Source: 80 FR 53744, Sept. 8, 2015, unless otherwise noted.



Sec.  52i.1  To what programs does this part apply?

    This part applies to grants awarded under section 464z-3(h) of the 
Public Health Service Act (the Act), which authorizes the Director of 
the National Institute on Minority Health and Health Disparities (NIMHD) 
to carry out a program of research endowment grants to eligible 
institutions to facilitate minority health and health disparities 
research (the NIMHD Research Endowment Program), and, with the exception 
of Sec. Sec.  52i.5 and 52i.6, applies to that portion of an award made 
under section 464z-4(f) of the Act authorized by the NIMHD Director for 
research endowment.



Sec.  52i.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Center of Excellence means, for purposes of grants authorized by 
section 464z-3(h) of the Act, an institution designated as a Center of 
Excellence and receiving a grant under section 736 (42 U.S.C. 293) or 
section 464z-4 (42 U.S.C. 285t-1) of the Act.
    Director means the Director, NIMHD, of the National Institutes of 
Health.
    Endowment fund means a fund that is established by state law, by an 
institution, or by a foundation associated with an institution that is 
exempt from taxation and is maintained for the purpose of generating 
income for the support of minority and health disparities research or 
research training if the funds are from a grant made under section 464z-
3 of the Act. The principal or corpus of the fund may not be spent 
except as noted in Sec.  52i.8(b).
    Endowment fund corpus means an amount equal to the total grant funds 
awarded under this part or equal to the amount designated as endowment 
under section 464z-4 of the Act.
    Endowment fund income means the income generated from investing the 
corpus, i.e., the amount of which exceeds the endowment fund corpus.
    Health disparities research means basic, clinical, and behavioral 
research on health disparity populations (including individual members 
and communities of such populations) that relates to health disparities, 
including the causes of such disparities and methods to prevent, 
diagnose, and treat such disparities.
    Health disparity population means a population that, as determined 
by the Director of the NIMHD after consultation with the Director of the 
Agency for Healthcare Research and Quality, has a significant disparity 
in the overall rate of disease incidence, prevalence, morbidity, 
mortality, or survival rates in the population as compared to the health 
status of the general population.
    Health disparity students means students of minority health 
disparity populations or other health disparities populations.
    Institutional endowment (IE) means the corporate or system-wide 
endowment fund that is the sum total of the endowment assets of all 
campuses and their components. This includes, but is not limited to, 
endowments managed by an institution's foundations/associations as well 
as state university systems.
    Institution system-wide means all campuses and components.
    Minority health conditions means, with respect to individuals who 
are members of minority groups, all diseases, disorders, and conditions 
(including with respect to mental health and substance abuse):
    (1) Unique to, more serious, or more prevalent in such individuals;
    (2) For which the factors of medical risk or types of medical 
intervention may be different for such individuals, or for which it is 
unknown whether such factors or types are different for such 
individuals; or
    (3) With respect to which there has been insufficient research 
involving such individuals as subjects or insufficient data on such 
individuals.
    Minority health disparities research means basic, clinical, and 
behavioral

[[Page 337]]

research on minority health conditions, including research to prevent, 
diagnose, and treat such conditions.
    Racial and ethnic minority or minority group means American Indians 
(including Alaska Natives, Eskimos, and Aleuts), Asian Americans, Native 
Hawaiians and other Pacific Islanders, Blacks, and Hispanics. Hispanic 
means individuals whose origin is Mexican, Puerto Rican, Cuban, Central 
or South American, or other Spanish culture or origin.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.



Sec.  52i.3  Who is eligible to apply?

    (a) To be eligible for a grant under section 464z-3(h) of the Act an 
applicant:
    (1) Must be a Center of Excellence under section 736 (42 U.S.C. 293) 
or section 464z-4 (42 U.S.C. 285t-1) of the Act, and
    (2) Must have an institutional endowment that is equal to or less 
than 50 percent of the national median of endowment funds at 
institutions that conduct similar biomedical research and training of 
health professionals.
    (b) To be eligible for a portion of a grant award to be expended as 
a research endowment under section 464z-4(f) of the Act, an applicant:
    (1) Must be a designated biomedical and behavioral research 
institution under section 464z-4 of the Act, and
    (2) Must submit those materials prescribed by the Director, NIMHD.



Sec.  52i.4  Under what conditions may an eligible institution designate 
a foundation as the recipient of a research endowment grant?

    A number of universities and other organizations have established 
closely affiliated, but separately incorporated, organizations to 
facilitate the administration of research and other programs supported 
by federal funds. Such legally independent entities are often referred 
to as ``foundations,'' although this term does not necessarily appear in 
the name of the organization. An institution awarded an endowment grant 
under section 464z-3(h) of the Act or using designated grant funds for 
endowment purposes under section 464z-4(f) of the Act may designate a 
foundation associated with the institution to receive the endowment 
funds only for investment purposes if:
    (a) The institution assures in its application that the foundation 
is legally authorized to receive the endowment funds and to administer 
the endowment funds in accordance with the regulations set forth in this 
part;
    (b) The foundation agrees to administer the endowment funds in 
accordance with the regulations in this part;
    (c) The institution agrees to be liable for any violation by the 
foundation of any applicable regulation, including any violation 
resulting in monetary liability; and
    (d) The grantee institution has control and is responsible for the 
administration of the grant accounts.



Sec.  52i.5  How to apply for a grant.

    (a) Each institution interested in applying for a grant under 
section 464z-3(h) of the Act must submit an application at such time and 
in such form and manner as the Secretary may prescribe.
    (b) An institution described in Sec.  52i.3 that has received a 
grant under this part may apply for another grant under this part if:
    (1)(i) The institution still meets the eligibility requirements in 
Sec.  52i.3; and
    (ii) The institution is in the last year of funding provided by NIH 
under this part; or
    (2) The institution no longer has an active grant under this part 
from NIH.



Sec.  52i.6  Evaluation and award of research endowment grant applications.

    All applications filed in accordance with this part and meeting the 
minimal eligibility requirements shall be evaluated and recommended by 
technical and scientific peer review. The review evaluation shall take 
into account, among other pertinent factors:
    (a) The scientific and technical merit of the proposed project to 
facilitate minority health disparities research and other health 
disparities research;

[[Page 338]]

    (b) The likelihood of its producing meaningful results;
    (c) The adequacy of the applicant's resources available for the 
project; and
    (d) The adequacy of the applicant's plan for managing the endowment 
fund.



Sec.  52i.7  Grant awards.

    (a) Within the limits of funds, and upon such review and 
recommendation as may be required by law, the Director shall award a 
grant to those applicants whose approved projects will in the Director's 
judgment best promote the purposes of this part.
    (b) An institution described in Sec.  52i.3 that receives a grant 
under this part or an institution described in section 464z-4(f) of the 
Act authorized to use grant funds for endowment purposes shall follow 
the spending rules under the law of the state in which the institution 
is located and the spending rules/policies adopted by the recipient 
institution, provided that such spending rules are not inconsistent with 
applicable federal regulations/policies.
    (c) Grants awarded under this part or grant funds designated for 
endowment purposes as described under section 464z-4(f) of the Act must 
be invested no later than 90 days after the start date of the grant.
    (d) The institution, in investing the endowment fund established 
under this section, shall exercise the judgment and care, under the 
circumstances then prevailing, that a person of prudence, discretion, 
and intelligence would exercise in the management of such person's own 
affairs and avoid all appearances of conflict of interest in the 
management of this fund.
    (e) The total amount of an endowment grant under this part or the 
designated amount of the grant under section 464z-4(f) of the Act must 
be maintained as corpus by the institution for 20 years from the end of 
the project period.
    (f) In the case of situations in which investment conditions result 
in the corpus referred to in paragraph (e) of this section having a net 
market value less than the value of the funds at the time of their 
receipt, appropriate actions must be taken (e.g., careful review of the 
investment strategy) in order to preserve the value of the endowment 
corpus.
    (g) An institution described in Sec.  52i.3 receiving an endowment 
grant under section 464z-3(h) of the Act may not simultaneously receive 
endowment funds under section 464z-4(f) of the Act.
    (h) Consistent with section 464z-4(f) of the Act, the Director, 
NIMHD, may designate for a research endowment some of the funds awarded 
to a Center of Excellence for research education and training.



Sec.  52i.8  When and for what purposes may a grantee spend 
the endowment fund corpus?

    (a) A grantee may not withdraw or spend any part of the endowment 
fund corpus for a total of 20 years from the end of the project period.
    (b) At the end of the 20-year period, during which the endowment 
corpus must be maintained, the grantee institution is encouraged to 
preserve the endowment fund corpus but may use the endowment fund corpus 
for any purpose that expands or develops the institution's minority 
health and/or health disparities research and/or training capacity.



Sec.  52i.9  How much endowment fund income may a grantee spend 
and for what purposes?

    (a) Any endowment income realized in the initial year following the 
grant award under this part shall not be expended to support 
programmatic activities until after conclusion of the initial year of 
the grant.
    (b) After the first year of the grant, a grantee awarded funds under 
this part may spend endowment income realized from funds it receives 
solely in accordance with the regulations of this part, the terms and 
conditions of the award, NIMHD policies and procedures, and the 
grantee's strategic plan that has been approved by the NIMHD and 
includes priorities for the use of the endowment fund income.



Sec.  52i.10  How shall a grantee calculate the amount of endowment 
fund income that it may withdraw and spend?

    A grantee awarded funds under this part shall calculate the amount 
of endowment fund income that it may

[[Page 339]]

withdraw and spend at a particular time as follows:
    (a) On each date that the grantee plans a withdrawal of endowment 
fund income, the grantee must determine the amount of the income by 
calculating the value of the fund that exceeds the endowment fund 
corpus.
    (b) If the total value of the endowment fund exceeds the endowment 
fund corpus, the grantee may withdraw and spend the excess amount, i.e., 
the endowment fund income, in accordance with Sec.  52i.9.



Sec.  52i.11  What shall a grantee record and report?

    A grantee awarded funds under this part shall:
    (a) Maintain appropriate records in compliance with this part and 
other requirements as referenced in terms of the award, including 
documentation of:
    (1) The type and amount of investments of the endowment fund;
    (2) The amount of endowment fund income and corpus;
    (3) The amount and purpose of expenditures of endowment fund income; 
and
    (4) The expenses and charges associated with the management of the 
endowment funds if such expenses and charges were paid from endowment 
fund income.
    (b) Retain records in accordance with 45 CFR 75.361. The endowment 
fund corpus, fund income, and fund expenditures must be reported over a 
20-year period, and supporting records are to be retained for 3 years 
after the submission of the final report to the NIMHD;
    (c) Permit authorized officials the authority to conduct a review, 
as set forth in 45 CFR 75.364 (which states that the Department of 
Health and Human Services (HHS) awarding agencies, the HHS Inspector 
General, the U.S. Comptroller General, and any of their duly authorized 
representatives ``have the right of timely and unrestricted access to 
any books, documents, papers, or other records of recipients that are 
pertinent to the awards, in order to make audits, examinations, 
excerpts, transcripts, or copies of such documents''); and
    (d) Submit Financial Status Reports, as set forth in 45 CFR 75.341, 
as required by the NIMHD and in the form prescribed. A final Financial 
Status Report shall be required 20 years after the end of the project 
period.

[80 FR 53744, Sept. 8, 2015, as amended at 85 FR 72908, Nov. 16, 2020]



Sec.  52i.12  What happens if a grantee fails to administer the research 
endowment grant in accordance with applicable regulations?

    (a) The Director, after giving notice and an opportunity for a 
hearing, may authorize the termination of a grant awarded and/or 
recovery of funds under this part during the 20-year period if the 
grantee:
    (1) Withdraws or spends any part of the endowment fund corpus in 
violation of this part;
    (2) Spends any portion of the endowment fund income not permitted to 
be spent in this part;
    (3) Fails to invest the endowment fund corpus in accordance with the 
investment standards set forth in this part;
    (4) Fails to meet the requirements in Sec.  52i.7; or
    (5) Otherwise fails to comply with the terms and conditions of the 
award.
    (b) Recovery of funds may include up to the amount of endowment 
awards plus any income earned.



Sec.  52i.13  Other HHS policies and regulations that apply.

    Several other regulations and policies apply to grants under this 
part. These include, but are not limited to:
    (a) 2 CFR part 376--HHS Nonprocurement debarment and suspension.
    (b) 42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure.
    (c) 42 CFR part 93--Public Health Service policies on research 
misconduct.
    (d) 45 CFR part 16--Procedures of the Departmental Grant Appeals 
Board.
    (e) 45 CFR part 46--Protection of human subjects.
    (f) 45 CFR part 74--Uniform administrative requirements for awards 
and subawards to institutions of higher education, hospitals, other 
nonprofit

[[Page 340]]

organizations, and commercial organizations; and certain grants and 
agreements with states, local governments, and Indian tribal 
governments.
    (g) 45 CFR part 80--Nondiscrimination under programs receiving 
federal assistance through the Department of Health and Human Services 
effectuation of Title VI of the Civil Rights Act of 1964.
    (h) 45 CFR part 81--Practice and procedure for hearings under part 
80 of this chapter.
    (i) 2 CFR part 382--Requirements for drug-free workplace (financial 
assistance).
    (j) 45 CFR part 84--Nondiscrimination on the basis of handicap in 
programs or activities receiving federal financial assistance.
    (k) 45 CFR part 86--Nondiscrimination on the basis of sex in 
education programs or activities receiving federal financial assistance.
    (l) 45 CFR part 91--Nondiscrimination on the basis of age in 
programs or activities receiving federal financial assistance from HHS.
    (m) 45 CFR part 92--Uniform administrative requirements for grants 
and cooperative agreements to State, local, and tribal governments.
    (n) 45 CFR part 93--New restrictions on lobbying.
    (o) NIH Guidelines for Research Involving Recombinant or Synthetic 
Nucleic Acid Molecules at http://osp.od.nih.gov/sites/default/files/
NIH_Guidelines_0.pdf. Further information may be obtained from the NIH 
Office of Biotechnology Activities via email at [email protected] or 
the OBA Web site at http://osp.od.nih.gov/office-biotechnology-
activities.
    (p) NIH Guidelines on the Inclusion of Women and Minorities as 
Subjects in Clinical Research at http://grants.nih.gov/grants/guide/
notice-files/NOT-OD-02-001.html. Further information may be obtained 
from the NIH Office of Research on Women's Health via email at 
[email protected] or the ORWH Web site at http://ORWH.od.nih.gov.
    (q) NIH Grants Policy Statement (October 1, 2013). This version is 
located on the NIH Web site at http://grants.nih.gov/grants/policy/
nihgps_2013. [Note: this policy is subject to change, and interested 
persons should contact the Office of Policy for Extramural Research 
Administration (OPERA), Office of Extramural Research, NIH, 6701 
Rockledge Drive, Suite 350, MSC 7974, Bethesda, MD 20892-7974 (telephone 
301-435-0938 or toll-free 800-518-4726), to obtain references to the 
current version and any amendments. Information may be obtained also by 
contacting the OPERA Division of Grants Policy via email at 
[email protected]. Previous versions of the NIH Grants Policy 
Statement are archived at http://grants.nih.gov/grants/policy/
policy.htm.]
    (r) Public Health Service Policy on Humane Care and Use of 
Laboratory Animals, Office of Laboratory Animal Welfare, NIH (Revised 
August 2002). [Note: this policy is subject to change, and interested 
persons should contact the Office of Laboratory Animal Welfare, NIH, 
Rockledge 1, Suite 360, MSC 7982, 6705 Rockledge Drive, Bethesda, MD 
20892-7982 (telephone 301-594-2382, not a toll-free number), to obtain 
references to the current version and any amendments. Information may be 
obtained also via the OLAW Web site at http://grants.nih.gov/grants/
olaw/olaw.htm.]



Sec.  52i.14  Additional conditions.

    The Director may, with respect to any grant award, impose additional 
conditions prior to, or at the time of, any award when in the Director's 
judgment the conditions are necessary to ensure the carrying out of the 
purposes of the award, the interests of the public health, or the 
conservation of grant funds.



PART 53_GRANTS, LOANS AND LOAN GUARANTEES FOR CONSTRUCTION AND MODERNIZATION 
OF HOSPITALS AND MEDICAL FACILITIES--Table of Contents



Subparts A-K [Reserved]

    Subpart L_Services for Persons Unable To Pay; Community Service; 
                            Nondiscrimination

Sec.
53.111 Services for persons unable to pay.
53.112 Nondiscrimination.
53.113 Community service.

[[Page 341]]

Subpart M [Reserved]

               Subpart N_Loan Guarantees and Direct Loans

53.154 Waiver of right of recovery.
53.155 Modification of loans.
53.156 Fees for modification requests.

    Authority: Secs. 215, 603, 609, 621, 623, Public Health Service Act 
as amended, 58 Stat. 690, 78 Stat. 451 and 456, 84 Stat. 344 and 346 (42 
U.S.C. 216, 291c, 291i, 291j-1 and 291j-3; 31 U.S.C. 9701).

Subparts A-K [Reserved]



    Subpart L_Services for Persons Unable To Pay; Community Service; 
                            Nondiscrimination



Sec.  53.111  Services for persons unable to pay.

    (a) Applicability. The provisions of this section apply to every 
applicant which heretofore has given or hereafter will give an assurance 
that it will make available a reasonable volume of services to persons 
unable to pay therefor but shall not apply to an applicant (1) for more 
than 20 years after the completion of construction of any facility with 
respect to which funds have been paid under section 606 of the Act or 
(2) beyond the period during which any amount of a direct loan made 
under sections 610 or 623 of the Act, or any amount of a loan with 
respect to which a loan guarantee and interest subsidy has been provided 
under sections 623 and 624 of the Act remains unpaid.
    (b) Definitions. As used in this section:
    (1) The term facility includes hospitals, facilities for long-term 
care, outpatient facilities, rehabilitation facilities, and public 
health centers;
    (2) The term applicant means an applicant for, or recipient of, a 
grant, a loan guarantee or a loan under the Act;
    (3) Fiscal year means the fiscal year of the applicant;
    (4) The term operating costs means the actual operating costs of the 
applicant for a fiscal year as determined in accordance with cost 
determination principles and requirements under title XVIII of the 
Social Security Act (42 U.S.C. 1395): Provided, That such ``operating 
costs'' shall be determined for the applicant's entire facility and for 
all patients regardless of the source of payment for such care: And 
provided further, That in determining such operating costs there shall 
be deducted the amount of all actual or estimated reimbursements, as 
applicable, for services received or to be received pursuant to title 
XVIII and XIX of the Social Security Act (42 U.S.C. 1395 and 1936);
    (5) The term reasonable cost means the cost of providing services to 
a specific patient determined in accordance with the cost determination 
principles and requirements under title XVIII of the Social Security Act 
(42 U.S.C. 1395) and subpart D of the regulations thereunder (20 CFR 
part 405, \1\ part 401 et seq.);
---------------------------------------------------------------------------

    \1\ Redesignated as 42 CFR part 405 at 42 FR 52826, Sept. 30, 1977.
---------------------------------------------------------------------------

    (6) The term uncompensated services means services which are made 
available to persons unable to pay therefor without charge or at a 
charge which is less than the reasonable cost of such services. The 
level of such services is measured by the difference between the amount 
charged such persons for such services and the reasonable cost thereof;
    (7) Reasonable volume of services to persons unable to pay therefor 
means a level of uncompensated services which meets a need for such 
services in the area served by an applicant and which is within the 
financial ability of such applicant to provide.
    (c) Assurance. (1) Before an application under this part is 
recommended by a State agency to the Secretary for approval, the State 
agency shall obtain an assurance from the applicant that there will be 
made available in the facility or portion thereof to be constructed or 
modernized a reasonable volume of services to persons unable to pay 
therefor. The requirement of an assurance from an applicant shall be 
waived if the applicant demonstrates to the satisfaction of the State 
agency, subject to subsequent approval by the Secretary, that such a 
requirement is not feasible from a financial viewpoint.
    (2) Prior to recommending that such requirement be waived, the State 
agency shall publish in a newspaper of general circulation in the area 
served by

[[Page 342]]

the applicant a notice of the request for such waiver and invite public 
comment thereon, allowing not less than 30 days therefor. All comments 
received shall be available for public inspection, and shall be 
considered by the State agency in arriving at its recommendation. Notice 
of the determination on the request for waiver shall be given to all 
interested persons and to the public before the approval of the 
Secretary is sought.
    (d) Presumptive compliance guideline. An applicant which, for a 
fiscal year, (1) budgets for the support of, and makes available on 
request, uncompensated services at a level not less than the lesser of 3 
percent of operating costs or 10 percent of all Federal assistance 
provided to or on behalf of the applicant under the Act, or (2) 
certifies that it will not exclude any person from admission on the 
ground that such person is unable to pay for needed services and that it 
will make available to each person so admitted services provided by the 
facility without charge or at a charge below reasonable cost which does 
not exceed any such person's ability to pay therefor as determined in 
accordance with criteria established pursuant to paragraph (g), shall be 
deemed in presumptive compliance with its assurance. In the case of a 
loan guarantee with interest subsidy or a direct loan guarantee be sold 
by the Secretary with an interest subsidy, the amount of Federal 
assistance shall include the total amount of the interest subsidy which 
the Secretary is, or will be, obligated to pay over the full life of the 
loan, as well as any other payments which the Secretary makes on behalf 
of the applicant in connection with the loan guarantee or the direct 
loan which has been sold.
    (e) Compliance reports. (1) Each applicant shall, not later than 120 
days after the end of a fiscal year, unless a longer period is approved 
by the State agency for good cause shown, file with the State agency a 
copy of its annual statement for such year as required by section 646 of 
the Act and Sec.  53.128(q), which shall set forth its operating costs.
    (2) With respect to each fiscal year for which a level of 
uncompensated services has been established in accordance with this 
section, the annual statement shall also set forth the amount of 
uncompensated services provided in such year.
    (i) The provision of a level of uncompensated services in such year 
which equals or exceeds the level established pursuant to paragraph (h) 
of this section for such year shall constitute compliance with the 
assurance.
    (ii) If the level of services provided was less than the level of 
uncompensated services established pursuant to paragraph (h) of this 
section, the applicant shall submit with such statement: A justification 
therefor, showing that the provision of such lower level of 
uncompensated services was reasonable under the circumstances; and a 
description of the steps it proposes to take to assure the availability 
and utilization of the level of uncompensated services to be established 
for the current fiscal year, which shall include an affirmative action 
plan, utilizing press releases or other appropriate means as the 
facility may desire to bring to the attention of the public the 
availability of such uncompensated services and the conditions of 
eligibility therefor.
    (3) Each applicant shall file with its annual statement a copy of 
that portion of its adopted budget for the current fiscal year relating 
to the support of uncompensated services in such year. Such budget for 
uncompensated services shall be based on the operating costs of the 
applicant for the preceding fiscal year and shall give due cognizance to 
probable increases in operating costs. Except in the case of a 
certification pursuant to paragraph (d)(2) of this section, if the 
budget statement does not conform to the presumptive compliance 
guideline, the applicant shall submit with its statement.
    (i) A justification therefor, showing that such lower level of 
uncompensated services is reasonable under the circumstances, and
    (ii) A plan to increase such uncompensated services to meet the 
presumptive compliance guideline or such other level of uncompensated 
services as may have been established or as it requests the State agency 
to establish in accordance with paragraph (h) of this section.

[[Page 343]]

    (4) The applicant shall also submit such additional reports related 
to compliance with its assurance as the State agency may reasonably 
require.
    (5) Pending the establishment of a level of uncompensated services 
for any fiscal year pursuant to paragraph (h) of this section, the 
applicant shall, in such fiscal year, provide a level of services which 
is the higher of
    (i) The level established for the preceding fiscal year (or if no 
such level has been established for such prior year, the level of 
services provided in such year) or
    (ii) The level proposed in its adopted budget for the current fiscal 
year.
    (f) Qualifying services. (1) In determining the amount of 
uncompensated services provided by an applicant, there shall be included 
only those services provided to an individual with respect to whom the 
applicant has made a written determination prior to the provision of 
such services that such individual is unable to pay therefor under the 
criteria established pursuant to 42 CFR 53.111(g), except that:
    (i) Such determination may be made after the provision of such 
services in the case of services provided on an emergency basis: 
Provided, That when billing is made for such service, such billing must 
be accompanied by substantially the information required in the posted 
notice under paragraph (i) of this section; and
    (ii) Such determination may be made after the provision of such 
services in the case of a change in circumstances as a result of the 
illness or injury occasioning such services (e.g., the patient's 
financial condition has changed due to a loss of wages resulting from 
the illness) or in case of insurance coverage or other resources being 
less than anticipated or the costs of services being greater than 
anticipated. Further, in all cases where such determination was not made 
prior to the provision of services, such services may not be included as 
uncompensated services if any collection effort has been made other than 
the rendering of bills permissible in the above exceptions: Provided, 
That such a determination may be made at any time if the determination 
was hindered or delayed by reason of erroneous or incomplete information 
furnished by or in behalf of the patient.
    (2) There shall be excluded from the computation of uncompensated 
services:
    (i) Any amount which the applicant has received, or is entitled to 
receive, from a third party insurer or under a governmental program; and
    (ii) The reasonable cost of any services for which payment in whole 
or in part would be available under a governmental program (e.g., 
Medicare and Medicaid) in which the applicant, although eligible to do 
so, does not participate, but only to the extent of such otherwise 
available payment.
    (g) Persons unable to pay for services. (1) The State agency shall 
set forth in its State plan, subject to approval by the Secretary, 
criteria for identifying persons unable to pay for services, which shall 
include persons who are otherwise self-supporting but unable to pay the 
full charge for needed services. Such criteria shall be based on the 
following or similar factors:
    (i) The health and medical care insurance coverage, personal or 
family income, the size of the patient's family, and other financial 
obligations and resources of the patient or the family in relation to 
the reasonable cost of the services;
    (ii) Generally recognized standards of need such as:
    (a) The State standard for the medically needy as determined for the 
purposes of the Aid for Families with Dependent Children program;
    (b) The current Social Security Administration poverty income level;
    (c) The current Office of Economic Opportunity Income Poverty 
Guidelines applicable in the area; or
    (iii) Any other equivalent measures which are found by the Secretary 
to provide a reasonable basis for determining an individual's ability to 
pay for medical and hospital services.
    (2) A copy of such criteria shall be provided by the applicant, upon 
request, to any patient or former patient of the applicant and to any 
person seeking services from the applicant.
    (3) The State agency shall provide a copy of such criteria to any 
person requesting it.

[[Page 344]]

    (h) Level of uncompensated services. (1) The State agency shall set 
forth in its State plan procedures for the determination for each 
applicant of the level of uncompensated services which constitutes a 
reasonable volume of services to persons unable to pay therefor provided 
that in no event shall the level of uncompensated services established 
under this section exceed the presumptive compliance guideline.
    (2) The State agency shall for the purpose of making such 
determination, review, and evaluate the annual statement, the budget and 
the related documents submitted by each applicant pursuant to paragraph 
(e) of this section, by applying the following criteria:
    (i) The financial status of the applicant, taking account of income 
from all sources, and its financial ability to provide uncompensated 
services;
    (ii) The nature and quantity of services provided by the applicant;
    (iii) The need within the area served by the applicant for the 
provision, without charge or at charge which is less than reasonable 
cost, for services of the nature provided or to be provided by the 
applicant; and
    (iv) The extent and nature of joint or cooperative programs with 
other facilities for the provision of uncompensated services, and the 
extent and nature of outreach services directed to the needs of 
underserved areas.
    (3) In accordance with its findings made after such review and 
evaluation, the State agency shall, within 60 days after receipt of the 
annual statement and related documents required by paragraph (e) of this 
section, for each fiscal year of an applicant which begins following the 
expiration of 90 days after the effective date of this regulation:
    (i) Establish a level of uncompensated services for each applicant 
which may be equal to or less than the presumptive compliance guideline: 
Provided, That if the State agency determines, in accordance with 
paragraph (h)(2) of this section, that (a) there is a need in the area 
served by an applicant for a level of uncompensated services greater 
than the level proposed in the applicant's budget statement, and (b) the 
applicant is financially able to provide such greater level of 
uncompensated services, the State agency shall establish such greater 
level as the level applicable to the applicant; and
    (ii) Accept or modify a plan submitted pursuant to paragraph (e) of 
this section.
    (4) The State agency shall notify the applicant in writing of the 
level of uncompensated services which it has established for the 
applicant for the fiscal year. At the time of notifying the applicant, 
the State agency shall also publish as a public notice in a newspaper of 
general circulation within the community served by the applicant the 
rate that has been established and a statement that the documents upon 
which the agency based its determination are available for public 
inspection at a location and time prescribed. In the case of the 
establishment by the State agency of a rate which is less than the 
presumptive compliance guideline, such notice shall also include a 
statement that persons wishing to object to the rate established may do 
so by writing to the State agency within 20 days after publication of 
the notice: Provided, That the applicant may object to any level 
established which is greater than the level proposed in the applicant's 
budget statement.
    (5) In accordance with the provisions of paragraph (h)(4) of this 
section, the applicant or any person or persons residing or located 
within the area served by the applicant, or any organization on behalf 
of such person or persons, may submit to the State agency within 20 days 
of the publication and sending of the notice objections to the rate 
established by the State agency for the applicant. Such objections may 
be supported in writing by factual information and argument. The State 
agency shall give public notice of receipt of the objections and shall 
make the objections and their supporting documents available for public 
inspection and comment. It may, if it believes that determination of the 
objections will be assisted by oral evidence or by oral argument, set a 
public hearing on the objections and shall give notice of such hearing 
to all interested parties and to the public. The State agency shall 
within 60 days of the expiration of

[[Page 345]]

the period within which objections may be filed, rule upon the 
objections in writing, stating its reason for sustaining or overruling 
them, in whole or in part, and establishing finally the rate of 
uncompensated services either the same as, above, or below the rate 
previously established, as may best accord with all of the evidence on 
file with or heard by the State agency. Notice of the final 
determination shall be mailed to all parties who filed objections or who 
participated in the proceedings leading to the redetermination.
    (6) Within 20 days of receipt of written notice of the final 
determination of a State agency after ruling on objections to the rate 
established by the State agency, the applicant or any other interested 
person or organization may submit to the Secretary a written request for 
review of the State agency determination. Such review shall be made upon 
the record of the State agency determination which shall be sustained if 
supported by substantial evidence and is not otherwise arbitrary or 
capricious. If the Secretary or his designee determines that the rate 
established by the State agency is unsupported by the evidence in the 
record or is otherwise arbitrary or capricious, the Secretary or his 
designee shall, upon the basis of the record or upon other evidence or 
information which is before him or which he may obtain, establish a 
level of uncompensated services which he determines, in accordance with 
the criteria set out in paragraph (h)(2) of this section, is 
appropriate.
    (7) The level of uncompensated services established for an applicant 
under this section for any fiscal year shall constitute a reasonable 
volume of services to persons unable to pay therefor with respect to 
such applicant for such fiscal year.
    (i) Posted notice. The applicant shall post notice (which shall be 
multilingual where the applicant serves a multilingual community), in 
substantially the following form, in appropriate areas within the 
facility (admissions, office, emergency department and business office) 
for the purpose of informing patients or potential patients that 
criteria for eligibility and applications are available upon request:

                    Notice of Hill-Burton Obligation

    This hospital (or other facility) is required by law to give a 
reasonable amount of service at no cost or less than full cost to people 
who cannot pay. If you think that you are eligible for these services, 
please contact our business office (give office location) and ask for 
assistance. If you are not satisfied with the results, you may contact 
(the State Hill-Burton agency with address).
    Provided, That an applicant which has selected a presumptive 
compliance guideline under paragraph (d)(1) of this section may, at its 
option, either (1) add to such notice language stating that the 
facility's obligation is limited to a specified dollar volume of 
uncompensated services and that if the facility has, during a specified 
period (e.g., year, quarter, month), already provided a volume of 
uncompensated services sufficient to satisfy such obligation, any person 
inquiring about such services will be given a written statement to that 
effect which shall also state when additional uncompensated services 
will be available; or (2) post an additional notice stating that the 
facility's obligation has been satisfied for the current period and 
stating when additional uncompensated services will be available.

    (j) Evaluation and enforcement. The State plan shall provide for 
evaluation and enforcement of the assurance in accordance with the 
following requirements:
    (1) The State agency shall,
    (i) At least annually, perform evaluations of the amount of the 
various services provided in each facility with respect to which Federal 
assistance has been provided under the Act, to determine whether such 
assurance is being complied with; and
    (ii) Establish procedures for the investigation of complaints that 
such assurance is not being complied with.
    (2) Evaluation pursuant to paragraph (j)(1) of this section shall be 
based on the annual budget of each facility for uncompensated services 
and on financial statements of such facilities filed pursuant to section 
646 of the Act and Sec.  53.128(q), and on such other information, 
including reports of investigations and hearing decisions, as the State 
agency deems relevant and material.
    (3) The State plan shall provide for adequate methods of enforcement 
of

[[Page 346]]

the assurance, including effective sanctions to be applied against any 
facility which fails to comply with such assurance. Such sanctions may 
include, but need not be limited to, license revocation, termination of 
State assistance, and court action.
    (k) Reports. (1) The State agency shall, not less often than 
annually, report in writing to the Secretary its evaluation of each 
facility's compliance with the assurance, the disposition of each 
complaint received by the State agency, proposed remedial action with 
respect to each facility found by the State agency to be not in 
compliance with the assurance, and the status of such remedial action.
    (2) In addition, the State agency shall promptly report to the 
Regional Attorney and Regional Health Director of the Department of 
Health and Human Services the institution of any legal action against a 
facility or the State agency involving compliance with the assurance.

[37 FR 14721, July 22, 1972, as amended at 38 FR 16354, June 22, 1973; 
40 FR 46203, Oct. 6, 1975]



Sec.  53.112  Nondiscrimination.

    (a) Before an application is recommended by a State agency to the 
Secretary for approval, the State agency shall obtain an assurance from 
the applicant that all portions and services of the entire facility for 
the construction or modernization of which, or in connection with which, 
aid under the Act is sought will be made available without 
discrimination on account of creed and no professionally qualified 
person will be discriminated against on account of creed with respect to 
the privilege of professional practice in the facility.
    (b) Each construction contract is subject to the condition that the 
applicant shall comply with the requirements of Executive Order 11246, 
September 24, 1965 (30 FR 12319), relating to nondiscrimination in 
construction contract employment, and the applicable rules, regulations, 
and procedures prescribed pursuant thereto.
    (c) Attention is called to the requirement of title VI of the Civil 
Rights Act of 1964 (42 U.S.C. 2000d; 78 Stat. 252) which provides that 
no person in the United States shall, on the ground of race, color, or 
national origin be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance. A regulation 
implementing such title VI, applicable to assistance under this part for 
construction and modernization of hospitals and medical facilities, has 
been issued by the Secretary of Health and Human Services with the 
approval of the President (45 CFR part 80).

[37 FR 182, Jan. 6, 1972, as amended at 39 FR 31767, Aug. 30, 1974]



Sec.  53.113  Community service.

    (a) Applicability. The provisions of this section apply to every 
applicant which heretofore has given or hereafter will give a community 
service assurance.
    (b) Definitions. As used in this section:
    (1) The term community service assurance means an assurance required 
by regulations promulgated pursuant to section 603(e)(1) of the Act or 
the predecessor of that section (section 622(f), Public Health Service 
Act, enacted by Pub. L. 79-725, 60 Stat. 1041).
    (2) The term facility has the same meaning as is given it in Sec.  
53.111(b)(1).
    (3) The term applicant has the same meaning as is given it in Sec.  
53.111(b)(2).
    (4) The term fiscal year has the same meaning as is given it in 
Sec.  53.111(b)(3).
    (c) Assurance. Before an application under this part is recommended 
by a State agency to the Secretary for approval, the State agency shall 
obtain an assurance from the applicant that the facility will furnish a 
community service.
    (d) Compliance. In order to comply with its community service 
assurance an applicant must:
    (1)(i) Make the services it furnishes available to the general 
public, or
    (ii) Limit the availability of such services only on the basis of 
age, medical indigency, or type or kind of medical or mental disability, 
or
    (iii) If the facility constitutes a medical or nursing care unit of 
a home or other institution, make such home or

[[Page 347]]

other institution available in accordance with paragraph (d)(1) (i) or 
(ii) of this section; and
    (2)(i) Make arrangements, if eligible to do so, for reimbursement 
for services with:
    (A) Those principal State and local governmental third-party payors 
which provide reimbursement for services that is not less than the 
actual cost of such services as determined in accordance with accepted 
cost accounting principles; and
    (B) Those Federal governmental third-party programs, such as 
Medicare and Medicaid, to the extent that the applicant is entitled to 
reimbursement at reasonable cost under a formula established in 
accordance with applicable Federal law.
    (ii) Take such additional steps as may be necessary to ensure that 
admission to and services of the facility will be available to 
beneficiaries of the governmental programs specified in paragraph 
(d)(2)(i) of this section without discrimination (or preference) on 
account of their being such beneficiaries.
    (e) Reports. The annual statement required by section 646 of the Act 
and Sec.  53.128(q), a copy of which must be submitted to the State 
agency in accordance with the requirements of Sec.  53.111(e)(1), shall 
set forth the amount of the reimbursement received pursuant to each 
arrangement with a principal governmental third-party payor.
    (f) Evaluation and enforcement. The State plan shall provide for 
evaluation and enforcement of the community service assurance in 
accordance with the following requirements:
    (1) The State agency shall,
    (i) At least annually, evaluate the compliance of facilities with 
such assurance; and
    (ii) Establish procedures for the investigation of complaints that 
such assurance is not being complied with.
    (2) The State plan shall provide for adequate methods of enforcement 
of the assurance, including effective sanctions to be applied against 
any facility which fails to comply with such assurance. Such sanctions 
may include, but need not be limited to, license revocation, termination 
of State assistance and court action.
    (g) Reports. (1) The State agency shall, not less often than 
annually, report in writing to the Secretary its general evaluation of 
facilities' compliance with the assurance, the disposition of each 
complaint received by the State agency, proposed remedial action with 
respect to each facility found by the State agency to be not in 
compliance with the assurance, and the status of such remedial action.
    (2) In addition, the State agency shall promptly report to the 
Regional Attorney and Regional Health Director of the Department of 
Health and Human Services the institution of any legal action against a 
facility or the State agency involving compliance with the assurance.

[39 FR 31767, Aug. 30, 1974, as amended at 42 FR 16780, Mar. 30, 1977]

Subpart M [Reserved]



               Subpart N_Loan Guarantees and Direct Loans



Sec.  53.154  Waiver of right of recovery.

    In determining whether there is good cause for waiver of any right 
of recovery which he may have against a nonprofit private agency by 
reason of any payments made pursuant to a loan guarantee, or against a 
public agency by reason of the failure of such agency to make payments 
of principal and interest on a direct loan to such agency, the Secretary 
shall take into consideration the extent to which:
    (a) The facility with respect to which the loan guarantee or direct 
loan was made will continue to be devoted by the applicant or other 
owner to use for the purpose for which it was constructed or another 
public or nonprofit purpose which will promote the purposes of the Act;
    (b) There are reasonable assurances that for the remainder of the 
repayment period of the loan other public or non-profit facilities not 
previously utilized for the purpose for which the facility was 
constructed will be so utilized and are substantially equivalent in 
nature and extent for such purposes; and

[[Page 348]]

    (c) Such recovery would seriously curtail the provision of medical 
services to persons in need of such services in the area.

[37 FR 182, Jan. 6, 1972]



Sec.  53.155  Modification of loans.

    No official of the Department of Health and Human Services will 
approve any proposal to modify the terms of a loan guaranteed under 
title VI of the Public Health Service Act (42 U.S.C. 291 et seq.) and 
this subpart which would permit the use of the guaranteed loan (or the 
guarantee) as collateral for an issue of tax-exempt securities.

[48 FR 42984, Sept. 21, 1983]



Sec.  53.156  Fees for modification requests.

    (a) Fees will be charged for the processing of requests for parity, 
and for major and minor modifications of the terms of documents 
evidencing and securing direct and guaranteed loans. In accordance with 
the requirements of the User Charge Statute, 31 U.S.C. 9701(b), the 
Secretary determines the amount of the application fee that must be 
submitted with each type of modification.
    (1) As used in this section, a request for parity allows new debt to 
share lien position (i.e., collateral) with an existing Hill-Burton 
loan.
    (2) As used in this section, a major modification is any 
modification involving the release of $100,000 or more of collateral; a 
corporate restructuring that involves a transfer of assets; master 
indenture requests; modifications to a sinking fund; defeasance requests 
and requests for additional secured indebtedness; and any, other 
modification that involves a comparably significant use of Department 
resources.
    (3) As used in this section, a minor modification is any 
modification involving the release of less than $100,000 of collateral; 
an easement; and any other modification that involves a comparable use 
of Department resources.
    (b) A request for modification is to be accompanied by a certified 
check or money order in the amount of the appropriate fee, payable to 
the U.S. Treasury. The fees for modification requests submitted on or 
after October 28, 1986 are as follows:
    (1) $1,500 for a minor modification,
    (2) $4,500 for a major modification, and
    (3) $5,500 for a request for parity.
    (c) A submitter may withdraw its request for modification within 10 
business days following its receipt and receive a refund of the fee.
    (d) If the Secretary determines that a change in the amount of a fee 
is appropriate, the Department will issue a notice of proposed 
rulemaking in the Federal Register to announce the proposed amount.

[51 FR 39376, Oct. 28, 1986]



  PART 54_CHARITABLE CHOICE REGULATIONS APPLICABLE TO STATES RECEIVING 
  SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANTS AND/OR PROJECTS 
  FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS GRANTS--Table of Contents



Sec.
54.1 Scope.
54.2 Definitions.
54.3 Nondiscrimination against religious organizations.
54.4 Religious activities.
54.5 Religious character and independence.
54.6 Employment practices.
54.7 Nondiscrimination requirement.
54.8 Right to services from an alternative provider.
54.9 Assurances and State oversight of the Charitable Choice 
          requirements.
54.10 Fiscal accountability.
54.11 Effects on State and local funds.
54.12 Treatment of intermediate organizations.
54.13 Educational requirements for personnel in drug treatment programs.

    Authority: 42 U.S.C. 300x-65, et seq., 42 U.S.C. 290kk, et seq., 42 
U.S.C. 300x-21, et seq., 42 U.S.C. 290cc-21, et seq., and 42 U.S.C. 
2000bb, et seq.

    Source: 68 FR 56444, Sept. 30, 2003, unless otherwise noted.



Sec.  54.1  Scope.

    These provisions apply only to funds provided directly to pay for 
substance abuse prevention and treatment services under 42 U.S.C. 300x-
21 et seq., and 42 U.S.C. 290cc-21 to 290cc-35. This part does not apply 
to direct funding under

[[Page 349]]

any such authorities for activities that do not involve the provision of 
substance abuse services, such as for infrastructure activities 
authorized under Section 1971 of the PHS Act, 42 U.S.C. 300y, and for 
technical assistance activities. This part implements the SAMHSA 
Charitable Choice provisions, 42 U.S.C. 300x-65 and 42 U.S.C. 290kk, et 
seq.



Sec.  54.2  Definitions.

    (a) Applicable program means the programs authorized under:
    (1) The Substance Abuse Prevention and Treatment (SAPT) Block Grant, 
42 U.S.C. 300x to 300x-66, and
    (2) The Projects for Assistance in Transition from Homelessness 
(PATH) Formula Grants, 42 U.S.C. 290cc-21 to 290cc-35 insofar as they 
fund substance abuse prevention and/or treatment services.
    (b) Religious organization means a nonprofit religious organization.
    (c) Program beneficiary means an individual who receives substance 
abuse services under a program funded in whole or in part by applicable 
programs.
    (d) Program participant means a public or private entity that has 
received financial assistance, under an applicable program.
    (e) SAMHSA means the U.S. Substance Abuse and Mental Health Services 
Administration.
    (f) SAMHSA Charitable Choice provisions means the provisions of 42 
U.S.C. 300x-65 and 42 U.S.C. 290kk, et seq.
    (g) Direct funding or Funds provided directly means funding that is 
provided to an organization directly by a governmental entity or 
intermediate organization that has the same duties under this part as a 
governmental entity, as opposed to funding that an organization receives 
as the result of the genuine and independent private choice of a 
beneficiary through a voucher, certificate, coupon, or other similar 
mechanism.



Sec.  54.3  Nondiscrimination against religious organizations.

    (a) Religious organizations are eligible, on the same basis as any 
other organization, to participate in applicable programs, as long as 
their services are provided consistent with the Establishment Clause and 
the Free Exercise Clause of the First Amendment to the United States 
Constitution. Except as provided herein or in the SAMHSA Charitable 
Choice provisions, nothing in these regulations shall restrict the 
ability of the Federal government, or a State or local government, from 
applying to religious organizations the same eligibility conditions in 
applicable programs as are applied to any other nonprofit private 
organization.
    (b) Neither the Federal government nor a State or local government 
receiving funds under these programs shall discriminate against an 
organization that is, or applies to be, a program participant on the 
basis of religion or the organization's religious character or 
affiliation.



Sec.  54.4  Religious activities.

    No funds provided directly from SAMHSA or the relevant State or 
local government to organizations participating in applicable programs 
may be expended for inherently religious activities, such as worship, 
religious instruction, or proselytization. If an organization conducts 
such activities, it must offer them separately, in time or location, 
from the programs or services for which it receives funds directly from 
SAMHSA or the relevant State or local government under any applicable 
program, and participation must be voluntary for the program 
beneficiaries.



Sec.  54.5  Religious character and independence.

    A religious organization that participates in an applicable program 
will retain its independence from Federal, State, and local governments 
and may continue to carry out its mission, including the definition, 
practice and expression of its religious beliefs. The organization may 
not expend funds that it receives directly from SAMHSA or the relevant 
State or local government to support any inherently religious 
activities, such as worship, religious instruction, or proselytization. 
Among other things, faith-based organizations may use space in their 
facilities to provide services supported by applicable programs, without 
removing religious

[[Page 350]]

art, icons, scriptures, or other symbols. In addition, a SAMHSA-funded 
religious organization retains the authority over its internal 
governance, and it may retain religious terms in its organization's 
name, select its board members on a religious basis, and include 
religious references in its organization's mission statements and other 
governing documents.



Sec.  54.6  Employment practices.

    (a) The participation of a religious organization in, or its receipt 
of funds from, an applicable program does not affect that organization's 
exemption provided under 42 U.S.C. 2000e-1 regarding employment 
practices.
    (b) To the extent that 42 U.S.C. 300x-57(a)(2) or 42 U.S.C. 290cc-
33(a)(2) precludes a program participant from employing individuals of a 
particular religion to perform work connected with the carrying on of 
its activities, those provisions do not apply if such program 
participant is a religious corporation, association, educational 
institution, or society and can demonstrate that its religious exercise 
would be substantially burdened by application of these religious 
nondiscrimination requirements to its employment practices in the 
program or activity at issue. In order to make this demonstration, the 
program participant must certify: that it sincerely believes that 
employing individuals of a particular religion is important to the 
definition and maintenance of its religious identity, autonomy, and/or 
communal religious exercise; that it makes employment decisions on a 
religious basis in analogous programs; that the grant would materially 
affect its ability to provide the type of services in question; and that 
providing the services in question is expressive of its values or 
mission. The organization must maintain documentation to support these 
determinations and must make such documentation available to SAMHSA upon 
request.
    (c) Nothing in this section shall be construed to modify or affect 
any State law or regulation that relates to discrimination in 
employment.
    (d) The phrases ``with respect to the employment,'' ``individuals of 
a particular religion,'' and ``religious corporation, association, 
educational institution, or society'' shall have the same meaning as 
those terms have under section 702 of the Civil Rights Act of 1964, 42 
U.S.C. 2000e-1(a).



Sec.  54.7  Nondiscrimination requirement.

    A religious organization that is a program participant shall not, in 
providing program services or engaging in outreach activities under 
applicable programs, discriminate against a program beneficiary or 
prospective program beneficiary on the basis of religion, a religious 
belief, a refusal to hold a religious belief, or a refusal to actively 
participate in a religious practice.



Sec.  54.8  Right to services from an alternative provider.

    (a) General requirements. If an otherwise eligible program 
beneficiary or prospective program beneficiary objects to the religious 
character of a program participant, within a reasonable period of time 
after the date of such objection, such program beneficiary shall have 
rights to notice, referral, and alternative services, as outlined in 
paragraphs (b) through (d) of this section.
    (b) Notice. Program participants that refer an individual to 
alternative service providers, and the State government that administers 
the applicable programs, shall ensure that notice of the individual's 
right to services from an alternative provider is provided to all 
program beneficiaries or prospective beneficiaries. The notice must 
clearly articulate the program beneficiary's right to a referral and to 
services that reasonably meet the requirements of timeliness, capacity, 
accessibility, and equivalency as discussed in this section. A model 
notice is set out in appendix A to part 54a.
    (c) Referral to an alternative provider. If a program beneficiary or 
prospective program beneficiary objects to the religious character of a 
program participant that is a religious organization, that participating 
religious organization shall, within a reasonable time after the date of 
such objection, refer such individual to an alternative provider. The 
State shall have a system in place to ensure that referrals are made

[[Page 351]]

to an alternative provider. That system shall ensure that the following 
occurs:
    (1) The religious organization that is a program participant shall, 
within a reasonable time after the date of such objection, refer the 
beneficiary to an alternative provider;
    (2) In making such referral, the program participant shall consider 
any list that the State or local government makes available to entities 
in the geographic area that provide program services, which may include 
utilizing any treatment locator system developed by SAMHSA;
    (3) All referrals shall be made in a manner consistent with all 
applicable confidentiality laws, including, but not limited to, 42 CFR 
Part 2 (``Confidentiality of Alcohol and Drug Abuse Patient Records'');
    (4) Upon referring a program beneficiary to an alternative provider, 
the program participant shall notify the State or responsible unit of 
government of such referral; and
    (5) The program participant shall ensure that the program 
beneficiary makes contact with the alternative provider to which he or 
she is referred.
    (d) Provision and funding of alternative services. If an otherwise 
eligible applicant or recipient objects to the religious character of a 
SAMHSA-funded service provider, the recipient is entitled to receive 
services from an alternative provider. In such cases, the State or local 
agency must provide the individual with alternative services within a 
reasonable period of time, as defined by the State agency. That 
alternative provider must be reasonably accessible and have the capacity 
to provide comparable services to the individual. Such services shall 
have a value that is not less than the value of the services that the 
individual would have received from the program participant to which the 
individual had such objection, as defined by the State agency. The 
alternative provider need not be a secular organization. It must simply 
be a provider to which the recipient has no religious objection. States 
may define and apply the terms ``reasonably accessible,'' ``a reasonable 
period of time,'' ``comparable,'' ``capacity,'' and ``value that is not 
less than.'' The appropriate State or local governments that administer 
SAMHSA-funded programs shall ensure that notice of their right to 
alternative services is provided to applicants or recipients. The notice 
must clearly articulate the recipient's right to a referral and to 
services that reasonably meet the timeliness, capacity, accessibility, 
and equivalency requirements discussed above.
    (e) PATH annual report. As part of the annual report to SAMHSA, PATH 
grantees shall include a description of the activities the grantee has 
taken to comply with 42 CFR part 54.



Sec.  54.9  Assurances and State oversight of the Charitable Choice 
requirements.

    In order to ensure that States receiving grant funding under the 
SAPT block grant and PATH formula grant programs comply with the SAMHSA 
Charitable Choice provisions and provide oversight of religious 
organizations that provide substance abuse services under such programs, 
States are required as part of their applications for funding to certify 
that they will comply with all of the requirements of such provisions 
and the implementing regulations under this part, and that they will 
provide such oversight of religious organizations.



Sec.  54.10  Fiscal accountability.

    (a) Religious organizations that receive applicable program funds 
for substance abuse services are subject to the same regulations as 
other nongovernmental organizations to account, in accordance with 
generally accepted auditing and accounting principles, for the use of 
such funds.
    (b) Religious organizations shall segregate Federal funds they 
receive under an applicable program into a separate account from non-
Federal funds. Only the Federal funds shall be subject to audit by 
government under the SAMHSA program.



Sec.  54.11  Effects on State and local funds.

    If a State or local government contributes its own funds to 
supplement activities carried out under the applicable programs, the 
State or local government has the option to separate out

[[Page 352]]

the Federal funds or commingle them. If the funds are commingled, the 
provisions of this part shall apply to all of the commingled funds in 
the same manner, and to the same extent, as the provisions apply to the 
Federal funds.



Sec.  54.12  Treatment of intermediate organizations.

    If a nongovernmental organization (referred to here as an 
``intermediate organization''), acting under a contract or other 
agreement with the Federal Government or a State or local government, is 
given the authority under the contract or agreement to select 
nongovernmental organizations to provide services under any applicable 
program, the intermediate organization shall have the same duties under 
this part as the government. The intermediate organization retains all 
other rights of a nongovernmental organization under this part and the 
SAMHSA Charitable Choice provisions.



Sec.  54.13  Educational requirements for personnel in drug treatment programs.

    In determining whether personnel of a program participant that has a 
record of successful drug treatment for the preceding three years have 
satisfied State or local requirements for education and training, a 
State or local government shall not discriminate against education and 
training provided to such personnel by a religious organization, so long 
as such education and training is comparable to that provided by 
nonreligious organizations, or is comparable to education and training 
that the State or local government would otherwise credit for purposes 
of determining whether the relevant requirements have been satisfied.



PART 54a_CHARITABLE CHOICE REGULATIONS APPLICABLE TO STATES, LOCAL GOVERNMENTS 
AND RELIGIOUS ORGANIZATIONS RECEIVING DISCRETIONARY FUNDING UNDER TITLE V 
OF THE PUBLIC HEALTH SERVICE ACT, 42 U.S.C. 290aa, et seq., 
FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES--Table of Contents



Sec.
54a.1 Scope.
54a.2 Definitions.
54a.3 Nondiscrimination against religious organizations.
54a.4 Religious activities.
54a.5 Religious character and independence.
54a.6 Employment practices.
54a.7 Nondiscrimination requirement.
54a.8 Right to services from an alternative provider.
54a.9 Oversight of the Charitable Choice requirements.
54a.10 Fiscal accountability.
54a.11 Effect on State and local funds.
54a.12 Treatment of intermediate organizations.
54a.13 Educational requirements for personnel in drug treatment 
          programs.
54a.14 Determination of nonprofit status.

Appendix to Part 54a--Model Notice to Individuals Receiving Substance 
          Abuse Services.

    Authority: 42 U.S.C. 300x-65, and 42 U.S.C. 290kk, et seq., 42 
U.S.C. 290aa, et seq.

    Source: 68 FR 56446, Sept. 30, 2003, unless otherwise noted.



Sec.  54a.1  Scope.

    These provisions apply only to funds provided directly to pay for 
substance abuse prevention and treatment services under Title V of the 
Public Health Service Act, 42 U.S.C. 290aa, et seq., which are 
administered by the Substance Abuse and Mental Health Services 
Administration. This part does not apply to direct funding under any 
such authorities for only mental health services or for certain 
infrastructure and technical assistance activities, such as cooperative 
agreements for technical assistance centers, that do not provide 
substance abuse services to clients. This part implements the provisions 
of 42 U.S.C. 300x-65 and 42 U.S.C. 290kk, et seq.

[[Page 353]]



Sec.  54a.2  Definitions.

    (a) Applicable program means the programs authorized under Title V 
of the PHS Act, 42 U.S.C. 290aa, et seq., for the provision of substance 
abuse prevention and or treatment services.
    (b) Religious organization means a nonprofit religious organization.
    (c) Program beneficiary means an individual who receives substance 
abuse services under a program funded in whole or in part by applicable 
programs.
    (d) Program participant means a public or private entity that has 
received financial assistance under an applicable program.
    (e) SAMHSA means the Substance Abuse and Mental Health Services 
Administration.
    (f) SAMHSA Charitable Choice provisions means the provisions of 42 
U.S.C. 300x-65 and 42 U.S.C. 290kk, et seq.
    (g) Direct funding or Funds provided directly means funding that is 
provided to an organization directly by a governmental entity or 
intermediate organization that has the same duties under this part as a 
governmental entity, as opposed to funding that an organization receives 
as the result of the genuine and independent private choice of a 
beneficiary through a voucher, certificate, coupon, or other similar 
mechanism.



Sec.  54a.3  Nondiscrimination against religious organizations.

    (a) Religious organizations are eligible, on the same basis as any 
other organization, to participate in applicable programs as long as 
their services are provided consistent with the Establishment Clause and 
the Free Exercise Clause of the First Amendment to the United States 
Constitution. Except as provided herein or in the SAMHSA Charitable 
Choice provisions, nothing in these regulations shall restrict the 
ability of the Federal government, or a State or local government, from 
applying to religious organizations the same eligibility conditions in 
applicable programs as are applied to any other nonprofit private 
organization.
    (b) Neither the Federal government nor a State or local government 
receiving funds under these programs shall discriminate against an 
organization that is, or applies to be, a program participant on the 
basis of the organization's religious character or affiliation.



Sec.  54a.4  Religious activities.

    No funds provided directly from SAMHSA or the relevant State or 
local government to organizations participating in applicable programs 
may be expended for inherently religious activities, such as worship, 
religious instruction, or proselytization. If an organization conducts 
such activities, it must offer them separately, in time or location, 
from the programs or services for which it receives funds directly from 
SAMHSA or the relevant State or local government under any applicable 
program, and participation must be voluntary for the program 
beneficiaries.



Sec.  54a.5  Religious character and independence.

    A religious organization that participates in an applicable program 
will retain its independence from Federal, State, and local governments 
and may continue to carry out its mission, including the definition, 
practice and expression of its religious beliefs. The organization may 
not expend funds that it receives directly from SAMHSA or the relevant 
State or local government to support any inherently religious 
activities, such as worship, religious instruction, or proselytization. 
Among other things, faith-based organizations may use space in their 
facilities to provide services supported by applicable programs, without 
removing religious art, icons, scriptures, or other symbols. In 
addition, a SAMHSA-funded religious organization retains the authority 
over its internal governance, and it may retain religious terms in its 
organization's name, select its board members on a religious basis, and 
include religious references in its organization's mission statements 
and other governing documents.



Sec.  54a.6  Employment practices.

    (a) The participation of a religious organization in or its receipt 
of funds from an applicable program does not affect that organization's 
exemption provided under 42 U.S.C. 2000e-1 regarding employment 
practices.

[[Page 354]]

    (b) Nothing in this section shall be construed to modify or affect 
any State law or regulation that relates to discrimination in 
employment.



Sec.  54a.7  Nondiscrimination requirement.

    A religious organization that is a program participant shall not, in 
providing program services or engaging in outreach activities under 
applicable programs, discriminate against a program beneficiary or 
prospective program on the basis of religion, a religious belief, a 
refusal to hold a religious belief, or a refusal to actively participate 
in a religious practice.



Sec.  54a.8  Right to services from an alternative provider.

    (a) General requirements. If an otherwise eligible program 
beneficiary or prospective program beneficiary objects to the religious 
character of a program participant, within a reasonable period of time 
after the date of such objection, such program beneficiary shall have 
rights to notice, referral, and alternative services, as outlined in 
paragraphs (b) through (d) of this section. With respect to SAMHSA 
discretionary programs, for purposes of determining what is the 
appropriate Federal, State, or local government, the following principle 
shall apply: When SAMHSA provides funding directly to another unit of 
government, such as a State or local government, that unit of government 
is responsible for providing the alternative services. When SAMHSA 
provides discretionary grant funding directly to a nongovernmental 
organization, SAMHSA is the responsible unit of government.
    (b) Notice. Program participants that refer an individual to 
alternative providers, and the appropriate Federal, State, or local 
governments that administer the applicable programs, shall ensure that 
notice of the individual's rights to services from an alternative 
provider is provided to all program beneficiaries or prospective 
beneficiaries. The notice must clearly articulate the program 
beneficiary's right to a referral and to services that reasonably meet 
the requirements of timeliness, capacity, accessibility, and equivalency 
as discussed in this section. A model notice is set out in appendix A to 
this part.
    (c) Referral to services from an alternative provider. If a program 
beneficiary or a prospective program beneficiary objects to the 
religious character of a program participant that is a religious 
organization, that participating religious organization shall, within a 
reasonable time after the date of such objection, refer such individual 
to an alternative provider.
    (1) When the State or local government is the responsible unit of 
government, the State shall have a system in place to ensure that such 
referrals are made. That system shall ensure that the following occurs:
    (i) The religious organization that is a program participant shall, 
within a reasonable time after the date of such objection, refer the 
beneficiary to an alternative provider;
    (ii) In making such referral, the religious organization shall 
consider any list that the State or local government makes available to 
entities in the geographic area that provide program services, which may 
include utilizing any treatment locator system developed by SAMHSA;
    (iii) All referrals are to be made in a manner consistent with all 
applicable confidentiality laws, including, but not limited to, 42 CFR 
part 2 (``Confidentiality of Alcohol and Drug Abuse Patient Records'');
    (iv) Upon referring a program beneficiary to an alternative 
provider, the religious organization shall notify the responsible unit 
of government of such referral; and
    (v) The religious organization shall ensure that the program 
beneficiary makes contact with the alternative provider to which he or 
she is referred.
    (2) When SAMHSA is the responsible unit of government, the referral 
process is as follows:
    (i) When a program beneficiary requests alternative services, the 
religious organization will seek to make such a referral.
    (ii) If the religious organization cannot locate an appropriate 
provider of alternative services, the religious organization will 
contact SAMHSA. They will work together to identify additional 
alternative providers, utilizing

[[Page 355]]

the SAMHSA Treatment Locator system, if appropriate.
    (iii) The religious organization will contact these alternative 
providers and seek to make the referral, in a manner consistent with all 
applicable confidentiality laws, including, but not limited to, 42 CFR 
part 2 (``Confidentiality of Alcohol and Drug Abuse Patient Records'').
    (iv) In the event the religious organization is still unable to 
locate an alternative provider, it may again contact SAMHSA for 
assistance.
    (d) Referral reporting procedures. The program participant shall 
notify the appropriate Federal, State or local government agency that 
administers the program of such referral. If a State or local government 
is the responsible unit of government, it may determine its own 
reporting procedures. When SAMHSA is the responsible unit of government, 
this notification will occur during the course of the regular reports 
that may be required under the terms of the funding award.
    (e) Provision and funding of alternative services. The responsible 
unit of government, as defined in paragraph (a) of this section, shall 
provide to an otherwise eligible program beneficiary or prospective 
program beneficiary who objects to the religious character of a program 
participant, services and fund services from an alternative provider 
that is reasonably accessible to, and has the capacity to provide such 
services to the individual. Such services shall have a value that is not 
less than the value of the services that the individual would have 
received from the program participant to which the individual had such 
objection. The appropriate State or local governments that administer 
SAMHSA-funded programs shall ensure that notice of their right to 
alternative services is provided to applicants or recipients. The 
alternative provider need not be a secular organization. It must simply 
be a provider to which the program beneficiary has no religious 
objection.
    (1) When the State receives a discretionary grant from SAMHSA, it 
shall utilize its own implementation procedures for these provisions and 
shall use funds from the SAMHSA discretionary grant to finance such 
alternative services, as needed;
    (2) When the local government receives a discretionary grant from 
SAMHSA, it shall utilize State implementation procedures for these 
provisions and shall use funds from the SAMHSA discretionary grant to 
finance such alternative services, as needed;
    (3) When a religious organization receives a discretionary grant 
from SAMHSA, if a publicly funded alternative provider is available that 
is reasonably accessible and can provide equivalent services, the 
religious organization shall refer the beneficiary to that provider. 
However, if such a provider is not available, the religious organization 
shall contract with an alternative provider to provide such services and 
may finance such services with funds from the SAMHSA discretionary 
grant.



Sec.  54a.9  Oversight of the Charitable Choice requirements.

    In order to ensure that program funds are used in compliance with 
the SAMHSA Charitable Choice provisions, applicants for funds under 
applicable programs are required, as part of their applications for 
funding, to certify that they will comply with all of the requirements 
of the SAMHSA Charitable Choice provisions and the implementing 
regulations under this part.



Sec.  54a.10  Fiscal accountability.

    (a) Religious organizations that receive applicable program funds 
for substance abuse services are subject to the same regulations as 
other nongovernmental organizations to account, in accordance with 
generally accepted auditing and accounting principles, for the use of 
such funds.
    (b) Religious organizations shall segregate Federal funds they 
receive under applicable programs into a separate account from non-
Federal funds. Only the Federal funds shall be subject to audit by the 
government under the SAMHSA program.



Sec.  54a.11  Effect on State and local funds.

    If a State or local government contributes its own funds to 
supplement

[[Page 356]]

activities carried out under the applicable programs, the State or local 
government has the option to separate out the Federal funds or commingle 
them. If the funds are commingled, the provisions of this part shall 
apply to all of the commingled funds, in the same manner, and to the 
same extent, as the provisions apply to the Federal funds.



Sec.  54a.12  Treatment of intermediate organizations.

    If a nongovernmental organization (referred to here as an 
``intermediate organization''), acting under a contract or other 
agreement with the Federal Government or a State or local government, is 
given the authority under the contract or agreement to select 
nongovernmental organizations to provide services under any applicable 
program, the intermediate organization shall have the same duties under 
this part as the government. The intermediate organization retains all 
other rights of a nongovernmental organization under this part and the 
SAMHSA Charitable Choice provisions.



Sec.  54a.13  Educational requirements for personnel 
in drug treatment programs.

    In determining whether personnel of a program participant that has a 
record of successful drug treatment for the preceding three years have 
satisfied State or local requirements for education and training, a 
State or local government shall not discriminate against education and 
training provided to such personnel by a religious organization, so long 
as such education and training is comparable to that provided by 
nonreligious organizations, or is comparable to education and training 
that the State or local government would otherwise credit for purposes 
of determining whether the relevant requirements have been satisfied.



Sec.  54a.14  Determination of nonprofit status.

    The nonprofit status of any SAMHSA applicant can be determined by 
any of the following:
    (a) Reference to the organization's listing in the Internal Revenue 
Service's (IRS) most recent list of tax-exempt organizations described 
in section 501(c)(3) of the IRS code.
    (b) A copy of a currently valid IRS Tax exemption certificate.
    (c) A statement from a State taxing body, State Attorney General, or 
other appropriate State official certifying that the applicant 
organization has a nonprofit status and that none of its net earnings 
accrue to any private shareholder or individuals.
    (d) A certified copy of the organization's certificate of 
incorporation or similar document if it clearly establishes the 
nonprofit status of the organization.
    (e) Any of the above proof for a State or national parent 
organization and a statement signed by the parent organization that the 
applicant organization is a local nonprofit affiliate.



    Sec. Appendix to Part 54a--Model Notice of Individuals Receiving 
                        Substance Abuse Services

     Model Notice to Individuals Receiving Substance Abuse Services

    No provider of substance abuse services receiving Federal funds from 
the U.S. Substance Abuse and Mental Health Services Administration, 
including this organization, may discriminate against you on the basis 
of religion, a religious belief, a refusal to hold a religious belief, 
or a refusal to actively participate in a religious practice.
    If you object to the religious character of this organization, 
Federal law gives you the right to a referral to another provider of 
substance abuse services. The referral, and your receipt of alternative 
services, must occur within a reasonable period of time after you 
request them. The alternative provider must be accessible to you and 
have the capacity to provide substance abuse services. The services 
provided to you by the alternative provider must be of a value not less 
than the value of the services you would have received from this 
organization.



PART 55a_PROGRAM GRANTS FOR BLACK LUNG CLINICS--Table of Contents



                      Subpart A_General Provisions

Sec.
55a.101 Definitions.
55a.102 Who is eligible to apply for a Black Lung clinics grant?
55a.103 What criteria has HHS established for deciding which grant 
          application to fund?

[[Page 357]]

55a.104 What confidentiality requirements must be met?
55a.105 How must grantees carry out their projects?
55a.106 Provision for waiver by the Secretary.
55a.107 What other regulations apply?

                       Subpart B_Grants to States

55a.201 What is required for a State application?

             Subpart C_Grants to Entities Other Than States

55a.301 What is required for an application from an entity other than a 
          State?

    Authority: Sec. 427(a), Federal Mine Safety and Health Act of 1977, 
92 Stat. 100 (30 U.S.C. 937(a)).

    Source: 50 FR 7913, Feb. 27, 1985, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  55a.101  Definitions.

    Act, as used in this part, means the Federal Mine Safety and Health 
Act of 1977, as amended (30 U.S.C. 801 et seq.).
    Secretary means the Secretary of Health and Human Services and any 
other officer or empolyee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    Miner or coal miner means any individual who works or has worked in 
or around a coal mine or coal preparation facility in the extraction or 
preparation of coal. The term also includes an individual who works or 
has worked in coal mine construction or transportation in or around a 
coal mine, to the extent that the individual was exposed to coal dust as 
a result of employment.



Sec.  55a.102  Who is eligible to apply for a Black Lung clinics grant?

    Any State or public or private entity may apply for a grant under 
this part.



Sec.  55a.103  What criteria has HHS established for deciding 
which grant application to fund?

    (a) The Secretary will give preference to a State, which meets the 
requirements of this part and applies for a grant under this part, over 
other applicants in that State.
    (b) Within the limits of funds available for these purposes the 
Secretary may award grants to assist in the carrying out of those 
programs which will in the Secretary's judgment best promote the 
purposes of section 427(a) of the Act, taking into account;
    (1) The number of miners to be served and their needs; and
    (2) The quality and breadth of services to be provided.



Sec.  55a.104  What confidentiality requirements must be met?

    All information as to personal facts and circumstances obtained by 
the grantee's staff about recipients of services shall be held 
confidential and shall not be disclosed without the individual's consent 
except as may be required by law or as may be necessary to provide 
service to the individual or to provide for audits with appropriate 
safeguards for confidentiality of patient records. Otherwise, 
information may be disclosed only in summary, statistical, or other form 
which does not identify particular individuals.



Sec.  55a.105  How must grantees carry out their projects?

    Grantees must carry out their projects in accordance with their 
applications and the provisions of this part.



Sec.  55a.106  Provision for waiver by the Secretary.

    The Secretary may, for good cause shown, waive provisions of these 
regulations.



Sec.  55a.107  What other regulations apply?

    Other regulations which apply to the Black Lung Clinics Program 
include, but are not limited to, the following:

42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure;
42 CFR part 50, subpart E--Maximum allowable cost for drugs;
45 CFR part 16--Procedures of the Departmental Grant Appeals Board;
45 CFR part 19--Limitations on payment or reimbursement for drugs;
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards;
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and

[[Page 358]]

Human Services effectuation of title VI of the Civil Rights Act of 1964;
45 CFR part 81--Practice and procedure for hearings under part 80;
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial 
assistance; and
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.

[50 FR 7913, Feb. 27, 1985, as amended at 81 FR 3008, Jan. 20, 2016]



                       Subpart B_Grants to States



Sec.  55a.201  What is required for a State application?

    An approvable State application must contain assurances that the 
State will:
    (a) Provide the following services for active and inactive miners in 
the State:
    (1) Primary care;
    (2) Patient and family education and counseling;
    (3) Outreach;
    (4) Patient care coordination, including individual patient care 
plans for all patients;
    (5) Antismoking advice; and
    (6) Other symptomatic treatments.
    (b) Provide medical services in consultation with a physician with 
special training or experience in the diagnosis and treatment of 
respiratory diseases.
    (c) Meet all criteria for approval and designation by the Department 
of Labor under 20 CFR part 725 to perform disability examination and 
provide treatment under the Act.
    (d) Use grant funds under this part to supplement and not supplant 
existing services of the State.
    (e) Provide the services described above for those miners previously 
served by a Black Lung Clinic in the State for which grant support 
expires during the funding period of the State's grant.
    (f) Provide services described above regardless of a person's 
ability to pay.
    (g) Audit its expenditures from amounts received under this part in 
accordance with the provisions of subpart F of 45 CFR part 75.

(Approved by the Office of Management and Budget under control number 
0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985; 81 
FR 3008, Jan. 20, 2016]



             Subpart C_Grants to Entities Other Than States



Sec.  55a.301  What is required for an application from an entity 
other than a State?

    An approvable application must contain the following:
    (a) A plan for the provision of the services required by Sec.  
55a.201(a), consistent with the requirements of Sec.  55a.201 (b) and 
(c). The plan must also contain at least the following elements:
    (1) A description of the target population to whom services are to 
be provided, including a statement of the need for services;
    (2) An assurance that charges shall be made for services rendered as 
follows:
    (i) A schedule shall be maintained listing fees or payments for the 
provision of services, designed to cover reasonable costs of operations;
    (ii) A schedule of discounts adjusted on the basis of a patient's 
ability to pay shall be maintained. The schedule of discounts must 
provide for a full discount to individuals and families with annual 
incomes at or below the poverty line established in accordance with 
section 673(2) of the Community Services Block Grant Act (42 U.S.C. 
9902(2)), (except that nominal fees for service may be requested, but 
not required, from individuals and families with annual incomes at or 
below the poverty line). No discounts shall be provided to individuals 
and families with annual incomes greater than twice the poverty line; 
and
    (iii) Where third-party payors (including Government Agencies) are 
authorized or under a legal obligation to pay all or a portion of such 
charges, all services covered by that reimbursement plan will be billed 
and every reasonable effort will be made to obtain payment.

[[Page 359]]

    (b) An assurance that no person will be denied services because of 
inability to pay.
    (c) An assurance that grant funds received under this part will be 
used to supplement and not supplant existing services of the grantee.

(Approved by the Office of Management and Budget under control number 
0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985]



PART 56_GRANTS FOR MIGRANT HEALTH SERVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
56.101 Applicability.
56.102 Definitions.
56.103 Eligibility.
56.104 Application.
56.105 Accord with health planning.
56.106 Amount of grant.
56.107 Priorities for grants.
56.108 Use of grant funds.
56.109 Grant payments.
56.110 Nondiscrimination.
56.111 Confidentiality.
56.112 Publications and copyright.
56.113 Grantee accountability.
56.114 Applicability of 45 CFR part 75.

   Subpart B_Grants for Planning and Developing Migrant Health Centers

56.201 Applicability.
56.202 Application.
56.203 Project elements.
56.204 Grant evaluation and award.

          Subpart C_Grants for Operating Migrant Health Centers

56.301 Applicability.
56.302 Application.
56.303 Project elements.
56.304 Governing board.
56.305 Grant evaluation and award.

         Subpart D_Grants for Operating Migrant Health Entities

56.401 Applicability.
56.402 Application.
56.403 Project elements.
56.404 Grant evaluation and award.

  Subpart E_Grants for Planning and Developing Migrant Health Programs

56.501 Applicability.
56.502 Application.
56.503 Project elements.
56.504 Grant evaluation and award.

         Subpart F_Grants for Operating Migrant Health Programs

56.601 Applicability.
56.602 Application.
56.603 Project elements.
56.604 Grant evaluation and award.

                Subpart G_Grants for Technical Assistance

56.701 Applicability.
56.702 Application.
56.703 Project elements.
56.704 Grant evaluation and award.

      Subpart H_Acquisition and Modernization of Existing Buildings

56.801 Applicability of 42 CFR part 51c, subpart E.

    Authority: Secs. 215, 319, Public Health Service Act (42 U.S.C. 216, 
247d).

    Source: 42 FR 60406, Nov. 25, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  56.101  Applicability.

    The regulations of this subpart are applicable to all grants 
authorized by section 319 of the Public Health Service Act (42 U.S.C. 
247d).



Sec.  56.102  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act (42 U.S.C. 201 et seq.), 
as amended.
    (b)(1) Agriculture means farming in all its branches, including--
    (i) Cultivation and tillage of the soil;
    (ii) The production, cultivation, growing, and harvesting of any 
commodity grown on, in, or as an adjunct to or part of a commodity grown 
in, or on, the land; and
    (iii) Any practice (including preparation and processing for market 
and delivery to storage or to market or to carriers for transportation 
to market) performed by a farmer or on a farm incident to or in 
conjunction with an activity described in subsection (ii).
    (c) Catchment area means the geographic area served by a project 
funded under section 319 of the Act.
    (d) Environmental health services means the detection and 
alleviation of unhealthful conditions of the environment of the persons 
served by the

[[Page 360]]

project, such as problems associated with water supply, sewage 
treatment, solid waste disposal, rodent and parasite infestation, field 
sanitation, and housing conditions and the treatment of medical 
conditions arising therefrom. For the purposes of this part, the 
detection and alleviation of unhealthful conditions of the environment 
includes the notification of appropriate Federal, State, or local 
authorities responsible for correcting such conditions and the making of 
arrangements therefor with such authorities.
    (e) Health professionals means professionals (such as physicians, 
dentists, nurses, podiatrists, optometrists, and physicians' extenders) 
who are engaged in the delivery of health services and who meet all 
applicable Federal or State requirements to provide their professional 
services.
    (f) High impact area means a catchment area which has not less than 
6,000 migratory agricultural workers, seasonal agricultural workers, and 
members of the families of such workers residing within its boundaries 
for more than two months in the most recent calendar year for which 
statistical data acceptable to the Secretary is available.
    (g)(1) Migrant health center means an entity which either through 
its staff and supporting resources or through contracts or cooperative 
arrangements with other public or private entities provides for 
migratory agricultural workers, seasonal agricultural workers, and the 
members of the families of such workers, within its catchment area:
    (i) Primary health services;
    (ii) As determined by the Secretary to be appropriate for particular 
centers, supplemental health services necessary for the adequate support 
of primary health services;
    (iii) Referral to providers of supplemental health services and 
payment, as determined by the Secretary to be appropriate and feasible, 
for the provision of such services;
    (iv) Environmental health services, as determined by the Secretary 
to be appropriate for particular centers;
    (v) As determined by the Secretary to be appropriate for particular 
centers, infectious and parasitic disease screening and control 
services;
    (vi) As determined by the Secretary to be appropriate for particular 
centers, accident prevention programs, including prevention of excessive 
exposure to pesticides through, but not limited to, notification of 
appropriate Federal, State or local authorities of hazardous conditions 
due to pesticide use; and
    (vii) Information on the availability and proper use of health 
services.
    (2) For purposes of paragraph (g)(1) of this section, the provision 
of a given service by a center will be determined by the Secretary to be 
appropriate where
    (i) There is a need, as determined by the Secretary, for the 
provision of such service to individuals described in paragraph (g)(1) 
of this section in the catchment area; and
    (ii) The provision of such service by the center is feasible, taking 
into consideration the center's projected revenues, other resources, and 
grant support under this part.
    (h) Migratory agricultural worker means an individual whose 
principal employment is in agriculture on a seasonal basis, who has been 
so employed within the last 24 months, and who establishes for the 
purpose of such employment a temporary place of abode;
    (i) Nonprofit, as applied to any private agency, institution, or 
organization, means one which is a corporation or association, or is 
owned and operated by one or more corporations or associations, no part 
of the net earnings of which inures, or may lawfully inure, to the 
benefit of any private shareholder or individual.
    (j) Physician means a licensed doctor of medicine or doctor of 
osteopathy.
    (k) Primary care means preventive, diagnostic, treatment, 
consultant, referral, and other services rendered by physicians 
(including, as appropriate, physicians' extenders), routine associated 
laboratory services and diagnostic radiologic services, and emergency 
health services.
    (l) Primary health services means:
    (1) Diagnostic, treatment, consultative referral, and other services 
rendered by physicians and, where feasible, by physicians' extenders, 
such as

[[Page 361]]

physicians' assistants, nurse clinicians, and nurse practitioners;
    (2) Diagnostic laboratory services and diagnostic radiologic 
services;
    (3) Preventive health services, including children's eye and ear 
examinations, prenatal and post-partum care, perinatal services, well 
child care (including periodic screening), immunizations, and voluntary 
family planning services;
    (4) Emergency medical services, including provision, through clearly 
defined arrangements, for access of users of the center to health care 
for medical and dental emergencies during and after the center's 
regularly scheduled hours;
    (5) Transportation services as needed for adequate patient care, 
sufficient so that residents of the catchment area served by the center 
with special difficulties of access to services provided by the center 
receive such services; and
    (6) Preventive dental services provided by a licensed dentist or 
other qualified personnel, including--
    (i) Oral hygiene instruction;
    (ii) Oral prophylaxis, as necessary; and
    (iii) Topical application of fluorides, and the prescription of 
fluorides for systemic use when not available in the community water 
supply.
    (m) Seasonal agricultural worker means an individual whose principal 
employment is in agriculture on a seasonal basis and who is not a 
migratory agricultural worker.
    (n) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (o) Supplemental health services means health services which are not 
included as primary health services and which are:
    (1) Inpatient and outpatient hospital services;
    (2) Home health services;
    (3) Extended care facility services;
    (4) Rehabilitative services (including physical and occupational 
therapy) and long-term physical medicine;
    (5) Mental health services, including services of psychiatrists, 
psychologists, and other appropriate mental health professionals;
    (6) Dental services other than those provided as primary health 
services;
    (7) Vision services, including routine eye and vision examinations 
and provision of eyeglasses, as appropriate and feasible;
    (8) Allied health services;
    (9) Pharmaceutical services, including the provision of prescription 
drugs;
    (10) Therapeutic radiologic services;
    (11) Ambulatory surgical services;
    (12) Public health services (including nutrition education and 
social services);
    (13) Health education services; and
    (14) Services including the services of outreach workers, which 
promote and facilitate optimal use of primary health services and 
services referred to in the preceding subparagraphs of this paragraph 
and, if a substantial number of individuals in the population served by 
the center are of limited English-speaking ability, the services of 
outreach workers and other personnel fluent in the language or languages 
spoken by such individuals.



Sec.  56.103  Eligibility.

    Any public or nonprofit private entity is eligible to apply for a 
grant under this part.



Sec.  56.104  Application.

    (a) An application for a grant under this part shall be submitted to 
the Secretary at such time and in such form and manner as the Secretary 
may prescribe.
    (b) The application shall contain a budget and narrative plan of the 
manner in which the applicant intends to conduct the project and carry 
out the requirements of this part. The application must describe how and 
the extent to which the project has met, or plans to meet, each of the 
requirements in subpart B (relating to grants for planning and 
development of migrant health centers), subpart C (relating to grants 
for the operation of migrant health centers), subpart D (relating to 
grants for the operation of migrant health entities), subpart E 
(relating to grants for planning and developing migrant health 
programs), subpart F (relating to grants for the operation of

[[Page 362]]

migrant health programs), or subpart G (relating to grants for technical 
assistance), as applicable. In addition, applications must include:
    (1) A statement of specific, measurable objectives and the methods 
to be used to assess the achievement of the objectives in specified time 
periods and at least on an annual basis.
    (2) The precise boundaries of the catchment area to be served by the 
applicant. In addition, the application shall include information 
sufficient to enable the Secretary to determine that the applicant's 
catchment area meets the following criteria:
    (i) The size of such area is such that the services to be provided 
by the applicant are available and accessible to the residents of the 
area promptly and as appropriate;
    (ii) The boundaries of such area conform, to the extent practicable, 
to relevant boundaries of political subdivisions, school districts, and 
areas served by Federal and State health and social service programs; 
and
    (iii) The boundaries of such area eliminate, to the extent possible, 
barriers resulting from the area's physical characteristics, its 
residential patterns, its economic and social groupings, and available 
transportation.
    (3)(i) The number of migratory agricultural workers and members of 
their families, and seasonal agricultural workers and members of their 
families which resided in the project's catchment area in the most 
recent calendar year for which statistical data acceptable to the 
Secretary is available; and
    (ii) The approximate period or periods of residence of all groups of 
migratory agricultural workers and their families counted under 
paragraph (b)(3)(i) of this section.
    (4) The results of an assessment of the need that the population to 
be served has for the services to be provided by the project (or in the 
case of applications for planning and development projects, the methods 
to be used in assessing such need), taking into consideration the 
following factors:
    (i) Available health resources in relation to size of the catchment 
area and population of migratory and seasonal agricultural workers and 
their families in such area, including appropriate ratios of primary 
care physicians in general or family practice, internal medicine, 
pediatrics, or obstetrics and gynecology, to such population;
    (ii) Health indices for such population, such as infant mortality 
rate;
    (iii) Economic factors affecting such population's use of health 
services, such as percentage of such population with incomes below the 
poverty level;
    (iv) Demographic factors affecting such population's need and demand 
for health services, such as percentage of such population age 65 and 
over; and
    (v) Special factors of access resulting from the conditions of 
employment of such workers (including working hours, housing, and 
sanitation).
    (5) Position descriptions for personnel who will be utilized in 
carrying out the activities of the project and a statement indicating 
the need for the positions to be supported with grant funds to 
accomplish the objectives of the project.
    (6) Letters and other forms of evidence showing that efforts have 
been made to secure financial and professional assistance and support 
for the project within the proposed catchment area and the continuing 
involvement of the community in the development and operation of the 
project.
    (7) An assurance that an independent certified public accountant 
will be engaged to certify that the project's system for the management 
and control of its finances will be in accord with sound financial 
management practices, including applicable Federal requirements.
    (8) A list of all services proposed to be provided by the project.
    (9) A list of services which are to be provided directly by the 
project through its own staff and resources and a description of any 
contractual or other arrangements (including copies of documents, where 
available) entered into, or planned for the provision of services.
    (10) The schedule of fees and/or payments and schedule of discounts 
for services provided by the project.
    (11) If the applicant provides services to populations other than 
migratory and seasonal agricultural workers and

[[Page 363]]

their families, identification of such populations.

    Note: Funds granted under this part and non-Federal funds required 
to be expended by the project as a condition of any such grant may not 
be used to provide services to individuals who are not migratory or 
seasonal agricultural workers or members of the families of such 
workers.

    (12) Evidence that all applicable requirements for review and/or 
approval of the application under title XV of the Act have been met.
    (13) An assurance that the project will be conducted in accordance 
with the applicable requirements of this part.
    (c) The application must be executed by an individual authorized to 
act for the applicant and to assume on behalf of the applicant the 
obligations imposed by the statute, the applicable regulations of this 
part, and any additional conditions of the grant.

(Sec. 215, Public Health Service Act, 58 Stat. 690, 67 Stat. 631 (42 
U.S.C. 216); sec. 329, Public Health Service Act, 95 Stat. 569 (42 
U.S.C. 254b)).

[42 FR 60406, Nov. 25, 1977, as amended at 48 FR 29202, June 24, 1983; 
48 FR 45559, Oct. 6, 1983]



Sec.  56.105  Accord with health planning.

    A grant may be made under this part only if the applicable 
requirements of title XV of the Act relating to review and approval by 
the appropriate health planning agencies have been met.



Sec.  56.106  Amount of grant.

    (a) The amount of any award under this part will be determined by 
the Secretary on the basis of his estimate of the sum necessary for a 
designated portion of direct project costs plus an additional amount for 
indirect costs, if any, which will be calculated by the Secretary 
either:
    (1) On the basis of the estimate of the actual indirect costs 
reasonably related to the project; or
    (2) On the basis of a percentage of all, or a portion of, the 
estimated direct costs of the project when there are reasonable 
assurances that the use of such percentage will not exceed the 
approximate actual indirect costs. Such award may include an estimated 
provisional amount for indirect costs or for designated direct costs 
(such as fringe benefit rates) subject to upward (within the limits of 
available funds) as well as downward adjustments to actual costs when 
the amount properly expended by the grantee for provisional items has 
been determined by the Secretary: Provided, however, That no grant shall 
be made for an amount in excess of the total costs found necessary by 
the Secretary to carry out the project.
    (i) In determining the percentage of project costs to be borne by 
the grantee, factors which the Secretary will take into consideration 
will include the following:
    (A) The ability of the grantee to finance its share of project costs 
from non-Federal sources;
    (B) The need in the area served by the project for the services to 
be provided; and
    (C) The extent to which the project will provide services in an 
innovative manner which the Secretary desires to stimulate in the 
interest of developing more effective health service delivery systems on 
a regional or national basis.
    (ii) At any time after approval of an application under this part, 
the Secretary may retroactively agree to a percentage of project costs 
to be borne by the grantee lower than that determined pursuant to 
paragraph (a)(2)(i) of this section where he finds that changed 
circumstances justify a smaller contribution.
    (iii) In determining the grantee's share of project costs, costs 
borne by Federal grant funds, or costs used to match other Federal 
grants, may not be included except as otherwise provided by law or 
regulations.
    (b) All grant awards shall be in writing, and shall set forth the 
amount of funds granted and the period for which support is recommended.
    (c) Neither the approval of any project nor any grant award, shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application.

[[Page 364]]



Sec.  56.107  Priorities for grants.

    (a) Grants under sections 319(c) (1)(A), 319(d)(1)(A), 319(d)(1)(B) 
of the Act and subparts B, C, and D of this part shall be made in 
accordance with the following priorities:
    (1) Highest priority will be given to approvable applications which 
propose to serve catchment areas in which 6,000 or more migratory 
agricultural workers and members of their families reside for more than 
two months in the calendar year.
    (2) Second priority will be given to approvable applications which 
propose to serve catchment areas in which fewer than 6,000 but more than 
1,000 migratory agricultural workers and members of their families 
reside for more than two months in the applicable calendar year.
    (3) Third priority will be given to approvable applications which 
propose to serve catchment areas in which migratory agricultural workers 
and members of their families reside but in which fewer than 1,000 such 
persons reside for more than two months in the applicable calendar year.
    (4) Fourth priority will be given to approvable applications which 
propose to serve catchment areas in which migratory agricultural workers 
and members of their families reside in the applicable calendar year but 
in which no such persons reside for more than two months in such year.
    (5) Fifth priority will be given to approvable applications which 
propose to serve catchment areas in which no migratory agricultural 
workers or members of their families reside for any period in the 
applicable calendar year but in which 6,000 or more seasonal 
agricultural workers and the members of their families reside.
    (6) Lowest priority will be given to approvable applications which 
propose to serve catchment areas in which no migratory agricultural 
workers or members of their families reside for any period in the 
applicable calendar year and in which fewer than 6,000 seasonal 
agricultural workers and the members of their families reside.
    (b) Grants under sections 319(c) (1)(B) and 319(d)(1)(C) of the Act 
and subparts E and F of this part will be made in accordance with 
priorities set forth in paragraphs (a)(2) through (a)(6) of this 
section, in the order set forth.
    (c) For the purposes of this section, the applicable calendar year 
will be the calendar year for which data is provided in accordance with 
Sec.  56.104(b)(3) of this subpart.



Sec.  56.108  Use of grant funds.

    (a) Any funds granted pursuant to this part, as well as other funds 
to be used in performance of the approved project, may be expended 
solely for carrying out the approved project in accordance with section 
319 of the Act, the applicable regulations of this part, the terms and 
conditions of the award, and the applicable cost principles prescribed 
in 45 CFR part 75, subpart E.
    (b) Project funds awarded under this part may be used for, but need 
not be limited to, the following:
    (1) The costs of acquiring and modernizing existing buildings 
(including the costs of amortizing the principal of, and paying interest 
on, loans), but only in accordance with subpart H of this part and as 
approved in the grant award;
    (2) The costs of obtaining technical assistance to develop and 
improve the management or service capability of the project but only as 
approved by the Secretary;
    (3) To reimburse members of the grantee's governing board 
established pursuant to Sec.  56.304 of subpart C, or advisory council 
established pursuant to Sec.  56.603(q) of subpart F, if any, for 
reasonable expenses actually incurred by reason of their participation 
in the activities of such board or council;
    (4) To reimburse such governing board or advisory council members 
who are individuals eligible to be served by the project for wages lost 
by reason of participation in the activities of such board or council;
    (5) The cost of delivering health services to migratory agricultural 
workers, seasonal agricultural workers and the members of their families 
within the project's catchment area, within the following limitations: 
grant funds may be used to pay the full cost of project services to such 
individuals and families with annual incomes at or below

[[Page 365]]

those set forth in the poverty guidelines updated periodically in the 
Federal Register by the U.S. Department of Health and Human Services 
under the authority of 42 U.S.C. 9902(2); and to pay the portion of the 
cost of services provided in accordance with the schedule of discounts 
which, under such schedule, is uncompensated; Provided, That
    (i) Charges will be made to such individuals and families in 
accordance with Sec.  56.303(f) of subpart C or Sec.  56.603(e) of 
subpart F, as applicable;
    (ii) Reasonable effort shall be made to collect such charges under a 
billing and collections system; and
    (iii) The charge to grant funds shall exclude any amounts collected 
pursuant to paragraph (b)(5)(ii) of this section;
    (6) The cost of insurance for medical emergency and out-of-area 
coverage; and
    (7) The cost of providing to the staff and governing board, if any, 
of the project training related to the management of an ambulatory care 
facility, and to the staff of a project funded under subpart C, D, or F 
of this part, training related to the provision of primary, supplemental 
and environmental health services provided or to be provided by the 
project, consistent with the applicable requirements of 45 CFR part 75.
    (c) Prior approval by the Secretary of revisions of the budget and 
project plan is required whenever there is to be a significant change in 
the scope or nature of project activities.

[42 FR 60406, Nov. 25, 1977, as amended at 81 FR 3008, Jan. 20, 2016; 85 
FR 72908, Nov. 16, 2020]



Sec.  56.109  Grant payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred, to the extent he 
determines such payments necessary to promote prompt initiation and 
advancement of the approved project.



Sec.  56.110  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in 
particular section 601 of such Act which provides that no person in the 
United States shall on the grounds of race, color, or national origin be 
excluded from participation in, be denied the benefits of, or be 
subjected to discrimination under any program or activity receiving 
Federal financial assistance. A regulation implementing such title VI, 
which applies to grants made under this part, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80). In addition, no person shall, on the grounds 
of age, sex, creed, or marital status (unless otherwise medically 
indicated), be excluded from participation in, be denied the benefits 
of, or be subjected to discrimination under any program or activity so 
receiving Federal financial assistance.
    (b) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of his handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance.



Sec.  56.111  Confidentiality.

    All information as to personal facts and circumstances obtained by 
the project staff about recipients of services shall be held 
confidential and shall not be divulged without the individual's consent 
except as may be required by law or as may be necessary to provide 
service to the individual or to provide for medical audits by the 
Secretary or his designee with appropriate safeguards for 
confidentiality of patient records. Otherwise, information may be 
disclosed only in summary, statistical, or other form which does not 
identify particular individuals.



Sec.  56.112  Publications and copyright.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright

[[Page 366]]

without prior approval any publications, films, or similar materials 
developed or resulting from a project supported by a grant under this 
part, subject, however, to a royalty-free, non-exclusive, and 
irrevocable license or right in the Government to reproduce, translate, 
publish, use, disseminate, and dispose of such materials and to 
authorize others to do so.



Sec.  56.113  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other funds, including funds derived 
from other grant awards. With respect to each approved project, the 
grantee shall account for the sum total of all amounts paid as well as 
other funds and in-kind contributions by presenting or otherwise making 
available evidence satisfactory to the Secretary of expenditures for 
direct and indirect costs meeting the requirements of this part: 
Provided, however, That when the amount awarded for indirect costs was 
based on a predetermined fixed-percentage of estimated direct costs, the 
amount allowed for indirect costs shall be computed on the basis of such 
predetermined fixed-percentage rates applied to the total, or a selected 
element thereof, of the reimbursable direct costs incurred.
    (b) Accounting for interest earned on grant funds. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the government of the 
political subdivisions of the State. All grantees other than a State, as 
so defined, must return all interest earned on grant funds to the 
Federal Government.
    (c) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full account, as 
provided herein, as of the date of the termination of grant support. The 
Secretary may require other special and periodic accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project, 
the sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section;
    (ii) Any credits for earned interest pursuant to paragraph (b) of 
this section;
    (iii) Any other amounts due pursuant to 45 CFR 75.307, 75.371 
through 75.385, and 75.316 through 75.325.

Such total sum shall constitute a debt owed by the grantee to the 
Federal Government and shall be recovered from the grantee or its 
successors or assignees by setoff or other action as provided by law.

[42 FR 60406, Nov. 25, 1977, as amended at 81 FR 3008, Jan. 20, 2016]



Sec.  56.114  Applicability of 45 CFR part 75.

    The provisions of 45 CFR part 75, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part.

[80 FR 3008, Jan. 20, 2016]



   Subpart B_Grants for Planning and Developing Migrant Health Centers



Sec.  56.201  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(c)(1)(A) of the Act for projects for planning and developing 
migrant health centers in high impact areas.



Sec.  56.202  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
56.104 of subpart A of this part, contain information sufficient to 
enable the Secretary to determine that the project for which the grant 
is sought will meet the requirements of this part.

[[Page 367]]



Sec.  56.203  Project elements.

    A project for planning and developing a migrant health center 
supported under this subpart must:
    (a) Determine (by survey or other appropriate means) the approximate 
number of (1) migratory agricultural workers and the members of their 
families, and (2) seasonal agricultural workers and the members of their 
families, within the proposed catchment area in the calendar year in 
which the grant is made and the period of time these workers and their 
families reside in the catchment area during such year.
    (b) Prepare an assessment of the need of the population proposed to 
be served by the migrant health center for the services set forth in 
Sec.  56.102(g)(1) of subpart A of this part. This assessment of need 
must, at a minimum, include the factors listed in Sec.  56.104(b)(3) 
(i)-(iv).
    (c) Design a migrant health center program for such population, 
based on the assessment prepared pursuant to paragraph (b) of this 
section which indicates in detail how the proposed center will fulfill 
the needs identified in that assessment and meet the requirements of 
subpart C of this part.
    (d) Develop a plan for the implementation of the program designed 
pursuant to paragraph (c) of this section. This implementation plan must 
provide for the time-phased recruitment and training of the personnel 
essential for the operation of a migrant health center and the gradual 
assumption of operational status of the project so that the project 
will, in the judgment of the Secretary, meet the requirements contained 
in subpart C of this part by the end of the project period.
    (e) Implement the plan developed pursuant to paragraph (d) of this 
section in accordance with such paragraph.
    (f) Make efforts to secure within the proposed catchment area of 
such center, to the extent possible, financial and professional 
assistance and support for the project.
    (g) Initiate and encourage continuing community involvement in the 
development and operation of the project through, for example, 
contributions or loans of cash, services, equipment, full-or part-time 
staff, space, materials, or facilities.
    (h) Provide for sufficient staff, qualified by training and 
experience, to carry out the project and establish standards and 
qualifications for personnel (including the project director).
    (i) Utilize, to the maximum extent feasible, other Federal, State, 
local, and private resources available for support of the project, prior 
to use of project funds under this subpart.
    (j) Provide the means for evaluating the project's progress in 
achievement of its specific objectives, and submit such progress reports 
on the project as the Secretary may from time to time request.



Sec.  56.204  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which, in his judgment, will provide 
needed health services in a catchment area which will not be served by 
another project funded under this part and meet the applicable 
requirements of section 319(c)(1)(A) of the Act and this part, in 
accordance with priorities established pursuant to section 319(b) of the 
Act and Sec.  56.107 of subpart A of this part; Provided, That in the 
case of applicants which propose to serve substantially the same 
catchment areas or where available funds are insufficient to fund all 
approvable applications within a priority category specified in Sec.  
56.107,
    (1) Priority shall be given to applications submitted by community-
based organizations which are representative of the population to be 
served by the project. For purposes of this paragraph, an applicant 
shall be deemed to be such an organization if it provides a formal 
mechanism (such as membership on the organization's governing body or 
membership on an advisory body) which gives migratory seasonal 
agricultural workers and their families significant involvement in the 
formulation of the organization's policies; and
    (2) Where all such applicants are community-based organizations 
representative of the population to be served by the project, the 
Secretary shall award the grant to the applicants

[[Page 368]]

which will, in his judgment, best promote the purposes of section 
319(c)(1)(A) of the Act and the applicable regulations of this part, 
taking into account with respect to each application:
    (i) The degree to which the proposed project satisfactorily provides 
for the elements set forth in Sec.  56.203;
    (ii) The administrative and management capability of the applicant;
    (iii) The extent to which community resources will be utilized in 
the project; and
    (iv) The degree to which the applicant intends to integrate services 
supported by a grant under this part with health services provided under 
other federally assisted health services or reimbursement programs or 
projects.
    (b) The Secretary shall award no more than two grants under this 
subpart for the same project.



          Subpart C_Grants for Operating Migrant Health Centers



Sec.  56.301  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(d)(1)(A) of the Act for the costs of operation of migrant 
health centers in high impact areas.



Sec.  56.302  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
56.104 of subpart A of this part,
    (a) Be submitted by an entity (which may be a co-applicant) which 
the Secretary determines is a migrant health center, and
    (b) Contain information sufficient to enable the Secretary to 
determine that the center will meet the requirements of this part.



Sec.  56.303  Project elements.

    A migrant health center supported under this subpart must:
    (a) Provide the health services of the center so that such services 
are available and accessible promptly, as appropriate, and in a manner 
which will assure continuity of service to the migratory and seasonal 
agricultural workers and their families within the center's catchment 
area.
    (b) Implement a system for maintaining the confidentiality of 
patient records in accordance with the requirements of Sec.  56.111 of 
subpart A of this part.
    (c) Have an ongoing quality assurance program which provides for the 
following:
    (1) Organizational arrangements, including a focus of 
responsibility, to support the quality assurance program and the 
provision of high quality patient care;
    (2) Periodic assessment of the appropriateness of the utilization of 
services and the quality of services provided or proposed to be provided 
by the center, and by other providers through contract or other 
cooperative arrangement with the center. Such assessments must:
    (i) Be conducted by physicians or by other appropriate health 
professionals under the supervision of physicians or, as appropriate, by 
health professionals who are peers of the health professionals who 
provided the services;
    (ii) Be based on the systematic collection and evaluation of patient 
records; and
    (iii) Identify and document the necessity for change in the 
provision of services by the center and result in the institution of 
such change, where indicated.
    (d) Develop management and control systems which are in accordance 
with sound financial management procedures, including the provision for 
an audit (1) conducted in accordance with the ``Guide for Audits of 
Migrant Health Grants'' of the DHHS Audit Agency, and (2) conducted with 
reasonable frequency, usually annually but not less frequently than 
every two years (unless waived for cause by the Secretary), to be made 
by qualified individuals who are sufficiently independent of those who 
authorize the expenditure of Federal funds to produce unbiased opinions, 
conclusions, or judgments, and to determine, at a minimum, the fiscal 
integrity of grant financial transactions and reports, and

[[Page 369]]

compliance with the applicable regulations of this part and the terms 
and conditions of the grant.
    (e) Where the cost of care and services furnished by or through the 
center is to be reimbursed under title XIX or title XX of the Social 
Security Act, obtain or make every reasonable effort to obtain a written 
agreement with the title XIX or title XX State agency for such 
reimbursement.
    (f) Have prepared a schedule of fees or payments for the provision 
of its services designed to cover its reasonable costs of operation and 
a corresponding schedule of discounts adjusted on the basis of the 
patient's ability to pay. The schedule of discounts must provide for a 
full discount to individuals and families with annual incomes at or 
below those set forth in the poverty guidelines updated periodically in 
the Federal Register by the U.S. Department of Health and Human Services 
under the authority of 42 U.S.C. 9902(2); (except that nominal fees for 
service may be collected from such individuals and families) and for no 
discount to individuals and families with annual incomes greater than 
twice those set forth in such Guidelines.
    (g) Make every reasonable effort, including the establishment of 
systems for eligibility determination, billing, and collection, to
    (1) Collect reimbursement for its costs in providing health services 
to persons who are entitled to insurance benefits under title XVIII of 
the Social Security Act, to medical assistance under a State plan 
approved under title XIX of such Act, to social services and family 
planning under title XX of such Act, or to assistance for medical 
expenses under any other public assistance program, grant program, or 
private health insurance or benefit program on the basis of the schedule 
of fees prepared pursuant to paragraph (f) of this section without 
application of any discounts, and
    (2) Secure from patients payments for services in accordance with 
the schedule of fees and discounts required by paragraph (f) of this 
section.
    (h) Have a governing board which meets the requirements of Sec.  
56.304.
    (i) Have developed an overall plan and budget for the center that:
    (1) Provides for an annual operating budget and a three-year 
financial management plan which includes all anticipated income and 
expenses related to items which would, under generally accepted 
accounting principles, be considered income and expense items;
    (2) Provides for a capital expenditure plan for at least a three-
year period (including the year to which the operating budget described 
in paragraph (h)(i)(1) is applicable) which includes and identifies in 
detail the anticipated sources of financing for, and the objective of, 
each anticipated expenditure in excess of $100,000 related to the 
acquisition of land, the improvement of land, buildings, and equipment 
and the replacement, modernization and expansion of buildings and 
equipment which would, under generally accepted accounting principles, 
be considered capital items;
    (3) Provides for plan review and updating at least annually; and
    (4) Is prepared under the direction of the governing board by a 
committee consisting of representatives of the governing board, the 
administrative staff, and the medical staff, if any, of the center.
    (j) Establish basic statistical data, cost accounting, management 
information, and reporting or monitoring systems which will enable the 
center to provide such statistics and other information as the Secretary 
may reasonably require relating to the center's costs of operation, 
patterns of utilization of services, and the availability, 
accessibility, and acceptability of its services, and to make such 
reports to the Secretary in a timely manner with such frequency as the 
Secretary may reasonably require.
    (k) Review its catchment area annually to insure that the criteria 
set out in Sec.  56.104(b)(2) are met and, if criteria are not met, 
revise its catchment area, with the approval of the Secretary, to 
conform with such criteria to the extent feasible.
    (l) In the case of a center which serves a population including a 
substantial proportion of individuals of limited English-speaking 
ability, have developed a plan and made arrangements responsive to the 
needs of such populations for providing services to

[[Page 370]]

the extent practicable in the language and cultural context most 
appropriate to such individuals, and have identified an individual on 
its staff who is fluent in both that language and in English and whose 
responsibilities include providing guidance to such individuals and to 
appropriate staff members with respect to cultural sensitivities and 
bridging linguistic and cultural differences. If more than one non-
English language is spoken by such group or groups, an individual or 
individuals fluent in those languages and English must be so identified.
    (m) Be operated in a manner calculated to preserve human dignity and 
to maximize acceptability and effective utilization of services.
    (n) To the extent possible, coordinate and integrate project 
activities with the activities of other federally funded, as well as 
State and local, health services delivery projects and programs serving 
the same population.
    (o) Establish means for evaluating progress toward the achievement 
of the specific objectives of the project.
    (p) Provide sufficient staff, qualified by training and experience, 
to carry out the activities of the center.
    (q) Assure that facilities utilized in the performance of the 
project meet applicable fire and life safety codes.
    (r) Utilize, to the maximum extent feasible, other Federal, State 
and local, and private resources available for support of the project, 
prior to use of project funds under this part.
    (s) Provide for community participation through, for example, 
contributions of cash or services, loans of full- or part-time staff, 
equipment, space, materials, or facilities.
    (t) Where the center will provide services through contract or other 
cooperative arrangements with other providers of services, the center 
must:
    (1) Enter into the contract or arrangement only if the provider of 
services will provide the services in a timely manner and make the 
services accessible and acceptable to the population to be served;
    (2) Make payment for services so provided only pursuant to 
agreements with the providers in accordance with a schedule of rates and 
payment procedures established and maintained by the center. The center 
must be prepared to substantiate that such rates are reasonable and 
necessary;
    (3) Directly provide at least primary care unless the center has 
made arrangements for the provision of primary care which include 
transfer of all medical and financial information relating to such care 
to the center; and
    (4) Enter into contracts or arrangements for the provision of 
primary health services only if alternative resources are reasonably 
available to provide these services in the event of termination of such 
arrangements.
    (u) Operate in a manner such that no migratory or seasonal 
agricultural worker or member of their family will be denied service by 
reason of his or her inability to pay therefor. Provided, however, That 
a charge for the provision of services will be made to the extent that a 
third party (including a Government agency) is authorized or is under 
legal obligation to pay such charges.

[42 FR 60406, Nov. 25, 1977, as amended at 85 FR 72908, Nov. 16, 2020]



Sec.  56.304  Governing board.

    The governing board of the center must meet the following 
requirements:
    (a) Size. The board must consist of at least 9 but not more than 25 
members except that this provision may be waived by the Secretary for 
good cause shown.
    (b) Composition. (1) A majority of the board members must be 
migratory and seasonal agricultural workers and members of their 
families who are or will be served by the center and who, as a group, 
represent the individuals being or to be served in terms of demographic 
factors, such as race, ethnicity, and sex.
    (2) No more than two-thirds of the remaining members of the board 
may be individuals who derive more than 10 percent of their annual 
income from the health care industry.
    (3) The remaining members of the board must be representatives of 
the community in which the center's catchment area is located and shall 
be selected for their expertise in relevant subject areas, such as 
community affairs, local government, finance and banking, legal affairs, 
trade unions,

[[Page 371]]

and other commercial and industrial concerns, or social services within 
the community.
    (4) No member of the board shall be an employee of the center, or 
spouse or child, parent, brother or sister by blood of marriage of such 
an employee. The project director may be a nonvoting, ex-officio member 
of the board.
    (c) Selection of members. The method of selection must be prescribed 
in the by-laws or other internal governing rules of the center. Such by-
laws or other rules must specify a process of selection of individuals 
on the governing board who represent the population served or to be 
served by the center so that such individuals, as a group, are 
representative of such population. Such process of selection in the by-
laws or other rules is subject to approval by the Secretary.
    (d) Functions and responsibilities. (1) The governing board shall 
have authority for the establishment of policy in the conduct of the 
center.
    (2) The governing board shall hold regularly scheduled meetings, at 
least once each month, except for periods of the year, as specified in 
the bylaws, during which monthly meetings are not practical due to 
migration out of the catchment area.
    (3) Minutes must be kept for all regularly scheduled meetings of the 
board.
    (4) The governing board shall have specific responsibility for:
    (i) Approval of the selection and dismissal of the project director 
or chief executive officer of the center;
    (ii) Establishing personnel policies and procedures, including 
selection and dismissal procedures, salary and benefit scales;
    (iii) The development of bylaws which specify the responsibility of 
the board and principal operating officials of the centers;
    (iv) Adopting policy for financial management practices, including a 
system to assure accountability for center resources, approval of the 
annual project budget, center priorities, eligibility for services, 
including criteria for partial payment schedules, and long-range 
financial planning;
    (v) Evaluating center activities, including services utilization 
patterns, productivity of the center, patient satisfaction, achievement 
of project objectives, and development of a process for hearing and 
resolving patient grievances;
    (vi) Assuring that the center is operated in compliance with 
applicable Federal, State, and local laws and regulations; and
    (vii) Adopting health care policies including scope and availability 
of services, location and hours of services, and quality assurance 
procedures.



Sec.  56.305  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which, in his judgment, will provide 
needed health services in a catchment area which will not be served by 
another project funded under this part and meet the applicable 
requirements of section 319(d)(1)(A) of the Act and this part, in 
accordance with priorities established pursuant to section 319(b) of the 
Act and Sec.  56.107 of subpart A of this part: Provided, That in the 
case of applicants which propose to serve substantially the same 
catchment area or where available funds are insufficient to fund all 
approvable applications within a priority category specified in Sec.  
56.107, the Secretary will award grants to the applicants which, in his 
judgment, will best promote the purpose of section 319(d)(1)(A) of the 
Act and the applicable regulations of this part, taking into account 
with respect to each application:
    (1) The extent to which the project would provide for the elements 
set forth in Sec.  56.303;
    (2) The capability of the applicant to provide quality health care 
services;
    (3) The soundness of the financial management plan for assuring 
effective utilization of grant funds and maximizing non-grant revenue;
    (4) The administrative and management capability of the applicant;
    (5) The capability of the applicant to provide primary health 
services directly. In evaluating the relative capability of the 
applicant to provide such services directly, the Secretary shall

[[Page 372]]

take into consideration whether the direct provision of such services is 
inappropriate because:
    (i) Provision of such services through contract or other arrangement 
would be more cost-effective;
    (ii) Provision of such services directly would unnecessarily 
duplicate existing resources; or
    (iii) Provision of such services other than directly would enhance 
the accessibility or acceptability of such services to the population to 
be served.
    (6) The degree to which the applicant intends to integrate services 
supported by a grant under this part with health services provided under 
other federally assisted health services or reimbursement programs or 
projects;
    (7) The extent that community resources will be utilized by the 
project; and
    (8) Consistent with the other requirements of this part, the degree 
to which and the manner in which the applicant provides specific health 
services which the Secretary has, through publication of a notice in the 
Federal Register, established as services which should receive emphasis 
by applicants.



         Subpart D_Grants for Operating Migrant Health Entities



Sec.  56.401  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(d)(1)(B) of the Act for the costs of operation of entities 
which intend to become migrant health centers and which provide health 
services to migratory agricultural workers, seasonal agricultural 
workers, and the members of their families in high impact areas.



Sec.  56.402  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
56.104 of subpart A of this part,
    (a) Be submitted by an entity which the Secretary determines intends 
to become a migrant health center but which will not, at the time of the 
grant award, meet one or more of the requirements of paragraphs (a) 
through (l) of Sec.  56.303 of subpart C of this part; and
    (b) Contain information sufficient to enable the Secretary to 
determine that the project for which the grant is sought will meet the 
requirements of this part. Such information must include a plan which 
identifies which requirements of Sec.  56.303 will not be met at the 
time of grant award and provides a timetable for and a detailed 
statement of the means to be employed in meeting those requirements.



Sec.  56.403  Project elements.

    A project for the operation of a migrant health entity supported 
under this subpart must:
    (a) Meet all of the requirements of Sec.  56.303 of this part, 
Provided, That the project will not be required to meet the requirements 
of paragraphs (c), (h), (i), or (n) of such section if the Secretary 
finds that meeting any such requirement is not feasible or practical at 
the time of grant award.
    (b) Provide those services enumerated in Sec.  56.102(g)(1) of 
subpart A of this part which are specified in the grant award.
    (c) Meet the requirements of Sec.  56.303 of subpart C of this part 
by the end of the period of support under section 319(d)(1)(B) of the 
Act and this subpart, in accordance with the plan submitted under Sec.  
56.402(b) of this subpart.



Sec.  56.404  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purposes, the Secretary may award grants under this 
subpart to applicants therefor which, in his judgment, will provide 
needed health services in a catchment area not served by another project 
funded under this part and meet the applicable requirements of section 
319(d)(1)(B) of the Act and this part, in accordance with the priorities 
established pursuant to section 319(b) of the Act and Sec.  56.107 of 
subpart A of this part; Provided, That in the case of applicants which 
propose to serve substantially the same catchment area or where 
available funds are insufficient to fund all approvable applications 
within a priority

[[Page 373]]

category specified in Sec.  56.107, the Secretary will award the grant 
to the applicants which, in his judgment, will best promote the purposes 
of section 319(d)(1)(B) of the Act and the applicable regulations of 
this part, taking into account with respect to each application:
    (1) The degree to which the project would provide the services 
enumerated in Sec.  56.102(g)(1) and the feasibility of its providing 
all of such enumerated services by the end of the period of support 
under section 319(d)(1)(B) of the Act and this subpart;
    (2) The degree to which the applicant intends to integrate services 
supported by a grant under this subpart with health services provided 
under other federally assisted health service or reimbursement programs 
or projects;
    (3) The capability of the project to provide quality health care 
services;
    (4) The administrative and management capability of the applicant; 
and
    (5) The capability of the applicant to provide primary health 
services directly. In evaluating the relative capability of the 
applicant to provide such services directly, the Secretary shall take 
into consideration whether the direct provision of services is 
inappropriate because:
    (i) Provision of such services through contract or other arrangement 
would be more cost-effective;
    (ii) Provision of such services directly would unnecessarily 
duplicate existing resources; or
    (iii) Provision of the services other than directly would enhance 
the accessibility or acceptability of the services to the population 
served.
    (6) The extent to which community resources will be utilized by the 
project; and
    (7) Consistent with the other requirements of this part, the degree 
to which and the manner in which the applicant provides specific health 
services which the Secretary has, through publication of a notice in the 
Federal Register, established as services which should receive emphasis 
by applicants.
    (b) The Secretary shall:
    (1) Make no more than two grants for the same entity under section 
319(d)(1)(B) of the Act;
    (2) Not make any grant under section 319(d)(1)(B) to an entity 
which, for the same project, has been awarded more than one grant under 
section 319(c) of the Act;
    (3) Not make a grant under section 319(d)(1)(B) to an entity which 
has been awarded a grant under section 319(d)(1)(A) of the Act.



  Subpart E_Grants for Planning and Developing Migrant Health Programs



Sec.  56.501  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(c)(1)(B) of the Act for projects to plan and develop migrant 
health programs to provide health services to migratory agricultural 
workers, seasonal agricultural workers and the members of their families 
in areas in which no migrant health center exists and in which not more 
than 6,000 migratory agricultural workers and their families reside for 
more than two months.



Sec.  56.502  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
56.104 of subpart A of this part,
    (a) Be submitted for a project within a catchment area which
    (1) Is not served, in whole or in part, by a migrant health center, 
and
    (2) Has not more than 6,000 migratory agricultural workers and 
members of their families residing therein for more than 2 months per 
year; and
    (b) Contain information sufficient to enable the Secretary to 
determine that the project for which the grant is sought will meet the 
requirements of this part.



Sec.  56.503  Project elements.

    A project for the planning and development of a migrant health 
program supported under this subpart must:
    (a) Determine (by survey or other appropriate means) the approximate 
number of

[[Page 374]]

    (1) Migratory agricultural workers and the members of their 
families, and
    (2) Seasonal agricultural workers and the members of their families 
within the project's catchment area in the calendar year in which the 
grant is made and the period of time these workers and their families 
reside in the catchment area during such year.
    (b) Prepare an assessment of need of the population proposed to be 
served by the migrant health program for the services set forth in Sec.  
56.603(a) of subpart F of this part. This assessment of need must, at a 
minimum, consider the factors listed in Sec.  56.104(b)(3) (i)-(iv).
    (c) Design a migrant health program for such population, based on 
such assessment, which indicates in detail how the proposed program will 
fulfill the needs identified in that assessment and meet the 
requirements of subpart F of this part.
    (d) Develop a plan for the implementation of the program designed 
pursuant to paragraph (c) of this section. The implementation plan must 
provide for the time-phased recruitment and training of the personnel 
essential for the operation of a migrant health program and the gradual 
assumption of operational status of the project so that the project 
will, in the judgment of the Secretary, meet the requirements of subpart 
F of this part as of the end of the project period.
    (e) Implement the plan developed pursuant to paragraph (d) of this 
section in accordance with such paragraph.
    (f) Make efforts to secure within the proposed catchment area of 
such project, to the extent possible, financial and professional 
assistance and support for the project.
    (g) Initiate and encourage continuing community involvement in the 
development and operation of the project through, for example, 
contributions or loans of cash, services, equipment, full- or part-time 
staff, space, materials, or facilities.
    (h) Provide for sufficient staff, qualified by training and 
experience, to carry out the project and establish standards and 
qualifications for personnel (including the project director).
    (i) Utilize, to the maximum extent feasible, other Federal, State, 
local, and private resources available for support of the project, prior 
to use of project funds under this subpart.
    (j) Provide for the means of evaluating the project's progress in 
achievement of its specific objectives and submission of such progress 
reports on the project as the Secretary may from time to time request.



Sec.  56.504  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which, in his judgment, will provide 
needed health services in a catchment area not served by another project 
funded under this part and meet the applicable requirements of section 
319(c)(1)(B) of the Act and this part, in accordance with priorities 
established pursuant to section 319(b) of the Act and Sec.  56.107 of 
subpart A of this part; Provided, That in the case of applicants which 
propose to serve substantially the same catchment areas or where 
available funds are insufficient to fund all approvable applications 
within a priority category specified in Sec.  56.107,
    (1) Priority shall be given to applications submitted by community-
based organizations which are representative of the population to be 
served by the project. For purposes of this paragraph, an applicant 
shall be deemed to be such an organization if it provides a formal 
mechanism (such as membership on the organization's governing body or 
membership on an advisory body) which gives migratory and seasonal 
agricultural workers and their families significant involvement in the 
formulation of the organization's policies; and
    (2) Where all such applicants are community-based organizations 
representative of the population to be served by the project, the 
Secretary shall award the grant to the applicants which will, in his 
judgment, best promote the purposes of section 319(c)(1)(B) of the Act 
and the applicable regulations of this part, taking into account with 
respect to each application:
    (i) The degree to which the proposed project satisfactorily provides 
for the elements set forth in Sec.  56.203;

[[Page 375]]

    (ii) The administrative and management capability of the applicant;
    (iii) The extent to which community resources will be utilized in 
the project; and
    (iv) The degree to which the applicant intends to integrate services 
supported by a grant under this part with health services provided under 
other federally assisted health services or reimbursement programs or 
projects.
    (b) The Secretary shall award no more than one grant under this 
subpart for the same project.



         Subpart F_Grants for Operating Migrant Health Programs



Sec.  56.601  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(d)(1)(C) of the Act for projects for operating programs to 
provide health services to migratory agricultural workers, seasonal 
agricultural workers and the members of their families in areas in which 
no migrant health center exists and in which not more than 6,000 
migratory agricultural workers and their families reside for more than 
two months.



Sec.  56.602  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec.  
56.104 of subpart A of this part,
    (a) Be submitted for a project with a catchment area which
    (1) Is not served, in whole or in part, by a migrant health center, 
and
    (2) Has not more than 6,000 migratory agricultural workers and the 
members of their families residing therein for more than two months per 
year; and
    (b) Contain information sufficient to enable the Secretary to 
determine that the project for which the grant is sought will meet the 
requirements of this part.



Sec.  56.603  Project elements.

    A project for operating a migrant health program supported under 
this subpart must:
    (a) Provide to migratory and seasonal agricultural workers and the 
members of their families in its catchment area one or more of the 
following groups of services so that such services are available and 
accessible promptly as appropriate, and in a manner which will assure 
continuity of care, as approved by the Secretary and set forth 
(including specific services to be provided) in the grant award:
    (1) Emergency health care, including diagnostic and treatment 
services in an ambulatory health care setting or hospital and dental 
services for the alleviation of acute pain and suffering for medical 
emergencies, when provision of such services is necessary to avoid 
jeopardizing the patient's condition until appropriate services from 
other providers can reasonably be obtained;
    (2) Primary care;
    (3) Arrangements with existing health care facilities to furnish 
primary health services (other than primary care);
    (4) Other services set forth in Sec.  56.102(g)(1) which are needed 
to improve the health of such individuals.
    (b) Implement a system for maintaining the confidentiality of 
patient records in accordance with the requirement of Sec.  56.111 of 
subpart A of this part.
    (c) Develop management and control systems which are in accordance 
with sound financial management procedures, including the provision for 
an audit conducted in accordance with the DHHS Audit Agency Guide for 
Audits of Migrant Health Grants, as amended, on at least an annual basis 
(unless waived for cause by the Secretary), by an independent certified 
public accountant or public accountant licensed before December 31, 
1970, to determine, at a minimum, the fiscal integrity of grant 
financial transactions and reports and compliance with the regulations 
of this part and the terms and conditions of the grant.
    (d) When the cost of care and services furnished by or through the 
project is to be reimbursed under title XIX or title XX of the Social 
Security Act, obtain or make every reasonable effort to obtain a written 
agreement with the title XIX or title XX State agency for such 
reimbursement.

[[Page 376]]

    (e) Have prepared a schedule of fees or payments for the provision 
of its services designed to cover its reasonable costs of operation and 
a corresponding schedule of discounts adjusted on the basis of the 
patient's ability to pay. The schedule of discounts must provide for a 
full discount to individuals and families with annual incomes at or 
below those set forth in the poverty guidelines updated periodically in 
the Federal Register by the U.S. Department of Health and Human Services 
under the authority of 42 U.S.C. 9902(2); (except that nominal fees for 
service may be collected from individuals and families with annual 
incomes at or below such levels if imposition of such fees is consistent 
with project goals) and for no discount to individuals and families with 
annual incomes greater than twice those set forth in the Guidelines.
    (f) Make every reasonable effort, including the establishment of 
systems for eligibility determination, billing, and collection, to
    (1) Collect reimbursement for its costs in providing health services 
to persons who are entitled to insurance benefits under title XVIII of 
the Social Security Act, to medical assistance under a State plan 
approved under title XIX of such Act, to social services and family 
planning under title XX of such Act, or to assistance for medical 
expenses under any other public assistance program, grant program, or 
private health insurance or benefit program on the basis of the schedule 
of fees prepared pursuant to paragraph (e) of this section without 
application of any discounts, and
    (2) Secure from patients payments for services in accordance with 
the schedule of fees and discounts required by paragraph (e) of this 
section.
    (g) Develop an overall financial management plan and an operating 
budget for the project which include and identify, in accordance with 
generally accepted accounting principles, all anticipated current income 
and expense items and capital income and expense items, if any.
    (h) Establish basic statistical data, cost accounting, management 
information, and reporting or monitoring systems which will meet the 
project's management needs and shall enable the project to provide such 
statistics and other information as the Secretary may reasonably require 
relating to the project's costs of operation, patterns of utilization of 
services, and the availability, accessibility, and acceptability of its 
services, and to make such reports to the Secretary in a timely manner 
with such frequency as the Secretary may reasonably require.
    (i) Review its catchment area annually to insure that the criteria 
set out in Sec.  56.104(b)(2) are met and, where such criteria are not 
met, revise its catchment area, with the approval of the Secretary, to 
conform with such criteria to the extent feasible.
    (j) In the case of a project which serves a population including a 
substantial proportion of individuals of limited English-speaking 
ability, have a plan and made arrangements responsive to the needs of 
these populations for providing services to the extent practicable in 
the language and cultural context most appropriate to such individuals, 
and have identified an individual on its staff who is fluent in both 
that language and in English and whose responsibilities include 
providing guidance to such individuals and to appropriate staff members 
with respect to cultural sensitivities and bridging linguistic and 
cultural differences. If more than one non-English language is spoken by 
such group or groups, an individual or individuals fluent in those 
languages and English must be so identified.
    (k) Be operated in a manner calculated to preserve human dignity and 
to maximize acceptability and effective utilization of services.
    (l) To the extent possible, coordinate and integrate project 
activities with the activities of other federally funded, as well as 
State and local, health services delivery projects and programs serving 
the same population.
    (m) Establish means for evaluating progress toward the achievement 
of the specific objectives of the project.
    (n) Provide sufficient staff, qualified by training and experience, 
to carry out the activities of the project.
    (o) Assure that facilities utilized in the performance of the 
project meet applicable fire and life safety codes.

[[Page 377]]

    (p) Utilize, to the maximum extent feasible, other Federal, State 
and local, and private resources available for support of the project, 
prior to use of project funds under this part.
    (q) Provide for community participation through, for example, 
contributions of cash or services, loans of full- or part-time staff, 
equipment, space, materials, or facilities, and, to the extent feasible, 
establishment of an advisory council to advise with respect to the 
overall management of the project including services to be provided, the 
manner of their provision, and appointment of personnel. The membership 
of such advisory council shall be representative of the population to be 
served in terms of appropriate demographic characteristics, such as 
race, sex, and ethnicity.
    (r) Where the project will provide services through contract or 
other cooperative arrangements with other providers of services, the 
project must
    (1) Enter into any such contract or arrangement only if the provider 
of services will provide the services in a timely manner and make the 
services accessible and acceptable to the population to be served; and
    (2) Make payment for services so provided in accordance with a 
schedule of rates and payment procedures established and maintained by 
the project. The project must be prepared to substantiate that such 
rates are reasonable and necessary.
    (s) Operate in a manner such that no migratory or seasonal 
agricultural worker or member of their families will be denied service 
by reason of his or her inability to pay therefor. Provided, however, 
That a charge for the provision of services will be made to the extent 
that a third party (including a Government agency) is authorized or is 
under legal obligation to pay such charges.
    (t) Have an ongoing quality assurance program as described in Sec.  
56.303(c) except as the Secretary finds that such a program would not be 
feasible.

[42 FR 60406, Nov. 25, 1977, as amended at 85 FR 72908, Nov. 16, 2020]



Sec.  56.604  Grant evaluation and award.

    (a) Within the limit of funds determined by the Secretary to be 
available the Secretary may award grants under this subpart to 
applicants therefor which will, in his judgment, provide needed health 
services in a catchment area which will not be served by another project 
funded under this part and meet the applicable requirements of section 
319(d)(1)(C) of the Act and this subpart, in accordance with priorities 
established pursuant to section 319(b) of the Act and Sec.  56.107 of 
subpart A of this part; Provided, That in the case of applicants which 
propose to serve substantially the same catchment areas or where 
available funds are insufficient to fund all approvable applications 
within a priority category specified in Sec.  56.107,
    (1) Priority shall be given to applications submitted by community-
based organizations which are representative of the population to be 
served by the project. For purposes of this paragraph, an applicant 
shall be deemed to be such an organization if it provides a formal 
mechanism (such as membership on the organization's governing body or 
membership on an advisory body) which gives migratory seasonal 
agricultural workers and their families significant involvement in the 
formulation of the organization's policies; and
    (2) Where all such applicants are community-based organizations 
representative of the population to be served by the project, the 
Secretary shall award the grant to the applicants which will, in his 
judgment, best promote the purposes of section 319(d)(1)(C) of the Act 
and the applicable regulations of this part, taking into account with 
respect to each application:
    (i) The degree to which the proposed project satisfactorily provides 
for the elements set forth in Sec.  56.203;
    (ii) The administrative and management capability of the applicant;
    (iii) The extent to which community resources will be utilized in 
the project; and
    (iv) The degree to which the applicant intends to integrate services 
supported by a grant under this part with health services provided under 
other federally assisted health services or reimbursement programs or 
projects.

[[Page 378]]



                Subpart G_Grants for Technical Assistance



Sec.  56.701  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part except as otherwise set forth herein, are 
applicable to grants awarded pursuant to section 319(g) of the Act for 
the provision of technical and other non-financial assistance to 
grantees under sections 319(c)(1)(A), 319(d)(1)(A) and 319(d)(1)(B) of 
the Act.



Sec.  56.702  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must meet the requirements of Sec. Sec.  56.104(a), 
56.104(b) (1), (4), (7), (10), and (11), and 56.104(c) of subpart A of 
this part.



Sec.  56.703  Project elements.

    A project for the provision of technical assistance to migrant 
health centers and entities which intend to become migrant health 
centers which is supported under this subpart must:
    (a) Provide to such centers and entities as are specified in the 
grant award, such technical and other nonfinancial assistance (such as 
fiscal and program management assistance or training of the staff of 
such center or entity in such management) as may be specified in the 
grant award. Such technical or other nonfinancial assistance shall be 
designed to assist such centers and entities in:
    (1) Developing plans for becoming migrant centers; and/or
    (2) Meeting the requirements of sections 319(f)(2) of the Act.
    (b) Provide such assistance through its own staff or resources.
    (c) Where the project will provide training to the staff of a center 
or entity in management or the provision of health services, provide 
such training consistent, as applicable, with Sec.  56.108(b)(7).
    (d) Maintain such records and make such reports on the expenditure 
of funds under this subpart and provision of such assistance as the 
Secretary may require.



Sec.  56.704  Grant evaluation and award.

    Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 319(g) of the Act and applicable regulations of 
this part, taking into consideration:
    (a) The cost-effectiveness of the application; and
    (b) The number of centers and entities to be served by the 
applicant.



      Subpart H_Acquisition and Modernization of Existing Buildings



Sec.  56.801  Applicability of 42 CFR part 51c, subpart E.

    The provisions of 42 CFR part 51c, subpart E, establishing 
requirements for the acquisition and modernization of existing 
buildings, shall apply to all grants under section 319 of the Act for 
project costs which include the cost of acquisition and/or modernization 
of existing buildings (including the cost of amortizing the principal 
of, and paying the interest on, loans); except that, for purposes of 
this subpart, references within subpart E to part 51c, or to subparts of 
part 51c, shall be deemed to be references to part 56, or to the 
appropriate subparts of part 56, and references to section 330 of the 
Act shall be deemed to be references to section 319 of the Act.

[43 FR 5353, Feb. 7, 1978]



PART 57_GRANTS FOR CONSTRUCTION OF TEACHING FACILITIES, 
EDUCATIONAL IMPROVEMENTS, SCHOLARSHIPS AND STUDENT LOANS--Table of Contents



Subparts A-B [Reserved]

               Subpart C_Health Professions Student Loans

Sec.
57.201 Applicability.
57.202 Definitions.
57.203 Application by school.
57.204 Payment of Federal capital contributions and reallocation of 
          funds remitted to the Secretary.

[[Page 379]]

57.205 Health professions student loan funds.
57.206 Eligibility and selection of health professions student loan 
          applicants.
57.207 Maximum amount of health professions student loans.
57.208 Health professions student loan promissory note and disclosure 
          requirements.
57.209 Payment of health professions student loans.
57.210 Repayment and collection of health professions student loans.
57.211 Cancellation of health professions student loans for disability 
          or death.
57.212 [Reserved]
57.213 Continuation of provisions for cancellation of loans made prior 
          to November 18, 1971.
57.213a Loan cancellation reimbursement.
57.214 Repayment of loans made after November 17, 1971, for failure to 
          complete a program of study.
57.215 Records, reports, inspection, and audit.
57.216 What additional Department regulations apply to schools?
57.216a Performance standard.
57.217 Additional conditions.
57.218 Noncompliance.

                     Subpart D_Nursing Student Loans

57.301 Applicability.
57.302 Definitions.
57.303 Application by school.
57.304 Payment of Federal capital contributions and reallocation of 
          funds remitted to the Secretary.
57.305 Nursing student loan funds.
57.306 Eligibility and selection of nursing student loan applicants.
57.307 Maximum amount of nursing student loans.
57.308 Nursing student loan promissory note.
57.309 Payment of nursing student loans.
57.310 Repayment and collection of nursing student loans.
57.311 Cancellation of nursing student loans for disability or death.
57.312 Repayment of loans for service in a shortage area.
57.313 Loan cancellation for full-time employment as a registered nurse.
57.313a Loan cancellation reimbursement.
57.314 Repayment of loans made after November 17, 1971, for failure to 
          complete a program of study.
57.315 Records, reports, inspection, and audit.
57.316 What additional Department regulations apply to schools?
57.316a Performance standard.
57.317 Additional conditions.
57.318 Noncompliance.

     Subpart E_Grants for Construction of Nurse Training Facilities

57.409 Good cause for other use of completed facility.

Subparts F-O [Reserved]

     Subpart P_Loan Guarantees and Interest Subsidies to Assist in 
   Construction of Teaching Facilities for Health Profession Personnel

57.1501 Applicability.
57.1502 Definitions.
57.1503 Eligibility.
57.1504 Application.
57.1505 Approval of applications.
57.1506 Priority.
57.1507 Limitations applicable to loan guarantee.
57.1508 Amount of interest subsidy payments; limitations.
57.1509 Forms of credit and security instruments.
57.1510 Security for loans.
57.1511 Opinion of legal counsel.
57.1512 Length and maturity of loans.
57.1513 Repayment.
57.1514 Loan guarantee and interest subsidy agreements.
57.1515 Loan closing.
57.1516 Right of recovery-subordination.
57.1517 Waiver of right of recovery.
57.1518 Modification of loans.

Subparts Q-T [Reserved]

      Subpart U_Armed Forces Health Professions Scholarship Program

57.2001 Applicability.
57.2002 Definitions.
57.2003 Determinations of increased enrollment solely for the program.

Subpart V [Reserved]

          Subpart W_Physician Shortage Area Scholarship Grants

57.2201 Applicability.
57.2202 Definitions.
57.2203 Eligibility.
57.2204 Application.
57.2205 Priority for selection of scholarship recipients.
57.2206 Grant award.
57.2207 Amount of scholarship grant.
57.2208 Payment of scholarship grant.
57.2209 Conditions of scholarship grant.
57.2210 Failure to comply.
57.2211 Waiver or suspension.

Subparts AA-FF [Reserved]

[[Page 380]]

       Subpart GG_Payment for Tuition and Other Educational Costs

57.3201 To which programs do these regulations apply?
57.3202 How will allowable increases be determined?

Subparts HH-PP [Reserved]

Subparts A-B [Reserved]



               Subpart C_Health Professions Student Loans

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); secs. 740-747 of the Public 
Health Service Act, 77 Stat. 170-173, as amended by 90 Stat. 2266-2268, 
91 Stat. 390-391, 95 Stat. 920, 99 Stat. 532-536, and 102 Stat. 3125 (42 
U.S.C. 294m-q); renumbered as secs. 721-735, as amended by Pub. L. 102-
408, 106 Stat. 2011-2022 (42 U.S.C. 292q--292y).

    Source: 44 FR 29055, May 18, 1979, unless otherwise noted.



Sec.  57.201  Applicability.

    The regulations of this subpart apply to the federal capital 
contributions made by the Secretary to public or other nonprofit health 
professions schools for the establishment of health professions student 
loan funds and to loans made to students by schools from these funds.



Sec.  57.202  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Date upon which a student ceases to be a full-time student means the 
first day of the month which is nearest to the date upon which an 
individual ceases to be a full-time student as defined in this section.
    Default means the failure of a borrower of a loan made under this 
subpart to make an installment payment when due, or comply with any 
other term of the promissory note for such loan, except that a loan made 
under this subpart shall not be considered to be in default if the loan 
is discharged in bankruptcy, the borrower's repayment schedule has been 
renegotiated and the borrower is complying with the renegotiated 
schedule, or the loan is in forbearance.
    Federal capital loan means a loan made by the Secretary to a school 
under section 744(a) of the Act, as in effect prior to October 1, 1977, 
the proceeds of which are to be returned to the Secretary.
    Full-time student means a student who is enrolled in a health 
professions school and pursuing a course of study which is a full-time 
academic workload, as determined by the school, leading to a degree 
specified in section 722(b) of the Act.
    Grace period means the period of 1 year beginning on the date upon 
which a student ceases to be a full-time student at a school of 
medicine, osteopathic medicine, dentistry, pharmacy, podiatric medicine, 
optometry, or veterinary medicine.
    Health professions school or school, for purposes of this subpart, 
means a public or private nonprofit school of medicine, school of 
dentistry, school of osteopathic medicine, school of pharmacy, school of 
podiatric medicine, school of optometry, or school of veterinary 
medicine as defined in section 799(1)(A) of the Act.
    Health professions student loan means the amount of money advanced 
to a student by a school from a health professions student loan fund 
under a properly executed promissory note.
    Institutional capital contribution means the money provided by a 
school, in an amount not less than one-ninth of the federal capital 
contribution, and deposited in a health professions student loan fund.
    National of the United States means: (1) A citizen of the United 
States, or (2) a person who, though not a citizen of the United States, 
owes permanent allegiance to the United States, as defined in the 
Immigration and Nationality Act, at 8 U.S.C. section 1101(a)(22).
    School year means the traditional approximately 9-month September to 
June annual session. For the purpose of computing school year 
equivalents for students who, during a 12-month period, attend for a 
longer period than the traditional school year, the school year will be 
considered to be 9 months in length.
    Secretary means the Secretary of Health and Human Services and any

[[Page 381]]

other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    State means, in addition to the several States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the 
Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, the 
Republic of Palau, the Republic of the Marshall Islands, and the 
Federated States of Micronesia.

[44 FR 29055, May 18, 1979, as amended at 52 FR 20987, June 3, 1987; 53 
FR 46549, Nov. 17, 1988; 56 FR 19293, Apr. 26, 1991; 56 FR 25446, June 
4, 1991; 61 FR 6123, Feb. 16, 1996]



Sec.  57.203  Application by school.

    (a) Each school seeking a Federal capital contribution must submit 
an application at the time and in the form and manner that the Secretary 
may require. The application must be signed by an individual authorized 
to act for the applicant and to assume on behalf of the applicant the 
obligations imposed by the statute, the regulations of this subpart, and 
the terms and conditions of the award.
    (b) Each application will be reviewed to determine eligibility and 
the reasonableness of the amount of Federal support requested. The 
Secretary may require the applicant to submit additional data for this 
purpose.
    (c) An application will not be approved unless an agreement between 
the Secretary and the applicant school for a Federal capital 
contribution under section 721 of the Act is reached.

[44 FR 29055, May 18, 1979, as amended at 49 FR 38112, Sept. 27, 1984; 
56 FR 19293, Apr. 26, 1991; 57 FR 45734, Oct. 5, 1992; 61 FR 6123, Feb. 
16, 1996]



Sec.  57.204  Payment of Federal capital contributions and reallocation 
of funds remitted to the Secretary.

    (a) Annual payment. The Secretary will make payments to each school 
with which he or she has entered into an agreement under the Act at a 
time determined by him or her. If the total of the amounts requested for 
any fiscal year by all schools for Federal capital contributions exceeds 
the amount of Federal funds determined by the Secretary at the time of 
payment to be available for this purpose, the payment to each school 
will be reduced to whichever is smaller:
    (1) The amount requested in the application, or
    (2) An amount which bears the same ratio to the total amount of 
Federal funds determined by the Secretary at the time of payment to be 
available for that fiscal year for the Health Professions Student Loan 
Program as the number of full-time students estimated by the Secretary 
to be enrolled in that school bears to the estimated total number of 
full-time students in all participating schools during that year. 
Amounts remaining after these payments are made will be distributed in 
accordance with this paragraph among schools whose applications 
requested more than the amount paid to them, but with whatever 
adjustments that may be necessary to prevent the total paid to any 
school from exceeding the total requested by it.
    (b) Method of payment. The payment of Federal capital contributions 
to a school will be paid in a manner that avoids unnecessary 
accumulations of money in any health professions student loan fund.
    (c) Reallocation of funds remitted to the Secretary. All funds from 
a student loan fund established under this subpart which are remitted to 
the Secretary in any fiscal year shall be available for allotment under 
this subpart, in the same fiscal year and the succeeding fiscal year, to 
schools which, during the period beginning on July 1, 1972, and ending 
on September 30, 1985, established student loan funds with Federal 
capital contributions under this subpart. The Secretary will from time 
to time set dates by which the schools must file applications to receive 
a portion of these funds. If the total of the amounts requested for any 
fiscal year by eligible schools exceeds the amount of funds determined 
by the Secretary at the time of payment to be available for this 
purpose, the payment to each school will be reduced to whichever is 
smaller:
    (1) The amount requested in the application, or
    (2) An amount which bears the same ratio to the total amount of 
returned funds determined by the Secretary at

[[Page 382]]

the time of payment to be available for that fiscal year for the Health 
Professions Student Loan program as the number of full-time students 
estimated by the Secretary to be enrolled in that school bears to the 
estimated total number of full-time students in all eligible schools 
during that year.

Amounts remaining after these payments are made will be distributed in 
accordance with this paragraph among schools whose applications 
requested more than the amount paid to them, with whatever adjustments 
may be necessary to prevent the total paid to any school from exceeding 
the total requested by it.

[44 FR 29055, May 18, 1979, as amended at 53 FR 46549, Nov. 17, 1988; 56 
FR 19293, Apr. 26, 1991]



Sec.  57.205  Health professions student loan funds.

    (a) Funds established with Federal capital contributions. Any fund 
established by a school with Federal capital contributions will be 
accounted for separately from other funds, providing a clear audit trail 
for all transactions. At all times the fund must contain monies 
representing the institutional capital contribution. The school must at 
all times maintain all monies relating to the fund in one or more 
interest-bearing accounts or investment instruments which meet OMB 
requirements established for Federal monies held by third parties. The 
school must place all earnings into the fund but may first deduct from 
total earnings any reasonable and customary charges incurred through the 
use of an interest-bearing account. An institution shall exercise the 
level of care required of a fiduciary with regard to these deposits and 
investments, and shall be responsible for reimbursing the fund for any 
losses that occur due to the use of investments that are not federally 
insured.
    (1) The Federal capital contribution fund is to be used by the 
school only for:
    (i) Health professions student loans to full-time students;
    (ii) Capital distribution as provided in section 728 of the Act or 
as agreed to by the school and the Secretary; and
    (iii) Costs of litigation, costs associated with membership in 
credit bureaus, and to the extent specifically approved by the 
Secretary, other collection costs that exceed the usual expenses 
incurred in the collection of health professions student loans.
    (2) A school must review the balance in the fund on at least a semi-
annual basis to determine whether the fund balance compared with 
projected levels of expenditures and collections exceeds its needs. A 
school in closing status must review the balance in the fund on a 
quarterly basis. Monies identified as in excess of the school's needs 
must be reported, and the Federal share returned to the Federal 
Government, by the due date of the required report which identifies the 
excess monies. The school's determination is subject to the review and 
approval of the Secretary.
    (b) Funds established with Federal capital loans. (1) Each Federal 
capital loan is subject to the terms of the promissory note executed by 
an authorized official on behalf of the borrowing school.
    (2) The Federal capital loans must be carried in a special account 
of the school, to be used by the school only for (i) repayments of 
principal and interest on Federal capital loans; and (ii) costs of 
litigation; costs associated with membership in credit bureaus; and, to 
the extent specifically approved by the Secretary, other collection 
costs that exceed the usual expenses incurred in the collection of 
health professions student loans.
    (c) Failure to comply with the requirements of this section will 
subject a school to the noncompliance provisions of Sec.  57.218 and the 
Department's Claims Collections regulations (45 CFR part 30), as 
appropriate.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[44 FR 29055, May 18, 1979, as amended at 48 FR 25069, June 3, 1983; 56 
FR 40725, Aug. 15, 1991; 61 FR 6123, Feb. 16, 1996]



Sec.  57.206  Eligibility and selection of health professions 
student loan applicants.

    (a) Determination of eligibility. (1) Applicants are eligible for 
consideration for a health professions student loan if they are:
    (i) Residents of the United States and either a citizen or national 
of the

[[Page 383]]

United States, an alien lawfully admitted for permanent residence in the 
United States, a citizen of the Commonwealth of the Northern Mariana 
Islands, a citizen of the Republic of Palau, a citizen of the Republic 
of the Marshall Islands, or a citizen of the Federated States of 
Micronesia;
    (ii) Enrolled, or accepted for enrollment in the school as full-time 
students;
    (iii) In need of the amount of the loan to pursue a full-time course 
of study at the school;
    (iv) Of exceptional financial need in the case of students of 
medicine or osteopathic medicine. A student will be considered to 
demonstrate exceptional financial need if the school determines that his 
or her resources, as described in paragraph (b)(1) of this section, do 
not exceed the lesser of $6,700 or one-half of the costs of attendance 
at the school. Summer earnings, educational loans, veterans (G.I.) 
benefits and earnings during the school year will not be considered as 
resources in determining whether an applicant meets the eligibility 
criteria for exceptional financial need, but will be considered in 
determining the amount of funds a student may receive; and
    (v) In compliance with the requirement to register for the draft, if 
required to do so under section 3 of the Military Selective Service Act.
    (2) An applicant who has previously attended an institution of 
higher education must submit a financial aid transcript which includes 
at least the following data:
    (i) Applicant's name and social security number;
    (ii) Amounts and sources of loans and grants previously received by 
the applicant for study at an institution of higher education;
    (iii) Whether the applicant is in default on any of these loans, or 
owes a refund on any grants;
    (iv) Certification from each institution previously attended by the 
applicant that the applicant has received no financial aid, if 
applicable; and
    (v) From each institution previously attended, the signature of an 
official authorized by the institution to sign such transcripts on 
behalf of the institution.
    (b) Selection of applicants. The school will select qualified 
applicants, including medical (M.D. and D.O.) applicants, and determine 
the amount of student loans by considering:
    (1) The financial resources available to the student by using one of 
the national need analysis systems or any other procedure approved by 
the Secretary of Education in combination with other information which 
the school has regarding the student's financial status. The school must 
take into account, regardless of the tax status of the student, the 
expected contribution from parents, spouse, self or other family 
members; and
    (2) The costs reasonably necessary for the student's attendance at 
the school, including any special needs and obligations which directly 
affect the student's ability to attend the school on a full-time basis. 
The school must document the criteria used for determining these costs.
    (c) Selection of medical (M.D. and D.O.) student applicants. In 
addition to the factors in Sec.  57.206(b), the school must select 
medical (M.D. and D.O.) students graduating after June 30, 1979, based 
on the order of greatest need, taking into consideration the other 
resources available to the student through the school. For purposes of 
establishing priority for selecting medical (M.D. and D.O.) student 
applicants to receive health professions student loans, summer earnings, 
educational loans, veterans (G.I.) benefits, and earnings during the 
school year will be considered as financial resources.
    (d) Verification of loan information. The school must verify, to the 
best of its ability, the information provided by the student on the loan 
application. To comply with this requirement, a school may require that 
a student provide, for example: Photocopies of the parents', student's, 
and spouse's Federal income tax forms with original signatures for the 
most recent tax year (or certification that no Federal income tax return 
was filed); tax returns that are certified as having been received by 
the Internal Revenue Service; or other documentation that the school 
considers

[[Page 384]]

necessary to help assure that information on the loan application is 
correct.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[44 FR 32698, June 7, 1979, as amended at 48 FR 25069, June 3, 1983; 49 
FR 38112, Sept. 27, 1984; 52 FR 20987, June 3, 1987; 53 FR 46549, Nov. 
17, 1988; 56 FR 19293, Apr. 26, 1991; 61 FR 6123, Feb. 16, 1996]



Sec.  57.207  Maximum amount of health professions student loans.

    The total of the health professions student loans made from the fund 
to any student for a school year may not exceed $2,500 and the cost of 
tuition. The maximum amount loaned during a 12-month period to any 
student enrolled in a school which provides a course of study longer 
than the 9-month school year may be proportionately increased.



Sec.  57.208  Health professions student loan promissory note 
and disclosure requirements.

    (a) Promissory note form. Each health professions student loan must 
be evidenced by a properly executed promissory note in a form approved 
by the Secretary. The school must safeguard the promissory note against 
fire, theft, and tampering.
    (1) Each promissory note must state that the loan will bear interest 
on the unpaid balance computed only for periods during which repayment 
of the loan is required, at the rate of 5 percent per year.
    (2) Each promissory note must contain an acceleration clause 
provided by the Secretary, which will permit the acceleration of 
delinquent loans at the school's option.
    (3) A copy of each executed note must be supplied by the school to 
the student borrower.
    (b) Security. A school must require security or endorsement if the 
borrower is a minor and if, under the applicable State law, the note 
signed by him or her would not create a binding obligation. The school 
may not require security or endorsement in any other circumstances.
    (c) Disclosure requirements. (1) For any loan made after June 30, 
1986, the school shall, at the time the loan is made, provide the 
following loan information to the student:
    (i) The yearly and cumulative maximum amounts that may be borrowed 
by the student;
    (ii) The terms under which repayment of the loan will begin;
    (iii) The maximum number of years in which the loan must be repaid;
    (iv) The interest rate that will be paid by the borrower and the 
minimum amount of the required monthly payment;
    (v) The amount of any other fees charged to the borrower by the 
lender;
    (vi) Any options the borrower may have for deferral, cancellation, 
prepayment, consolidation, or other refinancing of the loan;
    (vii) A definition of default on the loan and a specification of the 
consequences which will result to the borrower if the borrower defaults, 
including a description of any arrangements which may be made with 
credit bureau organizations;
    (viii) To the extent practicable, the effect of accepting the loan 
on the eligibility of the borrower for other forms of student 
assistance; and
    (ix) A description of the actions that may be taken by the Federal 
Government to collect the loan, including a description of the type of 
information concerning the borrower that the Federal Government may 
disclose to:
    (A) Officers, employees, or agents of the Department of Health and 
Human Services,
    (B) Officers, employees, or agents of schools with which the 
Secretary has an agreement under this subpart, or
    (C) Any other person involved in the collection of a loan under this 
subpart.
    (2) For any loan made after June 30, 1986, the school shall, prior 
to the borrower's completion or termination of studies at the school, 
provide the following loan information to the student:
    (i) Each amount borrowed by the student under this subpart;
    (ii) The total amount borrowed by the student under this subpart; 
and
    (iii) A schedule for the repayment of the amounts borrowed under 
this subpart, including the number, amount, and frequency of payments to 
be made.

[[Page 385]]

    (3) In addition to the requirements set forth in paragraphs (c)(1) 
and (c)(2) of this section, the school must comply with the applicable 
requirements of Truth in Lending Regulation Z (12 CFR part 226).

(Approved by the Office of Management and Budget under control number 
0915-0047)

[44 FR 29055, May 18, 1979, as amended at 48 FR 25069, June 3, 1983; 50 
FR 34420, Aug. 23, 1985; 52 FR 20987, June 3, 1987; 56 FR 19293, Apr. 
26, 1991; 57 FR 45734, Oct. 5, 1992]



Sec.  57.209  Payment of health professions student loans.

    (a) Health professions student loans from any fund may be paid to or 
on behalf of student borrowers in installments considered appropriate by 
the school except that a school may not pay to or on behalf of any 
borrower more during any given installment period (e.g., semester, term, 
or quarter) than the school determines the student needs for that 
period.
    (b) No payment may be made from a fund to or on behalf of any 
student borrower if at the time of the payment the borrower is not a 
full-time student.



Sec.  57.210  Repayment and collection of health professions student loans.

    (a) Each health professions student loan, including accrued 
interests, will be repayable in equal or graduated periodic installments 
in amounts calculated on the basis of a 10-year repayment period. Except 
as otherwise provided in this paragraph, repayment of a loan must begin 
one year after the student ceases to be a full-time student.
    (1) If a borrower reenters the same or another school as a full-time 
student within the 1-year period, the date upon which interest will 
accrue and the repayment period will begin will be determined by the 
date on which the student last ceases to be a full-time student at that 
school.
    (2) The following periods will be excluded from the 10-year 
repayment period:
    (i) All periods for up to a total of 3 years of active duty 
performed by the borrower as a member of the Army, Navy, Air Force, 
Marine Corps, Coast Guard, National Oceanic and Atmospheric 
Administration Corps or the U.S. Public Health Service Corps;
    (ii) All periods for up to a total of 3 years of service as a 
volunteer under the Peace Corps Act;
    (iii) All periods of advanced professional training including 
internships and residencies, except as specified in paragraph (a)(2)(vi) 
of this section;
    (iv) All periods during which the borrower is pursuing a full-time 
course of study at an eligible health professions school;
    (v) A period not in excess of 2 years during which a borrower who is 
a full-time student in a health professions school leaves the school, 
with the intent to return to such school as a full-time student, to 
engage in a full-time educational activity which is directly related to 
the health profession for which the individual is preparing. To qualify 
for such deferment, the full-time educational activity must be one 
which:
    (A) Is part of a joint-degree program or a formal program of joint 
study in conjunction with the health profession for which the borrower 
is preparing at the school; or
    (B) Is an activity which will enhance the borrower's knowledge and 
skills in the health profession for which the borrower is preparing at 
the school, as determined by the school.

The borrower must request such deferment from the school in which he or 
she is enrolled no later than 60 days prior to leaving such school to 
engage in the full-time educational activity. The school must then 
determine, no later than 30 days prior to the borrower's leaving such 
school, whether the borrower qualifies for such deferment. A borrower 
who qualifies for this type of deferment receives the grace period upon 
completion or termination of his or her studies leading to the first 
professional degree in the health discipline being pursued. If the 
borrower fails to return to school, the school retroactively must begin 
the borrower's grace period based on the date the borrower terminated 
his or her studies at the school, and must begin the repayment period 
immediately following the end of the grace period; and

[[Page 386]]

    (vi) A period not in excess of 2 years during which a borrower who 
is a graduate of a health professions school participates in:
    (A) A fellowship training program which is directly related to the 
health profession for which the borrower prepared at the school, as 
determined by the school from which the borrower received his or her 
loan, and is engaged in by the borrower no later than 12 months after 
the completion of the borrower's participation in advanced professional 
training as described in paragraph (a)(2)(iii) of this section, or prior 
to the completion of such borrower's participation in such training. To 
qualify for such deferment, the fellowship training program must be one 
which:
    (1) Is a full-time activity in research or research training or in 
health care policy; and
    (2) Is a formally established fellowship program which was not 
created for a specific individual; or
    (B) A full-time educational activity which is directly related to 
the health profession for which the borrower prepared at the school, as 
determined by the school from which the borrower received his or her 
loan, and is engaged in by the borrower no later than 12 months after 
the completion of the borrower's participation in advanced professional 
training as described in paragraph (a)(2)(iii) of this section, or prior 
to the completion of the borrower's participation in such training. To 
qualify for such deferment, the full-time educational activity must be 
one which:
    (1) Is part of a joint-degree program in conjunction with the health 
profession for which the borrower prepared at the school; or
    (2) Is required for licensure, registration, or certification in the 
health profession for which the borrower received the HPSL loan; or
    (3) Is a full-time educational program in public health, health 
administration, or a health care discipline directly related to the 
health profession for which the borrower received the loan.
    (3) To receive a deferment, a borrower must, no later than 30 days 
prior to the onset of the activity (or no later than 30 days prior to 
the due date of the first payment if the borrower begins the activity 
during the grace period), and annually thereafter, provide the lending 
school with evidence of his or her status in the deferrable activity, 
and evidence that verifies deferment eligibility of the activity. This 
evidence must include certification by the Program Director or other 
authorized official that the borrower's activity meets the deferment 
requirements. The borrower must also notify the school upon completion 
or termination of the activity. It is the responsibility of the borrower 
to provide the lending school with all required information or other 
information regarding the requested deferment. The school may deny a 
request for deferment if it is not filed in accordance with the 
requirements of this section.
    (4) Subject to the provisions of paragraph (b)(3) of this section, a 
borrower must establish a repayment schedule with the school providing 
for payments not less often than quarterly. Any borrower whose repayment 
is delinquent more than 60 days must establish a monthly repayment 
schedule with the school. However, a borrower may at his or her option 
and without penalty, prepay all or part of the principal and accrued 
interest at any time.
    (5) A school may grant forbearance whenever extraordinary 
circumstances such as unemployment, poor health or other personal 
problems temporarily affect the borrower's ability to make scheduled 
loan repayments.
    (b)(1) Each school at which a fund is established must exercise due 
diligence in the collection of health professions student loans due the 
fund. In the exercise of due diligence, a school must follow procedures 
which are at least as extensive and effective as those used in the 
collection of other student loan accounts due the school, and must use 
the steps outlined below in accordance with collection practices which 
are generally accepted among institutions of higher education:
    (i) Conduct and document an entrance interview (individually or in 
groups) with the borrower prior to disbursing HPSL funds in an academic 
year. During the entrance interview the school must obtain documentation

[[Page 387]]

which indicates that the borrower is aware of the rights and 
responsibilities associated with HPSL funds and personal information 
which would assist in locating the borrower if he or she fails to keep 
the school informed of his or her current address. The requirements of 
this subparagraph may be met by correspondence, if the school determines 
that a face-to-face meeting (individually or in groups) is 
impracticable.
    (ii) Conduct and document an exit interview (individually or in 
groups) with the borrower. During the exit interview, the school must 
provide each borrower with information necessary to carry out the terms 
of repayment, remind the borrower of the rights and responsibilities 
associated with HPSL funds, and update the personal information 
collected prior to disbursing HPSL funds which would assist in locating 
the borrower if he or she fails to keep the school informed of his or 
her current address. If the borrower terminates studies without advance 
notice, the school must document attempts to inform the borrower of the 
substance of the exit interview and to secure exit interview information 
from the borrower by mail.
    (iii) Notify the borrower in writing of the impending repayment 
obligation at least twice during the grace period;
    (iv) Notify a borrower who is in deferment status in writing of the 
impending repayment obligation 1 to 3 months prior to the expiration of 
the approved period of deferment;
    (v) Perform regular billing;
    (vi) Follow up past due payments with a series of at least four 
documented and reasonably spaced attempts to contact the borrower, at 
least three of which must be in writing at not more than 30-day 
intervals, prior to the loan becoming 120 days past due, provided that 
the school has a current address for the borrower;
    (vii) Perform address searches when necessary;
    (viii) Use collection agents, which may include the use of an 
internal collection agent;
    (ix) Institute legal proceedings against borrowers after all other 
attempts at collection have failed, unless the school determines, 
subject to the approval of the Secretary, that such litigation would not 
be cost-effective; and
    (x) Become a member of a credit bureau and notify the credit bureau 
of accounts past due by more than 120 days.

In place of one or more of the procedures outlined above schools may 
substitute collection techniques that are equally or more effective, but 
only after they have demonstrated the effectiveness of the techniques 
and obtained written approval from the Secretary.
    (2) Late charge. (i) For any health professions student loan made 
after June 30, 1969, but prior to October 22, 1985, the school may fix a 
charge for failure of the borrower to pay all or any part of an 
installment when it is due and, in the case of a borrower who is 
entitled to deferment under section 722(c) of the Act for any failure to 
file timely and satisfactory evidence of the entitlement. The amount of 
the charge may not exceed $1 for the first month or part of a month by 
which the installment or evidence is late and $2 for each succeeding 
month or part of a month. The school may elect to add the amount of this 
charge to the principal amount of the loan as of the day after the day 
on which the installment or evidence was due, or to make the amount of 
the charge payable to the school no later than the due date of the next 
installment following receipt of the notice of the charge by the 
borrower.
    (ii) For any health professions student loan made on or after 
October 22, 1985, the school shall assess a charge for failure of the 
borrower to pay all or any part of an installment when the loan is more 
than 60 days past due and, in the case of a borrower who is entitled to 
deferment under section 722(c) of the Act, for any failure to file 
satisfactory evidence of the entitlement within 60 days of the date 
payment would otherwise be due. No charge may be made if the loan is 
less than 61 days past due. The amount of this charge may not exceed an 
amount equal to 6 percent of the amount due at the time the charge is 
calculated. The school may elect to add the amount of this charge to the 
principal amount of the loan as of the day on which the charge is 
calculated, or to make the amount of

[[Page 388]]

the charge payable to the school no later than the due date of the next 
installment following receipt of the notice of the charge by the 
borrower.
    (3) With respect to any health professions student loan made after 
June 30, 1969, the school may require the borrower to make payments of 
at least $15 per month on all outstanding health professions student 
loans during the repayment period.
    (4) A school must, on an annual basis, review and assess the 
collectibility of any loan more than 3 years past due. If the school 
determines that the prospects of future collection are promising enough 
to justify periodic review of the debt, and neither the statute of 
limitations nor the 10-year repayment period has expired, the school may 
retain the account for continued collections, provided that it makes an 
attempt at least semi-annually to collect from the borrower. When the 
due diligence procedures required by paragraph (b)(1) of this section 
have been exhausted, the school is responsible for determining the 
collection methods it will use for the semi-annual collection effort 
required on these loans. If the school determines that the prospects of 
future collection are not promising, or when the statute of limitations 
or the 10-year repayment period has expired, the loan must be considered 
uncollectible. A school may determine a loan to be uncollectible sooner 
than 3 years past due when it has evidence that the loan cannot be 
collected, but in no case should a school consider a loan as 
uncollectible if it has not been in default for a least 120 days. A 
school is not subject to the requirements in paragraphs (b)(4) (i) and 
(iii) of this section for loans that became uncollectible, as determined 
by the school, before August 1, 1985.
    (i) A school must request permission to write off an uncollectible 
loan within 30 days of the determination that it is uncollectible or 
reimburse the fund in the full amount of the loan, pursuant to Sec.  
57.210(b)(4)(iii). The 30-day period for submitting the loan for write-
off review begins on the date that the determination of uncollectibility 
is made, in accordance with paragraph (b)(4) of this section. In any 
instance where the Secretary determines that a school has failed to 
exercise due diligence in the collection of a loan, in accordance with 
the applicable regulatory requirements, the school will be required to 
place in the fund the full amount of principal, interest, and penalty 
charges that remains uncollected on the loan. Reimbursement must be made 
by the following June 30 or December 31, whichever is sooner, except 
that in no case will a school be required to reimburse the fund in less 
than 30 days following the Secretary's disapproval of the request for 
write-off approval.
    (ii) If the Secretary determines that a school has exercised due 
diligence in the collection of a loan, in accordance with the applicable 
regulatory requirements, or if the school determines that the loan was 
uncollectible prior to August 1, 1985, the school will be permitted to 
reduce its accounts receivable for the HPSL fund by the full amount of 
principal, interest, and penalty charges that remains uncollected on 
that loan and will not be required to return the Federal share of the 
loss to the Secretary.
    (iii) If a school does not request permission to write off an 
uncollectible loan within the required timeframe, it must reimburse the 
fund for the full amount of principal, interest, and penalty charges 
that remains uncollected on that loan. This reimbursement must be made 
by the following June 30 or December 31, whichever is sooner, except 
that in no case will a school be required to reimburse the fund in less 
than 30 days following its determination that a loan is uncollectible.
    (iv) Failure to comply with the requirement of this section will 
subject a school to the noncompliance provisions of Sec.  57.218 and the 
Department's Claims Collection regulations (45 CFR part 30), as 
appropriate.
    (5) Disclosure of taxpayer identity information. Upon written 
request by the Secretary, the Secretary of the Internal Revenue Service 
(IRS) may disclose the address of any taxpayer who has defaulted on a 
health professions student loan, for use only by officers, employees, or 
agents of the Department, to locate the defaulted borrower to collect 
the loan. Any such mailing address may be disclosed by the Secretary to

[[Page 389]]

any school from which the defaulted borrower received a health 
professions student loan, for use only by officers, employees, or agents 
of the school whose duties relate to the collection of health 
professions student loan funds, to locate the defaulted borrower to 
collect the loan. Any school which requests and obtains this address 
information must comply with the requirements of the Secretary and the 
IRS regarding the safeguarding and proper handling of this information.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[44 FR 29055, May 18, 1979, as amended at 48 FR 25069, June 3, 1983; 49 
FR 38112, Sept. 27, 1984; 50 FR 34420, Aug. 23, 1985; 52 FR 20988, June 
3, 1987; 53 FR 6092, Feb. 29, 1988; 56 FR 19293, Apr. 26, 1991; 56 FR 
40726, Aug. 15, 1991; 57 FR 45734, Oct. 5, 1992; 61 FR 6123, Feb. 16, 
1996]



Sec.  57.211  Cancellation of health professions students loans 
for disability or death.

    (a) Permanent and total disability. The Secretary will cancel a 
student borrower's indebtedness in accordance with section 722(d) of the 
Act if the borrower is found to be permanently and totally disabled on 
recommendation of the school and as supported by whatever medical 
certification the Secretary may require. A borrower is totally and 
permanently disabled if he or she is unable to engage in any substantial 
gainful activity because of a medically determinable impairment, which 
the Secretary expects to continue for a long time or to result in death.
    (b) Death. The Secretary will cancel a student borrower's 
indebtedness in accordance with section 722(d) of the Act upon the death 
of the borrower. The school to which the borrower was indebted must 
secure a certification of death or whatever official proof is conclusive 
under State law.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[44 FR 29055, May 18, 1979, as amended at 56 FR 19293, Apr. 26, 1991; 61 
FR 6123, Feb. 16, 1996]



Sec.  57.212  [Reserved]



Sec.  57.213  Continuation of provisions for cancellation of loans 
made prior to November 18, 1971.

    Individuals who received health professions student loans as 
students of medicine, osteopathic medicine, dentistry or optometry prior 
to November 18, 1971, may still receive cancellation of these loans for 
practicing in a shortage area or for practicing in a rural shortage area 
characterized by low family income. The regulations set forth in 42 CFR 
57.215(b) (1976), as adopted on February 7, 1974 remain applicable to 
cancellation on this basis. The provisions can be found at 39 FR 4774 
(February 7, 1974) and a copy can be obtained by writing to the Division 
of Student Assistance, Bureau of Health Professions, Room 8-34, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

[49 FR 38112, Sept. 27, 1984, as amended at 56 FR 19294, Apr. 26, 1991]



Sec.  57.213a  Loan cancellation reimbursement.

    (a) For loans made prior to October 22, 1985, in the event that 
insufficient funds are available to the Secretary in any fiscal year to 
enable him or her to pay to all schools their proportionate shares of 
all loans and interest canceled under this subpart for practice in a 
shortage area, death, or disability:
    (1) Each school will be paid an amount bearing the same ratio to the 
total of the funds available for that purpose as the principal of loans 
canceled by that school in that fiscal year bears to the total principal 
of loans canceled by all schools in that year; and
    (2) Any additional amounts to which a school is entitled will be 
paid by the Secretary at the time of distribution of the assets of the 
school's Fund under section 728 of the Act.
    (b) For loans made on or after October 22, 1985, a school may assess 
the borrower a charge to insure against the loss of the institutional 
share of a loan canceled due to the borrower's death or permanent and 
total disability. The school must develop annually a rate which reflects 
its cancellation experience. This charge shall not exceed .6

[[Page 390]]

percent of the loan amount. Funds collected under this provision must be 
maintained by the school in an insured, interest-bearing account (with 
any earned interest credited to this insurance fund), and used only to 
reimburse the school for the institutional share of any HPSL loan made 
on or after October 22, 1985, that is canceled due to the borrower's 
death or permanent and total disability. A school is not required to 
establish a separate bank account, but is required to maintain separate 
accountability.

[53 FR 46549, Nov. 17, 1988, as amended at 56 FR 19294, Apr. 26, 1991; 
57 FR 45734, Oct. 5, 1992; 61 FR 6123, Feb. 16, 1996]



Sec.  57.214  Repayment of loans made after November 17, 1971, 
for failure to complete a program of study.

    In the event that the Secretary undertakes to repay educational 
loans under section 722(k) of the Act, he or she will use the following 
criteria to make a determination as to each applicant's eligibility:
    (a) An applicant will be considered to have failed to complete the 
course of study leading to the first professional degree for which an 
eligible education loan was made upon certification by a health 
professions school that the individual ceased to be enrolled in the 
school subsequent to November 17, 1971;
    (b) An applicant will be considered to be in exceptionally needy 
circumstances if, upon comparison of the income and other financial 
resources of the applicant with his or her expenses and financial 
obligations, the Secretary determines that repayment of the loan would 
constitute a serious economic burden on the applicant. In making this 
determination, the Secretary will take into consideration the 
applicant's net financial assets, his or her potential earning capacity, 
and the relationship of the income available to the applicant to the 
low-income levels published annually by the Secretary under paragraph 
(c) of this section;
    (c) An applicant will be considered to be from a low-income family 
if the applicant comes from a family with an annual income below a level 
based on low-income thresholds according to family size published by the 
U.S. Bureau of the Census, adjusted annually for changes in the Consumer 
Price Index, and adjusted by the Secretary for use in this program, and 
the family has no substantial net financial assets. Income levels as 
adjusted will be published annually by the Secretary in the Federal 
Register.
    (d) An applicant will be considered to be from a disadvantaged 
family if the individual comes from a family in which the annual income 
minus unusual expenses which contribute to the economic burdens borne by 
the family does not exceed the low-income levels published by the 
Secretary under paragraph (c) of this section and the family has no 
substantial net financial assets;
    (e) An applicant will be considered as not having resumed his or her 
health professions studies within two years following the date the 
individual ceased to be a student upon a certification so stating from 
the applicant; and
    (f) An applicant will be considered as not reasonably expected to 
resume his or her health professions studies within two years following 
the date upon which he or she terminated these studies, based upon 
consideration of the reasons for the applicant's failure to complete 
these studies, taking into account such factors as academic, medical, or 
financial difficulties.

The Secretary will only repay education loans made subsequent to 
November 17, 1971.

[44 FR 29055, May 18, 1979, as amended at 61 FR 6123, Feb. 16, 1996; 61 
FR 9532, Mar. 8, 1996]



Sec.  57.215  Records, reports, inspection, and audit.

    (a) Each Federal capital contribution and Federal capital loan is 
subject to the condition that the school must maintain those records and 
file with the Secretary those reports relating to the operation of its 
health professions student loan funds as the Secretary may find 
necessary to carry out the purposes of the Act and these regulations. A 
school must submit required reports to the Secretary within 45 days of 
the close of the reporting period.
    (1) A school which fails to submit a required report for its Federal 
capital contribution fund within 45 days of the close of the reporting 
period:

[[Page 391]]

    (i) Shall be prohibited from receiving new Federal capital 
contributions;
    (ii) Must place the revolving fund and all subsequent collections in 
an insured interest-bearing account; and
    (iii) May make no loan disbursements.

The above restrictions apply until the Secretary determines that the 
school is in compliance with the reporting requirement.
    (2) A school that fails to submit a complete report within 6 months 
of the close of the reporting period will be subject to termination. The 
Secretary will provide the school with a written notice specifying his 
or her intention to terminate the school's participation in the program 
and stating that the school may request, within 30 days of the receipt 
of this notice, a formal hearing. If the school requests a hearing, it 
must within 90 days of the receipt of the notice, submit material, 
factual issues in dispute to demonstrate that there is cause for a 
hearing. These issues must be both substantive and relevant. The hearing 
will be held in the Washington, DC metropolitan area. The Secretary will 
deny a hearing if:
    (i) The request for a hearing is untimely (i.e., fails to meet the 
30-day requirement);
    (ii) The school does not provide a statement of material, factual 
issues in dispute within the 90-day required period; or
    (iii) The statement of factual issues in dispute is frivolous or 
inconsequential.

In the event that the Secretary denies a hearing, the Secretary will 
send a written denial to the school setting forth the reasons for 
denial. If a hearing is denied, or if as a result of the hearing, 
termination is still determined to be necessary, the school will be 
terminated from participation in the program and will be required to 
return the Federal share of the revolving fund to the Department. A 
school terminated for failure to submit a complete report within 6 
months of the close of the reporting period must continue to pursue 
collections and may reapply for participation in the program once it has 
submitted the overdue report.
    (3) The school must also comply with the requirements of 45 CFR part 
75 and section 798(e) of the Act concerning recordkeeping, audit, and 
inspection.
    (b) The following student records must be retained by the school for 
5 years after an individual student ceases to be a full-time student:
    (1) Approved student applications for health professions student 
loans;
    (2) Documentation of the financial need of applicants; and
    (3) Copy of financial aid transcript(s).
    (c) The following repayment records for each individual borrower 
must be retained for at least 5 years from the date of retirement of a 
loan:
    (1) The amount and date of each loan;
    (2) The amount and date of each payment or cancellation;
    (3) Records of periods of deferment;
    (4) Date, nature and result of each contact with the borrower or 
proper endorser in the collection of an overdue loan;
    (5) Copies of all correspondence to or from the borrower and 
endorser;
    (6) Copies of all correspondence with collection agents related to 
the individual borrower;
    (7) Copies of all correspondence with a credit bureau related to an 
individual borrower; and
    (8) Copies of all correspondence relating to uncollectible loans 
which have been written off by the Federal Government or repaid by the 
school.
    (d) The school must also retain other records as the Secretary may 
prescribe. In all cases where questions have arisen as a result of a 
Federal audit, the records must be retained until resolution of all 
questions.
    (e) Institutional officials who have information which indicates the 
potential or actual commission of fraud or other offenses against the 
United States, involving these loan funds, should promptly provide this 
information to the appropriate Regional Office of Inspector General for 
Investigations.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[48 FR 25070, June 3, 1983, as amended at 50 FR 34421, Aug. 23, 1985; 53 
FR 46549, Nov. 17, 1988; 56 FR 19294, Apr. 26, 1991; 57 FR 45734, Oct. 
5, 1992; 61 FR 6123, Feb. 16, 1996; 81 FR 3008, Jan. 20, 2016]

[[Page 392]]



Sec.  57.216  What additional Department regulations apply to schools?

    (a) Participating schools are advised that in addition to complying 
with the terms and conditions of these regulations, several other 
regulations apply under this subpart. These include, but are not limited 
to:

45 CFR part 76--Governmentwide Debarment and Suspension (nonprocurement) 
and Governmentwide Requirements for Drug-Free Workplace (Grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 83--Regulation for the administration and enforcement of 
sections 794 and 855 of the Public Health Service Act
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in Health and 
Human Services programs or activities receiving Federal financial 
assistance
45 CFR part 93--New Restrictions on Lobbying

    (b) The recipient may not discriminate on the basis of religion in 
the admission of individuals to its training programs.

[44 FR 29055, May 18, 1979, as amended at 56 FR 19294, Apr. 26, 1991; 57 
FR 45734, Oct. 5, 1992; 61 FR 6123, Feb. 16, 1996]



Sec.  57.216a  Performance standard.

    On June 30, 1984, and on each June 30 thereafter, except as provided 
in paragraph (b) of this section, each school must have a default rate 
(as calculated under paragraph (a) of this section) of not more than 5 
percent.
    (a) The default rate for each school shall be the ratio (stated as a 
percentage) that the defaulted principal amount outstanding of the 
school bears to the matured loans of the school. For this purpose:
    (1) The term defaulted principal amount outstanding means the total 
amount borrowed from the loan fund of a school that has reached the 
repayment stage (minus any principal amount repaid or canceled) on loans 
in default for more than 120 days; and
    (2) The term matured loans means the total principal amount of all 
loans made by a school under this subpart minus the total principal 
amount of loans made by the school to students who are:
    (i) Enrolled in a full-time course of study at the school; or
    (ii) In their grace period.
    (b) Any school that has a default rate greater than 5 percent on 
June 30 of any year will be required to:
    (1) Reduce its default rate by 50 percent (or a school with a 
default rate below 10 percent must reduce its rate to 5 percent) by the 
close of the following 6-month period; and
    (2) By the end of each succeeding 6-month period, reduce its default 
rate to 50 percent of the required rate for the previous 6-month period, 
until it reaches 5 percent.
    (c) Any school subject to the provisions of paragraph (b) of this 
section which fails to comply with those requirements will receive no 
new HPSL funds and will be required to:
    (1) Place the revolving fund monies and all subsequent collections 
into an insured interest-bearing account;
    (2) Make no loan disbursements; and
    (3) By the end of the succeeding 6-month period, reduce its default 
rate to 50 percent of the rate it failed to achieve under paragraph (b) 
of this section, or 5 percent. A school that meets this requirement will 
be permitted to resume the use of its health professions student loan 
funds, but must continue to comply with the requirements of paragraph 
(b)(2) of this section if its default rate is still greater than 5 
percent.
    (d) Any school subject to the provisions of paragraph (c)(3) of this 
section which fails to comply with those requirements will be subject to 
termination. The Secretary will provide the school with a written notice 
specifying his or her intention to terminate the school's participation 
in the program and stating that the school may request, within 30 days 
of the receipt of this notice, a formal hearing. If the school requests 
a hearing, it must within 90 days of the receipt of the notice, submit 
material, factual issues in

[[Page 393]]

dispute to demonstrate that there is cause for a hearing. These issues 
must be both substantive and relevant. The hearing will be held in the 
Washington, DC metropolitan area. The Secretary will deny a hearing if:
    (1) The request for a hearing is untimely (i.e., fails to meet the 
30-day requirement);
    (2) The school does not provide a statement of material, factual 
issues in dispute within the 90-day required period; or
    (3) The statement of factual issues in dispute is frivolous or 
inconsequential.

In the event that the Secretary denies a hearing, the Secretary will 
send a written denial to the school setting forth the reasons for 
denial. If a hearing is denied, or if as a result of the hearing, 
termination is still determined to be necessary, the school will be 
terminated from participation in the program and will be required to 
return the Federal share of the revolving fund to the Department. A 
school terminated for failure to comply with the provisions of paragraph 
(c)(3) of this section must continue to pursue collections and may 
reapply for participation in the program only when it has attained a 
default rate of 5 percent or less.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34423, Aug. 23, 1985, as amended at 52 FR 20988, June 3, 1987; 53 
FR 46550, Nov. 17, 1988; 56 FR 19294, Apr. 26, 1991]



Sec.  57.217  Additional conditions.

    The Secretary may with respect to any agreement entered into with 
any school under Sec.  57.205, impose additional conditions prior to or 
at the time of any award when in his or her judgment these conditions 
are necessary to assure or protect the advancement of the purposes of 
the agreement, the interest of the public health, or the conservation of 
funds awarded.



Sec.  57.218  Noncompliance.

    Wherever the Secretary finds that a participating school has failed 
to comply with the applicable provisions of the Act or the regulations 
of this subpart, he or she may, on reasonable notice to the school, 
withhold further payment of Federal capital contributions, and take such 
other action, including the termination of any agreement, as he or she 
finds necessary to enforce the Act and regulations. In this case no 
further expenditures shall be made from the health professions student 
loan fund or funds involved until the Secretary determines that there is 
no longer any failure of compliance.



                     Subpart D_Nursing Student Loans

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690, 
67 Stat. 631 (42 U.S.C. 216); secs. 835-842 of the Public Health Service 
Act, 77 Stat. 913-916, as amended by 99 Stat. 397-400, 536-537, and 102 
Stat. 3160-3161 (42 U.S.C. 297 a-i).

    Source: 50 FR 34434, Aug. 23, 1985, unless otherwise noted.



Sec.  57.301  Applicability.

    The regulations in this subpart apply to the Federal capital 
contributions made by the Secretary to public or other nonprofit schools 
of nursing for the establishment of nursing student loan funds and to 
loans made to students from these funds.



Sec.  57.302  Definitions.

    As used in this subpart:
    Academic year means the traditional, approximately 9-month September 
to June annual session. For the purpose of computing academic year 
equivalents for students who, during a 12-month period, attend for a 
longer period than the traditional academic year, the academic year will 
be considered to be of 9 months' duration.
    Act means the Public Health Service Act, as amended.
    Community health center means an entity as defined under section 
330(a) of the Public Health Service Act, and in regulations at 42 CFR 
51c.102(c).
    Date upon which a student ceases to be a full-time or half-time 
student means the first day of the month which is nearest to the date 
upon which an individual ceases to be a full-time or half-time student, 
as defined in this section.
    Default means the failure of a borrower of a loan made under this 
subpart to make an installment payment when due, or comply with any 
other term of the promissory note for such

[[Page 394]]

loan, except that a loan made under this subpart shall not be considered 
to be in default if the loan is discharged in bankruptcy, the borrower's 
repayment schedule has been renegotiated and the borrower is complying 
with the renegotiated schedule, or the loan is in forbearance.
    Federal capital loan means a loan made by the Secretary to a school 
under section 827(a) of the Act, as in effect prior to July 29, 1975, 
the proceeds of which are to be returned to the Secretary.
    Full-time student means a student who is enrolled in a school and 
pursuing a course of study which constitutes a full-time academic 
workload, as determined by the school, leading to a diploma in nursing, 
an associate degree in nursing or an equivalent degree, a baccalaureate 
degree in nursing or an equivalent degree, or a graduate degree in 
nursing.
    Good standing means the eligibility of a student to continue in 
attendance at the school where he or she is enrolled as a student in 
accordance with the school's standards and practices.
    Grace period means the period of 9 months beginning on the date upon 
which a student ceases to be a full-time or half-time student at a 
school of nursing.
    Half-time student means a student who is enrolled in a school and 
pursuing a course of study which constitutes at least one-half of a 
full-time academic workload but less than a full-time academic workload, 
as determined by the school, leading to a diploma in nursing, an 
associate degree in nursing or an equivalent degree, a baccalaureate 
degree in nursing or an equivalent degree, or a graduate degree in 
nursing.
    Indian Health Service health center means a health care facility 
(whether operated directly by the Indian Health Service or operated by a 
tribal contractor or grantee under the Indian Self-Determination Act), 
which is physically separated from a hospital, and which provides one or 
more clinical treatment services, such as physician, dentist or nursing 
services, available at least 40 hours a week for outpatient care to 
persons of Indian or Alaska Native descent.
    Institutional capital contribution means the money provided by a 
school, in an amount not less than one-ninth of the Federal capital 
contribution, and deposited in a nursing student loan fund.
    Migrant health center means an entity as defined under section 
329(a) of the Public Health Service Act, and in regulations at 42 CFR 
56.102(g).
    National of the United States means: (1) A citizen of the United 
States, or (2) a person who, though not a citizen of the United States, 
owes permanent allegiance to the United States, as defined in the 
Immigration and Nationality Act, at 8 U.S.C. 1101(a)(22).
    Native Hawaiian health center means an entity (as defined in section 
8 of Public Law 100-579)--
    (a) Which is organized under the laws of the State of Hawaii,
    (b) Which provides or arranges for health care services through 
practitioners licensed by the State of Hawaii, where licensure 
requirements are applicable,
    (c) Which is a public or private nonprofit entity, and
    (d) In which Native Hawaiian health practitioners significantly 
participate in the planning, management, monitoring, and evaluation of 
health services.
    Nursing facility means a facility as defined in section 1919(a) of 
the Social Security Act (SSA) (for fiscal year (FY) 1991 and subsequent 
fiscal years), except for FYs 1989 and 1990, the term means a ``skilled 
nursing facility,'' as such term is defined in section 1861(j) of the 
SSA, and an ``intermediate care facility,'' as such term is defined in 
section 1905(c) of such Act.
    Nursing student loan means the amount of money advanced to a student 
by a school from a nursing student loan fund under a properly executed 
promissory note.
    Registered nurse means an individual who has been licensed by a 
State Board of Nursing to practice professional nursing in accordance 
with State licensing laws requiring as a minimum one of the degrees or 
diplomas specified in this section.
    Rural health clinic means an entity as defined under section 
1861(aa)(2) of the

[[Page 395]]

Social Security Act, and in regulations at 42 CFR 491.2.
    School means a public or other nonprofit school of nursing, as 
defined in section 853 of the Act.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee to whom the authority involved has been 
delegated.
    State means, in addition to the several States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the 
Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, the 
Republic of Palau, the Republic of the Marshall Islands, and the 
Federated States of Micronesia.

[50 FR 34434, Aug. 23, 1985, as amended at 52 FR 10195, Mar. 30, 1987; 
53 FR 46554, Nov. 17, 1988; 56 FR 13771, Apr. 4, 1991; 61 FR 6123, Feb. 
16, 1996]



Sec.  57.303  Application by school.

    (a) Each school seeking a Federal capital contribution must submit 
an application at the time and in the form and manner that the Secretary 
may require. The application must be signed by an individual authorized 
to act for the applicant and to assume on behalf of the applicant the 
obligations imposed by the statute, the regulations of this subpart, and 
the terms and conditions of the award.
    (b) Each application will be reviewed to determine eligibility and 
the reasonableness of the amount of Federal support requested. The 
Secretary may require the applicant to submit additional data for this 
purpose.
    (c) An application will not be approved unless an agreement between 
the Secretary and the applicant school for a Federal capital 
contribution under section 835 of the Act is reached.

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 13771, Apr. 4, 1991; 57 
FR 45735, Oct. 5, 1992]



Sec.  57.304  Payment of Federal capital contributions and reallocation 
of funds remitted to the Secretary.

    (a) Annual payment. The Secretary will make payments at a time 
determined by him or her, to each school with which he or she has 
entered into an agreement under the Act.
    (1) For any fiscal year for which ``set-aside'' funds are available, 
the Secretary will first make payments in the manner described in (a)(2) 
of this section of not less than $1,000,000 of the amount of Federal 
funds determined by the Secretary at the time of payment to be available 
for making loans under this subpart. These funds will be paid to schools 
submitting an application for ``set-aside'' funds to be used only for 
the purpose of making loans to individuals qualified to receive loans 
under this subpart who, on the date they receive the loan, have not been 
employed on a full-time basis or been enrolled in any educational 
institution on a full-time basis for at least 7 years. An individual may 
not receive a loan under this subparagraph that exceeds $500 for any 
academic year.
    (2) If the total of the amounts requested for any fiscal year by all 
schools for Federal capital contributions minus the amount received 
under paragraph (a)(1) of this section exceeds the amount of Federal 
funds determined by the Secretary at the time of payment to be available 
for this purpose, the payment to each school will be reduced to 
whichever is smaller: (i) The amount requested in the application, or 
(ii) an amount which bears the same ratio to the total amount of Federal 
funds determined by the Secretary at the time of payment to be available 
for that fiscal year for the Nursing Student Loan program as the number 
of full-time students estimated by the Secretary to be enrolled in that 
school bears to the estimated total number of full-time students in all 
participating schools during that year.
    (3) Amounts remaining after these payments are made will be 
distributed in accordance with this paragraph among schools whose 
applications requested more than the amount paid to them, but with 
whatever adjustments that may be necessary to prevent the total paid to 
any school from exceeding the total requested by it.
    (b) Method of payment. The payment of Federal capital contributions 
to a school will be paid in a manner that avoids unnecessary 
accumulations of money in any nursing student loan fund.

[[Page 396]]

    (c) Reallocation of funds remitted to the Secretary. (1) All funds 
from a student loan fund established under this subpart which are 
remitted to the Secretary in any fiscal year shall be available for 
allotment under this subpart, in the same fiscal year and the succeeding 
fiscal year, to eligible nursing schools. In making these allotments, 
the Secretary shall give priority to nursing schools which established a 
student loan fund under this subpart after September 30, 1975. The 
Secretary will make payments to eligible schools at a time determined by 
him or her, according to the procedures indicated in paragraphs (c)(2) 
and (c)(3) of this section.
    (2) Eligible schools which established a nursing student loan fund 
after September 30, 1975. The Secretary will make awards first to those 
eligible schools that established a nursing student loan fund after 
September 30, 1975. If the total of the amounts requested for any fiscal 
year by these schools exceeds the amount of funds determined by the 
Secretary at the time of payment to be available for this purpose, the 
payment to each school will be reduced to whichever is smaller:
    (i) The amount requested in the application, or
    (ii) An amount which bears the same ratio to the total amount of 
returned funds determined by the Secretary at the time of payment to be 
available for that fiscal year for the Nursing Student Loan program as 
the number of full-time students estimated by the Secretary to be 
enrolled in that school bears to the estimated total number of full-time 
students in these eligible schools during that year.

Amounts remaining after these payments are made will be distributed in 
accordance with this paragraph among schools whose applications 
requested more than the amount paid to them, with whatever adjustments 
may be necessary to prevent the total paid to any school from exceeding 
the total requested by it.
    (3) Eligible schools which established a nursing student loan fund 
prior to October 1, 1975. If there are funds remaining after making 
awards as specified by paragraph (c)(2) of this section, the Secretary 
will make awards to eligible schools which established a nursing student 
loan fund prior to October 1, 1975. If the total of the amounts 
requested for any fiscal year by these schools exceeds the amount of 
funds determined by the Secretary at the time of payment to be available 
for this purpose, the payment to each school will be reduced to 
whichever is smaller:
    (i) The amount requested in the application, or
    (ii) An amount which bears the same ratio to the total amount of 
returned funds determined by the Secretary at the time of payment to be 
available for that fiscal year for the Nursing Student Loan program as 
the number of full-time students estimated by the Secretary to be 
enrolled in that school bears to the estimated total number of full-time 
students in these eligible schools during that year.

Amounts remaining after these payments are made will be distributed in 
accordance with this paragraph among schools whose applications 
requested more than the amount paid to them, with whatever adjustments 
may be necessary to prevent the total paid to any school from exceeding 
the total requested by it.

[50 FR 34434, Aug. 13, 1985, as amended at 53 FR 46554, Nov. 17, 1988]



Sec.  57.305  Nursing student loan funds.

    (a) Funds established with Federal capital contributions. Any fund 
established by a school with Federal capital contributions will be 
accounted for separately from other funds, providing a clear audit trail 
for all transactions. At all times the fund must contain monies 
representing the institutional capital contribution. The school must at 
all times maintain all monies relating to the fund in one or more 
interest-bearing accounts or investment instruments which meet OMB 
requirements established for Federal monies held by third parties, 
except that if the school documents that the costs associated with the 
use of an interest-bearing account would exceed expected earnings, the 
school is not required to maintain these monies in an interest-bearing 
account. The school must place all earnings into the fund but may first 
deduct from total earnings any reasonable and

[[Page 397]]

customary charges incurred through the use of an interest-bearing 
account. An institution shall exercise the level of care required of a 
fiduciary with regard to these deposits and investments, and shall be 
responsible for reimbursing the fund for any losses that occur due to 
the use of investments that are not federally insured.
    (1) The Federal capital contribution fund is to be used by the 
school only for:
    (i) Nursing student loans to full-time or half-time students;
    (ii) Capital distribution as provided in section 839 of the Act or 
as agreed to by the school and the Secretary; and
    (iii) Costs of litigation, costs associated with membership in 
credit bureaus, and to the extent specifically approved by the 
Secretary, other collection costs that exceed the usual expenses 
incurred in the collection of nursing student loans.
    (2) A school must review the balance in the fund on at least a semi-
annual basis to determine whether the fund balance compared with 
projected levels of expenditures and collections exceeds its needs. A 
school in closing status must review the balance in the fund on a 
quarterly basis. Monies identified as in excess of the school's needs 
must be reported, and the Federal share returned to the Federal 
Government, by the due date of the required report which identifies the 
excess monies. The school's determination is subject to the review and 
approval of the Secretary.
    (b) Funds established with Federal capital loans. (1) Each Federal 
capital loan is subject to the terms of the promissory note executed by 
an authorized official on behalf of the borrowing school.
    (2) The Federal capital loans must be carried in a special account 
of the school, to be used by the school only for: (i) Repayments of 
principal and interest on Federal capital loans; and (ii) costs of 
litigation, costs associated with membership in credit bureaus, and, to 
the extent specifically approved by the Secretary, other collection 
costs that exceed the usual expenses incurred in the collection of 
nursing student loans.
    (c) Failure to comply with the requirements of this section will 
subject a school to the noncompliance provisions of Sec.  57.318 and the 
Department's Claims Collections regulations (45 CFR part 30), as 
appropriate.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 40734, Aug. 15, 1991; 
61 FR 6123, Feb. 16, 1996]



Sec.  57.306  Eligibility and selection of nursing student loan applicants.

    (a) Determination of eligibility. (1) Applicants are eligible for 
consideration for a nursing student loan if they are:
    (i) Residents of the United States and either a citizen or national 
of the United States, an alien lawfully admitted for permanent residence 
in the United States, a citizen of the Commonwealth of the Northern 
Mariana Islands, a citizen of the Republic of Palau, a citizen of the 
Republic of the Marshall Islands, or a citizen of the Federated States 
of Micronesia;
    (ii) Enrolled, or accepted for enrollment in the school as full-time 
or half-time students;
    (iii) In need of the amount of the loan to pursue the course of 
study at the school; and
    (iv) Capable, in the opinion of the school, of maintaining good 
standing in the course of study.
    (2) An applicant who has previously attended an institution of 
higher education must submit a financial aid transcript which includes 
at least the following data:
    (i) Applicant's name and social security number;
    (ii) Amounts and sources of loans and grants previously received by 
the applicant for study at an institution of higher education;
    (iii) Whether the applicant is in default on any of these loans, or 
owes a refund on any grants;
    (iv) Certification from each institution previously attended by the 
applicant that the applicant has received no financial aid, if 
applicable; and
    (v) From each institution previously attended, the signature of an 
official authorized by the institution to sign such transcripts on 
behalf of the institution.
    (b) Selection of nursing student loan applicants and determinations 
of need.

[[Page 398]]

The school will select qualified applicants, make reasonable 
determinations of need, and determine the amount of student loans.
    (1) In selecting nursing student loan applicants the school will 
give preference to licensed practical nurses, and to persons with 
exceptional financial need. For purposes of this preference, a student 
will be considered to demonstrate exceptional financial need if the 
school determines that the student's resources, as described in 
paragraph (b)(2)(i) of this section, do not exceed one-half of the costs 
of attendance at the school. Summer earnings, educational loans, 
veterans (G.I.) benefits, earnings during the school year, and Aid to 
Families with Dependent Children (AFDC) will not be considered as 
resources in determining whether an applicant meets these criteria for 
exceptional financial need, but will be considered in determining the 
amount of funds a student may receive.
    (2) In determining whether a student is in need of a nursing student 
loan to pursue a full-time or half-time course of study at the school, 
the school will take into consideration:
    (i) The financial resources available to the student by using one of 
the national need analysis systems or any other procedure approved by 
the Secretary of Education in combination with other information which 
the school has regarding the student's financial status; and
    (ii) The costs reasonably necessary for the student's attendance at 
the school, including any special needs and obligations which directly 
affect the student's financial ability to attend the school on a full-
time or half-time basis. The school must document the criteria used for 
determining these costs.
    (c) Verification of loan information. The school must verify, to the 
best of its ability, the information provided by the student on the loan 
application. To comply with this requirement, a school may require that 
a student provide, for example: Photocopies of the parents', student's, 
and spouse's Federal income tax forms with original signatures for the 
most recent tax year (or certification that no Federal income tax return 
was filed); tax returns that are certified as having been received by 
the Internal Revenue Service; or other documentation that the school 
considers necessary to help assure that information on the loan 
application is correct.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 53 FR 46554, Nov. 17, 1988; 
56 FR 13771, Apr. 4, 1991; 61 FR 6123, Feb. 16, 1996]



Sec.  57.307  Maximum amount of nursing student loans.

    The total of the nursing student loans made from the fund to any 
student for an academic year may not exceed $2,500, except that for each 
of the final 2 academic years of the program, the total must not exceed 
$4,000. The maximum amount loaned during a 12-month period to any 
student enrolled in a school which provides a course of study longer 
than the 9-month academic year may be proportionately increased. The 
total of all nursing student loans to any student must not exceed 
$13,000.

[56 FR 13771, Apr. 4, 1991]



Sec.  57.308  Nursing student loan promissory note.

    (a) Promissory note form. Each nursing student loan must be 
evidenced by a properly executed promissory note in a form approved by 
the Secretary. The school must safeguard the promissory note against 
fire, theft, and tampering.
    (1) Each promissory note must state that the loan will bear interest 
on the unpaid balance computed only for periods during which repayment 
of the loan is required, at the rate of 5 percent per year.
    (2) Each promissory note must contain an acceleration clause 
provided by the Secretary, which will permit the acceleration of 
delinquent loans at the school's option.
    (3) A copy of each executed note must be supplied by the school to 
the student borrower.
    (b) Security. A school must require security or endorsement if the 
borrower is a minor and if, under the applicable State law, the note 
signed by him or

[[Page 399]]

her would not create a binding obligation. The school may not require 
security or endorsement in any other circumstances.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 13771, Apr. 4, 1991; 57 
FR 45735, Oct. 5, 1992]



Sec.  57.309  Payment of nursing student loans.

    (a) Nursing student loans from any fund may be paid to or on behalf 
of student borrowers in installments considered appropriate by the 
school except that a school may not pay to or on behalf of any borrower 
more during any given installment period (e.g., semester, term, or 
quarter) than the school determines the student needs for that period.
    (b) No payment may be made from a fund to or on behalf of any 
student borrower if at the time of the payment the borrower is not a 
full-time or half-time student.



Sec.  57.310  Repayment and collection of nursing student loans.

    (a) Each nursing student loan, including accrued interest, will be 
repayable in equal or graduated periodic installments in amounts 
calculated on the basis of a 10-year repayment period. Repayment of a 
loan must begin 9 months after the student ceases to be a full-time or 
half-time student, except that if a borrower reenters the same or 
another school as a full-time or half-time student within the 9-month 
period, the date upon which interest will accrue and the repayment 
period will begin will be determined by the date upon which the student 
last ceases to be a full-time or half-time student at that school.
    (1) The following periods will be excluded from the 10-year 
repayment period: (i) All periods up to a total of 3 years of active 
duty performed by the borrower as a member of the Army, Navy, Air Force, 
Marine Corps, Coast Guard, National Oceanic and Atmospheric 
Administration Corps or the U.S. Public Health Service Commissioned 
Corps;
    (ii) All periods up to a total of 3 years of service as a volunteer 
under the Peace Corps Act; and
    (iii) All periods up to a total of 10 years during which the 
borrower is pursuing a full-time or half-time course of study at a 
school leading to a baccalaureate degree in nursing or an equivalent 
degree, or to a graduate degree in nursing, or is otherwise pursuing 
advanced professional training in nursing (or training to be a nurse 
anesthetist). For purposes of this paragraph, ``otherwise pursuing 
advanced professional training in nursing'' shall include full-time or 
half-time training, beyond the first diploma or degree in nursing 
received by the particular borrower, of at least 1 academic year which 
will advance the borrower's knowledge of and strengthen his or her 
skills in the provision of nursing services. \1\
---------------------------------------------------------------------------

    \1\ Individuals who received nursing student loans prior to July 1, 
1969, remain subject to the repayment provisions of 42 CFR 
57.314(a)(3)(1976) as adopted on February 4, 1974. These provisions can 
be found at 39 FR 16473 (May 9, 1974), and a copy can be obtained by 
writing the Division of Student Assistance, Bureau of Health 
Professions, 5600 Fishers Lane, Parklawn Building, room 8-34, Rockville, 
MD 20857.
---------------------------------------------------------------------------

    (2) Subject to the provisions of paragraph (b)(3) of this section, a 
borrower must establish a repayment schedule with the school providing 
for payments not less often than quarterly. Any borrower whose repayment 
becomes more than 60 days past due must be placed on a monthly repayment 
schedule by the school. A borrower may at his or her option and without 
penalty, prepay all or part of the principal and accrued interest at any 
time.
    (3) A school may grant forbearance whenever extraordinary 
circumstances such as unemployment, poor health or other personal 
problems temporarily affect the borrower's ability to make scheduled 
loan repayments.
    (b) Collection of nursing student loans. (1) Each school at which a 
fund is established must exercise due diligence in the collection of 
nursing student loans due the fund. In the exercise of due diligence, a 
school must follow procedures which are at least as extensive and 
effective as those used in the collection of other student loan accounts

[[Page 400]]

due the school, and must use the steps outlined below in accordance with 
collection practices which are generally accepted among institutions of 
higher education:
    (i) Conduct and document an entrance interview (individually or in 
groups) with the borrower prior to disbursing NSL funds in any academic 
year. During the entrance interview the school must obtain documentation 
which indicates that the borrower is aware of the rights and 
responsibilities associated with NSL funds and personal information 
which would assist in locating the borrower if he or she fails to keep 
the school informed of his or her current address. The requirement of 
this subparagraph may be met by correspondence if the school determines 
that a face-to-face meeting (individually or in groups) is 
impracticable.
    (ii) Conduct and document an exit interview (individually or in 
groups) with the borrower. During the exit interview, the school must 
provide each borrower with information necessary to carry out the terms 
of repayment, remind the borrower of the rights and responsibilities 
associated with NSL funds, and update the personal information collected 
prior to disbursing NSL funds which would assist in locating the 
borrower if he or she fails to keep the school informed of his or her 
current address. If the borrower terminates studies without advance 
notice, the school must document attempts to inform the borrower of the 
substance of the exit interview and to secure exit interview information 
from the borrower by mail.
    (iii) Notify the borrower in writing of the impending repayment 
obligation at least twice during the grace period;
    (iv) Notify a borrower who is in deferment status in writing of the 
impending repayment obligation 1 to 3 months prior to the expiration of 
the approved period of deferment;
    (v) Perform regular billing;
    (vi) Follow up past due payments with a series of at least four 
documented and reasonably spaced attempts to contact the borrower, at 
least three of which must be in writing at not more than 30-day 
intervals, prior to the loan becoming 120 days past due, provided that 
the school has a current address for the borrower;
    (vii) Perform address searches when necessary;
    (viii) Use collection agents, which may include the use of an 
internal collection agent;
    (ix) Institute legal proceedings against borrowers after all other 
attempts at collection have failed, unless the school determines, 
subject to the approval of the Secretary, that such litigation would not 
be cost-effective; and
    (x) Become a member of a credit bureau and notify the credit bureau 
of accounts past due by more than 120 days.

In place of one or more of the procedures outlined above schools may 
substitute collection techniques that are equally or more effective, but 
only after they have demonstrated the effectiveness of the techniques 
and obtained written approval from the Secretary.
    (2) Late charge. (i) For any nursing student loan made after June 
30, 1969, but prior to October 1, 1985, the school may fix a charge for 
failure of the borrower to pay all or any part of an installment when it 
is due and, in the case of a borrower who is entitled to deferment under 
section 836(b)(2) of the Act, or cancellation or repayment under section 
836(b)(3) of the Act, for any failure to file timely and satisfactory 
evidence of the entitlement. The amount of the charge may not exceed $1 
for the first month or part of a month by which the installment or 
evidence is late and $2 for each succeeding month or part of a month. 
The school may elect to add the amount of this charge to the principal 
amount of the loan as of the day after the day on which the installment 
or evidence was due, or to make the amount of the charge payable to the 
school no later than the due date of the next installment following 
receipt of the notice of the charge by the borrower.
    (ii) For any nursing student loan made on or after October 1, 1985, 
the school shall assess a charge for failure of the borrower to pay all 
or any part of an installment when the loan is more than 60 days past 
due and, in the case of a borrower who is entitled to deferment under 
section 836(b)(2) of the Act, for any failure to file satisfactory

[[Page 401]]

evidence of the entitlement within 60 days of the date payment would 
otherwise be due. No charge may be made if the loan is less than 61 days 
past due. The amount of this charge may not exceed an amount equal to 6 
percent of the amount due at the time the charge is calculated. The 
school may elect to add the amount of this charge to the principal 
amount of the loan as of the day on which the charge is calculated, or 
to make the amount of the charge payable to the school no later than the 
due date of the next installment following receipt of the notice of the 
charge by the borrower.
    (3) With respect to any nursing student loan made after June 30, 
1969, the school may require the borrower to make payments of at least 
$15 per month on all outstanding nursing student loans during the 
repayment period.
    (4) A school must, on an annual basis, review and assess the 
collectibility of any loan more than 3 years past due. If the school 
determines that the prospects of future collection are promising enough 
to justify periodic review of the debt, and neither the statute of 
limitations nor the 10-year repayment period has expired, the school may 
retain the account for continued collections, provided that it makes an 
attempt at least semi-annually to collect from the borrower. When the 
due diligence procedures required by paragraph (b)(1) of this section 
have been exhausted, the school is responsible for determining the 
collection methods it will use for the semi-annual collection effort 
required on these loans. If the school determines that the prospects of 
future collection are not promising, or when the statute of limitations 
or the 10-year repayment period has expired, the loan must be considered 
uncollectible. A school may determine a loan to be uncollectible sooner 
than 3 years past due when it has evidence that the loan cannot be 
collected, but in no case should a school consider a loan as 
uncollectible if it has not been in default for at least 120 days. A 
school is not subject to the requirements in paragraphs (b)(4) (i) and 
(iii) of this section for loans that became uncollectible, as determined 
by the school, before January 1, 1983.
    (i) A school must request permission to write off an uncollectible 
loan within 30 days of the determination that it is uncollectible or 
reimburse the fund in the full amount of the loan, pursuant to Sec.  
57.310(b)(4)(iii). The 30-day period for submitting the loan for write-
off review begins on the date that the determination of uncollectibility 
is made, in accordance with paragraph (b)(4) of this section. In any 
instance where the Secretary determines that a school has failed to 
exercise due diligence in the collection of a loan, in accordance with 
the applicable regulatory requirements, the school will be required to 
place in the fund the full amount of principal, interest, and penalty 
charges that remains uncollected on the loan. Reimbursement must be made 
by the following June 30 or December 31, whichever is sooner, except 
that in no case will a school be required to reimburse the fund in less 
than 30 days following the Secretary's disapproval of the request for 
write-off approval.
    (ii) If the Secretary determines that a school has exercised due 
diligence in the collection of a loan, in accordance with the applicable 
regulatory requirements, or if the school determines that the loan was 
uncollectible prior to January 1, 1983, the school will be permitted to 
reduce its accounts receivable for the NSL fund by the full amount of 
principal, interest, and penalty charges that remains uncollected on 
that loan and will not be required to return the Federal share of the 
loss to the Secretary.
    (iii) If a school does not request permission to write off an 
uncollectible loan within the required timeframe, it must reimburse the 
fund for the full amount of principal, interest, and penalty charges 
that remains uncollected on that loan. This reimbursement must be made 
by the following June 30 or December 31, whichever is sooner, except 
that in no case will a school be required to reimburse the fund in less 
than 30 days following its determination that a loan is uncollectible.
    (iv) Failure to comply with the requirements of this section will 
subject a school to the noncompliance provisions of Sec.  57.318 and the 
Department's

[[Page 402]]

Claims Collection regulations (45 CFR part 30), as appropriate.
    (5) Disclosure of taxpayer identity information. Upon written 
request by the Secretary, the Secretary of the Internal Revenue Service 
(IRS) may disclose the address of any taxpayer who has defaulted on a 
nursing student loan, for use only by officers, employees, or agents of 
the Department, to locate the defaulted borrower to collect the loan. 
Any such mailing address may be disclosed by the Secretary to any school 
from which the defaulted borrower received a nursing student loan, for 
use only by officers, employees, or agents of the school whose duties 
relate to the collection of nursing student loan funds, to locate the 
defaulted borrower to collect the loan. Any school which requests and 
obtains such address information must comply with the requirements of 
the Secretary and the IRS regarding the safeguarding and proper handling 
of this information.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 52 FR 10195, Mar. 30, 1987; 
56 FR 13771, Apr. 4, 1991; 56 FR 40734, Aug. 15, 1991; 57 FR 45735, Oct. 
5, 1992; 61 FR 6123, Feb. 16, 1996]



Sec.  57.311  Cancellation of nursing student loans for disability or death.

    (a) Permanent and total disability. The Secretary will cancel a 
borrower's indebtedness in accordance with section 836(b)(4) of the Act 
if the borrower is found to be permanently and totally disabled on 
recommendation of the school and as supported by whatever medical 
certification the Secretary may require. A borrower is totally and 
permanently disabled if he or she is unable to engage in any substantial 
gainful activity because of a medically determinable impairment, which 
the Secretary expects to continue for a long time or to result in death.
    (b) Death. The Secretary will cancel a borrower's indebtedness in 
accordance with section 836(b)(4) of the Act upon the death of the 
borrower. The school to which the borrower was indebted must secure a 
certification of death or whatever official proof is conclusive under 
State law.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 13772, Apr. 4, 1991]



Sec.  57.312  Repayment of loans for service in a shortage area.

    (a) Service in a shortage area. Subject to the availability of 
funds, a person who:
    (1) Has obtained a degree as specified in section 846(a)(1) of the 
Act;
    (2) Has obtained one or more nursing student loans or any other 
loans necessary for costs (including tuition, books, fees, equipment, 
living and other expenses which the Secretary determines were necessary) 
of attending a school of nursing; and
    (3) Enters into an agreement with the Secretary to serve as a full-
time registered nurse for a period of not less than 2 years in an Indian 
Health Service health center, a Native Hawaiian health center, a public 
hospital, a migrant health center, a community health center, a nursing 
facility, a rural health clinic, or in a health facility determined by 
the Secretary to have a critical shortage of nurses, will have a portion 
of these loans repaid by the Secretary in accordance with paragraph (c) 
of this section. Prior to entering an agreement for repayment of loans, 
other than nursing student loans, the Secretary will require that 
satisfactory evidence be provided of the existence and reasonableness of 
the education loans (i.e., a copy of the written loan agreement 
establishing the loan).
    (b) When entering into agreements under paragraph (a) of this 
section, the Secretary shall give priority to:
    (1) Applicants with the greatest financial need; and
    (2) Applicants that, with respect to health facilities described in 
paragraph (a)(3) of this section, agree to serve in such facilities 
located in geographic areas with a shortage of and need for nurses, as 
determined by the Secretary.
    (3) In addition to the priorities under paragraphs (b) (1) and (2) 
of this section, should specific needs warrant, the Secretary may 
establish additional

[[Page 403]]

preferences which will be announced from time to time in the Federal 
Register.
    (c) Repayment. Loan repayment will be made by the Secretary to 
persons who meet the conditions set forth in paragraph (a) of this 
section. Payment will be as follows:
    (1) Upon completion by the borrower of the first year of service as 
specified in the agreement, the Secretary will pay 30 percent of the 
principal of, and the interest on, each loan which was unpaid as of the 
date the borrower began his or her service;
    (2) Upon completion by the borrower of the second year of service, 
the Secretary will pay another 30 percent of the principal of, and the 
interest on, each loan which was unpaid as of the date the borrower 
began his or her service;
    (3) Upon completion by the borrower of a third year of service, the 
Secretary will pay another 25 percent of the principal of, and the 
interest on, each loan which was unpaid as of the date the borrower 
began his or her service; and
    (4) No more than 85 percent of the principal of any loan will be 
paid under this section.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 13772, Apr. 4, 1991; 61 
FR 6123, Feb. 16, 1996]



Sec.  57.313  Loan cancellation for full-time employment as a registered nurse.

    (a) For loans made after November 18, 1971, and before September 29, 
1979. A person who: (1) Received one or more nursing student loans after 
November 18, 1971, and before September 29, 1979; (2) is in compliance 
with the requirements of title VIII of the Act and these regulations; 
and (3) engages in full-time employment as a registered nurse (including 
teaching in any of the fields of nurse training or service as an 
administrator, supervisor, or consultant in any of the fields of 
nursing) in any public or nonprofit private agency, institution, or 
organization (including neighborhood health centers) is entitled to have 
a portion of these nursing student loans canceled as follows: 15 percent 
of the total amount of the loans plus accrued interest on the loan which 
is unpaid on the first day of his or her service, for each of the first, 
second, and third year of service; and 20 percent of the total amount of 
the loan plus accrued interest on the loan for each complete fourth and 
fifth year of service thereafter, up to 85 percent of the total of the 
loans, plus accrued interest.
    (b) Continuation of provisions for cancellation of loans made prior 
to November 18, 1971. A person who received one or more nursing student 
loans prior to November 18, 1971, may still receive cancellation of 
these loans for service under section 836(h) of the Act. The regulations 
set forth in 42 CFR 57.316 (a) and (b)(6) (1976), as adopted on February 
4, 1974, remain applicable to cancellation on this basis. The provisions 
can be found at 39 FR 16473 (May 9, 1974) and a copy can be obtained by 
writing to the Division of Student Assistance, Bureau of Health 
Professions, Room 8-34, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857.
    (c) The determination of whether a person is entitled to have any 
portion of his or her nursing student loan canceled for full-time 
employment as a registered nurse will be made by the institution to 
whose fund his or her loan is payable, upon receipt and evaluation of an 
application for cancellation from that person.

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 13772, Apr. 4, 1991; 57 
FR 45735, Oct. 5, 1992; 61 FR 6123, Feb. 16, 1996]



Sec.  57.313a  Loan cancellation reimbursement.

    In the event that insufficient funds are available to the Secretary 
in any fiscal year to enable him or her to pay to all schools their 
proportionate shares of all loans and interest canceled under this 
subpart for full-time employment as a nurse, death, or disability:
    (a) Each school will be paid an amount bearing the same ratio to the 
total of the funds available for that purpose as the principal of loans 
canceled by that school in that fiscal year bears to the total principal 
of loans canceled by all schools in that year; and
    (b) Any additional amounts to which a school is entitled will be 
paid by the

[[Page 404]]

Secretary at the time of distribution of the assets of the school's fund 
under section 839 of the Act.



Sec.  57.314  Repayment of loans made after November 17, 1971, 
for failure to complete a program of study. \2\
---------------------------------------------------------------------------

    \2\ Effective November 26, 1984, the Secretary stopped accepting 
applications under Sec.  57.314 because Federal funds are not available 
for this provision.
---------------------------------------------------------------------------

    In the event that the Secretary undertakes to repay educational 
loans under section 836(i) of the Act, he or she will use the following 
criteria to make a determination as to each applicant's eligibility:
    (a) An applicant will be considered to have failed to complete the 
course of study in nursing for which an eligible education loan was made 
upon certification by a school of nursing that the individual ceased to 
be enrolled in the school subsequent to November 17, 1971;
    (b) An applicant will be considered to be in exceptionally needy 
circumstances if, upon comparison of the income and other financial 
resources of the applicant with his or her expenses and financial 
obligations, the Secretary determines that repayment of the loan would 
constitute a serious economic burden on the applicant. In making this 
determination, the Secretary will take into consideration the 
applicant's net financial assets, his or her potential earning capacity, 
and the relationship of the income available to the applicant to the 
low-income levels published annually by the Secretary in the Federal 
Register;
    (c) An applicant will be considered as not having resumed his or her 
nursing studies within 2 years following the date the individual ceased 
to be a student upon certification so stating from the applicant; and
    (d) An applicant will be considered as not reasonably expected to 
resume his or her nursing studies within 2 years following the date upon 
which he or she terminated these studies, based upon consideration of 
the reasons for the applicant's failure to complete these studies, 
taking into account such factors as academic, medical, or financial 
difficulties. The Secretary will only repay education loans made after 
November 17, 1971.

[50 FR 34434, Aug. 23, 1985, as amended at 56 FR 13772, Apr. 4, 1991; 57 
FR 45735, Oct. 5, 1992; 61 FR 6123, Feb. 16, 1996]



Sec.  57.315  Records, reports, inspection, and audit.

    (a) Records and reports. (1) Each Federal capital contribution and 
Federal capital loan is subject to the condition that the school must 
maintain those records and file with the Secretary those reports 
relating to the operation of its nursing student loan funds as the 
Secretary may find necessary to carry out the purposes of the Act and 
these regulations. A school must submit required reports to the 
Secretary within 45 days of the close of the reporting period.
    (i) A school which fails to submit a required report for its Federal 
capital contribution fund within 45 days of the close of the reporting 
period:
    (A) Shall be prohibited from receiving new Federal capital 
contributions;
    (B) Must place the revolving fund and all subsequent collections in 
an insured interest-bearing account; and
    (C) May make no loan disbursements.

The above restrictions apply until the Secretary determines that the 
school is in compliance with the reporting requirement.
    (ii) A school that fails to submit a complete report within 6 months 
of the close of the reporting period will be subject to termination. The 
Secretary will provide the school with a written notice specifying his 
or her intention to terminate the school's participation in the program 
and stating that the school may request, within 30 days of the receipt 
of this notice, a formal hearing. If the school requests a hearing, it 
must within 90 days of the receipt of the notice, submit material, 
factual issues in dispute to demonstrate that there is cause for a 
hearing. These issues must be both substantive and relevant. The hearing 
will be held in the Washington, DC metropolitan area. The Secretary will 
deny a hearing if:
    (A) The request for a hearing is untimely (ie., fails to meet the 
30-day requirement);

[[Page 405]]

    (B) The school does not provide a statement of material, factual 
issues in dispute within the 90-day required period; or
    (C) The statement of factual issues in dispute is frivolous or 
inconsequential.

In the event that the Secretary denies a hearing, the Secretary will 
send a written denial to the school setting forth the reasons for 
denial. If a hearing is denied, or if as a result of the hearing, 
termination is still determined to be necessary, the school will be 
terminated from participation in the program and will be required to 
return the Federal share of the revolving fund to the Department. A 
school terminated for failure to submit a complete report within 6 
months of the close of the reporting period must continue to pursue 
collections and may reapply for participation in the program once it has 
submitted the overdue report.
    (2) The following student records must be retained by the school for 
5 years after the individual student ceases to be a full-time or half-
time student:
    (i) Approved student applications for nursing student loans;
    (ii) Documentation of the financial need of applicants; and
    (iii) Copy of financial aid transcripts.
    (3) The following repayment records for each individual borrower 
must be retained for at least 5 years from the date of retirement of a 
loan:
    (i) The amount and date of each loan;
    (ii) The amount and date of each payment or cancellation;
    (iii) Records of periods of deferment;
    (iv) Date, nature, and result of each contract with the borrower or 
proper endorser in the collection of an overdue loan;
    (v) Copies of all correspondence to or from the borrower and 
endorser;
    (vi) Copies of all correspondence with a collection agency related 
to the individual borrower;
    (vii) Copies of all correspondence with a credit bureau related to 
an individual borrower; and
    (viii) Copies of all correspondence relating to uncollectible loans 
which have been written off by the Federal Government or repaid by the 
school.
    (4) The school must also retain other records as the Secretary may 
prescribe. In all cases where questions have arisen as a result of a 
Federal audit, the records must be retained until resolution of all 
questions.
    (b) Inspection and audit. (1) Any application for a Federal capital 
contribution will constitute the consent of the applicant school to 
inspection and fiscal audit, by the Secretary and the Comptroller 
General of the United States or any of their duly authorized 
representatives, of the fiscal and other records of the applicant school 
which relate to the Federal capital contribution or Federal capital 
loan.
    (2) The school must comply with the audit requirements of the 
Department of Health and Human Services' Administration of Grants 
regulations which are set forth in 45 CFR part 75.
    (c) Institutional officials who have information which indicates the 
potential or actual commission of fraud or other offenses against the 
United States, involving these loan funds, should promptly provide this 
information to the appropriate Regional Office of Inspector General for 
Investigations.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 53 FR 46555, Nov. 17, 1988; 
56 FR 13772, Apr. 4, 1991; 57 FR 45735, Oct. 1, 1992; 81 FR 3008, Jan. 
20, 2016]



Sec.  57.316  What additional Department regulations apply to schools?

    Participating schools are advised that in addition to complying with 
the terms and conditions of these regulations, several other regulations 
apply under this subpart. These include, but are not limited to:

45 CFR part 76--Governmentwide Debarment and Suspension (nonprocurement) 
and Governmentwide Requirements for Drug-Free Workplace (Grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 83--Regulation for the administration and enforcement of 
sections 794 and 855 of the Public Health Service Act

[[Page 406]]

45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in Health and 
Human Services programs or activities receiving Federal financial 
assistance
45 CFR part 93--New Restrictions on Lobbying

[56 FR 13772, Apr. 4, 1991, as amended at 57 FR 45735, Oct. 5, 1992; 61 
FR 6123, Feb. 16, 1996]



Sec.  57.316a  Performance standard.

    On June 30, 1986, and on each June 30 thereafter, except as provided 
in paragraph (b) of this section, each school must have a default rate 
(as calculated under paragraph (a) of this section) of not more than 5 
percent.
    (a) The default rate for each school shall be the ratio (stated as a 
percentage) that the defaulted principal amount outstanding of the 
school bears to the matured loans of the school. For this purpose:
    (1) The term ``defaulted principal amount outstanding'' means the 
total amount borrowed from the loan fund of a school that has reached 
the repayment stage (minus any principal amount repaid or canceled) on 
loans in default for more than 120 days; and
    (2) The term ``matured loans'' means the total principal amount of 
all loans made by a school under this subpart minus the total principal 
amount of loans made by the school to students who are:
    (i) Enrolled in a full-time or half-time course of study at the 
school; or
    (ii) In their grace period.
    (b) Any school that has a default rate greater than 5 percent on 
June 30, 1986, or on June 30 of any year thereafter will be required to:
    (1) Reduce its default rate by 50 percent (or a school with a 
default rate below 10 percent must reduce its rate to 5 percent) by the 
close of the following 6-month period; and
    (2) By the end of each succeeding 6-month period, reduce its default 
rate to 50 percent of the required rate for the previous 6-month period, 
until it reaches 5 percent.
    (c) Any school subject to the provisions of paragraph (b) of this 
section which fails to comply with those requirements will receive no 
new NSL funds and will be required to:
    (1) Place the revolving fund monies and all subsequent collections 
into an insured interest-bearing account;
    (2) Make no loan disbursements; and
    (3) By the end of the succeeding 6-month period, reduce its default 
rate to 50 percent of the rate it failed to achieve under paragraph (b) 
of this section, or 5 percent. A school that meets this requirement will 
be permitted to resume the use of its nursing student loan funds, but 
must continue to comply with the requirements of paragraph (b)(2) of 
this section if its default rate is still greater than 5 percent.

A school that meets the requirements of subparagraph (c)(3) of this 
section will be permitted to resume the use of its NSL funds, but must 
continue to comply with the requirements of subparagraph (b)(2) of this 
section if its delinquency rate is still greater than 5 percent.
    (d) Any school subject to the provisions of paragraph (c)(3) of this 
section which fails to comply with those requirements will be subject to 
termination. The Secretary will provide the school with a written notice 
specifying his or her intention to terminate the school's participation 
in the program and stating that the school may request, within 30 days 
of the receipt of this notice, a formal hearing. If the school requests 
a hearing, it must within 90 days of the receipt of the notice, submit 
material, factual issues in dispute to demonstrate that there is cause 
for a hearing. These issues must be both substantive and relevant. The 
hearing will be held in the Washington, DC metropolitan area. The 
Secretary will deny a hearing if:
    (1) The request for a hearing is untimely (i.e., fails to meet the 
30-day requirement);
    (2) The school does not provide a statement of material, factual 
issues in dispute within the 90-day required period; or
    (3) The statement of factual issues in dispute is frivolous or 
inconsequential.

In the event that the Secretary denies a hearing, the Secretary will 
send a

[[Page 407]]

written denial to the school setting forth the reasons for denial. If a 
hearing is denied, or if as a result of the hearing, termination is 
still determined to be necessary, the school will be terminated from 
participation in the program and will be required to return the Federal 
share of the revolving fund to the Department. A school terminated for 
failure to comply with the provisions of paragraph (c)(3) of this 
section must continue to pursue collections and may reapply for 
participation in the program only when it has attained a default rate of 
5 percent or less.

(Approved by the Office of Management and Budget under control number 
0915-0047)

[50 FR 34434, Aug. 23, 1985, as amended at 52 FR 10195, Mar. 30, 1987; 
53 FR 46555, Nov. 17, 1988; 56 FR 13772, Apr. 4, 1991]



Sec.  57.317  Additional conditions.

    The Secretary may, with respect to any agreement entered into with 
any school under Sec.  57.305, impose additional conditions prior to or 
at the time of any award when in his or her judgment the conditions are 
necessary to assure or protect advancement of the purposes of the 
agreement, the interest of the public health, or the conservation of 
funds awarded.



Sec.  57.318  Noncompliance.

    Whenever the Secretary finds that a participating school has failed 
to comply with the applicable provisions of the Act or the regulations 
of this subpart he or she may, on reasonable notice to the school, 
withhold further payments of Federal capital contributions and take 
other action, including the termination of any agreement, as he or she 
finds necessary to enforce the Act and regulations. In such case no 
further expenditures shall be made from the nursing student loan fund or 
funds involved until the Secretary determines that there is no longer 
any failure of compliance.



     Subpart E_Grants for Construction of Nurse Training Facilities

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216.



Sec.  57.409  Good cause for other use of completed facility.

    If, within 20 years after completion of construction (or, in the 
case of interim facilities prior to the time at which teaching in such 
facilities is moved to a permanent facility, whichever comes first), the 
facility shall cease to be used for any one or more of the purposes for 
which it was constructed, the Secretary, in determining whether there is 
good cause for releasing the applicant or other owner of the facility 
from the obligation so to use the facility, shall take into 
consideration the extent to which:
    (a) The facility will be devoted by the applicant or other owner to 
the teaching of other health personnel;
    (b) There are reasonable assurances that for the remainder of such 
period other facilities not previously utilized for nurse training will 
be so utilized and are substantially the equivalent in nature and extent 
for such purposes.

[37 FR 20548, Sept. 30, 1972]

Subparts F-O [Reserved]



     Subpart P_Loan Guarantees and Interest Subsidies to Assist in 
   Construction of Teaching Facilities for Health Profession Personnel

    Authority: Sec. 727, Public Health Service Act. 77 Stat. 170, as 
amended (42 U.S.C. 293g).

    Source: 38 FR 31836, Nov. 19, 1973, unless otherwise noted.



Sec.  57.1501  Applicability.

    The regulations of this subpart are applicable to loan guarantees 
and interest subsidy payments made pursuant to section 729 of the Public 
Health Service Act (42 U.S.C. 293i) to assist nonprofit private entities 
which are eligible for grants under subpart B of this part in carrying 
out projects for construction of teaching facilities for health 
professions personnel.



Sec.  57.1502  Definitions.

    As used in this subpart:
    (a) All terms not defined herein shall have the same meanings as 
given them in section 724 of the Act.

[[Page 408]]

    (b) Act means the Public Health Service Act, as amended.
    (c) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved may be delegated.
    (d) School means a school of medicine, dentistry, osteopathy, 
pharmacy, optometry, podiatry, veterinary medicine, or public health 
which provides a course of study or a portion thereof which leads 
respectively to a degree of doctor of medicine, doctor of dental surgery 
or an equivalent degree, doctor of osteopathy, doctor of optometry or an 
equivalent degree, doctor of podiatry or an equivalent degree, bachelor 
of science in pharmacy or an equivalent degree, doctor of veterinary 
medicine or an equivalent degree, or a graduate degree in public health, 
and which is accredited as provided in section 721(b)(1) of the Act.
    (e) Affiliated hospital or affiliated outpatient facility means a 
hospital or outpatient facility (as defined in section 645 of the Act) 
which, although not owned by such school, has a written agreement with a 
school of medicine, osteopathy, or dentistry eligible for assistance 
under subpart B of this part, providing for effective control by the 
school of the health professions teaching program in the hospital or 
outpatient facility.
    (f) Nonprofit as applied to any school, hospital, outpatient 
facility, or other entity means one which is owned and operated by one 
or more corporations or associations no part of the net earnings of 
which inures, or may lawfully inure to the benefit of any private 
shareholder or individual.
    (g) Council means the National Advisory Council on Health 
Professions Education (established pursuant to section 725 of the Act).



Sec.  57.1503  Eligibility.

    (a) Eligible applicants. In order to be eligible for a loan 
guarantee or interest subsidy under this subpart, the applicant shall:
    (1) Be a nonprofit private school of medicine, dentistry, 
osteopathy, pharmacy, optometry, podiatry, veterinary medicine, or 
public health, or any combination of such schools, or a nonprofit 
private affiliated hospital or affiliated outpatient facility: Provided, 
however, That in the case of an affiliated hospital or affiliated 
outpatient facility, an application which is approved by the school of 
medicine, osteopathy or dentistry with which the hospital or outpatient 
facility is affiliated and which otherwise complies with the 
requirements of subpart B of this part may be filed by any nonprofit 
private entity qualified to file an application under section 605 of the 
Act; and
    (2) Otherwise meet the applicable requirements set forth in section 
721(b) of the Act and Sec.  57.103 with respect to eligiblity for grants 
for construction of teaching facilities for health professions 
personnel.
    (b) Eligible loans. Subject to the provisions of this subpart, the 
Secretary may guarantee payment, when due, of principal and interest on, 
or may pay interest subsidies with respect to, or may both guarantee and 
pay interest subsidies with respect to any loan or portion thereof made 
to an eligible applicant by a non-Federal lender: Provided, That no such 
guarantee or interest subsidy shall apply to any loan the interest on 
which is exempt from Federal income taxation.



Sec.  57.1504  Application.

    Each applicant desiring to have a loan guaranteed or to have 
interest subsidies paid on its behalf, or any combination of such loan 
guarantee or interest subsidies, shall submit an application for such 
assistance in such form and manner and at such time as the Secretary may 
require. \1\
---------------------------------------------------------------------------

    \1\ Applications and instructions are available from the Division of 
Facilities Conversion and Utilization, Bureau of Health Maintenance 
Organizations and Resources Development, Parklawn Building, 5600 Fishers 
Lane, Rockville, MD 20857.
---------------------------------------------------------------------------

    (a) The application shall contain or be supported by such 
information as the Secretary may require to enable him to make the 
determinations required of him under the Act and this subpart.
    (b) The application shall be executed by an individual authorized to 
act for the applicant and to assume on behalf

[[Page 409]]

of the applicant the obligations imposed by the terms and conditions of 
any loan guarantee or agreement to pay interest subsidies, including the 
applicable regulations of this subpart.

[38 FR 31836, Nov. 19, 1973, as amended at 49 FR 38113, Sept. 27, 1984]



Sec.  57.1505  Approval of applications.

    (a) General. Any application for loan guarantee or interest 
subsidies, or for a combination of both, may be approved by the 
Secretary, after consultation with the Council, only if he makes each of 
the applicable determinations set forth in section 721(c) of the Act. In 
addition:
    (1) Any such approval shall be subject to compliance by the 
applicant with the applicable provisions set forth in Sec. Sec.  57.106, 
57.107, 57.108, and Provided however, That for purposes of the title 
assurance in Sec.  57.107(a) the period shall be not less than 20 years 
or the term of the guaranteed loan, whichever is longer or in the case 
of interim facilities, the term of the guaranteed loan, and
    (2) Any such application may be approved by the Secretary only if he 
determines:
    (i) That the applicant will have sufficient financial resources to 
enable him to comply with the terms and conditions of the loan;
    (ii) That the applicant has the necessary legal authority to 
finance, construct, and maintain the proposed project, to apply for and 
receive the loan, and to pledge or mortgage any assets or revenues to be 
given as security for such loan;
    (iii) That the loan will be made only with respect to the initial 
permanent financing of the project;
    (iv) That the loan will be secured by a lien against the facilities 
to be constructed or against other security satisfactory to the 
Secretary specified in Sec.  57.2210;
    (v) That the rate of interest on the loan does not exceed such 
percent per annum as the Secretary determines to be reasonable, taking 
into account the range of interest rates prevailing in the private 
market for similar loans and the risks assumed by the United States; and
    (vi) Such additional determinations as the Secretary finds necessary 
with respect to particular applications in order to protect the 
financial interests of the United States.
    (b) Loan guarantees. In addition to the requirements of paragraph 
(a) of this section, any application for a loan guarantee may be 
approved by the Secretary only if he determines that the loan with 
respect to which such guarantee is sought would not be available to the 
applicant on reasonable terms and conditions without such guarantee. To 
assist the Secretary in making such determination, each applicant for a 
loan guarantee shall submit statements from at least three non-Federal 
institutions normally engaged in making long-term loans for 
construction, describing whether, and the terms and conditions under 
which, each institution would make a loan to the applicant for the 
project described in the application.
    (c) Interest subsidies. In addition to the requirements of paragraph 
(a) of this section, any application for interest subsidies may be 
approved by the Secretary only if he determines that without such 
interest subsidy payments the applicant would not, over a substantial 
portion of the loan term, be able to repay the principal and interest of 
the loan without jeopardizing the quality of the educational program.

[38 FR 31836, Nov. 19, 1973, as amended at 85 FR 72908, Nov. 16, 2020]



Sec.  57.1506  Priority.

    (a) Priority in approving applications for loan guarantee and/or 
interest subsidies shall be determined in accordance with the factors 
specified in section 721(d) of the Act, and the following: (1) The 
relative need for increased enrollment and the availability of students; 
(2) the relative effectiveness of the project relative to the cost to 
the Federal Government; and (3) the relative ability of the applicant to 
make efficient and productive use of the facility constructed.
    (b) In the case of applications to aid in the construction of new 
schools of medicine, osteopathy, or dentistry, the

[[Page 410]]

Secretary shall give special consideration to those applications which 
contain or are reasonably supported by assurances that, because of the 
use that will be made by such school of already existing facilities 
(including Federal medical or dental facilities), the school will be 
able to accelerate the date on which it will begin its teaching program.



Sec.  57.1507  Limitations applicable to loan guarantee.

    (a) The amount of loan with respect to which a guarantee is made 
under this subpart shall be determined by the Secretary based upon such 
considerations as the availability of funds and the applicant's need 
therefor; Provided, That: (1) Subject to paragraph (a)(2) of this 
section, no loan with respect to which a guarantee is made for any 
project under this subpart may be in an amount which, when added to the 
amount of any grant made with respect to such project under part B of 
title VII of the Act or any other law of the United States, or to the 
total of such grants, exceeds 90 percent of the eligible cost of 
construction of such project as determined by the Secretary;
    (2) Notwithstanding paragraph (a)(1) of this section, the Secretary 
may in particular cases guarantee loans in excess of the amount 
specified in paragraph (a)(1) of this section where he determines that, 
because of special circumstances, such additional loan guarantee will 
further the purposes of part B of title VII of the Act. In making such 
determinations, the Secretary will in each case consider the following 
factors:
    (i) The need for the project in the area to be served;
    (ii) The availability of financing for the project on reasonable 
terms and conditions without such additional loan guarantee;
    (iii) Whether the project can be constructed without such additional 
loan guarantee; and
    (iv) Other relevant factors consistent with the purpose of part B of 
title VII of the Act and this subpart.
    (3) In determining the cost of construction of the project there 
shall be excluded from such cost all fees, interest, and other charges 
relating or attributable to the financing of the project except the 
following:
    (i) Reasonable fees attributable to services rendered by legal 
counsel in connection with such loan;
    (ii) With the approval of the Secretary, reasonable fees 
attributable to the services of a financial advisor in assisting the 
applicant in securing the loan and arranging for repayment thereof; and
    (iii) Interest attributable to the interim financing of construction 
of the project prior to the initial permanent financing thereof.
    (b) No loan guarantee under this subpart shall apply to more than 90 
percent of the loss of principal of and interest on such loan incurred 
by the holder of such loan upon default by the applicant.



Sec.  57.1508  Amount of interest subsidy payments; limitations.

    The length of time for which interest subsidy payments will be made 
under the agreement, the amount of loan with respect to which such 
payments will be made, and the level of such payments shall be 
determined by the Secretary on the basis of the availability of funds 
and his determination of the applicant's need therefor taking into 
consideration his analysis of the present and reasonable projected 
future financial ability of the applicant to repay the principal and 
interest of the loan without jeopardizing the quality of its educational 
program: Provided however, That each such interest subsidy payment shall 
not exceed the amount necessary to reduce by 3 percent per annum the net 
effective interest rate otherwise payable on the loan or the portion 
thereof with respect to which such interest subsidy is paid.



Sec.  57.1509  Forms of credit and security instruments.

    Each loan with respect to which a guarantee is made or interest 
subsidies are paid under this subpart shall be evidenced by a credit 
instrument and secured by a security instrument in such forms as may be 
acceptable to the Secretary.

[[Page 411]]



Sec.  57.1510  Security for loans.

    Each loan with respect to which a guarantee is made or interest 
subsidies are paid under this subpart shall be secured in a manner which 
the Secretary finds reasonably sufficient to insure repayment. The 
security may be one or a combination of the following:
    (a) A first mortgage on the facility and site thereof.
    (b) Negotiable stocks or bonds of a quality and value acceptable to 
the Secretary.
    (c) A pledge of unrestricted and unencumbered income from an 
endowment or other trust fund acceptable to the Secretary.
    (d) A pledge of a specified portion of annual general or special 
revenues of the applicant acceptable to the Secretary.
    (e) Such other security as the Secretary may find acceptable in 
specific instances.



Sec.  57.1511  Opinion of legal counsel.

    At appropriate stages in the application and approval procedure for 
a loan guarantee or interest subsidy, the applicant shall furnish to the 
Secretary a memorandum or opinion of legal counsel with respect to the 
legality of any proposed note issue, the legal authority of the 
applicant to issue the note and secure it by the proposed collateral, 
and the legality of the issue upon delivery. ``Legal counsel'' means 
either a law firm or individual lawyer, thoroughly experienced in the 
long-term financing of construction projects, and whose approving 
opinions have previously been accepted by lenders or lending 
institutions. The legal memorandum or opinion to be provided by legal 
counsel in each case shall be as follows:
    (a) A memorandum, submitted with the application for a loan 
guarantee or interest subsidy, stating that the applicant is or will be 
lawfully authorized to finance, construct, and maintain the project, and 
to issue the proposed obligations and to pledge or mortgage the assets 
and/or revenues offered to secure the loan, citing the basis for such 
authority; and
    (b) A final approving opinion, delivered to the Secretary at the 
time of delivery of the evidence of indebtedness to the lender, stating 
that the credit and security instruments executed by the applicant are 
duly authorized and delivered and that the indebtedness of the applicant 
is valid, binding, and payable in accordance with the terms on which the 
loan guarantee was approved by the Secretary.



Sec.  57.1512  Length and maturity of loans.

    The repayment period for loans with respect to which guarantees are 
made or interest subsidies paid under this subpart shall be limited to 
30 years: Provided, That:
    (a) The Secretary may, in particular cases where he determines that 
a repayment period of less than 30 years is more appropriate to an 
applicant's total financial plan, approve such shorter repayment period;
    (b) The Secretary may, in particular cases where he determines that, 
because of unusual circumstances, the applicant would be financially 
unable to amortize the loan over a repayment period of 30 years, approve 
a longer requirement period which shall in no case exceed 40 years; and
    (c) In no case shall a loan repayment period exceed the useful life 
of the facility to be constructed with the assistance of the loan.



Sec.  57.1513  Repayment.

    Unless otherwise specifically authorized by the Secretary, each loan 
with respect to which a guarantee is made or interest subsidies are paid 
shall be repayable in substantially level total annual installments of 
principal and interest, sufficient to amortize the loan through the 
final year of the life of the loan.



Sec.  57.1514  Loan guarantee and interest subsidy agreements.

    For each application for a loan guarantee or interest subsidy, or 
combination thereof, which is approved by the Secretary under this 
subpart, an offer to guarantee such loan and/or make interest subsidy 
payments with respect thereto will be sent to the applicant, setting 
forth the pertinent terms and conditions for the loan guarantee and/or 
interest subsidy, and will be conditioned upon the fulfillment of such

[[Page 412]]

terms and conditions. The accepted offer will constitute the loan 
guarantee agreement, the interest subsidy agreement, or the loan 
guarantee and interest subsidy agreement, as the case may be. Each such 
agreement shall include the applicable provisions set forth below:
    (a) Loan guarantee. Each agreement pertaining to a loan guarantee 
shall include the following provisions:
    (1) That the loan guarantee evidenced by the agreement shall be 
incontestable (i) in the hands of the applicant on whose behalf such 
loan guarantee is made except for fraud or misrepresentation on the part 
of such applicant, and (ii) as to any person who makes or contracts to 
make a loan to such applicant in reliance on such guarantee, except for 
fraud or misrepresentation on the part of such other person.
    (2) That the applicant shall be permitted to prepay up to 15 percent 
of the original principal amount of such loan in any calendar year 
without additional charge. The applicant and the lender may further 
agree that the applicant shall be permitted to prepay in excess of 15 
percent of the original amount of the loan in any calendar year without 
additional charge, but no such payment in excess of 15 percent shall be 
made without the prior written approval of the Secretary.
    (3) That if the applicant shall default in making periodic payment, 
when due, of the principal and interest on the loan guaranteed under the 
agreement, the holder of the loan shall promptly give the Secretary 
written notification of such default. The Secretary shall, immediately 
upon receipt of such notice, provide the holder with written 
acknowledgement of such receipt.
    (4) That if such default in making periodic payment when due of the 
principal and interest on the guaranteed loan is not cured within 90 
days after receipt by the Secretary of notice of such default, the 
holder of the loan shall have the right to make demand upon the 
Secretary, in such form and manner as the Secretary may prescribe, for 
payment of 90 percent of the amount of the overdue payments of principal 
and accrued interest, together with such reasonable late charges as are 
made in accordance with the terms of the credit instrument or security 
instrument evidencing or securing such loan. The Secretary shall pay 
such amount from funds available to him for these purposes.
    (5) That in the event of exercise by the holder of the loan of any 
right to accelerate payment of such loan as a result of the applicants 
default in making periodic payment when due of the principal and 
interest on the guaranteed loan, the Secretary shall, upon demand by the 
holder not less than 90 days after receipt by the Secretary of 
notification of such default, pay to such holder 90 percent of the total 
amount of principal and of interest on the loan remaining unpaid after 
the holder has exercised his right to foreclose upon and dispose of the 
security and has applied the proceeds thereby received to reduce the 
outstanding balance of the loan, in accordance with applicable law and 
the terms of the security instrument.
    (6) That the Secretary shall not guarantee any funds which are 
disbursed by a lender following notification by the Secretary to such 
lender that the Assurance executed by the Applicant under section 799A 
of the Act is no longer satisfactory.
    (b) Interest subsidy. Each agreement pertaining to the payment of 
interest subsidies with respect to a loan shall include the following 
provisions:
    (1) That the holder of the loan shall have a contractual right to 
receive from the United States interest subsidy payments in amounts 
sufficient to reduce by up to 3 percent per annum the net effective 
interest rate determined by the Secretary to be otherwise payable on 
such loan.
    (2) That payments of interest subsidies pursuant to paragraph (b)(1) 
of this section will be made by the Secretary, in accordance with the 
terms of the loan with respect to which the interest subsidies are paid, 
directly to the holder of such loan, or to a trustee or agent designated 
in writing to the Secretary by such holder, until such time as the 
Secretary is notified in writing by the holder that such loan has been 
transferred. Pursuant to such written notification of transfer, the 
Secretary will make such interest payments directly to the new holder

[[Page 413]]

(transferee) of the loan: Provided, however, That it shall be the 
responsibility of the holder to remit any payments of interest subsidy 
to the new holder which the Secretary may have made to the holder after 
such transfer and prior to receipt of such written notice, and the 
Secretary shall not be liable to any party for amounts remitted to the 
holder prior to receipt of such written notice and acknowledgment in 
writing by the Secretary of receipt of such notice.
    (3) That the holder of the loan will promptly notify the Secretary 
of any default or prepayment by the applicant with respect to the loan.
    (4) In the event of any exercise by the holder of the loan of the 
right to accelerate payment of such loan, whether as a result of default 
on the part of the applicant or otherwise, the Secretary's obligations 
with respect to the payment of interest subsidies shall cease.
    (5) Where, during the life of the loan with respect to which 
interest subsidies are to be paid, the applicant ceases to use the 
facility for the purposes for which constructed, the Secretary's 
obligation with respect to the payment of interest subsidies shall 
cease: Provided, however, That where the applicant is continuing to use 
the facility for purposes eligible for support under part B of title VII 
of the act, the Secretary may make a determination, based upon the 
health manpower needs of the community served by the facility as well as 
other relevant factors, to continue to make interest subsidy payments in 
accord with the agreement.
    (6) Where during the life of the loan with respect to which interest 
subsidies are to be paid, it is determined, after an opportunity for a 
hearing pursuant to 45 CFR part 83, that the Assurance executed by the 
applicant under section 704 (or its predecessor, section 799A) of the 
Act, is no longer satisfactory, the Secretary's obligation with respect 
to the payment of interest subsidies shall cease: Provided, however, 
That the Secretary shall resume making interest subsidy payments if he 
determines that a subsequent Assurance submitted by the applicant is 
satisfactory.
    (7) Where during the life of the loan with respect to which interest 
subsidies are to be paid, it is determined by the Secretary, after an 
opportunity for a hearing pursuant to 45 CFR parts 80 and 81, that the 
applicant has ceased to comply with the Assurance it has executed under 
45 CFR 80.4(d) concerning nondiscrimination on the basis of race, color 
or national origin, the Secretary's obligation with respect to the 
payment of interest subsidies shall cease: Provided, however, That the 
Secretary shall resume making interest subsidy payments if he 
subsequently determines that the applicant has come into compliance with 
the requirements of title VI of the Civil Rights Act of 1964 and 
implementing regulations.
    (8) Where during the life of the loan with respect to which interest 
subsidies are to be paid, it is determined by the Secretary after an 
opportunity for a hearing pursuant to title IX of the Education 
Amendments of 1972, that the applicant has ceased to comply with such 
title, and its implementing regulations, the Secretary's obligation with 
respect to the payment of interest subsidies shall cease: Provided, 
however, That the Secretary shall resume making interest subsidy 
payments if he subsequently determines that the applicant has come into 
compliance with the requirements of title IX of the Education Amendments 
of 1972 and implementing regulations.
    (c) General. In addition to the applicable requirements of 
paragraphs (a) and (b) of this section, each agreement, whether 
pertaining to a loan guarantee or interest subsidy or both, shall 
contain such other provisions as the Secretary finds necessary in order 
to protect the financial interests of the United States.

[38 FR 31836, Nov. 19, 1973, as amended at 49 FR 38113, Sept. 27, 1984]



Sec.  57.1515  Loan closing.

    Closing of any loan with respect to which a guarantee is made or 
interest subsidies are paid under this subpart shall be accomplished at 
such time as may be agreed upon by the parties to such loan and found 
acceptable to the Secretary.

[[Page 414]]



Sec.  57.1516  Right of recovery-subordination.

    (a) The United States shall be entitled to recover from the 
applicant for a loan guarantee under this subpart the amount of any 
payment made pursuant to such guarantee, unless the Secretary waives 
such right of recovery as provided in Sec.  57.1517.
    (b) Upon making of any payments pursuant to a loan guarantee under 
this subpart, the United States shall be subrogated to all of the rights 
of the recipient of the payments with respect to which the guarantee was 
made.



Sec.  57.1517  Waiver of right of recovery.

    In determining whether there is good cause for waiver of any right 
of recovery which he may have against any applicant by reason of any 
payments made pursuant to a loan guarantee under this subpart, the 
Secretary shall take into consideration the extent to which:
    (a) The facility with respect to which the loan guarantee was made 
will continue to be devoted by the applicant or other owner to the 
teaching of health professions personnel, or to other purposes in the 
sciences related to health for which funds are available under part B of 
title VII of the act and these regulations;
    (b) A hospital or outpatient facility will be used as provided for 
under title VI of the act;
    (c) There are reasonable assurances that for the remainder of the 
repayment period of the loan other facilities not previously utilized 
for the purpose for which the facility was constructed will be so 
utilized and are substantially equivalent in nature and extent for such 
purposes; and
    (d) Such recovery would seriously curtail the training of qualified 
health professions personnel in the area served by the facility.



Sec.  57.1518  Modification of loans.

    No official of the Department of Health and Human Services will 
approve any proposal to modify the terms of a loan guaranteed under 
title VII of the Public Health Service Act (42 U.S.C. 293 et seq.) and 
this subpart which would permit the use of the guaranteed loan (or the 
guarantee) as collateral for an issue of tax-exempt securities.

(Secs. 215 and 726, Public Health Service Act, 58 Stat. 690 and 85 Stat. 
432, 42 U.S.C. 216 and 293i, as amended)

[48 FR 42984, Sept. 21, 1983]

Subparts Q-T [Reserved]



      Subpart U_Armed Forces Health Professions Scholarship Program

    Authority: Sec. 2(a), Pub. L. 92-426, 86 Stat. 719 (10 U.S.C. 
2127(d)).

    Source: 38 FR 20447, Aug. 1, 1973, unless otherwise noted.



Sec.  57.2001  Applicability.

    In the event the Secretary of Defense decides to enter into one or 
more contracts under 10 U.S.C. 2127(d), the regulations in this subpart 
outline considerations the Secretary of Defense will take into account 
in determining whether an accredited civilian educational institution 
has increased its total enrollment for the sole purpose of accepting 
members of the Armed Forces health professions scholarship program.



Sec.  57.2002  Definitions.

    As used in this subpart:
    (a) Institution means a college, university, or other institution or 
a department, division, or other administrative unit within a college, 
university, or other institution, which provides primarily or 
exclusively a course of study in medicine, dentistry, or other health 
profession, as determined under regulations prescribed by the Secretary 
of Defense, leading to a degree in one of said health professions, and 
which is accredited by an accrediting agency or association recognized 
by the United States Commissioner of Education.
    (b) Enrollment in any fiscal year means the number of full-time 
students enrolled in an institution on October 15 of said year and 
pursuing a course of study which constitutes a full-time academic 
workload, as determined by the institution, leading to a degree in 
medicine, dentistry, or other health profession, as determined under 
regulations prescribed by the Secretary of

[[Page 415]]

Defense: Provided, That if the Secretary of Defense finds that a date 
other than October 15 would more accurately reflect an institution's 
enrollment in any fiscal year, the Secretary of Defense may use such 
other date in place of October 15 in making his determination under this 
subpart.
    (c) Fiscal year means the Federal fiscal year beginning July 1 and 
ending on the following June 30.
    (d) Program means the Armed Forces health professions scholarship 
program established under section 2(a) of the Uniformed Services Health 
Professions Revitalization Act of 1972 (86 Stat. 713, Pub. L. 92-426), 
and codified in chapter 105 of 10 U.S.C.



Sec.  57.2003  Determinations of increased enrollment solely for the program.

    In the event the Secretary of Defense decides to enter into one or 
more contracts under 10 U.S.C. 2127(d), his determination as to whether 
an institution has increased its total enrollment in any fiscal year for 
the sole purpose of accepting members of the program will take into 
account the following considerations:
    (a) A comparison of the total enrollment in said fiscal year with 
the total enrollments in immediately preceding fiscal years;
    (b) Any increases in enrollment to which the institution has 
directly or indirectly committed itself in said fiscal year under: (1) 
Other Federal programs, such as those set forth in title VII and VIII of 
the Public Health Service Act (42 U.S.C. 292 et seq.), the Veterans' 
Administration Medical School Assistance and Health Manpower Training 
Act of 1972 (Pub. L. 92-541, 86 Stat. 1100 (38 U.S.C. 5070 et seq.)) and 
section 225 of the Public Health Service Act (sec. 5, Pub. L. 92-585, 86 
Stat. 1293 (42 U.S.C. 234)); (2) programs of State or local governments 
or other public or private agencies, or (3) any legally binding 
arrangement: Provided, That insofar as a single increase may be applied 
to satisfy the commitments under two or more programs and/or other 
arrangements, said increase shall be considered to meet all such 
commitments;
    (c) Any unusual factors, such as: (1) An institution having been 
newly established or (2) an institution experiencing what is for it an 
abnormal rate of attrition and/or admission.

Subpart V [Reserved]



          Subpart W_Physician Shortage Area Scholarship Grants

    Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216).

    Source: 39 FR 28730, Aug. 9, 1974, unless otherwise noted.



Sec.  57.2201  Applicability.

    The regulations of this subpart are applicable to scholarship grants 
awarded under section 784 of the Public Health Service Act, which 
authorizes the Secretary to award scholarship grants to students of 
medicine and osteopathy who agree to engage in the full-time practice of 
primary care for a prescribed period of time (a) in a physician shortage 
area or (b) in such manner as to assure that of the patients receiving 
medical care in such practice a substantial portion will consist of 
migratory agricultural workers or members of their families.



Sec.  57.2202  Definitions.

    As used in this subpart, the following terms shall have the 
following meanings:
    (a) Act means the Public Health Service Act, as amended.
    (b) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (c) School means a public or other nonprofit school of medicine or 
osteopathy which provides a course of study, or a portion thereof, which 
leads respectively to a degree of Doctor of Medicine or Doctor of 
Osteopathy and which is accredited as provided in section 721(b)(1)(B) 
of the Act.
    (d) Scholarship grant means the amount of money awarded to an 
individual by the Secretary for an academic year pursuant to section 
784(a) of the Act.
    (e) Full-time student means a student who is enrolled, or accepted 
for enrollment, in a school and pursuing a course

[[Page 416]]

of study which constitutes a full-time academic workload, as determined 
by the school, leading to a degree specified in paragraph (c) of this 
section.
    (f) Academic year means the traditional, approximately 9-month 
September to June annual session. For the purpose of computing academic 
year equivalents for students who, during a 12-month period, attend for 
a longer period than the traditional academic year, the academic year 
will be considered to be of 9 months' duration.
    (g) National of the United States means (1) a citizen of the United 
States or (2) a person who, though not a citizen of the United States, 
owes permanent allegiance to the United States (8 U.S.C. 1101(a)(22)).
    (h) Professional training means the course of study leading to the 
degree of doctor of medicine or doctor of osteopathy, plus a period, not 
to exceed a total of four years, of internship and residency training.
    (i) Low-income background as applied to any individual means that 
the individual comes from a family with an annual income below low-
income levels developed pursuant to Sec.  57.605(c).
    (j) The practice of primary care means the provision of health 
services characterized by the delivery of first contact medicine, the 
assumption of longitudinal responsibility for the patient regardless of 
the presence or absence of disease, and the integration of the physical, 
psychological and social aspects of health care to the limits of the 
capability of the practitioner. For purposes of this section, primary 
care shall include the fields of general practice, family practice, 
general internal medicine, general pediatrics, and general obstetrics 
and gynecology.
    (k) Migratory agricultural worker means a domestic agricultural 
migratory worker as defined in Sec.  56.102(d).
    (l) Physician shortage area means an area designated by the 
Secretary pursuant to Sec.  57.216(a)(5) as an area having a need for 
and shortage of physicians.



Sec.  57.2203  Eligibility.

    To be eligible for a scholarship grant under this subpart, the 
applicant must:
    (a) Be a national of the United States or a permanent resident of 
the Trust Territory of the Pacific Islands or a lawful permanent 
resident of the United States, Puerto Rico, the Virgin Islands or Guam;
    (b) Be a full-time student in a school located in the United States, 
the Trust Territory of the Pacific Islands, Puerto Rico, the Virgin 
Islands, the Canal Zone, American Samoa or Guam; and
    (c) Agree to engage in the full-time practice of primary care as 
defined in Sec.  57.2202(j) in accord with conditions specified in Sec.  
57.2209.



Sec.  57.2204  Application.

    Each eligible applicant desiring a scholarship grant under this 
subpart shall submit an application at such time and in such form as the 
Secretary may prescribe.



Sec.  57.2205  Priority for selection of scholarship recipients.

    (a) When funds determined by the Secretary to be available for 
scholarship grants under this subpart are insufficient to permit the 
awarding of scholarships to all individuals applying therefor, the 
Secretary shall accord priority to eligible applicants as follows:
    (1) First priority for scholarship grants shall be accorded to 
applicants who (i) are from a low-income background as defined in Sec.  
57.2202 (i), (ii) reside in a physician shortage area and (iii) agree to 
return to such area and engage in the full-time practice of primary 
care. For purposes of this paragraph, an individual resides in a 
physician shortage area if he presently is residing in such an area or 
if he (or his parents) resided in such an area in the year prior to his 
admission to an institution of higher education.
    (2) Second priority shall be accorded to applicants meeting the 
criteria in paragraphs (a)(1) (ii) and (iii) of this section.
    (3) Third priority shall be accorded to applicants meeting the 
criterion in paragraph (a)(1)(i) of this section.
    (4) Fourth priority shall be accorded to other applicants.
    (b) Where there are insufficient funds available to make scholarship 
grants to all members of any single priority grouping enumerated in 
paragraph (a) of this section, the following criteria

[[Page 417]]

will be used to accord priority within each affected priority group:
    (1) Within the priority groupings specified in paragraphs (a) (1) 
and (2) of this section, the Secretary shall rank recipients according 
to the degree of the severity of shortage of physicians practicing 
primary care in such area. Scholarship grants shall be awarded within 
each priority group first to applicants within that grouping from 
physician shortage areas with the least favorable ratio of such 
physicians to the population to be served.
    (2) Within the priority groupings specified in paragraphs (a) (3) 
and (4) of this section, the Secretary shall award scholarship grants 
within each priority group first to applicants who agree to practice 
primary care in a physician shortage area with a substantial portion of 
migratory agricultural workers in such area; second, to applicants 
within that grouping who agree to practice in a physician shortage area; 
and third, to applicants within that grouping who agree to practice in 
such place or places, facility or facilities, and in such manner as the 
Secretary finds necessary to assure that, of the patients receiving 
medical care in such practice, a substantial portion will consist of 
persons who are migratory agricultural workers or members of their 
families.



Sec.  57.2206  Grant award.

    The Secretary may award scholarship grants to individuals who have 
been selected to receive scholarship grants in accordance with Sec.  
57.2205. Any such award under this subpart shall state the specific 
conditions under which the award is being made and shall indicate the 
distribution between funds awarded to cover the costs of tuition and 
fees payable to the school and funds awarded for the costs of equipment, 
supplies, books, and living expenses payable to the individual.



Sec.  57.2207  Amount of scholarship grant.

    (a) The amount of the scholarship grant to any student for any 
academic year shall be the total of (1) the lesser of (i) $5,000 or (ii) 
the amount determined by the Secretary to be the cost of tuition and 
fees; plus (2) an allowance for equipment, supplies, books and living 
expenses which shall be the lesser of (i) $3,600 or (ii) the difference 
between $5,000 and the amount determined pursuant to paragraph (a)(1) of 
this section.
    (b) The maximum amount of a scholarship grant during a 12-month 
period to any student enrolled in a school which provides a course of 
study longer than the traditional 9-month academic year may be 
proportionately increased.



Sec.  57.2208  Payment of scholarship grant.

    The portion of a scholarship grant awarded for the costs of tuition 
and fees as indicated on the notice of grant award document will be paid 
directly to the school upon receipt of an invoice from the school. The 
portion of the scholarship grant awarded for the costs of equipment, 
supplies, books, and living expenses will be paid to the individual in 
equal monthly installments.



Sec.  57.2209  Conditions of scholarship grant.

    (a) Any scholarship grant made to any individual under this subpart 
shall be awarded upon the condition that such individual will, following 
completion of his professional training, engage in the full-time 
practice of primary care for a period of 12 continuous months for each 
academic year (i.e., 9 months) for which a scholarship grant was made, 
as follows:
    (1) In the case of any individual selected pursuant to Sec.  
57.2205(a) (1) or (2), such practice must be in the physician shortage 
area to which such individual agreed to return: Provided however, That 
if the Secretary determines at the time the individual proposes to 
engage in the required practice that such area is no longer a physician 
shortage area and cannot reasonably be expected to become such an area 
within 2 years from such time, such practice shall, at the option of the 
individual, be either in any then current physician shortage area, or in 
such place or places, facility, or facilities, and in such manner as the 
Secretary finds necessary to assure that, of the patients receiving 
medical care in such practice, a substantial portion will consist of 
persons who are migratory agricultural workers or members of their 
families.

[[Page 418]]

    (2) In the case of any individual selected pursuant to Sec.  
57.2205(a) (3) or (4), such practice must be in accordance with the 
agreement described in Sec.  57.2205(b)(2) (i.e., in a physician 
shortage area with a substantial portion of migratory agricultural 
workers in such area; a physician shortage area; or in such place or 
places, facility or facilities, and in such manner as may be necessary 
to assure that, of the patients receiving medical care in such practice, 
a substantial portion will consist of persons who are migratory 
agricultural workers or members of their families; as the case may be).
    (b) Subject to the provision of Sec.  57.2211(f) and except as 
provided in paragraph (c) of this section, any individual to whom the 
conditions of this section apply must complete the practice required by 
paragraph (a) of this section within a period beginning on the date of 
completion by the individual of his professional training, as determined 
by the Secretary, and not to exceed the period of practice determined in 
accordance with such paragraph (a) of this section, plus 6 months.
    (c) Where an individual to whom the conditions of this section apply 
is currently performing an active duty service obligation under section 
235 of the Act, the individual must complete the practice required by 
paragraph (a) of this section within a period beginning on the date of 
completion by the individual of his service obligation under section 225 
of the Act or completion of his internship and residency training (not 
to exceed four years) if not previously received, whichever comes later, 
and not to exceed the period of practice determined in accordance with 
paragraph (a) of this section, plus 6 months.
    (d) Where an individual has received scholarship grant support for 
four academic years, such individual shall be considered to have 
received scholarship grant support for only three academic years if the 
Secretary determines (1) that such individual has served his internship 
or residency in a hospital (i) which is located in a physician shortage 
area, or (ii) in which a substantial portion of the patients of such 
hospital consists of persons who are migratory agricultural workers or 
members of the families of such workers and (2) that while so serving 
such internship or residency, he has received training or professional 
experience designed to prepare him to engage in the practice of primary 
care.
    (e) For purposes of paragraph (c)(2) of this section, (1) 
internships which will be recognized by the Secretary as providing 
training or professional experience designed to prepare an individual to 
engage in the practice of primary care are: Rotating internships without 
a major emphasis, rotating internships with an emphasis on internal 
medicine, rotating internships with an emphasis on pediatrics, rotating 
internships with an emphasis on obstetrics and gynecology, straight 
internships in internal medicine, straight internships in pediatrics and 
straight internships in obstetrics and gynecology; Provided, That such 
internships are approved or provisionally approved by the Council on 
Medical Education of the American Medical Association or the Board of 
Trustees of the American Osteopathic Association; and
    (2) Residencies which will be recognized as providing such training 
or experience are those in general practice, family practice, general 
internal medicine, general pediatrics and general obstetrics and 
gynecology; Provided, That such residencies are approved or 
provisionally approved by the Council on Medical Education of the 
American Medical Association or the Board of Trustees of the American 
Osteopathic Association.
    (f) No individual who has received a scholarship grant under this 
subpart may enter into an agreement with the Secretary pursuant to 
section 741(f) of the Act until either (1) such individual has completed 
the practice required by paragraph (a) of this section, or (2) the 
Secretary has determined that the United States is entitled to recover 
from such individual an amount determined in accordance with Sec.  
57.2210. In no case, however, shall a scholarship grant under this 
subpart be considered an educational loan for purposes of section 741(f) 
of the Act.

[39 FR 28730, Aug. 9, 1974, as amended at 41 FR 26685, June 29, 1976]

[[Page 419]]



Sec.  57.2210  Failure to comply.

    (a) Subject to the provision of Sec.  57.2211, if any individual 
fails to complete the course of study or fails, within the time period 
set forth in Sec.  57.2209(b), to meet the applicable conditions of 
practice imposed by receipt of a scholarship grant for the full number 
of months to which such condition is applicable, the United States shall 
be entitled to recover from such individual an amount determined in 
accordance with section 784(c)(3) of the Act; Provided however, That no 
interest shall accrue on any amount due the United States during any 
period for which the Secretary has suspended the obligation to repay 
pursuant to Sec.  57.2211(b).



Sec.  57.2211  Waiver or suspension.

    (a) Any obligation of any individual under this subpart will be 
cancelled upon the death of such individual as documented by a 
certification of death, or such other official proof as is conclusive 
under State law, and submitted to the Secretary.
    (b) Subject to the provision of paragraph (f) of this section, where 
an individual fails to complete the practice required by Sec.  
57.2209(a) within the period prescribed in Sec.  57.2209(b), the 
Secretary may waive or suspend for such period as determined by the 
Secretary the obligation of such individual to repay pursuant to Sec.  
57.2210 where the Secretary determines that compliance by such 
individual with such obligation (1) is impossible, or (2) would involve 
extreme hardship to such individual and enforcement of such obligation 
with respect to such individual would be against equity and good 
conscience.
    (c) For purposes of paragraph (b)(1) of this section, compliance by 
an individual will be deemed impossible where the Secretary determines, 
on the basis of such information and documentation as he may require, 
that the individual is permanently and totally disabled.
    (d) For purposes of paragraph (b)(2) of this section, in determining 
whether compliance by an individual would involve extreme hardship to 
such individual and would be against equity and good conscience, the 
Secretary will take into consideration the following:
    (1) The individual's present financial resources and obligations;
    (2) The individual's estimated future financial resources and 
obligations;
    (3) The reasons for the individual's failure to complete such 
practice within the prescribed period, such as problems of a personal 
nature; and
    (4) The extent to which the individual is practicing his profession 
in a manner consistent with the purposes of section 784 of the Act.
    (e) Where the Secretary determines that compliance by an individual 
with his obligation to engage in the practice of primary care in a 
specified shortage area pursuant to Sec.  57.2209(a) is impossible or 
would involve extreme hardship to such individual and enforcement of 
such obligation with respect to such individual would be against equity 
and good conscience, the Secretary may waive such obligation and permit 
the individual at his option to practice either in any then current 
physician shortage area, or in such place or places, facility or 
facilities, and in such manner as the Secretary finds necessary to 
assure that, of the patients receiving medical care in such practice, a 
substantial portion will consist of persons who are migratory 
agricultural workers or members of their families. The Secretary will 
take into consideration in determining whether to grant a waiver under 
this paragraph the extent to which the individual has problems of a 
personal nature, e.g., physical or mental disability, terminal illness 
in the family, or need for financial support that cannot be supplied by 
the required service, which intrude upon the individual's ability to 
perform the required service in the specified shortage area.
    (f) The Secretary may extend the period (prescribed in Sec.  
57.2209(b)) within which an individual must complete the practice 
required pursuant to Sec.  57.2209(a) for a period not to exceed one 
year where the Secretary finds that (1) such individual is unable to 
complete such practice within such period because of a temporary 
physical or mental disability, or (2) completion by such individual of 
such practice within such period would involve extreme hardship to such 
individual and that

[[Page 420]]

failure to so extend such period would be against equity and good 
conscience.

Subparts AA-FF [Reserved]



       Subpart GG_Payment for Tuition and Other Educational Costs

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690, as 
amended by 63 Stat. 35 (42 U.S.C. 216); sec. 711, Public Health Service 
Act, 90 Stat. 2253; section 710, PHS Act, as redesignated by Pub. L. 97-
35, 95 Stat. 915 (42 U.S.C. 292k).



Sec.  57.3201  To which programs do these regulations apply?

    The regulations in this subpart establish the criteria to be used in 
determining allowable increases in tuition and other educational costs 
for which the Secretary is responsible for payment under the following 
sections of the Public Health Service Act: The National Health Service 
Corps Scholarship Program (sec. 338A) (42 U.S.C. 254l) and the Indian 
Health Scholarship Program (awarded pursuant to sec. 338A-339G of the 
PHS Act) (25 U.S.C. 1613a). These programs are referred to herein as the 
``scholarship programs.'' The regulations apply to increases in tuition 
and other educational costs occurring after the school year beginning 
immediately before October 1, 1981.

[57 FR 45745, Oct. 5, 1992]



Sec.  57.3202  How will allowable increases be determined?

    (a) The Secretary is responsible for increases in tuition and other 
educational costs only if the same increase is charged to all students 
in the same category (for example, the same class year or place of 
residence) and without regard to whether the student is receiving 
support under the scholarship programs. A student participating in the 
scholarship programs may not be denied eligibility because of this 
participation for any discounts or rebates in tuition or other 
educational costs given to all other students in the same category at 
the institution.
    (b) Institutions whose enrollment contains 25 percent or more 
students participating in the scholarship programs, and whose percentage 
increase in tuition and other educational costs in any school year 
exceeds the previous calendar year's average inflation rate as indicated 
by the Consumer Price Index for All Urban Areas, may be requested to 
provide the Secretary with detailed cost breakdowns justifying the 
increase.
    (c) In the case of a school which is requested to provide the 
Secretary with cost increase justification under paragraph (b) of this 
section, the Secretary will be responsible for increases in tuition and 
other educational costs charged to students participating in the 
scholarship programs over the amount charged for the school year 
immediately preceding the increase only to the extent that they are: (1) 
Attributable to uncontrollable costs, such as fuel costs, mandated cost-
of-living increases in wages, salaries and fringe benefits, (2) 
attributable to costs of maintaining and improving the quality of the 
health professions education provided by the institution, such as hiring 
additional faculty to improve the faculty-student ratio, costs incurred 
in off-site training of students, and necessary improvements in teaching 
equipment. Increases in patient care and research costs are allowable as 
part of an increase in tuition and other educational costs only to the 
extent that they can be documented as clearly necessary to maintain and 
improve the quality of the education being supported; or (3) 
attributable to loss of revenue from other sources which was used solely 
for the maintenance and improvement of the educational system.

These three categories of valid escalators of tuition and other 
educational costs are exclusive. However, the examples within each 
category are merely illustrative and not meant to be inclusive.
    (d) If the Secretary, after reviewing all available data, 
information, and justifications submitted by an institution, determines 
that an increase in tuition and other educational costs is not allowable 
under the criteria described in paragraph (a) or (c) of this section, 
the Secretary will provide the affected institution a detailed written 
explanation of the basis of that determination. The Secretary will be 
responsible for that portion of tuition

[[Page 421]]

and other educational costs the Secretary determines to be allowable.

[45 FR 71568, Oct. 29, 1980]

Subparts HH-PP [Reserved]



PART 58_GRANTS FOR TRAINING OF PUBLIC HEALTH AND ALLIED HEALTH PERSONNEL--
Table of Contents



Subparts A-F [Reserved]



PART 59_GRANTS FOR FAMILY PLANNING SERVICES--Table of Contents



          Subpart A_Project Grants for Family Planning Services

Sec.
59.1 To what programs do these regulations apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning services grant?
59.4 How does one apply for a family planning services grant?
59.5 What requirements must be met by a family planning project?
59.6 What procedures apply to assure the suitability of informational 
          and educational material (print and electronic)?
59.7 What criteria will the Department of Health and Human Services use 
          to decide which family planning services projects to fund and 
          in what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 Confidentiality.
59.11 Additional conditions.

Subpart B [Reserved]

          Subpart C_Grants for Family Planning Service Training

59.201 Applicability.
59.202 Definitions.
59.203 Eligibility.
59.204 Application for a grant.
59.205 Project requirements.
59.206 Evaluation and grant award.
59.207 Payments.
59.208 Use of project funds.
59.209 Civil rights.
59.210 Inventions or discoveries.
59.211 Publications and copyright.
59.212 Grantee accountability.
59.213 [Reserved]
59.214 Additional conditions.
59.215 Applicability of 45 CFR part 75.



          Subpart A_Project Grants for Family Planning Services

    Source: 86 FR 56177, Oct. 7, 2021, unless otherwise noted.



Sec.  59.1  To what programs do these regulations apply?

    The regulations of this subpart are applicable to the award of 
grants under section 1001 of the Public Health Service Act (42 U.S.C. 
300) to assist in the establishment and operation of voluntary family 
planning projects. These projects shall consist of the educational, 
comprehensive medical, and social services necessary to aid individuals 
to determine freely the number and spacing of their children.



Sec.  59.2  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Adolescent-friendly health services are services that are 
accessible, acceptable, equitable, appropriate and effective for 
adolescents.
    Clinical services provider includes physicians, physician 
assistants, nurse practitioners, certified nurse midwives, and 
registered nurses with an expanded scope of practice who are trained and 
permitted by state-specific regulations to perform all aspects of the 
user (male and female) physical assessments recommended for 
contraceptive, related preventive health, and basic infertility care.
    Client-centered care is respectful of, and responsive to, individual 
client preferences, needs, and values; client values guide all clinical 
decisions.
    Culturally and linguistically appropriate services are respectful of 
and responsive to the health beliefs, practices and needs of diverse 
patients.
    Family means a social unit composed of one person, or two or more 
persons living together, as a household.
    Family planning services include a broad range of medically approved 
services, which includes Food and Drug Administration (FDA)-approved 
contraceptive products and natural family planning methods, for clients 
who want to prevent pregnancy and space births,

[[Page 422]]

pregnancy testing and counseling, assistance to achieve pregnancy, basic 
infertility services, sexually transmitted infection (STI) services, and 
other preconception health services.
    Health equity is when all persons have the opportunity to attain 
their full health potential and no one is disadvantaged from achieving 
this potential because of social position or other socially determined 
circumstances.
    Inclusive is when all people are fully included and can actively 
participate in and benefit from family planning, including, but not 
limited to, individuals who belong to underserved communities, such as 
Black, Latino, and Indigenous and Native American persons, Asian 
Americans and Pacific Islanders and other persons of color; members of 
religious minorities; lesbian, gay, bisexual, transgender, and queer 
(LGBTQ+) persons; persons with disabilities; persons who live in rural 
areas; and persons otherwise adversely affected by persistent poverty or 
inequality.
    Low-income family means a family whose total annual income does not 
exceed 100 percent of the most recent Poverty Guidelines issued pursuant 
to 42 U.S.C. 9902(2). ``Low-income family'' also includes members of 
families whose annual family income exceeds this amount, but who, as 
determined by the project director, are unable, for good reasons, to pay 
for family planning services. For example, unemancipated minors who wish 
to receive services on a confidential basis must be considered on the 
basis of their own resources.
    Nonprofit, as applied to any private agency, institution, or 
organization, means that no part of the entity's net earnings benefit, 
or may lawfully benefit, any private shareholder or individual.
    Quality healthcare is safe, effective, client-centered, timely, 
efficient, and equitable.
    Secretary means the Secretary of Health and Human Services (HHS) and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    Service site is a clinic or other location where Title X services 
are provided to clients. Title X recipients and/or their subrecipients 
may have service sites.
    State includes, in addition to the several States, the District of 
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana 
Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying 
Islands (Midway, Wake, et al.), the Marshall Islands, the Federated 
State of Micronesia, and the Republic of Palau.
    Trauma-informed means a program, organization, or system that is 
trauma-informed realizes the widespread impact of trauma and understands 
potential paths for recovery; recognizes the signs and symptoms of 
trauma in clients, families, staff, and others involved with the system; 
and responds by fully integrating knowledge about trauma into policies, 
procedures, and practices, and seeks to actively resist re-
traumatization.



Sec.  59.3  Who is eligible to apply for a family planning services grant?

    Any public or nonprofit private entity in a State may apply for a 
grant under this subpart.



Sec.  59.4  How does one apply for a family planning services grant?

    (a) Application for a grant under this subpart shall be made on an 
authorized form.
    (b) An individual authorized to act for the applicant and to assume 
on behalf of the applicant the obligations imposed by the terms and 
conditions of the grant, including the regulations of this subpart, must 
sign the application.
    (c) The application shall contain
    (1) A description, satisfactory to the Secretary, of the project and 
how it will meet the requirements of this subpart;
    (2) A budget and justification of the amount of grant funds 
requested;
    (3) A description of the standards and qualifications which will be 
required for all personnel and for all facilities to be used by the 
project; and
    (4) Such other pertinent information as the Secretary may require.

[[Page 423]]



Sec.  59.5  What requirements must be met by a family planning project?

    (a) Each project supported under this part must:
    (1) Provide a broad range of acceptable and effective medically 
approved family planning methods (including natural family planning 
methods) and services (including pregnancy testing and counseling, 
assistance to achieve pregnancy, basic infertility services, STI 
services, preconception health services, and adolescent-friendly health 
services). If an organization offers only a single method of family 
planning, it may participate as part of a project as long as the entire 
project offers a broad range of acceptable and effective medically 
approved family planning methods and services. Title X service sites 
that are unable to provide clients with access to a broad range of 
acceptable and effective medically approved family planning methods and 
services, must be able to provide a prescription to the client for their 
method of choice or referrals to another provider, as requested.
    (2) Provide services without subjecting individuals to any coercion 
to accept services or to employ or not to employ any particular methods 
of family planning. Acceptance of services must be solely on a voluntary 
basis and may not be made a prerequisite to eligibility for, or receipt 
of, any other services, assistance from or participation in any other 
program of the applicant.\1\
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 300a-8 provides that any officer or employee of the 
United States, officer or employee of any State, political subdivision 
of a State, or any other entity, which administers or supervises the 
administration of any program receiving Federal financial assistance, or 
person who receives, under any program receiving Federal assistance, 
compensation for services, who coerces or endeavors to coerce any person 
to undergo an abortion or sterilization procedure by threatening such 
person with the loss of, or disqualification for the receipt of, any 
benefit or service under a program receiving Federal financial 
assistance shall be fined not more than $1,000 or imprisoned for not 
more than one year, or both.
---------------------------------------------------------------------------

    (3) Provide services in a manner that is client-centered, culturally 
and linguistically appropriate, inclusive, and trauma-informed; protects 
the dignity of the individual; and ensures equitable and quality service 
delivery consistent with nationally recognized standards of care.
    (4) Provide services in a manner that does not discriminate against 
any client based on religion, race, color, national origin, disability, 
age, sex, sexual orientation, gender identity, sex characteristics, 
number of pregnancies, or marital status.
    (5) Not provide abortion as a method of family planning.\2\ A 
project must:
---------------------------------------------------------------------------

    \2\ Providers may separately be covered by federal statutes 
protecting conscience and/or civil rights.
---------------------------------------------------------------------------

    (i) Offer pregnant clients the opportunity to be provided 
information and counseling regarding each of the following options:
    (A) Prenatal care and delivery;
    (B) Infant care, foster care, or adoption; and
    (C) Pregnancy termination.
    (ii) If requested to provide such information and counseling, 
provide neutral, factual information and nondirective counseling on each 
of the options, and, referral upon request, except with respect to any 
option(s) about which the pregnant client indicates they do not wish to 
receive such information and counseling.
    (6) Provide that priority in the provision of services will be given 
to clients from low-income families.
    (7) Provide that no charge will be made for services provided to any 
clients from a low-income family except to the extent that payment will 
be made by a third party (including a government agency) which is 
authorized to or is under legal obligation to pay this charge.
    (8) Provide that charges will be made for services to clients other 
than those from low-income families in accordance with a schedule of 
discounts based on ability to pay, except that charges to persons from 
families whose annual income exceeds 250 percent of the levels set forth 
in the most recent Poverty Guidelines issued pursuant to 42 U.S.C. 
9902(2) will be made in accordance with a schedule of fees designed to 
recover the reasonable cost of providing services.

[[Page 424]]

    (i) Family income should be assessed before determining whether 
copayments or additional fees are charged.
    (ii) With regard to insured clients, clients whose family income is 
at or below 250 percent of the FPL should not pay more (in copayments or 
additional fees) than what they would otherwise pay when the schedule of 
discounts is applied.
    (9) Take reasonable measures to verify client income, without 
burdening clients from low-income families. Recipients that have lawful 
access to other valid means of income verification because of the 
client's participation in another program may use those data rather than 
re-verify income or rely solely on clients' self-report. If a client's 
income cannot be verified after reasonable attempts to do so, charges 
are to be based on the client's self-reported income.
    (10) If a third party (including a Government agency) is authorized 
or legally obligated to pay for services, all reasonable efforts must be 
made to obtain the third-party payment without application of any 
discounts. Where the cost of services is to be reimbursed under title 
XIX, XX, or XXI of the Social Security Act, a written agreement with the 
title XIX, XX, or XXI agency is required.
    (11)(i) Provide that if an application relates to consolidation of 
service areas or health resources or would otherwise affect the 
operations of local or regional entities, the applicant must document 
that these entities have been given, to the maximum feasible extent, an 
opportunity to participate in the development of the application. Local 
and regional entities include existing or potential subrecipients which 
have previously provided or propose to provide family planning services 
to the area proposed to be served by the applicant.
    (ii) Provide an opportunity for maximum participation by existing or 
potential subrecipients in the ongoing policy decision making of the 
project.
    (b) In addition to the requirements of paragraph (a) of this 
section, each project must meet each of the following requirements 
unless the Secretary determines that the project has established good 
cause for its omission. Each project must:
    (1) Provide for medical services related to family planning 
(including consultation by a clinical services provider, examination, 
prescription and continuing supervision, laboratory examination, 
contraceptive supplies), in person or via telehealth, and necessary 
referral to other medical facilities when medically indicated, and 
provide for the effective usage of contraceptive devices and practices.
    (2) Provide for social services related to family planning, 
including counseling, referral to and from other social and medical 
service agencies, and any ancillary services which may be necessary to 
facilitate clinic attendance.
    (3) Provide for opportunities for community education, 
participation, and engagement to:
    (i) Achieve community understanding of the objectives of the 
program;
    (ii) Inform the community of the availability of services; and
    (iii) Promote continued participation in the project by diverse 
persons to whom family planning services may be beneficial to ensure 
access to equitable, affordable, client-centered, quality family 
planning services.
    (4) Provide for orientation and in-service training for all project 
personnel.
    (5) Provide services without the imposition of any durational 
residency requirement or requirement that the patient be referred by a 
physician.
    (6) Provide that family planning medical services will be performed 
under the direction of a clinical services provider, with services 
offered within their scope of practice and allowable under state law, 
and with special training or experience in family planning.
    (7) Provide that all services purchased for project participants 
will be authorized by the project director or their designee on the 
project staff.
    (8) Provide for coordination and use of referrals and linkages with 
primary healthcare providers, other providers of healthcare services, 
local health and welfare departments, hospitals, voluntary agencies, and 
health services

[[Page 425]]

projects supported by other federal programs, who are in close physical 
proximity to the Title X site, when feasible, in order to promote access 
to services and provide a seamless continuum of care.
    (9) Provide that if family planning services are provided by 
contract or other similar arrangements with actual providers of 
services, services will be provided in accordance with a plan which 
establishes rates and method of payment for medical care. These payments 
must be made under agreements with a schedule of rates and payment 
procedures maintained by the recipient. The recipient must be prepared 
to substantiate that these rates are reasonable and necessary.
    (10) Provide, to the maximum feasible extent, an opportunity for 
participation in the development, implementation, and evaluation of the 
project by persons broadly representative of all significant elements of 
the population to be served, and by others in the community 
knowledgeable about the community's needs for family planning services.



Sec.  59.6  What procedures apply to assure the suitability of informational 
and educational material (print and electronic)?

    (a) A grant under this section may be made only upon assurance 
satisfactory to the Secretary that the project shall provide for the 
review and approval of informational and educational materials (print 
and electronic) developed or made available under the project by an 
Advisory Committee prior to their distribution, to assure that the 
materials are suitable for the population or community to which they are 
to be made available and the purposes of Title X of the Act. The project 
shall not disseminate any such materials which are not approved by the 
Advisory Committee.
    (b) The Advisory Committee referred to in paragraph (a) of this 
section shall be established as follows:
    (1) Size. The committee shall consist of no fewer than five members 
and up to as many members the recipient determines, except that this 
provision may be waived by the Secretary for good cause shown.
    (2) Composition. The committee shall include individuals broadly 
representative of the population or community for which the materials 
are intended (in terms of demographic factors such as race, ethnicity, 
color, national origin, disability, sex, sexual orientation, gender 
identity, sex characteristics, age, marital status, income, geography, 
and including but not limited to individuals who belong to underserved 
communities, such as Black, Latino, and Indigenous and Native American 
persons, Asian Americans and Pacific Islanders and other persons of 
color; members of religious minorities; lesbian, gay, bisexual, 
transgender, and queer (LGBTQ+) persons; persons with disabilities; 
persons who live in rural areas; and persons otherwise adversely 
affected by persistent poverty or inequality).
    (3) Function. In reviewing materials, the Advisory Committee shall:
    (i) Consider the educational, cultural, and diverse backgrounds of 
individuals to whom the materials are addressed;
    (ii) Consider the standards of the population or community to be 
served with respect to such materials;
    (iii) Review the content of the material to assure that the 
information is factually correct, medically accurate, culturally and 
linguistically appropriate, inclusive, and trauma informed;
    (iv) Determine whether the material is suitable for the population 
or community to which is to be made available; and
    (v) Establish a written record of its determinations.



Sec.  59.7  What criteria will the Department of Health and Human Services 
use to decide which family planning services projects to fund 
and in what amount?

    (a) Within the limits of funds available for these purposes, the 
Secretary may award grants for the establishment and operation of those 
projects which will in the Department's judgment best promote the 
purposes of section 1001 of the Act, taking into account:
    (1) The number of clients, and, in particular, the number of low-
income clients to be served;

[[Page 426]]

    (2) The extent to which family planning services are needed locally;
    (3) The ability of the applicant to advance health equity;
    (4) The relative need of the applicant;
    (5) The capacity of the applicant to make rapid and effective use of 
the federal assistance;
    (6) The adequacy of the applicant's facilities and staff;
    (7) The relative availability of non-federal resources within the 
community to be served and the degree to which those resources are 
committed to the project; and
    (8) The degree to which the project plan adequately provides for the 
requirements set forth in these regulations.
    (b) The Secretary shall determine the amount of any award on the 
basis of an estimate of the sum necessary for the performance of the 
project. No grant may be made for less than 90 percent of the project's 
costs, as so estimated, unless the grant is to be made for a project 
which was supported, under section 1001, for less than 90 percent of its 
costs in fiscal year 1975. In that case, the grant shall not be for less 
than the percentage of costs covered by the grant in fiscal year 1975.
    (c) No grant may be made for an amount equal to 100 percent for the 
project's estimated costs.



Sec.  59.8  How is a grant awarded?

    (a) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This anticipated period will usually be for three to five years.
    (b) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
recipient must submit a separate application to have the support 
continued for each subsequent year. Decisions regarding continuation 
awards and the funding level of such awards will be made after 
consideration of such factors as the recipient's progress and management 
practices and the availability of funds. In all cases, continuation 
awards require a determination by HHS that continued funding is in the 
best interest of the government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.



 Sec.  59.9  For what purpose may grant funds be used?

    Any funds granted under this subpart shall be expended solely for 
the purpose for which the funds were granted in accordance with the 
approved application and budget, the regulations of this subpart, the 
terms and conditions of the award, and the applicable cost principles 
prescribed in 45 CFR part 75.



Sec.  59.10  Confidentiality.

    (a) All information as to personal facts and circumstances obtained 
by the project staff about individuals receiving services must be held 
confidential and must not be disclosed without the individual's 
documented consent, except as may be necessary to provide services to 
the patient or as required by law, with appropriate safeguards for 
confidentiality. Otherwise, information may be disclosed only in 
summary, statistical, or other form which does not identify particular 
individuals. Reasonable efforts to collect charges without jeopardizing 
client confidentiality must be made. Recipient must inform the client of 
any potential for disclosure of their confidential health information to 
policyholders where the policyholder is someone other than the client.
    (b) To the extent practical, Title X projects shall encourage family 
participation.\3\ However, Title X projects may not require consent of 
parents or guardians for the provision of services to minors, nor can 
any Title X project staff notify a parent or guardian before or after a 
minor has requested and/or received Title X family planning services.
---------------------------------------------------------------------------

    \3\ 42 U.S.C. 300(a).
---------------------------------------------------------------------------



Sec.  59.11  Additional conditions.

    The Secretary may, with respect to any grant, impose additional 
conditions prior to, at the time of, or during

[[Page 427]]

any award, when in the Department's judgment these conditions are 
necessary to assure or protect advancement of the approved program, the 
interests of public health, or the proper use of grant funds.

Subpart B [Reserved]



          Subpart C_Grants for Family Planning Service Training

    Authority: Sec. 6(c), 84 Stat. 1507, 42 U.S.C. 300a-4; sec. 6(c), 84 
Stat. 1507, 42 U.S.C. 300a-1.

    Source: 37 FR 7093, Apr. 8, 1972, unless otherwise noted.



Sec.  59.201  Applicability.

    The regulations in this subpart are applicable to the award of 
grants pursuant to section 1003 of the Public Health Service Act (42 
U.S.C. 300a-1) to provide the training for personnel to carry out family 
planning service programs described in sections 1001 and 1002 of the 
Public Health Service Act (42 U.S.C. 300, 300a).



Sec.  59.202  Definitions.

    As used in this subpart:
    (a) Act means the Public Health Service Act.
    (b) State means one of the 50 States, the District of Columbia, 
Puerto Rico, Guam, the Virgin Islands, American Samoa, or the Trust 
Territory of the Pacific Islands.
    (c) Nonprofit private entity means a private entity no part of the 
net earnings of which inures, or may lawfully inure, to the benefit of 
any private shareholder or individual.
    (d) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (e) Training means job-specific skill development, the purpose of 
which is to promote and improve the delivery of family planning 
services.



Sec.  59.203  Eligibility.

    (a) Eligible applicants. Any public or nonprofit private entity 
located in a State is eligible to apply for a grant under this subpart.
    (b) Eligible projects. Grants pursuant to section 1003 of the Act 
and this subpart may be made to eligible applicants for the purpose of 
providing programs, not to exceed three months in duration, for training 
family planning or other health services delivery personnel in the 
skills, knowledge, and attitudes necessary for the effective delivery of 
family planning services: Provided, That the Secretary may in particular 
cases approve support of a program whose duration is longer than three 
months where he determines (1) that such program is consistent with the 
purposes of this subpart and (2) that the program's objectives cannot be 
accomplished within three months because of the unusually complex or 
specialized nature of the training to be undertaken.

[37 FR 7093, Apr. 8, 1972, as amended at 40 FR 17991, Apr. 24, 1975]



Sec.  59.204  Application for a grant.

    (a) An application for a grant under this subpart shall be submitted 
to the Secretary at such time and in such form and manner as the 
Secretary may prescribe. \1\ The application shall contain a full and 
adequate description of the project and of the manner in which the 
applicant intends to conduct the project and carry out the requirements 
of this subpart, and a budget and justification of the amount of grant 
funds requested, and such other pertinent information as the Secretary 
may require.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the Program 
Director, Family Planning Services, at the Regional Office of the 
Department of Health and Human Services for the region in which the 
project is to be conducted, or the Office of Family Planning, Office of 
the Assistant Secretary for Health, Washington, DC 20201.
---------------------------------------------------------------------------

    (b) The application shall be executed by an individual authorized to 
act for the applicant and to assume for the applicant the obligations 
imposed by the

[[Page 428]]

---------------------------------------------------------------------------
regulations of this subpart and any additional conditions of the grant.

(Sec. 6(c), Public Health Service Act, 84 Stat. 1506 and 1507 (42 U.S.C. 
300, 300a-1, and 300a-4))

[37 FR 7093, Apr. 8, 1972, as amended at 49 FR 38116, Sept. 27, 1984]



Sec.  59.205  Project requirements.

    An approvable application must contain each of the following unless 
the Secretary determines that the applicant has established good cause 
for its omission:
    (a) Assurances that:
    (1) No portion of the Federal funds will be used to train personnel 
for programs where abortion is a method of family planning.
    (2) No portion of the Federal funds will be used to provide 
professional training to any student as part of his education in pursuit 
of an academic degree.
    (3) No project personnel or trainees shall on the grounds of sex, 
religion, or creed be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under the project.
    (b) Provision of a methodology to assess the particular training 
(e.g., skills, attitudes, or knowledge) that prospective trainees in the 
area to be served need to improve their delivery of family planning 
services.
    (c) Provision of a methodology to define the objectives of the 
training program in light of the particular needs of trainees defined 
pursuant to paragraph (b) of this section.
    (d) Provision of a method for development of the training curriculum 
and any attendant training materials and resources.
    (e) Provision of a method for implementation of the needed training.
    (f) Provision of an evaluation methodology, including the manner in 
which such methodology will be employed, to measure the achievement of 
the objectives of the training program.
    (g) Provision of a method and criteria by which trainees will be 
selected.



Sec.  59.206  Evaluation and grant award.

    (a) Within the limits of funds available for such purpose, the 
Secretary may award grants to assist in the establishment and operation 
of those projects which will in his judgment best promote the purposes 
of section 1003 of the Act, taking into account:
    (1) The extent to which a training program will increase the 
delivery of services to people, particularly low-income groups, with a 
high percentage of unmet need for family planning services;
    (2) The extent to which the training program promises to fulfill the 
family planning services delivery needs of the area to be served, which 
may include, among other things:
    (i) Development of a capability within family planning service 
projects to provide pre- and in-service training to their own staffs;
    (ii) Improvement of the family planning services delivery skills of 
family planning and health services personnel;
    (iii) Improvement in the utilization and career development of 
paraprofessional and paramedical manpower in family planning services;
    (iv) Expansion of family planning services, particularly in rural 
areas, through new or improved approaches to program planning and 
deployment of resources;
    (3) The capacity of the applicant to make rapid and effective use of 
such assistance;
    (4) The administrative and management capability and competence of 
the applicant;
    (5) The competence of the project staff in relation to the services 
to be provided; and
    (6) The degree to which the project plan adequately provides for the 
requirements set forth in Sec.  59.205.
    (b) The amount of any award shall be determined by the Secretary on 
the basis of his estimate of the sum necessary for all or a designated 
portion of direct project costs plus an additional amount for indirect 
costs, if any, which will be calculated by the Secretary either: (1) On 
the basis of his estimate of the actual indirect costs reasonably 
related to the project, or (2) on the basis of a percentage of all, or a 
portion of, the estimated direct costs of the project when there are 
reasonable assurances that the use of such percentage will not exceed 
the approximate actual indirect costs. Such award may

[[Page 429]]

include an estimated provisional amount for indirect costs or for 
designated direct costs (such as travel or supply costs) subject to 
upward (within the limits of available funds) as well as downward 
adjustments to actual costs when the amount properly expended by the 
grantee for provisional items has been determined by the Secretary.
    (c) Allowability of costs shall be in conformance with the 
applicable cost principles prescribed by 45 CFR part 75, subpart E.
    (d) All grant awards shall be in writing, shall set forth the amount 
of funds granted and the period for which support is recommended.
    (e) Neither the approval of any project nor any grant award shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application annually at such times and in such form as the 
Secretary may direct.

[37 FR 7093, Apr. 8, 1972, as amended at 38 FR 26199, Sept. 19, 1973; 81 
FR 3009, Jan. 20, 2016]



Sec.  59.207  Payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred in the performance 
of the project to the extent he determines such payments necessary to 
promote prompt initiation and advancement of the approved project.



Sec.  59.208  Use of project funds.

    (a) Any funds granted pursuant to this subpart as well as other 
funds to be used in performance of the approved project shall be 
expended solely for carrying out the approved project in accordance with 
the statute, the regulations of this subpart, the terms and conditions 
of the award, and, except as may otherwise be provided in this subpart, 
the applicable cost principles prescribed by 45 CFR part 75, subpart E.
    (b) Prior approval by the Secretary of revision of the budget and 
project plan is required whenever there is to be a significant change in 
the scope or nature of project activities.
    (c) The Secretary may approve the payment of grant funds to trainees 
for:
    (1) Return travel to the trainee's point of origin.
    (2) Per diem during the training program, and during travel to and 
from the program, at the prevailing institutional or governmental rate, 
whichever is lower.

[37 FR 7093, Apr. 8, 1972, as amended at 38 FR 26199, Sept. 19, 1973; 81 
FR 3009, Jan. 20, 2016]



Sec.  59.209  Civil rights.

    Attention is called to the requirements of Title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in 
particular section 601 of such Act which provides that no person in the 
United States shall, on the grounds of race, color, or national origin 
be excluded from participation in, be denied the benefits of, or be 
subjected to discrimination under any program or activity receiving 
Federal financial assistance. A regulation impelmenting such title VI, 
which applies to grants made under this part, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80).



Sec.  59.210  Inventions or discoveries.

    Any grant award pursuant to Sec.  59.206 is subject to the 
regulations of the Department of Health and Human Services as set forth 
in 45 CFR parts 6 and 8, as amended. Such regulations shall apply to any 
activity for which grant funds are in fact used whether within the scope 
of the project as approved or otherwise. Appropriate measures shall be 
taken by the grantee and by the Secretary to assure that no contracts, 
assignments or other arrangements inconsistent with the grant obligation 
are continued or entered into and that all personnel involved in the 
supported activity are aware of and comply with such obligations. 
Laboratory notes, related technical data, and information pertaining to 
inventions and discoveries shall be maintained for such periods, and 
filed with or otherwise made available to the Secretary, or those he may 
designate at such times and in

[[Page 430]]

such manner, as he may determine necessary to carry out such Department 
regulations.



Sec.  59.211  Publications and copyright.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright without prior approval any 
publications, films or similar materials developed or resulting from a 
project supported by a grant under this part, subject, however, to a 
royalty-free, nonexclusive, and irrevocable license or right in the 
Government to reproduce, translate, publish, use, disseminate, and 
dispose of such materials and to authorize others to do so.



Sec.  59.212  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other grant funds, including funds 
derived from other grant awards. With respect to each approved project 
the grantee shall account for the sum total of all amounts paid by 
presenting or otherwise making available evidence satisfactory to the 
Secretary of expenditures for direct and indirect costs meeting the 
requirements of this part: Provided, however, That when the amount 
awarded for indirect costs was based on a predetermined fixed-percentage 
of estimated direct costs, the amount allowed for indirect costs shall 
be computed on the basis of such predetermined fixed-percentage rates 
applied to the total, or a selected element thereof, of the reimbursable 
direct costs incurred.
    (b) [Reserved]
    (c) Accounting for grant-related income--(1) Interest. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the governments of the 
political subdivisions of the State. All grantees other than a State, as 
defined in this subsection, must return all interest earned on grant 
funds to the Federal Government.
    (d) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full account, as 
provided herein, as of the date of the termination of grant support. The 
Secretary may require other special and periodic accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project the 
total sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section;
    (ii) Any credits for earned interest pursuant to paragraph (c)(1) of 
this section;
    (iii) Any other amounts due pursuant to 45 CFR 75.307, 75.371 
through 75.385, and 75.316-75.325.

Such total sum shall constitute a debt owed by the grantee to the 
Federal Government and shall be recovered from the grantee or its 
successors or assignees by setoff or other action as provided by law.

[36 FR 18465, Sept. 15, 1971, as amended at 38 FR 26199, Sept. 19, 1973; 
81 FR 3009, Jan. 20, 2016]



Sec.  59.213  [Reserved]



Sec.  59.214  Additional conditions.

    The Secretary may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in his judgment 
such conditions are necessary to assure or protect advancement of the 
approved project, the interests of public health, or the conservation of 
grant funds.



Sec.  59.215  Applicability of 45 CFR part 75.

    The provisions of 45 CFR part 75, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part.

[81 FR 3009, Jan. 20, 2016]

[[Page 431]]



PART 59a_NATIONAL LIBRARY OF MEDICINE GRANTS--Table of Contents



   Subpart A_Grants for Establishing, Expanding, and Improving Basic 
                                Resources

Sec.
59a.1 Programs to which these regulations apply.
59a.2 Definitions.
59a.3 Who is eligible for a grant?
59a.4 How are grant applications evaluated?
59a.5 Awards.
59a.6 How may funds or materials be used?
59a.7 Other HHS regulations that apply.

          Subpart B_Establishment of Regional Medical Libraries

59a.11 Programs to which these regulations apply.
59a.12 Definitions.
59a.13 Who is eligible for a grant?
59a.14 How to apply.
59a.15 Awards.
59a.16 What other conditions apply?
59a.17 Other HHS regulations that apply.

    Source: 56 FR 29189, June 26, 1991, unless otherwise noted.



   Subpart A_Grants for Establishing, Expanding, and Improving Basic 
                                Resources

    Authority: 42 U.S.C. 286b-2, 286b-5.



Sec.  59a.1  Programs to which these regulations apply.

    (a) The regulations of this subpart apply to grants of funds, 
materials, or both, for establishing, expanding, and improving basic 
medical library resources as authorized by section 474 of the Act (42 
U.S.C. 286b-5).
    (b) This subpart also applies to cooperative agreements awarded for 
this purpose. In these circumstances, references to ``grant(s)'' shall 
include ``cooperative agreements(s).''



Sec.  59a.2  Definitions.

    Undefined terms have the same meaning as provided in the Act. As 
used in this subpart:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Project period--See Sec.  59a.5(c).
    Related instrumentality means a public or private institution, 
organization, or agency, other than a medical library, whose primary 
function is the acquisition, preservation, dissemination, and/or 
processing of information relating to the health sciences.
    Secretary means the Secretary of Health and Human Services and any 
other official of the Department of Health and Human Services to whom 
the authority involved is delegated.



Sec.  59a.3  Who is eligible for a grant?

    Except as otherwise prohibited by law, any public or private 
nonprofit institution, organization, or agency authorized or qualified 
to carry on the functions of a medical library, and any public or 
private related instrumentality, is eligible for a grant under this 
subpart.



Sec.  59a.4  How are grant applications evaluated?

    The Secretary shall evaluate grant applications using the officers 
and employees, and experts, consultants, or groups engaged by the 
Secretary for that purpose. The Secretary's evaluation shall consider 
the scope of library or related services for the population and purposes 
served by the applicant. This evaluation shall include consideration of 
the following information which must be set forth in the grant 
application and such other information the Secretary considers 
pertinent:
    (a) Evidence of the applicant's efficiency in providing services,
    (b) Amount of available equipment and other resources on hand to 
satisfy the needs of the area served by the facility,
    (c) Extent of coordination with other libraries and related 
facilities, and
    (d) Potential for testing or demonstration of new or improved 
techniques in health-sciences informational services.

(Approved by the Office of Management and Budget under control number 
0925-0276)



Sec.  59a.5  Awards.

    (a) General. Within the limits of funds available, the Secretary may 
award grants to those applicants whose proposals for establishments, 
expansion, or improvement will, in the Secretary's judgment, best 
promote the purposes of section 474 of the Act (42 U.S.C. 286b-5).
    (b) Determination of award amount. An Award may not exceed 
$1,000,000 or

[[Page 432]]

other amount established by law for any fiscal year.
    (1) The scope of medical-library or related services provided by the 
applicant for the population and purposes it serves considering:
    (i) The number of graduate and undergraduate students, and 
physicians and other practitioners in health-related sciences making use 
of the applicant's library resources;
    (ii) The type and availability of library support staff;
    (iii) The type, size, and qualifications of the faculty of any 
school with which the applicant is affiliated;
    (iv) The staff of any hospitals or clinics with which the 
applicant's library is affiliated;
    (v) The geographic area served and, within that area, the medical-
library or related services otherwise available; and
    (2) The amount adequate to insure continuing financial support from 
non-Federal sources of the applicant's proposed activity during and 
after the period of award. The Secretary shall consider the level of 
non-Federal support for the proposed activity for periods prior to the 
fiscal year in which a grant is made. The Secretary shall require the 
applicant's assurance that non-Federal support will not be diminished as 
a result of the award and that adequate support for this activity will 
be continued during and after the period of Federal assistance.
    (c) Project period. (1) the notice of grant award specifies how long 
the Secretary intends to support the project without requiring the 
project to recompete for funds. This period, called the project period, 
will usually be for one to five years.
    (2) Generally, the grant will initially be for one year at a time 
and subsequent continuation awards will also be for one year at a time. 
A grantee must submit a separate application to have the support 
continued for each subsequent year. Decisions regarding continuation 
awards and the funding level of these awards will be made after 
consideration of such factors as the grantee's progress and management 
practices, and the availability of funds. In all cases, continuation 
awards require a determination by the Secretary that continued funding 
is in the best interest of the Federal Government.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award for any approved 
application or portion of an approved application.

[56 FR 29189, June 26, 1991, as amended at 59 FR 59168, Nov. 16, 1994]



Sec.  59a.6  How may funds or materials be used?

    The grantee shall expend funds or use materials provided by a grant 
under this subpart solely for the purposes for which the funds or 
materials were granted, in accordance with the pertinent provisions of 
the approved application and budget, the regulations of this subpart, 
the terms and conditions of the award, and the applicable cost 
principles in 45 CFR part 75, subpart E.

[56 FR 29189, June 26, 1991, as amended at 81 FR 3009, Jan. 20, 2016]



Sec.  59a.7  Other HHS regulations that apply.

    Several other regulations apply to grants under this subpart. These 
include, but are not necessarily limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR parts 6 and 8--Inventions and patents
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76 subparts A-F--Governmentwide debarment and suspension 
(nonprocurement) and requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance

[[Page 433]]

45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[56 FR 29189, June 26, 1991, as amended at 81 FR 3009, Jan. 20, 2016]



          Subpart B_Establishment of Regional Medical Libraries

    Authority: 42 U.S.C. 286b-2, 286b-6.



Sec.  59a.11  Programs to which these regulations apply.

    (a) This subpart applies to grants made under section 475 of the Act 
(42 U.S.C. 286b-6). Grants are awarded to medical libraries to enable 
them to serve as regional medical libraries for their geographic areas. 
The purpose of the program is to develop a national system of regional 
medical libraries, each of which would have sufficient facilities to 
supplement the services of other medical libraries in its region.
    (b) The purpose of the program may also be supported by contracts. 
Since the primary purpose of these contracts is to assist regional 
libraries and is not for the purpose of acquiring supplies or services 
for use of the Federal Government, the provisions of the Federal 
Acquisition Regulation (48 CFR chapter 1) do not apply. Any contract 
awarded pursuant to section 475 of the Act shall be subject to the 
applicable provisions of this subpart.



Sec.  59a.12  Definitions.

    Underfined terms have the same meaning as provided in the Act.
    As used in this subpart:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Annual operating expenses means the average annual operating 
expenses for the actual years of operation or an estimated amount based 
on the expenses of libraries or institutions of similar size and 
function.
    Board means the Board of Regents of the National Library of Medicine 
established by section 466 of the Act (42 U.S.C. 286a).
    Geographic area means an area that forms an academically and 
professionally integrated region. Factors considered are location and 
extent of communication facilities and systems, presence and 
distribution of educational and medical and health facilities and 
programs and other activities which, in the Secretary's opinion, justify 
the establishment and operation of a regional medical library.
    Modify and increase means the use of Federal funds or materials to 
supplement rather than supplant non-Federal funds available for library 
resources and services.
    Project period--See Sec.  59a.15(b).
    Secretary means the Secretary of Health and Human Services and any 
other official of the Department of Health and Human Services to whom 
the authority involved is delegated.



Sec.  59a.13  Who is eligible for a grant?

    Except as otherwise prohibited by law, any public or private 
nonprofit organization which is authorized and qualified to operate a 
medical library is eligible for a grant under this subpart.



Sec.  59a.14  How to apply.

    In addition to any other pertinent information which the Secretary 
may require, the applicant shall submit a grant application containing a 
detailed description of a program to provide health-sciences 
informational services for the geographic area in which it is located. 
The description shall include:
    (a) The need for services;
    (b) The adequacy of the applicant's existing or proposed facilities 
and resources to attain the purposes stated in the application;
    (c) The size and nature of the population to be served;
    (d) The region to be served;
    (e) Cooperative arrangements in effect, or proposed, with other 
qualified organizations; and
    (f) The justification for the funds requested.

(Approved by the Office of Management and Budget under control number 
0925-0276)



Sec.  59a.15  Awards.

    (a) General. The Secretary, with the advice of the Board in each 
case, shall award grants to those applicants whose arrangements and 
proposed services will, in the Secretary's judgment, have the greatest 
potential for fulfilling the need for a regional medical library.

[[Page 434]]

The Secretary, in determining the priority assigned an applicant, must 
consider:
    (1) The adequacy of the applicant's library in terms of collections, 
personnel, equipment, and other facilities; and
    (2) The size and nature of the population to be served in the 
applicant's region.
    (b) Project period. (1) The notice of grant award specifies how long 
the Secretary intends to support the project without requiring the 
project to recompete for funds. This period, called the project period, 
will usually be for one to five years.
    (2) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of these awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by the Secretary that continued funding is in the best 
interest of the Federal Government.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award for any approved 
application or portion of an approved application.



Sec.  59a.16  What other conditions apply?

    Although the Secretary may approve exceptions which are consistent 
with program purposes, in addition to other terms, conditions, and 
assurances required by law, each grantee must meet the following 
requirements:
    (a) Use of funds. Any funds granted under this subpart shall be 
expended solely for the purpose for which the funds were granted in 
accordance with the approved application and budget, the regulations of 
this subpart, the terms and conditions of the award, and the applicable 
cost principles in 45 CFR part 75, subpart E.
    (b) Library resources--(1) Provision of services. The grantee shall 
modify and increase its library resources to provide supportive services 
to other health-sciences informational activities.
    (2) Access to and fees for services. The grantee shall provide free 
loan services to qualified users or, in lieu of loans, make available 
photoduplicated or facsimile copies of biomedical materials which 
qualified requesters may retain. Reasonable fees may be charged for 
copies or other services (other than free loan services) provided by a 
grantee under this subpart: Provided, That equal access to the health-
information resources of the region or of the national network is 
assured. These fees shall be designed to recover expenses. The grantee's 
access policies shall determine the qualifications of individuals or 
organizations for access to the services provided under the grant, so 
long as those policies are consistent with the mandatory service 
undertakings of the program. The Secretary may review the grantee's 
access policies to assure compliance with this requirement.

(Approved by the Office of Management and Budget under control number 
0925-0276)

[56 FR 29189, June 26, 1991, as amended at 81 FR 3009, Jan. 20, 2016]



Sec.  59a.17  Other HHS regulations that apply.

    Several other regulations apply to grants under this subpart. These 
include, but are not necessarily limited to:

42 CFR part 50, subpart A--Responsibilities of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR parts 6 and 8--Inventions and patents
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76, subparts A-F--Governmentwide debarment and suspension 
(nonprocurement) and requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and

[[Page 435]]

Human Services--effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[56 FR 29189, June 26, 1991, as amended at 81 FR 3009, Jan. 20, 2016]

[[Page 436]]



             SUBCHAPTER E_FELLOWSHIPS, INTERNSHIPS, TRAINING





PART 61_FELLOWSHIPS--Table of Contents



                      Subpart A_Regular Fellowships

Sec.
61.1 Definitions.
61.2 Applicability.
61.3 Purpose of regular fellowships.
61.4 Establishment and conditions.
61.5 Qualifications.
61.6 Method of application.
61.7 Review of applications; committees; awards.
61.8 Benefits: Stipends; dependency allowances; travel allowances; 
          vacation.
61.9 Payments: Stipends; dependency allowances; travel allowances.
61.10 Benefits: Tuition and other expenses.
61.11 Payments: Tuition and other expenses.
61.12 Accountability.
61.13 Duration and continuation.
61.14 Separate consideration of information concerning moral character 
          or loyalty.
61.15 Moral character or loyalty; reference to Special Review Committee; 
          review and recommendation.
61.16 Termination of or refusal to continue award on grounds relating to 
          moral character or loyalty; hearing.
61.17 Termination on grounds other than those relating to moral 
          character or loyalty.
61.18 Publications.
61.19 Copyright and reproduction.
61.20 Inventions or discoveries.
61.21 Interest.
61.22 Nondiscrimination.

                      Subpart B_Service Fellowships

61.30 Definitions.
61.31 Applicability.
61.32 Purpose of service fellowships.
61.33 Establishment of service fellowships.
61.34 Qualifications.
61.35 Method of application.
61.36 Selection and appointment of service fellows.
61.37 Stipends, allowances, and benefits.
61.38 Duration of service fellowships.



                      Subpart A_Regular Fellowships

    Authority: Sec. 215, 58 Stat. 690, as amended, sec. 8, 77 Stat. 400; 
42 U.S.C. 216, 1857g; secs. 301, 402, 58 Stat. 691, as amended, 707, 
secs. 412, 422, 62 Stat. 464, 598, sec. 433, 64 Stat. 444, as amended, 
sec. 308, 74 Stat. 364, sec. 444, 76 Stat. 1073, sec. 3, 77 Stat. 394, 
secs. 394, 395, 79 Stat. 1062; 42 U.S.C. 241, 282, 287a, 288a, 289c, 
242f, 289g, 1857b, 280b-4, 280b-5.

    Source: 31 FR 12096, Sept. 16, 1966, unless otherwise noted.



Sec.  61.1  Definitions.

    As used in this part:
    (a) Continuation award is an award made by the Surgeon General, 
within the period of support recommended by a fellowship committee, 
without necessity for further action by the committee.
    (b) Noncitizen national means any person who, though not a citizen 
of the United States, owes permanent allegiance to the United States.
    (c) Regular fellowship means an award to support activity not 
requiring performance of services for the Public Health Service.
    (d) Surgeon General means the Surgeon General of the U.S. Public 
Health Service or his delegate.
    (e) Continental United States does not include Hawaii or Alaska.



Sec.  61.2  Applicability.

    The regulations in this subpart apply to the establishment, award, 
and operation of all regular fellowships awarded under the Public Health 
Service Act and the Clean Air Act.



Sec.  61.3  Purpose of regular fellowships.

    Regular fellowships are provided to encourage and promote:
    (a) Research and training for research relating to (1) the physical 
and mental diseases and impairments of man, (2) the organization, 
provision, and financing of health services, (3) the causes, prevention, 
and control of air pollution, and (4) medical library and related health 
sciences and communication of information.
    (b) Special scientific projects for the compilation of existing, or 
writing of original, contributions relating to scientific, social, or 
cultural advancements in sciences related to health.



Sec.  61.4  Establishment and conditions.

    All regular fellowships in the Public Health Service shall be 
established by the Surgeon General. In establishing a fellowship or 
series of fellowships, the Surgeon General shall prescribe in

[[Page 437]]

writing the conditions (in addition to those provided in the regulations 
in this part) under which the fellowships are to be awarded and held.



Sec.  61.5  Qualifications.

    In order to qualify for a regular fellowship, an applicant must:
    (a) Meet the Public Health Service requirements of general 
suitability, including professional and personal fitness.
    (b) Have been accepted by a public or other nonprofit institution 
for the purpose of the activity for which the fellowship is sought.
    (c) Be free from any disease or disability that would interfere with 
the accomplishment of the fellowship purpose.
    (d) If a citizen or noncitizen national of the United States, sign 
and file with the Surgeon General the following statement:

    I do solemnly swear (or affirm) that I bear true faith and 
allegiance to the United States of America and will support and defend 
the Constitution and laws of the United States against all its enemies, 
foreign and domestic.

    (e) Comply with such other requirements as may be prescribed by the 
Surgeon General.



Sec.  61.6  Method of application.

    Application for a regular fellowship shall be made on forms 
prescribed by the Surgeon General. In addition to the information 
supplied by the applicant in his application, such further information 
may be required as is necessary to determine his qualifications and 
fitness.



Sec.  61.7  Review of applications; committees; awards.

    The Surgeon General shall appoint one or more fellowship committees 
to examine the qualifications of applicants for fellowships and the 
merits of their proposals for research, training, or special scientific 
projects. A fellowship committee shall submit to the Surgeon General its 
recommendations concerning appointments. Awards of regular fellowships 
shall be made in writing by the Surgeon General.



Sec.  61.8  Benefits: Stipends; dependency allowances; 
travel allowances; vacation.

    Individuals awarded regular fellowships shall be entitled to such of 
the following benefits as are authorized for the particular series of 
fellowship:
    (a) Stipend.
    (b) Dependency allowances.
    (c) When authorized in advance, separate allowances for travel. Such 
allowances may not exceed amounts prescribed by the Surgeon General for
    (1) Travel to the place where the fellow is to be located during the 
fellowship term, and
    (2) Travel to return the fellow at the end of the fellowship term to 
his home or other place he left to carry out the fellowship, provided 
that (unless otherwise prescribed by the Surgeon General) such return 
travel is to or from a place outside the continental United States.

No allowances will be granted for shipping personal effects or household 
goods and no allowances will be granted for transporting dependents, 
except as authorized by the Surgeon General for travel undertaken by 
dependents (spouse and/or dependent children only) to or from a place 
outside the continental United States where the fellow is to be located 
during the fellowship term and for return from such place or except as 
otherwise prescribed by the Surgeon General for a particular series of 
fellowships.
    (d) Vacation. Stipends and allowances will not be increased, or be 
paid beyond the term of a fellowship, on account of vacation an 
individual might have been entitled to but did not take.



Sec.  61.9  Payments: Stipends; dependency allowances; travel allowances.

    Payments for stipends, dependency allowances, and the travel 
allowances specified in Sec.  61.8 may be made directly to the fellow or 
to the sponsoring institution for payment to the fellow.



Sec.  61.10  Benefits: Tuition and other expenses.

    The Surgeon General may authorize allowances for payment of 
expenses, in whole or in part, of tuition, fees, equipment, supplies, 
attendance at meetings required to carry out the purposes of

[[Page 438]]

the fellowship, or other expenses of the activities of the fellow.



Sec.  61.11  Payments: Tuition and other expenses.

    (a) Tuition and fees. Allowances for tuition and fees may be made to 
the fellow or sponsoring institution.
    (b) Other expenses; standard or maximum allowances. Any allowances 
for equipment, supplies, attendance at meetings, and other expenses 
shall, except as may otherwise be prescribed herein or by the Surgeon 
General, be paid to the sponsoring institution. The Surgeon General may 
establish a standard allowance or a maximum allowance for payment to the 
sponsoring institution for such expenses.
    (c) Attendance at meetings--fellows sponsored by Federal agencies. 
Allowances for expenses of attendance at meetings by fellows who are 
sponsored by Federal agencies may be paid directly to such fellows.
    (d) Installments. Payments to sponsoring institutions and to fellows 
under this section or under Sec.  61.9 may be made in advance or by way 
of reimbursement and, except as may otherwise be prescribed by the 
Surgeon General, in monthly installments.



Sec.  61.12  Accountability.

    Payments shall be subject to such requirements relating to 
accountability as may be specified by the Surgeon General.



Sec.  61.13  Duration and continuation.

    An award period may be any period not in excess of 2 years. The 
Surgeon General may make one or more continuation awards for an 
additional period upon a finding of satisfactory progress toward 
accomplishment of the purposes of the initial fellowship award. 
Additional support may be provided on appropriate justification after 
expiration of the period of support involved in the previous award.



Sec.  61.14  Separate consideration of information concerning 
moral character or loyalty.

    No information in the records or possession of the Public Health 
Service concerning the moral character or loyalty of a fellow will be 
made available to any fellowship committee involved in recommending 
appointments of fellows.



Sec.  61.15  Moral character or loyalty; reference to Special 
Review Committee; review and recommendation.

    (a) Moral character or loyalty; reference to Special Review 
Committee. Whenever the Surgeon General has substantial evidence with 
respect to any fellow (1) that the statement filed pursuant to Sec.  
61.5(d) was not made in good faith; or (2) that a fellow has (i) been 
convicted of a crime involving moral turpitude or (ii) engaged in 
conduct involving moral turpitude (unless in the case of either 
paragraph (a)(2) (i) or (ii) of this section, it is established that the 
fellow is, nevertheless, then a person of good moral character), the 
Surgeon General shall refer the pertinent records to a Special Review 
Committee established as prescribed in paragraph (b) of this section.
    (b) Special Review Committee; composition. The Special Review 
Committee shall be composed of a representative of the Office of the 
Surgeon General designated by the Surgeon General as chairman but 
nonvoting member, the appropriate Associate Director or comparable 
official of the bureau involved, the Chief of the Division of Research 
Grants, the Director of the Institute or the Chief of the Division which 
awarded the fellowship in question, or their delegates, and two 
additional members appointed by the Surgeon General.
    (c) Information; supplementation. The Committee may supplement the 
information referred to it by such correspondence, personal interviews, 
or other informal methods as necessary in order to make its 
recommendation as provided in paragraph (d) of this section.
    (d) Review and recommendation. The Committee shall review the 
pertinent records, determine whether there is substantial reason to 
believe that the award should be terminated or not continued either on 
grounds relating to moral character or on the ground that the statement 
filed pursuant to Sec.  61.5(d) was not made in good faith, and make its 
recommendation to the Surgeon

[[Page 439]]

General in writing, with reasons therefor, accordingly.



Sec.  61.16  Termination of or refusal to continue award on grounds 
relating to moral character or loyalty; hearing.

    If, after review of the recommendation of the Special Review 
Committee, the Surgeon General believes that the award should be 
terminated or should not be continued, he shall notify the fellow and 
sponsoring institution in writing that unless a request for a hearing is 
made by the fellow within 20 days after the fellow's receipt of such 
notice, his fellowship will be terminated or his application for 
continuation of the award denied. A copy of the regulations under this 
subpart and a copy of part 10 of title 45, Code of Federal Regulations, 
shall be enclosed with the notice. The notice shall set forth, as 
specifically as security permits, the grounds for the questions 
pertaining to moral character or loyalty. Any such request for a hearing 
shall be promptly submitted by the Surgeon General to the Chairman of 
the Departmental Fellowship Review Panel for handling in accordance with 
such part 10.



Sec.  61.17  Termination on grounds other than those relating to 
moral character or loyalty.

    The Surgeon General may terminate a fellowship upon receipt from the 
fellow of a written request for termination. The Surgeon General shall 
terminate any fellowship prior to the date it would otherwise expire if 
he determines that the fellow's performance is unsatisfactory or that 
the fellow or the sponsoring institution is unfit or unable to carry out 
the purpose of the fellowship. The fellow and the sponsoring institution 
shall be notified in writing of such termination.



Sec.  61.18  Publications.

    Publication, distribution, and disposition of all manuscripts and 
other materials resulting from a fellowship awarded hereunder shall be 
subject to the conditions that all such materials shall bear appropriate 
acknowledgment of Public Health Service support, that fellows shall 
furnish copies of such publications or other materials as may be 
requested by the Surgeon General, and to such other conditions as the 
Surgeon General may prescribe.



Sec.  61.19  Copyright and reproduction.

    Where the work accomplished under a fellowship award results in a 
book or other copyrightable material, the author is free to copyright 
the work, but the Public Health Service reserves a royalty-free, 
nonexclusive, and irrevocable license to reproduce, publish, or 
otherwise use, and to authorize others to use, all copyrightable or 
copyrighted material resulting from the fellowship award.



Sec.  61.20  Inventions or discoveries.

    Any fellowship award made hereunder is subject to the regulations of 
the Department of Health and Human Services set forth in title 45 CFR 
parts 6 and 8, as amended. Such regulations shall apply to any activity 
for which fellowship funds are in fact used, whether within the scope of 
the fellowship as approved or otherwise. Appropriate measures shall be 
taken by the fellow, the sponsoring institution, and the Surgeon General 
to assure that no contracts, assignments, or other arrangements 
inconsistent with the fellowship obligation are entered into or 
continued and that all personnel involved in the supported activity are 
aware of and comply with such obligation. Laboratory notes, related 
technical data and information pertaining to inventions or discoveries 
shall be maintained for such periods, and filed with or otherwise made 
available to the Surgeon General or those whom he may designate at such 
times and in such manner as he may determine necessary to comply with 
such Department regulations.



Sec.  61.21  Interest.

    Any interest earned through deposit or investment by the sponsoring 
institution of funds paid pursuant to the provisions of this subpart 
shall be paid to the United States as such interest is received by the 
sponsoring institution.



Sec.  61.22  Nondiscrimination.

    Attention is called to the fact that funds paid to a sponsoring 
institution

[[Page 440]]

pursuant to Sec.  61.11 in order to meet the expenses of the activities 
of a fellow are considered Federal financial assistance to such 
institution. The institution is thus subject in this respect to the 
prohibition against discrimination on the basis of race, color, or 
national origin imposed by title VI, Civil Rights Act of 1964, and the 
implementing Regulation of the Department of Health and Human Services 
(45 CFR part 80).



                      Subpart B_Service Fellowships

    Authority: 42 U.S.C. 209, 210, 216.

    Source: 31 FR 12098, Sept. 16, 1966, unless otherwise noted.



Sec.  61.30  Definitions.

    As used in this part:
    Continental United States does not include Hawaii or Alaska.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved may be delegated.
    Service Fellowship is one which requires the performance of 
services, either full or part time, for the Public Health Service.

[63 FR 9950, Feb. 27, 1998]



Sec.  61.31  Applicability.

    The regulations in this part apply to the establishment of service 
fellowships in the Public Health Service, the designation of persons to 
receive such fellowships, and the appointment of service fellows under 
authority of section 207(g) of the Public Health Service Act.



Sec.  61.32  Purpose of service fellowships.

    Service fellowships in the Public Health Service are for the purpose 
of encouraging and promoting research, studies, and investigations 
related to health. Such fellowships may be provided to secure the 
services of talented scientists for a period of limited duration for 
health-related research, studies, and investigations where the nature of 
the work or the character of the individual's services render customary 
employing methods impracticable or less effective.



Sec.  61.33  Establishment of service fellowships.

    All service fellowships shall be established by the Secretary. In 
establishing a service fellowship, or a series of service fellowships, 
the Secretary shall prescribe in writing the conditions (in addition to 
those provided in the regulations in this part) under which service 
fellows will be appointed and will hold their fellowships.

[63 FR 9950, Feb. 27, 1998]



Sec.  61.34  Qualifications.

    Scholastic and other qualifications shall be prescribed by the 
Secretary for each service fellowship, or series of service fellowships. 
Each individual appointed to a service fellowship shall:
    (a) Have presented satisfactory evidence of general suitability, 
including professional and personal fitness; and
    (b) Possess any other qualifications as reasonably may be 
prescribed.

[63 FR 9950, Feb. 27, 1998]



Sec.  61.35  Method of application.

    Application for a service fellowship shall be made in accordance 
with procedures established by the Secretary.

[63 FR 9950, Feb. 27, 1998]



Sec.  61.36  Selection and appointment of service fellows.

    The Secretary shall:
    (a) Prescribe a suitable professional and personal fitness review 
and an examination of the applicant's qualifications;
    (b) Designate in writing persons to receive service fellowships; and
    (c) Establish procedures for the appointment of service fellows.

[63 FR 9950, Feb. 27, 1998]



Sec.  61.37  Stipends, allowances, and benefits.

    (a) Stipends. Service fellows shall be entitled to such stipend as 
is authorized by the Secretary for each service fellowship or series of 
service fellowships.
    (b) Travel and transportation allowances. Under conditions 
prescribed by the Secretary, an individual appointed as a service fellow 
may be authorized

[[Page 441]]

personal travel allowances or transportation and per diem, travel 
allowances or transportation for his or her immediate family, and 
transportation of household goods and personal effects, in conjunction 
with travel authorized by the Secretary.
    (1) From place of residence, within or outside the continental 
United States, to first duty station,
    (2) For any change of duty station ordered by the Service during the 
term of the fellowship, and
    (3) From last duty station to the place of residence which he left 
to accept the fellowship, or to some other place at no greater cost to 
the Government.
    (4) A service fellow shall be entitled to travel allowances or 
transportation and per diem while traveling on official business away 
from his or her permanent duty station during the term of the 
fellowship. Except as otherwise provided herein, a service fellow shall 
be entitled to travel and transportation allowances authorized in this 
part at the same rates as may be authorized by law and regulations for 
other civilian employees of the Public Health Service. If a service 
fellow dies during the term of a fellowship, and the place of residence 
that was left by the service fellow to accept the fellowship was outside 
the continental United States, the payment of expenses of preparing the 
remains for burial and transporting them to the place of residence for 
interment may be authorized. In the case of deceased service fellows 
whose place of residence was within the continental United States, 
payment of the expenses of preparing the remains and transporting them 
to the place of residence for interment may be authorized as provided 
for other civilian employees of the Public Health Service.
    (c) Benefits. In addition to other benefits provided herein, service 
fellows shall be entitled to benefits as provided by law or regulation 
for other civilian employees of the Public Health Service.
    (d) Training. Service fellows are eligible for training at 
Government expense on the same basis as other civilian employees.

[31 FR 12098, Sept. 16, 1966, as amended at 63 FR 9950, Feb. 27, 1998]



Sec.  61.38  Duration of service fellowships.

    Initial appointments to service fellowships may be made for varying 
periods not in excess of 5 years. Such an appointment may be extended 
for varying periods not in excess of 5 years for each period in 
accordance with procedures and requirements established by the 
Secretary.

[63 FR 9951, Feb. 27, 1998]



PART 62_NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP AND LOAN REPAYMENT PROGRAMS--
Table of Contents



       Subpart A_National Health Service Corps Scholarship Program

Sec.
62.1 What is the scope and purpose of the National Health Service Corps 
          scholarship program?
62.2 Definitions.
62.3 Who is eligible to apply for a scholarship program award?
62.4 To whom will scholarship program awards be available in addition to 
          those individuals pursuing courses of study leading to degrees 
          in medicine, osteopathy or dentistry?
62.5 How is application made for a scholarship program award?
62.6 How will individuals be selected to participate in the scholarship 
          program?
62.7 What will an individual be awarded for participating in the 
          scholarship program?
62.8 What does an individual have to do in return for the scholarship 
          program award?
62.9 Under what circumstances can the period of obligated service be 
          deferred to complete approved graduate training?
62.10 What will happen if an individual does not comply with the terms 
          and conditions of participating in the scholarship program?
62.11 When can a scholarship program payment obligation be discharged in 
          bankruptcy?
62.12 Under what circumstances can the service or payment obligation be 
          canceled, waived or suspended?
62.13 What are the limitations on the receipt of concurrent benefits?
62.14 What are the special provisions relating to recipients of awards 
          under the PH/NHSC scholarship training program who will also 
          receive awards under the scholarship program?

[[Page 442]]

     Subpart B_National Health Service Corps Loan Repayment Program

62.21 What is the scope and purpose of the National Health Service Corps 
          Loan Repayment Program?
62.22 Definitions.
62.23 How will individuals be selected to participate in the Loan 
          Repayment Program?
62.24 Who is eligible to apply for the Loan Repayment Program?
62.25 What does the Loan Repayment Program provide?
62.26 What does an individual have to do in return for loan repayments 
          received under the Loan Repayment Program?
62.27 What will happen if an individual does not comply with the terms 
          and conditions of participation in the Loan Repayment Program?
62.28 Under what circumstances can the service or payment obligation be 
          canceled, waived or suspended?
62.29 Under what circumstances can the Loan Repayment Program obligation 
          be discharged in bankruptcy?
62.30 What other regulations and statutes apply?

           Subpart C_Grants for State Loan Repayment Programs

62.51 What is the scope and purpose of the State Loan Repayment Program?
62.52 Definitions.
62.53 Who is eligible for this program?
62.54 What must applications for the State Loan Repayment Program 
          contain?
62.55 What State Program Elements are required to ensure similarity with 
          the NHSC Loan Repayment Program?
62.56 How are the Federal grant funds and State matching funds to be 
          used under this program?
62.57 How will States be selected to participate in this program?
62.58 What other regulations apply?

                   Subpart D_Special Repayment Program

62.71 What is the scope and purpose of the Special Repayment Program?
62.72 Definitions.
62.73 What are the procedures for participation in the Special Repayment 
          Program?
62.74 How much credit will a Program participant receive for monetary 
          repayments made, or approved service performed, before 
          beginning service under the Special Repayment Program?
62.75 Will individuals serving under the Special Repayment Program 
          receive credit for partial service?
62.76 How will amounts of money due under the option under section 
          204(c)(1) of Public Law 100-177 be required to be repaid?

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 751 of the Public Health 
Service Act, 90 Stat. 2281 (42 U.S.C. 294t), unless otherwise noted.

    Source: 45 FR 55429, Aug. 20, 1980, unless otherwise noted.



       Subpart A_National Health Service Corps Scholarship Program



Sec.  62.1  What is the scope and purpose of the National 
Health Service Corps scholarship program?

    These regulations apply to the award of scholarships under the 
National Health Service Corps Scholarship Program authorized by section 
751 of the Public Health Service Act (42 U.S.C. 294t) to students 
receiving academic training in medicine, osteopathy, dentistry, and 
other health professions. The purpose of this program is to assure an 
adequate supply of trained health professionals for the National Health 
Service Corps which is used by the Secretary to improve the delivery of 
health services in health manpower shortage areas.



Sec.  62.2  Definitions.

    As used in this part:
    Acceptable level of academic standing means the level at which a 
full-time student retains eligibility to continue in attendance in 
school under the school's standards and practices.
    Act means the Public Health Service Act, as amended.
    Approved graduate training means those programs of graduate training 
in medicine, osteopathy, dentistry or other health professions which (a) 
lead to eligibility for board certification or which provide other 
evidence of completion, and (b) have been approved by the appropriate 
health professions body as determined by the Secretary.
    Full-time student means an individual pursuing a course of study 
leading to a degree in medicine, osteopathy, dentistry or an equivalent 
credential for a particular health profession who is enrolled for a 
sufficient number of credit hours in any academic term to complete the 
course of study within not more than the number of academic terms 
normally required at the school.

[[Page 443]]

If an individual is enrolled in a school and is pursuing a course of 
study which is designed to be completed in more than 4 years, the 
individual will be considered a full-time student for only the last 4 
years of the course of study.
    Health manpower shortage area means the geographic area, the 
population group, the public or nonprofit private medical facility, or 
other public facility which has been determined by the Secretary to have 
a shortage of health manpower under section 332 of the Act and its 
implementing regulations (42 CFR part 5).
    National of the United States means a citizen of the United States 
or a person who, though not a citizen of the United States, owes 
permanent allegiance to the United States.
    Public Health and National Health Service Corps Scholarship Training 
Program, or PH/NHSC Scholarship Training Program, means the program 
authorized by section 225 of the Act as in effect on September 30, 1977, 
and repealed on October 1, 1977.
    Scholarship Program means the National Health Service Corps 
Scholarship Program authorized by section 751 of the Act (42 U.S.C. 
294t).
    Scholarship Program participant or participant means an individual 
whose application to the Scholarship Program has been approved and whose 
contract has been accepted and signed by the Secretary.
    School means a school of medicine, osteopathy, dentistry, or other 
health profession which (a) provides training leading to a degree of 
doctor of medicine, doctor of osteopathy, doctor of dentistry, or an 
equivalent credential for a particular health profession, and (b) which 
is accredited by a body or bodies recognized for accreditation purposes 
by the Secretary of Education.
    School year means all or part of the 12-month period from July 1 
through June 30 during which an applicant is enrolled in a school as a 
full-time student.
    Service means the United States Public Health Service.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    State means one of the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin 
Islands, Guam, American Samoa, and the Trust Territory of the Pacific 
Islands.



Sec.  62.3  Who is eligible to apply for a scholarship program award?

    (a) To be eligible for a scholarship under this part an applicant 
must:
    (1) Be accepted for enrollment, or be enrolled, as a full-time 
student in a school located in a State;
    (2) Be pursuing a course of study or program offered by the school 
leading to a degree in medicine, osteopathy, dentistry, or an equivalent 
credential for a particular health profession;
    (3) Be eligible for, or hold, an appointment as a commissioned 
officer in the Regular or Reserve Corps of the Service or be eligible 
for selection for civilian service in the National Health Service Corps;
    (4) Be a National of the United States; and
    (5) Submit an application to participate in the Scholarship Program 
together with a signed contract as described in section 751(f) of the 
Act.
    (b) Any applicant who owes an obligation for professional practice 
to a State or other entity under an agreement entered into before filing 
an application under this part is ineligible for an award unless a 
written statement satisfactory to the Secretary is submitted from the 
State or entity that (1) there is no potential conflict in fulfilling 
the service obligation to the State or entity and the Scholarship 
Program, and that (2) the Scholarship Program service obligation will be 
served before the service obligation for professional practice owed to 
the State or entity.
    (c) Any individual who receives a scholarship under the Indian 
Health Service Scholarship Program (section 757 of the Act) or the 
Scholarship Program for First-Year Students of Exceptional Financial 
Need (section 758 of the Act) is ineligible to participate in the 
Scholarship Program during the

[[Page 444]]

School year(s) for which the scholarships under sections 757 or 758 of 
the Act were awarded.



Sec.  62.4  To whom will scholarship program awards be available in addition 
to those individuals pursuing courses of study leading to degrees in medicine, 
osteopathy, or dentistry?

    The Secretary will, from time-to-time, publish in the Federal 
Register a list of those health professions in addition to medicine, 
osteopathy, and dentistry for which the National Health Service Corps 
has need and for which support is available. The Secretary will also 
publish any other eligibility criteria, in addition to those in Sec.  
62.3, that may be required to assure that participants can be utilized 
during their periods of obligated service in a manner that will best 
meet the needs of the National Health Service Corps.



Sec.  62.5  How is application made for a scholarship program award?

    Each individual desiring a scholarship under this part must submit 
an application (including a signed contract as required under section 
751(f) of the Act) in the form and at the time prescribed by the 
Secretary.



Sec.  62.6  How will individuals be selected to participate in 
the scholarship program?

    (a) General. In deciding which applications for participation in the 
Scholarship Program will be approved, the Secretary will place the 
applications into categories based upon the selection priorities 
described in paragraph (b) of this section. Except for continuation 
awards (see paragraph (e) of this section) the Secretary will then 
evaluate each applicant under paragraph (c) of this section.
    (b) Priorities. (1) First priority will be given to individuals who 
have previously received a scholarship under the PH/NHSC Scholarship 
Training Program, a scholarship under this Scholarship Program, or a 
scholarship under section 758 of the Act, authorizing scholarships for 
first-year students of exceptional financial need. (2) Second priority 
will be given to applicants who are entering their first year of study.
    (c) Selection. (1) In selecting participants, the Secretary will 
take into consideration those factors which he or she determines 
necessary to assure effective participation in the Scholarship Program. 
These factors may include, but not be limited to (i) work experience, 
(ii) community background, (iii) career goals, (iv) faculty 
recommendation, and (v) academic performance.
    (2) Special consideration will be given to (i) medical and 
osteopathic students who indicate their intention to enter family 
practice, internal medicine, pediatrics, or osteopathic general practice 
residencies, (ii) dental students who indicate their intention to 
undertake general practice training following graduation or who plan no 
postgraduate training, and (iii) those individuals who indicate an 
intent to pursue other types of clinical practice or specialized 
training for which the National Health Service Corps has a particular 
need.
    (d) Duration of Scholarship award. Subject to the availability of 
funds for the Scholarship Program, the Secretary will award a 
participant a scholarship under this part for a period of 1 school year.
    (e) Continuation awards. Subject to the availability of funds for 
the Scholarship Program, the Secretary will award a continuation 
scholarship if (1) the participant requests a continuation, (2) the 
award will not extend the total period of Scholarship Program support 
beyond 4 years, and (3) the participant is eligible for continued 
participation in the Scholarship Program.



Sec.  62.7  What will an individual be awarded for participating in 
the scholarship program?

    (a) Amount of scholarship. (1) A scholarship award for each school 
year will consist of (i) tuition, (ii) reasonable educational expenses, 
including required fees, books, supplies, and required educational 
equipment, and (iii) a monthly stipend for the 12-month period beginning 
with the first month of each school year in which the individual is a 
participant. For purposes of this section ``required fees'' means those 
fees which are charged by the

[[Page 445]]

school to all students pursuing a similar curriculum and ``required 
educational equipment'' means educational equipment which must be rented 
or purchased by all students pursuing a similar curriculum at that 
school.
    (2) The Secretary may enter into a contract with the school in which 
the participant is enrolled for the direct payment of tuition and 
reasonable educational expenses in the participant's behalf.
    (b) Payment of scholarship: Leave-of-absence; repeated course work. 
The Secretary will suspend scholarship payments to or on behalf of a 
participant if the school (1) approves a leave-of-absence for the 
participant for health, personal, or other reasons, or (2) requires the 
participant to repeat course work for which the Secretary has previously 
made scholarship payments under Sec.  62.7. However, if the repeated 
course work does not delay the participant's graduation date, 
scholarship payments will continue except for any additional costs 
relating to the repeated course work. Any scholarship payments suspended 
under this paragraph will be resumed by the Secretary upon notification 
by the school that the participant has returned from the leave-of-
absence or has completed the repeated course work and is pursuing as a 
full-time student the course of study for which the scholarship was 
awarded.



Sec.  62.8  What does an individual have to do in return 
for the scholarship program award?

    (a) General. Except as provided in paragraphs (d), (f), and (g) of 
this section, each participant is obligated to (1) become a member of 
the National Health Service Corps employed as a Commissioned Officer in 
the Regular or Reserve Corps of the Service or as a Federal civilian in 
the full-time clinical practice of the participant's profession and (2) 
serve in the health manpower shortage area to which the participant is 
assigned by the National Health Service Corps.
    (b) Beginning of service. (1) The period of obligated service will 
begin when the Scholarship Program participant begins to provide 
services in the health manpower shortage area to which he or she is 
assigned by the Secretary. Except for those participants who receive a 
deferral under Sec.  62.9 (a) or (b), this assignment will be made by 
the Secretary as soon as possible following: (i) the completion of the 
participant's course of study leading to a degree in medicine, 
osteopathy, dentistry, or an equivalent credential for a particular 
health profession, and (ii) appointment of the participant as a 
Commissioned Officer in the Regular or Reserve Corps of the Service or 
as a civilian member of the National Health Service Corps.
    (2) For purposes of this paragraph, ``appointment'' means only those 
appointments as Commissioned Officers in the Regular or Reserve Corps of 
the Service or as civilian members of the National Health Service Corps 
made specifically for the purpose of serving a participant's period of 
obligated service.
    (c) Duration of service. Except as provided in Sec.  62.14(b)(1), 
the period for which the Scholarship Program participant is obligated to 
serve is equal to 1 year for each school year for which the participant 
receives a scholarship award under this part, or 2 years, whichever is 
greater.
    (d) Service by detail. If the Secretary determines that there is no 
need in a health manpower shortage area for a member of the profession 
in which the Scholarship Program participant is obligated to provide 
service, the Scholarship Program participant may be detailed to serve 
the period of obligated service as a full-time member of the profession 
for which the participant has been trained, in any unit of the 
Department of Health and Human Services as the Secretary may determine.
    (e) Creditability of approved graduate training. Except as provided 
in Sec.  62.14(b)(2), no period of approved graduate training will be 
credited toward satisfying the period of obligated service incurred 
under the Scholarship Program.
    (f) Service under the National Research Service Award Program. (1) A 
Scholarship Program participant who demonstrates exceptional promise for 
medical research may perform the period of obligated service owed under 
this section by participating in the National

[[Page 446]]

Research Service Award Program for individual postdoctoral fellows 
authorized under section 472 of the Act.
    (2) Exceptional promise for medical research will be demonstrated if 
the participant applies for a National Research Service Award for 
individual postdoctoral fellows, is selected to participate in this 
research program, and accepts the offer of participation. A Scholarship 
Program participant in the National Research Service Award Program will 
receive credit toward satisfying the period of obligated service 
incurred under this section for any period of time he or she is engaged 
in activities which meet the service requirements of the National 
Research Service Award Program.
    (3) If the time served under the National Research Service Award 
Program is less than the total period of obligated service owed under 
the Scholarship Program, the participant will serve the remainder of the 
Scholarship Program service obligation (i) in activities which meet the 
criteria for service under the National Research Service Award Program, 
as approved by the Secretary or (ii) as a member of the National Health 
Service Corps providing health services in the full-time clinical 
practice of his or her health profession. A participant who fails to 
begin or complete the service requirements under the National Research 
Service Award Program may be subject to the default penalty under Sec.  
62.10(c) of this part and the default penalties under the National 
Research Service Award Program.
    (g) Release from service obligation to engage in private practice. 
The Secretary will release a participant from all or part of the service 
obligation if the participant applies for a release under section 753 of 
the Act and agrees in writing to engage for a period equal to the 
remaining period of the participant's service obligation in the full-
time private clinical practice of the participant's health profession, 
under the requirements of section 753 of the Act.



Sec.  62.9  Under what circumstances can the period of obligated service 
be deferred to complete approved graduate training?

    (a) Requested deferment. Upon the request of any participant 
receiving a degree from a school of medicine, osteopathy, or dentistry, 
veterinary medicine, optometry, podiatry or pharmacy, the Secretary will 
defer the beginning date of the obligated service to allow the 
participant to complete an approved graduate training program. The 
period of this deferment may not exceed (1) three years for any 
participant receiving a degree from a school of medicine, osteopathy or 
dentistry, or (2) one year for any participant receiving a degree from a 
school of veterinary medicine, optometry, podiatry or pharmacy. The 
Secretary may, however, extend this period of deferment if the Secretary 
determines that the extension is consistent with the needs of the 
National Health Service Corps.
    (b) Required deferment. Each participant receiving a degree in 
medicine or osteopathy who does not intend to enter training which can 
be completed within the deferment period granted under paragraph (a) of 
this section must complete at least one year of approved graduate 
training before beginning the period of obligated service. This one year 
of training must be in (1) an allopathic flexible first-year program 
whose sponsorship includes approved residencies in family practice, 
internal medicine, pediatrics, or a categorical first-year program in 
family practice, internal medicine, or pediatrics; (2) a rotating 
internship in osteopathic medicine; or (3) such other programs as the 
Secretary determines provides comparable experience. Any participant 
receiving a degree in medicine or osteopathy who fails to complete the 
one year of required training or an approved graduate training program 
for which a deferment was granted under paragraph (a) of this section 
will be subject to the default penalties of Sec.  62.10(c).
    (c) Altering deferment. Before altering the length or type of 
approved graduate training for which the period of obligated service was 
deferred under paragraphs (a) or (b) of this section,

[[Page 447]]

the participant must request and obtain the Secretary's approval of the 
alteration.
    (d) Additional terms of deferment. The Secretary may prescribe 
additional terms and conditions for deferment under paragraphs (a), (b), 
and (c) of this section as necessary to carry out the purposes of the 
Scholarship Program.
    (e) Beginning of service after deferment. Any participant whose 
period of obligated service has been deferred under paragraphs (a) or 
(b) of this section must begin the obligated service when the 
participant begins to provide health services in the health manpower 
shortage area to which he or she is assigned by the Secretary. This 
assignment will be made by the Secretary as soon as possible following 
(1) the completion of the requested or required graduate training for 
which the deferment was granted, and (2) appointment as a Commissioned 
Officer in the Regular or Reserve Corps of the Service or as a civilian 
member of the National Health Service Corps.



Sec.  62.10  What will happen if an individual does not comply with 
the terms and conditions of participating in the scholarship program?

    (a) If a participant, other than one described in paragraph (b) of 
this section, fails to accept payment or instructs the school not to 
accept payment of the scholarship provided by the Secretary, the 
participant must, in addition to any service or other obligation 
incurred under the contract, pay to the United States the amount of 
$1,500 liquidated damages. Payment of this amount must be made within 30 
days of the date on which the participant fails to accept payment of the 
scholarship award or instructs the school not to accept payment.
    (b) When a participant fails to maintain an acceptable level of 
academic standing, is dismissed from the school for disciplinary 
reasons, or voluntarily terminates the course of study or program for 
which the scholarship was awarded before completing the course of study 
or program, the participant must, instead of performing any service 
obligation, pay to the United States an amount equal to all scholarship 
funds awarded under Sec.  62.7. Payment of this amount must be made 
within 3 years of the date the participant becomes liable to make 
payment under this paragraph.
    (c) If a participant fails to begin or complete the period of 
obligated service incurred under Sec.  62.8, including failing to comply 
with the applicable terms and conditions of a deferment granted by the 
Secretary, the participant must pay to the United States an amount 
determined by the formula set forth in section 754(c) of the Act. 
Payment of this amount shall be made within 1 year of the date that the 
participant failed to begin or complete the period of obligated service, 
as determined by the Secretary.



Sec.  62.11  When can a scholarship program payment obligation 
be discharged in bankruptcy?

    In accordance with section 754(d)(3) of the Act, any payment 
obligation incurred under Sec.  62.10 may not be discharged in 
bankruptcy under title XI of the United States Code until 5 years after 
the date on which the payment obligation is due.



Sec.  62.12  Under what circumstances can the service or payment obligation 
be canceled, waived or suspended?

    (a) Any obligation of a participant for service or payment will be 
canceled upon the death of the participant.
    (b)(1) A participation may seek a waiver or suspension of the 
service or payment obligations incurred under this part by written 
request to the Secretary setting forth the bases, circumstances, and 
causes which support the requested action. The Secretary may approve a 
request for a suspension for a period of 1 year. A renewal of this 
suspension may also be granted.
    (2) The Secretary may waive or suspend any service or payment 
obligation incurred by a participant whenever compliance by the 
participant (i) is impossible, or (ii) would involve extreme hardship to 
the participant and if enforcement of the service or payment obligation 
would be against equity and good conscience.
    (c) Compliance by a participant with a service or payment obligation 
will be considered impossible if the Secretary determines, on the basis 
of information

[[Page 448]]

and documentation as may be required, that the participant suffers from 
a physical or mental disability resulting in the permanent inability of 
the participant to perform the service or other activities which would 
be necessary to comply with the obligation.
    (d) In determining whether to waive or suspend any or all of the 
service or payment obligations of a participant as imposing an undue 
hardship and being against equity and good conscience, the Secretary, on 
the basis of information and documentation as may be required, will 
consider:
    (1) The participant's present financial resources and obligations;
    (2) The participant's estimated future financial resources and 
obligations; and
    (3) The extent to which the participant has problems of a personal 
nature, such as physical or mental disability, terminal illness in the 
immediate family which so intrude on the participant's present and 
future ability to perform as to raise a presumption that the individual 
will be unable to perform the obligation incurred.



Sec.  62.13  What are the limitations on the receipt of concurrent benefits?

    Under section 741(f) or 836(h) of the Act, the Secretary may agree 
to repay a portion of an individual's educational loans in return for 
the individual's agreement to practice his or her profession in an area 
in need of health manpower. However, a Scholarship Program participant 
may not enter into an agreement with the Secretary under section 741(f) 
or 836(h) of the Act, until either:
    (a) The participant has completed the service obligation under the 
Scholarship Program,
    (b) The Secretary has recovered from the participant an amount 
determined under Sec.  62.10, or
    (c) Any service or payment obligation has been waived under Sec.  
62.12.

In no case shall a scholarship received under these regulations be 
considered an educational loan for the purposes of section 741(f) or 
836(h) of the Act.



Sec.  62.14  What are the special provisions relating to recipients of awards 
under the PH/NHSC scholarship training program who will also receive awards 
under the scholarship program?

    (a) Except as provided in paragraph (b) of this section, if a 
participant has previously received an award under the PH/NHSC 
Scholarship Training Program and also receives an award under the 
Scholarship Program, the terms and conditions of these regulations will 
apply to the participant's entire obligation incurred under both the PH/
NHSC Scholarship Training Program and the Scholarship Program.
    (b) If a participant has received an award under the PH/NHSC 
Scholarship Training Program and also receives an award under the 
Scholarship Program, the following conditions apply:
    (1) Period of obligated service--carry over. The period of obligated 
service owed by the participant is equal to the total number of school 
years for which scholarship support was awarded under both the PH/NHSC 
Scholarship Training Program and the Scholarship Program without regard 
to either Program's minimum support requirement under 42 CFR 62.7(a) 
(1976) as adopted on May 22, 1974 (see 39 FR 17962), and under Sec.  
62.8(c) of this part.
    (2) Credit for internship and residency training. (i) If a 
participant received a scholarship under the PH/NHSC Scholarship 
Training Program for any school year beginning before October 12, 1976, 
the participant will receive credit toward satisfying the periods of 
obligated service incurred under the PH/NHSC Scholarship Training 
Program and under Sec.  62.8 of this part for any periods of internship 
or residency training served in a Service or National Health Service 
Corps facility.
    (ii) If a participant received a scholarship for the first time 
during the 1977-78 school year under the PH/NHSC Scholarship Training 
Program, the participant will only receive 1 year of credit toward 
satisfying the period of obligated service incurred under the PH/NHSC 
Scholarship Training Program for internship or residency training served 
in a Service or National Health Service Corps facility.

[[Page 449]]

    (3) Default penalties. The PH/NHSC Scholarship Training Program 
default penalty will apply to a participant who fails to begin or 
complete the active duty service obligation incurred under that Program, 
and the Sec.  62.10 default penalties will apply to a participant who 
fails to begin or complete the service obligation incurred under Sec.  
62.8 of these regulations. In determining which default penalty to apply 
when an individual who has received a Scholarship award under both the 
PH/NHSC Scholarship Training Program and the Scholarship Program fails 
to begin or complete his service obligation, the service obligations 
will be considered to have been served in the order in which they were 
incurred.



     Subpart B_National Health Service Corps Loan Repayment Program

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 338B of the Public Health 
Service Act, 101 Stat. 992 (42 U.S.C. 2541-1).

    Source: 54 FR 13462, Apr. 3, 1989, unless otherwise noted.



Sec.  62.21  What is the scope and purpose of the National Health 
Service Corps Loan Repayment Program?

    The regulations of this subpart apply to the award of health 
professions educational loan payments under the National Health Service 
Corps Loan Repayment Program authorized by section 338B of the Public 
Health Service Act (42 U.S.C. 2541-1). The purpose of the Program is to 
assure an adequate supply of trained health professionals for the 
National Health Service Corps. These professionals will be assigned by 
the Secretary to provide necessary health services to persons living in 
designated health manpower shortage areas.



Sec.  62.22  Definitions.

    The definitions in Sec.  62.2 of this part will apply for the 
purpose of this subpart, except for the definition of approved graduate 
training. The following definitions will also apply for purposes of this 
subpart:
    Approved graduate training means a program of graduate training in 
allopathic or osteopathic medicine, dentistry or other health profession 
which (a) leads to eligibility for board certification or which provides 
other evidence of completion, (b) has been approved by the appropriate 
health professions body as determined by the Secretary and (c) is in the 
specialty or type of training specified by the Program participant in 
the Loan Repayment Program Contract or, at the Program participant's 
request and at the Secretary's option, is in a specialty or area of 
training determined by the Secretary to be consistent with the needs of 
the National Health Service Corps.
    Commercial loans means loans made by banks, credit unions, savings 
and loan associations, insurance companies, schools, and other financial 
or credit institutions which are subject to examination and supervision 
in their capacity as lenders by an agency of the United States or of the 
State in which the lender has its principal place of business.
    Educational expenses means the costs of the health professions 
education, exclusive of the tuition, such as fees, books, supplies, and 
educational equipment and materials.
    Government loans means loans which are made by Federal, State, 
county or city agencies which are authorized by law to make such loans.
    Living expenses means the costs of room and board, transportation 
and commuting costs and other costs incurred during an individual's 
attendance at a health professions school.
    Loan Repayment Program means the National Health Service Corps Loan 
Repayment Program authorized by section 338B of the Act (42 U.S.C. 2541-
1).
    Loan Repayment Program Contract means the agreement, which is signed 
by an applicant and the Secretary, for the Loan Repayment Program 
wherein the applicant agrees to accept repayment of health professions 
educational loans and to serve in accordance with the provisions of 
section 338B of the Act and this subpart for a prescribed period of 
obligated service.
    Medically underserved area means health manpower shortage area as 
defined in Sec.  62.2.

[[Page 450]]

    Program participant means an individual whose application to the 
Loan Repayment Program has been approved and whose contract has been 
accepted and signed by the Secretary.
    Qualifying loans means government and commercial loans for actual 
costs paid for tuition, reasonable educational expenses, and reasonable 
living expenses relating to the obtainment of a degree in allopathic or 
osteopathic medicine, dentistry, or other health profession. Such loans 
must have documentation which is contemporaneous with the training 
received in a health professions school. If health professions 
educational loans are refinanced, the original documentation of the 
loan(s) will be required to be submitted to the Secretary to establish 
the contemporaneous nature of such loans.
    Reasonable educational and living expenses means those educational 
and living expenses which are equal to or less than the sum of the 
school's estimated standard student budgets for educational and living 
expenses for the degree program and for the year(s) during which the 
Program participant is/was enrolled in the school. However, if the 
school attended by the Program participant does/did not have a standard 
student budget or if a Program participant requests repayment for 
educational and living expenses which are in excess of the standard 
student budgets described in the preceding sentence, the Program 
participant must submit documentation, as required by the Secretary, to 
substantiate the reasonableness of all educational and living expenses 
incurred by the Program participant. To the extent that the Secretary 
determines, upon review of the Program participant's documentation, that 
all or a portion of the educational and living expenses are reasonable, 
these expenses will qualify for repayment.



Sec.  62.23  How will individuals be selected to participate 
in the Loan Repayment Program?

    (a) In determining which applications from eligible individuals for 
participation in the Loan Repayment Program will be accepted for 
consideration, the Secretary will apply the following criteria:
    (1) The extent to which an individual's training is in a health 
profession or specialty determined by the Secretary to be needed by the 
National Health Service Corps;
    (2) The individual's commitment to serve in medically underserved 
areas;
    (3) The availability of the individual for service, with highest 
consideration being given to individuals who will be available for 
service at the earliest dates;
    (4) The length of the individual's proposed service obligation, with 
greatest consideration being given to persons who agree to serve for 
longer periods of time; and
    (5) The individual's academic standing, prior professional 
experience in a health manpower shortage area, board certification, 
residency achievements, peer recommendations, depth of past residency 
practice experience and other criteria related to professional 
competence or conduct.
    (b) Among qualified applicants, the Secretary will give priority to 
applications from individuals whose health professions or specialties 
are most needed by the NHSC and who are, in the Secretary's judgement, 
most committed to practice in medically underserved areas.
    (c) By notice published in the Federal Register from time to time, 
the Secretary will specify the professions and specialties most needed 
by the National Health Service Corps.



Sec.  62.24  Who is eligible to apply for the Loan Repayment Program?

    (a) To be eligible to participate in the Loan Repayment Program an 
individual must:
    (1)(i) Be enrolled as a full-time student in the final year of a 
course of study or program approved by the Secretary which leads to a 
degree in allopathic or osteopathic medicine, dentistry or other health 
profession and which is offered by an accredited school in a State or
    (ii) Be enrolled in an approved graduate training program in 
allopathic or osteopathic medicine or dentistry or other health 
profession in a State, or
    (iii) Have a degree in allopathic or osteopathic medicine or 
dentistry or

[[Page 451]]

other health profession and have completed an approved graduate training 
program in a State (or received a waiver of the completion requirement 
under Sec.  62.26(d) of this subpart) and have a current and valid 
license to practice such health profession in a State;
    (2) Be eligible for, or hold, an appointment as a commissioned 
officer in the Regular or Reserve Corps of the Public Health Service or 
be eligible for selection for civilian service in the National Health 
Service Corps;
    (3) Submit an application to participate in the Loan Repayment 
Program; and
    (4) Sign and submit to the Secretary, at the time of the submission 
of such application, a written contract agreeing to accept repayment of 
health professions educational loans and to serve (in accordance with 
this subpart) for the applicable period of obligated service in a health 
manpower shortage area as determined by the Secretary.
    (b) Any individual who owes an obligation for health professional 
service to the Federal Government or a State or other entity under an 
agreement with such Federal, State or other entity is ineligible for the 
Loan Repayment Program unless such obligation will be completely 
satisfied prior to the beginning of service under this Program.
    (c) Individuals in breach of a written contract entered into under 
section 338A of the Act and liable to the United States under section 
338E(b) of the Act, in breach of a written contract entered into under 
section 225 of the Act (as in effect on September 30, 1977) and liable 
to the United States under section 225(f)(1) of the Act (as in effect on 
September 30, 1977) or in breach of any other obligation for health 
professional service to a Federal, State or local government entity are 
not eligible for participation in the Loan Repayment Program.

(Approved by the Office of Management and Budget under control number 
0915-0127)



Sec.  62.25  What does the Loan Repayment Program provide?

    (a) Loan repayment. For each year of service the individual agrees 
to serve, with a minimum of 2 years of obligated service, the Secretary 
may pay:
    (1) Except as provided in paragraph (a)(2) of this section, up to 
$20,000 per year of a Program participant's qualifying loans or
    (2) Up to $25,000 per year for a Program participant's qualifying 
loans if the Program participant agrees to provide obligated service in 
the Indian Health Service or a health facility or program operated by a 
tribe or tribal organization under the Indian Self-Determination Act.

The Secretary may establish different levels of annual loan repayment to 
encourage Program participants to serve in a manner which is in the best 
interest of the Loan Repayment Program. No loan repayments will be made 
for any professional practice performed prior to the effective date of 
the Loan Repayment Program Contract. Once a loan repayment contract has 
been signed by both parties, the Secretary will obligate such funds as 
will be necessary to ensure that sufficient funds will be available to 
make loan repayments for the duration of the period of obligated 
service.
    (b) Site visit. The Secretary may reimburse an individual for the 
actual and reasonable travel expenses associated with one trip from the 
individual's residence to a site for the purpose of evaluating such site 
for service under the Loan Repayment Program.
    (c) Tax liability payments. The Secretary may, upon a Program 
participant's written request, make payments in a reasonable amount, as 
determined by the Secretary, to reimburse the Program participant for 
all or part of the increased Federal, State and local tax liability 
resulting from loan repayments received under the Loan Repayment 
Program. To maximize the Federal resources available for placing 
participants in HMSAs, supplementary payments for increased tax 
liability will only be made under unusual circumstances, and in no cases 
will these tax liability payments exceed 20% of the annual amounts of 
the loans being repaid. Program participants wishing to receive tax 
liability payments must submit their requests for such payments in a 
manner prescribed by the Secretary and must provide the Secretary with 
any documentation the Secretary determines is necessary to

[[Page 452]]

establish a Program participant's increased tax liability. The Secretary 
will determine, based on the availability of funds and such other 
factors as the Secretary determines, the amounts of any such payments 
that may be made.

(Information collection requirements contained in paragraph (c) were 
approved by the Office of Management and Budget under control number 
0915-0131)

[54 FR 13462, Apr. 3, 1989, as amended at 57 FR 56996, Dec. 2, 1992]



Sec.  62.26  What does an individual have to do in return for loan repayments 
received under the Loan Repayment Program?

    (a) A Program participant whose eligibility for the Loan Repayment 
Program is based on Sec.  62.24(a)(1)(i) of this subpart must maintain 
full-time enrollment, at an acceptable level of academic standing, in 
that course of study until its completion. Upon completion of that 
course of study, a Program participant who received a degree in 
allopathic or osteopathic medicine must enter approved graduate training 
and a Program participant who received a degree in a health profession 
other than allopathic or osteopathic medicine may enter approved 
graduate training. Once a Program participant enters approved graduate 
training, he or she must also meet the requirements set forth in 
paragraphs (b) (1), (2), (3), and (4) of this section. If a Program 
participant who received a degree in a health profession other than 
allopathic or osteopathic medicine does not enter approved graduate 
training; service, in accordance with paragraph (e) of this section, 
must commence as soon as possible upon the Program participant's 
completion of the course of study leading to his or her health 
professions degree.
    (b) A Program participant whose eligibility for the Loan Repayment 
Program is based on Sec.  62.24(a)(1)(ii) of this subpart must: (1) 
Continue in his or her approved graduate training program at an 
acceptable level of academic standing; (2) provide the Secretary with 
annual documentation of continued participation in that approved 
graduate training program at an acceptable level of academic standing; 
(3) successfully complete that approved graduate training program; and 
(4) commence service, in accordance with paragraph (e) of this section, 
as soon as possible upon completion of approved graduate training.
    (c) A Program participant whose eligibility for the Loan Repayment 
Program is based on Sec.  62.24(a)(1)(iii) of this subpart must commence 
service, in accordance with paragraph (e) of this section, as soon as 
possible after the effective date of the Loan Repayment Program 
Contract.
    (d) If a Program participant fails to complete approved graduate 
training, the Secretary may, on his or her own initiative or at the 
Program participant's request, waive, for good cause, the completion 
requirement. Good cause will be deemed to exist if the Secretary 
determines that the Program participant has sufficient health 
professions training to be utilized by and make a substantial 
contribution to the National Health Service Corps. If waiver of the 
completion requirement in paragraph (b) of this section is granted; 
service, in accordance with paragraph (e) of this section, must commence 
as soon as possible after the granting of the waiver.
    (e) Except for Program participants who fail to complete their 
course of study leading to a health professions degree or who fail to 
complete approved graduate training and do not receive a waiver pursuant 
to paragraph (d) of this section, each program participant must:
    (1) Serve in a health manpower shortage area to which he or she is 
assigned by the Secretary as a member of the National Health Service 
Corps or serve pursuant to section 338D of the Act in a health manpower 
shortage area selected by the Secretary and
    (2) Accept employment in a full-time clinical practice of the 
Program participant's profession, as
    (i) A commissioned officer in the Regular or Reserve Corps of the 
Public Health Service,
    (ii) A civilian member of the National Health Service Corps who is 
an employee of the United States,
    (iii) A member of the National Health Service Corps who is not an 
employee of the United States, or

[[Page 453]]

    (iv) A private practitioner who is providing obligated service under 
the provisions of section 338D of the Act.
    (f) The minimum length of obligated service is two years, or such 
longer period as the Program participant may agree to. The maximum 
length of obligated service is four years. If a Program participant 
agrees to an original contract of two or three years, such contract may 
be extended, subject to the availability of appropriated funding, for 
one year or two years (up to the four-year maximum). A one-year 
extension will not reactivate the statutory minimum requirement of two 
years of service.

(Information collection requirements contained in paragraph (b)(2) were 
approved by the Office of Management and Budget under control number 
0915-0131)



Sec.  62.27  What will happen if an individual does not comply with the terms 
and conditions of participation in the Loan Repayment Program?

    Program participants who default on their Loan Repayment Program 
Contracts will be subject to the applicable monetary payment provisions 
set forth at section 338E of the Act. Payment of any amount owed under 
section 338E of the Act shall be made within one year of the date the 
participant breached his or her Loan Repayment Contract, as determined 
by the Secretary.



Sec.  62.28  Under what circumstances can the service or payment obligation 
be canceled, waived or suspended?

    A service or payment obligation under the Loan Repayment Program 
will be canceled or may be waived or suspended as provided in Sec.  
62.12 of this part of the regulations.



Sec.  62.29  Under what circumstances can the Loan Repayment Program 
obligation be discharged in bankruptcy?

    Any payment obligation incurred under Sec.  62.27 of this subpart 
may be released by a discharge in bankruptcy under title 11 of the 
United States Code only if such discharge is granted after the 
expiration of the five-year period beginning on the first date that 
payment was required, and only if the bankruptcy court finds that 
nondischarge of the obligation would be unconscionable.



Sec.  62.30  What other regulations and statutes apply?

    Other regulations and statutes which apply to this subpart include 
but are not limited to:

Debt Collection Act of 1982, Pub. L. 97-365 (5 U.S.C. 5514) including 
Section 4, Requirement that Applicant Furnish Taxpayer Identifying 
Number;
Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
Privacy Act of 1974 (5 U.S.C. 552a);
Section 215(a) of the Public Health Service Act, as amended (42 U.S.C. 
216(a)), for PHS commissioned officers, and 5 U.S.C. 3301 for civil 
service employees both of which authorize verification of an 
individual's suitability for employment;
Privacy Act of 1974; Alteration of System of Records, 52 FR 21622-21627, 
June 8, 1987, regarding the collection, maintenance and allowable use of 
personal information requested from program applicants.



           Subpart C_Grants for State Loan Repayment Programs

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 338H of the Public Health 
Service Act, 101 Stat. 999 (42 U.S.C. 254q-1).

    Source: 54 FR 13464, Apr. 3, 1989, unless otherwise noted.



Sec.  62.51  What is the scope and purpose of the State Loan Repayment Program?

    The regulations of this subpart apply to the award of grants 
authorized by section 338H of the Public Health Service Act (42 U.S.C. 
254q-1) to support the establishment of State programs similar to the 
National Health Service Corps Loan Repayment Program authorized by 
section 338B of the Public Health Service Act (42 U.S.C. 2541-1). The 
purpose of this program is to improve the delivery of health services in 
medically underserved areas.



Sec.  62.52  Definitions.

    In addition to the definitions in Sec.  62.2 of this part, the 
following definitions will apply for purposes of this subpart:
    The definitions of Qualifying loans, Commercial loans, Government 
loans,

[[Page 454]]

Educational expenses, and Living expenses as contained in Sec.  62.22 of 
this part will apply for purposes of this subpart.
    Medically underserved area means health manpower shortage area or an 
area which has been designated by a State pursuant to standards 
described in Sec.  62.54(b)(1) of this subpart which the Secretary has 
deemed acceptable.
    State Loan Repayment Program or program means a State loan repayment 
program authorized under section 338H (42 U.S.C. 254q-1) of the Act.



Sec.  62.53  Who is eligible for this program?

    Any State is eligible to apply for a grant under this subpart.



Sec.  62.54  What must applications for the State Loan 
Repayment Program contain?

    (a) An application for a grant under this subpart shall be submitted 
to the Secretary at such time and in such form and manner as the 
Secretary requires.
    (b) The application shall contain a budget and narrative statement 
describing the manner in which the applicant intends to conduct the 
project and carry out the requirements of this subpart. In addition, 
applications must include:
    (1) A description of the State's standards for the designation of 
medically underserved areas, except that no description of designation 
standards will be required if the State elects to use health manpower 
shortage areas designated by the Secretary;
    (2) An assessment of the need and demand in medically underserved 
areas within the State for health professions manpower with special 
emphasis on individuals whose training is in a health profession or 
specialty identified by the Secretary pursuant to Sec.  62.23(b) of this 
part. This assessment should include such demographic indicators of the 
need as the economic accessibility of health care services in the State 
as measured by poverty levels, the percentage of the service area 
population without health insurance, and the health status of the 
population as measured by the rates of infant mortality, low birth 
weight, geographic barriers and other indicators;
    (3) A proposal for the placement of the health profession providers 
in medically underserved areas with the greatest need and demand in 
accordance with the need/demand assessment completed in compliance with 
paragraph (b)(2) of this section;
    (4) Adequate assurances that sufficient current year State funds are 
available to cover the non-Federal share of State Loan Repayment Program 
costs;
    (5) A description of how the program would meet the requirements of 
Sec.  62.55 to demonstrate its similarity to the NHSC Loan Repayment 
program;
    (6) A description of the source of, and plans for the use of, State 
matching funds;
    (7) A description of how the program would be coordinated with 
Federal, State and other organized activities within the State which 
relate to health manpower services and resources;
    (8) Identification of the State entity and key personnel who would 
administer the grant and a description of the qualifications and 
experience of that entity and its personnel concerning the State's 
health service delivery system and health manpower needs;
    (9) A description of the State's plans for administration of the 
State's Loan Repayment Program which may include such provisions as 
annual levels of loan repayment to be made under the program, the number 
of health professionals to be funded, the frequency and timing of the 
loan repayments, program incentives for longer periods of service, 
procedures for monitoring the service of program participants and 
placing professionals in default for failure to complete their service 
obligation, penalties for default, provisions for waivers and 
suspensions, and a description of the contract/obligation process to be 
used by the State to obligate individuals receiving State loan 
repayments;
    (10) A description of the State's need for Federal assistance in 
obtaining health professions resources and demonstrated inability to 
obtain such resources without Federal assistance;
    (11) A description of how the State will accord special 
consideration to

[[Page 455]]

medically underserved areas with large minority populations; and
    (12) The signature of an individual authorized to act for the State 
and to assume on behalf of the State the obligations imposed by the 
statute, the applicable regulations of this subpart and any additional 
conditions of the grant.

(Approved by the Office of Management and Budget under control number 
0915-0131)



Sec.  62.55  What State Program Elements are required to ensure similarity 
with the NHSC Loan Repayment Program?

    A State Loan Repayment Program supported under this subpart must:
    (a) Establish priorities for loan repayment applicants consistent 
with the provisions of Sec.  62.23 of this part;
    (b) Contract only with a person who is (1) enrolled as a full-time 
student in the final year of a course of study or program in an 
accredited school in a State leading to a degree in allopathic or 
osteopathic medicine, dentistry or other health profession, or (2) 
enrolled in an accredited graduate training program in a State in 
allopathic or osteopathic medicine or dentistry or other health 
profession, or (3) a practitioner licensed by a State who has completed 
training in an accredited graduate training program in allopathic or 
osteopathic medicine, dentistry or other health profession;
    (c) Provide that health professionals participating in a State Loan 
Repayment Program shall:
    (1) Serve for at least 2 years in a medically underserved area 
identified pursuant to Sec.  62.54(b)(3) of this subpart in the full-
time clinical practice of their profession,
    (2) Charge for his or her professional services at the usual and 
customary rate prevailing in the area in which such services are 
provided, except that if a person is unable to pay such charge, such 
person shall be charged at a reduced rate or not charged any fee,
    (3) In providing health services, not discriminate against any 
person on the basis of such person's ability to pay for such services or 
because payment for the health services provided to such person will be 
made under the insurance program established under part A or B of title 
XVIII of the Social Security Act or under a State plan for medical 
assistance approved under title XIX of such Act, and
    (4) Agree to accept an assignment under section 1842(b)(3)(B)(ii) of 
such Act for all services for which payment may be made under part B of 
title XVIII of such Act and enter into an appropriate agreement with the 
State agency which administers the State plan for medical assistance 
under title XIX of such Act to provide service to individuals entitled 
to medical assistance under the plan;
    (d) Repay qualifying loans for participating health professionals;
    (e) Provide that the loans of health professionals will be repaid on 
a periodic basis after the receipt of obligated services by such 
participant for such period; and



Sec.  62.56  How are the Federal grant funds and State matching funds 
to be used under this program?

    The Federal share of any program shall not exceed 75 percent of the 
cost of the approved State program. The Federal share must be used to 
repay the qualifying loans of health professionals. No portion of the 
Federal share shall be used to pay for administrative costs of any State 
Loan Repayment Program. The State's share of the program may be used to 
repay qualifying loans of health professionals or administrative costs 
of the State's Loan Repayment Program, or a combination of both. All 
program administrative costs are to be borne by the State. No portion of 
the State's share of the program shall consist of Federal funds.



Sec.  62.57  How will States be selected to participate in this program?

    Within the limits of funds available under section 338H of the Act, 
the Secretary may award grants to State applicants whose proposed Loan 
Repayment Programs will, in his or her judgment, best promote the 
purposes of section 338H of the Act, taking into account, among other 
pertinent factors:
    (a) The need of the State for health professions manpower;
    (b) The number and type of providers the State proposes to support 
through this program;

[[Page 456]]

    (c) The acceptableness of the State's standards for the designation 
of medically underserved areas and the appropriateness of the proposed 
placements of obligated providers;
    (d) The degree of similarity between the proposed State Loan 
Repayment Program and the National Health Service Corps Loan Repayment 
Program;
    (e) The adequacy of the qualifications, the administrative and 
managerial ability and the experience of the State staff to administer 
and carry out the proposed project;
    (f) The suitability of the applicant's approach and the degree to 
which the applicant's project is coordinated with Federal, State and 
other organized activities for meeting the State's health professions 
manpower needs and resources, including mechanisms for an ongoing 
evaluation of the program's activities;
    (g) The source and plans for use of the State match (including the 
percentage of the State's match that is proposed to be used for loan 
repayments), the degree to which the State match exceeds 25% or has 
increased over time, and the amount of the match relative to the needs 
and resources of the States; and
    (h) The extent to which special consideration will be extended to 
medically underserved areas with large minority populations.



Sec.  62.58  What other regulations apply?

    Other regulations which apply to this subpart include but are not 
limited to:

45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 50--Policies of general applicability: Subpart D--Public 
Health Service grant appeals procedure
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services-
Effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in programs and 
activities receiving or benefiting from Federal financial assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[54 FR 13464, Apr. 3, 1989, as amended at 81 FR 3009, Jan. 20, 2016]



                   Subpart D_Special Repayment Program

    Authority: Sec. 215 of the Public Health Service Act 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 204, Pub. L. 100-177, 101 
Stat. 1000.

    Source: 56 FR 56597, Nov. 6, 1991, unless otherwise noted.



Sec.  62.71  What is the scope and purpose of the Special Repayment Program?

    These regulations apply to the Special Repayment Program authorized 
under section 204 of Pub. L. 100-177, which provides a time-limited 
opportunity for persons who were, on November 1, 1987, in breach of a 
written contract under the Public Health and National Health Service 
Corps Scholarship Training Program or the National Health Service Corps 
Scholarship Program to satisfy their scholarship obligations through 
full-time clinical service. These regulations do not apply to any Public 
Health and National Health Service Corps Scholarship Training Program or 
National Health Service Corps Scholarship Program obligation which the 
Secretary has determined was completely satisfied through service or 
monetary payment prior to November 1, 1987. The purpose of this program 
is to supply trained health professionals for the National Health 
Service Corps, which is used by the Secretary to improve the delivery of 
health services in health manpower shortage areas.



Sec.  62.72  Definitions.

    In addition to the definitions in Sec.  62.2 of this part, the 
following definitions will apply for purposes of this subpart:
    Eligible defaulters means those individuals who, as of November 1, 
1987, were:
    (1) In breach of a written contract entered into under section 338A 
of the Act and liable to the United States under section 338E(b) of the 
Act and/or

[[Page 457]]

in breach of a written contract entered into under section 225 of the 
Act (as in effect on September 30, 1977) and liable to the United States 
under section 225(f)(1) of the Act (as in effect on September 30, 1977); 
and
    (2) Not already serving their obligations on December 1, 1987, under 
a judgment, forbearance agreement, or other written agreement to serve.
    HPOL means the Health Manpower Shortage Area Placement Opportunity 
List described in section 204(b) of Pub. L. 100-177.
    Match means that the Secretary has received documentation of:
    (1) An offer of employment from a HPOL or SHPOL site which specifies 
at least the agreed upon salary and start date; and
    (2) The Program participant's acceptance of that offer. Provided, 
however, that if the Program participant would be self-employed, a match 
means that the Secretary has approved a program participant's private 
practice option application under section 338D(a) of the Act.
    Prior approved service means service performed prior to a Program 
participant's service start date under the Special Repayment Program:
    (1) As a member of the National Health Service Corps pursuant to an 
assignment by the Secretary under section 333 of the Act;
    (2) Under a written private practice option agreement signed by the 
Secretary pursuant to section 338D of the Act; or
    (3) In compliance with section 338C(e) of the Act.
    Program participant means an eligible defaulter whose contract under 
section 204 of Pub. L. 100-177 has been accepted and signed by the 
Secretary.
    Scholarship amount means the sum of any amounts paid to, or on the 
behalf of, a scholarship recipient under the PH/NHSC Scholarship 
Training Program and/or the Scholarship Program.
    SHPOL means the Supplemental Health Manpower Shortage Area Placement 
Opportunity List described in section 204(d) of Pub. L. 100-177.
    Special Repayment Program or Program means the program authorized by 
section 204 of Pub. L. 100-177.
    Total debt means the debt that would be owed by a Program 
participant under section 225(f)(1) of the Act, as in effect on 
September 30, 1977, and/or section 338E(b) of the Act, as if no payments 
had been made on the debt.



Sec.  62.73  What are the procedures for participation in 
the Special Repayment Program?

    (a) Notice of eligibility for participation in the program. On or 
before February 29, 1988, the Secretary will, subject to paragraph (h) 
of this section, send written notice to each eligible defaulter of the 
opportunity provided under this Program. The notice will be sent to the 
last known address of each eligible defaulter and will describe the 
special repayment options available under the Program.
    (b) Selection of repayment method. On or before May 29, 1988, 
eligible defaulters who wish to participate in this Program must sign 
and submit to the Secretary a written contract to provide service in 
accordance with either section 204(b) or section 204(c) of Pub. L. 100-
177. The election between section 204(b) and section 204(c) of Pub. L. 
100-177 is binding on the eligible defaulters.
    (c) Service sites. Program participants will receive a listing of 
approved sites appropriate to the service option they have selected. 
Program participants electing service under section 204(b) of Pub. L. 
100-177 will receive a HPOL. Program participants electing service under 
section 204(c) of Pub. L. 100-177 will receive a SHPOL. The HPOL or 
SHPOL sent to the Program participant will be specific to the Program 
participant's profession and his or her specialty training which is most 
needed by the National Health Service Corps. The Secretary is not 
required to identify placements for Program participants in a medical 
specialty for which the National Health service Corps has no need.
    (d) Time frames for matching and commencing service. If a program 
participant electing to serve under section 204(b) of Pub. L. 100-177 
chooses to serve at a remaining site on the 1988 HPOL, such participant 
must match to a site and must begin serving at the site by October 1, 
1988. If a Program

[[Page 458]]

participant electing to serve under section 204(b) of Pub. L. 100-177 
chooses to serve at a site on the 1989 HPOL, such participant must match 
to a HPOL site by February 15, 1989, and must begin service at the site 
by October 1, 1989. If a Program participant has elected to serve under 
section 204(c) of Pub. L. 100-177, such participant must match to a 
SHPOL site by May 15, 1989, and must begin service at that site by 
October 1, 1989.
    (e) Site visits. The Program participant is responsible for the 
costs of any site visit(s) and any other contact with the site to obtain 
employment at the site.
    (f) Effect of failure to meet established time frames. If a Program 
participant does not match to a site or begin service at that site 
within the time frames described in paragraph (d) of this section, the 
Secretary will determine that such individual is not relieved of his or 
her liability to the United States under the PH/NHSC Scholarship 
Training Program and/or Scholarship Program (including accrued interest 
and/or damages).
    (g) Service. Service must be performed in accordance with subpart II 
of part D of title III of the Act. Service credit will begin after a 
Program participant has matched to a HPOL or SHPOL site and has 
commenced service at that site in accordance with subpart II of part D 
of title III of the Act.
    (h) Secretary's exclusion authority. The Secretary is authorized, at 
any time, to deny or terminate an individual's participation in the 
Program for reasons related to the individual's professional competence 
or conduct.



Sec.  62.74  How much credit will a Program participant receive 
for monetary repayments made, or for approved service performed, 
before beginning service under the Special Repayment Program?

    (a) Prior approved service performed by a Program participant will 
be credited to the Program participant for the purpose of calculating 
the Program participant's remaining service obligation under this 
Program. Thus, the Program participant's remaining service obligation 
will be calculated by subtracting the number of days of the Program 
participant's prior approved service from the number of days of the 
Program participant's original service obligation under the PH/NHSC 
Scholarship Training Program and/or the Scholarship Program. If a 
Program participant has made monetary payments, his or her remaining 
service obligation will be reduced by converting the monetary payments 
into days of service credit as set forth in paragraph (b) or (c) of this 
section, whichever is applicable.
    (b) Program participants who elect to serve pursuant to section 
204(b) and section 204(c)(2) of Pub. L. 100-177, will not receive a 
refund of any amounts previously paid but will receive service credit 
for those payments as follows:
    (1) The number of days of service credit will be calculated by 
dividing the total amount paid by the Program participant prior to the 
Program participant's service start date by the total debt as of the 
service start date and multiplying the result of that division by the 
number of days of the participant's remaining service obligation (as 
determined by the formula set forth in the second sentence of paragraph 
(a) of this section).
    (2) If the Program participant defaults on a contract under this 
Program, prior monetary payments will not be credited to service but 
will be applied to the monetary debt owed by the Program participant.
    (c) Program participants who elect to serve under section 204(c)(1) 
of Pub. L. 100-177 must pay an amount equal to the scholarship amount. 
Any amounts paid by the Program participant prior to or after entry into 
the Program, in accordance with Sec.  62.76 of this subpart, will be 
used to reduce the Program participant's financial obligation incurred 
under section 204(c)(1) of Pub. L. 100-177. In some cases, the amounts 
paid before or after entry into the Program will exceed the scholarship 
amount. These payments in excess of the scholarship amount will be 
converted into days of service credit under the formula set forth in 
paragraph (b)(1) of this section. If a Program participant defaults on a 
contract under this option, the monies paid in excess of the scholarship 
amount will not be credited to service but will be credited toward the 
monetary debt owed by the

[[Page 459]]

Program participant under section 338E(b) of the Act or section 
225(f)(1) of the Act, as in effect on September 30, 1977. The 
scholarship amount paid upon entering this option will be forfeited.



Sec.  62.75  Will individuals serving under the Special Repayment Program 
receive credit for partial service?

    (a) With respect to obligations under the Scholarship Program, a 
credit will be allowed for partial service under the Special Repayment 
Program and will result in a reduction of the Program participant's 
financial obligation in accordance with the following formula:
[GRAPHIC] [TIFF OMITTED] TC13NO91.003

In which:

`A' is the amount the United States is entitled to recover;
`0' is the sum of the amounts paid to or on behalf of the Program 
participant under the Scholarship Program and the interest on such 
amounts which would be payable if, at the time the amounts were paid, 
they were loans bearing interest at the maximum legal prevailing rate, 
as determined by the Treasurer of the United States;
`t' is the sum of (1) the number of months of prior approved service 
plus (2) the number of months of the Program participant's period of 
obligated service under the Program including any additional months of 
service incurred pursuant to section 204(c)(2) of Pub. L. 100-177;
`s' is the number of months of prior approved service performed by the 
Program participant before commencing service under this Program; and
`r' is the number of months of service performed by the Program 
participant in compliance with this Program.

However, where a judgment has been entered against a Program 
participant, the formula will be revised such that:

`30' is the amount of the judgment representing the Program 
participant's liability under the Scholarship Program, including any 
accrued post judgment interest and excluding any monetary payments on 
the judgment which may have been made by the Program participant;
`t' is the sum of (1) the number of months of prior approved service 
performed by the Program participant after entry of the judgment but 
before commencing service under this Program plus (2) the number of 
months of the Program participant's period of obligated service under 
the Program including any additional months of service incurred pursuant 
to section 204(c)(2) of Pub. L. 100-177; and
`s' is the number of months of prior approved service performed by the 
Program participant after the entry of the judgment but before 
commencing service under this Program.

    (b) With respect to obligations under the PH/NHSC Scholarship 
Training Program, if a Program participant fails to complete the period 
of obligated service under the Program (including any additional months 
of service incurred pursuant to section 204(c)(1) of Pub. L. 100-177), 
no credit for partial service under this Program will be allowed.
    (c) Where participants have obligations under both the Scholarship 
Program and the PH/NHSC Scholarship Training Program, credit for service 
will be applied against the scholarship obligations in the order in 
which they were incurred.



Sec.  62.76  How will amounts of money due under the option under 
section 204(c)(1) of Public Law 100-177 be required to be repaid?

    Program participants who elect to serve under section 204(c)(1) of 
Pub. L. 100-177 will be required to pay the full scholarship amount at 
least 60 days prior to the service start date specified in the 
documentation submitted to the Secretary.



PART 63_TRAINEESHIPS--Table of Contents



Sec.
63.1 To what programs do these regulations apply?
63.2 Definitions.
63.3 What is the purpose of traineeships?
63.4 What are the minimum qualifications for awards?
63.5 How will NIH make awards?
63.6 How to apply.
63.7 What are the benefits of awards?
63.8 What are the terms and conditions of awards?
63.9 How may NIH terminate awards?
63.10 Other HHS regulations and policies that apply.

    Authority: 42 U.S.C. 216, 282(b)(13), 284(b)(1)(C), 285a-2(b)(3), 
286b-3, 287c-21(a).

    Source: 60 FR 10719, Feb. 27, 1995, unless otherwise noted.

[[Page 460]]



Sec.  63.1  To what programs do these regulations apply?

    (a) The regulations in this part apply to research traineeships 
awarded by the Director, NIH, each director of a national research 
institute of NIH, the Director of the National Library of Medicine, and 
the Director of the National Center for Complementary and Alternative 
Medicine, or their designees, pursuant to sections 402(b)(13), 
405(b)(1)(C), 413(b)(3), 472, and 485(D)(a) of the Act, respectively.
    (b) The regulations of this part do not apply to research training 
under the National Research Service Award Program governed by 42 CFR 
part 66 or to the Mental Health Traineeship Program governed by 42 CFR 
part 64a.
    (c) Except as otherwise permitted under section 413(b)(3) of the 
Act, the regulations of this part do not apply to residency training of 
physicians or other health professionals.

[65 FR 66512, Nov. 6, 2000]



Sec.  63.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Award means an award of funds under sections 402(b)(13), 
405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of the Act 
which authorize research training or traineeships.
    Awardee means an individual awarded a traineeship under sections 
402(b)(13), 405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of 
the Act which authorize research training or traineeships.
    Director means the Director, NIH, the director of a national 
research institute of NIH, the Director of the National Library of 
Medicine, and the Director of the National Center for Complementary and 
Alternative Medicine, or any official of NIH to whom the authority 
involved has been delegated.
    HHS means the Department of Health and Human Services.
    NIH means the National Institutes of Health.
    PHS means the Public Health Service.
    Research misconduct shall have the same meaning as prescribed in 
Sec.  93.103 of this chapter.
    Traineeship means an award under the regulations of this part to a 
qualified individual for that person's subsistence and other expenses 
during the period that person is participating in the research training 
approved under the award.

[60 FR 10719, Feb. 27, 1995, as amended at 65 FR 66513, Nov. 6, 2000; 85 
FR 72909, Nov. 16, 2020]



Sec.  63.3  What is the purpose of traineeships?

    The purpose of an NIH research traineeship is to provide support for 
financial subsistence to an individual during a period in which the 
awardee is acquiring training in:
    (a) Basic and/or clinical biomedical or behavioral research relating 
to human health, including extending healthy life and reducing the 
burdens of illness, or
    (b) Medical library science or related fields pertaining to sciences 
related to health or the communication of health sciences information.
    Traineeships are intended to make available in the United States an 
increased number of persons having special competence in these research 
fields through developmental training and practical research experience 
in the facilities of NIH, with supplemental training at other qualified 
institutions (see Sec.  63.8(a)).



Sec.  63.4  What are the minimum qualifications for awards?

    Minimum qualifications for any traineeship shall be established by 
the Director and shall be uniformly applicable to all applicants in each 
traineeship program. These minimum qualifications may include 
requirements as to citizenship, medical standards, academic degrees, 
professional or other training or experience, and other factors as may 
be necessary to the fulfillment of the purpose of the traineeship. The 
Director may, as a matter of general policy or, in individual cases, 
waive compliance with any minimum qualification so established to the 
extent that the applicant or applicants have substantially equivalent 
qualifications or have such special training, experience or opportunity 
for service as to make an award

[[Page 461]]

particularly appropriate, and to the extent the Director finds it is 
consistent with the fulfillment of the purpose of the traineeship.



Sec.  63.5  How will NIH make awards?

    Subject to the regulations of this part, the Director may award 
traineeships to those qualified applicants who are best able in that 
official's judgment to carry out the purpose of the traineeships. These 
awards may be made for a period of one (1) year or other period, 
including extensions or renewals, as may be specified.



Sec.  63.6  How to apply.

    (a) Application for a traineeship shall be made in writing as 
prescribed by the Director.
    (b) In addition to other pertinent information, the Director may 
require each applicant to submit the following information:
    (1) Certification of the applicant's citizenship status;
    (2) The applicant's educational background and other qualifications 
and experience, including previous academic and professional degrees, if 
any; and
    (3) The subject area of the proposed training.
    (c) By applying, eligible individuals agree to abide by HHS, PHS, 
and NIH regulations, and the terms and conditions of the traineeship 
award which may require compliance with policies and procedures that 
apply to the proper conduct of research, such as research involving 
human and animal subjects, patient care, hospital and laboratory 
procedures, handling of confidential information, and outside 
employment.



Sec.  63.7  What are the benefits of awards?

    (a) Subject to the availability of funds, each individual awarded a 
traineeship may receive a stipend fixed in an amount determined by the 
Director.
    (b) Additional allowances and benefits may be authorized by and at 
the discretion of the Director, taking into account the cost of living 
and other factors such as the requirements of the training program and 
availability of discretionary funds. Discretionary allowances and 
benefits may include: health benefits coverage; dependents' allowance; 
travel to pre-award interviews, to first duty station, and return to the 
place of origin upon conclusion of the traineeship; tuition and 
institution fees; and other specific costs as may be necessary to 
fulfill the purpose of the training program.



Sec.  63.8  What are the terms and conditions of awards?

    All traineeships shall be subject to the following terms and 
conditions:
    (a) Training must be carried out at a facility of the NIH, but may 
be supplemented by additional training acquired at another institution 
which is found by the Director to be directly related to the purpose of 
the traineeship and necessary to its successful completion.
    (b) Payments shall be made to the awardee or to the institution for 
payment to the awardee in accordance with payment schedules as 
prescribed by the Director for each traineeship program.
    (c) The awardee shall reimburse NIH for any overpayment of stipends 
or other allowances because of early termination of the traineeship or 
any other reason, unless waived for good cause shown by the awardee.
    (d) The Director may establish procedures and requirements 
applicable to traineeship awards, consistent with the regulations in 
this part, regarding: (1) The proper conduct of research investigations, 
including research involving human and animal subjects; (2) patient 
care; (3) hospital and laboratory procedures; (4) handling of 
confidential information; (5) outside employment; and (6) additional 
conditions the Director finds necessary to fulfill the purpose of the 
traineeship.
    (e) The awardee shall sign an agreement to comply with the terms and 
conditions of the traineeship.



Sec.  63.9  How may NIH terminate awards?

    The Director may terminate a traineeship at any time:
    (a) Upon written request of the awardee; or
    (b) If it is determined that the awardee has committed research 
misconduct, is ineligible, or has materially failed to comply with the 
terms and conditions

[[Page 462]]

of the award or to carry out the purpose for which the award was made; 
or
    (c) If the awardee is convicted of a felony, or an offense involving 
any illegal drug or substance, or any offense involving a lack of 
financial integrity or business honesty; or
    (d) Because of programmatic changes or lack of funds.

[65 FR 66513, Nov. 6, 2000, as amended at 85 FR 72909, Nov. 16, 2020]



Sec.  63.10  Other HHS regulations and policies that apply.

    Several other policies and regulations apply to awards under this 
part. These include, but are not necessarily limited to:

45 CFR part 46--Protection of human subjects.
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research. (Note: Interested 
persons should contact the Office of Research on Women's Health, NIH, 
Room 201, Building 1, MSC 0161, Bethesda, MD 20892-0161; telephone 301-
402-1770 (not a toll-free number) to obtain copies of this policy.)
59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules. (Note: Interested persons should contact the 
Office of Biotechnology Activities, NIH, Suite 323, 6000 Executive 
Boulevard, MSC 7010, Bethesda, MD 20892-7010; telephone 301-496-9838 
(not a toll-free number) to obtain copies of the policy.)
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals'' (Revised September 1986), Office of Laboratory Animal Welfare, 
NIH. (Note: Interested persons should contact the Office of Laboratory 
Animal Welfare, NIH, Rockledge Building I, 6705 Rockledge Drive, Suite 
1050, MSC 7982, Bethesda, MD 20892-7982; telephone 301-496-7163 (not a 
toll-free number) to obtain copies of the policy.)

[60 FR 10719, Feb. 27, 1995, as amended at 65 FR 66513, Nov. 6, 2000]



PART 63a_NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS--Table of Contents



Sec.
63a.1 To what programs do these regulations apply?
63a.2 Definitions.
63a.3 What is the purpose of training grants?
63a.4 Who is eligible for a training grant?
63a.5 How to apply for a training grant.
63a.6 How are training grant applications evaluated?
63a.7 Awards.
63a.8 How long does grant support last?
63a.9 What are the terms and conditions of awards?
63a.10 How may training grant funds be spent?
63a.11 Other HHS regulations and policies that apply.

    Authority: 42 U.S.C. 216, 2421(b)(3), 284(b)(1)(C), 285g-10, 
287c(b), 300cc-15(a)(1), 300cc-41(a)(3)(C), 7403(h)(2).

    Source: 61 FR 55111, Oct. 24, 1996, unless otherwise noted.



Sec.  63a.1  To what programs do these regulations apply?

    (a) The regulations of this part apply to:
    (1) Grants awarded by the John E. Fogarty International Center for 
Advanced Study in the Health Sciences, NIH, for training in 
international cooperative biomedical research endeavors, as authorized 
under section 307(b)(3) of the Act;
    (2) Grants awarded by NIH for research training with respect to the 
human diseases, disorders, or other aspects of human health or 
biomedical research for which the institute or other awarding component 
was established, for which fellowship support is not provided under 
section 487 of the Act and which is not residency training of physicians 
or other health professionals, as authorized by sections 405(b)(1)(C), 
452G, 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and,
    (3) Grants awarded by the National Institute of Environmental Health 
Sciences, NIH, for the education and

[[Page 463]]

training of physicians in environmental health, as authorized under 
section 103(h)(2) of the Clean Air Act, as amended.
    (b) The regulations of this part also apply to cooperative 
agreements awarded to support the training specified in paragraph (a) of 
this section. References to ``grant(s)'' shall include ``cooperative 
agreement(s).''
    (c) The regulations of this part do not apply to:
    (1) Research training support under the National Research Service 
Awards Program (see part 66 of this chapter);
    (2) Research training support under the NIH Center Grants programs 
(see part 52a of this chapter);
    (3) Research training support under traineeship programs (see part 
63 of this chapter);
    (4) Research training support under the NIH AIDS Research Loan 
Repayment Program (see section 487A of the Act); or
    (5) Research training support under the National Library of Medicine 
training grant programs (see part 64 of this chapter).

[61 FR 55111, Oct. 24, 1996, as amended at 71 FR 42296, July 26, 2006]



Sec.  63a.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    HHS means the Department of Health and Human Services.
    NIH means the National Institutes of Health and its organizational 
components that award training grants.
    Nonprofit as applied to any agency or institution, means an agency 
or institution which is a corporation or association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    Program director means the single individual named by the grantee in 
the grant application and approved by the Secretary, who is responsible 
for the management and conduct of the training program.
    Project period See Sec.  63a.8(a).
    Secretary means the Secretary of Health and Human Services and any 
other official of HHS to whom the authority involved is delegated.
    Stipend means a payment to an individual to help meet that 
individual's subsistence expenses during the training period.
    Training grant means an award of funds to an eligible agency or 
institution for a training program authorized under Sec.  63a.1 to carry 
out one or more of the purposes set forth in Sec.  63a.3.



Sec.  63a.3  What is the purpose of training grants?

    The purpose of a training grant is to provide financial assistance 
to an eligible agency or institution to enable it to provide research 
training to individuals in the diagnosis, prevention, treatment, or 
control of human diseases or disorders, or other aspects of human health 
or biomedical research, or in environmental health, in order to increase 
the number of facilities which provide qualified training and the number 
of persons having special competence in these fields.



Sec.  63a.4  Who is eligible for a training grant?

    (a) General. Except as otherwise provided in this section or as 
prohibited by law, any public or private for-profit or nonprofit agency, 
institution, or entity is eligible for a training grant.
    (b) International training grants for AIDS research. Any 
international organization concerned with public health is eligible for 
a training grant to support individuals for research training relating 
to acquired immunodeficiency syndrome (AIDS), as authorized under 
section 2315(a)(1) of the Act. In awarding these grants, preference 
shall be given to:
    (1) Training activities conducted by, or in cooperation with, the 
World Health Organization and
    (2) With respect to training activities in the Western Hemisphere, 
activities conducted by, or in cooperation with, the Pan American Health 
Organization or the World Health Organization.



Sec.  63a.5  How to apply for a training grant.

    Any agency, institution, or entity interested in applying for a 
grant under this part must submit an application at the time and in the 
form and manner that the Secretary may require.

[[Page 464]]



Sec.  63a.6  How are training grant applications evaluated?

    The Secretary shall evaluate applications through the officers and 
employees, experts, consultants, or groups engaged by the Secretary for 
that purpose, including review or consultation with the appropriate 
advisory council or other body as may be required by law. The 
Secretary's evaluation will be for merit and shall take into account, 
among other pertinent factors, the significance of the program, the 
qualifications and competency of the program director and proposed 
staff, the adequacy of the selection criteria for trainees under the 
program, the adequacy of the applicant's resources available for the 
program, and the amount of grant funds necessary for completion of its 
objectives.



Sec.  63a.7  Awards.

    Criteria. Within the limits of available funds, the Secretary may 
award training grants for training programs which:
    (a) Are determined to be meritorious, and
    (b) Best carry out the purposes of the particular statutory program 
described in Sec.  63a.1 and the regulations of this part.



Sec.  63a.8  How long does grant support last?

    (a) The notice of the grant award specifies how long the Secretary 
intends to support the project without requiring the grantee to 
recompete for funds. This period, called the ``project period,'' will 
usually be for one to five years.
    (b) Generally, the grant will be initially for one year and 
subsequent continuation awards will be for one year at a time. A grantee 
must submit a separate application at the time and in the form and 
manner that the Secretary may require to have the support continued for 
each subsequent year. Decisions regarding continuation awards and the 
funding level of these awards will be made after consideration of such 
factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require 
determination by the Secretary that continued funding is in the best 
interest of the Federal Government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Any balance of federally obligated grant funds remaining 
unobligated by the grantee at the end of a budget period may be carried 
forward to the next budget period, for use as prescribed by the 
Secretary, provided that a continuation award is made. If at any time 
during a budget period it becomes apparent to the Secretary that the 
amount of Federal funds awarded and available to the grantee for that 
period, including any unobligated balance carried forward from prior 
periods, exceeds the grantee's needs for that period, the Secretary may 
adjust the amounts awarded by withdrawing the excess.



Sec.  63a.9  What are the terms and conditions of awards?

    In addition to the requirements imposed by law, grants awarded under 
this part are subject to any terms and conditions imposed by the 
Secretary to carry out the purpose of the grant or assure or protect 
advancement of the approved program, the interests of the public health, 
or the conservation of grant funds.



Sec.  63a.10  How may training grant funds be spent?

    (a) Authorized expenditures; general. A grantee shall expend funds 
it receives under this part solely in accordance with the approved 
application and budget, the regulations of this part, the terms and 
conditions of the grant award, and the applicable cost principles in 45 
CFR part 75, subpart E.
    (b) Authorized categories of expenditures. Subject to any 
limitations imposed in the approved application and budget or as a 
condition of the award, grant funds may be expended for the following 
costs:
    (1) Expenses of the grantee in providing training and instruction 
under

[[Page 465]]

the particular program, including salaries of faculty and support 
personnel, and the costs of equipment and supplies;
    (2) Stipends and allowances to individuals during the period of 
their training and instruction; and,
    (3) If separately justified and authorized under the particular 
program, tuition, fees, and trainee travel expenses which are necessary 
to carry out the purpose of the training grant.
    (c) Expenditures not authorized. Grant funds may not be expended 
for:
    (1) Compensation for employment or for the performance of personal 
services by individuals receiving training and instruction; or
    (2) Payments to any individual who does not meet the minimum 
qualifications for training and instruction established by the grantee 
and approved by the Secretary or who has failed to demonstrate 
satisfactory participation in the training in accordance with the usual 
standards and procedures of the grantee.

[61 FR 55111, Oct. 24, 1996, as amended at 81 FR 3009, Jan. 20, 2016]



Sec.  63a.11  Other HHS regulations and policies that apply.

    Several other HHS regulations and policies apply to this part. These 
include, but are not necessarily limited to:

42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform administrative requirements, cost principles, 
and audit requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Research on Women's Health, NIH, Room 201, 
Building 1, MSC 0161, Bethesda, MD 20892-0161 (301-402-1770; not a toll-
free number) to obtain references to the current version and any 
amendments.

59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (301-496-
9838; not a toll-free number) to obtain references to the current 
version and any amendments.

``NIH Grants Policy Statement,'' (December 1, 2003). This version is 
located on the NIH Web site at: http://grants./policy/nihgps_2003/
index.htm.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Policy for Extramural Research 
Administration (OPERA), Office of Extramural Research, NIH, 6701 
Rockledge Drive, Suite 350, MSC 7974, Bethesda, Maryland 20892-7974, 
telephone 301-435-0938 (or toll-free 800-518-4726), to obtain references 
to the current version and any amendments. Information may also be 
obtained by contacting the OPERA Division of Grants Policy via e-mail at 
http://[email protected]. Previous versions of the NIH Grants 
Policy Statement are archived at http://grants.nih.gov/grantspolicy/
policy.htm.

``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office of Laboratory Animal Welfare (Amended August, 2002).

    Note: This policy is subject to change, and interested persons 
should contact the Office of Laboratory Animal Welfare, 6705 Rockledge 
Drive, Suite 360, MSC 7982, Bethesda, Maryland 20892-7982, telephone 
301-594-2382 (not a toll-free number), to obtain references to the 
current version and any amendments. Information may also be obtained by 
browsing the Office of Laboratory

[[Page 466]]

Animal Welfare Home Page site on the World Wide Web (http://
www.grants.nih.gov/grants/olaw/olaw.htm).

[61 FR 55111, Oct. 24, 1996, as amended at 71 FR 42296, July 26, 2006; 
81 FR 3009, Jan. 20, 2016]



PART 64_NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS--Table of Contents



Sec.
64.1 Programs to which these regulations apply.
64.2 Definitions.
64.3 Who is eligible for a grant?
64.4 How to apply for a grant.
64.5 How are grant applications evaluated?
64.6 Awards.
64.7 What other conditions apply?
64.8 How may funds be used?
64.9 Other HHS regulations that apply.

    Authority: 42 U.S.C. 216, 286b-3.

    Source: 56 FR 29192, June 26, 1991, unless otherwise noted.



Sec.  64.1  Programs to which these regulations apply.

    (a) The regulations of this part apply to grants under section 472 
of the Public Health Service Act (42 U.S.C. 286b-3) to public and 
private nonprofit institutions to assist in developing, expanding, and 
improving training programs (excluding training in a biomedical 
specialty and residency training) in library science and the field of 
communications of information pertaining to sciences relating to health.
    (b) The regulations of this part also apply to cooperative 
agreements awarded for these purposes. References to ``grant(s)'' shall 
include ``cooperative agreement(s).''
    (c) The regulations of this part do not apply to research training 
support under the National Research Service Awards Program (see part 66 
of this chapter).



Sec.  64.2  Definitions.

    As used in this part:
    HHS means the Department of Health and Human Services.
    Nonprofit private entity means an agency, organization, institution, 
or other entity which may not lawfully hold or use any part of its net 
earnings to the benefit of any private shareholder or individual which 
does not hold or use its net earnings for that purpose.
    Other trainee costs means those costs other than stipends, such as 
tuition, fees, and trainee travel, which are directly associated with 
and necessary for the training of individuals receiving stipends and 
which are incurred within the period of training.
    Project director means the single individual named by the grantee in 
the grant application and approved by the Secretary, who is responsible 
for the management and conduct of the project.
    Project period. See Sec.  64.6(b).
    Secretary means the Secretary of Health and Human Services and any 
other official of HHS to whom the authority involved is delegated.
    Stipend means a payment to an individual that is intended to help 
meet that individual's subsistence expenses during training.
    Training grant means an award of funds to an eligible entity for a 
project authorized under Sec.  64.1(a).



Sec.  64.3  Who is eligible for a grant?

    Except as otherwise prohibited by law, any public or private 
nonprofit entity is eligible for a training grant.



Sec.  64.4  How to apply for a grant.

    Applications for grants must include the following information:
    (a) Required information on the proposed project. (1) The nature, 
duration, and purpose of the training for which the application is 
filed.
    (2) The name and qualifications of the project director and any key 
personnel responsible for the proposed project.
    (3) A description of the facilities, staff, support services, and 
other organizational resources available to carry out the project.
    (4) The intended number of trainees and the minimum qualifications 
and criteria for their selection.
    (5) A description of the plan for evaluating the proposed project.
    (6) Other pertinent information the Secretary may require to 
evaluate the proposed project.
    (b) Required information on costs. (1) A budget for the proposed 
project and a

[[Page 467]]

justification of the amount of grant funds requested.
    (2) If institutional expenses are requested, a separate statement of 
the amounts requested for personal services, equipment, supplies, or 
other non-personal services.
    (3) If stipend costs are requested, a statement for each grant year 
of the estimated number of individuals to whom stipends will be provided 
and the length of time for which the stipend support will be provided. 
If other trainee costs are requested, they must be separately stated and 
justified.

(Approved by the Office of Management and Budget under control number 
0925-0276)



Sec.  64.5  How are grant applications evaluated?

    The Secretary shall evaluate applications through the officers and 
employees, experts, consultants, or groups engaged by the Secretary for 
that purpose. The Secretary's evaluation will be for technical merit and 
shall take into account, among other pertinent factors, the significance 
of the project, the qualifications and competency of the project 
director and proposed staff, the adequacy of selection criteria for 
trainees for the project, the adequacy of the applicant's resources 
available for the project, and the amount of grant funds necessary for 
completion of its objectives.



Sec.  64.6  Awards.

    (a) Criteria. Within the limits of available funds, the Secretary 
may award training grants to carry out those projects which:
    (1) Are determined by the Secretary to be technically meritorious; 
and
    (2) In the judgment of the Secretary best promote the purpose of the 
grant program as authorized by section 472 of the Act (42 U.S.C. 286b-
3), the regulations of this part (see Sec.  64.1), and address program 
priorities.
    (b) Project period. (1) The notice of grant award specifies how long 
the Secretary intends to support the project without requiring the 
project to recompete for funds. This period, called the project period, 
will usually be for one to five years.
    (2) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of these awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by the Secretary that continued funding is in the best 
interest of the Federal Government.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (4) Any balance of federally obligated grant funds remaining 
unobligated by the grantee at the end of a budget period may be carried 
forward to the next budget period, for use as prescribed by the 
Secretary, provided a continuation award is made. If at any time during 
a budget period it becomes apparent to the Secretary that the amount of 
Federal funds awarded and available to the grantee for that period, 
including any unobligated balance carried forward from prior periods, 
exceeds the grantee's needs for that period, the Secretary may adjust 
the amounts awarded by withdrawing the excess.



Sec.  64.7  What other conditions apply?

    (a) Grants awarded under this part are subject to the following 
conditions:
    (1) The grantee may not materially change the quality, nature, or 
duration of the project unless the written approval of the Secretary is 
obtained prior to the change.
    (2) The grantee must submit to the Secretary, in the manner 
prescribed by the Secretary, the name and other pertinent information 
regarding each individual who is awarded a stipend under a grant.
    (b) The Secretary may impose additional conditions prior to the 
award of

[[Page 468]]

any grant under this part if it is determined by the Secretary that the 
conditions are necessary to carry out the purpose of the grant.

(Approved by the Office of Management and Budget under control number 
0925-0276)



Sec.  64.8  How may funds be used?

    A grantee shall expend funds it receives under this part solely in 
accordance with the approved application and budget, the regulations of 
this part, the terms and conditions of the grant award, and the 
applicable cost principles in 45 CFR part 75, subpart E. The funds may 
not be expended for:
    (a) Compensation for employment or for the performance of personal 
services by individuals receiving training and instruction; or
    (b) Payments to any individual who does not meet the minimum 
qualifications for training and instruction established by the grantee 
and approved by the Secretary or who has failed to demonstrate 
satisfactory participation in the training in accordance with the usual 
standards and procedures of the grantee.

[56 FR 29192, June 26, 1991, as amended at 81 FR 3009, Jan. 20, 2016]



Sec.  64.9  Other HHS regulations that apply.

    Several other regulations apply to grants under this part. These 
include, but are not necessarily limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.
45 CFR part 76--subparts A-F.
Governmentwide debarment and suspension (nonprocurement) and 
          requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under 45 CFR part 80 
of this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.

[56 FR 29192, June 26, 1991, as amended at 81 FR 3009, Jan. 20, 2016]



PART 64a_OBLIGATED SERVICE FOR MENTAL HEALTH TRAINEESHIPS--Table of Contents



Sec.
64a.101 Purpose.
64a.102 To whom do these regulations apply?
64a.103 Definitions.
64a.104 What requirements are imposed upon grantees?
64a.105 What are the conditions of obligated service?

    Authority: Sec. 803, Pub. L. 96-398, 94 Stat. 1607-1608 (42 U.S.C. 
242a).

    Source: 46 FR 39979, Aug. 5, 1981, unless otherwise noted.



Sec.  64a.101  Purpose.

    This part establishes requirements to implement the service payback 
obligation of individuals who receive clinical traineeships in 
pyschology, psychiatry, social work, or nursing (that are not of limited 
duration or experimental nature) under section 303 of the Public Health 
Service Act.



Sec.  64a.102  To whom do these regulations apply?

    This part applies to any institution which receives a training grant 
under section 303 of the Public Health Service Act and to any individual 
who receives a stipend or other trainee allowances under such a grant 
for any period beginning on or after July 1, 1981, for clincial training 
in the field of psychology, psychiatry, nursing, or social work, except 
for training that is of a limited duration or experimental nature.



Sec.  64a.103  Definitions.

    As used in this part:
    Act means the Public Health Service Act as amended by Pub. L. 96-
398.
    Clinical traineeship means a stipend or other trainee allowances 
provided to an individual for clinical training in psychology, 
psychiatry, nursing, or social work, except for training that is of a

[[Page 469]]

limited duration or experimental nature, under a training grant 
authorized by section 303 of the Act.
    Community Mental Health Centers Act means the Community Mental 
Health Centers Act (42 U.S.C. 2689 et seq.) other than Part D thereof.
    Experimental nature refers to the training of undergraduates; the 
training of individuals in disciplines other than psychology, 
psychiatry, nursing, or social work; and any other training which the 
Secretary specifically designates as experimental in the notice of award 
for a training grant under section 303 of the Act.
    Limited duration means a period that is equal to or less than 180 
days, computed cumulatively over a two year period which begins on the 
first day of the clinical traineeship.
    Mental Health Systems Act means the Mental Health Systems Act (42 
U.S.C. 9401 et seq.).
    Nonprofit private entity means an agency, organization, institution 
or other entity which may not lawfully hold or use any part of its net 
earnings to the benefit of any private shareholder or individual and 
which does not hold or use its net earnings for that purpose.
    Other trainee allowances means financial assistance for those costs 
not covered by stipends, such as tuition, fees, and trainee travel, 
which are directly associated with and necessary to the training of 
individuals receiving stipends and are incurred within the period of 
training.
    Secretary means the Secretary of Health and Human Services or other 
official of the Department to whom the authority involved has been 
delegated.
    Stipend means financial assistance to an individual that is intended 
to help meet that individual's subsistence expenses during training.



Sec.  64a.104  What requirements are imposed upon grantees?

    Recipients of training grants under section 303 of the Act that 
provide a clinical traineeship to any individual must:
    (a) Give each such individual written notice of the service payback 
and recovery requirements of this part at the time the individual 
becomes a candidate for the traineeship;
    (b) Before awarding a clinical traineeship, conduct an entrance 
interview with the individual in order to explain and emphasize the 
service obligation the individual is incurring, obtain the individual's 
written assurance that he or she will satisfy the requirements of Sec.  
64a.105, and document, in accordance with paragraph (d) of this section, 
the entrance interview on the form containing the individual's written 
assurance.
    (c) At the time of termination of the clinical traineeship,
    (1) Notify the Secretary in writing of the date on which the 
individual's traineeship is terminated;
    (2) Conduct an exit interview with the individual to remind the 
trainee of the service obligation, to fully explain the consequences 
that will incur should the trainee fail to satisfy the obligation, and, 
to tell the individual that the Secretary has been notified of the date 
of termination of the traineeship; and
    (3) Document, in accordance with paragraph (d) of this section, the 
exit interview on the form notifying the Secretary of the termination of 
the traineeship.
    (d) Document the entrance and exit interviews with at least the 
following information: The date of the interview, the names of the 
participants involved in the interview, and a statement that the 
interview included an explanation to the individual of the service 
payback requirement and the consequences of failing to fulfill the 
service payback requirement.

(Approved by the Office of Management and Budget under control number 
0930-0120)

[46 FR 39979, Aug. 5, 1981, as amended at 52 FR 18359, May 15, 1987]



Sec.  64a.105  What are the conditions of obligated service?

    In order to receive a clinical traineeship an individual must comply 
with the following conditions:
    (a) Written assurance. Prior to the award of a clinical traineeship, 
the individual must sign a written assurance (in such form and manner as 
the Secretary prescribes) that he or she will

[[Page 470]]

satisfy the requirements of this section.
    (b) Commencement and crediting of service. (1) An individual must 
start the obligated service within twenty-four months after termination 
of the clinical traineeship and carry out the service on a continuous 
basis unless, as specified in paragraph (e) of this section, the 
individual has requested and had approved, respectively, an extension of 
the time for beginning the service, or a break in service.
    (2) Following termination of the traineeship, the individual must 
annually provide (in such form and manner as the Secretary prescribes) a 
written report describing those previous years' activities which are 
related to service that fulfills the payback obligation. The Secretary 
will review this report and credit all service performed in those 
categories specified in paragraph (d) of this section toward the 
individual's payback obligation, except any service which is performed:
    (i) Before termination of the individual's clinical traineeship; and
    (ii) As part of any activity, such as course work, preparation of a 
dissertation or thesis, or practicum, which is needed to complete the 
training for which the individual received the traineeship.
    (c) Duration of obligation. The period of service payback must equal 
the period of support under the clinical traineeship on a month for 
month basis.
    (d) Performance of the obligated service--(1) General requirements. 
The obligated service must consist of the provision of service for which 
the individual was trained (in the training program for which the 
clinical traineeship was received) and must be performed on a full-time 
basis (not less than 30 hours per week averaged over the obligated 
service period).
    (2) Preferred service. Except as provided under paragraph (d)(3) of 
this section, the individual must provide the obligated service in:
    (i) A public inpatient mental institution;
    (ii) Any entity which is receiving or has received a grant under the 
Mental Health Systems Act or the Community Mental Health Centers Act;
    (iii) A psychiatric manpower shortage area designated by the 
Secretary under section 332 of the Public Health Service Act and 42 CFR 
part 5;
    (iv) Any public or private nonprofit entity or in any nursing home 
(whether public, private nonprofit, or for profit) in which 50 percent 
or more of those served are within one or more of the following groups: 
Racial or ethnic minorities (American Indian or Alaskan Native, Asian or 
Pacific Islander, Black, Hispanic), chronically mentally ill, mentally 
retarded, criminal or delinquent populations, rape victims, physically 
handicapped, abusers of alcohol, or persons addicted to drugs or other 
substances, children and adolescents, the elderly, poverty populations, 
migrants, members of the armed forces (or veterans if seen in a Federal 
facility), residents of areas other than those defined as urbanized by 
the Department of Commerce, or any other special populations, such as 
groups of refugees or disaster victims, which are specifically 
designated by the Secretary for this purpose.
    (3) Alternate service. If the individual obtains the written 
approval of the Secretary, the individual may fulfill his or her 
obligation by:
    (i) Serving in any public or private nonprofit entity or in any 
nursing home (whether public, private nonprofit, or for profit) in which 
not less than 25 percent of those served are within one or more of the 
underserved population groups listed in paragraph (d)(2)(iv) of this 
section. The individual must demonstrate a service commitment of more 
than 50 percent of his or her time to the targeted populations.
    (ii) Teaching, conducting research, or conducting evaluation 
directed at improving alcohol, drug abuse or mental health services to 
one or more of the priority population groups listed in paragraph 
(d)(2)(iv) of this section, or working in a position which fosters the 
closer collaboration of health and alcohol, drug abuse or mental health 
services.
    (iii) Providing in a public or private nonprofit entity 
consultation, training and education, liaison, community support or 
other professional services for which the individual was trained when

[[Page 471]]

the individual's work is directed toward improving alcohol, drug abuse 
or mental health services to the priority populations listed in 
paragraph (d)(2)(iv) of this section.
    (e) Conditions for deferral or break in service, waiver, or 
cancellation. (1) Upon receipt of a written request showing good cause 
therefor by the individual having a payback obligation, the Secretary 
may:
    (i) Extend the period for beginning the obligated service (24 months 
after termination of the clinical traineeship), permit breaks in the 
required continuous service or extend the period for repayment under 
paragraph (g)(2) of this section, if it is determined that:
    (A) An extension or break in service is necessary for the completion 
of training;
    (B) Performance of the obligation must be delayed because a 
temporary disability makes present performance impossible; or
    (C) Performance of the obligation must be delayed because present 
performance would involve a substantial hardship and failure to extend 
the period would be against equity and good conscience.
    (ii) Waive, in whole or in part, the service payback and recovery 
requirements of this section if it is determined that fulfillment would 
be impossible because the individual is permanently and totally 
disabled.
    (iii) In making determinations under Sec.  64a.105(e)(1)(i)(C), the 
Secretary will take into consideration the following factors:
    (A) The individual's present financial resources and obligations;
    (B) The individual's estimated future financial resources and 
obligations;
    (C) The reasons for the individual's failure to complete the 
requirements within the prescribed period, such as problems of a 
personal nature;
    (D) The unavailability of employment opportunities appropriate to 
the individual's education and training; and
    (E) Any other extenuating circumstances.
    (2) Upon receipt of written notice giving evidence of a conflicting 
obligation under section 752 or 753 of the Act or of an election to 
fulfill an obligation under section 472 of the Act prior to an 
obligation under this section, the Secretary will extend the period for 
beginning service (24 months after termination of the clinical 
traineeship), permit breaks in the required continuous service or extend 
the period for repayment under paragraph (g)(1), as appropriate.
    (3) The service payback and recovery obligations of an individual 
will be cancelled upon the submission to the Secretary of a certificate 
of that individual's death or other evidence which the Secretary 
determines to be satisfactory.
    (f) Conflicting or multiple payback obligations. In any case where 
the individual has, in addition to a payback obligation incurred under 
this section, an obligation to perform service under section 752 or 753 
of the Act (because of receipt of a National Health Service Corps 
scholarship) or under section 472 of the Act (because of receipt of a 
National Research Service Award), or both, performance of the same 
activity may not be counted toward more than one of these obligations. 
In determining the order in which obligations must be fulfilled, 
obligations under section 752 or 753 take precedence over obligations 
incurred under this section. However, with respect to obligations under 
this section and 472, the individual may elect which obligation to 
fulfill first. Any individual who has an obligation under section 752 or 
753 or makes an election to fulfill an obligation under section 472 
prior to an obligation under this section, must give written notice to 
the Secretary as provided by paragraph (e)(3) of this section.
    (g) Recovery for failure to perform obligated service. (1) If an 
individual fails to begin or complete the obligated service in 
accordance with the requirements of paragraphs (a) through (f) of this 
section, that individual is obligated to repay the United States an 
amount equal to three times the cost of the award (including stipends 
and other trainee allowances) plus interest on that amount calculated 
for the total period since the trainee failed to perform the obligated 
service at the rate set by the Secretary of the Treasury

[[Page 472]]

for National Research Service Awards prevailing on the date on which the 
period of appointment begins, multiplied, in any case in which the 
service that was required has been performed in part, by the percentage 
which the length of service that was not performed is to the length of 
the service that was required to be performed. The amount will be 
determined under the following formula:
[GRAPHIC] [TIFF OMITTED] TC13NO91.004

where

A = the amount the United States is entitled to recover;
[thetas] = the cost of the clinical traineeship (including stipends and 
other trainee allowances);
m = the number of months since the trainee failed to perform obligated 
service;
i = the National Research Service Award rate on the date which the 
period of appointment begins divided by twelve;
t = the total number of months of the service obligation;
s = the number of months that have been served.

    (2) Unless the Secretary extends the repayment period as provided in 
paragraph (e) of this section, the individual shall pay to the United 
States the total amount which the United States is entitled to recover 
under paragraph (g)(1) of this section immediately upon the date that 
the individual fails to begin or complete the period of obligated 
service (including failing to comply with the applicable terms and 
conditions of an extension or break in service granted the individual) 
or upon the date that the individual indicates his or her intention not 
to fulfill the service obligation as determined by the Secretary. The 
amount is considered a debt owed to the United States, with interest 
accruing monthly upon the total debt as provided under paragraph (g)(1) 
of this section.

[46 FR 39979, Aug. 5, 1981, as amended at 52 FR 18359, May 15, 1987]



PART 65_NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES 
HAZARDOUS WASTE WORKER TRAINING--Table of Contents



Sec.
65.1 To what projects do these regulations apply?
65.2 Definitions.
65.3 Who is eligible to apply for a grant?
65.4 Project requirements.
65.5 How will applications be evaluated?
65.6 How long does grant support last?
65.7 For what purposes may grant funds be spent?
65.8 What additional Department regulations apply to grantees?
65.9 Additional conditions.

    Authority: 42 U.S.C. 9660a; 49 U.S.C. App. 1816.

    Source: 55 FR 42568, Oct. 22, 1990, unless otherwise noted.



Sec.  65.1  To what projects do these regulations apply?

    (a) The regulations in this part apply to:
    (1) The program of grants for the training and education of workers 
who are or are likely to be engaged in activities related to hazardous 
waste removal or containment, or emergency response that is authorized 
under section 126(g) of the SARA; and
    (2) The program of grants to support qualified non-profit 
organizations for the purpose of providing training and education to 
hazardous materials employees regarding: the safe unloading, loading, 
handling, storage, and transportation of hazardous materials; and, 
emergency preparedness for responding to accidents or incidents 
involving the transportation of hazardous materials that is authorized 
under section 118 of the HMTA.
    (b) Grants are available for curriculum and training materials 
development, technical support of training, direct student training, 
training program evaluation and related activities. Target populations 
for this training are workers and supervisors who are or are likely to 
be engaged in hazardous substance removal or other activities which 
expose or potentially expose these workers to hazardous substances in 
activities such as:

[[Page 473]]

    (1) Waste handling and processing at waste generators and active and 
inactive hazardous substance treatment, storage, and disposal 
facilities;
    (2) Clean up, removal, containment, or remedial actions at waste 
sites;
    (3) Hazardous substance emergency response;
    (4) Hazardous substance disposal site risk assessment and 
investigation, clean up, or remedial actions; and
    (5) Transportation of hazardous wastes.
    Target populations may also be regulated under standards promulgated 
by the Secretary of Labor, the Secretary of Transportation, the 
Administrator of the Environmental Protection Agency, and other agencies 
under section 126(g) of the SARA or section 106(b) of the HMTA.
    (c) Two types of grants are available: Program grants covering the 
full range of activities, including program development, direct worker 
training and education, and program evaluation; and planning grants 
under the SARA.
    (1) Planning grants are intended to assist organizations which 
demonstrate potential for providing hazardous worker training, but need 
additional developmental efforts prior to initiation of full curriculum 
development and training activities. A limited number of one-year 
planning grants may be funded at a level determined appropriate by the 
Director. After successful completion of a one-year planning grant, a 
recipient may apply for a full program grant on a competitive basis.
    (2) Full program grants will be awarded to organizations with 
demonstrated capability to provide worker health and safety training and 
education and demonstrated ability to identify, describe, and access 
target populations. Full program grantees must be able to immediately 
initiate curriculum development and worker training activities.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec.  65.2  Definitions.

    As used in this part:
    Award or grant means a grant or cooperative agreement made under 
section 126(g) of the SARA or section 118 of the HMTA.
    Director means the Director, National Institute of Environmental 
Health Sciences, or the Director's delegate.
    HHS means the Department of Health and Human Services.
    HMTA means the Hazardous Materials Transportation Act, as amended 
(49 U.S.C. App. 1801 et seq.).
    NIEHS means the National Institute of Environmental Health Sciences, 
an organizational component of the National Institutes of Health, as 
authorized by sections 401(b)(1)(L) and 463 of the Public Health Service 
Act (42 U.S.C. 281(b)(1)(L) and 285(l).
    NIH means the National Institutes of Health.
    Nonprofit as applied to any agency, organization, institution, or 
other entity means a corporation or association no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    SARA means the Superfund Amendments and Reauthorization Act of 1986, 
Public Law 99-499, as amended (42 U.S.C. 9601 et seq.).
    Stipend means a payment to an organization that is intended to help 
meet that organization's subsistence expenses for trainees during the 
training period.
    Training grant means an award of funds to an eligible entity for a 
project authorized under Sec.  65.1.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec.  65.3  Who is eligible to apply for a grant?

    Public and private nonprofit entities providing worker health and 
safety education and training may apply for grants under these 
regulations. Applicants for a grant may use services, as appropriate, of 
other public or private organizations necessary to develop, administer, 
or evaluate proposed worker training programs so long as the majority of 
the work is done by the applicant.



Sec.  65.4  Project requirements.

    In addition to meeting the requirements specified in the 
application, the instructions accompanying it, and the regulations 
referred to in Sec.  65.8, each

[[Page 474]]

applicant must meet the following requirements:
    (a) Two or more nonprofit organizations may join in a single 
application and share grant resources in order to maximize worker group 
coverage, enhance the effectiveness of training, and bring together 
appropriate academic disciplines and talents. Joint applications must 
describe the cooperative arrangements for program integration and 
effectiveness. Specific expertise, facilities, or services to be 
provided by each participating member must be identified.
    (b) Each applicant must detail the nature, duration, and purpose of 
the training for which the application is filed. The proposed training 
program must meet the standards promulgated by the Secretary of Labor 
and Secretary of Transportation under section 126(g) of the SARA or 
section 106(b) of the HMTA, and such additional requirements as the 
Director may prescribe to ensure appropriate health and safety training.
    (c) The applicant must provide assurance that the applicant will not 
discriminate in the selection of trainees or instructors on the basis of 
membership or nonmembership in a union.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec.  65.5  How will applications be evaluated?

    (a) The Director shall evaluate applications through the officers 
and employees, and experts and consultants engaged by the Director for 
that purpose. The Director's first level of evaluation will be for 
technical merit and shall take into account, among other pertinent 
factors, the significance of the project, the qualifications and 
competency of the project director and proposed staff (including the 
ability to manage complex training programs), the adequacy of selection 
criteria for trainees for the project, the adequacy of the detailed 
training plan including provision for hands-on training, the adequacy of 
the applicant's resources available for the project, the amount of grant 
funds necessary for completion of its objectives, and how well the 
projects meet training criteria in OSHA's Hazardous Waste Operations and 
Emergency Response Regulation (29 CFR 1910.120) and/or how well they 
cover the target populations listed in Sec.  65.1(b). A second level of 
review will be conducted for program relevance.
    (b) Within the limits of funds available, the Director may award 
training grants to carry out those projects which have satisfied the 
requirements of the regulations of this part; are determined by the 
Director to be technically meritorious; and in the judgment of the 
Director best promote the purposes of the grant programs authorized by 
section 126(g) of the SARA or section 118 of the HMTA, the regulations 
of this part, and program priorities.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec.  65.6  How long does grant support last?

    (a) The notice of grant award specifies how long NIEHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (b) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices and the 
availability of funds. In all cases, continuation awards require a 
determination by the NIEHS that continued funding is in the best 
interest of the Federal Government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.



Sec.  65.7  For what purposes may grant funds be spent?

    Individuals receiving training shall be entitled only to the 
stipends and allowances included in a budget approved

[[Page 475]]

by the Director, taking into account the cost of living and such other 
factors as the needs of the program and the availability of funds.



Sec.  65.8  What additional Department regulations apply to grantees?

    Several other regulations and policies apply to grants under this 
part. These include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.
45 CFR part 76, subparts A-F--Government-wide debarment and suspension 
(nonprocurement) and government-wide requirements for drug-free 
workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
Effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in Health and 
Human Services programs and activities receiving Federal financial 
assistance.
45 CFR part 93--New restrictions on lobbying.

[55 FR 42568, Oct. 22, 1990, as amended at 81 FR 3009, Jan. 20, 2016]



Sec.  65.9  Additional conditions.

    The Director may with respect to any award impose additional 
conditions prior to, or at the time of, any award when, in the 
Director's judgment, such conditions are necessary to assure the 
carrying out of the purposes of the award, the interest of the public 
health, or the conservation of funds awarded.



PART 65a_NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES 
HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS--Table of Contents



Sec.
65a.1 To what programs do these regulations apply?
65a.2 Definitions.
65a.3 Who is eligible to apply for a grant?
65a.4 What are the program requirements?
65a.5 How to apply.
65a.6 How will applications be evaluated?
65a.7 Awards.
65a.8 How long does grant support last?
65a.9 What are the terms and conditions of award?
65a.10 For what purposes may grant funds be spent?
65a.11 Other HHS regulations and policies that apply.

    Authority: 42 U.S.C. 216, 9660(a).

    Source: 61 FR 55114, Oct. 24, 1996, unless otherwise noted.



Sec.  65a.1  To what programs do these regulations apply?

    (a) The regulations of this part apply to the award of grants to 
support programs for basic research and training directed towards 
understanding, assessing, and attenuating the adverse effects on human 
health resulting from exposure to hazardous substances, as authorized 
under section 311(a) of the Act (42 U.S.C. 9660(a)). The purpose of 
these programs is to carry out coordinated, multi-component, 
interdisciplinary research consisting of at least three or more 
biomedical research projects relating to hazardous substances and at 
least one non-biomedical research project in the fields of ecology, 
hydrogeology, and/or engineering, and including the training of 
investigators as part of the grantee's overall program.
    (b) The regulations of this part also apply to cooperative 
agreements awarded to support the programs described in paragraph (a) of 
this section. References to ``grant(s)'' shall include ``cooperative 
agreement(s).''
    (c) The regulations of this part do not apply to:
    (1) Research training support under the National Research Service 
Awards Program (see part 66 of this chapter),

[[Page 476]]

    (2) Research, demonstration, and training support under the NIH 
Center Grants programs (see part 52a of this chapter),
    (3) Research training support under traineeship programs (see parts 
63 and 64a of this chapter), or
    (4) Research training support under the NIH AIDS Research Loan 
Repayment Program authorized under section 487A of the Public Health 
Service Act, as amended (42 U.S.C. 288-1).



Sec.  65a.2  Definitions.

    As used in this part:
    Act means the Comprehensive Environmental Response, Compensation, 
and Liability Act of 1980, as amended (42 U.S.C. 9601 et seq.).
    Award or grant means a grant or cooperative agreement awarded under 
section 311(a) of the Act (42 U.S.C. 9660(a)).
    Director means the Director of the National Institute of 
Environmental Health Sciences, or the Director's delegate.
    HHS means the Department of Health and Human Services.
    Institution of higher education means an educational institution in 
any state which (1) admits as regular students only persons having a 
certificate of graduation from a school providing secondary education, 
or the recognized equivalent of such a certificate, (2) is legally 
authorized within the state to provide a program of education beyond 
secondary education, (3) provides an educational program for which it 
awards a bachelor's degree or provides not less than a two-year program 
which is acceptable for full credit toward a bachelor's degree, (4) is a 
public or other nonprofit institution, and (5) is accredited by a 
nationally recognized accrediting agency or association or, if not so 
accredited, (i) is an institution with respect to which the Secretary of 
Education has determined that there is satisfactory assurance, 
considering the resources available to the institution, the period of 
time, if any, during which it has operated, the effort it is making to 
meet accreditation standards, and the purpose for which this 
determination is being made, that the institution will meet the 
accreditation standards of a nationally recognized accrediting agency or 
association within a reasonable time, or (ii) is an institution whose 
credits are accepted, on transfer, by not less than three institutions 
which are so accredited, for credit on the same basis as if transferred 
from an institution so accredited. The term also includes any school 
which provides not less than a one-year program of training to prepare 
students for gainful employment in a recognized occupation and which 
meets the provisions of paragraphs (1), (2), (4), and (5) of this 
definition. The term also includes a public or nonprofit private 
educational institution in any state which, in lieu of the requirement 
in paragraph (1), admits as regular students persons who are beyond the 
age of compulsory school attendance in the state in which the 
institution is located and who meet the requirements of section 1091(d) 
of title 20 U.S. Code, as amended. For purposes of this definition, the 
Secretary of Education publishes a list of nationally recognized 
accrediting agencies or associations which that official determines to 
be reliable authority as to the quality of training offered. This list 
is found in the brochure, ``Nationally Recognized Accrediting Agencies 
and Associations Criteria and Procedures for Listing by the U.S. 
Secretary of Education and Current List.''

    Note: This brochure is subject to change, and interested persons 
should contact the U.S. Department of Education Office of Post-Secondary 
Education, Accreditation and State Liaison Division, ROB 3, 7th and D 
Streets, S.W., Room 37-15, Washington, DC 20202-5244 (202-708-7417; not 
a toll-free number) to obtain a current version of the brochure and any 
amendments.

    NIEHS means the National Institute of Environmental Health Sciences, 
an organizational component of the National Institutes of Health, as 
authorized under sections 401(b) and 463 of the Public Health Service 
Act, as amended (42 U.S.C. 281(b) and 185l).
    NIH means the National Institutes of Health.
    Nonprofit, as applied to any agency, organization, institution, or 
other entity, means a corporation or association

[[Page 477]]

no part of the net earnings of which insures or may lawfully inure to 
the benefit of any private shareholder or individual.
    PHS means the Public Health Service.
    Program means the activity to carry out research and training 
supported by a grant under this part.
    Program director means the single individual designated by the 
grantee in the grant application and approved by the Director, who is 
responsible for the scientific and technical direction of the research 
component and the conduct of the training component under a program.
    Project period means the period of time, from one to five years, 
specified in the notice of grant award that NIEHS intends to support a 
proposed program without requiring the program awardee to recompete for 
funds.
    Secretary means, unless the context otherwise requires, the 
Secretary of Health and Human Services or other official of HHS to whom 
the authority involved is delegated.



Sec.  65a.3  Who is eligible to apply for a grant?

    (a) Except as otherwise prohibited by law, any public or private 
nonprofit institution of higher education may apply for an award under 
this part.
    (b) Awardee institutions may carry out portions of the research or 
training components of an award through contracts with appropriate 
organizations, including:
    (1) Generators of hazardous wastes;
    (2) Persons involved in the detection, assessment, evaluation, and 
treatment of hazardous substances;
    (3) Owners and operators of facilities at which hazardous substances 
are located; and
    (4) State and local governments.



Sec.  65a.4  What are the program requirements?

    The applicant shall include the following in its proposed program 
for which support is requested under this part:
    (a) Basic research component. The program shall include three or 
more meritorious biomedical research projects, including epidemiologic 
studies relating to the study of the adverse effects of hazardous 
substances on human health, and at least one meritorious project 
involving hydrogeologic or ecologic research which shall cumulatively 
address:
    (1) Methods and technologies to detect hazardous substances in the 
environment;
    (2) Advanced techniques for the detection, assessment, and 
evaluation of the effects of these substances on human health;
    (3) Methods to assess the risks to human health presented by these 
substances; and
    (4) Basic biological, chemical, and/or physical methods to reduce 
the amount and toxicity of these substances.
    (b) Training component. The program shall include the following 
kinds of training, as part of or in conjunction with the basic research 
component:
    (1) Graduate training in environmental and occupational health and 
safety and in public health and engineering aspects of hazardous waste 
control; and/or
    (2) Graduate training in the geosciences, including hydrogeology, 
geological engineering, geophysics, geochemistry, and related fields, 
necessary to meet professional personnel needs in the public and private 
sectors and to carry out the purposes of the Act; and
    (3) Worker training relating to handling hazardous substances, which 
includes short courses and continuing education for state and local 
health and environmental agency personnel and other personnel engaged in 
the handling of hazardous substances, in the management of facilities at 
which hazardous substances are located, and in the evaluation of the 
hazards to human health presented by these facilities.



Sec.  65a.5  How to apply.

    Each institution desiring a grant under this part must submit an 
application at the time and in the form and manner as the Secretary may 
require.

[[Page 478]]



Sec.  65a.6  How will applications be evaluated?

    The Director shall evaluate applications through the officers and 
employees, experts, consultants, or groups engaged by the Director for 
that purpose, including review by the National Advisory Environmental 
Health Sciences Council in accordance with peer review requirements set 
forth in part 52h of this chapter. The Director's first level of 
evaluation will be for technical merit and shall take into account, 
among other pertinent factors, the significance of the program, the 
qualifications and competency of the program director and proposed 
staff, the adequacy of the applicant's resources available for the 
program, and the amount of grant funds necessary for completion of its 
objectives. A second level of review will be conducted by the National 
Advisory Environmental Health Sciences Council.



Sec.  65a.7  Awards.

    Criteria. Within the limits of available funds, the Director may 
award grants to carry out those programs which:
    (a) Are determined by the Director to be meritorious; and
    (b) In the judgment of the Director, best promote the purposes of 
the grant program, as authorized under section 311(a) of the Act and the 
regulations of this part, and best address program priorities.



Sec.  65a.8  How long does grant support last?

    (a) The notice of grant award specifies how long NIEHS intends to 
support the project without requiring the grantee to recompete for 
funds. This period, called the project period, may be for 1-5 years.
    (b) Generally, the grant will initially be for one year, and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application at the time and in the form 
and manner as the Secretary may require to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of these awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by the Director that continued funding is in the best 
interest of the Federal Government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation or other award with respect to 
any approved application or portion of an approved application.
    (d) Any balance of federally obligated grant funds remaining 
unobligated by the grantee at the end of a budget period may be carried 
forward to the next budget period, for use as prescribed by the 
Director, provided a continuation award is made. If at any time during a 
budget period it becomes apparent to the Director that the amount of 
Federal funds awarded and available to the grantee for that period, 
including any unobligated balance carried forward from prior periods, 
exceeds the grantee's needs for that period, the Director may adjust the 
amounts awarded by withdrawing the excess.



Sec.  65a.9  What are the terms and conditions of awards?

    In addition to being subject to other applicable regulations (see 
Sec.  65a.11), grants awarded under this part are subject to the 
following terms and conditions:
    (a) Material changes. Except as otherwise provided by 45 CFR 75.308, 
the grantee may not materially change the quality, nature, scope, or 
duration of the program unless the written approval of the Director is 
obtained prior to the change.
    (b) Additional conditions. The Director may impose additional 
conditions prior to the award of any grant under this part if it is 
determined by the Director that the conditions are necessary to carry 
out the purpose of the grant or assure or protect advancement of the 
approved program, the interests of the public health, or the 
conservation of grant funds.

[61 FR 55114, Oct. 24, 1996, as amended at 81 FR 3010, Jan. 20, 2016]

[[Page 479]]



Sec.  65a.10  For what purposes may grant funds be spent?

    A grantee shall spend funds it receives under this part solely in 
accordance with the approved application and budget, the regulations of 
this part, the terms and conditions of the award, and the applicable 
cost principles prescribed in 45 CFR part 75, subpart E.

[61 FR 55114, Oct. 24, 1996, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  65a.11  Other HHS regulations and policies that apply.

    Several other HHS regulations and policies apply to awards under 
this part. These include but are not necessarily limited to:

42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought
42 CFR part 52h--Scientific peer review of research grant applications 
and research and development contract projects
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research

    Note: This policy is subject to change, and interested persons 
should contact the Office of Research on Women's Health, NIH, Room 201, 
Building 1, MSC 0161, Bethesda, MD 20892-0161 (301-402-1770; not a toll-
free number) to obtain references to the current version and any 
amendments.

59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (301-496-
9838; not a toll-free number) to obtain references to the current 
version and any amendments.]
    ``PHS Grants Policy Statement,'' DHHS Publication No. (OASH) 94-
50,000 (Revised April 1, 1994), as amended by Addendum, dated January 
24, 1995.

    Note: This policy is subject to change, and interested persons 
should contact the Extramural Outreach and Information Resources Office 
(EOIRO), Office of Extramural Research, 6701 Rockledge Drive, Room 6208, 
MSC 7910, Bethesda, MD 20892-7910 (301-435-0714; not a toll-free number) 
to obtain references to the current version and any amendments. 
Information may also be obtained by contacting the EOIRO via its e-mail 
address ([email protected]) and by browsing the NIH Home Page 
site on the World Wide Web (http://www.nih.gov).]

    ``Public Health service Policy on Humane Care and Use of Laboratory 
animals,'' Office for Protection from Research Risks, HIH (Revised 
September 1986).

    Note: This policy is subject to change, and interested persons 
should contact the Office for Protection for Research Risks, NIH, Suite 
3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-
496-7005; not a toll-free number) to obtain references to the current 
version and any amendments.]

[61 FR 55114, Oct. 24, 1996, as amended at 81 FR 3010, Jan. 20, 2016]



PART 66_NATIONAL RESEARCH SERVICE AWARDS--Table of Contents



                         Subpart A_Direct Awards

Sec.
66.101 Applicability.
66.102 Definitions.
66.103 Eligibility.
66.104 Application.
66.105 Requirements.
66.106 Awards.
66.107 Payments to awardees.
66.108 Payments to institutions.
66.109 Termination.

[[Page 480]]

66.110 Service, payback, and recovery requirements.
66.111 Suspension, waiver, and cancellation.
66.112 Other HHS regulations and policies that apply.
66.113 Publications.
66.114 Copyright.
66.115 Additional conditions.

                     Subpart B_Institutional Grants

66.201 Applicability.
66.202 Definitions.
66.203 Eligibility.
66.204 Application.
66.205 Requirements.
66.206 Grant awards.
66.207 Other HHS regulations and policies that apply.
66.208 Additional conditions.

    Authority: 42 U.S.C. 216, 288.

    Source: 48 FR 24880, June 3, 1983, unless otherwise noted.



                         Subpart A_Direct Awards



Sec.  66.101  Applicability.

    The regulations in this subpart apply to National Research Service 
Awards made by the Secretary to individuals for research and training to 
undertake research, under section 487 of the Public Health Service Act, 
as amended (42 U.S.C. 288).

[66 FR 29499, May 31, 2001]



Sec.  66.102  Definitions.

    As used in this subpart:
    (a) Act means the Public Health Service Act, as amended.
    (b) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (c) Nonprofit institution means a corporation or association in 
which no part of the net earnings inures or may lawfully inure to the 
benefit of any private shareholder or individual.
    (d) Award means a National Research Service Award under section 487 
of the Act (42 U.S.C. 288).
    (e) Residency means post-graduate training for doctors of medicine, 
osteopathy, dentistry, optometry, and podiatry, nurses, and other 
individuals providing health care directly to patients, in which the 
majority of the time is spent in non-research clinical training.
    (f) Noncitizen national of the United States means a person who, 
though not a citizen of the United States, owes permanent allegiance to 
the United States [8 U.S.C. 1101(a) (22)].
    (g) Predoctoral training means training at the post-baccalaureate 
level in a program leading to the award of a doctor of philosophy of 
science, or equivalent degree. For purposes of Awards under the Minority 
Access to Research Careers programs of the National Institute of General 
Medical Sciences and the Career Opportunities in Research Education and 
Training programs of the National Institute of Mental Health, 
predoctoral training also means training in a program leading to the 
award of a baccalaureate in science or equivalent degree.
    (h) Postdoctoral training means training of individuals holding a 
doctor of philosophy, science, medicine, dentistry, osteopathy, 
optometry, podiatry, veterinary medicine, engineering, nursing sciences, 
public health, or equivalent degree.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29499, May 31, 2001]



Sec.  66.103  Eligibility.

    To be eligible for a National Research Service Award an individual 
must:
    (a) Be a citizen, noncitizen national of the United States, or 
lawfully admitted to the United States for permanent residence at the 
time of the award.
    (b) Propose to engage in such research, or training to undertake 
research, in a program specified in section 487(a)(1)(A) of the Act; and
    (c) Propose to engage in such research or training to undertake 
research on a full-time basis except in cases of disability or pressing 
family need.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec.  66.104  Application.

    (a) Eligible individuals may apply for an Award using the form and 
by the dates the Secretary prescribes.

[[Page 481]]

    (b) In addition to any other pertinent information that the 
Secretary may require, each application shall detail:
    (1) The applicant's educational background and other qualifications 
and experience, including previous academic and professional degrees;
    (2) The subject area of the proposed research or training;
    (3) The proposed period of Award:
    (4) If the proposed period of Award would provide the individual 
with aggregate support in excess of five years at the predoctoral level 
or three years at the postdoctoral level, the justification for this 
request; and
    (5) The availability of necessary resources and facilities at the 
institution where the research or training would be conducted.

(Approved by the Office of Management and Budget under control number 
0925-0002)

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec.  66.105  Requirements.

    The Secretary shall make an Award to an individual under this 
subpart only if:
    (a) For any Award made for an individual's initial twelve months of 
NRSA postdoctoral research or training, the individual has assured the 
Secretary, in the form and manner the Secretary may prescribe, that he 
or she will satisfy the requirements of Sec.  66.110.
    (b) If the proposed research or training would take place at an 
institution other than the National Institutes of Health, the 
institution has assured the Secretary, in the form and manner the 
Secretary may prescribe, that:
    (1) The applicant has been accepted to the institution for the 
purpose of engaging in the research or training for which an Award is 
being sought;
    (2) The Award will not be used to support a residency; and
    (3) In the event an Award is made the institution will make 
available to the applicant any resources and facilities described in the 
application as necessary to carry out the research or training; and
    (c) The individual has assured the Secretary, in the form and manner 
the Secretary may prescribe, that the Award to the individual will not 
be used to support a residency.

(Approved by the Office of Management and Budget under control number 
0925-0002)

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec.  66.106  Awards.

    (a) Within the limits of funds available, the Secretary shall make 
Awards to those applicants:
    (1) Who have satisfied the requirements of Sec.  66.105; and
    (2) Whose proposed research or training would, in the judgment of 
the Secretary, best promote the purposes of section 487(a)(1)(A) of the 
Act, taking into consideration among other pertinent factors:
    (i) The scientific, technical, or educational merit of the 
particular proposal;
    (ii) The availability of resources and facilities to carry it out;
    (iii) The qualifications and experience of the applicant; and
    (iv) The need for personnel in the subject area of the proposed 
research or training.
    (b) In making Awards, the Secretary shall take account of the 
Nation's overall need for biomedical research by giving special 
consideration to physicians who agree to undertake a minimum of two 
years of biomedical research.
    (c) All Awards shall be in writing. Each shall specify:
    (1) The period of the Award;
    (2) The total recommended stipends and allowances provided for the 
entire Award period;
    (3) The amount awarded for the intitial year of that period (see 
Sec.  66.107); and
    (4) The amount of the payments to the institution for the cost of 
services provided the awardee by the institution during the initial year 
of that period (see Sec.  66.108).
    (d) Neither the approval of any application nor any Award shall 
commit or obligate the United States in any way to make additional, 
supplemental, continuation, or other Award with respect to any approved 
application or portion thereof.

[[Page 482]]

    (e) No individual may receive an aggregate of more than five years 
of support at the predoctoral level and three years at the postdoctoral 
level unless the Secretary waives, for good cause shown, this limitation 
for the individual. In determining what constitutes ``good cause,'' the 
Secretary shall take into account such factors as whether the applicant 
proposes to pursue a combined program leading to the degrees of doctor 
of medicine and doctor of philosophy.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec.  66.107  Payments to awardees.

    (a) Individuals receiving Awards shall be entitled to the stipends, 
tuition, fees, and allowances the Secretary may designate, taking into 
account the cost of living, and such other factors as the needs of the 
program and the availability of funds.
    (b) The Secretary shall pay stipends, tuition, fees and allowances 
to the awardee or the sponsoring institution for payment to the awardee.



Sec.  66.108  Payments to institutions.

    The institution shall be entitled to an allowance to help defray the 
cost of support services (including the cost of faculty salaries, 
supplies, equipment, general research support, and related items) 
provided to the individual by the institution. The Secretary shall 
determine the amount of payments based upon reasonable costs to the 
institution of establishing and maintaining the quality of research and 
training programs for which it receives support under this subpart. The 
Secretary may make payments to the institution either in advance or by 
way of reimbursement.



Sec.  66.109  Termination.

    (a) The Secretary may terminate an Award prior to its normal 
expiration date:
    (1) At the written request of the awardee; or
    (2) If the Secretary finds that the awardee has materially failed to 
comply with the terms and conditions of the Award or to carry out the 
purpose for which it was made.
    (b) In the event an Award is terminated, the Secretary shall notify 
the awardee in writing of this determination, the reasons for 
termination, the effective date, and any procedural rights available.



Sec.  66.110  Service, payback, and recovery requirements.

    (a) Each individual who receives an Award for postdoctoral research 
or training shall engage in a month of research training, research, or 
teaching that is health-related (or any combination thereof) for each 
month of support received, up to a maximum of twelve months. Such period 
shall be served in accordance with the usual patterns of such employment 
or training.
    (b) In any case in which an individual receives an Award for more 
than twelve months, the thirteenth month and each subsequent month of 
performing activities under the Award shall be considered to be 
activities toward satisfaction of the requirement established in 
paragraph (a) of this section.
    (c) Except as provided in Sec.  66.111, an individual subject to the 
requirements for service in paragraph (a) of this section must begin to 
undertake the service on a continuous basis within two years after the 
expiration or termination for his or her Award.
    (d) If the individual fails to undertake or perform the service in 
accordance with the requirements of this section, the United States 
shall be entitled to recover from the individual an amount determined in 
accordance with the formula:
[GRAPHIC] [TIFF OMITTED] TR31MY01.005


In which

A is the amount the United States is entitled to recover;
0 is the sum of the total amount paid to the individual for the months 
of postdoctoral support up to a maximum of twelve months;
t is total number of months in the individual's service obligation;
and s is the number of months of the obligation served by him or her in 
accordance with paragraph (a) or (b) of this section.

    (e) Except as provided in Sec.  66.111, the individual shall pay to 
the United

[[Page 483]]

States any amount which it is entitled to recover under paragraph (d) of 
this section within a three-year period beginning on the date the United 
States becomes entitled to recovery that amount. Interest shall accrue 
to the United States until any amount due it under paragraph (d) of the 
section is paid. The rate of interest will be fixed by the Secretary of 
the Treasury after taking into consideration private consumer rates of 
interest prevailing on the date the United States becomes entitled to 
recovery.

[66 FR 29500, May 31, 2001]



Sec.  66.111  Suspension, waiver, and cancellation.

    (a) The Secretary may extend the period for undertaking service 
described in Sec.  66.110(c), permit breaks in the continuous service 
required under Sec.  66.110(c), or extend the period of repayment under 
Sec.  66.110(e) if the Secretary determines that:
    (1) An extension or break in service is necessary so the individual 
may complete his or her research training;
    (2) Completion during the period would be impossible because the 
individual is temporarily disabled; or
    (3) Completion during the period would involve a substantial 
hardship to the individual and failure to extend to the period would be 
against equity and good conscience.
    (b) The Secretary may waive, in whole or in part, the obligation of 
the individual to repay pursuant to Sec.  66.110(d) if the Secretary 
determines that:
    (1) Fulfillment would be impossible because the individual is 
permanently and totally disabled; or
    (2) Fulfillment would involve a substantial hardship to the 
individual and enforcement of the obligation would be against equity and 
good conscience.
    (c) In making determinations under Sec.  66.111 (a)(3) and (b)(2), 
the Secretary will take into consideration such factors as:
    (1) The individual's present financial resources and obligations;
    (2) The individual's estimated future financial resources and 
obligations;
    (3) The reasons for the individual's failure to complete the 
requirements within the prescribed period, such as problems of a 
personal nature;
    (4) The extent to which the individual has been engaged in 
activities encompassed by Sec.  66.110(a) and (b);
    (5) Whether the individual has received sufficient training to be 
qualified to perform any such activities;
    (6) The unavailability of employment opportunities appropriate to 
the individual's education and training; and
    (7) Any other extenuating circumstances.
    (d) Any obligations of any individual under this subpart will be 
cancelled upon the death of that individual.

[48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983, as amended at 66 
FR 29500, May 31, 2001]



Sec.  66.112  Other HHS regulations and policies that apply.

    Several other regulations and policies may apply to individuals and 
institutions receiving payments under this subpart. These include, but 
are not limited to:

45 CFR part 46--Protection of human subjects
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this Title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
51 FR 16958 (May 7, 1986)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Science Policy, Office of Biotechnology 
Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, 
Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to

[[Page 484]]

obtain references to the current version and any amendments.

[49 FR 38116, Sept. 27, 1984, as amended at 66 FR 29500, May 31, 2001]



Sec.  66.113  Publications.

    Publication, distribution, and disposition of all manuscripts and 
other materials resulting from an Award shall be subject to the 
conditions that all such materials shall bear appropriate 
acknowledgement of Department of Health and Human Services support and 
that the awardee shall furnish copies of these manuscripts or other 
materials as the Secretary may reasonably request.



Sec.  66.114  Copyright.

    Where the work accomplished under an Award results in a book or 
other copyrightable material, the author is free to copyright the work, 
but the United States reserves a royalty-free, nonexclusive, and 
irrevocable license to reproduce, publish, or otherwise use, and to 
authorize others to use, all copyrightable or copyrighted material 
resulting from the Award.



Sec.  66.115  Additional conditions.

    The Secretary may with respect to any Award or class of Awards 
impose additional conditions prior to or at the time of any Award when 
in the Secretary's judgment such conditions are necessary to assure the 
carrying out of the purposes of the Award, the interests of the public 
health, or the conservation of funds awarded.



                     Subpart B_Institutional Grants



Sec.  66.201  Applicability.

    The regulations in this subpart apply to grants under section 487 of 
the Public Health Service Act, as amended (42 U.S.C. 288), to public 
institutions and to nonprofit private institutions to enable those 
institutions to make National Research Service Awards to individuals for 
research and training to undertake research, in programs specified in 
section 487 of the Act.

[66 FR 29500, May 31, 2001]



Sec.  66.202  Definitions.

    The definitions in Sec.  66.102 of subpart A of this part apply to 
this subpart.

[48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983]



Sec.  66.203  Eligibility.

    To be eligible for a grant under this subpart, an applicant must be:
    (a) A public or nonprofit private institution; and
    (b) Located in a State, the District of Columbia, Puerto Rico, the 
Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust 
Territory of the Pacific Islands.



Sec.  66.204  Application.

    (a) Application for a grant under this subpart shall be made on a 
form approved for that purpose by the Secretary. Applicants shall submit 
completed forms on or before the dates the Secretary may prescribe.
    (b) In addition to any other pertinent information that the 
Secretary may require, each application shall set forth in detail:
    (1) The subject area or areas in which the proposed research or 
training will be conducted;
    (2) The resources and facilities available for use by recipients of 
Awards in carrying out this research or training;
    (3) The names, qualifications, and experience of the program 
director and principal staff members who will be responsible for the 
proposed program;
    (4) The criteria to be employed in selecting recipients of Awards;
    (5) The estimated number of recipients of Awards under the grant;
    (6) The proposed project period and a detailed budget and 
justification for the amount of grant funds requested; and
    (7) Proposed methods for monitoring and evaluating the performance 
of individual recipients of Awards, as well as the overall program.

(Approved by the Office of Management and Budget under control number 
0925-0022)



Sec.  66.205  Requirements.

    (a) No Award shall be made to an individual from a grant under this 
subpart unless:

[[Page 485]]

    (1) For any award made for an individual's initial twelve months of 
NRSA postdoctoral research training, the individual has assured the 
Secretary, in the form and manner the Secretary may prescribe, that he 
or she will satisfy the requirements of Sec.  66.110 of subpart A of 
this part;
    (2) The individual is a citizen or noncitizen national of the United 
States or has been lawfully admitted to the United States for permanent 
residence at the time of the award;
    (3) The Award includes a provision for termination in the event the 
recipient is found by the institution to have materially failed to 
comply with the terms and conditions of the Award or to carry out the 
purpose for which it was made; and
    (4) The Award is not to be used to support a residency.
    (b) No Award shall be made to an individual under such grant which 
would provide that individual with aggregate support in excess of five 
years for predoctoral training and three years for postdoctoral 
training, unless the Secretary for good cause shown as provided in Sec.  
66.106(e) of subpart A of this part, waives the application of the 
limitation with respect to that individual;
    (c) The provisions of Sec. Sec.  66.110 and 66.111 of subpart A of 
this part constitute terms and conditions of any Award made from a grant 
under this subpart.

(Approved by the Office of Management and Budget under control number 
0925-0022)

[48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983, as amended at 66 
FR 29501, May 31, 2001]



Sec.  66.206  Grant awards.

    (a) Within the limits of funds available, the Secretary shall award 
grants to those applicants:
    (1) Whose applications have been reviewed and recommended for 
approval by the appropriate national advisory council or board;
    (2) Who have satisfied the requirements of Sec.  66.105; and
    (3) Whose proposed programs would, in the judgment of the Secretary, 
best promote the purposes of section 487(a)(1)(B) of the Act, taking 
into consideration among other pertinent factors:
    (i) The scientific, technical, or educational merit of the proposed 
program;
    (ii) The adequacy of the resources and facilities available to the 
applicant;
    (iii) The qualifications and experience of the program director and 
principal staff members;
    (iv) The degree of the need for personnel in the subject area or 
areas of the proposed research or training;
    (v) The extent to which the applicant, in making Awards, gives 
special consideration to physicians who agree to undertake a minimum of 
two years of biomedical research;
    (vi) The administrative and management capability of the applicant;
    (vii) The reasonableness of the proposed budget in relation to the 
proposed program; and
    (viii) The adequacy of the methods for monitoring and evaluating the 
performance of individual recipients and the overall program.
    (b) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 3-5 
years.
    (c) Generally the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of any approved application.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29501, May 31, 2001]

[[Page 486]]



Sec.  66.207  Other HHS regulations and policies that apply.

    Several other regulations and policies apply to grants under this 
subpart. These include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Award
45 CFR part 76--Governmentwide debarment and suspension (non 
procurement) and governmentwide requirements for drug-free workplace 
(grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
48 FR 24556--Guidelines for Research Involving Recombinant DNA Molecules 
published by the National Institutes of Health
51 FR 16958 (May 7, 1986)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to change, and interested persons 
should contact the Office of Biotechnology Activities, NIH, Suite 302, 
6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-
9838 (not a toll-free number) to obtain references to the current 
version and any amendments.

[49 FR 38116, Sept. 27, 1984, as amended at 66 FR 29501, May 31, 2001; 
81 FR 3010, Jan. 20, 2016]



Sec.  66.208  Additional conditions.

    The Secretary may, with respect to any grant award, impose 
additional conditions prior to or at the time of any award when in the 
Secretary's judgment those conditions are necessary to assure or protect 
advancement of the approved program, the interests of the public health, 
or the conservation of grant funds.



PART 67_AGENCY FOR HEALTH CARE POLICY AND RESEARCH GRANTS AND CONTRACTS--
Table of Contents



  Subpart A_Research Grants for Health Services Research, Evaluation, 
                Demonstration, and Dissemination Projects

Sec.
67.10 Purpose and scope.
67.11 Definitions.
67.12 Eligible applicants.
67.13 Eligible projects.
67.14 Application.
67.15 Peer review of applications.
67.16 Evaluation and disposition of applications.
67.17 Grant award.
67.18 Use of project funds.
67.19 Other applicable regulations.
67.20 Confidentiality.
67.21 Control of data and availability of publications.
67.22 Additional conditions.

    Subpart B_Peer Review of Contracts for Health Services Research, 
          Evaluation, Demonstration, and Dissemination Projects

67.101 Purpose and scope.
67.102 Definitions.
67.103 Peer review of contract proposals.
67.104 Confidentiality.
67.105 Control of data and availability of publications.

    Authority: Pub. L. 103-43, 107 Stat. 214-215, Pub. L. 102-410, 106 
Stat. 2094-2101 and sec. 6103, Pub. L. 101-239, 103 Stat. 2189-2208, 
Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6); and 
sec. 1142, Social Security Act (42 U.S.C. 1320b-12).

    Source: 62 FR 12908, Mar. 18, 1997, unless otherwise noted.



  Subpart A_Research Grants for Health Services Research, Evaluation, 
                Demonstration, and Dissemination Projects



Sec.  67.10  Purpose and scope.

    The regulations of this subpart apply to the award by AHCPR of 
grants and cooperative agreements under:
    (a) Title IX of the Public Health Service Act to support research, 
evaluation, demonstration, and dissemination projects, including 
conferences, on

[[Page 487]]

health care services and systems for the delivery of such services, as 
well as to establish and operate multidisciplinary health services 
research centers.
    (b) Section 1142 of the Social Security Act to support research on 
the outcomes, effectiveness, and appropriateness of health care services 
and procedures, including but not limited to, evaluations of alternative 
services and procedures; projects to improve methods and data bases for 
outcomes, effectiveness, and other research; dissemination of research 
information and clinical guidelines, conferences, and research on 
dissemination methods.



Sec.  67.11  Definitions.

    As used in this subpart--
    Administrator means the Administrator and any other officer or 
employee of the Agency for Health Care Policy and Research to whom the 
authority involved may be delegated.
    Agency for Health Care Policy and Research (AHCPR) means that unit 
of the Department of Health and Human Services established by section 
901 of the Public Health Service Act.
    Direct costs means the costs that can be identified specifically 
with a particular cost objective, such as compensation of employees for 
the time and effort devoted specifically to the approved project, and 
the costs of materials acquired, consumed, or expended specifically for 
the purpose of the approved project.
    Grant means an award of financial assistance as defined in 45 CFR 
Part 75, including cooperative agreements.
    Grantee means the organizational entity or individual to which a 
grant, including a cooperative agreement, under Title IX of the Public 
Health Service Act or section 1142 of the Social Security Act and this 
subpart is awarded and which is responsible and accountable both for the 
use of the funds provided and for the performance of the grant-supported 
project or activities. The grantee is the entire legal entity even if 
only a particular component is designated in the award document.
    Nonprofit as applied to a private entity, means that no part of the 
net earnings of such entity inures or may lawfully inure to the benefit 
of any shareholder or individual.
    Peer review group means a panel of experts, established under 
section 922(c) of the PHS Act, who by virtue of their training or 
experience are eminently qualified to carry out the duties of such peer 
review group as set out in this subpart. Officers and employees of the 
United States may not constitute more than 25 percent of the membership 
of any such group under this subpart.
    PHS Act means the Public Health Service Act, as amended.
    Principal investigator means a single individual, designated in the 
grant application and approved by the Administrator, who is responsible 
for the scientific and technical direction of the project.
    Social Security Act means the Social Security Act, as amended.

[62 FR 12908, Mar. 18, 1997, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  67.12  Eligible applicants.

    Any public or nonprofit private entity or any individual is eligible 
to apply for a grant under this subpart.



Sec.  67.13  Eligible projects.

    Projects for research, evaluations, demonstrations, dissemination of 
information (including research on dissemination), and conferences, 
related to health care services and the delivery of such services, are 
eligible for grant support. These include, but are not limited to, 
projects in the following categories:
    (a) Effectiveness, efficiency, and quality of health care services;
    (b) Outcomes of health care services and procedures;
    (c) Clinical practice, including primary care and practice-oriented 
research;
    (d) Health care technologies, facilities, and equipment, including 
assessments of health care technologies and innovative approaches to 
such assessments, and technology diffusion;
    (e) Health care costs and financing, productivity, and market 
forces;
    (f) Health promotion and disease prevention;
    (g) Health statistics and epidemiology;

[[Page 488]]

    (h) Medical liability;
    (i) AID/HIV infection, particularly with respect to issues of access 
and delivery of health care services;
    (j) Rural health services;
    (k) The health of low-income, minority, elderly, and other 
underserved populations, including women and children; and
    (l) Information dissemination and research on dissemination 
methodologies, directed to health care providers, practitioners, 
consumers, educators, review organizations, and others.



Sec.  67.14  Application.

    (a) To apply for a grant, an entity or individual must submit an 
application in the form and at the time that the Administrator requires. 
The application must be signed by an individual authorized to act for 
the applicant and to assume on behalf of the applicant the obligations 
imposed by the PHS Act and the Social Security Act, as pertinent, the 
regulations of this subpart, and any additional terms or conditions of 
any grant awarded.
    (b) In addition to information requested on the application form, 
the applicant must provide such other information as the Administrator 
may request.



Sec.  67.15  Peer review of applications.

    (a) General procedures for peer review. (1) All applications for 
support under this subpart will be submitted by the Administrator for 
review to a peer review group, in accordance with section 922(a) of the 
PHS Act, except that applications eligible for review under section 
922(d)(2) of the PHS Act (``small grants'') may be reviewed under 
adjusted procedures in accordance with paragraph (b) of this section.
    (2) Members of the peer review group will be selected based upon 
their training and experience in relevant scientific and technical 
fields, taking into account, among other factors:
    (i) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) 
completed by the individual and/or the individual's pertinent experience 
and expertise;
    (ii) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of such research;
    (iii) The extent of the professional recognition received by the 
individual as reflected by awards and other honors received from 
scientific and professional organizations outside the Department of 
Health and Human Services;
    (iv) The need of the peer review group to include within its 
membership experts representing various areas of specialization within 
relevant scientific and technical fields, or specific health care 
issues; and
    (v) Appropriate representation based on gender, racial/ethnic 
origin, and geography.
    (3) Review by the peer review group under paragraph (a) of this 
section is conducted by using the criteria set out in paragraph (c) of 
this section.
    (4) The peer review group to which an application has been submitted 
under paragraph (a) of this section shall make a written report to the 
Administrator on each application, which shall contain the following 
parts:
    (i) The first part of the report shall consist of a factual summary 
of the proposed project, including a description of its purpose, 
scientific approach, location, and total budget.
    (ii) The second part of the report shall address the scientific and 
technical merit of the proposed project with a critique of the proposed 
project with regard to the factors described in paragraphs (c)(1)(i) 
through (c)(1)(x) or (c)(2)(i) through (c)(2)(vii) of this section as 
applicable. This portion of the report shall include a set of 
recommendations to the Administrator with respect to the disposition of 
the application based upon its scientific and technical merit. The peer 
review panel may recommend to the Administrator that an application:
    (A) Be given consideration for funding,
    (B) Be deferred for a later decision, pending receipt of additional 
information, or
    (C) Not be given further consideration.
    (iii) For each application recommended for further consideration by 
the Administrator, the report shall

[[Page 489]]

also provide a priority score based on the scientific and technical 
merit of the proposed project, and make recommendations on the 
appropriate project period and level of support. The report may also 
address, as applicable, the degree to which the proposed project relates 
to AHCPR-announced priorities.
    (b) Procedural adjustments for small grants. (1) The Administrator 
may make adjustments in the peer review procedures established in 
accordance with paragraph (a) of this section for grant applications 
with total direct costs that do not exceed the amount specified in 
section 922(d)(2) of the PHS Act, hereafter referred to as ``small 
grants.''
    (2) Non-Federal and Federal experts will be selected by the 
Administrator for the review of small grant applications on the basis of 
their training and experience in particular scientific and technical 
fields, their knowledge of health services research and the application 
of research findings, and their special knowledge of the issue(s) being 
addressed or methods and technology being used in the specific proposal.
    (3) Review of applications for small grants may be by a review group 
established in accordance with paragraph (a) of this section, or by 
individual field readers, or by an ad hoc group of reviewers.
    (4) The review criteria set forth in paragraph (c) of this section 
shall be used for the review of small grant applications.
    (5) Each reviewer or group of reviewers to whom an application has 
been submitted under paragraph (b) of this section shall make a written 
report to the Administrator on each application. Each report shall 
summarize the findings of the review and provide a recommendation to the 
Administrator on whether the application should be given further 
consideration. For applications recommended for further consideration, 
the report may also address, as applicable, the degree to which the 
proposed project relates to AHCPR-announced priorities.
    (c) Review criteria. The review criteria set out in this paragraph 
apply to both applications reviewed by peer review panels in accordance 
with paragraph (a) of this section, and applications for small grants 
reviewed in accordance with paragraph (b) of this section.
    (1) General review criteria. In carrying out a review under this 
section for grants (other than conference grants), the following review 
criteria will be taken into account, where appropriate:
    (i) The significance and originality from a scientific or technical 
standpoint of the goals of the project;
    (ii) The adequacy of the methodology proposed to carry out the 
project;
    (iii) The availability of data or the adequacy of the proposed plan 
to collect data required in the analyses;
    (iv) The adequacy and appropriateness of the plan for organizing and 
carrying out the project;
    (v) The qualifications and experience of the principal investigator 
and proposed staff;
    (vi) The reasonableness of the budget and the time frame for the 
project, in relation to the work proposed;
    (vii) The adequacy of the facilities and resources available to the 
grantee;
    (viii) The extent to which women and minorities are adequately 
represented in study populations;
    (ix) Where an application involves activities which could have an 
adverse effect upon humans, animals, or the environment, the adequacy of 
the proposed means for protecting against or minimizing such effects; 
and
    (x) Any additional criteria that may be announced by the 
Administrator from time to time for specific categories of grant 
applications (e.g., proposed projects for support of research centers) 
eligible for support under this subpart.
    (xi) In addition to the scientific and technical criteria above, 
peer reviewers may be asked to consider the degree to which a proposed 
project addresses any special AHCPR priorities that have been announced 
by the Administrator, as applicable.
    (2) Review criteria for conference grants. In carrying out reviews 
of conference grants under paragraphs (a) and (b) of this section, the 
following review criteria will be taken into account, as appropriate:
    (i) The significance of the proposed conference, specifically the 
importance

[[Page 490]]

of the issue or problem being addressed, including methodological or 
technical issues for dealing with the development, conduct, or use of 
health services research;
    (ii) The qualifications of the staff involved in planning and 
managing the conference;
    (iii) The adequacy of the facilities and other resources available 
for the conference;
    (iv) the appropriateness of the proposed budget, including other 
sources of funding;
    (v) The extent to which the health concerns of women and minorities 
will be addressed in the conference topic(s), as appropriate;
    (vi) The plan for evaluating and disseminating the results of the 
conference; and
    (vii) Any additional criteria that may be announced by the 
Administrator.
    (viii) In addition to the scientific and technical criteria above, 
peer reviewers may be asked to consider the degree to which a proposed 
project addresses any special AHCPR priorities that have been announced 
by the Administrator, as appropriate.
    (d) Conflict of interest. (1) Members of peer review groups will be 
screened for potential conflicts of interest prior to appointment and 
will be required to follow Department policies and procedures consistent 
with the Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635), Executive Order 12674 (as modified by 
Executive Order 12731).
    (2) In addition to any restrictions referenced under paragraph 
(d)(1) of this section:
    (i) No member of a peer review group (or individual reviewer) may 
participate in or be present during any review by such group of a grant 
application in which, to the member's knowledge, any of the following 
has a financial interest:
    (A) The member or his or her spouse, minor child, or partner;
    (B) Any organization in which the member is serving as an officer, 
director, trustee, general partner, or employee; or
    (C) Any organization with which the member is negotiating or has any 
arrangement concerning prospective employment or other similar 
association, and further;
    (ii) In the event that any member of a peer review group or his or 
her spouse, parent, child, or partner is currently or expected to be the 
principal investigator or member of the staff responsible for carrying 
out any research or development activities contemplated as part of a 
grant application, that member of the group, or the group, may be 
disqualified from the review and the review conducted by another group 
with the expertise to do so. An ad hoc group selected in accordance with 
Sec.  67.15(a), or Sec.  67.15(b) as applicable, may also be used for 
the review. Any individual reviewer to whom the conditions of this 
paragraph apply would also be disqualified as a reviewer.
    (iii) No member of a peer review group or individual may participate 
in any review under this subpart of a specific grant application for 
which the member has had or is expected to have any other responsibility 
or involvement (whether preaward or postaward) as an officer or employee 
of the United States.
    (3) Where permissible under the standards and order(s) cited in 
paragraph (d)(1) of this section, the Administrator may waive the 
requirements in paragraph (d)(2) of this section if it is determined 
that there is no other practical means for securing appropriate expert 
advice on a particular grant application.

[62 FR 12909, Mar. 18, 1997, as amended at 62 FR 37124, July 10, 1997]



Sec.  67.16  Evaluation and disposition of application.

    (a) Evaluation. After appropriate peer review in accordance with 
Sec.  67.15, the Administrator will evaluate applications recommended 
for further consideration, taking into account, among other factors:
    (1) The degree to which the purposes of Title IX of the PHS Act and 
section 1142 of the Social Security Act, as applicable, are being 
addressed;
    (2) Recommendations made by reviewers pursuant to Sec.  67.15;
    (3) Any recommendations made by the National Advisory Council for

[[Page 491]]

Health Care Policy, Research, and Evaluation, as applicable;
    (4) The appropriateness of the budget;
    (5) The extent to which the research proposal and the fiscal plan 
provide assurance that effective use will be made of grant funds;
    (6) The demonstrated business management capability of the 
applicant;
    (7) The demonstrated competence and skill of the staff, especially 
the senior personnel, in light of the scope of the project;
    (8) The probable usefulness of the results of the project for 
dealing with national health care issues, policies, and programs; and
    (9) The degree to which AHCPR-announced priorities or purposes are 
being addressed.
    (b) Disposition. On the basis of the evaluation of the application 
as provided in paragraph (a) of this section, the Administrator shall: 
give consideration for funding, defer for a later decision, pending 
receipt of additional information, or give no further consideration for 
funding, to any application for a grant under this subpart; except that 
the Administrator may not fund an application which has not been 
recommended for further consideration as a result of peer review in 
accordance with Sec.  67.15. A recommendation against further 
consideration shall not preclude reconsideration, if the application is 
revised, responding to issues and questions raised during the review, 
and resubmitted for peer review at a later date.



Sec.  67.17  Grant award.

    (a) Within the limits of available funds, the Administrator may 
award grants to those applicants whose projects are being considered for 
funding, which in the judgment of the Administrator, will promote best 
the purposes of Title IX of the PHS Act and (if applicable) section 1142 
of the Social Security Act, AHCPR priorities, and the regulations of 
this subpart.
    (b) The Notice of Grant Award specifies how long the Administrator 
intends to support the project without requiring the project to 
recompete for funds. This period, called the project period, will 
usually be for 3-5 years, except for small grants, which usually are 1 
year awards. The project period as specified in the Notice of Grant 
Award shall begin no later than 9 months following the date of the 
award, except that the project period must begin in the same fiscal year 
as that from which funds are being awarded.
    (c) Upon request from the grantee, Department grants policy permits 
an extension of the project period for up to 12 months, without 
additional funds, when more time is needed to complete the research. The 
Administrator may approve a request for an additional extension of time 
based on unusual circumstances with written justification submitted by 
the grantee, prior to the completion of the project period. In no case 
will an additional extension of more than 12 months be approved.
    (d) Generally, a grant award will be for 1 year, and subsequent 
continuation awards will be for 1 year at a time. A grantee must submit 
a separate continuation application to have the support continued for 
each subsequent year. Decisions regarding continuation awards and the 
funding level of such awards will be made after consideration of such 
factors as the grantee's progress and management practices and the 
availability of funds. In all cases, continuation awards require a 
determination by the Administrator that continuation is in the best 
interest of the Federal Government.
    (e) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application.
    (f) Small grants. For particular categories of small grants, such as 
dissertation research support, the Administrator may establish a limit 
on total direct costs to be awarded. Any categorical limits will be 
announced in advance of the deadline for receipt of applications for 
such small grants.
    (g) Supplemental awards. (1) Except for small grants, supplemental 
awards that would exceed 20 percent of the AHCPR approved direct costs 
of the project during the project period, or that request an increase in 
funds to

[[Page 492]]

support a change or a significant expansion of the scope of the project, 
will be reviewed as competing supplemental grants in accordance with 
Sec.  67.15(a). A supplemental award for preparation of data in suitable 
form for transmittal in accordance with Sec.  67.21 shall be excluded 
from the 20 percent aggregate.
    (2) In the case of small grants, as defined in section 922(d)(2) of 
the PHS Act, the Administrator will not approve a supplemental award 
during the project period (excluding any supplemental award for 
preparation of data in suitable form for transmittal in accordance with 
Sec.  67.21) that will, in the aggregate, exceed 10 percent of the AHCPR 
approved direct costs of the project.
    (h) Noncompeting continuation awards. Each project with a project 
period in excess of 2 years and with direct costs over the project 
period in excess of the amount specified in section 922(d)(2) may be 
reviewed during the second budget period and during each subsequent 
budget period by at least two members of the peer review group that 
reviewed the initial application, or individuals who participated in 
that review, to the extent practicable. Recommendations to the 
Administrator for continuation support will be based upon evaluation of:
    (1) The progress of the project in meeting project objectives;
    (2) The appropriateness of the management of the project and 
allocation of resources within the project;
    (3) The adequacy and appropriateness of the plan for carrying out 
the project during the budget period in light of the accomplishments 
during previous budget periods; and
    (4) The reasonableness of the proposed budget for the subsequent 
budget period.



Sec.  67.18  Use of project funds.

    Grant funds must be spent solely for carrying out the approved 
project in accordance with Title IX of PHS Act, section 1142 of the 
Social Security Act (if applicable), the regulations of this subpart, 
the terms and conditions of the award, and the provisions of 45 CFR part 
75.

[62 FR 12908, Mar. 18, 1997, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  67.19  Other applicable regulations.

    Several other regulations apply to grants under this subpart. These 
include, but are not limited to:

37 CFR part 401--Inventions and patents
42 CFR part 50 subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50 subpart D--Public Health Service grant appeals procedure
42 CFR part 50 subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought
45 CFR part 16--Procedures of the departmental grant appeals board
45 CFR part 46--Protection of human subjects
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under Part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in DHHS programs 
or activities receiving Federal financial assistance
45 CFR part 93--New restrictions on lobbying

[62 FR 12908, Mar. 18, 1997, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  67.20  Confidentiality.

    The confidentiality of identifying information obtained in the 
course of conducting or supporting grant and cooperative agreement 
activities under this subpart is protected by section 903(c) of the PHS 
Act. Specifically:
    (a) No information obtained in the course of conducting or 
supporting grant and cooperative agreement activities under this 
subpart, if the entity or individual supplying the information or 
described in it is identifiable, may be used for any purpose other than 
the purpose for which it was supplied,

[[Page 493]]

unless the identifiable entity or individual supplying the information 
or described in it has consented to such other use, in the recorded form 
and manner as the Administrator may require; and
    (b) No information obtained in the course of grant and cooperative 
agreement activities conducted or supported under this subpart maybe 
published or released in other form if the individual who supplied the 
information or who is described in it is identifiable, unless such 
individual has consented, in the recorded form and manner as the 
Administrator may require, to such publication or release.



Sec.  67.21  Control of data and availability of publications.

    Except as otherwise provided in the terms and conditions of the 
award and subject to the confidentiality requirements of section 903(c) 
of the PHS Act, section 1142(d) of the Social Security Act, and Sec.  
67.20 of this subpart:
    (a) All data collected or assembled for the purpose of carrying out 
health services research, evaluation, demonstration, or dissemination 
projects supported under this subpart shall be made available to the 
Administrator, upon request:
    (b) All publications, reports, papers, statistics, or other 
materials developed from work supported, in whole or in part, by an 
award made under this subpart must be submitted to the Administrator in 
a timely manner. All such publications must include an acknowledgement 
that such materials are the results of, or describe, a grant activity 
supported by AHCPR;
    (c) The AHCPR retains a royalty-free, non-exclusive, and irrevocable 
license to reproduce, publish, use, or disseminate any copyrightable 
material developed in the course of or under a grant for any purpose 
consistent with AHCPR's statutory responsibilities, and to authorize 
others to do so for the accomplishment of AHCPR purposes; and
    (d) Except for identifying information protected by section 903(c) 
of the PHS Act, the Administrator, as appropriate, will make information 
obtained with AHCPR grant support available, and arrange for 
dissemination of such information and material on as broad a basis as 
practicable and in such form as to make them as useful as possible to a 
variety of audiences, including health care providers, practitioners, 
consumers, educators, and policymakers.



Sec.  67.22  Additional conditions.

    The Administrator may, with respect to any grant awarded under this 
subpart, impose additional conditions prior to or at the time of any 
award when in the Administrator's judgment such conditions are necessary 
to assure or protect advancement of the approved project, the interest 
of the public health, or the conservation of grant funds.



    Subpart B_Peer Review of Contracts for Health Services Research, 
          Evaluation, Demonstration, and Dissemination Projects



Sec.  67.101  Purpose and scope.

    (a) The regulations of this subpart apply to the peer review of 
contracts under:
    (1) Title IX of the Public Health Service Act to support research, 
evaluation, demonstration, and dissemination projects, including 
conferences, on health care services and systems for the delivery of 
such services; and development of clinical practice guidelines, quality 
standards, performance measures, and review criteria.
    (2) Section 1142 of the Social Security Act to support research on 
the outcomes, effectiveness, and appropriateness of health care services 
and procedures, including, but not limited to, evaluations of 
alternative services and procedures; projects to improve methods and 
data bases for outcomes and effectiveness research; dissemination of 
research information and clinical practice guidelines, as well as 
quality standards, performance measures, and review criteria; 
conferences; and research on dissemination methods.
    (b) The regulations of this subpart also contain provisions 
respecting confidentiality of research data, control of data, and 
availability of information.

[[Page 494]]



Sec.  67.102  Definitions.

    Contract proposal means a written offer to enter into a contract 
submitted to a contracting officer by an individual or non-Federal 
organization, and including at a minimum a description of the nature, 
purpose, duration, cost of project and methods, personnel, and 
facilities to be utilized in carrying out the requirements of the 
contract.
    Peer review group means a panel of experts, as required by section 
922(c) of the PHS Act, established to conduct technical and scientific 
review of contract proposals and to make recommendations to the 
Administrator regarding the merits of such proposals.
    Request for proposals means a Government solicitation to prospective 
offerors, under procedures for negotiated contracts, to submit a 
proposal to fulfill specific agency requirements based on terms and 
conditions defined in the solicitation. The solicitation contains 
information sufficient to enable all offerors to prepare competitive 
proposals, and is as complete as possible with respect to: The nature of 
work to be performed; descriptions and specifications of items to be 
delivered; performance schedule; special requirements, clauses or other 
circumstances affecting the contract; and criteria by which the 
proposals will be evaluated.



Sec.  67.103  Peer review of contract proposals.

    (a) All contract proposals for AHCPR support will be submitted by 
the Administrator for review to a peer review group, as required in 
section 922(a) of the PHS Act. Proposals will be reviewed in accordance 
with the Federal Acquisition Regulations and the Health and Human 
Services Acquisition Regulations (48 CFR Ch. I and III) and the 
requirements of the pertinent Request for Proposal.
    (b) Establishment of peer review groups. In accordance with section 
922(c) of the PHS Act, the Administrator shall establish such peer 
review groups as may be necessary to review all contract proposals 
submitted to AHCPR.
    (c) Composition of peer review groups. The peer review groups shall 
be composed of individuals, in accordance with section 922(c) of the PHS 
Act, as amended, who by virtue of their training or experience are 
eminently qualified to carry out the duties of such a peer review group. 
Officers and employees of the United States may not constitute more than 
25 percent of the membership of any such group. Members of the peer 
review group will be selected based upon their training or experience in 
relevant scientific and technical fields, taking into account, among 
other factors:
    (1) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) 
completed by the individual and/or, as appropriate, the individual's 
pertinent experience and expertise;
    (2) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of such research;
    (3) The extent of the professional recognition received by the 
individual as reflected by awards and other honors received from 
scientific and professional organizations outside the Department of 
Health and Human Services;
    (4) The need of the peer review group to include in its membership 
experts representing various areas of specialization in relevant 
scientific and technical fields, or specific health care issues; and
    (5) Appropriate representation based on gender, racial/ethnic 
origin, and geography, to the extent practicable.
    (d) Term of peer review group members. Notwithstanding section 
922(c)(3) of the PHS Act, members of peer review groups appointed to 
review contract proposals will be appointed to such groups for a limited 
period of time, as determined by the Administrator; such as on an annual 
basis, or until the peer review of the contract proposals is completed, 
or until the expiration of the contract(s) awarded as a result of the 
peer review.
    (e) Conflict of interest. (1) Members of peer review groups will be 
screened for potential conflicts of interest prior to appointment and 
will be required to follow Department policies and procedures consistent 
with the Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635) and

[[Page 495]]

Executive Order 12674 (as modified by Executive Order 12731).
    (2) In addition to any restrictions referenced under paragraph 
(e)(1) of this section:
    (i) No member of a peer review group may participate in or be 
present during any review by such group of a contract proposal in which, 
to the member's knowledge, any of the following has a financial 
interest:
    (A) The member or his or her spouse, minor child, or partner;
    (B) Any organization in which the member is serving as an officer, 
director, trustee, general partner, or employee; or
    (C) Any organization with which the member is negotiating or has any 
arrangement concerning prospective employment or other similar 
association, and further;
    (ii) In the event any member of a peer review group or his or her 
spouse, parent, child, or partner is currently or expected to be the 
project director or member of the staff responsible for carrying out any 
contract requirements as specified in the contract proposal, that member 
is disqualified and will be replaced as appropriate.



Sec.  67.104  Confidentiality.

    Identifying information obtained in the course of conducting AHCPR 
contract activities under this subpart is protected by section 903(c) of 
the PHS Act. Specifically:
    (a) No information obtained in the course of conducting AHCPR 
contract activities under this subpart, if the entity or individual 
supplying the information or described in it is identifiable, may be 
used for any purpose other than the purpose for which it was supplied, 
unless the identifiable entity or individual supplying the information 
or described in it has consented to such other use, in the recorded form 
and manner as the Administrator may require.
    (b) No information obtained in the course of conducting AHCPR 
contract activities under this subpart may be published or released in 
other form if the individual who supplied the information or who is 
described in it is identifiable, unless such individual has consented, 
in the recorded form and manner as the Administrator may require, to 
such publication or release.



Sec.  67.105  Control of data and availability of publications.

    (a) Data will be collected, maintained, and supplied as provided in 
each contract subject to the confidentiality requirements of section 
903(c) of the PHS Act, section 1142(d) of the Social Security Act, and 
Sec.  67.104 of this subpart.
    (b) All publications, reports, papers, statistics, or other 
materials developed from work supported in whole or in part by contracts 
under Title IX of the PHS Act or section 1142 of the Social Security 
Act, if applicable, must be submitted to the Administrator in accordance 
with the terms of the contract. All publications must include an 
acknowledgment that such materials are the results of, or describe, a 
contractual activity supported by AHCPR.
    (c) In accordance with 48 CFR 52.227-14, unless otherwise specified 
in the contract, AHCPR will retain a license to use, disclose, 
reproduce, prepare derivative works from, distribute copies to the 
public, and perform publicly and display publicly any copyrightable 
materials produced under a contract for any purpose consistent with 
AHCPR's statutory responsibilities, and to have or permit others to do 
so for accomplishment of AHCPR purposes.
    (d) Except for identifying information protected by section 903(c) 
of the PHS Act, the Administrator, as appropriate, will make information 
provided in accordance with paragraphs (a) and (b) of this section 
available, and arrange for dissemination of such information and 
materials on as broad a basis as practicable and in such form as to make 
them as useful as possible to a variety of audiences, including health 
care providers, practitioners, consumers, educators, and policymakers.



PART 68_NATIONAL INSTITUTES OF HEALTH (NIH) LOAN REPAYMENT PROGRAMS (LRPs)--
Table of Contents



Sec.
68.1 What is the scope and purpose of the NIH LRPs?
68.2 Definitions.
68.3 Who is eligible to apply?

[[Page 496]]

68.4 Who is eligible to participate?
68.5 Who is ineligible to participate?
68.6 How do individuals apply to participate in the NIH LRPs?
68.7 How are applicants selected to participate in the NIH LRPs?
68.8 What do the NIH LRPs provide to participants?
68.9 What loans qualify for repayment?
68.10 What loans are ineligible for repayment?
68.11 What does an individual have to do in return for loan repayments 
          received under the NIH LRPs?
68.12 How does an individual receive loan repayments beyond the initial 
          applicable contract period?
68.13 What will happen if an individual does not comply with the terms 
          and conditions of participation in the NIH LRPs?
68.14 Under what circumstances can the service or payment obligation be 
          canceled, waived, or suspended?
68.15 When can an NIH LRP payment obligation be discharged in 
          bankruptcy?
68.16 Additional conditions.
68.17 What other regulations and statutes apply?


    Authority: 42 U.S.C. 254o, 42 U.S.C. 288-1, 42 U.S.C. 288-2, 42 
U.S.C. 288-3, 42 U.S.C. 288-5, 42 U.S.C. 288-5a, 42 U.S.C. 288-6, 42 
U.S.C. 285t-2.

    Source: 78 FR 20468, Apr. 5, 2013, unless otherwise noted.



Sec.  68.1  What are the scope and purpose of the NIH LRPs?

    The regulations of this part apply to the award of educational loan 
payments authorized by sections 487A, 487B, 487C, 487E, 487F,\1\ and 
464z-5 of the Public Health Service Act (42 U.S.C. 288-1, 42 U.S.C. 288-
2, 42 U.S.C. 288-3, 42 U.S.C. 288-5, 42 U.S.C. 288-5a, 42 U.S.C. 288-6, 
42 U.S.C. 285t-2). The purpose of these programs is to address the need 
for biomedical and behavioral researchers by providing an economic 
incentive to appropriately qualified health professionals who are 
engaged in qualifying research supported by domestic nonprofit funding 
or as employees of the NIH. The NIH Loan Repayment Programs include 
eight separate programs, three that are Intramural (for NIH researchers) 
and five that are Extramural (for non-NIH researchers).
---------------------------------------------------------------------------

    \1\ There are two sections 487F. Section 1002(b) of Public Law 106-
310 added section 487F, 42 U.S.C. 288-6, the Pediatric Research Loan 
Repayment Program. Subsequently, section 205 of Public Law 106-505 also 
added section 487F, 42 U.S.C. 288-5a, enacting the Loan Repayment 
Program for Clinical Researchers.
---------------------------------------------------------------------------

    (a) The Intramural LRPs include:
    (1) Loan Repayment Program for Research with Respect to Acquired 
Immune Deficiency Syndrome (or AIDS Research LRP);
    (2) Loan Repayment Program for General Research (or General Research 
LRP), including a program for Accreditation Council for Graduate Medical 
Education (ACGME) Fellows; and
    (3) Loan Repayment Program for Clinical Researchers from 
Disadvantaged Backgrounds (or Clinical Research LRP for Individuals from 
Disadvantaged Backgrounds). This program is also included as a separate 
program under the Extramural LRPs.
    (b) The Extramural LRPs include:
    (1) Loan Repayment Program for Contraception and Infertility 
Research (or Contraception and Infertility Research LRP);
    (2) Loan Repayment Program for Clinical Researchers from 
Disadvantaged Backgrounds (or Clinical Research LRP for Individuals from 
Disadvantaged Backgrounds);
    (3) Loan Repayment Program for Clinical Researchers (or Clinical 
Research LRP);
    (4) Loan Repayment Program for Pediatric Research (or Pediatric 
Research LRP); and
    (5) Loan Repayment Program for Health Disparities Research (or 
Health Disparities Research LRP).



Sec.  68.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    AIDS Research means research activities related to the Acquired 
Immunodeficiency Syndrome that qualify for inclusion in the AIDS 
Research LRP.
    Applicant means an individual who applies to and meets the 
eligibility criteria for the NIH LRPs.
    Breach of contract results when a participant fails to complete the 
research service or other obligation(s) required under the contract and 
may be subject to assessment of monetary damages and penalties as 
defined by statute.
    Clinical research is patient-oriented clinical research conducted 
with

[[Page 497]]

human subjects, or research on the causes and consequences of disease in 
human populations involving material of human origin (such as tissue 
specimens and cognitive phenomena) for which an investigator or 
colleague directly interacts with human subjects in an outpatient or 
inpatient setting to clarify a problem in human physiology, 
pathophysiology or disease, or epidemiologic or behavioral studies, 
outcomes research or health services research, or developing new 
technologies, therapeutic interventions, or clinical trials.
    Commercial loans means loans made for educational purposes by banks, 
credit unions, savings and loan associations, not-for-profit 
organizations, insurance companies, schools, and other financial or 
credit institutions that are subject to examination and supervision in 
their capacity as lending institutions by an agency of the United States 
or of the state in which the lender has its principal place of business.
    Contraception research is defined as research with the ultimate goal 
of providing new or improved methods of preventing pregnancy.
    Current payment status means that a qualified educational loan is 
not past due in its payment schedule, as determined by the lending 
institution.
    Debt threshold means the minimum amount of qualified educational 
debt an individual must have, on their program eligibility date, in 
order to be eligible for LRP benefits, as established by the Secretary.
    Director means the Director of the National Institute on Minority 
Health and Health Disparities (NIMHD) or designee.
    Educational expenses means the cost of the health professional's 
undergraduate, graduate, and health professional school's education, 
including the tuition expenses and other educational expenses such as 
living expenses, fees, books, supplies, educational equipment and 
materials, and laboratory expenses.
    Extramural LRPs refers to those programs for which health 
professionals, who are not NIH employees and have program-specified 
degrees and domestic nonprofit support, are eligible to apply. The 
Extramural LRPs include:
    (1) Contraception and Infertility Research LRP;
    (2) Clinical Research LRP for Individuals from Disadvantaged 
Backgrounds;
    (3) Clinical Research LRP;
    (4) Pediatric Research LRP; and
    (5) Health Disparities Research LRP.
    General research pertains to research that falls within the basic 
science or clinical research parameters and is not targeted toward a 
specific area (e.g., AIDS) or type of research (e.g., clinical 
research). The focus is on biomedical and behavioral research studies 
and investigations across a variety of scientific disciplines within the 
mission of the NIH.
    Government loans means educational loans made by U.S. Federal, 
state, county, or city agencies that are authorized by law to make such 
loans.
    Health disparities population: a population is a health disparity 
population if, as determined by the Director after consultation with the 
Director of the Agency for Healthcare Research and Quality, there is a 
significant disparity in the overall rate of disease incidence, 
prevalence, morbidity, mortality, or survival rates in the population as 
compared to the health status of the general population.
    Individual from disadvantaged background. (1) Comes from an 
environment that inhibited the individual from obtaining the knowledge, 
skill and ability required to enroll in and graduate from a health 
professions school; or
    (2) Comes from a family with an annual income below a level based on 
low-income thresholds according to family size published by the U.S. 
Bureau of the Census, adjusted annually for changes in the Consumer 
Price Index, and adjusted by the Secretary for use in HHS programs. The 
Secretary periodically publishes these income levels in the Federal 
Register.
    Infertility research is defined as research with the long-range 
objective of evaluating, treating, or ameliorating conditions that 
result in the failure of couples to either conceive or bear young.
    Institute or Center (IC) means an Institute or Center of the 
National Institutes of Health (NIH).
    Intramural LRPs refers to those programs for which applicants must 
be

[[Page 498]]

employed by the NIH. The intramural LRPs include:
    (1) AIDS Research LRP;
    (2) General Research LRP; and
    (3) Clinical Research LRP for Individuals from Disadvantaged 
Backgrounds.
    Institutional base salary or salary is the annual income or 
compensation that the organization pays for the applicant's appointment, 
whether the time is spent on research, teaching, patient care, or other 
activities.
    Living expenses means the reasonable cost of room and board, 
transportation and commuting costs, and other reasonable costs incurred 
during an individual's attendance at an educational institution and is 
part of the educational loan.
    Loan Repayment Programs (LRPs) refers to the NIH Loan Repayment 
Programs, including those authorized by sections 487A, 487B, 487C, 487E, 
487F, and 464z-5 of the Act, as amended.
    Loan Repayment Program contract refers to the agreement signed by an 
applicant and the Secretary or Director (for the following extramural 
LRPs: Health Disparities Research LRP and Clinical Research LRP for 
Individuals from Disadvantaged Backgrounds only). Under such an 
agreement, an Intramural LRP applicant agrees to conduct qualified 
research as an NIH employee, and an Extramural LRP applicant agrees to 
conduct qualified research supported by domestic nonprofit funding, in 
exchange for repayment of the applicant's qualified educational loan(s) 
for a prescribed period.
    NIH refers to the National Institutes of Health.
    Nonprofit funding/support: applicants must conduct qualifying 
research supported by a domestic nonprofit foundation, nonprofit 
professional association, or other nonprofit institution (e.g., 
university), or a U.S. or other government agency (Federal, state or 
local). A domestic foundation, professional association, or institution 
is considered to be nonprofit if exempt from Federal tax under the 
provisions of Section 501 of the Internal Revenue Code (26 U.S.C. 501).
    Participant means an individual whose application to any of the NIH 
LRPs has been approved and whose Program contract has been executed by 
the Secretary or the Director.
    Pediatric research is defined as research directly related to 
diseases, disorders, and other conditions in children, including 
pediatric pharmacology.
    Program refers to the NIH Loan Repayment Program, or LRP.
    Program eligibility date means the date on which an individual's LRP 
contract is executed by the Secretary or the Director.
    Qualified Educational Loans and Interest/Debt (see Educational 
Expenses) as established by the Secretary, include Government and 
commercial educational loans and interest for:
    (1) Undergraduate, graduate, and health professional school tuition 
expenses;
    (2) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and
    (3) Reasonable living expenses, including the cost of room and 
board, transportation and commuting costs, and other reasonable living 
expenses incurred.
    Reasonable educational and living expenses means those educational 
and living expenses that are equal to or less than the sum of the 
school's estimated standard student budget for educational and living 
expenses for the degree program and for the year(s) during which the 
participant was enrolled in school. If there is no standard budget 
available from the school, or if the participant requests repayment for 
educational and living expenses that exceed the standard student budget, 
reasonableness of educational and living expenses incurred must be 
substantiated by additional contemporaneous documentation, as determined 
by the Secretary.
    Repayable debt means the proportion, as established by the 
Secretary, of an individual's total qualified educational debt that can 
be paid by an NIH LRP.
    Salary has the same meaning as institutional base salary.
    School means undergraduate, graduate, and health professions schools 
that are accredited by a body or bodies

[[Page 499]]

recognized for accreditation purposes by the U.S. Secretary of 
Education.
    Secretary means the Secretary of Health and Human Services or 
designee.
    Service means the Public Health Service.
    State means one of the fifty states, the District of Columbia, the 
Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. 
Virgin Islands, Guam, American Samoa, and the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau.
    Waiver means a waiver of the service obligation granted by the 
Secretary when compliance by the participant is impossible or would 
involve extreme hardship, or where enforcement with respect to the 
individual would be unconscionable. (See Breach of contract.)
    Withdrawal means a request by a participant, prior to the Program 
making payments on his or her behalf, for withdrawal from Program 
participation. A withdrawal is without penalty to the participant and 
without obligation to the Program.



Sec.  68.3  Who is eligible to apply?

    To be eligible for consideration for the NIH LRPs, applicants must 
meet the following criteria:
    (a) Be citizens, nationals, or permanent residents of the United 
States;
    (b) Have the necessary degree from an accredited institution as 
determined by the NIH to be consistent with the needs of the LRP;
    (c)(1) For Intramural LRPs only: Applicants must be employed by the 
NIH and engage in qualified full-time research as specified by the LRP 
and be recommended by the employing IC or have a firm commitment of 
employment from an authorized official of the NIH;
    (2) For Extramural LRPs only: Applicants must be conducting 
qualified research for an average of at least 20 hours per week that is 
supported by a domestic nonprofit foundation, nonprofit professional 
association, or other nonprofit institution (e.g., university), or a 
U.S. or other government agency (Federal, state or local);
    (d) Have total qualifying educational loan debt as determined on the 
program eligibility date;
    (e) The NIH or the employing institution must provide an assurance 
that the applicant will be employed/appointed and provided research 
support for the applicable term of the LRP contract; and
    (f) Recipients of LRP awards must conduct their research in 
accordance with applicable Federal, state, and local law (e.g., 
applicable human subject protection regulations).
    (g) For Clinical Research for Individuals from Disadvantaged 
Background only: Individual must be from a disadvantaged background. 
(See Sec.  68.2, Definitions, Individual from disadvantaged background.)



Sec.  68.4  Who is eligible to participate?

    To be eligible to participate in the NIH LRPs, individuals must:
    (a) Meet the eligibility requirements specified in Sec.  68.3 of 
this part;
    (b) Not be ineligible for participation as specified in Sec.  68.5 
of this part;
    (c) Engage in qualified research for the contractual period;
    (d) Engage in such research for the percentage of time specified for 
the particular LRP; and
    (e) Comply with all other terms and conditions of the applicable 
Loan Repayment Program.



Sec.  68.5  Who is ineligible to participate?

    The following individuals are ineligible for NIH LRP participation:
    (a) Persons who do not meet the eligibility requirements as 
specified under Sec.  68.3 of this part;
    (b) Any individual who has or had a Federal judgment lien against 
his/her property arising from Federal debt;
    (c) Persons who owe an obligation of health professional service to 
the Federal Government, a state, or other entity, unless deferrals or 
extensions are granted for the length of the service of their LRP 
contract. The following are examples of programs that have a service 
obligation:
    (1) Armed Forces (Army, Navy, or Air Force) Professions Scholarship 
Program,
    (2) Exceptional Financial Need (EFN) Scholarship Program,

[[Page 500]]

    (3) Financial Assistance for Disadvantaged Health Professions 
Students (FADHPS),
    (4) Indian Health Service (IHS) Scholarship Program,
    (5) National Health Service Corps (NHSC) Scholarship Program,
    (6) National Research Service Award (NRSA) Program, and/or Loan 
Repayment Programs, NURSE Corps Scholarship and Loan Repayment Programs,
    (7) NIH Undergraduate Scholarship Program (UGSP),
    (8) Physicians Shortage Area Scholarship Program,
    (9) Primary Care Loan (PCL) Program, and
    (10) Public Health Service Scholarship (PHS) Program;
    (d) For extramural LRPs only: Individuals who receive any research 
funding support or salary from a for-profit institution or organization, 
or Federal Government employees working more than 20 hours per week;
    (e) Current recipients of NIH intramural training awards, e.g., NIH 
Intramural Research Training Awards (IRTA) or Cancer Research Training 
Awards (CRTA);
    (f) Individuals conducting research for which funding is precluded 
by Federal law, regulation, or HHS/NIH policy or that does not comply 
with applicable Federal, state, and local law regarding the conduct of 
the research (e.g., applicable human subject protection regulations);
    (g) Individuals with only ineligible loans or loans that are not 
educational; and
    (h) Individuals who do not have sufficient qualifying educational 
debt to meet the debt threshold.



Sec.  68.6  How do individuals apply to participate in the NIH LRPs?

    An application for participation in an NIH LRP shall be submitted to 
the NIH, which is responsible for the Program's administration, in such 
form and manner as the Secretary prescribes.



Sec.  68.7  How are applicants selected to participate in the NIH LRPs?

    The NIH LRP awards are competitive. To be selected for participation 
in an NIH LRP, applicants must satisfy the following requirements:
    (a) Applicants must meet the eligibility requirements specified in 
Sec. Sec.  68.3 and 68.4 of this part.
    (b) Applicants must not be ineligible for participation as specified 
in Sec.  68.5 of this part.
    (c) Upon receipt, applications for any of the NIH LRPs will be 
reviewed for eligibility and completeness by the NIH Division of Loan 
Repayment. Incomplete or ineligible applications will not be processed 
or reviewed further.
    (d)(1) Applications for the Intramural LRPs that are deemed eligible 
and complete are submitted to the Loan Repayment Committee (LRC), which 
reviews, ranks, and approves/disapproves LRP awards. The LRC is composed 
of senior intramural scientists, including basic (bench) and clinical 
researchers and science policy administrators. Since LRP participation 
in the Intramural programs is contingent upon NIH employment, applicants 
must be recommended by the employing IC of the NIH to be considered by 
the LRC.
    (2) Applications for the Extramural LRPs that are deemed eligible 
and complete will be referred by the NIH Center for Scientific Review 
(CSR) to an appropriate NIH IC for peer review. In evaluating the 
application, reviewers are directed to consider the following components 
and how they relate to the likelihood that the applicant will continue 
in a research career:
    (i) Applicant's potential to pursue a career in research as defined 
by the appropriate LRP:
    (A) Appropriateness of the applicant's previous training and 
experience to prepare for a research career.
    (B) Appropriateness of the proposed research activities during the 
LRP contract to foster a career in research.
    (C) Commitment to a research career, as reflected by the personal 
statement of long-term career goals and plan to achieve those goals.
    (D) Strength of the letters of recommendations attesting to the 
applicant's potential for a successful career in research.
    (ii) Quality of the overall environment to prepare the applicant for 
a research career:

[[Page 501]]

    (A) Quality and availability of appropriate scientific mentors and 
colleagues to help achieve or enhance the applicant's research 
independence, including the mentors' record in mentoring researchers, 
funding history, and research productivity.
    (B) Quality and appropriateness of institutional resources and 
facilities.
    (iii) For the Health Disparities Research LRP, at least 50 percent 
of the contracts are required by statute to be for appropriately 
qualified health professionals who are members of a health disparity 
population.



Sec.  68.8  What do the NIH LRPs provide to participants?

    (a) Loan repayments: For each year of the applicable service period 
the individual agrees to serve, the NIH may pay up to $35,000 per year 
of a participant's repayable debt.
    (b) Payments are made directly to a participant's lender(s). If 
there is more than one outstanding qualified educational loan, the NIH 
will repay the loans in the following order, unless the NIH determines 
significant savings would result from paying loans in a different order 
of priority:
    (1) Loans guaranteed by the U.S. Department of Health and Human 
Services;
    (2) Loans guaranteed by the U.S. Department of Education;
    (3) Loans made or guaranteed by a state;
    (4) Loans made by a school; and
    (5) Loans made by other entities.
    (c) Tax liability payments: In addition to the loan repayments, the 
NIH shall make tax payments in an amount equal to 39 percent of the 
total annual loan repayment to the Internal Revenue Service on the 
participant's behalf. The NIH may make additional payments to those 
participants who show increased Federal, State, and/or local taxes as a 
result of loan repayments.
    (d) Under paragraphs (a), (b), and (c) of this section, the NIH will 
make loan and tax liability payments to the extent appropriated funds 
are available for these purposes.



Sec.  68.9  What loans qualify for repayment?

    The NIH LRPs will repay participants' lenders the principal, 
interest, and related expenses of qualified U.S. Government and 
commercial educational loans obtained by participants for the following:
    (a) Undergraduate, graduate, and health professional school tuition 
expenses;
    (b) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and
    (c) Reasonable living expenses, including the cost of room and 
board, transportation and commuting costs, and other living expenses, as 
determined by the NIH.



Sec.  68.10  What loans are ineligible for repayment?

    The following loans are ineligible for repayment under the NIH LRPs:
    (a) Loans not obtained from a bank, credit union, savings and loan 
association, not-for-profit organization, insurance company, school, and 
other financial or credit institution that is subject to examination and 
supervision in its capacity as a lending institution by an agency of the 
United States or of the state in which the lender has its principal 
place of business;
    (b) Loans for which supporting documentation is not available;
    (c) Loans that have been consolidated with loans of other 
individuals, such as spouses or children;
    (d) Loans or portions of loans obtained for educational or living 
expenses that exceed the standard of reasonableness as determined by the 
participant's standard school budget for the year in which the loan was 
made and are not determined by the NIH to be reasonable based on 
additional documentation provided by the individual;
    (e) Loans, financial debts, or service obligations incurred under 
the following programs, or similar programs, which provide loans, 
scholarships, loan repayments, or other awards in exchange for a future 
service obligation:
    (1) Armed Forces (Army, Navy, or Air Force) Professions Scholarship 
Program,

[[Page 502]]

    (2) Exceptional Financial Need (EFN) Scholarship Program,
    (3) Financial Assistance for Disadvantaged Health Professions 
Students (FADHPS),
    (4) Indian Health Service Scholarship Program,
    (5) National Health Service Corps Scholarship Program,
    (6) National Institutes of Health Undergraduate Scholarship Program 
(UGSP),
    (7) National Research Service Award (NRSA) Program,
    (8) Physicians Shortage Area Scholarship Program,
    (9) Primary Care Loans (PCL), and
    (10) Public Health Service Scholarship Program;
    (f) Any loan in default, delinquent, or not in a current payment 
status;
    (g) Any Federal educational loan debt--including debt arising from 
the conversion of a service obligation to a loan--that has been in 
default or written off as uncollectible is ineligible for repayment 
under the Program, even if currently considered to be in good standing;
    (h) Loan amounts that participants were due to have been paid prior 
to the LRP contract start date;
    (i) Parents PLUS loans (except the Graduate PLUS loans for 
students);
    (j) Loans for which promissory notes have been signed after the LRP 
contract start date (with the exception of qualifying student loan 
consolidations); and
    (k) Home equity loans or other noneducational loans.



Sec.  68.11  What does an individual have to do in return for loan repayments 
received under the NIH LRPs?

    Individuals must agree to:
    (a) Engage in qualified research for the applicable contract service 
period;
    (b)(1) For Intramural LRPs: Engage in such research full-time as 
employees of NIH, or;
    (2) For Extramural LRPs: Engage in such research for an average of 
20 hours per week supported by a domestic nonprofit foundation, 
nonprofit professional association, or other nonprofit institution 
(e.g., university), or a U.S. or other government agency (Federal, state 
or local);
    (c) Keep all loan accounts in good standing, provide timely 
documentation as needed, including payment verification, service 
verification, change of research, change of institution, etc. Failure to 
provide such documentation may result in early termination, and the 
individual may be subject to statutory financial penalties; and
    (d) Satisfy all of the other terms and conditions of the LRP and the 
LRP Contract (e.g., Obligations of the Participant). Failure to adhere 
to the terms and conditions of the LRP contract may result in early 
termination, and the individual may be subject to statutory financial 
penalties.



Sec.  68.12  How does an individual receive loan repayments 
beyond the initial applicable contract period?

    An individual may apply for a competitive extension contract for at 
least a one-year period if the individual is engaged in qualifying 
research and satisfies the eligibility requirements specified under 
Sec. Sec.  68.3 and 68.4 of this part for the extension period and has 
remaining repayable debt as established by the Secretary.



Sec.  68.13  What will happen if an individual does not comply with 
the terms and conditions of participation in the NIH LRPs?

    Program participants who breach their Loan Repayment Program 
Contracts will be subject to the applicable monetary payment provisions 
set forth at section 338E of the Act (42 U.S.C. 254o). Payment of any 
amount owed under section 338E of the Act shall be made within one year 
of the date the participant breached his or her Loan Repayment Program 
Contract, unless the NIH specifically authorizes a longer period. 
Terminations will not be considered a breach of contract in cases where 
such terminations are beyond the control of the participant as follows:
    (a) Terminations for convenience of the government will not be 
considered a breach of contract and monetary damages will not be 
assessed.
    (b) Occasionally, a participant's research assignment or funding may 
evolve and change to the extent that the individual is no longer engaged 
in

[[Page 503]]

approved research. Similarly, the research needs and priorities of the 
IC and/or the NIH may change to the extent that a determination is made 
that a health professional's skills may be better utilized in a 
nonresearch assignment. Normally, job changes of this nature will not be 
considered a breach of contract on the part of either the NIH or the 
participant. Under these circumstances, the following will apply:
    (1) Program participation will cease as of the date an individual is 
no longer engaged in approved research;
    (2) Based on the approval of the NIH, the participant will be 
released from the remainder of his or her service obligation without 
assessment of damages or monetary penalties. The participant in this 
case will be permitted to retain all Program benefits made or owed by 
the NIH on his/her behalf up to the date the individual is no longer 
engaged in research, less the pro rata portion of any benefits advanced 
beyond the period of completed service.



Sec.  68.14  Under what circumstances can the service or payment obligation 
be canceled, waived, or suspended?

    (a) Any obligation of a participant for service or payment will be 
canceled upon the death of the participant.
    (b)(1) The NIH may waive or suspend any service or payment 
obligation incurred by the participant upon request whenever compliance 
by the participant:
    (i) Is impossible;
    (ii) Would involve extreme hardship to the participant; or
    (iii) If enforcement of the service or payment obligation would be 
unconscionable.
    (2) The NIH may approve a request for a suspension of the service or 
payment obligations for a period of up to one (1) year.
    (c) Compliance by a participant with a service or payment obligation 
will be considered impossible if the NIH determines, on the basis of 
information and documentation as may be required, that the participant 
suffers from a permanent physical or mental disability resulting in the 
inability of the participant to perform the service or other activities 
that would be necessary to comply with the obligation.
    (d) In determining whether to waive or suspend any or all of the 
service or payment obligations of a participant as imposing an undue 
hardship and being against good conscience, the NIH, on the basis of 
such information and documentation as may be required, will consider:
    (1) The participant's present financial resources and obligations;
    (2) The participant's estimated future financial resources and 
obligations; and
    (3) The extent to which the participant has problems of a personal 
nature, such as a physical or mental disability or terminal illness in 
the immediate family, which so intrude on the participant's present and 
future ability to perform as to raise a presumption that the individual 
will be unable to perform the obligation incurred.



Sec.  68.15  When can an NIH LRP payment obligation be discharged 
in bankruptcy?

    Any payment obligation incurred under Sec.  68.13 of this part may 
be discharged in bankruptcy under Title 11 of the United States Code 
only if such discharge is granted after the expiration of the seven-year 
period beginning on the first date that payment is required and only if 
the bankruptcy court finds that a non-discharge of the obligation would 
be unconscionable.



Sec.  68.16  Additional conditions.

    (a) When a shortage of funds exists, participants may be funded only 
partially, as determined by the NIH. However, once an NIH LRP contract 
has been signed by both parties, the NIH will obligate such funds as 
necessary to ensure that sufficient funds will be available to pay 
benefits for the duration of the period of obligated service unless, by 
mutual written agreement, the parties specify otherwise.
    (b) Additional conditions may be imposed as deemed necessary.



Sec.  68.17  What other regulations and statutes apply?

    Several other regulations and statutes apply to this part. These 
include, but are not necessarily limited to:
    (a) Debt Collection Act of 1982 (31 U.S.C. 3701 note);

[[Page 504]]

    (b) Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
    (c) Federal Debt Collection Procedures Act of 1990 (28 U.S.C. 176); 
and
    (d) Privacy Act of 1974 (5 U.S.C. 552a).



PART 68b_NATIONAL INSTITUTES OF HEALTH (NIH) UNDERGRADUATE SCHOLARSHIP PROGRAM 
REGARDING PROFESSIONS NEEDED BY NATIONAL RESEARCH INSTITUTES (UGSP)--
Table of Contents



Sec.
68b.1 What is the scope and purpose of the National Institutes of Health 
          Undergraduate Scholarship Program Regarding Professions Needed 
          by National Research Institutes?
68b.2 Definitions.
68b.3 Who is eligible to apply for a Scholarship Program award?
68b.4 How is an application made for a Scholarship Program award?
68b.5 How will applicants be selected to participate in the Scholarship 
          Program?
68b.6 What will an individual be awarded for participating in the 
          Scholarship Program?
68b.7 What does an individual have to do in return for the Scholarship 
          Program award?
68b.8 Under what circumstances can the period of obligated service be 
          deferred to complete approved graduate training?
68b.9 What will happen if an individual does not comply with the terms 
          and conditions of participating in the Scholarship Program?
68b.10 When can a Scholarship Program payment obligation be discharged 
          in bankruptcy?
68b.11 Under what circumstances can the service or payment obligation be 
          canceled, waived, or suspended?
68b.12 What other regulations and statutes apply?

    Authority: 42 U.S.C. 288-4.

    Source: 80 FR 48274, Aug. 12, 2015, unless otherwise noted.



Sec.  68b.1  What is the scope and purpose of the National Institutes 
of Health Undergraduate Scholarship Program Regarding Professions 
Needed by National Research Institutes?

    This part applies to the award of scholarships under the National 
Institutes of Health Undergraduate Scholarship Program Regarding 
Professions Needed by National Research Institutes, authorized by 
section 487D of the Public Health Service Act (42 U.S.C. 288-4), to 
undergraduate students attending schools, as the term is defined in this 
part. The purpose of this program is to help ensure an adequate supply 
of trained health professionals for the National Institutes of Health, 
which has the mission to uncover new knowledge that will lead to better 
health.



Sec.  68b.2  Definitions.

    As used in this part:
    Academic year means all or part of a 9-month period during which an 
applicant is enrolled in an undergraduate school as a full-time student.
    Acceptable level of academic standing means the level at which a 
full-time student retains eligibility to continue in attendance under 
the school's standards and practices.
    Act means the Public Health Service Act, as amended.
    Applicant means an individual who applies to and meets the 
eligibility criteria for the UGSP.
    Application means forms that have been completed in such manner, and 
containing such agreements, assurances, and information, as determined 
to be necessary by the Director.
    Approved graduate training means graduate programs leading to a 
doctoral-level degree (e.g., Ph.D., M.D., D.O., D.D.S., D.V.M., M.D./
Ph.D., and equivalent degrees) in a profession needed by the National 
Institutes of Health.
    Director means the Director of the National Institutes of Health or 
his/her designee.
    Full-time student means an individual registered for a sufficient 
number of credit hours to be classified as full-time, as defined by the 
school attended.
    Individual from Disadvantaged Background means:
    (1) An individual who--
    (i) Comes from an environment that inhibited (but did not prevent) 
him or her from obtaining the knowledge, skills, and abilities required 
to enroll in an undergraduate institution; or
    (ii) Comes from a family with an annual income below established 
low-income thresholds.

[[Page 505]]

    (2) These low-income thresholds are based on family size, published 
by the U.S. Bureau of the Census, adjusted annually for changes in the 
Consumer Price Index, and adjusted by the Secretary of Health and Human 
Services for use in the U.S. Department of Health and Human Services' 
health professions programs. The Secretary periodically publishes these 
income levels in the Federal Register.
    Scholarship Program means the National Institutes of Health 
Undergraduate Scholarship Program Regarding Professions Needed by 
National Research Institutes authorized by section 487D of the Act (42 
U.S.C. 288-4).
    Scholarship Program participant or participant means an individual 
whose application to the Scholarship Program has been approved and whose 
contract has been signed by the Director.
    Scholarship Program Review Committee means the committee that 
reviews, ranks, and accepts or declines applications for Program 
participation. This committee also ascertains whether a participant will 
be awarded continued scholarship support after his or her initial 
acceptance.
    School means a 4-year college or university that:
    (1) Is accredited by an agency recognized by the Commission on 
Recognition of Post-Secondary Accreditation; and
    (2) Is located in a State.
    State means one of the several U.S. States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, 
the U.S. Virgin Islands, Guam, American Samoa, Palau, Marshall Islands, 
and the Federated States of Micronesia.



Sec.  68b.3  Who is eligible to apply for a Scholarship Program award?

    (a) To be eligible for a scholarship under this part, applicants 
must meet the following requirements:
    (1) Applicants must be accepted for enrollment, or be enrolled, as 
full-time undergraduate students in a school;
    (2) Applicants must have an overall grade point average of at least 
3.5 or a 3.5 average in their major field of study (on a 4.0 scale) or 
be ranked within the top five percent of their current class (or those 
students entering, if applying in their freshman year);
    (3) Applicants must come from a disadvantaged background as defined 
by Sec.  68b.2;
    (4) Applicants must meet the citizenship requirements for federal 
employment; and
    (5) Applicants must submit an application to participate in the 
Scholarship Program together with a signed contract as outlined in 
sections 487D(a) and (f) of the Act.
    (b) Any applicant who owes an obligation for service to a State or 
other entity under an agreement entered into before filing an 
application under this part is ineligible for an award unless a written 
statement satisfactory to the Director is submitted from the State or 
entity that:
    (1) There is no potential conflict in fulfilling the service 
obligation to the State or entity and the Scholarship Program, and
    (2) The Scholarship Program service obligation will be served before 
the service obligation for professional practice owed to the State or 
entity.



Sec.  68b.4  How is an application made for a Scholarship Program award?

    Each individual desiring a scholarship under this part must submit 
an application (including a signed contract as required under section 
487D(a) of the Act) in such form and manner as the Director may 
prescribe.



Sec.  68b.5  How will applicants be selected to participate in 
the Scholarship Program?

    (a) General. In deciding which applications for participation in the 
Scholarship Program will be approved, the Director will place the 
applications into categories based upon the selection priorities 
described in paragraph (b) of this section. Except for renewal awards 
(see paragraph (e) of this section), the Director will then evaluate 
each applicant under paragraph (c) of this section.
    (b) Priorities. (1) First priority will be given to applicants who 
have completed at least 2 years of undergraduate course work, including 
four core science courses, and are classified by

[[Page 506]]

their educational institutions as juniors or seniors as of the beginning 
of the academic year of scholarship. (Core science courses include, but 
are not limited to, biology, chemistry, physics, and calculus.)
    (2) Second priority will be given to applicants who have completed 
four core science courses, as defined above.
    (3) Third priority will be given to applicants who are matriculated 
freshmen or sophomores.
    (c) Selection. In selecting participants and determining 
continuation of program support, the Director will take into 
consideration those factors determined necessary to ensure effective 
participation in the Scholarship Program. These factors may include, but 
are not limited to:
    (1) Biomedical research experience and performance,
    (2) Academic performance,
    (3) Career goals, and
    (4) Recommendations.
    (d) Duration of Scholarship award. Subject to the availability of 
funds appropriated for the Scholarship Program, the Director may, at 
his/her discretion, award scholarships under this part for a period of 
one, two, or three academic years.
    (e) Continuation of scholarship support. Subject to the availability 
of funds for the Scholarship Program, the Director may continue 
scholarship support if:
    (1) The participant requests a continuation of scholarship support;
    (2) The scholarship will not extend the total period of Scholarship 
Program support beyond 4 years; and
    (3) The participant is eligible for continued participation in the 
Scholarship Program, as determined by the Scholarship Program Review 
Committee.



Sec.  68b.6  What will an individual be awarded for participating in 
the Scholarship Program?

    (a) Amount of scholarship. (1) Subject to a maximum annual award of 
$20,000, a scholarship award for each school year will consist of:
    (i) Tuition;
    (ii) Reasonable educational expenses, including required fees, 
books, supplies, and required educational equipment;
    (iii) Reasonable living expenses for the academic year as documented 
in the school's financial aid budget; and
    (iv) For purposes of this section, ``required fees'' means those 
fees that are charged by the school to all students pursuing a similar 
curriculum, and ``required educational equipment'' means educational 
equipment that must be purchased by all students pursuing a similar 
curriculum at that school.
    (2) The Director may enter into an agreement with the school in 
which the participant is enrolled for the direct payment of tuition and 
reasonable educational expenses on the participant's behalf.
    (b) Payment of scholarship: Leave-of-absence; repeated course work. 
The Director will suspend scholarship payments to or on behalf of a 
participant if the school:
    (1) Approves a leave-of-absence for the participant for health, 
personal, or other reasons; or
    (2) Requires the participant to repeat course work for which the 
Director has previously made scholarship payments under Sec.  68b.6. 
However, if the repeated course work does not delay the participant's 
graduation date, scholarship payments will continue except for any 
additional costs relating to the repeated course work. Any scholarship 
payments suspended under this paragraph will be resumed by the Director 
upon notification by the school that the participant has returned from 
the leave-of-absence or has completed the repeated course work and is 
pursuing as a full-time student the course of study for which the 
scholarship was awarded.



Sec.  68b.7  What does an individual have to do in return 
for the Scholarship Program award?

    (a) General. For each academic year of scholarship support received, 
participants must serve as full-time employees of the National 
Institutes of Health:
    (1) For not less than 10 consecutive weeks of each year during which 
the participant receives the scholarship; and

[[Page 507]]

    (2) For 12 months for each academic year for which the scholarship 
has been provided.
    (b) Beginning of service. The period of obligated service under 
paragraph (a)(2) of this section must begin within 60 days of obtaining 
the undergraduate degree, except for participants who receive a 
deferment under Sec.  68b.8.



Sec.  68b.8  Under what circumstances can the period of obligated service 
be deferred to complete approved graduate training?

    (a) Requested deferment. Upon the request of any participant 
receiving an undergraduate degree, the Director may defer the beginning 
date of the obligated service to allow the participant to complete an 
approved graduate training program. Individuals desiring a deferment 
under this part must submit a request in such form and manner as the 
Director may prescribe.
    (b) Altering deferment. Before altering the length or type of 
approved graduate training for which the period of obligated service was 
deferred under paragraph (a) of this section, the participant must 
request and obtain the Director's approval of the alteration.
    (c) Additional terms of deferment. The Director may prescribe 
additional terms and conditions for deferment under paragraphs (a) and 
(b) of this section as necessary to carry out the purposes of the 
Scholarship Program.
    (d) Beginning of service after deferment. Any participant whose 
period of obligated service has been deferred under paragraph (a) of 
this section must begin the obligated service within 30 days of the 
expiration of their deferment.



Sec.  68b.9  What will happen if an individual does not comply with 
the terms and conditions of participating in the Scholarship Program?

    (a) When a participant fails to maintain an acceptable level of 
academic standing, is dismissed from the school for disciplinary 
reasons, or voluntarily terminates the course of study or program for 
which the scholarship was awarded before completing the course of study 
or program, the participant must, instead of performing any service 
obligation, pay to the United States an amount equal to all scholarship 
funds awarded under Sec.  68b.6. Payment of this amount must be made 
within 3 years of the date the participant becomes liable to make 
payment under this paragraph (a).
    (b) If, for any reason not specified in Sec.  68b.11(b), a 
participant fails to begin or complete the period of obligated service 
incurred under Sec.  68b.7, including failing to comply with the 
applicable terms and conditions of a deferment granted by the Director, 
the participant must pay to the United States an amount determined by 
the penalties set forth in section 487D(e) of the Act. Payment of this 
amount shall be made within one year of the date that the participant 
failed to begin or complete the period of obligated service, as 
determined by the Director.



Sec.  68b.10  When can a Scholarship Program payment obligation 
be discharged in bankruptcy?

    Any payment obligation incurred under Sec.  68b.9 may be discharged 
in bankruptcy under Title 11 of the United States Code only if such 
discharge is granted after the expiration of the seven-year period 
beginning on the first date that payment is required and only if the 
bankruptcy court finds that a nondischarge of the obligation would be 
unconscionable.



Sec.  68b.11  Under what circumstances can the service or payment obligation 
be canceled, waived, or suspended?

    (a) Any obligation of a participant for service or payment to the 
federal government under this part will be canceled upon the death of 
the participant.
    (b) The Director may waive or suspend any service or payment 
obligation incurred by the participant upon request whenever compliance 
by the participant:
    (1) Is impossible, or
    (2)(i) Would involve extreme hardship, and
    (ii) If enforcement of the service or payment obligation would be 
unconscionable, as required by section 487 D(e) of the Act, 42 U.S.C. 
288-4(e).
    (c) The Director may approve a request for a suspension of the 
service or payment obligations for a period of one

[[Page 508]]

year. A renewal of this suspension may also be granted.
    (d) Compliance by a participant with a service or payment obligation 
will be considered impossible if the Director determines, on the basis 
of information and documentation as may be required, that the 
participant suffers from a physical or mental disability resulting in 
the permanent inability of the participant to perform the service or 
other activities that would be necessary to comply with the obligation.
    (e) In determining whether to waive or suspend any or all of the 
service or payment obligations of a participant as imposing an undue 
hardship and being against equity and good conscience, the Director, on 
the basis of information and documentation as may be required, will 
consider:
    (1) The participant's present financial resources and obligations;
    (2) The participant's estimated future financial resources and 
obligations; and
    (3) The extent to which the participant has problems of a personal 
nature, such as physical or mental disability or terminal illness in the 
immediate family, which so intrude on the participant's present and 
future ability to perform as to raise a presumption that the individual 
will be unable to begin or complete the obligation incurred.



Sec.  68b.12  What other regulations and statutes apply?

    Several other regulations and statutes apply to this part. These 
include, but are not necessarily limited to:
    (a) Debt Collection Act of 1982 (31 U.S.C. 3701 et seq.);
    (b) Debt Collection Improvement Act of 1996 (31 U.S.C. 3701 note);
    (c) Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
    (d) Federal Debt Collection Procedures Act of 1990 (28 U.S.C. 176); 
and
    (e) Privacy Act of 1974 (5 U.S.C. 552a).

[[Page 509]]



             SUBCHAPTER F_QUARANTINE, INSPECTION, LICENSING





PART 70_INTERSTATE QUARANTINE--Table of Contents



Sec.
70.1 General definitions.
70.2 Measures in the event of inadequate local control.
70.3 All communicable diseases.
70.4 Report of disease.
70.5 Requirements relating to travelers under a Federal order of 
          isolation, quarantine, or conditional release.
70.6 Apprehension and detention of persons with quarantinable 
          communicable diseases.
70.7 Responsibility with respect to minors, wards, and patients.
70.8 Members of military and naval forces.
70.9 Vaccination clinics.
70.10 Public health prevention measures to detect communicable disease.
70.11 Report of death or illness onboard aircraft operated by an 
          airline.
70.12 Medical examinations.
70.13 Payment for care and treatment.
70.14 Requirements relating to the issuance of a Federal order for 
          quarantine, isolation, or conditional release.
70.15 Mandatory reassessment of a Federal order for quarantine, 
          isolation, or conditional release.
70.16 Medical review of a Federal order for quarantine, isolation, or 
          conditional release.
70.17 Administrative records relating to Federal quarantine, isolation, 
          or conditional release.
70.18 Penalties.

    Authority: Secs. 215 and 311 of the Public Health Service (PHS) Act, 
as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as amended 
(42 U.S.C. 264-272); 31 U.S.C. 9701.

    Source: 65 FR 49908, Aug. 16, 2000, unless otherwise noted.



Sec.  70.1  General definitions.

    As used in this part, terms shall have the following meaning:
    Airline means any air carrier or foreign air carrier providing air 
transportation as that term is defined in 49 U.S.C. 40102(a)(2), (a)(5), 
and (a)(21).
    Apprehension means the temporary taking into custody of an 
individual or group for purposes of determining whether Federal 
quarantine, isolation, or conditional release is warranted.
    CDC means the Centers for Disease Control and Prevention, Department 
of Health and Human Services.
    Communicable diseases means illnesses due to infectious agents or 
their toxic products, which may be transmitted from a reservoir to a 
susceptible host either directly as from an infected person or animal or 
indirectly through the agency of an intermediate plant or animal host, 
vector, or the inanimate environment.
    Communicable period means the period or periods during which the 
etiologic agent may be transferred directly or indirectly from the body 
of the infected person or animal to the body of another.
    Communicable stage means the stage during which an infectious agent 
may be transmitted either directly or indirectly from an infected 
individual to another individual.
    Conditional release means the temporary supervision by a public 
health official (or designee) of an individual or group, who may have 
been exposed to a quarantinable communicable disease to determine the 
risk of disease spread and includes public health supervision through 
in-person visits, telephone, or through electronic or Internet-based 
monitoring.
    Contaminated environment means the presence of an infectious agent 
on a surface, including on inanimate articles, or in a substance, 
including food, water, or in the air.
    Conveyance means an aircraft, train, road vehicle, vessel (as 
defined in this section) or other means of transport, including 
military.
    Director means the Director, Centers for Disease Control and 
Prevention, Department of Health and Human Services, or another 
authorized representative as approved by the CDC Director or the 
Secretary of HHS.
    Electronic or Internet-based monitoring means mechanisms or 
technologies allowing for the temporary public health supervision of an 
individual under conditional release and may include communication 
through electronic mail, SMS texts, video or audio conference, webcam 
technologies, integrated voice-response systems, entry of information 
into a Web-based forum, wearable

[[Page 510]]

tracking technologies, and other mechanisms or technologies as 
determined by the Director or supervising health authority.
    Ill person means an individual who:
    (1) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]C] 
or greater, or feels warm to the touch, or gives a history of feeling 
feverish) accompanied by one or more of the following: Skin rash, 
difficulty breathing, persistent cough, decreased consciousness or 
confusion of recent onset, new unexplained bruising or bleeding (without 
previous injury), persistent diarrhea, persistent vomiting (other than 
air sickness), headache with stiff neck, appears obviously unwell; or
    (2) Has a fever that has persisted for more than 48 hours; or
    (3) Has symptoms or other indications of communicable disease, as 
the CDC may announce through posting of a notice in the Federal 
Register.
    Incubation period means the time from the moment of exposure to an 
infectious agent that causes a communicable disease until signs and 
symptoms of the communicable disease appear in the individual or, if 
signs and symptoms do not appear, the latest date signs and symptoms 
could reasonably be expected to appear. For a quarantinable communicable 
disease, incubation period means the precommunicable stage.
    Indigent means an individual whose annual family income is below 
200% of the applicable poverty guidelines updated periodically in the 
Federal Register by the U.S. Department of Health and Human Services 
under the authority of 42 U.S.C. 9902(2) or, if no income is earned, 
liquid assets totaling less than 15% of the applicable poverty 
guidelines.
    Interstate traffic (1) Means:
    (i) The movement of any conveyance or the transportation of persons 
or property, including any portion of such movement or transportation 
that is entirely within a State or possession--
    (ii) From a point of origin in any State or possession to a point of 
destination in any other State or possession; or
    (iii) Between a point of origin and a point of destination in the 
same State or possession but through any other State, possession, or 
contiguous foreign country.
    (2) Interstate traffic does not include the following:
    (i) The movement of any conveyance which is solely for the purpose 
of unloading persons or property transported from a foreign country, or 
loading persons or property for transportation to a foreign country.
    (ii) The movement of any conveyance which is solely for the purpose 
of effecting its repair, reconstruction, rehabilitation, or storage.
    Isolation means the separation of an individual or group reasonably 
believed to be infected with a quarantinable communicable disease from 
those who are healthy to prevent the spread of the quarantinable 
communicable disease.
    Master or operator with respect to a vessel, means the sea crew 
member with responsibility for vessel operation and navigation, or a 
similar individual with responsibility for a conveyance. Consistent with 
the definition of ``operate'' in 14 CFR 1.1, ``operator'' means, with 
respect to aircraft, any person who uses, causes to use, or authorizes 
to use an aircraft, for the purpose (except as provided in 14 CFR 91.13) 
of air navigation including the piloting of an aircraft, with or without 
the right of legal control (as owner, lessee, or otherwise).
    Medical examination means the assessment of an individual by an 
authorized and licensed health worker to determine the individual's 
health status and potential public health risk to others and may include 
the taking of a medical history, a physical examination, and collection 
of human biological samples for laboratory testing as may be needed to 
diagnose or confirm the presence or extent of infection with a 
quarantinable communicable disease.
    Medical reviewer means a physician, nurse practitioner, or similar 
medical professional qualified in the diagnosis and treatment of 
infectious diseases who is appointed by the Secretary or Director to 
conduct medical reviews under this part and may include an HHS or CDC 
employee, provided that the employee differs from the CDC official who 
issued the Federal order for

[[Page 511]]

quarantine, isolation, or conditional release.
    Non-invasive means procedures conducted by an authorized public 
health worker (i.e., an individual with education and training in the 
field of public health) or another individual with suitable public 
health training and includes the visual examination of the ear, nose, 
and mouth; temperature assessments using an ear, oral, cutaneous, or 
noncontact thermometer, or thermal imaging; and other procedures not 
involving the puncture or incision of the skin or insertion of an 
instrument or foreign material into the body or a body cavity excluding 
the ear, nose, and mouth.
    Possession means U.S. Territory.
    Precommunicable stage means the stage beginning upon an individual's 
earliest opportunity for exposure to an infectious agent and ending upon 
the individual entering or reentering the communicable stage of the 
disease or, if the individual does not enter the communicable stage, the 
latest date at which the individual could reasonably be expected to have 
the potential to enter or reenter the communicable stage.
    Public health emergency as used in this part means:
    (1) Any communicable disease event as determined by the Director 
with either documented or significant potential for regional, national, 
or international communicable disease spread or that is highly likely to 
cause death or serious illness if not properly controlled; or
    (2) Any communicable disease event described in a declaration by the 
Secretary pursuant to 319(a) of the Public Health Service Act (42 U.S.C. 
247d (a)); or
    (3) Any communicable disease event the occurrence of which is 
notified to the World Health Organization, in accordance with Articles 6 
and 7 of the International Health Regulations, as one that may 
constitute a Public Health Emergency of International Concern; or
    (4) Any communicable disease event the occurrence of which is 
determined by the Director-General of the World Health Organization, in 
accordance with Article 12 of the International Health Regulations, to 
constitute a Public Health Emergency of International Concern; or
    (5) Any communicable disease event for which the Director-General of 
the World Health Organization, in accordance with Articles 15 or 16 of 
the International Health Regulations, has issued temporary or standing 
recommendations for purposes of preventing or promptly detecting the 
occurrence or reoccurrence of the communicable disease.
    Public health prevention measures means the assessment of an 
individual through non-invasive procedures and other means, such as 
observation, questioning, review of travel documents, records review, 
and other non-invasive means, to determine the individual's health 
status and potential public health risk to others.
    Qualifying stage is statutorily defined (42 U.S.C. 264(d)(2)) to 
mean:
    (1) The communicable stage of a quarantinable communicable disease; 
or
    (2) The precommunicable stage of the quarantinable communicable 
disease, but only if the quarantinable communicable disease would be 
likely to cause a public health emergency if transmitted to other 
individuals.
    Quarantine means the separation of an individual or group reasonably 
believed to have been exposed to a quarantinable communicable disease, 
but who are not yet ill, from others who have not been so exposed, to 
prevent the possible spread of the quarantinable communicable disease.
    Quarantinable communicable disease means any of the communicable 
diseases listed in an Executive Order, as provided under section 361 of 
the Public Health Service Act. Executive Order 13295, of April 4, 2003, 
as amended by Executive Order 13375 of April 1, 2005, contains the 
current revised list of quarantinable communicable diseases, and may be 
obtained at http://www.cdc.gov and http://www.archives.gov/
federal_register. If this Order is amended, HHS will enforce that 
amended order immediately and update that Web site.
    Reasonably believed to be infected, as applied to an individual, 
means specific articulable facts upon which a public

[[Page 512]]

health officer could reasonably draw the inference that an individual 
has been exposed, either directly or indirectly, to the infectious agent 
that causes a quarantinable communicable disease, as through contact 
with an infected person or an infected person's bodily fluids, a 
contaminated environment, or through an intermediate host or vector, and 
that as a consequence of the exposure, the individual is or may be 
harboring in the body the infectious agent of that quarantinable 
communicable disease.
    Representatives means a physician, nurse practitioner, or similar 
medical professional qualified in the diagnosis and treatment of 
infectious diseases, and an attorney who is knowledgeable of public 
health practices, who are appointed by the Secretary or Director and may 
include HHS or CDC employees, to assist an indigent individual under 
Federal quarantine, isolation, or conditional release with a medical 
review under this part.
    Secretary means the Secretary of Health and Human Services (HHS) or 
any other officer or employee of that Department to whom the authority 
involved has been delegated.
    State means any of the 50 states, plus the District of Columbia.
    U.S. Territory means any territory (also known as possessions) of 
the United States, including American Samoa, Guam, the Northern Mariana 
Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands.
    Vessel means any passenger-carrying, cargo, or towing vessel 
exclusive of:
    Fishing boats including those used for shell-fishing;
    Tugs which operate only locally in specific harbors and adjacent 
waters;
    Barges without means of self-propulsion;
    Construction-equipment boats and dredges; and
    Sand and gravel dredging and handling boats.

[65 FR 49908, Aug. 16, 2000, as amended at 77 FR 75884, Dec. 26, 2012; 
82 FR 6968, Jan. 19, 2017]



Sec.  70.2  Measures in the event of inadequate local control.

    Whenever the Director of the Centers for Disease Control and 
Prevention determines that the measures taken by health authorities of 
any State or possession (including political subdivisions thereof) are 
insufficient to prevent the spread of any of the communicable diseases 
from such State or possession to any other State or possession, he/she 
may take such measures to prevent such spread of the diseases as he/she 
deems reasonably necessary, including inspection, fumigation, 
disinfection, sanitation, pest extermination, and destruction of animals 
or articles believed to be sources of infection.



Sec.  70.3  All communicable diseases.

    A person who has a communicable disease in the communicable period 
shall not travel from one State or possession to another without a 
permit from the health officer of the State, possession, or locality of 
destination, if such permit is required under the law applicable to the 
place of destination. Stop-overs other than those necessary for 
transportation connections shall be considered as places of destination.



Sec.  70.4  Report of disease.

    The master of any vessel or person in charge of any conveyance 
engaged in interstate traffic, on which a case or suspected case of a 
communicable disease develops shall, as soon as practicable, notify the 
local health authority at the next port of call, station, or stop, and 
shall take such measures to prevent the spread of the disease as the 
local health authority directs.



Sec.  70.5  Requirements relating to travelers under a Federal order 
of isolation, quarantine, or conditional release.

    (a) The following provisions are applicable to any individual under 
a Federal order of isolation, quarantine, or conditional release with 
regard to a quarantinable communicable disease or to any individual 
meeting the requirements of paragraph (d), (e), or (f) of this section:
    (1) Except as specified under the terms of a Federal conditional 
release order, no such individual shall travel in interstate traffic or 
from one State or U.S. territory to another without a

[[Page 513]]

written travel permit issued by the Director.
    (2) Requests for a travel permit must state the reasons why the 
travel is being requested, mode of transportation, the places or 
individuals to be visited, the precautions, if any, to be taken to 
prevent the potential transmission or spread of the communicable 
disease, and other information as determined necessary by the Director 
to assess the individual's health condition and potential for 
communicable disease spread to others.
    (3) The Director will consider all requests for a permit and, taking 
into consideration the risk of introduction, transmission, or spread of 
the communicable disease, may condition the permit upon compliance with 
such precautionary measures as the Director shall prescribe. The 
Director shall respond to a request for a permit within 5 business days.
    (4) An individual to whom a permit has been issued shall retain it 
in his/her possession throughout the course of his/her authorized travel 
and comply with all conditions prescribed therein, including 
presentation of the permit to the operators of conveyances, as required 
by its terms.
    (5) An individual who has had his/her request for a permit denied, 
or who has had a travel permit suspended or revoked, may submit a 
written appeal to the Director (excluding the CDC official who denied, 
suspended, or revoked the permit). The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the Director 
(excluding the CDC official who denied, suspended, or revoked the 
permit) within 10 calendar days of the denial, suspension, or revocation 
of the permit. The Director (excluding the CDC official who denied, 
suspended, or revoked the permit) will issue a written response to the 
appeal within 3 business days, which shall constitute final agency 
action.
    (b) The operator of any conveyance operating in interstate traffic 
shall not:
    (1) Accept for transportation any individual whom the operator 
knows, or reasonably should know, to be under a Federal order of 
isolation, quarantine, or conditional release, unless such an individual 
presents a permit issued by the Director or a copy of the Federal 
conditional release order authorizing such travel;
    (2) Transport any individual whom the operator knows, or reasonably 
should know, to be under a Federal order of isolation, quarantine, or 
conditional release in violation of any of the terms or conditions 
prescribed in the travel permit or conditional release order issued by 
the Director.
    (c) Whenever a conveyance operating in interstate traffic transports 
an individual under a Federal order or travel permit, the Director may 
require that the operator of the conveyance submit the conveyance to 
inspection, sanitary measures, and other measures, as the Director deems 
necessary to prevent the possible spread of communicable disease.
    (d) The Director may additionally apply the provisions in paragraphs 
(a) through (c) of this section to individuals traveling entirely 
intrastate and to conveyances that transport such individuals upon the 
request of a State or local health authority of jurisdiction. The 
Director shall consider the State or local health authority's request 
for assistance and taking into consideration the risk of introduction, 
transmission, or spread of the communicable disease, grant or deny, in 
his/her discretion, the request for assistance.
    (e) The Director may additionally apply the provisions in paragraphs 
(a) through of this section (c) to individuals traveling interstate or 
entirely intrastate and to conveyances that transport such individuals 
whenever the Director makes a determination under 42 CFR 70.2 that based 
on the existence of inadequate local control such measures are needed to 
prevent the spread of any of the communicable diseases from such State 
or U.S. territory to any other State or U.S. territory.
    (f) The Director may additionally apply the provisions in paragraphs 
(a) through (c) of this section to individuals under a State or local 
order, or written agreement, for quarantine, isolation, or conditional 
release and to conveyances that may transport such individuals, upon the 
request of a State

[[Page 514]]

or local health authority of jurisdiction or whenever the Director makes 
a determination of inadequate local control under 42 CFR 70.2. The 
Director shall consider the State or local health authority's request 
for assistance and taking into consideration the risk of introduction, 
transmission, or spread of the communicable disease, grant or deny, in 
his/her discretion, the request for assistance.
    (g) The Director may exempt individuals and non-public conveyances, 
such as ambulances, air ambulance flights, or private vehicles, from the 
requirements of this section.

[82 FR 6970, Jan. 19, 2017]



Sec.  70.6  Apprehension and detention of persons with quarantinable 
communicable diseases.

    (a) The Director may authorize the apprehension, medical 
examination, quarantine, isolation, or conditional release of any 
individual for the purpose of preventing the introduction, transmission, 
and spread of quarantinable communicable diseases, as specified by 
Executive Order, based upon a finding that:
    (1) The individual is reasonably believed to be infected with a 
quarantinable communicable disease in a qualifying stage and is moving 
or about to move from a State into another State; or
    (2) The individual is reasonably believed to be infected with a 
quarantinable communicable disease in a qualifying stage and constitutes 
a probable source of infection to other individuals who may be moving 
from a State into another State.
    (b) The Director will arrange for adequate food and water, 
appropriate accommodation, appropriate medical treatment, and means of 
necessary communication for individuals who are apprehended or held in 
quarantine or isolation under this part.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.7  Responsibility with respect to minors, wards, and patients.

    A parent, guardian, physician, nurse, or other such person shall not 
transport, or procure or furnish transportation for any minor child or 
ward, patient or other such person who is in the communicable period of 
a communicable disease, except in accordance with provisions of this 
part.



Sec.  70.8  Members of military and naval forces.

    The provisions of Sec. Sec.  70.3, 70.4, 70.5, 70.7, and this 
section shall not apply to members of the military or naval forces, and 
medical care or hospital beneficiaries of the Army, Navy, Veterans' 
Administration, or Public Health Service, when traveling under competent 
orders: Provided, That in the case of persons otherwise subject to the 
provisions of Sec.  70.5 the authority authorizing the travel requires 
precautions to prevent the possible transmission of infection to others 
during the travel period.



Sec.  70.9  Vaccination clinics.

    (a) The Director may establish vaccination clinics, through contract 
or otherwise, authorized to administer vaccines and/or other 
prophylaxis.
    (b) A vaccination fee may be charged for individuals not enrolled in 
Medicare Part B to cover costs associated with administration of the 
vaccine and/or other prophylaxis. Such fee is to be collected at the 
time that the vaccine is administered. The vaccination fee, if imposed, 
is shown in the following table:

------------------------------------------------------------------------
                                                Effective
                   Vaccine                        dates        Amount
------------------------------------------------------------------------
Fluarix.....................................   \1\1/25/05   \2\ $25.00
------------------------------------------------------------------------
\1\ Continuing for one year.
\2\ $7.00 for the vaccine and $18.00 for administration.


[70 FR 3493, Jan. 25, 2005]



Sec.  70.10  Public health prevention measures to detect communicable disease.

    (a) The Director may conduct public health prevention measures at 
U.S. airports, seaports, railway stations, bus terminals, and other 
locations where individuals may gather to engage in interstate travel, 
through non-invasive procedures determined appropriate by the Director 
to detect the presence of communicable diseases.

[[Page 515]]

    (b) As part of the public health prevention measures, the Director 
may require individuals to provide contact information such as U.S. and 
foreign addresses, telephone numbers, email addresses, and other contact 
information, as well as information concerning their intended 
destination, health status, known or possible exposure history, and 
travel history.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.11  Report of death or illness onboard aircraft 
operated by an airline.

    (a) The pilot in command of an aircraft operated by an airline who 
is conducting a commercial passenger flight in interstate traffic under 
a regular schedule shall report as soon as practicable to the Director 
the occurrence onboard of any deaths or the presence of ill persons 
among passengers or crew and take such measures as the Director may 
direct to prevent the potential spread of the communicable disease, 
provided that such measures do not affect the airworthiness of the 
aircraft or the safety of flight operations.
    (b) The pilot in command of an aircraft operated by an airline who 
reports in accordance with paragraph (a) of this section shall be deemed 
to satisfy the reporting obligation under 42 CFR 70.4.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.12  Medical examinations.

    (a) The Director may require an individual to undergo a medical 
examination as part of a Federal order for quarantine, isolation, or 
conditional release for a quarantinable communicable disease.
    (b) The Director shall promptly arrange for the medical examination 
to be conducted when one is required under this section and shall as 
part of the Federal order advise the individual that the medical 
examination shall be conducted by an authorized and licensed health 
worker, and with prior informed consent.
    (c) As part of the medical examination, the Director may require an 
individual to provide information and undergo such testing as may be 
reasonably necessary to diagnose or confirm the presence or extent of 
infection with a quarantinable communicable disease.
    (d) Individuals reasonably believed to be infected based on the 
results of a medical examination may be isolated, or if such results are 
inconclusive or unavailable, individuals may be quarantined or 
conditionally released in accordance with this part.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.13  Payment for care and treatment.

    (a) The Director may authorize payment for the care and treatment of 
individuals subject to medical examination, quarantine, isolation, and 
conditional release, subject to paragraphs (b) through (h) of this 
section.
    (b) Payment for care and treatment shall be in the CDC's sole 
discretion and subject to the availability of appropriations.
    (c) Payment shall be secondary to the obligation of the United 
States or any third-party (i.e., any State or local governmental entity, 
private insurance carrier, or employer), under any other law or 
contractual agreement, to pay for such care and treatment, and shall be 
paid by the Director only after all third-party payers have made payment 
in satisfaction of their obligations.
    (d) Payment may include costs for providing ambulance or other 
medical transportation when such services are deemed necessary by the 
Director for the individual's care and treatment.
    (e) Payment shall be limited to those amounts the hospital, medical 
facility, or medical transportation service would customarily bill the 
Medicare system using the International Classification of Diseases, 
Clinical Modification (ICD-CM), and relevant regulations promulgated by 
the Centers for Medicare and Medicaid Services in existence at the time 
of billing.
    (f) For quarantinable communicable diseases, payment shall be 
limited to costs for services and items reasonable and necessary for the 
care and treatment of the individual or group for the time period 
beginning when the Director refers the individual or group to the 
hospital or medical facility and

[[Page 516]]

ends when, as determined by the Director, the period of apprehension, 
quarantine, isolation, or conditional release expires.
    (g) For diseases other than those described in paragraph (f) of this 
section, such payment shall be limited to costs for services and items 
reasonable and necessary for care and treatment of the individual for 
the time period that begins when the Director refers the individual to 
the hospital or medical facility and ends when the individual's 
condition is diagnosed, as determined by the Director, as an illness 
other than a quarantinable communicable disease.
    (h) For ambulance or other medical transportation, payment shall be 
limited to the costs for such services and other items reasonable and 
necessary for the individual's safe medical transport.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.14  Requirements relating to the issuance of a Federal order 
for quarantine, isolation, or conditional release.

    (a) A Federal order authorizing quarantine, isolation, or 
conditional release shall be in writing, signed by the Director, and 
contain the following information:
    (1) The identity of the individual or group subject to the order;
    (2) The location of the quarantine or isolation or, in the case of 
conditional release, the entity to who and means by which the individual 
shall report for public health supervision;
    (3) An explanation of the factual basis underlying the Director's 
reasonable belief that the individual is in the qualifying stage of a 
quarantinable communicable disease;
    (4) An explanation of the factual basis underlying the Director's 
reasonable belief that the individual is moving or about to move from 
one State into another or constitutes a probable source of infection to 
others who may be moving from one State into another;
    (5) An explanation that the Federal order will be reassessed no 
later than 72 hours after it has been served and an explanation of the 
medical review of the Federal order pursuant to this part, including the 
right to request a medical review, present witnesses and testimony at 
the medical review, and to be represented at the medical review by 
either an advocate (e.g., an attorney, family member, or physician) at 
the individual's own expense, or, if indigent, to have representatives 
appointed at the government's expense;
    (6) An explanation of the criminal penalties for violating a Federal 
order of quarantine, isolation, or conditional release; and
    (7) An explanation that if a medical examination is required as part 
of the Federal order that the examination will be conducted by an 
authorized and licensed health worker, and with prior informed consent.
    (b) A Federal order authorizing quarantine, isolation, or 
conditional release shall be served on the individual no later than 72 
hours after the individual has been apprehended, except that the Federal 
order may be published or posted in a conspicuous location if the 
Federal order is applicable to a group of individuals and individual 
service would be impracticable.
    (c) The Director shall arrange for translation or interpretation 
services of the Federal order as needed.
    (d) Nothing in this section shall affect the constitutional or 
statutory rights of individuals to obtain judicial review of their 
Federal detention.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.15  Mandatory reassessment of a Federal order for quarantine, 
isolation, or conditional release.

    (a) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) shall reassess the 
need to continue the quarantine, isolation, or conditional release of an 
individual no later than 72 hours after the service of the Federal 
order.
    (b) As part of the reassessment, the Director (excluding the CDC 
official who issued the quarantine, isolation, or conditional release 
order) shall review all records considered in issuing the Federal order, 
including travel records, records evidencing exposure or infection with 
a quarantinable communicable disease, as well as any relevant new 
information.

[[Page 517]]

    (c) As part of the reassessment, and where applicable, the Director 
(excluding the CDC official who issued the quarantine, isolation, or 
conditional release order) shall consider and make a determination 
regarding whether less restrictive alternatives would adequately serve 
to protect the public health.
    (d) At the conclusion of the reassessment, the Director (excluding 
the CDC official who issued the quarantine, isolation, or conditional 
release order) shall promptly issue and serve a written Federal order 
directing that the quarantine, isolation, or conditional release be 
continued, modified, or rescinded.
    (e) In the event that the Director orders that the quarantine, 
isolation, or conditional release be continued or modified, the written 
Federal order shall explain the process for requesting a medical review 
under this part.
    (f) The Director's written Federal order shall be promptly served on 
the individual, except that the Federal order may be served by 
publication or by posting in a conspicuous location if the Federal order 
is applicable to a group of individuals and individual service would be 
impracticable.
    (g) The Director shall arrange for translation or interpretation 
services of the Federal order as needed.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.16  Medical review of a Federal order for quarantine, isolation, 
or conditional release.

    (a) The Director shall, as soon as practicable, arrange for a 
medical review upon a request by an individual under Federal quarantine, 
isolation, or conditional release.
    (b) A request for a medical review may only occur after the 
Director's mandatory reassessment under section 70.15 and following the 
service of a Federal order continuing or modifying the quarantine, 
isolation, or conditional release.
    (c) The medical review shall be for the purpose of ascertaining 
whether the Director has a reasonable belief that the individual is 
infected with a quarantinable communicable disease in a qualifying 
stage.
    (d) The Director shall notify the individual in writing of the time 
and place of the medical review.
    (e) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) shall designate a 
medical reviewer to review the medical or other evidence presented at 
the review, make medical or other findings of fact, and issue a 
recommendation concerning whether the Federal order for quarantine, 
isolation, or conditional release should be rescinded, continued, or 
modified.
    (f) The individual under Federal quarantine, isolation, or 
conditional release may authorize an advocate (e.g., an attorney, family 
member, or physician) at his or her own expense to submit medical or 
other evidence and, in the medical reviewer's discretion, be allowed to 
present a reasonable number of medical experts. The Director (excluding 
the CDC official who issued the quarantine, isolation, or conditional 
release order) shall appoint representatives at government expense to 
assist the individual for purposes of the medical review upon a request 
and certification, under penalty of perjury, by that individual that he 
or she is indigent.
    (g) Prior to the convening of the review, the individual or his/her 
authorized advocate or representatives shall be provided a reasonable 
opportunity to examine the available medical and other records involved 
in the medical review that pertain to that individual.
    (h) The Director shall take such measures that he/she determines to 
be reasonably necessary to allow an individual under Federal quarantine 
or isolation to communicate with any authorized advocate or 
representatives in such a manner as to prevent the possible spread of 
the quarantinable communicable disease.
    (i) The medical reviewer may order a medical examination of an 
individual when, in the medical reviewer's professional judgment, such 
an examination would assist in assessing the individual's medical 
condition.
    (j) As part of the review, and where applicable, the medical 
reviewer shall

[[Page 518]]

consider and accept into the record evidence concerning whether less 
restrictive alternatives would adequately serve to protect public 
health.
    (k) The medical review shall be conducted by telephone, audio or 
video conference, or through other means that the medical reviewer 
determines in his/her discretion are practicable for allowing the 
individual under quarantine, isolation, or conditional release to 
participate in the medical review.
    (l) At the conclusion of the review, the medical reviewer shall, 
based upon his or her review of the facts and other evidence made 
available during the medical review, issue a written report to the 
Director (excluding the CDC official who issued the quarantine, 
isolation, or conditional release order) concerning whether, in the 
medical reviewer's professional judgment, the Federal quarantine, 
isolation, or conditional release should be rescinded, continued, or 
modified. The written report shall include a determination regarding 
whether less restrictive alternatives would adequately serve to protect 
public health. The written report shall be served on the individual and 
the individual's authorized advocate or representatives.
    (m) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) shall, as soon as 
practicable, review the written report and any objections that may be 
submitted by the individual or the individual's authorized advocate or 
representatives that contest the findings and recommendation contained 
in the medical reviewer's written report. Upon conclusion of the review, 
the Director (excluding the CDC official who issued the quarantine, 
isolation, or conditional release order) shall promptly issue a written 
Federal order directing that the quarantine, isolation, or conditional 
release be continued, modified, or rescinded. In the event that the 
Director (excluding the CDC official who issued the quarantine, 
isolation, or conditional release order) continues or modifies the 
Federal quarantine, isolation, or conditional release, the Director's 
written order shall include a statement that the individual may request 
that the Director rescind the Federal quarantine, isolation, or 
conditional release, but based only on a showing of significant, new or 
changed facts or medical evidence that raise a genuine issue as to 
whether the individual should continue to be subject to Federal 
quarantine, isolation, or conditional release. The written Federal order 
shall be promptly served on the individual and the individual's 
authorized advocate or representatives, except that the Federal order 
may be served by publication or by posting in a conspicuous location if 
applicable to a group of individuals and individual service would be 
impracticable.
    (n) The Director's written order shall not constitute final agency 
action until it has been served on the individual and the individual's 
authorized advocate or representatives, or alternatively, if applicable 
to a group of individuals and individual service would be impracticable, 
it is published or posted.
    (o) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) may order the 
consolidation of one or more medical reviews if the number of 
individuals or other factors makes the holding of individual medical 
reviews impracticable.
    (p) The Director may issue additional instructions as may be 
necessary or desirable governing the conduct of medical reviews.
    (q) The Director shall arrange for translation or interpretation 
services as needed for purposes of this section.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.17  Administrative records relating to Federal quarantine, 
isolation, or conditional release.

    (a) The administrative record of an individual under Federal 
quarantine, isolation, or conditional release shall, where applicable, 
consist of the following:
    (1) The Federal order authorizing quarantine, isolation, or 
conditional release, including any subsequent Federal orders continuing 
or modifying the quarantine, isolation or conditional release;
    (2) Records of any available medical, laboratory, or other 
epidemiologic information that are in the agency's possession and that 
were considered in

[[Page 519]]

issuing the Federal quarantine, isolation, or conditional release order, 
or any subsequent Federal orders;
    (3) Records submitted by the individual under quarantine, isolation, 
or conditional release, or by an authorized advocate or representatives, 
as part of a request for rescission of the Federal quarantine, 
isolation, or conditional release or as part of a medical review;
    (4) The written findings and report of the medical reviewer, 
including any transcripts of the medical review and any written 
objections submitted by the individual under Federal quarantine, 
isolation, or conditional release, or by any authorized advocate or 
representatives;
    (b) An individual subject to a Federal public health order shall 
upon request be served with a copy of his or her own administrative 
record in its entirety.

[82 FR 6971, Jan. 19, 2017]



Sec.  70.18  Penalties.

    (a) Persons in violation of this part are subject to a fine of no 
more than $100,000 if the violation does not result in a death or one 
year in jail, or both, or a fine of no more than $250,000 if the 
violation results in a death or one year in jail, or both, or as 
otherwise provided by law.
    (b) Violations by organizations are subject to a fine of no more 
than $200,000 per event if the violation does not result in a death or 
$500,000 per event if the violation results in a death or as otherwise 
provided by law.

[82 FR 6971, Jan. 19, 2017]



PART 71_FOREIGN QUARANTINE--Table of Contents



              Subpart A_Definitions and General Provisions

Sec.
71.1 Scope and definitions.
71.2 Penalties.
71.3 Designation of yellow fever vaccination centers; Validation stamps.
71.4 Requirements relating to the transmission of airline passenger, 
          crew, and flight information for public health purposes.
71.5 Requirements relating to the transmission of vessel passenger, 
          crew, and voyage information for public health purposes.

                   Subpart B_Measures at Foreign Ports

71.11 Bills of health.

        Subpart C_Notice of Communicable Disease Prior to Arrival

71.20 Public health prevention measures to detect communicable disease.
71.21 Report of death or illness.

     Subpart D_Health Measures at U.S. Ports: Communicable Diseases

71.29 Administrative records relating to quarantine, isolation, or 
          conditional release.
71.30 Payment for care and treatment.
71.31 General provisions.
71.32 Persons, carriers, and things.
71.33 Persons: Isolation and surveillance.
71.34 Carriers of U.S. military services.
71.35 Report of death or illness on carrier during stay in port.
71.36 Medical examinations.
71.37 Requirements relating to the issuance of a Federal order for 
          quarantine, isolation, or conditional release.
71.38 Mandatory reassessment of a Federal order for quarantine, 
          isolation, or conditional release (surveillance).
71.39 Medical review of a Federal order for quarantine, isolation, or 
          conditional release.
71.40 Suspension of the right to introduce and prohibition of the 
          introduction of persons into the United States from designated 
          foreign countries or places for public health purposes.

 Subpart E_Requirements Upon Arrival at U.S. Ports: Sanitary Inspection

71.41 General provisions.
71.42 Disinsection of imports.
71.43 Exemption for mails.
71.44 Disinsection of aircraft.
71.45 Food, potable water, and waste: U.S. seaports and airports.
71.46 Issuance of Deratting Certificates and Deratting Exemption 
          Certificates.
71.47 Special provisions relating to airports: Office and isolation 
          facilities.
71.48 Carriers in intercoastal and interstate traffic.

                         Subpart F_Importations

71.50 Scope and definitions.
71.51 Dogs and cats.
71.52 Turtles, tortoises, and terrapins.
71.53 Requirements for importers of nonhuman primates.
71.54 Import regulations for infectious biological agents, infectious 
          substances, and vectors.
71.55 Importation of human remains.

[[Page 520]]

71.56 African rodents and other animals that may carry the monkeypox 
          virus.
71.63 Suspension of entry of animals, articles, or things from 
          designated foreign countries and places into the United 
          States.

    Authority: Secs. 215 and 311 of Public Health Service (PHS) Act. as 
amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as amended (42 
U.S.C. 264-272).

    Source: 50 FR 1519, Jan. 11, 1985, unless otherwise noted.



              Subpart A_Definitions and General Provisions



Sec.  71.1  Scope and definitions.

    (a) The provisions of this part contain the regulations to prevent 
the introduction, transmission, and spread of communicable disease from 
foreign countries into the States or territories (also known as 
possessions) of the United States. Regulations pertaining to preventing 
the interstate spread of communicable diseases are contained in 21 CFR 
parts 1240 and 1250 and 42 CFR part 70.
    (b) As used in this part the term:
    Airline means any air carrier or foreign air carrier providing air 
transportation, as that term is defined in 49 U.S.C. 40102(a)(2), 
(a)(5), and (a)(21).
    Apprehension means the temporary taking into custody of an 
individual or group for purposes of determining whether quarantine, 
isolation, or conditional release is warranted.
    Carrier means a ship, aircraft, train, road vehicle, or other means 
of transport, including military.
    Commander means the pilot in command of an aircraft as defined in 14 
CFR 1.1.
    Communicable disease means an illness due to a specific infectious 
agent or its toxic products which arises through transmission of that 
agent or its products from an infected person or animal or a reservoir 
to a susceptible host, either directly, or indirectly through an 
intermediate animal host, vector, or the inanimate environment.
    Conditional release means surveillance as defined under this part 
and includes public health supervision through in-person visits by a 
health official or designee, telephone, or through any electronic or 
internet-based means as determined by the Director.
    Contaminated environment means the presence of an infectious agent 
on a surface, including on inanimate articles, or in a substance, 
including food, water, or in the air.
    Contamination means the presence of undesirable substances or 
material which may contain infectious agents or their toxic products.
    Controlled Free Pratique means permission for a carrier to enter a 
U.S. port, disembark, and begin operation under certain stipulated 
conditions.
    Deratting Certificate means a certificate issued under the 
instructions of the Director, in the form prescribed by the 
International Health Regulations, recording the inspection and deratting 
of the ship.
    Deratting Exemption Certificate means a certificate issued under the 
instructions of the Director, in the form prescribed by the 
International Health Regulations, recording the inspection and exemption 
from deratting of the ship which is rodent free.
    Detention means the temporary holding of a person, ship, aircraft, 
or other carrier, animal, or thing in such place and for such period of 
time as may be determined by the Director.
    Director means the Director, Centers for Disease Control, Public 
Health Service, Department of Health and Human Services, or his/her 
authorized representative.
    Disinfection means the killing of infectious agents or inactivation 
of their toxic products outside the body by direct exposure to chemical 
or physical agents.
    Disinfestation means any chemical or physical process serving to 
destroy or remove undesired small animal forms, particularly arthropods 
or rodents, present upon the person, the clothing, or the environment of 
an individual, or upon animals and carriers.
    Disinsection means the operation in which measures are taken to kill 
the insect vectors of human disease present in carriers and containers.
    Educational purpose means use in the teaching of a defined 
educational program at the university level or equivalent.

[[Page 521]]

    Electronic or internet-based monitoring means mechanisms or 
technologies allowing for the temporary public health supervision of an 
individual under conditional release and may include communication 
through electronic mail, SMS texts, video or audio conference, webcam 
technologies, integrated voice-response systems, entry of information 
into a web-based forum, wearable tracking technologies, and other 
mechanisms or technologies as determined by the Director.
    Exhibition purpose means use as a part of a display in a facility 
comparable to a zoological park or in a trained animal act. The animal 
display must be open to the general public at routinely scheduled hours 
on 5 or more days of each week. The trained animal act must be routinely 
scheduled for multiple performances each week and open to the general 
public except for reasonable vacation and retraining periods.
    Ill person means an individual:
    (i) Who if onboard an aircraft:
    (A) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]C] 
or greater, or feels warm to the touch, or gives a history of feeling 
feverish) accompanied by one or more of the following: Skin rash, 
difficulty breathing, persistent cough, decreased consciousness or 
confusion of recent onset, new unexplained bruising or bleeding (without 
previous injury), persistent diarrhea, persistent vomiting (other than 
air sickness), headache with stiff neck, appears obviously unwell; or
    (B) Has a fever that has persisted for more than 48 hours; or
    (C) Has symptoms or other indications of communicable disease, as 
the Director may announce through posting of a notice in the Federal 
Register.
    (ii) Who if onboard a vessel:
    (A) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]C] 
or greater; or feels warm to the touch; or gives a history of feeling 
feverish) accompanied by one or more of the following: Skin rash, 
difficulty breathing or suspected or confirmed pneumonia, persistent 
cough or cough with bloody sputum, decreased consciousness or confusion 
of recent onset, new unexplained bruising or bleeding (without previous 
injury), persistent vomiting (other than sea sickness), headache with 
stiff neck; or
    (B) Has a fever that has persisted for more than 48 hours; or
    (C) Has acute gastroenteritis, which means either diarrhea, defined 
as three or more episodes of loose stools in a 24-hour period or what is 
above normal for the individual, or vomiting accompanied by one or more 
of the following: One or more episodes of loose stools in a 24-hour 
period, abdominal cramps, headache, muscle aches, or fever (temperature 
of 100.4 [deg]F [38 [deg]C] or greater); or
    (D) Has symptoms or other indications of communicable disease, as 
the Director may announce through posting of a notice in the Federal 
Register.
    Indigent means an individual whose annual family income is below 
200% of the applicable poverty guidelines updated periodically in the 
Federal Register by the U.S. Department of Health and Human Services 
under the authority of 42 U.S.C. 9902(2) or, if no income is earned, 
liquid assets totaling less than 15% of the applicable poverty 
guidelines.
    International Health Regulations or IHR means the International 
Health Regulations of the World Health Organization, adopted by the 
Fifty-Eighth World Health Assembly in 2005, as may be further amended, 
and subject to the United States' reservation and understandings.
    International voyage means:
    (i) In the case of a carrier, a voyage between ports or airports of 
more than one country, or a voyage between ports or airports of the same 
country if the ship or aircraft stopped in any other country on its 
voyage; or
    (ii) In the case of a person, a voyage involving entry into a 
country other than the country in which that person begins his/her 
voyage.
    Isolation means the separation of an individual or group who is 
reasonably believed to be infected with a quarantinable communicable 
disease from those who are healthy to prevent the spread of the 
quarantinable communicable disease.
    Master or operator with respect to a vessel, means the sea crew 
member with responsibility for vessel operation

[[Page 522]]

and navigation, or a similar individual with responsibility for a 
carrier. Consistent with the definition of ``operate'' in 14 CFR 1.1, 
``operator'' means, with respect to aircraft, any person who uses, 
causes to use or authorizes to use aircraft, for the purpose (except as 
provided in 14 CFR 91.13) of air navigation including the piloting of 
aircraft, with or without the right of legal control (as owner, lessee, 
or otherwise).
    Medical examination means the assessment of an individual by an 
authorized and licensed health worker to determine the individual's 
health status and potential public health risk to others and may include 
the taking of a medical history, a physical examination, and collection 
of human biological samples for laboratory testing as may be needed to 
diagnose or confirm the presence or extent of infection with a 
quarantinable communicable disease.
    Medical reviewer means a physician, nurse practitioner, or similar 
medical professional qualified in the diagnosis and treatment of 
infectious diseases who is appointed by the Secretary or Director to 
conduct medical reviews under this part and may include an HHS or CDC 
employee, provided that the employee differs from the CDC official who 
issued the Federal order for quarantine, isolation, or conditional 
release.
    Military services means the U.S. Army, the U.S. Air Force, the U.S. 
Navy, and the U.S. Coast Guard.
    Non-invasive means procedures conducted by an authorized public 
health worker (i.e., an individual with education and training in the 
field of public health) or another individual with suitable public 
health training and includes the visual examination of the ear, nose, 
and mouth; temperature assessments using an ear, oral, cutaneous, or 
noncontact thermometer, or thermal imaging; and other procedures not 
involving the puncture or incision of the skin or insertion of an 
instrument or foreign material into the body or a body cavity excluding 
the ear, nose, and mouth.
    Possession means U.S. territory.
    Public health prevention measures means the assessment of an 
individual through non-invasive procedures and other means, such as 
observation, questioning, review of travel documents, records review, 
and other non-invasive means, to determine the individual's health 
status and potential public health risk to others.
    Quarantine means the separation of an individual or group reasonably 
believed to have been exposed to a quarantinable communicable disease, 
but who is not yet ill, from others who have not been so exposed, to 
prevent the possible spread of the quarantinable communicable disease.
    Quarantinable communicable disease means any of the communicable 
diseases listed in an Executive Order, as provided under Sec.  361 of 
the Public Health Service Act (42 U.S.C. Sec.  264). Executive Order 
13295, of April 4, 2003, as amended by Executive Order 13375 of April 1, 
2005, contains the current revised list of quarantinable communicable 
diseases, and may be obtained at http://www.cdc.gov and http://
www.archives.gov/federal_register. If this Order is amended, HHS will 
enforce that amended order immediately and update that Web site.
    Representatives means a physician, nurse practitioner, or similar 
medical professional qualified in the diagnosis and treatment of 
infectious diseases, and an attorney who is knowledgeable of public 
health practices, who are appointed by the Secretary or Director and may 
include HHS or CDC employees, to assist an indigent individual under 
Federal quarantine, isolation, or conditional release with a medical 
review under this part.
    Scientific purpose means use for scientific research following a 
defined protocol and other standards for research projects as normally 
conducted at the university level. The term also includes the use for 
safety testing, potency testing, and other activities related to the 
production of medical products.
    Secretary means the Secretary of Health and Human Services (HHS) or 
any other officer or employee of that Department to whom the authority 
involved has been delegated.
    Surveillance means the temporary supervision by a public health 
official (or designee) of an individual or group,

[[Page 523]]

who may have been exposed to a quarantinable communicable disease, to 
determine the risk of disease spread.
    U.S. port means any seaport, airport, or border crossing point under 
the control of the United States.
    U.S. territory means any territory (also known as possessions) of 
the United States, including American Samoa, Guam, the Northern Mariana 
Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands.
    United States means the 50 States, District of Columbia, and the 
territories (also known as possessions) of the United States, including 
American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of 
Puerto Rico, and the U.S. Virgin Islands.
    Vector means any animals (vertebrate or invertebrate) including 
arthropods or any noninfectious self-replicating system (e.g., plasmids 
or other molecular vector) or animal products that are known to 
transfer, or are capable of transferring, an infectious biological agent 
to a human.

[50 FR 1519, Jan. 11, 1985, as amended at 77 FR 75890, Dec. 26, 2012; 82 
FR 6973, Jan. 19, 2017]



Sec.  71.2  Penalties.

    (a) Persons in violation of this part are subject to a fine of no 
more than $100,000 if the violation does not result in a death or one 
year in jail, or both, or a fine of no more than $250,000 if the 
violation results in a death or one year in jail, or both, or as 
otherwise provided by law. (b) Violations by organizations are subject 
to a fine of no more than $200,000 per event if the violation does not 
result in a death or $500,000 per event if the violation results in a 
death or as otherwise provided by law.

[82 FR 6975, Jan. 19, 2017]



Sec.  71.3  Designation of yellow fever vaccination centers; Validation stamps.

    (a) Designation of yellow fever vaccination centers. (1) The 
Director is responsible for the designation of yellow fever vaccination 
centers authorized to issue certificates of vaccination. This 
responsibility is delegated by the Director to a State or territorial 
health department with respect to yellow fever vaccination activities of 
non-Federal medical, public health facilities, and licensed physicians 
functioning within the respective jurisdictions of a State or 
territorial health department. Designation may be made upon application 
and presentation of evidence satisfactory to a State or territorial 
health department that the applicant has adequate facilities and 
professionally trained personnel for the handling, storage, and 
administration of a safe, potent, and pure yellow fever vaccine. Medical 
facilities of Federal agencies are authorized to obtain yellow fever 
vaccine without being designated as a yellow fever vaccination center by 
the Director.
    (2) A designated yellow fever vaccination center shall comply with 
the instruction issued by the Director or by a delegated officer or 
employee of a State or territorial health department for the handling, 
storage, and administration of yellow fever vaccine. If a designated 
center fails to comply with such instruction, after notice to the 
center, the Director or, for non-Federal centers, a State or territorial 
health department, may revoke designation.
    (b) Validation stamps. International Certificates of Vaccination 
against cholera and yellow fever issued for vaccinations performed in 
the United States shall be validated by:
    (1) The Seal of the Public Health Service; or
    (2) The Seal of the Department of State; or
    (3) The stamp of the Department of Defense; or
    (4) The stamp issued to the National Aeronautics and Space 
Administration; or
    (5) The stamp issued by a State or territorial health department; or
    (6) An official stamp of a design and size approved by the Director 
for such purpose.



Sec.  71.4  Requirements relating to the transmission of airline passenger, 
crew, and flight information for public health purposes.

    (a) Any airline with a flight arriving into the United States, 
including any intermediate stops between the flight's origin and final 
destination, shall make the data elements in paragraph

[[Page 524]]

(b) of this section available to the Director for passengers or crew 
who, as determined by the Director, may be at risk of exposure to a 
communicable disease, to the extent that such data are already available 
and maintained by the airline, within 24 hours of an order by the 
Director and in a format available and acceptable to both the airline 
and the Director.
    (b) The data elements referred to in paragraph (a) of this section 
include:
    (1) Full name (last, first, and, if available, middle or others);
    (2) Date of birth;
    (3) Sex;
    (4) Country of residence;
    (5) If a passport is required: Passport number, passport country of 
issuance, and passport expiration date;
    (6) If a travel document other than a passport is required: Travel 
document type, travel document number, travel document country of 
issuance and travel document expiration date;
    (7) Address while in the United States (number and street, city, 
State, and zip code), except that U.S. citizens and lawful permanent 
residents will provide address of permanent residence in the U.S. 
(number and street, city, State, and zip code);
    (8) Primary contact phone number to include country code;
    (9) Secondary contact phone number to include country code;
    (10) Email address;
    (11) Airline name;
    (12) Flight number;
    (13) City of departure;
    (14) Departure date and time;
    (15) City of arrival;
    (16) Arrival date and time; and
    (17) Seat number.
    (c) No later than February 21, 2019, the Secretary or Director will 
publish and seek comment on a report evaluating the burden of this 
section on affected entities and duplication of activities in relation 
to mandatory passenger data submissions to DHS/CBP. The report will 
specifically recommend actions that streamline and facilitate use and 
transmission of any duplicate information collected.
    (d) Notwithstanding paragraph (a) of this section, any airline with 
a flight arriving into the United States, including any intermediate 
stops between the flight's origin and final destination, shall collect 
and, within 24 hours of an order by the Director, transmit to the 
Director the data elements in paragraph (e) of this section, in a format 
acceptable to the Director, for the passengers or crew who may be at 
risk of exposure to a communicable disease, for the purposes of public 
health follow-up, such as health education, treatment, prophylaxis, or 
other appropriate public health interventions, including travel 
restrictions.
    (e) The data elements referred to in paragraph (d) of this section 
include, to the extent that such information exists for the individual:
    (1) Full name (last, first, and, if available, middle or others);
    (2) Address while in the United States (number and street, city, 
State, and zip code), except that U.S. citizens and lawful permanent 
residents will provide address of permanent residence in the U.S. 
(number and street, city, State, and zip code);
    (3) Primary contact phone number to include country code;
    (4) Secondary contact phone number to include country code; and
    (5) Email address.

[82 FR 6975, Jan. 19, 2017, as amended at 82 FR 31728, July 10, 2017; 85 
FR 7880, Feb. 12, 2020]



Sec.  71.5  Requirements relating to the transmission of vessel passenger, 
crew, and voyage information for public health purposes.

    (a) The operator of any vessel carrying 13 or more passengers 
(excluding crew) and, which is not a ferry as defined under 46 U.S.C. 
2101 and U.S. Coast Guard (USCG) regulations (46 CFR 2.10-25), shall 
make the data elements in paragraph (b) of this section available to the 
Director for passengers or crew who, as determined by the Director, may 
be at risk of exposure to a communicable disease, to the extent that 
such data are already in the operator's possession, within 24 hours of 
an order by the Director and in a format available and acceptable to 
both the operator and the Director.
    (b) The data elements referred to in paragraph (a) of this section 
include:
    (1) Full name (last, first, and, if available middle or others);

[[Page 525]]

    (2) Date of birth;
    (3) Sex;
    (4) Country of residence;
    (5) If a passport is required: Passport number, passport country of 
issuance, and passport expiration date;
    (6) If a travel document other than a passport is required: Travel 
document type, travel document number, travel document country of 
issuance and travel document expiration date;
    (7) Address while in the United States (number and street, city, 
State, and zip code), except that U.S. citizens and lawful permanent 
residents will provide address of permanent residence in the United 
States (number and street, city, State, and zip code; as applicable);
    (8) Primary contact phone number to include country code;
    (9) Secondary contact phone number to include country code;
    (10) Email address;
    (11) Vessel operator;
    (12) Vessel name;
    (13) Voyage number;
    (14) Embarkation port and date;
    (15) Disembarkation port and date;
    (16) All port stops; and
    (17) Cabin number.
    (c) No later than February 21, 2019, the Secretary or Director will 
publish and seek comment on a report evaluating the burden of this 
section on affected entities and duplication of activities in relation 
to mandatory passenger data submissions to DHS/CBP. The report will 
specifically recommend actions that streamline and facilitate use and 
transmission of any duplicate information collected.

[82 FR 6975, Jan. 19, 2017]



                   Subpart B_Measures at Foreign Ports



Sec.  71.11  Bills of health.

    A carrier at any foreign port clearing or departing for any U.S. 
port shall not be required to obtain or deliver a bill of health.



        Subpart C_Notice of Communicable Disease Prior to Arrival



Sec.  71.20  Public health prevention measures to detect communicable disease.

    (a) The Director may conduct public health prevention measures, at 
U.S. ports of entry or other locations, through non-invasive procedures 
as defined in section 71.1 to detect the potential presence of 
communicable diseases.
    (b) As part of the public health prevention measures, the Director 
may require individuals to provide contact information such as U.S. and 
foreign addresses, telephone numbers, email addresses, and other contact 
information, as well as information concerning their intended 
destination, health status, known or possible exposure history, and 
travel history.

[82 FR 6975, Jan. 19, 2017]



Sec.  71.21  Report of death or illness.

    (a) The master of a ship destined for a U.S. port shall report 
immediately to the quarantine station at or nearest the port at which 
the ship will arrive, the occurrence, on board, of any death or any ill 
person among passengers or crew (including those who have disembarked or 
have been removed) during the 15-day period preceding the date of 
expected arrival or during the period since departure from a U.S. port 
(whichever period of time is shorter).
    (b) The commander of an aircraft destined for a U.S. airport shall 
report immediately to the quarantine station at or nearest the airport 
at which the aircraft will arrive, the occurrence, on board, of any 
death or ill person among passengers or crew.
    (c) In addition to paragraph (a) of this section, the master of a 
ship carrying 13 or more passengers must report 24 hours before arrival 
the number of cases (including zero) of acute gastroenteritis (AGE) in 
passengers and crew recorded in the ship's medical log during the 
current cruise. All cases of acute gastroenteritis (AGE) that occur 
after the 24 hour report must

[[Page 526]]

also be reported not less than 4 hours before arrival.

(Approved by the Office of Management and Budget under control number 
0920-0134)

[50 FR 1519, Jan. 11, 1985, as amended at 82 FR 31729, July 10, 2017]



     Subpart D_Health Measures at U.S. Ports: Communicable Diseases



Sec.  71.29  Administrative records relating to quarantine, isolation, 
or conditional release.

    (a) The administrative record of an individual under quarantine, 
isolation, or conditional release shall, where applicable, consist of 
the following:
    (1) The Federal order authorizing quarantine, isolation, or 
conditional release, including any subsequent Federal orders continuing 
or modifying the quarantine, isolation or conditional release;
    (2) Records of any available medical, laboratory, or other 
epidemiologic information that are in the agency's possession and that 
were considered in issuing the Federal quarantine, isolation, or 
conditional release order, or any subsequent Federal orders;
    (3) Records submitted by the individual under quarantine, isolation, 
or conditional release, or by an authorized advocate or representatives, 
as part of a request for rescission of the quarantine, isolation, or 
conditional release or as part of a medical review;
    (4) The written findings and report of the medical reviewer, 
including any transcripts of the medical review and any written 
objections submitted by the individual under Federal quarantine, 
isolation, or conditional release, or by an authorized advocate or 
representatives;
    (b) An individual subject to a Federal public health order shall, 
upon request, be served with a copy of his or her own administrative 
record in its entirety.

[82 FR 6975, Jan. 19, 2017]



Sec.  71.30  Payment for care and treatment.

    (a) The Director may authorize payment for the care and treatment of 
individuals subject to medical examination, quarantine, isolation, and 
conditional release, subject to paragraphs (b) through (h) of this 
section.
    (b) Payment for care and treatment shall be in the Director's sole 
discretion and subject to the availability of appropriations.
    (c) Payment shall be secondary to the obligation of the United 
States or any third-party (including any State or local governmental 
entity, private insurance carrier, or employer), under any other law or 
contractual agreement, to pay for such care and treatment, and shall be 
paid by the Director only after all third-party payers have made payment 
in satisfaction of their obligations.
    (d) Payment may include costs for providing ambulance or other 
medical transportation when such services are deemed necessary by the 
Director for the individual's care and treatment.
    (e) Payment shall be limited to those amounts the hospital, medical 
facility, or medical transportation service would customarily bill the 
Medicare system using the International Classification of Diseases, 
Clinical Modification (ICD-CM), and relevant regulations promulgated by 
the Centers for Medicare and Medicaid Services in existence at the time 
of billing.
    (f) For quarantinable communicable diseases, payment shall be 
limited to costs for services and items reasonable and necessary for the 
care and treatment of the individual for the time period beginning when 
the Director refers the individual to the hospital or medical facility 
and ends when, as determined by the Director, the period of 
apprehension, quarantine, isolation, or conditional release expires.
    (g) For diseases other than those described in paragraph (f) of this 
section, such payment shall be limited to costs for services and items 
reasonable and necessary for care and treatment of the individual for 
the time period that begins when the Director refers the individual to 
the hospital or medical facility and ends when the individual's 
condition is diagnosed, as determined by the Director, as an illness 
other than a quarantinable communicable disease.
    (h) For ambulance or other medical transportation, payment shall be 
limited to the costs for such services and other items reasonable and 
necessary

[[Page 527]]

for the safe medical transport of the individual.

[82 FR 6975, Jan. 19, 2017]



Sec.  71.31  General provisions.

    (a) Upon arrival at a U.S. port, a carrier will not undergo 
inspection unless the Director determines that a failure to inspect will 
present a threat of introduction of communicable diseases into the 
United States, as may exist when the carrier has on board individual(s) 
reportable in accordance with Sec.  71.21 or meets the circumstances 
described in Sec.  71.42. Carriers not subject to inspection under this 
section will be subject to sanitary inspection under Sec.  71.41 of this 
part.
    (b) The Director may require detention of a carrier until the 
completion of the measures outlined in this part that are necessary to 
prevent the introduction or spread of a communicable disease. The 
Director may issue a controlled free pratique to the carrier stipulating 
what measures are to be met, but such issuance does not prevent the 
periodic boarding of a carrier and the inspection of persons and records 
to verify that the conditions have been met for granting the pratique.



Sec.  71.32  Persons, carriers, and things.

    (a) Whenever the Director has reason to believe that any arriving 
person is infected with or has been exposed to any of the communicable 
diseases listed in an Executive Order, as provided under section 361(b) 
of the Public Health Service Act, he/she may isolate, quarantine, or 
place the person under surveillance and may order disinfection or 
disinfestation, fumigation, as he/she considers necessary to prevent the 
introduction, transmission or spread of the listed communicable 
diseases. Executive Order 13295, of April 4, 2003, as provided under 
section 361 of the Public Health Service Act (42 U.S.C. 264), and as 
amended by Executive Order 13375 of April 1, 2005, contains the current 
revised list of quarantinable communicable diseases, and may be obtained 
at http://www.cdc.gov and http://www.archives.gov/federal- register. If 
this Order is amended, HHS will enforce that amended order immediately 
and update this reference.
    (b) Whenever the Director has reason to believe that any arriving 
carrier or article or thing on board the carrier is or may be infected 
or contaminated with a communicable disease, he/she may require 
detention, disinfection, disinfestation, fumigation, or other related 
measures respecting the carrier or article or thing as he/she considers 
necessary to prevent the introduction, transmission, or spread of 
communicable diseases.

[68 FR 17559, Apr. 10, 2003, as amended at 77 FR 75891, Dec. 26, 2012]



Sec.  71.33  Persons: Isolation and surveillance.

    (a) The Director will arrange for adequate food and water, 
appropriate accommodation, appropriate medical treatment, and means of 
necessary communication for persons who are apprehended or held in 
isolation or quarantine under this subpart.
    (b) The Director may require isolation where surveillance is 
authorized in this subpart whenever the Director considers the risk of 
transmission of infection to be exceptionally serious.
    (c) Every person who is placed under surveillance by authority of 
this subpart shall, during the period of surveillance:
    (1) Give information relative to his/her health and his/her intended 
destination and submit to surveillance, including electronic and 
internet-based monitoring as required by the Director or by the State or 
local health department having jurisdiction over the areas to be 
visited, and report for such medical examinations as may be required.
    (2) Inform the Director prior to departing the United States or 
prior to traveling to any address other than that stated as the intended 
destination.
    (d) From time to time the Director may, in accordance with section 
322 of the Public Health Service Act, enter into agreements with public 
or private medical or hospital facilities for providing care and 
treatment for persons detained under this part.

(Approved by the Office of Management and Budget under control number 
0920-0134)

[50 FR 1519, Jan. 11, 1985; 50 FR 3910, Jan. 29, 1985; 82 FR 6976, Jan. 
19, 2017]

[[Page 528]]



Sec.  71.34  Carriers of U.S. military services.

    (a) Carriers belonging to or operated by the military services of 
the United States may be exempted from inspection if the Director is 
satisfied that they have complied with regulations of the military 
services which also meet the requirements of the regulations in this 
part. (For applicable regulations of the military services, see Army 
Regulation No. 40-12, Air Force Regulation No. 161-4, Secretary of the 
Navy Instruction 6210.2, and Coast Guard Commandant Instruction 6210.2).
    (b) Notwithstanding exemption from inspection of carriers under this 
section, animals or articles on board shall be required to comply with 
the applicable requirements of subpart F of this part.



Sec.  71.35  Report of death or illness on carrier during stay in port.

    The master of any carrier at a U.S. port shall report immediately to 
the quarantine station at or nearest the port the occurrence, on board, 
of any death or any ill person among passengers or crew.

(Approved by the Office of Management and Budget under control number 
0920-0134)



Sec.  71.36  Medical examinations.

    (a) The Director may require that an individual arriving into the 
United States undergo a medical examination as part of a Federal order 
for quarantine, isolation, or conditional release.
    (b) The Director shall promptly arrange for the medical examination 
to be conducted when one is required under this section and shall as 
part of the Federal order advise the individual that the medical 
examination shall be conducted by an authorized and licensed health 
worker, and with prior informed consent.
    (c) As part of the medical examination, the Director may require 
that an individual provide information and undergo such testing, as may 
be reasonably necessary, to diagnose or confirm the presence, absence, 
or extent of infection with a quarantinable communicable disease.
    (d) Individuals reasonably believed to be infected, based on the 
results of a medical examination, may be isolated, or if such results 
are inconclusive or unavailable, individuals may be quarantined or 
conditionally released in accordance with this part.

[82 FR 6976, Jan. 19, 2017]



Sec.  71.37  Requirements relating to the issuance of a Federal order 
for quarantine, isolation, or conditional release.

    (a) A Federal order authorizing quarantine, isolation, or 
conditional release shall be in writing, signed by the Director, and 
contain the following information:
    (1) The identity of the individual or group subject to the order;
    (2) The location of the quarantine or isolation or, in the case of 
conditional release, the entity to who and means by which the individual 
shall report for public health supervision;
    (3) An explanation of the factual basis underlying the Director's 
reasonable belief that the individual is exposed to or infected with a 
quarantinable communicable disease;
    (4) An explanation that the Federal order will be reassessed no 
later than 72 hours after it has been served and an explanation of the 
medical review of the Federal order pursuant to this part, including the 
right to request a medical review, present witnesses and testimony at 
the medical review, and to be represented at the medical review by 
either an advocate (e.g., an attorney, family member, or physician) at 
the individual's own expense, or, if indigent, to have representatives 
appointed at the government's expense;
    (5) An explanation of the criminal penalties for violating a Federal 
order of quarantine, isolation, or conditional release; and
    (6) An explanation that if a medical examination is required as part 
of the Federal order that the examination will be conducted by an 
authorized and licensed health worker, and with prior informed consent.
    (b) A Federal order authorizing quarantine, isolation, or 
conditional release shall be served on the individual no later than 72 
hours after the individual has been apprehended, except that the

[[Page 529]]

Federal order may be published or posted in a conspicuous location if 
applicable to a group of individuals and individual service would be 
impracticable.
    (c) The Director shall arrange for translation or interpretation 
services of the Federal order as needed.
    (d) Nothing in these regulations shall affect the constitutional or 
statutory rights of individuals to obtain judicial review of their 
federal detention.

[82 FR 6976, Jan. 19, 2017]



Sec.  71.38  Mandatory reassessment of a Federal order for quarantine, 
isolation, or conditional release (surveillance).

    (a) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) shall reassess the 
need to continue the quarantine, isolation, or conditional release of an 
individual no later than 72 hours after the service of the Federal 
order.
    (b) As part of the reassessment, the Director (excluding the CDC 
official who issued the quarantine, isolation, or conditional release 
order) shall review all records considered in issuing the Federal order, 
including travel records, records evidencing exposure or infection with 
a quarantinable communicable disease, as well as any relevant new 
information.
    (c) As part of the reassessment, and where applicable, the Director 
(excluding the CDC official who issued the quarantine, isolation, or 
conditional release order) shall consider and make a determination 
regarding whether less restrictive alternatives would adequately serve 
to protect the public health.
    (d) At the conclusion of the reassessment, the Director (excluding 
the CDC official who issued the quarantine, isolation, or conditional 
release order) shall promptly issue a written Federal order directing 
that the quarantine, isolation, or conditional release be continued, 
modified, or rescinded.
    (e) In the event that the Director orders that the quarantine, 
isolation, or conditional release be continued or modified, the written 
Federal order shall explain the process for requesting a medical review 
under this part.
    (f) The Director's written Federal order shall be promptly served on 
the individual, except that the Federal order may be served by 
publication or by posting in a conspicuous location if applicable to a 
group of individuals and individual service would be impracticable.
    (g) The Director shall arrange for translation or interpretation 
services of the Federal order as needed.

[82 FR 6976, Jan. 19, 2017]



Sec.  71.39  Medical review of a Federal order for quarantine, isolation, 
or conditional release.

    (a) The Director shall, as soon as practicable, arrange for a 
medical review upon a request by an individual under Federal quarantine, 
isolation, or conditional release.
    (b) A request for a medical review may only occur after the 
Director's mandatory reassessment under 71.38 and following the issuance 
and service of a Federal order continuing or modifying the quarantine, 
isolation, or conditional release.
    (c) The medical review shall be for the purpose of ascertaining 
whether the Director has a reasonable belief that the individual is 
infected with a quarantinable communicable disease.
    (d) The Director shall notify the individual in writing of the time 
and place of the medical review.
    (e) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) shall designate a 
medical reviewer to review the medical or other evidence presented at 
the review, make medical or other findings of fact, and issue a 
recommendation concerning whether the Federal order for quarantine, 
isolation, or conditional release should be rescinded, continued, or 
modified.
    (f) The individual subject to Federal quarantine, isolation, or 
conditional release may authorize an advocate (e.g., an attorney, family 
member, or physician) at his or her own expense to submit medical or 
other evidence and, in the medical reviewer's discretion, be allowed to 
present a reasonable number of medical experts. The Director shall 
appoint representatives at government

[[Page 530]]

expense to assist the individual for purposes of the medical review upon 
a request and certification, under penalty of perjury, by that 
individual that he/she is indigent.
    (g) Prior to the convening of the review, the individual or his/her 
authorized advocate or representatives shall be provided a reasonable 
opportunity to examine the available medical and other records involved 
in the medical review pertaining to that individual.
    (h) The Director shall take such measures that he/she determines to 
be reasonably necessary to allow an individual under Federal quarantine 
or isolation to communicate with any authorized advocate or 
representatives in such a manner as to prevent the possible spread of 
the quarantinable communicable disease.
    (i) The medical reviewer may order a medical examination of an 
individual when, in the medical reviewer's professional judgment, such 
an examination would assist in assessing the individual's medical 
condition.
    (j) As part of the review, and where applicable, the medical 
reviewer shall consider and accept into the record evidence concerning 
whether less restrictive alternatives would adequately serve to protect 
public health.
    (k) The medical review shall be conducted by telephone, audio or 
video conference, or through other means that the medical reviewer 
determines in his/her discretion are practicable for allowing the 
individual under quarantine, isolation, or conditional release to 
participate in the medical review.
    (l) At the conclusion of the review, the medical reviewer shall, 
based upon his or her review of the facts and other evidence made 
available during the medical review, issue a written report to the 
Director (excluding the CDC official who issued the quarantine, 
isolation, or conditional release order) concerning whether, in the 
medical reviewer's professional judgment, the Federal quarantine, 
isolation, or conditional release should continue. The written report 
shall include a determination regarding whether less restrictive 
alternatives would adequately serve to protect public health. The 
written report shall be served on the individual and the individual's 
authorized advocate or representatives.
    (m) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) shall, as soon as 
practicable, review the written report and any objections that may be 
submitted by the individual or the individual's advocate or 
representatives that contest the findings and recommendation contained 
in the medical reviewer's written report. Upon conclusion of the review, 
the Director (excluding the CDC official who issued the quarantine, 
isolation, or conditional release order) shall promptly issue a written 
Federal order directing that the quarantine, isolation, or conditional 
release be continued, modified, or rescinded. In the event that the 
Director (excluding the CDC official who issued the quarantine, 
isolation, or conditional release order) continues or modifies the 
Federal quarantine, isolation, or conditional release, the Director's 
written order shall include a statement that the individual may request 
that the Director rescind the Federal quarantine, isolation, or 
conditional release, but based only on a showing of significant, new or 
changed facts or medical evidence that raise a genuine issue as to 
whether the individual should continue to be subject to Federal 
quarantine, isolation, or conditional release. The written Federal order 
shall be promptly served on the individual and the individual's 
authorized advocate or representatives, except that the Federal order 
may be served by publication or by posting in a conspicuous location if 
applicable to a group of individual's and individual service would be 
impracticable.
    (n) The Director's written order shall not constitute final agency 
action until it has been served on the individual or the individual's 
authorized advocate or representatives, or alternatively, if applicable 
to a group of individuals and individual service would be impracticable, 
it is published or posted.
    (o) The Director (excluding the CDC official who issued the 
quarantine, isolation, or conditional release order) may order the 
consolidation of one or more medical reviews if the number of 
individuals or other factors makes the

[[Page 531]]

holding of individual medical reviews impracticable.
    (p) The Director may issue additional instructions as may be 
necessary or desirable governing the conduct of medical reviews.
    (q) The Director shall arrange for translation or interpretation 
services as needed for purposes of this section.

[82 FR 6976, Jan. 19, 2017]



Sec.  71.40  Suspension of the right to introduce and prohibition of 
the introduction of persons into the United States from designated 
foreign countries or places for public health purposes.

    (a) The Director may prohibit, in whole or in part, the introduction 
into the United States of persons from designated foreign countries (or 
one or more political subdivisions or regions thereof) or places, only 
for such period of time that the Director deems necessary to avert the 
serious danger of the introduction of a quarantinable communicable 
disease, by issuing an order in which the Director determines that:
    (1) By reason of the existence of any quarantinable communicable 
disease in a foreign country (or one or more political subdivisions or 
regions thereof) or place there is serious danger of the introduction of 
such quarantinable communicable disease into the United States; and
    (2) This danger is so increased by the introduction of persons from 
such country (or one or more political subdivisions or regions thereof) 
or place that a suspension of the right to introduce such persons into 
the United States is required in the interest of public health.
    (b) For purposes of this section:
    (1) Introduction into the United States means the movement of a 
person from a foreign country (or one or more political subdivisions or 
regions thereof) or place, or series of foreign countries or places, 
into the United States so as to bring the person into contact with 
persons or property in the United States, in a manner that the Director 
determines to present a risk of transmission of a quarantinable 
communicable disease to persons, or a risk of contamination of property 
with a quarantinable communicable disease, even if the quarantinable 
communicable disease has already been introduced, transmitted, or is 
spreading within the United States;
    (2) Prohibit, in whole or in part, the introduction into the United 
States of persons means to prevent the introduction of persons into the 
United States by suspending any right to introduce into the United 
States, physically stopping or restricting movement into the United 
States, or physically expelling from the United States some or all of 
the persons;
    (3) Serious danger of the introduction of such quarantinable 
communicable disease into the United States means the probable 
introduction of one or more persons capable of transmitting the 
quarantinable communicable disease into the United States, even if 
persons or property in the United States are already infected or 
contaminated with the quarantinable communicable disease;
    (4) The term Place includes any location specified by the Director, 
including any carrier, as that term is defined in 42 CFR 71.1, whatever 
the carrier's flag, registry, or country of origin; and
    (5) Suspension of the right to introduce means to cause the 
temporary cessation of the effect of any law, rule, decree, or order 
pursuant to which a person might otherwise have the right to be 
introduced or seek introduction into the United States.
    (c) Any order issued by the Director under this section shall 
include a statement of the following:
    (1) The foreign countries (or one or more political subdivisions or 
regions thereof) or places from which the introduction of persons shall 
be prohibited;
    (2) The period of time or circumstances under which the introduction 
of any persons or class of persons into the United States shall be 
prohibited;
    (3) The conditions under which that prohibition on introduction 
shall be effective in whole or in part, including any relevant 
exceptions that the Director determines are appropriate;
    (4) The means by which the prohibition shall be implemented; and

[[Page 532]]

    (5) The serious danger posed by the introduction of the 
quarantinable communicable disease in the foreign country or countries 
(or one or more political subdivisions or regions thereof) or places 
from which the introduction of persons is being prohibited.
    (d) When issuing any order under this section, the Director shall, 
as practicable under the circumstances, consult with all Federal 
departments or agencies whose interests would be impacted by the order. 
The Director shall, as practicable under the circumstances, provide the 
Federal departments or agencies with a copy of the order before issuing 
it. In circumstances when it is impracticable to engage in such 
consultation before taking action to protect the public health, the 
Director shall consult with the Federal departments or agencies as soon 
as practicable after issuing his or her order, and may then modify the 
order as he or she determines appropriate. In addition, the Director 
may, as practicable under the circumstances, consult with any State or 
local authorities that he or she deems appropriate in his or her 
discretion.
    (1) If the order will be implemented in whole or in part by State 
and local authorities who have agreed to do so under 42 U.S.C. 243(a), 
then the Director shall explain in the order the procedures and 
standards by which those authorities are expected to aid in the 
enforcement of the order.
    (2) If the order will be implemented in whole or in part by 
designated customs officers (including any individual designated by the 
Department of Homeland Security to perform the duties of a customs 
officer) or Coast Guard officers under 42 U.S.C. 268(b), or another 
Federal department or agency, then the Director shall, in coordination 
with the Secretary of Homeland Security or other applicable Federal 
department or agency head, explain in the order the procedures and 
standards by which any authorities or officers or agents are expected to 
aid in the enforcement of the order, to the extent that they are 
permitted to do so under their existing legal authorities.
    (e) This section does not apply to:
    (1) Members of the armed forces of the United States and associated 
personnel if the Secretary of Defense provides assurance to the Director 
that the Secretary of Defense has taken or will take measures such as 
quarantine or isolation, or other measures maintaining control over such 
individuals, to prevent the risk of transmission of the quarantinable 
communicable disease into the United States; or
    (2) Other United States government employees or contractors on 
orders abroad, or their accompanying family members who are on their 
orders or are members of their household, if the Director receives 
assurances from the relevant head of agency and determines that the head 
of the agency or department has taken or will take, measures such as 
quarantine or isolation, to prevent the risk of transmission of a 
quarantinable communicable disease into the United States.
    (f) This section shall not apply to U.S. citizens, U.S. nationals, 
and lawful permanent residents.
    (g) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or circumstance, 
shall be construed so as to continue to give the maximum effect to the 
provision permitted by law, unless such holding shall be one of utter 
invalidity or unenforceability, in which event the provision shall be 
severable from this section and shall not affect the remainder thereof 
or the application of the provision to persons not similarly situated or 
to dissimilar circumstances.

[85 FR 56458, Sept. 11, 2020]



 Subpart E_Requirements Upon Arrival at U.S. Ports: Sanitary Inspection



Sec.  71.41  General provisions.

    Carriers arriving at a U.S. port from a foreign area shall be 
subject to a sanitary inspection to determine whether there exists 
rodent, insect, or other vermin infestation, contaminated food or water, 
or other insanitary conditions requiring measures for the prevention of 
the introduction, transmission, or spread of communicable disease.

[[Page 533]]



Sec.  71.42  Disinfection of imports.

    When the cargo manifest of a carrier lists articles which may 
require disinfection under the provisions of this part, the Director 
shall disinfect them on board or request the appropriate customs officer 
to keep the articles separated from the other cargo pending appropriate 
disposition.



Sec.  71.43  Exemption for mails.

    Except to the extent that mail contains any article or thing subject 
to restrictions under subpart F of this part, nothing in the regulations 
in this part shall render liable to detention, disinfection, or 
destruction any mail conveyed under the authority of the postal 
administration of the United States or of any other Government.



Sec.  71.44  Disinsection of aircraft.

    (a) The Director may require disinsection of an aircraft if it has 
left a foreign area that is infected with insect-borne communicable 
disease and the aircraft is suspected of harboring insects of public 
health importance.
    (b) Disinsection shall be the responsibility of the air carrier or, 
in the case of aircraft not for hire, the pilot in command, and shall be 
subject to monitoring by the Director.
    (c) Disinsection of the aircraft shall be accomplished immediately 
after landing and blocking.
    (1) The cargo compartment shall be disinsected before the mail, 
baggage, and other cargo are discharged.
    (2) The rest of the aircraft shall be disinsected after passengers 
and crew deplane.
    (d) Disinsection shall be performed with an approved insecticide in 
accordance with the manufacturer's instructions. The current list of 
approved insecticides and sources may be obtained from the Division of 
Quarantine, Center for Prevention Services, Centers for Disease Control, 
Atlanta, GA 30333.



Sec.  71.45  Food, potable water, and waste: U.S. seaports and airports.

    (a) Every seaport and airport shall be provided with a supply of 
potable water from a watering point approved by the Commissioner of Food 
and Drugs, Food and Drug Administration, in accordance with standards 
established in title 21, Code of Federal Regulations, parts 1240 and 
1250.
    (b) All food and potable water taken on board a ship or aircraft at 
any seaport or airport intended for human consumption thereon shall be 
obtained from sources approved in accordance with regulations cited in 
paragraph (a) of this section.
    (c) Aircraft inbound or outbound on an international voyage shall 
not discharge over the United States any excrement, or waste water or 
other polluting materials. Arriving aircraft shall discharge such matter 
only at servicing areas approved under regulations cited in paragraph 
(a) of this section.



Sec.  71.46  Issuance of Deratting Certificates 
and Deratting Exemption Certificates.

    Valid Deratting Certificates or Deratting Exemption Certificates are 
not required for ships to enter a U.S. seaport. In accordance with 
Article 17 of the International Health Regulations, the Public Health 
Service may perform rodent infestation inspections and issue Deratting 
Certificates and Deratting Exemption Certificates.



Sec.  71.47  Special provisions relating to airports: 
Office and isolation facilities.

    Each U.S. airport which receives international traffic shall provide 
without cost to the Government suitable office, isolation, and other 
exclusive space for carrying out the Federal responsibilities under this 
part.



Sec.  71.48  Carriers in intercoastal and interstate traffic.

    Carriers, on an international voyage, which are in traffic between 
U.S. ports, shall be subject to inspection as described in Sec. Sec.  
71.31 and 71.41 when there occurs on board, among passengers or crew, 
any death, or any ill person, or when illness is suspected to be caused 
by insanitary conditions.



                         Subpart F_Importations



Sec.  71.50  Scope and definitions.

    (a) The purpose of this subpart is to prevent the introduction, 
transmission, and spread of communicable human

[[Page 534]]

disease resulting from importations of various animal hosts or vectors 
or other etiological agents from foreign countries into the United 
States.
    (b) In addition to terms in Sec.  71.1, the terms below, as used in 
this subpart, shall have the following meanings:
    Animal product or Product means the hide, hair, skull, teeth, bones, 
claws, blood, tissue, or other biological samples from an animal, 
including trophies, mounts, rugs, or other display items.
    Death certificate means an official government document that 
certifies that a death has occurred and provides identifying information 
about the deceased, including (at a minimum) name, age, and sex. The 
document must also certify the time, place, and cause of death (if 
known). If the official government document is not written in English, 
then it must be accompanied by an English language translation of the 
official government document, the authenticity of which has been 
attested to by a person licensed to perform acts in legal affairs in the 
country where the death occurred. In lieu of a death certificate, a copy 
of the Consular Mortuary Certificate and the Affidavit of Foreign 
Funeral Director and Transit Permit, shall together constitute 
acceptable identification of human remains.
    Educational purpose means use in the teaching of a defined 
educational program at the university level or equivalent.
    Exhibition purpose means use as part of a display in a facility 
comparable to a zoological park or in a trained animal act. The animal 
display must be open to the general public at routinely scheduled hours 
on 5 or more days of each week. The trained animal act must be routinely 
schedule for multiple performances each week and open to the general 
public except for reasonable vacation and retraining periods.
    Human remains means a deceased human body or any portion of a 
deceased human body, except:
    (i) Clean, dry bones or bone fragments; human hair; teeth; 
fingernails or toenails; or
    (ii) A deceased human body and portions thereof that have already 
been fully cremated prior to import; or
    (iii) Human cells, tissues or cellular or tissue-based products 
intended for implantation, transplantation, infusion, or transfer into a 
human recipient.
    Importer means any person importing or attempting to import an item 
regulated under this subpart.
    In transit means animals that are located within the United States, 
whether their presence is anticipated, scheduled, or not, as part of the 
movement of those animals between a foreign country of departure and 
foreign country of final destination without clearing customs and 
officially entering the United States.
    Isolation when applied to animals means the separation of an ill 
animal or ill group of animals from individuals, or other animals, or 
vectors of disease in such a manner as to prevent the spread of 
infection.
    Leak-proof container means a container that is puncture-resistant 
and sealed in such a manner as to contain all contents and prevent 
leakage of fluids during handling, storage, transport, or shipping, such 
as
    (i) A double-layered plastic, puncture-resistant body bag (i.e., two 
sealed body bags, one inside the other);
    (ii) A casket with an interior lining certified by the manufacturer 
to be leak-proof and puncture-resistant; or
    (iii) A sealed metal body-transfer case.
    Licensed veterinarian means an individual who has obtained both an 
advanced degree and valid license to practice animal medicine.
    Person means any individual or partnership, firm, company, 
corporation, association, organization, or similar legal entity, 
including those that are not-for-profit.
    Quarantine when applied to animals means the practice of separating 
live animals that are reasonably believed to have been exposed to a 
communicable disease, but are not yet ill, in a setting where the animal 
can be observed for evidence of disease, and where measures are in place 
to prevent transmission of infection to humans or animals.
    Render noninfectious means treating an animal product (e.g., by 
boiling, irradiating, soaking, formalin fixation,

[[Page 535]]

or salting) in such a manner that renders the product incapable of 
transferring an infectious biological agent to a human.
    Scientific purpose means use for scientific research following a 
defined protocol and other standards for research projects as normally 
conducted at the university level. The term also includes the use for 
safety testing, potency testing, and other activities related to the 
production of medical products.
    You or your means an importer, owner, or an applicant.

[77 FR 75891, Dec. 26, 2012, as amended at 85 FR 42741, July 15, 2020]



Sec.  71.51  Dogs and cats.

    (a) Definitions. As used in this section the term:
    Cat means all domestic cats.
    Confinement means restriction of a dog or cat to a building or other 
enclosure at a U.S. port, en route to destination and at destination, in 
isolation from other animals and from persons except for contact 
necessary for its care or, if the dog or cat is allowed out of the 
enclosure, muzzling and keeping it on a leash.
    Dog means all domestic dogs.
    Owner means owner or agent.
    Valid rabies vaccination certificate means a certificate which was 
issued for a dog not less than 3 months of age at the time of 
vaccination and which:
    (1) Identifies a dog on the basis of breed, sex, age, color, 
markings, and other identifying information.
    (2) Specifies a date of rabies vaccination at least 30 days before 
the date of arrival of the dog at a U.S. port.
    (3) Specifies a date of expiration which is after the date of 
arrival of the dog at a U.S. port. If no date of expiration is 
specified, then the date of vaccination shall be no more than 12 months 
before the date of arrival at a U.S. port.
    (4) Bears the signature of a licensed veterinarian.
    (b) General requirements for admission of dogs and cats--(1) 
Inspection by Director. The Director shall inspect all dogs and cats 
which arrive at a U.S. port, and admit only those dogs and cats which 
show no signs of communicable disease as defined in Sec.  71.1.
    (2) Examination by veterinarian and confinement of dogs and cats. 
When, upon inspection, a dog or cat does not appear to be in good health 
on arrival (e.g., it has symptoms such as emaciation, lesions of the 
skin, nervous system disturbances, jaundice, or diarrhea), the Director 
may require prompt confinement and give the owner an opportunity to 
arrange for a licensed veterinarian to examine the animal and give or 
arrange for any tests or treatment indicated. The Director will consider 
the findings of the examination and tests in determining whether or not 
the dog or cat may have a communicable disease. The owner shall bear the 
expense of the examination, tests, and treatment. When it is necessary 
to detain a dog or cat pending determination of its admissibility, the 
owner shall provide confinement facilities which in the judgment of the 
Director will afford protection against any communicable disease. The 
owner shall bear the expense of confinement. Confinement shall be 
subject to conditions specified by the Director to protect the public 
health.
    (3) Record of sickness or death of dogs and cats and requirements 
for exposed animals. (i) The carrier responsible for the care of dogs 
and cats shall maintain a record of sickness or death of animals en 
route to the United States and shall submit the record to the quarantine 
station at the U.S. port upon arrival. Dogs or cats which have become 
sick while en route or are dead on arrival shall be separated from other 
animals as soon as the sickness or death is discovered, and shall be 
held in confinement pending any necessary examination as determined by 
the Director.
    (ii) When, upon inspection, a dog or cat appears healthy but, during 
shipment, has been exposed to a sick or dead animal suspected of having 
a communicable disease, the exposed dog or cat shall be admitted only if 
examination or tests made on arrival reveal no evidence that the animal 
may be infected with a communicable disease. The provisions of paragraph 
(b)(2) of this section shall be applicable to the examination or tests.
    (4) Sanitation. When the Director finds that the cages or other 
containers

[[Page 536]]

of dogs or cats arriving in the United States are in an insanitary or 
other condition that may constitute a communicable disease hazard, the 
dogs or cats shall not be admitted in such containers unless the owner 
has the containers cleaned and disinfected.
    (c) Rabies vaccination requirements for dogs. (1) A valid rabies 
vaccination certificate is required at a U.S. port for admission of a 
dog unless the owner submits evidence satisfactory to the Director that:
    (i) If a dog is less than 6 months of age, it has been only in a 
country determined by the Director to be rabies-free (a current list of 
rabies-free countries may be obtained from the Division of Quarantine, 
Center for Prevention Services, Centers for Disease Control, Atlanta, GA 
30333); or
    (ii) If a dog is 6 months of age or older, for the 6 months before 
arrival, it has been only in a country determined by the Director to be 
rabies-free; or
    (iii) The dog is to be taken to a research facility to be used for 
research purposes and vaccination would interfere with its use for such 
purposes.
    (2) Regardless of the provisions of paragraph (c)(1) of this 
section, the Director may authorize admission as follows:
    (i) If the date of vaccination shown on the vaccination certificate 
is less than 30 days before the date of arrival, the dog may be 
admitted, but must be confined until at least 30 days have elapsed since 
the date of vaccination;
    (ii) If the dog is less than 3 months of age, it may be admitted, 
but must be confined until vaccinated against rabies at 3 months of age 
and for at least 30 days after the date of vaccination;
    (iii) If the dog is 3 months of age or older, it may be admitted, 
but must be confined until it is vaccinated against rabies. The dog must 
be vaccinated within 4 days after arrival at destination but no more 
than 10 days after arrival at a U.S. port. It must be kept in 
confinement for at least 30 days after the date of vaccination.
    (3) When a dog is admitted under paragraph (c)(2) of this section, 
the Director shall notify the health department or other appropriate 
agency having jurisdiction at the point of destination and shall provide 
the address of the specified place of confinement and other pertinent 
information to facilitate surveillance and other appropriate action.
    (d) Certification requirements. The owner shall submit such 
certification regarding confinement and vaccination prescribed under 
this section as may be required by the Director.
    (e) Additional requirements for the importation of dogs and cats. 
Dogs and cats shall be subject to such additional requirements as may be 
deemed necessary by the Director or to exclusion if coming from areas 
which the Director has determined to have high rates of rabies.
    (f) Requirements for dogs and cats in transit. The provisions of 
this section shall apply to dogs and cats transported through the United 
States from one foreign country to another, except as provided below:
    (1) Dogs and cats that appear healthy, but have been exposed to a 
sick or dead animal suspected of having a communicable disease, need not 
undergo examination or tests as provided in paragraph (b)(3) of this 
section if the Director determines that the conditions under which they 
are being transported will afford adequate protection against 
introduction of communicable disease.
    (2) Rabies vaccination is not required for dogs that are transported 
by aircraft or ship and retained in custody of the carrier under 
conditions that would prevent transmission of rabies.
    (g) Disposal of excluded dogs and cats. A dog or cat excluded from 
the United States under the regulations in this part shall be exported 
or destroyed. Pending exportation, it shall be detained at the owner's 
expense in the custody of the U.S. Customs Service at the U.S. port.

(Approved by the Office of Management and Budget under control number 
0920-0134)



Sec.  71.52  Turtles, tortoises, and terrapins.

    (a) Definitions. As used in this section the term:
    Turtles includes all animals commonly known as turtles, tortoises, 
terrapins, and all other animals of the order Testudinata, class 
Reptilia, except

[[Page 537]]

marine species (Families Dermochelidae and Cheloniidae).
    (b) Importation; general prohibition. Except as otherwise provided 
in this section, live turtles with a carapace length of less than 4 
inches and viable turtle eggs may not be imported into the United 
States.
    (c) Exceptions. (1) Live turtles with a carapace length of less than 
4 inches and viable turtle eggs may be imported into the United States, 
provided that such importation is not in connection with a business, and 
the importation is limited to lots of fewer than seven live turtles or 
fewer than seven viable turtle eggs, or any combinations of such turtles 
and turtle eggs totaling fewer than seven, for any entry.
    (2) Seven or more live turtles with a carapace length of less than 4 
inches, or seven or more viable turtle eggs or any combination of 
turtles and turtle eggs totaling seven or more, may be imported into the 
United States for bona fide scientific or educational purposes or for 
exhibition when accompanied by a permit issued by the Director.
    (3) The requirements in paragraphs (c)(1) and (c)(2) of this section 
shall not apply to the eggs of marine turtles excluded from these 
regulations under Sec.  71.52(a).
    (d) Application for permits. Applications for permits to import 
turtles, as set forth in paragraph (c)(2) of this section, shall be made 
by letter to the Director, and shall contain, identify, or describe, the 
name and address of the applicant, the number of specimens, and the 
common and scientific names of each species to be imported, the holding 
facilities, the intended use of the turtles following their importation, 
the precautions to be undertaken to prevent infection of members of the 
public with Salmonella and Arizona bacteria, and any other information 
and assurances the Director may require.
    (e) Criteria for issuance of permits. A permit may be issued upon a 
determination that the holder of the permit will isolate or otherwise 
confine the turtles and will take such other precautions as may be 
determined by the Director to be necessary to prevent infection of 
members of the public with Salmonella and Arizona bacteria and on 
condition that the holder of the permit will provide such reports as the 
Director may require.
    (f) Interstate Regulations. Upon admission at a U.S. Port, turtles 
and viable turtle eggs become subject to Food and Drug Administration 
Regulations (21 CFR 1240.62) regarding general prohibition.
    (g) Other permits. Permits to import certain species of turtles may 
be required under other Federal regulations (50 CFR parts 17 and 23) 
protecting such species.

(Approved by the Office of Management and Budget under control number 
0920-0134)



Sec.  71.53  Requirements for importers of nonhuman primates.

    (a) Purpose. The purpose of this section is to prevent the 
transmission of communicable disease from nonhuman primates (NHPs) 
imported into the United States, or their offspring, to humans. The 
regulations in this section are in addition to other regulations 
promulgated by the Secretary to prevent the introduction, transmission, 
and spread of communicable diseases under 42 CFR part 71, subpart A and 
42 CFR part 70.
    (b) Scope. This section applies to any person importing a live NHP 
into the United States, including existing importers, any person 
applying to become a registered importer, and any person importing NHP 
products.
    (1) Importers must make their facilities, vehicles, equipment, and 
business records, including employee health records and animal health 
records, used in the importation of NHPs, available to HHS/CDC for 
inspection during operating business days and hours, and at other 
necessary and reasonable times, to enable HHS/CDC to ascertain 
compliance with the regulations in this section.
    (2) Nothing in this section supersedes or preempts enforcement of 
emergency response requirements imposed by statutes or other 
regulations.
    (c) Acronyms, initialisms, and definitions.
    (1) For the purposes of this section:
    AAALAC means the Association for Assessment and Accreditation of 
Laboratory Animal Care International.

[[Page 538]]

    AZA means the Association of Zoos and Aquariums.
    CITES means the Convention on International Trade in Endangered 
Species.
    ELISA means enzyme-linked immunosorbent assay, a type of laboratory 
test that measures antibodies or detects antigens for specific 
pathogens.
    HHS/CDC means U.S. Department of Health and Human Services, Centers 
for Disease Control and Prevention, or an authorized representative 
acting on its behalf.
    IACUC means Institutional Animal Care and Use Committee.
    MOT means mammalian old tuberculin, a biological product used as a 
diagnostic tool in the evaluation for mycobacterial (TB and related 
bacteria) infections.
    NIOSH means the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    PPE means personal protective equipment, such as gloves, 
respirators, and other devices used in preventing the spread of 
communicable diseases.
    SOPs means standard operating procedures.
    TB means tuberculosis.
    TST means tuberculin skin test.
    USDA means United States Department of Agriculture.
    (2) For purposes of this section, the terms listed below shall have 
the following meanings:
    Animal act means any use of NHPs, including offspring, for 
entertainment in which the NHPs are trained to perform some behavior or 
action and are part of a routinely scheduled show, performance, or 
exhibition, open to the general public.
    Breeding colony means a facility where NHPs, including offspring, 
are maintained for reproductive purposes.
    Broker means a person or organization within the United States that 
acts as an official agent of an exporter of NHPs from another country, 
or as an intermediary between such an exporter and an importer of NHPs.
    Cohort means a group of NHPs imported together into the United 
States.
    Director means the Director of the Centers for Disease Control and 
Prevention, U.S. Department of Health and Human Services, or an 
authorized representative.
    Educational purpose means the use of NHPs, including offspring, in 
the teaching of a defined educational program at the university level or 
equivalent.
    Exhibition purposes means the use of NHPs, including offspring, as 
part of a public display open to the general public during routinely 
scheduled hours in a facility that meets or exceeds AZA accreditation 
standards.
    Importer means any person importing, or attempting to import, a live 
NHP into the United States, including an applicant to become a 
registered importer. Within the meaning of this section, ``importer'' 
includes any person maintaining a facility or institution housing NHPs 
during quarantine. Within the meaning of this section, ``importer'' also 
includes the agent of any animal act, laboratory, or zoo that is subject 
to or carries out responsibilities in accordance with the regulations in 
this section.
    In transit means NHPs located within the United States that are not 
intended for import, whether scheduled or not, as part of the movement 
of those NHPs between a foreign country of departure and foreign country 
of final destination.
    Lab or laboratory means a facility in the United States accredited 
by AAALAC or licensed by USDA, conducting research using NHPs, having 
foreign based facilities, and intending to transfer or transferring one 
or more NHPs that were originally part of an institutionally approved, 
ongoing protocol, from its foreign-based facility into its United States 
facility for purposes related to that specific research project.
    Licensed veterinarian means a person who has graduated from a 
veterinary school accredited by the American Veterinary Medical 
Association's Council on Education, or has a certificate issued by the 
American Veterinary Medical Association's Education Commission for 
Foreign Veterinary Graduates, or has received equivalent formal 
education as determined by the HHS/CDC; and has received training

[[Page 539]]

and/or experience in the care and management of nonhuman primates.
    Medical consultant means an occupational health physician, 
physician's assistant, or registered nurse, who is knowledgeable about 
the risks to human health associated with NHPs.
    Nonhuman primate or NHP means all nonhuman members of the Order 
Primates.
    NHP product or Product means skulls, skins, bodies, blood, tissues, 
or other biological samples from a nonhuman primate, including trophies, 
mounts, rugs, or other display items.
    Offspring means the direct offspring of any live NHPs imported into 
the United States and the descendants of any such offspring.
    Old World Nonhuman Primate means all nonhuman primates endemic to 
Asia or Africa.
    Pathogen means any organism or substance capable of causing a 
communicable disease.
    Permitted purpose means the use of NHPs for scientific, educational, 
or exhibition purposes as defined in this section.
    Person means any individual or partnership, firm, company, 
corporation, association, organization, including a not-for-profit 
organization, such as a sanctuary, or other legal entity.
    Quarantine means the practice of isolating live NHPs for at least 31 
days after arrival in a U.S. quarantine facility where the NHPs are 
observed for evidence of infection with communicable disease, and where 
measures are in place to prevent transmission of infection to humans or 
NHPs within the cohort.
    Quarantine facility means a facility used by a registered importer 
of NHPs for the purpose of quarantining imported NHPs.
    Quarantine room means a room in a registered import facility for 
housing imported NHPs during the quarantine period.
    Scientific purposes means the use of NHPs including offspring for 
research following a defined protocol and other standards for research 
projects as normally conducted at the university level.
    Zoo means:
    (1) Within the United States, an AZA-accredited and professionally 
maintained park, garden, or other place in which animals are kept for 
public exhibition and viewing; or
    (2) Outside of the United States, a professionally maintained park, 
garden, or other place in which animals are kept for public exhibition 
and viewing that meets or exceeds the accrediting standards of the AZA.
    Zoonotic disease means any infectious agent or communicable disease 
that is capable of being transmitted from animals (both wild and 
domestic) to humans.
    (d) General prohibition on importing nonhuman primates. (1) A person 
may not import live NHPs into the United States unless the person is 
registered with HHS/CDC as a NHP importer in accordance with this 
section.
    (2) A person may only import live NHPs into the United States for:
    (i) Permitted purposes, as defined under paragraph (c)(2) of this 
section; or
    (ii) Use in breeding colonies, provided that all offspring will be 
used only as replacement breeding stock or for permitted purposes.
    (3) A person may not accept, maintain, sell, resell, or otherwise 
distribute imported NHPs (including their offspring) for use as pets, as 
a hobby, or as an avocation with occasional display to the general 
public.
    (e) Disposal of prohibited or excluded NHPs. (1) HHS/CDC may seize, 
examine, isolate, quarantine, export, treat, or destroy any NHP if:
    (i) It is imported through a location other than an authorized port 
of entry;
    (ii) It is imported for other than permitted purposes;
    (iii) It is maintained, sold, resold, or distributed for other than 
permitted purpose;
    (iv) It is imported by a person who is not a registered importer; or
    (v) It is otherwise deemed to constitute a public health threat by 
the Director.
    (2) For any NHP arriving in the United States through an 
unauthorized location, for other than the permitted purposes, or by a 
person who is not a registered importer, the person attempting to import 
that NHP, must, as

[[Page 540]]

approved by the Director and at the person's own expense, do one of the 
following:
    (i) Export or arrange for destruction of the NHP, or
    (ii) Donate the NHP for a scientific, educational, or exhibition 
purpose after quarantine at a HHS/CDC-registered facility.
    (3) If the person attempting to import a NHP fails to dispose of the 
NHP by one of the options described in paragraph (e)(2) of this section, 
the Director will dispose of the NHP at the person's expense.
    (4) Pending disposal of any prohibited or excluded NHPs, the NHP 
will be detained at the person's expense at a location approved by the 
Director.
    (f) Authorized ports of entry for live NHPs. (1) An importer may 
import live NHPs into the United States only through a port of entry 
where a HHS/CDC quarantine station is located. The list of current HHS/
CDC quarantine stations can be found at http://www.HHS/CDC.gov/
quarantine/QuarantineStations.html.
    (2) In the event that the importer is unable to provide for entry at 
a port where a HHS/CDC quarantine station is located, the importer may 
only import live NHPs into the United States through another port of 
entry if the Director provides advance written approval.
    (3) If prior written approval is not obtained from the Director, the 
importer and excluded NHPs will be subject to the provisions of 
paragraph (e) of this section.
    (g) Registration or renewal of importers. Before importing any live 
NHP into the United States, including those that are part of an animal 
act or those involved in zoo-to-zoo or laboratory-to-laboratory 
transfers, an importer must register with and receive written approval 
from the Director.
    (1) To register, or to renew a registration certificate, as an 
importer, a person must submit the following documents to HHS/CDC:
    (i) A completed registration/application form;
    (ii) A completed statement of intent that describes the number and 
types of NHPs intended for import during the registration period, the 
intended permitted purposes for which the NHPs will be imported;
    (iii) Written SOPs that include all elements required in paragraphs 
(h) through (n) of this section;
    (iv) A copy of all federal, state, or local registrations, licenses, 
and/or permits; and
    (v) A signed, self-certification stating that the importer is in 
compliance with the regulations contained in this section and agrees to 
continue to comply with the regulations in this section.
    (2) Upon receiving the documentation required by this section, the 
Director will review the application and either grant or deny the 
application for registration as an importer. Applications that are 
denied may be appealed under paragraph (u) of this section.
    (i) Before issuing a registration, the Director may inspect any 
business record, facility, vehicle, or equipment to be used in importing 
NHPs.
    (ii) Unless revoked in accordance with paragraph (t) of this 
section, a registration certificate issued under this section is 
effective for two years beginning from the date HHS/CDC issues the 
registration certificate.
    (iii) An importer must apply to HHS/CDC for renewal of the 
registration certificate not less than 30 days and not more than 60 days 
before the existing registration expires.
    (3) All importers must comply with the requirements of paragraphs 
(h) through (n) of this section.
    (h) Documentation. An importer must develop, and document compliance 
with, a written policy that states imported NHPs, including their 
offspring, will only be used and distributed for permitted purposes.
    (1) An importer must collect or create a record of the intended 
purpose of importation for each imported NHP and the purpose must comply 
with one of the permitted purposes. An importer must retain written 
certifications demonstrating that the NHPs and their offspring will 
continue to be used for permitted purposes for three years after the 
distribution or transfer of the NHP.
    (2) An importer must retain records regarding each distribution of 
imported NHPs. Each record must include the identity of any recipients, 
the number

[[Page 541]]

and identity of each NHP in each shipment or sale, and the dates of each 
shipment or sale, for three years after the distribution or transfer of 
the NHP.
    (3) An importer must maintain these records in an organized manner, 
either electronically or in a central location that is at or in close 
proximity to the NHP facility to allow HHS/CDC to easily inspect the 
records during HHS/CDC site visits during regular business hours or 
within one hour of such visits. If records are maintained 
electronically, they must be time-dated in a manner than cannot be 
altered, and redundant back-up copies must be made in a manner that 
protects against loss.
    (4) Before distributing or transferring an imported NHP, an importer 
must:
    (i) Communicate to the recipients of NHPs, in writing, the 
restrictions and definitions of permitted purposes; and
    (ii) Obtain written certifications from the intended recipient that 
the NHPs will be used and distributed only for permitted purposes.
    (i) Worker protection plan and personal protective Equipment. (1) In 
addition to complying with the requirements of this section, an importer 
must comply with all relevant federal and state requirements relating to 
occupational health and safety.
    (2) Importers must have a written worker protection plan for anyone 
whose duties may result in exposure to NHPs, including procedures for 
appropriate response measures in the event of an emergency. An importer 
must adhere to the plan and SOPs and must ensure that each worker 
covered under the plan also adheres to it and all pertinent SOPs.
    (3) An importer must contact HHS/CDC immediately by telephone, text, 
or email, as specified in the importer's SOP, to report any instance of 
a worker exposed to a zoonotic illness and must include instructions for 
contacting HHS/CDC in its worker protection plan.
    (4) A worker protection plan must include the following:
    (i) Procedures to protect and train transport workers in how to 
avoid and respond to zoonotic disease exposures associated with NHPs, 
including procedures for appropriate responses in the event of a vehicle 
crash or other emergency during transport;
    (ii) Hazard evaluation and worker communication procedures that 
adhere to those in paragraph (i)(5) of this section;
    (iii) PPE requirements that adhere to those in paragraph (i)(6) of 
this section;
    (iv) TB-control requirements that adhere to those in paragraph 
(i)(7) of this section;
    (v) If applicable, SOPs that adhere to requirements relating to 
macaques as described in paragraph (i)(8) of this section;
    (vi) An infection-prevention program, including infection-prevention 
methods requiring, at a minimum, PPE and workplace practices for 
preventing infection among workers whose duties may result in exposure 
to NHPs and:
    (A) SOPs that include requirements for preventing workplace 
infection from potentially contaminated needles or other sharp 
instruments and that, at a minimum, prohibit workers from recapping used 
needles by hand; removing needles by hand; or otherwise bending, 
breaking, or manipulating used needles by hand.
    (B) SOPs requiring that used disposable syringes and needles, 
scalpel blades, and other sharp items be placed in puncture-resistant 
containers kept as close to the work site as practical and disinfected 
and/or disposed of as hazardous waste.
    (C) SOPs requiring that removable, disposable PPE be autoclaved, 
incinerated, or otherwise disposed of as biohazardous waste. 
Nondisposable clothing worn in the quarantine facility must be 
disinfected on site before laundering.
    (D) An infection-prevention program that requires NHP handlers to 
cleanse all bites, scratches, and/or mucosal surfaces or abraded skin 
exposed to blood or body fluids immediately and thoroughly.
    (E) Infection-prevention procedures that require workers to 
immediately flush their eyes with water for at least 15 minutes 
following an exposure of blood or body fluids to the eye.
    (vii) Post-exposure procedures that provide potentially exposed 
workers with direct and rapid access to a medical consultant including:

[[Page 542]]

    (A) Procedures ensuring that exposed workers have direct and 
immediate access to a medical consultant who has been previously 
identified in the SOPs to HHS/CDC.
    (B) For potential exposures to herpes B virus, post-exposure 
procedures that require the routing of diagnostic specimens to the 
National B Virus Resource Center located at Georgia State University in 
Atlanta, Georgia, or another location as specified by HHS/CDC.
    (viii) Procedures for documenting the frequency of worker training, 
including for those working in the quarantine facility.
    (5) As part of the worker protection plan described in this 
paragraph (i), an importer must establish, implement, and maintain 
hazard evaluation and worker communication procedures that include the 
following:
    (i) A description of the known zoonotic disease and injury hazards 
associated with handling NHPs;
    (ii) The need for PPE when handling NHPs and training in proper use 
of PPE, including re-training and reinforcement of appropriate use;
    (iii) Procedures for monitoring workers for signs of zoonotic 
illness, including procedures that ensure reporting to HHS/CDC by 
telephone, text, or email within 24 hours of the occurrence of illness 
in any worker suspected of having a zoonotic disease; and
    (iv) Procedures for disinfection of garments, supplies, equipment, 
and waste.
    (6) As part of the worker protection plan described in this 
paragraph (i), an importer must identify the PPE required for each task 
or working area. Additionally, in this part of the worker protection 
plan, an importer must ensure the following:
    (i) Any required PPE must be available to workers when needed;
    (ii) Workers in direct contact with NHPs must wear the following:
    (A) Gloves of sufficient thickness to reduce the risk of cuts, 
scratches, and punctures;
    (B) At a minimum, disposable NIOSH-approved N95 respirators, in 
compliance with OSHA 29 CFR Sec.  1910.134, which requires a respiratory 
protection program;
    (C) Face shields or eye protection; and
    (D) Outer protective clothing when opening crates, removing foreign 
materials from crates, feeding NHPs, removing dead NHPs, or handling 
bedding materials.
    (iii) Workers handling crates or pallets containing NHPs must wear 
the following:
    (A) Elbow-length, reinforced leather gloves or equivalent gloves 
that prevent penetration of splinters, other crating materials, or 
debris;
    (B) Outer protective clothing;
    (C) Waterproof shoes or boots;
    (D) NIOSH-approved respiratory protection that is compliant with 
OSHA regulations at 29 CFR 1910.134, and;
    (E) Face shields or eye protection.
    (iv) Workers whose faces may come within 5 feet of an NHP must wear 
disposable NIOSH-approved N95 respirators and either face shields or eye 
protection to protect against aerosol or droplet transmission of 
pathogens;
    (v) Workers must remove disposable PPE and discard as a biohazard; 
and
    (vi) Workers must not drink, eat, or smoke while physically handling 
NHPs or cages, crates, or other materials from such NHPs.
    (7) For TB protection, an importer must ensure the following:
    (i) Workers in a facility housing NHPs must have a baseline 
evaluation for TB prior to working with NHPs and an evaluation at least 
annually;
    (ii) Prompt and direct access to a medical consultant who is capable 
of performing the evaluation and maintaining records for such tests;
    (iii) If an NHP is found to have laboratory-confirmed TB, any worker 
who had previously entered any room where a confirmed NHP has been 
housed must promptly undergo a post-exposure TB evaluation and
    (A) If that test is negative, the worker must undergo another TB 
evaluation 3 months later; and
    (B) If either test is reactive, the worker must be referred for 
medical evaluation; and
    (C) The HHS/CDC must be immediately notified of the results of the 
medical evaluation by telephone, text, or email as specified in the 
importer's SOPs.

[[Page 543]]

    (iv) Compliance with exposure-control planning elements under 29 CFR 
1910.1030 for workers who will have parenteral and other contact with 
blood or other potentially infectious material from NHPs and compliance 
with the respiratory protection requirements in 29 CFR 1910.134.
    (8) For importation of macaques, an importer must develop, implement 
and adhere to a written PPE program to prevent herpes B virus 
transmission. The program must be based on a thorough hazard assessment 
of all work procedures, potential routes of exposure (e.g., bites, 
scratches, or mucosal exposures), and potential adverse health outcomes.
    (9) An importer must keep records of all serious febrile illnesses 
(fever greater than 101.3 degrees Fahrenheit [38.5 degrees Celsius] for 
more than 48 hours) in workers having exposure to NHPs in transit or in 
quarantine. The record must be kept by the importer as part of the 
worker's administrative records. The importer must promptly notify HHS/
CDC by telephone, text, or email if such an illness occurs. An importer 
must ensure that the medical consultant providing care is informed that 
the patient works with and/or has been exposed to NHPs.
    (j) SOP requirements and equipment standards for crating, caging, 
and transporting live nonhuman primates. Equipment standards for 
crating, caging, and transporting live NHPs must be in accordance with 
USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and 
International Air Transport Association standards, and an importer must 
establish, implement, maintain, and adhere to SOPs that ensure the 
following requirements are met:
    (1) Any crate used to transport NHPs must be free of sharp 
projections that could scratch or otherwise injure workers or NHPs.
    (2) Glass items must not be used for feeding or watering NHPs during 
transport.
    (3) NHPs must only be removed from crates in an approved quarantine 
facility under the supervision of a licensed veterinarian.
    (4) NHPs must not be removed from crates during transport.
    (5) Upon arrival into the United States, only an importer or an 
authorized representative may receive the NHPs from a conveyance (e.g., 
airplane, ship). The importer must establish an emergency contingency 
plan in the unlikely event they are unable to meet the shipment.
    (6) All reusable items must be decontaminated between uses.
    (7) At all times during transport, crates containing NHPs must be 
separated by a physical barrier from workers, other individuals, and all 
other animals and cargo, or by a spatial barrier greater than 5 feet, 
that prevents contamination of cargo or individuals with bodily fluids, 
feces, or soiled bedding.
    (8) At all times during transport, individuals traveling with the 
shipment must be protected from shared air of NHPs to prevent the 
transmission of zoonotic diseases. Airflow must be unidirectional from 
NHP transport workers to NHPs or, if any air is recirculated to the NHP 
transport workers, it must be HEPA-filtered. If a ventilation system is 
not in place, all NHP transport workers must wear respiratory 
protection.
    (9) If traveling by plane, crates containing NHPs should be loaded 
in the cargo hold last and removed first, must be placed on plastic that 
prevents spillage onto the deck of the plane, and must be placed on 
pallets or double crated to ensure separation from other cargo.
    (10) Workers, as well as NHPs, must be protected from communicable 
disease exposures at any facility used en route, including 
transportation holding facilities. An importer must maintain a 
description of any transportation holding facilities and document the 
communicable disease prevention measures taken to protect workers at 
facilities used en route.
    (11) For each import, documentation must be made of the communicable 
disease-prevention procedures to be carried out in every step of the 
chain of custody, from the time of embarkation of the NHPs at the 
country of origin until arrival at the quarantine facility.

[[Page 544]]

    (12) Procedures to ensure that aircraft, ship, vehicles, and related 
equipment are decontaminated following transport.
    (13) Used PPE, bedding, and other potentially contaminated material 
must be removed from the ground transport vehicle upon arrival at the 
quarantine facility and disposed of as biohazardous waste.
    (k) Ground transport vehicles. An importer must establish, 
implement, maintain, and adhere to SOPs for ground transport vehicles 
transporting NHPs that meet the following requirements.
    (1) Ground transport vehicles must have a separate cargo compartment 
with separate heating, ventilation, and air-conditioning systems.
    (2) The interior surfaces of ground transport vehicle cargo 
compartments must be of smooth construction, easy to clean and 
disinfect.
    (3) Used PPE, bedding, and other potentially contaminated material 
must be removed from the ground transport vehicle upon arrival at the 
quarantine facility and disposed of as biohazardous waste by a licensed 
facility.
    (4) Ground transport vehicle cargo compartments must be large enough 
to allow safe stowage of NHP crates in a manner that allows ready access 
to each NHP during transit without unloading any crates.
    (5) After transport of the NHP shipment from the port of entry to 
the quarantine facility, the importer must notify HHS/CDC in writing, 
text message, or email as specified within the SOP, within 48 hours of 
the time the shipment arrived at the quarantine facility.
    (6) As part of the notification of arrival in paragraph (k)(5) of 
this section, an importer must inform HHS/CDC whether suspected or 
confirmed transmission or spread of communicable disease occurred during 
transport, including notification of NHPs that died, became ill, or were 
injured during transport, or malfunctions associated with disease-
mitigation procedures or equipment.
    (l) Quarantine facilities. (1) The requirements of this paragraph 
(l) relating to quarantine facilities do not apply to laboratory-to-
laboratory transfers or zoo-to-zoo transfers that are in compliance with 
paragraphs (p)(2) and (q)(2) of this section, respectively.
    (2) An importer must maintain a quarantine facility for holding a 
cohort during the required quarantine period. NHPs must be quarantined 
for 31 days after arrival at the importer's quarantine facility. HHS/CDC 
may extend the quarantine period if an importer or HHS/CDC finds or 
suspects that an NHP is infected with, or has been exposed to, a 
zoonotic disease, or if an importer or HHS/CDC finds a need for 
additional diagnostic testing.
    (i) For any quarantine facility established or maintained under this 
section, an importer must establish, implement, maintain, and adhere to 
SOPs that meet the following physical security requirements:
    (A) The facility must be locked and secure, with access limited to 
authorized, trained, and knowledgeable personnel.
    (B) An importer must limit access to NHP quarantine areas to 
authorized personnel who are responsible for the transport, study, care, 
or treatment of the NHPs.
    (ii) An importer must keep the number of workers involved in the 
care, transport, and inspection of NHPs to the minimum necessary to 
perform these functions.
    (iii) The facility must be designed and operated in such a manner as 
to allow for adequate disinfecting.
    (iv) The facility must have adequate equipment and space for 
discarding and disinfecting all equipment, clothing, and caging.
    (v) Each heating ventilation and air-conditioning unit in the 
quarantine facility must be designed so that there is no mixing of air 
among quarantine rooms and each quarantine room must remain under 
negative air pressure in relationship to the common hallway or 
anteroom(s) adjacent to the quarantine room.
    (vi) Each quarantine room must have air flow indicators (pressure 
gauges or visual flow indicators) that are affixed outside the 
quarantine room that indicate the direction of airflow into or out of 
quarantine rooms and adjoining common hallways and anterooms.

[[Page 545]]

    (3) An importer must establish, implement, maintain, and adhere to 
SOPs for handling, monitoring, and testing NHPs in quarantine that meet 
the following requirements:
    (i) An importer must ensure that all NHPs are identified 
individually with a unique number or alphanumeric code permanently 
applied to the NHP by tattoo, microchip, or other permanent identifier 
before importation or after the 31-day quarantine. Tattoos, microchips, 
or other permanent identifiers must not be applied during the quarantine 
period.
    (ii) Health certificates, shipping documents, and NHP health records 
must include the number or code required in paragraph (l)(3)(i) of this 
section, as well as the age, sex, and species of the NHP.
    (iii) An importer must ensure NHPs are confined in a squeeze-back 
cage whenever possible and that any individual NHP is anesthetized, 
tranquilized, or otherwise restrained before handling.
    (iv) A description of handling and transporting samples. For any 
procedure involving the use of a syringe, a separate, disposable needle 
and syringe must be used, including a sterile needle and syringe for 
withdrawing medication from any multi-dose vials (e.g., ketamine).
    (v) Before any contaminated item is removed from a quarantine 
facility, an importer must ensure that all NHP waste, bedding, uneaten 
food, or other possibly contaminated items are disinfected, autoclaved, 
or double-bagged for disposal as biomedical waste by a licensed 
facility.
    (vi) All cages, feeding bottles, reusable items, and other 
contaminated items must be disinfected between uses and before disposal.
    (vii) Any equipment used for infusion of NHPs must be autoclaved or 
incinerated, as appropriate.
    (viii) During the quarantine period, an importer must monitor NHPs 
for signs of any zoonotic illness, including signs consistent with 
yellow fever, monkeypox, or filovirus disease.
    (A) If any NHP appears ill during quarantine, an importer must 
monitor that NHP for signs of zoonotic illness, including filovirus 
disease, and ensure appropriate treatment.
    (B) If an Old World NHP displays signs suggestive of filovirus 
infection (e.g., diarrhea with melena or frank blood, bleeding from 
external orifices or petechiae, or suffusive hemorrhage), and survives, 
an importer must collect serum samples on day 31 of quarantine and test 
these samples for antibodies to filovirus while the entire cohort 
remains in quarantine. An importer must test the serum for 
immunoglobulin G (IgG) antibodies to filovirus by using an ELISA 
methodology, or other method approved by HHS/CDC.
    (C) An importer must not knowingly request a release from HHS/CDC of 
any ill NHP from quarantine under paragraph (l)(4) of this section.
    (ix) For each NHP in a quarantine facility, an importer must 
administer at least three TSTs on the eyelid using old mammalian 
tuberculin (MOT), with at least 2 weeks between tests, before the NHP is 
released from import quarantine. TSTs must be read and recorded at 24, 
48, and 72 hours, and a grading scale for interpretation of these tests 
must be listed in an SOP for TB testing.
    (A) An importer must ensure that any cohort with positive or 
suspicious TST reaction remains in quarantine and receives at least five 
additional TSTs (each administered at least two weeks apart) following 
removal of the last affected NHP.
    (B) The validity of TB test results may be compromised if during 
quarantine an NHP contracts a viral illness, including measles; is 
treated with steroids; or is immunized. An importer must document such 
occurrence(s) and hold the NHPs until they have recovered from the 
illness or are no longer on treatment, and for a recommended time after 
recovery (to be determined in consultation with HHS/CDC, depending on 
the illness or treatment in question) before TB tests are performed.
    (C) An importer must retain records of all TSTs performed during the 
lifetime of each NHP at the facility housing the NHP until the NHP is 
transferred to another facility. These records must accompany the NHP 
during moves to other facilities.

[[Page 546]]

    (x) An importer must ensure that different cohorts of NHPs are 
quarantined in separate quarantine rooms.
    (A) If mixing of cohorts should occur, an importer must treat the 
mixed cohort as a single cohort.
    (B) All NHPs within that mixed cohort must remain in quarantine 
until each NHP in that mixed cohort has completed the minimum 31-day 
quarantine period.
    (C) Quarantined NHPs must be housed in such a manner that they do 
not expose non-quarantined NHPs to non-filtered air and other 
potentially infectious materials, including soiled bedding, caging, and 
other potentially contaminated items.
    (4) Before releasing a NHP from quarantine, an importer must obtain 
written permission from HHS/CDC. HHS/CDC may permit the release of a 
cohort from quarantine when all the following conditions have been met:
    (i) The 31-day quarantine period, including any required extension 
of quarantine, has been completed.
    (ii) HHS/CDC has confirmed receipt of written notification of the 
health status of the NHPs in the shipment from the quarantine facility's 
licensed veterinarian as required by paragraph (m)(4) of this section.
    (iii) HHS/CDC confirms that the importer has addressed and resolved 
to HHS/CDC's satisfaction any NHP or worker communicable disease issues 
that were reported to HHS/CDC during shipment.
    (5) If HHS/CDC notifies an importer of any evidence that NHPs have 
been exposed to a zoonotic disease, the importer must, at the importer's 
expense, implement or cooperate in the HHS/CDC's implementation of 
additional measures to rule out the spread of suspected zoonotic disease 
before releasing a shipment from quarantine, including examination, 
additional diagnostic procedures, treatment, detention, isolation, 
seizure, or destruction of exposed animals.
    (6) An importer must establish, implement, and adhere to SOPs for 
safe handling and necropsy of any NHP that dies in quarantine. The SOPs 
must ensure the following:
    (i) The carcass of the NHP must be placed in a waterproof double-bag 
and properly stored for necropsy, specimen collection, autoclaving and/
or incineration, and disposal;
    (ii) A necropsy must be performed by a veterinary pathologist or 
state-licensed veterinarian. Each necropsy report must address all major 
organ systems and incorporate clinical history and laboratory findings;
    (iii) Necropsy and appropriate laboratory testing of the NHP must 
document the cause of death and/or rule out zoonotic illness;
    (iv) Necropsy must be performed under biosafety level 3 (BSL3) or 
enhanced biosafety level 2 ``plus'' (BSL2 + ) to protect against 
exposure to highly infectious agents;
    (v) Any samples of tissues, blood, serum, and/or transudates (bodily 
fluid) collected during necropsy must be retained until the NHP shipment 
has been released from quarantine by HHS/CDC, in case other testing is 
required by HHS/CDC;
    (vi) Fresh and formalin-fixed tissue specimens, including 
tracheobronchial lymph node, liver, lung, and spleen, regardless of 
necropsy findings, must be collected for laboratory examination;
    (vii) Any granulomatous lesions found in any NHP at necropsy, 
regardless of whether TB in the NHP was previously suspected, must be 
submitted to a laboratory for laboratory examination for acid-fast 
bacilli and for mycobacterial culture; and
    (viii) In the event that an Old World NHP dies or is euthanized for 
any reason other than trauma or unexpected adverse environmental 
conditions during quarantine, liver tissue for filovirus antigen by 
using the antigen-capture ELISA method must be submitted to a qualified 
laboratory for testing. The laboratory should provide documentation of 
test validation and records of ongoing quality assurance.
    (m) Health reporting requirements for nonhuman primates. (1) An 
importer must notify HHS/CDC of the events listed in this paragraph (m) 
by telephone, text, or email.
    (2) An importer must notify HHS/CDC within 24 hours of the 
occurrence of any morbidity or mortality of NHPs in quarantine 
facilities, or following a zoo-to-zoo or laboratory-to-laboratory 
transfer.

[[Page 547]]

    (3) For any morbidity or mortality from time of embarkation from 
country of origin to release from HHS/CDC quarantine, an importer must 
report the circumstances to HHS/CDC promptly, including the cause of 
death for each NHP.
    (4) Upon completion of the quarantine period and before an importer 
releases any NHP, cohort, or mixed cohort from quarantine, the importer 
must ensure that the quarantine facility's licensed veterinarian 
notifies HHS/CDC in writing of the health status of the shipment.
    (5) An importer must notify HHS/CDC within 24 hours if any NHP tests 
positive for filovirus virus antigen or antibody.
    (6) An importer must report to HHS/CDC within 24 hours, any positive 
or suspicious TST results, necropsy findings, or laboratory results. Any 
report required under this section must include a copy or summary of the 
individual NHP's health records.
    (n) Recordkeeping and reporting requirements for importing NHPs. (1) 
Before authorizing the import of any NHPs, an importer must be in 
compliance with all applicable elements of the importer's SOPs.
    (2) At least seven days before importing a shipment of NHPs, an 
importer must notify HHS/CDC in writing or by email of the impending 
shipment and provide the following information:
    (i) The importer's name and address;
    (ii) Number and species of NHPs being imported;
    (iii) Description of crates;
    (iv) Means of individually identifying NHPs;
    (v) Origin of NHPs, including the country, the exporter, and the 
exporter's address;
    (vi) Use of NHPs under paragraph (h) of this section;
    (vii) Specific itinerary with names, dates, flights, times, 
airports, sea ports, and responsible parties to contact at every step of 
travel, including all ground transportation;
    (viii) Port of entry;
    (ix) If arriving by flight, the name of the airline and its flight 
number;
    (x) If arriving by vehicle, the name of the vehicle's owner and its 
license plate number;
    (xi) If arriving by ship, the name of the ship and its vessel 
number;
    (xii) Name and address of the destination quarantine facility;
    (xiii) Name, address, and contact information for shipper, if other 
than the importer;
    (xiv) If applicable, name, address, and contact information for 
broker in the United States;
    (xv) Name, address, and contact information for the person(s) 
responsible for off-loading NHPs in the United States;
    (xvi) Name, address, and contact information for any party 
responsible for ground transportation from port of entry to quarantine 
facility;
    (xvii) Expected quarantine facility, if different from the importer;
    (xviii) Master air waybill number for shipment;
    (xix) CITES permit number and expiration date.
    (o) Animal acts. (1) All animal acts must be registered with HHS/CDC 
under paragraph (g) of this section. In addition to the requirements in 
paragraph (g) of this section, which incorporates the requirements in 
paragraphs (h) through (m), an importer must provide:
    (i) A description of the animal act that includes each NHP.
    (ii) Brochures, advertising materials, and/or documentation of 
recent or planned animal act performances.
    (iii) A current list of all NHPs in the animal act, indicating each 
NHP's name, species, sex, age, distinguishing physical description, and 
unique identifier such as a tattoo, microchip, or other permanent 
identifier.
    (iv) Prior to entry or re-entry into the United States, specific 
itinerary with names, dates, flights, times, airports, sea ports, and 
responsible parties to contact at every step of travel, including all 
ground transportation.
    (v) A description, diagram, and photographs of the facilities where 
the importer houses the NHPs in the animal act in the United States, 
including illustrations of the primate caging and/or enclosures; the 
relationship of these cages or enclosures to other structures on the 
property and adjoining properties; whether the primate facilities are 
open to the air or fully enclosed;

[[Page 548]]

and the physical security measures of the facility.
    (vi) Documentation signed by a licensed veterinarian describing the 
physical exam performed on each NHP in the animal act. Such examinations 
must be performed at least once a year. The physical exam must include 
the following:
    (A) Routine complete blood counts, clinical chemistries, fecal 
exams, and any additional testing indicated by the physical exam.
    (B) At least once a year, TB testing with MOT and interpreted as 
stated in paragraph (l)(3)(ix) of this section;
    (C) NHPs with positive TST results must be evaluated for potential 
antituberculosis chemotherapy in consultation with HHS/CDC.
    (D) If the NHP is a chimpanzee, serology and antigen testing for 
hepatitis B, serology for hepatitis C, and any additional titers must be 
performed as indicated by clinical history or exam. A chimpanzee found 
serologically positive for hepatitis B and/or hepatitis C is ineligible 
for entry or re-entry into the United States, unless confirmatory 
evidence signed by a licensed veterinarian shows that there is no 
hepatitis B or hepatitis C virus present in the NHP.
    (vii) SOPs for transporting the NHPs internationally, including the 
shipping crates or enclosures, the type of conveyance, and measures to 
minimize human exposure to the NHPs.
    (viii) A copy of a negative TST conducted within the past 12 months, 
or medical documentation that the individual is free of clinically 
active TB, for each trainer and/or handler.
    (ix) A copy of each SOP for responding to suspected zoonotic 
diseases.
    (x) If macaques are in the animal act, an SOP for responding to 
potential herpes B-virus exposures.
    (p) Zoo-to-zoo transfers. (1) Persons who will only be importing 
live NHPs into the United States through transfer from one zoo to 
another must comply with all the elements listed in paragraphs (g), (h), 
(n), (i)(1) through (5), (i)(6)(i), (i)(6)(v), (i)(6)(vi), (i)(7) 
through (9); (j)(1), (j)(2), (j)(5), (j)(10) through (12); (k)(5) and 
(k)(6); and (m)(1), (m)(2), (m)(5), and (m)(6) of this section.
    (2) If a zoo is importing one or more NHPs into the United States 
from another zoo, the recipient zoo must, before the transfer, submit 
the following information for approval by HHS/CDC:
    (i) A copy of each NHP's veterinary medical records, including 
regular testing for TB from the previous zoo for HHS/CDC's approval. The 
medical record should include a positive identification of the NHP, such 
as a tattoo, microchip, or photograph.
    (ii) A copy of a current health certificate, including documentation 
of a negative TB test, signed by a state licensed veterinarian within 14 
days of the transfer stating that the NHP(s) appear healthy and are free 
from communicable diseases; and
    (iii) Documentation which verifies that the recipient zoo is 
registered in accordance with this section, and
    (iv) A specific itinerary with names, dates, flights, times, 
airports, seaports, and responsible parties to contact at every step of 
travel, including all ground transportation.
    (3) Persons importing live NHPs that are transferred from one zoo to 
another, who are not able to meet the requirements listed in paragraphs 
(p)(2)(i) and (ii) of this section, must comply with all the elements in 
paragraphs (g), (h), (i), (j), (k), (l), (m), and (n) of this section.
    (q) Laboratory-to-laboratory transfers. (1) A laboratory 
transferring NHPs on an established research protocol from its foreign-
based facility to its U.S.-based laboratory must comply with all the 
elements listed in paragraphs (g), (h), (i), (j), (k), and (n) of this 
section; and paragraphs (m)(1), (m)(2), (m)(5), and (m)(6) of this 
section.
    (2) If a lab is receiving one or more NHPs for purposes related to 
an ongoing research project from another established research facility 
outside the United States, the recipient facility must, before the 
transfer, submit the following to HHS/CDC for approval:
    (i) A copy of each NHP's veterinary medical records, including 
regular testing for TB from the previous lab for HHS/CDC's approval. The 
medical record should include a positive identification of the NHP, such 
as a tattoo, microchip, or photograph.

[[Page 549]]

    (ii) A copy of a current health certificate(s), including 
documentation of a negative TST, signed by a state-licensed veterinarian 
within 14 days of the transfer stating that the NHP(s) appear healthy 
and are free from communicable diseases; and
    (iii) Documentation of the ongoing IACUC-approved research project 
and the reason the NHP needs to be transported to the U.S. laboratory 
facility.
    (iv) A specific itinerary with names, dates, flights, times, 
airports, seaports, and responsible parties to contact at every step of 
travel, including all ground transportation.
    (3) Persons importing live NHPs that are transferred from one lab to 
another, who are not able to meet the requirements listed in paragraphs 
(q)(2)(i), (ii), and (iii) of this section, must comply with all the 
elements in paragraphs (g), (h), (i), (j), (k), (l), (m), and (n) of 
this section.
    (r) In transit shipments of NHPs. (1) Before arrival into the United 
States, brokers of in transit shipments must notify HHS/CDC of all 
scheduled in transit shipments of NHPs not intended for import into the 
United States and provide the following information:
    (i) Number and species of NHPs in the shipment;
    (ii) Origin of NHPs, including the country, the exporter, and the 
exporter's address;
    (iii) Name and full address of the final destination quarantine 
facility in the importing country;
    (iv) Means of individually identifying NHPs, if required by the 
importing country;
    (v) A specific itinerary while in the United States including names, 
dates, flights, times, airports, seaports, and responsible parties to 
contact at every step of travel within the United States, including all 
ground transportation;
    (vi) Description of crates;
    (vii) SOPs describing procedures to protect and train transport 
workers from exposure to communicable disease while handling NHPs;
    (viii) SOPs describing procedures to prevent contamination of other 
articles and cargo during transit, including physical separation of 
crates from other cargo;
    (ix) SOPs describing procedures to decontaminate aircraft, ships, 
vehicles, and related equipment following transport; and
    (x) Proposed use, if any, of in transit holding facilities and steps 
to be taken to protect workers, as well as NHPs, from communicable 
disease exposure at each facility to be used en route.
    (2) While located in the United States, in transit shipments must be 
housed and cared for in a manner consistent with requirements for NHPs 
intended for import into the United States as specified in paragraphs 
(j) and (k) of this section.
    (s) Revocation and reinstatement of an importer's registration. (1) 
If the Director determines that an importer has failed to comply with 
any applicable provisions of this section, including the importer's 
SOPs, the Director may revoke the importer's registration.
    (2) HHS/CDC will send the importer a notice of revocation stating 
the grounds upon which the proposed revocation is based.
    (i) If the importer wishes to contest the revocation, the importer 
must file a written response to the notice within 20 calendar days after 
receiving the notice.
    (A) As part of the response, an importer may request that the 
Director review the written record.
    (B) If an importer fails to file a response within 20 calendar days, 
all of the grounds listed in the proposed revocation will be deemed 
admitted, in which case the notice shall constitute final agency action.
    (ii) [Reserved]
    (3) If an importer's response is timely, the Director will review 
the registration, the notice of revocation, and the response, and make a 
decision in writing based on the written record.
    (4) As soon as practicable after completing the written record 
review, the Director will issue a decision in writing that shall 
constitute final agency action. The Director will serve the importer 
with a copy of the written decision.
    (5) The Director may reinstate a revoked registration after 
inspecting the importer's facility, examining its records, conferring 
with the importer,

[[Page 550]]

and receiving information and assurance from the importer of compliance 
with the requirements of this section.
    (t) Nonhuman primate products. (1) NHP products may be imported 
without obtaining a permit under this section if accompanied by 
documentation demonstrating that the products have been rendered 
noninfectious using one of the following methods:
    (i) Boiling in water for an appropriate time so as to ensure that 
any matter other than bone, horns, hooves, claws, antlers, or teeth is 
removed; or
    (ii) Gamma irradiation at a dose of at least 20 kilo Gray at room 
temperature (20 [deg]C or higher); or
    (iii) Soaking, with agitation, in a 4% (w/v) solution of washing 
soda (sodium carbonate, Na2CO3) maintained at pH 
11.5 or above for at least 48 hours; or
    (iv) Soaking, with agitation, in a formic acid solution (100 kg salt 
[NaCl] and 12 kg formic acid per 1,000 liters water) maintained at below 
pH 3.0 for at least 48 hours; wetting and dressing agents may be added;
    (v) In the case of raw hides, salting for at least 28 days with sea 
salt containing 2% washing soda (sodium carbonate, 
Na2CO3);
    (vi) Formalin fixation; or
    (vii) Another method approved by HHS/CDC.
    (viii) Fully taxidermied products are considered rendered 
noninfectious, and so do not require a permit from the Director.
    (2) NHP products that have not been rendered noninfectious are 
considered to pose a potential human health risk and may only be 
imported under the following circumstances:
    (i) The product must be accompanied by a permit issued by the 
Director. Requests for permits should be accompanied by an explanation 
of the product's intended use and a description of how the product will 
be handled to ensure that it does not pose a zoonotic disease threat to 
humans. The Director will review the request for a permit, and 
accompanying materials, and issue a decision that shall constitute final 
agency action.
    (ii) The product may only be imported for bona fide scientific, 
educational, or exhibition purposes.
    (iii) A permit will only be issued if the product will be received 
by a facility equipped to handle potentially infectious NHP materials.
    (iv) The product must comply with any other applicable federal 
requirements, including those relating to packaging, shipping, and 
transport of potentially infectious, biohazardous substances as well as 
those for select agents pursuant to 42 CFR part 73, 7 CFR part 331, and 
9 CFR part 121.
    (u) Appeal of denial for a permit to import. If the HHS/CDC denies 
your request for a permit under this section, you may appeal that denial 
to the HHS/CDC Director.
    (1) You must submit your appeal in writing to the HHS/CDC Director, 
stating the reasons for the appeal and demonstrating that there is a 
genuine and substantial issue of fact in dispute.
    (2) You must submit the appeal within 5 business days after you 
receive the denial.
    (3) HHS/CDC will issue a written response to the appeal, which shall 
constitute final Agency action.
    (v) Filovirus testing fee. (1) Non-human primate importers shall be 
charged a fee for filovirus testing of non-human primate liver samples 
submitted to the Centers for Disease Control and Prevention (CDC).
    (2) The fee shall be based on the cost of reagents and other 
materials necessary to perform the testing; the use of the laboratory 
testing facility; irradiation for inactivation of the sample; personnel 
costs associated with performance of the laboratory tests; and 
administrative costs for test planning, review of assay results, and 
dissemination of test results.
    (3) An up-to-date fee schedule is available from the Division of 
Global Migration & Quarantine, Centers for Disease Control and 
Prevention, 1600 Clifton Road, Atlanta, Georgia 30333. Any changes in 
the fee schedule will be published in the Federal Register.
    (4) The fee must be paid in U.S. dollars at the time that the 
importer submits the specimens to HHS/CDC for testing.

[78 FR 11538, Feb. 15, 2013]

[[Page 551]]



Sec.  71.54  Import regulations for infectious biological agents, 
infectious substances, and vectors.

    (a) The following definitions apply to this section:
    Animal. Any member of the animal kingdom except a human including an 
animal product (e.g., a mount, rug, or other display item composed of 
the hide, hair, skull, teeth, bones, or claws).
    Diagnostic specimen. Specimens of human and animal matter (including 
tissue, blood, body discharges, fluids, excretions or similar material), 
or environmental samples.
    Genomic material. Deoxyribonucleic acid (DNA) or Ribonucleic acid 
(RNA) comprising the genome or organism's hereditary information, that 
may be single-stranded or double-stranded, and in a linear, circular, or 
segmented configuration and may be positive sense (same polarity as 
mRNA), negative sense, or ambisense (mixture of the two).
    Infectious biological agent. A microorganism (including, but not 
limited to, bacteria (including rickettsiae), viruses, fungi, or 
protozoa) or prion, whether naturally occurring, bioengineered, or 
artificial, or a component of such microorganism or prion that is 
capable of causing communicable disease in a human.
    Infectious substance. Any material that is known or reasonably 
expected to contain an infectious biological agent.
    Select agents and toxins. Biological agents and toxins that could 
pose a severe threat to public health and safety as listed in 42 CFR 
73.3 and 73.4.
    Vector. Any animals (vertebrate or invertebrate) including 
arthropods or any noninfectious self-replicating system (e.g., plasmids 
or other molecular vector) or animal products (e.g., a mount, rug, or 
other display item composed of the hide, hair, skull, teeth, bones, or 
claws of an animal) that are known to transfer or are capable of 
transferring an infectious biological agent to a human.
    (b) Unless excluded pursuant to paragraph (f) of this section, a 
person may not import into the United States any infectious biological 
agent, infectious substance, or vector unless:
    (1) It is accompanied by a permit issued by the Centers for Disease 
Control and Prevention (CDC). The possession of a permit issued by the 
CDC does not satisfy permitting requirements placed on materials by the 
U.S. Department of Agriculture that may pose hazards to agriculture or 
agricultural production in addition to hazards to human health.
    (2) The importer is in compliance with all of the permit 
requirements and conditions that are outlined in the permit issued by 
the CDC.
    (3) The importer has implemented biosafety measures commensurate 
with the hazard posed by the infectious biological agent, infectious 
substance, and/or vector to be imported, and the level of risk given its 
intended use.
    (4) The importer takes measures to help ensure that the shipper 
complies with all applicable legal requirements concerning the 
packaging, labeling, and shipment of infectious substances.
    (c) If noted as a condition of the issued permit, subsequent 
transfers of any infectious biological agent, infectious substance or 
vector within the United States will require an additional permit issued 
by the CDC.
    (d) A permit is valid only for:
    (1) The time period and/or term indicated on the permit, and
    (2) Only for so long as the permit conditions continue to be met.
    (e) A permit can be denied, revoked or suspended if:
    (1) The biosafety measures of the permit holder are not commensurate 
with the hazard posed by the infectious biological agent, infectious 
substance, or vector, and the level of risk given its intended use; or,
    (2) The permit holder fails to comply with all conditions, 
restrictions, and precautions specified in the permit.
    (f) A permit issued under this part is not required for an item if:
    (1) It is a biological agent listed in 42 CFR Part 73 as a select 
agent and its importation has been authorized in accordance with 42 CFR 
73.16 or 9 CFR 121.16.
    (2) With the exception of bat or nonhuman primate specimens, it is a 
diagnostic specimen not known by the importer to contain, or suspected 
by

[[Page 552]]

the importer of containing, an infectious biological agent and is 
accompanied by an importer certification statement confirming that the 
material is not known to contain or suspected of containing an 
infectious biological agent, or has been rendered noninfectious.
    (3) With the exception of live bats or bat or nonhuman primate 
products, it is an animal or animal product being imported for 
educational, exhibition, or scientific purposes and is accompanied by 
documentation confirming that the animal or animal product is not known 
to contain (or suspected of containing) an infectious biological agent 
or has been rendered noninfectious.
    (4) It consists only of nucleic acids that cannot produce infectious 
forms of any infectious biological agent and the specimen is accompanied 
by an importer certification statement confirming that the material is 
not known to contain or suspected of containing an infectious biological 
agent.
    (5) It is a product that is cleared, approved, licensed, or 
otherwise authorized under any of the following laws:
    (i) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), or
    (ii) Section 351 of the Public Health Service Act pertaining to 
biological products (42 U.S.C. 262), or
    (iii) The Virus-Serum-Toxin Act (21 U.S.C. 151-159).
    (6) It is an animal or animal product listed in 42 CFR Part 71 and 
its importation has been authorized in accordance with 42 CFR 71.52, 
71.53, or 71.56.
    (g) To apply for a permit, an individual must:
    (1) Submit a signed, completed CDC Form 0.753 (Application for 
Permit to Import Biological Agents or Vectors of Human Disease into the 
United States) to the HHS/CDC Import Permit Program.
    (2) Have in place biosafety measures that are commensurate with the 
hazard posed by the infectious biological agent, infectious substance, 
and/or vector to be imported, and the level of risk given its intended 
use.
    (h) Issuance of a permit may be contingent upon an inspection of the 
importer's facility by the CDC to evaluate whether the importer's 
biosafety measures (e.g., physical structure and features of the 
facility, and operational and procedural safeguards) are commensurate 
with the hazard posed by the infectious biological agent, infectious 
substance, and/or vector, and the level of risk given its intended use.
    (i) Denial, suspension, or revocation of a permit under this section 
may be appealed to the CDC Director. The appeal must be in writing, 
state the factual basis for the appeal, and be submitted to the CDC 
Director within 30 calendar days of the denial, suspension, or 
revocation of the permit. HHS/CDC will issue a written response to the 
appeal, which shall constitute final agency action.

[78 FR 7678, Feb. 4, 2013]



Sec.  71.55  Importation of human remains.

    (a) Human remains imported into the United States, or in transit 
within the United States and not intended for import, must be fully 
contained within a leak-proof container that is packaged and shipped in 
accordance with all applicable legal requirements.
    (b) The provisions of 42 CFR 71.54 shall apply to all imported human 
remains known to contain or reasonably suspected of containing an 
infectious biological agent.
    (c) Unless accompanied by a permit issued under 42 CFR 71.54, human 
remains imported into the United States must meet one of the following 
requirements:
    (1) Human remains imported for burial, entombment, or cremation 
must:
    (i) Be consigned directly to a licensed mortuary, cemetery, or 
crematory for immediate and final preparation prior to burial, 
entombment, or cremation; and
    (ii) Unless embalmed, be accompanied by a death certificate or, if 
the death certificate is incomplete or missing, an importer 
certification statement confirming that the human remains are not known 
to contain or stating why the human remains are not reasonably suspected 
of containing an infectious biological agent.
    (2) Human remains imported for medical examination or autopsy must:
    (i) Be consigned directly to an entity authorized to perform such 
functions

[[Page 553]]

under the laws of the applicable jurisdiction prior to subsequent 
burial, entombment, or cremation; and
    (ii) Unless embalmed, be accompanied by a death certificate or, if 
the death certificate is incomplete or missing, an importer 
certification statement confirming that the human remains are not known 
to contain or stating why the human remains are not reasonably suspected 
of containing an infectious biological agent.
    (3) Human remains imported for any other purpose, unless embalmed, 
must be accompanied by an importer certification statement confirming 
that the human remains are not known to contain or stating why the human 
remains are not reasonably suspected of containing an infectious 
biological agent.
    (d) The Director may suspend the importation of human remains under 
42 CFR 71.63 if the Director designates the foreign country and 
determines that such an action is necessary to protect the public 
health.

[85 FR 42741, July 15, 2020]



Sec.  71.56  African rodents and other animals that may 
carry the monkeypox virus.

    (a) What actions are prohibited? What animals are affected? (1) 
Except as provided in paragraphs (a)(2) and (a)(3) of this section,
    (i) You must not import or attempt to import any rodents, whether 
dead or alive, that were obtained, directly or indirectly, from Africa, 
or whose native habitat is Africa, any products derived from such 
rodents, any other animal, whether dead or alive, whose importation the 
Director has prohibited by order, or any products derived from such 
animals; and
    (ii) You must not prevent or attempt to prevent the Centers for 
Disease Control and Prevention (CDC) from causing an animal to be 
quarantined, re-exported, or destroyed under a written order.
    (2) The prohibitions in paragraph (a)(1) of this section do not 
apply if you have written permission from CDC to import a rodent that 
was obtained, directly or indirectly, from Africa, or whose native 
habitat is Africa, or an animal whose importation the Director has 
prohibited by order.
    (i) To obtain such written permission from CDC, you must send a 
written request to Division of Global Migration and Quarantine, National 
Center for Infectious Diseases, Centers for Disease Control and 
Prevention, 1600 Clifton Rd., Atlanta, GA 30333. You may also fax your 
request to the Division of Global Migration and Quarantine (using the 
same address in the previous sentence) at 404-498-1633.
    (ii) Your request must state the reasons why you need an exemption, 
describe the animals involved, describe the number of animals involved, 
describe how the animals will be transported (including carrying 
containers or cages, precautions for handlers, types of vehicles used, 
and other procedures to minimize exposure of animals and precautions to 
prevent animals from escaping into the environment), describe any 
holding facilities, quarantine procedures, and/or veterinarian 
evaluation involved in the animals' movement, and explain why an 
exemption will not result in the spread of monkeypox within the United 
States. Your request must be limited to scientific, exhibition, or 
educational purposes.
    (iii) We will respond in writing to all requests, and we also may 
impose conditions in granting an exemption. If we deny your request, you 
may appeal that denial. Your appeal must be in writing and be submitted 
to the CDC official whose office denied your request, and you must 
submit the appeal within two business days after you receive the denial. 
Your appeal must state the reasons for the appeal and show that there is 
a genuine and substantial issue of fact in dispute. We will issue a 
written response to the appeal, which shall constitute final agency 
action.
    (3) The prohibitions in paragraph (a) of this section do not apply 
to products derived from rodents that were obtained, directly or 
indirectly, from Africa, or whose native habitat is Africa, or products 
derived from any other animal whose importation the Director has 
prohibited by order if such products have been properly processed to 
render them noninfectious so that they

[[Page 554]]

pose no risk of transmitting or carrying the monkeypox virus. Such 
products include, but are not limited to, fully taxidermied animals and 
completely finished trophies; and they may be imported without written 
permission from CDC.
    (b) What actions can CDC take? (1) To prevent the monkeypox virus 
from spreading and becoming established in the United States, we may, in 
addition to any other authorities under this part:
    (i) Issue an order causing an animal to be placed in quarantine,
    (ii) Issue an order causing an animal to be re-exported,
    (iii) Issue an order causing an animal to be destroyed, or
    (iv) Take any other action necessary to prevent the spread of the 
monkeypox virus.
    (2) Any order causing an animal to be quarantined, re-exported, or 
destroyed will be in writing.
    (c) How do I appeal an order? If you received a written order to 
quarantine or re-export an animal or to cause an animal to be destroyed, 
you may appeal that order. Your appeal must be in writing and be 
submitted to the CDC official whose office issued the order, and you 
must submit the appeal within 2 business days after you receive the 
order. Your appeal must state the reasons for the appeal and show that 
there is a genuine and substantial issue of fact in dispute. We will 
issue a written response to the appeal, which shall constitute final 
agency action.

[68 FR 62369, Nov. 4, 2003]



Sec.  71.63  Suspension of entry of animals, articles, or things 
from designated foreign countries and places into the United States.

    (a) The Director may suspend the entry into the United States of 
animals, articles, or things from designated foreign countries 
(including political subdivisions and regions thereof) or places 
whenever the Director determines that such an action is necessary to 
protect the public health and upon a finding that:
    (1) There exists in a foreign country (including one or more 
political subdivisions and regions thereof) or place a communicable 
disease the introduction, transmission, or spread of which would 
threaten the public health of the United States; and
    (2) The entry of imports from that country or place increases the 
risk that the communicable disease may be introduced, transmitted, or 
spread into the United States.
    (b) The Director shall designate the foreign countries or places and 
the period of time or conditions under which the introduction of imports 
into the United States shall be suspended. The Secretary or Director 
will coordinate in advance with other Federal agencies that have 
overlapping authority in the regulation of entry of animals, articles, 
or other things, as may be necessary to implement and enforce this 
provision.

[82 FR 6978, Jan. 19, 2017]

                           PART 72 [RESERVED]



PART 73_SELECT AGENTS AND TOXINS--Table of Contents



Sec.
73.0 Applicability and related requirements.
73.1 Definitions.
73.2 Purpose and scope.
73.3 HHS select agents and toxins.
73.4 Overlap select agents and toxins.
73.5 Exemptions for HHS select agents and toxins.
73.6 Exemptions for overlap select agents and toxins.
73.7 Registration and related security risk assessments.
73.8 Denial, revocation, or suspension of registration.
73.9 Responsible Official.
73.10 Restricting access to select agents and toxins; security risk 
          assessments.
73.11 Security.
73.12 Biosafety.
73.13 Restricted experiments.
73.14 Incident response.
73.15 Training.
73.16 Transfers.
73.17 Records.
73.18 Inspections.
73.19 Notification of theft, loss, or release.
73.20 Administrative review.
73.21 Civil money penalties.

    Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of Title II 
of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).

    Source: 70 FR 13316, Mar. 18, 2005, unless otherwise noted.

[[Page 555]]



Sec.  73.0  Applicability and related requirements.

    All individuals and entities that possess SARS-CoV, Lujo virus, or 
Chapare virus must provide notice to CDC regarding their possession of 
SARS-CoV, Lujo virus, or Chapare virus on or before December 4, 2012. 
Currently registered individuals and entities possessing SARS-CoV, Lujo 
virus, or Chapare virus must meet all the requirements of this part by 
December 4, 2012. All previously unregistered individuals and entities 
possessing SARS-CoV, Lujo virus, or Chapare virus must meet all of the 
requirements of this part by April 3, 2013.

[77 FR 61110, Oct. 5, 2012, as amended at 77 FR 71702, Dec. 4, 2012]



Sec.  73.1  Definitions.

    For purposes of this part:
    Administrator means the Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Animal and Plant Health Inspection Service (APHIS) means the Animal 
and Plant Health Inspection Service of the U.S. Department of 
Agriculture.
    Attorney General means the Attorney General of the United States or 
any person authorized to act for the Attorney General.
    Biological agent means any microorganism (including, but not limited 
to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious 
substance, or any naturally occurring, bioengineered, or synthesized 
component of any such microorganism or infectious substance, capable of 
causing death, disease, or other biological malfunction in a human, an 
animal, a plant, or another living organism; deterioration of food, 
water, equipment, supplies, or material of any kind; or deleterious 
alteration of the environment.
    CDC means Centers for Disease Control and Prevention of the 
Department of Health and Human Services.
    Conotoxins means short, paralytic alpha conotoxins containing the 
following amino acid sequence 
X1CCX2PACGX3X4X5X6
CX7, whereas:

(1) C = Cysteine residues are all present as disulfides, with the 1st 
          and 3rd Cysteine, and the 2nd and 4th Cysteine forming 
          specific disulfide bridges;
(2) The consensus sequence includes known toxins [alpha]-MI and [alpha]-
          GI (shown above) as well as [alpha]-GIA, Ac1.1a, [alpha]-CnIA, 
          [alpha]-CnIB;
(3) X1 = any amino acid(s) or Des-X;
(4) X2 = Asparagine or Histidine;
(5) P = Proline;
(6) A = Alanine;
(7) G = Glycine;
(8) X3 = Arginine or Lysine;
(9) X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, 
          Phenylalanine or Tryptophan;
(10) X5 = Tyrosine, Phenylalanine, or Tryptophan;
(11) X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, 
          or Asparagine;
(12) X7 = Any amino acid(s) or Des X; and
(13) ``Des X'' = ``an amino acid does not have to be present at this 
          position.'' For example if a peptide sequence were XCCHPA then 
          the related peptide CCHPA would be designated as Des-X.
    Diagnosis means the analysis of specimens for the purpose of 
identifying or confirming the presence or characteristics of a select 
agent or toxin provided that such analysis is directly related to 
protecting the public health or safety, animal health or animal 
products, or plant health or plant products.
    Entity means any government agency (Federal, State, or local), 
academic institution, corporation, company, partnership, society, 
association, firm, sole proprietorship, or other legal entity.
    HHS means the Department of Health and Human Services.
    HHS Secretary means the Secretary of the Department of Health and 
Human Services or his or her designee, unless otherwise specified.
    HHS select agent and/or toxin means a biological agent or toxin 
included in Sec.  73.3.
    Information security means protecting information and information 
systems from unauthorized access, use, disclosure, disruption, 
modification, or destruction in order to provide--
    (1) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information 
authenticity;
    (2) Confidentiality, which means preserving authorized restrictions 
on access and disclosure, including means for protecting personal 
privacy and proprietary information; and

[[Page 556]]

    (3) Availability, which means ensuring timely and reliable access to 
and use of information.
    Occupational exposure means any reasonably anticipated skin, eye, 
mucous membrane, parenteral contact, or respiratory aerosol exposure to 
select agents or toxins that may result from the performance of an 
employee's duties.
    Overlap select agent and/or toxin means a biological agent or toxin 
listed in Sec.  73.4 and 9 CFR part 121.4.
    Principal investigator means the one individual who is designated by 
the entity to direct a project or program and who is responsible to the 
entity for the scientific and technical direction of that project or 
program.
    Proficiency testing means the process of determining the competency 
of an individual or laboratory to perform a specified test or procedure.
    Recombinant nucleic acids means:
    (1) Molecules that are constructed by joining nucleic acid molecules 
and that can replicate in a living cell or
    (2) Molecules that result from the replication of those described in 
paragraph (1) of this definition.
    Responsible Official means the individual designated by an entity 
with the authority and control to ensure compliance with the regulations 
in this part.
    Security barrier means a physical structure that is designed to 
prevent entry by unauthorized persons.
    Select agent and/or toxin means unless otherwise specified, all of 
the biological agents or toxins listed in Sec. Sec.  73.3 and 73.4.
    Specimen means samples of material from humans, animals, plants or 
the environment or isolates or cultures from such samples for the 
diagnosis, verification, or proficiency testing.
    State means any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto 
Rico, the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Synthetic nucleic acids means:
    (1) Molecules that are chemically or by other means synthesized or 
amplified, including those that are chemically or otherwise modified but 
can base pair with naturally occurring nucleic acid molecules (i.e., 
synthetic nucleic acids) or
    (2) Molecules that result from the replication of those described in 
paragraph (1) of this definition.
    Toxin means the toxic material or product of plants, animals, 
microorganisms (including, but not limited to, bacteria, viruses, fungi, 
rickettsiae, or protozoa), or infectious substances, or a recombinant or 
synthesized molecule, whatever their origin and method of production, 
and includes any poisonous substance or biological product that may be 
engineered as a result of biotechnology, produced by a living organism; 
or any poisonous isomer or biological product, homolog, or derivative of 
such a substance.
    United States means all of the States.
    USDA means the United States Department of Agriculture.
    Validated inactivation procedure means a procedure, whose efficacy 
is confirmed by data generated from a viability testing protocol, to 
render a select agent non-viable but allows the select agent to retain 
characteristics of interest for future use; or to render any nucleic 
acids that can produce infectious forms of any select agent virus non-
infectious for future use.
    Viability testing protocol means a protocol to confirm the validated 
inactivation procedure by demonstrating the material is free of all 
viable select agent.
    Verification means the demonstration of obtaining established 
performance (e.g., accuracy, precision, and the analytical sensitivity 
and specificity) specifications for any procedure used for diagnosis.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61110, Oct. 5, 2012; 82 
FR 6290, Jan. 19, 2017]



Sec.  73.2  Purpose and scope.

    This part implements the provisions of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 setting forth the 
requirements for possession, use, and transfer of select agents and 
toxins. The biological agents and toxins listed in this part have the 
potential to pose a severe threat to public health and safety, to

[[Page 557]]

animal health, or to animal products. Overlap select agents and toxins 
are subject to regulation by both CDC and APHIS.



Sec.  73.3  HHS select agents and toxins.

    (a) Except for exclusions under paragraphs (d) and (e) of this 
section, the HHS Secretary has determined that the biological agents and 
toxins listed in this section have the potential to pose a severe threat 
to public health and safety. The select agents and toxins marked with an 
asterisk (*) are designated as Tier 1 select agents and toxins and are 
subject to additional requirements as listed in this part.
    (b) HHS select agents and toxins:

Abrin
Bacillus cereus Biovar anthracis*
Botulinum neurotoxins*
Botulinum neurotoxin producing species of Clostridium*
Conotoxins (Short, paralytic alpha conotoxins containing the following 
amino acid sequence 
X1CCX2PACGX3X4X5X6
CX7) \1\
---------------------------------------------------------------------------

    \1\ C = Cysteine residues are all present as disulfides, with the 
1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific 
disulfide bridges; The consensus sequence includes known toxins [alpha]-
MI and [alpha]-GI (shown above) as well as [alpha]-GIA, Ac1.1a, [alpha]-
CnIA, [alpha]-CnIB; X1 = any amino acid(s) or Des-X; X2 = Asparagine or 
Histidine; P = Proline; A = Alanine; G = Glycine; X3 = Arginine or 
Lysine; X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, 
Phenylalanine or Tryptophan; X5 = Tyrosine, Phenylalanine, or 
Tryptophan; X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, or 
Asparagine; X7 = Any amino acid(s) or Des X and; ``Des X'' = ``an amino 
acid does not have to be present at this position.'' For example if a 
peptide sequence were XCCHPA then the related peptide CCHPA would be 
designated as Des-X.
---------------------------------------------------------------------------

Coxiella burnetii
Crimean-Congo hemorrhagic fever virus
Diacetoxyscirpenol
Eastern equine encephalitis virus
Ebola virus*
Francisella tularensis*
Lassa fever virus
Lujo virus
Marburg virus*
Monkeypox virus
Reconstructed replication competent forms of the 1918 pandemic influenza 
virus containing any portion of the coding regions of all eight gene 
segments (Reconstructed 1918 influenza virus)
Ricin
Rickettsia prowazekii
SARS coronavirus (SARS-CoV)
SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate 
manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-
CoV virulence factors.
Saxitoxin
South American hemorrhagic fever viruses:
    Chapare
    Guanarito
    Junin
    Machupo
    Sabia
Staphylococcal enterotoxins (subtypes A-E)
T-2 toxin
Tetrodotoxin
Tick-borne encephalitis virus
    Far Eastern subtype
    Siberian subtype
Kyasanur Forest disease virus
Omsk haemorrhagic fever virus
Variola major virus (Smallpox virus)*
Variola minor virus (Alastrim)*
Yersinia pestis*

    (c) Genetic Elements, Recombinant and/or Synthetic Nucleic Acids, 
and Recombinant and/or Synthetic Organisms:
    (1) Nucleic acids that can produce infectious forms of any of the 
select agent viruses listed in paragraph (b) of this section.
    (2) Recombinant and/or Synthetic nucleic acids that encode for the 
toxic form(s) of any of the toxins listed in paragraph (b) of this 
section if the nucleic acids:
    (i) Can be expressed in vivo or in vitro, or
    (ii) Are in a vector or recombinant host genome and can be expressed 
in vivo or in vitro.
    (3) HHS select agents and toxins listed in paragraph (b) of this 
section that have been genetically modified.
    (d) HHS select agents or toxins that meet any of the following 
criteria are excluded from the requirements of this part:
    (1) Any HHS select agent or toxin that is in its naturally occurring 
environment provided the select agent or toxin has not been 
intentionally introduced, cultivated, collected, or otherwise extracted 
from its natural source.
    (2) Non-viable HHS select agents or nontoxic HHS toxins.
    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.

[[Page 558]]

    (4) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus that has been subjected to a 
validated inactivation procedure that is confirmed through a viability 
testing protocol. Surrogate strains that are known to possess equivalent 
properties with respect to inactivation can be used to validate an 
inactivation procedure; however, if there are known strain-to-strain 
variations in the resistance of a select agent to an inactivation 
procedure, then an inactivation procedure validated on a lesser 
resistant strain must also be validated on the more resistant strains.
    (5) Material containing a select agent that is subjected to a 
procedure that removes all viable select agent cells, spores, or virus 
particles if the material is subjected to a viability testing protocol 
to ensure that the removal method has rendered the material free of all 
viable select agent.
    (6) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus not subjected to a validated 
inactivation procedure or material containing a select agent not 
subjected to a procedure that removes all viable select agent cells, 
spores, or virus particles if the material is determined by the HHS 
Secretary to be effectively inactivated or effectively removed. To apply 
for a determination an individual or entity must submit a written 
request and supporting scientific information to CDC. A written decision 
granting or denying the request will be issued.
    (7) Except as required in Sec.  73.16(l), the aggregate amount of 
the toxin under the control of a principal investigator, treating 
physician or veterinarian, or commercial manufacturer or distributor 
does not, at any time, exceed the following amounts: 1000 mg of Abrin; 1 
mg of Botulinum neurotoxins; 100 mg of Conotoxins (Short, paralytic 
alpha conotoxins containing the following amino acid sequence 
X1CCX2PACGX3X4X5X6
CX7); 10,000 mg of Diacetoxyscirpenol; 1000 mg of Ricin; 500 
mg of Saxitoxin; 100 mg of Staphylococcal enterotoxins (subtypes A-E); 
10,000 mg of T-2 toxin; or 500 mg of Tetrodotoxin. Provided that,
    (i) The toxin is transferred only after the transferor uses due 
diligence and documents the identification of the recipient and the 
legitimate need (e.g., prophylactic, protective, bona fide research, or 
other peaceful purpose) claimed by the recipient to use such toxin. 
Information to be documented includes, but is not limited to, the 
recipient identity information, including the recipient's name, 
institution name, address, telephone number and email address; name of 
the toxin and the total amount transferred; and the legitimate need 
claimed by the recipient. Notwithstanding the provisions of paragraph 
(d) of this section, the HHS Secretary retains the authority to, without 
prior notification, inspect and copy or request the submission of the 
due diligence documentation to the CDC.
    (ii) Reports to CDC if they detect a known or suspected violation of 
Federal law or become aware of suspicious activity related to a toxin 
listed in this part.
    (8) An animal inoculated with or exposed to an HHS select toxin.
    (9) An HHS select toxin identified in an original food sample or 
clinical sample.
    (10) For those laboratories that are not exempt under Sec.  73.5(a) 
and Sec.  73.6(a), Botulinum neurotoxin that is produced as a byproduct 
in the study of Botulinum neurotoxin producing species of Clostridium so 
long as the toxin has not been intentionally cultivated, collected, 
purified, or otherwise extracted, and the material containing the toxin 
is rendered non-toxic and disposed of within 30 days of the initiation 
of the culture.
    (11) Waste generated during the delivery of patient care by health 
care professionals from a patient diagnosed with an illness or condition 
associated with a select agent, where that waste is decontaminated or 
transferred for destruction by complying with state and Federal 
regulations within seven calendar days of the conclusion of patient 
care.
    (12) Any South American genotypes of Eastern Equine Encephalitis 
Virus and any West African Clade of

[[Page 559]]

Monkeypox virus provided that the individual or entity can identify that 
the agent is within the exclusion category.
    (e) An attenuated strain of a select agent or a select toxin 
modified to be less potent or toxic may be excluded from the 
requirements of this part based upon a determination by the HHS 
Secretary that the attenuated strain or modified toxin does not pose a 
severe threat to public health and safety.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will be 
listed on the National Select Agent Registry Web site at http://
www.selectagents.gov/.
    (2) If an excluded attenuated strain or modified toxin is subjected 
to any manipulation that restores or enhances its virulence or toxic 
activity, the resulting select agent or toxin will be subject to the 
requirements of this part.
    (3) An individual or entity may make a written request to the HHS 
Secretary for reconsideration of a decision denying an application for 
the exclusion of an attenuated strain of a select agent or a select 
toxin modified to be less potent or toxic. The written request for 
reconsideration must state the facts and reasoning upon which the 
individual or entity relies to show the decision was incorrect. The HHS 
Secretary will grant or deny the request for reconsideration as promptly 
as circumstances allow and will state, in writing, the reasons for the 
decision.
    (f) Any HHS select agent or toxin seized by a Federal law 
enforcement agency will be excluded from the requirements of this part 
during the period between seizure of the select agent or toxin and the 
transfer or destruction of such agent or toxin provided that:
    (1) As soon as practicable, the Federal law enforcement agency 
transfers the seized select agent or toxin to an entity eligible to 
receive such agent or toxin or destroys the agent or toxin by a 
recognized sterilization or inactivation process,
    (2) The Federal law enforcement agency safeguards and secures the 
seized select agent or toxin against theft, loss, or release, and 
reports any theft, loss, or release of such agent or toxin, and
    (3) The Federal law enforcement agency reports the seizure of the 
select agent or toxin to CDC or APHIS.
    (i) The seizure of Bacillus cereus Biovar anthracis, Botulinum 
neurotoxins, Botulinum neurotoxin producing species of Clostridium, 
Ebola viruses, Francisella tularensis, Marburg virus, Variola major 
virus (Smallpox virus), Variola minor (Alastrim), or Yersinia pestis 
must be reported within 24 hours by telephone, facsimile, or e-mail. 
This report must be followed by submission of APHIS/CDC Form 4 within 
seven calendar days after seizure of the select agent or toxin.
    (ii) For all other HHS select agents or toxins, APHIS/CDC Form 4 
must be submitted within seven calendar days after seizure of the agent 
or toxin.
    (iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
    (4) The Federal law enforcement agency reports the final disposition 
of the select agent or toxin by submission of APHIS/CDC Form 4. A copy 
of the completed form must be maintained for three years.

[70 FR 13316, Mar. 18, 2005, as amended at 70 FR 61049, Oct. 20, 2005; 
73 FR 61365, Oct. 16, 2008; 73 FR 64554, Oct. 30, 2008; 77 FR 61110, 
Oct. 5, 2012; 79 FR 26861, May 12, 2014; 81 FR 63143, Sept. 14, 2016; 82 
FR 6290, Jan. 19, 2017; 86 FR 64081, Nov. 17, 2021]



Sec.  73.4  Overlap select agents and toxins.

    (a) Except for exclusions under paragraphs (d) and (e) of this 
section, the HHS Secretary has determined that the biological agents and 
toxins listed in this section have the potential to pose a severe threat 
to public health and safety, to animal health, or to animal products. 
The select agents and toxins marked with an asterisk (*) are designated 
as Tier 1 select agents and toxins and are subject to additional 
requirements as listed in this part.
    (b) Overlap select agents and toxins:

Bacillus anthracis *
Bacillus anthracis Pasteur strain
Brucella abortus
Brucella melitensis
Brucella suis

[[Page 560]]

Burkholderia mallei *
Burkholderia pseudomallei *
Hendra virus
Nipah virus
Rift Valley fever virus
Venezuelan equine encephalitis virus

    (c) Genetic Elements, Recombinant and/or Synthetic Nucleic Acids, 
and Recombinant and/or Synthetic Organisms:
    (1) Nucleic acids that can produce infectious forms of any of the 
overlap select agent viruses listed in paragraph (b) of this section.
    (2) Recombinant and/or synthetic nucleic acids that encode for the 
toxic form(s) of any overlap toxins listed in paragraph (b) of this 
section if the nucleic acids:
    (i) Can be expressed in vivo or in vitro, or
    (ii) Are in a vector or recombinant host genome and can be expressed 
in vivo or in vitro.
    (3) Overlap select agents and toxins listed in paragraph (b) of this 
section that have been genetically modified.
    (d) Overlap select agents or toxins that meet any of the following 
criteria are excluded from the requirements of this part:
    (1) Any overlap select agent or toxin that is in its naturally 
occurring environment provided that the select agent or toxin has not 
been intentionally introduced, cultivated, collected, or otherwise 
extracted from its natural source.
    (2) Non-viable overlap select agents or nontoxic overlap toxins.
    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.
    (4) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus that has been subjected to a 
validated inactivation procedure that is confirmed through a viability 
testing protocol. Surrogate strains that are known to possess equivalent 
properties with respect to inactivation can be used to validate an 
inactivation procedure; however, if there are known strain-to-strain 
variations in the resistance of a select agent to an inactivation 
procedure, then an inactivation procedure validated on a lesser 
resistant strain must also be validated on the more resistant strains.
    (5) Material containing a select agent that is subjected to a 
procedure that removes all viable select agent cells, spores, or virus 
particles if the material is subjected to a viability testing protocol 
to ensure that the removal method has rendered the material free of all 
viable select agent.
    (6) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus not subjected to a validated 
inactivation procedure or material containing a select agent not 
subjected to a procedure that removes all viable select agent cells, 
spores, or virus particles if the material is determined by the HHS 
Secretary or Administrator to be effectively inactivated or effectively 
removed. To apply for a determination an individual or entity must 
submit a written request and supporting scientific information to CDC or 
APHIS. A written decision granting or denying the request will be 
issued.
    (7) An overlap select toxin identified in an original food sample or 
clinical sample.
    (8) Waste generated during the delivery of patient care by health 
care professionals from a patient diagnosed with an illness or condition 
associated with a select agent, where that waste is decontaminated or 
transferred for destruction by complying with state and Federal 
regulations within seven calendar days of the conclusion of patient 
care.
    (9) Any subtypes of Venezuelan equine encephalitis virus except for 
Subtypes IAB or IC provided that the individual or entity can identify 
that the agent is within the exclusion category.
    (e) An attenuated strain of a select agent, or a select toxin 
modified to be less potent or toxic, may be excluded from the 
requirements of this part based upon a determination by the HHS 
Secretary that the attenuated strain or modified toxin does not pose a 
severe threat to public health and safety.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or

[[Page 561]]

denying the request will be issued. An exclusion will be effective upon 
notification to the applicant. Exclusions will be listed on the National 
Select Agent Registry Web site at http://www.selectagents.gov/.
    (2) If an excluded attenuated strain or modified toxin is subjected 
to any manipulation that restores or enhances its virulence or toxic 
activity, the resulting select agent or toxin will be subject to the 
requirements of this part.
    (3) An individual or entity may make a written request to the HHS 
Secretary or Administrator for reconsideration of a decision denying an 
application for the exclusion of an attenuated strain of a select agent 
or a select toxin modified to be less potent or toxic. The written 
request for reconsideration must state the facts and reasoning upon 
which the individual or entity relies to show the decision was 
incorrect. The HHS Secretary or Administrator will grant or deny the 
request for reconsideration as promptly as circumstances allow and will 
state, in writing, the reasons for the decision.
    (f) Any overlap select agent or toxin seized by a Federal law 
enforcement agency will be excluded from the requirements of this part 
during the period between seizure of the select agent or toxin and the 
transfer or destruction of such agent or toxin provided that:
    (1) As soon as practicable, the Federal law enforcement agency 
transfers the seized select agent or toxin to an entity eligible to 
receive such agent or toxin or destroys the agent or toxin by a 
recognized sterilization or inactivation process,
    (2) The Federal law enforcement agency safeguards and secures the 
seized select agent or toxin against theft, loss, or release, and 
reports any theft, loss, or release of such agent or toxin, and
    (3) The Federal law enforcement agency reports the seizure of the 
overlap select agent or toxin to CDC or APHIS.
    (i) The seizure of Bacillus anthracis, Burkholderia mallei and 
Burkholderia pseudomallei must be reported within 24 hours by telephone, 
facsimile, or e-mail. This report must be followed by submission of 
APHIS/CDC Form 4 within seven calendar days after seizure of the overlap 
select agent or toxin.
    (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 
must be submitted within seven calendar days after seizure of the select 
agent or toxin.
    (iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
    (4) The Federal law enforcement agency reports the final disposition 
of the overlap select agent or toxin by the submission of APHIS/CDC Form 
4. A copy of the completed form must be maintained for three years.

[70 FR 13316, Mar. 18, 2005, as amended at 73 FR 61366, Oct. 16, 2008; 
77 FR 61111, Oct. 5, 2012; 79 FR 26861, May 12, 2014; 82 FR 6291, Jan. 
19, 2017]



Sec.  73.5  Exemptions for HHS select agents and toxins.

    (a) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer a HHS select agent or toxin that is contained 
in a specimen presented for diagnosis or verification will be exempt 
from the requirements of this part for such agent or toxin contained in 
the specimen, provided that:
    (1) Unless directed otherwise by the HHS Secretary, within seven 
calendar days after identification of the select agent or toxin (except 
for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-
E)), or within 30 calendar days after identification of Botulinum 
neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), the select 
agent or toxin is transferred in accordance with Sec.  73.16 or 
destroyed on-site by a recognized sterilization or inactivation process,
    (2) The select agent or toxin is secured against theft, loss, or 
release during the period between identification of the select agent or 
toxin and transfer or destruction of such agent or toxin, and any theft, 
loss, or release of such agent or toxin is reported, and
    (3) Unless otherwise directed by the HHS Secretary, the clinical or 
diagnostic specimens collected from a patient infected with a select 
agent are transferred in accordance with Sec.  73.16 or destroyed on-
site by a recognized sterilization or inactivation process within seven 
calendar days after delivery of

[[Page 562]]

patient care by health care professionals has concluded, and
    (4) The identification of the agent or toxin is reported to CDC or 
APHIS, the specimen provider, and to other appropriate authorities when 
required by Federal, State, or local law by telephone, facsimile, or 
email. This report must be followed by submission of APHIS/CDC Form 4 to 
APHIS or CDC within seven calendar days after identification.
    (i) The identification of any of the following HHS select agents or 
toxins must be immediately reported by telephone, facsimile, or e-mail: 
Bacillus cereus Biovar anthracis,, Botulinum neurotoxins, Botulinum 
neurotoxin producing species of Clostridium, Ebola viruses, Francisella 
tularensis, Marburg virus, Variola major virus (Smallpox virus), Variola 
minor (Alastrim), or Yersinia pestis. This report must be followed by 
submission of APHIS/CDC Form 4 within seven calendar days after 
identification.
    (ii) For all other HHS select agents or toxins, APHIS/CDC Form 4 
must be submitted within seven calendar days after identification.
    (iii) Less stringent reporting may be required based on 
extraordinary circumstances, such as a widespread outbreak.
    (iv) A copy of APHIS/CDC Form 4 must be maintained for three years.
    (b) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer a HHS select agent or toxin that is contained 
in a specimen presented for proficiency testing will be exempt from the 
requirements of this part for such agent or toxin contained in the 
specimen, provided that:
    (1) Unless directed otherwise by the HHS Secretary, within 90 
calendar days of receipt, the select agent or toxin is transferred in 
accordance with Sec.  73.16 or destroyed on-site by a recognized 
sterilization or inactivation process,
    (2) The select agent or toxin is secured against theft, loss, or 
release during the period between identification of the select agent or 
toxin and transfer or destruction of such agent or toxin, and the theft, 
loss, or release of such agent or toxin is reported, and
    (3) The identification of the select agent or toxin, and its 
derivative, is reported to CDC or APHIS and to other appropriate 
authorities when required by Federal, State, or local law. To report the 
identification of a select agent or toxin, APHIS/CDC Form 4 must be 
submitted within 90 calendar days of receipt of the select agent or 
toxin. A copy of the completed form must be maintained for three years.
    (c) Unless the HHS Secretary issues an order making specific 
provisions of this part applicable to protect public health and safety, 
products that are, bear, or contain listed select agents or toxins that 
are cleared, approved, licensed, or registered under any of the 
following laws, are exempt from the provisions of this part insofar as 
their use meets the requirements of such laws:
    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.),
    (2) Section 351 of the Public Health Service Act pertaining to 
biological products (42 U.S.C. 262),
    (3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C. 
151-159), or
    (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136 et seq.).
    (d) The HHS Secretary may exempt from the requirements of this part 
an investigational product that is, bears, or contains a select agent or 
toxin, when such product is being used in an investigation authorized 
under any Federal Act and additional regulation under this part is not 
necessary to protect public health and safety.
    (1) To apply for an exemption, an individual or entity must submit a 
completed APHIS/CDC Form 5.
    (2) The HHS Secretary shall make a determination regarding the 
application within 14 calendar days after receipt, provided the 
application meets all of the requirements of this section and the 
application establishes that the investigation has been authorized under 
the cited Act. A written decision granting or denying the request will 
be issued.
    (3) The applicant must notify CDC or APHIS when an authorization for 
an investigation no longer exists. This exemption automatically 
terminates when such authorization is no longer in effect.

[[Page 563]]

    (e) The HHS Secretary may temporarily exempt an individual or entity 
from the requirements of this part based on a determination that the 
exemption is necessary to provide for the timely participation of the 
individual or entity in response to a domestic or foreign public health 
emergency. With respect to the emergency involved, the exemption may not 
exceed 30 calendar days, except that one extension of an additional 30 
calendar days may be granted.

[70 FR 13316, Mar. 18, 2005, as amended at 73 FR 61366, Oct. 16, 2008; 
77 FR 61112, Oct. 5, 2012; 82 FR 6292, Jan. 19, 2017]



Sec.  73.6  Exemptions for overlap select agents and toxins.

    (a) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer an overlap select agent or toxin that is 
contained in a specimen presented for diagnosis or verification will be 
exempt from the requirements of this part for such agent or toxin 
contained in the specimen, provided that:
    (1) Unless directed otherwise by the HHS Secretary or Administrator, 
within seven calendar days after identification, the select agent or 
toxin is transferred in accordance with Sec.  73.16 or 9 CFR part 121.16 
or destroyed on-site by a recognized sterilization or inactivation 
process,
    (2) The select agent or toxin is secured against theft, loss, or 
release during the period between identification of the select agent or 
toxin and transfer or destruction of such agent or toxin, and any theft, 
loss, or release of such agent or toxin is reported, and
    (3) Unless otherwise directed by the HHS Secretary or Administrator, 
the clinical or diagnostic specimens collected from a patient infected 
with a select agent are transferred in accordance with Sec.  73.16 or 
destroyed on-site by a recognized sterilization or inactivation process 
within seven calendar days after delivery of patient care by health care 
professionals has concluded, and
    (4) The identification of the agent or toxin is reported to CDC or 
APHIS, the specimen provider, and to other appropriate authorities when 
required by Federal, State, or local law by telephone, facsimile, or 
email. This report must be followed by submission of APHIS/CDC Form 4 to 
APHIS or CDC within seven calendar days after identification.
    (i) The identification of any of the following overlap select agents 
or toxins must be immediately reported by telephone, facsimile, or e-
mail: Bacillus anthracis, Burkholderia mallei and Burkholderia 
pseudomallei. This report must be followed by submission of APHIS/CDC 
Form 4 within seven calendar days after identification.
    (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 
must be submitted within seven calendar days after identification.
    (iii) Less stringent reporting may be required based on 
extraordinary circumstances, such as a widespread outbreak.
    (iv) A copy of APHIS/CDC Form 4 must be maintained for three years.
    (b) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer an overlap select agent or toxin that is 
contained in a specimen presented for proficiency testing will be exempt 
from the requirements of this part for such agent or toxin contained in 
the specimen, provided that:
    (1) Unless directed otherwise by the HHS Secretary or Administrator, 
within 90 calendar days of receipt, the select agent or toxin is 
transferred in accordance with Sec.  73.16 or 9 CFR part 121.16 or 
destroyed on-site by a recognized sterilization or inactivation process,
    (2) The select agent or toxin is secured against theft, loss, or 
release during the period between identification of the select agent or 
toxin and transfer or destruction of such agent or toxin, and the theft, 
loss, or release of such agent or toxin is reported, and
    (3) The identification of the select agent or toxin, and its 
derivative, is reported to CDC or APHIS and to other appropriate 
authorities when required by Federal, State, or local law. To report the 
identification of an overlap select agent or toxin, APHIS/CDC Form 4 
must be submitted within 90 calendar days of receipt of the select agent 
or toxin. A copy of the completed form must be maintained for three 
years.
    (c) Unless the HHS Secretary issues an order making specific 
provisions of this part applicable to protect public

[[Page 564]]

health and safety, products that are, bear, or contain listed select 
agents or toxins that are cleared, approved, licensed, or registered 
under any of the following laws, are exempt from the provisions of this 
part insofar as their use meets the requirements of such laws:
    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.),
    (2) Section 351 of the Public Health Service Act pertaining to 
biological products (42 U.S.C. 262),
    (3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C. 
151-159), or
    (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136 et seq.).
    (d) The HHS Secretary, after consultation with Administrator, may 
exempt from the requirements of this part an investigational product 
that is, bears, or contains an overlap select agent or toxin, may be 
exempted when such product is being used in an investigation authorized 
under any Federal Act and additional regulation under this part is not 
necessary to protect public health and safety.
    (1) To apply for an exemption, an individual or entity must submit a 
completed APHIS/CDC Form 5.
    (2) The HHS Secretary shall make a determination regarding the 
application within 14 calendar days after receipt, provided the 
application meets all of the requirements of this section and the 
application establishes that the investigation has been authorized under 
the cited Act. A written decision granting or denying the request will 
be issued.
    (3) The applicant must notify CDC or APHIS when an authorization for 
an investigation no longer exists. This exemption automatically 
terminates when such authorization is no longer in effect.
    (e) The HHS Secretary may exempt an individual or entity from the 
requirements of this part based on a determination that the exemption is 
necessary to provide for the timely participation of the individual or 
entity in response to a domestic or foreign public health emergency. The 
HHS Secretary may extend the exemption once for additional 30 days.
    (f) Upon request of the Administrator, the HHS Secretary may exempt 
an individual or entity from the requirements, in whole or in part, of 
this part for 30 calendar days if the Administrator has granted the 
exemption for agricultural emergency. The HHS Secretary may extend the 
exemption once for an additional 30 calendar days.

[70 FR 13316, Mar. 18, 2005, as amended at 73 FR 61366, Oct. 16, 2008; 
77 FR 61112, Oct. 5, 2012; 79 FR 26862, May 12, 2014;82 FR 6292, Jan. 
19, 2017]



Sec.  73.7  Registration and related security risk assessments.

    (a) Unless exempted under Sec.  73.5, an individual or entity shall 
not possess, use, or transfer any HHS select agent or toxin without a 
certificate of registration issued by the HHS Secretary. Unless exempted 
under Sec.  73.6 or 9 CFR part 121.6, an individual or entity shall not 
possess, use, or transfer overlap select agents or toxins, without a 
certificate of registration issued by the HHS Secretary and 
Administrator.
    (b) As a condition of registration, each entity is required to be in 
compliance with the requirements of this part for select agents and 
toxins listed on the registration regardless of whether the entity is in 
actual possession of the select agent or toxin. With regard to toxins, 
the entity registered for possession, use or transfer of a toxin must be 
in compliance with the requirements of this part regardless of the 
amount of toxin currently in its possession.
    (c) As a condition of registration, each entity must designate an 
individual to be its Responsible Official. While most registrants are 
likely to be entities, in the event that an individual applies for and 
is granted a certificate of registration, the individual will be 
considered the Responsible Official.
    (d)(1) As a condition of registration, the following must be 
approved by the HHS Secretary or Administrator based on a security risk 
assessment by the Attorney General:
    (i) The individual or entity,
    (ii) The Responsible Official, and
    (iii) Unless otherwise exempted under this section, any individual 
who owns or controls the entity.

[[Page 565]]

    (2) Federal, State, or local governmental agencies, including public 
accredited academic institutions, are exempt from the security risk 
assessments for the entity and the individual who owns or controls such 
entity.
    (3) An individual will be deemed to own or control an entity under 
the following conditions: \1\
---------------------------------------------------------------------------

    \1\ These conditions may apply to more than one individual.
---------------------------------------------------------------------------

    (i) For a private institution of higher education, an individual 
will be deemed to own or control the entity if the individual is in a 
managerial or executive capacity with regard to the entity's select 
agents or toxins or with regard to the individuals with access to the 
select agents or toxins possessed, used, or transferred by the entity.
    (ii) For entities other than institutions of higher education, an 
individual will be deemed to own or control the entity if the 
individual:
    (A) Owns 50 percent or more of the entity, or is a holder or owner 
of 50 percent or more of its voting stock, or
    (B) Is in a managerial or executive capacity with regard to the 
entity's select agents or toxins or with regard to the individuals with 
access to the select agents or toxins possessed, used, or transferred by 
the entity.
    (4) An entity will be considered to be an institution of higher 
education if it is an institution of higher education as defined in 
section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), 
or is an organization described in 501(c)(3) of the Internal Revenue 
Code of 1986, as amended (26 U.S.C. 501(c)(3)).
    (5) To obtain a security risk assessment, an individual or entity 
must submit the information necessary to conduct a security risk 
assessment to the Attorney General.
    (e) To apply for a certificate of registration that covers only HHS 
select agents or toxins, an individual or entity must submit the 
information requested in the registration application package (APHIS/CDC 
Form 1) to CDC. To apply for a certificate of registration that does not 
cover only HHS select agents or toxins (i.e., covers at least one 
overlap select agent and/or toxin, or covers any combination of HHS 
select agents and/or toxins and USDA select agents and/or toxins), an 
individual or entity must submit the information requested in the 
registration application package (APHIS/CDC Form 1) to CDC or APHIS, but 
not both.
    (f) Prior to the issuance of a certificate of registration, the 
Responsible Official must promptly provide notification of any changes 
to the application for registration by submitting the relevant page(s) 
of the registration application.
    (g) The issuance of a certificate of registration may be contingent 
upon inspection or submission of additional information, such as the 
security plan, biosafety plan, incident response plan, or any other 
documents required to be prepared under this part.
    (h) A certificate of registration will be valid for one physical 
location (a room, a building, or a group of buildings) where the 
Responsible Official will be able to perform the responsibilities 
required in this part, for specific select agents or toxins, and for 
specific activities.
    (i) A certificate of registration may be amended to reflect changes 
in circumstances (e.g., replacement of the Responsible Official or other 
personnel changes, changes in ownership or control of the entity, 
changes in the activities involving any select agents or toxins, or the 
addition or removal of select agents or toxins).
    (1) Prior to any change, the Responsible Official must apply for an 
amendment to a certificate of registration by submitting the relevant 
page(s) of the registration application.
    (2) The Responsible Official will be notified in writing if an 
application to amend a certificate of registration has been approved. 
Approval of the amendment may be contingent upon an inspection or 
submission of additional information, such as the security plan, 
biosafety plan, incident response plan, or any other documents required 
to be prepared under this part.
    (3) No change may be made without such approval.
    (j) An entity must immediately notify CDC or APHIS if it loses the 
services of its Responsible Official. In the event that an entity loses 
the services

[[Page 566]]

of its Responsible Official, an entity may continue to possess or use 
select agents or toxins only if it appoints as the Responsible Official 
another individual who has been approved by the HHS Secretary or 
Administrator following a security risk assessment by the Attorney 
General and who meets the requirements of this part.
    (k) A certificate of registration will be terminated upon the 
written request of the entity if the entity no longer possesses or uses 
any select agents or toxins and no longer wishes to be registered.
    (l) A certificate of registration will be valid for a maximum of 
three years.

[70 FR 13316, Mar. 18, 2005, as amended at 82 FR 6292, Jan. 19, 2017]



Sec.  73.8  Denial, revocation, or suspension of registration.

    (a) An application may be denied or a certificate of registration 
revoked or suspended if:
    (1) The individual or entity, the Responsible Official, or an 
individual who owns or controls the entity is within any of the 
categories described in 18 U.S.C. 175b,
    (2) The individual or entity, the Responsible Official, or an 
individual who owns or controls the entity as reasonably suspected by 
any Federal law enforcement or intelligence agency of:
    (i) Committing a crime specified in 18 U.S.C. 2332b(g)(5),
    (ii) Knowing involvement with an organization that engages in 
domestic or international terrorism (as defined in 18 U.S.C. 2331) or 
with any other organization that engages in intentional crimes of 
violence, or
    (iii) Being an agent of a foreign power (as defined in 50 U.S.C. 
1801).
    (3) The individual or entity does not meet the requirements of this 
part, or
    (4) It is determined that such action is necessary to protect public 
health and safety.
    (b) Upon revocation or suspension of a certificate of registration, 
the individual or entity must:
    (1) Immediately stop all use of each select agent or toxin covered 
by the revocation or suspension order,
    (2) Immediately safeguard and secure each select agent or toxin 
covered by the revocation or suspension order from theft, loss, or 
release, and
    (3) Comply with all disposition instructions issued by the HHS 
Secretary for the select agent or toxin covered by the revocation or 
suspension.
    (c) Denial of an application for registration and revocation of 
registration may be appealed under Sec.  73.20. However, any denial of 
an application for registration or revocation of a certificate of 
registration will remain in effect until a final agency decision has 
been rendered.



Sec.  73.9  Responsible Official.

    (a) An individual or entity required to register under this part 
must designate an individual to be the Responsible Official. The 
Responsible Official must:
    (1) Be approved by the HHS Secretary or Administrator following a 
security risk assessment by the Attorney General,
    (2) Be familiar with the requirements of this part,
    (3) Have authority and responsibility to act on behalf of the 
entity,
    (4) Ensure compliance with the requirements of this part,
    (5) Have a physical (and not merely a telephonic or audio/visual) 
presence at the registered entity to ensure that the entity is in 
compliance with the select agent regulations and be able to respond in a 
timely manner to onsite incidents involving select agents and toxins in 
accordance with the entity's incident response plan, and
    (6) Ensure that annual inspections are conducted for each registered 
space where select agents or toxins are stored or used in order to 
determine compliance with the requirements of this part. The results of 
each inspection must be documented, and any deficiencies identified 
during an inspection must be corrected and the corrections documented.
    (7) Ensure that individuals are provided the contact information for 
the HHS Office of Inspector General Hotline and the USDA Office of 
Inspector General Hotline so that they may anonymously report any 
biosafety or security concerns related to select agents and toxins.

[[Page 567]]

    (8) Investigate to determine the reason for any failure of a 
validated inactivation procedure or any failure to remove viable select 
agent from material. If the Responsible Official is unable to determine 
the cause of a deviation from a validated inactivation procedure or a 
viable select agent removal method; or receives a report of any 
inactivation failure after the movement of material to another location, 
the Responsible Official must report immediately by telephone or email 
the inactivation or viable agent removal method failure to CDC or APHIS.
    (9) Review, and revise as necessary, each of the entity's validated 
inactivation procedures or viable select agent removal methods. The 
review must be conducted annually or after any change in Principal 
Investigator, change in the validated inactivation procedure or viable 
select agent removal method, or failure of the validated inactivation 
procedure or viable select agent removal method. The review must be 
documented and training must be conducted if there are any changes to 
the validated inactivation procedure, viable select agent removal 
method, or viability testing protocol.
    (b) An entity may designate one or more individuals to serve as an 
alternate Responsible Official, who acts for the Responsible Official in 
his/her absence. These individuals must have the authority and control 
to ensure compliance with the regulations when acting as the Responsible 
Official.
    (c) The Responsible Official must report the identification and 
final disposition of any select agent or toxin contained in a specimen 
presented for diagnosis or verification.
    (1) The identification of any of the following select agents or 
toxins must be immediately reported by telephone, facsimile, or e-mail: 
Bacillus anthracis,, Bacillus cereus Biovar anthracis,'' Botulinum 
neurotoxins, Botulinum neurotoxin producing species of Clostridium, 
Burkholderia mallei, Burkholderia pseudomallei Francisella tularensis, 
Ebola viruses, , Marburg virus, Variola major virus (Smallpox virus), 
Variola minor (Alastrim), or Yersinia pestis. The final disposition of 
the agent or toxin must be reported by submission of APHIS/CDC Form 4 
within seven calendar days after identification. A copy of the completed 
form must be maintained for three years.
    (2) To report the identification and final disposition of any other 
select agent or toxin, APHIS/CDC Form 4 must be submitted within seven 
calendar days after identification. A copy of the completed form must be 
maintained for three years.
    (3) Less stringent reporting may be required based on extraordinary 
circumstances, such as a widespread outbreak.
    (d) The Responsible Official must report the identification and 
final disposition of any select agent or toxin contained in a specimen 
presented for proficiency testing. To report the identification and 
final disposition of a select agent or toxin, APHIS/CDC Form 4 must be 
submitted within 90 calendar days of receipt of the agent or toxin. A 
copy of the completed form must be maintained for three years.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61112, Oct. 5, 2012; 82 
FR 6292, Jan. 19, 2017]



Sec.  73.10  Restricting access to select agents and toxins; 
security risk assessments.

    (a) An individual or entity required to register under this part may 
not provide an individual access to a select agent or toxin, and an 
individual may not access a select agent or toxin, unless the individual 
is approved by the HHS Secretary or Administrator, following a security 
risk assessment by the Attorney General.
    (b) An individual will be deemed to have access at any point in time 
if the individual has possession of a select agent or toxin (e.g., 
ability to carry, use, or manipulate) or the ability to gain possession 
of a select agent or toxin.
    (c) Each individual with access to select agents or toxins must have 
the appropriate education, training, and/or experience to handle or use 
such agents or toxins.
    (d) To apply for access approval, each individual must submit the 
information necessary to conduct a security risk assessment to the 
Attorney General.

[[Page 568]]

    (e) A person with a valid approval from the HHS Secretary or 
Administrator to have access to select agents and toxins may request, 
through his or her Responsible Official, that the HHS Secretary or 
Administrator provide their approved access status to another registered 
individual or entity for a specified period of time. A Responsible 
Official must immediately notify the Responsible Official of the visited 
entity if the person's access to select agents and toxins has been 
terminated.
    (f) An individual's security risk assessment may be expedited upon 
written request by the Responsible Official and a showing of good cause 
(e.g., public health or agricultural emergencies, national security, or 
a short term visit by a prominent researcher). A written decision 
granting or denying the request will be issued.
    (g) An individual's access approval will be denied or revoked if the 
individual is within any of the categories described in 18 U.S.C. 175b,
    (h) An individual's access approval may be denied, limited, or 
revoked if:
    (1) The individual is reasonably suspected by any Federal law 
enforcement or intelligence agency of committing a crime specified in 18 
U.S.C. 2332b(g)(5), knowing involvement with an organization that 
engages in domestic or international terrorism (as defined in 18 U.S.C. 
2331) or with any other organization that engages in intentional crimes 
of violence, or being an agent of a foreign power (as defined in 50 
U.S.C. 1801), or
    (2) It is determined such action is necessary to protect public 
health and safety.
    (i) An individual may appeal the HHS Secretary's decision to deny, 
limit, or revoke access approval under Sec.  73.20.
    (j) Access approval is valid for a maximum of three years.
    (k) The Responsible Official must immediately notify CDC or APHIS 
when an individual's access to select agents or toxins is terminated by 
the entity and the reasons therefore.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61112, Oct. 5, 2012; 82 
FR 6293, Jan. 19, 2017]



Sec.  73.11  Security.

    (a) An individual or entity required to register under this part 
must develop and implement a written security plan. The security plan 
must be sufficient to safeguard the select agent or toxin against 
unauthorized access, theft, loss, or release.
    (b) The security plan must be designed according to a site-specific 
risk assessment and must provide graded protection in accordance with 
the risk of the select agent or toxin, given its intended use. A current 
security plan must be submitted for initial registration, renewal of 
registration, or when requested.
    (c) The security plan must:
    (1) Describe procedures for physical security, inventory control, 
and information systems control,
    (2) Contain provisions for the control of access to select agents 
and toxins including the safeguarding of animals (including arthropods) 
or plants intentionally or accidentally exposed to or infected with a 
select agent, against unauthorized access, theft, loss or release.
    (3) Contain provisions for routine cleaning, maintenance, and 
repairs,
    (4) Establish procedures for removing unauthorized or suspicious 
persons,
    (5) Describe procedures for addressing loss or compromise of keys, 
keycards, passwords, combinations, etc. and protocols for changing 
access permissions or locks following staff changes,
    (6) Contain procedures for reporting unauthorized or suspicious 
persons or activities, loss or theft of select agents or toxins, release 
of select agents or toxins, or alteration of inventory records, and
    (7) Contain provisions for ensuring that all individuals with access 
approval from the HHS Secretary or Administrator understand and comply 
with the security procedures.
    (8) Describe procedures for how the Responsible Official will be 
informed of suspicious activity that may be criminal in nature and 
related to the entity, its personnel, or its select agents or toxins; 
and describe procedures for how the entity will notify the appropriate 
Federal, State, or local law enforcement agencies of such activity.

[[Page 569]]

    (9) Contain provisions for information security that:
    (i) Ensure that all external connections to systems which manage 
security for the registered space are isolated or have controls that 
permit only authorized and authenticated users;
    (ii) Ensure that authorized and authenticated users are only granted 
access to select agent and toxin related information, files, equipment 
(e.g., servers or mass storage devices) and applications as necessary to 
fulfill their roles and responsibilities, and that access is modified 
when the user's roles and responsibilities change or when their access 
to select agents and toxins is suspended or revoked;
    (iii) Ensure that controls are in place that are designed to prevent 
malicious code (such as, but not limited to, computer virus, worms, 
spyware) from compromising the confidentiality, integrity, or 
availability of information systems which manage access to spaces 
registered under this part or records in Sec.  73.17;
    (iv) Establish a robust configuration management practice for 
information systems to include regular patching and updates made to 
operating systems and individual applications; and
    (v) Establish procedures that provide backup security measures in 
the event that access control systems, surveillance devices, and/or 
systems that manage the requirements of section 17 of this part are 
rendered inoperable.
    (10) Contain provisions and policies for shipping, receiving, and 
storage of select agents and toxins, including documented procedures for 
receiving, monitoring, and shipping of all select agents and toxins. 
These provisions must provide that an entity will properly secure 
containers on site and have a written contingency plan for unexpected 
shipments.
    (d) An individual or entity must adhere to the following security 
requirements or implement measures to achieve an equivalent or greater 
level of security:
    (1) Allow access only to individuals with access approval from the 
HHS Secretary or Administrator,
    (2) Allow individuals not approved for access from the HHS Secretary 
or Administrator to conduct routine cleaning, maintenance, repairs, or 
other activities not related to select agents or toxins only when 
continuously escorted by an approved individual if the potential for 
access to select agents or toxins exists,
    (3) Provide for the control of select agents and toxins by requiring 
freezers, refrigerators, cabinets, and other containers where select 
agents or toxins are stored to be secured against unauthorized access 
(e.g., card access system, lock boxes),
    (4) Inspect all suspicious packages before they are brought into or 
removed from the area where select agents or toxins are used or stored,
    (5) Establish a protocol for intra-entity transfers under the 
supervision of an individual with access approval from the HHS Secretary 
or Administrator, including chain-of-custody documents and provisions 
for safeguarding against theft, loss, or release,
    (6) Require that individuals with access approval from the HHS 
Secretary or Administrator refrain from sharing with any other person 
their unique means of accessing a select agent or toxin (e.g., keycards 
or passwords),
    (7) Require that individuals with access approval from the HHS 
Secretary or Administrator immediately report any of the following to 
the Responsible Official:
    (i) Any loss or compromise of keys, passwords, combination, etc.,
    (ii) Any suspicious persons or activities,
    (iii) Any loss or theft of select agents or toxins,
    (iv) Any release of a select agent or toxin, and
    (v) Any sign that inventory or use records for select agents or 
toxins have been altered or otherwise compromised, and
    (vi) Any loss of computer, hard drive or other data storage device 
containing information that could be used to gain access to select 
agents or toxins.
    (8) Separate areas where select agents and toxins are stored or used 
from the public areas of the building.
    (e) Entities must conduct complete inventory audits of all affected 
select agents and toxins in long-term storage when any of the following 
occur:

[[Page 570]]

    (1) Upon the physical relocation of a collection or inventory of 
select agents or toxins for those select agents or toxins in the 
collection or inventory;
    (2) Upon the departure or arrival of a principal investigator for 
those select agents and toxins under the control of that principal 
investigator; or
    (3) In the event of a theft or loss of a select agent or toxin, all 
select agents and toxins under the control of that principal 
investigator.
    (f) In addition to the requirements contained in paragraphs (c) and 
(d) of this section, the security plan for an individual or entity 
possessing a Tier 1 select agent or toxin must also:
    (1) Describe procedures for conducting a pre-access suitability 
assessment of persons who will have access to a Tier 1 select agent or 
toxin;
    (2) Describe procedures for how an entity's Responsible Official 
will coordinate their efforts with the entity's safety and security 
professionals to ensure security of Tier 1 select agents and toxins and 
share, as appropriate, relevant information; and
    (3) Describe procedures for the ongoing assessment of the 
suitability of personnel with access to a Tier 1 select agent or toxin. 
The procedures must include:
    (i) Self- and peer-reporting of incidents or conditions that could 
affect an individual's ability to safely have access to or work with 
select agents and toxins, or to safeguard select agents and toxins from 
theft, loss, or release;
    (ii) The training of employees with access to Tier 1 select agents 
and toxins on entity policies and procedures for reporting, evaluation, 
and corrective actions concerning the assessment of personnel 
suitability; and
    (iii) The ongoing suitability monitoring of individuals with access 
to Tier 1 select agents and toxins.
    (4) Entities with Tier 1 select agents and toxins must prescribe the 
following security enhancements:
    (i) Procedures that will limit access to a Tier 1 select agent or 
toxin to only those individuals who are approved by the HHS Secretary or 
Administrator, following a security risk assessment by the Attorney 
General, have had an entity-conducted pre-access suitability assessment, 
and are subject to the entity's procedures for ongoing suitability 
assessment;
    (ii) Procedures that limit access to laboratory and storage 
facilities outside of normal business hours to only those specifically 
approved by the Responsible Official or designee;
    (iii) Procedures for allowing visitors, their property, and vehicles 
at the entry and exit points to the registered space, or at other 
designated points of entry to the building, facility, or compound that 
are based on the entity's site-specific risk assessment;
    (iv) A minimum of three security barriers where each security 
barrier adds to the delay in reaching secured areas where select agents 
and toxins are used or stored. One of the security barriers must be 
monitored in such a way as to detect intentional and unintentional 
circumventing of established access control measures under all 
conditions (day/night, severe weather, etc.) The final barrier must 
limit access to the select agent or toxin to personnel approved by the 
HHS Secretary or Administrator, following a security risk assessment by 
the Attorney General.
    (v) All registered space or areas that reasonably afford access to 
the registered space must be protected by an intrusion detection system 
(IDS) unless physically occupied;
    (vi) Personnel monitoring the IDS must be capable of evaluating and 
interpreting the alarm and alerting the designated security response 
force or law enforcement;
    (vii) For powered access control systems, describe procedures to 
ensure that security is maintained in the event of the failure of access 
control systems due to power disruption affecting registered space;
    (viii) The entity must:
    (A) Determine that the response time for security forces or local 
police will not exceed 15 minutes where the response time is measured 
from the time of an intrusion alarm, or report of a security incident, 
to the arrival of the responders at the first security barrier or;
    (B) Provide security barriers that are sufficient to delay 
unauthorized access until the response force arrives in order to 
safeguard the select agents

[[Page 571]]

and toxins from theft, intentional release, or unauthorized access. The 
response time is measured from the time of an intrusion alarm, or report 
of a security incident, to the arrival of the responders at the first 
security barrier.
    (5) Entities that possess Variola major virus and Variola minor 
virus must have the following additional security requirements:
    (i) Require personnel with independent unescorted access to Variola 
major or Variola minor virus to have a Top Secret security clearance;
    (ii) Require Variola major or Variola minor virus storage locations 
to be under the surveillance of closed circuit television that is 
monitored;
    (iii) After hours access procedures for Variola major or Variola 
minor virus must require notification of the entity's security staff 
prior to entry into the Variola laboratory and upon exit;
    (iv) Require that observation zones be maintained in outdoor areas 
adjacent to the physical barrier at the perimeter of the entity and be 
large enough to permit observation of the activities of people at that 
barrier in the event of its penetration;
    (v) Provide for a minimum of four barriers for the protection of the 
Variola major or Variola minor virus, one of which must be a perimeter 
fence;
    (vi) Require a numbered picture badge identification subsystem to be 
used for all individuals who are authorized to access Variola major or 
Variola minor without escort;
    (vii) Require the use, at all times, of properly trained and 
equipped security force personnel able to interdict threats identified 
in the site specific risk assessment;
    (viii) Identify security force personnel designated to strengthen 
onsite response capabilities, and that will be onsite and available at 
all times to carry out their assigned response duties;
    (ix) Provide for security patrols to periodically check external 
areas of the registered areas to include physical barriers and building 
entrances;
    (x) Require that all on-duty security force personnel shall be 
capable of maintaining continuous communication with support and 
response assets by way of security operations center;
    (xi) Require that Variola major and Variola minor material in long 
term storage be stored in tamper-evident systems;
    (xii) Require that all spaces containing working or permanent 
Variola major or Variola minor stocks be locked and protected by an 
intrusion alarm system that will alarm upon the unauthorized entry of a 
person anywhere into the area;
    (xiii) Require that alarms required pursuant to this section 
annunciate in a continuously manned security operations center located 
within the facility; and
    (xiv) Require that the security operations center shall be located 
within a building so that the interior is not visible from the perimeter 
of the protected area.
    (g) In developing a security plan, an individual or entity should 
consider the document entitled, ``Security Guidance for Select Agent or 
Toxin Facilities.'' This document is available on the National Select 
Agent Registry at http://www.selectagents.gov/.
    (h) The plan must be reviewed annually and revised as necessary. 
Drills or exercises must be conducted at least annually to test and 
evaluate the effectiveness of the plan. The plan must be reviewed and 
revised, as necessary, after any drill or exercise and after any 
incident. Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61112, Oct. 5, 2012; 79 
FR 26862, May 12, 2014; 82 FR 6293, Jan. 19, 2017]



Sec.  73.12  Biosafety.

    (a) An individual or entity required to register under this part 
must develop and implement a written biosafety plan that is commensurate 
with the risk of the select agent or toxin, given its intended use. The 
biosafety plan must contain sufficient information and documentation to 
describe the biosafety and containment procedures for the select agent 
or toxin, including

[[Page 572]]

any animals (including arthropods) or plants intentionally or 
accidentally exposed to or infected with a select agent. The current 
biosafety plan must be submitted for initial registration, renewal of 
registration, or when requested. The biosafety plan must include the 
following provisions:
    (1) The hazardous characteristics of each agent or toxin listed on 
the entity's registration and the biosafety risk associated with 
laboratory procedures related to the select agent or toxin;
    (2) Safeguards in place with associated work practices to protect 
entity personnel, the public, and the environment from exposure to the 
select agent or toxin including, but not limited to: Personal protective 
equipment and other safety equipment; containment equipment including, 
but not limited to, biological safety cabinets, animal caging systems, 
and centrifuge safety containers; and engineering controls and other 
facility safeguards;
    (3) Written procedures for each validated method used for 
disinfection, decontamination or destruction, as appropriate, of all 
contaminated or presumptively contaminated materials including, but not 
limited to: Cultures and other materials related to the propagation of 
select agents or toxins, items related to the analysis of select agents 
and toxins, personal protective equipment, animal caging systems and 
bedding (if applicable), animal carcasses or extracted tissues and 
fluids (if applicable), laboratory surfaces and equipment, and effluent 
material; and
    (4) Procedures for the handling of select agents and toxins in the 
same spaces with non-select agents and toxins to prevent unintentional 
contamination.
    (b) The biosafety and containment procedures must be sufficient to 
contain the select agent or toxin (e.g., physical structure and features 
of the entity, and operational and procedural safeguards).
    (c) In developing a biosafety plan, an individual or entity should 
consider:
    (1) The CDC/NIH publication, ``Biosafety in Microbiological and 
Biomedical Laboratories.'' This document is available on the National 
Select Agent Registry Web site at http://www.selectagents.gov.
    (2) The ``NIH Guidelines for Research Involving Recombinant or 
Synthetic Nucleic Acid Molecules,'' (NIH Guidelines). This document is 
available on the National Select Agent Registry Web site at http://
www.selectagents.gov.
    (d) The biosafety plan must include an occupational health program 
for individuals with access to Tier 1 select agents and toxins, and 
those individuals must be enrolled in the occupational health program.
    (e) The plan must be reviewed annually and revised as necessary. 
Drills or exercises must be conducted at least annually to test and 
evaluate the effectiveness of the plan. The plan must be reviewed and 
revised, as necessary, after any drill or exercise and after any 
incident. Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61114, Oct. 5, 2012; 82 
FR 6293, Jan. 19, 2017]



Sec.  73.13  Restricted experiments.

    (a) An individual or entity may not conduct, or possess products 
resulting from, the following experiments unless approved by and 
conducted in accordance with the conditions prescribed by the HHS 
Secretary:
    (1) Experiments that involve the deliberate transfer of, or 
selection for, a drug resistance trait to select agents that are not 
known to acquire the trait naturally, if such acquisition could 
compromise the control of disease agents in humans, veterinary medicine, 
or agriculture.
    (2) Experiments involving the deliberate formation of synthetic or 
recombinant DNA containing genes for the biosynthesis of select toxins 
lethal for vertebrates at an LD[50] <100 ng/kg body weight.
    (3) Experiments that involve the creation of SARS-CoV/SARS-CoV-2 
chimeric viruses resulting from any deliberate manipulation of SARS-CoV-
2 to incorporate nucleic acids coding for SARS-CoV virulence factors or 
vice versa.

[[Page 573]]

    (b) The HHS Secretary may revoke approval to conduct any of the 
experiments in paragraph (a) of this section, or revoke or suspend a 
certificate of registration, if the individual or entity fails to comply 
with the requirements of this part.
    (c) To apply for approval to conduct any of the experiments in 
paragraph (a) of this section, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61114, Oct. 5, 2012; 79 
FR 26862, May 12, 2014; 86 FR 64081, Nov. 17, 2021]



Sec.  73.14  Incident response.

    (a) An individual or entity required to register under this part 
must develop and implement a written incident response plan based upon a 
site specific risk assessment.\2\ The incident response plan must be 
coordinated with any entity-wide plans, kept in the workplace, and 
available to employees for review. The current incident response plan 
must be submitted for initial registration, renewal of registration, or 
when requested.
---------------------------------------------------------------------------

    \2\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or regulations.
---------------------------------------------------------------------------

    (b) The incident response plan must fully describe the entity's 
response procedures for the theft, loss, or release of a select agent or 
toxin; inventory discrepancies; security breaches (including information 
systems); severe weather and other natural disasters; workplace 
violence; bomb threats and suspicious packages; and emergencies such as 
fire, gas leak, explosion, power outage, and other natural and man-made 
events.
    (c) The response procedures must account for hazards associated with 
the select agent or toxin and appropriate actions to contain such select 
agent or toxin, including any animals (including arthropods) or plants 
intentionally or accidentally exposed to or infected with a select 
agent.
    (d) The incident response plan must also contain the following 
information:
    (1) The name and contact information (e.g., home and work) for the 
individual or entity (e.g., responsible official, alternate responsible 
official(s), biosafety officer, etc.),
    (2) The name and contact information for the building owner and/or 
manager, where applicable,
    (3) The name and contact information for tenant offices, where 
applicable,
    (4) The name and contact information for the physical security 
official for the building, where applicable,
    (5) Personnel roles and lines of authority and communication,
    (6) Planning and coordination with local emergency responders,
    (7) Procedures to be followed by employees performing rescue or 
medical duties,
    (8) Emergency medical treatment and first aid,
    (9) A list of personal protective and emergency equipment, and their 
locations,
    (10) Site security and control,
    (11) Procedures for emergency evacuation, including type of 
evacuation, exit route assignments, safe distances, and places of 
refuge, and
    (12) Decontamination procedures.
    (e) Entities with Tier 1 select agents and toxins must have the 
following additional incident response policies or procedures:
    (1) The incident response plan must fully describe the entity's 
response procedures for failure of intrusion detection or alarm system; 
and
    (2) The incident response plan must describe procedures for how the 
entity will notify the appropriate Federal, State, or local law 
enforcement agencies of suspicious activity that may be criminal in 
nature and related to the entity, its personnel, or its select agents or 
toxins.
    (f) The plan must be reviewed annually and revised as necessary. 
Drills or exercises must be conducted at least annually to test and 
evaluate the effectiveness of the plan. The plan must be reviewed and 
revised, as necessary, after any drill or exercise and after any 
incident. Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and

[[Page 574]]

corrective action(s) taken, and the names of registered entity personnel 
participants.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61114, Oct. 5, 2012; 82 
FR 6293, Jan. 19, 2017]



Sec.  73.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biocontainment, biosafety, 
security (including security awareness), and incident response to:
    (1) Each individual with access approval from the HHS Secretary or 
Administrator. The training must address the particular needs of the 
individual, the work they will do, and the risks posed by the select 
agents or toxins. The training must be accomplished prior to the 
individual's entry into an area where a select agent is handled or 
stored, or within 12 months of the date the individual was approved by 
the HHS Secretary or the Administrator for access, whichever is earlier.
    (2) Each individual not approved for access to select agents and 
toxins by the HHS Secretary or Administrator before that individual 
enters areas under escort where select agents or toxins are handled or 
stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, 
storage areas, shipping/receiving areas, production facilities, etc.). 
Training for escorted personnel must be based on the risk associated 
with accessing areas where select agents and toxins are used and/or 
stored. The training must be accomplished prior to the individual's 
entry into where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage areas, 
shipping/receiving areas, production facilities, etc.).
    (b) Entities with Tier 1 select agents and toxins must conduct 
annual insider threat awareness briefings on how to identify and report 
suspicious behaviors.
    (c) Refresher training must be provided annually for individuals 
with access approval from the HHS Secretary or Administrator or at such 
time as the registered individual or entity significantly amends its 
security, incident response, or biosafety plans.
    (d) The Responsible Official must ensure a record of the training 
provided to each individual with access to select agents and toxins and 
each escorted individual (e.g., laboratory workers, visitors, etc.) is 
maintained. The record must include the name of the individual, the date 
of the training, a description of the training provided, and the means 
used to verify that the employee understood the training.
    (e) The Responsible Official must ensure and document that 
individuals are provided the contact information of the HHS Office of 
Inspector General Hotline and the USDA Office of Inspector General 
Hotline so that they may anonymously report any safety or security 
concerns related to select agents and toxins.

[77 FR 61114, Oct. 5, 2012, as amended at 82 FR 6293, Jan. 19, 2017]



Sec.  73.16  Transfers.

    (a) Except as provided in paragraphs (c) and (d) of this section, a 
select agent or toxin may only be transferred to individuals or entities 
registered to possess, use, or transfer that agent or toxin. A select 
agent or toxin may only be transferred under the conditions of this 
section and must be authorized by CDC or APHIS prior to the transfer. 
\4\
---------------------------------------------------------------------------

    \4\ This section does not cover transfers within an entity when the 
sender and the recipient are covered by the same certificate of 
registration.
---------------------------------------------------------------------------

    (b) A transfer may be authorized if:
    (1) The sender:
    (i) Has at the time of transfer a certificate of registration that 
covers the particular select agent or toxin to be transferred and meets 
all requirements in this part,
    (ii) Meets the exemption requirements for the particular select 
agent or toxin to be transferred, or
    (iii) Is transferring the select agent or toxin from outside the 
United States and meets all import requirements.
    (2) At the time of transfer, the recipient has a certificate of 
registration that includes the particular select agent or toxin to be 
transferred and meets all of the requirements of this part.
    (c) A select agent or toxin that is contained in a specimen for 
proficiency

[[Page 575]]

testing may be transferred without prior authorization from CDC or APHIS 
provided that, at least seven calendar days prior to the transfer, the 
sender reports to CDC or APHIS the select agent or toxin to be 
transferred and the name and address of the recipient.
    (d) On a case-by-case basis, the HHS Secretary may authorize a 
transfer of a select agent or toxin, not otherwise eligible for transfer 
under this part under conditions prescribed by the HHS Secretary.
    (e) To obtain authorization for transfer, APHIS/CDC Form 2 must be 
submitted.
    (f) After authorization is provided by APHIS or CDC, the packaging 
of the select agent(s) and toxin(s) is performed by an individual 
approved by the HHS Secretary or Administrator to have access to select 
agents and toxins and is in compliance with all applicable laws 
concerning packaging.
    (g) The sender must comply with all applicable laws governing 
packaging and shipping.
    (h) Transportation in commerce starts when the select agent(s) or 
toxin(s) are packaged for shipment and ready for receipt by a courier 
transporting select agent(s) or toxin(s) and ends when the package is 
received by the intended recipient who is an individual approved by the 
HHS Secretary or Administrator to have access to select agents and 
toxins, following a security risk assessment by the Attorney General.
    (i) The recipient must submit a completed APHIS/CDC Form 2 within 
two business days of receipt of a select agent or toxin.
    (j) The recipient must immediately notify CDC or APHIS if the select 
agent or toxin has not been received within 48 hours after the expected 
delivery time, or if the package containing select agents or toxins has 
been damaged to the extent that a release of the select agent or toxin 
may have occurred.
    (k) An authorization for a transfer shall be valid only for 30 
calendar days after issuance, except that such an authorization becomes 
immediately null and void if any facts supporting the authorization 
change (e.g., change in the certificate of registration for the sender 
or recipient, change in the application for transfer).
    (l) A registered individual or entity transferring an amount of a 
HHS toxin otherwise excluded under the provisions of Sec.  73.3(d) must:
    (1) Transfer the amounts only after the transferor uses due 
diligence and documents that the recipient has a legitimate need (e.g., 
prophylactic, protective, bona fide research, or other peaceful purpose) 
to handle or use such toxins. Information to be documented includes, but 
is not limited, to the recipient information, toxin and amount 
transferred, and declaration that the recipient has legitimate purpose 
to store and use such toxins.
    (2) Report to CDC if they detect a known or suspected violation of 
Federal law or become aware of suspicious activity related to a toxin 
listed in Sec.  73.3(d) of this part.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61115, Oct. 5, 2012; 79 
FR 26862, May 12, 2014; 82 FR 6294, Jan. 19, 2017]



Sec.  73.17  Records.

    (a) An individual or entity required to register under this part 
must maintain complete records relating to the activities covered by 
this part. Such records must include:
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
organisms containing recombinant and/or synthetic nucleic acids) held in 
long-term storage (placement in a system designed to ensure viability 
for future use, such as in a freezer or lyophilized materials), 
including:
    (i) The name and characteristics (e.g., strain designation, GenBank 
Accession number, etc.),
    (ii) The quantity acquired from another individual or entity (e.g., 
containers, vials, tubes, etc.), date of acquisition, and the source,
    (iii) Where stored (e.g., building, room, and freezer or other 
storage container),
    (iv) When moved from storage and by whom and when returned to 
storage and by whom,

[[Page 576]]

    (v) The select agent used, purpose of use, and, when applicable, 
final disposition,
    (vi) Records created under Sec.  73.16 and 9 CFR 121.16 (Transfers),
    (vii) For intra-entity transfers (sender and the recipient are 
covered by the same certificate of registration), the select agent, the 
quantity transferred, the date of transfer, the sender, and the 
recipient, and
    (viii) Records created under Sec.  73.19 and 9 CFR part 121.19 
(Notification of theft, loss, or release),
    (2) An accurate, current accounting of any animals or plants 
intentionally or accidentally exposed to or infected with a select agent 
(including number and species, location, and appropriate disposition);
    (3) Accurate, current inventory for each toxin held, including:
    (i) The name and characteristics,
    (ii) The quantity acquired from another individual or entity (e.g., 
containers, vials, tubes, etc.), date of acquisition, and the source,
    (iii) The initial and current quantity amount (e.g., milligrams, 
milliliters, grams, etc.),
    (iv) The toxin used and purpose of use, quantity, date(s) of the use 
and by whom,
    (v) Where stored (e.g., building, room, and freezer or other storage 
container),
    (vi) When moved from storage and by whom and when returned to 
storage and by whom including quantity amount,
    (vii) Records created under Sec.  73.16 and 9 CFR part 121.16 
(Transfers),
    (viii) For intra-entity transfers (sender and the recipient are 
covered by the same certificate of registration), the toxin, the 
quantity transferred, the date of transfer, the sender, and the 
recipient,
    (ix) Records created under Sec.  73.19 and 9 CFR part 121.19 
(Notification of theft, loss, or release), and
    (x) If destroyed, the quantity of toxin destroyed, the date of such 
action, and by whom,
    (4) A current list of all individuals that have been granted access 
approval from the HHS Secretary or Administrator,
    (5) Information about all entries into areas containing select 
agents or toxins, including the name of the individual, name of the 
escort (if applicable), and date and time of entry,
    (6) Accurate, current records created under Sec.  73.9 and 9 CFR 
part 121.9 (Responsible Official), Sec.  73.11 and 9 CFR part 121.11 
(Security), Sec.  73.12 and 9 CFR part 121.12 (Biosafety), Sec.  73.14 
and 9 CFR part 121. 14 (Incident response), and Sec.  73.15 and 9 CFR 
part 121.15 (Training), and
    (7) A written explanation of any discrepancies.
    (8) For select agents or material containing select agents or 
regulated nucleic acids that can produce infectious forms of any select 
agent virus that have been subjected to a validated inactivation 
procedure or a procedure for removal of viable select agent:
    (i) A written description of the validated inactivation procedure or 
viable select agent removal method used, including validation data;
    (ii) A written description of the viability testing protocol used;
    (iii) A written description of the investigation conducted by the 
entity Responsible Official involving an inactivation or viable select 
agent removal failure and the corrective actions taken;
    (iv) The name of each individual performing the validated 
inactivation or viable select agent removal method;
    (v) The date(s) the validated inactivation or viable select agent 
removal method was completed;
    (vi) The location where the validated inactivation or viable select 
agent removal method was performed; and
    (vii) A certificate, signed by the Principal Investigator, that 
includes the date of inactivation or viable select agent removal, the 
validated inactivation or viable select agent removal method used, and 
the name of the Principal Investigator. A copy of the certificate must 
accompany any transfer of inactivated or select agent removed material.
    (b) The individual or entity must implement a system to ensure that 
all records and data bases created under this part are accurate and 
legible, have controlled access, and authenticity may be verified.

[[Page 577]]

    (c) The individual or entity must promptly produce upon request any 
information that is related to the requirements of this part but is not 
otherwise contained in a record required to be kept by this section. The 
location of such information may include, but is not limited to, 
biocontainment certifications, laboratory notebooks, institutional 
biosafety and/or animal use committee minutes and approved protocols, 
and records associated with occupational health and suitability 
programs. All records created under this part must be maintained for 3 
years.

[70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61115, Oct. 5, 2012; 82 
FR 6294, Jan. 19, 2017]



Sec.  73.18  Inspections.

    (a) Without prior notification, the HHS Secretary, shall be allowed 
to inspect any site at which activities regulated by this part are 
conducted and shall be allowed to inspect and copy any records relating 
to the activities covered by this part.
    (b) Prior to issuing a certificate of registration to an individual 
or entity, the HHS Secretary may inspect and evaluate the premises and 
records to ensure compliance with this part.



Sec.  73.19  Notification of theft, loss, or release.

    (a) Upon discovery of the theft or loss of a select agent or toxin, 
an individual or entity must immediately notify CDC or APHIS and 
appropriate Federal, State, or local law enforcement agencies. Thefts or 
losses must be reported even if the select agent or toxin is 
subsequently recovered or the responsible parties are identified.
    (1) The theft or loss of a select agent or toxin must be reported 
immediately by telephone, facsimile, or e-mail. The following 
information must be provided:
    (i) The name of the select agent or toxin and any identifying 
information (e.g., strain or other characterization information),
    (ii) An estimate of the quantity lost or stolen,
    (iii) An estimate of the time during which the theft or loss 
occurred,
    (iv) The location (building, room) from which the theft or loss 
occurred, and
    (v) The list of Federal, State, or local law enforcement agencies to 
which the individual or entity reported, or intends to report the theft 
or loss.
    (2) A completed APHIS/CDC Form 3 must submitted within seven 
calendar days.
    (b) Upon discovery of a release of an agent or toxin causing 
occupational exposure or release of a select agent or toxin outside of 
the primary barriers of the biocontainment area, an individual or entity 
must immediately notify CDC or APHIS.
    (1) The release of a select agent or toxin must be reported by 
telephone, facsimile, or e-mail. The following information must be 
provided:
    (i) The name of the select agent or toxin and any identifying 
information (e.g., strain or other characterization information),
    (ii) An estimate of the quantity released,
    (iii) The time and duration of the release,
    (iv) The environment into which the release occurred (e.g., in 
building or outside of building, waste system),
    (v) The location (building, room) from which the release occurred,
    (vi) The number of individuals potentially exposed at the entity,
    (vii) Actions taken to respond to the release, and
    (viii) Hazards posed by the release.
    (2) A completed APHIS/CDC Form 3 must be submitted within seven 
calendar days.



Sec.  73.20  Administrative review.

    (a) An individual or entity may appeal a denial, revocation, or 
suspension of registration under this part. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to the 
HHS Secretary within 30 calendar days of the decision.
    (b) An individual may appeal a denial, limitation, or revocation of 
access approval under this part. The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the HHS Secretary 
within 180 calendar days of the decision.

[[Page 578]]

    (c) The HHS Secretary's decision constitutes final agency action.

[77 FR 61115, Oct. 5, 2012]



Sec.  73.21  Civil money penalties.

    (a) The Inspector General of the Department of Health and Human 
Services is delegated authority to conduct investigations and to impose 
civil money penalties against any individual or entity in accordance 
with regulations in 42 CFR part 1003 for violations of the regulations 
in this part, as authorized by the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188). 
The delegation of authority includes all powers contained in section 6 
of the Inspector General Act of 1978 (5 U.S.C. App.).
    (b) The administrative law judges in, assigned to, or detailed to 
the Departmental Appeals Board have been delegated authority to conduct 
hearings and to render decisions in accordance with 42 CFR part 1005 
with respect to the imposition of civil money penalties, as authorized 
by the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002 (Pub. L. 107-188). This delegation includes, but is not 
limited to, the authority to administer oaths and affirmations, to 
subpoena witnesses and documents, to examine witnesses, to exclude or 
receive and give appropriate weight to materials and testimony offered 
as evidence, to make findings of fact and conclusions of law, and to 
determine the civil money penalties to be imposed.
    (c) The Departmental Appeals Board of the Department of Health and 
Human Services is delegated authority to make final determinations with 
respect to the imposition of civil money penalties for violations of the 
regulations of this part.



PART 75_STANDARDS FOR THE ACCREDITATION OF EDUCATIONAL PROGRAMS FOR 
AND THE CREDENTIALING OF RADIOLOGIC PERSONNEL--Table of Contents



Sec.
75.1 Background and purpose.
75.2 Definitions.
75.3 Applicability.

Appendix A to Part 75--Standards for Accreditation of Educational 
          Programs for Radiographers
Appendix B to Part 75--Standards for Accreditation of Dental Radiography 
          Training for Dental Hygienists
Appendix C to Part 75--Standards for Accreditation of Dental Radiography 
          Training for Dental Assistants
Appendix D to Part 75--Standards for Accreditation of Educational 
          Programs for Nuclear Medicine Technologists
Appendix E to Part 75--Standards for Accreditation of Educational 
          Programs for Radiation Therapy Technologists
Appendix F to Part 75--Standards for Licensing Radiographers, Nuclear 
          Medicine Technologists, and Radiation Therapy Technologists
Appendix G to Part 75--Standards for Licensing Dental Hygienists and 
          Dental Assistants in Dental Radiography

    Authority: Sec. 979 of the Consumer-Patient Radiation Health and 
Safety Act of 1981, Pub. L. 97-35, 95 Stat. 599-600 (42 U.S.C. 10004).

    Source: 50 FR 50717, Dec. 11, 1985, unless otherwise noted.



Sec.  75.1  Background and purpose.

    (a) The purpose of these regulations is to implement the provisions 
of section 979 of the Consumer-Patient Radiation Health and Safety Act 
of 1981, 42 U.S.C. 10004, which requires the establishment by the 
Secretary of Health and Human Services of standards for the 
accreditation of programs for the education of certain persons who 
administer radiologic procedures and for the credentialing of such 
persons.
    (b) Section 979 requires the Secretary, after consultation with 
specified Federal agencies, appropriate agencies of States, and 
appropriate professional organizations, to promulgate by regulation the 
minimum standards described above. These standards distinguish between 
the occupations of (1) radiographer, (2) dental hygienist, (3) dental 
assistant, (4) nuclear medicine technologist, and (5) radiation therapy 
technologist. In the interest of public safety and to prevent the 
hazards of improper use of medical radiation identified by Congress in 
its determination of the need for standards, the Secretary is also 
authorized to prepare standards for other occupational

[[Page 579]]

groups utilizing ionizing and non-ionizing radiation as he/she finds 
appropriate. However, the standards set out below are limited to the 
five occupational groups listed above, utilizing ionizing radiation. 
Nothing in these accreditation standards is intended to discriminate 
against proprietary schools.



Sec.  75.2  Definitions.

    All terms not defined herein shall have the meaning given them in 
the Act. As used in this part:
    Accreditation, as applied to an educational program, means 
recognition, by a State government or by a nongovernmental agency or 
association, of a specialized program of study as meeting or exceeding 
certain established qualifications and educational standards. As applied 
to a health care or educational institution, accreditation means 
recognition, by a State government or by a nongovernmental agency or 
association, of the institution as meeting or exceeding certain 
established standards or criteria for that type of institution.
    Act means the Consumer-Patient Radiation Health and Safety Act of 
1981, 42 U.S.C. 10001-10008.
    Continuing competency means the maintenance of knowledge and skills 
and/or demonstrated performance that are adequate and relevant to 
professional practice needs.
    Credentialing means any process whereby a State Government or 
nongovernmental agency or association grants recognition to an 
individual who meets certain predetermined qualifications.
    Dental hygienist means a person licensed by the State as a dental 
hygienist.
    Dental assistant means a person other than a dental hygienist who 
assists a dentist in the care of patients.
    Educational program means a set of formally structured activities 
designed to provide students with the knowledge and skills necessary to 
enter an occupation, with evaluation of student performance according to 
predetermined objectives.
    Energized laboratory means any facility which contains equipment 
that generates ionizing radiation. This does not include facilities for 
training students when the equipment is not powered to emit ionizing 
radiation, e.g., practice in setting controls and positioning of 
patients.
    Formal training means training or education, including either 
didactic or clinical practicum or both, which has a specified objective, 
planned activities for students, and suitable methods for measuring 
student attainment, and which is offered, sponsored, or approved by an 
organization or institution which is able to meet or enforce these 
criteria.
    Ionizing radiation means any electromagnetic or particulate 
radiation (X-rays, gamma rays, alpha and beta particles, high speed 
electrons, neutrons, and other nuclear particles) which interacts with 
atoms to produce ion pairs in matter.
    Licensed practitioner means a licensed doctor of medicine, 
osteopathy, dentistry, podiatry, or chiropractic.
    Licensure means the process by which an agency of State government 
grants permission to persons meeting predetermined qualifications to 
engage in an occupation.
    Nuclear medicine technologist means a person other than a licensed 
practitioner who prepares and administers radio-pharmaceuticals to human 
beings and conducts in vivo or in vitro detection and measurement of 
radioactivity for medical purposes.
    Permit means an authorization issued by a State for specific tasks 
or practices rather than the entire scope of practice in an occupation.
    Radiation therapy technologist means a person other than a licensed 
practitioner who utilizes ionizing radiation-generating equipment for 
therapeutic purposes on human subjects.
    Radiographer means an individual other than a licensed practitioner 
who (1) performs, may be called upon to perform, or who is licensed to 
perform a comprehensive scope of diagnostic radiologic procedures 
employing equipment which emits ionizing radiation, and (2) is delegated 
or exercises responsibility for the operation of radiation-generating 
equipment, the shielding of patient and staff from unnecessary 
radiation, the appropriate exposure of radiographs, or other procedures 
which

[[Page 580]]

contribute to any significant extent to the site or dosage of ionizing 
radiation to which a patient is exposed. Radiographers are distinguished 
from personnel whose use of diagnostic procedures is limited to a few 
specific body sites and/or standard procedures, from those personnel in 
other clinical specialties who may occasionally be called upon to assist 
in diagnostic radiology, and from those technicians or assistants whose 
activities do not, to any significant degree, determine the site or 
dosage of radiation to which a patient is exposed.
    Radiologist means a physician certified in radiology by the American 
Board of Radiology or the American Osteopathic Board of Radiology.



Sec.  75.3  Applicability.

    (a) Federal Government. Except as provided in section 983 of the 
Act, the credentialing standards set out in the Appendixes to this part 
apply to those individuals who administer or propose to administer 
radiologic procedures, in each department, agency and instrumentality of 
the Federal Government as follows:
    (1) Radiographer Standards apply to all individuals who are 
radiographers as defined in Sec.  75.2 and who are not practitioners 
excepted by the Act.
    (2) Nuclear Medicine Technologist Standards apply to all individuals 
who are nuclear medicine technologists as defined in Sec.  75.2, who 
perform in vivo nuclear medicine procedures, and who are not 
practitioners excepted by the Act. For purposes of this Act, any 
administration of radiopharmaceuticals to human beings is considered an 
in vivo procedure.
    (3) Radiation Therapy Technologist Standards apply to all 
individuals who perform radiation therapy and who are not practitioners 
excepted by the Act.
    (4) Dental Hygienist Standards apply to all dental hygienists who 
perform dental radiography.
    (5) Dental Assistant Standards apply to all dental assistants who 
perform dental radiography.
    (6) The following persons are deemed to have met the requirements of 
these standards:
    (i) Persons employed by the Federal government as radiologic 
personnel prior to the effective date of this regulation and who show 
evidence of current or fully satisfactory performance or certification 
of such from a licensed practitioner:
    (ii) Uniformed military personnel who receive radiologic training 
from or through the Armed Forces of the United States and who meet 
standards established by the Department of Defense or components 
thereof, provided that those standards are determined by such Department 
or component to offer equivalent protection of patient health and 
safety:
    (iii) Foreign national employed by the Federal government in 
positions outside of the United States who show evidence of training, 
experience, and competence determined by the employing agency to be 
equally protective of patients health and safety; and
    (iv) Persons first employed by the Federal government as radiologic 
personnel after the effective date of this regulation who (a) received 
training from institutions in a State or foreign jurisdiction which did 
not accredit training in that particular field at the time of 
graduation, or (b) practiced in a State or foreign jurisdiction which 
did not license that particular field or which did not allow special 
eligibility to take a licensure examination for those who did not 
graduate from an accredited educational program; provided that such 
persons show evidence of training, experience, and competence determined 
by the Office of Personnel Management or the employing agency to be 
equally protective of patient health and safety.
    (7) The following persons are exempted from these standards:
    (i) Persons who are trained to perform, or perform, covered 
radiologic procedures in emergency situations which preclude use of 
fully qualified personnel; and
    (ii) Students in approved training programs.
    (8) A department, agency, or instrumentality of the Federal 
government may, after consultation with the Secretary, use alternative 
criteria which it determines would offer equivalent protection of 
patient health and safety.

[[Page 581]]

    (b) States. The States may, but are not required to, adopt standards 
for accreditation and credentialing that are consistent with the 
standards set out in the appendixes to this part.



 Sec. Appendix A to Part 75--Standards for Accreditation of Educational 
                       Programs for Radiographers

                    A. Description of the Profession

    The radiographer shall perform effectively by:
    1. Applying knowledge of the principles of radiation protection for 
the patient, self, and others.
    2. Applying knowledge of anatomy, positioning, and radiographic 
techniques to accurately demonstrate anatomical structures on a 
radiograph.
    3. Determining exposure factors to achieve optimum radiographic 
technique with a minimum of radiation exposure to the patient.
    4. Examining radiographs for the purpose of evaluating technique, 
positioning, and other pertinent technical qualities.
    5. Exercising discretion and judgment in the performance of medical 
imaging procedures.
    6. Providing patient care essential to radiologic procedures.
    7. Recognizing emergency patient conditions and initiating 
lifesaving first aid.

                             B. Sponsorship

    1. Accreditation will be granted to the institution that assumes 
primary responsibility for curriculum planning and selection of course 
content; coordinates classroom teaching and supervised clinical 
education; appoints faculty to the program; receives and processes 
applications for admission; and grants the degree or certificate 
documenting completion of the program.
    2. Educational programs may be established in:
    (a) Community and junior colleges, senior colleges, and 
universities;
    (b) Hospitals;
    (c) Medical schools;
    (d) Postsecondary vocational/technical schools and institutions; and
    (e) Other acceptable institutions which meet comparable standards.
    3. The sponsoring institutions and affiliate(s) must be accredited 
by a recognized agency. When the sponsoring institution and 
affilitate(s) are not so recognized, they may be considered as meeting 
the requirements of accreditation if the institution meets or exceeds 
established equivalent standards.

                       C. Instructional Facilities

    1. General. Appropriate classroom and clinical space, modern 
equipment, and supplies for supervised education shall be provided.
    2. Laboratory. Energized laboratories utilized for teaching purposes 
shall be certified as required for compliance with Federal and/or State 
radiation safety regulations. The use of laboratories shall be governed 
by established educational objectives.
    3. Reference Materials. Adequate up-to-date scientific books, 
periodicals, and other reference materials related to the curriculum and 
profession shall be readily accessible to students.

                          D. Clinical Education

    1. The clinical phase of the educational program shall provide an 
environment for supervised competency-based clinical education and 
experience and offer a sufficient and well-balanced variety of 
radiographic examinations and equipment.
    2. An acceptable ratio of students to registered technologists shall 
be maintained in the clinical teaching environment.
    3. A clinical instructor(s), who shall be responsible for 
supervising students according to objectives, shall be identified for 
each primary clinical education center.
    4. The maximum student enrollment shall not exceed the capacity 
recommended on the basis of volume and variety of radiographic 
procedures, resources, and personnel available for teaching purposes.
    5. In programs where didactic and clinical experience are not 
provided in the same institution, accreditation shall be given only to 
the institution responsible for admissions, curriculum, and academic 
credit. The accredited institution shall be responsible for coordinating 
the program and assuring that the activities assigned to the students in 
the clinical setting are educational. There shall be a uniform contract 
between the accredited institution and each of its affiliate hospitals, 
clearly defining the responsibilities and obligations of each.

                              E. Curriculum

    1. The structure of the curriculum shall be based on not less than 
two calendar years of full-time study or its equivalent.
    2. Instruction shall follow a planned outline that includes:
    (a) The assignment of appropriate instructional materials;
    (b) Classroom presentations, discussions and demonstrations; and
    (c) Examinations in the didactic and clinical aspects of the 
program.
    3. All professional courses, including clinical education, must 
include specific curriculum content that shall include, but shall not be 
limited to:
    (a) Introduction to radiologic technology;

[[Page 582]]

    (b) Medical ethics;
    (c) Imaging;
    (d) Radiographic processing technique;
    (e) Human structure and function;
    (f) Medical terminology;
    (g) Principals of radiographic exposure;
    (h) Radiographic procedures;
    (i) Principles of radiation protection;
    (j) Radiographic film evaluation;
    (k) Methods of patient care;
    (l) Pathology;
    (m) Radiologic physics; and
    (n) Radiation biology.
    Related subjects added to the professional curriculum shall meet the 
requirements of the degree-granting institution.

                               F. Finances

    Financial resources for operation for the educational program shall 
be assured through regular budgets, gifts, grants, endowments, or fees.

                               G. Faculty

    1. Program Director. A program director shall be designated who is 
credentialed in radiography. The program director's responsibilities in 
teaching, administration, and coordination of the educational program in 
radiography shall not be adversely affected by educationally unrelated 
functions.
    (a) Minimum qualifications. A minimum of two years of professional 
experience and proficiency in instructing, curriculum design, program 
planning, and counseling.
    (b) Responsibilities. (1) The program director, in consultation with 
the medical director/advisor (G. 2.) shall be responsible for the 
organization, administration, periodic review, records, continued 
development, and general policy and effectiveness of the program.
    (2) Opportunities for continuing education shall be provided for all 
faculty members.
    2. Medical Director/Medical Advisor--(a) minimum qualifications. The 
medical director/ medical advisor shall be a qualified radiologist, 
certified by the American Board of Radiology, or shall possess suitable 
equivalent qualifications.
    (b) Responsibilities. The medical director/medical advisor shall 
work in consultation with the program director in developing the goals 
and objectives of the program and implementing the standards for their 
achievement.
    3. Instructors. All instructors shall be qualified through academic 
preparation and experience to teach the assigned subjects.

                               H. Students

                                Admission

    (a) Candidates for admission shall satisfy the following minimum 
requirements: Completion of four years of high school; successful 
completion of a standard equivalency test; or certification of 
equivalent education by an organization recognized by the United States 
Department of Education. Courses in physics, chemistry, biology, 
algebra, and geometry are strongly recommended.
    (b) The number of students enrolled in each class shall be 
commensurate with the most effective learning and teaching practices and 
should also be consistent with acceptable student-teacher ratios.

                               I. Records

    Records shall be maintained as dictated by good educational 
practices.

    Note: Educational programs accredited by an organization recommended 
by the United States Department of Education are considered to have met 
these standards.



   Sec. Appendix B to Part 75--Standards for Accreditation of Dental 
               Radiography Training for Dental Hygienists

                             A. Sponsorship

    Sponsorship must be by an entity that assumes primary responsibility 
for the planning and conduct of competency-based didactic and clinical 
training in dental radiography.
    1. This responsibility must include: defining the curriculum in 
terms of program goals, instructional objectives, learning experiences 
designed to achieve goals and objectives, and evaluation procedures to 
assess attainment of goals and objectives; coordinating classroom 
teaching and supervised clinical experiences; appointing faculty; 
receiving and processing applications for admission; and granting 
documents of successful completion of the program.
    2. The formal training in dental radiography may be a part of a 
total program of dental hygiene education accredited by an organization 
recognized by the United States Department of Education.
    3. The sponsoring entity and the dental radiography training must be 
approved by the State entity responsible for approving dental hygiene 
education programs or the State entity responsible for credentialing 
dental personnel in radiography.

                              B. Curriculum

    Dental radiography training for dental hygienists must provide 
sufficient content and instructional time to assure competent 
performance.
    1. The dental radiography curriculum content and learning 
experiences must include the theoretical aspects of the subject as well 
as practical application of techniques. The theoretical aspects should 
provide content

[[Page 583]]

necessary for dental hygienists to understand the critical nature of the 
radiological procedures they perform and of the judgments they make as 
related to patient and operator radiation safety.
    2. The dental radiography curriculum must include content in seven 
areas: radiation physics; radiation biology; radiation health, safety, 
and protection; X-ray films and radiographic film quality; radiographic 
techniques; darkroom and processing techniques; and film mounting.

--Radiation Physics. Curriculum content should include: historical 
background; role of radiology in modern dentistry; types of radiation; 
X-ray production principles; operation of X-ray equipment; properties of 
X-radiation; and X-radiation units, detection and monitoring devices.
--Radiation Biology. Curriculum content should include: Interaction of 
ionizing radiation with cells, tissues, and matter; factors influencing 
biological response of cells and tissues to ionizing radiation; somatic 
and genetic effects of radiation exposure; and cumulative effects of X-
radiation and latent period.
--Radiation Health, Safety, and Protection. Curriculum content should 
include: Sources and types of radiation exposure; public health 
implications and public concerns; principles of radiological health 
including collimation and filtration; radiation protection methods in 
the dental office; necessity for high diagnostic yield with a reduction 
of X-radiation exposure; and monitoring devices.
--X-ray Films and Radiographic Film Quality. Curriculum content should 
include: X-radiation production and scatter; X-ray beam quality and 
quantity; factors influencing radiographic density, contrast, 
definition, and distortion; film characteristics; dosage related to film 
speed; types of films, cassettes, and screens; and film identification 
systems.
--Radiographic Techniques. Curriculum content should include: imagery 
geometry; patient positioning; film/film holder positioning; cone 
positioning and exposure settings for the intraoral paralleling 
technique, bisecting the angle technique, and techniques for occlusal 
radiographs; extaroral panoramic techniques; and patient variations that 
affect the above techniques.
--Darkroom and Processing Techniques. Curriculum content should include: 
solution chemistry and quality maintenance; darkroom equipment and safe 
lighting; film processing techniques; automatic film processing; and 
processing errors.
--Film Mounting. Curriculum content should include: anatomical landmarks 
essential to mounting films; film mounting procedures; and diagnostic 
quality of radiographs.

    3. The curriculum must also include clinical practice assignments.

--Clinical practice assignments must be an integral part of the 
curriculum so that Dental Hygienists have the opportunity to develop 
competence in making radiographs. Faculty supervision must be provided 
during a student's radiographic technique experience. Students must 
demonstrate competence in making diagnostically acceptable radiographs 
prior to their clinical practice where there is not direct supervision 
by faculty.
--Dental hygienists must demonstrate knowledge of radiation safety 
measures before making radiographs and, where possible, should 
demonstrate competence on manikins before making radiographs on 
patients. Radiographs must be exposed for diagnostic purposes and not 
solely to demonstrate techniques or obtain experience.
--The clinical experience should provide opportunity to make a variety 
of radiographs and radiographic surveys including primary, mixed, and 
permanent dentitions, as well as edentulous and partially edentulous 
patients.

                          C. Student Evaluation

    Evaluation procedures must be developed to assess performance and 
achievement of dental radiography program objectives.

                               D. Faculty

    The dental radiography training must be conducted by faculty who are 
qualified in the curriculum subject matter.
    1. This may include a D.D.S./D.M.D. degree; graduation from an 
accredited dental assisting or dental hygiene education program with a 
certificate or an associate or baccalaureate degree; status as a 
Certified Dental Assistant certified by the Dental Assisting National 
Board; or recognition as equivalently qualified by the State entity 
which approved the training program in dental radiography.
    2. The faculty-to-student ratio must be adequate to achieve the 
stated objectives of the curriculum.

                              E. Facilities

    Adequate radiographic facilities must be available to permit 
achievement of the dental radiography training objectives. The design, 
location, and construction of radiographic facilities must provide 
optimum protection from X-radiation for patients and operators. 
Equipment shall meet State and Federal laws related to radiation. 
Monitoring devices shall be worn by dental personnel. Lead aprons must 
be placed to protect patients. Safe storage for films must be provided. 
Darkroom facilities and equipment must be available and of a quality 
that

[[Page 584]]

assures that films will not be damaged or lost.

                          F. Learning Resources

    A wide range of printed materials, instructional aids, and equipment 
must be available to support instruction. Current specialized reference 
texts should be provided; and models, replicas, slides, and films which 
depict current techniques should be available for use in instruction. As 
appropriate self-instructional materials become available, they should 
be provided for the student's use.

    Note: Educational programs accredited by an organization recognized 
by the United States Department of Education are considered to have met 
these standards. Under existing licensure provisions in all States, 
becoming a dental hygienist requires graduation from a dental hygiene 
education program accredited by an organization recognized by the United 
States Department of Education. In lieu of this requirement, Alabama 
accepts graduation from a State-approved preceptorship program.



   Sec. Appendix C to Part 75--Standards for Accreditation of Dental 
               Radiography Training for Dental Assistants

                             A. Sponsorship

    Sponsorship must be an entity that assumes primary responsibility 
for the planning and conduct of competency-based didactic and clinical 
training in dental radiography.
    1. This responsibility must include: Defining the curriculum in 
terms of program goals, instructional objectives, learning experiences 
designed to achieve goals and objectives, and evaluation procedures to 
assess attainment of goals and objectives; coordinating classroom 
teaching and supervised clinical experiences; appointing faculty; 
receiving and processing applications for admission; and granting 
documents of successful completion of the program.
    2. Dental radiography training may be freestanding (as a continuing 
education course offered by State dental/dental auxiliary societies, or 
by dental/dental auxiliary education programs); or be a part of an 
educational program in dental assisting. Such dental assisting education 
programs may be accredited by an organization recognized by the United 
States Department of Education; or located in a school accredited by an 
institutional accrediting agency recognized by the United States 
Department of Education or approved by the State agency responsible for 
secondary and postsecondary education, or approved by a Federal agency 
conducting dental assistant education in that Agency.
    3. The sponsoring entity and the dental radiography training must be 
approved by the State entity responsible for approving dental assisting 
education programs, or the State entity responsible for credentialing 
dental personnel in radiography.

                              B. Curriculum

    Dental radiography training for dental assistants must provide 
sufficient content and instructional time to assure competent 
performance.
    1. The dental radiography curriculum content and learning 
experiences must include the theoretical aspects of the subject as well 
as practical application of techniques. The theoretical aspects should 
provide content necessary for dental assistants to understand the 
critical nature of the radiological procedures they perform and of the 
judgments they make as related to patient and operator radiation safety.
    2. The dental radiography curriculum must include content in seven 
areas: radiation physics; radiation biology; radiation health, safety, 
and protection; X-ray films and radiographic film quality; radiographic 
techniques; darkroom and processing techniques; and film mounting.

--Radiation Physics. Curriculum content should include: Historical 
background; role of radiology in modern dentistry; types of radiation; 
X-ray production principles; operation of X-ray equipment; properties of 
X-radiation; and X-radiation units, detection and monitoring devices.
--Radiation Biology. Curriculum content should include: interaction of 
ionizing radiation with cells, tissues, and matter; factors influencing 
biological response of cells and tissues to ionizing radiation; somatic 
and genetic effects of radiation exposure; and cumulative effects of X-
radiation and latent period.
--Radiation Health, Safety, and Protection. Curriculum content should 
include: sources and types of radiation exposure; public health 
implications and public concerns; principles of radiological health 
including collimation and filtration; radiation protection methods in 
the dental office; necessity for high diagnostic yield with a reduction 
of X-radiation exposure; and monitoring devices.
--X-ray Films and Radiographic Film Quality. Curriculum content should 
include: X-radiation production and scatter; X-ray beam quality and 
quantity; factors influencing radiographic density, contrast, 
definition, and distortion; film characteristics; dosage related to film 
speed; types of films, cassettes, and screens; and film identification 
systems.

[[Page 585]]

--Radiographic Techniques. Curriculum content should include: imagery 
geometry; patient positioning; film/film holder positioning; cone 
positioning and exposure settings for the intraoral paralleling 
technique, bisecting the angle technique, and techniques for occlusal 
radiographs; extraoral panoramic techniques; and patient variations that 
affect the above techniques.
--Darkroom and Processing Techniques. Curriculum content should include: 
Solution chemistry and quality maintenance; darkroom equipment and safe 
lighting; film processing techniques; automatic film processing; and 
processing errors.
--Film Mounting. Curriculum content should include: anatomical landmarks 
essential to mounting films; film mounting procedures; and diagnostic 
quality of radiographs.

    3. The curriculum must also include clinical practice assignments.

--Clinical practice assignments must be an integral part of the 
curriculum so that Dental Assistants have the opportunity to develop 
competence in making radiographs. The clinical experience may be 
conducted in the dental office in which the Dental Assistant is employed 
or is serving an externship. Faculty and/or employing dentist 
supervision must be provided during a student's radiographic technique 
experience. Students must demonstrate competence in making 
diagnostically acceptable radiographs prior to their clinical practice 
when there is not direct supervision by faculty and/or the employing 
dentist.
--Dental Assistants must demonstrate knowledge of radiation safety 
measures before making radiographs, and where possible should 
demonstrate competence on manikins before making radiographs on 
patients. Radiographs must be exposed for diagnostic purposes and not 
solely to demonstrate techniques or obtain experience.
--The clinical experience should provide opportunity to make a variety 
of radiographs and radiographic surveys, including primary, mixed, and 
permanent dentitions, as well as edentulous and partially edentulous 
patients.

                          C. Student Evaluation

    Evaluation procedures must be developed to assess performance and 
achievement of dental radiography program objectives.

                               D. Faculty

    The dental radiography training must be conducted by faculty who are 
qualified in the curriculum subject matter.
    1. This may include a D.D.S./D.M.D. degree; graduation from an 
accredited dental assisting or dental hygiene education program with a 
certificate or an associate or baccalaureate degree; status as a 
Certified Dental Assistant certified by the Dental Assisting National 
Board; or recognition as equivalently qualified by the State entity (or 
Federal agency where appropriate) which approves the educational program 
in dental radiography.
    2. The faculty-to-student ratio must be adequate to achieve the 
stated objectives of the curriculum.

                              E. Facilities

    Adequate radiographic facilities must be available to permit 
achievement of the dental radiography training objectives. The design, 
location, and construction of radiographic facilities must provide 
optimum protection from X-radiation for patients and operators. 
Equipment shall meet State and Federal laws related to radiation. 
Monitoring devices shall be worn by dental personnel. Lead aprons must 
be placed to protect patients. Safe storage for films must be provided. 
Darkroom facilities and equipment must be available and of a quality 
that assures that films will not be damaged or lost.

                          F. Learning Resources

    A wide range of printed materials, instructional aids, and equipment 
must be available to support instruction. Current specialized reference 
texts should be provided; and models, replicas, slides, and films which 
depict current techniques should be available for use in instruction. As 
appropriate self-instructional materials become available, they should 
be provided for the student's use.

    Note: Educational programs accredited by an organization recognized 
by the United States Department of Education are considered to have met 
these standards.



 Sec. Appendix D to Part 75--Standards for Accreditation of Educational 
               Programs for Nuclear Medicine Technologists

                             A. Sponsorship

    1. Accreditation will be granted to the institution that assumes 
primary responsibility for curriculum planning and selection of course 
content; coordinates classroom teaching and supervised clinical 
education; appoints faculty to the program; receives and processes 
applications for admission; and grants the degree or certificate 
documenting completion of the program.
    2. Educational programs may be established in:
    (a) Community and junior colleges, senior colleges, and 
universities;
    (b) Hospitals and clinics;
    (c) Laboratories;

[[Page 586]]

    (d) Medical schools;
    (e) Postsecondary vocational/technical schools and institutions; and
    (f) Other acceptable institutions which meet comparable standards.
    3. The sponsoring institution and affiliate(s) must be accredited by 
a recognized agency. When the sponsoring institution and affiliate(s) 
are not so recognized, they may be considered as meeting the 
requirements of accreditation if the institution meets or exceeds 
established equivalent standards.
    4. Responsibilities of the sponsor and each affiliate for program 
administration, instruction, supervision, etc., must be carefully 
described in written affiliation agreements.

                              B. Curriculum

    Instruction must follow a plan which documents:
    1. A structured curriculum including clinical education with clearly 
written syllabi which describe learning objectives and competencies to 
be achieved. The curriculum shall be based on not less than one calendar 
year of full-time study or its equivalent.
    2. The minimum professional curriculum that includes the following:
    (a) Methods of patient care;
    (b) Radiation safety and protection;
    (c) Nuclear medicine physics;
    (d) Radiation physics;
    (e) Nuclear instrumentation;
    (f) Statistics;
    (g) Radionuclide chemistry;
    (h) Radiopharmacology;
    (i) Departmental organization and function;
    (j) Radiation biology;
    (k) Nuclear medicine in vivo and in vitro procedures;
    (l) Radionuclide therapy;
    (m) Computer applications; and
    (n) Clinical practicum.
    3. Assignment of appropriate instructional materials.
    4. Classroom presentations, discussions, and demonstrations.
    5. Supervised practice, experience, and discussions. This shall 
include the following:
    (a) Patient care and patient recordkeeping;
    (b) Participation in the quality assurance program;
    (c) The preparation, calculation, identification, administration, 
and disposal of radiopharmaceuticals;
    (d) Radiation safety techniques that will minimize radiation 
exposure to the patient, public, fellow workers, and self;
    (e) The performance of an adequate number and variety of imaging and 
non-imaging procedures; and
    (f) Clinical correlation of nuclear medicine procedures.
    6. Evaluation of student's knowledge, problem-solving skills, and 
motor and clinical competencies.
    7. The competencies necessary for graduation.

                              C. Resources

    1. The program must have qualified program officials. Primary 
responsibilities shall include program development, organization, 
administration, evaluation, and revision. The following program 
officials must be identified:
    (a) Program Director--(1) Responsibilities. The program director of 
the educational program shall have overall responsibility for the 
organization, administration, periodic review, continued development, 
and general effectiveness of the program. The director shall provide 
supervision and coordination to the instructional staff in the academic 
and clinical phases of the program. Regular visits to the affiliates by 
the program director must be scheduled.
    (2) Qualifications. The program director must be a physician or 
nuclear medicine technologist. The program director must demonstrate 
proficiency in instruction, curriculum design, program planning, and 
counseling.
    (b) Medical Director--(1) Responsibilities. The medical director of 
the program shall provide competent medical direction and shall 
participate in the clinical instruction. In multiaffiliate programs each 
clinical affiliate must have a medical director.
    (2) Qualifications. The medical director must be a physician 
qualified in the use of radionuclides and a diplomate of the American 
Board(s) of Nuclear Medicine, or Pathology, or Radiology, or possess 
suitable equivalent qualifications.
    (c) Clinical Supervisor. Each clinical affiliate must appoint a 
clinical supervisor.
    (1) Responsibilities. The clinical supervisor shall be responsible 
for the clinical education and evaluation of students assigned to that 
clinical affiliate.
    (2) Qualifications. The clinical supervisor must be a technologist 
credentialed in nuclear medicine technology.
    2. Instructional Staff--(a) Responsibilities. The instructional 
staff shall be responsible for instruction in the didactic and/or 
clinical phases of the program. They shall submit course outlines for 
each course assigned by the program director; evaluate students and 
report progress as required by the sponsoring institution; and cooperate 
with the program director in the periodic review and upgrading of course 
material.
    (b) Qualifications. The instructors must be qualified, 
knowledgeable, and effective in teaching the subjects assigned.
    (c) Instructor-to-student ratio. The instructor-to-student ratio 
shall be adequate to

[[Page 587]]

achieve the stated objectives of the curriculum.
    (d) Professional development. Accredited programs shall assure 
continuing education in the health profession or occupation and ongoing 
instruction for the faculty in curriculum design and teaching 
techniques.
    3. Financial resoures for continued operation of the educational 
program must be assured.
    4. Physical Resources. (a) General. Adequate classrooms, 
laboratories, and other facilities shall be provided.
    (b) Equipment and Supplies. Modern nuclear medicine equipment, 
accurately calibrated, in working order, and meeting applicable Federal 
and State standards, if any, must be available for the full range of 
diagnostic and therapeutic procedures as outlined in the curriculum.
    (c) Reference Materials. Reference materials appropriate to the 
curriculum shall be readily accessible to students.
    (d) Records. Records shall be maintained as dictated by good 
educational practices.
    5. Instructional Resources. Instructional aids such as clinical 
materials, reference materials, demonstration and other multimedia 
materials must be provided.

                               D. Students

                         Admission Requirements

    Persons admitted into nuclear medicine technology programs shall 
have completed high school or its equivalent. They shall have completed 
postsecondary courses in the following areas:
    (1) Human anatomy and physiology;
    (2) Physics;
    (3) Mathematics;
    (4) Medical terminology;
    (5) Oral and written communications;
    (6) General chemistry; and
    (7) Medical ethics.
    Prerequisites may be completed during nuclear medicine training. 
Educational institutions such as junior colleges, universities, and 
technical vocational institutes may provide these prerequisite courses 
as part of an integrated program in nuclear medicine technology (i.e., 
two to four years).

                         E. Operational Policies

    Students may not take the responsibility nor the place of qualified 
staff. However, students may be permitted to perform procedures after 
demonstrating proficiency, with careful supervision.

                    F. Continuing Program Evaluation

    1. Periodic and systematic review of the program's effectiveness 
must be documented.
    2. One element of program evaluation shall be the initial employment 
of graduates of the program.

    Note: Educational programs accredited by an organization recognized 
by the United States Department of Education are considered to have met 
these standards.



 Sec. Appendix E to Part 75--Standards for Accreditation of Educational 
              Programs for Radiation Therapy Technologists

                             A. Sponsorship

    1. Educational programs may be established in:
    (a) Community and junior colleges, senior colleges, and 
universities;
    (b) Hospitals, clinics, or autonomous radiation oncology centers 
meeting the criteria for major cancer management centers or meeting 
demonstrably equivalent standards;
    (c) Medical schools; and
    (d) Postsecondary vocational/technical schools and institutions.
    2. The sponsoring institution and affiliates, if any, must be 
accredited by recognized agencies or meet equivalent standards. When 
more than one clinical education center is used, each must meet the 
standards of a major cancer management center.
    3. When didactic preparation and supervised clinical education are 
not provided in the same institution, accreditation must be obtained by 
the sponsoring institution for the total program. This institution will 
be the one responsible for admission, curriculum, and academic credit. 
The accredited institution shall be responsible for coordinating the 
program and assuring that the activities assigned to the student in the 
clinical setting are educational. There shall be a uniform, written, 
affiliation agreement between the accredited institution and each 
clinical education center, clearly defining the responsibilities and 
obligations of each.

                              B. Curriculum

    Educational programs of 24 months and 12 months or their equivalents 
may be developed. A 24-month program shall admit those candidates with a 
high school diploma (or equivalent) as outlined in D.1. The 12-month 
program shall be designed for those students admitted with backgrounds 
as outlined in D.2.
    Instruction must follow a plan which documents:
    1. A structured curriculum with clearly written course syllabi which 
describe competencies and learning objectives to be achieved. The 
curriculum shall include but not necessarily be limited to the 
following:
    (a) Orientation to radiation therapy technology;
    (b) Medical ethics and law;
    (c) Methods of patient care;
    (d) Medical terminology;
    (e) Human structure and function;

[[Page 588]]

    (f) Oncologic pathology;
    (g) Radiation oncology;
    (h) Radiobiology;
    (i) Mathematics;
    (j) Radiation physics;
    (k) Radiation protection;
    (l) Radiation oncology technique;
    (m) Radiographic imaging; and
    (n) Clinical dosimetry.

The curriculum must include a plan for well-structured competency-based 
clinical education.

    2. Assignment of appropriate instructional materials.
    3. Classroom presentations, discussions, and demonstrations.
    4. Supervised clinical education and laboratory practicum.
    5. Evaluation of students to assess knowledge, problem-solving 
skills, and motor and clinical competencies.
    6. Program graduates must demonstrate competencies including, but 
not limited to, the following:
    (a) Practice oral and written communications;
    (b) Maintain records of treatment administered;
    (c) Perform basic mathematical functions;
    (d) Demonstrate knowledge of human structure, function, and 
pathology;
    (e) Demonstrate knowledge of radiation physics in radiation 
interactions and radiation protection techniques;
    (f) Provide basic patient care and cardiopulmonary resuscitation;
    (g) Deliver a planned course of radiation therapy;
    (h) Verify physician's prescribed course of radiation therapy and 
recognize errors in computation;
    (i) Demonstrate awareness of patterns of physical and emotional 
stress exhibited by patients;
    (j) Produces and utilize immobilization and beam directional 
devices;
    (k) Prepare commonly used brachytherapy sources;
    (l) Demonstrate knowledge of methods of calibration of equipment, 
and quality assurance;
    (m) Prepare isodose summations;
    (n) Detect malfunctioning equipment;
    (o) Apply rules and regulations for radiation safety, and detect 
defects which might pose a radiation hazard;
    (p) Understand the function of equipment and accessories;
    (q) Demonstrate knowledge of methods of continuing patient 
evaluation (follow up);
    (r) Apply wedge and compensating filters;
    (s) Recognize patients' clinical progress, complications, and 
demonstrate knowledge of when to withhold treatment until consultation 
with the physician; and
    (t) Interact with patients and families concerning the physical and 
psychological needs of patients.

                              C. Resources

    1. Program Officials. The program must have a qualified program 
official or officials. Primary responsibilities shall include program 
development, organization, administration, evaluation, and revision. A 
program director is necessary; other program officials may be required.
    (a) Program Director--(1) Responsibilities.
--The director of the educational program shall be responsible for the 
organization, administration, periodic review, continued development, 
and general effectiveness of the program. The program director's 
responsibilities in teaching, administration, and coordination of the 
educational program in radiation therapy technology shall not be 
adversely affected by educationally unrelated functions.
--In a college-sponsored program, or a hospital-sponsored multiple 
affiliate program, the program director shall be an employee of the 
sponsoring institution. A schedule of regular affiliate visits must be 
maintained.

    (2) Qualifications.

--Must be a technologist qualified in radiation therapy technology and 
educational methodologies.
--Must be credentialed in radiation therapy technology or possess 
suitable equivalent qualifications.
--Must have at least two years' experience as an instructor in an 
accredited educational program.
    (b) Clinical Supervisor. Each clinical education center shall 
appoint a clinical supervisor.
    (1) Responsibilities. The clinical supervisor shall be responsible 
for the clinical education and evaluation of students assigned to that 
clinical education center.
    (2) Qualifications. Must be a technologist, with suitable 
experience, qualified in radiation therapy technology and educational 
methodologies and must be credentialed in radiation therapy technology.
    (c) Medical Director/Medical Advisor--
    (1) Responsibilities. The medical director/medical advisor shall 
work in consultation with the program director in developing the goals 
and objectives of the program and implementing the standards for 
achievement.
    (2) Qualifications. The medical director/medical advisor shall be a 
qualified radiation oncologist certified by the American Board of 
Radiology, or shall possess suitable equivalent qualifications.
    2. Instructional Staff-- (a) Responsibilities. The instructional 
staff shall be responsible for submitting course outlines for each 
course assigned by the program director; evaluating students and 
reporting progress

[[Page 589]]

as required by the sponsoring institution; and cooperating with the 
program director in the periodic review and upgrading of course 
material.
    (b) Qualifications. The instructors must be individually qualified, 
must be effective in teaching the subjects assigned, and must meet the 
standards required by the sponsoring institution.
    (c) Instructor-to-Student Ratio. The instructor-to-student ratio 
shall be adequate to achieve the stated objectives of the curriculum.
    (d) Professional Development. Programs shall have a policy that 
encourages continuing education in radiation therapy technology and 
assures ongoing instruction for the faculty in curriculm design and 
teaching strategies.
    3. Financial Resources. Financial resources for continued operation 
of the educational program must be assured.
    4. Physical Resources--(a) General. Adequate classrooms, 
laboratories, and other facilities shall be provided. All affiliated 
institutions shall provide space required for these facilities.
    (b) Equipment and Supplies. Appropriate modern equipment and 
supplies in sufficient quantities shall be provided.
    (c) Laboratory. Energized laboratories must meet Federal and/or 
State radiation and safety regulations.
    (d) Reference Materials. An adequate supply of up-to-date books, 
periodicals, and other reference materials related to the curriculum and 
the profession shall be readily available to students.
    (e) Records. Records shall be maintained as dictated by good 
educational practices.
    5. Instructional Resources. Instructional aids such as clinical 
materials, reference materials, and demonstration and other multimedia 
materials must be provided.

                               D. Students

                                Admission

    1. Applicants must be high school graduates (or equivalent) with an 
educational background in basic science and mathematics.
    2. For admission to a 12-month program, the candidate must satisfy 
one of the following requirements:
    (a) Graduation from an accredited or equivalent program in 
radiography.
    (b) Successful completion or challenge of courses in the following 
prerequisite content areas:

--Radiation physics;
--Human structure and function;
--Radiation protection;
--Medical ethics and law;
--Methods of patient care;
--Medical terminology; and
--Mathematics.

    (c) Successful demonstration of the following competencies:

--Practice oral and written communications;
--Perform basic mathematical functions;
--Demonstrate knowledge of human structure and function;
--Demonstrate knowledge of radiation physics in radiation interactions 
and radiation protection techniques;
--Provide basic patient care and cardiopulmonary resuscitation;
--Demonstrate awareness of patterns of physical and emotional stress 
exhibited by patients;
--Apply rules and regulations for radiation safety, detect defects which 
might pose a radiation hazard, and maintain control, if a radiation 
accident occurs; and
--Interact with patients and families concerning patients physical and 
psychological needs.

                    E. Continuing Program Evaluation

    1. A process for periodic and systematic review of the program's 
effectiveness must be documented and reflected in policies.
    2. Program evaluation shall include the employment performance of 
recent graduates.

    Note: Educational programs accredited by an organization recognized 
by the United States Department of Education are considered to have met 
these standards.



   Sec. Appendix F to Part 75--Standards for Licensing Radiographers, 
   Nuclear Medicine Technologists, and Radiation Therapy Technologists

    The following section describes basic elements to be incorporated in 
credentialing programs of States that choose to regulate personnel who 
perform radiologic procedures.

                              A. Licensure

    1. Only eligible applicants who have passed the licensure 
examination shall be licensed as Radiographers, Nuclear Medicine 
Technologists, or Radiation Therapy Technologists.
    2. Licenses shall be renewed at periodic intervals.

                             B. Eligibility

    1. For regular eligibility to take the licensure examination, 
applicants shall have successfully completed an accredited program of 
formal education in radiography, nuclear medicine technology, or 
radiation therapy technology.
    2. Special eligibility to take the licensure examination shall be 
provided for applicants

[[Page 590]]

whose training and/or experience are equal to, or in excess of, those of 
a graduate of an accredited educational program.

                             C. Examination

    A criterion-referenced examination in radiography, nuclear medicine 
technology, or radiation therapy technology shall be utilized to test 
the knowledge and competencies of applicants.

                        D. Continuing Competency

    The licensed Radiographer, Nuclear Medicine Technologist, or 
Radiation Therapy Technologist shall maintain continuing competency in 
the area in which he/she is practicing.

                       E. Policies and Procedures

    An organization that seeks to be recognized for the certifying of 
personnel shall adopt definite policies to ensure validity, objectivity, 
and fairness in the certifying process. The National Commission for 
Health Certifying Agencies (NCHCA) has published suitable criteria for a 
certifying organization to adopt with respect to policies for: (1) 
Determination of appropriate examination content (but not the actual 
content for any specific occupation); (2) construction of examinations; 
(3) administration of examinations; and (4) fulfilling responsibilities 
to applicants. An organization (whether an NCHCA member or not) that 
adopts these or equivalent criteria will meet all of the requirements of 
this section of these standards.



 Sec. Appendix G to Part 75--Standards for Licensing Dental Hygienists 
               and Dental Assistants in Dental Radiography

    The following section describes basic elements to be incorporated in 
credentialing programs of States that choose to regulate personnel who 
perform radiologic procedures.
    Currently, Dental Hygienists are credentialed through individual 
State licensure processes, all of which include assessment of competence 
in dental radiography. In all States, Dental Hygienists are required to 
be licensed prior to practicing. The existing State dental hygiene 
licensure processes meet the intent and purpose of the Consumer-Patient 
Radiation Health and Safety Act of 1981 and the standards for licensing 
Dental Hygienists in dental radiography set forth below.

                           A. Licensure/Permit

    1. To those who have passed a licensure or designated dental 
radiography examination, a license or permit shall be issued by the 
State entity responsible for credentialing dental personnel.
    2. Licenses or permits shall be renewed at periodic intervals.

                             B. Eligibility

    1. An individual shall provide proof of graduating student status or 
graduation from an accredited or approved dental hygiene or dental 
assisting education program.
    2. For dental assistants, special eligibility to take the 
examination shall be provided to applicants with appropriate 
combinations of training and/or experience.

                             C. Examination

    A criterion-referenced examination in dental radiography shall be 
utilized to test the knowledge and competencies of applicants.

                        D. Continuing Competency

    The Dental Hygienist or Dental Assistant shall be required to 
maintain continuing competency in the area in which he/she is 
practicing.

                       E. Policies and Procedures

    An organization that seeks to be recognized for the certifying of 
personnel shall adopt definite policies to ensure validity, objectivity, 
and fairness in the certifying process. The National Commission for 
Health Certifying Agencies (NCHCA) has published suitable criteria for a 
certifying organization to adopt with respect to policies for: (1) 
Determination of appropriate examination content (but not the actual 
content for any specific occupation); (2) construction of examinations; 
(3) administration of examinations; and (4) fulfilling responsibilities 
to applicants. An organization (whether an NCHCA member or not) that 
adopts these or equivalent criteria will meet all of the requirements of 
this section of these standards.

[[Page 591]]



    SUBCHAPTER G_OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED 
                               ACTIVITIES



                           PART 80 [RESERVED]



PART 81_GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER 
THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000--
Table of Contents



                         Subpart A_Introduction

Sec.
81.0 Background.
81.1 Purpose and Authority.
81.2 Provisions of EEOICPA concerning this part.

                          Subpart B_Definitions

81.4 Definition of terms used in this part.

      Subpart C_Data Required To Estimate Probability of Causation

81.5 Use of personal and medical information
81.6 Use of radiation dose information.

 Subpart D_Requirements for Risk Models Used To Estimate Probability of 
                                Causation

81.10 Use of cancer risk assessment models in NIOSH-IREP.
81.11 Use of uncertainty analysis in NIOSH-IREP.
81.12 Procedure for updating NIOSH-IREP.

        Subpart E_Guidelines To Estimate Probability of Causation

81.20 Required use of NIOSH-IREP.
81.21 Cancers requiring the use of NIOSH-IREP.
81.22 General guidelines for use of NIOSH-IREP.
81.23 Guidelines for cancers for which primary site is unknown.
81.24 Guidelines for leukemia.
81.25 Guidelines for claims involving two or more primary cancers.

    Authority: 42 U.S.C. 7384n(c); E.O. 13179, 65 FR 77487, 3 CFR, 2000 
Comp., p. 321.

    Source: 67 FR 22309, May 2, 2002, unless otherwise noted.



                         Subpart A_Introduction



Sec.  81.0  Background.

    The Energy Employees Occupational Illness Compensation Program Act 
(EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the 
payment of compensation benefits to covered employees and, where 
applicable, survivors of such employees, of the United States Department 
of Energy, its predecessor agencies and certain of its contractors and 
subcontractors. Among the types of illnesses for which compensation may 
be provided are cancers. There are two categories of covered employees 
with cancer under EEOICPA for whom compensation may be provided. The 
regulations that follow under this part apply only to the category of 
employees described under paragraph (a) of this section.
    (a) One category is employees with cancer for whom probability of 
causation must be estimated or determined, as required under 20 CFR 
30.115.
    (b) The second category is members of the Special Exposure Cohort 
seeking compensation for a specified cancer, as defined under EEOICPA. 
The U.S. Department of Labor (DOL) which has primary authority for 
implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 et 
seq. that identify current members of the Special Exposure Cohort and 
requirements for compensation. Pursuant to section 7384(q) of EEOICPA, 
the Secretary of HHS is authorized to add additional classes of 
employees to the Special Exposure Cohort.



Sec.  81.1  Purpose and Authority.

    (a) The purpose of this regulation is to establish guidelines DOL 
will apply to adjudicate cancer claims for covered employees seeking 
compensation for cancer, other than as members of the Special Exposure 
Cohort seeking compensation for a specified cancer. To award a claim, 
DOL must first determine that it is at least as likely as not that the 
cancer of the employee was caused by radiation doses incurred by

[[Page 592]]

the employee in the performance of duty. These guidelines provide the 
procedures DOL must apply and identify the information DOL will use.
    (b) Section 7384(n)(b) of EEOICPA requires the President to 
promulgate these guidelines. Executive Order 13179 assigned 
responsibility for promulgating these guidelines to the Secretary of 
HHS.



Sec.  81.2  Provisions of EEOICPA concerning this part.

    EEOICPA imposes several general requirements concerning the 
development of these guidelines. It requires that the guidelines produce 
a determination as to whether it is at least as likely as not (a 50% or 
greater probability) that the cancer of the covered employee was related 
to radiation doses incurred by the employee in the performance of duty. 
It requires the guidelines be based on the radiation dose received by 
the employee, incorporating the methods of dose reconstruction to be 
established by HHS. It requires determinations be based on the upper 99 
percent confidence interval (credibility limit) of the probability of 
causation in the RadioEpidemiological tables published under section 
7(b) of the Orphan Drug Act (42 U.S.C. 241 note), as such tables may be 
updated. EEOICPA also requires HHS consider the type of cancer, past 
health-related activities, the risk of developing a radiation-related 
cancer from workplace exposure, and other relevant factors. Finally, it 
is important to note EEOICPA does not include a requirement limiting the 
types of cancers to be considered radiogenic for these guidelines.



                          Subpart B_Definitions



Sec.  81.4  Definition of terms used in this part.

    (a) Covered employee, for purposes of this part, means an individual 
who is or was an employee of DOE, a DOE contractor or subcontractor, or 
an atomic weapons employer, and for whom DOL has requested HHS to 
perform a dose reconstruction.
    (b) Dose and dose rate effectiveness factor (DDREF) means a factor 
applied to a risk model to modify the dose-risk relationship estimated 
by the model to account for the level of the dose and the rate at which 
the dose is incurred. As used in IREP, a DDREF value of greater than one 
implies that chronic or low doses are less carcinogenic per unit of dose 
than acute or higher doses.
    (c) Dose-response relationship means a mathematical expression of 
the way that the risk of a biological effect (for example, cancer) 
changes with increased exposure to a potential health hazard (for 
example, ionizing radiation).
    (d) EEOICPA means the Energy Employees Occupational Illness 
Compensation Program Act of 2000, 42 U.S.C. Sec. Sec.  7384-7385 [1994, 
supp. 2001].
    (e) Equivalent dose means the absorbed dose in a tissue or organ 
multiplied by a radiation weighting factor to account for differences in 
the effectiveness of the radiation in inducing cancer.
    (f) External dose means the portion of the equivalent dose that is 
received from radiation sources outside of the body.
    (g) ICD-10-CM means the International Statistical Classification of 
Diseases and Related Health Problems, Tenth Revision, Clinical 
Modification, https://www.cdc.gov/nchs/icd/icd10cm.htm.
    (h) Interactive RadioEpidemiological Program (IREP) means a computer 
software program that uses information on the dose-response 
relationship, and specific factors such as a claimant's radiation 
exposure, gender, age at diagnosis, and age at exposure to calculate the 
probability of causation for a given pattern and level of radiation 
exposure.
    (i) Internal dose means the portion of the equivalent dose that is 
received from radioactive materials taken into the body.
    (j) Inverse dose rate effect means a phenomenon in which the 
protraction of an exposure to a potential health hazard leads to greater 
biological effect per unit of dose than the delivery of the same total 
amount in a single dose. An inverse dose rate effect implies that the 
dose and dose rate effectiveness factor (DDREF) is less than one for 
chronic or low doses.
    (k) Linear energy transfer (LET) means the average amount of energy 
transferred to surrounding body tissues

[[Page 593]]

per unit of distance the radiation travels through body tissues (track 
length). Low LET radiation is typified by gamma and x rays, which have 
high penetrating capabilities through various tissues, but transfer a 
relatively small amount of energy to surrounding tissue per unit of 
track length. High LET radiation includes alpha particles and neutrons, 
which have weaker penetrating capability but transfer a larger amount of 
energy per unit of track length.
    (l) NIOSH means the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, United States 
Department of Health and Human Services.
    (m) Primary cancer means a cancer defined by the original body site 
at which the cancer was incurred, prior to any spread (metastasis) to 
other sites in the body.
    (n) Probability of causation means the probability or likelihood 
that a cancer was caused by radiation exposure incurred by a covered 
employee in the performance of duty. In statistical terms, it is the 
cancer risk attributable to radiation exposure divided by the sum of the 
baseline cancer risk (the risk to the general population) plus the 
cancer risk attributable to the radiation exposure.
    (o) RadioEpidemiological Tables means tables that allow computation 
of the probability of causation for various cancers associated with a 
defined exposure to radiation, after accounting for factors such as age 
at exposure, age at diagnosis, and time since exposure.
    (p) Relative biological effectiveness (RBE) means a factor applied 
to a risk model to account for differences between the amount of cancer 
effect produced by different forms of radiation. For purposes of 
EEOICPA, the RBE is considered equivalent to the radiation weighting 
factor.
    (q) Risk model means a mathematical model used under EEOICPA to 
estimate a specific probability of causation using information on 
radiation dose, cancer type, and personal data (e.g., gender, smoking 
history).
    (r) Secondary site means a body site to which a primary cancer has 
spread (metastasized).
    (s) Specified cancer is a term defined in Sec.  7384(l)(17) of 
EEOICPA and 20 CFR 30.5(gg) that specifies types of cancer that, 
pursuant to 20 CFR part 30, may qualify a member of the Special Exposure 
Cohort for compensation. It includes leukemia (other than chronic 
lymphocytic leukemia), multiple myeloma, non-Hodgkin's lymphoma, renal 
cancers, and cancers of the lung (other than carcinoma in situ diagnosed 
at autopsy), thyroid, male breast, female breast, esophagus, stomach, 
pharynx, small intestine, pancreas, bile ducts, gall bladder, salivary 
gland, urinary bladder, brain, colon, ovary, liver (not associated with 
cirrhosis or hepatitis B), and bone.
    (t) Uncertainty is a term used in this rule to describe the lack of 
precision of a given estimate, the extent of which depends upon the 
amount and quality of the evidence or data available.
    (u) Uncertainty distribution is a statistical term meaning a range 
of discrete or continuous values arrayed around a central estimate, 
where each value is assigned a probability of being correct.
    (v) Upper 99 percent confidence interval is a term used in EEOICPA 
to mean credibility limit, the probability of causation estimate 
determined at the 99th percentile of the range of uncertainty around the 
central estimate of probability of causation.

[67 FR 22309, May 2, 2002, as amended at 84 FR 37590, Aug. 1, 2019]



      Subpart C_Data Required To Estimate Probability of Causation



Sec.  81.5  Use of personal and medical information.

    Determining probability of causation may require the use of the 
following personal and medical information provided to DOL by claimants 
under DOL regulations 20 CFR part 30:
    (a) Year of birth.
    (b) Cancer diagnosis (by ICD-10-CM code) for primary and secondary 
cancers.
    (c) Date of cancer diagnosis.
    (d) Gender.
    (e) Race/ethnicity (if the claim is for skin cancer or a secondary 
cancer for which skin cancer is a likely primary cancer).

[[Page 594]]

    (f) Smoking history (if the claim is for lung cancer or a secondary 
cancer for which lung cancer is a likely primary cancer).

[67 FR 22309, May 2, 2002, as amended at 84 FR 37590, Aug. 1, 2019]



Sec.  81.6  Use of radiation dose information.

    Determining probability of causation will require the use of 
radiation dose information provided to DOL by the National Institute for 
Occupational Safety and Health (NIOSH) under HHS regulations 42 CFR part 
82. This information will include annual dose estimates for each year in 
which a dose was incurred, together with uncertainty distributions 
associated with each dose estimate. Dose estimates will be distinguished 
by type of radiation (low linear energy transfer (LET), protons, 
neutrons, alpha, low-energy x-ray) and by dose rate (acute or chronic) 
for external and internal radiation dose.



 Subpart D_Requirements for Risk Models Used To Estimate Probability of 
                                Causation



Sec.  81.10  Use of cancer risk assessment models in NIOSH IREP.

    (a) The risk models used to estimate probability of causation for 
covered employees under EEOICPA will be based on risk models updated 
from the 1985 NIH Radioepidemiological Tables. These 1985 tables were 
developed from analyses of cancer mortality risk among the Japanese 
atomic bomb survivor cohort. The National Cancer Institute (NCI) and 
Centers for Disease Control and Prevention (CDC) are updating the 
tables, replacing them with a sophisticated analytic software program. 
This program, the Interactive RadioEpidemiological Program (IREP) \1\, 
models the dose-response relationship between ionizing radiation and 33 
cancers using morbidity data from the same Japanese atomic bomb survivor 
cohort. In the case of thyroid cancer, radiation risk models are based 
on a pooled analysis of several international cohorts \1a\.
---------------------------------------------------------------------------

    \1\ NIOSH-IREP is available for public review on the NIOSH homepage 
at: www.cdc.gov/niosh/ocas/ocasirep/html.
    \1a\ Ron E, Lubin JH, Shore RE, et al. ``Thyroid cancer after 
exposure to external radiation: a pooled analysis of seven studies.'' 
Radiat. Res. 141:259-277, 1995.
---------------------------------------------------------------------------

    (b) NIOSH will change the risk models in IREP, as needed, to reflect 
the radiation exposure and disease experiences of employees covered 
under EEOICPA, which differ from the experiences of the Japanese atomic 
bomb survivor cohort. Changes will be incorporated in a version of IREP 
named NIOSH-IREP, specifically designed for adjudication of claims under 
EEOICPA. Possible changes in IREP risk models include the following:
    (1) Addition of risk models to IREP, as needed, for claims under 
EEOICPA (e.g., malignant melanoma and other skin cancers)
    (2) Modification of IREP risk models to incorporate radiation 
exposures unique to employees covered by EEOICPA (e.g., radon and low 
energy x rays from employer-required medical screening programs, 
adjustment of relative biological effectiveness distributions based on 
neutron energy).
    (3) Modification of IREP risk models to incorporate new 
understanding of radiation-related cancer effects relevant to employees 
covered by EEOICPA (e.g., incorporation of inverse dose-rate 
relationship between high LET radiation exposures and cancer; adjustment 
of the low-dose effect reduction factor for acute exposures).
    (4) Modification of IREP risk models to incorporate new 
understanding of the potential interaction between cancer risk 
associated with occupational exposures to chemical carcinogens and 
radiation-related cancer effects.
    (5) Modification of IREP risk models to incorporate temporal, race 
and ethnicity-related differences in the frequency of certain cancers 
occurring generally among the U.S. population.
    (6) Modifications of IREP to facilitate improved evaluation of the 
uncertainty distribution for the probability of causation for claims 
based on two or more primary cancers.

[[Page 595]]



Sec.  81.11  Use of uncertainty analysis in NIOSH-IREP.

    (a) EEOICPA requires use of the uncertainty associated with the 
probability of causation calculation, specifically requiring the use of 
the upper 99% confidence interval (credibility limit) estimate of the 
probability of causation estimate. As described in the NCI document, \2\ 
uncertainty from several sources is incorporated into the probability of 
causation calculation performed by NIOSH-IREP. These sources include 
uncertainties in estimating: radiation dose incurred by the covered 
employee; the radiation dose-cancer relationship (statistical 
uncertainty in the specific cancer risk model); the extrapolation of 
risk (risk transfer) from the Japanese to the U.S. population; 
differences in the amount of cancer effect caused by different radiation 
types (relative biological effectiveness or RBE); the relationship 
between the rate at which a radiation dose is incurred and the level of 
cancer risk produced (dose and dose rate effectiveness factor or DDREF); 
and, the role of non-radiation risk factors (such as smoking history).
---------------------------------------------------------------------------

    \2\ Draft Report of the NCI-CDC Working Group to Revise the 1985 NIH 
Radioepidemiological Tables, May 31, 2000, p. 17-18, p. 22-23.
---------------------------------------------------------------------------

    (b) NIOSH-IREP will operate according to the same general protocol 
as IREP for the analysis of uncertainty. It will address the same 
possible sources of uncertainty affecting probability of causation 
estimates, and in most cases will apply the same assumptions 
incorporated in IREP risk models. Different procedures and assumptions 
will be incorporated into NIOSH-IREP as needed, according to the 
criteria outlined under Sec.  81.10.



Sec.  81.12  Procedure to update NIOSH-IREP.

    (a) NIOSH may periodically revise NIOSH-IREP to add, modify, or 
replace cancer risk models, improve the modeling of uncertainty, and 
improve the functionality and user-interface of NIOSH-IREP.
    (b) Revisions to NIOSH-IREP may be recommended by the following 
sources:
    (1) NIOSH,
    (2) The Advisory Board on Radiation and Worker Health,
    (3) Independent reviews of NIOSH-IREP or elements thereof by 
scientific organizations (e.g., National Academy of Sciences),
    (4) DOL,
    (5) Public comment.
    (c) NIOSH will submit substantive changes to NIOSH-IREP (changes 
that would substantially affect estimates of probability of causation 
calculated using NIOSH-IREP, including the addition of new cancer risk 
models) to the Advisory Board on Radiation and Worker Health for review. 
NIOSH will obtain such review and address any recommendations of the 
review before completing and implementing the change.
    (d) NIOSH will inform the public of proposed changes provided to the 
Advisory Board for review. HHS will provide instructions for obtaining 
relevant materials and providing public comment in the notice announcing 
the Advisory Board meeting, published in the Federal Register.
    (e) NIOSH will publish periodically a notice in the Federal Register 
informing the public of proposed substantive changes to NIOSH-IREP 
currently under development, the status of the proposed changes, and the 
expected completion dates.
    (f) NIOSH will notify DOL and publish a notice in the Federal 
Register notifying the public of the completion and implementation of 
substantive changes to NIOSH-IREP. In the notice, NIOSH will explain the 
effect of the change on estimates of probability of causation and will 
summarize and address relevant comments received by NIOSH.
    (g) NIOSH may take into account other factors and employ other 
procedures than those specified in this section, if circumstances arise 
that require NIOSH to implement a change more immediately than the 
procedures in this section allow.

[[Page 596]]



        Subpart E_Guidelines To Estimate Probability of Causation



Sec.  81.20  Required use of NIOSH-IREP.

    (a) NIOSH-IREP is an interactive software program for estimating 
probability of causation for covered employees seeking compensation for 
cancer under EEOICPA, other than as members of the Special Exposure 
Cohort seeking compensation for a specified cancer.
    (b) DOL is required to use NIOSH-IREP to estimate probability of 
causation for all cancers, as identified under Sec. Sec.  81.21 and 
81.23.



Sec.  81.21  Cancers requiring the use of NIOSH-IREP.

    (a) DOL will calculate probability of causation for all cancers 
using NIOSH-IREP.
    (b) Carcinoma in situ (ICD-10-CM codes D00-D09), neoplasms of 
uncertain behavior (ICD-10-CM codes D37-D44 and D48), and neoplasms of 
unspecified nature (ICD-10-CM code D49) are assumed to be malignant, for 
purposes of estimating probability of causation.
    (c) All secondary and unspecified cancers of the lymph node (ICD-10-
CM codes C77 and C7B.01) shall be considered secondary cancers (cancers 
resulting from metastasis of cancer from a primary site). For claims 
identifying cancers of the lymph node, Table 1 in Sec.  81.23(a) 
provides guidance for assigning a primary site and calculating 
probability of causation using NIOSH-IREP.

[84 FR 37590, Aug. 1, 2019]



Sec.  81.22  General guidelines for use of NIOSH-IREP.

    DOL will use procedures specified in the NIOSH-IREP Operating Guide 
to calculate probability of causation estimates under EEOICPA. The guide 
provides current, step-by-step instructions for the operation of IREP. 
The procedures include entering personal, diagnostic, and exposure data; 
setting/confirming appropriate values for variables used in 
calculations; conducting the calculation; and, obtaining, evaluating, 
and reporting results.



Sec.  81.23  Guidelines for cancers for which primary site is unknown.

    (a) In claims for which the primary cancer site cannot be 
determined, but a site of metastasis is known, DOL will calculate 
probability of causation estimates for various likely primary sites. 
Table 1 of this paragraph (a) indicates the primary cancer site(s) DOL 
will use in NIOSH-IREP when the primary cancer site is unknown.

                        Table 1 to Paragraph (a)

Primary cancers (ICD-10-CM codes) for which probability of causation is 
to be calculated, if only a secondary cancer site is known. ``M'' 
indicates cancer site should be used for males only, and ``F'' indicates 
the cancer site should be used for females only.

------------------------------------------------------------------------
                                             ICD-10-CM code of likely
   Secondary cancer  (ICD-10-CM code)            primary cancers
------------------------------------------------------------------------
Lymph nodes of head, face and neck       C01, C02, C07(M), C08(M),
 (C77.0).                                 C09(M), C10(M), C14(F),
                                          C32(M), C33, C34, C43, C44,
                                          C50(F), C73(F), D03.
Intrathoracic lymph nodes (C77.1)......  C15(M), C33, C34, C50(F).
Intra-abdominal lymph nodes (C77.2)....  C15(M), C16(M), C18, C25(F),
                                          C33, C34, C50(F), C53(F),
                                          C61(M), C64, C65, C66, C68,
                                          C82(F), C84(F) (excluding
                                          C84.6, C84.7), C85(F), C86(F)
                                          (excluding C86.5, C86.6),
                                          C91.4(F), C96(F).
Lymph nodes of axilla and upper limb     C33, C34, C43, C50(F) , D03.
 (C77.3).
Inguinal and lower limb lymph nodes      C19(M), C20(M), C21(M), C33,
 (C77.4).                                 C34, C43, C44(F), C60(M),
                                          C63(M), D03.
Intrapelvic lymph nodes (C77.5)........  C18(M), C19(F), C20(F), C21(F),
                                          C33(M), C34(M), C53(F),
                                          C54(F), C61(M), C67.
Lymph nodes of multiple sites (C77.8)..  C15(M), C16(M), C18(M), C33,
                                          C34, C50(F).
Lymph nodes, site unspecified (C77.9)..  C15(M), C16, C18, C33, C34,
                                          C43, C50(F), C61(M), D03.
Lung (C78.0)...........................  C18, C33, C34, C43(M), C50(F),
                                          C61(M), C67(M), C64, C65, C66,
                                          C68, D03(M).
Mediastinum (C78.1)....................  C15(M), C33, C34, C50(F).
Pleura (C78.2).........................  C15(M), C18(M), C33, C34,
                                          C50(F), C56(F), C57(F),
                                          C61(M), C64(M), C65(M),
                                          C66(M), C68(M).

[[Page 597]]

 
Other respiratory organs (C78.3).......  C15, C18(M), C32, C33, C34,
                                          C44(M), C50(F), C61(M),
                                          C73(F).
Small intestine, including duodenum      C17, C18, C25, C33, C34, C49,
 (C78.4).                                 C43(M), C50(F), C56(F),
                                          C57(F), C64(M), C65(M),
                                          C66(M), C68(M), D03(M).
Large intestine and rectum (C78.5).....  C18, C19, C20, C21, C33, C34,
                                          C50(F), C56(F), C57(F),
                                          C61(M).
Retroperitoneum and peritoneum (C78.6).  C16, C18, C19(M), C20(M),
                                          C21(M), C25, C33(M), C34(M),
                                          C49, C50(F), C54(F), C56(F),
                                          C57(F).
Liver, specified as secondary (C78.7)..  C16(M), C18, C19(M), C20(M),
                                          C21(M), C25, C33, C34, C50(F).
Other digestive organs (C78.8).........  C15(M), C16, C18, C25, C33,
                                          C34, C50(F), C61(M).
Kidney (C79.0).........................  C18, C33, C34, C50(F), C53(F),
                                          C61(M), C67, C64, C65, C66,
                                          C68, C82(F), C84(F) (excluding
                                          C84.6, C84.7), C85(F), C86(F)
                                          (excluding C86.5, C86.6),
                                          C91.4(F), C96(F).
Other urinary organs (C79.1)...........  C18, C50(F), C53(F), C56(F),
                                          C57(F), C61(M), C67, C64(F),
                                          C65(F), C66(F), C68(F).
Skin (C79.2)...........................  C18, C33, C34, C49(M), C43,
                                          C44(M), C50(F), C64(M),
                                          C65(M), C66(M), C68(M), D03.
Brain and spinal cord (C79.3)..........  C33, C34, C43(M), C50(F),
                                          D03(M).
Other parts of nervous system (C79.4)..  C33, C34, C43(M), C50(F),
                                          C61(M), C82, C84 (excluding
                                          C84.6, C84.7), C85, C86
                                          (excluding C86.5, C86.6),
                                          C91.4, C96, D03(M).
Bone and bone marrow (C79.5)...........  C33, C34, C50(F), C61(M).
Ovary (C79.6)..........................  C18(F), C50(F), C56(F), C57(F).
Adrenal gland (C79.7)..................  C18(F), C33, C34, C50(F).
Other specified sites (C79.8)..........  C18, C33, C34, C43(M), C50(F),
                                          C56(F), C57(F), C61(M),
                                          C67(M), D03(M).
Unspecified sites (C79.9)..............  C18, C33, C34, C43(M), C50(F),
                                          C56(F), C57(F), C61(M),
                                          C67(M), D03(M).
Carcinoid tumor of distant lymph nodes   C15(M), C16, C18, C33, C34,
 (C7B.01).                                C43, C50(F),C61(M), D03.
Carcinoid tumor of liver (C7B.02)......  C16(M), C18, C19(M), C20(M),
                                          C21(M), C25, C33, C34, C50(F).
Carcinoid tumor of bone (C7B.03).......  C33, C34, C50(F), C61(M).
Carcinoid tumor of peritoneum (C7B.04).  C16, C18, C19(M), C20(M),
                                          C21(M), C25, C33(M), C34(M),
                                          C49, C50(F), C54(F), C56(F),
                                          C57(F).
Merkel cell carcinoma (C7B.1)..........  C18, C33, C34, C49(M), C43,
                                          C44(M), C50(F), C64(M),
                                          C65(M), C66(M), C68(M), D03.
------------------------------------------------------------------------

    (b) DOL will select the site producing the highest estimate for 
probability of causation to adjudicate the claim.

[67 FR 22309, May 2, 2002, as amended at 84 FR 37590, Aug. 1, 2019]



Sec.  81.24  Guidelines for leukemia.

    (a) For claims involving leukemia, DOL will calculate one or more 
probability of causation estimates from up to three of the four 
alternate leukemia risk models included in NIOSH-IREP, as specified in 
the NIOSH-IREP Operating Guide. These include: ``Leukemia, all types'' 
(ICD-10-CM codes C91-C95), ``acute lymphocytic leukemia'' (ICD-10-CM 
code C91.0), and ``acute myelogenous leukemia'' (ICD-10-CM codes C92.6 
and C92.A).
    (b) For leukemia claims in which DOL calculates multiple probability 
of causation estimates, as specified in the NIOSH-IREP Operating Guide, 
the probability of causation estimate DOL assigns to the claim will be 
based on the leukemia risk model producing the highest estimate for 
probability of causation.

[67 FR 22309, May 2, 2002, as amended at 84 FR 37591, Aug. 1, 2019]



Sec.  81.25  Guidelines for claims including two or more primary cancers.

    For claims including two or more primary cancers, DOL will use 
NIOSH-IREP to calculate the estimated probability of causation for each 
cancer individually. Then DOL will perform the following calculation 
using the probability of causation estimates produced by NIOSH-IREP:

                               Equation 1

Calculate: 1-[{1-PC1{time}  x {1-PC2{time}  x . . 
. x {1-PCn{time} ] = PCtotal,

where PC1 is the probability of causation for one of the 
primary cancers identified in the claim, PC2 is the 
probability of causation for a second primary cancer identified in the

[[Page 598]]

claim, and PCn is the probability of causation for the nth 
primary cancer identified in the claim. PCtotal is the 
probability that at least one of the primary cancers (cancers 1 through 
``n'') was caused by the radiation dose estimated for the claim when 
Equation 1 is evaluated based on the joint distribution of 
PC1, . . ., PCn.\3\ DOL will use the probability 
of causation value calculated for PCtotal to adjudicate the 
claim.
---------------------------------------------------------------------------

    \3\ Evaluating Equation 1 based on the individual upper 99th 
percentiles of PC1, . . ., PCn approximates the 
upper 99th percentile of PCtotal whenever PC1, . . 
., PCn are highly related, e.g., when a common dose-
reconstruction is the only non-negligible source of uncertainty in the 
individual PCi's. However, this approximation can 
overestimate it if other sources of uncertainty contribute independently 
to the PC1, . . ., PCn, whereas treating the joint 
distribution as fully independent could substantially underestimate the 
upper 99th percentile of PCtotal whenever the individual 
PCi's are positively correlated.

[67 FR 22309, May 2, 2002; 67 FR 62096, Oct. 3, 2002; 84 FR 37591, Aug. 
1, 2019]



PART 82_METHODS FOR CONDUCTING DOSE RECONSTRUCTION UNDER THE ENERGY EMPLOYEES 
OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000--Table of Contents



                         Subpart A_Introduction

Sec.
82.0 Background Information on this part.
82.1 What is the purpose of this part?
82.2 What are the basics of dose reconstruction?
82.3 What are the requirements for dose reconstruction under EEOICPA?
82.4 How will DOL use the results of the NIOSH dose reconstructions?

                          Subpart B_Definitions

82.5 Definition of terms used in this part.

                  Subpart C_Dose Reconstruction Process

82.10 Overview of the dose reconstruction process.
82.11 For which claims under EEOICPA will NIOSH conduct a dose 
          reconstruction?
82.12 Will it be possible to conduct dose reconstructions for all 
          claims?
82.13 What sources of information may be used for dose reconstructions?
82.14 What types of information could be used in dose reconstructions?
82.15 How will NIOSH evaluate the completeness and adequacy of 
          individual monitoring data?
82.16 How will NIOSH add to monitoring data to remedy limitations of 
          individual monitoring and missed dose?
82.17 What types of information could be used to supplement or 
          substitute for individual monitoring data?
82.18 How will NIOSH calculate internal dose to the primary cancer 
          site(s)?
82.19 How will NIOSH address uncertainty about dose levels?

      Subpart D_Reporting and Review of Dose Reconstruction Results

82.25 When will NIOSH report dose reconstruction results, and to whom?
82.26 How will NIOSH report dose reconstruction results?
82.27 How can claimants obtain reviews of their NIOSH dose 
          reconstruction results by NIOSH?
82.28 Who can review NIOSH dose reconstruction files on individual 
          claimants?

 Subpart E_Updating Scientific Elements Underlying Dose Reconstructions

82.30 How will NIOSH inform the public of any plans to change scientific 
          elements underlying the dose reconstruction process to 
          maintain methods reasonably current with scientific progress?
82.31 How can the public recommend changes to scientific elements 
          underlying the dose reconstruction process?
82.32 How will NIOSH make changes in scientific elements underlying the 
          dose reconstruction process, based on scientific progress?
82.33 How will NIOSH inform the public of changes to the scientific 
          elements underlying the dose reconstruction process?

    Authority: 42 U.S.C. 7384n(d) and (e); E.O. 13179, 65 FR 77487, 3 
CFR, 2000 Comp., p. 321.

    Source: 67 FR 22330, May 2, 2002, unless otherwise noted.



                         Subpart A_Introduction



Sec.  82.0  Background information on this part.

    The Energy Employees Occupational Illness Compensation Program Act 
(EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the 
payment of compensation benefits to covered employees and, where 
applicable, survivors of such employees, of the United States Department 
of Energy (``DOE''), its predecessor agencies and certain of its 
contractors and subcontractors.

[[Page 599]]

Among the types of illnesses for which compensation may be provided are 
cancers. There are two categories of covered employees with cancer under 
EEOICPA for whom compensation may be provided. The regulations that 
follow under this part apply only to the category of employees described 
under paragraph (a) of this section.
    (a) One category is employees with cancer for whom a dose 
reconstruction must be conducted, as required under 20 CFR 30.115.
    (b) The second category is members of the Special Exposure Cohort 
seeking compensation for a specified cancer, as defined under EEOICPA. 
The U.S. Department of Labor (DOL) which has primary authority for 
implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 and 
30.213 that identify current members of the Special Exposure Cohort and 
requirements for compensation. Pursuant to section 3626 of EEOICPA, the 
Secretary of HHS is authorized to add additional classes of employees to 
the Special Exposure Cohort.



Sec.  82.1  What is the purpose of this part?

    The purpose of this part is to provide methods for determining a 
reasonable estimate of the radiation dose received by a covered employee 
with cancer under EEOICPA, through the completion of a dose 
reconstruction. These methods will be applied by the National Institute 
for Occupational Safety and Health (NIOSH) in a dose reconstruction 
program serving claimants under EEOICPA, as identified under Sec.  82.0.



Sec.  82.2  What are the basics of dose reconstruction?

    The basic principle of dose reconstruction is to characterize the 
radiation environments to which workers were exposed and to then place 
each worker in time and space within this exposure environment. Then 
methods are applied to translate exposure to radiation into quantified 
radiation doses at the specific organs or tissues relevant to the types 
of cancer occurring among the workers. A hierarchy of methods is used in 
a dose reconstruction, depending on the nature of the exposure 
conditions and the type, quality, and completeness of data available to 
characterize the environment.
    (a) If found to be complete and adequate, individual worker 
monitoring data, such as dosimeter readings and bioassay sample results, 
are given the highest priority in assessing exposure. These monitoring 
data are interpreted using additional data characterizing the workplace 
radiation exposures. If radiation exposures in the workplace environment 
cannot be fully characterized based on available data, default values 
based on reasonable and scientific assumptions may be used as 
substitutes. For dose reconstructions conducted in occupational illness 
compensation programs, this practice may include use of assumptions that 
represent the worst case conditions. For example, if the solubility 
classification of an inhaled material can not be determined, the dose 
reconstruction would use the classification that results in the largest 
dose to the organ or tissue relevant to the cancer and that is possible 
given existing knowledge of the material and process.
    (b) If individual monitoring data are not available or adequate, 
dose reconstructions may use monitoring results for groups of workers 
with comparable activities and relationships to the radiation 
environment. Alternatively, workplace area monitoring data may be used 
to estimate the dose. As with individual worker monitoring data, 
workplace exposure characteristics are used in combination with 
workplace monitoring data to estimate dose.
    (c) If neither adequate worker nor workplace monitoring data are 
available, the dose reconstruction may rely substantially on process 
description information to analytically develop an exposure model. For 
internal exposures, this model includes such factors as the quantity and 
composition of the radioactive substance (the source term), the chemical 
form, particle size distribution, the level of containment, and the 
likelihood of dispersion.



Sec.  82.3  What Are the Requirements for Dose Reconstruction Under EEOICPA?

    (a) Dose reconstructions are to be conducted for the following 
covered

[[Page 600]]

employees with cancer seeking compensation under EEOICPA: An employee 
who was not monitored for exposure to radiation at DOE or Atomic Weapons 
Employer (AWE) facilities; an employee who was monitored inadequately 
for exposure to radiation at such facilities; or an employee whose 
records of exposure to radiation at such facility are missing or 
incomplete. Technical limitations of radiation monitoring technology and 
procedures will require HHS to evaluate each employee's recorded dose. 
In most, if not all cases, monitoring limitations will result in 
possibly undetected or unrecorded doses, which are estimated using 
commonly practiced dose reconstruction methods and would have to be 
added to the dose record.
    (b) Section 7384(n)(e) of EEOICPA requires the reporting of 
radiation dose information resulting from dose reconstructions to the 
covered employees for whom claims are being adjudicated. DOE is 
specifically charged with this responsibility but the Department of 
Health and Human Services (HHS), which will be producing the dose 
reconstruction information, will report its findings directly to the 
claimant, as well as to DOL and DOE. HHS will also make available to 
researchers and the general public information on the assumptions, 
methodology, and data used in estimating radiation doses, as required by 
EEOICPA.



Sec.  82.4  How Will DOL Use the Results of the NIOSH Dose Reconstructions?

    Under 42 CFR part 81, DOL will apply dose reconstruction results 
together with information on cancer diagnosis and other personal 
information provided to DOL by the claimant to calculate an estimated 
probability of causation. This estimate is the probability that the 
cancer of the covered employee was caused by radiation exposure at a 
covered facility of DOE or an Atomic Weapons Employer (AWE).



                          Subpart B_Definitions



Sec.  82.5  Definition of terms used in this part.

    (a) Atomic weapons employer (AWE) means any entity, other than the 
United States, that:
    (1) processed or produced, for use by the United States, material 
that emitted radiation and was used in the production of an atomic 
weapon, excluding uranium mining and milling; and,
    (2) is designated by the Secretary of Energy as an atomic weapons 
employer for purposes of EEOICPA.
    (b) Bioassay means the determination of the kinds, quantities, or 
concentrations, and in some cases, locations of radioactive material in 
the human body, whether by direct measurement or by analysis, and 
evaluation of radioactive material excreted or eliminated by the body.
    (c) Claimant means the individual who has filed with the Department 
of Labor for compensation under EEOICPA.
    (d) Covered employee means, for the purposes of this part, an 
individual who is or was an employee of DOE, a DOE contractor or 
subcontractor, or an atomic weapons employer, and for whom DOL has 
requested HHS to perform a dose reconstruction.
    (e) Covered facility means any building, structure, or premises, 
including the grounds upon which such building, structure, or premise is 
located:
    (1) In which operations are, or have been, conducted by, or on 
behalf of, the DOE (except for buildings, structures, premises, grounds, 
or operations covered by Executive Order 12344, dated February 1, 1982, 
pertaining to the Naval Nuclear Propulsion Program); and,
    (2) With regard to which the DOE has or had:
    (i) A proprietary interest; or,
    (ii) Entered into a contract with an entity to provide management 
and operation, management and integration, environmental remediation 
services, construction, or maintenance services; or
    (3) A facility owned by an entity designated by the Secretary of 
Energy as an atomic weapons employer for purposes of EEOICPA that is or 
was used to process or produce, for use by the United States, material 
that emitted radiation and was used in the production of an atomic 
weapon, excluding uranium mining or milling.
    (f) DOE means the U.S. Department of Energy, and includes 
predecessor

[[Page 601]]

agencies of DOE, including the Manhattan Engineering District.
    (g) DOL means the U.S. Department of Labor.
    (h) EEOICPA means the Energy Employees Occupational Illness 
Compensation Program Act of 2000, 42 U.S.C. 7384-7385 [1994, supp. 
2001].
    (i) Equivalent dose is the absorbed dose in a tissue multiplied by a 
radiation weighting factor to account for differences in the 
effectiveness of the radiation in inducing cancer.
    (j) External dose means that portion of the equivalent dose that is 
received from radiation sources outside of the body.
    (k) Internal dose means that portion of the equivalent dose that is 
received from radioactive materials taken into the body.
    (l) NIOSH means the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    (m) Primary cancer means a cancer defined by the original body site 
at which the cancer was incurred, prior to any spread (metastasis) 
resulting in tumors at other sites in the body.
    (n) Probability of causation means the probability or likelihood 
that a cancer was caused by radiation exposure incurred by a covered 
employee in the performance of duty. In statistical terms, it is the 
cancer risk attributable to radiation exposure divided by the sum of the 
baseline cancer risk (the risk to the general population) plus the 
cancer risk attributable to the radiation exposure. This concept is 
further explained under 42 CFR part 81, which provides guidelines by 
which DOL will determine probability of causation under EEOICPA.
    (o) Radiation means ionizing radiation, including alpha particles, 
beta particles, gamma rays, x rays, neutrons, protons and other 
particles capable of producing ions in the body. For purposes of this 
rule, radiation does not include sources of non-ionizing radiation such 
as radio-frequency radiation, microwaves, visible light, and infrared or 
ultraviolet light radiation.
    (p) Specified cancer is a term defined in Section 3621(17) of 
EEOICPA and 20 CFR 30.5(dd) that specifies types of cancer that, 
pursuant to 20 CFR part 30, may qualify a member of the Special Exposure 
Cohort for compensation. It includes leukemia (other than chronic 
lymphocytic leukemia), multiple myeloma, non-Hodgkin's lymphoma, and 
cancers of the lung (other than carcinoma in situ diagnosed at autopsy), 
thyroid, male breast, female breast, esophagus, stomach, pharynx, small 
intestine, pancreas, bile ducts, gall bladder, salivary gland, urinary 
bladder, brain, colon, ovary, liver (not associated with cirrhosis or 
hepatitis), and bone. Pursuant to section 2403 of Public Law 107-20, 
this definition will include renal cancer effective October 1, 2001.
    (q) Uncertainty distribution is a statistical term meaning a range 
of discrete or continuous values arrayed around a central estimate, 
where each value is assigned a probability of being correct.
    (r) Worst-case assumption is a term used to describe a type of 
assumption used in certain instances for certain dose reconstructions 
conducted under this rule. It assigns the highest reasonably possible 
value, based on reliable science, documented experience, and relevant 
data, to a radiation dose of a covered employee.



                  Subpart C_Dose Reconstruction Process



Sec.  82.10  Overview of the dose reconstruction process.

    (a) Upon receipt of a claims package from the Department of Labor, 
as provided under 20 CFR part 30, NIOSH will request from DOE records on 
radiation dose monitoring and radiation exposures associated with the 
employment history of the covered employee. Additionally, NIOSH may 
compile data, and information from NIOSH records that may contribute to 
the dose reconstruction. For each dose reconstruction, NIOSH will 
include records relevant to internal and external exposures to ionizing 
radiation, including exposures from medical screening x rays that were 
required as a condition of employment.
    (b) NIOSH will evaluate the initial radiation exposure record 
compiled to: Reconcile the exposure record with the

[[Page 602]]

reported employment history, as necessary; complete preliminary 
calculations of dose, based upon this initial record, and prepare to 
consult with the claimant. Any discrepancies in the employment history 
information will be reconciled with the assistance of DOE, as necessary.
    (c) NIOSH will interview the claimant. The interview may be 
conducted in one or more sessions. The purpose of the interview is to:
    (1) Explain the dose reconstruction process;
    (2) Confirm elements of the employment history transmitted to NIOSH 
by DOL;
    (3) Identify any relevant information on employment history that may 
have been omitted;
    (4) Confirm or supplement monitoring information included in the 
initial radiation exposure record;
    (5) Develop detailed information on work tasks, production 
processes, radiologic protection and monitoring practices, and incidents 
that may have resulted in undocumented radiation exposures, as 
necessary;
    (6) Identify co-workers and other witnesses with information 
relevant to the radiation exposures of the covered worker to supplement 
or confirm information on work experiences, as necessary.
    (d) NIOSH will provide a report to the claimant summarizing the 
findings of the interview, titled: ``NIOSH Claimant Interview under 
EEOICPA.'' The report will also notify the claimant of the opportunity 
to contact NIOSH if necessary, by a specified date, to make any written 
corrections or additions to information provided by the claimant during 
the interview process.
    (e) Information provided by the claimant will be accepted and used 
for dose reconstruction, providing it is reasonable, supported by 
substantial evidence, and is not refuted by other evidence. In assessing 
whether the information provided by the claimant is supported by 
substantial evidence, NIOSH will consider:
    (1) Consistency of the information with other information in the 
possession of NIOSH, from radiation safety programs, research, medical 
screening programs, labor union documents, worksite investigations, dose 
reconstructions conducted by NIOSH under EEOICPA, or other reports 
relating to the circumstances at issue;
    (2) Consistency of the information with medical records provided by 
the claimant;
    (3) Consistency of the information with practices or exposures 
demonstrated by the dose reconstruction record developed for the 
claimant; and,
    (4) Confirmation of information by co-workers or other witnesses.
    (f) NIOSH will seek to confirm information provided by the claimant 
through review of available records and records requested from DOE.
    (g) As necessary, NIOSH will request additional records from DOE to 
characterize processes and tasks potentially involving radiation 
exposure for which dose and exposure monitoring data is incomplete or 
insufficient for dose reconstruction.
    (h) NIOSH will review the adequacy of monitoring data and 
completeness of records provided by DOE. NIOSH will request 
certification from DOE that record searches requested by NIOSH have been 
completed.
    (i) As necessary, NIOSH will characterize the internal and external 
exposure environments for parameters known to influence the dose. For 
internal exposures, examples of these parameters include the mode of 
intake, the composition of the source term (i.e., the radionuclide type 
and quantity), the particle size distribution and the absorption type. 
When it is not possible to characterize these parameters, NIOSH may use 
default values, when they can be established reasonably, fairly, and 
based on relevant science. For external exposures, the radiation type 
(gamma, x-ray, neutron, beta, or other charged particle) and radiation 
energy spectrum will be evaluated. When possible, the effect of non-
uniformity and geometry of the radiation exposure will be assessed.
    (j) For individual monitoring records that are incomplete, NIOSH may 
assign doses using techniques discussed in Sec.  82.16. Once the 
resulting data set is complete, NIOSH will construct an occupational 
exposure matrix, using the

[[Page 603]]

general hierarchical approach discussed in Sec.  82.2. This matrix will 
contain the estimated annual equivalent dose(s) to the relevant organ(s) 
or tissue(s), for the period from the initial date of potential exposure 
at a covered facility until the date the cancer was diagnosed. The 
equivalent dose(s) will be calculated using the current, standard 
radiation weighting factors from the International Commission on 
Radiological Protection. \1\
---------------------------------------------------------------------------

    \1\ The current weighting factors of the International Commission on 
Radiological Protection are provided in ICRP 60: ``1990 Recommendations 
of the International Commission on Radiological Protection.'' Ann. ICRP 
21 (1-3):6.
---------------------------------------------------------------------------

    (k) At any point during steps of dose reconstruction described in 
paragraphs (f) through (j) of this section, NIOSH may determine that 
sufficient research and analysis has been conducted to complete the dose 
reconstruction. Research and analysis will be determined sufficient if 
one of the following three conditions is met:
    (1) From acquired experience, it is evident the estimated cumulative 
dose is sufficient to qualify the claimant for compensation (i.e., the 
dose produces a probability of causation of 50% or greater);
    (2) Dose is determined using worst-case assumptions related to 
radiation exposure and intake, to substitute for further research and 
analyses; or,
    (3) Research and analysis indicated under steps described in 
paragraphs (f)-(j) of this section have been completed. Worst-case 
assumptions will be employed under condition 2 to limit further research 
and analysis only for claims for which it is evident that further 
research and analysis will not produce a compensable level of radiation 
dose (a dose producing a probability of causation of 50% or greater), 
because using worst-case assumptions it can be determined that the 
employee could not have incurred a compensable level of radiation dose. 
For all claims in which worst-case assumptions are employed under 
condition 2, the reasoning that resulted in the determination to limit 
further research and analysis will be clearly described in the draft of 
the dose reconstruction results reported to the claimant under Sec.  
82.25 and in the dose reconstruction results reported to the claimant 
under Sec.  82.26.
    (l) After providing the claimant with a copy of a draft of the dose 
reconstruction report to be provided to DOL, NIOSH will conduct a 
closing interview with the claimant to review the dose reconstruction 
results and the basis upon which the results were calculated. This will 
be the final opportunity during the dose reconstruction process for the 
claimant to provide additional relevant information that may affect the 
dose reconstruction. The closing interview may require multiple 
sessions, if the claimant requires time to obtain and provide additional 
information, and to allow NIOSH time to integrate the new information 
into a new draft of the dose reconstruction report. NIOSH will determine 
whether to grant requests for time to provide additional information, 
based on whether the requests are reasonable and the claimant is 
actively seeking the information specified.
    (m) Subject to any additional information provided by the claimant 
and revision of the draft dose reconstruction report under Sec.  
82.10(l), the claimant is required to return form OCAS-1 to NIOSH, 
certifying that the claimant has completed providing information and 
that the record for dose reconstruction should be closed. Upon receipt 
of the form, NIOSH will forward a final dose reconstruction report to 
DOL, DOE, and to the claimant.
    (n) NIOSH will not forward the dose reconstruction report to DOL for 
adjudication without receipt of form OCAS-1 signed by the claimant or a 
representative of the claimant authorized pursuant to 20 CFR 30.600. If 
the claimant or the authorized representative of the claimant fails to 
sign and return form OCAS-1 within 60 days, or 60 days following the 
claimant's final provision of additional information and receipt of a 
revised draft dose reconstruction report under Sec.  82.10 (l), 
whichever occurs last, after notifying the claimant or the authorized 
representative, NIOSH may administratively close the dose reconstruction 
and notify DOL of this action. Upon receiving this notification by 
NIOSH, DOL may administratively close the claim.

[[Page 604]]

    (o) Once actions under Sec.  82.10 (m) are completed, the record for 
dose reconstruction shall be closed unless reopened at the request of 
DOL under 20 CFR part 30.



Sec.  82.11  For which claims under EEOICPA will NIOSH conduct 
a dose reconstruction?

    NIOSH will conduct a dose reconstruction for each claim determined 
by DOL to be a claim for a covered employee with cancer under DOL 
regulations at 20 CFR 30.210(b), subject to the limitation and exception 
noted in Sec.  82.12. Claims for covered employees who are members of 
the Special Exposure Cohort seeking compensation for a specified cancer, 
as determined by DOL under 20 CFR 30.210(a), do not require and will not 
receive a dose reconstruction under this rule.



Sec.  82.12  Will it be possible to conduct dose reconstructions 
for all claims?

    It is uncertain whether adequate information of the types outlined 
under Sec.  82.14 will be available to complete a dose reconstruction 
for every claim eligible under Sec.  82.11.
    (a) NIOSH will notify in writing any claimants for whom a dose 
reconstruction cannot be completed once that determination is made, as 
well as in the closing interview provided for under Sec.  82.10(l).
    (b) Notification will describe the basis for finding a dose 
reconstruction cannot be completed, including the following:
    (1) A summary of the information obtained from DOE and other 
sources; and, (2) a summary of necessary information found to be 
unavailable from DOE and other sources.
    (c) NIOSH will notify DOL and DOE when it is unable to complete a 
dose reconstruction for the claimant. This will result in DOL producing 
a recommended decision to deny the claim, since DOL cannot determine 
probability of causation without a dose estimate produced by NIOSH under 
this rule.
    (d) A claimant for whom a dose reconstruction cannot be completed, 
as indicated under this section, may have recourse to seek compensation 
under provisions of the Special Exposure Cohort (see 20 CFR part 30). 
Pursuant to section 7384q of EEOICPA, the Secretary of HHS is authorized 
to add classes of employees to the Special Exposure Cohort. NIOSH will 
provide the claimant with any information and forms that HHS provides to 
classes of employees seeking to petition to be added to the Special 
Exposure Cohort.



Sec.  82.13  What sources of information may be used for dose reconstructions?

    NIOSH will use the following sources of information for dose 
reconstructions, as necessary:
    (a) DOE and its contractors, including Atomic Weapons Employers and 
the former worker medical screening program;
    (b) NIOSH and other records from health research on DOE worker 
populations;
    (c) Interviews and records provided by claimants;
    (d) Co-workers of covered employees, or others with information 
relevant to the covered employee's exposure, that the claimant 
identified during the initial interview with NIOSH;
    (e) Labor union records from unions representing employees at 
covered facilities of DOE or AWEs; and,
    (f) Any other relevant information.



Sec.  82.14  What types of information could be used in dose reconstructions?

    NIOSH will obtain the types of information described in this section 
for dose reconstructions, as necessary and available:
    (a) Subject and employment information, including:
    (1) Gender;
    (2) Date of birth; and,
    (3) DOE and/or AWE employment history, including: job title held by 
year, and work location(s): including site names(s), building 
numbers(s), technical area(s), and duration of relevant employment or 
tasks.
    (b) Worker monitoring data, including:
    (1) External dosimetry data, including external dosimeter readings 
(film badge, TLD, neutron dosimeters); and,
    (2) Pocket ionization chamber data.
    (c) Internal dosimetry data, including:
    (1) Urinalysis results;
    (2) Fecal sample results;

[[Page 605]]

    (3) In Vivo measurement results;
    (4) Incident investigation reports;
    (5) Breath radon and/or thoron results;
    (6) Nasal smear results;
    (7) External contamination measurements; and
    (8) Other measurement results applicable to internal dosimetry.
    (d) Monitoring program data, including:
    (1) Analytical methods used for bioassay analyses;
    (2) Performance characteristics of dosimeters for different 
radiation types;
    (3) Historical detection limits for bioassay samples and dosimeter 
badges;
    (4) Bioassay sample and dosimeter collection/exchange frequencies;
    (5) Documentation of record keeping practices used to record data 
and/or administratively assign dose; and,
    (6) Other information to characterize the monitoring program 
procedures and evaluate monitoring results.
    (e) Workplace monitoring data, including:
    (1) Surface contamination surveys;
    (2) General area air sampling results;
    (3) Breathing zone air sampling results;
    (4) Radon and/or thoron monitoring results;
    (5) Area radiation survey measurements (beta, gamma and neutron); 
and,
    (6) Fixed location dosimeter results (beta, gamma and neutron); and,
    (7) Other workplace monitoring results.
    (f) Workplace characterization data, including:
    (1) Information on the external exposure environment, including: 
radiation type (gamma, x-ray, proton, neutron, beta, other charged 
particle); radiation energy spectrum; uniformity of exposure (whole body 
vs partial body exposure); irradiation geometry;
    (2) Information on work-required medical screening x rays; and,
    (3) Other information useful for characterizing workplace radiation 
exposures.
    (g) Information characterizing internal exposures, including:
    (1) Radionuclide(s) and associated chemical forms;
    (2) Results of particle size distribution studies;
    (3) Respiratory protection practices; and
    (4) Other information useful for characterizing internal exposures.
    (h) Process descriptions for each work location, including:
    (1) General description of the process;
    (2) Characterization of the source term (i.e., the radionuclide and 
its quantity);
    (3) Extent of encapsulation;
    (4) Methods of containment;
    (5) Other information to assess potential for irradiation by source 
or airborne dispersion radioactive material.



Sec.  82.15  How will NIOSH evaluate the completeness and adequacy of 
individual monitoring data?

    (a) NIOSH will evaluate the completeness and adequacy of an 
individual's monitoring data provided by DOE through one or more 
possible measures including, but not limited to:
    (1) Comparisons with information provided by claimants, co-workers, 
and other witnesses;
    (2) Comparisons with available information on area monitoring, 
production processes, and radiologic protection programs;
    (3) Comparisons with information documented in the records of unions 
representing covered employees;
    (4) Comparisons with data available on co-workers; and
    (5) Reviews of DOE contractor record systems.
    (b) NIOSH will evaluate the instruments and procedures used to 
collect individual monitoring data to determine whether they adequately 
characterized the radiation environments in which the covered employee 
worked, (adequately for the purpose of dose reconstruction,) based on 
present-day scientific understanding. For external dosimeter 
measurements, this includes an evaluation of the dosimeter response to 
the radiation types (gamma, x-ray, neutron, beta, or other charged 
particle) and the associated energy spectrum. For internal exposure, the 
methods used to analyze bioassay samples will be reviewed to determine

[[Page 606]]

their ability to detect the radionuclides present in the work 
environment. An analysis of the monitoring or exchange frequencies for 
the monitoring programs will also be conducted to determine the 
potential for undetected dose.



Sec.  82.16  How will NIOSH add to monitoring data to remedy limitations 
of individual monitoring and missed dose?

    (a) For external dosimeter results that are incomplete due to 
historical record keeping practices, NIOSH will use commonly practiced 
techniques, such as those described in the NIOSH Research Issues 
Workshop, \2\ to estimate the missing component of dose and to add this 
to the total dose estimate. For monitoring periods where external 
dosimetry data are missing from the records, NIOSH will estimate a 
claimant's dose based on interpolation, using available monitoring 
results from other time periods close to the period in question, or 
based on monitoring data on other workers engaged in similar tasks.
---------------------------------------------------------------------------

    \2\ NIOSH [1995]. NIOSH research issues workshop: epidemiologic use 
of nondetectable values in radiation exposure measurements. Cincinnati, 
OH: U.S. Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health, DHHS (NIOSH) Publication No. 224647 
(NTIS--PB 95189601).
---------------------------------------------------------------------------

    (b) NIOSH will review historical bioassay sample detection limits 
and monitoring frequencies to determine, when possible, the minimum 
detectable dose for routine internal dose monitoring programs. This 
``missed dose'' will establish the upper limit of internal dose that a 
worker could have received for periods when bioassay sample analysis 
results were below the detection limit. Using ICRP biokinetic models, 
NIOSH will estimate the internal dose and include an associated 
uncertainty distribution.



Sec.  82.17  What types of information could be used to supplement 
or substitute for individual monitoring data?

    Three types of information could be used:
    (a) Monitoring data from co-workers, if NIOSH determines they had a 
common relationship to the radiation environment; or,
    (b) A quantitative characterization of the radiation environment in 
which the covered employee worked, based on an analysis of historical 
workplace monitoring information such as area dosimeter readings, 
general area radiation and radioactive contamination survey results, air 
sampling data; or,
    (c) A quantitative characterization of the radiation environment in 
which the employee worked, based on analysis of data describing 
processes involving radioactive materials, the source materials, 
occupational tasks and locations, and radiation safety practices.



Sec.  82.18  How will NIOSH calculate internal dose to 
the primary cancer site(s)?

    (a) The calculation of dose from ingested, inhaled or absorbed 
radioactivity involves the determination of the types and quantities of 
radionuclides that entered the body. NIOSH will use the results of all 
available bioassay monitoring information as appropriate, based on 
assessment of the technical characteristics of the monitoring program. 
If bioassay monitoring data are unavailable or inadequate, the dose 
reconstruction will rely on the results of air sampling measurements, 
radiation sources, work processes and practices, and incidents involving 
radiation contamination, as necessary.
    (b) NIOSH will calculate the dose to the organ or tissue of concern 
using the appropriate current metabolic models published by ICRP. Using 
data available to NIOSH, the models will be based on exposure conditions 
representative of the work environment. When NIOSH cannot establish 
exposure conditions with sufficient specificity, the dose calculation 
will assume exposure conditions that maximize the dose to the organ 
under consideration. When the cancer covered by a claim is in a tissue 
not covered by existing ICRP models, NIOSH will use the ICRP model that 
best approximates the model needed, while giving the benefit of the 
doubt to the claimant. For internal exposures, NIOSH will select the 
highest dose estimate from among the

[[Page 607]]

modeled organs or tissues that do not concentrate the radionuclide.
    (c) Internal doses will be calculated for each year of exposure from 
the date of initial exposure to the date of cancer diagnosis.



Sec.  82.19  How will NIOSH address uncertainty about dose levels?

    The estimate of each annual dose will be characterized with a 
probability distribution that accounts for the uncertainty of the 
estimate. This information will be used by DOL in the calculation of 
probability of causation, under HHS guidelines for calculating 
probability of causation estimates at 42 CFR 81. In this way, claimants 
will receive the benefit of the doubt in cases in which the actual dose 
may have exceeded the best estimate calculated by NIOSH.



      Subpart D_Reporting and Review of Dose Reconstruction Results



Sec.  82.25  When will NIOSH report dose reconstruction results, and to whom?

    NIOSH will report dose reconstruction results to DOL and to the 
claimant, as provided for under Sec.  82.10. Draft results will be 
reported to the claimant upon tentative completion of the dose 
reconstruction. Final results will be reported to the claimant, DOL and 
DOE after NIOSH receives certification from the claimant that the 
claimant has completed providing information to NIOSH for the dose 
reconstruction (Form OCAS-1).



Sec.  82.26  How will NIOSH report dose reconstruction results?

    (a) NIOSH will provide dose reconstruction results to the claimant, 
DOL, and DOE in a report: ``NIOSH Report of Dose Reconstruction under 
EEOICPA.'' The report itself will not provide information on probability 
of causation, which DOL must calculate to determine a recommended 
decision on the claim.
    (b) The report will include the following information, as relevant:
    (1) Annual dose estimates (or a fraction thereof) related to covered 
employment for each year from the date of initial radiation exposure at 
a covered facility to the date of cancer diagnosis;
    (2) Separate dose estimates for acute and chronic exposures, 
different types of ionizing radiation, and internal and external doses, 
providing internal dose information only for the organ or tissue 
relevant to the primary cancer site(s) established in the claim;
    (3) Uncertainty distributions associated with each dose estimated, 
as necessary;
    (4) Explanation of each type of dose estimate included in terms of 
its relevance for estimating probability of causation;
    (5) Identification of any information provided by the claimant 
relevant to dose estimation that NIOSH decided to omit from the basis 
for dose reconstruction, justification for the decision, and if 
possible, a quantitative estimate of the effect of the omission on the 
dose reconstruction results; and
    (6) A summary and explanation of information and methods applied to 
produce the dose reconstruction estimates, including any factual 
findings and the evidence upon which those findings are based.
    (c) As provided under Sec.  82.10(l), NIOSH staff will conduct a 
closing interview with claimants to explain the dose reconstruction 
report.



Sec.  82.27  How can claimants obtain reviews of their NIOSH dose 
reconstruction results by NIOSH?

    (a) Claimants can seek reviews of their dose reconstruction through 
the processes established by DOL under 20 CFR 30. DOL will request NIOSH 
to review dose reconstructions under the following conditions, as 
provided under 20 CFR 30.318:
    (1) DOL may determine that factual findings of the dose 
reconstruction do not appear to be supported by substantial evidence; 
or,
    (2) Although the methodology established by HHS under this Part is 
binding on DOL, DOL may determine that arguments concerning the 
application of this methodology should be considered by NIOSH.
    (b) NIOSH may review completed dose reconstructions on its own 
initiative and with the assistance of DOL to

[[Page 608]]

identify denied claims when either of the following circumstances arise:
    (1) NIOSH obtains records or information on radiation exposures of 
DOE or AWE employees that could substantially increase the level of 
radiation doses estimated in the completed dose reconstructions; or
    (2) NIOSH changes a scientific element underlying dose 
reconstructions according to the provisions of Subpart E of this rule 
and the change could substantially increase the level of radiation doses 
estimated in the completed dose reconstructions.
    (c) When NIOSH completes the review of a dose reconstruction, NIOSH 
will provide a report describing the basis for the review, the methods 
employed in the review, and the review findings to the claimant, DOL, 
and DOE.



Sec.  82.28  Who can review NIOSH dose reconstruction files 
on individual claimants?

    (a) Claimants and DOL will be provided individual dose 
reconstruction files, upon request. Claimants should note, however, that 
a complete summary of the data and methods used in a dose reconstruction 
will be included in the ``NIOSH Report of Dose Reconstruction under 
EEOICPA''.
    (b) Researchers and the public will be provided limited access to 
NIOSH dose reconstruction files, subject to provisions and restrictions 
of the Privacy Act for the protection of confidential information on 
individuals.



       Subpart E_Updating the Scientific Elements Underlying Dose 
                             Reconstructions



Sec.  82.30  How will NIOSH inform the public of any plans to change 
scientific elements underlying the dose reconstruction process 
to maintain methods reasonably current with scientific progress?

    Periodically, NIOSH will publish a notice in the Federal Register 
notifying the public of plans to change scientific elements underlying 
the dose reconstruction process under EEOICPA to reflect scientific 
progress. Notice will include a summary of the planned changes and the 
expected completion date for such changes.



Sec.  82.31  How can the public recommend changes to scientific elements 
underlying the dose reconstruction process?

    (a) At any time, the public can submit written recommendations to 
NIOSH for changes to scientific elements underlying the dose 
reconstruction process, based on relevant new research findings and 
technological advances. NIOSH will provide these recommendations to the 
Advisory Board on Radiation and Worker Health to be addressed at a 
public meeting of the Advisory Board, with notification provided to the 
source of the recommendations. Recommendations should be addressed to: 
Director, Office of Compensation Analysis and Support, National 
Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS-
R45, Cincinnati, Ohio 45226.
    (b) The public can also submit recommendations by e-mail. 
Instructions will be provided on the NIOSH Internet homepage at 
www.cdc.gov/niosh/ocas.



Sec.  82.32  How will NIOSH make changes in scientific elements 
underlying the dose reconstruction process, based on scientific progress?

    NIOSH will present proposed changes to the Advisory Board on 
Radiation and Worker Health prior to implementation. These proposed 
changes will be summarized in a notice published in the Federal 
Register. The public will have the opportunity to comment on proposed 
changes at the meeting of the Advisory Board and/or in written comments 
submitted for this purpose. NIOSH will fully consider the comments of 
the Advisory Board and of the public before deciding upon any changes.



Sec.  82.33  How will NIOSH inform the public of changes to 
the scientific elements underlying the dose reconstruction process?

    (a) NIOSH will publish a notice in the Federal Register informing 
the public of changes and the rationale for the changes. This notice 
will also provide a summary of the recommendations and comments received 
from the Advisory

[[Page 609]]

Board and the public, as well as responses to the comments.
    (b) NIOSH may take into account other factors and employ other 
procedures than those specified in this subpart, if circumstances arise 
that require NIOSH to implement a change more immediately than the 
procedures in this subpart allow.



 PART 83_PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS 
 OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL 
 ILLNESS COMPENSATION PROGRAM ACT OF 2000--Table of Contents



                         Subpart A_Introduction

Sec.
83.0 Background information on the procedures in this part.
83.1 What is the purpose of the procedures in this part?
83.2 How will DOL use the designations established under the procedures 
          in this part?

                          Subpart B_Definitions

83.5 Definitions of terms used in the procedures in this part.

   Subpart C_Procedures for Adding Classes of Employees to the Cohort

83.6 Overview of the procedures in this part.
83.7 Who can submit a petition on behalf of a class of employees?
83.8 How is a petition submitted?
83.9 What information must a petition include?
83.10 If a petition satisfies all relevant requirements under Sec.  
          83.9, does this mean the class will be added to the Cohort?
83.11 What happens to petition submissions that do not satisfy all 
          relevant requirements under Sec. Sec.  83.7 through 83.9?
83.12 How will NIOSH notify petitioners, the Board, and the public of 
          petitions that have been selected for evaluation?
83.13 How will NIOSH evaluate petitions, other than petitions by 
          claimants covered under Sec.  83.14?
83.14 How will NIOSH evaluate a petition by a claimant whose dose 
          reconstruction NIOSH could not complete under 42 CFR Part 82?
83.15 How will the Board consider and advise the Secretary on a 
          petition?
83.16 How will the Secretary decide the outcome of a petition?
83.17 How will the Secretary report a final decision to add a class of 
          employees to the Cohort and any action of Congress concerning 
          the effect of the final decision?
83.18 How can petitioners obtain an administrative review of a final 
          decision by the Secretary?
83.19 How can the Secretary cancel or modify a final decision to add a 
          class of employees to the Cohort?

    Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000 
Comp., p. 321.

    Source: 69 FR 30780, May 28, 2004, unless otherwise noted.



                         Subpart A_Introduction



Sec.  83.0  Background information on the procedures in this part.

    The Energy Employees Occupational Illness Compensation Program Act, 
as amended (``EEOICPA'' or ``the Act''), 42 U.S.C. 7384-7385, provides 
for the payment of compensation benefits to covered employees and, where 
applicable, survivors of such employees, of DOE, its predecessor 
agencies and certain of its contractors and subcontractors. Among the 
types of illnesses for which compensation may be provided are cancers. 
There are two methods set forth in the statute for claimants to 
establish that a cancer incurred by a covered worker is compensable 
under EEOICPA. The first is to establish that the cancer is at least as 
likely as not related to covered employment at a DOE or Atomic Weapons 
Employer (``AWE'') facility pursuant to guidelines issued by the 
Department of Health and Human Services (``HHS''), which are found at 42 
CFR part 81. The second method to establish that a cancer incurred by a 
covered worker is compensable under EEOICPA is to establish that the 
worker is a member of the Special Exposure Cohort (``the Cohort'') and 
suffered a specified cancer after beginning employment at a DOE facility 
or AWE facility. In Section 3621(14) of EEOICPA (42 U.S.C. 7384l(14)) 
Congress included certain classes of employees in the Cohort. Section 
3626 of the Act (42 U.S.C. 7384q) authorizes the addition to the Cohort 
of other classes of employees. This authority has been delegated to the 
Secretary of HHS by Executive Order 13179.

[[Page 610]]



Sec.  83.1  What is the purpose of the procedures in this part?

    EEOICPA authorizes the President to add classes of employees to the 
Cohort, while providing Congress with the opportunity to review and 
expedite or reverse these decisions. The President delegated his 
authority to the Secretary of HHS. This part specifies the procedures by 
which HHS will determine whether to add new classes of employees from 
DOE and AWE facilities to the Cohort. HHS will consider adding new 
classes of employees in response to petitions by, or on behalf of, such 
classes of employees. The procedures specify requirements for petitions 
and for their consideration. These requirements are intended to ensure 
that petitions are submitted by authorized parties, are justified, and 
receive uniform, fair, scientific consideration. The procedures are also 
designed to give petitioners and interested parties opportunity for 
appropriate involvement in the process, and to ensure that the process 
is timely and consistent with requirements specified in EEOICPA. The 
procedures are not intended to provide a second opportunity to qualify a 
claim for compensation, once HHS has completed the dose reconstruction 
and DOL has determined that the cancer subject to the claim was not ``at 
least as likely as not'' caused by the estimated radiation doses. DOL 
has established procedures separate from those covered by this part, 
under 20 CFR part 30, for cancer claimants who want to contest the 
factual determinations or how NIOSH conducted their dose 
reconstructions.



Sec.  83.2  How will DOL use the designations established 
under the procedures in this part?

    DOL will adjudicate compensation claims for members of classes of 
employees added to the Cohort according to the same general procedures 
that apply to the statutorily defined classes of employees in the 
Cohort. Specifically, DOL will determine whether the claim is for a 
qualified member of the Cohort with a specified cancer, pursuant to the 
procedures set forth in 20 CFR part 30.



                          Subpart B_Definitions



Sec.  83.5  Definitions of terms used in the procedures in this part.

    (a) Advisory Board on Radiation and Worker Health (``the Board'') is 
a federal advisory committee established under EEOICPA and appointed by 
the President to advise HHS in implementing its responsibilities under 
EEOICPA.
    (b) Atomic Weapons Employer (``AWE'') is a statutory term of EEOICPA 
which means any entity, other than the United States, that:
    (1) Processed or produced, for use by the United States, material 
that emitted radiation and was used in the production of an atomic 
weapon, excluding uranium mining and milling: and,
    (2) Is designated by the Secretary of Energy as an atomic weapons 
employer for purposes of EEOICPA.
    (c) Computation of Time Periods: In this Rule, all prescribed or 
allowed time periods will be counted as calendar days from the business 
day of receipt by the submitter(s), the petitioner(s), NIOSH, or HHS. 
Receipt by NIOSH, the submitter(s) or petitioner(s) will be either the 
business day of actual receipt or three (3) business days after initial 
proof of mailing, whichever time period is shorter. Business days are 
defined as Monday through Friday, 8 a.m. to 4:30 p.m. est and ``legal 
holiday'' will be used as defined by the FED. R. CIV. P. 6(a).
    (d) Class of employees means, for the purposes of this part, a group 
of employees who work or worked at the same DOE facility or AWE 
facility, and for whom the availability of information and recorded data 
on radiation exposures is comparable with respect to the informational 
needs of dose reconstructions conducted under 42 CFR part 82.
    (e) HHS is the U.S. Department of Health and Human Services.
    (f) DOE is the U.S. Department of Energy, which includes predecessor 
agencies of DOE, including the Manhattan Engineering District.
    (g) DOL is the U.S. Department of Labor.
    (h) Employee, for the purposes of these procedures, means a person 
who is or was, for the purposes of EEOICPA, an employee of DOE, a DOE 
contractor

[[Page 611]]

or subcontractor, or an Atomic Weapons Employer.
    (i) NIOSH is the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    (j) OCAS is the Office of Compensation Analysis and Support, 
National Institute for Occupational Safety and Health, Centers for 
Disease Control and Prevention, U.S. Department of Health and Human 
Services.
    (k) Petitioner means an individual or organization that submits a 
petition on behalf of a class of employees and qualifies as a petitioner 
under Sec.  83.7. A single petition shall only include up to three 
petitioners.
    (l) Radiation means ionizing radiation, including alpha particles, 
beta particles, gamma rays, x rays, neutrons, protons and other 
particles capable of producing ions in the body. For the purposes of the 
proposed procedures, radiation does not include sources of non-ionizing 
radiation such as radio-frequency radiation, microwaves, visible light, 
and infrared or ultraviolet light radiation.
    (m) Secretary is the Secretary of Health and Human Services.
    (n) Specified cancer, as is defined in Section 3621(17) of EEOICPA 
(42 U.S.C. 7384l(17)) and the DOL regulation implementing EEOICPA (20 
CFR 30.5(dd)), means:
    (1) Leukemia (other than chronic lymphocytic leukemia) provided that 
onset of the disease was at least two years after initial occupational 
exposure;
    (2) Lung cancer (other than in situ lung cancer that is discovered 
during or after a post-mortem exam);
    (3) Bone cancer;
    (4) Renal cancers;
    (5) The following diseases, provided onset was at least 5 years 
after first exposure:
    (i) Multiple myeloma;
    (ii) Lymphomas (other than Hodgkin's disease);
    (iii) Primary cancer of the:
    (A) Thyroid;
    (B) Male or female breast;
    (C) Esophagus;
    (D) Stomach;
    (E) Pharynx;
    (F) Small intestine;
    (G) Pancreas;
    (H) Bile ducts;
    (I) Gall bladder;
    (J) Salivary gland;
    (K) Urinary bladder;
    (L) Brain;
    (M) Colon;
    (N) Ovary;
    (O) Liver (except if cirrhosis or hepatitis B is indicated).
    (6) The specified diseases designated in this section mean the 
physiological condition or conditions that are recognized by the 
National Cancer Institute under those names or nomenclature, or under 
any previously accepted or commonly used names or nomenclature.
    (o) Survivor means a surviving spouse, child, parent, grandchild and 
grandparent of a deceased covered employee as defined in EEOICPA.

[69 FR 30780, May 28, 2004, as amended at 70 FR 75952, Dec. 22, 2005; 72 
FR 37459, July 10, 2007]



   Subpart C_Procedures for Adding Classes of Employees to the Cohort



Sec.  83.6  Overview of the procedures in this part.

    The procedures in this part specify who may petition to add a class 
of employees to the Cohort, the requirements for such a petition, how a 
petition will be selected for evaluation by NIOSH and for the advice of 
the Board, and the process NIOSH, the Board, and the Secretary will use 
to consider a petition, leading to the Secretary's final determination 
to accept or deny adding a class to the Cohort. The rule provides for 
petitions in two distinct circumstances. One circumstance is when NIOSH 
has attempted to conduct a dose reconstruction for a cancer claimant, 
under 42 CFR part 82, and finds that the dose reconstruction cannot be 
completed, because there is insufficient information to estimate the 
radiation doses of the claimant with sufficient accuracy. The second 
circumstance includes all other possibilities. For example, a petition 
may be submitted representing a class of employees whose members have 
yet to file claims under EEOICPA, or even have yet to be diagnosed with 
cancer. As required by

[[Page 612]]

EEOICPA (42 U.S.C. 7384l(14)(c)(ii)), the procedures in this part 
include formal notice to Congress of any decision by the Secretary to 
add a class to the Cohort, and the opportunity for Congress to expedite 
or change the outcome of the decision within 180 days.



Sec.  83.7  Who can submit a petition on behalf of a class of employees?

    A petitioner or petitioners for a petition must be one or more, up 
to a maximum of three, of the following:
    (a) One or more DOE, DOE contractor or subcontractor, or AWE 
employees, who would be included in the proposed class of employees, or 
their survivors; or
    (b) One or more labor organizations representing or formerly having 
represented DOE, DOE contractor or subcontractor, or AWE employees, who 
would be included in the proposed class of employees; or
    (c) One or more individuals or entities authorized in writing by one 
or more DOE, DOE contractor or subcontractor, or AWE employees, who 
would be included in the proposed class of employees, or their 
survivors.



Sec.  83.8  How is a petition submitted?

    The petitioner(s) must send a petition in writing to NIOSH. A 
petition must provide identifying and contact information on the 
petitioner(s) and information to justify the petition, as specified 
under Sec.  83.9. Detailed instructions for preparing and submitting a 
petition, including an optional petition form, are available from NIOSH 
through direct request (1-800-35-NIOSH) or on the Internet at 
www.cdc.gov/niosh/ocas.



Sec.  83.9  What information must a petition include?

    (a) All petitions must provide identifying and contact information 
on the petitioner(s). The information required to justify a petition 
differs, depending on the basis of the petition. If the petition is by a 
claimant in response to a finding by NIOSH that the dose reconstruction 
for the claimant cannot be completed, then the petition must provide 
only the justification specified under paragraph (b) of this section. 
All other petitions must provide only the information specified under 
paragraph (c) of this section. The informational requirements for 
petitions are also summarized in Table 1 at the end of this section.
    (b) The petition must notify NIOSH that the claimant is petitioning 
on the basis that NIOSH found, under 42 CFR 82.12, that the dose 
reconstruction for the claimant could not be completed due to 
insufficient records and information.
    (c) The petition must include the following:
    (1) A proposed class definition \1\ specifying:
---------------------------------------------------------------------------

    \1\ HHS will determine the final class definition(s) for each 
petition (see Sec.  83.16).
---------------------------------------------------------------------------

    (i) The DOE facility or AWE facility \2\ at which the class worked;
---------------------------------------------------------------------------

    \2\ Depending on the factual circumstances present, a facility that 
meets the definition of an AWE facility or DOE facility covered under 
EEOICPA (42 U.S.C. 7384l(5) and (12)) could, among other possibilities, 
constitute a single building or structure, including the grounds upon 
which it is located, or a site encompassing numerous buildings or 
structures, including the grounds upon which it is located.
---------------------------------------------------------------------------

    (ii) The location or locations at the facility covered by the 
petition (e.g., building, technical area);
    (iii) The job titles and/or job duties of the class members;
    (iv) The period of employment relevant to the petition;
    (v) Identification of any exposure incident that was unmonitored, 
unrecorded, or inadequately monitored or recorded, if such incident 
comprises the basis of the petition; and
    (2) A description of the petitioner's (petitioners'') basis for 
believing records and information available are inadequate to estimate 
the radiation doses incurred by members of the proposed class of 
employees with sufficient accuracy. This description must include one of 
the following elements:
    (i) Documentation or statements provided by affidavit indicating 
that radiation exposures and doses to members of the proposed class were 
not monitored, either through personal or area monitoring; or
    (ii) Documentation or statements provided by affidavit indicating 
that

[[Page 613]]

radiation monitoring records for members of the proposed class have been 
lost, falsified, or destroyed; or
    (iii) A report from a health physicist or other individual with 
expertise in dose reconstruction documenting the limitations of existing 
DOE or AWE records on radiation exposures at the facility, as relevant 
to the petition. This report should specify the basis for believing 
these documented limitations might prevent the completion of dose 
reconstructions for members of the class under 42 CFR part 82 and 
related NIOSH technical implementation guidelines; or
    (iv) A scientific or technical report, published or issued by a 
government agency of the Executive Branch of government or the General 
Accounting Office, the Nuclear Regulatory Commission, or the Defense 
Nuclear Facilities Safety Board, or published in a peer-reviewed 
journal, that identifies dosimetry and related information that are 
unavailable (due to either a lack of monitoring or the destruction or 
loss of records) for estimating the radiation doses of employees covered 
by the petition.
    (3) If the petition is based on an exposure incident as described 
under paragraph (c)(1)(v) of this section, the petitioner(s) might be 
required to provide evidence that the incident occurred, but only if 
NIOSH is unable to obtain records or confirmation of the occurrence of 
such an incident from sources independent of the petitioner(s). Such 
evidence would not be required at the time the petition is submitted and 
the petitioner(s) would be directly informed of the need for this 
supplemental information. In such cases, either of the following may 
qualify as evidence:
    (i) Medical evidence that one or more members of the class may have 
incurred a high level radiation dose from the incident, such as a 
depressed white blood cell count associated with radiation exposure or 
the application of chelation therapy; or
    (ii) NIOSH will consider evidence provided by affidavit from one or 
more employees who witnessed the incident. If the petitioner cannot 
provide such affidavits because such employees are deceased, prevented 
by reasons of poor health or impairment, or cannot be identified or 
located, then the requirement for evidence provided by affidavit can be 
met by providing such an affidavit from one or more individuals who did 
not witness the incident, provided the individual was directly informed 
by one or more employees who witnessed the incident. \3\
---------------------------------------------------------------------------

    \3\ An affidavit may be from a petitioner but HHS does not require 
that an affidavit be from a petitioner.
---------------------------------------------------------------------------

    (4) The provision of any evidence under this section or other 
provisions of this part, including one or more affidavits, would not, in 
and of itself, be sufficient to confirm the facts presented by that 
evidence. NIOSH will consider the adequacy and credibility of any 
evidence provided.
    (5) If, under Sec.  83.15(a), NIOSH has already issued a Federal 
Register notice scheduling a Board meeting to consider a petition 
concerning a class of employees, then any petitions for such a class of 
employees submitted following this notice must, under paragraph (c)(2) 
of this section, present substantially new information that has not 
already been considered by NIOSH. For this purpose, NIOSH would find 
that information has been already considered by NIOSH if it were 
included in the petition(s) that were already considered by NIOSH or if 
it were addressed either in the report(s) by NIOSH evaluating such a 
petition or petitions under Sec.  83.13(c) or in a proposed decision by 
NIOSH responding to such a petition or petitions under Sec.  83.16(a).

[[Page 614]]



 Table 1 for Sec.   83.9: Summary of Informational Requirements for All
                                Petitions
   [Petitioner(s) must submit identifying and contact information and
                     either A. or B. of this table.]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A. The claimant's authorization of the   B. (1) A proposed class
 petition, based on NIOSH having found    definition identifying: (i)
 it could not complete a dose             Facility, (ii) relevant
 reconstrucitn for the claimant           locations at the facility;
 submitting the petition; or.             (iii) job titles/duties, (iv)
                                          period of employment, and if
                                          relevant, (v) exposure
                                          incident.
                                         (2) The basis for infeasibility
                                          of dose reconstruction;
                                          either: (i) lack of
                                          monitoring; or (ii)
                                          destruction, falsification, or
                                          loss of records; or (iii)
                                          expert report; or (iv)
                                          scientific or technical
                                          report.
------------------------------------------------------------------------



Sec.  83.10  If a petition satisfies all relevant requirements 
under Sec.  83.9, does this mean the class will be added to the Cohort?

    Satisfying the informational requirements for a petition does not 
mean the class will be added to the Cohort. It means the petition will 
receive a full evaluation by NIOSH, the Board, and HHS, as described 
under Sec. Sec.  83.13 through 83.16. The role of the petitioner(s) is 
to identify classes of employees that should be considered for addition 
to the Cohort.



Sec.  83.11  What happens to petitions that do not satisfy all 
relevant requirements under Sec. Sec.  83.7 through 83.9?

    (a) NIOSH will notify the petitioner(s) of any requirement that is 
not met by the petition, assist the petitioner(s) with guidance in 
developing relevant information, and provide 30 calendar days for the 
petitioner(s) to revise the petition accordingly.
    (b) After 30 calendar days from the date of notification under 
paragraph (a) of this section, NIOSH will notify any petitioner(s) whose 
petition remains unsatisfactory of the proposed finding of NIOSH that 
the petition fails to meet the specified requirements and the basis for 
this finding.
    (c) A petitioner may request in writing a review of a proposed 
finding within 30 calendar days of notification under paragraph (b) of 
this section. Petitioners must specify why the proposed finding should 
be reversed, based on the petition requirements and on the information 
that the petitioners had already submitted. The request may not include 
any new information or documentation that was not included in the 
completed petition. If the petitioner obtains new information within 
this 30-day period, the petitioner should provide it to NIOSH. NIOSH 
will consider this new information as a revision of the petition under 
paragraph (a) of this section.
    (d) Three HHS personnel, appointed by the Director of NIOSH, who 
were not involved in developing the proposed finding will complete 
reviews within 30 work days of the request for such a review. The 
Director of NIOSH will consider the results of the review and then make 
a final decision as to whether the petition satisfies the requirements 
for a petition.
    (e) Proposed findings established by NIOSH under paragraph (b) of 
this section will become final decisions in 31 calendar days if not 
reviewed under paragraph (d) of this section.
    (f) Based on new information, NIOSH may, at its discretion, 
reconsider a decision that a petition does not satisfy the requirements 
for a petition.
    (g) A petitioner whose petition has been found not to satisfy the 
requirements for a petition under either paragraph (d) or (e) of this 
section may submit to NIOSH a new petition for the identical class of 
employees at any time thereafter on the basis of new information not 
provided to NIOSH in the original petition. In such a case, the 
petitioner is required to fully re-address all the requirements of 
Sec. Sec.  83.7-83.9 in the petition.

[70 FR 75952, Dec. 22, 2005, as amended at 72 FR 37459, July 10, 2007]

[[Page 615]]



Sec.  83.12  How will NIOSH notify petitioners, the Board, and the public 
of petitions that have been selected for evaluation?

    (a) NIOSH will notify the petitioner(s) in writing that it has 
selected the petition for evaluation. NIOSH will also provide the 
petitioner(s) with information on the steps of the evaluation and other 
processes required pursuant to these procedures.
    (b) NIOSH will combine separate petitions and evaluate them as a 
single petition if, at this or at any point in the evaluation process 
under Sec. Sec.  83.13 and 83.14, NIOSH finds such petitions represent 
the same class of employees.
    (c) NIOSH will present petitions selected for evaluation to the 
Board with plans specific to evaluating each petition. Each evaluation 
plan will include the following elements:
    (1) An initial proposed definition for the class being evaluated, 
subject to revision as warranted by the evaluation conducted under Sec.  
83.13 or Sec.  83.14; and
    (2) A list of activities for evaluating the radiation exposure 
potential of the class and the adequacy of existing records and 
information needed to conduct dose reconstructions for all class members 
under 42 CFR part 82.
    (d) NIOSH may initiate work to evaluate a petition immediately, 
prior to presenting the petition and evaluation plan to the Board.
    (e) NIOSH will publish a notice in the Federal Register notifying 
the public of its decision to evaluate a petition.



Sec.  83.13  How will NIOSH evaluate petitions, other than petitions 
by claimants covered under Sec.  83.14?

    (a) NIOSH will collect information on the types and levels of 
radiation exposures that potential members of the class may have 
incurred, as specified under 42 CFR 83.14, from the following potential 
sources, as necessary:
    (1) The petition or petitions submitted on behalf of the class;
    (2) DOE and AWE facility records and information;
    (3) Potential members of the class and their survivors;
    (4) Labor organizations who represent or represented employees at 
the facility during the relevant period of employment;
    (5) Managers, radiation safety officials, and other witnesses 
present during the relevant period of employment at the DOE facility or 
AWE facility;
    (6) NIOSH records from epidemiological research on DOE populations 
and records from dose reconstructions conducted under 42 CFR part 82;
    (7) Records from research, dose reconstructions, medical screening 
programs, and other related activities conducted to evaluate the health 
and/or radiation exposures of DOE employees, DOE contractor or 
subcontractor employees, and/or AWE employees; and
    (8) Other sources.
    (b) The Director of OCAS may determine that records and/or 
information requested from DOE, an AWE, or another source to evaluate a 
petition is not, or will not be, available on a timely basis. Such a 
determination will be treated, for the purposes of the petition 
evaluation, as equivalent to a finding that the records and/or 
information requested are not available.
    (1) Before the Director of OCAS makes such a determination, the 
source(s) potentially in possession of such records and/or information 
will be allowed a reasonable amount of time, as determined by the 
Director of OCAS, to provide the records and/or information.
    (2) Such a determination may take into account the types and 
quantity of records and/or information requested from the source, as 
well as any other factors that might be relevant to the judgment under 
paragraph (b)(1) of this this section of the amount of time that is 
reasonable to provide the records and/or information, which would be 
decided on a case-by-case basis by the Director of OCAS.
    (c) NIOSH will evaluate records and information collected to make 
the following determinations:
    (1) Is it feasible to estimate the level of radiation doses of 
individual members of the class with sufficient accuracy? (i) Radiation 
doses can be estimated with sufficient accuracy if NIOSH has established 
that it has access to sufficient information to estimate the maximum 
radiation dose, for every type of cancer for which radiation doses are 
reconstructed, that could have been incurred in plausible circumstances 
by any

[[Page 616]]

member of the class, or if NIOSH has established that it has access to 
sufficient information to estimate the radiation doses of members of the 
class more precisely than an estimate of the maximum radiation dose. 
NIOSH must also determine that it has information regarding monitoring, 
source, source term, or process from the site where the employees worked 
to serve as the basis for a dose reconstruction. This basis requirement 
does not limit NIOSH to using only or primarily information from the 
site where the employee worked, but a dose reconstruction must, as a 
starting point, be based on some information from the site where the 
employee worked.
    (ii) In many circumstances, to establish a positive finding under 
paragraph (c)(1)(i) of this section would require, at a minimum, that 
NIOSH have access to reliable information on the identity or set of 
possible identities and maximum quantity of each radionuclide (the 
radioactive source material) to which members of the class were 
potentially exposed without adequate protection. Alternatively, if 
members of the class were potentially exposed without adequate 
protection to unmonitored radiation from radiation generating equipment 
(e.g., particle accelerator, industrial x-ray equipment), in many 
circumstances, NIOSH would require relevant equipment design and 
performance specifications or information on maximum emissions.
    (iii) In many circumstances, to establish a positive finding under 
paragraph (c)(1)(i) of this section would also require information 
describing the process through which the radiation exposures of concern 
may have occurred and the physical environment in which the exposures 
may have occurred.
    (iv) In many circumstances, access to personal dosimetry data and 
area monitoring data is not necessary to estimate the maximum radiation 
doses that could have been incurred by any member of the class, although 
radiation doses can be estimated more precisely with such data.
    (2) How should the class be defined, consistent with the findings of 
the analysis discussed under paragraph (c)(1) of this section? NIOSH 
will define the following characteristics of a class, taking into 
account the class definition proposed by the petition and modified as 
necessary to reflect the results of the evaluation under paragraph 
(c)(1) of this section:
    (i) Any of the following employment parameters, as necessary to 
identify members included in the class: facility, job titles, duties, 
and/or specific work locations at the facility, the relevant time 
period, and any additional identifying characteristics of employment; 
and
    (ii) If applicable, the identification of an exposure incident, when 
unmonitored radiation exposure during such an incident comprises the 
basis of the petition or the class definition.
    (3) Is there a reasonable likelihood that such radiation dose may 
have endangered the health of members of the class? If it is not 
feasible to estimate with sufficient accuracy radiation doses for 
members of the class, as provided under paragraph (c)(1) of this 
section, then NIOSH must determine, as required by the statute, that 
``there is a reasonable likelihood that such radiation dose may have 
endangered the health of members of the class'' (42 U.S.C. 7384q(b)(2)).
    (i) For classes of employees that may have been exposed to radiation 
during discrete incidents likely to have involved exceptionally high 
level exposures, such as nuclear criticality incidents or other events 
involving similarly high levels of exposures resulting from the failure 
of radiation protection controls, NIOSH will assume for the purposes of 
this section that any duration of unprotected exposure could cause a 
specified cancer, and hence may have endangered the health of members of 
the class. Presence with potential exposure during the discrete 
incident, rather than a quantified duration of potential exposure, will 
satisfy the health endangerment criterion.
    (ii) For health endangerment not established on the basis of a 
discrete incident, as described under paragraph (c)(3)(i) of this 
section, NIOSH will specify a minimum duration of employment to satisfy 
the health endangerment criterion as having been employed for a number 
of work days aggregating at least 250 work days within the parameters 
established for the class or in combination with work

[[Page 617]]

days within the parameters established for one or more other classes of 
employees in the Cohort.
    (d) NIOSH will submit a report of its evaluation findings to the 
Board and to the petitioner(s). The report will include the following 
elements:
    (1) An identification of the relevant petitions;
    (2) A proposed definition of the class or classes of employees to 
which the evaluation applies, and a summary of the basis for this 
definition, including, as necessary:
    (i) Any justification that may be needed for the inclusion of groups 
of employees who were not specified in the original petition(s);
    (ii) The identification of any groups of employees who were 
identified in the original petition(s) who should constitute a separate 
class of employees; or
    (iii) The merging of multiple petitions that represent a single 
class of employees;
    (3) The proposed class definition will address the following 
employment parameters:
    (i) The DOE facility or the AWE facility that employed the class;
    (ii) The job titles and/or job duties and/or work locations of class 
members;
    (iii) The period of employment within which a class member must have 
been employed at the facility under the job titles and/or performing the 
job duties and/or working in the locations specified in this class 
definition;
    (iv) If applicable, identification of an exposure incident, when 
potential radiation exposure during such an incident comprises the basis 
of the class definition;
    (v) If necessary, any other parameters that serve to define the 
membership of the class; and
    (vi) For a class for which it is not feasible to estimate radiation 
doses with sufficient accuracy, a minimum duration of employment within 
the parameters of the class for inclusion in the class, as defined under 
paragraph (c)(3) of this section;
    (4) A summary of the findings concerning the adequacy of existing 
records and information for reconstructing doses for individual members 
of the class under the methods of 42 CFR part 82 specifying, for each 
class defined in the report, whether NIOSH finds that it is feasible to 
estimate the radiation doses of members of the class with sufficient 
accuracy, and a description of the evaluation methods and information 
upon which these findings are based; and
    (5) For a class for which it is not feasible to estimate radiation 
doses with sufficient accuracy, a summary of the basis for establishing 
the duration of employment requirement with respect to health 
endangerment.
    (e) The NIOSH report under paragraph (d) of this section shall be 
completed within 180 calendar days of the receipt of the petition by 
NIOSH. The procedure for computing this time period is specified in 
Sec.  83.5(c). In addition, the computing of 180 calendar days shall not 
include any days during which the petitioner may be revising the 
petition to remedy deficiencies identified by NIOSH under Sec.  83.11(a) 
or (b), nor shall it include any days during which the petitioner may 
request a review of a proposed finding under Sec.  83.11(c) or during 
the conduct of such a review under Sec.  83.11(d).

[69 FR 30780, May 28, 2004, as amended at 72 FR 37459, July 10, 2007]



Sec.  83.14  How will NIOSH evaluate a petition by a claimant whose 
dose reconstruction NIOSH could not complete under 42 CFR part 82?

    (a) NIOSH may establish two classes for evaluation, to permit the 
timely adjudication of the existing cancer claim:
    (1) A class of employees defined using the research and analyses 
already completed in attempting the dose reconstruction for the employee 
identified in the claimant's petition; and
    (2) A class of co-workers similar to the class defined under 
paragraph (a)(1) of this section, to be defined by NIOSH on the basis of 
further research and analyses, using the procedures under Sec.  83.13.
    (b) NIOSH will determine the health endangerment criteria for adding 
the class under paragraph (a)(1) of this section to the Cohort, using 
the procedures under Sec.  83.13. NIOSH will report to the Board and to 
petitioner(s) the

[[Page 618]]

results of this determination, together with its finding under 42 CFR 
part 82 that there was insufficient information to complete the dose 
reconstruction. HHS will consider this finding under 42 CFR part 82 
sufficient, without further consideration, to determine that it is not 
feasible to estimate the levels of radiation doses of individual members 
of the class with sufficient accuracy.
    (c) NIOSH will evaluate the petition as it may concern a class of 
co-workers, as described under paragraph (a)(2) of this section, 
according to the procedures under Sec.  83.13.



Sec.  83.15  How will the Board consider and advise the Secretary 
on a petition?

    (a) NIOSH will publish a notice in the Federal Register providing 
notice of a Board meeting at which a petition will be considered, and 
summarizing the petition to be considered by the Board at the meeting 
and the findings of NIOSH from evaluating the petition.
    (b) The Board will consider the petition and the NIOSH evaluation 
report at the meeting, to which the petitioner(s) will be invited to 
present views and information on the petition and the NIOSH evaluation 
findings. In considering the petition, both NIOSH and the members of the 
Board will take all steps necessary to prevent the disclosure of 
information of a personal nature, concerning the petitioners or others, 
where disclosure would constitute a clearly unwarranted invasion of 
personal privacy.
    (c) In considering the petition, the Board may obtain and consider 
additional information not addressed in the petition or the initial 
NIOSH evaluation report.
    (d) NIOSH may decide to further evaluate a petition, upon the 
request of the Board. If NIOSH conducts further evaluation, it will 
report new findings to the Board and the petitioner(s).
    (e) Upon the completion of NIOSH evaluations and deliberations of 
the Board concerning a petition, the Board will develop and transmit to 
the Secretary a report containing its recommendations. The Board's 
report will include the following:
    (1) The identification and inclusion of the relevant petition(s);
    (2) The definition of the class of employees covered by the 
recommendation;
    (3) A recommendation as to whether or not the Secretary should 
designate the class as an addition to the Cohort;
    (4) The relevant criteria under Sec.  83.13(c) and findings and 
information upon which the recommendation is based, including NIOSH 
evaluation reports, information provided by the petitioners, any other 
information considered by the Board, and the deliberations of the Board.



Sec.  83.16  How will the Secretary decide the outcome(s) of a petition?

    (a) The Director of NIOSH will propose a decision to add or deny 
adding any class or classes of employees to the Cohort, including an 
iteration of the relevant criteria, as specified under Sec.  83.13(c), 
and a summary of the information and findings on which the proposed 
decision is based. This proposed decision will take into consideration 
the evaluations of NIOSH and the report and recommendations of the 
Board, and may also take into consideration information presented or 
submitted to the Board and the deliberations of the Board. In the case 
of a petition that NIOSH has determined encompasses more than one class 
of employees, the Director of NIOSH will issue a separate proposed 
decision for each separate class of employees.
    (b) The Secretary will make the final decision to add or deny adding 
a class to the Cohort, including the definition of the class, after 
considering information and recommendations provided to the Secretary by 
the Director of NIOSH and the Board. HHS will transmit a report of the 
decision to the petitioner(s), including an iteration of the relevant 
criteria, as specified under Sec.  83.13(c), and a summary of the 
information and findings on which the decision is based. HHS will also 
publish a notice summarizing the decision in the Federal Register.
    (c) If, under Sec.  83.15(e), the Board recommends that the 
Secretary designate a class covered by the petition as an addition to 
the Cohort, and if, under paragraph (b) of Sec.  83.16, the Secretary 
decides to deny adding the class, as defined by the Board, to the 
Cohort, then

[[Page 619]]

the Secretary will submit to Congress a determination that the statutory 
criteria specified under 42 U.S.C. 7384q(b)(1) and (2) have not been met 
for adding the class to the Cohort. The Secretary will submit this 
determination to Congress within 30 calendar days following receipt by 
the Secretary of the recommendation of the Board.

[70 FR 75953, Dec. 22, 2005]



Sec.  83.17  How will the Secretary report a final decision to add a class 
of employees to the Cohort and any action of Congress concerning 
the effect of the final decision?

    (a) If the Secretary designates a class of employees to be added to 
the Cohort, the Secretary will transmit to Congress a report providing 
the designation, the definition of the class of employees covered by the 
designation, and the criteria and findings upon which the designation 
was based. \4\
---------------------------------------------------------------------------

    \4\ See 42 U.S.C. 7384l(14)(C)(ii).
---------------------------------------------------------------------------

    (b) If, under Sec.  83.15(e), the Board recommends that the 
Secretary designate a class covered by the petition as an addition to 
the Cohort, and if, under paragraph (b) of Sec.  83.16, the Secretary 
decides to add a class to the Cohort that is inclusive of the class as 
defined by the Board, then the Secretary will transmit to Congress the 
report specified in paragraph (a) of this section within 30 calendar 
days following receipt by the Secretary of the recommendation of the 
Board.
    (c) A designation of the Secretary will take effect 30 calendar days 
after the date on which the report of the Secretary under paragraph (a) 
of this section is submitted to Congress, or is deemed to have been 
submitted to Congress, \5\ unless Congress takes an action that reverses 
or expedites the designation.
---------------------------------------------------------------------------

    \5\ Under 42 U.S.C. 7384q(c)(2)(C), if the Secretary does not submit 
within 30 days the determination required under paragraph (a) of Sec.  
83.17 of this part, then on the following day, ``it shall be deemed'' 
that the Secretary submitted the report specified under paragraph (b) of 
Sec.  83.17 of this part.
---------------------------------------------------------------------------

    (d) After either the expiration of the congressional review period 
or notification of final congressional action, whichever comes first, 
the Secretary will transmit to DOL and to the petitioner(s) a report 
providing the definition of the class and one of the following outcomes:
    (1) The addition of the class to the Cohort; or
    (2) The result of any action by Congress to reverse or expedite the 
decision of the Secretary to add the class to the Cohort.
    (e) The report specified under paragraph (d) of this section will be 
published on the Internet at http://www.cdc.gov/niosh/ocas and in the 
Federal Register.

[69 FR 30780, May 28, 2004, as amended at 70 FR 75953, Dec. 22, 2005]



Sec.  83.18  How can petitioners obtain an administrative review 
of a final decision by the Secretary?

    (a) HHS will allow petitioners to contest only a final decision to 
deny adding a class to the Cohort or a health endangerment determination 
under Sec.  83.13(c)(3)(ii). Such challenges must be submitted in 
writing within 30 calendar days and must include evidence that the final 
decision relies on a record of either substantial factual errors or 
substantial errors in the implementation of the procedures of this part. 
Challenges may not introduce new information or documentation concerning 
the petition or the NIOSH or Board evaluation(s) that was not submitted 
or presented by the petitioner(s) or others to NIOSH or to the Board 
prior to the Board's issuing its recommendations under Sec.  83.15.
    (b) A panel of three HHS personnel, independent of NIOSH and 
appointed by the Secretary, will conduct an administrative review based 
on a challenge submitted under paragraph (a) of this section and provide 
recommendations of the panel to the Secretary concerning the merits of 
the challenge and the resolution of issues contested by the challenge. 
Reviews by the panel will consider, in addition to the views and 
information submitted by the petitioner(s) in the challenge, the NIOSH 
evaluation report(s), the report containing the recommendations of the 
Board issued under Sec.  83.15, and recommendations of the Director of 
NIOSH to the Secretary. The reviews may also consider information 
presented or submitted to the Board and

[[Page 620]]

the deliberations of the Board prior to the issuance of the 
recommendations of the Board under Sec.  83.15. The panel shall consider 
whether HHS substantially complied with the procedures of this part, the 
factual accuracy of the information supporting the final decision, and 
the principal findings and recommendations of NIOSH and those of the 
Board issued under Sec.  83.15.
    (c) The Secretary will decide whether or not to revise a final 
decision contested by the petitioner(s) under this section after 
considering information and recommendations provided to the Secretary by 
the Director of NIOSH, the Board, and from the HHS administrative review 
conducted under paragraph (b) of this section. HHS will transmit a 
report of the decision to the petitioner(s).
    (d) If the Secretary decides under paragraph (c) of this section to 
change a designation under Sec.  83.17(a) of this part or a 
determination under Sec.  83.16(c) of this part, the Secretary will 
transmit to Congress a report providing such change to the designation 
or determination, including an iteration of the relevant criteria, as 
specified under Sec.  83.13(c), and a summary of the information and 
findings on which the decision is based. HHS will also publish a notice 
summarizing the decision in the Federal Register.
    (e) A new designation of the Secretary under this section will take 
effect 30 calendar days after the date on which the report of the 
Secretary under paragraph (d) of this section is submitted to Congress, 
unless Congress takes an action that reverses or expedites the 
designation. Such new designations and related congressional actions 
will be further reported by the Secretary pursuant to paragraphs (d) and 
(e) of Sec.  83.17.

[70 FR 75953, Dec. 22, 2005]



Sec.  83.19  How can the Secretary cancel or modify a final decision 
to add a class of employees to the Cohort?

    (a) The Secretary can cancel a final decision to add a class to the 
Cohort, or can modify a final decision to reduce the scope of a class 
added by the Secretary, if HHS obtains records relevant to radiation 
exposures of members of the class that enable NIOSH to estimate the 
radiation doses incurred by individual members of the class through dose 
reconstructions conducted under the requirements of 42 CFR part 82.
    (b) Before canceling a final decision to add a class or modifying a 
final decision to reduce the scope of a class, the Secretary intends to 
follow evaluation procedures that are substantially similar to those 
described in this part for adding a class of employees to the Cohort. 
The procedures will include the following:
    (1) Publication of a notice in the Federal Register informing the 
public of the intent of the Secretary to review the final decision on 
the basis of new information and describing procedures for this review;
    (2) An analysis by NIOSH of the utility of the new information for 
conducting dose reconstructions under 42 CFR part 82; the analysis will 
be performed consistently with the requirements for analysis of a 
petition by NIOSH under Sec. Sec.  83.13(c)(1) and (2), and 83.13(c)(2) 
and (3);
    (3) A recommendation by the Board to the Secretary as to whether or 
not the Secretary should cancel or modify his final decision that added 
the class to the Cohort, based upon a review by the Board of the NIOSH 
analysis under paragraph (b)(2) of this section and any other relevant 
information considered by the Board;
    (4) An opportunity for members of the class to contest a proposed 
decision to cancel or modify the prior final decision that added the 
class to the Cohort, including a reasonable and timely effort by the 
Secretary to notify members of the class of this opportunity; and
    (5) Publication in the Federal Register of a final decision to 
cancel or modify the prior final decision that added the class to the 
Cohort.

[69 FR 30780, May 28, 2004. Redesignated at 70 FR 75953, Dec. 22, 2005]



PART 84_APPROVAL OF RESPIRATORY PROTECTIVE DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
84.1 Purpose.

[[Page 621]]

84.2 Definitions.
84.3 Respirators for mine rescue or other emergency use in mines.

                   Subpart B_Application for Approval

84.10 Application procedures.
84.11 Contents of application.
84.12 Delivery of respirators and components by applicant; requirements.

                             Subpart C_Fees

84.20 Establishment of fees.
84.21 Fee calculation.
84.22 Fee administration.
84.23 Fee revision.
84.24 Authorization for additional examinations, inspections, tests, and 
          fees.

                   Subpart D_Approval and Disapproval

84.30 Certificates of approval; scope of approval.
84.31 Certificates of approval; contents.
84.32 Notice of disapproval.
84.33 Approval labels and markings; approval of contents; use.
84.34 Revocation of certificates of approval.
84.35 Changes or modifications of approved respirators; issuance of 
          modification of certificate of approval.
84.36 Delivery of changed or modified approved respirator.

                        Subpart E_Quality Control

84.40 Quality control plans; filing requirements.
84.41 Quality control plans; contents.
84.42 Proposed quality control plans; approval by the Institute.
84.43 Quality control records; review by the Institute; revocation of 
          approval.

  Subpart F_Classification of Approved Respirators; Scope of Approval; 
                    Atmospheric Hazards; Service Time

84.50 Types of respirators to be approved; scope of approval.
84.51 Entry and escape, or escape only; classification.
84.52 Respiratory hazards; classification.
84.53 Service time; classification.

       Subpart G_General Construction and Performance Requirements

84.60 Construction and performance requirements; general.
84.61 General construction requirements.
84.62 Component parts; minimum requirements.
84.63 Test requirements; general.
84.64 Pretesting by applicant; approval of test methods.
84.65 Conduct of examinations, inspections, and tests by the Institute; 
          assistance by applicant; observers; recorded data; public 
          demonstrations.
84.66 Withdrawal of applications.

              Subpart H_Self-Contained Breathing Apparatus

84.70 Self-contained breathing apparatus; description.
84.71 Self-contained breathing apparatus; required components.
84.72 Breathing tubes; minimum requirements.
84.73 Harnesses; installation and construction; minimum requirements.
84.74 Apparatus containers; minimum requirements.
84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum 
          requirements.
84.76 Facepieces; eyepieces; minimum requirements.
84.77 Inhalation and exhalation valves; minimum requirements.
84.78 Head harnesses; minimum requirements.
84.79 Breathing gas; minimum requirements.
84.80 Interchangeability of oxygen and air prohibited.
84.81 Compressed breathing gas and liquefied breathing gas containers; 
          minimum requirements.
84.82 Gas pressure gages; minimum requirements.
84.83 Timers; elapsed time indicators; remaining service life 
          indicators; minimum requirements.
84.84 Hand-operated valves; minimum requirements.
84.85 Breathing bags; minimum requirements.
84.86 Component parts exposed to oxygen pressures; minimum requirements.
84.87 Compressed gas filters; minimum requirements.
84.88 Breathing bag test.
84.89 Weight requirement.
84.90 Breathing resistance test; inhalation.
84.91 Breathing resistance test; exhalation.
84.92 Exhalation valve leakage test.
84.93 Gas flow test; open-circuit apparatus.
84.94 Gas flow test; closed-circuit apparatus.
84.95 Service time test; open-circuit apparatus.
84.96 Service time test; closed-circuit apparatus.
84.97 Test for carbon dioxide in inspired gas; open- and closed-circuit 
          apparatus; maximum allowable limits.
84.98 Tests during low temperature operation.
84.99 Man tests; testing conditions; general requirements.

[[Page 622]]

84.100 Man tests 1, 2, 3, and 4; requirements.
84.101 Man test 5; requirements.
84.102 Man test 6; requirements.
84.103 Man tests; performance requirements.
84.104 Gas tightness test; minimum requirements.

Tables to Subpart H of Part 84

                           Subpart I_Gas Masks

84.110 Gas masks; description.
84.111 Gas masks; required components.
84.112 Canisters and cartridges in parallel; resistance requirements.
84.113 Canisters and cartridges; color and markings; requirements.
84.114 Filters used with canisters and cartridges; location; 
          replacement.
84.115 Breathing tubes; minimum requirements.
84.116 Harnesses; installation and construction; minimum requirements.
84.117 Gas mask containers; minimum requirements.
84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit; 
          minimum requirements.
84.119 Facepieces; eyepieces; minimum requirements.
84.120 Inhalation and exhalation valves; minimum requirements.
84.121 Head harnesses; minimum requirements.
84.122 Breathing resistance test; minimum requirements.
84.123 Exhalation valve leakage test.
84.124 Facepiece tests; minimum requirements.
84.125 Particulate tests; canisters containing particulate filters; 
          minimum requirements.
84.126 Canister bench tests; minimum requirements.

Tables to Subpart I of Part 84

                   Subpart J_Supplied-Air Respirators

84.130 Supplied-air respirators; description.
84.131 Supplied-air respirators; required components.
84.132 Breathing tubes; minimum requirements.
84.133 Harnesses; installation and construction; minimum requirements.
84.134 Respirator containers; minimum requirements.
84.135 Half-mask facepieces, full facepieces, hoods, and helmets; fit; 
          minimum requirements.
84.136 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.137 Inhalation and exhalation valves; check valves; minimum 
          requirements.
84.138 Head harnesses; minimum requirements.
84.139 Head and neck protection; supplied-air respirators; minimum 
          requirements.
84.140 Air velocity and noise levels; hoods and helmets; minimum 
          requirements.
84.141 Breathing gas; minimum requirements.
84.142 Air supply source; hand-operated or motor driven air blowers; 
          Type A supplied-air respirators; minimum requirements.
84.143 Terminal fittings or chambers; Type B supplied-air respirators; 
          minimum requirements.
84.144 Hand-operated blower test; minimum requirements.
84.145 Motor-operated blower test; minimum requirements.
84.146 Method of measuring the power and torque required to operate 
          blowers.
84.147 Type B supplied-air respirator; minimum requirements.
84.148 Type C supplied-air respirator, continuous-flow class; minimum 
          requirements.
84.149 Type C supplied-air respirator, demand and pressure demand class; 
          minimum requirements.
84.150 Air-supply line tests; minimum requirements.
84.151 Harness test; minimum requirements.
84.152 Breathing tube test; minimum requirements.
84.153 Airflow resistance test, Type A and Type AE supplied-air 
          respirators; minimum requirements.
84.154 Airflow resistance test; Type B and Type BE supplied-air 
          respirators; minimum requirements.
84.155 Airflow resistance test; Type C supplied-air respirator, 
          continuous flow class and Type CE supplied-air respirator; 
          minimum requirements.
84.156 Airflow resistance test; Type C supplied-air respirator, demand 
          class; minimum requirements.
84.157 Airflow resistance test; Type C supplied-air respirator, 
          pressure-demand class; minimum requirements.
84.158 Exhalation valve leakage test.
84.159 Man tests for gases and vapors; supplied-air respirators; general 
          performance requirements.
84.160 Man test for gases and vapors; Type A and Type AE respirators; 
          test requirements.
84.161 Man tests for gases and vapors; Type B and Type BE respirators; 
          test requirements.
84.162 Man test for gases and vapors; Type C respirators, continuous-
          flow class and Type CE supplied-air respirators; test 
          requirements.
84.163 Man test for gases and vapors; Type C supplied-air respirators, 
          demand and pressure-demand classes; test requirements.

Tables to Subpart J of Part 84

[[Page 623]]

             Subpart K_Air-Purifying Particulate Respirators

84.170 Air-purifying particulate respirators; description.
84.171 Required components and attributes.
84.172 Airflow resistance test.
84.173 Exhalation valve leakage test.
84.174 Filter efficiency level determination test--non-powered series N, 
          R, and P filtration.
84.175 Instantaneous filter efficiency level determination test--PAPR 
          series HE, PAPR100-N, and PAPR100-P filtration.
84.176 Fit test--PAPR classes HE and PAPR100.
84.177 Total noise level test--PAPR classes HE and PAPR100.
84.178 Breath response type, airflow resistance test--PAPR classes HE 
          and PAPR100.
84.179 Silica dust loading test--PAPR series HE filtration.
84.180 Particulate loading test--PAPR series PAPR100-N and PAPR100-P 
          filtration.
84.181 Communication performance test--PAPR class PAPR100.

                Subpart L_Chemical Cartridge Respirators

84.190 Chemical cartridge respirators: description.
84.191 Chemical cartridge respirators; required components.
84.192 Cartridges in parallel; resistance requirements.
84.193 Cartridges; color and markings; requirements.
84.194 Filters used with chemical cartridges; location; replacement.
84.195 Breathing tubes; minimum requirements.
84.196 Harnesses; installation and construction; minimum requirements.
84.197 Respirator containers; minimum requirements.
84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods, and 
          helmets; fit; minimum requirements.
84.199 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.200 Inhalation and exhalation valves; minimum requirements.
84.201 Head harnesses; minimum requirements.
84.202 Air velocity and noise levels; hoods and helmets; minimum 
          requirements.
84.203 Breathing resistance test; minimum requirements.
84.204 Exhalation valve leakage test; minimum requirements.
84.205 Facepiece test; minimum requirements.
84.206 Particulate tests; respirators with filters; minimum 
          requirements; general.
84.207 Bench tests; gas and vapor tests; minimum requirements; general.

Tables to Subpart L of Part 84

Subpart M [Reserved]

                    Subpart N_Special Use Respirators

84.250 Vinyl chloride respirators; description.
84.251 Required components.
84.252 Gas masks; requirements and tests.
84.253 Chemical-cartridge respirators; requirements and tests.
84.254 Powered air-purifying respirators; requirements and tests.
84.255 Requirements for end-of-service-life indicator.
84.256 Quality control requirements.
84.257 Labeling requirements.

               Subpart O_Closed-Circuit Escape Respirators

84.300 Closed-circuit escape respirator; description.
84.301 Applicability to new and previously approved CCERs.
84.302 Required components, attributes, and instructions.
84.303 General testing conditions and requirements.
84.304 Capacity test requirements.
84.305 Performance test requirements.
84.306 Wearability test requirements.
84.307 Environmental treatments.
84.308 Additional testing.
84.309 Additional testing and requirements for dockable CCERs.
84.310 Post-approval testing.
84.311 Registration of CCER units upon purchase.

Subparts P-JJ [Reserved]

Appendix A to Part 84--Annual (Fixed) Respirator Certification Fees
Appendix B to Part 84--Application-Based Respirator Certification Fees

    Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 3, 5, 7, 811, 842(h), 
844.

    Source: 60 FR 30355, June 8, 1995, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 84 appear at 69 FR 
18803, Apr. 9, 2004.



                      Subpart A_General Provisions



Sec.  84.1  Purpose.

    The purpose of the regulations contained in this part 84 is:
    (a) To establish procedures and prescribe requirements which must be 
met in filing applications for approval by

[[Page 624]]

the National Institute for Occupational Safety and Health of respirators 
or changes or modifications of approved respirators;
    (b) To establish a schedule of fees to be charged each applicant for 
the inspections, examinations, and testing conducted by the Institute 
under the provisions of this part;
    (c) To provide for the issuance of certificates of approval or 
modifications of certificates of approval for respirators which have met 
the applicable construction, performance, and respiratory protection 
requirements set forth in this part; and
    (d) To specify minimum requirements and to prescribe methods to be 
employed by the Institute and by the applicant in conducting 
inspections, examinations, and tests to determine the effectiveness of 
respirators used during entry into or escape from hazardous atmospheres.



Sec.  84.2  Definitions.

    As used in this part--
    Applicant means an individual, partnership, company, corporation, 
association, or other organization that designs, manufactures, 
assembles, or controls the assembly of a respirator and who seeks to 
obtain a certificate of approval for such respirator.
    Approval means a certificate or formal document issued by the 
Institute stating that an individual respirator or combination of 
respirators has met the minimum requirements of this part, and that the 
applicant is authorized to use and attach an approval label to any 
respirator, respirator container, or instruction card for any respirator 
manufactured or assembled in conformance with the plans and 
specifications upon which the approval was based, as evidence of such 
approval.
    Approved means conforming to the minimum requirements of this part.
    Auxiliary equipment means a self-contained breathing apparatus, the 
use of which is limited in underground mine rescue and recovery 
operations to situations where the wearer has ready access to fresh air 
and at least one crew equipped with approved self-contained breathing 
apparatus of 2 hours or longer rating, is in reserve at a fresh-air 
base.
    Compressed-breathing gas means oxygen or air stored in a compressed 
state and supplied to the wearer in gaseous form.
    dBA means sound pressure levels in decibels, as measured with the A-
weighted network of a standard sound level meter using slow response.
    Dust means a solid mechanically produced particle with a size 
ranging from submicroscopic to macroscopic.
    A facepiece or mouthpiece is a respirator component designed to 
provide a gas-tight or dust-tight fit with the face and may include 
headbands, valves, and connections for canisters, cartridges, filters, 
or respirable gas source.
    Final inspection means that activity carried out on a product after 
all manufacturing and assembly operations are completed to insure 
completeness and adherence to performance or other specifications, 
including satisfactory appearance.
    Fume means a solid condensation particle, generally less than 1 
micrometer in diameter.
    Gas means an aeriform fluid which is in a gaseous state at ordinary 
temperature and pressure.
    Hazardous atmosphere means:
    (1) Any atmosphere containing a toxic or disease producing gas, 
vapor, dust, fume, mist, or pesticide, either immediately or not 
immediately dangerous to life or health; or
    (2) Any oxygen-deficient atmosphere.
    A hood or helmet is a respirator component which covers the wearer's 
head and neck, or head, neck, and shoulders, and is supplied with 
incoming respirable air for the wearer to breathe. It may include a 
headharness and connection for a breathing tube.
    Immediately dangerous to life or health means conditions that pose 
an immediate threat to life or health or conditions that pose an 
immediate threat of severe exposure to contaminants, such as radioactive 
materials, which are likely to have adverse cumulative or delayed 
effects on health.
    Incoming inspection means the activity of receiving, examining, and 
accepting only those materials and parts whose quality conforms to 
specification requirements.

[[Page 625]]

    In-process inspection means the control of products at the source of 
production and at each step of the manufacturing process, so that 
departures from specifications can be corrected before defective 
components or materials are assembled into the finished product.
    Institute or NIOSH means the National Institute for Occupational 
Safety and Health, Department of Health and Human Services.
    Liquefied-breathing gas means oxygen or air stored in liquid form 
and supplied to the wearer in a gaseous form.
    Loose fitting means respiratory inlet covering that covers the 
wearer's head and neck, or head, neck, and shoulders, or whole body 
(when integral to the design).
    Mist means a liquid condensation particle with a size ranging from 
submicroscopic to macroscopic.
    MSHA means the Mine Safety and Health Administration, U.S. 
Department of Labor.
    National Personal Protective Technology Laboratory (NPPTL) means the 
National Personal Protective Technology Laboratory, National Institute 
for Occupational Safety and Health (NIOSH), Centers for Disease Control 
and Prevention, Department of Health and Human Services, P.O. Box 18070, 
626 Cochrans Mill Road, Pittsburgh, PA 15236. NPPTL administers the 
NIOSH conformity assessment program for respiratory protective devices, 
replacing the former Certification and Quality Assurance Branch within 
the Division of Safety Research, Appalachian Laboratory for Occupational 
Safety and Health, NIOSH.
    Not immediately dangerous to life or health means any hazardous 
atmosphere which may produce physical discomfort immediately, chronic 
poisoning after repeated exposure, or acute adverse physiological 
symptoms after prolonged exposure.
    Oxygen-deficient atmosphere means an atmosphere which contains an 
oxygen partial pressure of less than 148 millimeters of mercury (19.5 
percent by volume at sea level).
    Powered air-purifying respirator means a device equipped with a 
facepiece, hood, or helmet, breathing tube, canister, cartridge, filter, 
canister with filter, or cartridge with filter, and a blower.
    Respirator means any device designed to provide the wearer with 
respiratory protection against inhalation of a hazardous atmosphere.
    Respirators for entry into and escape from means respiratory devices 
providing protection during entry into and escape from hazardous 
atmospheres.
    Respirators for escape only means respiratory devices providing 
protection only during escape from hazardous atmospheres.
    Respiratory inlet covering means that portion of a respirator that 
forms the protective barrier between the user's respiratory tract and an 
air-purifying device or breathing air source, or both.
    (Single-use respirator means a respirator that is entirely discarded 
after excessive resistance, sorbent exhaustion, or physical damage 
renders it unsuitable for further use.
    Tight fitting means a respiratory inlet covering that forms a 
complete gas tight or dust tight seal with the face or neck.
    Vapor means the gaseous state of a substance that is solid or liquid 
at ordinary temperature and pressure.
    Warning device is a component of a respiratory protective device 
that informs the wearer to take some action.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3906, Jan. 26, 2015; 85 
FR 20607, Apr. 14, 2020]



Sec.  84.3  Respirators for mine rescue or other emergency use in mines.

    (a)(1) NIOSH and the Mine Safety and Health Administration (MSHA), 
U.S. Department of Labor, shall jointly review and issue certifications 
for respirators used for mine emergencies and mine rescue, including any 
associated service-life plans, users' manuals and other supporting 
documentation.
    (2) Each certification for a respirator designed for mine rescue or 
other emergency use in mines shall include, as a condition of approval, 
any use limitations related to mine safety and health.
    (b) NIOSH and MSHA shall jointly determine appropriate recall and 
retrofit remedies for field complaints or identified deficiencies 
involving any

[[Page 626]]

respirators used in the mining environment.



                   Subpart B_Application for Approval



Sec.  84.10  Application procedures.

    (a) Inspection, examination, and testing leading to the approval of 
the types of respirators classified in subpart F of this part shall be 
undertaken by the Institute only pursuant to written applications which 
meet the minimum requirements set forth in this subpart B.
    (b) Applications must be submitted in accordance with the Standard 
Application Procedure for the Certification of Respirators under 42 CFR 
84, (Standard Application Procedure) available on the NPPTL Web site, to 
Records Room, National Personal Protective Technology Laboratory, P.O. 
Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.
    (c) Except as provided in Sec.  84.64, the examination, inspection, 
and testing of all respirators will be conducted or caused to be 
conducted by the National Personal Protective Technology Laboratory.
    (d) Applicants, manufacturers, or their representatives may visit or 
communicate with the National Personal Protective Technology Laboratory 
in order to discuss the requirements for approval of any respirator or 
the proposed designs thereof. No charge will be made for such 
consultation and no written report will be issued to applicants, 
manufacturers, or their representatives by the Institute as a result of 
such consultation.
    (e) Respirators having electrical or electronic components that are 
required to be permissible under chapter I of title 30 shall be tested 
in accordance with 30 CFR part 18. Applications for approval of such 
respirators by MSHA shall be submitted in writing to: MSHA, Approval and 
Certification Center, Box 251, Industrial Park Road, Triadelphia, West 
Virginia 26059.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3906, Jan. 26, 2015]



Sec.  84.11  Contents of application.

    (a) Each application for approval shall contain a complete written 
description of the respirator for which approval is requested together 
with drawings and specifications (and lists thereof) showing full 
details of construction of the respirator and of the materials used.
    (b) Drawings shall be titled, numbered, and dated; any revision 
dates shall be shown on the drawings, and the purpose of each revision 
being sought shall be shown on the drawing or described on an attachment 
to the drawing to which it applies.
    (c) Each application for approval shall contain a proposed plan for 
quality control which meets the minimum requirements set forth in 
subpart E of this part.
    (d) Each application shall contain a statement that the respirator 
has been pretested by the applicant as prescribed in Sec.  84.64, and 
shall include the results of such tests.
    (e) Each application for approval shall contain a statement that the 
respirator and component parts submitted for approval are either 
prototypes, or made on regular production tooling, with no operation 
included which will not be incorporated in regular production 
processing.

(The information collections contained in this section are approved 
under OMB control number 0920-0109)



Sec.  84.12  Delivery of respirators and components by applicant; requirements.

    (a) Each applicant shall, when an application is filed pursuant to 
Sec.  84.10, be advised by the Institute of the total number of 
respirators and component parts required for testing.
    (b) The applicant will deliver, at his or her own expense, the 
number of completely assembled respirators and component parts required 
for their examination, inspection, and testing, to the National Personal 
Protective Technology Laboratory.
    (c) Respirators and component parts submitted for approval must be 
made from materials specified in the application.
    (d) One completely assembled respirator approved under the 
provisions of this part may be retained by the Institute as a laboratory 
exhibit, the remaining respirators may be returned to the applicant at 
his own expense, upon

[[Page 627]]

written request within 30 days after notice of approval. If no such 
request is made, the respirators will be disposed of by the Institute in 
such manner as it deems appropriate.
    (e) Where a respirator fails to meet the requirements for approval 
set forth in this part, all respirators and components delivered in 
accordance with this section may be returned to the applicant at his own 
expense, upon written request within 30 days after notice of 
disapproval. If no such request is made, the respirators will be 
disposed of by the Institute in such manner as it deems appropriate.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3906, Jan. 26, 2015]



                             Subpart C_Fees

    Source: 80 FR 3906, Jan. 26, 2015, unless otherwise noted.



Sec.  84.20  Establishment of fees.

    (a) This section establishes a system under which NIOSH charges a 
fee for services provided to applicants for conformity assessment 
activities conducted by NIOSH for respiratory protective devices under 
42 CFR part 84. This section specifies the purposes for which fees will 
be assessed and the cost factors for such assessments.
    (b) Fees will be charged for:
    (1) Respirator certification application, approval, approval 
modification, records maintenance, and testing. Application processing 
under this Part by engineers, technicians and other specialists, 
including administrative review of applications, analysis of drawings, 
technical evaluation, testing, test set up and tear down, and 
consultation on applications, clerical services, computer tracking and 
status reporting, records control and security, and document preparation 
directly supporting application processing. This fee also contributes to 
a proportionate share of management, administration and operation of the 
NIOSH National Personal Protective Technology Laboratory;
    (2) Maintenance of testing and approval facilities and test 
equipment. Amortization of facility improvements and depreciation of 
buildings and equipment used for testing and evaluation or otherwise 
directly associated with application processing;
    (3) Site qualification. Initial review and approval, as specified 
under 42 CFR part 84 subpart E--Quality Control, of manufacturing 
facilities that may be used to manufacture respirators, principal 
components, and/or subassemblies;
    (4) Quality assurance maintenance. Quality site audits to verify 
conformance to the requirements of Sec. Sec.  84.33, 84.40, 84.41, 
84.42, 84.43; and
    (5) Maintenance of product performance. Product audits to verify the 
performance of commercially available respirators which have been 
granted a NIOSH certificate of approval.
    (c) Fees will not be charged for:
    (1) Technical assistance not related to application processing;
    (2) Technical programs including development of new technology 
programs;
    (3) Participation in research; and
    (4) Regulatory review activities, including participation in the 
development of health and safety standards, regulations, and 
legislation.



Sec.  84.21  Fee calculation.

    (a) This section explains the process NIOSH uses to calculate 
estimates of the direct and indirect costs of services provided in the 
course of application processing.
    (b) Upon completion of an initial administrative review of the 
application, NIOSH will calculate a fee estimate for each application, 
including the maximum cost of conducting additional tests under Sec.  
84.24, and will provide that estimate, with payment details, to the 
applicant. The fee estimate will be derived using the current schedules 
of fees published by NIOSH in Part 84. NIOSH will begin the technical 
evaluation once the applicant accepts the terms of the fee estimate and 
authorizes payment.
    (c) If NIOSH determines that actual costs for application processing 
and related testing will exceed the fee estimate provided to the 
applicant, NIOSH will provide a revised fee estimate for completing the 
application review before exceeding the previously-authorized fees. The 
applicant will have the

[[Page 628]]

option of either withdrawing the application and paying for services 
already performed or authorizing payment of the revised estimate, in 
which case NIOSH will continue the application review and testing.
    (d) If the actual cost of processing the application is less than 
the fee estimate NIOSH provided to the applicant, NIOSH will charge the 
actual cost.
    (e) If the applicant withdraws an application, the applicant will be 
invoiced for services already performed by NIOSH. Withdrawal of an 
application will be effective on the first business day following the 
date NIOSH receives a withdrawal notice from the applicant in writing. 
Withdrawal notices will be submitted to NIOSH in accordance with the 
Standard Application Procedure using the address specified in Sec.  
84.10.



Sec.  84.22  Fee administration.

    (a) Applicants will be invoiced for all fees incurred in the 
processing of an application when all required reviews, analyses, 
evaluations, and tests are completed or the application is withdrawn. 
Invoices will contain specific payment instructions and identify 
authorized methods of payment.
    (b) Applicants who hold active and/or obsolete certificates of 
approval will be invoiced by NIOSH annually for applicable maintenance 
fees, in accordance with the fee schedule published in Appendix A of 
this part.
    (c) NIOSH reserves the right to impose sanctions for any missed 
payment, and will administer such penalties after assessing the 
circumstances of the manufacturer and the needs of other stakeholders. 
Sanctions may include but are not limited to:
    (1) Refusal to accept future applications for approval;
    (2) Stop-sale of all approved product; and
    (3) Engaging appropriate government authorities to initiate debt 
collection procedures for the unpaid fees.



Sec.  84.23  Fee revision.

    (a) Each fee schedule will remain in effect for at least 2 years and 
will be revised as needed to reflect cost increases identified in 
biennial reviews.
    (b) Fee schedule updates will be proposed in a notice of proposed 
rulemaking published in the Federal Register.
    (c) The current fee schedules will be published in Appendix A and 
Appendix B of this part and will remain in effect until the effective 
date of the new fee schedules published in the Federal Register.



Sec.  84.24  Authorization for additional examinations, inspections, 
tests, and fees.

    NIOSH will conduct or cause to be conducted any additional 
examinations, inspections, or tests it deems necessary to determine the 
quality and effectiveness of any respirator submitted to NIOSH for the 
purposes of seeking a certificate of approval. The costs of such 
examinations, inspections, or tests will be paid by the applicant prior 
to issuance of a certificate of approval for the subject respirator.



                   Subpart D_Approval and Disapproval



Sec.  84.30  Certificates of approval; scope of approval.

    (a) The Institute shall issue certificates of approval pursuant to 
the provisions of this subpart only for individual, completely assembled 
respirators which have been examined, inspected, and tested, and which 
meet the minimum requirements set forth in subparts H through L of this 
part, as applicable.
    (b) The Institute will not issue certificates of approval for any 
respirator component or for any respirator subassembly.
    (c) The Institute shall not issue an informal notification of 
approval. However, if the application for approval, submitted in 
accordance with Sec.  84.11, states that the submitted respirator and 
component parts are only prototypes, the Institute will examine, 
inspect, and test such respirator and component parts in accordance with 
the provisions of this part. If, upon completion of such examinations, 
inspections and tests, it is found that the

[[Page 629]]

prototype meets the minimum requirements set forth in this part, the 
Institute may inform the applicant, in writing, of the results of the 
examinations, inspections, and tests, and may require him to resubmit 
respirators and component parts made on regular production tooling, with 
no operations included which will not be incorporated in regular 
production processing, for further examination, inspection, and testing, 
prior to issuance of the certificate of approval.
    (d) Applicants required to resubmit respirators and component parts 
made on regular production tooling, with no operation included which 
will not be incorporated in regular production processing, shall be 
charged fees in accordance with subpart C of this part.



Sec.  84.31  Certificates of approval; contents.

    (a) The certificate of approval shall contain a classification and a 
description of the respirator or combination of respirators for which it 
is issued, as provided in this part.
    (b) The certificate of approval shall specifically set forth any 
restrictions or limitations on the respirator's use in hazardous 
atmospheres.
    (c) Each certificate of approval shall be accompanied by the 
drawings and specifications (and lists thereof) submitted by the 
applicant in accordance with Sec.  84.11. These drawings and 
specifications shall be referenced in the certificate of approval, and 
shall be maintained by the applicant. The drawings and specifications 
listed in each certificate of approval shall set forth in detail the 
design and construction requirements which shall be met by the applicant 
during commercial production of the respirator.
    (d) Each certificate of approval shall be accompanied by a 
reproduction of the approval label design to be employed by the 
applicant with each approved respirator, as provided in Sec.  84.33.
    (e) No test data or specific laboratory findings will accompany any 
certificate of approval, however, the Institute will release pertinent 
test data and specific findings upon written request by the applicant, 
or as required by statute or regulation.
    (f) Each certificate of approval shall also contain the approved 
quality control plan as specified in Sec.  84.42.



Sec.  84.32  Notice of disapproval.

    (a) If, upon the completion of the examinations, inspections, and 
tests required to be conducted in accordance with the provisions of this 
part, it is found that the respirator does not meet the minimum 
requirements set forth in this part, the Institute shall issue a written 
notice of disapproval to the applicant.
    (b) Each notice of disapproval shall be accompanied by all pertinent 
data or findings with respect to the defects of the respirator for which 
approval was sought with a view to the possible correction of any such 
defects.
    (c) The Institute shall not disclose, except to the applicant or as 
required by statute or regulation, any data, findings, or other 
information with respect to any respirator for which a notice of 
disapproval is issued.



Sec.  84.33  Approval labels and markings; approval of contents; use.

    (a) Full-scale reproductions of approval labels and markings, and a 
sketch or description of the method of application and position on the 
harness, container, canister, cartridge, filter, or other component, 
together with instructions for the use and maintenance of the respirator 
shall be submitted to the Institute for approval.
    (b) Approval labels shall bear the emblem of the National Institute 
for Occupational Safety and Health and the seal of the Department of 
Health and Human Services, the applicant's name and address, an approval 
number assigned by the Institute and, where appropriate, restrictions or 
limitations placed upon the use of the respirator by the Institute. The 
approval number assigned by the Institute shall be designated by the 
prefix TC and a serial number.
    (c) The Institute shall, where necessary, notify the applicant when 
additional labels, markings, or instructions will be required.
    (d) Approval labels and markings shall only be used by the applicant 
to whom they were issued.

[[Page 630]]

    (e) Legible reproductions or abbreviated forms of the label approved 
by the Institute for use on each respirator shall be attached to or 
printed at the following locations:

------------------------------------------------------------------------
        Respirator type             Label type            Location
------------------------------------------------------------------------
Self-contained breathing        Entire...........  Harness assembly and
 apparatus.                                         canister (where
                                                    applicable).
Gas mask......................  Entire...........  Mask container and
                                                    canister.
Supplied air respirator.......  ......do.........  Respirator container
                                                    or instruction card.
Particulate respirator........  ......do.........  Respirator container
                                                    and filter
                                                    container.
                                Abbreviated......  Filters.
Chemical-cartridge respirator.  Entire...........  Respirator container,
                                                    cartridge container,
                                                    and filter
                                                    containers (where
                                                    applicable).
                                Abbreviated......  Cartridges and
                                                    filters and filter
                                                    containers.
------------------------------------------------------------------------

    (f) The use of any Institute approval label obligates the applicant 
to whom it is issued to maintain or cause to be maintained the approved 
quality control sampling schedule and the acceptable quality level for 
each characteristic tested, and to assure that it is manufactured 
according to the drawings and specifications upon which the certificate 
of approval is based.
    (g) Each respirator, respirator component, and respirator container 
shall, as required by the Institute to assure quality control and proper 
use of the respirator, be labeled distinctly to show the name of the 
applicant, and the name and letters or numbers by which the respirator 
or respirator component is designated for trade purposes, and the lot 
number, serial number, or approximate date of manufacture.



Sec.  84.34  Revocation of certificates of approval.

    The Institute reserves the right to revoke, for cause, any 
certificate of approval issued pursuant to the provisions of this part. 
Such causes include, but are not limited to, misuse of approval labels 
and markings, misleading advertising, and failure to maintain or cause 
to be maintained the quality control requirements of the certificate of 
approval.



Sec.  84.35  Changes or modifications of approved respirators; 
issuance of modification of certificate of approval.

    (a) Each applicant may, if he desires to change any feature of an 
approved respirator, request a modification of the original certificate 
of approval issued by the Institute for such respirator by filing an 
application for such modification in accordance with the provisions of 
this section.
    (b) Applications shall be submitted as for an original certificate 
of approval, with a request for a modification of the existing 
certificate to cover any proposed change.
    (c) The application shall be accompanied by appropriate drawings and 
specifications, and by a proposed quality control plan which meets the 
requirements of subpart E of this part.
    (d) The application for modification, together with the accompanying 
material, shall be examined by the Institute to determine whether 
testing will be required.
    (e) The Institute shall inform the applicant of the fee required for 
any additional testing and the applicant will be charged for the actual 
cost of any examination, inspection, or test required, and such fees 
shall be submitted in accordance with the provisions of subpart C of 
this part.
    (f) If the proposed change or modification meets the requirements of 
this part, a formal certificate of modification will be issued, 
accompanied, where necessary, by a list of new and revised drawings and 
specifications covering the change(s) and reproductions of revised 
approval labels.

(The information collections contained in this section are approved 
under OMB control number 0920-0109)



Sec.  84.36  Delivery of changed or modified approved respirator.

    An approved respirator for which a formal certificate of 
modification has been issued shall be delivered, with proper markings 
and containers, by the

[[Page 631]]

applicant to the National Personal Protective Technology Laboratory, as 
soon as it is commercially produced.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



                        Subpart E_Quality Control



Sec.  84.40  Quality control plans; filing requirements.

    As a part of each application for approval or modification of 
approval submitted pursuant to this part, each applicant shall file with 
the Institute a proposed quality control plan which shall be designed to 
assure the quality of respiratory protection provided by the respirator 
for which approval is sought.



Sec.  84.41  Quality control plans; contents.

    (a) Each quality control plan shall contain provisions for the 
management of quality, including:
    (1) Requirements for the production of quality data and the use of 
quality control records;
    (2) Control of engineering drawings, documentations, and changes;
    (3) Control and calibration of measuring and test equipment;
    (4) Control of purchased material to include incoming inspection;
    (5) Lot identification, control of processes, manufacturing, 
fabrication, and assembly work conducted in the applicant's plant;
    (6) Audit of final inspection of the completed product; and
    (7) The organizational structure necessary to carry out these 
provisions.
    (b) Each provision for incoming and final inspection in the quality 
control plan shall include a procedure for the selection of a sample of 
respirators and the components thereof for testing, in accordance with 
procedures set forth in Military Standard MIL-STD-414, 11 June 1957, 
including Change Notice No. 1, ``Sampling Procedures and Tables for 
Inspection by Variables for Percent Defective,'' or an approved 
equivalent sampling procedure, or an approved combination of sampling 
procedures. The procedure of Military Standard MIL-STD-105D, 29 April 
1963, ``Sampling Procedures and Tables for Inspection by Attributes,'' 
is an example of an equivalent sampling procedure. MIL-STD-414 is 
incorporated by reference and has been approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies may be obtained from DODSSP, Standardization Document Order Desk, 
700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be 
inspected at the NIOSH, National Personal Protective Technology 
Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 
15236, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D 
may be inspected or obtained from the NIOSH, National Personal 
Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill 
Road, Pittsburgh, PA 15236. Incoming bulk raw material inspection or 
verification of specification, and in-process inspection shall be 
sufficient to ensure control of product quality through the 
manufacturing cycle.
    (c) The sampling procedure shall include a list of the 
characteristics to be tested by the applicant or his agent.
    (d) The characteristics listed in accordance with paragraph (c) of 
this section shall be classified according to the potential effect of 
such defect and grouped into the following classes:
    (1) Critical. A defect that judgment and experience indicate is 
likely to result in a condition immediately hazardous to life or health 
for individuals using or depending upon the respirator;
    (2) Major A. A defect, other than critical, that is likely to result 
in failure to the degree that the respirator does not provide any 
respiratory protection, or a defect that reduces protection and is not 
detectable by the user;
    (3) Major B. A defect, other than Major A or critical, that is 
likely to result in reduced respiratory protection, and is detectable by 
the user; and
    (4) Minor. A defect that is not likely to materially reduce the 
usability of the respirator for its intended purpose, or a defect that 
is a departure from established standards and has little bearing on the 
effective use or operation of the respirator.

[[Page 632]]

    (e) The quality control inspection test method to be used by the 
applicant or his agent for each characteristic required to be tested 
shall be described in detail.
    (f) Each item manufactured shall be 100 percent inspected for 
defects in all critical characteristics and all defective items shall be 
rejected.
    (g) The Acceptable Quality Level (AQL) for each major or minor 
defect so classified by the applicant shall be:
    (1) Major A. 1.0 percent;
    (2) Major B. 2.5 percent; and
    (3) Minor. 4.0 percent.
    (h) Except as provided in paragraph (i) of this section, inspection 
level IV as described in MIL-STD-414, 11 June 1957, including Change 
Notice No.1, ``Sampling Procedures and Tables for Inspection by 
Variables for Percent Defective,'' or an equivalent procedure, shall be 
used for major and minor characteristics and 100 percent inspection for 
critical characteristics. Inspection level II as described in MIL-STD-
105D, 29 April 1963, ``Sampling Procedures and Tables for Inspection by 
Attributes,'' is an example of an equivalent procedure.
    (i) Subject to the approval of the Institute, where the quality 
control plan provisions for raw material, processes, manufacturing, and 
fabrication, inspections are adequate to ensure control of finished 
article quality, destructive testing of finished articles may be 
conducted at a lower level of inspection than that specified in 
paragraph (h) of this section.

(The information collections contained in this section are approved 
under OMB control number 0920-0109)

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.42  Proposed quality control plans; approval by the Institute.

    (a) Each proposed quality control plan submitted in accordance with 
this subpart shall be reviewed by the Institute to determine its 
effectiveness in ensuring the quality of respiratory protection provided 
by the respirator for which an approval is sought.
    (b) If the Institute determines that the proposed quality control 
plan submitted by the applicant will not ensure adequate quality 
control, the Institute shall require the applicant to modify the 
procedures and testing requirements of the plan prior to approval of the 
plan and issuance of any certificate of approval.
    (c) Approved quality control plans shall constitute a part of and be 
incorporated into any certificate of approval issued by the Institute, 
and compliance with such plans by the applicant shall be a condition of 
approval.



Sec.  84.43  Quality control records; review by the Institute; 
revocation of approval.

    (a) The applicant shall keep quality control inspection records 
sufficient to carry out the procedures required in MIL-STD-414, 11 June 
1957, including Change Notice No. 1, ``Sampling Procedures and Tables 
for Inspection by Variables for Percent Defective,'' or an approved 
equivalent sampling procedure. MIL-STD-105D, 29 April 1963, ``Sampling 
Procedures and Tables for Inspection by Attributes,'' is an example of 
an approved equivalent sampling procedure. MIL-STD-414 is incorporated 
by reference and has been approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from DODSSP, Standardization Document Order Desk, 700 
Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be 
inspected at the NIOSH, National Personal Protective Technology 
Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 
15236, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D 
may be inspected or obtained from the NIOSH, National Personal 
Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill 
Road, Pittsburgh, PA 15236.
    (b) The Institute reserves the right to have its representatives 
inspect the applicant's quality control test methods, equipment, and 
records, and to interview any employee or agent of the applicant in 
regard to quality control test methods, equipment, and records.

[[Page 633]]

    (c) The Institute reserves the right to revoke, for cause, any 
certificate of approval where it is found that the applicant's quality 
control test methods, equipment, or records do not ensure effective 
quality control over the respirator for which the approval was issued.

(The information collections contained in this section are approved 
under OMB control number 0920-0109)

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



  Subpart F_Classification of Approved Respirators; Scope of Approval; 
                    Atmospheric Hazards; Service Time



Sec.  84.50  Types of respirators to be approved; scope of approval.

    Approvals shall be issued for the types of respirators which have 
been classified pursuant to this subpart F, have been inspected, 
examined and tested by the Institute, in accordance with the provisions 
of subparts G through L of this part, and have been found to provide 
respiratory protection for fixed periods of time against the hazards 
specified in such approval.



Sec.  84.51  Entry and escape, or escape only; classification.

    Respirators described in subparts H through L of this part shall be 
classified for use as follows:
    (a) Entry and escape. Respirators designed and approved for use 
during entry into a hazardous atmosphere, and for escape from a 
hazardous atmosphere; or
    (b) Escape only. Respirators designed and approved for use only 
during escape from a hazardous atmosphere.



Sec.  84.52  Respiratory hazards; classification.

    Respirators described in subparts H through L of this part shall be 
classified as approved for use against any or all of the following 
respiratory hazards:
    (a) Oxygen deficiency;
    (b) Gases and vapors; and
    (c) Particles, including dusts, fumes and mists.



Sec.  84.53  Service time; classification.

    (a) Respirators described in subparts H through L of this part shall 
be classified, where applicable, as approved for use during the 
following prescribed service times:
    (1) Four hours;
    (2) Three hours;
    (3) Two hours;
    (4) One hour;
    (5) Forty-five minutes;
    (6) Thirty minutes;
    (7) Fifteen minutes;
    (8) Ten minutes;
    (9) Five minutes; or
    (10) Three minutes.
    (b) Other service times may be prescribed by the Institute.



       Subpart G_General Construction and Performance Requirements



Sec.  84.60  Construction and performance requirements; general.

    (a) The Institute shall issue approvals for the types of respirators 
described in subparts H through O of this part which have met the 
minimum requirements set forth for such respirators in this part.
    (b) In addition to the types of respirators specified in subparts H 
through L of this part, the Institute shall issue approvals for other 
respiratory protective devices not specifically described in this part 
subject to such additional requirements as may be imposed in accordance 
with Sec.  84.63(c).

[60 FR 30355, June 8, 1995, as amended at 77 FR 14192, Mar. 8, 2012; 85 
FR 20607, Apr. 14, 2020]



Sec.  84.61  General construction requirements.

    (a) Respirators will not be accepted by the Institute for 
examination, inspection and testing unless they are designed on sound 
engineering and scientific principles, constructed of suitable materials 
and evidence good workmanship.
    (b) Respirator components which come into contact with the wearer's 
skin shall be made of nonirritating materials.

[[Page 634]]

    (c) Components replaced during or after use shall be constructed of 
materials which will not be damaged by normal handling.
    (d) Mouthpieces, hoods, helmets, and facepieces, except those 
employed in single-use respirators, shall be constructed of materials 
which will withstand repeated disinfection as recommended by the 
applicant in his instructions for use of the device.



Sec.  84.62  Component parts; minimum requirements.

    (a) The component parts of each respirator shall be:
    (1) Designed, constructed, and fitted to insure against creation of 
any hazard to the wearer;
    (2) Assembled to permit easy access for inspection and repair of 
functional parts; and
    (3) Assembled to permit easy access to parts which require periodic 
cleaning and disinfecting.
    (b) Replacement parts shall be designed and constructed to permit 
easy installation and to maintain the effectiveness of the respirator.



Sec.  84.63  Test requirements; general.

    (a) Each respirator and respirator component shall when tested by 
the applicant and by the Institute, and meet the applicable requirements 
set forth in subparts H through O of this part.
    (b) Where a combination respirator is assembled from two or more 
types of respirators, as described in this part, each of the individual 
respirator types which have been combined shall, as applicable, meet the 
minimum requirements for such respirators set forth in subparts H 
through O of this part, and such combination respirators, except as 
specified in Sec.  84.70(b)(2), will be classified by the type of 
respirator in the combination which provides the least protection to the 
user.
    (c) In addition to the minimum requirements set forth in subparts H 
through O of this part, the Institute reserves the right to require, as 
a further condition of approval, any additional requirements deemed 
necessary to establish the quality, effectiveness, and safety of any 
respirator used as protection against hazardous atmospheres.
    (d) Where it is determined after receipt of an application that 
additional requirements will be required for approval, the Institute 
will notify the applicant in writing of these additional requirements, 
and necessary examinations, inspections, or tests, stating generally the 
reasons for such requirements, examinations, inspections, or tests.

[60 FR 30355, June 8, 1995, as amended at 77 FR 14192, Mar. 8, 2012; 85 
FR 20607, Apr. 14, 2020]



Sec.  84.64  Pretesting by applicant; approval of test methods.

    (a) Prior to making or filing any application for approval or 
modification of approval, the applicant shall conduct, or cause to be 
conducted, examinations, inspections, and tests of respirator 
performance which are equal to or exceed the severity of those 
prescribed in this part.
    (b) With the application, the applicant shall provide a statement to 
the Institute showing the types and results of the examinations, 
inspections, and tests required under paragraph (a) of this section and 
state that the respirator meets the minimum requirements of subparts H 
through O of this part, as applicable. Complete examination, inspection, 
and test data shall be retained on file by the applicant and be 
submitted, upon request, to the Institute.
    (c) The Institute may, upon written request by the applicant, 
provide drawings and descriptions of its test equipment and otherwise 
assist the applicant in establishing a test laboratory or securing the 
services of a testing agency.
    (d) No approval will be issued until the Institute has validated the 
applicant's test results.

[60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8, 2012; 85 
FR 20607, Apr. 14, 2020]



Sec.  84.65  Conduct of examinations, inspections, and tests by the Institute; 
assistance by applicant; observers; recorded data; public demonstrations.

    (a) All examinations, inspections, and tests conducted pursuant to 
subparts H through O of this part will be

[[Page 635]]

under the sole direction and control of the Institute.
    (b) The Institute may, as a condition of approval, require the 
assistance of the applicant or agents of the applicant during the 
assembly, disassembly, or preparation of any respirator or respirator 
component prior to testing or in the operation of such equipment during 
testing.
    (c) Only Institute personnel, persons assisting the Institute 
pursuant to paragraph (b) of this section, and such other persons as are 
requested by the Institute or the applicant to be observers, shall be 
present during any examination, inspection, or test conducted prior to 
the issuance of an approval by the Institute for the equipment under 
consideration.
    (d) The Institute shall hold as confidential any analyses, drawings, 
specifications, or materials submitted by the applicant and shall not 
disclose any principles or patentable features of such equipment, except 
as required by statute or regulation.
    (e) As a condition of each approval issued for any respirator, the 
Institute reserves the right, following the issuance of such approval, 
to conduct such public tests and demonstrations of the approved 
respiratory equipment as is deemed appropriate.

[60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8, 2012; 85 
FR 20607, Apr. 14, 2020]



Sec.  84.66  Withdrawal of applications.

    (a) Any applicant may, upon a written request submitted to the 
Institute, withdraw any application for approval of any respirator.
    (b) Upon the receipt of a written request from the applicant for the 
withdrawal of an application, NIOSH will invoice the applicant based on 
the fee calculated, as specified under Sec.  84.21(e).

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



              Subpart H_Self-Contained Breathing Apparatus



Sec.  84.70  Self-contained breathing apparatus; description.

    (a) Self-contained breathing apparatus, including all completely 
assembled, portable, self-contained devices designed for use as 
respiratory protection during entry into and escape from or escape only 
from hazardous atmospheres, are described as follows:
    (1) Closed-circuit apparatus. An apparatus of the type in which the 
exhalation is rebreathed by the wearer after the carbon dioxide has been 
effectively removed and a suitable oxygen concentration restored from 
sources composed of:
    (i) Compressed oxygen; or
    (ii) Chemical oxygen; or
    (iii) Liquid-oxygen.
    (2) Open-circuit apparatus. An apparatus of the following types from 
which exhalation is vented to the atmosphere and not rebreathed:
    (i) Demand-type apparatus. An apparatus in which the pressure inside 
the facepiece in relation to the immediate environment is positive 
during exhalation and negative during inhalation; or
    (ii) Pressure-demand-type apparatus. An apparatus in which the 
pressure inside the facepiece in relation to the immediate environment 
is positive during both inhalation and exhalation.
    (b) The following respirators may be classified as designed and 
approved for use during emergency entry into a hazardous atmosphere:
    (1) A combination respirator which includes a self-contained 
breathing apparatus; and
    (2) A Type ``C'' or Type ``CE'' supplied air respirator, where--
    (i) The self-contained breathing apparatus is classified for 3-, 5-, 
or 10-minute service time and the air line supply is used during entry; 
or
    (ii) The self-contained breathing apparatus is classified for 15 
minutes or longer service time and not more than 20 percent of the rated 
capacity of the air supply is used during entry.
    (c) Self-contained breathing apparatus classified for less than 1 
hour service time will not be approved for use during underground mine 
rescue and recovery operations except as auxiliary equipment.
    (d) Self-contained breathing apparatus classified for less than 30 
minutes' service time will not be approved for use as auxiliary 
equipment during

[[Page 636]]

underground mine rescue and recovery operations.

[60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8, 2012; 84 
FR 16412, Apr. 19, 2019]



Sec.  84.71  Self-contained breathing apparatus; required components.

    (a) Each self-contained breathing apparatus described in Sec.  84.70 
shall, where its design requires, contain the following component parts:
    (1) Facepiece or mouthpiece, and noseclip;
    (2) Respirable breathing gas container;
    (3) Supply of respirable breathing gas;
    (4) Gas pressure or liquid level gages;
    (5) Timer;
    (6) Remaining service life indicator or warning device;
    (7) Hand-operated valves;
    (8) Breathing bag;
    (9) Safety relief valve or safety relief system; and
    (10) Harness.
    (b) The components of each self-contained breathing apparatus shall 
meet the minimum construction requirements set forth in subpart G of 
this part.



Sec.  84.72  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with breathing 
apparatus shall be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces and mouthpieces;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm pressure.



Sec.  84.73  Harnesses; installation and construction; minimum requirements.

    (a) Each apparatus shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
apparatus in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of apparatus parts and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.



Sec.  84.74  Apparatus containers; minimum requirements.

    (a) Apparatus may be equipped with a substantial, durable container 
bearing markings which show the applicant's name, the type and 
commercial designation of the respirator it contains, and all 
appropriate approval labels.
    (b) Containers supplied by the applicant for carrying or storing 
self-contained breathing apparatus will be inspected, examined, and 
tested as components of the respirator for which approval is sought.
    (c) Containers for self-contained breathing apparatus shall be 
designed and constructed to permit easy removal of the apparatus.



Sec.  84.75  Half-mask facepieces, full facepieces, mouthpieces; 
fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes, either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for the optional use of corrective 
spectacles or lenses which shall not reduce the respiratory protective 
qualities of the apparatus.
    (c) Apparatus with mouthpieces shall be equipped with noseclips 
which are securely attached to the mouthpiece or apparatus and provide 
an airtight seal.
    (d) Facepieces shall be designed to prevent eyepiece, spectacle, and 
lens fogging.



Sec.  84.76  Facepieces; eyepieces; minimum requirements.

    (a) Facepieces shall be designed and constructed to provide adequate 
vision which is not distorted by the eyepiece.
    (b) All eyepieces shall be designed and constructed to be impact and 
penetration resistant. Federal Specification, Mask, Air Line: and 
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with 
interim amendment-1, July 30, 1969, is an example of

[[Page 637]]

an appropriate standard for determining impact and penetration 
resistance. Copies of GGG-M-125d may be obtained from the NIOSH, 
National Personal Protective Technology Laboratory, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.77  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against damage and distortion.
    (b) Exhalation valves shall be--
    (1) Protected against external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.



Sec.  84.78  Head harnesses; minimum requirements.

    (a) Facepieces shall be equipped with adjustable and replaceable 
head harnesses designed and constructed to provide adequate tension 
during suspension and an even distribution of pressure over the entire 
area in contact with the face.
    (b) Mouthpieces shall be equipped, where applicable, with adjustable 
and replaceable harnesses designed and constructed to hold the 
mouthpiece in place.



Sec.  84.79  Breathing gas; minimum requirements.

    (a) Breathing gas used to supply apparatus shall be respirable and 
contain no less than 19.5 (dry atmosphere) volume percent of oxygen.
    (b) Oxygen, including liquid oxygen, shall contain not less than 
99.0 percent, by volume, of pure O2, not more than 0.03%, by 
volume, carbon dioxide, and not more than 0.001%, by volume, carbon 
monoxide. Methods for making these determinations can be found in the 
U.S. Pharmacopeia National Formulary. Containers used for oxygen must 
not be treated with any toxic, sleep-inducing, narcosis-producing, or 
respiratory tract irritating compounds.
    (c) Compressed, gaseous breathing air shall meet the applicable 
minimum grade requirements for Type I gaseous air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade D or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American 
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. 
Copies may be inspected at the NIOSH, National Personal Protective 
Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, 
Pittsburgh, PA 15236, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (d) Compressed, liquefied breathing air shall meet the applicable 
minimum grade requirements for Type II liquid air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade B or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American 
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. 
Copies may be inspected at the NIOSH, National Personal Protective 
Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, 
Pittsburgh, PA 15236, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.80  Interchangeability of oxygen and air prohibited.

    Approvals shall not be issued by the Institute for any apparatus, 
combination of respirator assemblies, or any apparatus or respirator 
component which is designed or constructed to permit the interchangeable 
use of oxygen and air.

[[Page 638]]



Sec.  84.81  Compressed breathing gas and liquefied breathing gas containers; 
minimum requirements.

    (a) Compressed breathing gas and liquefied breathing gas containers 
shall meet the minimum requirements of the Department of Transportation 
for interstate shipment of such containers when fully charged.
    (b) Such containers shall be permanently and legibly marked to 
identify their contents, e.g., compressed breathing air, compressed 
breathing oxygen, liquefied breathing air, or liquefied breathing 
oxygen.
    (c) Containers normally removed from apparatus for refilling shall 
be equipped with a dial indicating gage which shows the pressure in the 
container.
    (d) Compressed breathing gas contained valves or a separate charging 
system or adapter provided with each apparatus shall be equipped with 
outlet threads specified for the service by the American Standards 
Association, Compressed Gas Cylinder Valve Outlet and Inlet Connections, 
B57.1-1965. B57.1-1965 is incorporated by reference and has been 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American 
National Standards Institute, Inc., 1430 Broadway, New York, NY Copies 
may be inspected at the NIOSH, National Personal Protective Technology 
Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 
15236, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.82  Gas pressure gages; minimum requirements.

    (a) Gas pressure gages employed on compressed breathing gas 
containers shall be calibrated in pounds per square inch.
    (b) Liquid-level gages shall be calibrated in fractions of total 
container capacity, or in units of liquid volume.
    (c) Gas pressure gages other than those specified in paragraphs (a) 
and (b) of this section shall be calibrated in:
    (1) Pounds per square inch; or
    (2) In fractions of total container capacity; or
    (3) Both in pounds per square inch and fractions of total container 
capacity.
    (d)(1) Dial-indicating gages shall be reliable to within 5 percent of full scale when tested both up and down the 
scale at each of 5 equal intervals.
    (2) The full-scale graduation of dial-indicating gages shall not 
exceed 150 percent of the maximum rated cylinder pressures specified for 
the container in applicable Department of Transportation specifications 
or permits.
    (e)(1) Stem-type gages shall be readable by sight and by touch and 
shall have a stem travel distance of not less than one-fourth inch 
between each graduation.
    (2) A minimum of five graduations shall be engraved on the stem of 
each gage and these graduations shall include readings for empty, one-
quarter, one-half, three-quarters, and full.
    (3) Stem gage readings shall not vary from true readings by more 
than one-sixteenth inch per inch of stem travel.
    (f) The loss of gas through a broken gage or severed gage connection 
shall not exceed 70 liters per minute when the cylinder pressure is 
6,900 kN/m.\2\ (1,000 pounds per square inch gage) or when the liquid 
level is at one-half.
    (g) Where gages are connected to the apparatus through a gage line, 
the gage and line shall be capable of being isolated from the apparatus 
except where the failure of the gage or line would not impair the 
performance or service life of the apparatus.
    (h) Oxygen pressure gages shall have the words ``Oxygen'' and ``Use 
No Oil'' marked prominently on the gage.
    (i)(1) Apparatus using compressed breathing gas, except apparatus 
classified for escape only, shall be equipped with gages visible to the 
wearer which indicate the remaining gas content in the container.
    (2) Apparatus using liquefied breathing gas, except apparatus 
classified for escape only, shall be equipped with

[[Page 639]]

gages visible to the wearer which indicate the remaining liquid content 
in the container; however, where the liquid content cannot be rapidly 
vented, and the service time of the device begins immediately after 
filling, a timer shall be provided in place of a visible gage.



Sec.  84.83  Timers; elapsed time indicators; remaining service 
life indicators; minimum requirements.

    (a) Elapsed time indicators shall be provided for apparatus with a 
chemical oxygen source, except:
    (1) Apparatus used for escape only; or
    (2) Liquefied breathing gas apparatus equipped with gages visible to 
the wearer which indicate the remaining liquid content in the container.
    (b) The timer or other indicator shall be accurately calibrated in 
minutes of remaining service life.
    (c) Timers shall be readable by sight and by touch during use by the 
wearer.
    (d) Timers shall be equipped with automatically preset alarms which 
will warn the wearer for a period of 7 seconds or more after the preset 
time has elapsed.
    (e) Remaining service-life indicators or warning devices shall be 
provided in addition to a pressure gage on compressed gas self-contained 
breathing apparatus, except apparatus used for escape only, and shall 
operate automatically without preadjustment by the wearer.
    (f) Each remaining service-life indicator or warning device must 
give an alarm when the remaining service life is reduced to a minimum of 
25 percent of its rated service time or any higher minimum percent value 
or values as specified in the approval. Open-circuit demand and 
pressure-demand respirators must alarm continuously until depletion of 
the breathing air supply. The percent value set for indicator activation 
must be identified by labels and/or markings on each respirator unit.

[60 FR 30355, June 8, 1995, as amended at 78 FR 2622, Jan. 14, 2013]



Sec.  84.84  Hand-operated valves; minimum requirements.

    (a) Hand-operated valves shall be designed and constructed to 
prevent removal of the stem from the valve body during normal usage to 
insure against a sudden release of the full pressure of the container 
when the valve is opened.
    (b) Valves shall be designed or positioned to prevent accidental 
opening and closing, and damage from external forces.
    (c) Valves operated during use of the apparatus shall be installed 
in locations where they can be readily adjusted by the wearer.
    (d) Main-line valves, designed and constructed to conserve gas in 
the event of a regulator or demand valve failure, shall be provided in 
addition to gas container valves, except when such failure will not 
affect performance.
    (e) Hand-operated bypass systems designed and constructed to permit 
the wearer to breathe and to conserve his gas supply in the event of a 
regulator or demand valve failure, shall be provided where necessary.
    (f) Valves installed on apparatus shall be clearly distinguishable 
from one another by sight and touch.
    (g) The bypass system valve control shall be colored red.
    (h) A main-line or bypass valve or system will not be required on 
apparatus for escape only.
    (i) Safety relief valves or systems, designed and constructed to 
release excess pressure in the breathing circuit, shall be provided on 
closed-circuit apparatus, and shall meet the following requirements:
    (1) The relief valve or system shall operate automatically when the 
pressure in the breathing circuit on the inhalation side of the 
breathing bag reaches 13 mm. (one-half inch) water-column height of 
pressure above the minimum pressure required to fill the breathing bag, 
within the breathing resistance requirements for the apparatus.
    (2) The relief valve or system shall be designed to prevent external 
atmospheres from entering the breathing circuit.
    (3) The relief valve or system shall be designed to permit manual 
overriding for test purposes and in the event of a failure in the valve 
or system.

[[Page 640]]



Sec.  84.85  Breathing bags; minimum requirements.

    (a) Breathing bags shall have sufficient volume to prevent gas waste 
during exhalation and to provide an adequate reserve for inhalation.
    (b) Breathing bags shall be constructed of materials which are 
flexible and resistant to gasoline vapors.
    (c) Breathing bags shall be installed in a location which will 
protect them from damage or collapse by external forces, except on 
apparatus classified for escape only.



Sec.  84.86  Component parts exposed to oxygen pressures; minimum requirements.

    Each applicant shall certify that the materials employed in the 
construction of component parts exposed to oxygen pressures above 
atmospheric pressure are safe and compatible for their intended use.



Sec.  84.87  Compressed gas filters; minimum requirements.

    All self-contained breathing apparatus using compressed gas shall 
have a filter downstream of the gas source to effectively remove 
particles from the gas stream.



Sec.  84.88  Breathing bag test.

    (a) Breathing bags will be tested in an air atmosphere saturated 
with gasoline vapor at room temperature (24-30 [deg]C./75-85 [deg]F.) 
for a continuous period of twice the rated time of the apparatus (except 
for apparatus for escape only where the test period shall be the rated 
time of the apparatus).
    (b) The bag will be operated during this test by a breathing machine 
with 24 respirations per minute and a minute-volume of 40 liters.
    (c) A breathing machine cam with a work rate of 622 kp.-m./min. will 
be used. The dimensions of a suitable breathing machine cam are 
available from the Institute upon request.
    (d) The air within the bag(s) shall not contain more than 100 parts 
per million of gasoline vapor at the end of the test.



Sec.  84.89  Weight requirement.

    (a) The completely assembled and fully charged apparatus shall not 
weigh more than 16 kg. (35 pounds); however, where the weight decreases 
by more than 25 percent of its initial charge weight during its rated 
service life, the maximum allowable weight of a completely assembled and 
fully charged apparatus shall be 18 kg. (40 pounds).
    (b) Where an apparatus employs equipment which contributes 
materially to the wearer's comfort, e.g., a cooling system, the 
completely assembled and fully charged apparatus shall not weigh more 
than 18 kg. (40 pounds) regardless of the decrease in weight during use.



Sec.  84.90  Breathing resistance test; inhalation.

    (a) Resistance to inhalation airflow will be measured in the 
facepiece or mouthpiece while the apparatus is operated by a breathing 
machine as described in Sec.  84.88.
    (b) The inhalation resistance of open-circuit apparatus shall not 
exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120 
liters per minute).
    (c) The inhalation resistance of closed-circuit apparatus shall not 
exceed the difference between exhalation resistance (Sec.  84.91(e)) and 
10 cm. (4 inches) water-column height.



Sec.  84.91  Breathing resistance test; exhalation.

    (a) Resistance to exhalation airflow will be measured in the 
facepiece or mouthpiece of open-circuit apparatus with air flowing at a 
continuous rate of 85 liters per minute.
    (b) The exhalation resistance of demand apparatus shall not exceed 
25 mm. (1 inch) water-column height.
    (c) The exhalation resistance of pressure-demand apparatus shall not 
exceed the static pressure in the facepiece by more than 51 mm. (2 
inches) water-column height.
    (d) The static pressure (at zero flow) in the facepiece shall not 
exceed 38 mm. (1.5 inches) water-column height.
    (e) Resistance to exhalation airflow will be measured in the 
facepiece or mouthpiece of closed-circuit apparatus with a breathing 
machine as described in Sec.  84.88, and the exhalation resistance shall 
not exceed 51 mm. (2 inches) water-column height.

[[Page 641]]



Sec.  84.92  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. (1 inch) water-column height while in a normal 
operating position.
    (b) Leakage between the valve and the valve seat shall not exceed 30 
milliliters per minute.



Sec.  84.93  Gas flow test; open-circuit apparatus.

    (a) A static-flow test will be performed on all open-circuit 
apparatus.
    (b) The flow from the apparatus shall be greater than 200 liters per 
minute when the pressure in the facepiece of demand-apparatus is lowered 
by 51 mm. (2 inches) water-column height when full container pressure is 
applied.
    (c) Where pressure demand apparatus are tested, the flow will be 
measured at zero gage pressure in the facepiece.
    (d) Where apparatus with compressed-breathing-gas containers are 
tested, the flow test shall also be made with 3,450 kN/m.\2\ (500 
p.s.i.g.) container pressure applied.



Sec.  84.94  Gas flow test; closed-circuit apparatus.

    (a) Where oxygen is supplied by a constant-flow device only, the 
rate of flow shall be at least 3 liters per minute for the entire rated 
service time of the apparatus.
    (b) Where constant flow is used in conjunction with demand flow, the 
constant flow shall be greater than 1.5 liters per minute for the entire 
rated service time.
    (c) All demand-flow devices shall provide at least 30 liters of 
oxygen per minute when in the fully open position.



Sec.  84.95  Service time test; open-circuit apparatus.

    (a) Service time will be measured with a breathing machine as 
described in Sec.  84.88.
    (b) The open-circuit apparatus will be classified according to the 
length of time it supplies air or oxygen to the breathing machine.
    (c) The service time obtained on this test will be used to classify 
the open-circuit apparatus in accordance with Sec.  84.53.



Sec.  84.96  Service time test; closed-circuit apparatus.

    (a) The closed-circuit apparatus will be classified according to the 
length of time it supplies adequate breathing gas to the wearer during 
man test No. 4 described in Table 4 of this subpart.
    (b) The service time obtained on man test No. 4 will be used to 
classify the closed-circuit apparatus in accordance with Sec.  84.53.



Sec.  84.97  Test for carbon dioxide in inspired gas; open- 
and closed-circuit apparatus; maximum allowable limits.

    (a) Open-circuit apparatus. (1) The concentration of carbon dioxide 
in inspired gas in open-circuit apparatus will be measured at the mouth 
while the apparatus mounted on a dummy head is operated by a breathing 
machine. An acceptable method for measuring the concentration of carbon 
dioxide is described in Bureau of Mines Report of Investigations 6865, A 
Machine-Test Method for Measuring Carbon Dioxide in the Inspired Air of 
Self-Contained Breathing Apparatus, 1966. Copies of Report of 
Investigations 6865 may be inspected or obtained from the NIOSH, 
National Personal Protective Technology Laboratory, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236.
    (2) The breathing rate will be 14.5 respirations per minute with a 
minute-volume of 10.5 liters.
    (3) A sedentary breathing machine cam will be used.
    (4) The apparatus will be tested at a temperature of 27 2 [deg]C. (80 5 [deg]F.).
    (5) A concentration of 5 percent carbon dioxide in air will be 
exhaled into the facepiece.
    (b) Closed-circuit apparatus. The concentration of carbon dioxide in 
inspired gas in closed-circuit apparatus will be measured at the mouth 
while the parts of the apparatus contributing to dead-air space are 
mounted on a dummy head and operated by the breathing machine as in 
paragraphs (a) (1) through (5) of this section.
    (c) During the testing required by paragraphs (a) and (b) of this 
section, the concentration of carbon dioxide in inspired gas at the 
mouth will be continuously recorded, and the maximum

[[Page 642]]

average concentration during the inhalation portion of the breathing 
cycle shall not exceed the following limits:

------------------------------------------------------------------------
                                                    Maximum allowable
                                                  average concentration
           Where the service time is               of carbon dioxide in
                                                 inspired air percent by
                                                          volume
------------------------------------------------------------------------
Not more than 30 minutes.......................                      2.5
1 hour.........................................                      2.0
2 hours........................................                      1.5
3 hours........................................                      1.0
4 hours........................................                      1.0
------------------------------------------------------------------------

    (d) In addition to the test requirements for closed-circuit 
apparatus set forth in paragraph (b) of this section, gas samples will 
be taken during the course of the man tests described in Tables 1, 2, 3, 
and 4 of this subpart. These gas samples will be taken from the closed-
circuit apparatus at a point downstream of the carbon dioxide sorbent, 
and they shall not contain more than 0.5 percent carbon dioxide at any 
time, except on apparatus for escape only, using a mouthpiece only, the 
sample shall not contain more than 1.5 percent carbon dioxide at any 
time.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.98  Tests during low temperature operation.

    (a) The applicant shall specify the minimum temperature for safe 
operation and two persons will perform the tests described in paragraphs 
(c) and (d) of this section, wearing the apparatus according to 
applicant's directions. At the specified temperature, the apparatus 
shall meet all the requirements described in paragraph (e) of this 
section.
    (b) The apparatus will be precooled at the specified minimum 
temperature for 4 hours.
    (c) The apparatus will be worn in the low temperature chamber for 30 
minutes, or for the service time of the apparatus, whichever is less.
    (d) During the test period, alternate 1-minute periods of exercise 
and rest will be required with the exercise periods consisting of 
stepping onto and off a box 21.5 cm. (8\1/2\ inches) high at a rate of 
30 cycles per minute.
    (e)(1) The apparatus shall function satisfactorily at the specified 
minimum temperature on duplicate tests.
    (2) The wearer shall have sufficient unobscured vision to perform 
the work.
    (3) The wearer shall not experience undue discomfort because of 
airflow restriction or other physical or chemical changes in the 
operation of the apparatus.
    (f) Auxiliary low-temperature parts which are commercially available 
to the user may be used on the apparatus to meet the requirements 
described in paragraph (e) of this section.



Sec.  84.99  Man tests; testing conditions; general requirements.

    (a) The man tests described in Tables 1, 2, 3, and 4 of this subpart 
represent the workload performed in the mining, mineral, or allied 
industries by a person wearing the apparatus tested.
    (b) The apparatus tested will be worn by Institute personnel trained 
in the use of self-contained breathing apparatus, and the wearer will, 
before participating in these tests, pass a physical examination 
conducted by a qualified physician.
    (c) All man tests will be conducted by the Institute.
    (d) The apparatus will be examined before each man test to ensure 
that it is in proper working order.
    (e) Breathing resistance will be measured within the facepiece or 
mouthpiece and the wearer's pulse and respiration rate will be recorded 
during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.
    (f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.
    (g) If man tests are not completed through no fault of the 
apparatus, the test will be repeated.



Sec.  84.100  Man tests 1, 2, 3, and 4; requirements.

    Man tests 1, 2, 3, and 4, set forth in Tables 1, 2, 3, and 4 of this 
subpart, respectively, prescribe the duration and sequence of specific 
activities. These tests will be conducted to--
    (a) Familiarize the wearer with the apparatus during use;
    (b) Provide for a gradual increase in activity;
    (c) Evaluate the apparatus under different types of work and 
physical orientation; and

[[Page 643]]

    (d) Provide information on the operating and breathing 
characteristics of the apparatus during actual use.



Sec.  84.101  Man test 5; requirements.

    (a) Test 5 will be conducted to determine the maximum length of time 
the apparatus will supply the respiratory needs of the wearer while he 
is sitting at rest.
    (b) The wearer will manipulate the devices controlling the supply of 
breathing gas to the advantage of the apparatus.
    (c) Samples of inspiration from within the apparatus facepiece or 
mouthpiece shall be taken once every 15 minutes, and shall meet the 
minimum requirement for oxygen specified in Sec.  84.79(a), and the 
maximum allowable average concentration of carbon dioxide specified in 
Sec.  84.97(c).
    (d) One sample of inspiration will be taken in the case of 3-, 5-, 
and 10-minute apparatus.



Sec.  84.102  Man test 6; requirements.

    (a) Man test 6 will be conducted with respect to liquefied breathing 
gas apparatus only.
    (b) This test will be conducted to evaluate operation of the 
apparatus in other than vertical positions.
    (c) The wearer will lie face downward for one-fourth the service 
life of the apparatus with a full charge of liquefied breathing gas, and 
then a one-quarter full charge of liquefied breathing gas.
    (d) The test will be repeated with the wearer lying on each side and 
on his back.
    (e) The oxygen content of the gas supplied to the wearer by the 
apparatus will be continuously measured.



Sec.  84.103  Man tests; performance requirements.

    (a) The apparatus shall satisfy the respiratory requirements of the 
wearer for the classified service time.
    (b) Fogging of the eyepiece shall not obscure the wearer's vision, 
and the wearer shall not experience undue discomfort because of fit or 
other characteristics of the apparatus.
    (c) When the ambient temperature during testing is 24 6 [deg]C. (75 10 [deg]F.), the 
maximum temperature of inspired air recorded during man tests shall not 
exceed the following, after correction for deviation from 24 [deg]C. (75 
[deg]F.):

------------------------------------------------------------------------
                                 Where percent     Maximum permissible
                                   relative      temperature of inspired
     Where service life of        humidity of    air shall not exceed--
        apparatus is--           inspired air  -------------------------
                                     is--         [deg]F.      [deg]C.
------------------------------------------------------------------------
\1/4\ hour or less............           0-100          135           57
\1/4\ hour to \3/4\ hour......            0-50          125           52
                                        50-100      \1\ 110       \1\ 43
1 to 2 hours..................            0-50          115           46
                                        50-100       \1\105        \1\41
3 hours.......................            0-50          110           43
                                        50-100       \1\100       \1\ 38
4 hours.......................            0-50          105           41
                                        50-100       \1\ 95       \1\ 35
------------------------------------------------------------------------
\1\ Where percent relative humidity is 50-100 and apparatus is designed
  for escape only, these maximum permissible temperatures will be
  increased by 5 [deg]C (10 [deg]F).



Sec.  84.104  Gas tightness test; minimum requirements.

    (a) Each apparatus will be tested for tightness by persons wearing 
it in an atmosphere of 1,000 p.p.m. isoamyl acetate.
    (b) Six persons will each wear the apparatus in the test 
concentrations specified in paragraph (a) of this section for 2 minutes 
and none shall detect the odor or taste of the test vapor.



[[Page 644]]

                     Tables to Subpart H of Part 84

                                      Table 1--Duration and Sequence of Specific Activities for Test 1, in Minutes
                                                               [42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Service time--
                                               ---------------------------------------------------------------------------------------------------------
                   Activity                         3         5        10        15        30        45
                                                 minutes   minutes   minutes   minutes   minutes   minutes   1 hour            2, 3, and 4 hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings.........................  ........  ........  ........         2         2         2         2  Perform 1 hour test 2, 3, or 4
                                                                                                                       times respectively.
Walks at 4.8 km. (3 miles) per hour...........         3         5         3         4         8        12        18
Sampling and readings.........................  ........  ........         2         2         2         2         2
Walks at 4.8 km. (3 miles) per hour...........  ........  ........         3         5         8        12        18
Sampling and readings.........................  ........  ........         2         2         2         2         2  ..................................
Walks at 4.8 km. (3 miles) per hour...........  ........  ........  ........  ........         6        13        16
Sampling and readings.........................  ........  ........  ........  ........         2         2         2  ..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------


                  Table 2--Duration and Sequence of Specific Activities For Test 2, in Minutes
                                           [42 CFR part 84, subpart H]
----------------------------------------------------------------------------------------------------------------
                                                                Service time--
                             -----------------------------------------------------------------------------------
          Activity                                                                                      2, 3 and
                                 3        5         10         15         30         45       1 hour    4 hours
                              minutes  minutes   minutes    minutes    minutes    minutes                 \1\
----------------------------------------------------------------------------------------------------------------
Sampling and readings.......  .......  .......  .........          2          2          2          2          2
Walks at 4.8 km. (3 miles)    .......  .......          1          1          3          4          6        10.
 per hour...................
Carries 23 kg. (50 pound)     .......  .......  1 time in  1 time in    2 times    3 times    4 times    5 times
 weight over overcast.......                    2 minutes  2 minutes       in 4       in 6       in 8      in 10
                                                                        minutes    minutes    minutes   minutes.
Walks at 4.8 km. (3 miles)    .......  .......  .........          1          3          3          3         5.
 per hour...................
Climbs vertical treadmill           1        1          1          1          1          1          1         1.
 \2\ (or equivalent)........
Walks at 4.8 km. (3 miles)    .......        1          1  .........  .........          2          3          5
 per hour...................
Climbs vertical treadmill     .......        1  .........  .........  .........          1          1         1.
 (or equivalent)............
Sampling and readings.......  .......  .......  .........  .........          2          2          2         2.
Walks at 4.8 km. (3 miles)    .......  .......  .........          2          2          3          5        11.
 per hour...................
Climbs vertical treadmill     .......  .......  .........          1          1          1          1         1.
 (or equivalent)............
Carries 23 kg. (50 pound)     .......  .......  .........  1 time in    3 times    4 times    5 times    5 times
 weight over overcast.......                               2 minutes       in 6       in 8      in 10      in 10
                                                                        minutes    minutes    minutes   minutes.
Sampling and readings.......  .......  .......          2  .........  .........          2          2         2.
Walks at 4.8 km. (3 miles)    .......  .......  .........          1          3          3          3  .........
 per hour...................
Climbs vertical treadmill     .......  .......          1          1          1          1          1       Then
 (or equivalent)............                                                                              repeat
                                                                                                           above
                                                                                                       activitie
                                                                                                         s once.
Walks at 4.8 km. (3 miles)    .......  .......          2  .........  .........          2          3
 per hour...................
Climbs vertical treadmill     .......  .......  .........  .........  .........          1          1  .........
 (or equivalent)............
Carries 20 kg. (45 pound)           1  .......  .........  .........  .........  .........          2  .........
 weight and walks at 4.8 km.
 (3 miles) per hour.........
Walks at 4.8 km. (3 miles)          1        2  .........  .........  .........          1          4  .........
 per hour...................

[[Page 645]]

 
Sampling and readings.......  .......  .......  .........          2          2          2          2  .........
----------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 2 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.
\2\ Treadmill shall be inclined 15[deg] from vertical and operated at a speed of 1 foot per second.


                  Table 3--Duration and Sequence of Specific Activities For Test 3, in Minutes
                                           [42 CFR part 84, subpart H]
----------------------------------------------------------------------------------------------------------------
                                                                  Service time--
                                 -------------------------------------------------------------------------------
            Activity                                                                                    2, 3 and
                                      3         5        10        15        30        45      1 hour    4 hours
                                   minutes   minutes   minutes   minutes   minutes   minutes               \1\
----------------------------------------------------------------------------------------------------------------
Sampling and readings...........  ........  ........  ........         2         2         2         2     (\2\)
Walks at 4.8 km. (3 miles) per    ........  ........         1         1         2         2         3  ........
 hour...........................
Runs at 9.7 km. (6 miles) per            1         1         1         1         1         1         1  ........
 hour...........................
Pulls 20 kg. (45 pound) weight    ........  15 times  ........  30 times  30 times  30 times  60 times  ........
 to 5 feet......................                in 1                in 2      in 2      in 2      in 6
                                              minute             minutes   minutes   minutes   minutes
Lies on side....................       1/2         1         1         2         3         4         5  ........
Lies on back....................       1/2         1         1         2         2         3         3  ........
Crawls on hands and knees.......         1         1         1         2         2         2         2  ........
Sampling and readings...........  ........  ........         2  ........         2         2         2  ........
Runs at 9.7 km. (6 miles) per     ........  ........  ........         1         1         1         1  ........
 hour...........................
Walks at 4.8 km. (3 miles) per    ........  ........  ........  ........         2         8        10  ........
 hour...........................
Pulls 20 kg. (45 pound) weight    ........  ........  30 times  ........  60 times  60 times  60 times  ........
 to 5 feet......................                          in 2                in 6      in 6      in 6
                                                       minutes             minutes   minutes   minutes
Sampling and readings...........  ........  ........  ........         2  ........         2         2  ........
Walks at 4.8 km. (3 miles) per    ........  ........         1  ........         3         4        10  ........
 hour...........................
Lies on side....................  ........  ........  ........  ........  ........         2         4  ........
Lies on back....................  ........  ........  ........  ........  ........         2         1  ........
Sampling and readings...........  ........  ........  ........  ........         2         2         2  ........
----------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 3 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.
\2\ Perform test No. 3 for 1 hr. apparatus; then perform test No. 1 for 1 hour apparatus.


                                      Table 4--Duration and Sequence of Specific Activities for Test 4, in Minutes
                                                               [42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Service time--
                                                     ---------------------------------------------------------------------------------------------------
                      Activity                            3         5        10        15        30        45
                                                       minutes   minutes   minutes   minutes   minutes   minutes   1 hour    2 hours   3 hours   4 hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings...............................  ........  ........  ........         2         2         2         2     (\2\)     (\3\)     (\4\)
Walks at 4.8 km. (3 miles) per hour.................  ........  ........  ........         1         2         2         2  ........  ........  ........
Climbs vertical treadmill \1\ (or equivalent).......         1         1         1         1         1         1         1  ........  ........  ........
Walks at 4.8 km. (3 miles) per hour.................  ........         1         1         1         2         2         2  ........  ........  ........
Pulls 20 kg. (45 pound) weight to 5 feet............  ........  30 times  30 times  30 times  60 times  60 times  60 times  ........  ........  ........
                                                                    in 2      in 2      in 2      in 5      in 5      in 5
                                                                 minutes   minutes   minutes   minutes   minutes   minutes
Walks at 4.8 km. (3 miles) per hour.................  ........  ........         1         1         1         2         3  ........  ........  ........

[[Page 646]]

 
Carries 23 kg. (50 pound) weight over overcast......  ........  ........  ........    1 time    1 time   2 times   4 times  ........  ........  ........
                                                                                        in 1      in 1      in 3      in 8
                                                                                      minute    minute   minutes   minutes
Sampling and readings...............................  ........  ........         2  ........         2         2         2  ........  ........  ........
Walks at 4.8 km. (3 miles) per hour.................  ........  ........  ........         1         3         3         4  ........  ........  ........
Runs at 9.7 km. (6 miles) per hour..................  ........         1         1         1         1         1         1  ........  ........  ........
Carries 23 kg. (50 pound) weight over overcast......  ........  ........    1 time    1 time   2 times   4 times   6 times  ........  ........  ........
                                                                              in 1      in 1      in 3      in 6      in 9
                                                                            minute    minute   minutes   minutes   minutes
Pulls 20 kg (45 pound) weight to 5 feet.............  15 times  ........  ........  15 times  60 times  30 times  36 times  ........  ........  ........
                                                          in 1                          in 1      in 5      in 2      in 3
                                                        minute                        minute   minutes   minutes   minutes
Sampling and readings...............................  ........  ........  ........         2         2         2         2  ........  ........  ........
Walks at 4.8 km. (3 miles) per hour.................         1  ........         1  ........  ........         2         6  ........  ........
Pulls 20 kg. (45 pound) weight to 5 feet............  ........  ........  ........  ........  ........  60 times  60 times  ........  ........  ........
                                                                                                            in 5      in 5
                                                                                                         minutes   minutes
Carries 20 kg. (45 pound) weight and walks at 4.8     ........  ........  ........  ........  ........         3         3  ........  ........  ........
 km. (3 miles) per hour.............................
Sampling and readings...............................  ........  ........  ........  ........  ........         2         2  ........  ........  ........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Treadmill shall be inclined 15[deg] from vertical and operated at a speed of 30 cm. (1 foot) per second.
\2\ Perform test No. 1 for 30-minute apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 30-minute apparatus.
\3\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus.
\4\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus twice (i.e., two
  one-hour tests).



                           Subpart I_Gas Masks



Sec.  84.110  Gas masks; description.

    (a) Gas masks including all completely assembled air purifying masks 
designed for use as respiratory protection during entry into atmospheres 
not immediately dangerous to life or health or escape only from 
hazardous atmospheres containing adequate oxygen to support life are 
described as follows:
    (1) Front-mounted or back-mounted gas mask. A gas mask which 
consists of a full facepiece, a breathing tube, a canister at the front 
or back, a canister harness, and associated connections.
    (2) Chin-style gas mask. A gas mask which consists of a full 
facepiece, a canister which is usually attached to the facepiece, and 
associated connections.

[[Page 647]]

    (3) Escape gas mask. A gas mask designed for use during escape only 
from hazardous atmospheres which consists of a facepiece or mouthpiece, 
a canister, and associated connections.
    (b) Gas masks shall be further described according to the types of 
gases or vapors against which they are designed to provide respiratory 
protection, as follows:

------------------------------------------------------------------------
 
Type of front-mounted or back-mounted gas mask:
  Acid gas \1 2 3\
  Ammonia
  Carbon monoxide
  Organic Vapor \1 2 3\
  Other gas(es) and vapor(s) \1 2 3\
  Combination of two or more of the above gases and vapors. \1 2 3\
  Combination of acid gas, ammonia, carbon monoxide, and organic vapors.
   \1 2 3\
Type of chin-style gas mask:
  Acid gas \1 2 3\
  Ammonia
  Carbon monoxide
  Organic vapor \1 2 3\
  Other gas(es) and vapor \1 2 3\
  Combination of two or more of the above gases and vapors. \1 2 3\
Type of escape gas mask:
  Acid gas \1 2 3 4\
  Ammonia \4\
  Carbon monoxide
  Organic vapor \1 2 3 4\
  Other gas(s) and vapor(s) \1 2 3 4\
  Combination of two or more of the above gases and vapors. \1 2 3 4\
------------------------------------------------------------------------
\1\ Approval may be for acid gases or organic vapors as a class or for
  specific acid gases or organic vapors.
\2\ Not for use against gases or vapors with poor warning properties
  (except where MSHA or Occupational Safety and Health Administration
  standards permit such use for a specific gas or vapor), or those which
  generate high heats or reaction with sorbent materials in the
  canister.
\3\ Use of the gas mask may be limited by factors such as lower
  explosive limit, toxicological effects, and facepiece fit. Limitations
  on gas mask service life and sorbent capacity limitations shall be
  specified by the applicant in instructions for selection, use and
  maintenance of the gas mask.
\4\ Eye protection may be required in certain concentrations of gases
  and vapors.

    (c) Gas masks for respiratory protection against gases and vapors 
other than those specified in paragraph (b) of this section, may be 
approved upon submittal of an application in writing for approval to the 
National Personal Protective Technology Laboratory listing the gas or 
vapor and suggested maximum use concentration for the specific type of 
gas mask. The Institute will consider the application and accept or 
reject it on the basis of effect on the wearer's health and safety and 
any field experience in use of gas masks for such exposures. If the 
application is accepted, the Institute will test such masks in 
accordance with the requirements of this subpart.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.111  Gas masks; required components.

    (a) Each gas mask described in Sec.  84.110 shall, where its design 
requires, contain the following component parts:
    (1) Facepiece or mouthpiece and noseclip;
    (2) Canister or cartridge;
    (3) Canister harness;
    (4) External check valve; and
    (5) Breathing tube.
    (b) The components of each gas mask shall meet the minimum 
construction requirements set forth in subpart G of this part.



Sec.  84.112  Canisters and cartridges in parallel; resistance requirements.

    Where two or more canisters or cartridges are used in parallel, 
their resistance to airflow shall be essentially equal.



Sec.  84.113  Canisters and cartridges; color and markings; requirements.

    The color and markings of all canisters and cartridges or labels 
shall conform with the requirements of the American National Standards 
Institute, American National Standard for Identification of Air-
Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI 
K13.1 is incorporated by reference and has been approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from American National Standards 
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be 
inspected at the NIOSH, National Personal Protective Technology 
Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 
15236, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]

[[Page 648]]



Sec.  84.114  Filters used with canisters and cartridges; 
location; replacement.

    (a) Particulate matter filters used in conjunction with a canister 
or cartridge shall be located on the inlet side of the canister or 
cartridge.
    (b) Filters shall be incorporated in or firmly attached to the 
canister or cartridge and each filter assembly shall, where applicable, 
be designed to permit its easy removal from and replacement in the 
canister or cartridge.



Sec.  84.115  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with gas masks shall be 
designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces or mouthpieces;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm pressure.



Sec.  84.116  Harnesses; installation and construction; minimum requirements.

    (a) Each gas mask shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
gas mask in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of gas mask parts, and where applicable, provide 
for holding a full facepiece in the ready position when not in use.



Sec.  84.117  Gas mask containers; minimum requirements.

    (a) Gas masks shall be equipped with a substantial, durable 
container bearing markings which show the applicant's name, the type and 
commercial designation of mask it contains and all appropriate approval 
labels.
    (b) Containers for gas masks shall be designed and constructed to 
permit easy removal of the mask.



Sec.  84.118  Half-mask facepieces, full facepieces, and mouthpieces; 
fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for optional use of corrective 
spectacles or lenses, which shall not reduce the respiratory protective 
qualities of the gas mask.
    (c) Half-mask facepieces shall not interfere with the fit of common 
industrial safety spectacles, as determined by the Institute's facepiece 
tests in Sec.  84.124.
    (d) Gas masks with mouthpieces shall be equipped with noseclips 
which are securely attached to the mouthpiece or gas mask and provide an 
airtight seal.
    (e) Facepieces shall be designed to prevent eyepiece fogging.



Sec.  84.119  Facepieces; eyepieces; minimum requirements.

    (a) Full facepieces shall be designed and constructed to provide 
adequate vision which is not distorted by the eye.
    (b) All eyepieces shall be designed and constructed to be impact and 
penetration resistant. Federal Specification, Mask, Air Line: and 
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with 
interim amendment-1, July 30, 1969, is an example of an appropriate 
standard for determining impact and penetration resistance. Copies of 
GGG-M-125d may be obtained from the NIOSH, National Personal Protective 
Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, 
Pittsburgh, PA 15236.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.120  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against damage and distortion.

[[Page 649]]

    (b) Inhalation valves shall be designed and constructed to prevent 
excessive exhaled air from adversely affecting cartridges, canisters, 
and filters.
    (c) Exhalation valves shall be protected against external influence, 
and designed and constructed to prevent inward leakage of contaminated 
air.



Sec.  84.121  Head harnesses; minimum requirements.

    (a) Facepieces shall be equipped with adjustable and replaceable 
head harnesses, designed and constructed to provide adequate tension 
during use and an even distribution of pressure over the entire area in 
contact with the face.
    (b) Mouthpieces shall be equipped, where applicable, with adjustable 
and replaceable harnesses designed and constructed to hold the 
mouthpiece in place.



Sec.  84.122  Breathing resistance test; minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece or 
mouthpiece of a gas mask mounted on a breathing machine both before and 
after each test conducted in accordance with Sec. Sec.  84.124, 84.125, 
and 84.126, with air flowing at a continuous rate of 85 liters per 
minute.
    (b) The maximum allowable resistance requirements for gas masks are 
as follows:

                           Maximum Resistance
                        [mm. water-column height]
------------------------------------------------------------------------
                                          Inhalation
         Type of gas mask         --------------------------  Exhalation
                                     Initial     Final \1\
------------------------------------------------------------------------
Front-mounted or back-mounted               60           75           20
 (without particulate filter)....
Front-mounted or back-mounted               70           85           20
 (with approved particulate
 filter).........................
Chin-style (without particulate             40           55           20
 filter).........................
Chin-style (with approved                   65           80           20
 particulate filter).............
Escape (without particulate                 60           75           20
 filter).........................
Escape (with approved particulate           70           85           20
 filter).........................
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Tables 5, 6, and 7
  of this subpart.



Sec.  84.123  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.



Sec.  84.124  Facepiece tests; minimum requirements.

    (a) The complete gas mask will be fitted to the faces of persons 
having varying facial shapes and sizes.
    (b) Where the applicant specifies a facepiece size or sizes for the 
gas mask, together with the approximate measurements of faces they are 
designed to fit, the Institute will insure that test subjects suit such 
facial measurements.
    (c) Any gas mask parts which must be removed to perform the 
facepiece or mouthpiece fit test shall be replaceable without special 
tools and without disturbing the facepiece or mouthpiece fit.
    (d) The facepiece or mouthpiece fit test, using positive or negative 
pressure recommended by the applicant and described in his instructions 
will be used before each test specified in paragraph (e) of this 
section, and in Sec.  84.125.
    (e)(1) Each wearer will enter a chamber containing 100 p.p.m. 
isoamyl acetate vapor for a half-mask facepiece and 1,000 p.p.m. isoamyl 
acetate vapor for a full facepiece or mouthpiece.
    (2) The facepiece or mouthpiece may be adjusted, if necessary, in 
the test chamber before starting the tests.
    (3) Each wearer will remain in the chamber for 8 minutes while 
performing the following activities:
    (i) Two minutes, nodding and turning head;
    (ii) Two minutes, calisthenic arm movements;
    (iii) Two minutes, running in place; and

[[Page 650]]

    (iv) Two minutes, pumping with a tire pump into a 28 liter (1 cubic 
foot) container.
    (4) Each wearer shall not detect the odor of isoamyl acetate during 
the test.



Sec.  84.125  Particulate tests; canisters containing particulate filters; 
minimum requirements.

    Gas mask canisters containing filters for protection against 
particulates (e.g. dusts, fumes, mists, and smokes) in combination with 
gases, vapors, or gases and vapors, shall also comply with the 
requirements as prescribed in Sec. Sec.  84.170 through 84.181, except 
for the airflow resistance test of Sec.  84.172.

[60 FR 30355, June 8, 1995, as amended at 85 FR 20607, Apr. 14, 2020]



Sec.  84.126  Canister bench tests; minimum requirements.

    (a)(1) Bench tests, except for carbon monoxide tests, will be made 
on an apparatus that allows the test atmosphere at 50 5 percent relative humidity and room temperature (25 
2.5 [deg]C.) to enter the canister continuously at 
concentrations and rates of flow specified in Tables 5, 6, and 7 of this 
subpart.
    (2) Three canisters will be removed from containers and tested as 
received from the applicant.
    (3) Two canisters, other than those described in paragraph (a)(2) of 
this section, will be equilibrated at room temperature by passing 25 
percent relative humidity air through them at 64 liters per minute for 6 
hours.
    (4) Two canisters, other than those described in paragraphs (a) (2) 
and (3) of this section, will be equilibrated at room temperature by 
passing 85 percent relative humidity air through them at 64 liters per 
minute for 6 hours.
    (5) The equilibrated canisters will be resealed, kept in an upright 
position at room temperature, and tested within 18 hours.
    (b) Front-mounted and back-mounted gas mask canisters will be tested 
and shall meet the minimum requirements set forth in Table 5 of this 
subpart.
    (c)(1) Front-mounted, and back-mounted, and chin-style canisters 
designated as providing respiratory protection against gases, ammonia, 
organic vapors, carbon monoxide and particulate contaminants shall have 
a window or other indicator to warn the gas mask wearer when the 
canister will no longer satisfactorily remove carbon monoxide from the 
inhaled air.
    (2) Other types of front- and back-mounted canisters may also be 
equipped with a window or other indicator to warn of imminent leakage of 
other gases or vapors.
    (3) The window indicator canisters will be tested as regular 
canisters, but shall show a satisfactory indicator change or other 
warning before the allowable canister penetration has occurred.
    (d) Chin-style gas mask canisters shall meet the minimum 
requirements set forth in Table 6 of this subpart.
    (e) Escape gas mask canisters shall meet the minimum requirements 
set forth in Table 7 of this subpart.
    (f) Powered air-purifying respirators with a canister(s) and 
particulate filter(s) must meet the as-received minimum service-life 
requirements and half of the equilibrated minimum service-life 
requirements set forth in Tables 5, 6, and 7 of subpart I using the 
flows specified in subpart K, Sec.  84.175(b) and equilibrated in 
accordance with paragraphs (a) through (e) of this section using the 
flows specified in subpart K, Sec.  84.175(b).

[60 FR 30355, June 8, 1995, as amended at 85 FR 20607, Apr. 14, 2020]

[[Page 651]]



                   Sec. Tables to Subpart I of Part 84

                          Table 5--Canister Bench Tests and Requirements for Front-Mounted and Back-Mounted Gas Mask Canisters
                                                               [42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Test atmosphere
                                                                   ----------------------------------------------------              Maximum    Minimum
                                                                                                             Flow rate  Number of   allowable   service
              Canister type                    Test condition                                 Concentration   (liters     tests    penetratin     life
                                                                          Gas or vapor          (parts per      per                (parts per  (minutes)
                                                                                                 million)     minute)               million)      \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas................................  As received               SO2                             20,000          64          3           5         12
                                          Equilibrated              Cl2                             20,000          64          3           5         12
                                          ........................  SO2                             20,000          32          4           5         12
                                          ........................  Cl2                             20,000          32          4           5         12
Organic vapor...........................  As received               CCl4                            20,000          64          3           5         12
                                          Equilibrated              CCl4                            20,000          32          4           5         12
Ammonia.................................  As received               NH3                             30,000          64          3          50         12
                                          Equilibrated              NH3                             30,000          32          4          50         12
Carbon monoxide.........................  As received               CO                              20,000      \4\ 64          2       (\3\)         60
                                          Equilibrated              CO                               5,000      \2\ 32          3       (\3\)         60
                                          ........................  CO                               3,000      \2\ 32          3       (\3\)         60
Combination of 2 or 3 of above types \5\
Combination of all above types \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere will be 25 2.5
  [deg]C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere entering the test fixture will be 0 2.5 [deg]C-0 [deg]C.
\5\ Test conditions and requirements will be applicable as shown in this table.
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and
  ammonia will be 6 min instead of 12 min.


                                    Table 6--Canister Bench Tests and Requirements for Chin-Style Gas Mask Canisters
                                                               [42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Test atmosphere
                                                                     -------------------------------------------------              Maximum     Minimum
                                                                                                            Flow rate  Number of   allowable    service
            Canister type                      Test condition                                Concentration   (liters     tests    penetration     life
                                                                           Gas or vapor        (parts per      per                 (parts per  (minutes)
                                                                                                million)     minute)                million)      \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas.............................  As received Equilibrated       SO2                          50,000          64          3           5          12
                                       .............................  Cl2                           5,000          64          3           5          12
                                       .............................  SO2                           5,000          32          4           5          12
                                       .............................  Cl2                           5,000          32          4           5          12
Organic vapor........................  As received Equilibrated       CCl4                          5,000          64          3           5          12
                                       .............................  CCl4                          5,000          32          4           5          12
Ammonia..............................  As received Equilibrated       NH3                           5,000          64          3          50          12
                                       As received Equilibrated       NH3                           5,000          32          4          50          12
Carbon monoxide......................  As received                    CO                           20,000      \2\ 64          2       (\3\)          60
                                       .............................  CO                            5,000      \4\ 32          3       (\3\)          60
                                       .............................  CO                            3,000      \2\ 32          3       (\3\)          60
Combination of 2 or 3 of above types
 \5\
Combination of all above types \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere will be 25 2.5
  [deg]C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere entering the test fixture will be 0 2.5 [deg]C-0 [deg]C.
\5\ Test conditions and requirements will be applicable as shown in this table.
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and
  ammonia will be 6 min instead of 12 min.


[[Page 652]]


                                      Table 7--Canister Bench Tests and Requirements for Escape Gas Mask Canisters
                                                               [42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Test atmosphere
                                                                     -------------------------------------------------              Maximum     Minimum
                                                                                                            Flow rate  Number of   allowable    service
            Canister type                      Test condition                                Concentration   (liters     tests    penetration     life
                                                                           Gas or vapor        (parts per      per                 (parts per  (minutes)
                                                                                                million)     minute)                million)      \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas.............................  As received..................  SO2                           5,000          64          3           5          12
                                       Equilibrated.................  Cl2                           5,000          64          3           5          12
                                                                      SO2                           5,000          32          4           5          12
                                                                      Cl2                           5,000          32          4           5          12
Organic vapor........................  As received..................  CCl4                          5,000          64          3           5          12
                                       Equilibrated.................  CCl4                          5,000          32          4           5          12
Ammonia..............................  As received..................  NH3                           5,000          64          3          50          12
                                       Equilibrated.................  NH3                           5,000          32          4          50          12
Carbon monoxide......................  As received..................  CO                           10,000      \2\ 32          2       (\3\)      \4\ 60
                                                                      CO                            5,000      \5\ 32          3       (\3\)          60
                                                                      CO                            3,000      \2\ 32          3       (\3\)          60
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3 pct; temperature of test atmosphere will be 25 2.5
  [deg]C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ If effluent temperature exceeds 100 [deg]C during this test, the escape gas mask shall be equipped with an effective heat exchanger.
\5\ Relative humidity of test atmosphere will be 95 3 pct; temperature of test atmosphere entering the test fixture will be 0
  2.5 [deg]C-0 [deg]C.



                   Subpart J_Supplied-Air Respirators



Sec.  84.130  Supplied-air respirators; description.

    Supplied-air respirators, including all completely assembled 
respirators designed for use as respiratory protection during entry into 
and escape from atmospheres not immediately dangerous to life or health 
are described as follows:
    (a) Type ``A'' supplied-air respirators. A hose mask respirator, for 
entry into and escape from atmospheres not immediately dangerous to life 
or health, which consists of a motor-driven or hand-operated blower that 
permits the free entrance of air when the blower is not operating, a 
strong large-diameter hose having a low resistance to airflow, a harness 
to which the hose and the life-line are attached and a tight-fitting 
facepiece.
    (b) Type ``AE'' supplied-air respirators. A Type ``A'' supplied-air 
respirator equipped with additional devices designed to protect the 
wearer's head and neck against impact and abrasion from rebounding 
abrasive material, and with shielding material such as plastic, glass, 
woven wire, sheet metal, or other suitable material to protect the 
window(s) of facepieces, hoods, and helmets which do not unduly 
interfere with the wearer's vision and permit easy access to the 
external surface of such window(s) for cleaning.
    (c) Type ``B'' supplied-air respirators. A hose mask respirator, for 
entry into and escape from atmospheres not immediately dangerous to life 
or health, which consists of a strong large-diameter hose with low 
resistance to airflow through which the user draws inspired air by means 
of his lungs alone, a harness to which the hose is attached, and a 
tight-fitting facepiece.
    (d) Type ``BE'' supplied-air respirators. A type ``B'' supplied-air 
respirator equipped with additional devices designed to protect the 
wearer's head and neck against impact and abrasion from rebounding 
abrasive material, and with shielding material such as plastic, glass, 
woven wire, sheet metal, or other suitable material to protect the 
window(s) of facepieces, hoods, and helmets which do not unduly 
interfere with the wearer's vision and permit easy access to the 
external surface of such window(s) for cleaning.
    (e) Type ``C'' supplied-air respirators. An airline respirator, for 
entry into and escape from atmospheres not immediately dangerous to life 
or health, which consists of a source of respirable breathing air, a 
hose, a detachable coupling, a control valve, orifice, a demand valve or 
pressure demand valve,

[[Page 653]]

an arrangement for attaching the hose to the wearer, and a facepiece, 
hood, or helmet.
    (f) Type ``CE'' supplied-air respirators. A type ``C'' supplied-air 
respirator equipped with additional devices designed to protect the 
wearer's head and neck against impact and abrasion from rebounding 
abrasive material, and with shielding material such as plastic, glass, 
woven wire, sheet metal, or other suitable material to protect the 
window(s) of facepieces, hoods, and helmets which do not unduly 
interfere with the wearer's vision and permit easy access to the 
external surface of such window(s) for cleaning.



Sec.  84.131  Supplied-air respirators; required components.

    (a) Each supplied-air respirator described in Sec.  84.130 shall, 
where its design requires, contain the following component parts:
    (1) Facepiece, hood, or helmet;
    (2) Air supply valve, orifice, or demand or pressure-demand 
regulator;
    (3) Hand operated or motor driven air blower;
    (4) Air supply hose;
    (5) Detachable couplings;
    (6) Flexible breathing tube; and
    (7) Respirator harness.
    (b) The component parts of each supplied-air respirator shall meet 
the minimum construction requirements set forth in subpart G of this 
part.



Sec.  84.132  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with supplied-air 
respirators shall be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm pressure.



Sec.  84.133  Harnesses; installation and construction; minimum requirements.

    (a) Each supplied-air respirator shall, where necessary, be equipped 
with a suitable harness designed and constructed to hold the components 
of the respirator in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of respirator parts, and where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.



Sec.  84.134  Respirator containers; minimum requirements.

    Supplied-air respirators shall be equipped with a substantial, 
durable container bearing markings which show the applicant's name, the 
type and commercial designation of the respirator it contains, and all 
appropriate approval labels.



Sec.  84.135  Half-mask facepieces, full facepieces, hoods, and helmets; 
fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for optional use of corrective 
spectacles or lenses, which shall not reduce the respiratory protective 
qualities of the respirator.
    (c) Hoods and helmets shall be designed and constructed to fit 
persons with various head sizes, provide for the optional use of 
corrective spectacles or lenses, and insure against any restriction of 
movement by the wearer.
    (d) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.



Sec.  84.136  Facepieces, hoods, and helmets; eyepieces; minimum requirements.

    (a) Facepieces, hoods, and helmets shall be designed and constructed 
to provide adequate vision which is not distorted by the eyepiece.
    (b) All eyepieces except those on Types B, BE, C, and CE supplied-
air respirators shall be designed and constructed to be impact and 
penetration

[[Page 654]]

resistant. Federal Specification, Mask, Air Line: and Respirator, Air 
Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim 
amendment-1, July 30, 1969, is an example of an appropriate standard for 
determining impact and penetration resistance. Copies of GGG-M-125d may 
be obtained from the NIOSH, National Personal Protective Technology 
Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 
15236.
    (c)(1) The eyepieces of AE, BE, and CE type supplied-air respirators 
shall be shielded by plastic, glass, woven wire, sheet metal, or other 
suitable material which does not interfere with the vision of the 
wearer.
    (2) Shields shall be mounted and attached to the facepiece to 
provide easy access to the external surface of the eyepiece for 
cleaning.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.137  Inhalation and exhalation valves; check valves; 
minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against distortion.
    (b) Exhalation valves shall be:
    (1) Protected against damage and external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.
    (c) Check valves designed and constructed to allow airflow toward 
the facepiece only shall be provided in the connections to the facepiece 
or in the hose fitting near the facepiece of all Type A, AE, B, and BE 
supplied-air respirators.



Sec.  84.138  Head harnesses; minimum requirements.

    Facepieces shall be equipped with adjustable and replaceable head 
harnesses which are designed and constructed to provide adequate tension 
during use, and an even distribution of pressure over the entire area in 
contact with the face.



Sec.  84.139  Head and neck protection; supplied-air respirators; 
minimum requirements.

    Type AE, BE, and CE supplied-air respirators shall be designed and 
constructed to provide protection against impact and abrasion from 
rebounding abrasive materials to the wearer's head and neck.



Sec.  84.140  Air velocity and noise levels; hoods and helmets; 
minimum requirements.

    Noise levels generated by the respirator will be measured inside the 
hood or helmet at maximum airflow obtainable within pressure and hose 
length requirements and shall not exceed 80 dBA.



Sec.  84.141  Breathing gas; minimum requirements.

    (a) Breathing gas used to supply supplied-air respirators shall be 
respirable breathing air and contain no less than 19.5 volume-percent of 
oxygen.
    (b) Compressed, gaseous breathing air shall meet the applicable 
minimum grade requirements for Type I gaseous air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade D or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American 
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. 
Copies may be inspected at the NIOSH, National Personal Protective 
Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, 
Pittsburgh, PA 15236, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (c) Compressed, liquefied breathing air shall meet the applicable 
minimum grade requirements for Type II liquid air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade B or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance

[[Page 655]]

with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from 
American National Standards Institute, Inc., 1430 Broadway, New York, NY 
10018. Copies may be inspected at the NIOSH, National Personal 
Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill 
Road, Pittsburgh, PA 15236, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[60 FR 30355, June 8, 1995, amended at 80 FR 3907, Jan. 26, 2015]



Sec.  84.142  Air supply source; hand-operated or motor driven air blowers; 
Type A supplied-air respirators; minimum requirements.

    (a) Blowers shall be designed and constructed to deliver an adequate 
amount of air to the wearer with either direction of rotation, unless 
constructed to permit rotation in one direction only, and to permit the 
free entrance of air to the hose when the blower is not operated.
    (b) No multiple systems, whereby more than one user is supplied by 
one blower, will be approved, unless each hose line is connected 
directly to a manifold at the blower.



Sec.  84.143  Terminal fittings or chambers; Type B supplied-air respirators; 
minimum requirements.

    (a) Blowers or connections to air supplies providing positive 
pressures shall not be approved for use on Type B supplied-air 
respirators.
    (b) Terminal fittings or chambers employed in Type B supplied-air 
respirators, shall be:
    (1) Installed in the inlet of the hose.
    (2) Designed and constructed to provide for the drawing of air 
through corrosion resistant material arranged so as to be capable of 
removing material larger than 0.149 mm. in diameter (149 micrometers, 
100-mesh, U.S. Standard sieve).
    (3) Installed to provide a means for fastening or anchoring the 
fitting or chamber in a fixed position in a zone of respirable air.



Sec.  84.144  Hand-operated blower test; minimum requirements.

    (a) Hand-operated blowers shall be tested by attaching them to a 
mechanical drive and operating them 6 to 8 hours daily for a period of 
100 hours at a speed necessary to deliver 50 liters of air per minute 
through each completely assembled respirator. Each respirator shall be 
equipped with the maximum length of hose with which the device is to be 
approved and the hose shall be connected to each blower or manifold 
outlet designed for hose connections.
    (b) The crank speed of the hand-operated blower shall not exceed 50 
revolutions per minute in order to deliver the required 50 liters of air 
per minute to each facepiece.
    (c) The power required to deliver 50 liters of air per minute to 
each wearer through the maximum length of hose shall not exceed one-
fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. 
(5 pounds) on a 20 cm. (8-inch) crank, as defined in Sec.  84.146.
    (d) The blower shall operate throughout the period without failure 
or indication of excessive wear of bearings or other working parts.



Sec.  84.145  Motor-operated blower test; minimum requirements.

    (a) Motor-operated blowers shall be tested by operating them at 
their specified running speed 6 to 8 hours daily for a period of 100 
hours when assembled with the kind and maximum length of hose for which 
the device is to be approved and when connected to each blower or 
manifold outlet designed for hose connections.
    (b) The connection between the motor and the blower shall be so 
constructed that the motor may be disengaged from the blower when the 
blower is operated by hand.
    (c) The blower shall operate throughout the period without failure 
or indication of excessive wear of bearings or other working parts.
    (d) Where a blower, which is ordinarily motor driven, is operated by 
hand, the power required to deliver 50 liters of air per minute to each 
wearer through the maximum length of hose shall not exceed one-fiftieth 
horsepower, and the torque shall not exceed

[[Page 656]]

a force of 2.3 kg. (5 pounds) on a 20 cm. (8-inch) crank, as defined in 
Sec.  84.146.
    (e) Where the respirator is assembled with the facepiece and 15 m. 
(50 feet) of the hose for which it is to be approved, and when connected 
to one outlet with all other outlets closed and operated at a speed not 
exceeding 50 revolutions of the crank per minute, the amount of air 
delivered into the respiratory-inlet covering shall not exceed 150 
liters per minute.



Sec.  84.146  Method of measuring the power and torque required 
to operate blowers.

    As shown in Figure 1 of this section, the blower crank is replaced 
by a wooden drum, a (13 cm. (5 inches) in diameter is convenient). This 
drum is wound with about 12 m. (40 feet) of No. 2 picture cord, b. A 
weight, c, of sufficient mass to rotate the blower at the desired speed 
is suspended from this wire cord. A mark is made on the cord about 3 to 
4.5 m. (10 to 15 feet) from the weight, c. Another mark is placed at a 
measured distance (6-9 m./20-30 feet is convenient) from the first. 
These are used to facilitate timing. To determine the torque or 
horsepower required to operate the blower, the drum is started in 
rotation manually at or slightly above the speed at which the power 
measurement is to be made. The blower is then permitted to assume 
constant speed, and then as the first mark on the wire leaves the drum, 
a stopwatch is started. The watch is stopped when the second mark leaves 
the drum. From these data the foot-pounds per minute and the torque may 
be calculated.

Figure 1--Apparatus for measuring power required to operate blower. (42 
                  CFR part 84, subpart J, Sec.  84.146)
[GRAPHIC] [TIFF OMITTED] TC01FE91.050


[[Page 657]]





Sec.  84.147  Type B supplied-air respirator; minimum requirements.

    No Type B supplied-air respirator shall be approved for use with a 
blower or with connection to an air supply device at positive pressures.



Sec.  84.148  Type C supplied-air respirator, continuous flow class; 
minimum requirements.

    (a) Respirators tested under this section shall be approved only 
when they supply respirable air at the pressures and quantities 
required.
    (b) The pressure at the inlet of the hose connection shall not 
exceed 863 kN/m.\2\ (125 pounds per square inch gage).
    (c) Where the pressure at any point in the supply system exceeds 863 
kN/m.\2\ (125 pounds per square inch gage), the respirator shall be 
equipped with a pressure-release mechanism that will prevent the 
pressure at the hose connection from exceeding 863 kN/m.\2\ (125 pounds 
per square inch gage) under any conditions.



Sec.  84.149  Type C supplied-air respirator, demand and pressure 
demand class; minimum requirements.

    (a) Respirators tested under this section shall be approved only 
when used to supply respirable air at the pressures and quantities 
required.
    (b) The manufacturer shall specify the range of air pressure at the 
point of attachment of the air-supply hose to the air-supply system, and 
the range of hose length for the respirator. For example, he might 
specify that the respirator be used with compressed air at pressures 
ranging from 280-550 kN/m.\2\ (40 to 80 pounds per square inch) with 
from 6 to 76 m. (15 to 250 feet) of air-supply hose.
    (c) The specified air pressure at the point of attachment of the 
hose to the air-supply system shall not exceed 863 kN/m.\2\ (125 pounds 
per square inch gage).
    (d)(1) Where the pressure in the air-supply system exceeds 863 kN/
m.\2\ (125 pounds per square inch gage), the respirator shall be 
equipped with a pressure-release mechanism that will prevent the 
pressure at the point of attachment of the hose to the air-supply system 
from exceeding 863 kN/m.\2\ (125 pounds per square inch gage).
    (2) The pressure-release mechanism shall be set to operate at a 
pressure not more than 20 percent above the manufacturer's highest 
specified pressure. For example, if the highest specified pressure is 
863 kN/m.\2\ (125 pounds per square inch), the pressure-release 
mechanism would be set to operate at a maximum of 1,035 kN/m.\2\ (150 
pounds per square inch).



Sec.  84.150  Air-supply line tests; minimum requirements.

    Air supply lines employed on Type A, Type B, and Type C supplied-air 
respirators shall meet the minimum test requirements set forth in Table 
8 of this subpart.



Sec.  84.151  Harness test; minimum requirements.

    (a)(1) Shoulder straps employed on Type A supplied-air respirators 
shall be tested for strength of material, joints, and seams and must 
separately withstand a pull of 113 kg. (250 pounds) for 30 minutes 
without failure.
    (2) Belts, rings, and attachments for life lines must withstand a 
pull of 136 kg. (300 pounds) for 30 minutes without failure.
    (3) The hose shall be firmly attached to the harness so as to 
withstand a pull of 113 kg. (250 pounds) for 30 minutes without 
separating, and the hose attachments shall be arranged so that the pull 
or drag of the hose behind an advancing wearer does not disarrange the 
harness or exert pull upon the facepiece.
    (4) The arrangement and suitability of all harness accessories and 
fittings will be considered.
    (b)(1) The harness employed on Type B supplied-air respirators shall 
not be uncomfortable, disturbing, or interfere with the movements of the 
wearer.
    (2) The harness shall be easily adjustable to various sizes.
    (3) The hose shall be attached to the harness in a manner that will 
withstand a pull of 45 kg. (100 pounds) for 30 minutes without 
separating or showing signs of failure.

[[Page 658]]

    (4) The design of the harness and attachment of the line shall 
permit dragging the maximum length of hose considered for approval over 
a concrete floor without disarranging the harness or exerting a pull on 
the facepiece.
    (5) The arrangement and suitability of all harness accessories and 
fittings will be considered.
    (c) The harness employed on Type C respirators shall be similar to 
that required on the Type B respirator, or, it may consist of a simple 
arrangement for attaching the hose to a part of the wearer's clothing in 
a practical manner that prevents a pull equivalent to dragging the 
maximum length of the hose over a concrete floor from exerting pull upon 
the respiratory-inlet covering.
    (d) Where supplied-air respirators have a rigid or partly rigid head 
covering, a suitable harness shall be required to assist in holding this 
covering in place.



Sec.  84.152  Breathing tube test; minimum requirements.

    (a)(1) Type A and Type B supplied-air respirators shall employ one 
or two flexible breathing tubes of the nonkinking type which extend from 
the facepiece to a connecting hose coupling attached to the belt or 
harness.
    (2) The breathing tubes employed shall permit free head movement, 
insure against closing off by kinking or by chin or arm pressure, and 
they shall not create a pull that will loosen the facepiece or disturb 
the wearer.
    (b) Breathing tubes employed on Type C supplied-air respirators of 
the continuous flow class shall meet the minimum requirements set forth 
in paragraph (a) of this section, however, an extension of the 
connecting hose may be employed in lieu of the breathing tubes required.
    (c)(1) A flexible, nonkinking type breathing tube shall:
    (i) Be employed on Type C supplied-air respirators of the demand and 
pressure-demand class; and
    (ii) Extend from the facepiece to the demand or pressure-demand 
valve, except where the valve is attached directly to the facepiece.
    (2) The breathing tube shall permit free head movement, insure 
against closing off by kinking or by chin or arm pressure, and shall not 
create a pull that will loosen the facepiece or disturb the wearer.



Sec.  84.153  Airflow resistance test, Type A and Type AE supplied-air 
respirators; minimum requirements.

    (a) Airflow resistance will be determined when the respirator is 
completely assembled with the respiratory-inlet covering, the air-supply 
device, and the maximum length of air-supply hose coiled for one-half 
its length in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.
    (b) The inhalation resistance, drawn at the rate of 85 liters (3 
cubic feet) per minute when the blower is not operating or under any 
practical condition of blower operation shall not exceed the following 
amounts:

------------------------------------------------------------------------
 Maximum length of hose for which     Maximum resistance, water column
      respirator is approved                       height
------------------------------------------------------------------------
      Feet             Meters            Inches           Millimeters
------------------------------------------------------------------------
           75                23               1.5                 38
          150                46               2.5                 64
          250                76               3.5                 89
          300                91               4.0                102
------------------------------------------------------------------------

    (c) The exhalation resistance shall not exceed 25 mm. (1 inch) of 
water-column height at a flow rate of 85 liters (3 cubic feet) per 
minute when the blower is not operating or under any practical condition 
of blower operation.



Sec.  84.154  Airflow resistance test; Type B and Type BE supplied-air 
respirators; minimum requirements.

    (a) Airflow resistance shall be determined when the respirator is 
completely assembled with the respiratory-inlet covering and the hose in 
the maximum length to be considered for approval, coiled in loops 1.5 to 
2.1 m. (5 to 7 feet) in diameter.
    (b) Airflow resistance shall not exceed 38 mm. (1.5 inches) of 
water-column height to air drawn at the flow rate of 85 liters (3 cubic 
feet) per minute.
    (c) The exhalation resistance shall not exceed 25 mm. (1 inch) of 
water-column height at this flow rate.

[[Page 659]]



Sec.  84.155  Airflow resistance test; Type C supplied-air respirator, 
continuous flow class and Type CE supplied-air respirator; 
minimum requirements.

    The resistance to air flowing from the respirator shall not exceed 
25 mm. (1 inch) of water-column height when the air flow into the 
respiratory-inlet covering is 115 liters (4 cubic feet) per minute.



Sec.  84.156  Airflow resistance test; Type C supplied-air respirator, 
demand class; minimum requirements.

    (a) Inhalation resistance shall not exceed 50 millimeters (2 inches) 
of water at an air flow of 115 liters (4 cubic feet) per minute.
    (b) The exhalation resistance to a flow of air at a rate of 85 
liters (3 cubic feet) per minute shall not exceed 25 millimeters (1 
inch) of water.



Sec.  84.157  Airflow resistance test; Type C supplied-air respirator, 
pressure-demand class; minimum requirements.

    (a) The static pressure in the facepiece shall not exceed 38 mm. 
(1.5 inches) of water-column height.
    (b) The pressure in the facepiece shall not fall below atmospheric 
at inhalation airflows less than 115 liters (4 cubic feet) per minute.
    (c) The exhalation resistance to a flow of air at a rate of 85 
liters (3 cubic feet) per minute shall not exceed the static pressure in 
the facepiece by more than 51 mm. (2 inches) of water-column height.



Sec.  84.158  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.



Sec.  84.159  Man tests for gases and vapors; supplied-air respirators; 
general performance requirements.

    (a) Wearers will enter a chamber containing a gas or vapor as 
prescribed in Sec. Sec.  84.160, 84.161, 84.162, and 84.163.
    (b) Each wearer will spend 10 minutes in work to provide 
observations on freedom of the device from leakage. The freedom and 
comfort allowed the wearer will also be considered.
    (c) Time during the test period will be divided as follows:
    (1) Five minutes. Walking, turning head, dipping chin; and
    (2) Five minutes. Pumping air with a tire pump into a 28-liter (1 
cubic foot) container, or equivalent work.
    (d) No odor of the test gas or vapor shall be detected by the wearer 
in the air breathed during any such test, and the wearer shall not be 
subjected to any undue discomfort or encumbrance because of the fit, air 
delivery, or other features of the respirator during the testing period.



Sec.  84.160  Man test for gases and vapors; Type A and Type AE respirators; 
test requirements.

    (a) The completely assembled respirator will be worn in a chamber 
containing 0.1 0.025 percent isoamyl acetate 
vapor, and the blower, the intake of the hose, and not more than 25 
percent of the hose length will be located in isoamyl acetate-free air.
    (b) The man in the isoamyl acetate atmosphere will draw his inspired 
air through the hose, connections, and all parts of the air device by 
means of his lungs alone (blower not operating).
    (c) The 10-minute work test will be repeated with the blower in 
operation at any practical speed up to 50 revolutions of the crank per 
minute.



Sec.  84.161  Man test for gases and vapors; Type B and Type BE respirators; 
test requirements.

    (a) The completely assembled respirator will be worn in a chamber 
containing 0.1 0.025 percent isoamyl acetate 
vapor, and the intake of the hose, and not more than 25 percent of the 
hose length will be located in isoamyl acetate-free air.
    (b) The man in the isoamyl acetate atmosphere will draw his inspired 
air through the hose and connections by means of his lungs alone.

[[Page 660]]



Sec.  84.162  Man test for gases and vapors; Type C respirators, 
continuous-flow class and Type CE supplied-air respirators; test requirements.

    (a) The completely assembled respirator will be worn in a chamber 
containing 0.1 0.025 percent isoamyl acetate 
vapor, the intake of the hose will be connected to a suitable source of 
respirable air, and not more than 25 percent of the hose length will be 
located in isoamyl acetate-free air.
    (b) The minimum flow of air required to maintain a positive pressure 
in the respiratory-inlet covering throughout the entire breathing cycle 
will be supplied to the wearer, provided however, that airflow shall not 
be less than 115 liters per minute for tight-fitting and not less than 
170 liters per minute for loose-fitting respiratory inlet-coverings.
    (c) The test will be repeated with the maximum rate of flow 
attainable within specified operating pressures.



Sec.  84.163  Man test for gases and vapors; Type C supplied-air respirators, 
demand and pressure-demand classes; test requirements.

    (a) The completely assembled respirator will be worn in a chamber 
containing 0.1 0.025 percent isoamyl acetate 
vapor, the intake of the hose will be connected to a suitable source of 
respirable air, and not more than 25 percent of the hose length will be 
located in isoamyl acetate-free air.
    (b) The test will be conducted at the minimum pressure with the 
maximum hose length and will be repeated at the maximum pressure with 
the minimum hose length.



                   Sec. Table to Subpart J of Part 84

                                 Table 8--Air-Supply-Line Requirements and Tests
                                           [42 CFR part 84, subpart J]
----------------------------------------------------------------------------------------------------------------
                                     Requirements for the air-supply lines of the indicated type of supplied-air
                                                                     respirators
       Specific requirements        ----------------------------------------------------------------------------
                                             Type A                  Type B                     Type C
----------------------------------------------------------------------------------------------------------------
Length of hose.....................  Maximum of 91 m. (300   Maximum of 23 m. (75    Maximum of 91 m. (300 feet)
                                      feet), in multiples     feet) in multiples of   in multiples of 7.6 m. (25
                                      of 7.6 m. (25 feet).    7.6 m. (25 feet).       feet). It will be
                                                                                      permissible for the
                                                                                      applicant to supply hose
                                                                                      of the approved type of
                                                                                      shorter length than 7.6 m.
                                                                                      (25 feet) provided it
                                                                                      meets the requirements of
                                                                                      the part.
Air flow...........................  None..................  None..................  The air-supply hose with
                                                                                      air regulating valve or
                                                                                      orifice shall permit a
                                                                                      flow of not less than 115
                                                                                      liters (4 cubic feet) per
                                                                                      minute to tight-fitting
                                                                                      and 170 liters (6 cubic
                                                                                      feet) per minute to loose-
                                                                                      fitting respiratory-inlet
                                                                                      coverings through the
                                                                                      maximum length of hose for
                                                                                      which approval is granted
                                                                                      and at the minimum
                                                                                      specified air-supply
                                                                                      pressure. The maximum flow
                                                                                      shall not exceed 425
                                                                                      liters (15 cubic feet) per
                                                                                      minute at the maximum
                                                                                      specified air-supply
                                                                                      pressure with the minimum
                                                                                      length of hose for which
                                                                                      approval is granted.

[[Page 661]]

 
Air flow...........................  ......do..............  ......do..............  The air-supply hose,
                                                                                      detachable coupling, and
                                                                                      demand valve of the demand
                                                                                      class or pressure-demand
                                                                                      valve of the pressure-
                                                                                      demand class for Type C
                                                                                      supplied-air respirators,
                                                                                      demand and pressure-demand
                                                                                      classes, shall be capable
                                                                                      of delivering respirable
                                                                                      air at a rate of not less
                                                                                      than 115 liters (4 cubic
                                                                                      feet) per minute to the
                                                                                      respiratory-inlet covering
                                                                                      at an inhalation
                                                                                      resistance not exceeding
                                                                                      50 millimeters (2 inches)
                                                                                      of water-column height
                                                                                      measured in the
                                                                                      respiratory-inlet covering
                                                                                      with any combination of
                                                                                      air-supply pressure and
                                                                                      length of hose within the
                                                                                      applicant's specified
                                                                                      range of pressure and hose
                                                                                      length. The air-flow rate
                                                                                      and resistance to
                                                                                      inhalation shall be
                                                                                      measured while the demand
                                                                                      or pressure-demand valve
                                                                                      is actuated 20 times per
                                                                                      minute by a source of
                                                                                      intermittent suction. The
                                                                                      maximum rate of flow to
                                                                                      the respiratory-inlet
                                                                                      covering shall not exceed
                                                                                      425 liters (15 cubic feet)
                                                                                      per minute under the
                                                                                      specified operating
                                                                                      conditions.
Air-regulating valve...............  ......do..............  ......do..............  If an air-regulating valve
                                                                                      is provided, it shall be
                                                                                      so designed that it will
                                                                                      remain at a specific
                                                                                      adjustment, which will not
                                                                                      be affected by the
                                                                                      ordinary movement of the
                                                                                      wearer. The valve must be
                                                                                      so constructed that the
                                                                                      air supply with the
                                                                                      maximum length of hose and
                                                                                      at the minimum specified
                                                                                      air-supply pressure will
                                                                                      not be less than 115
                                                                                      liters (4 cubic feet) of
                                                                                      air per minute to tight-
                                                                                      fitting and 170 liters (6
                                                                                      cubic feet) of air per
                                                                                      minute of loose-fitting
                                                                                      respiratory inlet
                                                                                      coverings for any
                                                                                      adjustment of the valve.
                                                                                      If a demand or pressure-
                                                                                      demand valve replaces the
                                                                                      air-regulating valve, it
                                                                                      shall be connected to the
                                                                                      air-supply at the maximum
                                                                                      air pressure for which
                                                                                      approval is sought by
                                                                                      means of the minimum
                                                                                      length of air-supply hose
                                                                                      for which approval is
                                                                                      sought. The outlet of the
                                                                                      demand or pressure-demand
                                                                                      valve shall be connected
                                                                                      to a source of
                                                                                      intermittent suction so
                                                                                      that the demand or
                                                                                      pressure-demand valve is
                                                                                      actuated approximately 20
                                                                                      times per minute for a
                                                                                      total of 100,000
                                                                                      inhalations. To expedite
                                                                                      this test, the rate of
                                                                                      actuation may be increased
                                                                                      if mutually agreeable to
                                                                                      the applicant and NIOSH.
                                                                                      During this test the valve
                                                                                      shall function without
                                                                                      failure and without
                                                                                      excessive wear of the
                                                                                      moving parts. The demand
                                                                                      or pressure-demand valve
                                                                                      shall not be damaged in
                                                                                      any way when subjected at
                                                                                      the outlet to a pressure
                                                                                      or suction of 25 cm. (10
                                                                                      inches) of water gage for
                                                                                      2 minutes.
Noncollapsibility..................  The hose shall not      Same as Type A........  None.
                                      collapse or exhibit
                                      permanent deformation
                                      when a force of 90
                                      kg. (200 pounds) is
                                      applied for 5 minutes
                                      between 2 planes 7.6
                                      cm. (3 inches) wide
                                      on opposite sides of
                                      the hose.

[[Page 662]]

 
Nonkinkability.....................  None..................  None..................  A 7.6 m. (25 foot) section
                                                                                      of the hose will be placed
                                                                                      on a horizontal-plane
                                                                                      surface and shaped into a
                                                                                      one-loop coil with one end
                                                                                      of the hose connected to
                                                                                      an airflow meter and the
                                                                                      other end of the hose
                                                                                      supplied with air at the
                                                                                      minimum specified supply
                                                                                      pressure. The connection
                                                                                      shall be in the plane of
                                                                                      the loop. The other end of
                                                                                      the hose will be pulled
                                                                                      tangentially to the loop
                                                                                      and in the plane of the
                                                                                      loop until the hose
                                                                                      straightens. To meet the
                                                                                      requirements of this test
                                                                                      the loop shall maintain a
                                                                                      uniform near-circular
                                                                                      shape and ultimately
                                                                                      unfold as a spiral,
                                                                                      without any localized
                                                                                      deformation that decreases
                                                                                      the flow of air to less
                                                                                      than 90 percent of the
                                                                                      flow when the hose is
                                                                                      tested while remaining in
                                                                                      a straight line.
Strength of hose and couplings.....  Hose and couplings      Same as Type A........  Hose and couplings shall
                                      shall not separate or                           not exhibit any separation
                                      fail when tested with                           or failure when tested
                                      a pull of 113 kg.                               with a pull of 45 kg. (100
                                      (250 pounds) for 5                              pounds) for 5 minutes and
                                      minutes.                                        when tested by subjecting
                                                                                      them to an internal air
                                                                                      pressure of 2 times the
                                                                                      maximum respirator-supply
                                                                                      pressure that is specified
                                                                                      by the applicant or at 173
                                                                                      kN/m. 2 (25 pounds per
                                                                                      square inch) gage,
                                                                                      whichever is higher.
Tightness..........................  No air leakage shall    None..................  Leakage of air exceeding 50
                                      occur when the hose                             cc. per minute at each
                                      and couplings are                               coupling shall not be
                                      joined and the                                  permitted when the hose
                                      joint(s) are immersed                           and couplings are joined
                                      in water and                                    and are immersed in water,
                                      subjected to an                                 with air flowing through
                                      internal air pressure                           the respirator under a
                                      of 35 kN/m. 2 (5                                pressure of 173 kN/m. 2
                                      pounds per square                               (25 pounds per square
                                      inch) gage.                                     inch) gage applied to the
                                                                                      inlet end of the air-
                                                                                      supply hose, or at twice
                                                                                      the maximum respirator-
                                                                                      supply pressure that is
                                                                                      specified by the
                                                                                      applicant, whichever is
                                                                                      higher.
Permeation of hose by gasoline.....  The permeation of the   Same as for Type A....  Same as for Type A, except
                                      hose by gasoline will                           the test period shall be 1
                                      be tested by                                    hour.
                                      immersing 7.6 m. (25
                                      feet) of hose and one
                                      coupling in gasoline,
                                      with air flowing
                                      through the hose at
                                      the rate of 8 liters
                                      per minute for 6
                                      hours. The air from
                                      the hose shall not
                                      contain more than
                                      0.01 percent by
                                      volume of gasoline
                                      vapor at the end of
                                      the test.
Detachable coupling................  None..................  None..................  A hand-operated detachable
                                                                                      coupling by which the
                                                                                      wearer can readily attach
                                                                                      or detach the connecting
                                                                                      hose shall be provided at
                                                                                      a convenient location.
                                                                                      This coupling shall be
                                                                                      durable, remain connected
                                                                                      under all conditions of
                                                                                      normal respirator use, and
                                                                                      meet the prescribed tests
                                                                                      for strength and tightness
                                                                                      of hose and couplings.
----------------------------------------------------------------------------------------------------------------


[[Page 663]]



             Subpart K_Air-Purifying Particulate Respirators

    Source: 85 FR 20608, Apr. 14, 2002, unless otherwise noted.



Sec.  84.170  Air-purifying particulate respirators; description.

    (a) Non-powered air-purifying particulate respirators (series N, R, 
and P). (1) Non-powered air-purifying particulate respirators utilize 
the wearer's negative inhalation pressure to draw the ambient air 
through the air-purifying filter elements (filters) to remove 
particulates from the ambient air. They are designed for use as 
respiratory protection against atmospheres with particulate contaminants 
at concentrations that are not immediately dangerous to life or health 
and that contain adequate oxygen to support life.
    (2) Non-powered air-purifying particulate respirators are classified 
into three series, N-, R-, and P-series. The N-series filters are 
restricted to use in those workplaces free of oil aerosols. The R- and 
P-series filters are intended for removal of any particulate that 
includes oil-based liquid particulates.
    (3) Non-powered air-purifying particulate respirators are classified 
according to the efficiency level of the filter(s) as tested according 
to the requirements of this part.
    (i) N100, R100, and P100 filters must demonstrate a minimum 
efficiency level of 99.97 percent.
    (ii) N99, R99, and P99 filters must demonstrate a minimum efficiency 
level of 99 percent.
    (iii) N95, R95, and P95 filters must demonstrate a minimum 
efficiency level of 95 percent.
    (b) Powered air-purifying particulate respirators (PAPR classes HE 
and PAPR100). (1) Powered air-purifying particulate respirators utilize 
a blower to move the ambient air through the air-purifying filter 
elements (filters) to remove particulate contaminants and deliver clean 
air to the respiratory inlet covering. They are designed for use as 
respiratory protection against atmospheres considered not immediately 
dangerous to life or health and that contain adequate oxygen to support 
life.
    (2) Powered air-purifying particulate respirators are classified 
into two classes, HE and PAPR100, and three series, HE, PAPR100-N, and 
PAPR100-P. The N-series filters are restricted to use in those 
workplaces free of oil aerosols. The P-series filters are intended for 
removal of any particulate that includes oil-based liquid particulates.
    (3) All three filter series, HE, PAPR100-N, and PAPR100-P, for 
powered air-purifying particulate respirators must demonstrate a minimum 
efficiency level of 99.97 percent.



Sec.  84.171  Required components and attributes.

    The components of each air-purifying particulate respirator must 
meet the minimum construction requirements set forth in subpart G of 
this part. Each air-purifying particulate respirator described in Sec.  
84.170 must, where its design requires, contain the following component 
parts:
    (a) Respiratory inlet covering. (1) Tight fitting respiratory inlet 
coverings must be designed and constructed to fit persons with various 
facial shapes and sizes either:
    (i) By providing more than one size; or
    (ii) By providing one size which will fit varying facial shapes and 
sizes.
    (2) Full facepieces must provide for optional use of corrective 
spectacles or lenses, which must not reduce the respiratory protective 
qualities of the respirator.
    (3) Loose fitting respiratory inlet coverings must be designed and 
constructed to fit persons with various head sizes, provide for the 
optional use of corrective spectacles or lenses, and insure against any 
restriction of movement by the wearer.
    (4) Mouthpieces must be equipped with noseclips which are securely 
attached to the mouthpiece or respirator and provide an airtight seal.
    (5) Respiratory inlet coverings that incorporate a lens or 
faceshield must be designed to prevent eyepiece fogging.
    (6) Half-mask facepieces must not interfere with the fit of common 
industrial safety spectacles, including corrective safety spectacles.

[[Page 664]]

    (7) Respiratory inlet coverings must be designed and constructed to 
provide adequate vision which is not distorted by the eyepieces.
    (b) Filter unit. The respirator manufacturer, as part of the 
application for certification, must specify the filter series and the 
filter efficiency level (i.e., ``N95,'' ``R95,'' ``P95,'' ``N99,'' 
``R99,'' ``P99,'' ``N100,'' ``R100,'' ``P100,'' ``HE,'' ``PAPR100-N'' or 
``PAPR100-P'') for which certification is being sought.
    (1) Filters for non-powered respirators (series N, R, and P) must be 
prominently labeled as follows:
    (i) N100 filters must be labeled ``N100 Particulate Filter (99.97% 
filter efficiency level)'' and must be a color other than magenta.
    (ii) R100 filters must be labeled ``R100 Particulate Filter (99.97% 
filter efficiency level)'' and must be a color other than magenta.
    (iii) P100 filters must be labeled ``P100 Particulate Filter (99.97% 
filter efficiency level)'' and must be color coded magenta.
    (iv) N99 filters must be labeled ``N99 Particulate Filter (99% 
filter efficiency level)'' and must be a color other than magenta.
    (v) R99 filters must be labeled ``R99 Particulate Filter (99% filter 
efficiency level)'' and must be a color other than magenta.
    (vi) P99 filters must be labeled ``P99 Particulate Filter (99% 
filter efficiency level)'' and must be a color other than magenta.
    (vii) N95 filters must be labeled as ``N95 Particulate Filter (95% 
filter efficiency level)'' and must be a color other than magenta.
    (viii) R95 filters must be labeled as ``R95 Particulate Filter (95% 
filter efficiency level)'' and must be a color other than magenta.
    (ix) P95 filters must be labeled as ``P95 Particulate Filter (95% 
filter efficiency level)'' and must be a color other than magenta.
    (2) Filters for powered respirators (classes HE and PAPR100) must be 
prominently labeled as follows:
    (i) HE filters must be labeled as ``HE Particulate Filter (99.97% 
filter efficiency level)'' and must be color coded magenta.
    (ii) PAPR100-N filters must be labeled as ``PAPR100-N Particulate 
Filter (99.97% filter efficiency level)'' and must be color coded 
magenta.
    (iii) PAPR100-P filters must be labeled as ``PAPR100-P Particulate 
Filter (99.97% filter efficiency level)'' and must be color coded 
magenta.
    (c) Valves. (1) Inhalation and exhalation valves must be protected 
against distortion.
    (2) Inhalation valves must be designed and constructed and provided 
where necessary to prevent excessive exhaled air from adversely 
affecting filters, except where filters are specifically designed to 
resist moisture.
    (3) Exhalation valves must be:
    (i) Provided where necessary;
    (ii) Protected against damage and external influence; and
    (iii) Designed and constructed to prevent inward leakage of 
contaminated air.
    (d) Head harness. (1) All facepieces must be equipped with head 
harnesses designed and constructed to provide adequate tension during 
use and an even distribution of pressure over the entire area in contact 
with the face.
    (2) Facepiece head harnesses, except those employed on filtering 
facepiece respirators, must be adjustable and replaceable.
    (3) Mouthpieces must be equipped, where applicable, with adjustable 
and replaceable harnesses, designed and constructed to hold the 
mouthpiece in place.
    (e) Breathing tube. Flexible breathing tubes used in conjunction 
with respirators must be designed and constructed to prevent:
    (1) Restriction of free head movement;
    (2) Disturbance of the fit of facepieces, mouthpieces, or loose 
fitting respiratory-inlet covering;
    (3) Interference with the wearer's activities; and
    (4) Shutoff of airflow due to kinking, or from chin or arm pressure.
    (f) Drink tube. (1) For particulate respirators equipped with a 
drink tube, the respirator must meet all requirements of the standard 
with the drink tube in place.
    (2) Dry drinking tube assembly will be subjected to a suction of 75 
mm

[[Page 665]]

water column height while in a normal operating position (closed).
    (3) Leakage through the drinking tube assembly must not exceed 30 mL 
per minute.
    (g) Container. (1) Except as provided in paragraph (b) of this 
section, each respirator must be equipped with a substantial, durable 
container bearing markings which show the applicant's name, the type of 
respirator it contains, and all appropriate approval labels.
    (2) Containers for respirators may provide for storage of more than 
one respirator; however, such containers must be designed and 
constructed to prevent contamination of respirators which are not 
removed, and to prevent damage to respirators during transit.
    (h) Harness. (1) Each respirator must, where necessary, be equipped 
with a suitable harness designed and constructed to hold the components 
of the respirator in position against the wearer's body.
    (2) Harnesses must be designed and constructed to permit easy 
removal and replacement of respirator parts, and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.
    (i) Attached blower--PAPR classes HE and PAPR100. Blowers must be 
designed to achieve the air flow rates required by the testing standards 
in Sec.  84.175.
    (j) Low-flow warning device--PAPR class PAPR100. (1) The design must 
include a low-flow warning. It must actively and readily indicate when 
flow inside the respiratory inlet covering falls below the minimum air 
flow defined in Sec.  84.175.
    (2) Any warning must be detectable by the wearer without any 
intervention by the wearer.
    (3) Warning devices must be configured so that they may not be de-
energized while the blower is energized.
    (4) During use, warning devices must not switch off automatically 
and must not be capable of being switched off by the wearer.
    (5) Any warnings which require different reactions by the wearer 
must be distinguishable from one another.
    (6) If the warning provided is audible only, or other warnings are 
not readily apparent to the wearer, the minimum sound level must be 80 
dBA.



Sec.  84.172  Airflow resistance test.

    (a) Resistance to airflow will be measured in the tight-fitting 
respiratory inlet covering of a complete particulate respirator mounted 
on a test fixture with air flowing at continuous rate of 85 2 liters per minute, before each test conducted in 
accordance with Sec.  84.173.
    (b) Resistance of a complete tight-fitting powered air-purifying 
particulate respirator system will be measured with the blower off if 
the manufacturer indicates that the respirator should not be doffed in 
the event of a blower failure.
    (c) The maximum allowable resistance requirements for air-purifying 
particulate respirators are as follows:

                                               Maximum Resistance
                                            [mm water-column height]
----------------------------------------------------------------------------------------------------------------
                                                                            Inhalation
                         Respirator type                         --------------------------------   Exhalation
                                                                      Initial          Final
----------------------------------------------------------------------------------------------------------------
Non-Powered (N, R, and P).......................................              35             N/A              25
Powered (tight fitting) (HE class and PAPR100 class)............              50              70              20
----------------------------------------------------------------------------------------------------------------



Sec.  84.173  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat must not exceed 30 mL 
per minute.



Sec.  84.174  Filter efficiency level determination test--non-powered series 
N, R, and P filtration.

    (a) Twenty filters of each non-powered air-purifying particulate 
respirator model will be tested for filter efficiency against:

[[Page 666]]

    (1) A solid sodium chloride particulate aerosol as per this section, 
if N-series certification is requested by the applicant.
    (2) A dioctyl phthalate (DOP) or equivalent liquid particulate 
aerosol as per this section, if R-series or P-series certification is 
requested by the applicant.
    (b) Filters including holders and gaskets, when separable, will be 
tested for filter efficiency level, as mounted on a test fixture in the 
manner as used on the respirator.
    (c) Prior to filter efficiency testing of 20 N-series filters, the 
20 to be tested will be taken out of their packaging and placed in an 
environment of 85  5 percent relative humidity at 
38  2.5 [deg]C for 25 1 
hours. Following the pre-conditioning, filters will be sealed in a gas-
tight container and tested within 10 hours.
    (d) When the filters do not have separable holders and gaskets, the 
exhalation valves will be blocked so as to ensure that leakage, if 
present, is not included in the filter efficiency level evaluation.
    (e) For non-powered air-purifying particulate respirators with a 
single filter, filters will be tested at a continuous airflow rate of 85 
 4 liters per minute. Where filters are to be used 
in pairs, the test-aerosol airflow rate will be 42.5  2 liters per minute through each filter.
    (f) Filter efficiency test aerosols:
    (1) When testing N-series filters, a sodium chloride or equivalent 
solid aerosol at 25  5 [deg]C and relative 
humidity of 30  10 percent that has been 
neutralized to the Boltzmann equilibrium state will be used. Each filter 
will be challenged with a concentration not exceeding 200 mg/m\3\.
    (2) When testing R-series and P-series filters, a neat cold-
nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25  5 [deg]C that has been neutralized to the Boltzmann 
equilibrium state will be used. Each filter will be challenged with a 
concentration not exceeding 200 mg/m\3\.
    (3) The test will continue until minimum efficiency is achieved or 
until an aerosol mass of at least 200  5 mg has 
contacted the filter. For P-series filters, if the filter efficiency is 
decreasing when the 200  5 mg challenge point is 
reached, the test will be continued until there is no further decrease 
in efficiency.
    (g) The sodium chloride test aerosol will have a particle size 
distribution with count median diameter of 0.075  
0.020 [micro]m and a standard geometric deviation not exceeding 1.86 at 
the specified test conditions as determined with a scanning mobility 
particle sizer or equivalent. The DOP aerosol will have a particle size 
distribution with count median diameter of 0.185  
0.020 [micro]m and a standard geometric deviation not exceeding 1.60 at 
the specified test conditions as determined with a scanning mobility 
particle sizer or equivalent.
    (h) The efficiency of the filter will be monitored and recorded 
throughout the test period by a suitable forward-light-scattering 
photometer or equivalent instrumentation.
    (i) The minimum efficiency for each of the 20 filters will be 
determined and recorded and must be equal to or greater than the filter 
efficiency criterion listed for each level as follows:

------------------------------------------------------------------------
                                                            Efficiency
                      Filter series                             (%)
------------------------------------------------------------------------
P100, R100, N100........................................  =99
                                                                     .97
P99, R99, N99...........................................  =99
P95, R95, N95...........................................  =95
------------------------------------------------------------------------



Sec.  84.175  Instantaneous filter efficiency level determination test--
PAPR series HE, PAPR100-N, and PAPR100-P filtration.

    (a) Three filters from each powered air-purifying particulate 
respirator for efficiency will be tested against a neat cold-nebulized 
dioctyl phthalate (DOP) or equivalent aerosol at 25  5 [deg]C that has been neutralized to the Boltzmann 
equilibrium state.
    (b) Single air-purifying particulate respirator filter units will be 
tested in an atmosphere concentration of 100 mg/m\3\ of DOP at the 
following continuous flow rates for a period of 5 to 10 seconds:

------------------------------------------------------------------------
                                                           Airflow rate
           Type of respiratory inlet  covering              (liters per
                                                              minute)
------------------------------------------------------------------------
Tight-fitting...........................................             115
Loose-fitting...........................................             170
------------------------------------------------------------------------

    (c) Powered air-purifying particulate respirators with multiple 
filter units

[[Page 667]]

will be tested by dividing the flow rate specified in paragraph (b) of 
this section by the total number of filters used.
    (d) The filter will be mounted on a connector in the same manner as 
used on the respirator and the total efficiency must be 
=99.97 percent.



Sec.  84.176  Fit test--PAPR classes HE and PAPR100.

    NIOSH will assess powered air-purifying respirator fit using either 
isoamyl acetate or generated aerosol.
    (a) Isoamyl acetate (IAA) fit test. The applicant must provide a 
charcoal-filled canister or cartridge of a size and resistance similar 
to the filter unit with connectors which can be attached to the 
facepiece in the same manner as the filter unit.
    (1) The canister or cartridge will be used in place of the filter 
unit, and persons will each wear a modified half-mask facepiece for 8 
minutes in a test chamber containing 100 parts (by volume) of isoamyl 
acetate vapor per million parts of air.
    (i) The following work schedule will be performed by each wearer in 
the test chamber:
    (A) Two minutes nodding up and down, and turning head side to side; 
and
    (B) Two minutes calisthenic arm movements.
    (C) Two minutes running in place.
    (D) Two minutes pumping with tire pump.
    (ii) The facepiece must be capable of adjustment, according to the 
applicant's instructions, to each wearer's face, and the odor of isoamyl 
acetate must not be detectable by any wearer during the test.
    (2) Where the respirator is equipped with a full facepiece, hood, 
helmet, or mouthpiece, the canister or cartridge will be used in place 
of the filter unit, and persons will each wear the modified respiratory 
inlet covering for 8 minutes in a test chamber containing 500 parts (by 
volume) of isoamyl acetate vapor per million parts of air, performing 
the work schedule specified in paragraph (b)(2) of this section.
    (b) Generated aerosol fit test. The powered air-purifying 
particulate respirator system is tested in an atmosphere containing 20-
40 mg/m\3\ corn oil aerosol having a mass median aerodynamic diameter of 
0.4 to 0.6 [micro]m.
    (1) The following activities will be performed by each wearer in the 
test chamber:
    (i) Two minutes, nodding and turning head;
    (ii) Two minutes, calisthenic arm movements;
    (iii) Two minutes, running in place; and
    (iv) Two minutes, pumping with a tire pump into a 28-liter (1 ft\3\) 
container.
    (2) The respiratory inlet covering will be adjusted, according to 
the applicant's instructions, to each wearer's face.
    (3) The appropriate fit factor must be exceeded during the entire 
test.



Sec.  84.177  Total noise level test--PAPR classes HE and PAPR100.

    Noise levels generated by any powered air-purifying respirators that 
cover the ears (i.e., hood or helmet) will be measured at the entrance 
to each ear at maximum airflow obtainable and must not exceed 80 dBA.



Sec.  84.178  Breath response type, airflow resistance test--
PAPR classes HE and PAPR100.

    Resistance to airflow will be measured with a breathing machine as 
described in Sec.  84.88.
    (a) Minimum inhalation resistance must be greater than zero mm of 
water-column height.
    (b) Maximum exhalation resistance must be less than 89 mm of water-
column height.



Sec.  84.179  Silica dust loading test--PAPR series HE filtration.

    (a) Three powered air-purifying particulate respirators will be 
tested for a period of 4 hours each at a flowrate not less than 115 
liters per minute for tight-fitting facepieces, and not less than 170 
liters per minute for loose-fitting hoods and helmets.
    (b) The relative humidity in the test chamber will be 20-80 percent, 
and the room temperature approximately 25 [deg]C.
    (c) The test suspension in the chamber will not be less than 50 nor 
more

[[Page 668]]

than 60 mg of flint (99 + percent free silica) per m\3\ of air.
    (d) The flint in suspension will be 99 + percent through a 270-mesh 
sieve.
    (e) The particle-size distribution of the test suspension will have 
a geometric mean of 0.4 to 0.6 [micro]m and the standard geometric 
deviation will not exceed 2.
    (f) The total amount of unretained test suspension in samples taken 
during testing must not exceed 14.4 mg for a powered air-purifying 
particulate respirator with tight-fitting facepiece, and 21.3 mg for a 
powered air-purifying particulate respirator with loose-fitting hood or 
helmet.



Sec.  84.180  Particulate loading test--PAPR series PAPR100-N 
and PAPR100-P filtration.

    (a) Twenty filters of each powered air-purifying particulate 
respirator design will be tested for filter efficiency against:
    (1) A solid sodium chloride particulate aerosol, in accordance with 
paragraph (d)(1) of this section, if series PAPR100-N approval is 
requested by the applicant.
    (2) A dioctyl phthalate or equivalent liquid particulate aerosol, in 
accordance with paragraph (d)(2) of this section, if series PAPR100-P 
approval is requested by the applicant.
    (b) Prior to filter efficiency testing of 20 series PAPR100-N 
filters, the 20 to be tested will be taken out of their packaging and 
placed in an environment of 85 5 percent relative 
humidity at 38 2.5 [deg]C for 25 1 hours. Following the pre-conditioning, filters will be 
sealed in a gas-tight container and tested within 10 hours.
    (c) For powered air-purifying particulate respirators with a single 
filter, filters will be tested at a continuous airflow rate of 85 4 liters per minute. Where filters are to be used in 
pairs, the test-aerosol airflow rate will be 42.5 2 liters per minute through each filter.
    (d) Filter efficiency test aerosols:
    (1) Series PAPR100-N filters:
    (i) A sodium chloride or equivalent solid aerosol at 25 5 [deg]C and relative humidity of 30 10 percent that has been neutralized to the Boltzmann 
equilibrium state will be used. Each filter will be challenged with a 
concentration not exceeding 200 mg/m\3\.
    (ii) The sodium chloride test aerosol will have a particle size 
distribution with count median diameter of 0.075 0.020 [micro]m and a standard geometric deviation not 
exceeding 1.86 at the specified test conditions as determined with a 
scanning mobility particle sizer or equivalent.
    (2) Series PAPR100-P filters:
    (i) A neat cold-nebulized dioctyl phthalate (DOP) or equivalent 
aerosol at 25  5 [deg]C that has been neutralized 
to the Boltzmann equilibrium state will be used. Each filter will be 
challenged with a concentration not exceeding 200 mg/m\3\.
    (ii) The DOP aerosol shall have a particle size distribution with 
count median diameter of 0.185 0.020 [micro]m and 
a standard geometric deviation not exceeding 1.60 at the specified test 
conditions as determined with a scanning mobility particle sizer or 
equivalent.
    (e) The test will continue until minimum efficiency is achieved or 
until an aerosol mass of at least 200 5 mg has 
contacted the filter. For PAPR100-P series filters, if the filter 
efficiency is decreasing when the 200 5 mg 
challenge point is reached, the test will be continued until there is no 
further decrease in efficiency.
    (f) The efficiency of the filter will be monitored and recorded 
throughout the test period by a suitable forward-light scattering 
photometer or equivalent instrumentation.
    (g) The minimum efficiency for each of the 20 filters will be 
determined and recorded and must be equal to or greater than the filter 
efficiency criterion for PAPR100-N and PAPR100-P, efficiency 
=99.97 percent, pursuant to Sec.  84.170(b).



Sec.  84.181  Communication performance test--PAPR class PAPR100.

    (a) Powered air-purifying respirators must be designed to allow for 
proper communication while worn.
    (b) A Modified Rhyme Test \7\ will be used to test the wearer's 
ability to communicate efficiently.
---------------------------------------------------------------------------

    \7\ The Modified Rhyme Test is used in speech intelligibility 
experiments. See https://www.nist.gov/ctl/pscr/modified-rhyme-test-
audio-library.

---------------------------------------------------------------------------

[[Page 669]]

    (c) The communications requirement is met if the overall performance 
rating is greater than or equal to 70 percent.



                Subpart L_Chemical Cartridge Respirators



Sec.  84.190  Chemical cartridge respirators: description.

    (a) Chemical cartridge respirators including all completely 
assembled respirators which are designed for use as respiratory 
protection during entry into or escape from atmospheres not immediately 
dangerous to life and health, are described according to the specific 
gases or vapors against which they are designed to provide respiratory 
protection, as follows:

------------------------------------------------------------------------
                                                            Maximum use
                                                          concentration,
        Type of chemical cartridge respirator \1\            parts per
                                                              million
------------------------------------------------------------------------
Ammonia.................................................            300
Chlorine................................................             10
Hydrogen chloride.......................................             50
Methyl amine............................................            100
Organic vapor...........................................      \2\ 1,000
Sulfur dioxide..........................................             50
Vinyl chloride..........................................             10
------------------------------------------------------------------------
\1\ Not for use against gases or vapors with poor warning properties
  (except where MSHA or Occupational Safety and Health Administration
  standards may permit such use for a specific gas or vapor) or those
  which generate high heats of reaction with sorbent material in the
  cartridge.
\2\ Maximum use concentrations are lower for organic vapors which
  produce atmospheres immediately hazardous to life or health at
  concentrations equal to or lower than this concentration.

    (b) Chemical cartridge respirators for respiratory protection 
against gases or vapors, which are not specifically listed with their 
maximum use concentration, may be approved if the applicant submits a 
request for such approval, in writing, to the Institute. The Institute 
shall consider each such application and accept or reject the 
application after a review of the effects on the wearer's health and 
safety and in the light of any field experience in use of chemical 
cartridge respirators as protection against such hazards.



Sec.  84.191  Chemical cartridge respirators; required components.

    (a) Each chemical cartridge respirator described in Sec.  84.190 
shall, where its design requires, contain the following component parts:
    (1) Facepiece, mouthpiece, and noseclip, hood, or helmet;
    (2) Cartridge;
    (3) Cartridge with filter;
    (4) Harness;
    (5) Breathing tube; and
    (6) Attached blower.
    (b) The components of each chemical cartridge respirator shall meet 
the minimum construction requirements set forth in subpart G of this 
part.



Sec.  84.192  Cartridges in parallel; resistance requirements.

    Where two or more cartridges are used in parallel, their resistance 
to airflow shall be essentially equal.



Sec.  84.193  Cartridges; color and markings; requirements.

    The color and markings of all cartridges or labels shall conform 
with the requirements of the American National Standards Institute, 
American National Standard for Identification of Air-Purifying 
Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is 
incorporated by reference and has been approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies may be obtained from American National Standards Institute, Inc., 
1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, 
National Personal Protective Technology Laboratory, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[60 FR 30355, June 8, 1995, as amended at 80 FR 3908, Jan. 26, 2015]



Sec.  84.194  Filters used with chemical cartridges; location; replacement.

    (a) Particulate matter filters used in conjunction with a chemical 
cartridge shall be located on the inlet side of the cartridge.
    (b) Filters shall be incorporated in or firmly attached to the 
cartridge and

[[Page 670]]

each filter assembly shall, where applicable, be designed to permit its 
easy removal from and replacement on the cartridge.



Sec.  84.195  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with respirators shall 
be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm pressure.



Sec.  84.196  Harnesses; installation and construction; minimum requirements.

    (a) Each respirator shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
respirator in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of respirator parts and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.



Sec.  84.197  Respirator containers; minimum requirements.

    Respirators shall be equipped with a substantial, durable container 
bearing markings which show the applicant's name, the type and 
commercial designation of the respirator it contains and all appropriate 
approval labels.



Sec.  84.198  Half-mask facepieces, full facepieces, mouthpieces, hoods, 
and helmets; fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Hoods and helmets shall be designed and constructed to fit 
persons with various head sizes, provide for the optional use of 
corrective spectacles or lenses, and insure against any restriction of 
movement by the wearer.
    (c) Mouthpieces shall be equipped with noseclips which are securely 
attached to the mouthpiece or respirator and provide an airtight fit.
    (d) Full facepieces shall provide for optional use of corrective 
spectacles or lenses which shall not reduce the respiratory protective 
qualities of the respirator.
    (e) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.



Sec.  84.199  Facepieces, hoods, and helmets; eyepieces; minimum requirements.

    Facepieces, hoods, and helmets shall be designed and constructed to 
provide adequate vision which is not distorted by the eyepieces.



Sec.  84.200  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against distortion.
    (b) Inhalation valves shall be designed and constructed to prevent 
excessive exhaled air from entering cartridges or adversely affecting 
canisters.
    (c) Exhalation valves shall be--
    (1) Protected against damage and external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.



Sec.  84.201  Head harnesses; minimum requirements.

    (a)(1) Facepieces for chemical cartridge respirators other than 
single-use vinyl chloride shall be equipped with adjustable and 
replaceable head harnesses designed and constructed to provide adequate 
tension during use and an even distribution of pressure over the entire 
area in contact with the face.
    (2) Facepieces for single-use vinyl chloride respirators shall be 
equipped with adjustable head harnesses designed and constructed to 
provide adequate tension during use and an even distribution of pressure 
over the entire area in contact with the face.

[[Page 671]]

    (b) Mouthpieces shall be equipped where applicable, with an 
adjustable and replaceable harness designed and constructed to hold the 
mouthpiece in place.



Sec.  84.202  Air velocity and noise levels; hoods and helmets; 
minimum requirements.

    Noise levels generated by the respirator will be measured inside the 
hood or helmet at maximum airflow obtainable and shall not exceed 80 
dBA.



Sec.  84.203  Breathing resistance test; minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a chemical cartridge respirator mounted 
on a test fixture with air flowing at a continuous rate of 85 liters per 
minute, both before and after each test conducted in accordance with 
Sec. Sec.  84.206 through 84.207.
    (b) The maximum allowable resistance requirements for chemical 
cartridge respirators are as follows:

                           Maximum Resistance
                    [Millimeter water column height]
------------------------------------------------------------------------
                                          Inhalation
    Type of chemical-cartridge    --------------------------  Exhalation
            respirator               Initial     Final \1\
------------------------------------------------------------------------
Other than single-use vinyl
 chloride respirators:
    For gases, vapors, or gases             40           45           20
     and vapors..................
    For gases, vapors, or gases             50           70           20
     and vapors, and particulates
Single-use respirator with
 valves:
    For vinyl chloride...........           20           25           20
    For vinyl chloride and                  30           45            2
     particulates................
Single-use respirator without
 valves:
    For vinyl chloride...........           15           20        (\2\)
    For vinyl chloride and                  25           40        (\2\)
     particulates................
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 of this
  subpart.
\2\ Same as inhalation.



Sec.  84.204  Exhalation valve leakage test; minimum requirements.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.



Sec.  84.205  Facepiece test; minimum requirements.

    (a) The complete chemical cartridge respirator will be fitted to the 
faces of persons having varying facial shapes and sizes.
    (b) Where the applicant specifies a facepiece size or sizes for the 
respirator together with the approximate measurement of faces they are 
designed to fit, the Institute will provide test subjects to suit such 
facial measurements.
    (c) Any chemical cartridge respirator part which must be removed to 
perform the facepiece or mouthpiece fit test shall be replaceable 
without special tools and without disturbing facepiece or mouthpiece 
fit.
    (d) The facepiece or mouthpiece fit test using the positive or 
negative pressure recommended by the applicant and described in his 
instructions will be used before each test.
    (e)(1) Each wearer will enter a chamber containing 100 p.p.m. 
isoamyl acetate vapor for half-mask facepieces, and 1,000 p.p.m. for 
full facepieces, mouthpieces, hoods, and helmets.
    (2) The facepiece or mouthpiece may be adjusted, if necessary, in 
the test chamber before starting the test.
    (3) Each wearer will remain in the chamber for 8 minutes while 
performing the following activities:
    (i) Two minutes, nodding and turning head;
    (ii) Two minutes, calisthenic arm movements;
    (iii) Two minutes, running in place; and
    (iv) Two minutes, pumping with a tire pump into a 28-liter (1 cubic-
foot) container.
    (4) Each wearer shall not detect the odor of isoamyl-acetate vapor 
during the test.

[[Page 672]]



Sec.  84.206  Particulate tests; respirators with filters; 
minimum requirements; general.

    (a) Three respirators with cartridges containing, or having attached 
to them, filters for protection against particulates will be tested in 
accordance with the provisions of Sec.  84.207.
    (b) In addition to the test requirements set forth in paragraph (a) 
of this section, three such respirators will be tested, as appropriate, 
in accordance with the provisions of Sec. Sec.  84.170 through 84.181; 
however, the maximum allowable resistance of complete particulate, and 
gas, vapor, or gas and vapor chemical cartridge respirators shall not 
exceed the maximum allowable limits set forth in Sec.  84.203.

[60 FR 30355, June 8, 1995, as amended at 85 FR 20607, Apr. 14, 2020]



Sec.  84.207  Bench tests; gas and vapor tests; minimum requirements; general.

    (a) Bench tests will be made on an apparatus that allows the test 
atmosphere at 50 5 percent relative humidity and 
room temperature, approximately 25 [deg]C, to enter the cartridges 
continuously at predetermined concentrations and rates of flow, and that 
has means for determining the test life of the cartridges.
    (b) Where two cartridges are used in parallel on a chemical 
cartridge respirator, the bench test will be performed with the 
cartridges arranged in parallel, and the test requirements will apply to 
the combination rather than to the individual cartridges.
    (c) Three cartridges or pairs of cartridges will be removed from 
containers and tested as received from the applicant.
    (d) Two air purifying cartridges or pairs of cartridges will be 
equilibrated at room temperature by passing 25 percent relative humidity 
air through them at the flow rate of 25 liters per minute (l.p.m.) for 6 
hours.
    (e) Two air purifying cartridges or pairs of cartridges will be 
equilibrated by passing 85 percent relative humidity air through them at 
the flow rate of 25 l.p.m.
    (f) All cartridges will be resealed, kept in an upright position, at 
room temperatures, and tested within 18 hours.
    (g) Cartridges will be tested and shall meet the minimum 
requirements set forth in Table 11 of this subpart.
    (h) Powered air-purifying respirators with a cartridge(s) and 
particulate filter(s) must meet the as-received minimum service-life 
requirements and half of the equilibrated minimum service-life 
requirements set forth in table 11 of subpart L using the flows 
specified in subpart K, Sec.  84.175(b) and equilibrated in accordance 
with paragraphs (a) through (g) of this section using the flows 
specified in subpart K, Sec.  84.175(b).

[60 FR 30355, June 8, 1995, as amended at 85 FR 20607, Apr. 14, 2020]



                   Sec. Tables to Subpart L of Part 84

                         Tables 9-10 [Reserved]

                                                    Table 11--Cartridge Bench Tests and Requirements
                                                               [42 CFR part 84, subpart L]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Test atmosphere
                                                               --------------------------------------   Flowrate    Number of   Penetration    Minimum
              Cartridge                     Test condition                             Concentration    (l.p.m.)      tests         \1\        life \2\
                                                                     Gas or vapor         (p.p.m.)                                (p.p.m.)      (min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ammonia..............................  As received............  NH3                            1000            64            3           50           50
Ammonia..............................  Equilibrated...........  NH3                            1000            32            4           50           50
Chlorine.............................  As received............  Cl2                             500            64            3            5           35
Chlorine.............................  Equilibrated...........  Cl2                             500            32            4            5           35
Hydrogen chloride....................  As received............  HCl                             500            64            3            5           50
Hydrogen chloride....................  Equilibrated...........  HCl                             500            32            4            5           50
Methylamine..........................  As received............  CH3 NH2                        1000            64            3           10           25
Methylamine..........................  Equilibrated...........  CH3 NH2                        1000            32            4           10           25
Organic vapors.......................  As received............  CCl4                           1000            64            3            5           50
Organic vapors.......................  Equilibrated...........  CCl4                           1000            32            4            5           50

[[Page 673]]

 
Sulfur dioxide.......................  As received............  SO2                             500            64            3            5           30
Sulfur dioxide.......................  Equilibrated...........  SO2                             500            32            4            5           30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Where a respirator is designed for respiratory protection against more than one type of gas or vapor, as for use in ammonia and in chlorine, the
  minimum life shall be one-half that shown for each type of gas or vapor. Where a respirator is designed for respiratory protection against more than
  one gas of a type, as for use in chlorine and sulfur dioxide, the stated minimal life shall apply.

Subpart M [Reserved]



                    Subpart N_Special Use Respirators



Sec.  84.250  Vinyl chloride respirators; description.

    Vinyl chloride respirators, including all completely assembled 
respirators which are designed for use as respiratory protection during 
entry into and escape from vinyl chloride atmospheres containing 
adequate oxygen to support life, are described according to their 
construction as follows:
    (a) Front-mounted or back-mounted gas masks;
    (b) Chin-style gas masks;
    (c) Chemical-cartridge respirators;
    (d) Powered air-purifying respirators; and
    (e) Other devices, including combination respirators.



Sec.  84.251  Required components.

    (a) Each vinyl chloride respirator described in Sec.  84.250 shall, 
where its design requires, contain the following component parts:
    (1) Facepiece;
    (2) Canister with end-of-service-life indicator;
    (3) Cartridge with end-of-service-life indicator;
    (4) Harness;
    (5) Attached blower; and
    (6) Breathing tube.
    (b) The components of each vinyl chloride respirator shall meet the 
minimum construction requirements set forth in Subpart G of this part.



Sec.  84.252  Gas masks; requirements and tests.

    (a) Except for the tests prescribed in Sec.  84.126, the minimum 
requirements and performance tests for gas masks, prescribed in Subpart 
I of this part, are applicable to vinyl chloride gas masks.
    (b) The following bench tests are applicable to canisters designed 
for use with gas masks for entry into and escape from vinyl chloride 
atmospheres containing adequate oxygen to support life:
    (1) Four canisters will be equilibrated at 25 5 [deg]C by passing 85 5 percent 
relative humidity air through them at 64 liters per minute for six 
hours.
    (2) The equilibrated canisters will be resealed, kept in an upright 
position at room temperature, and tested according to paragraph (b)(3) 
of this section within 18 hours.
    (3) The canisters equilibrated and stored as described in paragraphs 
(b) (1) and (2) of this section will be tested on an apparatus that 
allows the test atmosphere at 85 5 percent 
relative humidity and 25 5 [deg]C to enter the 
canister continuously at a concentration of 25 ppm vinyl chloride 
monomer at a total flow rate of 64 liters per minute.
    (4) The maximum allowable penetration after six hours of testing 
according to paragraph (b)(3) of this section shall not exceed 1 ppm 
vinyl chloride.
    (c) Where canisters are submitted for testing and approval with a 
service life of more than four hours, the period of time for testing for 
vinyl chloride penetration will be performed at 150% of the service life 
specified in the manufacturer's application. (Example: If a manufacturer 
requests approval of a respirator for six hours use against exposure to 
vinyl chloride, the maximum

[[Page 674]]

allowable penetration after nine hours of testing shall not exceed 1 ppm 
vinyl chloride.)



Sec.  84.253  Chemical-cartridge respirators; requirements and tests.

    (a) Except for the tests prescribed in Sec. Sec.  84.206 and 84.207, 
the minimum requirements and performance tests for chemical-cartridge 
respirators prescribed in Subpart L of this part are applicable to 
replaceable-cartridge and single-use vinyl chloride chemical-cartridge 
respirators.
    (b) The following bench tests are applicable to cartridges designed 
for use with chemical-cartridge respirators for entry into and escape 
from vinyl chloride atmospheres containing adequate oxygen to support 
life:
    (1) Where two cartridges are used in parallel on a chemical-
cartridge respirator, the bench test requirements will apply to the 
combination rather than the individual cartridges.
    (2) Four cartridges or pairs of cartridges will be equilibrated at 
25 5 [deg]C by passing 85 5 
percent relative humidity air through them at 25 liters per minute for 
six hours.
    (3) The equilibrated cartridges will be resealed, kept in an upright 
position, at room temperature, and tested according to paragraphs (b)(4) 
and (b)(5) of this section for other than single-use respirators or 
according to paragraphs (b)(6) and (b)(7) of this section for single-use 
respirators within 18 hours.
    (4) The cartridges or pairs of cartridges for other than single-use 
respirators, equilibrated and stored as described in paragraphs (b)(1), 
(b)(2), and (b)(3) of this section, will be tested on an apparatus that 
allows the test atmosphere at 85 5 percent 
relative humidity and 25 5 [deg]C, to enter the 
cartridges or pairs of cartridges continuously at a concentration of 10 
ppm vinyl chloride monomer at a total flowrate of 64 liters per minute.
    (5) The maximum allowable penetration after 90 minutes testing of 
cartridges or pairs of cartridges for other than single-use respirators, 
according to paragraph (b)(4) of this section shall not exceed 1 ppm 
vinyl chloride.
    (6) The single-use respirators, equilibrated and stored as described 
in paragraphs (b)(2) and (b)(3) of this section, will be tested on an 
apparatus that allows a test atmosphere at 85 5 
percent relative humidity and 25 5 [deg]C to be 
cycled through the respirator by a breathing machine at a concentration 
of 10 ppm vinyl chloride monomer at the rate of 24 respirations per 
minute at a minute volume of 40 0.6 liters. Air 
exhaled through the respirator will be 35 2 [deg]C 
with 94 3 percent relative humidity.
    (7) The maximum allowable penetration after 144 minutes testing of 
respirators, according to paragraph (b)(6) of this section, shall not 
exceed 1 ppm vinyl chloride.



Sec.  84.254  Powered air-purifying respirators; requirements and tests.

    (a) Except for the tests prescribed in Sec.  84.207, the minimum 
requirements and performance tests for powered air-purifying respirators 
prescribed in subpart L of this part are applicable to vinyl chloride 
powered air-purifying respirators.
    (b) The following bench tests are applicable to cartridges designed 
for use with powered air-purifying respirators for entry into and escape 
from vinyl chloride atmospheres containing adequate oxygen to support 
life:
    (1) Four cartridges will be equilibrated at 25 [deg]C by passing 85 5 percent 
relative humidity air through them at 115 liters per minute for tight-
fitting facepieces and 170 liters per minute for loose-fitting hoods and 
helmets, for six hours.
    (2) The equilibrated cartridges will be resealed, kept in an upright 
position at room temperature and tested according to paragraph (b)(3) of 
this section within 18 hours.
    (3) The cartridges equilibrated and stored as described in 
paragraphs (b) (1) and (2) of this section will be tested on an 
apparatus that allows the test atmosphere at 85 5 
percent relative humidity and 25 5 [deg]C to enter 
the cartridge continuously at a concentration of 25 ppm vinyl chloride 
monomer at a total flow rate of 115 liters per minute for tight-fitting 
facepieces and 170 liters per minute for loose-fitting hoods and 
helmets.

[[Page 675]]

    (4) The maximum allowable penetration after six hours of testing 
according to paragraph (b)(3) of this section shall not exceed 1 ppm 
vinyl chloride.



Sec.  84.255  Requirements for end-of-service-life indicator.

    (a) Each canister or cartridge submitted for testing and approval in 
accordance with Sec. Sec.  84.252, 84.253, and 84.254 shall be equipped 
with a canister or cartridge end-of-service-life indicator which shows a 
satisfactory indicator change or other obvious warning before 1 ppm 
vinyl chloride penetration occurs. The indicator shall show such change 
or afford such warning at 80 10 percent of the 
total service life to 1 ppm leakage, as determined by continuing each 
test described in Sec. Sec.  84.252(b), 84.253(b), and 84.254(b) until a 
1 ppm leakage of vinyl chloride occurs.
    (b) The applicant shall provide sufficient pretest data to verify 
the performance of the end-of-service-life indicator required in 
paragraph (a) of this section.



Sec.  84.256  Quality control requirements.

    (a) In addition to the construction and performance requirements 
specified in Sec. Sec.  84.251, 84.252, 84.253, 84.254, and 84.255, the 
quality control requirements in paragraphs (b), (c), and (d) of this 
section apply to approval of gas masks, chemical cartridge respirators, 
and powered air-purifying respirators for entry into and escape from 
vinyl chloride atmospheres containing adequate oxygen to support life.
    (b) The respirators submitted for approval as described in paragraph 
(a) of this section shall be accompanied by a complete quality control 
plan meeting the requirements of subpart E of this part.
    (c)(1) The applicant shall specify in the plan that a sufficient 
number of samples will be drawn from each bulk container of sorbent 
material and that where activated carbon is used, the following specific 
tests will be performed:
    (i) Apparent density;
    (ii) Iodine number;
    (iii) Moisture content;
    (iv) Carbon tetrachloride number; and
    (v) Mesh size.
    (2) The tests in paragraph (c)(1) of this section shall be performed 
in a quantity necessary to assure continued satisfactory conformance of 
the canisters and cartridges to the requirements of this subpart.
    (d) Final performance quality control tests on the complete 
canisters and cartridges shall be accomplished using the bench tests and 
procedures prescribed in Sec. Sec.  84.252, 84.253, 84.254, and 84.255.



Sec.  84.257  Labeling requirements.

    (a) A warning shall be placed on the label of each gas mask, 
chemical-cartridge respirator, and powered air-purifying respirator, and 
on the label of each canister and cartridge, alerting the wearer to the 
need for a fitting test in accordance with the manufacturer's facepiece 
fitting instructions, providing service life information, providing 
specific instructions for disposal, and advising that the wearer may 
communicate to NIOSH any difficulties that may be experienced in the 
design and performance of any gas mask, chemical-cartridge respirator, 
or powered air-purifying respirator approved under the requirements of 
this subpart. The service lives of respirators meeting the test 
requirements of this subpart shall be specified as follows:

Chemical-cartridge respirator....................................1 hour.
Gas mask........................................................4 hours.
Powered air-purifying respirator................................4 hours.

    (b) Where the service life of a respirator is approved for more than 
four hours, the service life for which the respirator has been approved 
will be specified.



               Subpart O_Closed-Circuit Escape Respirators

    Source: 77 FR 14193, Mar. 8, 2012, unless otherwise noted.



Sec.  84.300  Closed-circuit escape respirator; description.

    The closed-circuit escape respirator (CCER), technically a subset of 
self-contained breathing apparatus (SCBAs) which are otherwise covered 
under subpart H of this part, is used in certain industrial and other 
work settings in emergencies to enable users to escape

[[Page 676]]

from atmospheres that can be immediately dangerous to life and health. 
Known in the mining community as self-contained self-rescuers (SCSRs), 
and in other industries as emergency escape breathing devices (EEBDs) or 
apparatus (EEBAs), CCERs are relied upon primarily by underground coal 
miners, sailors in federal service, and railroad workers to escape 
dangerous atmospheres after a fire, explosion, or chemical release. 
CCERs are commonly worn on workers' belts or stored in close proximity 
to be accessible in an emergency. They are relatively small respirators, 
typically the size of a water canteen, that employ either compressed 
oxygen with a chemical system for removing exhaled carbon dioxide from 
the breathing circuit, or a chemical that both provides a source of 
oxygen and removes exhaled carbon dioxide. Users re-breathe their 
exhalations after the oxygen and carbon dioxide levels have been 
restored to suitable levels, which distinguishes these ``closed-
circuit'' self-contained respirators from ``open-circuit'' self-
contained respirators, which vent each exhalation.



Sec.  84.301  Applicability to new and previously approved CCERs.

    (a) Any CCER approval issued after April 9, 2012 must comply with 
the technical requirements of subpart O.
    (b) The continued manufacturing, labeling, and sale of closed-
circuit apparatus previously approved under subpart H is authorized for 
units required for use in underground coal mines pursuant to 30 CFR 
75.1714-1.
    (c) Any manufacturer-requested modification to a device approved 
under the subpart H technical requirements must comply with the subpart 
H technical requirements and address an identified worker safety or 
health concern to be granted an extension of the NIOSH approval. Major 
modifications to the configuration that will result in a new approval 
must meet and be issued approvals under the requirements of this subpart 
O.

[84 FR 16412, Apr. 19, 2019]



Sec.  84.302  Required components, attributes, and instructions.

    (a) Each CCER must include components and/or attributes appropriate 
to its design, as follows:
    (1) Eye protection: Each CCER must include safety goggles or an 
escape hood lens that protects against impact, fogging, and permeation 
by gas, vapor, and smoke, as specified under Sec.  84.308(c);
    (2) Thermal exposure indicators: If the manufacturer specifies a 
maximum and/or minimum environmental temperature limit for storage of 
the CCER, then the CCER must include a component, an attribute, or other 
means by which a person can determine whether the CCER has been exposed 
to temperatures that exceed the limit(s);
    (3) Chemical bed physical integrity indicators: If the CCER includes 
a chemical oxygen storage or chemical carbon dioxide scrubber that can 
be functionally damaged by impact, vibration, or any other environmental 
factor to which the CCER might be exposed, then the CCER must include a 
component, an attribute, or other means by which a person can detect any 
damage or alteration of the chemical oxygen storage or chemical carbon 
dioxide scrubber that could diminish the NIOSH-certified performance of 
the CCER, as tested under this subpart;
    (4) Oxygen storage vessel: If the CCER includes an oxygen storage 
vessel, the vessel must be approved by the U.S. Department of 
Transportation (DOT) under 49 CFR part 107, ``Hazardous Materials 
Program Procedures,'' unless exempted under subpart B of 49 CFR part 
107;
    (5) Tamper-resistant/tamper-evident casing: If the CCER is not 
designed for its casing to be opened prior to use for an actual escape 
(e.g., for maintenance, escape drills, or inspection of the components), 
the casing must include a component, an attribute, or other means to 
prevent a person from accidentally opening the casing and, upon such 
opening, to either prevent the casing from being closed or to clearly 
indicate to a potential user that the casing has been previously opened; 
and
    (6) Moisture damage indicators: If the CCER is not designed for its 
casing to be opened for inspection of its internal

[[Page 677]]

components, the casing must include a component, an attribute, or other 
means by which a person can detect any ingress of water or water vapor 
that could diminish the NIOSH-certified performance, as tested under 
this subpart.
    (7) Oxygen starter indicators: If the oxygen starter is a critical 
component of the CCER design, then the CCER must include a component, an 
attribute, or other means by which a person can detect observable 
damage, premature activation, or recognized potential defect of the 
starter.
    (b) Where an indicator is required, the indication of the occurrence 
of the monitored condition must be clear and unambiguous: It must not 
depend on a subjective interpretation of subtle, graduated, or other 
non-discrete changes to the indicator.
    (c) Where an indicator is required, the manufacturer shall provide 
NIOSH with an explanation of its function and operation, and shall 
provide relevant data and equipment to allow NIOSH to conduct a thorough 
evaluation of its accuracy and reliability.
    (d) The components of each CCER must meet the general construction 
requirements specified in Sec.  84.61.
    (e) The CCER must be resistant to the permeation of the breathing 
circuit by gasoline vapors. To verify such resistance, NIOSH will test 
one unit by applying the gasoline vapor permeation test specified on the 
NIOSH Web site at http://www.cdc.gov/niosh/npptl, using a breathing 
machine applying a ventilation rate of 40 liters per minute, performing 
the test for the longest duration achieved by any of the units that 
underwent the capacity testing specified under Sec.  84.304.
    (f) Exposed parts of the CCER must not be composed of metals or 
other materials that could, upon impact, create frictional sparks or 
that could store or generate static electrical charges of sufficient 
energy to ignite flammable gaseous mixtures.
    (g) The design, construction, or materials of the CCER must not 
constitute a hazard to the user as a result of the wearing, inspection, 
or use of the CCER.
    (h) CCER instructions and a service life plan must be provided to 
purchasers. This document must be clearly written.
    (1) Instructions must address the following topics and elements:
    (i) An explanation of how the CCER works;
    (ii) A schematic diagram of the CCER;
    (iii) Procedures for donning and use;
    (iv) Procedures for inspecting the operating condition of the CCER;
    (v) Procedures and conditions for storage, including but not limited 
to any recommended minimum and maximum temperatures for storage;
    (vi) Limitations on use, including but not limited to any 
recommended minimum and maximum temperatures for use;
    (vii) Procedures for disposal; and
    (viii) Procedures for registration of the unit with NIOSH, pursuant 
to Sec.  84.311.
    (2) The service life must be addressed covering at least the 
following topics:
    (i) The maximum number of years, from the date of manufacture, that 
the unit may remain available for use; this limit is intended to prevent 
the continued use of a unit that the applicant cannot assure would 
continue to perform as approved by NIOSH, due to reasonably foreseeable 
degradation of materials used in its construction;
    (ii) Any other conditions, other than that specified under paragraph 
(h)(2)(i) of this section, that should govern the removal from service 
of the CCER (including an indication given by the activation or 
operation of any required indicator showing the monitored condition has 
occurred); and
    (iii) Any procedures by which a user or others should inspect the 
CCER, perform any maintenance possible and necessary, and determine when 
the CCER should be removed from service.
    (i) Each individual CCER unit approval label shall identify the 
capacity rating and number of liters of oxygen as determined by the 
capacity testing, pursuant to Sec.  84.304.



Sec.  84.303  General testing conditions and requirements.

    (a) NIOSH will conduct capacity and performance tests on the CCER 
using a breathing and metabolic simulator to provide quantitative 
evaluations and

[[Page 678]]

human subjects on a treadmill to provide qualitative evaluations. 
Information on the design and operation of the simulator is available 
from the NIOSH Web site at http://www.cdc.gov/niosh/npptl. Technical 
specifications can be obtained from NIOSH by contacting the National 
Personal Protective Technology Laboratory (NPPTL) by mail: P.O. Box 
18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. Telephone: 412-386-
4000 (this is not a toll-free number). Email: [email protected].
    (b) Capacity, performance, and wearability tests will continuously 
monitor the stressors listed in Table 1. The stressors and their 
respective acceptable ranges will be measured at the interface between 
the CCER and the mouth by instruments capable of breath-by-breath 
measurement. Stressor measurements will be evaluated as 1-minute 
averages. The operating averages of each stressor will be calculated 
upon the completion of each test as the average of the 1-minute 
measurements of the stressor recorded during the test. The level of any 
excursion for a stressor occurring during a test will be defined by the 
1-minute average value(s) of the excursion(s).

                            Table 1--Monitored Stressors and Their Acceptable Ranges
----------------------------------------------------------------------------------------------------------------
                                         Acceptable range operating
                Stressor                           average                    Acceptable range excursion
----------------------------------------------------------------------------------------------------------------
Average inhaled CO2....................  <1.5%.....................  <=4%.
Average inhaled O2.....................  19.5%..........  =15%.
Peak Breathing Pressures...............  [Delta]P <=200 mm H2O.....  -300 <=[Delta]P <=200 mm H2O.
Wet-bulb temperature\1\................  <43 [deg]C................  <=50 [deg]C.
----------------------------------------------------------------------------------------------------------------
\1\ Wet-bulb temperature is a measurement of the temperature of a wet surface. It represents the temperature of
  the inhaled breathing gas in the CCER user's trachea.

    (c) Capacity and performance tests will conclude when the stored 
breathing gas supply has been fully expended.
    (d) NIOSH will determine a CCER to have failed a capacity, 
performance, or wearability test if any of the following occurs:
    (1) A 1-minute average measurement of any stressor listed in Table 1 
occurs outside the acceptable excursion range specified in Table 1; or 
an average stressor measurement calculated at the completion of a 
performance or capacity test exceeds the acceptable operating average 
range specified in Table 1; or
    (2) A human subject cannot complete the test for any reason related 
to the CCER, as determined by NIOSH.
    (e) Unless otherwise stated, tests required under this subpart will 
be conducted at the following ambient conditions:
    (1) Ambient temperatures of 23 [deg]C 3 
[deg]C; and
    (2) Atmospheric pressures of 735 mm Hg 15 mm 
Hg.



Sec.  84.304  Capacity test requirements.

    (a) NIOSH will conduct the capacity test on a total of 8 to 10 of 
the units submitted for approval, as follows:
    (1) Three units will be tested on a breathing and metabolic 
simulator in the condition in which they are received from the 
applicant;
    (2) Two units will be tested on a breathing and metabolic simulator 
after being subjected to the environmental treatments specified in Sec.  
84.307 of this subpart;
    (3) Two units will be tested on a breathing and metabolic simulator 
at the cold-temperature limit recommended by the manufacturer under 
Sec.  84.302(h)(1), after the unit has been stored for a minimum of 24 
hours at this limit; and
    (4) One unit, in the condition in which it is received from the 
applicant, will be tested by a human subject on a treadmill.
    (5) To approve a CCER for use in coal mines, two units will also be 
tested by a human subject under the specifications of Sec. Sec.  84.99 
and 84.100 that are applicable to man test 4.
    (b) The capacity test will begin upon the first inhalation from or 
exhalation into the unit.
    (c) Each unit will be tested at a constant work rate, depending on 
the capacity value specified by the manufacturer, according to the 
requirements

[[Page 679]]

specified in Table 2. All volumes are given at standard temperature (0 
C) and pressure (760 mm Hg), dry, unless otherwise noted.
    (d) NIOSH will rate an approved CCER using the appropriate capacity 
rating, as specified in Table 2.

                                       Table 2--Capacity Test Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             VCO2 (L/                RF (Breaths/
           Capacity rating              Capacity (L of O2)    VO2 (L/min)      min)      Ve (L/min)      min)
----------------------------------------------------------------------------------------------------------------
Cap 1...............................  20 <=L <=59...........         2.50         2.50           55           22
Cap 2...............................  60 <=L <=79...........         2.00         1.80           44           20
Cap 3...............................  L =80......         1.35         1.15           30           18
----------------------------------------------------------------------------------------------------------------
VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.
Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

    (e) NIOSH will document the least value achieved by the seven units 
tested using the breathing and metabolic simulator. NIOSH will quantify 
this value of achieved capacity within an increment of 5 liters, 
rounding intermediate values to the nearest lower 5-liter increment.



Sec.  84.305  Performance test requirements.

    (a) NIOSH will conduct the performance test on a total of six of the 
units submitted for approval, as follows:
    (1) Three units will be tested on a breathing and metabolic 
simulator in the condition in which they were received from the 
applicant; and
    (2) Two units will be tested on a breathing and metabolic simulator 
after being subjected to the environmental treatments specified in Sec.  
84.307; and
    (3) One unit will be tested, in the condition in which it was 
received from the applicant, by a human subject on a treadmill.
    (b) Except as provided under paragraph (c) of this section, the 
performance test will apply a repeating cycle of work rates, according 
to the sequence and requirements specified in Table 3, until the oxygen 
supply of the unit is exhausted.
    (c) Testing of CCERs with less than 50 liters of capacity, as 
determined by the capacity testing under Sec.  84.304, will require the 
submission of additional test units to fully apply the work-rate test 
sequence and requirements specified in Table 3. The testing of each 
individual unit will complete the cycle specified in Table 3 until the 
breathing supply of the initial test unit is exhausted. This initial 
test unit will then be replaced by a second unit, which will continue 
the test cycle, beginning at the work rate in the cycle at which the 
initial unit was exhausted, and completing the full period specified in 
Table 3 for that work rate before proceeding to the subsequent work 
rate, if any, specified in Table 3. Each initial testing unit will be 
replaced as many times as necessary to complete the cycle, not to exceed 
two replacement units per initial test unit.
    (d) The performance test will begin with two exhalations into the 
unit at the specified ventilation rate and then follow the 
manufacturer's instructions to determine the design's susceptibility to 
hypoxia upon initial donning.

                                     Table 3--Performance Test Requirements
----------------------------------------------------------------------------------------------------------------
                                                   Duration
                                                  per cycle                  VCO2 (L/                RF (breaths/
            Work-rate test sequence                  (in      VO2 (L/min)      min)      Ve (L/min)      min)
                                                   minutes)
----------------------------------------------------------------------------------------------------------------
1. Peak........................................            5         3.00         3.20         65.0           25
2. High........................................           15         2.00         1.80         44.0           20
3. Low.........................................           10         0.50         0.40         20.0           12
----------------------------------------------------------------------------------------------------------------
VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.
Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.


[[Page 680]]



Sec.  84.306  Wearability test requirements.

    (a) NIOSH will conduct the wearability test on a total of three of 
the units submitted for approval. Three human subjects (two males and 
one female), one subject per unit, will conduct the test. The three 
subjects will range in height and weight as follows: One subject of 
height =174 cm and weight =90 kg; one subject of 
either 163 cm <=height <174 cm, regardless of weight, or 72 kg 
=weight <90 kg, regardless of height; and one subject of 
height <163 cm and weight <72 kg. All units tested must meet all 
conditions specified in this section to receive approval.
    (b) NIOSH will evaluate the ease and speed with which users can don 
the CCER, as follows:
    (1) Each test subject will be provided with manufacturer 
instructions, and must be able to don the CCER correctly, isolating the 
lungs within 30 seconds; \1\ and
---------------------------------------------------------------------------

    \1\ This time limit does not apply to any additional steps that 
might be required after the lungs are protected to adjust the unit for 
wear.
---------------------------------------------------------------------------

    (2) A CCER must not include any design, construction, or material 
characteristic that can be anticipated or demonstrated, under plausible 
conditions, to hinder the user in the correct and timely donning of the 
CCER.
    (c) NIOSH will continuously monitor CCER use by each test subject 
during the activities specified in Table 4 to evaluate the ability of 
the CCER to provide an adequate and uninterrupted breathing supply, 
including but not limited to the requirements of Sec.  84.303(b), 
without harming or hindering a user. NIOSH will not approve a CCER if 
the use of any unit during these activities indicates any potential for 
the CCER to harm or hinder the user or to fail to provide an adequate 
and uninterrupted breathing supply to the user during reasonably 
anticipated conditions and activities of an escape.

                                     Table 4--Wearability Test Requirements
----------------------------------------------------------------------------------------------------------------
                    Activity                                             Minimum duration
----------------------------------------------------------------------------------------------------------------
Sitting.........................................  1 minute.
Stooped walking.................................  1 minute.
Crawling........................................  1 minute.
Lying on left side..............................  1 minute.
Lying on right side.............................  1 minute.
Lying on back...................................  1 minute.
Bending over to touch toes......................  1 minute.
Turning head from side to side..................  1 minute (at least 10 times).
Nodding head up and down........................  1 minute (at least 10 times).
Climbing steps or a laddermill..................  1 minute (1 step/second).
Carrying 50-lb bag on treadmill at 5 kph........  1 minute.
Lifting 20-lb weight from floor to an upright     1 minute (at least 10 times).
 position.
Running on treadmill at 10 kph..................  1 minute.
----------------------------------------------------------------------------------------------------------------



Sec.  84.307  Environmental treatments.

    (a) Four units submitted for approval will be tested for capacity 
and performance, pursuant to the requirements of Sec. Sec.  84.303 
through 84.305, after exposure to environmental treatments simulating 
extreme storage temperatures, shock, and vibration.
    (b) The units will be stored for 16 hours at a temperature of -45 
[deg]C and for 48 hours at a temperature of 71 [deg]C. Units will be 
returned to room temperature between high and low temperature 
treatments. The maximum rate of change for thermal loading shall not 
exceed 3 [deg]C per minute and constant temperatures shall be maintained 
within 2 [deg]C.
    (c) The units, in the casing in which they are deployed for 
individual use, will be subjected to physical shock according to the 
following procedure:
    (1) The unit will be dropped six times from a height of 1 meter onto 
a concrete surface; and
    (2) Each drop will test a different orientation of the unit, with 
two drops along each of its three major axes (top to bottom, left to 
right, and front to back).

[[Page 681]]

    (d) The units will be subjected to vibration according to the 
following procedure:
    (1) The unit will be firmly secured to a shaker table, which will be 
vibrated with motion applied along a single axis for 180 minutes;
    (2) The unit will be vibrated one axis at a time along each of three 
axes for a total of 9 hours; and
    (3) The vibration frequency regimen applied to each axis will be 
cyclical, repeating the sequence and specifications provided in Table 5 
every 20 minutes.

                    Table 5--Vibration Test Sequence
------------------------------------------------------------------------
                                       Frequency   Acceleration g (peak)
------------------------------------------------------------------------
1...................................         5-92               2.5
2...................................       92-500               3.5
3...................................     500-2000               1.5
------------------------------------------------------------------------



Sec.  84.308  Additional testing.

    (a) NIOSH will conduct additional tests, as indicated below, on one 
or more of the units submitted for approval. Each unit tested must meet 
the conditions specified in these tests for the CCER to receive 
approval.
    (b) NIOSH will perform safety hazard tests on any CCER that stores 
more than 200 liters of oxygen or that stores compressed oxygen at 
pressures exceeding 3,000 psi. The applicant must submit 15 units in 
addition to the 21-23 units required for testing under Sec. Sec.  84.304 
through 84.307. These units will be evaluated for fire and explosion 
hazards using the tests specified in RI 9333, pages 4-18; RI 8890, pages 
6-62; and PRC Report No. 4294, pages 18-62.
    (c) NIOSH will perform the following tests on the eye protection 
(gas-tight goggles or escape hood lens) of one or more units of every 
CCER submitted for approval:
    (1) NIOSH will test the effectiveness of the eye protection against 
dust using the method specified in ISO 4855-1981(E) Clause 13, Test for 
protection against dust. The result will be satisfactory if the 
reflectance after the test is equal to or greater than 80 percent of its 
value before testing.
    (2) NIOSH will test the effectiveness of the eye protection against 
gas using the method specified in ISO 4855-1981(E), Clause 14, Test for 
protection against gas. The test must not result in staining of the area 
enclosed by the eye protection.
    (3) NIOSH will test the durability of the eye protection using the 
method specified in International Standard ISO 4855-1981(E), Sub-clause 
3.1, Unmounted oculars. The lens shall not crack or fracture as a result 
of the test.
    (4) NIOSH will test the eye protection's resistance to fogging in 
accordance with the method specified in BS EN 168:2002, Clause 16, Test 
for resistance to fogging of oculars. The lens shall remain free from 
fogging for a minimum of 8 seconds, pursuant to Clause 16.
    (d) The standards required in this section are incorporated by 
reference into this section with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR Part 51. All approved 
material is available for inspection at NIOSH, National Personal 
Protection Technology Laboratory (NPPTL), Bruceton Research Center, 626 
Cochrans Mill Road, Pittsburgh, PA 15236. To arrange for an inspection 
at NIOSH, call 412-386-6111. Copies are also available for inspection at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (1) British Standards Institute, 389 Chiswick High Road, London W4 
4AL, UK, http://www.bsigroup.com/en/Standards-and-Publications:
    (i) BS EN 168:2002, Personal Eye Protectors--Non-Optical Test 
Methods, November 2001.
    (ii) [Reserved]
    (2) International Organization for Standardization, 1, ch. de la 
Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland, http://
www.iso.org/iso/store.htm:
    (i) ISO 4855-1981(E), Personal Eye Protectors--Non-Optical Test 
Methods, First edition April 1, 1981.
    (ii) [Reserved]
    (3) U.S. Department of the Interior, Bureau of Mines, 2401 E Street, 
NW., MS 9800, Washington, DC 20241-0001. These reports are also 
available from NIOSH upon request 1-800-CDC-INFO (232-4636).

[[Page 682]]

    (i) Pittsburgh Research Center (PRC) Report No. 4294, Evaluation of 
the Safety of One-Hour Chemical Self Rescuers, July 1980;
    (ii) Report of Investigations (RI) 8890, Evaluation of the Safety of 
One-Hour Compressed Oxygen Self-Rescuers--Results of Destructive 
Testing, 1984;
    (iii) RI 9333 Evaluation of the Safety of the CSE SR-100 Self-
Contained Self-Rescuer, 1991.



Sec.  84.309  Additional testing and requirements for dockable CCERs.

    (a) NIOSH will conduct additional testing of the CCERs that are 
designed to allow the user to resupply the oxygen source and the carbon 
dioxide scrubber while using the respirator during an escape.
    (1) NIOSH will test the docking mechanism and procedure to ensure 
that they maintain the integrity of the breathing circuit (against the 
intake of hazardous fumes or gases) and the continuity of the breathing 
gas supply throughout the docking process.
    (2) NIOSH will test the docking mechanism and procedure to ensure 
that users can employ the docking process reliably, safely, and quickly 
under escape conditions.
    (b) NIOSH will designate CCERs that pass the tests specified in this 
section as ``Dockable.''
    (c) NIOSH will assign the capacity rating to the dockable CCER, as 
specified under Sec.  84.304(d), by conducting the capacity testing 
using only the breathing gas supply included for the initial use of the 
wearable apparatus.
    (d) NIOSH will test the supplemental capacities of all breathing gas 
resupply units produced by the manufacturer for use with the dockable 
CCER. Such tests will follow procedures consistent with those specified 
under Sec.  84.304, including the rating requirements in Sec.  
84.304(d). The manufacturer must label the breathing gas resupply unit 
to indicate its capacity as tested by NIOSH and its compatibility with 
the CCER for which it is designed.
    (e) NIOSH may require the applicant to provide additional units of 
the CCER and breathing gas resupply units to conduct the testing 
specified in this section.
    (f) NIOSH will not approve a CCER with docking components, with or 
without the ``Dockable'' NIOSH designation, unless it satisfies the 
testing and other requirements of this section.



Sec.  84.310  Post-approval testing.

    (a) NIOSH will periodically test the capacity and performance of 
units of approved CCERs.
    (b) NIOSH may test units that are new and/or units that have been 
deployed in the field and have remaining service life.
    (c) NIOSH will conduct such testing pursuant to the methods 
specified in Sec. Sec.  84.303 through 84.305, except as provided under 
paragraphs (c)(1) and (2) of this section:
    (1) Post-approval tests may exclude human subject testing and 
environmental conditioning at the discretion of NIOSH.
    (2) The numbers of units of an approved CCER to be tested under this 
section may exceed the numbers of units specified for testing in 
Sec. Sec.  84.304 and 84.305.
    (d) Failure of a unit to meet the capacity and performance 
requirements of this section may result in revocation of the approval 
for the CCER or in requirements for specific remedial actions to address 
the cause or causes of the failure.
    (e) NIOSH will replace deployed units obtained for testing with new 
NIOSH-approved units of the same or similar design, at no cost to the 
employer.
    (f) To maintain the approved status of a CCER, an applicant must 
make available for purchase by NIOSH, within 3 months of a NIOSH 
purchase request, the number of units requested by the Institute. Within 
any 12-month period, NIOSH will not request to purchase more than 100 
units for post-approval testing.

[77 FR 14193, Mar. 8, 2012, as amended at 84 FR 16412, Apr. 19, 2019]



Sec.  84.311  Registration of CCER units upon purchase.

    (a) The user instructions will include a copy of procedures for 
registering the units with NIOSH. The applicant can obtain a copy of 
these procedures from the NIOSH web page: http://www.cdc.gov/niosh/
npptl.

[[Page 683]]

    (b) The applicant shall notify in writing each purchaser of the 
purpose of registering a unit with NIOSH, as specified under paragraph 
(c) of this section. If the purchaser is a distributor of the CCER, the 
applicant must request in writing that the distributor voluntarily 
notify in writing each of its purchasers of the purpose of registering a 
unit with NIOSH, as specified under paragraph (c) of this section.
    (c) ``The National Institute for Occupational Safety and Health 
(NIOSH) requests, but does not require, that purchasers of this 
respirator register each unit with NIOSH. Registration will enable 
NIOSH, which approved this model of respirator, to attempt to notify you 
if a problem is discovered that might affect the safety or performance 
of this respirator. Registration will also assist NIOSH in locating 
deployed units to periodically evaluate whether this respirator model is 
remaining effective under field conditions of storage and use.''

Subparts P-JJ [Reserved]

   Appendix A to Part 84--Annual (Fixed) Respirator Certification Fees

                          Respirator Certification Fee Schedule A--Annual (Fixed) Fees
                                          [Implemented on May 26, 2015]
----------------------------------------------------------------------------------------------------------------
             Fee type                   Legal citation               Amount                     Due date
----------------------------------------------------------------------------------------------------------------
Maintenance of Product Performance  42 CFR 84.20(b)(5)...   Annual    Upon
 (product audit).                                           fee: $761 per each          billing from NIOSH.\1\
                                                            approval holder.           
                                                                      October.
                                                            Variable fee: As billed
                                                            by NIOSH based on the
                                                            respirators chosen to be
                                                            tested each year.
Records Maintenance...............  42 CFR 84.20(b)(1)...  $50 for all listed \2\       Upon
                                                            approvals on file with      billing from NIOSH.\1\
                                                            NIOSH on July 1st of each  
                                                            year.                       October (beginning in
                                                                                        2015).
Quality Assurance Maintenance       42 CFR 84.20(b)(4)...   Annual    Upon
 (site audit).                                              fee: $3,000 per every       billing from NIOSH.\1\
                                                            manufacturing site         
                                                            registered with NIOSH.      October (beginning in
                                                                      2015).
                                                            Variable fee: \3\.
                                                           [squf] 1 day domestic
                                                            audit--$2,500 per site.
                                                           [squf] 2 day domestic
                                                            audit--$5,000 per site.
                                                           [squf] 1 day international
                                                            audit--$7,500 per site.
                                                           [squf] 2 day international
                                                            audit--$10,000 per site.
Maintenance of Testing and          42 CFR 84.20(b)(2)...  $34 per every listed \2\     Upon
 Approval Facilities.                                       approval on file with       billing from NIOSH.\1\
                                                            NIOSH on July 1st of each  
                                                            applicable year.            October (beginning in
                                                                                        2015).
Maintenance of Test Equipment.....  42 CFR 84.20(b)(2)...  $36 per every active \4\     Upon
                                                            approval on file with       billing from NIOSH.\1\
                                                            NIOSH on July 1st of each  
                                                            applicable year.            October (beginning in
                                                                                        2015).
----------------------------------------------------------------------------------------------------------------
\1\ For the first year that annual fees are in effect, NIOSH will provide manufacturers with a pre-invoice/
  advanced billing/invoice preview no later than July 1, 2015. The actual invoice will be sent in September
  2015.
\2\ ``Listed'' approvals include all active and obsolete approvals. The Certified Equipment List (CEL) reflects
  the current listed approvals maintained by NIOSH. See http://www.cdc.gov/niosh/npptl/topics/respirators/CEL/
  default.html.
\3\ Applies to design as well as manufacturing sites.
\4\ Does not include obsolete approvals.


[80 FR 3908, Jan. 26, 2015]



 Sec. Appendix B to Part 84--Application-Based Respirator Certification 
                                  Fees

                         Respirator Certification Fee Schedule B--Application-Based Fees
                                          [Implemented on May 26, 2015]
----------------------------------------------------------------------------------------------------------------
             Fee type                   Legal citation               Amount                     Due date
----------------------------------------------------------------------------------------------------------------
Application.......................  42 CFR 84.20(b)(1)...  $200 per application        Upon receipt of any
                                                            submitted.                  application request.
Approval..........................  42 CFR 84.20(b)(1)...  $100 per each certificate   Upon completion of the
                                                            of approval issued.         application and granting
                                                                                        of an approval number.

[[Page 684]]

 
Approval Modification.............  42 CFR 84.20(b)(1)...  $50 per each certificate    Upon completion of the
                                                            of approval modified.       application and issuing
                                                                                        a modified approval.
Site Qualification................  42 CFR 84.20(b)(3)...            Upon agreement on the
                                                            Existing approval holder,   date of the site
                                                            paper review: $400 per      qualification
                                                            each request to inspect     examination.
                                                            new production facility.
                                                            Non-
                                                            approval holders:.
                                                           [squf] Domestic site
                                                            visit--$2,500.
                                                           [squf] International site
                                                            visit--$7,500.
----------------------------------------------------------------------------------------------------------------


------------------------------------------------------------------------
            Standard Test Procedure                      Fee ($)
------------------------------------------------------------------------
                              Testing Fees
------------------------------------------------------------------------
Descriptor:....................................  For testing
                                                  respirators.
------------------------------------------------------------------------
Amount:........................................  See below.
------------------------------------------------------------------------
Basis:.........................................  Per each test.
------------------------------------------------------------------------
Due date:......................................  Upon initiation of
                                                  testing.
------------------------------------------------------------------------
                        Air-Purifying Respirators
------------------------------------------------------------------------
TEB-APR-STP-0001 Determination of particulate    150
 filter penetration (PAPR).
RCT-APR-STP-0003--Determination of exhalation    150
 resistance.
TEB-APR-STP-0004--Determination of exhalation    300
 valve leakage.
TEB-APR-STP-0005--Determination of qualitative   1,800
 isoamyl acetate (IAA) facepiece fit test.
TEB-APR-STP-0005A--Determination of qualitative  1,800
 isoamyl acetate (IAA) facepiece fit test.
TEB-APR-STP-0006--Determination of qualitative   1,800
 isoamyl acetate (IAA) facepiece fit test.
TEB-APR-STP-0007--Determination of inhalation    150
 resistance.
RCT-APR-STP-0012--Determination of air flow for  150
 powered air-purifying respirators.
RCT-APR-STP-0014--Determination of leakage of    300
 drinking tube and accessories for respirator
 facepieces.
RCT-APR-STP-0025--Determination of silica dust   1,200
 loading test for powered air-purifying
 respirator filters.
RCT-APR-STP-0030--Determination of noise level   450
 test, powered air-purifying respirator with
 hoods or helmets.
TEB-APR-STP-0033A--Determination of ammonia      750
 service-life test, air-purifying respirators
 with cartridges.
TEB-APR-STP-0033B--Determination of ammonia      750
 service-life test, air-purifying respirators
 with canisters.
TEB-APR-STP-0033C--Determination of ammonia      750
 service-life test, powered air-purifying
 respirators with cartridges.
TEB-APR-STP-0033D--Determination of ammonia      750
 service-life test, tight-fitting powered air-
 purifying respirators with gas mask
 canister(s).
RCT-APR-STP-0034--Carbon monoxide service life.  750
RCT-APR-STP-0035--Determination of chlorine      750
 service life.
RCT-APR-STP-0036--Determination of chlorine      750
 dioxide service life.
RCT-APR-STP-0037--Determination of a-            2,400
 chloroacetophenone (CN) service life.
RCT-APR-STP-0038--Determination of ethylene      450
 oxide service life.
TEB-APR-STP-0039A--Determination of              750
 formaldehyde service-life test, air-purifying
 respirators with cartridges.
TEB-APR-STP-0039B--Determination of              750
 formaldehyde service-life test, air-purifying
 respirators with canisters.
TEB-APR-STP-0039C--Determination of              750
 formaldehyde service-life test, powered air-
 purifying respirators with cartridges.
RCT-APR-STP-0040--Determination of hydrogen      500
 chloride service life.
RCT-APR-STP-0041--Determination of hydrogen      1,800
 cyanide service life.
RCT-APR-STP-0042--Determination of hydrogen      750
 fluoride service life.
TEB-APR-STP-0043A--Determination of hydrogen     750
 sulfide service-life test, air-purifying
 respirators with cartridges.
TEB-APR-STP-0043B--Determination of hydrogen     750
 sulfide service-life test, air-purifying
 respirators with canisters.
TEB-APR-STP-0043C--Determination of hydrogen     750
 sulfide service-life test, powered air-
 purifying respirators with cartridges.
RCT-APR-STP-0044--Determination of mercury       2,400
 vapor service life.
TEB-APR-STP-0045A--Determination of methylamine  450
 service-life test, air-purifying respirators
 with cartridges.
TEB-APR-STP-0045B--Determination of methylamine  450
 service-life test, air-purifying respirators
 with canisters.
TEB-APR-STP-0045C--Determination of methylamine  450
 service-life test, powered air-purifying
 respirators with cartridges.

[[Page 685]]

 
TEB-APR-STP-0045D--Determination of methylamine  450
 service-life test, tight-fitting powered air-
 purifying respirators with gas mask
 canister(s).
TEB-APR-STP-0046A--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, air-purifying respirators with
 cartridges.
TEB-APR-STP-0046B--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, air-purifying respirators with
 cartridges.
TEB-APR-STP-0046C--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, powered air-purifying respirators with
 cartridges.
TEB-APR-STP-0046D--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, tight-fitting powered air-purifying
 respirators with gas mask canister(s).
RCT-APR-STP-0047--Determination of phosphine     750
 service life.
TEB-APR-STP-0048A--Determination of sulfur       450
 dioxide service-life test, air-purifying
 respirators with cartridges.
TEB-APR-STP-0048B--Determination of sulfur       450
 dioxide service-life test, air-purifying
 respirators with canisters.
TEB-APR-STP-0048C--Determination of sulfur       450
 dioxide service-life test, powered air-
 purifying respirators with cartridges.
TEB-APR-STP-0048D--Determination of sulfur       450
 dioxide service-life test, tight-fitting
 powered air-purifying respirators with gas
 mask canisters.
RCT-APR-STP-0050--Determination of O-            2,400
 chlorobenzylidene malononitrile (CS) service
 life.
TEB-APR-STP-0051--Determination of particulate   1,200
 filter efficiency level for P100 series
 filters against liquid particulates for non-
 powered, air-purifying respirators.
TEB-APR-STP-0052--Determination of particulate   1,200
 filter efficiency level for P99 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0053--Determination of particulate   1,200
 filter efficiency level for P95 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0054--Determination of particulate   1,200
 filter efficiency level for R100 series
 filters against liquid particulates for non-
 powered, air-purifying respirators.
TEB-APR-STP-0055--Determination of particulate   1,200
 filter efficiency level for R99 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0056--Determination of particulate   1,200
 filter efficiency level for R95 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0057--Determination of particulate   1,200
 filter efficiency level for N100 series
 filters against solid particulates for non-
 powered, air-purifying respirators.
TEB-APR-STP-0058--Determination of particulate   1,200
 filter efficiency level for N99 series filters
 against solid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0059--Determination of particulate   1,200
 filter efficiency level for N95 series filters
 against solid particulates for non-powered,
 air-purifying respirators.
RCT-APR-STP-0060--Determination of end-of-       300
 service-life indicator drop.
RCT-APR-STP-0061--Determination of end-of-       300
 service-life indicator visibility.
RCT-APR-STP-0062--Determination of nitrogen      750
 dioxide service life.
RCT-APR-STP-0063--Determination of facepiece     300
 carbon dioxide and oxygen concentration
 levels--tight fitting, powered air-purifying
 respirators, with the blower unit running.
RCT-APR-STP-0064--Determination of facepiece     300
 carbon dioxide and oxygen concentration
 levels, tight fitting, powered air-purifying
 respirators, with the blower unit off.
RCT-APR-STP-0065--Determination of air flow      300
 resistance, breath responsive, powered air-
 purifying respirators.
RCT-APR-STP-0066--Determination of end-of-       300
 service-life indicator (ESLI).
RCT-APR-STP-0067--Particulate respirator         1800
 qualitative fit test utilizing saccharin or
 bitrex solutions.
------------------------------------------------------------------------
                        Air-Supplied Respirators
------------------------------------------------------------------------
RCT-ASR-STP-0100--Determination of strength of   150
 hoses and couplings, type C and CE supplied-
 air respirators.
RCT-ASR-STP-0101--Determination of tightness of  150
 hoses and couplings, type C and CE supplied-
 air respirators.
RCT-ASR-STP-0102--Determination of               150
 nonkinkability of hoses, type C and CE
 supplied-air respirators.
RCT-ASR-STP-0103--Determination of gasoline      450
 permeation of hoses and couplings, type C and
 CE supplied-air respirators.
RCT-ASR-STP-0104--Determination of air-          3,000
 regulating valve 100,000 cycles performance,
 demand and pressure-demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0105--Determination of airflow,      300
 continuous flow type C and CE supplied-air
 respirators.
RCT-ASR-STP-0105A--Determination of airflow,     300
 demand and pressure-demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0106--Determination of inhalation    150
 airflow resistance, pressure-demand type C and
 CE supplied-air respirators.
RCT-ASR-STP-0107--Determination of exhalation    150
 airflow resistance, pressure-demand type C and
 CE supplied-air respirators.
RCT-ASR-STP-0108--Determination of inhalation    150
 airflow resistance, demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0109--Determination of exhalation    150
 airflow resistance, demand type C and CE
 supplied-air respirators.

[[Page 686]]

 
RCT-ASR-STP-0110--Determination of gas-          450
 tightness test, isoamyl acetate (IAA), type C
 and CE supplied-air respirators.
RCT-ASR-STP-0111--Determination of air velocity  450
 and noise levels--sound level, type C and CE
 supplied-air respirators.
RCT-ASR-STP-0112--Determination of the level of  450
 protection provided by abrasive blast, type CE
 supplied-air respirators using a challenge
 aerosol of NaCl (sodium chloride) or corn oil.
RCT-ASR-STP-0113--Determination of airflow       150
 resistance--continuous-flow, type C and CE
 supplied-air respirators.
RCT-ASR-STP-0114--Determination of sound-level   450
 measurement--escape, open-circuit self-
 contained breathing apparatus using hoods or
 helmets.
RCT-ASR-STP-0115--Determination of rated         150
 service time--constant-flow, escape, open-
 circuit self-contained breathing apparatus.
RCT-ASR-STP-0116--Determination of airflow       150
 resistance--continuous-flow, escape, open-
 circuit self-contained breathing apparatus
 with hoods.
RCT-ASR-STP-0117--Determination of positive      150
 pressure--closed-circuit, pressure-demand,
 self-contained breathing apparatus.
RCT-ASR-STP-0118--Determination of low           1,200
 temperature operation--minimum temperature per
 applicant, open-circuit self-contained
 breathing apparatus.
RCT-ASR-STP-0119--Determination of low-          1,200
 temperature operation--minimum temperature per
 applicant, combination open-circuit self-
 contained breathing apparatus and type C and
 CE supplied-air respirators.
RCT-ASR-STP-0120--Determination of positive      75
 pressure--open-circuit, pressure-demand self-
 contained breathing apparatus.
RCT-ASR-STP-0121--Determination of rated         75
 service time--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0121A--Determination of rated        75
 service time--closed-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0122--Determination of exhalation    150
 breathing resistance--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0123--Determination of gas flow      150
 measurements--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0124--Determination of remaining     150
 service-life indicator--open-circuit, demand
 and pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0124A--Determination of alarm        150
 pressure--closed-circuit, demand and pressure-
 demand, self-contained breathing apparatus.
RCT-ASR-STP-0125--Determination of gas           750
 tightness--isoamyl acetate (IAA)--self-
 contained breathing apparatus with facepieces
 and mouthpieces.
RCT-ASR-STP-0125A--Determination of gas          750
 tightness--isoamyl acetate (IAA)--self-
 contained breathing apparatus with hoods or
 helmets.
RCT-ASR-STP-0126--Determination of by-pass       150
 valve flow--open-circuit, demand and pressure-
 demand, self-contained breathing apparatus.
RCT-ASR-STP-0127--Determination of by-pass       150
 valve flow--closed-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0128--Determination of accuracy of   150
 gauge--self-contained breathing apparatus.
RCT-ASR-STP-0132--Determination of inhalation    150
 breathing resistance--open-circuit, demand,
 self-contained breathing apparatus.
RCT-ASR-STP-0133--Determination of exhalation    150
 breathing resistance--open-circuit, pressure-
 demand, self-contained breathing apparatus
 using two second stage regulators.
RCT-ASR-STP-0134--Determination of gasoline      750
 permeation test on breathing bags--closed-
 circuit, self-contained breathing apparatus.
RCT-ASR-STP-0135--Determination of inhalation    150
 and exhalation breathing resistance--closed-
 circuit, demand and pressure-demand, self-
 contained breathing apparatus.
RCT-ASR-STP-0136--Determination of demand gas    150
 flow--closed-circuit, demand and pressure-
 demand, self-contained breathing apparatus.
RCT-ASR-STP-0137--Determination of continuous    450
 gas flow on constant flow with demand flow--
 closed-circuit, self-contained breathing
 apparatus.
RCT-ASR-STP-0138--Determination of safety        150
 relief valve operation--closed-circuit, demand
 and pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0139--Determination of facepiece     450
 carbon dioxide concentrations--self-contained
 breathing apparatus.
RCT-ASR-STP-0140--Man tests--self-contained      3,000
 breathing apparatus.
RCT-ASR-STP-0141--Man test number 5--closed-     150
 circuit, self-contained breathing apparatus.
RCT-ASR-STP-0142--Determination of vibration     750
 (Ro-Tap test) for man test number 1--escape,
 closed-circuit, demand, self-contained
 breathing apparatus.
RCT-ASR-STP-0143--Determination of low-          1,200
 temperature operation--minimum per
 manufacturer--closed-circuit, self-contained
 breathing apparatus.
RCT-ASR-STP-0144--Determination of continuous    300
 gas flow on constant flow--closed-circuit,
 self-contained breathing apparatus.
RCT-ASR-STP-0145--Determination of sound level   750
 measurements for remaining service-life
 indicators--self-contained breathing apparatus.
RCT-ASR-STP-0146--Determination of diaphragm     300
 over-pressurization--open-circuit, self-
 contained breathing apparatus with belt
 mounted regulators and breathing tubes.
RCT-ASR-STP-0147--Determination of mode          150
 transfer test--combination, open-circuit self-
 contained breathing apparatus and supplied-air
 respirators (SCBA/SAR).

[[Page 687]]

 
RCT-ASR-STP-0148--Determination of remote gauge  150
 leak-flow test--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0148A--Determination of remote       150
 gauge leak-flow test--closed-circuit, demand
 and pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0155--Man test number 6--self-       2,400
 contained breathing apparatus using liquefied
 gas.
------------------------------------------------------------------------
 Chemical, Biological, Radiologic, Nuclear (CBRN) Air-Purifying and Air-
                          Supplied Respirators
------------------------------------------------------------------------
NIOSH/NPPTL administrative support for all CBRN  1,300
 projects.
 RCT-CBRN-STP-0200, 0201--Determination of      6,000
 open-circuit self-contained breathing
 apparatus (SCBA) performance during dynamic
 testing against chemical agents of sarin (GB)
 vapor and distilled sulfur mustard (HD) vapor
 and liquid--GB live agent testing.
 RCT-CBRN-STP-0200, 0201--Determination of      6,000
 open-circuit self-contained breathing
 apparatus (SCBA) performance during dynamic
 testing against chemical agents sarin (GB)
 vapor and of distilled sulfur mustard (HD)
 vapor and liquid--HD live agent testing.
 RCT-CBRN-STP-0200, 0201--aerosol process TDA-  600
 99M only.
CET-APRS-STP-CBRN-0301--Determination of CBRN    1,000
 organic vapor (cyclohexane) service-life test.
CET-APRS-STP-CBRN-0302--Determination of CBRN    2,400
 acid gases (cyanogen chloride) service-life
 test.
CET-APRS-STP-CBRN-0303--Determination of CBRN    2,400
 acid gases (hydrogen cyanide) service-life
 test.
CET-APRS-STP-CBRN-0304--Determination of CBRN    1,400
 acid gases (phosgene) service-life test.
CET-APS-STP-CBRN-0305--Determination of CBRN     800
 acid gases (hydrogen sulfide) service-life
 test.
CET-APRS-STP-CBRN-0306--Determination of CBRN    800
 acid gases (sulfur dioxide) service-life test.
CET-APRS-STP-CBRN-0307--Determination of CBRN    1,000
 acid gases (ammonia) service-life test.
CET-APRS-STP-CBRN-0308--Determination of CBRN    1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test.
CET-APRS-STP-CBRN-0309--Determination of CBRN    1,000
 hydride gases (phosphine) service-life test.
CET-APRS-STP-CBRN-0310--Determination of CBRN    1,000
 formaldehyde service-life test, air-purifying
 respirators.
CET-APRS-STP-CBRN-0311--Laboratory durability    20,000
 conditioning process for environmental,
 transportation and rough handling use
 conditions on chemical, biological,
 radiological, and nuclear (CBRN) respiratory
 protective devices (RPD) standard conditioning
 procedure (SCP)--US Army Research Development
 and Engineering Command (RDECOM) environmental
 conditioning.
CET-APRS-STP-CBRN-0311--NPPTL environmental      16,000
 conditioning.
CET-APRS-STP-CBRN-0311--RDECOM modified          16,000
 environmental conditioning--minus 125
 canisters.
CET-APRS-STP-CBRN-0311--NPPTL modified           8,000
 environmental conditioning--minus 125
 canisters.
CET-APRS-STP-CBRN-0312--Determination of field   1,000
 of view for full facepiece chemical biological
 radiological nuclear (CBRN) respiratory
 protective devices (RPD).
TEB-CBRN-APR-STP-0313--Determination of          5,000
 communication performance test for speech
 conveyance and intelligibility of chemical
 biological radiological and nuclear (CBRN)
 full-facepiece air-purifying respirator.
CET-APRS-STP-CBRN-0314--Determination of lens    3,000
 fogging on full facepiece chemical biological
 radiological nuclear (CBRN) air-purifying
 respirator.
CET-APRS-STP-CBRN-0316--Determination of haze,   2,000
 luminous-transmittance, and abrasion-
 resistance properties of the primary lens
 system material for full-facepiece respiratory
 protective devices (RPD).
 RCT-CBRN-APR-STP-0350--Determination of full   7,000
 facepiece, tight-fitting, negative-pressure,
 air-purifying respirator (APR) performance
 during dynamic testing against the chemical
 agent vapor sarin (GB)--qualifier live agent
 testing (QLAT) only.
 RCT-CBRN-APR-STP-0350--remainder live agent    6,000
 testing (RLAT).
 RCT-CBRN-APR-STP-0351--Determination of full-  7,000
 facepiece, tight-fitting, negative-pressure,
 air-purifying respirator (APR) performance
 during dynamic testing against chemical agent
 distilled sulfur mustard (HD) vapor and liquid
 CBRN--qualifier live agent testing (QLAT) only.
 RCT-CBRN-APR-STP-0351--remainder live agent    6,000
 testing (RLAT).
 RCT-CBRN-APR-STP-0350 and RCT-CBRN-APR-STP-    600
 0351--aerosol process TDA-99M.
TEB-CBRN-APR-STP-0352--Determination of          20,000
 laboratory respirator protection level (LRPL)
 values for CBRN self-contained breathing
 apparatus (SCBA) facepieces or CBRN air-
 purifying respirator (APR)--LRPL.
TEB-CBRN-APR-STP-0352--partial laboratory        16,000
 respirator protection level (LRPL) (in cases
 where failure occurs with less than 50% of
 subjects tested).
* TEB-CBRN-APR-STP-0353--Weight and diameter...  200
CET-APRS-STP-CBRN-0401--Determination of CBRN    1,000
 organic vapor (cyclohexane) service-life test,
 air-purifying escape respirators.
CET-APRS-STP-CBRN-0402--Determination of CBRN    2,400
 acid gases (cyanogen chloride) service-life
 test, air-purifying escape respirators.
CET-APRS-STP-CBRN-0403--Determination of CBRN    2,400
 acid gases (hydrogen cyanide) service-life
 test, air-purifying escape respirators.
CET-APRS-STP-CBRN-0404--Determination of CBRN    1,400
 acid gases (phosgene) service-life test, air-
 purifying escape respirators.
CET-APRS-STP-CBRN-0405--Determination of CBRN    800
 acid gases (hydrogen sulfide) service-life
 test, air-purifying escape respirators.
CET-APRS-STP-CBRN-0406--Determination of CBRN    800
 acid gases (sulfur dioxide) service-life test,
 air-purifying escape respirators.
CET-APRS-STP-CBRN-0407--Determination of CBRN    1,000
 base gases (ammonia) service-life test, air-
 purifying escape respirators.

[[Page 688]]

 
CET-APRS-STP-CBRN-0408--Determination of CBRN    1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test, air-purifying escape
 respirators.
CET-APRS-STP-CBRN-0409--Determination of CBRN    1,000
 hydride gases (phosphine) service-life test,
 air-purifying escape respirators.
CET-APRS-STP-CBRN-0410--Determination of CBRN    1,000
 formaldehyde service-life test, air-purifying
 escape respirators.
CET-APRS-STP-CBRN-0411--Laboratory durability    22,000
 conditioning process for environmental,
 transportation and rough handling use
 conditions on chemical, biological,
 radiological and nuclear (CBRN) (air-purifying
 or self-contained) escape respirator--RDECOM
 environmental conditioning.
CET-APRS-STP-CBRN-0411--NPPTL environmental      20,000
 conditioning.
*  CET-APRS-STP-CBRN-0414--Fogging.............  4,000
*  CET-APRS-STP-CBRN-0417--Flammability, heat    14,000
 resistance.
 CET-APRS-STP-CBRN-0450--Determination of       7,000
 chemical agent permeation and penetration
 resistance performance against sarin (GB)
 vapor of chemical, biological, radiological,
 and nuclear (CBRN) air-purifying escape
 respirator--qualifier live agent testing
 (QLAT) only.
 CET-APRS-STP-CBRN-0450--remainder live agent   6,000
 testing (RLAT).
 CET-APRS-STP-CBRN-0451--Determination of       7,000
 chemical agent permeation and penetration
 resistance performance against sulfur mustard
 (HD) liquid and vapor of the chemical,
 biological, radiological, and nuclear (CBRN)
 air-purifying escape respirator--qualifier
 live agent testing (QLAT) only.
 CET-APRS-STP-CBRN-0451--remainder live agent   6,000
 testing (RLAT).
 CET-APRS-STP-CBRN-0450 and CET-APRS-STP-CBRN-  600
 0451--aerosol process TDA-99M.
TEB-CBRN-APR-STP-0452--Determination of          20,000
 laboratory respirator protection level (LRPL)
 values for CBRN air-purifying escape
 respirator--LRPL.
TEB-CBRN-APR-STP-0452--partial LRPL............  16,000
CET-APRS-STP-CBRN-0454--Determination of human   3,500
 subject breathing gas (HSBG) concentrations
 (carbon dioxide and oxygen) for chemical,
 biological, radiological and nuclear (CBRN)
 air-purifying escape respirator.
* CET-APRS-STP-CBRN-0455--Human subject          6,000
 breathing gas test.
CET-APRS-STP-CBRN-0456--Determination of         (\1\)
 practical performance level for chemical,
 biological, radiological and nuclear (CBRN)
 (air-purifying or self-contained) escape
 respirator.
CET-APRS-STP-CBRN-0499--Determination of         ( \1\)
 donning effectiveness of chemical, biological,
 radiological and nuclear (CBRN) (air-purifying
 or self-contained) escape respirator.
TEB-CBRN-STP-0501--Determination of CBRN         1,000
 organic vapor (cyclohexane) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0502--Determination of CBRN acid    2,400
 gases (cyanogen chloride) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0503--Determination of CBRN acid    2,400
 gases (hydrogen cyanide) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0504--Determination of CBRN acid    1,400
 gases (phosgene) service-life test, tight-
 fitting powered air-purifying respirators
 (PAPR).
TEB-CBRN-STP-0505--Determination of CBRN acid    800
 gases (hydrogen sulfide) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0506--Determination of CBRN acid    800
 gases (sulfur dioxide) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0507--Determination of CBRN base    1,000
 gases (ammonia) service-life test, tight-
 fitting powered air-purifying respirators
 (PAPR).
TEB-CBRN-STP-0508--Determination of CBRN         1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test, tight-fitting powered air-
 purifying respirators (PAPR).
TEB-CBRN-STP-0509--Determination of CBRN         1,000
 hydride gases (phosphine) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0510--Determination of CBRN         1,000
 formaldehyde service-life test, tight-fitting
 powered air-purifying respirators (PAPR).
TEB-APR-STP-0511-CBRN--Determination of CBRN     1,000
 organic vapor (cyclohexane) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0512-CBRN--Determination of CBRN     2,400
 acid gases (cyanogen chloride) service-life
 test, loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0513-CBRN--Determination of CBRN     2,400
 acid gases (hydrogen cyanide) service-life
 test, loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0514-CBRN--Determination of CBRN     1,400
 acid gases (phosgene) service-life test, loose-
 fitting powered air-purifying respirators
 (PAPR).
TEB-APR-0515-CBRN--Determination of CBRN acid    800
 gases (hydrogen sulfide) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0516-CBRN--Determination of CBRN     800
 acid gases (sulfur dioxide) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0517-CBRN--Determination of CBRN     1,000
 base gases (ammonia) service-life test, loose-
 fitting powered air-purifying respirators
 (PAPR).
TEB-APR-STP-0518-CBRN--Determination of CBRN     1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test, loose-fitting powered air-
 purifying respirators (PAPR).
TEB-APR-STP-0519-CBRN--Determination of CBRN     1,000
 hydride gases (phosphine) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0520-CBRN--Determination of CBRN     1,000
 formaldehyde service-life test, loose-fitting
 powered air-purifying respirators (PAPR).

[[Page 689]]

 
NPPTL-STP-CBRN-PAPR-0550--Determination of CBRN  7,000
 powered air-purifying respirator (PAPR)
 performance during dynamic testing against the
 chemical agent vapor sarin (GB) chemical,
 biological, radiological and nuclear (CBRN)
 standard testing procedure (STP).
NPPTL-STP-CBRN-PAPR-0551--Determination of       7,000
 CBRN, powered air-purifying respirator (PAPR)
 performance during dynamic testing against
 chemical agent distilled sulfur mustard (HD)
 vapor and distilled sulfur mustard (HD) liquid
 chemical, biological, radiological, and
 nuclear (CBRN) standard testing procedure
 (STP).
TEB-CBRN-APR-STP-0552--Determination of          20,000
 laboratory respirator protection level (LRPL)
 values for CBRN tight-fitting powered air-
 purifying respirator (PAPR).
TEB-CBRN-APR-STP-0553--Determination of          20,000
 laboratory respiratory protection level (LRPL)
 values for CBRN loose-fitting powered air-
 purifying respirator (PAPR).
------------------------------------------------------------------------
                        New and Unspecified Tests
------------------------------------------------------------------------
This category is to be used for new, on-going,   (\2\)
 tests which are developed between revisions of
 the test fee schedule or for special, one-time
 tests which are required for respirators with
 unique features (per 42 CFR 84.63).
------------------------------------------------------------------------
* Draft test procedure in place, but final STP has not been published.
 Test is conducted by U.S. Army Research, Development and Engineering
  Command Edgewood Chemical Biological Center (ECBC).
\1\ No Fee, done as part of LRPL (TEB-CBRN-APR-STP-0452).
\2\ $500/day + the actual cost of non-NPPTL staff (typically medical
  staff and test subjects).


[80 FR 3908, Jan. 26, 2015]



PART 85_REQUESTS FOR HEALTH HAZARD EVALUATIONS--Table of Contents



Sec.
85.1 Applicability.
85.2 Definitions.
85.3 Procedures for requesting health hazard evaluations.
85.3-1 Contents of a request for health hazard evaluations.
85.4 Acting on requests.
85.5 Authority for investigations.
85.6 Advance notice of visits.
85.7 Conduct of investigations.
85.8 Provision of suitable space for employee interviews and 
          examinations; identification of employees.
85.9 Representatives of employers and employees; employee requests.
85.10 Imminent dangers.
85.11 Notification of determination to employers, affected employees, 
          and Department of Labor.
85.12 Subsequent requests for health hazard evaluations.

    Authority: Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec. 508, 
83 Stat. 803; 30 U.S.C. 957.

    Source: 37 FR 23640, Nov. 7, 1972, unless otherwise noted.



Sec.  85.1  Applicability.

    This part 85 applies to health hazard evaluations requested by any 
employer or authorized representative of employees under section 
20(a)(6) of the Occupational Safety and Health Act of 1970 or section 
501(a)(11) of the Federal Mine Safety and Health Act of 1977. This part 
is not intended to preclude the use of other channels of communication 
with the National Institute for Occupational Safety and Health to obtain 
information and technical assistance concerning toxic substances or 
physical agents.

[45 FR 2652, Jan. 14, 1980]



Sec.  85.2  Definitions.

    Any term defined in the Occupational Safety and Health Act of 1970 
or the Federal Mine Safety and Health Act of 1977 and not defined below 
shall have the meaning given it in the respective Acts. As used in this 
part:
    OSH Act means the Occupational Safety and Health Act of 1970 (29 
U.S.C. 651, et seq.).
    FMSH Act means the Federal Mine Safety and Health Act of 1977 (30 
U.S.C. 801, et seq.).
    Authorized representative of employees means any person or 
organization meeting the conditions specified in Sec.  85.3-1(e) (1), 
(2), or (3).
    Employee has the same meaning as stated in the OSH Act and for the 
purposes of this part includes miner as defined in the FMSH Act.
    Employer has the same meaning as stated in the OSH Act and for the 
purposes of this part includes Operator as defined in the FMSH Act.

[[Page 690]]

    Health hazard evaluation means the investigation and the 
determination of potentially toxic or hazardous effects of: (a) Any 
substance normally used or found in any place of employment to which the 
OSH Act is applicable, or (b) any substance or physical agent normally 
used or found in any place of employment to which the FMSH Act is 
applicable.
    Investigation means a physical inspection of the place of employment 
under section 8 of the OSH Act or section 103 of the FMSH Act and 
includes inspection, sampling, observations, review of pertinent 
records, and other measurements reasonably necessary to determine 
whether any substance or physical agent found in the place of employment 
has potentially toxic or hazardous effects in the concentrations or 
levels used or found.
    NIOSH means the National Institute for Occupational Safety and 
Health, Center for Disease Control, Public Health Service, Department of 
Health and Human Services.
    NIOSH officer means a NIOSH employee who has been authorized by the 
Director, NIOSH, to conduct investigations according to this part.
    Physical agent means any condition produced by the environment and/
or work processes that can result in hazardous effects as defined in 
this section. Examples of physical agents are noise, temperature, 
illumination, vibration, radiation, and pressure.
    Place of employment means any coal or other mine, factory, plant, 
establishment, construction site, or other area, workplace, or 
environment where work is performed by any employee of an employer.
    Substance means any chemical or biological agent or dust which has 
the potential to produce toxic effects.
    Toxic effects or hazardous effects are those effects which result in 
short- or long-term disease, bodily injury, affect health adversely, or 
endanger human life.

[45 FR 2652, Jan. 14, 1980]



Sec.  85.3  Procedures for requesting health hazard evaluations.

    (a) Requests for health hazard evaluations should be addressed to 
the National Institute for Occupational Safety and Health as follows:
    (1) Requests from general industry. Hazard Evaluations and Technical 
Assistance Branch, Division of Surveillance, Hazard Evaluations, and 
Field Studies, NIOSH, 4676 Columbia Parkway, Cincinnati, OH 45226.
    (2) Requests from mining industry. Environmental Investigations 
Branch, Division of Respiratory Disease Studies, NIOSH, 944 Chestnut 
Ridge Road, Morgantown, WV 26505.
    (b) Requests for health hazard evaluations shall be submitted in 
writing and signed by either: (1) The employer in whose place of 
employment the substance or physical agent is normally found, or (2) an 
authorized representative of employees (see Sec.  85.3-1(e)) in the 
place of employment where the substance or physical agent is normally 
found.

[45 FR 2653, Jan. 14, 1980]



Sec.  85.3-1  Contents of a request for health hazard evaluation.

    Each request for health hazard evaluation shall contain:
    (a) The requester's name, address, and telephone number, if any.
    (b) The name and address of the place of employment where the 
substance or physical agent is normally found.
    (c) The specific process or type of work which is the source of the 
substance or physical agent, or in which the substance or physical agent 
is used.
    (d) Details of the conditions or circumstances which prompted the 
request.
    (e) A statement, if the requester is not the employer, that the 
requester is:
    (1) An authorized representative or an officer of the organization 
representing the employees for purposes of collective bargaining; or
    (2) An employee of the employer and is authorized by two or more 
employees employed in the same place of employment to represent them for 
purposes of these Acts (each such authorization shall be in writing and 
a copy submitted with the request for health hazard evaluation); or
    (3) One of three or less employees employed in the place of 
employment where the substance or physical agent is normally found.

[[Page 691]]

    (f) A statement indicating whether or not the name(s) of the 
requester or those persons who have authorized the requester to 
represent them may be revealed to the employer by NIOSH.
    (g) The following supplementary information if known to the 
requester:
    (1) Identity of each substance or physical agent involved;
    (2) The trade name, chemical name, and manufacturer of each 
substance involved;
    (3) Whether the substance or its container or the source of the 
physical agent has a warning label; and
    (4) The physical form of the substance or physical agent, number of 
people exposed, length of exposure (hours per day), and occupations of 
exposed employees.

    Note: NIOSH has developed two forms entitled ``Request for Health 
Hazard Evaluation'' and ``Request for Mining Health Hazard Evaluation'' 
to assist persons in requesting evaluations. The forms are available 
upon request from the offices listed in Sec.  85.3(a) (1) and (2) or 
from the Regional Consultant for Occupational Safety and Health in any 
Regional Office of the Department of Health and Human Services.

[45 FR 2653, Jan. 14, 1980]



Sec.  85.4  Acting on requests.

    (a) Upon receipt of a request for health hazard evaluation submitted 
under this part, NIOSH will determine whether or not there is reasonable 
cause to justify conducting an investigation.
    (b) If NIOSH determines that an investigation is justified, a NIOSH 
officer will inspect the place of employment, collect samples where 
appropriate, and perform tests necessary to the conduct of a health 
hazard evaluation, including medical examinations of employees.
    (c) If NIOSH determines that an investigation is not justified, the 
requester will be notified in writing of the decision.

[45 FR 2653, Jan. 14, 1980]



Sec.  85.5  Authority for investigations.

    (a) NIOSH officers who have been issued official NIOSH credentials 
(Form No. CDC/NIOSH 2.93) are authorized by the Director, NIOSH, under 
sections 20(a) (6) and 8 of the OSH Act and sections 501(a)(11) and 103 
of the FMSH Act: To enter without delay any place of employment for the 
purpose of conducting investigations of all pertinent processes, 
conditions, structures, machines, apparatus, devices, equipment, 
records, and materials within the place of employment; and to conduct 
medical examinations, anthropometric measurements, and functional tests 
of employees within the place of employment as may be directly related 
to the specific health hazard evaluation being conducted. Investigations 
will be conducted in a reasonable manner, during regular working hours 
or at other reasonable times and within reasonable limits. In connection 
with any investigation, the NIOSH officers may question privately any 
employer, owner, operator, agent, or employee from the place of 
employment; and review, abstract, and duplicate records required by the 
Acts and regulations and any other related records.
    (b) Areas under investigation which contain information classified 
by any agency of the United States Government in the interest of 
national security will be investigated only by NIOSH officers who have 
obtained the proper security clearance and authorization.

[45 FR 2653, Jan. 14, 1980]



Sec.  85.6  Advance notice of visits.

    (a) Advance notice of visits to the place of employment may be given 
to expedite a thorough and effective investigation. Advance notice will 
not be given when, in the judgment of the NIOSH officer, giving such 
notice would adversely affect the validity and effectiveness of the 
investigation.
    (b) Where a request in accordance with this part has been made by an 
authorized representative of employees, advance notice in accordance 
with paragraph (a) of this section will be given by NIOSH to the 
requester, the representative of the employees for purposes of 
collective bargaining if such representative is other than the 
requester, and to the employer.
    (c) Where a request in accordance with this part has been made by 
any employer, advance notice will be given by NIOSH to the employer. 
Upon the

[[Page 692]]

request of the employer, NIOSH will inform the authorized representative 
of employees of the visit: Provided, The employer furnishes NIOSH in 
writing with the identity of such representative and with such 
information as is necessary to enable NIOSH promptly to inform such 
representative of the visit.



Sec.  85.7  Conduct of investigations.

    (a) Prior to beginning an investigation, NIOSH officers shall 
present their credentials to the owner, operator, or agent in charge at 
the place of employment, explain the nature, purpose, and scope of the 
investigation and the records specified in Sec.  85.5 which they wish to 
review. Where the investigation is the result of a request submitted by 
an authorized representative of employees, a copy of the request shall 
be provided to the employer, except where the requester or any person 
authorizing the requester pursuant to Sec.  85.3-1(e)(2) has indicated 
that NIOSH not reveal his name to the employer, in which case a summary 
of the basis for the request shall be provided to the employer.
    (b) At the commencement of an investigation, the employer should 
precisely identify information which can be obtained in the workplace or 
workplaces to be inspected as trade secrets. If the NIOSH officer has no 
clear reason to question such identification, such information shall not 
be disclosed except in accordance with the provisions of section 
20(a)(6) and section 15 of the OSH Act or section 501(a)(11) of the FMSH 
Act. However, if NIOSH at any time questions such identification by an 
employer, not less than 15 days' notice to an employer shall be given of 
the intention to remove the trade secret designation from such 
information. The employer may within that period submit a request to the 
Director, NIOSH, to reconsider this intention and may provide additional 
information in support of the trade secret designation. The Director, 
NIOSH, shall notify the employer in writing of the decision which will 
become effective no sooner than 15 days after the date of such notice.
    (c) NIOSH officers are authorized to collect environmental samples 
and samples of substances or measurements of physical agents (including 
measurement of employee exposure by the attachment of personal sampling 
devices to employees with their consent), to take or obtain photographs 
related to the purpose of the investigation, employ other reasonable 
investigative techniques, including medical examinations of employees 
with the consent of such employees, and to question privately any 
employer, owner, operator, agent, or employee. The employer shall have 
the opportunity to review photographs taken or obtained for the purpose 
of identifying those which contain or might reveal a trade secret.
    (d) NIOSH officers shall comply with all safety and health rules and 
practices at the place of employment being investigated, and they shall 
provide and use appropriate protective clothing and equipment. In 
situations requiring specialized or unique types of protective 
equipment, such equipment shall be furnished by the employer.
    (e) The conduct of investigations shall be such as to preclude 
unreasonable disruption of the operations of the employer's 
establishment.

[37 FR 23640, Nov. 7, 1972, as amended at 45 FR 2653, Jan. 14, 1980; 49 
FR 4739, Feb. 8, 1984]



Sec.  85.8  Provision of suitable space for employee interviews 
and examinations; identification of employees.

    An employer shall, in request of the NIOSH officer, provide suitable 
space, if such space is reasonably available, to NIOSH to conduct 
private interviews with, and examinations of, employees. NIOSH officers 
shall consult with the employer as to the time and place of the medical 
examination and shall schedule such examinations so as to avoid undue 
disruption of the operations of the employer's establishment. NIOSH 
shall conduct, and assume the medical costs of, examinations conducted 
under this part.



Sec.  85.9  Representatives of employers and employees; employee requests.

    (a) NIOSH officers shall be in charge of investigations. Where the 
request for a health hazard evaluation has been made by an authorized 
representative of employees, a representative of the

[[Page 693]]

employer and a representative authorized by his employees who is an 
employee of the employer shall be given an opportunity to accompany the 
NIOSH officer during the initial physical inspection of any workplace 
for the purpose of aiding the investigation by identifying the suspected 
hazard. The NIOSH officer may permit additional employer representatives 
and such additional representatives authorized by employees to accompany 
him where he determines that such additional representatives will 
further aid the investigation. However, if in the judgment of the NIOSH 
officer, good cause has been shown why accompaniment by a third party 
who is not an employee of the employer is reasonably necessary to the 
conduct of an effective and thorough investigation of the workplace, 
such third party may accompany the NIOSH officer during the inspection: 
Provided, however, That access by such persons to areas described in 
paragraph (d) of this section shall be in accordance with the 
requirements of such provision, and access to areas described in 
paragraph (e) of this section shall be with the consent of the employer. 
A different employer and employee representative may accompany the 
officer during each different phase of an inspection if this will not 
interfere with the conduct of the investigation.
    (b) NIOSH officers are authorized to resolve all disputes as to who 
is the representative authorized by the employer and employees for the 
purpose of this section. If there is no authorized representative of 
employees, or if the NIOSH officer is unable to determine with 
reasonable certainty who is such representative, he shall consult with a 
reasonable number of employees concerning matters directly related to 
the health hazard evaluation.
    (c) NIOSH officers are authorized to deny the right of accompaniment 
under this section to any person whose conduct interferes with a fair 
and orderly physical inspection.
    (d) With regard to information classified by an agency of the U.S. 
Government in the interest of national security, only persons authorized 
to have access to such information may accompany an officer in areas 
containing such information.
    (e) Upon request of an employer, any representative authorized under 
this Sec.  85.9 by employees in any area containing trade secrets shall 
be an employee in that area or an employee authorized by the employer to 
enter that area.



Sec.  85.10  Imminent dangers.

    Whenever, during the course of, or as a result of, an investigation 
under this part, the NIOSH officer believes that there is a reasonable 
basis for an allegation of an imminent danger, NIOSH will immediately 
advise the employer and those employees who appear to be in immediate 
danger of such allegation and will inform appropriate representatives of 
the Department of Labor or the State agency designated under section 
18(b) of the OSH Act.

[37 FR 23640, Nov. 7, 1972, as amended at 45 FR 2653, Jan. 14, 1980]



Sec.  85.11  Notification of determination to employers, affected employees 
and Department of Labor.

    (a) Upon conclusion of an investigation, NIOSH will make a 
determination concerning the potentially toxic or hazardous effects of 
each substance or physical agent investigated as a result of the request 
for health hazard evaluation. At a minimum, the determination will: (1) 
Identify each substance or physical agent involved and describe, where 
appropriate, the concentrations or levels of the substance or physical 
agent found in the place of employment and the conditions of use, and 
(2) state whether each substance or physical agent has potentially toxic 
or hazardous effects in the concentrations or levels found, as well as 
the basis for the judgments.
    (b) Copies of the determination will be mailed to the employer and 
to the authorized representatives of employees.
    (c) Except as hereinafter provided, the employer shall post a copy 
of the determination for a period of 30 calendar days at or near the 
workplace(s) of affected employees. The employer shall take steps to 
insure that the posted determinations are not altered, defaced, or 
covered by other material

[[Page 694]]

during such period. The employer will not be required to post the 
determination if the employer requests that copies of the determination 
be mailed to affected employees and furnishes NIOSH with a list of the 
names and mailing addresses of the employees employed in the 
workplace(s) designated by the NIOSH Officer. In the latter event, NIOSH 
will mail such copies to affected employees at the mailing addresses 
provided by the employer.
    (d) For purposes of this section, the term ``affected employees'' 
means those employees determined by NIOSH to be exposed to the 
substance(s) or physical agent(s) which is the subject of the health 
hazard evaluation.
    (e) Copies of determinations made under the OSH Act will be 
forwarded to the Department of Labor and the appropriate State agency 
designated under section 18(b) of the OSH Act. Copies of determinations 
made under the FMSH Act will be forwarded to the Mine Safety and Health 
Administration of the Department of Labor; the Bureau of Mines, 
Department of the Interior; and the State agency which, in the judgment 
of NIOSH, would benefit the most from the information. If NIOSH 
determines that any substance or physical agent has potentially toxic or 
hazardous effects at the concentrations or levels at which it is used or 
found in a place of employment, and the substance or physical agent is 
not covered by a safety or health standard established under section 6 
of the OSH Act or section 101 of the FMSH Act, NIOSH will immediately 
submit the determination to the Secretary of Labor, together with all 
pertinent criteria.

[37 FR 23640, Nov. 7, 1972, as amended at 45 FR 2653, Jan. 14, 1980]



Sec.  85.12  Subsequent requests for health hazard evaluations.

    If a request is received for a health hazard evaluation in a place 
of employment in which an evaluation under this part was made 
previously, NIOSH may make another investigation if, as a result of the 
passage of time or additional information, another investigation would 
be consistent with the purposes of the Acts.

[45 FR 2654, Jan. 14, 1980]



PART 85a_OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS 
OF PLACES OF EMPLOYMENT--Table of Contents



Sec.
85a.1 Applicability.
85a.2 Definitions.
85a.3 Authority for investigations of places of employment.
85a.4 Procedures for initiating investigations of places of employment.
85a.5 Conduct of investigations of places of employment.
85a.6 Provision of suitable space for employee interviews and 
          examinations.
85a.7 Imminent dangers.
85a.8 Reporting of results of investigations of places of employment.

    Authority: Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec. 508, 
83 Stat. 803; 30 U.S.C. 957.



Sec.  85a.1  Applicability.

    (a) Except as otherwise provided in paragraph (b) of this section, 
the provisions of this part apply to investigations of places of 
employment which are conducted by NIOSH under sections 20 and 8 of the 
Occupational Safety and Health Act of 1970 and sections 501 and 103 of 
the Federal Mine Safety and Health Act of 1977.
    (b) The provisions of this part do not apply to those activities 
covered by part 85 of this chapter.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980]



Sec.  85a.2  Definitions.

    Any term defined in the Occupational Safety and Health Act of 1970 
or the Federal Mine Safety and Health Act of 1977 and not defined below 
shall have the meaning given it in the Acts. As used in this part:
    Assistant Regional Director means any one of the ten Occupational 
Safety and Health Administration Assistant Regional Directors for 
Occupational Safety and Health.
    Employee has the same meaning as stated in the OSH Act and for the 
purposes of this part includes miner as defined in the FMSH Act.

[[Page 695]]

    Employer has the same meaning as stated in the OSH Act and for the 
purposes of this part includes operator as defined in the FMSH Act.
    FMSH Act means the Federal Mine Safety and Health Act of 1977 (30 
U.S.C. 801 et seq.).
    Informed consent means the knowing consent of an individual or his 
legally authorized representative, so situated as to be able to exercise 
free power of choice without undue inducement or any element of force, 
fraud, deceit, duress, or other form of constraint or coercion. The 
basic elements of information necessary to such consent include:
    (1) A fair explanation of the procedures to be followed, and their 
purposes, including identification of any procedures which are 
experimental;
    (2) A description of any attendant discomforts and risks reasonably 
to be expected;
    (3) A description of any benefits reasonably to be expected;
    (4) A disclosure of any appropriate alternative procedures that 
might be advantageous for the subject;
    (5) An offer to answer any inquiries concerning the procedures; and
    (6) An instruction that the person is free to withdraw his consent 
and to discontinue participation in the investigation any time without 
prejudice to the subject.
    Investigation means research projects, experiments, demonstrations, 
studies, and similar activities of NIOSH which are conducted under 
section 20 of the OSH Act and section 501 of the FMSH Act.
    Legally authorized representative means an individual or judicial or 
other body authorized under applicable law to consent on behalf of a 
prospective subject to such subject's participation in the particular 
activity or procedure.
    MSHA District Office means any one of the Mine Safety and Health 
Administration's District Offices.
    NIOSH means the National Institute for Occupational Safety and 
Health of the Centers for Disease Control and Prevention, Department of 
Health and Human Services.
    NIOSH authorized representative means a person authorized by NIOSH 
to conduct investigations of places of employment, including any person 
that is fulfilling a contract agreement with NIOSH or is serving as an 
expert or consultant to NIOSH pursuant to the Act.
    OSH Act means the Occupational Safety and Health Act of 1970 (29 
U.S.C. 651 et seq.).
    Place of employment means any coal or other mine, factory, plant, 
establishment, construction site, or other area, workplace or 
environment where work is performed by any employee of an employer.

[79 FR 2792, Jan. 16, 2014]



Sec.  85a.3  Authority for investigations of places of employment.

    (a) NIOSH authorized representatives who have been issued official 
NIOSH credentials are authorized by the Director, NIOSH, under sections 
20 and 8 of the OSH Act, sections 501 and 103 of the FMSH Act, and this 
part. To enter without delay any place of employment for the purpose of 
conducting investigations of all pertinent processes, conditions, 
structures, machines, apparatus, devices, equipment, and materials 
within the place of employment; and to conduct medical examinations, 
anthropometric measurements and functional tests of employees within the 
place of employment as may be directly related to the specific 
investigation being conducted. Such investigations will be conducted in 
a reasonable manner, during regular working hours or at other reasonable 
times and within reasonable limits. In connection with any 
investigations, such NIOSH authorized representatives may question 
privately any employer, owner, operator, agent, or employee from the 
place of employment; and review, abstract, or duplicate employment 
records, medical records, records required by the Act and regulations, 
and other related records. In those instances where systems of records 
subject to review, abstraction or duplication are of a confidential 
nature, such as medical records, and are abstracted or duplicated, NIOSH 
will maintain such systems in accordance with the Privacy Act of 1974 (5 
U.S.C. 552a) and the implementing regulation of the Department of Health 
and Human Services (45 CFR part 5b).

[[Page 696]]

    (b) Areas under investigation which contain information classified 
by any agency of the United States Government in the interest of 
national security will be investigated only by NIOSH authorized 
representatives who have obtained the appropriate security clearance and 
authorization.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980]



Sec.  85a.4  Procedures for initiating investigations of places of employment.

    (a) Except as otherwise provided in paragraph (b) of this section, 
NIOSH authorized representatives will contact an official representative 
of the place of employment prior to any site visits and will provide the 
details of why an investigation of the place of employment is being 
conducted. Prior to the initiation of a site visit of a place of 
employment, representatives of the following organizations will be 
advised of the site visit and the reason for its conduct:
    (1) The appropriate State agency designated under section 18(b) of 
the OSH Act, or if no State agency has been designated under the OSH Act 
and in the case of the FMSH Act, the State agency which, in the judgment 
of NIOSH, would benefit the most from the investigation's findings;
    (2) The local union at the place of employment, if any;
    (3) The appropriate Assistant Regional Director, when investigations 
are conducted under the OSH Act;
    (4) The appropriate MSHA District Office when investigations are 
conducted under the FMSH Act.
    (b) Advance notice of site visits will not be given to the place of 
employment or local union at the place of employment when, in the 
judgment of the NIOSH authorized representatives, giving such notice 
would adversely affect the validity and effectiveness of an 
investigation. Those individuals and organizations specified in Sec.  
85a.4(a)(1), (a)(3), and (a)(4) will be notified prior to the initiation 
of such a site visit. After the site visit has been initiated, and, as 
soon as possible thereafter, the NIOSH authorized representatives will 
contact the organizations specified in Sec.  85a.4(a)(2) concerning the 
nature and details of the site visit.
    (c) In those instances where site visits are not necessary to the 
conduct of an investigation, the NIOSH authorized representatives will 
contact an official representative of the place of employment either 
verbally or through a written communication and provide the details of 
why an investigation of the place of employment is being conducted. If 
appropriate, the NIOSH authorized representatives will contact those 
individuals or organizations stipulated in paragraphs (a)(1) through (4) 
of this section about the nature and details of the investigation.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980; 79 
FR 2792, Jan. 16, 2014]



Sec.  85a.5  Conduct of investigations of places of employment.

    (a)(1) Prior to beginning a site visit, NIOSH authorized 
representatives will present their credentials to the employer, owner, 
operator or agent in charge at the place of employment, explain the 
nature, purpose and scope of the investigation and the records specified 
in Sec.  85a.3 which they wish to review, abstract or duplicate.
    (2) In those instances where site visits are not necessary to the 
conduct of an investigation and the initial contact is made verbally, 
NIOSH authorized representatives will, at the request of the employer, 
owner, operator or agent in charge at the place of employment, provide a 
written explanation of the nature, purpose and scope of the 
investigation and the records specified in Sec.  85a.3 which they wish 
to review, abstract or duplicate.
    (b)(1) At the commencement of an investigation, the employer, owner, 
operator or agent in charge at the place of employment shall precisely 
identify that information which is trade secret and might be seen or 
obtained by the NIOSH authorized representatives during the 
investigation. If the NIOSH authorized representatives have no clear 
reason to question such identification, such information will not be 
disclosed by NIOSH in accordance with the provisions of section 15 of 
the OSH Act. Generally, NIOSH will not question trade secret 
designations; however, if NIOSH at any time does question such 
identification, not less than 15 days'

[[Page 697]]

notice to the employer, owner, operator or agent will be given of the 
intention to remove the trade secret designation from such information. 
The employer, owner, operator or agent may within that period submit a 
request to the Director, NIOSH, to reconsider this intention and may 
provide additional information in support of the trade secret 
designation. The Director, NIOSH, will notify the employer, owner, 
operator or agent in writing of the decision which will become effective 
no sooner than 15 days after the date of such notice.
    (2) In those instances where the NIOSH authorized representative is 
a person fulfilling a contract agreement with NIOSH or is serving as an 
expert or consultant to NIOSH pursuant to the Act, the employer, owner, 
operator or agent in charge at the place of employment may, after 
advising the NIOSH contractor or consultant in writing, elect to 
withhold information deemed to be a trade secret from such a NIOSH 
authorized representative or prohibit entry into the area of the place 
of employment where such entry will reveal trade secrets. In those 
instances, where the subject information is needed or access to the area 
of the place of employment is necessary, in the judgment of NIOSH, to 
fulfill the goals of the investigation, NIOSH regular employees will 
then obtain the information or enter the subject area of the place of 
employment.
    (c)(1) NIOSH authorized representatives will be in charge of site 
visits conducted pursuant to this part.
    (2) Where there is a request by the representative of the State 
agency and/or employees, who were notified pursuant to Sec.  85a.4(a)(1) 
or Sec.  85a.4(a)(2) to accompany the NIOSH authorized representatives 
during the site visit of the place of employment, the NIOSH authorized 
representatives will allow this request if they determine that this will 
aid the investigation; or where, in the judgment of the NIOSH authorized 
representatives, good cause has been shown why accompaniment by a third 
party who is not an employee of the employer is reasonably necessary to 
the conduct of an effective and thorough site visit, they may permit 
such third party to accompany them during the site visit: Provided 
however, That access by such person(s) to areas described in Sec.  
85a.5(c)(4) shall be in accordance with the requirements of such 
provision and access to areas containing trade secrets shall be with the 
consent of the employer, owner, operator or agent in charge at the place 
of employment.
    (3) NIOSH authorized representatives are authorized to deny the 
right of accompaniment under this paragraph to any person whose conduct 
in their judgment interferes with a fair and orderly site visit. In all 
instances, a representative of the employer shall be permitted to 
accompany the NIOSH authorized representatives during the site visit of 
the place of employment.
    (4) With regard to information classified by an agency of the United 
States Government in the interest of national security, only persons 
authorized to have access to such information may accompany NIOSH 
authorized representatives in areas containing such information.
    (d)(1) NIOSH authorized representatives are authorized: To collect 
environmental samples and samples of substances; to measure 
environmental conditions and employee exposures (including measurement 
of employee exposure by the attachment of personal sampling devices to 
employees with their consent); to take or obtain photographs, video 
recordings related to the purpose of the investigation; to employ other 
reasonable investigative techniques, including medical examinations, 
anthropometric measurements and standardized and experimental functional 
tests of employees with the informed consent of such employees; to 
review, abstract, and duplicate such personnel records as are pertinent 
to mortality, morbidity, injury, safety, and other similar studies; and 
to question and interview privately any employer, owner, operator, 
agency, or employee from the place of employment. The employer, owner, 
operator, or agency shall have the opportunity to review photographs, 
and video recordings taken or obtained for the purpose of identifying 
those which contain or might reveal a trade secret.

[[Page 698]]

    (2) Prior to the conduct of medical examinations, anthropometric 
measurements or functional tests of any employees, the NIOSH authorized 
representatives will obtain approval of the procedures to be utilized 
from the NIOSH Institutional Review Board and no employee examination, 
measurement or test will be undertaken without the informed consent of 
such employee.
    (e) NIOSH authorized representatives will comply with all safety and 
health rules and practices at the place of employment and all NIOSH, 
Occupational Safety and Health Administration, and Mine Safety and 
Health Administration regulations and policies during a site visit and 
will provide and use appropriate protective clothing and equipment. In 
situations requiring specialized or unique types of protective 
equipment, such equipment shall be furnished by the employer, owner, 
operator or agent in charge at the place of employment.
    (f) The conduct of site visits will be such as to preclude 
unreasonable disruption of the operations of the place of employment.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980; 49 
FR 4739, Feb. 8, 1984; 79 FR 2793, Jan. 16, 2014]



Sec.  85a.6  Provision of suitable space for employee interviews 
and examinations.

    An employer, owner, operator or agent in charge at the place of 
employment shall, on request of the NIOSH authorized representatives, 
provide suitable space at the place of employment, if such space is 
reasonably available, to NIOSH to conduct private interviews with, and 
medical examinations, anthropometric measurements and functional tests 
of employees. NIOSH authorized representatives will consult with the 
employer, owner, operator or agent as to the time and place of the 
private interviews, medical examination, anthropometric measurements and 
functional tests and will schedule same so as to avoid undue disruption 
of work at the place of employment. NIOSH will conduct the medical 
interviews, measurements, examinations and tests specified under this 
part at its own expense.

[41 FR 45002, Oct. 14, 1976]



Sec.  85a.7  Imminent dangers.

    Whenever, during the course of, or as a result of, an investigation 
under this part, the NIOSH authorized representatives believe there is a 
reasonable basis for an allegation of an imminent danger, NIOSH will 
immediately advise the employer, owner, operator or agent in charge at 
the place of employment and those employees who appear to be in 
immediate danger of such allegation and will inform the agencies 
identified in Sec.  85a.4(a) through (4).

[79 FR 2793, Jan. 16, 2014]



Sec.  85a.8  Reporting of results of investigations of places of employment.

    (a)(1) Specific reports of investigations of each place of 
employment under this part, with identification of the place of 
employment, will be made available by NIOSH to the employer, owner, 
operator or agent in charge at the place of employment, with copies to 
the appropriate officials and Agencies notified pursuant to Sec.  
85a.4(a). Prior to release of such reports, a preliminary report will be 
sent by NIOSH to the employer, owner, operator or agent for review for 
trade secret information and technical inaccuracies that may 
inadvertently be presented in the report. If requested in writing, the 
data used to compile the reports will be made available by NIOSH to the 
employer, owner, operator or agent in charge at the place of employment, 
except that data will not be released in a form that is individually 
identifiable.
    (2) All specific reports of investigations of each place of 
employment under this part will be available to the public from the 
NIOSH Education and Information Division, 4676 Columbia Parkway, 
Cincinnati, Ohio 45226.
    (3) In certain instances, specific reports of investigations of each 
place of employment will not be prepared. In such instances, a closing 
conference at the place of employment will be conducted by the NIOSH 
authorized representatives and those individuals participating in the 
site visit to discuss

[[Page 699]]

the findings of the site visit and appropriate recommendations.
    (b)(1) Any specific findings of individual employee medical 
examinations, anthropometric measurements and functional tests will be 
released by NIOSH authorized representatives to the company physician, 
private physician, or other person only pursuant to the written 
authorization of the employee; otherwise, the specific findings and 
other personal records concerning individuals will be maintained in 
accordance with 45 CFR part 5b and section 3 of the Privacy Act of 1974 
(5 U.S.C. 552a). Notice of all NIOSH systems of records as defined in 45 
CFR 5b.1(n) as a result of the investigations of places of employment 
pursuant to this part will be published in the Federal Register under 
Notices of Systems of Records for the Department of Health and Human 
Services.
    (2) In cases where an employee shows positive significant medical 
findings, the employee and the physician(s) designated by the employee 
under Sec.  85a.8(b)(1) will be immediately notified by NIOSH.
    (3) A summary of the findings of the examinations for each employee 
will be sent by NIOSH to the individual.
    (c) The findings of a total investigation generally will be 
disseminated as part of NIOSH criteria documents, NIOSH technical 
reports, NIOSH information packets, scientific journals, presentations 
at technical meetings, or in other similar manners. These findings of a 
total investigation will be presented in a manner which does not 
identify any specific place of employment; however, it should be noted 
that the specific reports of investigations of each place of employment 
under this part are subject to mandatory disclosure, upon request, under 
the provisions of the Freedom of Information Act (5 U.S.C. 552).

[41 FR 45002, Oct. 14, 1976, as amended at 79 FR 2793, Jan. 16, 2014]



PART 86_GRANTS FOR EDUCATION PROGRAMS IN OCCUPATIONAL SAFETY AND HEALTH--
Table of Contents



                            Subpart A_General

Sec.
86.1 Applicability.
86.2 Definitions.
86.3 Inventions and discoveries.
86.4 Publications and copyrights.
86.5 Grant appeals procedure.

        Subpart B_Occupational Safety and Health Training Grants

86.10 Nature and purpose of training grants.
86.11 Eligibility.
86.12 Application for a grant.
86.13 Project requirements.
86.14 Evaluation and grant award.
86.15 Payments.
86.16 Use of project funds.
86.17 Nondiscrimination.
86.18 Grantee accountability.
86.19 Human subjects; animal welfare.
86.20 Additional conditions.
86.21 Applicability of 45 CFR part 74.

      Subpart C_Occupational Safety and Health Direct Traineeships

86.30 Nature and purpose of direct traineeships.
86.31 Eligibility; minimum requirements.
86.32 Application for direct traineeship.
86.33 Human subjects; animal welfare.
86.34 Evaluation and award of direct traineeships.
86.35 Payments.
86.36 Duration and continuation.
86.37 Terms and conditions.
86.38 Accountability.
86.39 Termination of direct traineeship.

    Authority: Sec. 8(g), 84 Stat. 1600, 29 U.S.C. 657(g); sec. 21(a), 
84 Stat. 1612, 29 U.S.C. 670(a).

    Source: 40 FR 29076, July 10, 1975, unless otherwise noted.



                            Subpart A_General



Sec.  86.1  Applicability.

    The regulations of this part are applicable to the award of training 
grants and direct traineeships pursuant to section 21(a)(1) of the 
Occupational Safety and Health Act of 1970 (29 U.S.C. 670(a)(1)) to 
assist in providing an adequate supply of qualified personnel to carry 
out the purposes of the Act.

[[Page 700]]



Sec.  86.2  Definitions.

    Any term not defined herein shall have the same meaning as given it 
in the Act. As used in this part:
    (a) Act means the Occupational Safety and Health Act of 1970 (29 
U.S.C. 651 et seq.).
    (b) [Reserved]
    (c) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (d) State means a State of the United States, the District of 
Columbia, Puerto Rico, the Virgin Islands, American Samoa, Guam, and the 
Trust Territory of the Pacific Islands.
    (e) Training means job-specific skill development, the purpose of 
which is to provide qualified personnel to carry out the purposes of the 
Act.

[40 FR 29076, July 10, 1975, as amended at 47 FR 53012, Nov. 24, 1982]



Sec.  86.3  Inventions and discoveries.

    Any grant award pursuant to Sec.  86.14 or Sec.  86.33 is subject to 
the regulations of the Department of Health and Human Services as set 
forth in 45 CFR parts 6 and 8, as amended. Such regulations shall apply 
to any activity for which grant funds are in fact used whether within 
the scope of the project as approved or otherwise. Appropriate measures 
shall be taken by the grantee and by the Secretary to assure that no 
contracts, assignments or other arrangements inconsistent with the grant 
obligation are continued or entered into and that all personnel involved 
in the supported activity are aware of and comply with such obligations. 
Laboratory notes, related technical data, and information pertaining to 
inventions and discoveries shall be maintained for such periods, and 
filed with or otherwise made available to the Secretary, or those he may 
designate at such times and in such manner, as he may determine 
necessary to carry out such Department regulations.



Sec.  86.4  Publications and copyrights.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright without prior approval any 
publications, films or similar materials developed or resulting from a 
project supported by a grant under this part, subject, however, to a 
royalty-free, nonexclusive, and irrevocable license or right in the 
Government to reproduce, translate, publish, use, disseminate, and 
dispose, of such materials and to authorize others to do so.



Sec.  86.5  Grant appeals procedure.

    The informal Public Health Service procedure for resolution of post-
award grant disputes set forth in subpart D of part 50 of this title and 
the Department post-award grant appeals procedure in 45 CFR part 16 are 
applicable to any award made pursuant to this part.



        Subpart B_Occupational Safety and Health Training Grants



Sec.  86.10  Nature and purpose of training grants.

    (a) Long-term training project grant. A long-term training project 
grant is an award of funds to an eligible institution or agency, 
hereinafter called the ``grantee,'' to pay part or all of the costs of 
organized identifiable activities, hereinafter termed the ``project,'' 
that are undertaken to establish, strengthen, or expand graduate, 
undergraduate, or special training, of persons in the field of 
occupational safety and health. Such grants may be used to support 
training in, for example, occupational medicine, industrial hygiene, 
industrial nursing and occupational safety engineering and the training 
of technicians and paraprofessionals in such areas.
    (b) Short-term training project grant. A short-term training project 
grant is an award of funds to an eligible institution or agency, 
hereinafter called the ``grantee,'' to pay part or all of the costs of 
organized identifiable activities, hereinafter termed the ``project'' 
that are undertaken to provide intensive training programs of less than 
1 year for any one or a combination of the following purposes:
    (1) To provide specialized instruction for occupational safety and 
health professional or career personnel which will increase their 
competence in an area in their respective fields.

[[Page 701]]

    (2) To prepare or expand the capabilities of occupational safety and 
health professional or career personnel for leadership roles as 
administrators or supervisors, and
    (3) To prepare or expand the teaching capabilities of occupational 
safety and health professionals and career personnel.
    (c) Educational Resource Center Grant. An educational resource 
center grant is an award of funds to an eligible institution or agency, 
hereinafter called the ``grantee,'' to pay part or all of the costs of 
organized identifiable activities, hereinafter termed the ``project,'' 
that are undertaken to provide for the combination of long-term and 
short-term training activities as described in Sec.  86.13 (c).

[40 FR 29076, July 10, 1975, as amended at 42 FR 52401, Sept. 30, 1977]



Sec.  86.11  Eligibility.

    (a) Eligible applicants. Any public or private educational or 
training agency or institution located in a state is eligible to apply 
for a grant under this subpart.
    (b) Projects eligible for long-term or short-term training grants or 
educational resource center grants. Any project found by the Secretary 
to be a long-term training project within the meaning of Sec.  86.10(a) 
or a short-term training project within the meaning of Sec.  86.10(b) or 
an educational resource center grant project within the meaning of Sec.  
86.10(c) shall be eligible for a grant award. However, no applicant is 
eligible for assistance for a separate training project grant in any 
project period in which it receives an educational resource center 
grant. Nothing in the section shall prevent an existing training grant 
from being incorporated into an educational resource center grant award.

[40 FR 29076, July 10, 1975, as amended at 42 FR 52401, Sept. 30, 1977; 
47 FR 53012, Nov. 24, 1982]



Sec.  86.12  Application for a grant.

    (a) An application for a grant under this subpart shall be submitted 
to the Secretary at such time and in such form and manner as the 
Secretary may prescribe. \1\ The application shall contain a full and 
adequate description of the project and of the manner in which the 
applicant intends to conduct the project in accordance with the 
requirements of this subpart, and a budget and justification of the 
amount of grant funds requested, and such other pertinent information as 
the Secretary may require.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the 
Procurement and Grants Office, Centers for Disease Control, Atlanta, GA 
30333.
---------------------------------------------------------------------------

    (b) The application shall be executed by an individual authorized to 
act for the applicant and to assume for the applicant the obligations 
imposed by the regulations of this subpart and any additional conditions 
of the grant.

[40 FR 29076, July 10, 1975, as amended at 49 FR 38117, Sept. 27, 1984]



Sec.  86.13  Project requirements.

    (a) An approvable application for a long-term training grant must 
contain each of the following, unless the Secretary determines that the 
applicant has established good cause for its omission.
    (1) Provision of a method for development of the training curriculum 
and any attendant training materials and resources;
    (2) Provision of a method for implementation of the needed training;
    (3) Provision of an evaluation methodology, including the manner in 
which such methodology will be employed, to measure the achievement of 
the objectives of the training program; and
    (4) Provision of a method by which trainees will be selected.
    (b) In addition to the requirements set forth in paragraph (a) of 
this section, an approvable application for a short-term training grant 
must contain each of the following, unless the Secretary determines that 
the applicant has established good cause for its omission.
    (1) Provision of a methodology to assess the particular skills, or 
knowledge that prospective trainees need to develop;
    (2) Provision of at least 18 hours of formal instruction for a 
period of not

[[Page 702]]

less than 2\1/2\ days and not more than 1 academic year; and
    (3) Assurances that no portion of the Federal funds will be used for 
(i) inservice training courses designed only for employees of a single 
agency, institution, or organization; (ii) correspondence courses; (iii) 
regular courses usually given for academic credit; or (iv) training the 
grantee's financial officers, program director, or the official who 
executed the application.
    (c) In addition to the requirements set forth in paragraphs (a), 
(b)(1), and (b)(3) (ii), (iii) and (iv) of this section, an approvable 
application for an educational resource center grant must contain each 
of the following, unless the Secretary determines that the applicant has 
established good cause for its omission:
    (1) A description, supported by appropriate documents, of 
cooperative arrangements to conduct an educational resource center among 
a medical school (with an established program in preventive or 
occupational medicine), a school of nursing, a school of public health 
or its equivalent, and a school of engineering or its equivalent. Other 
schools or departments with relevant disciplines and resources--e.g., 
toxicology, biostatistics, environmental health, law, business 
administration, education--may be represented and contribute as 
appropriate to the conduct of the total program.
    (2) The identification of an educational resource center Director 
who possesses a demonstrated capacity for sustained productivity and 
leadership in occupational safety and health training who shall oversee 
the general operation of the educational resource center program and 
shall, to the extent possible, directly participate in training 
activities.
    (3) A description of the full-time professional staff representing 
various disciplines and qualifications relevant to occupational safety 
and health and capable of planning, establishing, and carrying out or 
administering training projects undertaken by the educational resource 
center.
    (4) A description of the training and research expertise, 
appropriate facilities and ongoing training and research activities in 
occupational safety and health areas.
    (5) A description of its program for conducting education and 
training of occupational health physicians, occupational health nurses, 
industrial hygienists/engineers and safety personnel. There shall be 
full-time students in each of these core disciplines, with a goal of a 
minimum total of 30 full-time students. Training may also be conducted 
in other occupational safety and health career categories, e.g., 
industrial toxicology, biostatistics, epidemiology, and ergonomics. 
Training programs shall include appropriate field experience including 
experience with public health and safety agencies and labor-management 
health and safety activities.
    (6) A specific plan for making an impact on the curriculum taught by 
relevant medical specialties, including radiology, orthopedics, 
dermatology, internal medicine, neurology, perinatal medicine, and 
pathology.
    (7) A description of its program to assist other institutions or 
agencies located within the applicant's region including schools of 
medicine, nursing and engineering, among others, by providing curriculum 
materials and consultation for curriculum/course development in 
occupational safety and health, and by providing training opportunities 
for faculty members.
    (8) A specific plan for preparing, distributing, and conducting 
courses, seminars and workshops to provide short-term and continuing 
education training courses for physicians, nurses, industrial 
hygienists, safety engineers and other occupational safety and health 
professionals, paraprofessionals and technicians, including personnel of 
labor-management health and safety committees, in the geographical 
region in which the educational resource center is located. The content 
and orientation of the curriculum/courses shall take into consideration 
and address problems relevant to the geographic region served. The goal 
shall be that the training be made available each year to a minimum of 
200-250 trainees representing all of the above categories of personnel 
with priority given to providing occupational safety and health

[[Page 703]]

training to physicians in family practice, as well as in industrial 
practice, and industrial nurses. These courses shall be structured so 
that educational institutions, public health and safety agencies, 
professional societies or other appropriate agencies can utilize them to 
provide training at the local level to occupational safety and health 
personnel working in the workplace. Further, the educational resource 
center shall have a specific plan and demonstrated capability for 
implementing such training directly and through other institutions or 
agencies in the region including cooperative efforts with labor unions 
and industry trade associations where appropriate.

[40 FR 29076, July 10, 1975, as amended at 42 FR 52401, Sept. 30, 1977]



Sec.  86.14  Evaluation and grant award.

    Within the limits of funds available for such purpose the Secretary 
may award grants to assist in the establishment and operation of those 
projects which will in his judgment best promote the purposes of section 
21(a)(1) of the Act, taking into account:
    (a) In the case of long-term training grants:
    (1) The need for training in the area or areas of study outlined in 
the application;
    (2) The degree to which the proposal represents a strengthening or 
expansion of the applicant's program in such areas;
    (3) The record of the applicant's effectiveness in training in these 
or related areas as indicated, among other things, by the placement of 
its graduates;
    (4) The competence of the project staff in relation to the service 
to be provided;
    (5) The reasonableness of the budget in relation to the proposed 
project;
    (6) The applicant's resources, including equipment, facilities, and 
funds, available for the project;
    (7) The current and potential availability of students in the area 
of study to be offered and their prospective employability as a result 
of the proposed training;
    (8) The extent to which the applicant expects to absorb faculty 
positions initiated as a result of the grant; and
    (9) The degree to which the project adequately provides for the 
requirements set forth in Sec.  86.13(a).
    (b) In the case of short-term training:
    (1) The relationship of the contents of the course to the current 
and emergency training needs to carry out the purposes of the Act;
    (2) The qualifications of the instructional staff;
    (3) The speed with which the training can be put to use by the 
persons proposed to be trained;
    (4) The reasonableness of the budget in relation to the proposed 
project;
    (5) The success of previous offerings of this course, or related 
courses;
    (6) Evidence of ability to recruit trainees and the estimated number 
to be enrolled during each course offering; and
    (7) The degree to which the proposed project adequately provides for 
the requirements set forth in Sec.  86.13(b).
    (c) In the case of educational resource center grants:
    (1) The criteria set forth in paragraphs (a) and (b) of this 
section.
    (2) The degree to which the proposed project adequately provides for 
the requirements set forth in Sec.  86.13(c).
    (d) The amount of any award shall be determined by the Secretary on 
the basis of his estimate of the sum necessary for all or a designated 
portion of direct project costs plus an additional amount for indirect 
costs, if any, which will be calculated by the Secretary either (1) on 
the basis of his estimate of the actual indirect costs reasonably 
related to the project, or (2) on the basis of a percentage, not to 
exceed 8 percent, of all, or a portion of, the estimated direct costs of 
the project when there are reasonable assurances that the use of such 
percentage will not exceed the approximate actual indirect costs. Such 
award may include an estimated provisional amount for indirect costs or 
for designated direct costs (such as travel or supply costs) subject to 
upward (within the limits of available funds) as well as downward 
adjustments to actual costs when the amount properly expended by the 
grantee for provisional items has been determined by the Secretary.
    (e) All grant awards shall be in writing, shall set forth the amount 
of funds

[[Page 704]]

granted and the period for which support is recommended.
    (f) Neither the approval of any project nor any grant award shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application annually at such times and in such form as the 
Secretary may direct.

[40 FR 29076, July 10, 1975, as amended at 42 FR 52402, Sept. 30, 1977]



Sec.  86.15  Payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred in the performance 
of the project to the extent he determines such payments necessary to 
promote prompt initiation and advancement of the approved project.



Sec.  86.16  Use of project funds.

    (a) Any funds granted pursuant to this subpart as well as other 
funds to be used in performance of the approved project shall be 
expended solely for carrying out the approved project in accordance with 
section 21(a) of the Act, the regulations of this subpart, the terms and 
conditions of the award, and the applicable cost principles prescribed 
by subpart Q of 45 CFR part 74.
    (b) Prior written approval by the Secretary of revision of the 
budget and project plan is required whenever there is to be a 
significant change in the scope or nature of project activities, which 
in the case of short term training grants, includes any change in the 
course dates or training sites.
    (c) Grant funds are available for trainee stipends and for tuition, 
including fees and instructional materials, for travel costs related to 
training allowances. Stipends and allowances may not be increased or be 
paid beyond the term of the stipend on account of vacation an individual 
might have been entitled to but did not take.
    (d) Stipends may only be paid to a trainee who is a citizen of the 
United States, an alien lawfully admitted to the United States for 
permanent residence, or a permanent resident of Guam, American Samoa, or 
the Trust Territory of the Pacific Islands.
    (e) In the case of short term training grants, stipends may not be 
paid to persons receiving lecture fees, salary, travel expenses, or 
payment in any form as members of the course instructional staff.
    (f) Grant funds used for alterations and renovations shall be 
subject to the condition that the grantee shall comply with the 
requirements of Executive Order 11246, as amended, and with the 
applicable regulations prescribed pursuant thereto.



Sec.  86.17  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in 
particular section 601 of such Act which provides that no person in the 
United States shall on the grounds of race, color, or national origin be 
excluded from participation in, be denied the benefits of, or be 
subjected to, discrimination under any program or activity receiving 
Federal financial assistance. A regulation implementing such title VI, 
which applies to grants made under this subpart, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80).
    (b) Attention is called to the requirements of title IX of the 
Education Amendments of 1972 (86 Stat. 373, 20 U.S.C. 1681 et seq.) and 
in particular to section 901 of such Act which provides that no person 
in the United States shall, on the basis of sex, be excluded from 
participation in, be denied the benefits of, or be subjected to 
discrimination under any education program or activity receiving Federal 
financial assistance.
    (c) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of his handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance.

[[Page 705]]



Sec.  86.18  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other grant funds, including funds 
derived from other grant awards. With respect to each approved project 
the grantee shall account for the sum total of all amounts paid by 
presenting or otherwise making available evidence satisfactory to the 
Secretary of expenditures for direct and indirect costs meeting the 
requirements of this part: Provided, however, That when the amount 
awarded for indirect costs was based on a predetermined fixed-percentage 
of estimated direct costs, the amount allowed for indirect costs shall 
be computed on the basis of such predetermined fixed-percentage rates 
applied to the total, or a selected element thereof, of the reimbursable 
direct costs incurred.
    (b) Accounting for interest earned on grant funds. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the governments of the 
political sudivisions of the State. All grantees other than a State, as 
defined in this section, must return all interest earned on grant funds 
to the Federal Government.
    (c) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full account, as 
provided herein, as of the date of termination of grant support. The 
Secretary may require other special and periodic accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project the 
total sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section; and
    (ii) Any credits for earned interest pursuant to paragraph (b) of 
this section; and
    (iii) Any other amounts due pursuant to subparts F, M, and O of 45 
CFR part 74.

Such total sum shall constitute a debt owed by the grantee to the 
Federal Government and shall be recovered from the grantee or its 
successors or assignees by setoff or other action as provided by law.



Sec.  86.19  Human subjects; animal welfare.

    No grant award may be made under this subpart unless the applicant 
has complied with:
    (a) 45 CFR part 46 pertaining to the protection of human subjects; 
and
    (b) Chapter 1-43 of the Department Grants Administration Manual \2\ 
concerning animal welfare.
---------------------------------------------------------------------------

    \2\ The Department Grants Administration Manual is available for 
inspection at the Public Information Office of the several Department 
Regional Offices and available for purchase at the Government Printing 
Office, GPO Document No. 894-523.
---------------------------------------------------------------------------



Sec.  86.20  Additional conditions.

    The Secretary may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in his judgment 
such conditions are necessary to assure or protect advancement of the 
approved project, the interests of public health, or the conservation of 
grant funds.



Sec.  86.21  Applicability of 45 CFR part 74.

    The provisions of 45 CFR part 74, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part to States and local governments as those terms 
are defined in subpart A of that part 74. The relevant provisions of the 
following subparts of part 74 shall also apply to grants to all grantee 
organizations under this part:

                             45 CFR Part 74

Subpart and Subject
A General.
B Cash depositories.
C Bonding and insurance.
D Retention and custodial requirements for records.

[[Page 706]]

F Grant-related income.
G Matching and cost sharing.
K Grant payment requirements.
L Budget revision procedures.
M Grant closeout: Suspension, and termination.
O Property.
Q Cost principles.



      Subpart C_Occupational Safety and Health Direct Traineeships



Sec.  86.30  Nature and purpose of direct traineeships.

    A direct traineeship is an award of funds directly from the Federal 
Government to an individual (herein called the ``trainee'') for his 
subsistence and other expenses during a period in which he is acquiring 
training (a) in the occupational safety and health professions, (b) for 
research relating to occupational safety and health, or (c) for teaching 
in occupational safety and health.



Sec.  86.31  Eligibility; minimum requirements.

    In order to be eligible for an award under this subpart an applicant 
must:
    (a) Have been accepted by a public or private institution for the 
purpose of the activity for which the traineeship is sought.
    (b) Be a U.S. citizen, an alien lawfully admitted to the United 
States for permanent residence or a permanent resident of Guam, American 
Samoa, or the Trust Territory of the Pacific Islands.

[40 FR 29076, July 10, 1975, as amended at 47 FR 53012, Nov. 24, 1982]



Sec.  86.32  Application for direct traineeship.

    An application for a direct traineeship under this subpart shall be 
submitted to the Secretary at such times and in such form and manner as 
he may prescribe. \1\ In addition to the information supplied by the 
applicant in his application, such further information may be required 
as is necessary to determine his or her qualifications.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the 
Procurement and Grants Office, Centers for Disease Control, Atlanta, GA 
30333.

[40 FR 29076, July 10, 1975, as amended at 49 FR 38117, Sept. 27, 1984]



Sec.  86.33  Human subjects; animal welfare.

    Where the application is for training at a non-Federal institution, 
no award may be made under this subpart unless said institution has 
complied with:
    (a) 45 CFR part 46 pertaining to the protection of human subjects; 
and
    (b) Chapter 1-43 of the Department Grants Administration Manual \2\ 
concerning animal welfare.
---------------------------------------------------------------------------

    \2\ See footnote 2 to Sec.  86.19.
---------------------------------------------------------------------------



Sec.  86.34  Evaluation and award of direct traineeships.

    Within the limits of funds available for such purpose and subject to 
the regulations of this part, the Secretary may award direct 
traineeships to those qualified applicants who are in his judgment best 
able to carry out the purpose of the traineeships taking into 
consideration the need for training in the area of study specified in 
the application.



Sec.  86.35  Payments.

    (a) Individuals receiving awards shall be entitled to such stipends 
and allowances as the Secretary may designate, taking into account such 
factors as the needs of the program, the cost of living, and the 
availability of funds.

    (Note: These are prescribed in chapter 3-140 of the Department 
Grants Administration Manual \2\).

    (b) Payments of stipends and allowances will, at the discretion of 
the Secretary, be made directly to the trainee or to the sponsoring 
institution for payment directly to the trainee.



Sec.  86.36  Duration and continuation.

    Direct traineeship awards may be made for varying periods not in 
excess of 2 years. The Secretary may make one or more continuation 
awards for an additional period if he finds that satisfactory progress 
is being made toward accomplishment of the purpose of the initial 
traineeship award. Additional

[[Page 707]]

support may be provided on appropriate justification after expiration of 
the period of support in the previous award.



Sec.  86.37  Terms and conditions.

    All direct traineeship awards shall be subject to the following 
terms and conditions:
    (a) Training must be carried out at an institution found by the 
Secretary to provide a well-rounded course of instruction in the 
particular area of training for which the traineeship is awarded.
    (b) No direct traineeship may be utilized to compensate any trainee 
for personal services or employment on behalf of the United States or 
any person.



Sec.  86.38  Accountability.

    Accountability for payments will be subject to such requirements as 
may be specified by the Secretary.



Sec.  86.39  Termination of direct traineeship.

    (a) The Secretary may terminate a direct traineeship at any time 
upon request of the trainee.
    (b) After reasonable notice to the trainee and an opportunity for 
the presentation of the trainee's views and relevant evidence, the 
Secretary may terminate any direct traineeship prior to the date it 
would otherwise expire upon a determination that the trainee's 
performance is unsatisfactory, that the trainee is no longer attending 
the sponsoring institution, or that he or she is unfit or unable to 
carry out the purpose of the traineeship.
    (c) The views and evidence of the trainee shall be presented in 
writing unless the Secretary determines that an oral presentation is 
desirable.



PART 87_NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH RESEARCH 
AND DEMONSTRATION GRANTS--Table of Contents



Sec.
87.1 To which programs does this regulation apply?
87.2 Definitions.
87.3 Who is eligible to apply for a grant under this part?
87.4 For what purposes may grants be awarded?
87.5 What information must be included in the grant application?
87.6 How will grant applications be evaluated and the grants awarded?
87.7 For what period of time will grants be awarded?
87.8 How may a grantee use grant funds?
87.9 Which other HHS regulations apply?

    Authority: Sec. 8(g), 84 Stat. 1600 (29 U.S.C. 657(g)), sec. 508, 83 
Stat. 803 (30 U.S.C. 957).

    Source: 46 FR 58676, Dec. 3, 1981, unless otherwise noted.



Sec.  87.1  To which programs does this regulation apply?

    This regulation applies to research and demonstration project grants 
under:
    (a) Section 20(a)(1) of the Occupational Safety and Health Act of 
1970 (29 U.S.C. 669(a)(1)) for the support of studies related to 
occupational safety and health, and
    (b) Section 501 of the Federal Mine Safety and Health Act of 1977 
(30 U.S.C. 951) for the support of health research in mining. These 
grants are awarded and administered by the National Institute for 
Occupational Safety and Health, Centers for Disease Control, of the 
Public Health Service.



Sec.  87.2  Definitions.

    As used in this regulation:
    Demonstration project grant means an award of funds to an eligible 
applicant to assist in meeting the cost of conducting a demonstration, 
either on a pilot or full-scale basis, of the technical or economic 
feasibility or application of a new or improved procedure, method, 
technique, or approach that will further the research purposes described 
in Sec.  87.4.
    Principal investigator for a research project, or project director 
for a demonstration project, means a single individual who is 
responsible for the scientific and technical direction of the project.
    Research project grant means an award of funds to an eligible 
applicant to assist in meeting the costs of conducting an identified 
research activity or program, study, or experiment that will further the 
research purposes described in Sec.  87.4.

[[Page 708]]

    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.



Sec.  87.3  Who is eligible to apply for a grant under this part?

    Any public or private agency or institution is eligible to apply for 
a grant under this part, except Federal agencies or institutions not 
specifically authorized by law to receive such a grant.



Sec.  87.4  For what purposes may grants be awarded?

    (a) The Occupational Safety and Health Act authorizes grants for 
research, experiments, and demonstrations relating to occupational 
safety and health, including studies of the psychological factors 
involved. This authority includes projects to develop innovative 
methods, techniques, and approaches for dealing with occupational safety 
and health problems.
    (b) The Federal Mine Safety and Health Act authorizes grants for 
research projects designed to:
    (1) Improve working conditions and practices affecting health in 
coal or other mines and to prevent occupational diseases originating in 
the mining industry.
    (2) Develop epidemiological information to (i) identify and define 
positive factors involved in occupational diseases of miners, (ii) 
provide information on the incidence and prevalence of pneumoconiosis 
and other respiratory ailments of miners, and (iii) improve health 
standards.
    (3) Develop techniques for the prevention and control of 
occupational diseases of miners, including tests for hypersusceptibility 
and early detection.
    (4) Evaluate the effect on bodily impairment and occupational 
disability of miners afflicted with an occupational disease.
    (5) Study the relationship between coal or other mine environments 
and occupational diseases of miners.
    (6) Study matters involving the protection of life and the 
prevention of diseases in connection with persons who, although not 
miners, work with or around the products of coal or other mines in areas 
outside of such mines and under conditions which may adversely affect 
the health and well-being of such persons.
    (7) Develop effective respiratory equipment.



Sec.  87.5  What information must be included in the grant application?

    The application must contain a complete description of the objective 
of the project and the plan for carrying out the research or 
demonstration, the name and qualifications of the principal investigator 
or project director and principal staff members, the total resources and 
facilities that will be available, and a justification of the amount of 
grant funds requested.



Sec.  87.6  How will grant applications be evaluated and the grants awarded?

    (a) The Secretary may award grants to those applicants whose 
approved projects will best promote the purposes of either the 
Occupational Safety and Health Act or the Federal Mine Safety and Health 
Act on the basis of an evaluation conducted by experts or consultants 
engaged for this purpose.
    (b) This evaluation will take into account the scientific merit and 
significance of the project, the competency of the proposed staff in 
relation to the type of research or demonstration involved, the 
feasibility of the project, the likelihood of its producing meaningful 
results, the proposed project period, the adequacy of the applicant's 
resources available for the project, the amount of grant funds necessary 
for completion, and for mining grant applications, the recommendations 
of the Mine Health Research Advisory Committee.
    (c) The Secretary may evaluate and approve two or more concurrent 
applications, each dealing with one or more specified aspects of the 
project, and make two or more concurrent grant awards for the project. 
This may be necessary when a project involves a number of different but 
related problems, activities, or disciplines which would require 
evaluation by different groups, or when support for a project could be 
more effectively administered

[[Page 709]]

by separate handling of various aspects of the project.



Sec.  87.7  For what period of time will grants be awarded?

    (a) The notice of grant award specifies how long the Secretary 
intends to support the project without requiring the project to 
recompete for funds. This period, called the project period, will 
usually be for 3-5 years.
    (b) Generally, the grant will initially be for 1 year and subsequent 
continuation awards will also be for 1 year at a time. A grantee must 
submit a separate application to have the support continued for each 
subsequent year. Decisions regarding continuation awards and the funding 
level of such awards will be of such factors as the grantee's progress 
and management practices, and the availability of funds. In all cases, 
continuation awards require a determination by the Secretary that 
continued funding is in the best interest of the Federal Government.
    (c) Neither the approval of any application, nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.



Sec.  87.8  How may a grantee use grant funds?

    A grantee shall only spend funds it receives under this part 
according to the approved application and budget, the authorizing 
legislation, the terms and conditions of the grant award, the applicable 
cost principles specified in subpart Q of 45 CFR part 74, and the 
regulations of this part.



Sec.  87.9  Which other HHS regulations apply?

    Several other regulations apply to grants under this part. These 
include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearing under part 80 of this 
Title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[49 FR 38117, Sept. 27, 1984]



PART 88_WORLD TRADE CENTER HEALTH PROGRAM--Table of Contents



Sec.
88.1 Definitions.
88.2 General provisions.
88.3 Eligibility--currently-identified responders.
88.4 Eligibility criteria--WTC responders.
88.5 Application process--WTC responders.
88.6 Enrollment decision--WTC responders.
88.7 Eligibility--currently-identified survivors.
88.8 Eligibility criteria--WTC survivors.
88.9 Application process--WTC survivors.
88.10 Enrollment decision--screening-eligible survivors.
88.11 Initial health evaluation for screening-eligible survivors.
88.12 Enrollment decision--certified-eligible survivors.
88.13 Disenrollment.
88.14 Appeal of enrollment or disenrollment decision.
88.15 List of WTC-Related Health Conditions.
88.16 Addition of health conditions to the List of WTC-Related Health 
          Conditions.
88.17 Physician's determination of WTC-related health conditions.
88.18 Certification.
88.19 Decertification.
88.20 Authorization of treatment.
88.21 Appeal of certification, decertification, or treatment 
          authorization decision.
88.22 Reimbursement for medical treatment and services.
88.23 Appeal of reimbursement denial.
88.24 Coordination of benefits and recoupment.
88.25 Reopening of WTC Health Program final decisions.

    Authority: 42 U.S.C. 300mm to 300mm-61, Pub. L. 111-347, 124 Stat. 
3623, as amended by Pub. L. 114-113, 129 Stat. 2242.

    Source: 81 FR 90938, Dec. 15, 2016, unless otherwise noted.

[[Page 710]]



Sec.  88.1  Definitions.

    Act means Title XXXIII of the Public Health Service Act, as amended, 
42 U.S.C. 300mm through 300mm-61 (codifying Title I of the James Zadroga 
9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as amended by 
Pub. L. 114-113), which created the World Trade Center (WTC) Health 
Program.
    Aggravating means a health condition that existed on September 11, 
2001, and that, as a result of exposure to airborne toxins, any other 
hazard, or any other adverse condition resulting from the September 11, 
2001, terrorist attacks, requires medical treatment that is (or will be) 
in addition to, more frequent than, or of longer duration than the 
medical treatment that would have been required for such condition in 
the absence of such exposure.
    Certification means WTC Health Program review of a health condition 
in a particular WTC Health Program member for the purpose of 
identification and approval of a WTC-related health condition, as 
defined in this section and included on the List of WTC-Related Health 
Conditions in 42 CFR 88.15, or a health condition medically associated 
with a WTC-related health condition.
    Certified-eligible survivor means (1) an individual who has been 
identified as eligible for medical monitoring and treatment as of 
January 2, 2011; or (2) a screening-eligible survivor who is eligible 
for follow-up monitoring and treatment pursuant to Sec.  88.12(b).
    Clinical Center of Excellence (CCE) means a center or centers under 
contract with the WTC Health Program. A CCE:
    (1) Uses an integrated, centralized health care provider approach to 
create a comprehensive suite of health services that are accessible to 
enrolled WTC responders, screening-eligible survivors, or certified-
eligible survivors;
    (2) Has experience in caring for WTC responders and screening-
eligible survivors, or includes health care providers who have received 
WTC Health Program training;
    (3) Employs health care provider staff with expertise that includes, 
at a minimum, occupational medicine, environmental medicine, trauma-
related psychiatry and psychology, and social services counseling; and
    (4) Meets such other requirements as specified by the Administrator 
of the WTC Health Program.
    Data Center means a center or centers under contract with the WTC 
Health Program to:
    (1) Receive, analyze, and report to the Administrator of the WTC 
Health Program on data that have been collected and reported to the Data 
Center by the corresponding CCE(s);
    (2) Develop monitoring, initial health evaluation, and treatment 
protocols with respect to WTC-related health conditions;
    (3) Coordinate the outreach activities of the corresponding CCE;
    (4) Establish criteria for credentialing of medical providers 
participating in the Nationwide Provider Network;
    (5) Coordinate and administer the activities of the WTC Health 
Program Steering Committees; and
    (6) Meet periodically with the corresponding CCE(s) to obtain input 
on the analysis and reporting of data and on development of monitoring, 
initial health evaluation, and treatment protocols.
    Designated representative means an individual selected by an 
applicant, WTC responder, or a screening-eligible or certified-eligible 
survivor to represent his or her interests to the WTC Health Program.
    Ground Zero means a site in Lower Manhattan bounded by Vesey Street 
to the north, the West Side Highway to the west, Liberty Street to the 
south, and Church Street to the east in which stood the former World 
Trade Center complex.
    Health condition medically associated with a WTC-related health 
condition means a condition that results from treatment of a WTC-related 
health condition or results from progression of a WTC-related health 
condition.
    Initial health evaluation means assessment of one or more symptoms 
that may be associated with a WTC-related health condition and includes 
a medical and exposure history, a physical examination, and additional 
medical testing as needed to evaluate whether the individual has a WTC-
related

[[Page 711]]

health condition and is eligible for treatment under the WTC Health 
Program.
    Interested party means a representative of any organization 
representing WTC responders, a nationally recognized medical 
association, a WTC Health Program CCE or Data Center, a State or 
political subdivision, or any other interested person.
    List of WTC-Related Health Conditions means those conditions 
eligible for coverage in the WTC Health Program as identified in Sec.  
88.15 of this part.
    Medical emergency means a physical or mental health condition for 
which immediate treatment is necessary.
    Medically necessary treatment means the provision of services to a 
WTC Health Program member by physicians and other health care providers, 
including diagnostic and laboratory tests, prescription drugs, inpatient 
and outpatient hospital services, and other care that is appropriate, to 
manage, ameliorate, or cure a WTC-related health condition or a health 
condition medically associated with a WTC-related health condition, and 
which conforms to medical treatment protocols developed by the Data 
Centers, with input from the CCEs, and approved by the Administrator of 
the WTC Health Program.
    Monitoring means periodic physical and mental health assessment of a 
WTC responder or certified-eligible survivor in relation to exposure to 
airborne toxins, any other hazard, or any other adverse condition 
resulting from the September 11, 2001, terrorist attacks and which 
includes a medical and exposure history, a physical examination and 
additional medical testing as needed for surveillance or to evaluate 
symptom(s) to determine whether the individual has a WTC-related health 
condition.
    Nationwide Provider Network (NPN) means a network of providers 
throughout the United States under contract with the WTC Health Program 
to provide an initial health evaluation, monitoring, and treatment to 
enrolled WTC responders, screening-eligible survivors, or certified-
eligible survivors who live outside the New York metropolitan area.
    New York City disaster area means an area within New York City that 
is the area of Manhattan that is south of Houston Street and any block 
in Brooklyn that is wholly or partially contained within a 1.5-mile 
radius of the former World Trade Center complex.
    New York metropolitan area means the combined statistical areas 
comprising the Bridgeport-Stamford-Norwalk, CT Metropolitan Statistical 
Area; Kingston, NY Metropolitan Statistical Area; New Haven-Milford, CT 
Metropolitan Statistical Area; New York-Northern New Jersey-Long Island, 
NY-NJ-PA Metropolitan Statistical Area; Poughkeepsie-Newburgh-
Middletown, NY Metropolitan Statistical Area; Torrington, CT 
Micropolitan Statistical Area; Trenton-Ewing, NJ Metropolitan 
Statistical Area, as defined in OMB Bulletin 10-02, December 1, 2009.
    NIOSH means the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    One (1) day means the length of a standard work shift, or at least 4 
hours but less than 24 hours.
    Pentagon site means any area of the land (consisting of 
approximately 280 acres) and improvements thereon, located in Arlington, 
Virginia, on which the Pentagon Office Building, Federal Building Number 
2, the Pentagon heating and sewage treatment plants, and other related 
facilities are located, including various areas designated for the 
parking of vehicles, vehicle access, and other areas immediately 
adjacent to the land or improvements previously described that were 
affected by the terrorist-related aircraft crash on September 11, 2001; 
and those areas at Fort Belvoir in Fairfax County, Virginia and at the 
Dover Port Mortuary at Dover Air Force Base in Delaware involved in the 
recovery, identification, and transportation of human remains for the 
incident.
    Police department means any law enforcement department or agency, 
whether under Federal, state, or local jurisdiction, responsible for 
general police duties, such as maintenance of public order, safety, or 
health, enforcement of laws, or otherwise charged

[[Page 712]]

with prevention, detection, investigation, or prosecution of crimes.
    Scientific/Technical Advisory Committee means the WTC Health Program 
Scientific/Technical Advisory Committee whose members are appointed by 
the Administrator of the WTC Health Program to review scientific and 
medical evidence and to make recommendations to the Administrator on 
additional WTC Health Program eligibility criteria and on additional 
WTC-related health conditions.
    Screening-eligible survivor means an individual who is not a WTC 
responder and who claims symptoms of a WTC-related health condition and 
meets the eligibility criteria for a survivor specified in Sec.  88.8 of 
this part.
    September 11, 2001, terrorist attacks means the terrorist attacks 
that occurred on September 11, 2001, in New York City, at Shanksville, 
Pennsylvania, and at the Pentagon, and includes the aftermath of such 
attacks.
    Shanksville, Pennsylvania site means the property in Stonycreek 
Township, Somerset County, Pennsylvania, which is bounded by Route 30 
(Lincoln Highway), State Route 1019 (Buckstown Road), and State Route 
1007 (Lambertsville Road); and those areas at the Pennsylvania National 
Guard Armory in Friedens, Pennsylvania involved in the recovery, 
identification, and transportation of human remains for the incident.
    Staten Island Landfill means the landfill in Staten Island, NY 
called ``Fresh Kills.''
    Terrorist watch list means the lists maintained by the Federal 
government that will be utilized to screen for known terrorists.
    WTC means World Trade Center.
    WTC Health Program means the program established by Title XXXIII of 
the Public Health Service Act as amended, 42 U.S.C. 300mm to 300mm-61 
(codifying Title I of the James Zadroga 9/11 Health and Compensation Act 
of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113) to provide 
medical monitoring and treatment benefits for eligible responders to the 
September 11, 2001, terrorist attacks and initial health evaluation, 
monitoring, and treatment benefits for residents and other building 
occupants and area workers in New York City who were directly impacted 
and adversely affected by such attacks.
    WTC Health Program member means any responder, screening-eligible 
survivor, or certified-eligible survivor enrolled in the WTC Health 
Program.
    WTC Program Administrator (Administrator of the WTC Health Program, 
or Administrator) means, for the purposes of this part, the Director of 
the National Institute for Occupational Safety and Health, Centers for 
Disease Control and Prevention, Department of Health and Human Services, 
or his or her designee.
    WTC-related acute traumatic injury means a health condition eligible 
for coverage in the WTC Health Program as described in Sec.  88.15(e)(1) 
of this part.
    WTC-related health condition means an illness or health condition 
for which exposure to airborne toxins, any other hazard, or any other 
adverse condition resulting from the September 11, 2001, terrorist 
attacks, based on an examination by a medical professional with 
expertise in treating or diagnosing the health conditions in the List of 
WTC-Related Health Conditions, is substantially likely to be a 
significant factor in aggravating, contributing to, or causing the 
illness or health condition, including a mental health condition. Only 
those conditions on the List of WTC-Related Health Conditions codified 
in 42 CFR 88.15 may be considered WTC-related health conditions.
    WTC-related musculoskeletal disorder means a health condition 
eligible for coverage in the WTC Health Program as described in Sec.  
88.15(c)(1) of this part.
    WTC responder means an individual who has been identified as 
eligible for monitoring and treatment as described in Sec.  88.3 or who 
meets the eligibility criteria in Sec.  88.4.



Sec.  88.2  General provisions.

    (a) Designated representative. (1) An applicant or WTC Health 
Program member may appoint one individual to represent his or her 
interests under the WTC Health Program. The appointment must be made in 
writing and consistent with all relevant Federal laws and regulations in 
order for the designated representative to receive personal health 
information.

[[Page 713]]

    (2) There may be only one designated representative at any time. 
After one designated representative has been properly appointed, the WTC 
Health Program will not recognize another individual as the designated 
representative until the appointment of the previously designated 
representative is withdrawn in a signed writing.
    (3) A properly appointed designated representative who is recognized 
by the WTC Health Program may make a request or give direction to the 
WTC Health Program regarding the eligibility, certification, or any 
other administrative issue pertaining to the applicant or WTC Health 
Program member under the WTC Health Program, including appeals. Any 
notice requirement contained in this part or in the Act is fully 
satisfied if sent to the designated representative.
    (4) An applicant or WTC Health Program member may authorize any 
individual to represent him or her in regard to the WTC Health Program, 
unless that individual's service as a representative would violate any 
applicable provision of law (such as 18 U.S.C. 205 or 18 U.S.C. 208) or 
is otherwise prohibited by WTC Health Program policies and procedures or 
contract provisions.
    (5) A Federal employee may act as a representative only on behalf of 
the individuals specified in, and in the manner permitted by, 18 U.S.C. 
203 and 18 U.S.C. 205.
    (6) If an applicant or screening-eligible or certified-eligible 
survivor is a minor, a parent or guardian may act on his or her behalf.
    (7) If an applicant or WTC Health Program member is a mentally 
incompetent adult, an individual authorized under state or other 
applicable law to act on the applicant's or member's behalf may act as 
his or her designated representative as described in this section.
    (b) Transportation and travel expenses. The WTC Health Program may 
provide for necessary and reasonable transportation and expenses 
incident to the securing of medically necessary treatment through the 
NPN, involving travel of more than 250 miles.



Sec.  88.3  Eligibility--currently identified responders.

    (a) Responders who were identified as eligible for monitoring and 
treatment under the arrangements as in effect on January 2, 2011, 
between NIOSH and the consortium administered by Mount Sinai School of 
Medicine in New York City and the Fire Department, City of New York, are 
enrolled in the WTC Health Program.
    (1) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government will be 
considered to be enrolled in the WTC Health Program.
    (2) [Reserved]
    (b) WTC responders identified as enrolled under this section are not 
required to submit an application to the WTC Health Program.



Sec.  88.4  Eligibility criteria--WTC responders.

    (a) Responders to the New York City disaster area who have not been 
previously identified as eligible as provided for under Sec.  88.3 of 
this part may apply for enrollment in the WTC Health Program on or after 
July 1, 2011. Such individuals must meet the criteria in one of the 
following categories to be considered eligible for enrollment:
    (1) Firefighters and related personnel must meet the criteria 
specified in paragraph (a)(1)(i) or (ii) of this section:
    (i) The individual was an active or retired member of the Fire 
Department, City of New York (whether firefighter or emergency 
personnel), and participated at least 1 day in the rescue and recovery 
effort at any of the former World Trade Center sites (including Ground 
Zero, the Staten Island Landfill, or the New York City Chief Medical 
Examiner's Office), during the period beginning on September 11, 2001, 
and ending on July 31, 2002; or
    (ii) The individual is:
    (A) A surviving immediate family member of an individual who was an 
active or retired member of the Fire Department, City of New York 
(whether firefighter or emergency personnel), who was killed at Ground 
Zero on September 11, 2001, and

[[Page 714]]

    (B) Received any treatment for a WTC-related mental health condition 
on or before September 1, 2008.
    (2) Law enforcement officers and WTC rescue, recovery, and cleanup 
workers must meet the criteria specified in paragraph (a)(2)(i) or (ii) 
of this section:
    (i) The individual worked or volunteered onsite in rescue, recovery, 
debris cleanup, or related support services in lower Manhattan (south of 
Canal Street), the Staten Island Landfill, or the barge loading piers, 
for at least:
    (A) 4 hours during the period beginning on September 11, 2001, and 
ending on September 14, 2001; or
    (B) 24 hours during the period beginning on September 11, 2001, and 
ending on September 30, 2001; or
    (C) 80 hours during the period beginning on September 11, 2001, and 
ending on July 31, 2002.
    (ii) The individual was an active or retired member of the New York 
City Police Department or an active or retired member of the Port 
Authority Police of the Port Authority of New York and New Jersey who 
participated onsite in rescue, recovery, debris cleanup, or related 
support services, for at least:
    (A) 4 hours during the period beginning September 11, 2001, and 
ending on September 14, 2001, in lower Manhattan (south of Canal 
Street), including Ground Zero, the Staten Island Landfill, or the barge 
loading piers; or
    (B) 1 day beginning on September 11, 2001, and ending on July 31, 
2002, at Ground Zero, the Staten Island Landfill, or the barge loading 
piers; or
    (C) 24 hours during the period beginning on September 11, 2001, and 
ending on September 30, 2001, in lower Manhattan (south of Canal 
Street); or
    (D) 80 hours during the period beginning on September 11, 2001, and 
ending on July 31, 2002, in lower Manhattan (south of Canal Street).
    (3) Office of the Chief Medical Examiner of New York City employee. 
The individual was an employee of the Office of the Chief Medical 
Examiner of New York City involved in the examination and handling of 
human remains from the WTC attacks, or other morgue worker who performed 
similar post-September 11 functions for such Office staff, during the 
period beginning on September 11, 2001, and ending on July 31, 2002.
    (4) Port Authority Trans-Hudson Corporation Tunnel worker. The 
individual was a worker in the Port Authority Trans-Hudson Corporation 
Tunnel for at least 24 hours during the period beginning on February 1, 
2002, and ending on July 1, 2002.
    (5) Vehicle-maintenance worker. The individual was a vehicle-
maintenance worker who was exposed to debris from the former World Trade 
Center while retrieving, driving, cleaning, repairing, and maintaining 
vehicles contaminated by airborne toxins from the September 11, 2001, 
terrorist attacks; and conducted such work for at least 1 day during the 
period beginning on September 11, 2001, and ending on July 31, 2002.
    (b) Responders to the Pentagon site of the September 11, 2001, 
terrorist attacks, may apply for enrollment in the WTC Health Program on 
or after April 29, 2013. Individuals must meet the criteria below to be 
considered eligible for enrollment:
    (1) The individual was an active or retired member of a fire or 
police department (fire or emergency personnel), worked for a recovery 
or cleanup contractor, or was a volunteer; and
    (2) Performed rescue, recovery, demolition, debris cleanup, or other 
related services at the Pentagon site of the September 11, 2001, 
terrorist attacks, for at least 1 day beginning September 11, 2001, and 
ending on November 19, 2001.
    (c) Responders to the Shanksville, Pennsylvania site of the 
September 11, 2001, terrorist attacks, may apply for enrollment in the 
WTC Health Program on or after April 29, 2013. Individuals must meet the 
criteria below to be considered eligible for enrollment:
    (1) The individual was an active or retired member of a fire or 
police department (fire or emergency personnel), worked for a recovery 
or cleanup contractor, or was a volunteer; and
    (2) Performed rescue, recovery, demolition, debris cleanup, or other 
related services at the Shanksville, Pennsylvania site of the September 
11, 2001,

[[Page 715]]

terrorist attacks, for at least 1 day beginning September 11, 2001, and 
ending on October 3, 2001.
    (d) [Reserved]
    (e) The WTC Health Program will maintain a list of WTC responders.



Sec.  88.5  Application process--WTC responders.

    (a) An application to the WTC Health Program based on the criteria 
in Sec.  88.4 must be submitted with documentation of the applicant's 
employment affiliation (if relevant) and work activity during the dates, 
times, and locations specified in Sec.  88.4
    (1) Documentation may include but is not limited to a pay stub; 
official personnel roster; a written statement, under penalty of perjury 
by an employer; site credentials; or similar documentation.
    (2) An applicant who is unable to submit the required documentation 
must instead offer a written explanation of how he or she tried to 
obtain proof of presence, residence, or work activity and why the 
attempt was unsuccessful. The applicant must attest, under penalty of 
perjury, that he or she meets the criteria specified in Sec.  88.4.
    (b) The application and supporting documentation must be submitted 
to the WTC Health Program for consideration.
    (c) The WTC Health Program will notify the applicant in writing (or 
by email if an email address is provided by the applicant) of any 
deficiencies in the application or the supporting documentation.



Sec.  88.6  Enrollment decision--WTC responders.

    (a) Enrollment priority. The WTC Health Program will prioritize 
applications in the order in which they are received.
    (b) Enrollment eligibility. The WTC Health Program will decide if 
the applicant meets the eligibility criteria provided in Sec.  88.4.
    (c) Denial of enrollment. (1) The WTC Health Program will deny 
enrollment if the applicant fails to meet the applicable eligibility 
requirements.
    (2) The WTC Health Program may deny enrollment of a responder who is 
otherwise eligible and qualified if the Act's numerical limitations for 
newly enrolled responders have been met.
    (i) No more than 25,000 WTC responders, other than those enrolled 
pursuant to Sec. Sec.  88.3 and 88.4(a)(1)(ii), may be enrolled at any 
time. The Administrator of the WTC Health Program may decide, based on 
the best available evidence, that sufficient funds are available under 
the WTC Health Program Fund to provide treatment and monitoring only for 
individuals who are already enrolled as WTC responders at that time.
    (ii) [Reserved]
    (3) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government may qualify to 
be enrolled or be determined to be eligible for the WTC Health Program.
    (d) Notification of enrollment decision. (1) The WTC Health Program 
will decide if the applicant meets the current eligibility criteria for 
WTC responders in Sec.  88.4 and is qualified, and notify the applicant 
of the enrollment decision in writing within 60 calendar days of the 
date of receipt of the application. The 60-day time period will not 
include any days during which the applicant is correcting deficiencies 
in the application or supporting documentation.
    (2) If the WTC Health Program decides that an applicant is denied 
enrollment, the written notification will include an explanation, as 
appropriate, for the decision to deny enrollment and inform the 
applicant of the right to appeal the initial denial of eligibility and 
provide instructions on how to file an appeal.



Sec.  88.7  Eligibility--currently identified survivors.

    (a) Survivors who have been identified as eligible for medical 
treatment and monitoring as of January 2, 2011, are considered 
certified-eligible in the WTC Health Program.
    (1) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government will be 
considered to be a certified-eligible survivor in the WTC Health 
Program.
    (2) [Reserved]

[[Page 716]]

    (b) Survivors identified as certified-eligible under this section 
are not required to submit an application to the WTC Health Program.



Sec.  88.8  Eligibility criteria--WTC survivors.

    (a) Criteria for status as a screening-eligible survivor. An 
individual who is not a WTC responder, claims symptoms of a WTC-related 
health condition, and who has not been previously identified as eligible 
under Sec.  88.7 may apply to the WTC Health Program on or after July 1, 
2011, for a determination of eligibility for an initial health 
evaluation.
    (1) The WTC Health Program will determine an applicant's eligibility 
for an initial health evaluation based on one of the following criteria:
    (i) The screening applicant was present in the dust or dust cloud in 
the New York City disaster area on September 11, 2001.
    (ii) The screening applicant worked, resided, or attended school, 
childcare, or adult daycare in the New York City disaster area, for at 
least:
    (A) 4 days during the period beginning on September 11, 2001, and 
ending on January 10, 2002; or
    (B) 30 days during the period beginning on September 11, 2001, and 
ending on July 31, 2002.
    (iii) The screening applicant worked as a cleanup worker or 
performed maintenance work in the New York City disaster area during the 
period beginning on September 11, 2001, and ending on January 10, 2002, 
and had extensive exposure to WTC dust as a result of such work.
    (iv) The screening applicant:
    (A) Was deemed eligible to receive a grant from the Lower Manhattan 
Development Corporation Residential Grant Program;
    (B) Possessed a lease for a residence or purchased a residence in 
the New York City disaster area; and
    (C) Resided in such residence during the period beginning on 
September 11, 2001, and ending on May 31, 2003.
    (v) The screening applicant is an individual whose place of 
employment--
    (A) At any time during the period beginning on September 11, 2001, 
and ending on May 31, 2003, was in the New York City disaster area; and
    (B) Was deemed eligible to receive a grant from the Lower Manhattan 
Development Corporation WTC Small Firms Attraction and Retention Act 
program or other government incentive program designed to revitalize the 
lower Manhattan economy after the September 11, 2001, terrorist attacks.
    (2) [Reserved]
    (b) Criteria for status as a certified-eligible survivor. Survivors 
who have been determined to have screening-eligible status under Sec.  
88.10(a), may seek status as a certified-eligible survivor. Status as a 
certified-eligible survivor is based on a certification by the WTC 
Health Program that, pursuant to an initial health evaluation, the 
screening-eligible survivor has a WTC-related health condition and is 
eligible for follow-up monitoring and treatment.
    (c) The WTC Health Program will maintain a list of screening-
eligible and certified-eligible survivors.



Sec.  88.9  Application process--WTC survivors.

    (a) Application for status as a screening-eligible survivor. An 
application to the WTC Health Program based on the criteria in Sec.  
88.8(a) must be submitted with documentation of the applicant's 
location, presence or residence, and/or work activity during the 
relevant time period.
    (1) Documentation may include but is not limited to: Proof of 
residence, such as a lease or utility bill; attendance roster at a 
school or daycare; or pay stub, other employment documentation, or 
written statement, under penalty of perjury, by an employer indicating 
employment location during the relevant time period; or similar 
documentation. The applicant must also attest to symptoms of a WTC-
related health condition.
    (2) An applicant who is unable to submit the required documentation 
must instead offer a written explanation of how he or she tried to 
obtain proof of location, presence, or residence, and/or work activity 
and why the attempt was unsuccessful. The applicant must attest, under 
penalty of perjury, that he or she meets the criteria specified in Sec.  
88.8.

[[Page 717]]

    (3) The applicant will be notified of any deficiencies in the 
application or the supporting documentation.
    (b) Status as a certified-eligible survivor. No additional 
application is required for status as a certified-eligible survivor. If, 
based upon the screening-eligible survivor's initial health evaluation 
(see Sec.  88.11), the WTC Health Program certifies the diagnosis of a 
WTC-related health condition, then the survivor will automatically 
receive the status of a certified-eligible survivor.



Sec.  88.10  Enrollment decision--screening-eligible survivors.

    (a) The WTC Health Program will decide if the applicant meets the 
screening-eligible survivor criteria pursuant to Sec.  88.8(a) and is 
qualified, and notify the applicant of the enrollment decision in 
writing within 60 calendar days of the date of receipt of the 
application. The 60-day time period will not include any days during 
which the applicant is correcting deficiencies in the application or 
supporting documentation.
    (b) If the WTC Health Program decides that an applicant is denied 
enrollment, the written notification will include an explanation for the 
decision to deny enrollment and inform the applicant of the right to 
appeal the enrollment denial and provide instructions on how to file an 
appeal.
    (1) The WTC Health Program may deny screening-eligible survivor 
status if the applicant is ineligible under the criteria specified in 
Sec.  88.8(a).
    (2) The WTC Health Program may deny screening-eligible survivor 
status if the numerical limitation on certified-eligible survivors in 
Sec.  88.12(b)(3)(i) has been met.
    (3) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government may qualify to 
be a screening-eligible survivor in the WTC Health Program.



Sec.  88.11  Initial health evaluation for screening-eligible survivors.

    (a) A CCE or an NPN-affiliated physician will provide the screening-
eligible survivor an initial health evaluation to determine if the 
individual has a WTC-related health condition.
    (b) The WTC Health Program will provide only one initial health 
evaluation per screening-eligible survivor. The individual may request 
additional health evaluations at his or her own expense.
    (c) If the physician determines that the screening-eligible survivor 
has a WTC-related health condition, the physician will promptly transmit 
to the WTC Health Program his or her determination, consistent with the 
requirements of Sec.  88.17(a).



Sec.  88.12  Enrollment decision--certified-eligible survivors.

    (a) The WTC Health Program will prioritize certification requests in 
the order in which they are received.
    (b) The WTC Health Program will review the physician's 
determination, render a decision regarding certification of the 
individual's WTC-related health condition, and notify the individual of 
the decision and the reason for the decision in writing, pursuant to 
Sec. Sec.  88.17 and 88.18.
    (1) If the individual is a screening-eligible survivor and the 
individual's condition is certified as a WTC-related health condition, 
the individual will automatically receive the status of a certified-
eligible survivor.
    (2) If a screening-eligible survivor's condition is not certified as 
a WTC-related health condition pursuant to Sec. Sec.  88.17 and 88.18, 
the WTC Health Program will deny certified-eligible status. The 
screening-eligible survivor may appeal the decision to deny 
certification, as provided under Sec.  88.21.
    (3) The WTC Health Program may deny certified-eligible survivor 
status of an otherwise eligible and qualified screening-eligible 
survivor if the Act's numerical limitations for certified-eligible 
survivors have been met.
    (i) No more than 25,000 individuals, other than those described in 
Sec.  88.7, may be determined to be certified-eligible survivors at any 
time. The Administrator of the WTC Health Program may decide, based on 
the best available evidence, that sufficient funds are available under 
the WTC Health Program Fund to provide treatment and monitoring only for 
individuals who have already been certified as

[[Page 718]]

certified-eligible survivors at that time.
    (ii) [Reserved]
    (4) No individual who is determined to be a positive match to the 
terrorist watch list maintained by the Federal government may qualify to 
be a certified-eligible survivor in the WTC Health Program.



Sec.  88.13  Disenrollment.

    (a) The disenrollment of a WTC Health Program member may be 
initiated by the WTC Health Program in the following circumstances:
    (1) The WTC Health Program mistakenly enrolled an individual under 
Sec.  88.4 (WTC responders) or Sec.  88.8 (screening-eligible survivors) 
who did not provide sufficient proof of eligibility consistent with the 
required eligibility criteria; or
    (2) The WTC Health Program member's enrollment was based on 
incorrect or fraudulent information.
    (b) The disenrollment of a WTC Health Program member may be 
initiated by the enrollee for any reason.
    (c) A disenrolled WTC Health Program member will be notified in 
writing by the WTC Health Program of a disenrollment decision, provided 
an explanation, as appropriate, for the decision, and provided 
information on how to appeal the decision. A disenrolled WTC Health 
Program member disenrolled pursuant to paragraph (a) may appeal the 
disenrollment decision in accordance with Sec.  88.14.
    (d) A disenrolled WTC Health Program member who has been disenrolled 
in accordance with paragraphs (a) or (b) of this section may seek to re-
enroll in the WTC Health Program using the application and enrollment 
procedures, provided that the application is supported by new 
information.



Sec.  88.14  Appeal of enrollment or disenrollment decision.

    (a) Right to appeal. An applicant denied WTC Health Program 
enrollment, a disenrolled WTC Health Program member, or the applicant's 
or member's designated representative (appointed pursuant to Sec.  
88.2(a)) may appeal the enrollment denial or disenrollment decision.
    (b) Appeal request. (1) A letter requesting an appeal must be 
postmarked within 120 calendar days of the date of the letter from the 
Administrator notifying the denied applicant or disenrolled WTC Health 
Program member of the adverse decision. Electronic versions of a signed 
letter will be accepted if transmitted within 120 calendar days of the 
date of the Administrator's notification letter.
    (2) A valid request for an appeal must:
    (i) Be made in writing and signed;
    (ii) Identify the denied applicant or disenrolled WTC Health Program 
member and designated representative (if applicable);
    (iii) Describe the decision being appealed and state the reasons why 
the denied applicant, disenrolled WTC Health Program member, or 
designated representative believes the enrollment denial or 
disenrollment was incorrect and should be reversed. The appeal request 
may include relevant new information not previously considered by the 
WTC Health Program; and
    (iv) Be sent to the WTC Health Program at the address specified in 
the notice of denial or disenrollment.
    (3) Where the denial or disenrollment is based on information from 
the terrorist watch list, the appeal will be forwarded to the 
appropriate Federal agency.
    (c) Appeal process. Upon receipt of a valid appeal, the 
Administrator will appoint a Federal Official independent of the WTC 
Health Program to review the case. The Federal Official will review all 
available records relevant to the WTC Health Program's decision not to 
enroll the applicant or to disenroll the WTC Health Program member and 
assess whether the appeal should be granted. In conducting the review, 
the Federal Official's consideration will include the following: Whether 
the WTC Health Program substantially complied with all relevant WTC 
Health Program policies and procedures; whether the information 
supporting the WTC Health Program's decision was factually accurate; and 
whether the WTC Health Program's decision was reasonable as applied to 
the facts of the case.

[[Page 719]]

    (1) The Federal Official may consider additional relevant new 
information submitted by the denied applicant, disenrolled WTC Health 
Program member, or designated representative.
    (2) The Federal Official will provide his or her recommendation 
regarding the disposition of the appeal, including his or her findings 
and any supporting materials, to the Administrator.
    (d) Final decision and notification. The Administrator will review 
the Federal Official's recommendation and any relevant information and 
make a final decision on the appeal. The Administrator will notify the 
denied applicant or disenrolled WTC Health Program member and/or 
designated representative of the following in writing:
    (1) The recommendation and findings made by the Federal Official as 
a result of the review;
    (2) The Administrator's final decision on the appeal;
    (3) An explanation of the reason(s) for the Administrator's final 
decision on the appeal; and
    (4) Any administrative actions taken by the WTC Health Program in 
response to the Administrator's final decision.



Sec.  88.15  List of WTC-Related Health Conditions.

    WTC-related health conditions include the following disorders and 
conditions:
    (a) Aerodigestive disorders:
    (1) Interstitial lung diseases.
    (2) Chronic respiratory disorder--fumes/vapors.
    (3) Asthma.
    (4) Reactive airways dysfunction syndrome (RADS).
    (5) WTC-exacerbated and new-onset chronic obstructive pulmonary 
disease (COPD).
    (6) Chronic cough syndrome.
    (7) Upper airway hyperreactivity.
    (8) Chronic rhinosinusitis.
    (9) Chronic nasopharyngitis.
    (10) Chronic laryngitis.
    (11) Gastroesophageal reflux disorder (GERD).
    (12) Sleep apnea exacerbated by or related to a condition described 
in preceding paragraphs (a)(1) through (11) of this section.
    (b) Mental health conditions:
    (1) Posttraumatic stress disorder (PTSD).
    (2) Major depressive disorder.
    (3) Panic disorder.
    (4) Generalized anxiety disorder.
    (5) Anxiety disorder (not otherwise specified).
    (6) Depression (not otherwise specified).
    (7) Acute stress disorder.
    (8) Dysthymic disorder.
    (9) Adjustment disorder.
    (10) Substance abuse.
    (c) Musculoskeletal disorders:
    (1) WTC-related musculoskeletal disorder is a chronic or recurrent 
disorder of the musculoskeletal system caused by heavy lifting or 
repetitive strain on the joints or musculoskeletal system occurring 
during rescue or recovery efforts in the New York City disaster area in 
the aftermath of the September 11, 2001, terrorist attacks. For a WTC 
responder who received any treatment for a WTC-related musculoskeletal 
disorder on or before September 11, 2003, such a health condition 
includes:
    (i) Low back pain.
    (ii) Carpal tunnel syndrome (CTS).
    (iii) Other musculoskeletal disorders.
    (2) [Reserved].
    (d) Cancers:
    (1) Malignant neoplasms of the lip; tongue; salivary gland; floor of 
mouth; gum and other mouth; tonsil; oropharynx; hypopharynx; and other 
oral cavity and pharynx.
    (2) Malignant neoplasm of the nasopharynx.
    (3) Malignant neoplasms of the nose; nasal cavity; middle ear; and 
accessory sinuses.
    (4) Malignant neoplasm of the larynx.
    (5) Malignant neoplasm of the esophagus.
    (6) Malignant neoplasm of the stomach.
    (7) Malignant neoplasms of the colon and rectum.
    (8) Malignant neoplasms of the liver and intrahepatic bile duct.
    (9) Malignant neoplasms of the retroperitoneum and peritoneum; 
omentum; and mesentery.
    (10) Malignant neoplasms of the trachea; bronchus and lung; heart, 
mediastinum and pleura; and other ill-defined sites in the respiratory 
system and intrathoracic organs.

[[Page 720]]

    (11) Mesothelioma.
    (12) Malignant neoplasms of the peripheral nerves and autonomic 
nervous system; and other connective and soft tissue.
    (13) Malignant neoplasms of the skin (melanoma and non-melanoma), 
including scrotal cancer.
    (14) Malignant neoplasm of the female breast.
    (15) Malignant neoplasm of the ovary.
    (16) Malignant neoplasm of the prostate.
    (17) Malignant neoplasm of the urinary bladder.
    (18) Malignant neoplasm of the kidney.
    (19) Malignant neoplasms of the renal pelvis; ureter; and other 
urinary organs.
    (20) Malignant neoplasms of the eye and orbit.
    (21) Malignant neoplasm of the thyroid.
    (22) Malignant neoplasms of the blood and lymphoid tissues 
(including, but not limited to, lymphoma, leukemia, and myeloma).
    (23) Childhood cancers: any type of cancer diagnosed in a person 
less than 20 years of age.
    (24) Rare cancers: any type of cancer \1\ that occurs in less than 
15 cases per 100,000 persons per year in the United States.
---------------------------------------------------------------------------

    \1\ Based on 2005-2009 average annual data age-adjusted to the 2000 
U.S. population. See Glenn Copeland, Andrew Lake, Rick Firth, et al. 
(eds), Cancer in North America: 2005-2009. Volume One: Combined Cancer 
Incidence for the United States, Canada and North America, Springfield, 
IL: North American Association of Central Cancer Registries, Inc., June 
2012.
---------------------------------------------------------------------------

    (e) Acute traumatic injuries:
    (1) WTC-related acute traumatic injury is physical damage to the 
body caused by and occurring immediately after a one-time exposure to 
energy, such as heat, electricity, or impact from a crash or fall, 
resulting from a specific event or incident. For a WTC responder or 
screening-eligible or certified-eligible survivors who received any 
medical treatment for a WTC-related acute traumatic injury on or before 
September 11, 2003, such a health condition includes:
    (i) Eye injury.
    (ii) Burn.
    (iii) Head trauma.
    (iv) Fracture.
    (v) Tendon tear.
    (vi) Complex sprain.
    (vii) Other similar acute traumatic injuries.
    (2) [Reserved]



Sec.  88.16  Addition of health conditions to the List of WTC-Related 
Health Conditions.

    (a) Any interested party may submit a request to the Administrator 
of the WTC Health Program to add a condition to the List of WTC-Related 
Health Conditions in Sec.  88.15. The Administrator will evaluate the 
submission to decide whether it is a valid petition.
    (1) Each valid petition must include the following:
    (i) An explicit statement of an intent to petition the Administrator 
to add a health condition to the List of WTC-Related Health Conditions;
    (ii) Name, contact information, and signature of the interested 
party petitioning for the addition;
    (iii) Name and/or description of the condition(s) to be added;
    (iv) Reasons for adding the condition(s), including the medical 
basis for the association between the September 11, 2001, terrorist 
attacks and the condition(s) to be added.
    (2) Not later than 90 calendar days after the receipt of a valid 
petition, the Administrator will take one of the following actions:
    (i) Request a recommendation of the WTC Health Program Scientific/
Technical Advisory Committee;
    (ii) Publish in the Federal Register a proposed rule to add such 
health condition;
    (iii) Publish in the Federal Register the Administrator's decision 
not to publish a proposed rule and the basis for that decision; or
    (iv) Publish in the Federal Register a decision that insufficient 
evidence exists to take action under paragraph (a)(2)(i) through (iii) 
of this section.
    (3) The 90-day time period will not include any days during which 
the Administrator is consulting with the interested party to clarify the 
submission.
    (4) The Administrator may consider more than one petition 
simultaneously

[[Page 721]]

when the petitions propose the addition of the same health condition. 
Scientific/Technical Advisory Committee recommendations and Federal 
Register notices initiated by the Administrator pursuant to paragraph 
(a)(2) of this section may respond to more than one petition.
    (5) The Administrator will be required to consider a submission for 
a health condition previously reviewed by the Administrator and found 
not to qualify for addition to the List of WTC-Related Health Conditions 
as a valid new petition only if the submission presents a new medical 
basis (i.e., a basis not previously reviewed) for the association 
between the September 11, 2001, terrorist attacks and the condition to 
be added. A submission that provides no new medical basis and is 
received after the publication of a response in the Federal Register to 
a petition requesting the addition of the same health condition will not 
be considered a valid petition and will not be answered in a Federal 
Register notice pursuant to paragraph (a)(2), above. The interested 
party will be informed of the WTC Health Program's decision in writing.
    (b) The Administrator may propose to add a condition to the List of 
WTC-Related Health Conditions in Sec.  88.15 of this part by publishing 
a proposed rule in the Federal Register and providing interested parties 
a period of 30 calendar days to submit written comments. The 
Administrator may extend the comment period for good cause.
    (1) If the Administrator requests a recommendation from the WTC 
Health Program Scientific/Technical Advisory Committee, the Advisory 
Committee will submit its recommendation to the Administrator no later 
than 90 calendar days after the date of the transmission of the request 
or no later than a date specified by the Administrator (but not more 
than 180 calendar days after the request). The Administrator will 
publish a proposed rule or a decision not to publish a proposed rule in 
the Federal Register no later than 90 calendar days after the date of 
transmission of the Advisory Committee recommendation.
    (2) Before issuing a final rule to add a health condition to the 
List of WTC-Related Health Conditions, the Administrator will provide 
for an independent peer review of the scientific and technical evidence 
that would be the basis for issuing such final rule.



Sec.  88.17  Physician's determination of WTC-related health conditions.

    (a) A physician affiliated with either a CCE or NPN will promptly 
transmit to the WTC Health Program a determination that a member's 
exposure to airborne toxins, any other hazard, or any other adverse 
condition resulting from the September 11, 2001, terrorist attacks is 
substantially likely to be a significant factor in aggravating, 
contributing to, or causing the illness or health condition, including a 
mental health condition. The transmission will also include the basis 
for such determination. The physician's determination will be made based 
on an assessment of the following:
    (1) The individual's exposure to airborne toxins, any other hazard, 
or any other adverse condition resulting from the September 11, 2001, 
terrorist attacks.
    (2) The type of symptoms experienced by the individual and the 
temporal sequence of those symptoms.
    (b) For a health condition medically associated with a WTC-related 
health condition, the physician's determination must contain information 
establishing how the health condition has resulted from treatment of a 
previously certified WTC-related health condition or how it has resulted 
from progression of the certified WTC-related health condition.



Sec.  88.18  Certification.

    (a) WTC-related health condition. The WTC Health Program will review 
each physician determination and render a decision regarding 
certification of the condition as a WTC-related health condition. The 
WTC Health Program will notify the WTC Health Program member of the 
decision and the reason for the decision in writing.
    (b) Health condition medically associated with a WTC-related health 
condition. The WTC Health Program will review each physician 
determination and

[[Page 722]]

render a decision regarding certification of the condition as a health 
condition medically associated with a WTC-related health condition. The 
WTC Health Program will notify the WTC Health Program member in writing 
of the decision and the reason for the decision within 60 calendar days 
after the date the physician's determination is received.
    (1) In the course of review, the WTC Health Program may seek a 
recommendation about certification from a physician panel with 
appropriate expertise for the condition.
    (2) [Reserved]
    (c) Appeal right. If certification of a condition as a WTC-related 
health condition or a health condition medically associated with a WTC-
related health condition is denied, the WTC Health Program member may 
appeal the WTC Health Program's decision to deny certification, as 
provided under Sec.  88.21.



Sec.  88.19  Decertification.

    (a) The decertification of a WTC Health Program member's certified 
WTC-related health condition or health condition medically associated 
with a WTC-related health condition may be initiated by the WTC Health 
Program in the following circumstances:
    (1) The WTC Health Program finds that the member's exposure is 
inadequate or is otherwise not covered;
    (2) The WTC Health Program finds that the member's certified WTC-
related health condition was certified in error or erroneously 
considered to have been aggravated, contributed to, or caused by 
exposure to airborne toxins, any other hazard, or any other adverse 
condition resulting from the September 11, 2001, terrorist attacks, 
pursuant to Sec.  88.17(a); or
    (3) The WTC Health Program finds that the member's health condition 
was erroneously determined to be medically associated with a WTC-related 
health condition, pursuant to Sec.  88.17(b).
    (b) A WTC Health Program member will be notified in writing by the 
WTC Health Program of a decertification decision, provided an 
explanation, as appropriate, for the decision, and provided information 
on how to appeal the decision. A WTC Health Program member whose WTC-
related health condition or health condition medically associated with a 
WTC-related health condition is decertified may appeal the 
decertification decision in accordance with Sec.  88.21 of this part.



Sec.  88.20  Authorization of treatment.

    (a) Generally. Medically necessary treatment of certified WTC-
related health conditions and certified health conditions medically 
associated with WTC-related health conditions will be provided through 
the CCEs or the NPN as permitted under WTC Health Program treatment 
protocols and in accordance with all applicable WTC Health Program 
policies and procedures.
    (b) Standard for determining medical necessity. All treatment 
provided under the WTC Health Program will adhere to a standard which is 
reasonable and appropriate; based on scientific evidence, professional 
standards of care, expert opinion or any other relevant information; and 
which has been included in the medical treatment protocols developed by 
the Data Centers, with input from the CCEs, and approved by the 
Administrator of the WTC Health Program.
    (c) Treatment pending certification. While certification of a 
condition is pending, authorization for treatment of a WTC-related 
health condition or a health condition medically associated with a WTC-
related health condition must be obtained from the WTC Health Program 
before treatment is provided, except for the provision of treatment for 
a medical emergency.



Sec.  88.21  Appeal of certification, decertification, 
or treatment authorization decision.

    (a) Right to appeal. A WTC Health Program member or the member's 
designated representative (appointed pursuant to Sec.  88.2(a)) may 
appeal the following four types of decisions made by the WTC Health 
Program:
    (1) To deny certification of a health condition as a WTC-related 
health condition;
    (2) To deny certification of a health condition as medically 
associated with a WTC-related health condition;

[[Page 723]]

    (3) To decertify a WTC-related health condition or a health 
condition medically associated with a WTC-related health condition; or
    (4) To deny authorization of treatment for a certified health 
condition based on a finding that the treatment is not medically 
necessary.
    (b) Appeal request. (1) A letter requesting an appeal must be 
postmarked within 120 calendar days of the date of the letter from the 
Administrator of the WTC Health Program notifying the member of the 
adverse decision. Electronic versions of a signed letter will be 
accepted if transmitted within 120 calendar days of the date of the 
Administrator's notification letter.
    (2) A valid request for an appeal must:
    (i) Be made in writing and signed;
    (ii) Identify the member and designated representative (if 
applicable);
    (iii) Describe the decision being appealed and the reason(s) why the 
member or designated representative believes the decision is incorrect 
and should be reversed. The description may include, but is not limited 
to, the following: Scientific or medical information correcting factual 
errors that may have been submitted to the WTC Health Program by the CCE 
or NPN; information demonstrating that the WTC Health Program did not 
correctly follow or apply relevant WTC Health Program policies or 
procedures; or any information demonstrating that the WTC Health 
Program's decision was not reasonable given the facts of the case. The 
basis provided in the appeal request must be sufficiently detailed and 
supported by information to permit a review of the appeal. Any new 
information not previously considered by the WTC Health Program must be 
included with the appeal request, unless later requested by the WTC 
Health Program; and
    (iv) Be sent to the WTC Health Program at the address specified in 
the notice of denial.
    (3) The appeal request may also state an intent to make a 15-minute 
oral statement by telephone. The WTC Health Program member or designated 
representative will have a second opportunity to schedule an oral 
statement after being contacted by the WTC Health Program regarding the 
appeal.
    (c) Appeal process. Upon receipt of a valid appeal, the 
Administrator will appoint a Federal Official independent of the WTC 
Health Program to review the case. The Federal Official will review all 
available records relevant to the WTC Health Program's decision to deny 
certification of a health condition as a WTC-related health condition, 
deny certification of a health condition as medically associated with a 
WTC-related health condition, decertify the WTC-related health condition 
or health condition medically associated with a WTC-related health 
condition, or deny treatment authorization, and assess whether the 
appeal should be granted. The Federal Official's consideration will 
include the following: Whether the WTC Health Program substantially 
complied with all relevant WTC Health Program policies and procedures; 
whether the information supporting the WTC Health Program's decision was 
factually accurate; and whether the WTC Health Program's decision was 
reasonable as applied to the facts of the case.
    (1) In conducting his or her review, the Federal Official will 
review the case record, including any oral statement made by the WTC 
Health Program member or the member's designated representative, as well 
as additional relevant new information submitted with the appeal request 
or provided by the WTC Health Program member or the member's designated 
representative at the request of the WTC Health Program.
    (2) The Federal Official may consult one or more qualified experts 
to review the WTC Health Program's decision and any additional 
information provided by the WTC Health Program member or the member's 
designated representative. The expert reviewer(s) will submit their 
findings to the Federal Official.
    (3) The Federal Official will provide his or her recommendation 
regarding the disposition of the appeal, including his or her findings 
and any supporting materials (including the transcript of any oral 
statement and any expert reviewers' findings), to the Administrator.

[[Page 724]]

    (d) Final decision and notification. The Administrator will review 
the Federal Official's recommendation and any relevant information and 
make a final decision on the appeal. The Administrator will notify the 
WTC Health Program member and/or the member's designated representative 
of the following in writing:
    (1) The recommendation and findings made by the Federal Official as 
a result of the review;
    (2) The Administrator's final decision on the appeal;
    (3) An explanation of the reason(s) for the Administrator's final 
decision on the appeal; and
    (4) Any administrative actions taken by the WTC Health Program in 
response to the Administrator's final decision.



Sec.  88.22  Reimbursement for medical treatment and services.

    (a) Review of claims. Each claim for reimbursement for treatment 
will be reviewed by the WTC Health Program. Claims that cannot be 
validated by that process will be further assessed by the Administrator 
of the WTC Health Program.
    (b) Initial health evaluations, medical monitoring, and medically 
necessary treatment. (1) The costs incurred by a CCE or NPN-affiliated 
provider for providing a WTC Health Program member an initial health 
evaluation, medical monitoring, and/or medically necessary treatment or 
services for a WTC-related health condition or a health condition 
medically associated with a WTC-related health condition will be 
reimbursed according to the payment rates that apply to the provision of 
such treatment and services under the Federal Employees Compensation Act 
(FECA), 5 U.S.C. 8101 et seq., 20 CFR part 10.
    (i) The Administrator will reimburse a CCE or NPN-affiliated 
provider for treatment for which FECA rates have not been established 
pursuant to the applicable Medicare fee for service rate, as determined 
appropriate by the Administrator.
    (ii) The Administrator will reimburse a CCE or NPN-affiliated 
provider for treatment for which neither FECA nor Medicare fee for 
service rates have been established, at rates as determined appropriate 
by the Administrator.
    (2) If the treatment is determined not to be medically necessary or 
is inconsistent with WTC Health Program protocols, the Administrator 
will withhold reimbursement.
    (c) Outpatient prescription pharmaceuticals. Payment for costs of 
medically necessary outpatient prescription pharmaceuticals for a WTC-
related health condition or health condition medically associated with a 
WTC-related health condition will be reimbursed by the WTC Health 
Program under a contract with one or more pharmaceutical benefit 
management services.



Sec.  88.23  Appeal of reimbursement denial.

    After exhausting procedural and/or contractual administrative 
remedies, a CCE or NPN medical director or affiliated provider may 
submit a written appeal of a WTC Health Program decision to withhold 
reimbursement or payment for treatment found to be not medically 
necessary or not in accordance with approved WTC Health Program medical 
treatment protocols pursuant to Sec.  88.20 of this part. Appeal 
procedures are published on the WTC Health Program Web site.



Sec.  88.24  Coordination of benefits and recoupment.

    The WTC Health Program will attempt to recover the cost of payment 
for treatment, including pharmacy benefits, for a WTC Health Program 
member's certified WTC-related health condition or health condition 
medically associated with a WTC-related health condition by coordinating 
benefits with any workers' compensation insurance available \2\ for 
members'

[[Page 725]]

work-related health conditions, and with any public or private health 
insurance available \3\ for members' non-work-related health conditions.
---------------------------------------------------------------------------

    \2\ As described in PHS Act, sec. 3331(b). To the extent that 
payment for treatment of the member's work-related condition has been 
made, or can reasonably be expected to be made, under any other work-
related injury or illness benefit plan of the member's employer, the WTC 
Health Program will also attempt to recover the costs associated with 
treatment, including pharmacy benefits, for the member's certified WTC-
related health condition or health condition medically associated with a 
WTC-related health condition. See PHS Act, sec. 3331(b)(1). For purposes 
of this regulation, ``workers' compensation law or plan'' or ``workers' 
compensation insurance'' includes any other work-related injury or 
illness benefit plan of the WTC Health Program member's employer.
    \3\ As described in PHS Act, sec. 3331(c).
---------------------------------------------------------------------------

    (a) Where a WTC Health Program member's WTC-related health condition 
or health condition medically associated with a WTC-related health 
condition is eligible for workers' compensation or another illness or 
injury benefit plan to which New York City is obligated to pay, the WTC 
Health Program is the primary payer.
    (b) Where a WTC Health Program member has filed a workers' 
compensation claim for a WTC-related health condition or health 
condition medically associated with a WTC-related health condition and 
the claim is pending, the WTC Health Program is the primary payer; 
however, if the claim is ultimately accepted by the workers' 
compensation board, the workers' compensation insurer in question is 
responsible for reimbursing the WTC Health Program for any treatment 
provided and/or paid for during the pendency of the claim.
    (c) Where a WTC Health Program member has filed a workers' 
compensation claim for a WTC-related health condition or health 
condition medically associated with a WTC-related health condition, but 
a final decision is issued denying the compensation for the claim, the 
WTC Health Program is the primary payer.
    (d) Where a WTC Health Program member has filed a workers' 
compensation claim for a WTC-related health condition or health 
condition medically associated with a WTC-related health condition with 
a workers' compensation plan to which New York City is not obligated to 
pay, the workers' compensation insurer is the primary payer. The WTC 
Health Program is the secondary payer.
    (1) If a WTC Health Program member settles a workers' compensation 
claim by entering into a settlement agreement that releases the employer 
or insurance carrier from paying for future medical care, the settlement 
must protect the interests of the WTC Health Program. This may include 
setting aside adequate funds to pay for future medical expenses, as 
required by the WTC Health Program, which would otherwise have been paid 
by workers' compensation. In such situations, the WTC Health Program may 
require reimbursement for treatment services of a WTC-related health 
condition or health condition medically associated with a WTC-related 
health condition directly from the member.
    (2) The WTC Health Program will pay providers for treatment in 
accordance with Sec.  88.22(b); to the extent that the workers' 
compensation insurance pays for treatment at a lower rate, the WTC 
Health Program will recoup treatment costs at the workers' compensation 
insurance rate.
    (e) Where a WTC Health Program member's WTC-related health condition 
or health condition medically associated with a WTC-related health 
condition is not work-related, the WTC Health Program member's public or 
private health insurance plan is the primary payer. The WTC Health 
Program will pay costs not reimbursed by the public or private health 
insurance plan due to the application of deductibles, co-payments, co-
insurance, other cost sharing arrangements, or payment caps up to and in 
accordance with the rates described in Sec.  88.22(b).
    (f) Any coordination of benefits or recoupment situation not 
described in paragraphs (a) through (e) of this section will be handled 
pursuant to WTC Health Program policies and procedures, as found on the 
WTC Health Program Web site.



Sec.  88.25  Reopening of WTC Health Program final decisions.

    At any time, and without regard to whether new evidence or 
information is provided or obtained, the Administrator of the WTC Health 
Program may reopen any final decision made by the WTC Health Program 
pursuant to the

[[Page 726]]

provisions of this part. The Administrator may affirm, vacate, or modify 
such decision, or take any other action he or she deems appropriate.

[[Page 727]]



SUBCHAPTER H_HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS 
                   SUBSTANCES RELEASES AND FACILITIES





PART 90_ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table of Contents



Sec.
90.1 Purpose and applicability.
90.2 Definitions.
90.3 Procedures for requesting health assessments.
90.4 Contents of requests for health assessments.
90.5 Acting on requests.
90.6 Notification of determination to conduct a health assessment in 
          response to a request from the public.
90.7 Decision to conduct health effects study.
90.8 Conduct of health assessments and health effects studies.
90.9 Public health advisory.
90.10 Notice and comment period.
90.11 Reporting of results of health assessments and health effects 
          studies.
90.12 Confidentiality of information.
90.13 Recordkeeping requirements.
90.14 Documentation and cost recovery.

    Authority: 42 U.S.C. 9615; 42 U.S.C. 6939a(c).

    Source: 55 FR 5138, Feb. 13, 1990, unless otherwise noted.



Sec.  90.1  Purpose and applicability.

    The provisions of this part set forth the policies and procedures of 
the Agency for Toxic Substances and Disease Registry (ATSDR) with 
respect to its conduct of health assessments and health effects studies 
under section 104(i) of Comprehensive Environmental Response, 
Compensation, and Liability Act, as amended by the Superfund Amendments 
and Reauthorization Act of 1986, and section 3019 of the Resource 
Conservation and Recovery Act. These provisions apply to ATSDR, as well 
as its contractors, agents, and those carrying out health assessments 
and health effects studies pursuant to agreements with ATSDR, such as 
other Federal agencies and States.



Sec.  90.2  Definitions.

    Administrator means the Administrator of the Agency for Toxic 
Substances and Disease Registry or designee.
    ATSDR means the Agency for Toxic Substances and Disease Registry, 
Public Health Service, U.S. Department of Health and Human Services.
    CERCLA means the Comprehensive Environmental Response, Compensation, 
and Liability Act of 1980 (42 U.S.C. 9601 et seq., Pub. L. 96-520), as 
amended by the Superfund Amendments and Reauthorization Act of 1986 
(Pub. L. 99-499).
    EPA means the U.S. Environmental Protection Agency.
    Facility is defined in 42 U.S.C. 9601(9).
    Hazardous substance is defined in 42 U.S.C. 9601(14). In addition, 
the term includes any pollutant or contaminant which the Administrator 
determines is appropriate for the purposes of carrying out his or her 
responsibilities under CERCLA.
    Health assessment means the evaluation of data and information on 
the release of hazardous substances into the environment in order to 
assess any current or future impact on public health, develop health 
advisories or other recommendations, and identify studies or actions 
needed to evaluate and mitigate or prevent human health effects.
    Health effects study means research, investigation, or study 
performed by ATSDR or other parties pursuant to an agreement with ATSDR 
to evaluate the health effects of exposure to hazardous substances at 
specific sites. This term includes, but is not limited to, 
epidemiological studies, exposure and disease registries, and health 
surveillance programs. This term does not include health assessments.
    Owner or operator is defined in 42 U.S.C. 9601(20).
    Peer review means review for scientific quality by a panel 
consisting of no less than three nor more than seven members, who shall 
be disinterested scientific experts selected by the Administrator of 
ATSDR on the basis of their reputation for scientific objectivity and 
the lack of institutional ties

[[Page 728]]

with any person involved in the conduct of the study or research under 
review.
    Person means an individual, firm, corporation, association, 
partnership, consortium, joint venture, commercial entity, United States 
Government, State, municipality, commission, political subdivision of a 
State, Indian tribe, or any interstate body.
    Pollutant or contaminant is defined in 42 U.S.C. 9601(33).
    Public health advisory is a statement by ATSDR containing a finding 
that a release poses a significant risk to human health and recommending 
measures to be taken to reduce exposure and eliminate or substantially 
mitigate the significant risk to human health.
    Release is defined in 42 U.S.C. 9601(22).



Sec.  90.3  Procedures for requesting health assessments.

    (a) ATSDR will accept requests to perform health assessments for a 
particular facility or release from any person or group of persons.
    (b) All requests to ATSDR to perform health assessments should be 
addressed to: Assistant Administrator, Agency for Toxic Substances and 
Disease Registry, 1600 Clifton Road NE., Atlanta, GA 30333.



Sec.  90.4  Contents of requests for health assessments.

    (a) Each request for a health assessment shall contain:
    (1) The name, address (including zip code), and telephone number of 
the requestor;
    (2) The organization or group the requestor represents, if any;
    (3) The name, location, and description of the facility or release 
of concern;
    (4) A statement providing information that individuals have been 
exposed to a hazardous substance and that the probable source is a 
release, or sufficient information to allow the Administrator to make 
such a finding;
    (5) A statement requesting ATSDR to perform a health assessment.
    (b) At his or her discretion, consistent with the requirements of 
CERCLA, the Administrator may decide not to require the preceding 
information be submitted with a request for a health assessment.
    (c) Each request for a health assessment should include, where 
possible:
    (1) Any other information pertaining to the facility or release, 
such as the nature and amount of the hazardous substances of concern or 
the identities of parties believed to be potentially responsible for the 
release;
    (2) Potential pathways for human exposure, including a description 
of the media contaminated (e.g. soil, groundwater, air, etc.);
    (3) The demographic nature and proximity of the potentially affected 
human population; and
    (4) Other Federal, State, or local governmental agencies which were 
notified or that investigated the facility or release.
    (d) This data collection has been reviewed and approved by OMB in 
accordance with the Paperwork Reduction Act and assigned the control 
number 0920-0204.



Sec.  90.5  Acting on requests.

    (a) Upon receipt of a request for a health assessment submitted 
under this part, ATSDR will determine, in its discretion, whether or not 
there is a reasonable basis to justify conducting a health assessment. 
ATSDR will base this determination on, among other factors:
    (1) Whether individuals have been exposed to a hazardous substance, 
for which the probable source of such exposure is a release;
    (2) The location, concentration, and toxicity of the hazardous 
substances;
    (3) The potential for further human exposure;
    (4) The recommendations of other governmental agencies; and
    (5) The ATSDR resources available and other ATSDR priorities, such 
as its responsibilities to conduct other health assessments and health 
effects studies.
    (b) Where appropriate, ATSDR will request information from other 
Federal, State, and local governmental agencies, as well as other 
persons, pertaining to a facility or release which is the subject of a 
request from the public to ATSDR to conduct a health assessment.

[[Page 729]]

    (c) The requestor will be notified in writing of ATSDR's 
determination that either a health assessment will be performed, a 
health assessment will not be performed, or that further information 
concerning the facility or release is required before a decision can be 
made whether a health assessment will be performed.
    (d) If a health assessment is not initiated in response to a request 
from the public, ATSDR shall provide a written explanation to the 
requestor of why a health assessment is not appropriate.



Sec.  90.6  Notification of determination to conduct a health assessment 
in response to a request from the public.

    (a) Following a determination by ATSDR to conduct a health 
assessment in response to a request from the public, ATSDR shall notify 
in writing, at a minimum, the following parties of its intent to perform 
a health assessment:
    (1) The U.S. Environmental Protection Agency;
    (2) The appropriate State government environmental agency;
    (3) The appropriate State and local health departments;
    (4) The requestor;
    (5) The owner or operator of the facility of concern, if their 
identity is readily available to ATSDR.

In addition, ATSDR will notify, in writing or by telephone, other 
potentially responsible parties, if their identity is readily available 
to ATSDR.
    (b) At its discretion, ATSDR may notify any other persons which it 
feels may be affected by the release or have information pertaining to 
the release.



Sec.  90.7  Decision to conduct health effects study.

    (a) ATSDR may decide, in its discretion, based upon the results of a 
health assessment or other available information, to conduct a health 
effects study for a particular site or sites. Such a decision may, in 
appropriate circumstances, be made prior to the completion of a health 
assessment for a site or sites. When deciding whether to conduct a 
health effects study, ATSDR will consider such factors as the results 
and recommendations of a health assessment for the site or sites and the 
need for additional information to determine whether individuals have 
been exposed to hazardous substances, the degree to which such exposure 
has occurred, and any possible health effects resulting from such 
exposure.
    (b) Should ATSDR decide, in its discretion, to conduct a health 
effect study, it will notify the parties as specified in Sec.  90.6.



Sec.  90.8  Conduct of health assessments and health effects studies.

    (a) Any interested person or persons may submit data or information 
to ATSDR for it to consider in its conduct of a health assessment or a 
health effects study. In performing a health assessment or a health 
effects study, ATSDR will consider data and information it has 
independently generated or received from other parties, such as EPA, 
other Federal agencies, State and local governmental agencies, 
businesses, citizen organizations, and community groups.
    (b) ATSDR may determine it is necessary to conduct a site visit in 
connection with a health assessment or health effects study. The ATSDR 
representative may allow the participation of any person in the site 
visit which he or she, at his or her discretion, determines will aid in 
the conduct of the health assessment or health effects study.
    (c) In the event that the information necessary to perform a health 
assessment or health effects study is not readily available from other 
sources, ATSDR may arrange for sampling or additional data gathering at 
a facility or release for the limited purpose of determining the 
existence of current or potential health problems.



Sec.  90.9  Public health advisory.

    ATSDR may issue a public health advisory based on the findings of a 
health assessment, health effects, study, or other ATSDR involvement.



Sec.  90.10  Notice and comment period.

    Following internal review by ATSDR and external peer review of a 
draft final report of the results of a health effects study, ATSDR will 
publish a notice that the draft final report is available for public 
review and comment. At

[[Page 730]]

a minimum, the notice shall be published in at least one newspaper of 
general distribution in the local where the site is located. The notice 
shall describe how copies of the draft final report of the health 
effects study can be obtained and set a reasonable time period for 
interested persons to submit comments concerning the study. ATSDR may, 
at its discretion, respond in writing to comments it receives.



Sec.  90.11  Reporting of results of health assessments 
and health effects studies.

    (a) ATSDR shall provide a report of the results of a health 
assessment or health effects study to EPA, the appropriate State and 
local governmental agencies, any person requesting ATSDR to conduct the 
health assessment, and parties potentially responsible for the release, 
if their identity is readily available to ATSDR. In addition, such 
reports shall be available to the general public upon request.
    (b) In the event that ATSDR or its representatives conduct medical 
examinations of individuals in the course of a health effects study and 
the examination reveals a positive significant medical finding, the 
individual, and a physician if designated by the individual, will be 
promptly notified of that significant medical finding by ATSDR.
    (c) A summary of the findings of all medical examinations for each 
individual will be sent by ATSDR to that individual.
    (d) All studies and results of research conducted under this part 
(other than health assessments) shall be reported or adopted only after 
appropriate peer review.



Sec.  90.12  Confidentiality of information.

    (a) ATSDR shall consider any medical information in individually 
identifiable form to be confidential information and shall release such 
information only in accordance with the Privacy Act (5 U.S.C. 552a) or 
other applicable Federal law.
    (b) As provided under section 104(e)(7) of CERCLA, any records, 
reports, or information obtained from any person under this section 
shall be available to the public, except that upon a showing 
satisfactory to ATSDR by any person that records, reports, or 
information, or particular part thereof (other than health or safety 
effects data), to which any officer, employee, or representative of 
ATSDR has access under this part if made public would divulge 
information entitled to protection under the Trade Secrets Act (18 
U.S.C. 1905), such information or particular portion thereof shall be 
considered confidential in accordance with the purposes of that section, 
except that such record, report, document, or information may be 
disclosed to other officers, employees, or authorized representatives of 
the United States concerned with carrying out statutorily mandated 
duties.
    (c) In submitting data to ATSDR, a person may designate the data 
which such person believes is entitled to protection under paragraph (b) 
of this section and submit such designated data separately from other 
data submitted under this part. A designation under this paragraph shall 
be made in writing to the Administrator. However, should ATSDR at any 
time question such designation, not less than 15 days notice to the 
person sumitting the information shall be given of the intention to 
remove such trade secret designation from such information. The person 
may submit a request to the Administrator to reconsider this intention 
and may provide additional information in support of the trade secret 
designation. The Administrator shall notify the person in writing of the 
decision which will become effective no sooner than 15 days after the 
date of such notice.



Sec.  90.13  Recordkeeping requirements.

    (a) ATSDR shall maintain a record of all health assessments and 
health effects studies. The Administrator shall, at his or her 
discretion, determine the contents of the record. At a minimum, the 
record shall include:
    (1) The final ATSDR report of the health assessment or health 
effects study;
    (2) Nonconfidential data and other information upon which that 
report is based or which was considered by ATSDR;

[[Page 731]]

    (3) Nonconfidential data or other information submitted by 
interested persons pertaining to the health assessment or health effects 
study;
    (4) The protocol for the health effects study;
    (5) A list of the individuals responsible for external peer review 
of the report of a health effects study, their comments, and ATSDR's 
response to the comments; and
    (6) For health effects study, the notice announcing the availability 
of a draft final report for public review and comment, all comments 
received in response to the notice, and any responses to the comments by 
ATSDR.
    (b) The record may contain a confidential portion which shall 
include all information determined to be confidential by the 
Administrator under this part.
    (c) The Administrator may determine other documents are appropriate 
for inclusion in the record for health assessments or health effects 
studies.
    (d) Predecisional documents, including draft documents, are not 
documents upon which ATSDR bases its conclusions in health assessments 
or health effects studies, and are not usually included in the record 
for health assessments or health effects studies.
    (e) The record for ATSDR health assessments and health effects 
studies will be available for review, upon prior request, at ATSDR 
headquarters in Atlanta, Georgia.
    (f) Nothing in this section is intended to imply that ATSDR's 
decisions to conduct health assessments or health effects studies, or 
the reports of health assessments or health effects studies, are subject 
to judicial review.



Sec.  90.14  Documentation and cost recovery.

    (a) During all phases of ATSDR health assessments and health effects 
studies, documentation shall be completed and maintained to form the 
basis for cost recovery, as specified in section 107 of CERCLA.
    (b) Where appropriate, the information and reports compiled by ATSDR 
pertaining to costs shall be forwarded to the appropriate EPA regional 
office for cost recovery purposes.



PART 93_PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT--
Table of Contents



Sec.
93.25 Organization of this part.
93.50 Special terms.

                            Subpart A_General

93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Evidentiary standards.
93.107 Rule of interpretation.
93.108 Confidentiality.
93.109 Coordination with other agencies.

                          Subpart B_Definitions

93.200 Administrative action.
93.201 Allegation.
93.202 Charge letter.
93.203 Complainant.
93.204 Contract.
93.205 Debarment or suspension.
93.206 Debarring official.
93.207 Departmental Appeals Board or DAB.
93.208 Evidence.
93.209 Funding component.
93.210 Good faith.
93.211 Hearing.
93.212 Inquiry.
93.213 Institution.
93.214 Institutional member
93.215 Investigation.
93.216 Notice.
93.217 Office of Research Integrity or ORI.
93.218 Person.
93.219 Preponderance of the evidence.
93.220 Public Health Service or PHS.
93.221 PHS support.
93.222 Research.
93.223 Research misconduct proceeding.
93.224 Research record.
93.225 Respondent.
93.226 Retaliation.
93.227 Secretary or HHS.

               Subpart C_Responsibilities of Institutions

                        Compliance and Assurances

93.300 General responsibilities for compliance.
93.301 Institutional assurances.
93.302 Institutional compliance with assurances.
93.303 Assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 Responsibility for maintenance and custody of research records 
          and evidence.

[[Page 732]]

93.306 Using a consortium or person for research misconduct proceedings.

                        The Institutional Inquiry

93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an investigation.

                     The Institutional Investigation

93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Institutional investigation report.
93.314 Institutional appeals.
93.315 Notice to ORI of institutional findings and actions.
93.316 Completing the research misconduct process.

                  Other Institutional Responsibilities

93.317 Retention and custody of the research misconduct proceeding 
          record.
93.318 Notifying ORI of special circumstances.
93.319 Institutional standards.

 Subpart D_Responsibilities of the U.S. Department of Health and Human 
                                Services

                           General Information

93.400 General statement of ORI authority.
93.401 Interaction with other offices and interim actions.

                       Research Misconduct Issues

93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 Findings of research misconduct and proposed administrative 
          actions.
93.405 Notifying the respondent of findings of research misconduct and 
          HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research 
          misconduct.
93.411 Final HHS action with a settlement or finding of misconduct.

                     Institutional Compliance Issues

93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.

                        Disclosure of Information

93.414 Notice.

Subpart E_Opportunity To Contest ORI Findings of Research Misconduct and 
                       HHS Administrative Actions

                           General Information

93.500 General policy.
93.501 Opportunity to contest findings of research misconduct and 
          administrative actions.

                             Hearing Process

93.502 Appointment of the Administrative Law Judge and scientific 
          expert.
93.503 Grounds for granting a hearing request.
93.504 Grounds for dismissal of a hearing request.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge.
93.507 Ex parte communications.
93.508 Filing, forms, and service.
93.509 Computation of time.
93.510 Filing motions.
93.511 Prehearing conferences.
93.512 Discovery.
93.513 Submission of witness lists, witness statements, and exhibits.
93.514 Amendment to the charge letter.
93.515 Actions for violating an order or for disruptive conduct.
93.516 Standard and burden of proof.
93.517 The hearing.
93.518 Witnesses.
93.519 Admissibility of evidence.
93.520 The record.
93.521 Correction of the transcript.
93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge's ruling.

    Authority: 42 U.S.C. 216, 241, and 289b.

    Source: 70 FR 28384, May 17, 2005, unless otherwise noted.



Sec.  93.25  Organization of this part.

    This part is subdivided into five subparts. Each subpart contains 
information related to a broad topic or specific audience with special 
responsibilities as shown in the following table.

------------------------------------------------------------------------
                                     You will find provisions related to
         In subpart . . .                           . . .
------------------------------------------------------------------------
A.................................  General information about this rule.
B.................................  Definitions of terms used in this
                                     part.
C.................................  Responsibilities of institutions
                                     with PHS support.
D.................................  Responsibilities of the U.S.
                                     Department of Health and Human
                                     Services and the Office of Research
                                     Integrity.

[[Page 733]]

 
E.................................  Information on how to contest ORI
                                     research misconduct findings and
                                     HHS administrative actions.
------------------------------------------------------------------------



Sec.  93.50  Special terms.

    This part uses terms throughout the text that have special meaning. 
Those terms are defined in Subpart B of this part.



                            Subpart A_General



Sec.  93.100  General policy.

    (a) Research misconduct involving PHS support is contrary to the 
interests of the PHS and the Federal government and to the health and 
safety of the public, to the integrity of research, and to the 
conservation of public funds.
    (b) The U.S. Department of Health and Human Services (HHS) and 
institutions that apply for or receive Public Health Service (PHS) 
support for biomedical or behavioral research, biomedical or behavioral 
research training, or activities related to that research or research 
training share responsibility for the integrity of the research process. 
HHS has ultimate oversight authority for PHS supported research, and for 
taking other actions as appropriate or necessary, including the right to 
assess allegations and perform inquiries or investigations at any time. 
Institutions and institutional members have an affirmative duty to 
protect PHS funds from misuse by ensuring the integrity of all PHS 
supported work, and primary responsibility for responding to and 
reporting allegations of research misconduct, as provided in this part.



Sec.  93.101  Purpose.

    The purpose of this part is to--
    (a) Establish the responsibilities of HHS, PHS, the Office of 
Research Integrity (ORI), and institutions in responding to research 
misconduct issues;
    (b) Define what constitutes misconduct in PHS supported research;
    (c) Define the general types of administrative actions HHS and the 
PHS may take in response to research misconduct; and
    (d) Require institutions to develop and implement policies and 
procedures for--
    (1) Reporting and responding to allegations of research misconduct 
covered by this part;
    (2) Providing HHS with the assurances necessary to permit the 
institutions to participate in PHS supported research.
    (e) Protect the health and safety of the public, promote the 
integrity of PHS supported research and the research process, and 
conserve public funds.



Sec.  93.102  Applicability.

    (a) Each institution that applies for or receives PHS support for 
biomedical or behavioral research, research training or activities 
related to that research or research training must comply with this 
part.
    (b)(1) This part applies to allegations of research misconduct and 
research misconduct involving:
    (i) Applications or proposals for PHS support for biomedical or 
behavioral extramural or intramural research, research training or 
activities related to that research or research training, such as the 
operation of tissue and data banks and the dissemination of research 
information;
    (ii) PHS supported biomedical or behavioral extramural or intramural 
research;
    (iii) PHS supported biomedical or behavioral extramural or 
intramural research training programs;
    (iv) PHS supported extramural or intramural activities that are 
related to biomedical or behavioral research or research training, such 
as the operation of tissue and data banks or the dissemination of 
research information; and
    (v) Plagiarism of research records produced in the course of PHS 
supported research, research training or activities related to that 
research or research training.
    (2) This includes any research proposed, performed, reviewed, or 
reported, or any research record generated from that research, 
regardless of whether an application or proposal for

[[Page 734]]

PHS funds resulted in a grant, contract, cooperative agreement, or other 
form of PHS support.
    (c) This part does not supersede or establish an alternative to any 
existing regulations or procedures for handling fiscal improprieties, 
the ethical treatment of human or animal subjects, criminal matters, 
personnel actions against Federal employees, or actions taken under the 
HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR 
subparts 9.4 and 309.4.
    (d) This part does not prohibit or otherwise limit how institutions 
handle allegations of misconduct that do not fall within this part's 
definition of research misconduct or that do not involve PHS support.



Sec.  93.103  Research misconduct.

    Research misconduct means fabrication, falsification, or plagiarism 
in proposing, performing, or reviewing research, or in reporting 
research results.
    (a) Fabrication is making up data or results and recording or 
reporting them.
    (b) Falsification is manipulating research materials, equipment, or 
processes, or changing or omitting data or results such that the 
research is not accurately represented in the research record.
    (c) Plagiarism is the appropriation of another person's ideas, 
processes, results, or words without giving appropriate credit.
    (d) Research misconduct does not include honest error or differences 
of opinion.



Sec.  93.104  Requirements for findings of research misconduct.

    A finding of research misconduct made under this part requires 
that--
    (a) There be a significant departure from accepted practices of the 
relevant research community; and
    (b) The misconduct be committed intentionally, knowingly, or 
recklessly; and
    (c) The allegation be proven by a preponderance of the evidence.



Sec.  93.105  Time limitations.

    (a) Six-year limitation. This part applies only to research 
misconduct occurring within six years of the date HHS or an institution 
receives an allegation of research misconduct.
    (b) Exceptions to the six-year limitation. Paragraph (a) of this 
section does not apply in the following instances:
    (1) Subsequent use exception. The respondent continues or renews any 
incident of alleged research misconduct that occurred before the six-
year limitation through the citation, republication or other use for the 
potential benefit of the respondent of the research record that is 
alleged to have been fabricated, falsified, or plagiarized.
    (2) Health or safety of the public exception. If ORI or the 
institution, following consultation with ORI, determines that the 
alleged misconduct, if it occurred, would possibly have a substantial 
adverse effect on the health or safety of the public.
    (3) ``Grandfather'' exception. If HHS or an institution received the 
allegation of research misconduct before the effective date of this 
part.



Sec.  93.106  Evidentiary standards.

    The following evidentiary standards apply to findings made under 
this part.
    (a) Standard of proof. An institutional or HHS finding of research 
misconduct must be proved by a preponderance of the evidence.
    (b) Burden of proof. (1) The institution or HHS has the burden of 
proof for making a finding of research misconduct. The destruction, 
absence of, or respondent's failure to provide research records 
adequately documenting the questioned research is evidence of research 
misconduct where the institution or HHS establishes by a preponderance 
of the evidence that the respondent intentionally, knowingly, or 
recklessly had research records and destroyed them, had the opportunity 
to maintain the records but did not do so, or maintained the records and 
failed to produce them in a timely manner and that the respondent's 
conduct constitutes a significant departure from accepted practices of 
the relevant research community.
    (2) The respondent has the burden of going forward with and the 
burden of proving, by a preponderance of the evidence, any and all 
affirmative defenses raised. In determining whether HHS or the 
institution has carried the burden

[[Page 735]]

of proof imposed by this part, the finder of fact shall give due 
consideration to admissible, credible evidence of honest error or 
difference of opinion presented by the respondent.
    (3) The respondent has the burden of going forward with and proving 
by a preponderance of the evidence any mitigating factors that are 
relevant to a decision to impose administrative actions following a 
research misconduct proceeding.



Sec.  93.107  Rule of interpretation.

    Any interpretation of this part must further the policy and purpose 
of the HHS and the Federal government to protect the health and safety 
of the public, to promote the integrity of research, and to conserve 
public funds.



Sec.  93.108  Confidentiality.

    (a) Disclosure of the identity of respondents and complainants in 
research misconduct proceedings is limited, to the extent possible, to 
those who need to know, consistent with a thorough, competent, objective 
and fair research misconduct proceeding, and as allowed by law. 
Provided, however, that:
    (1) The institution must disclose the identity of respondents and 
complainants to ORI pursuant to an ORI review of research misconduct 
proceedings under Sec.  93.403.
    (2) Under Sec.  93.517(g), HHS administrative hearings must be open 
to the public.
    (b) Except as may otherwise be prescribed by applicable law, 
confidentiality must be maintained for any records or evidence from 
which research subjects might be identified. Disclosure is limited to 
those who have a need to know to carry out a research misconduct 
proceeding.



Sec.  93.109  Coordination with other agencies.

    (a) When more than one agency of the Federal government has 
jurisdiction of the subject misconduct allegation, HHS will cooperate in 
designating a lead agency to coordinate the response of the agencies to 
the allegation. Where HHS is not the lead agency, it may, in 
consultation with the lead agency, take appropriate action to protect 
the health and safety of the public, promote the integrity of the PHS 
supported research and research process and conserve public funds.
    (b) In cases involving more than one agency, HHS may refer to 
evidence or reports developed by that agency if HHS determines that the 
evidence or reports will assist in resolving HHS issues. In appropriate 
cases, HHS will seek to resolve allegations jointly with the other 
agency or agencies.



                          Subpart B_Definitions



Sec.  93.200  Administrative action.

    Administrative action means--
    (a) An HHS action in response to a research misconduct proceeding 
taken to protect the health and safety of the public, to promote the 
integrity of PHS supported biomedical or behavioral research, research 
training, or activities related to that research or research training 
and to conserve public funds; or
    (b) An HHS action in response either to a breach of a material 
provision of a settlement agreement in a research misconduct proceeding 
or to a breach of any HHS debarment or suspension.



Sec.  93.201  Allegation.

    Allegation means a disclosure of possible research misconduct 
through any means of communication. The disclosure may be by written or 
oral statement or other communication to an institutional or HHS 
official.



Sec.  93.202  Charge letter.

    Charge letter means the written notice, as well as any amendments to 
the notice, that are sent to the respondent stating the findings of 
research misconduct and any HHS administrative actions. If the charge 
letter includes a debarment or suspension action, it may be issued 
jointly by the ORI and the debarring official.



Sec.  93.203  Complainant.

    Complainant means a person who in good faith makes an allegation of 
research misconduct.

[[Page 736]]



Sec.  93.204  Contract.

    Contract means an acquisition instrument awarded under the HHS 
Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any 
small purchases awarded pursuant to FAR Part 13.



Sec.  93.205  Debarment or suspension.

    Debarment or suspension means the Government wide exclusion, whether 
temporary or for a set term, of a person from eligibility for Federal 
grants, contracts, and cooperative agreements under the HHS regulations 
at 45 CFR part 76 (nonprocurement) and 48 CFR subparts 9.4 and 309.4 
(procurement).



Sec.  93.206  Debarring official.

    Debarring official means an official authorized to impose debarment 
or suspension. The HHS debarring official is either--
    (a) The Secretary; or
    (b) An official designated by the Secretary.



Sec.  93.207  Departmental Appeals Board or DAB.

    Departmental Appeals Board or DAB means, depending on the context--
    (a) The organization, within the Office of the Secretary, 
established to conduct hearings and provide impartial review of disputed 
decisions made by HHS operating components; or
    (b) An Administrative Law Judge (ALJ) at the DAB.



Sec.  93.208  Evidence.

    Evidence means any document, tangible item, or testimony offered or 
obtained during a research misconduct proceeding that tends to prove or 
disprove the existence of an alleged fact.



Sec.  93.209  Funding component.

    Funding component means any organizational unit of the PHS 
authorized to award grants, contracts, or cooperative agreements for any 
activity that involves the conduct of biomedical or behavioral research, 
research training or activities related to that research or research 
training, e.g., agencies, bureaus, centers, institutes, divisions, or 
offices and other awarding units within the PHS.



Sec.  93.210  Good faith.

    Good faith as applied to a complainant or witness, means having a 
belief in the truth of one's allegation or testimony that a reasonable 
person in the complainant's or witness's position could have based on 
the information known to the complainant or witness at the time. An 
allegation or cooperation with a research misconduct proceeding is not 
in good faith if made with knowing or reckless disregard for information 
that would negate the allegation or testimony. Good faith as applied to 
a committee member means cooperating with the research misconduct 
proceeding by carrying out the duties assigned impartially for the 
purpose of helping an institution meet its responsibilities under this 
part. A committee member does not act in good faith if his/her acts or 
omissions on the committee are dishonest or influenced by personal, 
professional, or financial conflicts of interest with those involved in 
the research misconduct proceeding.



Sec.  93.211  Hearing.

    Hearing means that part of the research misconduct proceeding from 
the time a respondent files a request for an administrative hearing to 
contest ORI findings of research misconduct and HHS administrative 
actions until the time the ALJ issues a recommended decision.



Sec.  93.212  Inquiry.

    Inquiry means preliminary information-gathering and preliminary 
fact-finding that meets the criteria and follows the procedures of 
Sec. Sec.  93.307-93.309.



Sec.  93.213  Institution.

    Institution means any individual or person that applies for or 
receives PHS support for any activity or program that involves the 
conduct of biomedical or behavioral research, biomedical or behavioral 
research training, or activities related to that research or training. 
This includes, but is not limited to colleges and universities, PHS 
intramural biomedical or

[[Page 737]]

behavioral research laboratories, research and development centers, 
national user facilities, industrial laboratories or other research 
institutes, small research institutions, and independent researchers.



Sec.  93.214  Institutional member.

    Institutional member or members means a person who is employed by, 
is an agent of, or is affiliated by contract or agreement with an 
institution. Institutional members may include, but are not limited to, 
officials, tenured and untenured faculty, teaching and support staff, 
researchers, research coordinators, clinical technicians, postdoctoral 
and other fellows, students, volunteers, agents, and contractors, 
subcontractors, and subawardees, and their employees.



Sec.  93.215  Investigation.

    Investigation means the formal development of a factual record and 
the examination of that record leading to a decision not to make a 
finding of research misconduct or to a recommendation for a finding of 
research misconduct which may include a recommendation for other 
appropriate actions, including administrative actions.



Sec.  93.216  Notice.

    Notice means a written communication served in person, sent by mail 
or its equivalent to the last known street address, facsimile number or 
e-mail address of the addressee. Several sections of Subpart E of this 
part have special notice requirements.



Sec.  93.217  Office of Research Integrity or ORI.

    Office of Research Integrity or ORI means the office to which the 
HHS Secretary has delegated responsibility for addressing research 
integrity and misconduct issues related to PHS supported activities.



Sec.  93.218  Person.

    Person means any individual, corporation, partnership, institution, 
association, unit of government, or legal entity, however organized.



Sec.  93.219  Preponderance of the evidence.

    Preponderance of the evidence means proof by information that, 
compared with that opposing it, leads to the conclusion that the fact at 
issue is more probably true than not.



Sec.  93.220  Public Health Service or PHS.

    Public Health Service or PHS means the unit within the Department of 
Health and Human Services that includes the Office of Public Health and 
Science and the following Operating Divisions: Agency for Healthcare 
Research and Quality, Agency for Toxic Substances and Disease Registry, 
Centers for Disease Control and Prevention, Food and Drug 
Administration, Health Resources and Services Administration, Indian 
Health Service, National Institutes of Health, and the Substance Abuse 
and Mental Health Services Administration, and the offices of the 
Regional Health Administrators.



Sec.  93.221  PHS support.

    PHS support means PHS funding, or applications or proposals 
therefor, for biomedical or behavioral research, biomedical or 
behavioral research training, or activities related to that research or 
training, that may be provided through: Funding for PHS intramural 
research; PHS grants, cooperative agreements, or contracts or subgrants 
or subcontracts under those PHS funding instruments; or salary or other 
payments under PHS grants, cooperative agreements or contracts.



Sec.  93.222  Research.

    Research means a systematic experiment, study, evaluation, 
demonstration or survey designed to develop or contribute to general 
knowledge (basic research) or specific knowledge (applied research) 
relating broadly to public health by establishing, discovering, 
developing, elucidating or confirming information about, or the 
underlying mechanism relating to, biological causes, functions or 
effects, diseases, treatments, or related matters to be studied.

[[Page 738]]



Sec.  93.223  Research misconduct proceeding.

    Research misconduct proceeding means any actions related to alleged 
research misconduct taken under this part, including but not limited to, 
allegation assessments, inquiries, investigations, ORI oversight 
reviews, hearings, and administrative appeals.



Sec.  93.224  Research record.

    Research record means the record of data or results that embody the 
facts resulting from scientific inquiry, including but not limited to, 
research proposals, laboratory records, both physical and electronic, 
progress reports, abstracts, theses, oral presentations, internal 
reports, journal articles, and any documents and materials provided to 
HHS or an institutional official by a respondent in the course of the 
research misconduct proceeding.



Sec.  93.225  Respondent.

    Respondent means the person against whom an allegation of research 
misconduct is directed or who is the subject of a research misconduct 
proceeding.



Sec.  93.226  Retaliation.

    Retaliation for the purpose of this part means an adverse action 
taken against a complainant, witness, or committee member by an 
institution or one of its members in response to--
    (a) A good faith allegation of research misconduct; or
    (b) Good faith cooperation with a research misconduct proceeding.



Sec.  93.227  Secretary or HHS.

    Secretary or HHS means the Secretary of HHS or any other officer or 
employee of the HHS to whom the Secretary delegates authority.



               Subpart C_Responsibilities of Institutions

                        Compliance and Assurances



Sec.  93.300  General responsibilities for compliance.

    Institutions under this part must--
    (a) Have written policies and procedures for addressing allegations 
of research misconduct that meet the requirements of this part;
    (b) Respond to each allegation of research misconduct for which the 
institution is responsible under this part in a thorough, competent, 
objective and fair manner, including precautions to ensure that 
individuals responsible for carrying out any part of the research 
misconduct proceeding do not have unresolved personal, professional or 
financial conflicts of interest with the complainant, respondent or 
witnesses;
    (c) Foster a research environment that promotes the responsible 
conduct of research, research training, and activities related to that 
research or research training, discourages research misconduct, and 
deals promptly with allegations or evidence of possible research 
misconduct;
    (d) Take all reasonable and practical steps to protect the positions 
and reputations of good faith complainants, witnesses and committee 
members and protect them from retaliation by respondents and other 
institutional members;
    (e) Provide confidentiality to the extent required by Sec.  93.108 
to all respondents, complainants, and research subjects identifiable 
from research records or evidence;
    (f) Take all reasonable and practical steps to ensure the 
cooperation of respondents and other institutional members with research 
misconduct proceedings, including, but not limited to, their providing 
information, research records, and evidence;
    (g) Cooperate with HHS during any research misconduct proceeding or 
compliance review;
    (h) Assist in administering and enforcing any HHS administrative 
actions imposed on its institutional members; and
    (i) Have an active assurance of compliance.



Sec.  93.301  Institutional assurances.

    (a) General policy. An institution with PHS supported biomedical or 
behavioral research, research training or activities related to that 
research or research training must provide PHS with an assurance of 
compliance with this part, satisfactory to the Secretary.

[[Page 739]]

PHS funding components may authorize funds for biomedical and behavioral 
research, research training, or activities related to that research or 
research training only to institutions that have approved assurances and 
required renewals on file with ORI.
    (b) Institutional Assurance. The responsible institutional official 
must assure on behalf of the institution that the institution--
    (1) Has written policies and procedures in compliance with this part 
for inquiring into and investigating allegations of research misconduct; 
and
    (2) Complies with its own policies and procedures and the 
requirements of this part.



Sec.  93.302  Institutional compliance with assurances.

    (a) Compliance with assurance. ORI considers an institution in 
compliance with its assurance if the institution--
    (1) Establishes policies and procedures according to this part, 
keeps them in compliance with this part, and upon request, provides them 
to ORI, other HHS personnel, and members of the public;
    (2) Takes all reasonable and practical specific steps to foster 
research integrity consistent with Sec.  93.300, including--
    (i) Informs the institution's research members participating in or 
otherwise involved with PHS supported biomedical or behavioral research, 
research training or activities related to that research or research 
training, including those applying for support from any PHS funding 
component, about its policies and procedures for responding to 
allegations of research misconduct, and the institution's commitment to 
compliance with the policies and procedures; and
    (ii) Complies with its policies and procedures and each specific 
provision of this part.
    (b) Annual report. An institution must file an annual report with 
ORI which contains information specified by ORI on the institution's 
compliance with this part.
    (c) Additional information. Along with its assurance or annual 
report, an institution must send ORI such other aggregated information 
as ORI may request on the institution's research misconduct proceedings 
covered by this part and the institution's compliance with the 
requirements of this part.



Sec.  93.303  Assurances for small institutions.

    (a) If an institution is too small to handle research misconduct 
proceedings, it may file a ``Small Organization Statement'' with ORI in 
place of the formal institutional policies and procedures required by 
Sec. Sec.  93.301 and 93.304.
    (b) By submitting a Small Organization Statement, the institution 
agrees to report all allegations of research misconduct to ORI. ORI or 
another appropriate HHS office will work with the institution to develop 
and implement a process for handling allegations of research misconduct 
consistent with this part.
    (c) The Small Organization Statement does not relieve the 
institution from complying with any other provision of this part.



Sec.  93.304  Institutional policies and procedures.

    Institutions seeking an approved assurance must have written 
policies and procedures for addressing research misconduct that include 
the following--
    (a) Consistent with Sec.  93.108, protection of the confidentiality 
of respondents, complainants, and research subjects identifiable from 
research records or evidence;
    (b) A thorough, competent, objective, and fair response to 
allegations of research misconduct consistent with and within the time 
limits of this part, including precautions to ensure that individuals 
responsible for carrying out any part of the research misconduct 
proceeding do not have unresolved personal, professional, or financial 
conflicts of interest with the complainant, respondent, or witnesses;
    (c) Notice to the respondent, consistent with and within the time 
limits of this part;
    (d) Written notice to ORI of any decision to open an investigation 
on or before the date on which the investigation begins;

[[Page 740]]

    (e) Opportunity for the respondent to provide written comments on 
the institution's inquiry report;
    (f) Opportunity for the respondent to provide written comments on 
the draft report of the investigation, and provisions for the 
institutional investigation committee to consider and address the 
comments before issuing the final report;
    (g) Protocols for handling the research record and evidence, 
including the requirements of Sec.  93.305;
    (h) Appropriate interim institutional actions to protect public 
health, Federal funds and equipment, and the integrity of the PHS 
supported research process;
    (i) Notice to ORI under Sec.  93.318 and notice of any facts that 
may be relevant to protect public health, Federal funds and equipment, 
and the integrity of the PHS supported research process;
    (j) Institutional actions in response to final findings of research 
misconduct;
    (k) All reasonable and practical efforts, if requested and as 
appropriate, to protect or restore the reputation of persons alleged to 
have engaged in research misconduct but against whom no finding of 
research misconduct is made;
    (l) All reasonable and practical efforts to protect or restore the 
position and reputation of any complainant, witness, or committee member 
and to counter potential or actual retaliation against these 
complainants, witnesses, and committee members; and
    (m) Full and continuing cooperation with ORI during its oversight 
review under Subpart D of this part or any subsequent administrative 
hearings or appeals under Subpart E of this part. This includes 
providing all research records and evidence under the institution's 
control, custody, or possession and access to all persons within its 
authority necessary to develop a complete record of relevant evidence.



Sec.  93.305  Responsibility for maintenance and custody 
of research records and evidence.

    An institution, as the responsible legal entity for the PHS 
supported research, has a continuing obligation under this part to 
ensure that it maintains adequate records for a research misconduct 
proceeding. The institution must--
    (a) Either before or when the institution notifies the respondent of 
the allegation, inquiry or investigation, promptly take all reasonable 
and practical steps to obtain custody of all the research records and 
evidence needed to conduct the research misconduct proceeding, inventory 
the records and evidence, and sequester them in a secure manner, except 
that where the research records or evidence encompass scientific 
instruments shared by a number of users, custody may be limited to 
copies of the data or evidence on such instruments, so long as those 
copies are substantially equivalent to the evidentiary value of the 
instruments;
    (b) Where appropriate, give the respondent copies of, or reasonable, 
supervised access to the research records;
    (c) Undertake all reasonable and practical efforts to take custody 
of additional research records or evidence that is discovered during the 
course of a research misconduct proceeding, except that where the 
research records or evidence encompass scientific instruments shared by 
a number of users, custody may be limited to copies of the data or 
evidence on such instruments, so long as those copies are substantially 
equivalent to the evidentiary value of the instruments; and
    (d) Maintain the research records and evidence as required by Sec.  
93.317.



Sec.  93.306  Using a consortium or other person for research 
misconduct proceedings.

    (a) An institution may use the services of a consortium or person 
that the institution reasonably determines to be qualified by practice 
and experience to conduct research misconduct proceedings.
    (b) A consortium may be a group of institutions, professional 
organizations, or mixed groups which will conduct research misconduct 
proceedings for other institutions.
    (c) A consortium or person acting on behalf of an institution must 
follow the requirements of this part in conducting research misconduct 
proceedings.

[[Page 741]]

                        The Institutional Inquiry



Sec.  93.307  Institutional inquiry.

    (a) Criteria warranting an inquiry. An inquiry is warranted if the 
allegation--
    (1) Falls within the definition of research misconduct under this 
part;
    (2) Is within Sec.  93.102; and
    (3) Is sufficiently credible and specific so that potential evidence 
of research misconduct may be identified.
    (b) Notice to respondent and custody of research records. At the 
time of or before beginning an inquiry, an institution must make a good 
faith effort to notify in writing the presumed respondent, if any. If 
the inquiry subsequently identifies additional respondents, the 
institution must notify them. To the extent it has not already done so 
at the allegation stage, the institution must, on or before the date on 
which the respondent is notified or the inquiry begins, whichever is 
earlier, promptly take all reasonable and practical steps to obtain 
custody of all the research records and evidence needed to conduct the 
research misconduct proceeding, inventory the records and evidence, and 
sequester them in a secure manner, except that where the research 
records or evidence encompass scientific instruments shared by a number 
of users, custody may be limited to copies of the data or evidence on 
such instruments, so long as those copies are substantially equivalent 
to the evidentiary value of the instruments.
    (c) Review of evidence. The purpose of an inquiry is to conduct an 
initial review of the evidence to determine whether to conduct an 
investigation. Therefore, an inquiry does not require a full review of 
all the evidence related to the allegation.
    (d) Criteria warranting an investigation. An inquiry's purpose is to 
decide if an allegation warrants an investigation. An investigation is 
warranted if there is--
    (1) A reasonable basis for concluding that the allegation falls 
within the definition of research misconduct under this part and 
involves PHS supported biomedical or behavioral research, research 
training or activities related to that research or research training, as 
provided in Sec.  93.102; and
    (2) Preliminary information-gathering and preliminary fact-finding 
from the inquiry indicates that the allegation may have substance.
    (e) Inquiry report. The institution must prepare a written report 
that meets the requirements of this section and Sec.  93.309.
    (f) Opportunity to comment. The institution must provide the 
respondent an opportunity to review and comment on the inquiry report 
and attach any comments received to the report.
    (g) Time for completion. The institution must complete the inquiry 
within 60 calendar days of its initiation unless circumstances clearly 
warrant a longer period. If the inquiry takes longer than 60 days to 
complete, the inquiry record must include documentation of the reasons 
for exceeding the 60-day period.



Sec.  93.308  Notice of the results of the inquiry.

    (a) Notice to respondent. The institution must notify the respondent 
whether the inquiry found that an investigation is warranted. The notice 
must include a copy of the inquiry report and include a copy of or refer 
to this part and the institution's policies and procedures adopted under 
its assurance.
    (b) Notice to complainants. The institution may notify the 
complainant who made the allegation whether the inquiry found that an 
investigation is warranted. The institution may provide relevant 
portions of the report to the complainant for comment.



Sec.  93.309  Reporting to ORI on the decision to initiate an investigation.

    (a) Within 30 days of finding that an investigation is warranted, 
the institution must provide ORI with the written finding by the 
responsible institutional official and a copy of the inquiry report 
which includes the following information--
    (1) The name and position of the respondent;
    (2) A description of the allegations of research misconduct;
    (3) The PHS support, including, for example, grant numbers, grant 
applications, contracts, and publications listing PHS support;

[[Page 742]]

    (4) The basis for recommending that the alleged actions warrant an 
investigation; and
    (5) Any comments on the report by the respondent or the complainant.
    (b) The institution must provide the following information to ORI on 
request--
    (1) The institutional policies and procedures under which the 
inquiry was conducted;
    (2) The research records and evidence reviewed, transcripts or 
recordings of any interviews, and copies of all relevant documents; and
    (3) The charges for the investigation to consider.
    (c) Documentation of decision not to investigate. Institutions must 
keep sufficiently detailed documentation of inquiries to permit a later 
assessment by ORI of the reasons why the institution decided not to 
conduct an investigation. Consistent with Sec.  93.317, institutions 
must keep these records in a secure manner for at least 7 years after 
the termination of the inquiry, and upon request, provide them to ORI or 
other authorized HHS personnel.
    (d) Notification of special circumstances. In accordance with Sec.  
93.318, institutions must notify ORI and other PHS agencies, as 
relevant, of any special circumstances that may exist.

                     The Institutional Investigation



Sec.  93.310  Institutional investigation.

    Institutions conducting research misconduct investigations must:
    (a) Time. Begin the investigation within 30 days after determining 
that an investigation is warranted.
    (b) Notice to ORI. Notify the ORI Director of the decision to begin 
an investigation on or before the date the investigation begins and 
provide an inquiry report that meets the requirements of Sec.  93.307 
and Sec.  93.309.
    (c) Notice to the respondent. Notify the respondent in writing of 
the allegations within a reasonable amount of time after determining 
that an investigation is warranted, but before the investigation begins. 
The institution must give the respondent written notice of any new 
allegations of research misconduct within a reasonable amount of time of 
deciding to pursue allegations not addressed during the inquiry or in 
the initial notice of investigation.
    (d) Custody of the records. To the extent they have not already done 
so at the allegation or inquiry stages, take all reasonable and 
practical steps to obtain custody of all the research records and 
evidence needed to conduct the research misconduct proceeding, inventory 
the records and evidence, and sequester them in a secure manner, except 
that where the research records or evidence encompass scientific 
instruments shared by a number of users, custody may be limited to 
copies of the data or evidence on such instruments, so long as those 
copies are substantially equivalent to the evidentiary value of the 
instruments. Whenever possible, the institution must take custody of the 
records--
    (1) Before or at the time the institution notifies the respondent; 
and
    (2) Whenever additional items become known or relevant to the 
investigation.
    (e) Documentation. Use diligent efforts to ensure that the 
investigation is thorough and sufficiently documented and includes 
examination of all research records and evidence relevant to reaching a 
decision on the merits of the allegations.
    (f) Ensuring a fair investigation. Take reasonable steps to ensure 
an impartial and unbiased investigation to the maximum extent 
practicable, including participation of persons with appropriate 
scientific expertise who do not have unresolved personal, professional, 
or financial conflicts of interest with those involved with the inquiry 
or investigation.
    (g) Interviews. Interview each respondent, complainant, and any 
other available person who has been reasonably identified as having 
information regarding any relevant aspects of the investigation, 
including witnesses identified by the respondent, and record or 
transcribe each interview, provide the recording or transcript to the 
interviewee for correction, and include the recording or transcript in 
the record of the investigation.
    (h) Pursue leads. Pursue diligently all significant issues and leads 
discovered

[[Page 743]]

that are determined relevant to the investigation, including any 
evidence of additional instances of possible research misconduct, and 
continue the investigation to completion.



Sec.  93.311  Investigation time limits.

    (a) Time limit for completing an investigation. An institution must 
complete all aspects of an investigation within 120 days of beginning 
it, including conducting the investigation, preparing the report of 
findings, providing the draft report for comment in accordance with 
Sec.  93.312, and sending the final report to ORI under Sec.  93.315.
    (b) Extension of time limit. If unable to complete the investigation 
in 120 days, the institution must ask ORI for an extension in writing.
    (c) Progress reports. If ORI grants an extension, it may direct the 
institution to file periodic progress reports.



Sec.  93.312  Opportunity to comment on the investigation report.

    (a) The institution must give the respondent a copy of the draft 
investigation report and, concurrently, a copy of, or supervised access 
to, the evidence on which the report is based. The comments of the 
respondent on the draft report, if any, must be submitted within 30 days 
of the date on which the respondent received the draft investigation 
report.
    (b) The institution may provide the complainant a copy of the draft 
investigation report or relevant portions of that report. The comments 
of the complainant, if any, must be submitted within 30 days of the date 
on which the complainant received the draft investigation report or 
relevant portions of it.



Sec.  93.313  Institutional investigation report.

    The final institutional investigation report must be in writing and 
include:
    (a) Allegations. Describe the nature of the allegations of research 
misconduct.
    (b) PHS support. Describe and document the PHS support, including, 
for example, any grant numbers, grant applications, contracts, and 
publications listing PHS support.
    (c) Institutional charge. Describe the specific allegations of 
research misconduct for consideration in the investigation.
    (d) Policies and procedures. If not already provided to ORI with the 
inquiry report, include the institutional policies and procedures under 
which the investigation was conducted.
    (e) Research records and evidence. Identify and summarize the 
research records and evidence reviewed, and identify any evidence taken 
into custody but not reviewed.
    (f) Statement of findings. For each separate allegation of research 
misconduct identified during the investigation, provide a finding as to 
whether research misconduct did or did not occur, and if so--
    (1) Identify whether the research misconduct was falsification, 
fabrication, or plagiarism, and if it was intentional, knowing, or in 
reckless disregard;
    (2) Summarize the facts and the analysis which support the 
conclusion and consider the merits of any reasonable explanation by the 
respondent;
    (3) Identify the specific PHS support;
    (4) Identify whether any publications need correction or retraction;
    (5) Identify the person(s) responsible for the misconduct; and
    (6) List any current support or known applications or proposals for 
support that the respondent has pending with non-PHS Federal agencies.
    (g) Comments. Include and consider any comments made by the 
respondent and complainant on the draft investigation report.
    (h) Maintain and provide records. Maintain and provide to ORI upon 
request all relevant research records and records of the institution's 
research misconduct proceeding, including results of all interviews and 
the transcripts or recordings of such interviews.



Sec.  93.314  Institutional appeals.

    (a) While not required by this part, if the institution's procedures 
provide for an appeal by the respondent that could result in a reversal 
or modification of the findings of research misconduct in the 
investigation report, the institution must complete any such appeal 
within 120 days of its filing. Appeals from personnel or similar actions 
that

[[Page 744]]

would not result in a reversal or modification of the findings of 
research misconduct are excluded from the 120-day limit.
    (b) If unable to complete any appeals within 120 days, the 
institution must ask ORI for an extension in writing and provide an 
explanation for the request.
    (c) ORI may grant requests for extension for good cause. If ORI 
grants an extension, it may direct the institution to file periodic 
progress reports.



Sec.  93.315  Notice to ORI of institutional findings and actions.

    The institution must give ORI the following:
    (a) Investigation Report. Include a copy of the report, all 
attachments, and any appeals.
    (b) Final institutional action. State whether the institution found 
research misconduct, and if so, who committed the misconduct.
    (c) Findings. State whether the institution accepts the 
investigation's findings.
    (d) Institutional administrative actions. Describe any pending or 
completed administrative actions against the respondent.



Sec.  93.316  Completing the research misconduct process.

    (a) ORI expects institutions to carry inquiries and investigations 
through to completion and to pursue diligently all significant issues. 
An institution must notify ORI in advance if the institution plans to 
close a case at the inquiry, investigation, or appeal stage on the basis 
that the respondent has admitted guilt, a settlement with the respondent 
has been reached, or for any other reason, except the closing of a case 
at the inquiry stage on the basis that an investigation is not warranted 
or a finding of no misconduct at the investigation stage, which must be 
reported to ORI under Sec.  93.315.
    (b) After consulting with the institution on its basis for closing a 
case under paragraph (a) of this section, ORI may conduct an oversight 
review of the institution's handling of the case and take appropriate 
action including:
    (1) Approving or conditionally approving closure of the case;
    (2) Directing the institution to complete its process;
    (3) Referring the matter for further investigation by HHS; or,
    (4) Taking a compliance action.

                  Other Institutional Responsibilities



Sec.  93.317  Retention and custody of the research misconduct 
proceeding record.

    (a) Definition of records of research misconduct proceedings. As 
used in this section, the term ``records of research misconduct 
proceedings'' includes:
    (1) The records that the institution secures for the proceeding 
pursuant to Sec. Sec.  93.305, 93.307(b) and 93.310(d), except to the 
extent the institution subsequently determines and documents that those 
records are not relevant to the proceeding or that the records duplicate 
other records that are being retained;
    (2) The documentation of the determination of irrelevant or 
duplicate records;
    (3) The inquiry report and final documents (not drafts) produced in 
the course of preparing that report, including the documentation of any 
decision not to investigate as required by Sec.  93.309(d);
    (4) The investigation report and all records (other than drafts of 
the report) in support of that report, including the recordings or 
transcriptions of each interview conducted pursuant to Sec.  93.310(g); 
and
    (5) The complete record of any institutional appeal covered by Sec.  
93.314.
    (b) Maintenance of record. Unless custody has been transferred to 
HHS under paragraph (c) of this section, or ORI has advised the 
institution in writing that it no longer needs to retain the records, an 
institution must maintain records of research misconduct proceedings in 
a secure manner for 7 years after completion of the proceeding or the 
completion of any PHS proceeding involving the research misconduct 
allegation under subparts D and E of this part, whichever is later.
    (c) Provision for HHS custody. On request, institutions must 
transfer custody of or provide copies to HHS, of any institutional 
record relevant to a research misconduct allegation covered by this 
part, including the research

[[Page 745]]

records and evidence, to perform forensic or other analyses or as 
otherwise needed to conduct an HHS inquiry or investigation or for ORI 
to conduct its review or to present evidence in any proceeding under 
subparts D and E of this part.



Sec.  93.318  Notifying ORI of special circumstances.

    At any time during a research misconduct proceeding, as defined in 
Sec.  93.223, an institution must notify ORI immediately if it has 
reason to believe that any of the following conditions exist:
    (a) Health or safety of the public is at risk, including an 
immediate need to protect human or animal subjects.
    (b) HHS resources or interests are threatened.
    (c) Research activities should be suspended.
    (d) There is reasonable indication of possible violations of civil 
or criminal law.
    (e) Federal action is required to protect the interests of those 
involved in the research misconduct proceeding.
    (f) The research institution believes the research misconduct 
proceeding may be made public prematurely so that HHS may take 
appropriate steps to safeguard evidence and protect the rights of those 
involved.
    (g) The research community or public should be informed.



Sec.  93.319  Institutional standards.

    (a) Institutions may have internal standards of conduct different 
from the HHS standards for research misconduct under this part. 
Therefore, an institution may find conduct to be actionable under its 
standards even if the action does not meet this part's definition of 
research misconduct.
    (b) An HHS finding or settlement does not affect institutional 
findings or administrative actions based on an institution's internal 
standards of conduct.



 Subpart D_Responsibilities of the U.S. Department of Health and Human 
                                Services

                           General Information



Sec.  93.400  General statement of ORI authority.

    (a) ORI review. ORI may respond directly to any allegation of 
research misconduct at any time before, during, or after an 
institution's response to the matter. The ORI response may include, but 
is not limited to--
    (1) Conducting allegation assessments;
    (2) Determining independently if jurisdiction exists under this part 
in any matter;
    (3) Forwarding allegations of research misconduct to the appropriate 
institution or HHS component for inquiry or investigation;
    (4) Recommending that HHS should perform an inquiry or investigation 
or issue findings and taking all appropriate actions in response to the 
inquiry, investigation, or findings;
    (5) Notifying or requesting assistance and information from PHS 
funding components or other affected Federal and state offices and 
agencies or institutions;
    (6) Reviewing an institution's findings and process;
    (7) Making a finding of research misconduct; and
    (8) Proposing administrative actions to HHS.
    (b) Requests for information. ORI may request clarification or 
additional information, documentation, research records, or evidence 
from an institution or its members or other persons or sources to carry 
out ORI's review.
    (c) HHS administrative actions. (1) In response to a research 
misconduct proceeding, ORI may propose administrative actions against 
any person to the HHS and, upon HHS approval and final action in 
accordance with this part, implement the actions.
    (2) ORI may propose to the HHS debarring official that a person be 
suspended or debarred from receiving Federal funds and may propose to 
other appropriate PHS components the implementation of HHS 
administrative

[[Page 746]]

actions within the components' authorities.
    (d) ORI assistance to institutions. At any time, ORI may provide 
information, technical assistance, and procedural advice to 
institutional officials as needed regarding an institution's 
participation in research misconduct proceedings.
    (e) Review of institutional assurances. ORI may review institutional 
assurances and policies and procedures for compliance with this part.
    (f) Institutional compliance. ORI may make findings and impose HHS 
administrative actions related to an institution's compliance with this 
part and with its policies and procedures, including an institution's 
participation in research misconduct proceedings.



Sec.  93.401  Interaction with other offices and interim actions.

    (a) ORI may notify and consult with other offices at any time if it 
has reason to believe that a research misconduct proceeding may involve 
that office. If ORI believes that a criminal or civil fraud violation 
may have occurred, it shall promptly refer the matter to the Department 
of Justice (DOJ), the HHS Inspector General (OIG), or other appropriate 
investigative body. ORI may provide expertise and assistance to the DOJ, 
OIG, PHS offices, other Federal offices, and state or local offices 
involved in investigating or otherwise pursuing research misconduct 
allegations or related matters.
    (b) ORI may notify affected PHS offices and funding components at 
any time to permit them to make appropriate interim responses to protect 
the health and safety of the public, to promote the integrity of the PHS 
supported research and research process, and to conserve public funds.
    (c) The information provided will not be disclosed as part of the 
peer review and advisory committee review processes, but may be used by 
the Secretary in making decisions about the award or continuation of 
funding.

                       Research Misconduct Issues



Sec.  93.402  ORI allegation assessments.

    (a) When ORI receives an allegation of research misconduct directly 
or becomes aware of an allegation or apparent instance of research 
misconduct, it may conduct an initial assessment or refer the matter to 
the relevant institution for an assessment, inquiry, or other 
appropriate actions.
    (b) If ORI conducts an assessment, it considers whether the 
allegation of research misconduct appears to fall within the definition 
of research misconduct, appears to involve PHS supported biomedical or 
behavior research, research training or activities related to that 
research or research training, as provided in Sec.  93.102, and whether 
it is sufficiently specific so that potential evidence may be identified 
and sufficiently substantive to warrant an inquiry. ORI may review all 
readily accessible, relevant information related to the allegation.
    (c) If ORI decides that an inquiry is warranted, it forwards the 
matter to the appropriate institution or HHS component.
    (d) If ORI decides that an inquiry is not warranted it will close 
the case and forward the allegation in accordance with paragraph (e) of 
this section.
    (e) ORI may forward allegations that do not fall within the 
jurisdiction of this part to the appropriate HHS component, Federal or 
State agency, institution, or other appropriate entity.



Sec.  93.403  ORI review of research misconduct proceedings.

    ORI may conduct reviews of research misconduct proceedings. In 
conducting its review, ORI may--
    (a) Determine whether there is HHS jurisdiction under this part;
    (b) Consider any reports, institutional findings, research records, 
and evidence;
    (c) Determine if the institution conducted the proceedings in a 
timely and fair manner in accordance with this part with sufficient 
thoroughness, objectivity, and competence to support the conclusions;

[[Page 747]]

    (d) Obtain additional information or materials from the institution, 
the respondent, complainants, or other persons or sources;
    (e) Conduct additional analyses and develop evidence;
    (f) Decide whether research misconduct occurred, and if so who 
committed it;
    (g) Make appropriate research misconduct findings and propose HHS 
administrative actions; and
    (h) Take any other actions necessary to complete HHS' review.



Sec.  93.404  Findings of research misconduct and proposed 
administrative actions.

    After completing its review, ORI either closes the case without a 
finding of research misconduct or--
    (a) Makes findings of research misconduct and proposes and obtains 
HHS approval of administrative actions based on the record of the 
research misconduct proceedings and any other information obtained by 
ORI during its review; or
    (b) Recommends that HHS seek to settle the case.



Sec.  93.405  Notifying the respondent of findings of research misconduct 
and HHS administrative actions.

    (a) When the ORI makes a finding of research misconduct or seeks to 
impose or enforce HHS administrative actions, other than debarment or 
suspension, it notifies the respondent in a charge letter. In cases 
involving a debarment or suspension action, the HHS debarring official 
issues a notice of proposed debarment or suspension to the respondent as 
part of the charge letter. The charge letter includes the ORI findings 
of research misconduct and the basis for them and any HHS administrative 
actions. The letter also advises the respondent of the opportunity to 
contest the findings and administrative actions under Subpart E of this 
part.
    (b) The ORI sends the charge letter by certified mail or a private 
delivery service to the last known address of the respondent or the last 
known principal place of business of the respondent's attorney.



Sec.  93.406  Final HHS actions.

    Unless the respondent contests the charge letter within the 30-day 
period prescribed in Sec.  93.501, the ORI finding of research 
misconduct is the final HHS action on the research misconduct issues and 
the HHS administrative actions become final and will be implemented, 
except that the debarring official's decision is the final HHS action on 
any debarment or suspension actions.



Sec.  93.407  HHS administrative actions.

    (a) In response to a research misconduct proceeding, HHS may impose 
HHS administrative actions that include but are not limited to:
    (1) Clarification, correction, or retraction of the research record.
    (2) Letters of reprimand.
    (3) Imposition of special certification or assurance requirements to 
ensure compliance with applicable regulations or terms of PHS grants, 
contracts, or cooperative agreements.
    (4) Suspension or termination of a PHS grant, contract, or 
cooperative agreement.
    (5) Restriction on specific activities or expenditures under an 
active PHS grant, contract, or cooperative agreement.
    (6) Special review of all requests for PHS funding.
    (7) Imposition of supervision requirements on a PHS grant, contract, 
or cooperative agreement.
    (8) Certification of attribution or authenticity in all requests for 
support and reports to the PHS.
    (9) No participation in any advisory capacity to the PHS.
    (10) Adverse personnel action if the respondent is a Federal 
employee, in compliance with relevant Federal personnel policies and 
laws.
    (11) Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts 
9.4 and 309.4, or both.
    (b) In connection with findings of research misconduct, HHS also may 
seek to recover PHS funds spent in support of the activities that 
involved research misconduct.
    (c) Any authorized HHS component may impose, administer, or enforce 
HHS administrative actions separately or in coordination with other HHS

[[Page 748]]

components, including, but not limited to ORI, the Office of Inspector 
General, the PHS funding component, and the debarring official.



Sec.  93.408  Mitigating and aggravating factors in HHS administrative actions.

    The purpose of HHS administrative actions is remedial. The 
appropriate administrative action is commensurate with the seriousness 
of the misconduct, and the need to protect the health and safety of the 
public, promote the integrity of the PHS supported research and research 
process, and conserve public funds. HHS considers aggravating and 
mitigating factors in determining appropriate HHS administrative actions 
and their terms. HHS may consider other factors as appropriate in each 
case. The existence or nonexistence of any factor is not determinative:
    (a) Knowing, intentional, or reckless. Were the respondent's actions 
knowing or intentional or was the conduct reckless?
    (b) Pattern. Was the research misconduct an isolated event or part 
of a continuing or prior pattern of dishonest conduct?
    (c) Impact. Did the misconduct have significant impact on the 
proposed or reported research record, research subjects, other 
researchers, institutions, or the public health or welfare?
    (d) Acceptance of responsibility. Has the respondent accepted 
responsibility for the misconduct by--
    (1) Admitting the conduct;
    (2) Cooperating with the research misconduct proceedings;
    (3) Demonstrating remorse and awareness of the significance and 
seriousness of the research misconduct; and
    (4) Taking steps to correct or prevent the recurrence of the 
research misconduct.
    (e) Failure to accept responsibility. Does the respondent blame 
others rather than accepting responsibility for the actions?
    (f) Retaliation. Did the respondent retaliate against complainants, 
witnesses, committee members, or other persons?
    (g) Present responsibility. Is the respondent presently responsible 
to conduct PHS supported research?
    (h) Other factors. Other factors appropriate to the circumstances of 
a particular case.



Sec.  93.409  Settlement of research misconduct proceedings.

    (a) HHS may settle a research misconduct proceeding at any time it 
concludes that settlement is in the best interests of the Federal 
government and the public health or welfare.
    (b) Settlement agreements are publicly available, regardless of 
whether the ORI made a finding of research misconduct.



Sec.  93.410  Final HHS action with no settlement or finding 
of research misconduct.

    When the final HHS action does not result in a settlement or finding 
of research misconduct, ORI may:
    (a) Provide written notice to the respondent, the relevant 
institution, the complainant, and HHS officials.
    (b) Take any other actions authorized by law.



Sec.  93.411  Final HHS action with settlement or finding 
of research misconduct.

    When a final HHS action results in a settlement or research 
misconduct finding, ORI may:
    (a) Provide final notification of any research misconduct findings 
and HHS administrative actions to the respondent, the relevant 
institution, the complainant, and HHS officials. The debarring official 
may provide a separate notice of final HHS action on any debarment or 
suspension actions.
    (b) Identify publications which require correction or retraction and 
prepare and send a notice to the relevant journal.
    (c) Publish notice of the research misconduct findings.
    (d) Notify the respondent's current employer.
    (e) Take any other actions authorized by law.

[[Page 749]]

                     Institutional Compliance Issues



Sec.  93.412  Making decisions on institutional noncompliance.

    (a) Institutions must foster a research environment that discourages 
misconduct in all research and that deals forthrightly with possible 
misconduct associated with PHS supported research.
    (b) ORI may decide that an institution is not compliant with this 
part if the institution shows a disregard for, or inability or 
unwillingness to implement and follow the requirements of this part and 
its assurance. In making this decision, ORI may consider, but is not 
limited to the following factors--
    (1) Failure to establish and comply with policies and procedures 
under this part;
    (2) Failure to respond appropriately when allegations of research 
misconduct arise;
    (3) Failure to report to ORI all investigations and findings of 
research misconduct under this part;
    (4) Failure to cooperate with ORI's review of research misconduct 
proceedings; or
    (5) Other actions or omissions that have a material, adverse effect 
on reporting and responding to allegations of research misconduct.



Sec.  93.413  HHS compliance actions.

    (a) An institution's failure to comply with its assurance and the 
requirements of this part may result in enforcement action against the 
institution.
    (b) ORI may address institutional deficiencies through technical 
assistance if the deficiencies do not substantially affect compliance 
with this part.
    (c) If an institution fails to comply with its assurance and the 
requirements of this part, HHS may take some or all of the following 
compliance actions:
    (1) Issue a letter of reprimand.
    (2) Direct that research misconduct proceedings be handled by HHS.
    (3) Place the institution on special review status.
    (4) Place information on the institutional noncompliance on the ORI 
Web site.
    (5) Require the institution to take corrective actions.
    (6) Require the institution to adopt and implement an institutional 
integrity agreement.
    (7) Recommend that HHS debar or suspend the entity.
    (8) Any other action appropriate to the circumstances.
    (d) If the institution's actions constitute a substantial or 
recurrent failure to comply with this part, ORI may also revoke the 
institution's assurance under Sec. Sec.  93.301 or 93.303.
    (e) ORI may make public any findings of institutional noncompliance 
and HHS compliance actions.

                        Disclosure of Information



Sec.  93.414  Notice.

    (a) ORI may disclose information to other persons for the purpose of 
providing or obtaining information about research misconduct as 
permitted under the Privacy Act, 5 U.S.C. 552a.
    (b) ORI may publish a notice of final agency findings of research 
misconduct, settlements, and HHS administrative actions and release and 
withhold information as permitted by the Privacy Act and the Freedom of 
Information Act, 5 U.S.C. 552.



Subpart E_Opportunity To Contest ORI Findings of Research Misconduct and 
                       HHS Administrative Actions

                           General Information



Sec.  93.500  General policy.

    (a) This subpart provides a respondent an opportunity to contest ORI 
findings of research misconduct and HHS administrative actions, 
including debarment or suspension, arising under 42 U.S.C. 289b in 
connection with PHS supported biomedical and behavioral research, 
research training, or activities related to that research or research 
training.
    (b) A respondent has an opportunity to contest ORI research 
misconduct findings and HHS administrative actions under this part, 
including debarment or suspension, by requesting an

[[Page 750]]

administrative hearing before an Administrative Law Judge (ALJ) 
affiliated with the HHS DAB, when--
    (1) ORI has made a finding of research misconduct against a 
respondent; and
    (2) The respondent has been notified of those findings and any 
proposed HHS administrative actions, including debarment or suspension, 
in accordance with this part.
    (c) The ALJ's ruling on the merits of the ORI research misconduct 
findings and the HHS administrative actions is subject to review by the 
Assistant Secretary for Health in accordance with Sec.  93.523. The 
decision made under that section is the final HHS action, unless that 
decision results in a recommendation for debarment or suspension. In 
that case, the decision under Sec.  93.523 shall constitute findings of 
fact to the debarring official in accordance with 45 CFR 76.845(c).
    (d) Where a proposed debarment or suspension action is based upon an 
ORI finding of research misconduct, the procedures in this part provide 
the notification, opportunity to contest, and fact-finding required 
under the HHS debarment and suspension regulations at 45 CFR part 76, 
subparts H and G, respectively, and 48 CFR Subparts 9.4 and 309.4.



Sec.  93.501  Opportunity to contest findings of research misconduct 
and administrative actions.

    (a) Opportunity to contest. A respondent may contest ORI findings of 
research misconduct and HHS administrative actions, including any 
debarment or suspension action, by requesting a hearing within 30 days 
of receipt of the charge letter or other written notice provided under 
Sec.  93.405.
    (b) Form of a request for hearing. The respondent's request for a 
hearing must be--
    (1) In writing;
    (2) Signed by the respondent or by the respondent's attorney; and
    (3) Sent by certified mail, or other equivalent (i.e., with a 
verified method of delivery), to the DAB Chair and ORI.
    (c) Contents of a request for hearing. The request for a hearing 
must--
    (1) Admit or deny each finding of research misconduct and each 
factual assertion made in support of the finding;
    (2) Accept or challenge each proposed HHS administrative action;
    (3) Provide detailed, substantive reasons for each denial or 
challenge;
    (4) Identify any legal issues or defenses that the respondent 
intends to raise during the proceeding; and
    (5) Identify any mitigating factors that the respondent intends to 
prove.
    (d) Extension for good cause to supplement the hearing request. (1) 
After receiving notification of the appointment of the ALJ, the 
respondent has 10 days to submit a written request to the ALJ for 
supplementation of the hearing request to comply fully with the 
requirements of paragraph (c) of this section. The written request must 
show good cause in accordance with paragraph (d)(2) of this section and 
set forth the proposed supplementation of the hearing request. The ALJ 
may permit the proposed supplementation of the hearing request in whole 
or in part upon a finding of good cause.
    (2) Good cause means circumstances beyond the control of the 
respondent or respondent's representative and not attributable to 
neglect or administrative inadequacy.

                             Hearing Process



Sec.  93.502  Appointment of the Administrative Law Judge 
and scientific expert.

    (a) Within 30 days of receiving a request for a hearing, the DAB 
Chair, in consultation with the Chief Administrative Law Judge, must 
designate an Administrative Law Judge (ALJ) to determine whether the 
hearing request should be granted and, if the hearing request is 
granted, to make recommended findings in the case after a hearing or 
review of the administrative record in accordance with this part.
    (b) The ALJ may retain one or more persons with appropriate 
scientific or technical expertise to assist the ALJ in evaluating 
scientific or technical issues related to the findings of research 
misconduct.
    (1) On the ALJ's or a party's motion to appoint an expert, the ALJ 
must give the parties an opportunity to submit nominations. If such a 
motion is

[[Page 751]]

made by a party, the ALJ must appoint an expert, either:
    (i) The expert, if any, who is agreed upon by both parties and found 
to be qualified by the ALJ; or,
    (ii) If the parties cannot agree upon an expert, the expert chosen 
by the ALJ.
    (2) The ALJ may seek advice from the expert(s) at any time during 
the discovery and hearing phases of the proceeding. The expert(s) shall 
provide advice to the ALJ in the form of a written report or reports 
that will be served upon the parties within 10 days of submission to the 
ALJ. That report must contain a statement of the expert's background and 
qualifications. Any comment on or response to a report by a party, which 
may include comments on the expert's qualifications, must be submitted 
to the ALJ in accordance with Sec.  93.510(c). The written reports and 
any comment on, or response to them are part of the record. Expert 
witnesses of the parties may testify on the reports and any comments or 
responses at the hearing, unless the ALJ determines such testimony to be 
inadmissible in accordance with Sec.  93.519, or that such testimony 
would unduly delay the proceeding.
    (c) No ALJ, or person hired or appointed to assist the ALJ, may 
serve in any proceeding under this subpart if he or she has any real or 
apparent conflict of interest, bias, or prejudice that might reasonably 
impair his or her objectivity in the proceeding.
    (d) Any party to the proceeding may request the ALJ or scientific 
expert to withdraw from the proceeding because of a real or apparent 
conflict of interest, bias, or prejudice under paragraph (c) of this 
section. The motion to disqualify must be timely and state with 
particularity the grounds for disqualification. The ALJ may rule upon 
the motion or certify it to the Chief ALJ for decision. If the ALJ rules 
upon the motion, either party may appeal the decision to the Chief ALJ.
    (e) An ALJ must withdraw from any proceeding for any reason found by 
the ALJ or Chief ALJ to be disqualifying.



Sec.  93.503  Grounds for granting a hearing request.

    (a) The ALJ must grant a respondent's hearing request if the ALJ 
determines there is a genuine dispute over facts material to the 
findings of research misconduct or proposed administrative actions, 
including any debarment or suspension action. The respondent's general 
denial or assertion of error for each finding of research misconduct, 
and any basis for the finding, or for the proposed HHS administrative 
actions in the charge letter, is not sufficient to establish a genuine 
dispute.
    (b) The hearing request must specifically deny each finding of 
research misconduct in the charge letter, each basis for the finding and 
each HHS administrative action in the charge letter, or it is considered 
an admission by the respondent. If the hearing request does not 
specifically dispute the HHS administrative actions, including any 
debarment or suspension actions, they are considered accepted by the 
respondent.
    (c) If the respondent does not request a hearing within the 30-day 
time period prescribed in Sec.  93.501(a), the finding(s) and any 
administrative action(s), other than debarment or suspension actions, 
become final agency actions at the expiration of the 30-day period. 
Where there is a proposal for debarment or suspension, after the 
expiration of the 30-day time period the official record is closed and 
forwarded to the debarring official for a final decision.
    (d) If the ALJ grants the hearing request, the respondent may waive 
the opportunity for any in-person proceeding, and the ALJ may review and 
decide the case on the basis of the administrative record. The ALJ may 
grant a respondent's request that waiver of the in-person proceeding be 
conditioned upon the opportunity for respondent to file additional 
pleadings and documentation. ORI may also supplement the administrative 
record through pleadings, documents, in-person or telephonic testimony, 
and oral presentations.

[[Page 752]]



Sec.  93.504  Grounds for dismissal of a hearing request.

    (a) The ALJ must dismiss a hearing request if the respondent--
    (1) Does not file the request within 30 days after receiving the 
charge letter;
    (2) Does not raise a genuine dispute over facts or law material to 
the findings of research misconduct and any administrative actions, 
including debarment and suspension actions, in the hearing request or in 
any extension to supplement granted by the ALJ under Sec.  93.501(d);
    (3) Does not raise any issue which may properly be addressed in a 
hearing;
    (4) Withdraws or abandons the hearing request; or
    (b) The ALJ may dismiss a hearing request if the respondent fails to 
provide ORI with notice in the form and manner required by Sec.  93.501.



Sec.  93.505  Rights of the parties.

    (a) The parties to the hearing are the respondent and ORI. The 
investigating institution is not a party to the case, unless it is a 
respondent.
    (b) Except as otherwise limited by this subpart, the parties may--
    (1) Be accompanied, represented, and advised by an attorney;
    (2) Participate in any case-related conference held by the ALJ;
    (3) Conduct discovery of documents and other tangible items;
    (4) Agree to stipulations of fact or law that must be made part of 
the record;
    (5) File motions in writing before the ALJ;
    (6) Present evidence relevant to the issues at the hearing;
    (7) Present and cross-examine witnesses;
    (8) Present oral arguments;
    (9) Submit written post-hearing briefs, proposed findings of fact 
and conclusions of law, and reply briefs within reasonable time frames 
agreed upon by the parties or established by the ALJ as provided in 
Sec.  93.522; and
    (10) Submit materials to the ALJ and other parties under seal, or in 
redacted form, when necessary, to protect the confidentiality of any 
information contained in them consistent with this part, the Privacy 
Act, the Freedom of Information Act, or other Federal law or regulation.



Sec.  93.506  Authority of the Administrative Law Judge.

    (a) The ALJ assigned to the case must conduct a fair and impartial 
hearing, avoid unnecessary delay, maintain order, and assure that a 
complete and accurate record of the proceeding is properly made. The ALJ 
is bound by all Federal statutes and regulations, Secretarial 
delegations of authority, and applicable HHS policies and may not refuse 
to follow them or find them invalid, as provided in paragraph (c)(4) of 
this section. The ALJ has the authorities set forth in this part.
    (b) Subject to review as provided elsewhere in this subpart, the ALJ 
may--
    (1) Set and change the date, time, schedule, and place of the 
hearing upon reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences with the parties to identify or simplify the 
issues, or to consider other matters that may aid in the prompt 
disposition of the proceeding;
    (4) Administer oaths and affirmations;
    (5) Require the attendance of witnesses at a hearing;
    (6) Rule on motions and other procedural matters;
    (7) Require the production of documents and regulate the scope and 
timing of documentary discovery as permitted by this part;
    (8) Require each party before the hearing to provide the other party 
and the ALJ with copies of any exhibits that the party intends to 
introduce into evidence;
    (9) Issue a ruling, after an in camera inspection if necessary, to 
address the disclosure of any evidence or portion of evidence for which 
confidentiality is requested under this part or other Federal law or 
regulation, or which a party submitted under seal;
    (10) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;

[[Page 753]]

    (11) Examine witnesses and receive evidence presented at the 
hearing;
    (12) Admit, exclude, or limit evidence offered by a party;
    (13) Hear oral arguments on facts or law during or after the 
hearing;
    (14) Upon motion of a party, take judicial notice of facts;
    (15) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact;
    (16) Conduct any conference or oral argument in person, by 
telephone, or by audio-visual communication;
    (17) Take action against any party for failing to follow an order or 
procedure or for disruptive conduct.
    (c) The ALJ does not have the authority to--
    (1) Enter an order in the nature of a directed verdict;
    (2) Compel settlement negotiations;
    (3) Enjoin any act of the Secretary; or
    (4) Find invalid or refuse to follow Federal statutes or 
regulations, Secretarial delegations of authority, or HHS policies.



Sec.  93.507  Ex parte communications.

    (a) No party, attorney, or other party representative may 
communicate ex parte with the ALJ on any matter at issue in a case, 
unless both parties have notice and an opportunity to participate in the 
communication. However, a party, attorney, or other party representative 
may communicate with DAB staff about administrative or procedural 
matters.
    (b) If an ex parte communication occurs, the ALJ will disclose it to 
the other party and make it part of the record after the other party has 
an opportunity to comment.
    (c) The provisions of this section do not apply to communications 
between an employee or contractor of the DAB and the ALJ.



Sec.  93.508  Filing, forms, and service.

    (a) Filing. (1) Unless the ALJ provides otherwise, all submissions 
required or authorized to be filed in the proceeding must be filed with 
the ALJ.
    (2) Submissions are considered filed when they are placed in the 
mail, transmitted to a private delivery service for the purpose of 
delivering the item to the ALJ, or submitted in another manner 
authorized by the ALJ.
    (b) Forms. (1) Unless the ALJ provides otherwise, all submissions 
filed in the proceeding must include an original and two copies. The ALJ 
may designate the format for copies of nondocumentary materials such as 
videotapes, computer disks, or physical evidence. This provision does 
not apply to the charge letter or other written notice provided under 
Sec.  93.405.
    (2) Every submission filed in the proceeding must include the title 
of the case, the docket number, and a designation of the nature of the 
submission, such as a ``Motion to Compel the Production of Documents'' 
or ``Respondent's Proposed Exhibits.''
    (3) Every submission filed in the proceeding must be signed by and 
contain the address and telephone number of the party on whose behalf 
the document or paper was filed, or the attorney of record for the 
party.
    (c) Service. A party filing a submission with the ALJ must, at the 
time of filing, serve a copy on the other party. Service may be made 
either to the last known principal place of business of the party's 
attorney if the party is represented by an attorney, or, if not, to the 
party's last known address. Service may be made by--
    (1) Certified mail;
    (2) First-class postage prepaid U.S. Mail;
    (3) A private delivery service;
    (4) Hand-delivery; or
    (5) Facsimile or other electronic means if permitted by the ALJ.
    (d) Proof of service. Each party filing a document or paper with the 
ALJ must also provide proof of service at the time of the filing. Any of 
the following items may constitute proof of service:
    (1) A certified mail receipt returned by the postal service with a 
signature;
    (2) An official record of the postal service or private delivery 
service;
    (3) A certificate of service stating the method, place, date of 
service, and person served that is signed by an individual with personal 
knowledge of these facts; or
    (4) Other proof authorized by the ALJ.

[[Page 754]]



Sec.  93.509  Computation of time.

    (a) In computing any period of time under this part for filing and 
service or for responding to an order issued by the ALJ, the computation 
begins with the day following the act or event, and includes the last 
day of the period unless that day is a Saturday, Sunday, or legal 
holiday observed by the Federal government, in which case it includes 
the next business day.
    (b) When the period of time allowed is less than 7 days, 
intermediate Saturdays, Sundays, and legal holidays observed by the 
Federal government must be excluded from the computation.
    (c) Where a document has been filed by placing it in the mail, an 
additional 5 days must be added to the time permitted for any response. 
This paragraph does not apply to a respondent's request for hearing 
under Sec.  93.501.
    (d) Except for the respondent's request for a hearing, the ALJ may 
modify the time for the filing of any document or paper required or 
authorized under the rules in this part to be filed for good cause 
shown. When time permits, notice of a party's request for extension of 
the time and an opportunity to respond must be provided to the other 
party.



Sec.  93.510  Filing motions.

    (a) Parties must file all motions and requests for an order or 
ruling with the ALJ, serve them on the other party, state the nature of 
the relief requested, provide the legal authority relied upon, and state 
the facts alleged.
    (b) All motions must be in writing except for those made during a 
prehearing conference or at the hearing.
    (c) Within 10 days after being served with a motion, or other time 
as set by the ALJ, a party may file a response to the motion. The moving 
party may not file a reply to the responsive pleading unless allowed by 
the ALJ.
    (d) The ALJ may not grant a motion before the time for filing a 
response has expired, except with the parties' consent or after a 
hearing on the motion. However, the ALJ may overrule or deny any motion 
without awaiting a response.
    (e) The ALJ must make a reasonable effort to dispose of all motions 
promptly, and, whenever possible, dispose of all outstanding motions 
before the hearing.



Sec.  93.511  Prehearing conferences.

    (a) The ALJ must schedule an initial prehearing conference with the 
parties within 30 days of the DAB Chair's assignment of the case.
    (b) The ALJ may use the initial prehearing conference to discuss--
    (1) Identification and simplification of the issues, specification 
of disputes of fact and their materiality to the ORI findings of 
research misconduct and any HHS administrative actions, and amendments 
to the pleadings, including any need for a more definite statement;
    (2) Stipulations and admissions of fact including the contents, 
relevancy, and authenticity of documents;
    (3) Respondent's waiver of an administrative hearing, if any, and 
submission of the case on the basis of the administrative record as 
provided in Sec.  93.503(d);
    (4) Identification of legal issues and any need for briefing before 
the hearing;
    (5) Identification of evidence, pleadings, and other materials, if 
any, that the parties should exchange before the hearing;
    (6) Identification of the parties' witnesses, the general nature of 
their testimony, and the limitation on the number of witnesses and the 
scope of their testimony;
    (7) Scheduling dates such as the filing of briefs on legal issues 
identified in the charge letter or the respondent's request for hearing, 
the exchange of witness lists, witness statements, proposed exhibits, 
requests for the production of documents, and objections to proposed 
witnesses and documents;
    (8) Scheduling the time, place, and anticipated length of the 
hearing; and
    (9) Other matters that may encourage the fair, just, and prompt 
disposition of the proceedings.
    (c) The ALJ may schedule additional prehearing conferences as 
appropriate, upon reasonable notice to or request of the parties.
    (d) All prehearing conferences will be audio-taped with copies 
provided to the parties upon request.

[[Page 755]]

    (e) Whenever possible, the ALJ must memorialize in writing any oral 
rulings within 10 days after the prehearing conference.
    (f) By 15 days before the scheduled hearing date, the ALJ must hold 
a final prehearing conference to resolve to the maximum extent possible 
all outstanding issues about evidence, witnesses, stipulations, motions 
and all other matters that may encourage the fair, just, and prompt 
disposition of the proceedings.



Sec.  93.512  Discovery.

    (a) Request to provide documents. A party may only request another 
party to produce documents or other tangible items for inspection and 
copying that are relevant and material to the issues identified in the 
charge letter and in the respondent's request for hearing.
    (b) Meaning of documents. For purposes of this subpart, the term 
documents includes information, reports, answers, records, accounts, 
papers, tangible items, and other data and documentary evidence. This 
subpart does not require the creation of any document. However, 
requested data stored in an electronic data storage system must be 
produced in a form reasonably accessible to the requesting party.
    (c) Nondisclosable items. This section does not authorize the 
disclosure of--
    (1) Interview reports or statements obtained by any party, or on 
behalf of any party, of persons whom the party will not call as witness 
in its case-in-chief;
    (2) Analyses and summaries prepared in conjunction with the inquiry, 
investigation, ORI oversight review, or litigation of the case; or
    (3) Any privileged documents, including but not limited to those 
protected by the attorney-client privilege, attorney-work product 
doctrine, or Federal law or regulation.
    (d) Responses to a discovery request. Within 30 days of receiving a 
request for the production of documents, a party must either fully 
respond to the request, submit a written objection to the discovery 
request, or seek a protective order from the ALJ. If a party objects to 
a request for the production of documents, the party must identify each 
document or item subject to the scope of the request and state the basis 
of the objection for each document, or any part that the party does not 
produce.
    (1) Within 30 days of receiving any objections, the party seeking 
production may file a motion to compel the production of the requested 
documents.
    (2) The ALJ may order a party to produce the requested documents for 
in camera inspection to evaluate the merits of a motion to compel or for 
a protective order.
    (3) The ALJ must compel the production of a requested document and 
deny a motion for a protective order, unless the requested document is--
    (i) Not relevant or material to the issues identified in the charge 
letter or the respondent's request for hearing;
    (ii) Unduly costly or burdensome to produce;
    (iii) Likely to unduly delay the proceeding or substantially 
prejudice a party;
    (iv) Privileged, including but not limited to documents protected by 
the attorney-client privilege, attorney-work product doctrine, or 
Federal law or regulation; or
    (v) Collateral to issues to be decided at the hearing.
    (4) If any part of a document is protected from disclosure under 
paragraph (d)(3) of this section, the ALJ must redact the protected 
portion of a document before giving it to the requesting party.
    (5) The party seeking discovery has the burden of showing that the 
ALJ should allow it.
    (e) Refusal to produce items. If a party refuses to provide 
requested documents when ordered by the ALJ, the ALJ may take corrective 
action, including but not limited to, ordering the noncompliant party to 
submit written answers under oath to written interrogatories posed by 
the other party or taking any of the actions at Sec.  93.515.



Sec.  93.513  Submission of witness lists, witness statements, and exhibits.

    (a) By 60 days before the scheduled hearing date, each party must 
give the ALJ a list of witnesses to be offered during the hearing and a 
statement describing the substance of their proposed testimony, copies 
of any prior

[[Page 756]]

written statements or transcribed testimony of proposed witnesses, a 
written report of each expert witness to be called to testify that meets 
the requirements of Federal Rule of Civil Procedure 26(a)(2)(B), and 
copies of proposed hearing exhibits, including copies of any written 
statements that a party intends to offer instead of live direct 
testimony. If there are no prior written statements or transcribed 
testimony of a proffered witness, the party must submit a detailed 
factual affidavit of the proposed testimony.
    (b) A party may supplement its submission under paragraph (a) of 
this section until 30 days before the scheduled hearing date if the ALJ 
determines:
    (1) There are extraordinary circumstances; and
    (2) There is no substantial prejudice to the objecting party.
    (c) The parties must have an opportunity to object to the admission 
of evidence submitted under paragraph (a) of this section under a 
schedule set by the ALJ. However, the parties must file all objections 
before the final prehearing conference.
    (d) If a party tries to introduce evidence after the deadlines in 
paragraph (a) of this section, the ALJ must exclude the offered evidence 
from the party's case-in-chief unless the conditions of paragraph (b) of 
this section are met. If the ALJ admits evidence under paragraph (b) of 
this section, the objecting party may file a motion to postpone all or 
part of the hearing to allow sufficient time to prepare and respond to 
the evidence. The ALJ may not unreasonably deny that motion.
    (e) If a party fails to object within the time set by the ALJ and 
before the final prehearing conference, evidence exchanged under 
paragraph (a) of this section is considered authentic, relevant and 
material for the purpose of admissibility at the hearing.



Sec.  93.514  Amendment to the charge letter.

    (a) The ORI may amend the findings of research misconduct up to 30 
days before the scheduled hearing.
    (b) The ALJ may not unreasonably deny a respondent's motion to 
postpone all or part of the hearing to allow sufficient time to prepare 
and respond to the amended findings.



Sec.  93.515  Actions for violating an order or for disruptive conduct.

    (a) The ALJ may take action against any party in the proceeding for 
violating an order or procedure or for other conduct that interferes 
with the prompt, orderly, or fair conduct of the hearing. Any action 
imposed upon a party must reasonably relate to the severity and nature 
of the violation or disruptive conduct.
    (b) The actions may include--
    (1) Prohibiting a party from introducing certain evidence or 
otherwise supporting a particular claim or defense;
    (2) Striking pleadings, in whole or in part;
    (3) Staying the proceedings;
    (4) Entering a decision by default;
    (5) Refusing to consider any motion or other action not timely 
filed; or
    (6) Drawing the inference that spoliated evidence was unfavorable to 
the party responsible for its spoliation.



Sec.  93.516  Standard and burden of proof.

    (a) Standard of proof. The standard of proof is the preponderance of 
the evidence.
    (b) Burden of proof. (1) ORI bears the burden of proving the 
findings of research misconduct. The destruction, absence of, or 
respondent's failure to provide research records adequately documenting 
the questioned research is evidence of research misconduct where ORI 
establishes by a preponderance of the evidence that the respondent 
intentionally, knowingly, or recklessly had research records and 
destroyed them, had the opportunity to maintain the records but did not 
do so, or maintained the records and failed to produce them in a timely 
manner and the respondent's conduct constitutes a significant departure 
from accepted practices of the relevant research community.
    (2) The respondent has the burden of going forward with and the 
burden of proving, by a preponderance of the evidence, any and all 
affirmative defenses raised. In determining whether ORI has carried the 
burden of proof imposed by

[[Page 757]]

this part, the ALJ shall give due consideration to admissible, credible 
evidence of honest error or difference of opinion presented by the 
respondent.
    (3) ORI bears the burden of proving that the proposed HHS 
administrative actions are reasonable under the circumstances of the 
case. The respondent has the burden of going forward with and proving by 
a preponderance of the evidence any mitigating factors that are relevant 
to a decision to impose HHS administrative actions following a research 
misconduct proceeding.



Sec.  93.517  The hearing.

    (a) The ALJ will conduct an in-person hearing to decide if the 
respondent committed research misconduct and if the HHS administrative 
actions, including any debarment or suspension actions, are appropriate.
    (b) The ALJ provides an independent de novo review of the ORI 
findings of research misconduct and the proposed HHS administrative 
actions. The ALJ does not review the institution's procedures or 
misconduct findings or ORI's research misconduct proceedings.
    (c) A hearing under this subpart is not limited to specific findings 
and evidence set forth in the charge letter or the respondent's request 
for hearing. Additional evidence and information may be offered by 
either party during its case-in-chief unless the offered evidence is--
    (1) Privileged, including but not limited to those protected by the 
attorney-client privilege, attorney-work product doctrine, or Federal 
law or regulation.
    (2) Otherwise inadmissible under Sec. Sec.  93.515 or 93.519.
    (3) Not offered within the times or terms of Sec. Sec.  93.512 and 
93.513.
    (d) ORI proceeds first in its presentation of evidence at the 
hearing.
    (e) After both parties have presented their cases-in-chief, the 
parties may offer rebuttal evidence even if not exchanged earlier under 
Sec. Sec.  93.512 and 93.513.
    (f) Except as provided in Sec.  93.518(c), the parties may appear at 
the hearing in person or by an attorney of record in the proceeding.
    (g) The hearing must be open to the public, unless the ALJ orders 
otherwise for good cause shown. However, even if the hearing is closed 
to the public, the ALJ may not exclude a party or party representative, 
persons whose presence a party shows to be essential to the presentation 
of its case, or expert witnesses.



Sec.  93.518  Witnesses.

    (a) Except as provided in paragraph (b) of this section, witnesses 
must give testimony at the hearing under oath or affirmation.
    (b) The ALJ may admit written testimony if the witness is available 
for cross-examination, including prior sworn testimony of witnesses that 
has been subject to cross-examination. These written statements must be 
provided to all other parties under Sec.  93.513.
    (c) The parties may conduct direct witness examination and cross-
examination in person, by telephone, or by audio-visual communication as 
permitted by the ALJ. However, a respondent must always appear in-person 
to present testimony and for cross-examination.
    (d) The ALJ may exercise reasonable control over the mode and order 
of questioning witnesses and presenting evidence to--
    (1) Make the witness questioning and presentation relevant to 
deciding the truth of the matter; and
    (2) Avoid undue repetition or needless consumption of time.
    (e) The ALJ must permit the parties to conduct cross-examination of 
witnesses.
    (f) Upon request of a party, the ALJ may exclude a witness from the 
hearing before the witness' own testimony. However, the ALJ may not 
exclude--
    (1) A party or party representative;
    (2) Persons whose presence is shown by a party to be essential to 
the presentation of its case; or
    (3) Expert witnesses.



Sec.  93.519  Admissibility of evidence.

    (a) The ALJ decides the admissibility of evidence offered at the 
hearing.
    (b) Except as provided in this part, the ALJ is not bound by the 
Federal Rules of Evidence (FRE). However, the ALJ may apply the FRE 
where appropriate (e.g., to exclude unreliable evidence).

[[Page 758]]

    (c) The ALJ must admit evidence unless it is clearly irrelevant, 
immaterial, or unduly repetitious. However, the ALJ may exclude relevant 
and material evidence if its probative value is substantially outweighed 
by the danger of unfair prejudice, confusion of the issues, or by 
considerations of undue delay or needless presentation of cumulative 
evidence under FRE 401-403.
    (d) The ALJ must exclude relevant and material evidence if it is 
privileged, including but not limited to evidence protected by the 
attorney-client privilege, the attorney-work product doctrine, or 
Federal law or regulation.
    (e) The ALJ may take judicial notice of matters upon the ALJ's own 
initiative or upon motion by a party as permitted under FRE 201 
(Judicial Notice of Adjudicative Facts).
    (1) The ALJ may take judicial notice of any other matter of 
technical, scientific, or commercial fact of established character.
    (2) The ALJ must give the parties adequate notice of matters subject 
to judicial notice and adequate opportunity to show that the ALJ 
erroneously noticed the matters.
    (f) Evidence of crimes, wrongs, or acts other than those at issue in 
the hearing is admissible only as permitted under FRE 404(b) (Character 
Evidence not Admissible to Prove Conduct; Exceptions, Other Crimes).
    (g) Methods of proving character are admissible only as permitted 
under FRE 405 (Methods of Proving Character).
    (h) Evidence related to the character and conduct of witnesses is 
admissible only as permitted under FRE Rule 608 (Evidence of Character 
and Conduct of Witness).
    (i) Evidence about offers of compromise or settlement made in this 
action is inadmissible as provided in FRE 408 (Compromise and Offers to 
Compromise).
    (j) The ALJ must admit relevant and material hearsay evidence, 
unless an objecting party shows that the offered hearsay evidence is not 
reliable.
    (k) The parties may introduce witnesses and evidence on rebuttal.
    (l) All documents and other evidence offered or admitted into the 
record must be open to examination by both parties, unless otherwise 
ordered by the ALJ for good cause shown.
    (m) Whenever the ALJ excludes evidence, the party offering the 
evidence may make an offer of proof, and the ALJ must include the offer 
in the transcript or recording of the hearing in full. The offer of 
proof should consist of a brief oral statement describing the evidence 
excluded. If the offered evidence consists of an exhibit, the ALJ must 
mark it for identification and place it in the hearing record. However, 
the ALJ may rely upon the offered evidence in reaching the decision on 
the case only if the ALJ admits it.



Sec.  93.520  The record.

    (a) HHS will record and transcribe the hearing, and if requested, 
provide a transcript to the parties at HHS' expense.
    (b) The exhibits, transcripts of testimony, any other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for the decision by the ALJ.
    (c) For good cause shown, the ALJ may order appropriate redactions 
made to the record at any time.
    (d) The DAB may return original research records and other similar 
items to the parties or awardee institution upon request after final HHS 
action, unless under judicial review.



Sec.  93.521  Correction of the transcript.

    (a) At any time, but not later than the time set for the parties to 
file their post-hearing briefs, any party may file a motion proposing 
material corrections to the transcript or recording.
    (b) At any time before the filing of the ALJ's decision and after 
consideration of any corrections proposed by the parties, the ALJ may 
issue an order making any requested corrections in the transcript or 
recording.



Sec.  93.522  Filing post-hearing briefs.

    (a) After the hearing and under a schedule set by the ALJ , the 
parties may file post-hearing briefs, and the ALJ may allow the parties 
to file reply briefs.
    (b) The parties may include proposed findings of fact and 
conclusions of law in their post-hearing briefs.

[[Page 759]]



Sec.  93.523  The Administrative Law Judge's ruling.

    (a) The ALJ shall issue a ruling in writing setting forth proposed 
findings of fact and any conclusions of law within 60 days after the 
last submission by the parties in the case. If unable to meet the 60-day 
deadline, the ALJ must set a new deadline and promptly notify the 
parties, the Assistant Secretary for Health and the debarring official, 
if debarment or suspension is under review. The ALJ shall serve a copy 
of the ruling upon the parties and the Assistant Secretary for Health.
    (b) The ruling of the ALJ constitutes a recommended decision to the 
Assistant Secretary for Health. The Assistant Secretary for Health may 
review the ALJ's recommended decision and modify or reject it in whole 
or in part after determining it, or the part modified or rejected, to be 
arbitrary and capricious or clearly erroneous. The Assistant Secretary 
for Health shall notify the parties of an intention to review the ALJ's 
recommended decision within 30 days after service of the recommended 
decision. If that notification is not provided within the 30-day period, 
the ALJ's recommended decision shall become final. An ALJ decision that 
becomes final in that manner or a decision by the Assistant Secretary 
for Health modifying or rejecting the ALJ's recommended decision in 
whole or in part is the final HHS action, unless debarment or suspension 
is an administrative action recommended in the decision.
    (c) If a decision under Sec.  93.523(b) results in a recommendation 
for debarment or suspension, the Assistant Secretary for Health shall 
serve a copy of the decision upon the debarring official and the 
decision shall constitute findings of fact to the debarring official in 
accordance with 45 CFR 76.845(c). The decision of the debarring official 
on debarment or suspension is the final HHS decision on those 
administrative actions.



                         SUBCHAPTER I [RESERVED]



[[Page 760]]



                          SUBCHAPTER J_VACCINES





PART 100_VACCINE INJURY COMPENSATION--Table of Contents



Sec.
100.1 Applicability.
100.2 Average cost of a health insurance policy.
100.3 Vaccine injury table.

    Authority: Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 300aa-1 
note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); and sec. 
13632(a)(3) of Public Law 103-66.



Sec.  100.1  Applicability.

    This part applies to the National Vaccine Injury Compensation 
Program (VICP) under subtitle 2 of title XXI of the Public Health 
Service (PHS) Act.

[60 FR 7693, Feb. 8, 1995]



Sec.  100.2  Average cost of a health insurance policy.

    For purposes of determining the amount of compensation under the 
VICP, section 2115(a)(3)(B) of the PHS Act, 42 U.S.C. 300aa-15(a)(3)(B), 
provides that certain individuals are entitled to receive an amount 
reflecting lost earnings, less certain deductions. One of the deductions 
is the average cost of a health insurance policy, as determined by the 
Secretary. The Secretary has determined that the average cost of a 
health insurance policy is $363.12 for 2006. This figure is calculated 
periodically (generally on an annual basis) using the most recent 
Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) data 
available as the baseline for the average monthly cost of a health 
insurance policy. This baseline is adjusted by the annual percentage 
increase/decrease obtained from the most recent annual Kaiser Family 
Foundation and Health Research and Educational Trust (KFF/HRET) Employer 
Health Benefits survey or other authoritative source that may be more 
accurate or appropriate in the future. The revised amount will be 
effective upon its delivery by the Secretary to the United States Court 
of Federal Claims, and the amount will be published as a notice in the 
Federal Register periodically (generally on an annual basis).

[72 FR 36612, July 5, 2007]



Sec.  100.3  Vaccine injury table.

    (a) In accordance with section 312(b) of the National Childhood 
Vaccine Injury Act of 1986, title III of Public Law 99-660, 100 Stat. 
3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health 
Service Act, as amended (PHS Act) (42 U.S.C. 300aa-14(c)), the following 
is a table of vaccines, the injuries, disabilities, illnesses, 
conditions, and deaths resulting from the administration of such 
vaccines, and the time period in which the first symptom or 
manifestation of onset or of the significant aggravation of such 
injuries, disabilities, illnesses, conditions, and deaths is to occur 
after vaccine administration for purposes of receiving compensation 
under the Program. Paragraph (b) of this section sets forth additional 
provisions that are not separately listed in this Table but that 
constitute part of it. Paragraph (c) of this section sets forth the 
qualifications and aids to interpretation for the terms used in the 
Table. Conditions and injuries that do not meet the terms of the 
qualifications and aids to interpretation are not within the Table. 
Paragraph (d) of this section sets forth a glossary of terms used in 
paragraph (c).

                          Vaccine Injury Table
------------------------------------------------------------------------
                                                        Time period for
                                                       first symptom or
                                       Illness,        manifestation of
                                  disability, injury      onset or of
             Vaccine                 or condition         significant
                                        covered        aggravation after
                                                            vaccine
                                                        administration
------------------------------------------------------------------------
I. Vaccines containing tetanus    A. Anaphylaxis....  <=4 hours.
 toxoid (e.g., DTaP, DTP, DT,     B. Brachial         2-28 days (not
 Td, or TT).                       Neuritis.           less than 2 days
                                                       and not more than
                                                       28 days).
                                  C. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  D. Vasovagal        <=1 hour.
                                   syncope.

[[Page 761]]

 
II. Vaccines containing whole     A. Anaphylaxis....  <=4 hours.
 cell pertussis bacteria,
 extracted or partial cell
 pertussis bacteria, or specific
 pertussis antigen(s) (e.g.,
 DTP, DTaP, P, DTP-Hib).
                                  B. Encephalopathy   <=72 hours.
                                   or encephalitis.
                                  C. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  D. Vasovagal        <=1 hour.
                                   syncope.
III. Vaccines containing          A. Anaphylaxis....  <=4 hours.
 measles, mumps, and rubella      B. Encephalopathy   5-15 days (not
 virus or any of its components    or encephalitis.    less than 5 days
 (e.g., MMR, MM, MMRV).                                and not more than
                                                       15 days).
                                  C. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  D. Vasovagal        <=1 hour.
                                   syncope.
IV. Vaccines containing rubella   A. Chronic          7-42 days (not
 virus (e.g., MMR, MMRV).          arthritis.          less than 7 days
                                                       and not more than
                                                       42 days).
V. Vaccines containing measles    A.                  7-30 days (not
 virus (e.g., MMR, MM, MMRV).      Thrombocytopenic    less than 7 days
                                   purpura.            and not more than
                                                       30 days).
                                  B. Vaccine-Strain
                                   Measles Viral
                                   Disease in an
                                   immunodeficient
                                   recipient.
                                  --Vaccine-strain    Not applicable.
                                   virus identified.
                                  --If strain         <=12 months.
                                   determination is
                                   not done or if
                                   laboratory
                                   testing is
                                   inconclusive.
VI. Vaccines containing polio     A. Paralytic Polio
 live virus (OPV).
                                  --in a non-         <=30 days.
                                   immunodeficient
                                   recipient.
                                  --in an             <=6 months.
                                   immunodeficient
                                   recipient.
                                  --in a vaccine      Not applicable.
                                   associated
                                   community case.
                                  B. Vaccine-Strain
                                   Polio Viral
                                   Infection.
                                  --in a non-         <=30 days.
                                   immunodeficient
                                   recipient.
                                  --in an             <=6 months.
                                   immunodeficient
                                   recipient.
                                  --in a vaccine      Not applicable.
                                   associated
                                   community case.
VII. Vaccines containing polio    A. Anaphylaxis....  <=4 hours.
 inactivated virus (e.g., IPV).
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
VIII. Hepatitis B vaccines......  A. Anaphylaxis....  <=4 hours.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
IX. Haemophilus influenzae type   A. Shoulder Injury  <=48 hours.
 b (Hib) vaccines.                 Related to
                                   Vaccine
                                   Administration.
                                  B. Vasovagal        <=1 hour.
                                   syncope.
X. Varicella vaccines...........  A. Anaphylaxis....  <=4 hours.
                                  B. Disseminated
                                   varicella vaccine-
                                   strain viral
                                   disease.
                                  --Vaccine-strain    Not applicable.
                                   virus identified.
                                  --If strain         7-42 days (not
                                   determination is    less than 7 days
                                   not done or if      and not more than
                                   laboratory          42 days).
                                   testing is
                                   inconclusive.
                                  C. Varicella        Not applicable.
                                   vaccine-strain
                                   viral
                                   reactivation.
                                  D. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  E. Vasovagal        <=1 hour.
                                   syncope.
XI. Rotavirus vaccines..........  A. Intussusception  1-21 days (not
                                                       less than 1 day
                                                       and not more than
                                                       21 days).
XII. Pneumococcal conjugate       A. Shoulder Injury  <=48 hours.
 vaccines.                         Related to
                                   Vaccine
                                   Administration.
                                  B. Vasovagal        <=1 hour.
                                   syncope.
XIII. Hepatitis A vaccines......  A. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  B. Vasovagal        <=1 hour.
                                   syncope.
XIV. Seasonal influenza vaccines  A. Anaphylaxis....  <=4 hours.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.

[[Page 762]]

 
                                  D. Guillain-        3-42 days (not
                                   Barr[eacute]        less than 3 days
                                   Syndrome.           and not more than
                                                       42 days).
XV. Meningococcal vaccines......  A. Anaphylaxis....  <=4 hours.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
XVI. Human papillomavirus (HPV)   A. Anaphylaxis....  <=4 hours.
 vaccines.
                                  B. Shoulder Injury  <=48 hours.
                                   Related to
                                   Vaccine
                                   Administration.
                                  C. Vasovagal        <=1 hour.
                                   syncope.
XVII. Any new vaccine             A. Shoulder Injury  <=48 hours.
 recommended by the Centers for    Related to         ..................
 Disease Control and Prevention    Vaccine            <=1 hour.
 for routine administration to     Administration.
 children and/or pregnant women,  B. Vasovagal
 after publication by the          syncope.
 Secretary of a notice of
 coverage.
------------------------------------------------------------------------

    (b) Provisions that apply to all conditions listed. (1) Any acute 
complication or sequela, including death, of the illness, disability, 
injury, or condition listed in paragraph (a) of this section (and 
defined in paragraphs (c) and (d) of this section) qualifies as a Table 
injury under paragraph (a) except when the definition in paragraph (c) 
requires exclusion.
    (2) In determining whether or not an injury is a condition set forth 
in paragraph (a) of this section, the Court shall consider the entire 
medical record.
    (3) An idiopathic condition that meets the definition of an illness, 
disability, injury, or condition set forth in paragraph (c) of this 
section shall be considered to be a condition set forth in paragraph (a) 
of this section.
    (c) Qualifications and aids to interpretation. The following 
qualifications and aids to interpretation shall apply to, define and 
describe the scope of, and be read in conjunction with paragraphs (a), 
(b), and (d) of this section:
    (1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially 
lethal systemic reaction that occurs as a single discrete event with 
simultaneous involvement of two or more organ systems. Most cases 
resolve without sequela. Signs and symptoms begin minutes to a few hours 
after exposure. Death, if it occurs, usually results from airway 
obstruction caused by laryngeal edema or bronchospasm and may be 
associated with cardiovascular collapse. Other significant clinical 
signs and symptoms may include the following: Cyanosis, hypotension, 
bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or 
trachea and/or larynx with stridor and dyspnea. There are no specific 
pathological findings to confirm a diagnosis of anaphylaxis.
    (2) Encephalopathy. A vaccine recipient shall be considered to have 
suffered an encephalopathy if an injury meeting the description below of 
an acute encephalopathy occurs within the applicable time period and 
results in a chronic encephalopathy, as described in paragraph (d) of 
this section.
    (i) Acute encephalopathy. (A) For children less than 18 months of 
age who present:
    (1) Without a seizure, an acute encephalopathy is indicated by a 
significantly decreased level of consciousness that lasts at least 24 
hours.
    (2) Following a seizure, an acute encephalopathy is demonstrated by 
a significantly decreased level of consciousness that lasts at least 24 
hours and cannot be attributed to a postictal state--from a seizure or a 
medication.
    (B) For adults and children 18 months of age or older, an acute 
encephalopathy is one that persists at least 24 hours and is 
characterized by at least two of the following:
    (1) A significant change in mental status that is not medication 
related (such as a confusional state, delirium, or psychosis);

[[Page 763]]

    (2) A significantly decreased level of consciousness which is 
independent of a seizure and cannot be attributed to the effects of 
medication; and
    (3) A seizure associated with loss of consciousness.
    (C) The following clinical features in themselves do not demonstrate 
an acute encephalopathy or a significant change in either mental status 
or level of consciousness: Sleepiness, irritability (fussiness), high-
pitched and unusual screaming, poor feeding, persistent inconsolable 
crying, bulging fontanelle, or symptoms of dementia.
    (D) Seizures in themselves are not sufficient to constitute a 
diagnosis of encephalopathy and in the absence of other evidence of an 
acute encephalopathy seizures shall not be viewed as the first symptom 
or manifestation of an acute encephalopathy.
    (ii) Exclusionary criteria for encephalopathy. Regardless of whether 
or not the specific cause of the underlying condition, systemic disease, 
or acute event (including an infectious organism) is known, an 
encephalopathy shall not be considered to be a condition set forth in 
the Table if it is shown that the encephalopathy was caused by:
    (A) An underlying condition or systemic disease shown to be 
unrelated to the vaccine (such as malignancy, structural lesion, 
psychiatric illness, dementia, genetic disorder, prenatal or perinatal 
central nervous system (CNS) injury); or
    (B) An acute event shown to be unrelated to the vaccine such as a 
head trauma, stroke, transient ischemic attack, complicated migraine, 
drug use (illicit or prescribed) or an infectious disease.
    (3) Encephalitis. A vaccine recipient shall be considered to have 
suffered encephalitis if an injury meeting the description below of 
acute encephalitis occurs within the applicable time period and results 
in a chronic encephalopathy, as described in paragraph (d) of this 
section.
    (i) Acute encephalitis. Encephalitis is indicated by evidence of 
neurologic dysfunction, as described in paragraph (c)(3)(i)(A) of this 
section, plus evidence of an inflammatory process in the brain, as 
described in paragraph (c)(3)(i)(B) of this section.
    (A) Evidence of neurologic dysfunction consists of either:
    (1) One of the following neurologic findings referable to the CNS: 
Focal cortical signs (such as aphasia, alexia, agraphia, cortical 
blindness); cranial nerve abnormalities; visual field defects; abnormal 
presence of primitive reflexes (such as Babinski's sign or sucking 
reflex); or cerebellar dysfunction (such as ataxia, dysmetria, or 
nystagmus); or
    (2) An acute encephalopathy as set forth in paragraph (c)(2)(i) of 
this section.
    (B) Evidence of an inflammatory process in the brain (central 
nervous system or CNS inflammation) must include cerebrospinal fluid 
(CSF) pleocytosis (5 white blood cells (WBC)/mm\3\ in 
children 2 months of age and adults; 15 WBC/mm3 in 
children <2 months of age); or at least two of the following:
    (1) Fever (temperature = 100.4 degrees Fahrenheit);
    (2) Electroencephalogram findings consistent with encephalitis, such 
as diffuse or multifocal nonspecific background slowing and periodic 
discharges; or
    (3) Neuroimaging findings consistent with encephalitis, which 
include, but are not limited to brain/spine magnetic resonance imaging 
(MRI) displaying diffuse or multifocal areas of hyperintense signal on 
T2-weighted, diffusion-weighted image, or fluid-attenuation inversion 
recovery sequences.
    (ii) Exclusionary criteria for encephalitis. Regardless of whether 
or not the specific cause of the underlying condition, systemic disease, 
or acute event (including an infectious organism) is known, encephalitis 
shall not be considered to be a condition set forth in the Table if it 
is shown that the encephalitis was caused by:
    (A) An underlying malignancy that led to a paraneoplastic 
encephalitis;
    (B) An infectious disease associated with encephalitis, including a 
bacterial, parasitic, fungal or viral illness (such as herpes viruses, 
adenovirus, enterovirus, West Nile Virus, or human immunodeficiency 
virus), which may

[[Page 764]]

be demonstrated by clinical signs and symptoms and need not be confirmed 
by culture or serologic testing; or
    (C) Acute disseminated encephalomyelitis (ADEM). Although early ADEM 
may have laboratory and clinical characteristics similar to acute 
encephalitis, findings on MRI are distinct with ADEM displaying evidence 
of acute demyelination (scattered, focal, or multifocal areas of 
inflammation and demyelination within cerebral subcortical and deep 
cortical white matter; gray matter involvement may also be seen but is a 
minor component); or
    (D) Other conditions or abnormalities that would explain the vaccine 
recipient's symptoms.
    (4) Intussusception. (i) For purposes of paragraph (a) of this 
section, intussusception means the invagination of a segment of 
intestine into the next segment of intestine, resulting in bowel 
obstruction, diminished arterial blood supply, and blockage of the 
venous blood flow. This is characterized by a sudden onset of abdominal 
pain that may be manifested by anguished crying, irritability, vomiting, 
abdominal swelling, and/or passing of stools mixed with blood and mucus.
    (ii) For purposes of paragraph (a) of this section, the following 
shall not be considered to be a Table intussusception:
    (A) Onset that occurs with or after the third dose of a vaccine 
containing rotavirus;
    (B) Onset within 14 days after an infectious disease associated with 
intussusception, including viral disease (such as those secondary to 
non-enteric or enteric adenovirus, or other enteric viruses such as 
Enterovirus), enteric bacteria (such as Campylobacter jejuni), or 
enteric parasites (such as Ascaris lumbricoides), which may be 
demonstrated by clinical signs and symptoms and need not be confirmed by 
culture or serologic testing;
    (C) Onset in a person with a preexisting condition identified as the 
lead point for intussusception such as intestinal masses and cystic 
structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or 
duplication cysts);
    (D) Onset in a person with abnormalities of the bowel, including 
congenital anatomic abnormalities, anatomic changes after abdominal 
surgery, and other anatomic bowel abnormalities caused by mucosal 
hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch 
Scholein purpura, hematoma, or hemangioma); or
    (E) Onset in a person with underlying conditions or systemic 
diseases associated with intussusception (such as cystic fibrosis, 
celiac disease, or Kawasaki disease).
    (5) Chronic arthritis. Chronic arthritis is defined as persistent 
joint swelling with at least two additional manifestations of warmth, 
tenderness, pain with movement, or limited range of motion, lasting for 
at least 6 months.
    (i) Chronic arthritis may be found in a person with no history in 
the 3 years prior to vaccination of arthropathy (joint disease) on the 
basis of:
    (A) Medical documentation recorded within 30 days after the onset of 
objective signs of acute arthritis (joint swelling) that occurred 
between 7 and 42 days after a rubella vaccination; and
    (B) Medical documentation (recorded within 3 years after the onset 
of acute arthritis) of the persistence of objective signs of 
intermittent or continuous arthritis for more than 6 months following 
vaccination; and
    (C) Medical documentation of an antibody response to the rubella 
virus.
    (ii) The following shall not be considered as chronic arthritis: 
Musculoskeletal disorders such as diffuse connective tissue diseases 
(including but not limited to rheumatoid arthritis, juvenile idiopathic 
arthritis, systemic lupus erythematosus, systemic sclerosis, mixed 
connective tissue disease, polymyositis/determatomyositis, fibromyalgia, 
necrotizing vasculitis and vasculopathies and Sjogren's Syndrome), 
degenerative joint disease, infectious agents other than rubella 
(whether by direct invasion or as an immune reaction), metabolic and 
endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and 
cartilage disorders, and arthritis associated with ankylosing 
spondylitis, psoriasis, inflammatory bowel disease, Reiter's Syndrome, 
blood disorders, or

[[Page 765]]

arthralgia (joint pain), or joint stiffness without swelling.
    (6) Brachial neuritis. This term is defined as dysfunction limited 
to the upper extremity nerve plexus (i.e., its trunks, divisions, or 
cords). A deep, steady, often severe aching pain in the shoulder and 
upper arm usually heralds onset of the condition. The pain is typically 
followed in days or weeks by weakness in the affected upper extremity 
muscle groups. Sensory loss may accompany the motor deficits, but is 
generally a less notable clinical feature. Atrophy of the affected 
muscles may occur. The neuritis, or plexopathy, may be present on the 
same side or on the side opposite the injection. It is sometimes 
bilateral, affecting both upper extremities. A vaccine recipient shall 
be considered to have suffered brachial neuritis as a Table injury if 
such recipient manifests all of the following:
    (i) Pain in the affected arm and shoulder is a presenting symptom 
and occurs within the specified time-frame;
    (ii) Weakness;
    (A) Clinical diagnosis in the absence of nerve conduction and 
electromyographic studies requires weakness in muscles supplied by more 
than one peripheral nerve.
    (B) Nerve conduction studies (NCS) and electromyographic (EMG) 
studies localizing the injury to the brachial plexus are required before 
the diagnosis can be made if weakness is limited to muscles supplied by 
a single peripheral nerve.
    (iii) Motor, sensory, and reflex findings on physical examination 
and the results of NCS and EMG studies, if performed, must be consistent 
in confirming that dysfunction is attributable to the brachial plexus; 
and
    (iv) No other condition or abnormality is present that would explain 
the vaccine recipient's symptoms.
    (7) Thrombocytopenic purpura. This term is defined by the presence 
of clinical manifestations, such as petechiae, significant bruising, or 
spontaneous bleeding, and by a serum platelet count less than 50,000/
mm\3\ with normal red and white blood cell indices. Thrombocytopenic 
purpura does not include cases of thrombocytopenia associated with other 
causes such as hypersplenism, autoimmune disorders (including 
alloantibodies from previous transfusions) myelodysplasias, 
lymphoproliferative disorders, congenital thrombocytopenia or hemolytic 
uremic syndrome. Thrombocytopenic purpura does not include cases of 
immune (formerly called idiopathic) thrombocytopenic purpura that are 
mediated, for example, by viral or fungal infections, toxins or drugs. 
Thrombocytopenic purpura does not include cases of thrombocytopenia 
associated with disseminated intravascular coagulation, as observed with 
bacterial and viral infections. Viral infections include, for example, 
those infections secondary to Epstein Barr virus, cytomegalovirus, 
hepatitis A and B, human immunodeficiency virus, adenovirus, and dengue 
virus. An antecedent viral infection may be demonstrated by clinical 
signs and symptoms and need not be confirmed by culture or serologic 
testing. However, if culture or serologic testing is performed, and the 
viral illness is attributed to the vaccine-strain measles virus, the 
presumption of causation will remain in effect. Bone marrow examination, 
if performed, must reveal a normal or an increased number of 
megakaryocytes in an otherwise normal marrow.
    (8) Vaccine-strain measles viral disease. This term is defined as a 
measles illness that involves the skin and/or another organ (such as the 
brain or lungs). Measles virus must be isolated from the affected organ 
or histopathologic findings characteristic for the disease must be 
present. Measles viral strain determination may be performed by methods 
such as polymerase chain reaction test and vaccine-specific monoclonal 
antibody. If strain determination reveals wild-type measles virus or 
another, non-vaccine-strain virus, the disease shall not be considered 
to be a condition set forth in the Table. If strain determination is not 
done or if the strain cannot be identified, onset of illness in any 
organ must occur within 12 months after vaccination.
    (9) Vaccine-strain polio viral infection. This term is defined as a 
disease caused by poliovirus that is isolated from the

[[Page 766]]

affected tissue and should be determined to be the vaccine-strain by 
oligonucleotide or polymerase chain reaction. Isolation of poliovirus 
from the stool is not sufficient to establish a tissue specific 
infection or disease caused by vaccine-strain poliovirus.
    (10) Shoulder injury related to vaccine administration (SIRVA). 
SIRVA manifests as shoulder pain and limited range of motion occurring 
after the administration of a vaccine intended for intramuscular 
administration in the upper arm. These symptoms are thought to occur as 
a result of unintended injection of vaccine antigen or trauma from the 
needle into and around the underlying bursa of the shoulder resulting in 
an inflammatory reaction. SIRVA is caused by an injury to the 
musculoskeletal structures of the shoulder (e.g. tendons, ligaments, 
bursae, etc.). SIRVA is not a neurological injury and abnormalities on 
neurological examination or nerve conduction studies (NCS) and/or 
electromyographic (EMG) studies would not support SIRVA as a diagnosis 
(even if the condition causing the neurological abnormality is not 
known). A vaccine recipient shall be considered to have suffered SIRVA 
if such recipient manifests all of the following:
    (i) No history of pain, inflammation or dysfunction of the affected 
shoulder prior to intramuscular vaccine administration that would 
explain the alleged signs, symptoms, examination findings, and/or 
diagnostic studies occurring after vaccine injection;
    (ii) Pain occurs within the specified time-frame;
    (iii) Pain and reduced range of motion are limited to the shoulder 
in which the intramuscular vaccine was administered; and
    (iv) No other condition or abnormality is present that would explain 
the patient's symptoms (e.g. NCS/EMG or clinical evidence of 
radiculopathy, brachial neuritis, mononeuropathies, or any other 
neuropathy).
    (11) Disseminated varicella vaccine-strain viral disease. 
Disseminated varicella vaccine-strain viral disease is defined as a 
varicella illness that involves the skin beyond the dermatome in which 
the vaccination was given and/or disease caused by vaccine-strain 
varicella in another organ. For organs other than the skin, the disease 
must be demonstrated in the involved organ and not just through mildly 
abnormal laboratory values. If there is involvement of an organ beyond 
the skin, and no virus was identified in that organ, the involvement of 
all organs must occur as part of the same, discrete illness. If strain 
determination reveals wild-type varicella virus or another, non-vaccine-
strain virus, the viral disease shall not be considered to be a 
condition set forth in the Table. If strain determination is not done or 
if the strain cannot be identified, onset of illness in any organ must 
occur 7- 42 days after vaccination.
    (12) Varicella vaccine-strain viral reactivation disease. Varicella 
vaccine-strain viral reactivation disease is defined as the presence of 
the rash of herpes zoster with or without concurrent disease in an organ 
other than the skin. Zoster, or shingles, is a painful, unilateral, 
pruritic rash appearing in one or more sensory dermatomes. For organs 
other than the skin, the disease must be demonstrated in the involved 
organ and not just through mildly abnormal laboratory values. There must 
be laboratory confirmation that the vaccine-strain of the varicella 
virus is present in the skin or in any other involved organ, for example 
by oligonucleotide or polymerase chain reaction. If strain determination 
reveals wild-type varicella virus or another, non-vaccine-strain virus, 
the viral disease shall not be considered to be a condition set forth in 
the Table.
    (13) Vasovagal syncope. Vasovagal syncope (also sometimes called 
neurocardiogenic syncope) means loss of consciousness (fainting) and 
postural tone caused by a transient decrease in blood flow to the brain 
occurring after the administration of an injected vaccine. Vasovagal 
syncope is usually a benign condition but may result in falling and 
injury with significant sequela. Vasovagal syncope may be preceded by 
symptoms such as nausea, lightheadedness, diaphoresis, and/or pallor. 
Vasovagal syncope may be associated with transient seizure-like 
activity, but recovery of orientation and

[[Page 767]]

consciousness generally occurs simultaneously with vasovagal syncope. 
Loss of consciousness resulting from the following conditions will not 
be considered vasovagal syncope: organic heart disease, cardiac 
arrhythmias, transient ischemic attacks, hyperventilation, metabolic 
conditions, neurological conditions, and seizures. Episodes of recurrent 
syncope occurring after the applicable time period are not considered to 
be sequela of an episode of syncope meeting the Table requirements.
    (14) Immunodeficient recipient. Immunodeficient recipient is defined 
as an individual with an identified defect in the immunological system 
which impairs the body's ability to fight infections. The identified 
defect may be due to an inherited disorder (such as severe combined 
immunodeficiency resulting in absent T lymphocytes), or an acquired 
disorder (such as acquired immunodeficiency syndrome resulting from 
decreased CD4 cell counts). The identified defect must be demonstrated 
in the medical records, either preceding or postdating vaccination.
    (15) Guillain-Barr[eacute] Syndrome (GBS). (i) GBS is an acute 
monophasic peripheral neuropathy that encompasses a spectrum of four 
clinicopathological subtypes described below. For each subtype of GBS, 
the interval between the first appearance of symptoms and the nadir of 
weakness is between 12 hours and 28 days. This is followed in all 
subtypes by a clinical plateau with stabilization at the nadir of 
symptoms, or subsequent improvement without significant relapse. Death 
may occur without a clinical plateau. Treatment related fluctuations in 
all subtypes of GBS can occur within 9 weeks of GBS symptom onset and 
recurrence of symptoms after this time-frame would not be consistent 
with GBS.
    (ii) The most common subtype in North America and Europe, comprising 
more than 90 percent of cases, is acute inflammatory demyelinating 
polyneuropathy (AIDP), which has the pathologic and electrodiagnostic 
features of focal demyelination of motor and sensory peripheral nerves 
and nerve roots. Another subtype called acute motor axonal neuropathy 
(AMAN) is generally seen in other parts of the world and is predominated 
by axonal damage that primarily affects motor nerves. AMAN lacks 
features of demyelination. Another less common subtype of GBS includes 
acute motor and sensory neuropathy (AMSAN), which is an axonal form of 
GBS that is similar to AMAN, but also affects the sensory nerves and 
roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric 
motor flaccid weakness, sensory abnormalities, and/or autonomic 
dysfunction caused by autoimmune damage to peripheral nerves and nerve 
roots. The diagnosis of AIDP, AMAN, and AMSAN requires:
    (A) Bilateral flaccid limb weakness and decreased or absent deep 
tendon reflexes in weak limbs;
    (B) A monophasic illness pattern;
    (C) An interval between onset and nadir of weakness between 12 hours 
and 28 days;
    (D) Subsequent clinical plateau (the clinical plateau leads to 
either stabilization at the nadir of symptoms, or subsequent improvement 
without significant relapse; however, death may occur without a clinical 
plateau); and,
    (E) The absence of an identified more likely alternative diagnosis.
    (iii) Fisher Syndrome (FS), also known as Miller Fisher Syndrome, is 
a subtype of GBS characterized by ataxia, areflexia, and 
ophthalmoplegia, and overlap between FS and AIDP may be seen with limb 
weakness. The diagnosis of FS requires:
    (A) Bilateral ophthalmoparesis;
    (B) Bilateral reduced or absent tendon reflexes;
    (C) Ataxia;
    (D) The absence of limb weakness (the presence of limb weakness 
suggests a diagnosis of AIDP, AMAN, or AMSAN);
    (E) A monophasic illness pattern;
    (F) An interval between onset and nadir of weakness between 12 hours 
and 28 days;
    (G) Subsequent clinical plateau (the clinical plateau leads to 
either
    stabilization at the nadir of symptoms, or subsequent improvement 
without significant relapse; however, death may occur without a clinical 
plateau);
    (H) No alteration in consciousness;

[[Page 768]]

    (I) No corticospinal track signs; and
    (J) The absence of an identified more likely alternative diagnosis.
    (iv) Evidence that is supportive, but not required, of a diagnosis 
of all subtypes of GBS includes electrophysiologic findings consistent 
with GBS or an elevation of cerebral spinal fluid (CSF) protein with a 
total CSF white blood cell count below 50 cells per microliter. Both CSF 
and electrophysiologic studies are frequently normal in the first week 
of illness in otherwise typical cases of GBS.
    (v) To qualify as any subtype of GBS, there must not be a more 
likely alternative diagnosis for the weakness.
    (vi) Exclusionary criteria for the diagnosis of all subtypes of GBS 
include the ultimate diagnosis of any of the following conditions: 
chronic immune demyelinating polyradiculopathy (CIDP), carcinomatous 
meningitis, brain stem encephalitis (other than Bickerstaff brainstem 
encephalitis), myelitis, spinal cord infarct, spinal cord compression, 
anterior horn cell diseases such as polio or West Nile virus infection, 
subacute inflammatory demyelinating polyradiculoneuropathy, multiple 
sclerosis, cauda equina compression, metabolic conditions such as 
hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal 
toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy 
(such as vincristine, platinum compounds, or nitrofurantoin), porphyria, 
critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, 
organophosphate poisoning, botulism, critical illness myopathy, 
polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above 
list is not exhaustive.
    (d) Glossary for purposes of paragraph (c) of this section--(1) 
Chronic encephalopathy. (i) A chronic encephalopathy occurs when a 
change in mental or neurologic status, first manifested during the 
applicable Table time period as an acute encephalopathy or encephalitis, 
persists for at least 6 months from the first symptom or manifestation 
of onset or of significant aggravation of an acute encephalopathy or 
encephalitis.
    (ii) Individuals who return to their baseline neurologic state, as 
confirmed by clinical findings, within less than 6 months from the first 
symptom or manifestation of onset or of significant aggravation of an 
acute encephalopathy or encephalitis shall not be presumed to have 
suffered residual neurologic damage from that event; any subsequent 
chronic encephalopathy shall not be presumed to be a sequela of the 
acute encephalopathy or encephalitis.
    (2) Injected refers to the intramuscular, intradermal, or 
subcutaneous needle administration of a vaccine.
    (3) Sequela means a condition or event which was actually caused by 
a condition listed in the Vaccine Injury Table.
    (4) Significantly decreased level of consciousness is indicated by 
the presence of one or more of the following clinical signs:
    (i) Decreased or absent response to environment (responds, if at 
all, only to loud voice or painful stimuli);
    (ii) Decreased or absent eye contact (does not fix gaze upon family 
members or other individuals); or
    (iii) Inconsistent or absent responses to external stimuli (does not 
recognize familiar people or things).
    (5) Seizure includes myoclonic, generalized tonic-clonic (grand 
mal), and simple and complex partial seizures, but not absence (petit 
mal), or pseudo seizures. Jerking movements or staring episodes alone 
are not necessarily an indication of seizure activity.
    (e) Coverage provisions. (1) Except as provided in paragraph (e)(2), 
(3), (4), (5), (6), (7), or (8) of this section, this section applies 
only to petitions for compensation under the program filed with the 
United States Court of Federal Claims on or after February 21, 2017.
    (2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X 
of the Table) are included in the Table as of August 6, 1997.
    (3) Rotavirus vaccines (Item XI of the Table) are included in the 
Table as of October 22, 1998.
    (4) Pneumococcal conjugate vaccines (Item XII of the Table) are 
included in the Table as of December 18, 1999.

[[Page 769]]

    (5) Hepatitis A vaccines (Item XIII of the Table) are included on 
the Table as of December 1, 2004.
    (6) Trivalent influenza vaccines (Included in item XIV of the Table) 
are included on the Table as of July 1, 2005. All other seasonal 
influenza vaccines (Item XIV of the Table) are included on the Table as 
of November 12, 2013.
    (7) Meningococcal vaccines and human papillomavirus vaccines (Items 
XV and XVI of the Table) are included on the Table as of February 1, 
2007.
    (8) Other new vaccines (Item XVII of the Table) will be included in 
the Table as of the effective date of a tax enacted to provide funds for 
compensation paid with respect to such vaccines. An amendment to this 
section will be published in the Federal Register to announce the 
effective date of such a tax.

[82 FR 6299, Jan. 19, 2017, as amended at 86 FR 68427, Dec. 2, 2021]



PART 110_COUNTERMEASURES INJURY COMPENSATION PROGRAM--Table of Contents



                      Subpart A_General Provisions

Sec.
110.1 Purpose.
110.2 Summary of available benefits.
110.3 Definitions.

             Subpart B_Persons Eligible To Receive Benefits

110.10 Eligible requesters.
110.11 Survivors.

                       Subpart C_Covered Injuries

110.20 How to establish a covered injury.

                      Subpart D_Available Benefits

110.30 Benefits available to different categories of requesters under 
          this Program.
110.31 Medical benefits.
110.32 Benefits for lost employment income.
110.33 Death benefits.

            Subpart E_Procedures for Filing Request Packages

110.40 How to obtain forms and instructions.
110.41 How to file a Request Package.
110.42 Deadlines for filing Request Forms.
110.43 Deadlines for submitting documentation.
110.44 Legal or personal representatives of requesters.
110.45 Multiple survivors.
110.46 Amending a request package.

    Subpart F_Documentation Required for the Secretary To Determine 
                               Eligibility

110.50 Medical records necessary for the Secretary to determine whether 
          a covered injury was sustained.
110.51 Documentation an injured countermeasure recipient must submit for 
          the Secretary to make a determination of eligibility for 
          Program benefits.
110.52 Documentation a survivor must submit for the Secretary to make a 
          determination of eligibility for death benefits.
110.53 Documentation the executor or administrator of the estate of a 
          deceased injured countermeasure recipient must submit for the 
          Secretary to make a determination of eligibility for benefits 
          to the estate.

Subpart G_Documentation Required for the Secretary To Determine Program 
                                Benefits

110.60 Documentation a requester who is determined to be eligible must 
          submit for the Secretary to make a determination of medical 
          benefits.
110.61 Documentation a requester who is determined to be eligible must 
          submit for the Secretary to make a determination of lost 
          employment income benefits.
110.62 Documentation a requester who is determined to be an eligible 
          survivor must submit for the Secretary to make a determination 
          of death benefits.
110.63 Documentation a legal or personal representative must submit when 
          filing on behalf of a minor or on behalf of an adult who lacks 
          legal capacity to receive payment of benefits.

                  Subpart H_Secretarial Determinations

110.70 Determinations the Secretary must make before benefits can be 
          paid.
110.71 Insufficient documentation for eligibility and benefits 
          determinations.
110.72 Sufficient documentation for eligibility and benefits 
          determinations.
110.73 Approval of benefits.
110.74 Disapproval of benefits.

              Subpart I_Calculation and Payment of Benefits

110.80 Calculation of medical benefits.
110.81 Calculation of benefits for lost employment income.
110.82 Calculation of death benefits.
110.83 Payment of all benefits.
110.84 The Secretary's right to recover benefits paid under this Program 
          from third-party payers.

[[Page 770]]

       Subpart J_Reconsideration of the Secretary's Determinations

110.90 Reconsideration of the Secretary's eligibility and benefits 
          determinations.
110.91 Secretary's review authority.
110.92 No additional judicial or administrative review of determinations 
          made under this part.

             Subpart K_Covered Countermeasures Injury Tables

110.100 Injury Tables.

    Authority: 42 U.S.C. 247d-6e.

    Source: 75 FR 63675, Oct. 15, 2010, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  110.1  Purpose.

    This part implements the Public Readiness and Emergency Preparedness 
Act (PREP Act), which amended the Public Health Service Act (herein 
after ``PHS Act'' or ``the Act'') by including section 319F-3, and 
section 319F-4 entitled ``Covered Countermeasure Process.'' Section 
319F-4 of the PHS Act directs the Secretary of Health and Human 
Services, following issuance of a declaration under section 319F-3(b), 
to establish procedures for the Countermeasures Injury Compensation 
Program (herein after ``CICP'' or ``the Program'') to provide medical 
and lost employment income benefits to certain individuals who sustained 
a covered injury as the direct result of the administration or use of a 
covered countermeasure consistent with a declaration issued pursuant to 
section 319F-3(b), or in the good faith belief that administration or 
use of the covered countermeasure was consistent with a declaration. 
Also, if the Secretary determines that an individual died as a direct 
result of a covered injury, the Act provides for certain survivors of 
that individual to receive death benefits.



Sec.  110.2  Summary of available benefits.

    (a) The Act authorizes three forms of benefits to, or on behalf of, 
requesters determined to be eligible by the Secretary:
    (1) Payment or reimbursement for reasonable and necessary medical 
services and items to diagnose or treat a covered injury, or to 
diagnose, treat, or prevent its health complications, as described in 
Sec.  110.31.
    (2) Lost employment income incurred as a result of a covered injury, 
as described in Sec.  110.32.
    (3) Death benefits to certain survivors if the Secretary determines 
that the death of the injured countermeasure recipient was the direct 
result of a covered injury, as described in Sec.  110.33.
    (b) In general, the benefits paid under the Program, are secondary 
to any obligation of any third-party payer to provide or pay for such 
benefits. The benefits available under the CICP usually will be paid 
only after the requester has in good faith attempted to obtain all other 
available coverage from all third-party payers with an obligation to pay 
for or provide such benefits (e.g., medical insurance for medical 
services or items, workers' compensation program(s) for lost employment 
income). However, as provided in Sec.  110.84, the Secretary has the 
discretion to pay benefits under this Program before a potential third-
party payer makes a determination on the availability of similar 
benefits and has the right to later pursue a claim against any third-
party payer with a legal or contractual obligation to pay for, or 
provide, such benefits.



Sec.  110.3  Definitions.

    This section defines certain words and phrases found throughout this 
part.
    (a) Act or PHS Act means the Public Health Service Act, as amended.
    (b) Alternative calculation means the calculation used in Sec.  
110.82(c) of this part for the death benefit available to dependents 
younger than 18 years old at the time of payment.
    (c) Approval means a decision by the Secretary or her designee that 
the requester is eligible for benefits under the Program.
    (d) Benefits means payments and/or compensation for reasonable and 
necessary medical expenses or provision of services described in Sec.  
110.31, lost employment income described in Sec.  110.32, and/or payment 
to certain survivors of death benefits described in Sec.  110.33.

[[Page 771]]

    (e)(1) Child means any natural, illegitimate, adopted, posthumous 
child, or stepchild of a deceased injured countermeasure recipient who, 
at the time of the countermeasure recipient's death is:
    (i) 18 years of age or younger; or
    (ii) Between 19 and 22 years of age and a full-time student; or
    (iii) Incapable of self-support due to a physical or mental 
disability.
    (2) Posthumous child means a child born after the death of the 
parent.
    (3) Stepchild means a child of an injured countermeasure recipient's 
spouse but who is not the child of the injured countermeasure recipient. 
For a stepchild to be eligible for survivor death benefits under the 
Program, the stepchild's parent must have been married to the injured 
countermeasure recipient at the time of that injured countermeasure 
recipient's death, and the stepchild must have been supported by the 
injured countermeasure recipient.
    (f) Covered Countermeasure means the term that is defined in section 
319F-3(i)(1) of the PHS Act and described in a declaration issued under 
section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(i)(I), (b)). To be a 
covered countermeasure for purposes of this part, the countermeasure 
must have been administered or used pursuant to the terms of a 
declaration, or in a good faith belief of such; and
    (1) Administered or used within a State (as defined in Sec.  
110.3(bb)), or otherwise in the territory of the United States; or
    (2) Administered to, or used by, otherwise eligible individuals--
    (i) At American embassies or military installations abroad (such as 
military bases, ships, and camps); or
    (ii) At North Atlantic Treaty Organization (NATO) installations 
(subject to the NATO Status Agreement) where American servicemen and 
servicewomen are stationed.
    (g) Covered Injury means death, or a serious injury as described in 
Sec.  110.3(z), and determined by the Secretary in accordance with Sec.  
110.20 of this part to be:
    (1) An injury meeting the requirements of a Covered Countermeasures 
Injury Table, which is presumed to be the direct result of the 
administration or use of a covered countermeasure unless the Secretary 
determines there is another more likely cause; or
    (2) An injury (or its health complications) that is the direct 
result of the administration or use of a covered countermeasure. This 
includes serious aggravation caused by a covered countermeasure of a 
pre-existing condition.
    (h) Declaration means a recommendation issued by the Secretary under 
section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(b)), for the 
manufacture, testing, development, distribution, administration, or use 
of one or more covered countermeasures, following her determination that 
a specific disease, condition, or threat represents a public health 
emergency or a credible risk of a future public health emergency.
    (i) Dependent means, for purposes of lost employment income 
benefits, a person whom the Internal Revenue Service would consider to 
be the injured countermeasure recipient's dependent at the time the 
covered injury was sustained. For purposes of survivor death benefits, 
dependent means a person whom the Internal Revenue Service would 
consider to be the deceased injured countermeasure recipient's dependent 
at the time the covered injury was sustained, and who is younger than 
the age of 18 at the time of filing the Request Form.
    (j) Disapproval means a decision by the Secretary that the 
individual requesting benefits is not eligible to receive benefits under 
the Program for the specified injury that is the basis of the Request 
for Benefits.
    (k) Effective period of the declaration means the time span 
specified in a declaration, or as amended by the Secretary.
    (l) Federal Employees' Compensation Act (FECA) Program means the 
workers' compensation benefits program for civilian officers and 
employees of the Federal Government established under 5 U.S.C. 8101 et 
seq. as amended, and implemented by the United States Department of 
Labor in regulations codified at 20 CFR part 10, as amended.
    (m) Healthcare provider means an individual licensed, certified, or 
registered by an appropriate authority and who is qualified and 
authorized to

[[Page 772]]

provide health care services, such as diagnosing and treating physical 
or mental health conditions, prescribing medications, and providing 
primary and/or specialty care.
    (n) Injured countermeasure recipient means an individual:
    (1) Who, with respect to administration or use of a covered 
countermeasure pursuant to a Secretarial declaration:
    (i) Meets the specifications of the pertinent declaration; or
    (ii) Is administered or uses a covered countermeasure in a good 
faith belief that he or she is in a category described by paragraph 
(1)(i) of this definition; and
    (2) Sustained a covered injury as defined in Sec.  110.3(g).
    (3) If a covered countermeasure is administered to, or used by, a 
pregnant woman in accordance with paragraphs (1)(i) or (1)(ii) of this 
definition, any child from that pregnancy who survives birth is an 
injured countermeasure recipient if the child is born with, or later 
sustains, a covered injury (as defined in section 110.3(g)) as the 
direct result of the covered countermeasure's administration to, or use 
by, the mother during her pregnancy.
    (o) Lacks legal capacity means legally incompetent to receive 
payment(s) of benefits, as determined under applicable law.
    (p) Medical records means documentation associated with primary 
care, hospital in-patient and out-patient care, specialty consultations, 
and diagnostic testing and results.
    (q) Payer of last resort means that the Program pays benefits 
secondary to all other public and private third-party payers who have an 
obligation to pay for such benefits.
    (r) Program means the Countermeasures Injury Compensation Program 
(CICP).
    (s) PREP Act means the Public Readiness and Emergency Preparedness 
Act, codified as sections 319F-3 and 319F-4 of the PHS Act (42 U.S.C. 
247d-6d, 42 U.S.C. 247d-6e).
    (t) Public Safety Officers' Benefits (PSOB) Program means the 
Program established under Subpart 1 of part L of title I of the Omnibus 
Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.), as 
amended, and implemented by the United States Department of Justice in 
regulations codified at 28 CFR part 32, as amended.
    (u) Representative (legal or personal) means someone other than the 
person for whom Program benefits are sought, and who is authorized to 
file the Request Package on the requester's behalf pursuant to Sec.  
110.44.
    (v) Requester means an injured countermeasure recipient, or 
survivor, or the estate of a deceased injured countermeasure recipient 
(through the executor or administrator of the estate) who files a 
Request Package for Program benefits, or on whose behalf a Request 
Package is filed, under this part.
    (w) Request Form or Request for Benefits Form means the document 
designated by the Secretary for applying for Program benefits under this 
part.
    (x) Request Package means the Request Form, all documentation 
submitted by, or on behalf of, the requester, and all documentation 
obtained by the Secretary as authorized by, or on behalf of, the 
requester for determinations of Program eligibility and benefits under 
this part.
    (y) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority conferred on the Secretary under the PREP 
Act has been delegated.
    (z) Serious injury means serious physical injury. Physical 
biochemical alterations leading to physical changes and serious 
functional abnormalities at the cellular or tissue level in any bodily 
function may, in certain circumstances, be considered serious injuries. 
As a general matter, only injuries that warranted hospitalization 
(whether or not the person was actually hospitalized) or injuries that 
led to a significant loss of function or disability (whether or not 
hospitalization was warranted) will be considered serious injuries.
    (aa) Standard calculation means the calculation used in Sec.  
110.82(b) of this part for the death benefit available to all eligible 
survivors (other than surviving dependents younger than the age of 18 
who do not fit the definition of ``child'' under Sec.  110.3(e)).

[[Page 773]]

    (bb) State means any State of the United States of America, the 
District of Columbia, United States territories, commonwealths, and 
possessions, the Republic of the Marshall Islands, the Republic of 
Palau, and the Federated States of Micronesia.
    (cc) Survivor means a person meeting the requirements of Sec.  
110.11 with respect to a deceased injured countermeasure recipient who 
died as a direct result of a covered injury.
    (dd) Table or Table of Injuries means a Table of Covered 
Countermeasure Injuries to be included under Subpart K of this part, 
including the definitions and requirements set out therein.
    (ee) Third-party payer means the United States (other than for 
payments of benefits under this Program) or any other third party, 
including but not limited to, any State or local governmental entity, 
private insurance carrier, or employer, any public or private entity 
with a legal or contractual obligation to pay for or provide benefits. 
The Program is the payer of last resort.

[75 FR 63675, Oct. 15, 2010, as amended at 76 FR 62308, Oct. 7, 2011]



             Subpart B_Persons Eligible To Receive Benefits



Sec.  110.10  Eligible requesters.

    (a) The following requesters may, as determined by the Secretary, be 
eligible to receive benefits from this Program:
    (1) Injured countermeasure recipients, as described in Sec.  
110.3(n);
    (2) Survivors, as described in Sec.  110.3(cc) and Sec.  110.11; or
    (3) Estates of deceased injured countermeasure recipients through 
individuals authorized to act on behalf of the deceased injured 
countermeasure recipient's estate under applicable State law (i.e., 
executors or administrators).
    (b) If a countermeasure recipient dies, his or her survivor(s) and/
or the executor or administrator of his or her estate may file a new 
Request Package (or Request Package(s)) or amend a previously filed 
Request Package. A new Request Package may be filed whether or not a 
Request Package was previously submitted by, or on behalf of, the 
deceased injured countermeasure recipient, but must be filed within the 
filing deadlines described in Sec.  110.42. Amendments to previously 
filed Request Packages and the filing deadlines for such amendments are 
described in Sec.  110.46.
    (c) The benefits available to different categories of requesters are 
described in Sec.  110.30.



Sec.  110.11  Survivors.

    (a) Survivors of injured countermeasure recipients who died as the 
direct result of a covered injury. If the Secretary determines that an 
injured countermeasure recipient died as the direct result of a covered 
injury (or injuries), his or her survivor(s) may be eligible for death 
benefits.
    (b) Survivors who may be eligible to receive benefits and the order 
of priority for benefits. (1) The Act uses the same categories of 
survivors and order of priority for benefits as established and defined 
by the PSOB Program, except as provided in paragraphs (b)(3), (4), and 
(5) of this section.
    (2) The PSOB Program's categories of survivors (known in the PSOB 
Program as beneficiaries) and order of priority for receipt of death 
benefits are detailed under subpart 1 of part L of title I of the 
Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et 
seq.), as amended, as implemented in 28 CFR part 32.
    (3) In the PSOB Program, the person who is survived must have 
satisfied the eligibility requirements for a deceased public safety 
officer, whereas the person who is survived under this Program must be a 
deceased injured countermeasure recipient who would otherwise have been 
eligible under this part.
    (4) Unlike the PSOB Program, if there are no survivors eligible to 
receive death benefits under the PSOB Program (as set forth in paragraph 
(b)(2) of this section), the legal guardian of a deceased minor who was 
a countermeasure recipient may be eligible as a survivor under this 
Program. Such legal guardianship must be determined by a court of 
competent jurisdiction under applicable State law.
    (5) A surviving dependent younger than the age of 18 whose legal 
guardian opts to receive a death benefit under

[[Page 774]]

the alternative calculation on the dependent's behalf will have the same 
priority as surviving eligible children under the PSOB Program 
(consistent with paragraph (b)(2) of this section) even if the dependent 
is not the surviving eligible child of the deceased countermeasure 
recipient for purposes of the PSOB Program. However, such a dependent 
may only be eligible to receive benefits under the alternative death 
benefits calculation, described in Sec.  110.82(c), and is not eligible 
to receive death benefits under the standard calculation described in 
Sec.  110.82(b). Death benefits paid under the alternative calculation 
will be paid to the dependents' legal guardian(s) on behalf of all such 
dependents.
    (6) Any change in the order of priority of survivors or of the 
eligible category of survivors under the PSOB Program shall apply to 
requesters seeking death benefits under this Program on the effective 
date of the change, even prior to any corresponding amendment to this 
part. Such changes will apply to Request Packages pending with the 
Program on the effective date of the change, as well as to Requests 
filed after that date.



                       Subpart C_Covered Injuries



Sec.  110.20  How to establish a covered injury.

    (a) General. Only serious injuries, as described in Sec.  110.3(z), 
or deaths are covered under the Program. In order to be eligible for 
benefits under the Program, a requester must submit documentation 
showing that a covered injury, as described in Sec.  110.3(g), was 
sustained as the direct result of the administration or use of a covered 
countermeasure pursuant to the terms of a declaration under section 
319F-3(b) of the PHS Act (including administration or use during the 
effective period of the declaration) or as the direct result of the 
administration or use of a covered countermeasure in a good faith belief 
that it was administered or used pursuant to the terms of a declaration 
(including administration or use during the effective period of the 
declaration). A requester can establish that a covered injury was 
sustained by demonstrating to the Secretary that a Table injury 
occurred, as described in paragraph (c) of this section. In the 
alternative, a requester can establish that an injury was actually 
caused by a covered countermeasure, as described in paragraph (d) of 
this section. The Secretary may obtain the opinions of qualified medical 
experts in making determinations concerning covered injuries.
    (b) Table injuries. A Table lists and explains injuries that, based 
on compelling, reliable, valid, medical and scientific evidence, are 
presumed to be caused by a covered countermeasure, and the time periods 
in which the onset (i.e., first sign or symptom) of these injuries must 
occur after administration or use of the covered countermeasures. If an 
injury occurred within the listed time periods, and at the level of 
severity required, there is a rebuttable presumption that the covered 
countermeasure was the cause of the injury. A Table is accompanied by 
Qualifications and Aids to Interpretation which provide an explanation 
of the injuries listed on a Table. A requester may establish that a 
covered injury occurred by demonstrating that the countermeasure 
recipient sustained an injury listed on a Table, within the time 
interval defined by the Table's Definitions and Requirements. In such 
circumstances, the requester need not demonstrate the cause of the 
injury because the Secretary will presume, only for purposes of making 
determinations under this Subpart, that the injury was the direct result 
of the administration or use of a covered countermeasure. Even if the 
Table requirements are satisfied, however, an injury will not be 
considered a covered injury if the Secretary determines, based on her 
review of the evidence, that a source other than the countermeasure more 
likely caused the injury. In such circumstances, the Table presumption 
of causation will be rebutted.
    (c) Injuries for which causation must be shown (non-Table injuries). 
If an injury is not included on a Table or if the injury does not meet 
the requirements set out for an injury that is listed on a Table (e.g., 
the first sign or symptom of the injury did not occur within the time 
interval specified on the Table), the requester must demonstrate that

[[Page 775]]

the injury occurred as the direct result of the administration or use of 
a covered countermeasure. Such proof must be based on compelling, 
reliable, valid, medical and scientific evidence. Temporal association 
between receipt of the countermeasure and onset of the injury is not 
sufficient by itself to prove that the countermeasure caused the injury.
    (d) Injuries resulting from the underlying condition for which the 
countermeasure was administered or used. An injury sustained as the 
direct result of the covered condition or disease for which the 
countermeasure was administered or used, and not as the direct result of 
the administration or use of the covered countermeasure, is not a 
covered injury (e.g., if the covered countermeasure is ineffective in 
treating or preventing the underlying condition or disease).



                      Subpart D_Available Benefits



Sec.  110.30  Benefits available to different categories of requesters 
under this Program.

    (a) Benefits available to injured countermeasure recipients. A 
requester who is an injured countermeasure recipient may be eligible to 
receive either medical benefits or benefits for lost employment income, 
or both.
    (b) Benefits available to survivors. A requester who is an eligible 
survivor of a deceased injured countermeasure recipient may be eligible 
to receive a death benefit if the death was caused by the covered injury 
or its health complications.
    (c) Benefits available to estates of deceased injured countermeasure 
recipients. The estate of an otherwise eligible deceased injured 
countermeasure recipient may be eligible to receive medical benefits or 
benefits for lost employment income, or both, if such benefits were 
accrued during the deceased countermeasure recipient's lifetime, or at 
the time of death, as a result of a covered injury or its health 
complications, but have not yet been paid in full by the Program. Such 
medical benefits and benefits for lost employment income may be 
available regardless of the cause of death. The estate of the deceased 
injured countermeasure recipient may not receive a death benefit. Death 
benefits are only available to certain survivors.



Sec.  110.31  Medical benefits.

    (a) Injured countermeasure recipients may receive payments or 
reimbursements for medical services and items that the Secretary 
determines to be reasonable and necessary to diagnose or treat a covered 
injury, or to diagnose, treat, or prevent the health complications of a 
covered injury. The Secretary may pay for such medical services and 
items in an effort to cure, counteract, or minimize the effects of any 
covered injury, or any health complication of a covered injury, or to 
give relief, reduce the degree or the period of disability, or aid in 
lessening the amount of benefits to a requester (e.g., a surgical 
procedure that lessens the amount of time and expense for the treatment 
of a covered injury). The Secretary may make such payments or 
reimbursements if reasonable and necessary medical services and items 
have already been provided or if they are likely to be needed in the 
future. In making determinations about which medical services and items 
are reasonable and necessary, the Secretary may consider whether those 
medical services and items were prescribed or recommended by a 
healthcare provider, and may consider whether the applicable service or 
item is within the standard of care for that condition.
    (b) To receive medical benefits for the health complications of a 
covered injury, a requester must demonstrate that the complications are 
the direct result of the covered injury. Examples of health 
complications include, but are not limited to, ill-effects that stem 
from the covered injury, an adverse reaction to a prescribed medication 
or as a result of a diagnostic test used in connection with a covered 
injury, or a complication of a surgical procedure used to treat a 
covered injury.
    (c) The calculation of medical benefits available under this Program 
is described in Sec.  110.80. Although there are no caps on medical 
benefits, the Secretary may limit payments to the

[[Page 776]]

amounts that she determines are reasonable for services and items 
considered reasonable and necessary. All payment or reimbursement for 
medical services and items is secondary to any obligation of any third-
party payer to pay for or provide such services or items to the 
requester. As provided in Sec.  110.84, the Secretary retains the right 
to recover medical benefits paid by the Program to requesters if third-
party payers are obligated to provide those benefits. Requesters are 
expected to make good faith efforts to pursue medical benefits and 
services from their primary payers. The Secretary reserves the right to 
disapprove medical benefits if the requester fails to do so.
    (d) The Secretary may make payments of medical benefits or 
reimbursements of medical expenses described in this section to the 
estate of a deceased injured countermeasure recipient as long as such 
payments or expenses were accrued during the deceased injured 
countermeasure recipient's lifetime, or at the time of death, as the 
result of the covered injury or its health complications, and were not 
paid in full by the Program before the deceased injured countermeasure 
recipient died.



Sec.  110.32  Benefits for lost employment income.

    (a) Requesters who are determined to be eligible for Program 
benefits as injured countermeasure recipients may be able to receive 
benefits for loss of employment income incurred as a result of a covered 
injury (or its health complications, as described in Sec.  110.31(b)). 
Compensation for lost wages is paid as a percentage of the amount of 
employment income earned at the time of injury and lost as the result of 
the covered injury or its health complications. The period of time 
requested for lost employment income benefits must be supported by the 
severity of the covered injury as demonstrated by the medical and 
employment records.
    (b) The method and amount of benefits for lost employment income are 
described in Sec.  110.81. Benefits for lost employment income will be 
adjusted if there are fewer than ten days of lost employment income. 
Pursuant to law, and as described in Sec.  110.81, benefits provided for 
lost employment income may also be adjusted for annual and lifetime 
caps. Payment of benefits for lost employment income is secondary to any 
obligation of any third-party payer to pay for lost employment income or 
to provide disability or retirement benefits to the requester. It is the 
obligation of requesters to follow all specified procedures to apply for 
and acquire third-party benefits. The Secretary has the discretion to 
disapprove lost employment income benefits if the requester fails to do 
so. As provided in Sec.  110.84, the Secretary reserves the right to 
recover lost employment income benefits paid by the Program to 
requesters if third-party payers are obligated to provide those 
benefits.
    (c) The Secretary does not require an individual to use paid leave 
(e.g., sick leave or vacation leave) for lost work days. However, if an 
individual uses paid leave for lost work days, the Secretary will not 
consider those days to be days of lost employment income unless the 
individual reimburses the employer for the paid leave taken and the 
employer restores the leave that was used. This puts the individual back 
in the same position as if he or she had not used paid leave for the 
lost work days.
    (d) The Secretary may pay benefits for lost employment income to the 
estate of a deceased injured countermeasure recipient as long as such 
benefits were accrued during the deceased injured countermeasure 
recipient's lifetime as the result of a covered injury or its health 
complications, and were not paid in full by the Program before the 
deceased injured countermeasure recipient died. However, no such lost 
employment income may be paid after the receipt, by the survivor or 
survivors of a deceased injured countermeasure recipient, of death 
benefits under Sec.  110.82.



Sec.  110.33  Death benefits.

    (a) Eligible survivors may be able to receive a death benefit under 
this Program if the Secretary determines that an otherwise eligible 
countermeasure recipient sustained a covered injury and died as a direct 
result of the injury

[[Page 777]]

or its health complications. The method and amount of death benefits are 
described in Sec.  110.82. As provided in Sec.  110.84, the Secretary 
retains the right to recover death benefits paid by the Program if 
third-party payers are obligated to provide those benefits. There are 
two different calculations for death benefits: the standard calculation 
and the alternative calculation.
    (b) The standard calculation, described in Sec.  110.82(b), is based 
upon the death benefit available under the PSOB Program and is available 
to all eligible survivors with one exception (surviving dependents 
younger than the age of 18 who do not fit the definition of ``child'' 
under Sec.  110.3(e)). In the event that death benefits were paid under 
the PSOB Program with respect to the deceased injured countermeasure 
recipient, no death benefits may be paid under the standard calculation. 
In addition, death benefits under this standard calculation are 
secondary to disability benefits under the PSOB Program. If a disability 
benefit was paid under the PSOB Program, the amount of that disability 
benefit would be deducted from benefits payable under the standard 
calculation.
    (c) The alternative calculation, described in Sec.  110.82(c), is 
based on the injured countermeasure recipient's employment income at the 
time of the covered injury. Payment under this calculation is only 
available to surviving dependents who are younger than the age of 18 at 
the time of payment. The legal guardian(s) of such surviving dependents 
must select the death benefit as calculated under this alternative 
calculation before it will be paid. Annual and lifetime caps may apply. 
The payment of a death benefit as calculated under this alternative 
calculation is secondary to other benefits paid or payable with respect 
to the deceased injured countermeasure recipient, namely:
    (1) Compensation for loss of employment income (except for lost 
employment income under this Program);
    (2) Death or disability benefits (i.e., payments including, but not 
limited to, those under the PSOB Program) on behalf of the dependent(s) 
or their legal guardian(s);
    (3) Retirement benefits on behalf of the dependent(s) or their legal 
guardians; or
    (4) Life insurance benefits on behalf of the dependent(s).



            Subpart E_Procedures for Filing Request Packages



Sec.  110.40  How to obtain forms and instructions.

    (a) Copies of all necessary forms and instructions will be 
available:
    (1) By writing to the Countermeasures Injury Compensation Program, 
Healthcare Systems Bureau, Health Resources and Services Administration, 
Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857.
    (2) By calling 1-888-ASK-HRSA. This is a toll-free number.
    (3) By downloading them from the Internet at http://www.hrsa.gov/
countermeasurescomp/. Click on the link to ``Forms and Instructions.''
    (b) Before reviewing a Request for Benefits, the Secretary will 
assign a case number to the Request for Benefits and so inform the 
requester (or his or her representative) in writing. All correspondence 
to the requester (or his or her representative) about a specific Request 
for Benefits will be referenced by this case number.



Sec.  110.41  How to file a Request Package.

    A Request Package comprises all the forms and documentation that are 
submitted to enable the Secretary to determine eligibility and calculate 
benefits. Request Packages may be submitted through the U.S. Postal 
Service, commercial carrier, or private courier service. The 
Countermeasures Injury Compensation Program will not accept Request 
Packages that are hand-delivered. Electronic submissions are not 
currently accepted, but may be in the future. The Program will publish a 
notice if electronic filing becomes available. Requesters (or their 
representatives) should send all forms and documentation to the 
Countermeasures Injury Compensation Program, Healthcare Systems Bureau, 
Health Resources and Services Administration, Parklawn Building, Room 
11C-26,

[[Page 778]]

5600 Fishers Lane, Rockville, MD 20857. All documentation to the Program 
must include the case number once one has been assigned to the 
requester.



Sec.  110.42  Deadlines for filing Request Forms.

    (a) General. All Request Forms (or Letters of Intent, described in 
paragraph (b) of this section) must be filed within one year of the date 
of the administration or use of a covered countermeasure that is alleged 
to have caused the injury. If no previous Request Form (or Letter of 
Intent) has been filed, this deadline also applies to survivor(s) of an 
injured countermeasure recipient who is deceased, and to the executor or 
administrator of his or her estate. If a Request Form (or Letter of 
Intent) was previously filed, Sec.  110.46 describes amendments to 
Request Packages.
    (b) Letters of Intent. Until Request Forms and Instructions are 
available, requesters must file a Letter of Intent to File, in order to 
establish that their Requests for Benefits are timely filed within the 
one-year deadline. Directions for submitting a Letter of Intent (to 
file) are available on the Program's Web site at http://www.hrsa.gov/
countermeasurescomp/ or by calling 1-888-ASK-HRSA. Even once Request 
Forms are available, the Secretary has the discretion to accept Letters 
of Intent (to file) for purposes of meeting the filing deadline. 
However, when Request Forms and Instructions are available, all 
requesters who have submitted Letters of Intent must still file Request 
Forms as soon as possible.
    (c) Determination of proper filing. The filing date is the date the 
Request Form (or Letter of Intent) is postmarked. A legibly dated 
receipt from a commercial carrier, a private courier service, or the 
U.S. Postal Service will be considered equivalent to a postmark. If and 
when Request Forms are accepted electronically, the filing date is the 
date the Request Form is submitted electronically. A Request Form will 
not be considered filed unless it has been completed (to the fullest 
extent possible) and signed by the requester or his or her personal or 
legal representative. After filing a Request Form within the governing 
filing deadline, a requester must update the Request Package to reflect 
new information as it becomes available (e.g., copies of medical records 
generated after the initial submission of the Request Package).
    (d) Request Forms not filed within the one-year deadline. If the 
Secretary determines that a Request Form or Letter of Intent was not 
filed within the governing filing deadline set out in this section, the 
Request Form (or Letter of Intent) will not be processed and the 
requester will not be eligible for benefits under this Program.
    (e) Constructive receipt. The Secretary reserves the right to 
consider a legal claim filed with the Federal Government (e.g., a 
Federal Tort Claims Act claim or a petition with the National Vaccine 
Injury Compensation Program) concerning an alleged injury resulting from 
the administration or use of a covered countermeasure to be a filing of 
a Request Form or Letter of Intent for purposes of determining the 
filing date under this Program. The date of such constructive filing 
will be the official filing date of the action, i.e., when all 
applicable requirements for proper filing in that forum have been met.
    (f) Request Forms (or amendments to Request Forms) based on initial 
publication of a Table of Injuries or modifications to an existing 
Table. The Secretary may publish a new Table (or Tables) by amendment(s) 
to subpart K of this part. The effect of such a new Table or amendment 
may enable a requester who previously could not establish a Table injury 
to do so. In such circumstances, within one year after the effective 
date of the establishment of, or amendment to, the Table, the requester 
must file a new Request Form if one was previously submitted and 
eligibility was denied or if one was not previously submitted. If the 
Secretary has not made a determination, she will automatically review 
any pending Request Forms in light of the new or amended Table(s).

[75 FR 63675, Oct. 15, 2010, as amended at 76 FR 62309, Oct. 7, 2011]

[[Page 779]]



Sec.  110.43  Deadlines for submitting documentation.

    (a) Documentation for eligibility determinations. A requester will 
satisfy the filing deadline as long as the signed Request Form is 
completed (to the fullest extent possible) and submitted within the 
governing filing deadline described in Sec.  110.42. The Secretary 
generally will not begin review of a requester's eligibility until all 
the documentation necessary to make this determination has been 
submitted.
    (b) Documentation for benefits determinations. Although the 
Secretary will accept documentation required to make benefits 
determinations (i.e., calculate benefits available, if any) at the time 
the Request Form is filed or any time thereafter, requesters need not 
submit such documentation until they have been notified that the 
Secretary has determined eligibility. The Secretary will not generally 
begin review of the benefits available to a requester until the 
documentation necessary to make a benefits determination has been 
submitted.



Sec.  110.44  Legal or personal representatives of requesters.

    (a) Generally. Persons other than a requester (e.g., a lawyer, 
guardian, family member, friend) may file a Request Package on a 
requester's behalf as his or her legal or personal representative. A 
requester need not use the services of a lawyer to apply for benefits 
under this Program. A legal representative, or a personal representative 
(who does not need to be a lawyer) is only required, as described in 
this section, for requesters who are minors or adults who lack legal 
capacity to receive payment of benefits. In the event that a legal or 
personal representative files on behalf of a requester, the 
representative will be bound by the obligations and documentation 
requirements that apply to the requester (e.g., if a requester is 
required to submit employment records, the representative must file the 
requester's employment records). The representative must also satisfy 
the requirements specific to representatives set out in this part. If a 
requester has a representative, the Program will generally direct all 
communications to the representative. However, the Secretary reserves 
the right of the Program to contact the requester directly if necessary, 
and to conduct a follow-up survey to determine the ability of the 
Program to meet requesters' needs.
    (b) Legal or personal representatives of legally competent adults. A 
requester who is a legally competent adult may use a legal or personal 
representative to submit a Request Package on his or her behalf. In such 
circumstances, the requester must indicate on the Request Form that he 
or she is authorizing the representative to seek benefits under this 
Program on his or her behalf.
    (c) Legal or personal representatives of minors and adults who lack 
legal capacity to receive payment of benefits. A requester who is a 
minor or an adult who lacks legal capacity to receive payment of 
benefits must use a legal or personal representative to apply for 
benefits under this Program on his or her behalf. In such circumstances, 
the representative must indicate, in the place provided on the Request 
Form, that the requester is a minor or an adult who lacks legal capacity 
to receive payment of benefits and that the representative is filing on 
behalf of the requester. In addition, before the requester will be paid 
by the Program, the representative must submit the documentation 
described in Sec.  110.63. A minor who is emancipated, as determined by 
a court of competent jurisdiction, does not need a legal or personal 
representative to file a Request Form or Request Package on his or her 
behalf.
    (d) No payment or reimbursement for legal or personal 
representatives' fees or costs. The Act does not authorize the Secretary 
to pay for, or reimburse, any fees or costs associated with the 
requester's use of the services of a legal or personal representative 
under this Program, including those of an attorney.



Sec.  110.45  Multiple survivors.

    Multiple survivors of the same deceased injured countermeasure 
recipient may file Request Forms separately or together. Multiple 
survivors may also submit one set of any required documentation on 
behalf of all of the requesting survivors as long as such

[[Page 780]]

documentation is identical for each survivor.



Sec.  110.46  Amending a Request Package.

    (a) Generally. All requesters may amend their documentation 
concerning eligibility up to the time the Secretary has made an 
eligibility determination. Requesters are expected to submit additional 
medical records as they become available. Requesters also may amend 
their information or documentation concerning the calculation of 
benefits until the Secretary has made a benefits determination. Once an 
eligibility determination has been made, the Secretary will not accept 
additional documentation concerning eligibility, except as described in 
paragraphs (b) and (c) of this section. Once a benefits determination 
has been made, the Secretary will not accept additional documentation 
regarding the type or amount of benefits for that covered injury, except 
as described in paragraphs (b) and (c) of this section.
    (b) Requesters who are survivors. If an injured countermeasure 
recipient submitted a Request Form within the filing deadline, but 
subsequently dies, or the executor or administrator timely filed on 
behalf of the estate, the survivor(s) may amend the previously filed 
Request Package at any time by filing a new Request Form in order to be 
considered for death benefits. Such an amendment can be filed regardless 
of whether the Secretary made an eligibility determination or paid 
benefits with respect to the deceased injured countermeasure recipient's 
Request Package. However, a survivor filing an amendment to a previously 
filed Request Package may only be eligible for benefits if the 
previously filed Request Package was filed within the governing filing 
deadline. All documentation that has already been submitted with respect 
to the deceased injured countermeasure recipient will be considered part 
of the survivor requester's Request Package, and he or she is not 
required to resubmit such documentation. Survivor requesters must also 
file an amendment to a Request Package if there is a change in the order 
of priority of survivors, as described in Sec.  110.11.
    (c) Requests in which the benefits are sought for the estate of a 
deceased injured countermeasure recipient. If an injured countermeasure 
recipient submitted a Request Form within the filing deadline, but 
subsequently dies before all due benefits are paid by the Program, the 
executor or administrator of his or her estate may amend his or her 
Request Package at any time in order for the estate to be considered for 
benefits. This opportunity to amend applies also if the Request Form was 
timely filed by a survivor. Such an amendment can be filed regardless of 
whether the Secretary made an eligibility determination or paid benefits 
with respect to the deceased injured countermeasure recipient's Request 
Package. However, the executor or administrator of the deceased injured 
countermeasure recipient's estate filing an amendment to a previously 
filed Request Package may only be eligible to receive benefits on behalf 
of the estate if the previously filed Request Package was filed within 
the governing deadline. All documentation that has already been 
submitted with respect to the deceased injured countermeasure recipient 
will be considered part of that person's Request Package, and the 
executor or administrator of the estate is not required to resubmit such 
documentation.



    Subpart F_Documentation Required for the Secretary To Determine 
                               Eligibility



Sec.  110.50  Medical records necessary for the Secretary to determine 
whether a covered injury was sustained.

    (a) In order to determine whether an injured countermeasure 
recipient sustained a covered injury, a requester must arrange for his 
or her medical providers to submit to the Program the following medical 
records, as defined in Sec.  110.3(p):
    (1) All medical records documenting medical visits, procedures, 
consultations, and test results that occurred on or after the date of 
administration or use of the covered countermeasure; and
    (2) All hospital records, including the admission history and 
physical examination, the discharge summary, all physician subspecialty 
consultation reports, all physician and nursing

[[Page 781]]

progress notes, and all test results that occurred on or after the date 
of administration or use of the covered countermeasure; and
    (3) All medical records for one year prior to administration or use 
of the covered countermeasure as necessary to indicate an injured 
countermeasure recipient's pre-existing medical history.
    (b) A requester may submit additional medical documentation that he 
or she believes will support the Request Package. Although generally not 
required if a Table injury was sustained, a requester may introduce 
additional medical documentation or scientific evidence in order to 
establish that an injury was caused by a covered countermeasure. Letters 
from treating physicians may be submitted as additional evidence, but 
may not substitute for the medical documentation required in paragraph 
(a) of this section.
    (c) If certain medical records listed in paragraph (a) of this 
section are unavailable to the Program after the requester has made 
reasonable efforts to facilitate the records being sent to the Program, 
the requester must submit a statement describing the reasons for the 
records' unavailability and the efforts he or she has made to arrange 
for the health care providers to submit them. The Secretary has the 
discretion to accept this statement in place of the unavailable medical 
records. In this circumstance, the Secretary may attempt to obtain the 
records on the requester's behalf.
    (d) In certain circumstances, the Secretary may require additional 
records to make a determination that a covered injury was sustained 
(e.g., medical records more than one year prior to the date of 
administration or use of the covered countermeasure) or may determine 
that certain records described in paragraph (a) of this section are not 
necessary for an eligibility determination.
    (e) Although the Secretary prefers to receive medical records 
directly from healthcare providers, she has the discretion to accept 
them from the requester.



Sec.  110.51  Documentation an injured countermeasure recipient must submit 
for the Secretary to make a determination of eligibility for Program benefits.

    (a) An injured countermeasure recipient (or his or her legal or 
personal representative) must submit all of the following documentation 
in order for the Secretary to make a determination of eligibility:
    (1) A completed and signed Request Form submitted within the filing 
deadline described in Sec.  110.42; and
    (2) Records sufficient to demonstrate that the injured 
countermeasure recipient used or was administered a covered 
countermeasure; and
    (3) Records sufficient to demonstrate that the injured 
countermeasure recipient sustained a covered injury, as defined in Sec.  
110.3(g), in accordance with the requirements set forth in Sec.  110.50; 
and
    (4) A copy of each signed Authorization for Health Information Form 
authorizing the release of records to the Program that was sent by the 
requester to each healthcare provider instructing that the records be 
submitted directly to the Program.
    (b) In certain circumstances, some of the above documentation may 
not be required, or additional documentation may be required, in which 
case the Secretary will so notify the requester. For example, the 
Secretary may require records sufficient to demonstrate that the injured 
countermeasure recipient was administered or used a covered 
countermeasure in accordance with the provisions of a Secretarial 
declaration, or in the good faith belief that it was so administered or 
used, if she is unable to determine this from the records submitted. In 
order to meet the specifications of a declaration, some individuals will 
need to show that the activity giving rise to the injury (i.e., 
administration or use of the covered countermeasure) was authorized in 
accordance with the public health and medical response of the Authority 
Having Jurisdiction, as defined in the pertinent declaration, to 
prescribe, administer, deliver, distribute or dispense the covered 
countermeasure following a declaration of an emergency, as defined

[[Page 782]]

in the pertinent declaration. For purposes of this part, this 
requirement can be satisfied by showing that the covered countermeasure 
was administered or used following the declaration of an emergency, as 
defined in the pertinent declaration, by an Authority Having 
Jurisdiction, as defined in the pertinent declaration either:
    (1) Pursuant to a written agreement or other formal arrangement with 
an Authority Having Jurisdiction; or
    (2) In accordance with the written recommendations of an Authority 
Having Jurisdiction.



Sec.  110.52  Documentation a survivor must submit for the Secretary 
to make a determination of eligibility for death benefits.

    (a) A requester who is a survivor under Sec.  110.11 must submit the 
following documentation in order for a determination of eligibility for 
a death benefit to be made:
    (1) All of the documentation required for individuals in Sec.  
110.51. There is no need to duplicate documentation already submitted to 
satisfy the requirements of other subparts in this part. For example, if 
the deceased injured countermeasure recipient had previously filed, the 
documentation submitted does not have to be re-submitted; and
    (2) A death certificate for the deceased countermeasure recipient. 
If a death certificate is unavailable, the requester must submit a 
letter providing the reasons for its unavailability. The Secretary has 
the discretion to accept other documentation as evidence that the 
injured countermeasure recipient is deceased; and
    (3) Medical records sufficient to establish that the deceased 
injured countermeasure recipient died as the result of the covered 
injury or its health complications. Such medical records may be the same 
as those required under Sec.  110.50. If an autopsy was performed, the 
requester must submit a complete copy of the final autopsy report; and
    (4) Documentation showing that the requester is an eligible 
survivor, pursuant to Sec.  110.11 (e.g., birth certificate or marriage 
certificate); and
    (5) Verification, on the place provided on the Request Form, either 
that there are no other eligible survivors (e.g., for surviving eligible 
children, that there is no surviving spouse, no other surviving eligible 
children, and no other surviving dependents younger than the age of 18 
who may be eligible for the death benefit under the alternative 
calculation) or that other eligible survivors exist (along with the 
information known about such survivors). Section 110.11 describes 
eligible survivors and the priorities of survivorship; and
    (6) Even if a Request Form had previously been filed by the injured 
countermeasure recipient, the survivor(s) must submit a new Request 
Form.
    (b) [Reserved]



Sec.  110.53  Documentation the executor or administrator of the estate 
of a deceased injured countermeasure recipient must submit for the Secretary 
to make a determination of eligibility for benefits to the estate.

    (a) The executor or administrator of the estate of a deceased 
injured countermeasure recipient must submit the following documentation 
in order for a determination of eligibility for benefits to the estate 
to be made:
    (1) All of the documentation required for individuals in Sec.  
110.51;
    (2) A death certificate for the deceased injured countermeasure 
recipient. If a death certificate is unavailable, the executor or 
administrator must submit a letter providing the reasons for its 
unavailability. The Secretary has the discretion to accept other 
documentation as evidence that the injured countermeasure recipient is 
deceased; and
    (3) Documentation showing that the individual is the executor or 
administrator of the estate of the deceased injured countermeasure 
recipient, e.g., Letter of Administration issued by a court of competent 
jurisdiction; and
    (4) Even if a Request Form had previously been filed by the injured 
countermeasure recipient, the executor or administrator of the estate 
must submit a new Request Form.
    (b) [Reserved]

[[Page 783]]



Subpart G_Documentation Required for the Secretary To Determine Program 
                                Benefits



Sec.  110.60  Documentation a requester who is determined to be eligible 
must submit for the Secretary to make a determination of medical benefits.

    (a) A requester determined by the Secretary to be eligible for 
Program benefits and who seeks payment or reimbursement for medical 
services or items must provide the following, in addition to the 
documentation submitted under subpart F of this part:
    (1) List of third-party payers. The requester must submit a list of 
all third-party payers that may have an obligation to pay for or provide 
any medical services or items to the injured countermeasure recipient 
for which payment or reimbursement is being sought under this Program. 
Such third-party payers may include, but are not limited to, health 
maintenance organizations, health insurance companies, workers' 
compensation programs, Medicare, Medicaid, Department of Veterans 
Affairs, military treatment facilities (MTFs), and any other entities 
obligated to provide medical services or items or reimburse individuals 
for medical expenses. Such a list must include the injured 
countermeasure recipient's account numbers and other applicable 
information. If the requester knows of no such third-party payer, he or 
she must so certify in writing. If the requester becomes aware that a 
third-party payer may have such an obligation, the requester must inform 
the Secretary within ten business days of becoming aware of this 
information, even after benefits have been paid by the Program.
    (2) Documents for medical services or items provided since the onset 
of the covered injury. A requester seeking payment or reimbursement for 
medical services or items already provided for a covered injury or its 
health complications must submit an itemized statement from each 
healthcare provider or entity (e.g., clinic, hospital, doctor, or 
pharmacy) and third-party payer listing the services or items provided 
to diagnose or treat the covered injury or its health complications and 
the amounts paid or expected to be paid by third parties for such 
services or items (e.g., an Explanation of Benefits from the 
individual's health insurance company). If no third-party payer has an 
obligation to pay for or provide such services or items, the requester 
must so certify in writing and submit an itemized list of the services 
or items provided (including the total cost of such services or items). 
To assist the Secretary in making a determination as to whether such 
services or items were reasonable and necessary to diagnose or treat a 
covered injury, or to diagnose, treat, or prevent its health 
complications, the requester may submit, in addition to the required 
medical records, documentation showing that a health-care provider 
prescribed or recommended such services or items. The medical records 
must support the requested services and items.
    (3) Documents for medical services and items expected to be provided 
in the future. A requester seeking payments for medical services or 
items resulting from a covered injury or its health complications 
expected to be provided in the future must submit a statement from each 
healthcare provider (e.g., a treating neurologist for neurological 
issues and a treating cardiologist for cardiac issues) describing those 
services and items that appear likely to be needed to diagnose or treat 
the covered injury, or to diagnose, treat, or prevent its health 
complications, in the future. The medical records must support the 
requested services and items. A requester must submit documentation, if 
available, concerning the likely cost of, and the amount expected to be 
covered by third-party payers for, such services or items. Consent for 
the Program to communicate directly with the healthcare providers may 
also be required.
    (b) [Reserved]



Sec.  110.61  Documentation a requester who is determined to be eligible 
must submit for the Secretary to make a determination of lost 
employment income benefits.

    (a) A requester determined by the Secretary to be eligible for 
Program benefits and who seeks benefits for lost employment income must 
provide, in

[[Page 784]]

addition to the documentation submitted under subpart F of this part, 
documentation describing:
    (1) The number of days (including partial days) of work missed by 
the injured countermeasure recipient as a result of the covered injury 
or its health complications for which employment income was lost (e.g., 
time sheet from the relevant pay period(s) showing work days missed). As 
stated in Sec.  110.32(c), days for which an individual used paid leave 
will be considered days of work for which employment income was received 
and, therefore, would not qualify for lost employment income benefits. 
However, if the injured countermeasure recipient reimburses the employer 
for the paid leave taken and the employer restores the leave that was 
used, the individual may be eligible for lost employment income benefits 
for those days; and
    (2) The injured countermeasure recipient's gross employment income 
at the time the covered injury was sustained (e.g., the individual's 
Federal tax return or pay stub(s) from all employers at the time of the 
covered injury); and
    (3) Whether the injured countermeasure recipient had one or more 
dependents at the time the covered injury was sustained (e.g., the 
individual's Federal tax return at the time of the covered injury); and
    (4) A list of all third-party payers that have paid, or that may be 
obligated to pay, benefits to the injured countermeasure recipient for 
loss of employment income or provide disability and/or retirement 
benefits for which payment or reimbursement is being sought under this 
Program (e.g., State workers' compensation programs, disability 
insurance programs, Uniform Services Retirement Board determinations, 
Department of Veterans Affairs determinations, etc.). A requester must 
submit documentation, if available, concerning the amount of such 
payments or benefits paid or payable to, or on behalf of, the injured 
countermeasure recipient by third-party payers. If the requester knows 
of no such third-party payer, he or she must so certify in writing. If, 
at any time, the requester becomes aware that a third-party payer may 
have such an obligation, the requester must inform the Secretary within 
ten business days of becoming aware of this information, even after 
benefits have been paid by the Program.
    (b) [Reserved]



Sec.  110.62  Documentation a requester who is determined to be 
an eligible survivor must submit for the Secretary to make 
a determination of death benefits.

    (a) A requester determined by the Secretary to be an eligible 
survivor and who seeks a death benefit under Sec.  110.82(b) (the 
standard calculation) must provide, in addition to the documentation 
submitted under subpart F of this part, a written certification 
informing the Secretary whether a disability or death benefit was paid 
or payable under the PSOB Program with respect to the deceased injured 
countermeasure recipient. If such benefit was provided, the requester 
must submit documentation showing the amount of the benefit paid by the 
PSOB Program. If the deceased injured countermeasure recipient was 
covered under the PSOB and no such benefit was, or will be provided, the 
certification must explain whether any survivors are eligible for a 
death benefit under the PSOB Program and, if so, whether a death benefit 
may be paid or payable under the PSOB Program.
    (b) The legal guardian seeking a death benefit under Sec.  110.82(c) 
(the alternative calculation) on behalf of a dependent younger than the 
age of 18 determined by the Secretary to be an eligible survivor must 
provide, in addition to the documentation submitted under Subpart F of 
this part, the following:
    (1) Documentation showing that the deceased injured countermeasure 
recipient is survived by one or more dependents younger than the age of 
18. Such documentation must show the date of birth of all such 
dependents (e.g., copies of birth certificates);
    (2) Documentation showing that the requester is the legal guardian 
of all of the dependents described in paragraph (b)(1) of this section, 
as required under Sec.  110.63(a). If multiple dependents have different 
legal guardians, the legal guardian of each of the dependents must 
submit such documentation;

[[Page 785]]

    (3) A written selection by each legal guardian, on behalf of all of 
the dependents described in paragraph (b)(1) of this section for whom he 
or she is the legal guardian, to receive proportional death benefits 
under the alternative calculation as described in Sec.  110.82(c), in 
place of proportional benefits available under the standard calculation 
as described in Sec.  110.82(b). Written selections are described in 
Sec.  110.82(c)(1);
    (4) Documentation showing the deceased injured countermeasure 
recipient's gross employment income at the time the covered injury was 
sustained (e.g., the decedent's Federal tax return or pay stub(s) from 
all employers at the time of the covered injury); and
    (5) A description of all third-party payers that have paid for, or 
that may be required to pay for, the benefits described in Sec.  
110.82(c)(3)(i). This description must include the amount of such 
benefits that have been paid or that may be paid in the future. If the 
representative knows of no such third-party payer, he or she must so 
certify in writing. If, at any time, the representative becomes aware 
that a third-party payer may have such an obligation, he or she must 
inform the Secretary within ten business days of becoming aware of this 
information, even after benefits have been paid by the Program.



Sec.  110.63  Documentation a legal or personal representative must submit 
when filing on behalf of a minor or on behalf of an adult 
who lacks legal capacity to receive payment of benefits.

    Before benefits will be paid by the Program to an eligible requester 
who is a minor or an adult who lacks legal capacity to receive payment 
of benefits, his or her legal or personal representative must submit the 
following, in addition to the documentation required under Subpart F of 
this part and, as applicable, Sec. Sec.  110.60-110.62:
    (a) For an eligible requester who is a minor:
    (1) Documentation showing that the requester is a minor (e.g., birth 
certificate); and
    (2) Documentation showing that the representative is the legal 
guardian of the property or estate of the minor (e.g., appointment of 
guardianship by a court of competent jurisdiction). If a minor has more 
than one legal guardian, this documentation is required only of one 
legal guardian. In the alternative, documentation showing that the minor 
is considered emancipated under applicable State law. In accordance with 
Sec.  110.83(b), the Program reserves the right to waive the requirement 
of documentation of guardianship for good cause.
    (b) For an eligible requester who is an adult who lacks legal 
capacity to receive payment of benefits:
    (1) Documentation showing that the requester is an adult who lacks 
this legal capacity (e.g., declaration of legal incapacity issued by a 
court of competent jurisdiction, or comparable documentation); and
    (2) A decree by a court of competent jurisdiction establishing a 
guardianship or conservatorship of the requester's estate under 
applicable State law, or durable power of attorney, if applicable. In 
accordance with Sec.  110.83(b), the Program reserves the right to waive 
this requirement for good cause.



                  Subpart H_Secretarial Determinations



Sec.  110.70  Determinations the Secretary must make 
before benefits can be paid.

    Before the Secretary will pay benefits under this Program, she must 
determine that:
    (a) The requester or his or her representative submitted a completed 
and signed Request Form within the governing filing deadline; and
    (b) The requester meets the eligibility requirements set out in this 
part (including a determination that a covered injury was sustained); 
and
    (c) The requester is entitled to receive benefits from the Program. 
In making this determination, the Secretary will decide the type(s) and 
amounts of benefits that will be paid to the requester.



Sec.  110.71  Insufficient documentation for eligibility 
and benefits determinations.

    In the event that there is insufficient documentation in the Request 
Package

[[Page 786]]

for the Secretary to make the applicable determinations under this part, 
the Secretary will so notify the requester, or his or her 
representative. The requester will be given 60 calendar days from the 
date of the Secretary's notification to submit the required 
documentation. If the requester is unable to provide the additional 
documentation, he or she may provide a written explanation of the 
reason(s) that the requested documentation is unavailable and the 
efforts the requester has made to obtain the documents. The Secretary 
may accept such a statement in place of the required documentation or 
disapprove the Request for Benefits due to insufficient documentation. 
If insufficient documentation is submitted in response to the 
Secretary's letter, the Secretary may disapprove the Request for 
Benefits.



Sec.  110.72  Sufficient documentation for eligibility 
and benefits determinations.

    (a) Eligibility determinations. When the Secretary determines that 
there is sufficient documentation in the Request Package to evaluate a 
requester's eligibility, she will begin the review to determine whether 
the requester is eligible for Program benefits. If the Secretary 
determines that the requester is not eligible, the Secretary will inform 
the requester (or his or her representative) in writing of the 
disapproval, and the right to reconsideration of the determination, as 
described in subpart J.
    (b) Benefits determinations. If the Secretary determines that the 
requester is eligible for benefits, she will, after receiving adequate 
documentation from the requester for a benefits determination, either 
calculate the amount and types of benefits, as described in subpart I of 
this part, or request additional documentation in order to calculate the 
benefits that can be paid (e.g., an Explanation of Benefits from the 
requester's health insurance company, if none was submitted). As 
provided in subpart J, requesters have the right to reconsideration of 
the Secretary's determination of the category and amount of benefits 
payable under the Program.
    (c) Additional documentation required. At any time after a Request 
Form has been filed, the Secretary may ask a requester to supplement or 
amend the Request Package by providing additional information or 
documentation.



Sec.  110.73  Approval of benefits.

    When the Secretary has determined that benefits will be paid to a 
requester and has calculated the type and amount of such benefits, she 
will so notify the requester (or his or her representative) in writing. 
The Secretary will make payments in accordance with Sec.  110.83. Once 
all benefits have been paid, the Request Package can no longer be 
amended (except for survivor benefits). The payment determination will 
constitute final agency action with regard to the particular 
countermeasure injury that is the subject of the Request for Benefits 
and payment (i.e., the Request for Benefits is closed with regard to the 
injury that is the basis of the payment of benefits).



Sec.  110.74  Disapproval of benefits.

    (a) If the Secretary determines that a requester is not eligible for 
payments under the Program, the Secretary will disapprove the Request 
for Benefits and provide the requester, or his or her representative, 
with written notice of the basis for the disapproval, and the right to 
reconsideration of the determination, as provided in Sec.  110.90.
    (b) The Secretary may disapprove a Request for Benefits even before 
the requester has submitted all the required documentation (e.g., the 
Secretary may determine that a requester did not meet the filing 
deadline, or that a covered countermeasure was not used or 
administered).
    (c) The Secretary may re-open a disapproved Request for Benefits on 
her own accord should medical or scientific evidence later become 
available to justify a re-determination of the disapproval of 
eligibility or payments. In extraordinary circumstances, to be 
determined at the Secretary's discretion, she may re-open a disapproved 
Request for Benefits even after the requester has exercised the right to 
reconsideration and the disapproval determination has been upheld in 
accordance with the procedures set out in Sec.  110.90.

[[Page 787]]



              Subpart I_Calculation and Payment of Benefits



Sec.  110.80  Calculation of medical benefits.

    In calculating medical benefits, the Secretary will take into 
consideration all reasonable costs for reasonable and necessary medical 
items and services to diagnose or treat a countermeasure recipient's 
covered injury, or to diagnose, treat, or prevent its health 
complications, as described in Sec.  110.31. The Secretary will consider 
and may rely upon benefits documentation submitted by the requester 
(e.g., bills, Explanation of Benefits, and cost-related documentation to 
support the expenses relating to the covered injury or its health 
complications), as required by Sec.  110.60. The Secretary will make 
such payments only to the extent that such costs were not, and will not 
be, paid by any third-party payer and only if no third-party payer had 
or has an obligation to pay for or provide such services or items to the 
requester, except as provided in Sec. Sec.  110.83(c) and 110.84. There 
are no caps on the benefits for reasonable and necessary medical 
expenses that may be provided under the Program.



Sec.  110.81  Calculation of benefits for lost employment income.

    (a) Primary calculation. Benefits under this section may be paid for 
days of work lost as a result of a covered injury or its health 
complications if the injured countermeasure recipient lost employment 
income for the lost work days as reasonable based on the degree of 
injury or disability. As stated in Sec.  110.32(c), days for which an 
individual used paid leave will be considered days of work for which 
employment income was received and, therefore, would not qualify for 
lost employment income benefits. However, if the injured countermeasure 
recipient reimburses the employer for the paid leave taken and the 
employer restores the leave that was used, the individual may be 
eligible for lost employment income benefits for those days;
    (1) The Secretary will calculate the rate of benefits to be paid for 
the lost work days based on the injured countermeasure recipient's gross 
employment income, which includes income from self-employment, at the 
time he or she sustained the covered injury. The Secretary may not, 
except with respect to injured individuals who are minors, consider 
projected future earnings in this calculation.
    (i) For an injured countermeasure recipient with no dependents at 
the time the covered injury was sustained, the benefits are 66\2/3\ 
percent of the individual's gross employment income at the time of 
injury.
    (ii) For an injured countermeasure recipient with one or more 
dependents at the time the covered injury was sustained, the benefits 
are 75 percent of the individual's gross employment income at the time 
of injury; and
    (iii) In the case of an injured countermeasure recipient who is a 
minor, the Secretary may consider the provisions of 5 U.S.C. 8113 
(authorizing the FECA Program), and any implementing regulations, in 
determining the amount of payments under this section and the 
circumstances under which such payments are reasonable and necessary.
    (b) Adjustment for inflation. Benefits for lost employment income 
paid under the Program that represent future lost employment income will 
be adjusted annually to account for inflation.
    (c) Limitations on benefits paid. The Secretary will reduce the 
benefits calculated under paragraphs (a) and (b) of this section 
according to the limitations described in this paragraph (c):
    (1) Number of lost work days. An injured countermeasure recipient 
will be compensated for ten or more days of work lost if he or she lost 
employment income for those days as a result of the covered injury (or 
its health complications). If the number of days of lost employment 
income due to the covered injury (or its health complications) is fewer 
than ten, the Secretary will reduce the number of lost work days by five 
days. If the injured countermeasure recipient lost employment income for 
a period of five days or fewer, no benefits for lost employment income 
will be paid. Lost work days do not need to be consecutive. Partial days 
of lost employment income may be aggregated to calculate the total 
number of lost work days. The Secretary has the discretion to consider

[[Page 788]]

the reasonableness of the number of work days (or partial work days) 
lost as a result of a covered injury or its health complications in this 
calculation, and to consider alternative work schedules in determining 
the number of work days lost.
    (2) Annual limitation. The maximum amount that an injured 
countermeasure recipient may receive in any one year in benefits for 
lost employment income under this Program is $50,000.
    (3) Lifetime limitation. The maximum amount that an injured 
countermeasure recipient can receive during his or her lifetime in 
benefits for lost employment income under this Program is the amount of 
the death benefit calculated under the PSOB Program in the same fiscal 
year as the year in which this lifetime cap is reached. This amount is 
the maximum death benefit payable to survivors under this Program using 
the standard calculation described in Sec.  110.82(b). However, this 
lifetime cap does not apply if the Secretary determines that the 
countermeasure recipient has a covered injury (or injuries) meeting the 
definition of ``disability'' in section 216(i) of the Social Security 
Act, 42 U.S.C. 416(i).
    (4) Termination of payments. The Secretary will not pay benefits for 
lost employment income after the injured countermeasure recipient 
reaches the age of 65.
    (d) Reductions for other coverage. From the amount of benefits 
calculated under paragraphs (a), (b), and (c) of this section, the 
Secretary will make reductions:
    (1) For all payments made, or expected to be made in the future, to 
the injured countermeasure recipient for compensation of lost employment 
income or disability or retirement benefits, by any third-party payer in 
relation to the covered injury or its health complications, consistent 
with Sec.  110.32(b); and
    (2) So that the total amount of benefits for lost employment income 
paid to an injured countermeasure recipient under this Program, together 
with the total amounts paid (or payable) by third-party payers, as 
described in paragraph (d)(1) of this section, does not exceed 66\2/3\ 
percent (or 75 percent, if the injured countermeasure recipient had at 
least one dependent at the time the covered injury was sustained) of his 
or her employment income at the time of the covered injury for the lost 
work days.
    (3) If an injured countermeasure recipient receives a lump-sum 
payment from any third-party payer under any obligation described in 
paragraph (d)(1) of this section, the Secretary shall consider such a 
payment to be received over a period of years, rather than in a single 
year. The Secretary has discretion as to how to apportion such payments 
over multiple years.



Sec.  110.82  Calculation of death benefits.

    (a) General. (1) If the legal guardian(s) of dependents younger than 
18 years of age does not file a written selection to receive death 
benefits under the alternative calculation, as described in paragraph 
(c)(1) of this section, or if the Secretary does not approve such a 
selection, the Secretary will pay proportionate death benefits under the 
standard calculation to all of the eligible survivors with priority to 
receive death benefits under the standard calculation, as described in 
Sec.  110.33(b) and paragraph (b) of this section.
    (2) If the Secretary approves a written selection to receive 
benefits under the alternative calculation, as described in paragraph 
(c)(1) of this section:
    (i) If no other eligible survivors are of equal priority to receive 
death benefits, the Secretary will pay a death benefit in an amount 
calculated under the alternative calculation to the aggregate of the 
dependents on whose behalf the election was filed; and
    (ii) If other eligible survivors are of equal priority to receive 
death benefits as the dependents receiving death benefits under the 
alternative calculation, the Secretary will pay the other eligible 
survivors a proportionate amount of the death benefit available and 
calculated under the standard calculation. In such circumstances, the 
Secretary will pay the aggregate of the dependents receiving a death 
benefit under the alternative calculation a proportionate share of the 
benefits available under that calculation (in place of the

[[Page 789]]

proportionate share of the death benefit that would be available under 
the standard calculation). For example, if a deceased countermeasure 
recipient is survived by a dependent ten year-old child and a spouse who 
is not the child's legal guardian (e.g., the dependent child's parents 
were the deceased injured countermeasure recipient and his or her former 
spouse), the current surviving spouse would be able to receive his or 
her share of the death benefit under the standard calculation, and the 
dependent child's legal guardian, on behalf of the minor, would receive 
either the child's proportionate share of the death benefit under the 
standard calculation or the child's proportionate share of the death 
benefit available under the alternative calculation (if the legal 
guardian filed a written selection for such a death benefit and the 
Secretary approved the selection).
    (b) Standard calculation of death benefits. (1) The maximum death 
benefit available under the standard calculation of death benefits 
(described in this paragraph) is the amount of the comparable death 
benefit calculated under the PSOB Program in the same fiscal year in 
which the injured countermeasure recipient died (regardless of whether 
the PSOB Program reduces the amount of its death benefits because of a 
limit in appropriations).
    (2) No death benefit will be paid under the standard calculation if 
a death benefit is paid, or if survivors are eligible to receive a death 
benefit, under the PSOB Program with respect to the deceased injured 
countermeasure recipient.
    (3) The death benefit will not be reduced under the standard 
calculation if a total and permanent disability benefit has been, or 
will be paid under the PSOB Program with respect to the deceased injured 
countermeasure recipient. However, the death benefit will be reduced if 
a temporary and partial disability benefit has been, or will be paid 
under the PSOB Program with respect to that individual. If the PSOB 
Program disability benefit paid was reduced because of a limitation on 
appropriations, a death benefit will be available under the standard 
calculation to the extent necessary to ensure that the total amount of 
disability benefits paid under the PSOB Program, together with the 
amount of death benefits paid under the standard calculation, equals the 
amount of the death benefit described in paragraph (b)(1) of this 
section.
    (4) Under the standard calculation, death benefits will be paid in a 
lump sum.
    (c) Alternative calculation of death benefits available to surviving 
dependents younger than the age of 18. If a deceased countermeasure 
recipient had at least one dependent who is younger than the age of 18 
(and will be younger than the age of 18 at the time of the payment), the 
legal guardian(s) of all such dependents may request benefits under the 
alternative calculation described in this paragraph. To receive such a 
benefit, the legal guardian, on behalf of all such dependents for whom 
he or she is the legal guardian, must file a selection to receive 
benefits under the alternative calculation, as described in paragraph 
(c)(1) of this section, and the Secretary must approve such selection. 
If multiple dependents have different legal guardians, each legal 
guardian is responsible for requesting benefits under the standard 
calculation or for filing a selection for a death benefit under the 
alternative calculation. If a single dependent has more than one legal 
guardian, one legal guardian may file the selection. Payments made under 
the alternative calculation will be made to the legal guardian(s) of all 
of the dependents on behalf of all of those dependents until they reach 
the age of 18.
    (1) Selection of benefits under the alternative calculation. Before 
a payment of a death benefit will be approved under the alternative 
calculation, the legal guardian(s) of the dependents for whom he or she 
is the legal guardian must file a written selection, on behalf of all 
such dependents, to receive a death benefit under the alternative 
calculation. If such a selection is approved by the Secretary, these 
dependents will be paid a proportionate share of the death benefit under 
the alternative calculation in place of the proportionate share of 
benefits that would otherwise be available to them under the standard 
calculation.

[[Page 790]]

    (2) Amount of payments. The maximum death benefit available under 
this paragraph is 75 percent of the deceased injured countermeasure 
recipient's income (including income from self-employment) at the time 
he or she sustained the covered injury that resulted in death, adjusted 
to account for inflation, except as follows:
    (i) The maximum payment of death benefits that may be made on behalf 
of the aggregate of the dependents in any one year is $50,000;
    (ii) All payments made under this paragraph will stop once the 
youngest of the dependents reaches the age of 18.
    (3) Reductions for other coverage. The total amount of death 
benefits provided under the alternative calculation (described in this 
paragraph) will be reduced so that the total amount of payments made (or 
expected to be made) under obligations described in paragraph (c)(3)(i) 
of this section, together with the death benefits paid under the 
alternative calculation, is not greater than the amount of payments 
described in paragraph (c)(2) of this section. In other words, the total 
amount of death benefits paid to dependents under the alternative 
calculation may be reduced if third-party payers have paid (or are 
expected to pay) for certain benefits so that such dependents will 
receive a total sum (combining the death benefit under the alternative 
calculation and the actual and expected benefits covered by third-party 
payers) that is not greater than the death benefit that would be 
available under the alternative calculation if there were no third-party 
payer(s) to pay such benefits. The total amount of death benefits will 
not be reduced by lost employment income paid by the Program.
    (i) The amount of death benefits paid under the alternative 
calculation will be reduced for all payments made, or expected to be 
made in the future, by any third-party payer for:
    (A) Compensation for the deceased countermeasure recipient's loss of 
employment income on behalf of the dependents or their legal 
guardians(s) (but not any lost employment income benefits paid by the 
Program);
    (B) Disability, retirement, or death benefits in relation to the 
deceased countermeasure recipient (including, but not limited to, death 
and disability benefits under the PSOB Program) on behalf of the 
dependents or their legal guardian(s); and
    (C) Life insurance benefits on behalf of the dependents;
    (4) Timing of payments. Payments made under this paragraph will be 
made on an annual basis, beginning from the time of the initial payment, 
to the legal guardian(s) on behalf of the aggregate of the dependents 
receiving the payment. In the year in which the youngest dependent 
reaches the age of 18, payments under this section will be paid on a pro 
rata basis for the period of time before that dependent reaches the age 
of 18. Once a dependent reaches the age of 18, the payments under this 
alternative calculation will no longer be made on his or her behalf. 
Because payments under the alternative calculation are to be made on 
behalf of dependents who are younger than the age of 18, if a dependent 
meets this requirement at the time of filing of the Request Form, but 
reaches the age of 18 (or is older than 18 years of age) at the time of 
the initial payment, no payment will be made to the dependent's legal 
guardian on his or her behalf under the alternative calculation.



Sec.  110.83  Payment of all benefits.

    (a) The Secretary determines the mechanism of payment of Program 
benefits. She may choose to pay any benefits under this Program through 
lump-sum payments. If the Secretary determines that there is a 
reasonable likelihood that the payments of medical benefits, benefits 
for lost employment income, or death benefits paid under the alternative 
calculation (described in Sec.  110.82(c)) will be required for a period 
in excess of one year from the date the Secretary determines the 
requester is eligible for such benefits, payments may be made through a 
lump-sum payment, the purchase of an annuity or medical insurance 
policy, establishment of a trust (including a U.S. grantor reversionary 
trust) or execution of an appropriate structured settlement agreement, 
at the Secretary's discretion. Payments, annuities, policies, or 
agreements must be actuarially determined to have a value

[[Page 791]]

equal to the present value of the projected total amount of benefits 
that the requester is eligible to receive under Sec. Sec.  110.80, 
110.81, and 110.82. Lump sum payments will be made through an electronic 
funds transfer to an account of the requester.
    (b) If the requester is a minor, the payment will be made on the 
minor's behalf to the account of the legal guardian of the estate or 
property of the minor. In accepting such payments, the legal guardian of 
a minor requester is obligated to use the funds for the benefit of the 
minor and to take any actions necessary to comply with State law 
requirements pertaining to such payments. If the requester is an adult 
who lacks the legal capacity to receive payment(s), the legal guardian 
must establish a guardianship or conservatorship of the estate account 
with court oversight, in accordance with State law, and payment will be 
made to that account. Documentation of guardianship (or conservatorship) 
is required for requesters who are minors or adults who lack legal 
capacity unless the Secretary waives this requirement for good cause.
    (c) The Secretary has the discretion to make interim payments of 
benefits under this Program, even before a final determination as to the 
type(s) and total amount of benefits that will be paid. Interim payments 
will be made only in exceptional cases. The Secretary may, for example, 
make an interim payment of medical benefits that have been calculated 
before a final determination on benefits for lost employment income is 
completed, or of past medical benefits that have been calculated before 
a final calculation of future medical benefits is completed. The 
Secretary may make an interim payment even before a final eligibility or 
benefits determination is made (e.g., if a piece of documentation has 
not been obtained because a person with a severe countermeasure-related 
injury is hospitalized, but all other documentation is consistent with 
the requester meeting the eligibility requirements). If such a 
requester's documentation is incomplete, the requester must submit the 
required documentation within the time-frame determined by the 
Secretary. The requester must agree that he or she will be obligated to 
repay the Secretary such benefits in the event that a Program payment is 
later determined to be incorrect. Any payments made on an interim basis 
will not entitle a requester to seek reconsideration of the Secretary's 
decision on these benefits until the Secretary makes a final benefits 
determination.



Sec.  110.84  The Secretary's right to recover benefits paid 
under this Program from third-party payers.

    Upon payment of benefits under this Program, the Secretary will be 
subrogated to the rights of the requester and may assert a claim against 
any third-party payer with a legal or contractual obligation to pay for 
(or provide) such benefits and may recover from such third-party 
payer(s) the amount of benefits paid up to the amount of benefits the 
third-party payer has or had an obligation to pay for (or provide). In 
other words, the Secretary may pay benefits before the requester 
receives a payment from a third-party payer in certain circumstances. In 
those circumstances, the Secretary has a right to be reimbursed by the 
third-party payer. The circumstances in which the Secretary may assert 
this right include those in which the Secretary pays benefits under this 
Program to a requester before a final decision is made that a third-
party payer has an obligation to pay such benefits to the requester. 
Requesters receiving benefits under this Program (or their 
representatives) shall assist the Secretary in recovering such benefits. 
In the event that a requester receives a benefit from a third-party 
payer after receiving the same type of benefits from the Secretary under 
this Program, the Secretary has a right to recover from the requester 
the amount of the benefit(s) received. The requester must notify and 
reimburse the Program within ten business days of receiving the third-
party payment(s).

[[Page 792]]



       Subpart J_Reconsideration of the Secretary's Determinations



Sec.  110.90  Reconsideration of the Secretary's eligibility 
and benefits determinations.

    (a) Right of reconsideration. A requester has the right to seek 
reconsideration of the Secretary's determination that he or she is not 
eligible for Program benefits. In addition, a requester who asserts that 
the amount of the benefits paid (or the fact that certain benefits were 
not paid or payable) is incorrect may also seek reconsideration. A 
requester may not seek reconsideration of the Secretary's decision as to 
the mechanism of payment. Requests for reconsideration must be in 
writing, describe the reason(s) why the decision should be reconsidered, 
and be postmarked within 60 calendar days of the date of the Secretary's 
decision on the Request for Benefits. Because no new documentation will 
be considered in the reconsideration process, the reconsideration 
request may not include or refer to any documentation that was not 
before the Secretary at the time of her determination.
    (b) Letters seeking reconsideration. A requester, or his or her 
representative, may send the letter seeking reconsideration through the 
U.S. Postal Service, commercial carrier, or a private courier service. 
The Secretary will not accept reconsideration requests delivered by 
hand. Electronic submissions of letters seeking reconsideration are not 
currently accepted, but may be accepted in the future. The Program will 
publish a notice if an electronic method becomes available. Letters sent 
through the U.S. Postal Service, commercial carrier or private courier 
service must be sent to the Associate Administrator, Healthcare Systems 
Bureau, Health Resources and Services Administration, 5600 Fishers Lane, 
Room 12-105, Rockville, Maryland 20857.
    (c) Reconsideration process. When the Associate Administrator of the 
Healthcare Systems Bureau (the Associate Administrator), receives a 
request for reconsideration, a qualified panel, independent of the 
Program, will be convened to review the Secretary's determination. The 
panel will base its recommendation on the documentation before the 
Secretary when the determination was made. The panel will perform its 
own review and make its own findings, which will be submitted to the 
Associate Administrator. The Associate Administrator will then review 
the panel's recommendation(s) and make a final determination, which will 
be sent to the requester (or his or her representative). This will be 
the Secretary's final action on the request for reconsideration and will 
be considered the Secretary's final determination on the request for 
Program benefits with regard to the injury that is the subject of that 
Request Package. Requesters may not seek review of a decision made on 
reconsideration.
    (d) Effect of reconsideration on amending a Request Package. As 
stated in Sec.  110.46, a Request Package cannot be amended after 
exhaustion of the reconsideration process, except for amendments by 
survivors seeking death benefits or executors or administrators on 
behalf of an estate.



Sec.  110.91  Secretary's review authority.

    Under section 319F-4(b)(4) of the Public Health Service Act (42 
U.S.C. 247d-6e(b)(4)) (referencing section 262 of the PHS Act (42 U.S.C. 
239a)), the Secretary may, at any time, on her own motion or on 
application, review any determination made under this part (including, 
but not limited to, determinations concerning eligibility, entitlement 
to benefits, and the calculation of amount of benefits under the 
Program). Upon review, the Secretary may affirm, vacate, or modify the 
determination in any manner the Secretary deems appropriate.



Sec.  110.92  No additional judicial or administrative review 
of determinations made under this part.

    (a) Under section 319F-4(b)(4) of the PHS Act (42 U.S.C. 247d-
6e(b)(4)) (referencing section 262 of the PHS Act (42 U.S.C. 239a)), no 
judicial review of the Secretary's actions concerning eligibility and 
benefits determinations

[[Page 793]]

under this part (including, but not limited to, determinations 
concerning eligibility, the type or amount of benefits, and the method 
of payment of benefits) is permitted. In addition, no further 
administrative review of such actions are permitted unless the President 
specifically directs otherwise.
    (b) Under section 319F-4(b)(5)(c) of the PHS Act (42 U.S.C. 247d-
6e(b)(5)(c)), no judicial review of the Secretary's actions in 
establishing or amending a Table (or Tables) for purposes of this part 
(which include, but are not limited to, identifying injuries on a Table 
(or choosing not to identify injuries on a Table), establishing time-
frames or definitions for Table injuries, and amending a Table) is 
permitted.



             Subpart K_Covered Countermeasures Injury Tables



Sec.  110.100  Injury Tables.

    (a) Pandemic influenza countermeasures injury table.

------------------------------------------------------------------------
                                                     Time interval (for
                                                      first symptom or
                                                      manifestation of
   Covered countermeasures      Serious physical       onset of injury
      under Secretarial         injury (illness,    after administration
        declarations           disability, injury,    or use of covered
                                or condition) \1\      countermeasure,
                                                      unless otherwise
                                                         specified)
------------------------------------------------------------------------
I. Pandemic influenza         A. Anaphylaxis......  A. 0-4 hours.
 vaccines administered by     B. Deltoid Bursitis.  B. 0-48 hours.
 needle into or through the   C. Vasovagal Syncope  C. 0-1 hour.
 skin.
II. Pandemic influenza        A. Anaphylaxis......  A. 0-4 hours.
 intranasal vaccines.
III. Pandemic influenza 2009  A. Guillain-          A. 3-42 days (not
 H1N1 vaccine.                 Barr[eacute]          less than 72 hours
                               Syndrome.             and not more than
                                                     42 days).
IV. Oseltamivir Phosphate     A. Anaphylaxis......  A. 0-4 hours.
 (Tamiflu) when administered
 or used for pandemic
 influenza.
V. Zanamivir (Relenza) when   A. Anaphylaxis......  A. 0-4 hours.
 administered or used for
 pandemic influenza.
VI. Peramivir when            A. Anaphylaxis......  A. 0-4 hours.
 administered or used for
 2009 H1N1 influenza.
VII. Pandemic influenza       A. No condition       A. Not applicable.
 personal respiratory          covered \2\.
 protection devices.
VIII. Pandemic influenza      A. Postintubation     A. 2-42 days (not
 respiratory support devices.  Tracheal Stenosis.    less than 48 hours
                                                     and not more than
                                                     42 days) after
                                                     extubation (removal
                                                     of a tracheostomy
                                                     or endotracheal
                                                     tube).
                              B. Ventilator-        B. More than 48
                               Associated            hours after
                               Pneumonia and         intubation
                               Ventilator-           (placement of an
                               Associated            endotracheal or
                               Tracheobronchitis.    tracheostomy tube)
                                                     and up to 48 hours
                                                     after extubation
                                                     (removal of the
                                                     tube).
                              C. Ventilator-        C. Throughout the
                               Induced Lung Injury.  time of intubation
                                                     (breathing through
                                                     an endotracheal or
                                                     tracheostomy tube)
                                                     and up to 48 hours
                                                     after extubation
                                                     (removal of the
                                                     tube).
IX. Pandemic influenza        A. Bleeding Events..  A. Throughout the
 respiratory support device:                         time of
 Extra-corporeal membrane                            anticoagulation
 oxygenation (ECMO).                                 treatment for ECMO
                                                     therapy, including
                                                     the time needed to
                                                     clear the effect of
                                                     the anti-coagulant
                                                     treatment from the
                                                     body.
X. Pandemic influenza         A. No condition       A. Not applicable.
 diagnostic testing devices.   covered.
------------------------------------------------------------------------
\1\ Serious physical injury as defined in 42 CFR 110.3(z). Only injuries
  that warranted hospitalization (whether or not the person was actually
  hospitalized) or injuries that led to a significant loss of function
  or disability will be considered serious physical injuries.
\2\ The use of ``No condition covered'' in the Table reflects that the
  Secretary at this time does not find compelling, reliable, valid,
  medical and scientific evidence to support that any serious injury is
  presumed to be caused by the associated covered countermeasure. For
  injuries alleged to be due to covered countermeasures for which there
  is no associated Table injury, requesters must demonstrate that the
  injury occurred as the direct result of the administration or use of
  the covered countermeasure. See 42 CFR 110.20(b), (c).

    (b) Qualifications and aids to interpretation (table definitions and 
requirements). The following definitions and requirements shall apply to 
the Table

[[Page 794]]

set forth in paragraph (a) of this section and only apply for purposes 
of this subpart.
    (1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially 
lethal systemic reaction that occurs as a single discrete event with 
simultaneous involvement of two or more organ systems. Most cases 
resolve without sequelae. Signs and symptoms begin minutes to a few 
hours after exposure. Death, if it occurs, usually results from airway 
obstruction caused by laryngeal edema or bronchospasm and may be 
associated with cardiovascular collapse. Other significant clinical 
signs and symptoms may include the following: Cyanosis, hypotension, 
bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or 
trachea and/or larynx with stridor and dyspnea. There are no specific 
pathological findings to confirm a diagnosis of anaphylaxis.
    (2) Deltoid bursitis. Deltoid bursitis is an inflammation of the 
bursa that lies beneath the deltoid muscle and between the acromion 
process and the rotator cuff. Subdeltoid bursitis manifests with pain in 
the lateral aspect of the shoulder similar to rotator cuff tendonitis. 
The presence of tenderness on direct palpation beneath the acromion 
process distinguishes this bursitis from rotator cuff tendonitis. 
Similar to tendonitis, isolated bursitis will have full passive range of 
motion. Other causes of bursitis such as trauma (other than from 
vaccination), metabolic disorders, and systemic diseases such as 
rheumatoid arthritis, dialysis, and infection will not be considered 
Table injuries. This list is not exhaustive. The deltoid bursitis must 
occur in the same shoulder that received the pandemic influenza vaccine.
    (3) Vasovagal syncope. Vasovagal syncope (also sometimes called 
neurocardiogenic syncope) means loss of consciousness (fainting) and 
loss of postural tone caused by a transient decrease in blood flow to 
the brain occurring after the administration of an injected 
countermeasure. Vasovagal syncope is usually a benign condition but may 
result in falling and injury with significant sequelae. Vasovagal 
syncope may be preceded by symptoms such as nausea, lightheadedness, 
diaphoresis, and/or pallor. Vasovagal syncope may be associated with 
transient seizure-like activity, but recovery of orientation and 
consciousness generally occurs simultaneously. Loss of consciousness 
resulting from the following conditions will not be considered vasovagal 
syncope: Organic heart disease; cardiac arrhythmias; transient ischemic 
attacks; hyperventilation; metabolic conditions; neurological 
conditions; psychiatric conditions; seizures; trauma; and situational as 
can occur with urination, defecation, or cough. This list is not 
complete. Episodes of recurrent syncope occurring after the applicable 
time period are not considered to be sequelae of an episode of syncope 
meeting the Table requirements.
    (4) Guillain-Barr[eacute] Syndrome (GBS). (i) GBS is an acute 
monophasic peripheral neuropathy that currently is known to encompass a 
spectrum of four clinicopathological subtypes described below. For each 
subtype of GBS, the interval between the first appearance of symptoms 
and the nadir of weakness is between 12 hours and 28 days. This is 
followed in all subtypes by a clinical plateau with stabilization at the 
nadir of symptoms, or subsequent improvement without significant 
relapse. Death may occur without a clinical plateau. Treatment related 
fluctuations in all subtypes of GBS can occur within 9 weeks of GBS 
symptom onset and recurrence of symptoms after this time frame would not 
be consistent with GBS.
    (ii) The most common subtype in North America and Europe, comprising 
more than 90 percent of cases, is acute inflammatory demyelinating 
polyneuropathy (AIDP) which has the pathologic and electrodiagnostic 
features of focal demyelination of motor and sensory peripheral nerves 
and nerve roots. Another subtype called acute motor axonal neuropathy 
(AMAN) is generally seen in other parts of the world and is predominated 
by axonal damage that primarily affects motor nerves. AMAN lacks 
features of demyelination. Another less common subtype of GBS includes 
acute motor and sensory neuropathy (AMSAN), which is an axonal form of 
GBS that is similar to AMAN, but also affects the sensory nerves and 
roots.

[[Page 795]]

AIDP, AMAN, and AMSAN are typically characterized by symmetric motor 
flaccid weakness, sensory abnormalities, and/or autonomic dysfunction 
caused by autoimmune damage to peripheral nerves and nerve roots. The 
diagnosis of AIDP, AMAN, and AMSAN requires bilateral flaccid limb 
weakness and decreased or absent deep tendon reflexes in weak limbs; a 
monophasic illness pattern; an interval between onset and nadir of 
weakness between 12 hours and 28 days; subsequent clinical plateau (the 
clinical plateau leads to either stabilization at the nadir of symptoms, 
or subsequent improvement without significant relapse); and, the absence 
of an identified more likely alternative diagnosis. Death may occur 
without a clinical plateau.
    (iii) Fisher syndrome (FS), also known as Miller-Fisher Syndrome, is 
a subtype of GBS characterized by ataxia, areflexia, and 
ophthalmoplegia, and overlap between FS and AIDP may be seen with limb 
weakness. The diagnosis of FS requires bilateral ophthalmoparesis; 
bilateral reduced or absent tendon reflexes; ataxia; the absence of limb 
weakness (the presence of limb weakness suggests a diagnosis of AIDP); a 
monophasic illness pattern; an interval between onset and nadir of 
weakness between 12 hours and 28 days; subsequent clinical plateau (the 
clinical plateau leads to either stabilization at the nadir of symptoms, 
or subsequent improvement without significant relapse); no alteration in 
consciousness; no corticospinal track signs; and, the absence of an 
identified more likely alternative diagnosis. Death may occur without a 
clinical plateau.
    (iv) Evidence that is supportive, but not required, of a diagnosis 
of all subtypes of GBS includes electrophysiologic findings consistent 
with GBS or an elevation of cerebral spinal fluid (CSF) protein with a 
total CSF white blood cell count below 50 cells per microliter. The 
results of both CSF and electrophysiologic studies are frequently normal 
in the first week of illness in otherwise typical cases of GBS.
    (v) For GBS to qualify as a Table injury there must not be a more 
likely alternative diagnosis for the weakness. Exclusionary criteria for 
the diagnosis of all subtypes of GBS include the ultimate diagnosis of 
any of the following conditions: Chronic immune demyelinating 
polyradiculopathy (``CIDP''), carcinomatous meningitis, brain stem 
encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, 
spinal cord infarct, spinal cord compression, anterior horn cell 
diseases such as polio or West Nile virus infection, subacute 
inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, 
cauda equina compression, metabolic conditions such as hypermagnesemia 
or hypophosphatemia, tick paralysis, heavy metal toxicity (such as 
arsenic, gold, or thallium), drug-induced neuropathy (such as 
vincristine, platinum compounds, or nitrofurantoin), porphyria, critical 
illness neuropathy, vasculitis, diphtheria, myasthenia gravis, 
organophosphate poisoning, botulism, critical illness myopathy, 
polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above 
list is not exhaustive.
    (5) Tracheal stenosis. (i) Postintubation tracheal stenosis means an 
iatrogenic (caused by medical treatment) and symptomatic stricture of 
the airway (narrowing of the windpipe) resulting from:
    (A) Trauma or necrosis from an endotracheal tube; or
    (B) Stomal injury from a tracheostomy; or
    (C) A combination of the two.
    (ii) Tracheal stenosis or narrowing due to tumors (malignant or 
benign), infections of the trachea (such as tuberculosis, fungal 
diseases), radiotherapy, tracheal surgery, trauma, congenital, and 
inflammatory or autoimmune diseases will not be considered post-
intubation tracheal stenosis. Post-intubation tracheal stenosis requires 
either tracheostomy with placement of a tracheostomy tube or 
endotracheal intubation. Diagnosis requires symptoms of upper airway 
obstruction such as stridor (inspiratory wheeze) or exertional dyspnea 
(increased shortness of breath with exertion), and positive radiologic 
studies showing abnormal narrowing of the trachea or

[[Page 796]]

bronchoscopic evaluation that demonstrates abnormal narrowing.
    (6) Ventilator-Associated Pneumonia (VAP) and Ventilator-Associated 
Tracheobronchitis (VAT). (i) VAP is defined as an iatrogenic pneumonia 
caused by the medical treatment of mechanical ventilation. Similarly, 
VAT is an iatrogenic infection of the trachea and/or bronchi caused by 
mechanical ventilation. The initial manifestation of VAP and VAT must 
occur more than 48 hours after intubation (placement of the breathing 
tube) and up to 48 hours after extubation (removal of the breathing 
tube). VAP will be considered to be present when the patient 
demonstrates a new or progressive radiographic infiltrate that is in the 
lungs and consistent with pneumonia, fever, leukocytosis (increased 
white blood cell count) or leucopenia (decreased white blood cell 
count), purulent (containing pus) tracheal secretions from a tracheal 
aspirate, and a positive lower respiratory tract culture. The positive 
lower respiratory tract culture is a diagnostic requirement only if 
there has not been a change in antibiotics in the 72 hours prior to 
collection of the culture. In addition, a tracheal aspirate that does 
not demonstrate bacteria or inflammatory cells in a patient without a 
change in antibiotics in the previous 72 hours is unlikely to be VAP and 
shall not be considered a condition set forth in the Table.
    (ii) VAT will be considered to be present when the patient 
demonstrates fever, leukocytosis or leukopenia, purulent tracheal 
secretions, and a positive tracheal aspirate culture in the absence of a 
change of antibiotics within the 72 hours prior to culture. Tracheal 
colonization with microorganisms is common in intubated patients, but in 
the absence of clinical findings is not a sign of VAT.
    (7) Ventilator-Induced Lung Injury (VILI). VILI results from 
mechanical trauma such as volutrauma leading to rupture of alveoli (air 
sacs in the lungs where oxygen and carbon dioxide are exchanged with the 
blood) with subsequent abnormal leakage of air. VILI manifests as 
iatrogenic pneumothorax (abnormal air from alveolar rupture in the 
pleural space), pneumomediastinum (abnormal air from alveolar rupture in 
the mediastinum (middle part of the chest between the lungs)), pulmonary 
interstitial emphysema (abnormal air in the lung interstitial space 
between the alveoli), subpleural air cysts (an extreme form of pulmonary 
emphysema where the abnormal air in the interstitial space has pooled 
into larger pockets), subcutaneous emphysema (abnormal air from alveolar 
rupture that has dissected into the skin), pneumopericardium (abnormal 
air from alveolar rupture that has traveled to the pericardium (covering 
of the heart)), pneumoperitoneum (abnormal air from alveolar rupture 
that has moved into the abdominal space), or systemic air embolism 
(abnormal air from alveolar rupture that has moved into the blood). To 
qualify as Table injuries, these manifestations must occur in patients 
who are being mechanically ventilated at the time of initial 
manifestation of the VILI.
    (8) Bleeding events. Bleeding events are defined as excessive or 
abnormal bleeding in patients who are under the pharmacologic effects of 
anticoagulant therapy provided for extracorporeal membrane oxygenation 
(ECMO) treatment.
    (c) Smallpox countermeasures injury table.

                        Table 2 to Paragraph (c)
------------------------------------------------------------------------
                                                         Time interval
                                                      (for first symptom
                                                       or manifestation
                                   Serious physical   of onset of injury
  Covered countermeasures under    injury  (illness,         after
          declarations                disability,      administration or
                                      injury, or        use of covered
                                    condition) \1\      countermeasure,
                                                       unless otherwise
                                                          specified)
------------------------------------------------------------------------
I. Smallpox Vaccines Replication- A. Anaphylaxis....  A. 0-4 hours.
 Deficient.                       B. Vasovagal        B. 0-1 hour.
                                   Syncope.
II. Smallpox Vaccines             A. Anaphylaxis....  A. 0-4 hours.
 Replication-Competent.           B. Vasovagal        B. 0-1 hour.
                                   Syncope.
                                  C. Significant      C. 1-21 days.
                                   Local Skin
                                   Reaction.
                                  D. Stevens-Johnson  D. 4-28 days.
                                   Syndrome/Toxic
                                   Epidermal
                                   Necrolysis.
                                  E. Inadvertent      E. 1-21 days.
                                   Autoinoculation.
                                  F. Generalized      F. 6-9 days.
                                   Vaccinia.
                                  G. Eczema           G. 3-21 days.
                                   Vaccinatum.

[[Page 797]]

 
                                  H. Progressive      H. 3-21 days.
                                   Vaccinia.
                                  I. Post-vaccinial   I. 5-14 days.
                                   Encephalopathy,
                                   Encephalitis or
                                   Encephalomyelitis
                                   (PVEM).
                                  J. Vaccinial        J. 0-21 days.
                                   Myocarditis,
                                   Pericarditis, or
                                   Myopericarditis
                                   (MP).
III. Vaccinia Immunoglobulin      A. Anaphylaxis....  A. 0-4 hours.
 Intravenous (VIGIV).             B. Transfusion-     B. 0-72 hours.
                                   Related Acute
                                   Lung Injury
                                   (TRALI).
                                  C. Acute Renal      C. 0-10 days.
                                   Failure (ARF).
                                  D. Drug-Induced     D. Within 48 hours
                                   Aseptic             after the first
                                   Meningitis (DIAM).  dose and up to 48
                                                       hours after the
                                                       last dose of
                                                       VIGIV.
                                  E. Hemolysis......  E. 12 hours to 14
                                                       days.
IV. Cidofovir...................  A. No Condition     A. Not Applicable.
                                   Covered \2\.
V. Tecovirimat..................  A. No Condition     A. Not Applicable.
                                   Covered \2\.
VI. Brincidofovir...............  A. No Condition     A. Not Applicable.
                                   Covered \2\.
VII. Smallpox Infection           A. No Condition     A. Not Applicable.
 Diagnostic Testing Devices.       Covered \2\.
------------------------------------------------------------------------
\1\ Serious physical injury as defined in Sec.   110.3(z). Only injuries
  that warranted hospitalization (whether or not the person was actually
  hospitalized) or injuries that led to a significant loss of function
  or disability will be considered serious physical injuries.
\2\ The use of ``No condition covered'' in this Table 2 reflects that
  the Secretary evaluated the countermeasure, but at this time does not
  find compelling, reliable, valid, medical, and scientific evidence to
  support that any serious injury is presumed to be caused by the
  associated covered countermeasure. For injuries alleged to be due to
  covered countermeasures for which there is no associated Table 2
  injury, requesters must demonstrate that the injury occurred as the
  direct result of the administration or use of the covered
  countermeasure. See Sec.   110.20(b) and (c).

    (d) Qualifications and aids to interpretation (table definitions and 
requirements). The following definitions and requirements shall apply to 
the Table set forth in paragraph (c) of this section and only apply for 
purposes of this subpart.
    (1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially 
lethal systemic reaction that occurs as a single discrete event with 
simultaneous involvement of two or more organ systems. Most cases 
resolve without sequelae. Signs and symptoms begin within minutes to a 
few hours after exposure. Death, if it occurs, usually results from 
airway obstruction caused by laryngeal edema or bronchospasm and may be 
associated with cardiovascular collapse. Other significant clinical 
signs and symptoms may include the following: Cyanosis, hypotension, 
bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or 
trachea and/or larynx with stridor and dyspnea. There are no specific 
pathological findings to confirm a diagnosis of anaphylaxis.
    (2) Vasovagal syncope. Vasovagal syncope (also sometimes called 
neurocardiogenic syncope) means loss of consciousness (fainting) and 
loss of postural tone caused by a transient decrease in blood flow to 
the brain occurring after the administration of an injected 
countermeasure. Vasovagal syncope is usually a benign condition, but may 
result in falling and injury with significant sequelae. Vasovagal 
syncope may be preceded by symptoms, such as nausea, lightheadedness, 
diaphoresis (sweating), and/or pallor. Vasovagal syncope may be 
associated with transient seizure-like activity, but recovery of 
orientation and consciousness generally occurs simultaneously. Loss of 
consciousness resulting from the following conditions will not be 
considered vasovagal syncope: Organic heart disease, cardiac 
arrhythmias, transient ischemic attacks, hyperventilation, metabolic 
conditions, neurological conditions, psychiatric conditions, seizures, 
trauma, and situational as can occur with urination, defecation, or 
cough. This list is not complete as other conditions that are not 
associated with the vaccine also may cause loss of consciousness. 
Episodes of recurrent syncope occurring after the applicable timeframe 
are not considered to be sequelae of an episode of syncope meeting the 
Table 2 requirements.
    (3) Significant local skin reaction. Significant local skin reaction 
is an unexpected and extreme response at the vaccination or inoculation 
site that results in a significant scar that is serious enough to 
require surgical intervention. The onset of this injury is the

[[Page 798]]

initial skin lesion at the vaccination site that generally occurs with 
replication-competent smallpox vaccinations. Minor scarring or minor 
local reactions do not constitute a Table 2 injury. A robust take, 
defined as an area of redness at the vaccination site that exceeds 7.5 
cm in diameter with associated swelling, warmth and pain, is generally 
considered an expected response to the vaccination or inoculation. A 
robust take, in itself, does not constitute a Table 2 injury, even when 
the redness and swelling involves the entire upper arm with associated 
enlargement and tenderness of the glands (lymph nodes) in the underarm 
(axilla).
    (4) Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN). 
SJS/TEN is a spectrum of acute hypersensitivity reactions that affects 
skin, mucous membranes, and sometimes, internal organs (systemic 
toxicity) associated with the use or administration of replication- 
competent smallpox vaccines. For purposes of Table 2, both skin and 
mucous membrane rash or lesions must be present. Rash or lesion 
distribution must be widespread. Rash must not have a symmetric acral 
distribution (affecting arms, hands, legs or feet). Two or more mucosal 
sites must be involved. Mucosal lesions generally manifest as painful 
lesions in sites, such as the mouth or eyes. Skin rash or lesions in 
SJS/TEN usually consist of red or purple raised areas (erythematous 
macules), blisters, and ulcerations.
    (5) Inadvertent autoinoculation (IA). IA is the spread of vaccinia 
virus from an existing vaccination site to a second location usually by 
scratching the vaccination site and subsequently spreading the virus, 
which produces a new vaccinial lesion on the same person who received 
the vaccination. IA is the most common adverse event associated with the 
replication-competent smallpox vaccine.
    (6) Generalized vaccinia (GV). GV is a vaccinial infection that 
occurs from the spread of vaccinia from an existing vaccination or 
inoculation site, with the use or administration of a replication-
competent smallpox vaccine, to otherwise normal skin, resulting in 
multiple new areas of vaccinial rash or lesions. The vaccinia is 
believed to be spread through the blood. The rash or lesions, 
characterized by multiple blisters (vesicles or pustules), generally 
evolve in a similar sequence or manner as the original vaccination site.
    (7) Eczema vaccinatum (EV). EV is the transmission or the spread of 
vaccinia virus from a vaccination site, after the use or administration 
of a replication-competent smallpox vaccine, to skin that has been 
affected by, or is currently affected with, eczema or atopic dermatitis. 
EV is characterized by lesions that include multiple blisters (vesicles 
or pustules), which generally evolve in a similar sequence or manner as 
the original vaccination site. The lesions may come together to form 
larger lesions. Lesions may also spread to patches of skin that have 
never been involved with eczema or atopic dermatitis. The new lesions, 
if cultured, will be positive for vaccinia virus. A person with EV may 
become severely ill with signs and symptoms that involve the whole body 
(systemic illness), such as fever, malaise, or enlarged glands (lymph 
nodes).
    (8) Progressive vaccinia (PV). PV is the failure to initiate the 
healing process in an initial vaccination or inoculation site, after the 
use or administration of a replication-competent smallpox vaccine, by 21 
days after exposure to vaccinia, with progressive ulceration or necrosis 
at the vaccination site leading to a large destructive ulcer. PV is seen 
in people who are immunocompromised (have an impaired immune system) and 
is characterized by a complete or near complete lack of inflammation or 
absence of inflammatory cells in the dermis of the skin at the 
vaccination site. The diagnosis of PV may be made before 21 days after 
exposure, especially in a known immunocompromised individual who 
develops a lesion at the vaccination site. PV may spread through the 
blood to any location in the body. No one who experiences a significant 
healing process of the vaccination site within 21 days after receipt of 
the replication-competent smallpox vaccine or exposure to vaccinia has 
PV.
    (9) Post-vaccinial encephalopathy, encephalitis, and 
encephalomyelitis (PVEM). PVEM is a spectrum of overlapping conditions 
that includes post-vaccinial encephalopathy, encephalitis,

[[Page 799]]

and encephalomyelitis, and, for the purposes of Table 2, is treated as 
one injury. For the purposes of Table 2, PVEM is an autoimmune central 
nervous system injury that occurs after the use or administration of a 
replication-competent smallpox vaccine. In rare cases, the vaccinia 
virus is isolated from the central nervous system. Manifestations 
usually occur abruptly and may include fever, vomiting, loss of appetite 
(anorexia), headache, general malaise, impaired consciousness, 
confusion, disorientation, delirium, drowsiness, seizures, language 
difficulties (aphasia), coma, muscular incoordination (ataxia), urinary 
incontinence, urinary retention, and clinical signs consistent with 
inflammation of the spinal cord (myelitis), such as paralysis or 
meningismus (meningeal irritation). Long-term central nervous system 
impairments, such as paralysis, seizure disorders, or developmental 
delays are known to occur as sequelae of the acute PVEM. No clinical 
criteria, radiographic findings, or laboratory tests are specific for 
the diagnosis of PVEM. Symptoms that occur before 5 days or more than 14 
days after receiving the smallpox vaccine should not be attributed to 
it. In addition, encephalopathy caused by an infection, a toxin, a 
metabolic disturbance, a structural lesion, a genetic disorder, or 
trauma would not meet the Table 2 definition.
    (10) Vaccinial myocarditis, pericarditis, or myopericarditis (MP). 
For purposes of Table 2, MP is vaccinial myocarditis, pericarditis, or 
myopericarditis. Vaccinial myocarditis is defined as an inflammation of 
the heart muscle (myocardium) because of receiving the replication-
competent smallpox vaccine. Vaccinial pericarditis is defined as an 
inflammation of the covering of the heart (pericardium) because of 
receiving the smallpox vaccine. Vaccinial myopericarditis is defined as 
an inflammation of both the heart muscle and its covering because of 
receiving the smallpox vaccine. The inflammation associated with MP may 
range in severity from very mild (subclinical) to life threatening. In 
many mild cases, myocarditis is diagnosed solely by transient 
electrocardiographic (EKG) abnormalities (e.g., ST segment and T wave 
changes), increased cardiac enzymes, or mild echocardiographic 
abnormalities. Arrhythmias, abnormal heart sounds, heart failure, and 
death may occur in more severe cases. Pericarditis generally manifests 
with chest pain, abnormal heart sounds (pericardial friction rub), EKG 
abnormalities (e.g., ST segment and T wave changes), and/or increased 
fluid accumulation around the heart. A Table 2 injury of MP requires 
sufficient evidence in the medical records of the occurrence of acute 
MP.
    (11) Transfusion-related acute lung injury (TRALI). TRALI is defined 
as the onset of respiratory distress within 6 hours in non-critically 
ill patients, and 72 hours in critically ill patients, after receipt of 
blood products containing plasma, in this case, VIGIV. The relative 
level of illness will be determined on a case-by-case basis after 
reviewing the medical records and the medical history. The respiratory 
distress is the result of receiving a plasma containing transfusion 
(VIGIV) and subsequently developing pulmonary edema, respiratory 
distress, and hypoxia. TRALI occurs as the result of an antibody 
response in the host to the donor antibodies within the plasma product. 
Pulmonary edema is non-cardiac in nature and does not occur more than 72 
hours after receiving VIGIV. Pulmonary edema occurring more than 72 
hours after receiving a blood product containing plasma (VIGIV) or 
associated with cardiac dysfunction is not TRALI and is excluded as a 
countermeasure-related injury. TRALI has been identified as a major 
cause of mortality in those individual receiving plasma-containing 
transfusions. A Table 2 injury for TRALI has occurred in a recipient if 
there is sufficient evidence in the medical record of an occurrence of 
TRALI and the pulmonary edema is not caused by cardiac dysfunction or 
other causes and occurs within 72 of receiving a blood product 
containing plasma, in this case VIGIV.
    (12) Acute renal failure (ARF). ARF is the sudden loss of the 
kidneys' ability to perform their main function of eliminating excess 
fluids and electrolytes (salts), as well as waste material from the 
blood. ARF, which is also called acute kidney injury, develops

[[Page 800]]

rapidly over a few hours or a few days. ARF can be fatal and requires 
intensive treatment; however, ARF may be reversible. ARF may cause 
permanent loss of kidney function, or end-stage renal disease 
necessitating dialysis or transplant. A Table 2 injury for ARF has 
occurred if there is sufficient evidence in the medical record of an 
occurrence of ARF within the identified timeframe and the individual 
received the associated countermeasure (VIGIV).
    (13) Drug-induced aseptic meningitis (DIAM). (i) DIAM is an 
inflammation of the meninges (linings of the brain) that is not caused 
by a bacteria or virus, but is caused by a drug or medication. The 
symptoms of meningitis include severe headache, nuchal (neck) rigidity, 
drowsiness, fever, photophobia (light sensitivity), painful eye 
movements, nausea, and vomiting. Discontinuation of the medication leads 
to a resolution of the symptoms. DIAM is thought to occur because of an 
immunological hypersensitivity reaction to a specific medication. In the 
case of immunoglobulins, DIAM may be precipitated by the immunologically 
active components within the plasma or because of the stabilizers used 
within the product. The symptoms of DIAM may reoccur with another 
exposure to the offending agent.
    (ii) A Table 2 injury for DIAM has occurred in a recipient if there 
is sufficient evidence in the medical record of an occurrence of DIAM 
within the identified timeframe and the individual received the 
associated countermeasure (VIGIV). DIAM occurring in the absence of the 
use of VIGIV, or DIAM occurring with the use of VIGIV outside the 
established timeframe of onset, which is any time after the first dose 
and up to 48 hours after the last dose of this medication, is not a 
Table 2 injury.
    (14) Hemolysis. Hemolysis is the physical breakdown of red blood 
cells (RBCs) either through natural attrition or as caused by external 
factors. The RBC's function is to transport oxygen throughout the body 
in the hemoglobin contained within the RBC. Additionally, the RBCs 
contain the majority of the body's potassium stores. With hemolysis, the 
body is unable to transport oxygen effectively, and the person develops 
hypoxia. Additionally, the rapid breakdown of the cell releases large 
amounts of potassium into the blood stream, which can cause abnormal 
heart rhythms and cardiac arrest. In severe cases of hemolysis, a blood 
transfusion may be required to correct the resulting anemia. A Table 2 
injury for hemolysis has occurred if there is sufficient evidence in the 
medical record of an occurrence of hemolysis, and the patient received 
the associated countermeasure (VIGIV). Hemolysis occurring in the 
absence of the use of VIGIV and outside of the timeframe of 12 hours to 
14 days after receiving VIGIV is not a Table 2 injury. Hemolysis 
occurring from a more likely alternative diagnosis, such as infections, 
toxins, poisons, hemodialysis, or medications, is not a Table 2 injury. 
This list of conditions that can cause hemolysis, not associated with 
VIGIV, is not exhaustive, and all additional diagnoses within the 
medical documentation will be evaluated.

[80 FR 47416, Aug. 7, 2015, as amended at 86 FR 45657, Aug. 16, 2021]

[[Page 801]]



                SUBCHAPTER K_HEALTH RESOURCES DEVELOPMENT





PART 121_ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK--Table of Contents



Sec.
121.1 Applicability.
121.2 Definitions.
121.3 The OPTN.
121.4 OPTN Policies: Secretarial review and appeals.
121.5 Listing requirements.
121.6 Organ procurement.
121.7 Identification of organ recipient.
121.8 Allocation of organs.
121.9 Designated transplant program requirements.
121.10 Reviews, evaluation, and enforcement.
121.11 Record maintenance and reporting requirements.
121.12 Advisory Committee on Organ Transplantation.
121.13 Definition of human organ under section 301 of the National Organ 
          Transplant Act of 1984, as amended.
121.14 Reimbursement for living organ donors: incidental non-medical 
          expenses.

    Authority: Sections 215, 371-377, and 377E of the PHS Act (42 U.S.C. 
216, 273-274d, 274f-5); sections 1102, 1106, 1138 and 1871 of the Social 
Security Act (42 U.S.C. 1302, 1306, 1320b-8, and 1395hh); section 301 of 
the National Organ Transplant Act, as amended (42 U.S.C. 274e); and E.O. 
13879, 84 FR 33817.

    Source: 63 FR 16332, Apr. 2, 1998, unless otherwise noted.



Sec.  121.1  Applicability.

    (a) The provisions of this part, with the exception of Sec. Sec.  
121.13 and 121.14, apply to the operation of the Organ Procurement and 
Transplantation Network (OPTN) and the Scientific Registry.
    (b) The provisions of Sec.  121.13 apply to the prohibition set 
forth in section 301 of the National Organ Transplant Act, as amended.
    (c) The provisions of Sec.  121.14 apply to the reimbursement of 
specified incidental non-medical expenses incurred toward living organ 
donation under section 377 of the Public Health Service Act, as amended.
    (d) In accordance with section 1138 of the Social Security Act, 
hospitals in which organ transplants are performed and which participate 
in the programs under titles XVIII or XIX of the Social Security Act, 
and organ procurement organizations designated under section 1138(b) of 
the Social Security Act, are subject to the requirements of this part.

[85 FR 59444, Sept. 22, 2020]



Sec.  121.2  Definitions.

    As used in this part--
    Act means the Public Health Service Act, as amended.
    Designated transplant program means a transplant program that has 
been found to meet the requirements of Sec.  121.9.
    Family member means a family member of a transplant candidate, 
transplant recipient, or organ donor.
    OPTN computer match program means a set of computer-based 
instructions which compares data on a cadaveric organ donor with data on 
transplant candidates on the waiting list and ranks the candidates 
according to OPTN policies to determine the priority for allocating the 
donor organ(s).
    Organ means a human kidney, liver, heart, lung, pancreas, intestine 
(including the esophagus, stomach, small and/or large intestine, or any 
portion of the gastrointestinal tract) or vascularized composite 
allograft (defined in this section). Blood vessels recovered from an 
organ donor during the recovery of such organ(s) are considered part of 
an organ with which they are procured for purposes of this part if the 
vessels are intended for use in organ transplantation and labeled ``For 
use in organ transplantation only.''
    Organ donor means a human being who is the source of an organ for 
transplantation into another human being.
    Organ procurement organization or OPO means an entity so designated 
by the Secretary under section 1138(b) of the Social Security Act.
    Organ procurement and transplantation network or OPTN means the 
network established pursuant to section 372 of the Act.
    Potential transplant recipient or potential recipient means a 
transplant candidate who has been ranked by the OPTN computer match 
program as the

[[Page 802]]

person to whom an organ from a specific cadaveric organ donor is to be 
offered.
    Scientific Registry means the registry of information on transplant 
recipients established pursuant to section 373 of the Act.
    Secretary means the Secretary of Health and Human Services and any 
official of the Department of Health and Human Services to whom the 
authority involved has been delegated.
    Transplant candidate means an individual who has been identified as 
medically suited to benefit from an organ transplant and has been placed 
on the waiting list by the individual's transplant program.
    Transplant hospital means a hospital in which organ transplants are 
performed.
    Transplant physician means a physician who provides non-surgical 
care and treatment to transplant patients before and after transplant.
    Transplant program means a component within a transplant hospital 
which provides transplantation of a particular type of organ.
    Transplant recipient means a person who has received an organ 
transplant.
    Transplant surgeon means a physician who provides surgical care and 
treatment to transplant recipients.
    Vascularized composite allograft means a body part:
    (1) That is vascularized and requires blood flow by surgical 
connection of blood vessels to function after transplantation;
    (2) Containing multiple tissue types;
    (3) Recovered from a human donor as an anatomical/structural unit;
    (4) Transplanted into a human recipient as an anatomical/structural 
unit;
    (5) Minimally manipulated (i.e., processing that does not alter the 
original relevant characteristics of the organ relating to the organ's 
utility for reconstruction, repair, or replacement);
    (6) For homologous use (the replacement or supplementation of a 
recipient's organ with an organ that performs the same basic function or 
functions in the recipient as in the donor);
    (7) Not combined with another article such as a device;
    (8) Susceptible to ischemia and, therefore, only stored temporarily 
and not cryopreserved; and
    (9) Susceptible to allograft rejection, generally requiring 
immunosuppression that may increase infectious disease risk to the 
recipient.
    Waiting list means the OPTN computer-based list of transplant 
candidates.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999; 72 
FR 10619, Mar. 9, 2007; 72 FR 10925, Mar. 12, 2007; 78 FR 40042, July 3, 
2013]



Sec.  121.3  The OPTN.

    (a) Organization of the OPTN. (1) The OPTN shall establish a Board 
of Directors of whatever size the OPTN determines appropriate. The Board 
of Directors shall include:
    (i) Approximately 50 percent transplant surgeons or transplant 
physicians;
    (ii) At least 25 percent transplant candidates, transplant 
recipients, organ donors and family members. These members should 
represent the diversity of the population of transplant candidates, 
transplant recipients, organ donors and family members served by the 
OPTN including, to the extent practicable, the minority and gender 
diversity of this population. These members shall not be employees of, 
or have a similar relationship with OPOs, transplant centers, voluntary 
health organizations, transplant coordinators, histocompatibility 
experts, or other non-physician transplant professionals; however, the 
Board may waive this requirement for not more than 50 percent of these 
members; and
    (iii) Representatives of OPOs, transplant hospitals, voluntary 
health associations, transplant coordinators, histocompatibility 
experts, non-physician transplant professionals, and the general public.
    (2) The Board of Directors shall elect an Executive Committee from 
the membership of the Board. The Executive Committee shall include at 
least one general public member, one OPO representative, approximately 
50 percent transplant surgeons and transplant physicians, and at least 
25 percent transplant candidates, transplant

[[Page 803]]

recipients, organ donors, and family members.
    (3) The Board of Directors shall appoint an Executive Director of 
the OPTN. The Executive Director may be reappointed upon the Board's 
determination that the responsibilities of this position have been 
accomplished successfully.
    (4) The Board of Directors shall establish such other committees as 
are necessary to perform the duties of the OPTN. Committees established 
by the Board of Directors shall include:
    (i) Representation by transplant coordinators, organ procurement 
organizations, and transplant hospitals, and at least one transplant 
candidate, transplant recipient, organ donor or family member; and
    (ii) To the extent practicable, minority and gender representation 
reflecting the diversity of the population of transplant candidates, 
transplant recipients, organ donors and family members served by the 
OPTN.
    (b) Membership of the OPTN. (1) The OPTN shall admit and retain as 
members the following:
    (i) All organ procurement organizations;
    (ii) Transplant hospitals participating in the Medicare or Medicaid 
programs; and
    (iii) Other organizations, institutions, and individuals that have 
an interest in the fields of organ donation or transplantation.
    (2) To apply for membership in the OPTN:
    (i) An OPO shall provide to the OPTN the name and address of the 
OPO, and the latest year of designation under section 1138(b) of the 
Social Security Act;
    (ii) A transplant hospital shall provide to the OPTN the name and 
address of the hospital, a list of its transplant programs by type of 
organ; and
    (iii) Any other organization, institution, or individual eligible 
under paragraph (c)(1)(iii) of this section shall demonstrate to the 
OPTN an interest in the fields of organ donation or transplantation.
    (3) The OPTN shall accept or reject as members entities or 
individuals described in paragraph (c)(1)(iii) of this section within 90 
days.
    (4) Applicants rejected for membership in the OPTN may appeal to the 
Secretary. Appeals shall be submitted in writing within 30 days of 
rejection of the application. The Secretary may:
    (i) Deny the appeal; or
    (ii) Direct the OPTN to take action consistent with the Secretary's 
response to the appeal.
    (c) Corporate status of the OPTN. (1) The OPTN shall be a private, 
not-for-profit entity.
    (2) The requirements of this section do not apply to any parent, 
sponsoring, or affiliated organization of the OPTN, or to any activities 
of the contracting organization that are not integral to the operation 
of the OPTN. Such an organization is free to establish its own corporate 
procedures.
    (3) No OPTN member is required to become a member of any 
organization that is a parent, sponsor, contractor, or affiliated 
organization of the OPTN, to comply with the by-laws of any such 
organization, or to assume any corporate duties or obligations of any 
such organization.
    (d) Effective date. The organization designated by the Secretary as 
the OPTN shall have until June 30, 2000, or six months from its initial 
designation as the OPTN, whichever is later, to meet the requirements of 
this section, except that the Secretary may extend such period for good 
cause.

[63 FR 16332, Apr. 2, 1998, as amended at 63 FR 35847, July 1, 1998; 64 
FR 56658, Oct. 20, 1999]



Sec.  121.4  OPTN policies: Secretarial review and appeals.

    (a) The OPTN Board of Directors shall be responsible for developing, 
with the advice of the OPTN membership and other interested parties, 
policies within the mission of the OPTN as set forth in section 372 of 
the Act and the Secretary's contract for the operation of the OPTN, 
including:
    (1) Policies for the equitable allocation of cadaveric organs in 
accordance with Sec.  121.8;
    (2) Policies, consistent with recommendations of the Centers for 
Disease Control and Prevention, for the testing of organ donors and 
follow-up of transplant recipients to prevent the spread of infectious 
diseases;

[[Page 804]]

    (3) Policies that reduce inequities resulting from socioeconomic 
status, including, but not limited to:
    (i) Ensuring that payment of the registration fee is not a barrier 
to listing for patients who are unable to pay the fee;
    (ii) Procedures for transplant hospitals to make reasonable efforts 
to obtain from all available sources, financial resources for patients 
unable to pay such that these patients have an opportunity to obtain a 
transplant and necessary follow-up care;
    (iii) Recommendations to private and public payers and service 
providers on ways to improve coverage of organ transplantation and 
necessary follow-up care; and
    (iv) Reform of allocation policies based on assessment of their 
cumulative effect on socioeconomic inequities;
    (4) Policies regarding the training and experience of transplant 
surgeons and transplant physicians in designated transplant programs as 
required by Sec.  121.9;
    (5) Policies for nominating officers and members of the Board of 
Directors; and
    (6) Policies on such other matters as the Secretary directs.
    (b) The Board of Directors shall:
    (1) Provide opportunity for the OPTN membership and other interested 
parties to comment on proposed policies and shall take into account the 
comments received in developing and adopting policies for implementation 
by the OPTN; and
    (2) Provide to the Secretary, at least 60 days prior to their 
proposed implementation, proposed policies it recommends to be 
enforceable under Sec.  121.10 (including allocation policies). These 
policies will not be enforceable until approved by the Secretary. The 
Board of Directors shall also provide to the Secretary, at least 60 days 
prior to their proposed implementation, proposed policies on such other 
matters as the Secretary directs. The Secretary will refer significant 
proposed policies to the Advisory Committee on Organ Transplantation 
established under Sec.  121.12, and publish them in the Federal Register 
for public comment. The Secretary also may seek the advice of the 
Advisory Committee on Organ Transplantation established under Sec.  
121.12 on other proposed policies, and publish them in the Federal 
Register for public comment. The Secretary will determine whether the 
proposed policies are consistent with the National Organ Transplant Act 
and this part, taking into account the views of the Advisory Committee 
and public comments. Based on this review, the Secretary may provide 
comments to the OPTN. If the Secretary concludes that a proposed policy 
is inconsistent with the National Organ Transplant Act or this part, the 
Secretary may direct the OPTN to revise the proposed policy consistent 
with the Secretary's direction. If the OPTN does not revise the proposed 
policy in a timely manner, or if the Secretary concludes that the 
proposed revision is inconsistent with the National Organ Transplant Act 
or this part, the Secretary may take such other action as the Secretary 
determines appropriate, but only after additional consultation with the 
Advisory Committee on the proposed action.
    (c) The OPTN Board of Directors shall provide the membership and the 
Secretary with copies of its policies as they are adopted, and make them 
available to the public upon request. The Secretary will publish lists 
of OPTN policies in the Federal Register, indicating which ones are 
enforceable under Sec.  121.10 or subject to potential sanctions of 
section 1138 of the Social Security Act. The OPTN shall also 
continuously maintain OPTN policies for public access on the Internet, 
including current and proposed policies.
    (d) Any interested individual or entity may submit to the Secretary 
in writing critical comments related to the manner in which the OPTN is 
carrying out its duties or Secretarial policies regarding the OPTN. Any 
such comments shall include a statement of the basis for the comments. 
The Secretary will seek, as appropriate, the comments of the OPTN on the 
issues raised in the comments related to OPTN policies or practices. 
Policies or practices that are the subject of critical comments remain 
in effect during

[[Page 805]]

the Secretary's review, unless the Secretary directs otherwise based on 
possible risk to the health of patients or to public safety. The 
Secretary will consider the comments in light of the National Organ 
Transplant Act and the regulations under this part and may consult with 
the Advisory Committee on Organ Transplantation established under Sec.  
121.12. After this review, the Secretary may:
    (1) Reject the comments;
    (2) Direct the OPTN to revise the policies or practices consistent 
with the Secretary's response to the comments; or
    (3) Take such other action as the Secretary determines appropriate.
    (e) The OPTN shall implement policies and shall:
    (1) Provide information to OPTN members about these policies and the 
rationale for them; and
    (2) Update policies developed in accordance with this section to 
accommodate scientific and technological advances.
    (3) Identify all covered body parts in any policies specific to 
vascularized composite allografts, defined in Sec.  121.2.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999; 78 
FR 40042, July 3, 2013]



Sec.  121.5  Listing requirements.

    (a) A transplant hospital which is an OPTN member may list 
individuals, consistent with the OPTN's criteria under Sec.  
121.8(b)(1), only for a designated transplant program.
    (b) Transplant hospitals shall assure that individuals are placed on 
the waiting list as soon as they are determined to be candidates for 
transplantation. The OPTN shall advise transplant hospitals of the 
information needed for such listing.
    (c) An OPTN member shall pay a registration fee to the OPTN for each 
transplant candidate it places on the waiting list. The amount of such 
fee shall be calculated to cover (together with contract funds awarded 
by the Secretary) the reasonable costs of operating the OPTN and shall 
be determined by the OPTN with the approval of the Secretary. No less 
often than annually, and whether or not a change is proposed, the OPTN 
shall submit to the Secretary a statement of its proposed registration 
fee, together with such supporting information as the Secretary finds 
necessary to determine the reasonableness or adequacy of the fee 
schedule and projected revenues. This submission is due at least three 
months before the beginning of the OPTN's fiscal year. The Secretary 
will approve, modify, or disapprove the amount of the fee within a 
reasonable time of receiving the OPTN's submission.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999]



Sec.  121.6  Organ procurement.

    The suitability of organs donated for transplantation shall be 
determined as follows:
    (a) Tests. An OPTN member procuring an organ shall assure that 
laboratory tests and clinical examinations of potential organ donors are 
performed to determine any contraindications for donor acceptance, in 
accordance with policies established by the OPTN.
    (b) HIV. (1) Organs from individuals infected with human 
immunodeficiency virus (HIV) may be transplanted only into individuals 
who--
    (i) Are infected with HIV before receiving such organ(s); and
    (ii)(A) Are participating in clinical research approved by an 
institutional review board, as defined in 45 CFR part 46, under the 
research criteria published by the Secretary under subsection (a) of 
section 377E of the Public Health Service Act, as amended; or
    (B) The Secretary has published, through appropriate procedures, a 
determination under section 377E(c) of the Public Health Service Act, as 
amended, that participation in such clinical research, as a requirement 
for transplants of organs from individuals infected with HIV, is no 
longer warranted.
    (2) Except as provided in paragraph (b)(3) of this section, the OPTN 
shall adopt and use standards of quality with respect to organs from 
individuals infected with HIV to the extent the Secretary determines 
necessary to allow the conduct of research in accordance with the 
criteria described in paragraph (b)(1)(ii)(A) of this section.

[[Page 806]]

    (3) If the Secretary has determined under paragraph (b)(1)(ii)(B) of 
this section that participation in clinical research is no longer 
warranted as a requirement for transplants of organs from individuals 
infected with HIV, the OPTN shall adopt and use standards of quality 
with respect to organs from individuals infected with HIV as directed by 
the Secretary, consistent with 42 U.S.C. 274, and in a way that ensures 
the changes will not reduce the safety of organ transplantation.
    (c) Acceptance criteria. Transplant programs shall establish 
criteria for organ acceptance, and shall provide such criteria to the 
OPTN and the OPOs with which they are affiliated.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999; 80 
FR 26467, May 8, 2015]



Sec.  121.7  Identification of organ recipient.

    (a) List of potential transplant recipients. (1) An OPTN member 
procuring an organ shall operate the OPTN computer match program within 
such time as the OPTN may prescribe to identify and rank potential 
recipients for each cadaveric organ procured.
    (2) The rank order of potential recipients shall be determined for 
each cadaveric organ using the organ specific allocation criteria 
established in accordance with Sec.  121.8.
    (3) When a donor or donor organ does not meet a transplant program's 
donor acceptance criteria, as established under Sec.  121.6(c), 
transplant candidates of that program shall not be ranked among 
potential recipients of that organ and shall not appear on a roster of 
potential recipients of that organ.
    (b) Offer of organ for potential recipients. (1) Organs shall be 
offered for potential recipients in accordance with policies developed 
under Sec.  121.8 and implemented under Sec.  121.4.
    (2) Organs may be offered only to potential recipients listed with 
transplant programs having designated transplant programs of the same 
type as the organ procured.
    (3) An organ offer is made when all information necessary to 
determine whether to transplant the organ into the potential recipient 
has been given to the transplant hospital.
    (4) A transplant program shall either accept or refuse the offered 
organ for the designated potential recipient within such time as the 
OPTN may prescribe. A transplant program shall document and provide to 
the OPO and to the OPTN the reasons for refusal and shall maintain this 
document for one year.
    (c) Transportation of organ to potential recipient--(1) 
Transportation. The OPTN member that procures a donated organ shall 
arrange for transportation of the organ to the transplant hospital.
    (2) Documentation. The OPTN member that is transporting an organ 
shall assure that it is accompanied by written documentation of 
activities conducted to determine the suitability of the organ donor and 
shall maintain this document for one year.
    (3) Packaging. The OPTN member that is transporting an organ shall 
assure that it is packaged in a manner that is designed to maintain the 
viability of the organ.
    (d) Receipt of an organ. Upon receipt of an organ, the transplant 
hospital responsible for the potential recipient's care shall determine 
whether to proceed with the transplant. In the event that an organ is 
not transplanted into the potential recipient, the OPO which has a 
written agreement with the transplant hospital must offer the organ for 
another potential recipient in accordance with paragraph (b)(2) of this 
section.
    (e) Blood vessels considered part of an organ. A blood vessel that 
is considered part of an organ under this part shall be subject to the 
allocation requirements and policies pertaining to the organ with which 
the blood vessel is procured until and unless the transplant center 
receiving the organ determines that the blood vessel is not needed for 
the transplantation of that organ.
    (f) Wastage. Nothing in this section shall prohibit a transplant 
program from transplanting an organ into any medically suitable 
candidate if to do otherwise would result in the organ not being used 
for transplantation. The transplant program shall notify the OPTN and 
the OPO which made the

[[Page 807]]

organ offer of the circumstances justifying each such action within such 
time as the OPTN may prescribe.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999; 72 
FR 10925, Mar. 12, 2007]



Sec.  121.8  Allocation of organs.

    (a) Policy development. The Board of Directors established under 
Sec.  121.3 shall develop, in accordance with the policy development 
process described in Sec.  121.4, policies for the equitable allocation 
of cadaveric organs among potential recipients. Such allocation 
policies:
    (1) Shall be based on sound medical judgment;
    (2) Shall seek to achieve the best use of donated organs;
    (3) Shall preserve the ability of a transplant program to decline an 
offer of an organ or not to use the organ for the potential recipient in 
accordance with Sec.  121.7(b)(4)(d) and (e);
    (4) Shall be specific for each organ type or combination of organ 
types to be transplanted into a transplant candidate;
    (5) Shall be designed to avoid wasting organs, to avoid futile 
transplants, to promote patient access to transplantation, and to 
promote the efficient management of organ placement;
    (6) Shall be reviewed periodically and revised as appropriate;
    (7) Shall include appropriate procedures to promote and review 
compliance including, to the extent appropriate, prospective and 
retrospective reviews of each transplant program's application of the 
policies to patients listed or proposed to be listed at the program; and
    (8) Shall not be based on the candidate's place of residence or 
place of listing, except to the extent required by paragraphs (a)(1)-(5) 
of this section.
    (b) Allocation performance goals. Allocation policies shall be 
designed to achieve equitable allocation of organs among patients 
consistent with paragraph (a) of this section through the following 
performance goals:
    (1) Standardizing the criteria for determining suitable transplant 
candidates through the use of minimum criteria (expressed, to the extent 
possible, through objective and measurable medical criteria) for adding 
individuals to, and removing candidates from, organ transplant waiting 
lists;
    (2) Setting priority rankings expressed, to the extent possible, 
through objective and measurable medical criteria, for patients or 
categories of patients who are medically suitable candidates for 
transplantation to receive transplants. These rankings shall be ordered 
from most to least medically urgent (taking into account, in accordance 
with paragraph (a) of this section, and in particular in accordance with 
sound medical judgment, that life sustaining technology allows 
alternative approaches to setting priority ranking for patients). There 
shall be a sufficient number of categories (if categories are used) to 
avoid grouping together patients with substantially different medical 
urgency;
    (3) Distributing organs over as broad a geographic area as feasible 
under paragraphs (a)(1)-(5) of this section, and in order of decreasing 
medical urgency; and
    (4) Applying appropriate performance indicators to assess transplant 
program performance under paragraphs (c)(2)(i) and (c)(2)(ii) of this 
section and reducing the inter-transplant program variance to as small 
as can reasonably be achieved in any performance indicator under 
paragraph (c)(2)(iii) of this section as the Board determines 
appropriate, and under paragraph (c)(2)(iv) of this section. If the 
performance indicator ``waiting time in status'' is used for allocation 
purposes, the OPTN shall seek to reduce the inter-transplant program 
variance in this indicator, as well as in other selected performance 
indicators, to as small as can reasonably be achieved, unless to do so 
would result in transplanting less medically urgent patients or less 
medically urgent patients within a category of patients.
    (c) Allocation performance indicators. (1) Each organ-specific 
allocation policy shall include performance indicators. These indicators 
must measure how well each policy is:
    (i) Achieving the performance goals set out in paragraph (b) of this 
section; and
    (ii) Giving patients, their families, their physicians, and others 
timely and

[[Page 808]]

accurate information to assess the performance of transplant programs.
    (2) Performance indicators shall include:
    (i) Baseline data on how closely the results of current allocation 
policies approach the performance goals established under paragraph (b) 
of this section;
    (ii) With respect to any proposed change, the amount of projected 
improvement in approaching the performance goals established under 
paragraph (b) of this section;
    (iii) Such other indicators as the Board may propose and the 
Secretary approves; and
    (iv) Such other indicators as the Secretary may require.
    (3) For each organ-specific allocation policy, the OPTN shall 
provide to the Secretary data to assist the Secretary in assessing organ 
procurement and allocation, access to transplantation, the effect of 
allocation policies on programs performing different volumes of 
transplants, and the performance of OPOs and the OPTN contractor. Such 
data shall be required on performance by organ and status category, 
including program-specific data, OPO-specific data, data by program 
size, and data aggregated by organ procurement area, OPTN region, the 
Nation as a whole, and such other geographic areas as the Secretary may 
designate. Such data shall include the following measures of inter-
transplant program variation: risk-adjusted total life-years pre-and 
post-transplant, risk-adjusted patient and graft survival rates 
following transplantation, risk-adjusted waiting time and risk-adjusted 
transplantation rates, as well as data regarding patients whose status 
or medical urgency was misclassified and patients who were 
inappropriately kept off a waiting list or retained on a waiting list. 
Such data shall cover such intervals of time, and be presented using 
confidence intervals or other measures of variance, as may be required 
to avoid spurious results or erroneous interpretation due to small 
numbers of patients covered.
    (d) Transition patient protections--(1) General. When the OPTN 
revises organ allocation policies under this section, it shall consider 
whether to adopt transition procedures that would treat people on the 
waiting list and awaiting transplantation prior to the adoption or 
effective date of the revised policies no less favorably than they would 
have been treated under the previous policies. The transition procedures 
shall be transmitted to the Secretary for review together with the 
revised allocation policies.
    (2) Special rule for initial revision of liver allocation policies. 
When the OPTN transmits to the Secretary its initial revision of the 
liver allocation policies, as directed by paragraph (e)(1) of this 
section, it shall include transition procedures that, to the extent 
feasible, treat each individual on the waiting list and awaiting 
transplantation on October 20, 1999 no less favorably than he or she 
would have been treated had the revised liver allocation policies not 
become effective. These transition procedures may be limited in duration 
or applied only to individuals with greater than average medical urgency 
if this would significantly improve administration of the list or if 
such limitations would be applied only after accommodating a substantial 
preponderance of those disadvantaged by the change in the policies.
    (e) Deadlines for initial reviews. (1) The OPTN shall conduct an 
initial review of existing allocation policies and, except as provided 
in paragraph (e)(2) of this section, no later than November 16, 2000 
shall transmit initial revised policies to meet the requirements of 
paragraphs (a) and (b) of this section, together with supporting 
documentation to the Secretary for review in accordance with Sec.  
121.4.
    (2) No later than March 16, 2000 the OPTN shall transmit revised 
policies and supporting documentation for liver allocation to meet the 
requirements of paragraphs (a) and (b) of this section to the Secretary 
for review in accordance with Sec.  121.4. The OPTN may transmit these 
materials without seeking further public comment under Sec.  121.4(b).
    (f) Secretarial review of policies, performance indicators, and 
transition patient protections. The OPTN's transmittal to the Secretary 
of proposed allocation policies and performance indicators shall include 
such supporting material, including the results of model-based computer 
simulations, as

[[Page 809]]

the Secretary may require to assess the likely effects of policy changes 
and as are necessary to demonstrate that the proposed policies comply 
with the performance indicators and transition procedures of paragraphs 
(c) and (d) of this section.
    (g) Variances. The OPTN may develop, in accordance with Sec.  121.4, 
experimental policies that test methods of improving allocation. All 
such experimental policies shall be accompanied by a research design and 
include data collection and analysis plans. Such variances shall be time 
limited. Entities or individuals objecting to variances may appeal to 
the Secretary under the procedures of Sec.  121.4.
    (h) Directed donation. Nothing in this section shall prohibit the 
allocation of an organ to a recipient named by those authorized to make 
the donation.

[64 FR 56659, Oct. 20, 1999, as amended at 64 FR 71626, Dec. 21, 1999]



Sec.  121.9  Designated transplant program requirements.

    (a) To receive organs for transplantation, a transplant program in a 
hospital that is a member of the OPTN shall abide by these rules and 
shall:
    (1) Be a transplant program approved by the Secretary for 
reimbursement under Medicare; or
    (2) Be an organ transplant program which has adequate resources to 
provide transplant services to its patients and agrees promptly to 
notify the OPTN and patients awaiting transplants if it becomes inactive 
and which:
    (i) Has letters of agreement or contracts with an OPO;
    (ii) Has on site a transplant surgeon qualified in accordance with 
policies developed under Sec.  121.4;
    (iii) Has on site a transplant physician qualified in accordance 
with policies developed under Sec.  121.4;
    (iv) Has available operating and recovery room resources, intensive 
care resources and surgical beds and transplant program personnel;
    (v) Shows evidence of collaborative involvement with experts in the 
fields of radiology, infectious disease, pathology, immunology, 
anesthesiology, physical therapy and rehabilitation medicine, 
histocompatibility, and immunogenetics and, as appropriate, hepatology, 
pediatrics, nephrology with dialysis capability, and pulmonary medicine 
with respiratory therapy support;
    (vi) Has immediate access to microbiology, clinical chemistry, 
histocompatibility testing, radiology, and blood banking services, as 
well as the capacity to monitor treatment with immunosuppressive drugs; 
and
    (vii) Makes available psychiatric and social support services for 
transplant candidates, transplant recipients, and their families; or
    (3) Be a transplant program in a Department of Veterans Affairs, 
Department of Defense, or other Federal hospital.
    (b) To apply to be a designated transplant program, transplant 
programs shall provide to the OPTN such documents as the OPTN may 
require which show that they meet the requirements of Sec.  121.9(a) 
(1), (2), or (3).
    (c) The OPTN shall, within 90 days, accept or reject applications to 
be a designated transplant program.
    (d) Applicants rejected for designation may appeal to the Secretary. 
Appeals shall be submitted in writing within 30 days of rejection of the 
application. The Secretary may:
    (1) Deny the appeal; or
    (2) Direct the OPTN to take action consistent with the Secretary's 
response to the appeal.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56660, Oct. 20, 1999]



Sec.  121.10  Reviews, evaluation, and enforcement.

    (a) Review and evaluation by the Secretary. The Secretary or her/his 
designee may perform any reviews and evaluations of member OPOs and 
transplant programs which the Secretary deems necessary to carry out 
her/his responsibilities under the Public Health Service Act and the 
Social Security Act.
    (b) Review and evaluation by the OPTN. (1) The OPTN shall design 
appropriate plans and procedures, including survey instruments, a peer 
review process, and data systems, for purposes of:

[[Page 810]]

    (i) Reviewing applications submitted under Sec.  121.3(c) for 
membership in the OPTN;
    (ii) Reviewing applications submitted under Sec.  121.9(b) to be a 
designated transplant program; and
    (iii) Conducting ongoing and periodic reviews and evaluations of 
each member OPO and transplant hospital for compliance with these rules 
and OPTN policies.
    (2) Upon the approval of the Secretary, the OPTN shall furnish 
review plans and procedures, including survey instruments and a 
description of data systems, to each member OPO and transplant hospital. 
The OPTN shall furnish any revisions of these documents to member OPOs 
and hospitals, after approval by the Secretary, prior to their 
implementation.
    (3) At the request of the Secretary, the OPTN shall conduct special 
reviews of OPOs and transplant programs, where the Secretary has reason 
to believe that such entities may not be in compliance with these rules 
or OPTN policies or may be acting in a manner which poses a risk to the 
health of patients or to public safety. The OPTN shall conduct these 
reviews in accordance with such schedules as the Secretary specifies and 
shall make periodic reports to the Secretary of progress on such reviews 
and on other reviews conducted under the requirements of this paragraph.
    (4) The OPTN shall notify the Secretary in a manner prescribed by 
the Secretary within 3 days of all committee and Board of Directors 
meetings in which transplant hospital and OPO compliance with these 
regulations or OPTN policies is considered.
    (c) Enforcement of OPTN rules--(1) OPTN recommendations. The Board 
of Directors shall advise the Secretary of the results of any reviews 
and evaluations conducted under paragraph (b)(1)(iii) or paragraph 
(b)(3) of this section which, in the opinion of the Board, indicate 
noncompliance with these rules or OPTN policies, or indicate a risk to 
the health of patients or to the public safety, and shall provide any 
recommendations for appropriate action by the Secretary. Appropriate 
action may include removal of designation as a transplant program under 
Sec.  121.9, termination of a transplant hospital's participation in 
Medicare or Medicaid, termination of a transplant hospital's 
reimbursement under Medicare and Medicaid, termination of an OPO's 
reimbursement under Medicare and Medicaid, if the noncompliance is with 
a policy designated by the Secretary as covered by section 1138 of the 
Social Security Act, or such other compliance or enforcement measures 
contained in policies developed under Sec.  121.4.
    (2) Secretary's action on recommendations. Upon the Secretary's 
review of the Board of Directors' recommendations, the Secretary may:
    (i) Request further information from the Board of Directors or the 
alleged violator, or both;
    (ii) Decline to accept the recommendation;
    (iii) Accept the recommendation, and notify the alleged violator of 
the Secretary's decision; or
    (iv) Take such other action as the Secretary deems necessary.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56661, Oct. 20, 1999]



Sec.  121.11  Record maintenance and reporting requirements.

    (a) Record maintenance. Records shall be maintained and made 
available subject to OPTN policies and applicable limitations based on 
personal privacy as follows:
    (1) The OPTN and the Scientific Registry, as appropriate, shall:
    (i) Maintain and operate an automated system for managing 
information about transplant candidates, transplant recipients, and 
organ donors, including a computerized list of individuals waiting for 
transplants;
    (ii) Maintain records of all transplant candidates, all organ donors 
and all transplant recipients;
    (iii) Operate, maintain, receive, publish, and transmit such records 
and information electronically, to the extent feasible, except when hard 
copy is requested; and
    (iv) In making information available, provide manuals, forms, flow 
charts, operating instructions, or other explanatory materials as 
necessary to understand, interpret, and use the information accurately 
and efficiently.

[[Page 811]]

    (2) Organ procurement organizations and transplant programs--(i) 
Maintenance of records. All OPOs and transplant programs shall maintain 
such records pertaining to each potential donor identified, each organ 
retrieved, each recipient transplanted and such other transplantation-
related matters as the Secretary deems necessary to carry out her/his 
responsibilities under the Act. The OPO or transplant program shall 
maintain these records for seven years.
    (ii) Access to facilities and records. OPOs and transplant hospitals 
shall permit the Secretary and the Comptroller General, or their 
designees, to inspect facilities and records pertaining to any aspect of 
services performed related to organ donation and transplantation.
    (b) Reporting requirements. (1) The OPTN and the Scientific 
Registry, as appropriate, shall:
    (i) In addition to special reports which the Secretary may require, 
submit to the Secretary a report not less than once every fiscal year on 
a schedule prescribed by the Secretary. The report shall include the 
following information in a form prescribed by the Secretary:
    (A) Information that the Secretary prescribes as necessary to assess 
the effectiveness of the Nation's organ donation, procurement and 
transplantation system;
    (B) Information that the Secretary deems necessary for the report to 
Congress required by Section 376 of the Act; and,
    (C) Any other information that the Secretary prescribes.
    (ii) Provide to the Scientific Registry data on transplant 
candidates and recipients, and other information that the Secretary 
deems appropriate. The information shall be provided in the form and on 
the schedule prescribed by the Secretary;
    (iii) Provide to the Secretary any data that the Secretary requests;
    (iv) Make available to the public timely and accurate program-
specific information on the performance of transplant programs. This 
shall include free dissemination over the Internet, and shall be 
presented, explained, and organized as necessary to understand, 
interpret, and use the information accurately and efficiently. These 
data shall be updated no less frequently than every six months (or such 
longer period as the Secretary determines would provide more useful 
information to patients, their families, and their physicians), and 
shall include risk-adjusted probabilities of receiving a transplant or 
dying while awaiting a transplant, risk-adjusted graft and patient 
survival following the transplant, and risk-adjusted overall survival 
following listing for such intervals as the Secretary shall prescribe. 
These data shall include confidence intervals or other measures that 
provide information on the extent to which chance may influence 
transplant program-specific results. Such data shall also include such 
other cost or performance information as the Secretary may specify, 
including but not limited to transplant program-specific information on 
waiting time within medical status, organ wastage, and refusal of organ 
offers. These data shall also be presented no more than six months later 
than the period to which they apply;
    (v) Respond to reasonable requests from the public for data needed 
for bona fide research or analysis purposes, to the extent that the 
OPTN's or Scientific Registry's resources permit, or as directed by the 
Secretary. The OPTN or the Scientific Registry may impose reasonable 
charges for the separable costs of responding to such requests. Patient-
identified data may be made available to bona fide researchers upon a 
showing that the research design requires such data for matching or 
other purposes, and that appropriate confidentiality protections, 
including destruction of patient identifiers upon completion of 
matching, will be followed. All requests shall be processed 
expeditiously, with data normally made available within 30 days from the 
date of request;
    (vi) Respond to reasonable requests from the public for data needed 
to assess the performance of the OPTN or Scientific Registry, to assess 
individual transplant programs, or for other purposes. The OPTN or 
Scientific Registry may impose charges for the separable costs of 
responding to such

[[Page 812]]

requests. An estimate of such charges shall be provided to the requester 
before processing the request. All requests should be processed 
expeditiously, with data normally made available within 30 days from the 
date of request; and
    (vii) Provide data to an OPTN member, without charge, that has been 
assembled, stored, or transformed from data originally supplied by that 
member.
    (2) An organ procurement organization or transplant hospital shall, 
as specified from time to time by the Secretary, submit to the OPTN, to 
the Scientific Registry, as appropriate, and to the Secretary 
information regarding transplantation candidates, transplant recipients, 
donors of organs, transplant program costs and performance, and other 
information that the Secretary deems appropriate. Such information shall 
be in the form required and shall be submitted in accordance with the 
schedule prescribed. No restrictions on subsequent redisclosure may be 
imposed by any organ procurement organization or transplant hospital.
    (c) Public access to data. The Secretary may release to the public 
information collected under this section when the Secretary determines 
that the public interest will be served by such release. The information 
which may be released includes, but is not limited to, information on 
the comparative costs and patient outcomes at each transplant program 
affiliated with the OPTN, transplant program personnel, information 
regarding instances in which transplant programs refuse offers of organs 
to their patients, information regarding characteristics of individual 
transplant programs, information regarding waiting time at individual 
transplant programs, and such other data as the Secretary determines 
will provide information to patients, their families, and their 
physicians that will assist them in making decisions regarding 
transplantation.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56661, Oct. 20, 1999]



Sec.  121.12  Advisory Committee on Organ Transplantation.

    The Secretary will establish, consistent with the Federal Advisory 
Committee Act, the Advisory Committee on Organ Transplantation. The 
Secretary may seek the comments of the Advisory Committee on proposed 
OPTN policies and such other matters as the Secretary determines.

[64 FR 56661, Oct. 20, 1999]



Sec.  121.13  Definition of human organ under section 301 
of the National Organ Transplant Act of 1984, as amended.

    Human organ, as covered by section 301 of the National Organ 
Transplant Act of 1984, as amended, means the human (including fetal) 
kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, 
skin, intestine (including the esophagus, stomach, small and/or large 
intestine, or any portion of the gastrointestinal tract) or any 
vascularized composite allograft defined in Sec.  121.2. It also means 
any subpart thereof, including that derived from a fetus.

[78 FR 40042, July 3, 2013]



Sec.  121.14  Reimbursement for living organ donors: 
incidental non-medical expenses.

    (a) The following incidental non-medical expenses incurred by 
donating individuals toward making living donations of their organs may 
be reimbursed:
    (1) Lost wages;
    (2) Child-care expenses; and
    (3) Elder-care expenses.
    (b) [Reserved]

[85 FR 59444, Sept. 22, 2020]



PART 124_MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION--Table of Contents



 Subpart A_Project Grants for Public Medical Facility Construction and 
                              Modernization

Sec.
124.1 Applicability.
124.2 Definitions.
124.3 Eligibility.
124.4 Application.
124.5 Grant evaluation and award.

[[Page 813]]

124.6 Grant payments.
124.7 Use of grant funds.
124.8 Grantee accountability.
124.9 Nondiscrimination.
124.10 Additional conditions.
124.11 Applicability of 45 CFR part 75.

Subparts B-E [Reserved]

Subpart F_Reasonable Volume of Uncompensated Services To Persons Unable 
                                 to Pay

124.501 Applicability.
124.502 Definitions.
124.503 Compliance level.
124.504 Notice of availability of uncompensated services.
124.505 Eligibility criteria.
124.506 Allocation of services; plan requirement.
124.507 Written determinations of eligibility.
124.508 Cessation of uncompensated services.
124.509 Reporting requirements.
124.510 Record maintenance requirements.
124.511 Investigation and determination of compliance.
124.512 Enforcement.
124.513 Public facility compliance alternative.
124.514 Compliance alternative for facilities with small annual 
          obligations.
124.515 Compliance alternative for community health centers, migrant 
          health centers and certain National Health Service Corps 
          sites.
124.516 Charitable facility compliance alternative.
124.517 Unrestricted availability compliance alternative for Title VI-
          assisted facilities.
124.518 Agreements with State agencies.

                       Subpart G_Community Service

124.601 Applicability.
124.602 Definitions.
124.603 Provision of services.
124.604 Posted notice.
124.605 Reporting and record maintenance requirements.
124.606 Investigation and enforcement.
124.607 Agreements with State agencies.

Appendix to Subpart G of Part 124--Interim Procedures and Criteria for 
          Review by Health Systems Agencies of Applications Under 
          Section 1625 of the Public Health Service Act

                    Subpart H_Recovery of Grant Funds

124.701 Applicability.
124.702 Definitions.
124.703 Federal right of recovery.
124.704 Notification of sale, transfer, or change of use.
124.705 Amount of recovery.
124.706 Calculation of interest.
124.707 Waiver of recovery where facility is sold or transferred to a 
          proprietary entity.
124.708 Waiver of recovery--good cause for other use of facility.
124.709 Withdrawal of waiver.

    Authority: Secs. 215, 1602, 1625, Public Health Service Act (42 
U.S.C. 216, 300o-1, 300r), unless otherwise noted.

    Source: 42 FR 62270, Dec. 9, 1977, unless otherwise noted.



 Subpart A_Project Grants for Public Medical Facility Construction and 
                              Modernization



Sec.  124.1  Applicability.

    The regulations of this subpart are applicable to grants under 
section 1625 of the Public Health Service Act for construction and 
modernization projects designed to:
    (a) Eliminate or prevent imminent safety hazards as defined by 
Federal, State or local fire, building, or life safety codes or 
regulations, or
    (b) Avoid noncompliance with State or voluntary licensure or 
accreditation standards.



Sec.  124.2  Definitions.

    As used in this subpart:
    (a) Act means the Public Health Service Act, as amended.
    (b) Construction means construction of new buildings and initial 
equipment of such buildings and, in any case in which it will help to 
provide a service not previously provided in the community, equipment of 
any buildings. It includes architect's fees, but excludes the cost of 
off-site improvements and, except with respect to public health centers, 
the cost of the acquistion of land.
    (c) Cost means the amount found by the Secretary to be necessary for 
construction or modernization under a project, except that such term 
does not include any amount found by the Secretary to be attributable to 
expansion of the bed capacity of any facility.
    (d) Equipment means those items which are necessary for the 
functioning of the facility but does not include items of current 
operating expense

[[Page 814]]

such as food, fuel, pharmaceuticals, dressings, paper, printed forms, 
and housekeeping supplies.
    (e) Facility for long-term care means a facility (including a 
skilled nursing care or intermediate care facility), providing inpatient 
care for convalescent or chronic disease patients who require skilled 
nursing or intermediate care and related medical services:
    (1) Which is a hospital (other than a hospital primarily for the 
care and treatment of mentally ill or tuberculosis patients) or is 
operated in connection with a hospital, or
    (2) In which such care and medical services are prescribed by, or 
are performed under the general direction of, persons licensed to 
practice medicine or surgery in the State.
    (f) Health systems agency means an agency which has been 
conditionally or fully designated pursuant to section 1515 of the Act 
and 42 CFR part 122.
    (g) Hospital includes general, tuberculosis, and other types of 
hospitals, and related facilities such as laboratories, outpatient 
departments, nurses' home facilities, extended care facilities, 
facilities related to programs for home health services, self-care 
units, and central service facilities, operated in connection with 
hospitals, and education or training facilities for health professional 
personnel operated as an integral part of a hospital, but does not 
include any facility furnishing primarily domiciliary care.
    (h) Major repair means those repairs to an existing building, 
excluding routine maintenance, which restore the building to a sound 
state, the cost of which is a least 10 percent of plant value or 
$200,000, whichever is greater. Plant value means the historic book 
value of the building at the time of application for assistance under 
this subpart.
    (i) Medical facility means a hospital, public health center, 
outpatient medical facility, rehabilitation facility, or a facility for 
long-term care.
    (j) Modernization means the alteration, expansion (excluding 
expansion which increases bed capacity), major repair, remodeling, 
replacement, and renovation of existing buildings (including initial 
equipment thereof), and the replacement of obsolete equipment of 
existing buildings, including energy conservation projects.
    (k) Outpatient medical facility means a facility, located in or 
apart from a hospital, for the diagnosis or diagnosis and treatment of 
ambulatory patients (including ambulatory inpatients):
    (1) Which is operated in connection with a hospital, or
    (2) In which patient care of a specialized nature (such as in an eye 
clinic, dental clinic, or ambulatory surgical center) is provided under 
the professional supervision of persons licensed to practice medicine or 
surgery in the State, or in the case of dental diagnosis or treatment, 
under the professional supervision of persons licensed to practice 
dentistry in the State, or
    (3) Which offers to patients not requiring hospitalization the 
services of licensed physicians in various medical specialties, and 
which provides to its patients a reasonably full range of diagnostic and 
treatment services.
    (l) Public health center means a publicly owned facility for the 
provision of public health services, including related facilities such 
as laboratories, clinics, and administrative offices operated in 
connection with such a facility.
    (m) Quasi-public corporation means a private, nonprofit corporation 
which has been formally given one or more governmental powers by a 
general-purpose unit of government to enable it to carry out its work.
    (n) Rehabilitation facility means a facility which is operated for 
the primary purpose of assisting in the rehabilitation of disabled 
persons through an integrated program of medical evaluation and 
services, and psychological, social, or vocational evaluation and 
services, under competent professional supervision, and in the case of 
which the major portion of the required evaluation and services is 
furnished within the facility; and either the facility is operated in 
connection with a hospital, or all medical and related health services 
are prescribed by, or are under the general direction of persons 
licensed to practice medicine or surgery in the State.
    (o) Secretary means the Secretary of Health and Human Services and 
any

[[Page 815]]

other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    (p) State means any one of the several States, the Commonwealth of 
Puerto Rico, Guam, American Samoa, the Trust Territory of the Pacific 
Islands, the Virgin Islands, and the District of Columbia.
    (q) State health planning and development agency or State Agency 
means the agency of a State government which has been conditionally or 
fully designated under section 1521 of the Act and 42 CFR part 123.
    (r) Title means a fee simple, or such other estate or interest in 
the project site (including a leasehold on which the rental does not 
exceed 4 percent of the value of the land) as the Secretary finds 
sufficient to assure undisturbed use and possession for the purpose of 
construction or modernization and operation of the project for a period 
of not less than twenty years.
    (s) Urban or rural poverty area means a census tract, census county 
division, or minor civil division, as applicable, in which the 
percentage of the residents with incomes below the poverty level, as 
defined by the Secretary of Commerce is not less than the percentage 
derived in accordance with the following sentence. This percentage shall 
be derived so that the percentage of the total population of the United 
States residing in all such areas is equal to the percentage of the 
total population of the United States with incomes below such poverty 
level, plus five percent.



Sec.  124.3  Eligibility.

    (a) Eligible applicants. A grant under section 1625 may only be made 
to a State or political subdivision of a State, including any city, 
town, county, borough, hospital district authority, or public or quasi-
public corporation for a project described in paragraph (b) of this 
section for a medical facility owned, operated, or owned and operated by 
the State or political subdivision.
    (b) Eligible project. A grant under section 1625 may be made only 
for a construction and/or modernization project designed to:
    (1) Eliminate or prevent safety hazards which under Federal, State, 
and/or local fire, building or life safety codes or regulations, will, 
in the judgment of the Secretary result in one or more of the following:
    (i) Loss of licensure for the facility.
    (ii) Closing of all or a substantial part of the facility,
    (iii) Loss of eligibility for reimbursement under title XVIII or 
title XIX of the Social Security Act; or
    (2) Avoid noncompliance with State licensure or voluntary 
accreditation standards where noncompliance will, in the judgment of the 
Secretary, result in one or both of the following:
    (i) Loss of licensure for the facility,
    (ii) Loss of accreditation resulting in loss of eligibility for 
reimbursement under title XVIII or title XIX of the Social Security Act.



Sec.  124.4  Application.

    An application for a grant under this subpart must be submitted 
directly to the Secretary at such time and in such form and manner as 
the Secretary may prescribe. The application must be executed by an 
individual authorized to act for the applicant and assume on behalf of 
the applicant the obligations imposed by the Act, this subpart, and the 
terms and conditions of the grant. The application must contain the 
following:
    (a) A description of the site of the project.
    (b) A full description, with all appropriate documentation, of:
    (1) The imminent safety hazards, licensure and/or accreditation 
problems of the facility;
    (2) The type and amount of assistance sought under this subpart;
    (3) The construction of modernization project for which funds are 
sought, describing how it will remedy the problems described pursuant to 
paragraph (b)(1) of this section, with a complete schedule for the 
proposed construction or modernization; and
    (4) How failure to remedy the problems described pursuant to 
paragraph (b) (1) of this section will affect the population served by 
the facility.
    (c) In the case of a modernization project for continuation of 
existing health services, a finding by the State

[[Page 816]]

Agency of the continued need for such services. In the case of a 
construction or modernization project for new health services, a finding 
by the State Agency of the need for such services. The finding of need 
shall be based on the following criteria:
    (1) In a State which has a program approved by the Secretary under 
section 1523(a)(4)(B) of the Act, a State certificate of need program, 
or a program under section 1122 of the Social Security Act, the State 
Agency shall use the criteria used in conducting reviews under such 
program. In a State which has more than one such program, the State 
Agency shall use the criteria of one of the programs and notify the 
Secretary of the program criteria used.
    (2) In a State which does not have a program approved by the 
Secretary under section 1523(a)(4)(B) of the Act, a State certificate of 
need program or a program under section 1122 of the Social Security Act, 
the State Agency shall base its finding of need on the following 
criteria:
    (i) Whether the proposed project is needed or projected as necessary 
to meet the needs in the community in terms of health services required; 
Provided, That projects for highly specialized services (such as open-
heart surgery, renal transplantation, or radiation therapy) which will 
draw from patient populations outside the community in which the project 
is situated will receive appropriate consideration;
    (ii) Whether the proposed project can be adequately staffed and 
operated when completed;
    (iii) Whether the proposed capital expenditure is economically 
feasible and can be accommodated in the patient charge structure of the 
health facility without unreasonable increases; and
    (iv) Whether the project will foster cost containment or improved 
quality of care through improved efficiency and productivity, including 
promotion of cost-effective factors such as ambulatory care, preventive 
health care services, home health care, and design and construction 
economies, or through increased competition between different health 
services delivery systems.
    (d) [Reserved]
    (e) An assurance that adequate financial support will be available 
for completion of the project, supported by a detailed project budget 
satisfactory to the Secretary which includes all existing and 
anticipated sources of funds for the project.
    (f) An assurance that adequate financial support will be available 
for maintenance and operation of the project when completed, supported 
by budgets and detailed expenditure and revenue information satisfactory 
to the Secretary for both the facility and the applicant for the past 
three fiscal years and budget and projections of expenditures and 
revenue for the future three fiscal years. Where a certificate of need 
or a favorable finding under section 1122 of the Social Security Act is 
required in order for the project to operate and/or receive 
reimbursement from governmental programs for health services provided, 
assurance from the applicant satisfactory to the Secretary that the 
applicant will submit, consistent with the provisions of Sec.  124.5(d), 
any such required certificates of need and/or section 1122 finding.
    (g) An assurance that the applicant would not be able to complete 
the project without the grant applied for, supported by a description of 
all efforts to obtain funds needed to complete the project and the 
results of such efforts.
    (h) An assurance that all times after the application is approved 
there will be made available in the facility or portion thereof to be 
constructed or modernized, a reasonable volume of services to persons 
unable to pay therefor. The applicant shall comply with the standards 
and procedures of 42 CFR 53.111, except as the Secretary may prescribe 
pursuant to section 1602(6) of the Act. The functions of the State 
Agency designated under section 604 of the Act under 42 CFR 53.111 will 
be performed by the Secretary, except to the extent they are otherwise 
assigned.
    (i) An assurance that at all times after the application is approved 
the facility or portion thereof to be constructed or modernized will be 
made available to all persons residing or employed in the area served by 
the facility. The applicant shall comply with the standards and 
procedures of 42 CFR

[[Page 817]]

53.113, except as the Secretary may prescribe pursuant to section 
1602(6) of the Act. The functions of the State Agency designated under 
section 604 of the Act under 42 CFR 53.113 will be performed by the 
Secretary, except to the extent they are otherwise assigned.
    (j) An assurance that title to the project site is or will be vested 
in one or more of the entities filing the application or in a public or 
other nonprofit entity which is to operate the facility on completion of 
the project, with such documentation as the Secretary may require.
    (k) In the case of an application for construction or modernization 
of an outpatient medical facility, an assurance, supported by a written 
transfer agreement (or written documentation that such agreement will be 
obtained) with identified hospitals, that the services of a general 
hospital will be available to patients at such facility who are in need 
of hospital care.
    (l) Evidence that: (1) The appropriate health systems agency has 
been given the opportunity to review the application in accordance with 
section 1513(e) of the Act and the requirements of the appendix to this 
subpart, with the result of any such review.
    (2) The application has been reviewed in accordance with the 
applicable requirements of OMB Circular A-95.
    (m) An analysis satisfactory to the Secretary and such other 
information and materials as the Secretary may require concerning the 
environmental impact of the proposed construction or modernization 
project.
    (n) An assessment satisfactory to the Secretary of the project site 
in light of the considerations set forth in Executive Order 11296 (31 FR 
10663, August 10, 1966) concerning the evaluation of flood hazards in 
locating Federally supported facilities.
    (o) In the case of a project which involves the displacement of 
persons or businesses, an assurance that the applicant will comply with 
the applicable provisions of the Uniform Relocation Assistance and Real 
Property Acquisition Policies Act of 1970 (42 U.S.C. 4601 et seq.).
    (p)(1) An assurance that all laborers and mechanics employed by 
contractors or subcontractors in the performance of work on a project 
will be paid wages at rates not less than those prevailing on similar 
construction in the locality as determined by the Secretary of Labor in 
accordance with the Act of March 3, 1931 (40 U.S.C. 276a-276a-5, known 
as the Davis-Bacon Act); and
    (2) An assurance that the following conditions and provisions will 
be included in all construction contracts:
    (i) The provisions of ``DHHS Requirements for Federally Assisted 
Construction Contracts Regarding Labor Standards and Equal Employment 
Opportunity,'' Form DHHS 514 (rev. July 1976) (issued by the Office of 
Grants and Procurement Management, U.S. Department of Health and Human 
Services) pertaining to the Davis-Bacon Act, the Contract Work Hours 
Standards Act, and the Copeland Act (Anti-Kickback) regulations except 
in the case of contracts in the amount of $2,000 or less; and pertaining 
to Executive Order 11246, September 24, 1965 (30 FR 12319), relating to 
nondiscrimination in construction contract employment except in the case 
of contracts in the amount of $10,000 or less, and
    (ii) Representatives of the Secretary will have access at all 
reasonable times to work wherever it is in preparation or progress, and 
the contractor shall provide proper facilities for such access and 
inspection.
    (q) Such other information as the Secretary may require.

[42 FR 62270, Dec. 9, 1977, as amended at 49 FR 33021, Aug. 20, 1984]



Sec.  124.5  Grant evaluation and award.

    (a)(1) Within the limits of funds available for such purpose, the 
Secretary may award grants under this subpart for project costs to 
applicants with approvable applications therefor which will, in his 
judgment, best promote the purposes of section 1625 of the Act, taking 
into consideration:
    (i) The severity and seriousness of the safety hazard, licensure or 
accreditation problem or problems.
    (ii) The relative need of the population to be served for the 
services to be provided, including the availability of alternatives for 
meeting the need.
    (iii) The financial need of the applicant.

[[Page 818]]

    (iv) The extent to which the facility will serve persons below the 
poverty level, as determined by the Secretary of Commerce.
    (v) The extent to which the project will foster cost containment or 
improve the quality of care through enhanced efficiency and 
productivity.
    (2) Priority for funding shall be based on the extent to which 
services will be made available relative to the cost of the project.
    (b) The amount of any grant under this subpart may not exceed 75 
percent of the cost of the project for which the grant is made unless 
the project is located in an area determined by the Secretary to be an 
urban or rural poverty area, in which case the grant may, as determined 
by the Secretary, cover up to 100 percent of such costs.
    (c) If an applicant has not entered into a legally enforceable fixed 
price contract for the project for which funds are awarded under this 
subpart within 180 days of the date of the grant award, the grant award 
will automatically become null and void.
    (d) Where a grant has been awarded to an applicant under this 
subpart on the condition that any applicable certificates of need and 
section 1122 finding required under Sec.  124.4(f) will be provided, if 
such certificates and finding have not been received by the Secretary 
within 180 days of the grant award, the grant award will automatically 
become null and void.



Sec.  124.6  Grant payments.

    Grant payments shall be made to the applicant in accordance with the 
requirements of 45 CFR 75.305.

[42 FR 62270, Dec. 9, 1977, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  124.7  Use of grant funds.

    Any funds granted pursuant to this subpart, as well as funds assured 
by the applicant for the project, shall be expended solely for carrying 
out the approved project in accordance with section 1625 of the Act, the 
regulations of this subpart, the terms and conditions of the grant 
award, and the applicable cost principles prescribed by 45 CFR part 75, 
subpart E.

[42 FR 62270, Dec. 9, 1977, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  124.8  Grantee accountability.

    (a) Records requirements. (1) Applicants who have received Federal 
assistance under this subpart shall maintain, in accounting records 
which are separate from the records of all other funds, records which 
fully disclose the following:
    (i) The amount of all payments received from the Secretary under 
this subpart,
    (ii) Amounts and sources of all funds, in addition to funds received 
under this subpart, applied to the construction or modernization project 
funded under this subpart,
    (iii) Disposition of all funds for the construction or modernization 
project funded under this subpart,
    (iv) Total cost of the project approved under this subpart, and
    (2) Upon request, applicants shall make such records, books, papers, 
or other documents available to the Secretary and the Comptroller 
General of the United States or any of their duly authorized 
representatives which, in their opinion, may be related or pertinent to 
the grant under this subpart.
    (b) Annual financial statement. An applicant who receives grant 
assistance under this subpart shall, not later than 120 days after the 
end of its fiscal year, unless a longer period is approved by the 
Secretary for good cause shown, file an annual financial statement which 
meets the requirements of section 1634 of the Act.



Sec.  124.9  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in that 
particular section 601 of such Act which provides that no person in the 
United States shall, on the grounds of race, color or national origin be 
excluded from participation in, be denied the benefits of, or be 
subjected to discrimination under any program or activity receiving 
Federal financial assistance. A regulation implementing such title VI, 
which is applicable to grants made under this subpart,

[[Page 819]]

has been issued by the Secretary with the approval of the President (45 
CFR part 80).
    (b) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of the handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance. A regulation 
implementing section 504 has been issued (45 CFR part 84 (42 FR 22676, 
May 4, 1977)).
    (c) All portions and services of the entire facility for the 
construction or modernization of which, or in connection with which aid 
under the Act is sought must be made available without discrimination on 
account of creed and the applicant may not discriminate against any 
qualified person on account of creed with respect to the privilege of 
professional practice in the facility.
    (d) Attention is also called to the requirements of title IX of the 
Education amendments of 1972 and in particular to section 901 of such 
Act (20 U.S.C. 1681) which provides that no person in the United States 
shall, on the basis of sex be excluded from participation in, be denied 
the benefits of, or be subjected to discrimination under any education 
program or activity receiving Federal financial assistance (45 CFR part 
86).
    (e) Each construction contract is subject to the condition that the 
applicant shall comply with the requirements of section 321 of the 
Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and 
Rehabilitation Act of 1970, as amended, which provides that alcohol 
abusers and alcoholics who are suffering from medical conditions shall 
not be discriminated against in admission or treatment, solely because 
of their alcohol abuse or alcoholism by any private or public general 
hospital that receives support in any form from any federally funded 
program.
    (f) Each construction contract is subject to the condition that the 
applicant shall comply with the requirements of section 407 of the Drug 
Abuse Office and Treatment Act of 1972, as amended, which provides that 
drug abusers who are suffering from medical conditions shall not be 
discriminated against because of their drug abuse or drug dependence, by 
any private or public general hospital that receives support in any form 
from any federally funded program.



Sec.  124.10  Additional conditions.

    The Secretary may impose additional conditions prior to or at the 
time of any grant award when in the Secretary's judgment such conditions 
are necessary to assure or protect advancement of the project in 
accordance with the purposes of the Act and the regulations of this 
subpart or the conservation of grant funds.



Sec.  124.11  Applicability of 45 CFR part 75.

    The provisions of 45 CFR part 75, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part.''.

[81 FR 3010, Jan. 20, 2016]

Subparts B-E [Reserved]



Subpart F_Reasonable Volume of Uncompensated Services to Persons Unable 
                                 To Pay

    Authority: 42 U.S.C. 216; 42 U.S.C. 300s(3).

    Source: 52 FR 46031, Dec. 3, 1987, unless otherwise noted.



Sec.  124.501  Applicability.

    (a) The provisions of this subpart apply to any recipient of Federal 
assistance under title VI or XVI of the Public Health Service Act that 
gave an assurance that it would make available, in the facility or 
portion of the facility constructed, modernized or converted with that 
assistance, a reasonable volume of services to persons unable to pay for 
the services.
    (b) The provisions of this subpart apply to facilities for the 
following periods:
    (1) Facilities assisted under title VI. Except as otherwise herein 
provided, a facility assisted under title VI of the Act shall provide 
uncompensated services

[[Page 820]]

at the annual compliance level required by Sec.  124.503(a) for:
    (i) Twenty years after the completion of construction, in the case 
of a facility for which the Secretary provided grant assistance under 
section 606 of the Act; or
    (ii) The period from completion of construction until the amount of 
a direct loan under sections 610 and 623 of the Act, or the amount of a 
loan with respect to which the Secretary provided a guarantee and 
interest subsidy under section 623 of the Act, is repaid, in the case of 
a facility for which such a loan was made.
    (iii) ``Completion of construction'' means:
    (A) The date on which the Secretary determines the facility was 
opened for service;
    (B) If the opening date is not available, it means the date on which 
the Secretary approved the final part of the facility's application for 
assistance under title VI of the Act;
    (C) If the date of final approval is not available, it means 
whatever date the Secretary determines most reasonably approximates the 
date of final approval.
    (2) Facilities assisted under title XVI. The provisions of this 
subpart apply to a facility assisted under title XVI of the Act at all 
times following the Secretary's approval of the facility's application 
for assistance under title XVI, except that if the facility does not at 
the time of that approval provide health services, the assurance applies 
at all times following the facility's initial provision of health 
services to patients, as determined by the Secretary.



Sec.  124.502  Definitions.

    As used in this subpart--
    (a) Act means the Public Health Service Act, as amended.
    (b) Allowable credit for services provided to a specific patient 
means the lesser of the facility's usual charge for those services, or 
the usual charge multiplied by the percentage which the total allowable 
cost as reported by the facility in the facility's preceding fiscal year 
under title XVIII of the Social Security Act (42 U.S.C. 1395, et seq.) 
and the implementing regulations (42 CFR part 413) bears to the 
facility's total patient revenues for the year.
    (c) Applicant means a person who requests uncompensated services or 
on whose behalf uncompensated services are requested.
    (d) CPI means the National Consumer Price Index for medical care.
    (e) Facility means an entity that received assistance under title VI 
or XVI of the Act and provided an assurance that it would provide a 
reasonable volume of services to persons unable to pay for the services.
    (f) Federal assistance means assistance received by the facility 
under title VI or title XVI of the Act and any assistance supplementary 
to that title VI or title XVI assistance received by the facility under 
any of the following acts: the District of Columbia Medical Facilities 
Construction Act of 1968, 82 Stat. 631 (Pub. L. 90-457); the Public 
Works Acceleration Act of 1962 (42 U.S.C. 2641, et seq.); the Public 
Works and Economic Development Act of 1965 (42 U.S.C. 3121, et seq.); 
the Appalachian Regional Development Act of 1965, as amended (40 U.S.C. 
App.); the Local Public Works Capital Development and Investment Act of 
1976 (Pub. L. 94-369). In the case of a loan guaranteed by the Secretary 
with an interest subsidy, the amount of Federal assistance under title 
VI or title XVI for a fiscal year is the total amount of the interest 
subsidy that the Secretary will have paid by the close of that fiscal 
year, as well as any other payments which the Secretary has made as of 
the beginning of the fiscal year on behalf of the facility in connection 
with the loan guarantee or the direct loan which has been sold.
    (g) Fiscal year means the facility's fiscal year.
    (h) Nursing home means a facility which received Federal assistance 
for and operates as a facility for long-term care as defined at, as 
applicable, section 645(h) or section 1624(6) of the Act.
    (i) Operating costs for any fiscal year means the total operating 
expenses of a facility as set forth in an audited financial statement, 
minus the amount of reimbursement, if any, received (or if not received, 
claimed) in that year under titles XVIII and XIX of the Social Security 
Act.

[[Page 821]]

    (j) Persons unable to pay means persons who meet the eligibility 
criteria set out in Sec.  124.505.
    (k) Request for uncompensated services means any indication by or on 
behalf of an individual seeking services of the facility of the 
individual's inability to pay for services. A request for uncompensated 
services may be made at any time, including following institution of a 
collection action against the individual.
    (l) Secretary means the Secretary of Health and Human Services or 
[his or her] delegatee.
    (m) Uncompensated services means:
    (1) For facilities other than those certified under Sec.  124.513, 
Sec.  124.514, Sec.  124.515, or Sec.  124.516, health services that are 
made available to persons unable to pay for them without charge or at a 
charge which is less than the allowable credit for those services. The 
amount of uncompensated services provided in a fiscal year is the total 
allowable credit for services less the amount charged for the services 
following an eligibility determination. Excluded are services provided 
more than 96 hours following notification to the facility by a quality 
improvement organization that it disapproved the services under section 
1155(a)(1) or section 1154(a)(1) of the Social Security Act.
    (2) For facilities certified under Sec.  124.513, Sec.  124.514, 
Sec.  124.515, or Sec.  124.516, services as defined in paragraph (m)(1) 
of this section and services that are made available to persons unable 
to pay for them under programs described by the documentation provided 
under Sec.  124.513(c)(2), Sec.  124.514(c)(2), or Sec.  124.516(c)(2), 
as applicable, or pursuant to the terms of the applicable grant or 
agreement as provided in Sec.  124.515. Except as provided in Sec.  
124.516, excluded are services reimbursed by Medicare, Medicaid, or 
other third party programs, including services for which reimbursement 
was provided as payment in full, and services provided more than 96 
hours following notification to the facility by a quality improvement 
organization that it disapproved the services under section 1155(a)(1) 
or section 1154(a)(1) of the Social Security Act.

[52 FR 46031, Dec. 3, 1987, as amended at 59 FR 44639, Aug. 30, 1994]



Sec.  124.503  Compliance level.

    (a) Annual compliance level. Subject to the provisions of this 
subpart, a facility is in compliance with its assurance to provide a 
reasonable volume of services to persons unable to pay if it provides 
for the fiscal year uncompensated services at a level not less than the 
lesser of--
    (1) Three percent of its operating costs for the most recent fiscal 
year for which an audited financial statement is available;
    (2) Ten percent of all Federal assistance provided to or on behalf 
of the facility, adjusted by a percentage equal to the percentage change 
in the CPI between the year in which the facility received assistance or 
1979, whichever is later, and the most recent year for which a published 
index is available.
    (b) Deficits. If in any fiscal year a facility fails to meet its 
annual compliance level, it shall provide uncompensated services in an 
amount sufficient to make up that deficit in subsequent years, and its 
period of obligation shall be extended until the deficit is made up.
    (1) Types of deficits. For purposes of determining the timing and 
amount of any deficit make-up, there are two types of deficits:
    (i) Justifiable deficits. A justifiable deficit is one in which the 
facility did not meet its annual compliance level due to either 
financial inability (as determined under Sec.  124.511(c)) or, although 
otherwise in compliance with this subpart, a lack of eligible applicants 
for uncompensated services during the fiscal year.
    (ii) Noncompliance deficits. A noncompliance deficit is one in which 
the facility failed to meet its annual compliance level due to 
noncompliance with this subpart.
    (2) Timing of deficit make-up--(i) Justifiable deficits. (A) A 
facility assisted under title VI of the Act may make up a justifiable 
deficit at any time during its period of obligation or in the year (or 
years, if necessary) immediately following its period of obligation.
    (B) A facility assisted under title XVI of the Act is not required 
to make up a justifiable deficit.

[[Page 822]]

    (ii) Noncompliance deficits. (A) A facility must begin to make up a 
noncompliance deficit in the fiscal year following the finding of 
noncompliance by the Secretary.
    (B) A facility which claimed financial inability under Sec.  
124.509(a)(2)(iii) and is found by the Secretary, pursuant to Sec.  
124.511(c), to have been financially able to provide uncompensated 
services in the year in which the deficit was incurred shall begin to 
make up the deficit beginning in the fiscal year following the 
Secretary's finding.
    (C) A facility required to make up a noncompliance deficit but which 
is determined by the Secretary, pursuant to Sec.  124.511(c), to be 
financially unable to do so in the year following the Secretary's 
finding of noncompliance shall make up the deficit in accordance with a 
schedule set by the Secretary.
    (3) Deficit make-up amount. (i) The amount of a deficit in any 
fiscal year is the difference between the facility's annual compliance 
level for that year and the amount of uncompensated services provided in 
that year.
    (ii) The amount of a justifiable deficit must be adjusted by a 
percentage equal to the percentage change in the CPI between the CPI 
available in the fiscal year in which the deficit was incurred and the 
CPI available in the fiscal year in which it was made up.
    (iii) An amount equal to the result of dividing the amount of any 
noncompliance deficit for a fiscal year by the number of years of 
obligation remaining and adjusting it by a percentage equal to the 
percentage change in the CPI between the CPI available in the fiscal 
year in which the deficit was incurred and the CPI available in the 
fiscal year in which it was made up shall be added to a facility's 
annual compliance level for each fiscal year following the fiscal year 
of the finding of noncompliance.
    (4) Affirmative action plan for precluding future deficits. Except 
where a facility reports to the Secretary in accordance with Sec.  
124.509(a)(2)(iii) that it was financially unable to provide 
uncompensated services at the annual compliance level, a facility that 
fails to meet its annual compliance level in any fiscal year shall, in 
the following year, develop and implement a plan of action that can 
reasonably be expected to enable the facility to meet its annual 
compliance level. Such actions may include special notice to the 
community through newspaper, radio, and television, or expansion of 
service to Category B, or, with respect to nursing homes, Category C, 
persons. The Secretary may require changes to the plan. Where a facility 
fails to comply with this section, the Secretary may require it to make 
up the deficit in the fiscal year following the year in which it was 
required to institute the plan.
    (c) Excesses. (1) Except for facilities certified under Sec.  
124.513, Sec.  124.514, Sec.  124.515, Sec.  124.516, or Sec.  124.517, 
if a facility provides in a fiscal year uncompensated services in an 
amount exceeding its annual compliance level, it may apply the amount of 
excess to reduce its annual compliance level in any subsequent fiscal 
year. The facility may use any excess amount to reduce its annual 
compliance level only if the services in excess of the annual compliance 
level are provided in accordance with the requirements of this subpart.
    (2) Calculation and adjustment of excess. (i) The amount of an 
excess in uncompensated services in any fiscal year is the difference 
between the amount of uncompensated services the facility provided in 
that year and the facility's annual compliance level for that year.
    (ii) The amount of any excess compliance applied to reduce a 
facility's annual compliance level must be adjusted by a percentage 
equal to the percentage change in the CPI between the CPI available in 
the fiscal year in which the facility provided the excess, and the CPI 
available in the fiscal year in which the facility applies the excess to 
reduce its annual compliance level or satisfy its remaining obligation.
    (3) Except as provided in subparagraph (1) of this paragraph, a 
facility assisted under title VI may in any fiscal year apply the amount 
of excess credited under this paragraph to satisfy the remainder of its 
obligation to provide uncompensated services. A facility's remaining 
obligation is determined as follows:
    (i) Where the annual compliance level in such fiscal year is 
established under paragraph (a)(2) of this section, the remaining 
obligation is:

[[Page 823]]

    (A) For grant assistance, 10 percent of each grant under obligation, 
multiplied by the number of years remaining in its period of obligation, 
adjusted as provided for in paragraph (a)(2) of this section, plus any 
deficits required to be made up and less any unused excesses accrued in 
prior years; and
    (B) For loan assistance, the facility's annual compliance level 
multiplied by the number of years remaining in the scheduled life of the 
loan, plus the sum of 10 percent of each yearly cumulative total of 
additional interest subsidy or other payments (which the Secretary will 
have made in connection with the guaranteed loan or a direct loan which 
has been sold) in each subsequent year remaining in the scheduled life 
of the loan, plus any deficits required to be made up, and less any 
unused excesses accrued in prior years; or
    (ii) Where the annual compliance level in such fiscal year is 
established under paragraph (a)(1) of this section, the remaining 
obligation is the average of the facility's annual compliance levels in 
the previous three years, multiplied by the number of years remaining in 
its period of obligation, plus any deficits required to be made up under 
this section, and less any unused excesses accrued in prior years.

[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987, as amended at 60 
FR 16756, Mar. 31, 1995; 66 FR 49266, Sept. 26, 2001]



Sec.  124.504  Notice of availability of uncompensated services.

    (a) Published notice. A facility shall publish in a newspaper of 
general circulation in its area notice of its uncompensated services 
obligation before the beginning of its fiscal year. The notice shall 
include:
    (1) The plan of allocation the facility proposes to adopt;
    (2) The amount of uncompensated services the facility intends to 
make available in the fiscal year or a statement that the facility will 
provide uncompensated services to all persons unable to pay who request 
uncompensated services;
    (3) An explanation, if the amount of uncompensated services the 
facility intends to make available in a fiscal year is less than the 
annual compliance level. If a facility has satisfied its remaining 
uncompensated services obligation since the last published notice under 
this paragraph, or will satisfy the remaining obligation during the 
fiscal year, the explanation must include this information; and
    (4) A statement inviting interested parties to comment on the 
allocation plan.
    (b) Posted notice. (1) The facility shall post notices, which the 
Secretary supplies in English and Spanish, in appropriate areas in the 
facility, including but not limited to the admissions areas, the 
business office, and the emergency room.
    (2) If in the service area of the facility the ``usual language of 
households'' of ten percent or more of the population according to the 
most recent figures published by the Bureau of the Census is other than 
English or Spanish, the facility shall translate the notice into that 
language and post the translated notice on signs substantially similar 
in size and legibility to and posted with those supplied under paragraph 
(b)(1) of this section.
    (3) The facility shall make reasonable efforts to communicate the 
contents of the posted notice to persons who it has reason to believe 
cannot read the notice.
    (c) Individual written notice. (1) In any period during a fiscal 
year in which uncompensated services are available in the facility, the 
facility shall provide individual written notice of the availability of 
uncompensated services to each person who seeks services in the facility 
on behalf of himself or another. The individual written notice must:
    (i) State that the facility is required by law to provide a 
reasonable amount of care without or below charge to people who cannot 
afford care;
    (ii) Set forth the criteria the facility uses for determining 
eligibility for uncompensated services (in accordance with the financial 
eligibility criteria and the allocation plan);
    (iii) State the location in the facility where anyone seeking 
uncompensated services may request them; and
    (iv) State that the facility will make a written determination of 
whether the person will receive uncompensated services, and the date by 
or period

[[Page 824]]

within which the determination will be made.
    (2) The facility shall provide the individual written notice before 
providing services, except where the emergency nature of the services 
provided makes prior notice impractical. If this exception applies, the 
facility shall provide the individual written notice to the next of kin 
or to the patient as soon as practical, but not later than when first 
presenting a bill for services.
    (3) The facility shall make reasonable efforts to communicate the 
contents of the individual written notice to persons who it has reason 
to believe cannot read the notice.



Sec.  124.505  Eligibility criteria.

    (a) A person unable to pay for health services is a person who--
    (1) Is not covered, or receives services not covered, under a third-
party insurer or governmental program, except where the person is not 
covered because the facility fails to participate in a program in which 
it is required to participate by Sec.  124.603(c);
    (2) Falls into one of the following categories:
    (i) Category A--A person whose annual individual or family income, 
as applicable, is not greater than the current poverty line issued by 
the Secretary pursuant to 42 U.S.C. 9902 that applies to the individual 
or family. The facility shall provide uncompensated services to persons 
in Category A without charge.
    (ii) Category B--A person whose annual individual or family income, 
as applicable, is greater than but not more than twice the poverty line 
issued by the Secretary pursuant to 42 U.S.C. 9902 that applies to the 
individual or family. If persons in Category B are included in the 
allocation plan, the facility shall provide uncompensated services to 
these persons without charge, or in accordance with a schedule of 
charges as specified in the allocation plan.
    (iii) Category C--With respect only to persons seeking or receiving 
nursing home services, a person whose annual or family income, as 
applicable, is more than twice but not greater than three times the 
poverty line issued by the Secretary pursuant to 42 U.S.C. 9902 that 
applies to the individual or family. If persons in Category C are 
included in the allocation plan, the facility shall provide 
uncompensated services to these persons without charge, or in accordance 
with a schedule of charges as specified in the allocation plan; and
    (3) Requests services within the facility's allocation plan in 
effect at the time of the request.
    (b) For purposes of determining eligibility for uncompensated 
services, revisions of the poverty line are effective 60 days from the 
date of their publication in the Federal Register.
    (c) A person is eligible for uncompensated services if the person's 
individual or family annual income, as applicable, is at or below the 
level established under paragraph (a)(2) of this section, when 
calculated by either of the following methods:
    (1) Multiplying by four the person's or family's income, as 
applicable, for the three months preceding the request for uncompensated 
services;
    (2) Using the person's or family's income, as applicable, for the 
twelve months preceding the request for uncompensated services.

[52 FR 46031, Dec. 3, 1987, as amended at 60 FR 16756, Mar. 31, 1995]



Sec.  124.506  Allocation of services; plan requirement.

    (a)(1) A facility shall provide its uncompensated services in 
accordance with a plan that sets out the method by which the facility 
will distribute its uncompensated services among persons unable to pay. 
The plan must:
    (i) State the type of services that will be made available;
    (ii) Specify the method, if any, for distributing those services in 
different periods of the year;
    (iii) State whether Category B or, in the case of nursing homes 
only, Category C persons will be provided uncompensated services, and if 
so, whether the services will be available without charge or at a 
reduced charge;
    (iv) If services will be made available to Category B persons at a 
reduced charge, specify the method used for reducing charges, and 
provide that the method is applicable to all persons in Category B;

[[Page 825]]

    (v) With respect to nursing homes only, if services will be made 
available to Category C persons at a reduced charge, specify the method 
used for reducing charges, provided that such method may not result in 
greater reductions than those afforded to Category B persons, and 
provide that this method is applicable to all persons in Category C; and
    (vi) Provide that the facility provides uncompensated services to 
all persons eligible under the plan who request uncompensated services.
    (2) A facility must adopt an allocation plan that meets the 
requirements of paragraph (a) by publishing the plan in a newspaper of 
general circulation in its area. The plan may take effect no earlier 
than 60 days following the date of publication.
    (b)(1) If in any fiscal year a facility fails to adopt and publish a 
plan in accordance with paragraph (a) of this section, it shall provide 
uncompensated services in accordance with the last plan it published in 
a newspaper of general circulation in its area.
    (2) If no plan was previously published in accordance with paragraph 
(a)(2) of this section, the facility must provide uncompensated services 
without charge to all applicants in Category A and Category B, and, with 
respect to nursing homes, Category C, who request service in the 
facility. This requirement applies until the facility ceases to provide 
uncompensated services under Sec.  124.508 or until an allocation plan 
published in accordance with paragraph (a)(2) of this section becomes 
effective.
    (c) A facility may revise its allocation plan during the fiscal year 
by publishing the revised plan in a newspaper of general circulation in 
the area it serves. A revised plan may take effect no earlier than 60 
days following the date of publication.

[52 FR 46031, Dec. 3, 1987, as amended at 60 FR 16756, Mar. 31, 1995]



Sec.  124.507  Written determinations of eligibility.

    (a) Determinations of eligibility must be in writing, be made in 
accordance with this section, and a copy of the determination must be 
provided to the applicant promptly.
    (b) Content of determinations--(1) Favorable determinations. A 
determination that an applicant is eligible must indicate:
    (i) That the facility will provide uncompensated services at no 
charge or at a specified charge less than the allowable credit for the 
services;
    (ii) The date on which services were requested;
    (iii) The date on which the determination was made;
    (iv) The applicant's individual or family income, as applicable, and 
family size; and
    (v) The date on which services were or will be first provided to the 
applicant.
    (2) Conditional determinations. (i) As a condition to providing 
uncompensated services, a facility may:
    (A) Require the applicant to furnish any information that is 
reasonably necessary to substantiate eligibility; and
    (B) Require the applicant to apply for any benefits under third 
party insurer or governmental programs to which he/she is or could be 
entitled upon proper application.
    (ii) A conditional determination must:
    (A) Comply with paragraph (b)(1) of this section; and
    (B) State the condition(s) under which the applicant will be found 
eligible.
    (iii) When a facility determines that the condition(s) upon which a 
conditional determination was made has been met, or will not be met, it 
shall make a favorable determination or denial on the request, as 
appropriate, in accordance with this section.
    (3) Denials. A facility must provide to each applicant denied the 
uncompensated services requested, in whole or in part, a dated statement 
of the reasons for the denial.
    (c) Timing of determinations--(1) Preservice determinations. (i) 
Facilities other than nursing homes shall make a determination of 
eligibility within two working days following a request for 
uncompensated services which is made before receipt of outpatient 
services or before discharge for inpatient services;
    (ii) Nursing homes shall make a determination of eligibility within 
ten

[[Page 826]]

working days, but no later than two working days following the date of 
admission, following a request for uncompensated services made prior to 
admission.
    (2) Postservice determinations. All facilities shall make a 
determination of eligibility not later than the end of the first full 
billing cycle following a request for uncompensated services which is 
made after receipt of outpatient services, discharge for inpatient 
services, or admission for nursing home services.

[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987]



Sec.  124.508  Cessation of uncompensated services.

    (a) Facilities not certified under Sec.  124.513, Sec.  124.514, 
Sec.  124.515, Sec.  124.516, or Sec.  124.517. Where a facility, other 
than a facility certified under Sec.  124.513, Sec.  124.514, Sec.  
124.515, Sec.  124.516, or Sec.  124.517, has maintained the records 
required by Sec.  124.510(a) and determines based thereon that it has 
met its annual compliance level for the fiscal year or the appropriate 
level for the period specified in its allocation plan, it may, for the 
remainder of that year or period:
    (1) Cease providing uncompensated services;
    (2) Cease providing individual notices in accordance with Sec.  
124.504(c);
    (3) Remove the posted notices required by Sec.  124.504(b); and
    (4) Post an additional notice stating that it has satisfied its 
obligation for the fiscal year or appropriate period and when additional 
uncompensated services will be available.
    (b) Facilities certified under Sec.  124.514. Where a facility 
certified under Sec.  124.514 has maintained the records required by 
Sec.  124.510(c) and determines based thereon that it has met its 
compliance level, under Sec.  124.514(d), for the fiscal year, it may, 
for the remainder of the fiscal year:
    (1) Cease providing uncompensated services; and
    (2) Discontinue providing notice pursuant to Sec.  124.514(b)(2).

[52 FR 46031, Dec. 3, 1987, as amended at 59 FR 44639, Aug. 30, 1994; 66 
FR 49266, Sept. 26, 2001]



Sec.  124.509  Reporting requirements.

    (a) Facilities not certified under Sec.  124.513, Sec.  124.514, 
Sec.  124.515, Sec.  124.516, or Sec.  124.517--(1) Timing of reports. 
(i) A facility shall submit to the Secretary a report to assist the 
Secretary in determining compliance with this subpart once every three 
fiscal years, on a schedule to be prescribed by the Secretary.
    (ii) A facility shall submit the required report more frequently 
than once every three years under the following circumstances:
    (A) If the facility determines that in the preceding fiscal year it 
did not provide uncompensated services at the annual compliance level, 
it shall submit a report.
    (B) If the Secretary determines, and notifies the facility in 
writing that a report is needed for proper administration of the 
program, the facility shall submit a report within 90 days after 
receiving notice from the Secretary, or within 90 days after the close 
of the fiscal year, whichever is later.
    (iii) Except as specified in paragraph (a)(1)(ii)(B) of this 
section, the reports required by this section shall be submitted within 
90 days after the close of the fiscal year, unless a longer period is 
approved by the Secretary for good cause.
    (2) Content of report. The report must include the following 
information in a form prescribed by the Secretary:
    (i) Information that the Secretary prescribes to permit a 
determination of whether a facility has met the annual compliance level 
for the fiscal years covered by the report;
    (ii) The date on which the notice required by Sec.  124.504(a) was 
published, and the name of the newspaper that printed the notice;
    (iii) If the amount of uncompensated services provided by the 
facility in the preceding fiscal year was lower than the annual 
compliance level, an explanation of why the facility did not meet the 
required level. If the facility claims that it failed to meet the 
required compliance level because it was financially unable to do so, it 
shall explain and provide documentation prescribed by the Secretary;

[[Page 827]]

    (iv) If the facility is required to submit an affirmative action 
plan, a copy of the plan.
    (v) Other information that the Secretary prescribes.
    (3) Institution of suit. Not later than 10 days after being served 
with a summons or complaint the facility shall notify the HHS Regional 
Health Administrator \1\ for the Region in which it is located of any 
legal action brought against it alleging that it has failed to comply 
with the requirements of this subpart.
---------------------------------------------------------------------------

    \1\ The addresses of the HHS Regional Offices are set out in 45 CFR 
5.31.
---------------------------------------------------------------------------

    (b) Facilities certified under Sec.  124.513 or Sec.  124.516. A 
facility certified under Sec.  124.513 or Sec.  124.516 shall comply 
with paragraph (a)(3) of this section and shall submit within 90 days 
after the close of its fiscal year, as appropriate:
    (1) A certification, signed by the responsible official of the 
facility, that there has been no material change in the factors upon 
which the certification was based; or
    (2) A certification, signed by the responsible official of the 
facility and supported by appropriate documentation, that there has been 
a material change in the factors upon which the certification was based.
    (c) Facilities certified under Sec.  124.514. A facility certified 
under Sec.  124.514 shall comply with paragraph (a)(3) of this section 
and shall submit within 90 days after the close of its fiscal year, as 
appropriate:
    (1)(i) A certification, signed by the responsible official of the 
facility, that there has been no material change in the factors upon 
which the certification was based; or
    (ii) A certification, signed by the responsible official of the 
facility and supported by appropriate documentation, that there has been 
a material change in the factors upon which the certification was based; 
and
    (2) A certification, signed by the responsible official of the 
facility, of the amount of uncompensated services provided in the 
previous fiscal year.
    (d) Facilities certified under Sec.  124.515. A facility certified 
under Sec.  124.515 shall submit such reports as are required by the 
terms of its grant under section 329 or 330 or by its agreement under 
section 334 of the Act, as applicable, at such intervals as the 
Secretary may require.
    (e) Facilities certified under Sec.  124.517. If a facility 
certified under Sec.  124.517 ceases to provide uncompensated services 
consistent with its certification under that section because of 
financial inability, it shall report such cessation to the Secretary 
within 90 days of the cessation and provide any documentation or 
information relating to the provision or cessation of uncompensated 
services that the Secretary may require.

(Approved by the Office of Management and Budget under control number 
0915-0077)

[52 FR 46031, Dec. 3, 1987, as amended at 52 FR 48362, Dec. 21, 1987; 54 
FR 52939, Dec. 26, 1989; 59 FR 44639, Aug. 30, 1994; 66 FR 49266, Sept. 
26, 2001]



Sec.  124.510  Record maintenance requirements.

    (a) Facilities not certified under Sec.  124.513, Sec.  124.514, 
Sec.  124.515, Sec.  124.516, or Sec.  124.517. (1) A facility shall 
maintain, make available for public inspection consistent with personal 
privacy, and provide to the Secretary on request, any records necessary 
to document its compliance with the requirements of this subpart in any 
fiscal year, including:
    (i) Any documents from which the information required to be reported 
under Sec.  124.509(a) was obtained;
    (ii) Accounts which clearly segregate uncompensated services from 
other accounts; and
    (iii) Copies of written determinations of eligibility under Sec.  
124.507.
    (2) A facility shall retain the records maintained pursuant to 
paragraph (a)(1) for three years after submission of the report required 
by Sec.  124.509(a)(1), except where a longer period is required by the 
Secretary, or until 180 days following the close of the Secretary's 
assessment investigation under Sec.  124.511(b), whichever is less.
    (3) A facility shall, within 60 days of the end of each fiscal year, 
determine the amount of uncompensated services it provided in that 
fiscal year. Documents that support the facility's determination shall 
be made available to the public on request. If a report is or

[[Page 828]]

will be filed under Sec.  124.509(a)(1), a facility may respond to a 
request by providing a copy of the report to the requester.
    (b) Facilities certified under Sec.  124.513, Sec.  124.514, Sec.  
124.516, or Sec.  124.517. A facility certified under Sec.  124.513, 
Sec.  124.514, Sec.  124.516, or Sec.  124.517 shall retain, make 
available for public inspection consistent with personal privacy, and 
provide to the Secretary on request any records necessary to document 
compliance with the applicable requirements of this subpart in any 
fiscal year, including those documents provided to the Secretary under 
Sec.  124.513(c), Sec.  124.514(c), Sec.  124.516(c), or Sec.  
124.517(b), as applicable. A facility shall maintain these records for 
three years, except where a longer period is required as a result of an 
investigation by the Secretary. In such cases, records must be kept 
until 180 days following the close of the Secretary's assessment 
investigation under Sec.  124.511(b).
    (c) Facilities certified under Sec.  124.515. A facility certified 
under Sec.  124.515 shall maintain the records required by its grant 
under section 329 or section 330 or its agreement under section 334 of 
the Act, as applicable, for such period of time as the grant agreement 
may require.

(Information collection requirements in paragraphs (a) and (b) approved 
by the Office of Management and Budget under control number 0915-0103)

[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987; 59 FR 44639, 
Aug. 30, 1994; 66 FR 49266, Sept. 26, 2001]



Sec.  124.511  Investigation and determination of compliance.

    (a) Complaints. A complaint that a facility is out of compliance 
with the requirements of this subpart may be filed with the Secretary by 
any person.
    (1) A complaint is considered to be filed with the Secretary on the 
date the following information is received in the Office of the HHS 
Regional Health Administrator for the Region in which the facility is 
located:
    (i) The name and address of the person making the complaint or on 
whose behalf the complaint is made;
    (ii) The name and location of the facility;
    (iii) The date or approximate date on which the event occurred; and
    (iv) A statement of what actions the complainant considers to 
violate the requirements of this subpart.
    (2) The Secretary promptly provides a copy of the complaint to the 
facility named in the complaint.
    (3) When the Secretary investigates a facility, the facility, 
including a facility certified under Sec.  124.513, Sec.  124.514, Sec.  
124.515, Sec.  124.516, or Sec.  124.517, shall provide to the Secretary 
on request any documents, records and other information concerning its 
operation that relate to the requirements of this subpart. A facility 
will be presumed to be out of compliance with its assurance unless it 
supplies documentation sufficient to show compliance with the applicable 
provisions of this subpart.
    (4) Section 1627 of the Act provides that if the Secretary dimisses 
a complaint or the Attorney General has not brought an action for 
compliance within six months from the date on which the compliant is 
filed, the person filing it may bring a private action to effectuate 
compliance with the assurance. If the Secretary determines that he/she 
will be unable to issue a decision on a complaint or otherwise take 
appropriate action within the six month period, the Secretary may, based 
on priorities for the disposition of complaints that are established to 
promote the most effective use of enforcement resources, or on the 
request of the applicant, dismiss the complaint without a finding as to 
compliance prior to the end of the six month period, but no earlier than 
45 days after the complaint is filed.
    (b) Assessments. The Secretary periodically investigates and 
assesses facilities to ascertain compliance with the requirements of 
this subpart, including certification of the amount of uncompensated 
services provided in a fiscal year or years, and provides guidance and 
prescribes corrective action to correct noncompliance.
    (1) Compliance after February 1, 1988. (i) The Secretary may certify 
that a facility has substantially complied with its assurance for a 
fiscal year or years, and such certification shall establish that the 
facility provided the amount

[[Page 829]]

of uncompensated services certified for the period covered by the 
certification.
    (ii) A certification of substantial compliance shall be based on the 
amount properly claimed by the facility pursuant to Sec.  124.509(a), 
utilizing procedures determined by the Secretary to be sufficient to 
establish that the facility has substantially complied with its 
assurance for the period covered by the certification. The procedures 
will include examination of individual account data to the extent deemed 
necessary by the Secretary.
    (iii) A certification of substantial compliance will be made where 
the Secretary determines that, for the period covered by the 
certification, the facility provided uncompensated services to eligible 
persons who had equal opportunity to apply therefor. In making this 
determination, the Secretary will consider, in descending order of 
importance, whether--
    (A) Corrective action prescribed pursuant to Sec.  124.512(b) has 
been taken by the facility;
    (B) Any noncompliance with the requirements of this subpart may be 
remedied by corrective action under Sec.  124.512(b);
    (C) The facility had procedures in place that complied with the 
requirements of Sec.  124.504(c), Sec.  124.505, Sec.  124.507, Sec.  
124.509, Sec.  124.513(b)(2), Sec.  124.514(b)(2), Sec.  124.515, Sec.  
124.516(b)(1) or (b)(2), as applicable, or Sec.  124.517(b), and 
systematically and correctly followed such procedures.
    (2) Compliance prior to February 1, 1988. The Secretary will 
determine the amount of creditable services provided prior to the 
effective date of these rules using the compliance standards applicable 
under the rules as promulgated on May 18, 1979, based on procedures 
determined by the Secretary to be sufficient to establish that the 
facility provided such amounts of uncompensated services in the 
period(s) being assessed.
    (c) Determinations of financial inability. In determining whether a 
facility was or is financially able to meet its annual compliance level, 
the Secretary will consider any comments submitted by interested 
parties. In making this determination, the Secretary will consider 
factors such as:
    (1) The ratio of revenues to expenses;
    (2) The occupancy rate;
    (3) The ratio of current assets to current liabilities;
    (4) The average cost per patient day;
    (5) The number of days of operating expenses in accounts payable;
    (6) The number of days of revenues in accounts receivable;
    (7) The sinking fund (or depreciation fund) balance;
    (8) The debt coverage ratio; and
    (9) The availability of restricted or unrestricted funds (such as an 
endowment) available for charitable use.

[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987; 53 FR 5576, Feb. 
25, 1988; 59 FR 44639, Aug. 30, 1994; 66 FR 49266, Sept. 26, 2001; 85 FR 
72909, Nov. 16, 2020]



Sec.  124.512  Enforcement.

    (a) If the Secretary finds, based on his/her investigation under 
Sec.  124.511, that a facility did not comply with the requirements of 
this subpart, the Secretary may take any action authorized by law to 
secure compliance, including but not limited to, voluntary agreement or 
a request to the Attorney General to bring an action against the 
facility for specific performance.
    (b) A facility, including a facility certified under Sec.  124.513, 
Sec.  124.514, Sec.  124.516, or Sec.  124.517, that has denied 
uncompensated services to any person because it failed to comply with 
the requirements of this subpart will not be in compliance with its 
assurance until it takes whatever steps are necessary to remedy fully 
the noncompliance, including:
    (1) Provision of uncompensated services to applicants improperly 
denied;
    (2) Repayment of amounts improperly collected from persons eligible 
to receive uncompensated services; and
    (3) Other corrective actions prescribed by the Secretary.
    (c) The Secretary may disallow all of the uncompensated services 
claimed in a fiscal year where the Secretary finds that the facility was 
in substantial noncompliance with its assurance because it failed to:
    (1) Have a system for providing notice to eligible persons as 
required by Sec.  124.504(c), Sec.  124.513(b)(2), Sec.  124.514(b)(2), 
Sec.  124.516 (b)(2)(ii)(A), or Sec.  124.517(b)(2), as applicable;

[[Page 830]]

    (2) Comply with the applicable reporting requirements of Sec.  
124.509;
    (3) Have a system for maintaining records of uncompensated services 
provided in accordance with Sec.  124.510; or
    (4) Take corrective action prescribed pursuant to paragraph (b) of 
this section.
    (d) In the absence of a finding of substantial compliance or 
substantial noncompliance in a fiscal year, the Secretary may disallow 
uncompensated services claimed by a facility in that fiscal year to the 
extent that the Secretary finds that such services are not documented as 
uncompensated services under Sec.  124.510 or are subject to 
disallowance under Sec.  124.513(d) or Sec.  124.514(d), as applicable.

[52 FR 46031, Dec. 3, 1987, as amended at 59 FR 44639, Aug. 30, 1994; 66 
FR 49266, Sept. 26, 2001]



Sec.  124.513  Public facility compliance alternative.

    (a) Effect of certification. The Secretary may certify a facility 
which meets the requirements of paragraphs (b) and (c) of this section 
as a ``public facility''. A facility which is so certified is not 
required to comply with this subpart except as otherwise herein 
provided.
    (b) Criteria for qualification. A public facility may qualify for 
certification under this section if all of the following criteria are 
met:
    (1) It is a facility which is owned and operated by a unit of State 
or local government or a quasi-public corporation as defined at 42 CFR 
124.2(m).
    (2) It provides health services without charge or at a substantially 
reduced rate to persons who are determined by the facility to qualify 
therefor under a program of discounted health services. A ``program of 
discounted health services'' must provide for financial and other 
objective eligibility criteria and procedures, including notice prior to 
nonemergency service, that assure effective opportunity for all persons 
to apply for and obtain a determination of eligibility for such 
services, including a determination prior to service where requested; 
provided that, such criteria and procedures are not required where the 
facility makes all services available to all persons at no or nominal 
charge.
    (3)(i) It received, for the three most recent fiscal years, at least 
10 percent of its total operating revenue (net patient revenue plus 
other operating revenue, exclusive of any amounts received, or if not 
received, claimed, as reimbursement under titles XVIII and XIX of the 
Social Security Act) from State and local tax appropriations or other 
State and local government revenues, or from a quasi-public corporation 
as defined at 42 CFR 124.2(m), to cover operating deficits attributable 
to the provision of discounted services; or
    (ii) If provided, in each of the three most recent fiscal years, 
uncompensated services under this subpart or under programs described by 
the documentation provided under Sec.  124.513(c)(2) in an amount not 
less than twice the annual compliance level computed under Sec.  
124.503(a).
    (c) Procedures for certification. To be certified under this 
section, a facility must submit to the Secretary, in addition to other 
materials that the Secretary may from time to time require, copies of 
the following:
    (1) Audited financial statements or official State or local 
government documents (such as annual reports or budget documents), for 
the three most recent fiscal years, sufficient to show that the facility 
meets the criteria in paragraph (b)(3)(i) or (ii) of this section.
    (2) A complete description of its program(s) of discounted health 
services, including charging and collection policies of the facility, 
and eligibility criteria and notice and determination procedures used 
under its program(s) of discounted services.
    (d) Period of effectiveness. (1) A certification by the Secretary 
under this section remains in effect until withdrawn. The Secretary may 
disallow credit under this subpart when the Secretary determines that 
there has been a material change in any factor upon which certification 
was based or substantial noncompliance with this subpart. The Secretary 
may withdraw certification where the change or noncompliance has not 
been adequately remedied or otherwise continues.

[[Page 831]]

    (2) Deficits--(i) Title VI-assisted facilities with assessed 
deficits. Where a facility assisted under title VI of the Act has been 
assessed as having a deficit under Sec.  124.503(b) that has not been 
made up prior to certification under this section, the facility may make 
up that deficit by either--
    (A) Demonstrating to the Secretary's satisfaction, that it met the 
requirements of paragraph (b) of this section for each year in which a 
deficit was assessed; or
    (B) Providing an additional period of service under this section on 
the basis of one (or portion of a) year of certification for each year 
(or portion of a year) of deficit assessed. The period of obligation 
applicable to the facility under Sec.  124.501(b) shall be extended 
until the deficit is made up in accordance with the preceding sentence.
    (ii) Title VI-assisted facilities which have not been assessed. 
Where any period of compliance under this subpart of a facility assisted 
under title VI of the Act has not been assessed, the facility will be 
presumed to have no allowable credit for such period. The facility may 
either--
    (A) Make up such deficit in accordance with paragraph (d)(2)(i) of 
this section; or
    (B) Submit an independent certified audit, conducted in accordance 
with procedures specified by the Secretary, of the facility's records 
maintained pursuant to Sec.  124.510. If the audit establishes to the 
Secretary's satisfaction that no, or a lesser, deficit exists for the 
period in question, the facility will receive credit for the period so 
justified. Any deficit which the Secretary determines still remains must 
be made up in accordance with paragraph (d)(2)(i) of this section.
    (iii) Title XVI-assisted facilities. (A) A facility assisted under 
title XVI of the Act which has an assessed deficit which was not made up 
prior to certification under this section shall make up that deficit in 
accordance with paragraph (d)(2)(i)(A) of this section. If it cannot 
make the showing required by that paragraph, it shall make up the 
deficit when its certification under this section is withdrawn.
    (B) A facility assisted under title XVI of the Act whose compliance 
with this subpart has not been completely assessed will be presumed to 
have no allowable credit for the unassessed period. The facility may 
make up the deficit by--
    (1) Following the procedure of subparagraph (d)(2)(iii)(A) of this 
section; or
    (2) Submitting an independent certified audit, conducted in 
accordance with procedures specified by the Secretary, of the facility's 
records maintained pursuant to Sec.  124.510. If the audit establishes 
to the Secretary's satisfaction that no, or a lesser, deficit exists for 
the period in question, the facility will receive credit for the period 
so justified. Any deficit which the Secretary determines still remains 
must be made up in accordance with paragraph (d)(2)(iii)(A) of this 
section.

(Approved by the Office of Management and Budget under control number 
0915-0103)

[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987]



Sec.  124.514  Compliance alternative for facilities 
with small annual obligations.

    (a) Effect of certification. The Secretary may certify a facility 
which meets the requirements of paragraphs (b) and (c) of this section 
as a ``facility with a small annual obligation.'' A facility which is so 
certified is not required to comply with this subpart except as 
otherwise herein provided.
    (b) Criteria for qualification. A facility may qualify for 
certification under this section if all of the following criteria are 
met:
    (1)(i) Title VI-assisted facilities. (A) For the facility's fiscal 
year in which this section becomes effective, the level, computed under 
Sec.  124.503(c) (3), divided by the number of years remaining in its 
period of obligation (including an additional year or portion of a year 
for each year or portion of a year in which a deficit was incurred and 
has not been made up), is not more than $10,000;
    (B) For a subsequent fiscal year, the level computed under paragraph 
(A) of this paragraph (b)(1)(i), is at or less than $10,000, adjusted by 
a percentage equal to the percentage change in the CPI available in the 
year in which this section becomes effective and the most

[[Page 832]]

recent year for which a published index is available.
    (ii) Title XVI-assisted facilities. (A) For the facility's fiscal 
year in which this section becomes effective, the level under Sec.  
124.503(a), plus the amount of any noncompliance deficits which have not 
been made up, is at or less than $10,000.
    (B) For a subsequent fiscal year, the level, computed under 
paragraph (A) of this paragraph (b)(1)(ii), is at or less than $10,000, 
adjusted as provided in paragraph (b)(1)(i)(B) of this section.
    (2) It provides health services without charge or at a substantially 
reduced rate to persons who are determined by the facility to qualify 
threrefor under a program of discounted health services. A ``program of 
discounted health services'' must provide for financial and other 
objective eligibility criteria and procedures, including notice prior to 
nonemergency service, that assure effective opportunity for all persons 
to apply for and obtain a determination of eligibility for such 
services, including a determination prior to service where requested; 
Provided that, such criteria and procedures are not required where the 
facility makes all services available to all persons at no or nominal 
charge.
    (c) Procedures for certification. To be certified under this 
section, a facility must submit to the Secretary, in addition to other 
materials that the Secretary may from time to time require, a complete 
description of its program(s) of discounted health services, including 
charging and collection policies of the facility, and eligibility 
criteria and notice and determination precedures used under its 
program(s) of discounted services.
    (d) Period of effectiveness. A certification by the Secretary under 
this section remains in effect until withdrawn. During the period in 
which such certification is in effect, the facility must provide 
uncompensated services in an amount not less than the level applicable 
under paragraph (b)(1) of this section for each fiscal year. The 
Secretary may disallow credit under this subpart when the Secretary 
determines that there has been a material change in any factor upon 
which certification was based or substantial noncompliance with this 
subpart. The Secretary may withdraw certification where the change or 
noncompliance cannot be or has not been adequately remedied or 
noncompliance otherwise continues.
    (e) Deficits. (1) Where the compliance level of a facility assisted 
under title VI of the Act is computed under paragraph (b)(1)(i)(A) of 
this section as including additional year(s) or a portion of a year, the 
facility's period of obligation under this subpart shall be extended by 
such additional period, until certification is withdrawn.
    (2) Where a facility has been assessed as having a deficit under 
Sec.  124.503(b) that has not been made up prior to withdrawal of 
certification under this section or fails to provide services as 
required by paragraph (d) of this section, the facility must make up the 
deficit in accordance with Sec.  124.503(b) following withdrawal of 
certification.

(Approved by the Office of Management and Budget under control number 
0915-0077)

[52 FR 46031, Dec. 3, 1987, as amended at 52 FR 48362, Dec. 21, 1987; 54 
FR 52939, Dec. 26, 1989]



Sec.  124.515  Compliance alternative for community health centers, 
migrant health centers and certain National Health Service Corps sites.

    (a) Period of effectiveness. For each fiscal year for which a 
facility that receives a grant to operate a community health center 
under section 330 of the Act or a migrant health center under section 
329 of the Act is in substantial compliance with the terms and 
conditions of such grant relating to the provision of services at a 
discount, the facility shall be certified as having met its annual 
compliance level in accordance with the requirements of this subpart and 
shall not be required otherwise to comply with the requirements of this 
subpart for that fiscal year. This provision also applies to any 
facility that has signed a memorandum of agreement with the Secretary 
under section 334 of the Act if the services provided by the National 
Health Service Corps professional(s) assigned pursuant to that agreement 
constitute all of the medical services provided by the facility.

[[Page 833]]

    (b) Deficits--(1) Title VI-assisted facilities with assessed 
deficits. Where a facility assisted under title VI of the Act has been 
assessed as having a deficit under Sec.  124.503(b) that has not been 
made up prior to certification under this section, the facility may make 
up that deficit by either--
    (i) Demonstrating to the Secretary's satisfaction that it met the 
requirements of paragraph (a) of this section for each year in which a 
deficit was assessed; or
    (ii) Providing an additional period of service under this section on 
the basis of one (or portion of a) year of certification for each year 
(or portion of a year) of deficit assessed. The period of obligation 
applicable to the facility under Sec.  124.501(b) shall be extended 
until the deficit is made up in accordance with the preceding sentence.
    (2) Title VI-assisted facilities which have not been assessed. Where 
any period of compliance under this subpart of a facility assisted under 
title VI of the Act has not been assessed, the facility will be presumed 
to have no allowable credit for such period. The facility may either--
    (i) Make up such deficit in accordance with paragraph (b)(1) of this 
section; or
    (ii) Submit an independent certified audit, conducted in accordance 
with procedures specified by the Secretary, of the facility's records 
maintained pursuant to Sec.  124.510. If the audit establishes to the 
Secretary's satisfaction that no, or a lesser, deficit exists for the 
period in question, the facility will receive credit for the period so 
justified. Any deficit which the Secretary determines still remains must 
be made up in accordance with paragraph (b)(1) of this section.
    (3) Title XVI-assisted facilities. (i) A facility assisted under 
title XVI of the Act which has an assessed deficit which was not made up 
prior to certification under this section shall make up that deficit in 
accordance with paragraph (b)(1)(i) of this section. If it cannot make 
the showing required by that paragraph, it shall make up the deficit 
when it is no longer certified under this section.
    (ii) A facility assisted under title XVI of the Act whose compliance 
with this subpart has not been completely assessed will be presumed to 
have no allowable credit for the unassessed period. The facility may 
make up the deficit by--
    (A) Following the procedure of paragraph (b)(3)(i) of this section; 
or
    (B) Submitting an independent certified audit, conducted in 
accordance with procedures specified by the Secretary, of the facility's 
records maintained pursuant to Sec.  124.510. If the audit establishes 
to the Secretary's satisfaction that no, or a lesser, deficit exists for 
the period in question, the facility will receive credit for the period 
so justified. Any deficit which the Secretary determines still remains 
must be made up in accordance with paragraph (b)(3)(i) of this section.

(Approved by the Office of Management and Budget under control number 
0915-0077)

[52 FR 46031, Dec. 3, 1987, as amended at 52 FR 48362, Dec. 21, 1987; 54 
FR 52939, Dec. 26, 1989]



Sec.  124.516  Charitable facility compliance alternative.

    (a) Effect of certification. The Secretary may certify as a 
``charitable facility'' a facility which meets the applicable 
requirements of this section. A facility which is certified or 
provisionally certified as a charitable facility is not required to 
comply with this subpart except as provided in this section.
    (b) Methods of qualification for certification or provisional 
certification. (1) A facility may qualify for certification under this 
section if it meets the criteria of paragraph (c)(1) or paragraph (c)(2) 
of this section.
    (2) A facility may qualify for a provisional certification under 
this section if it provides an assurance that meets the requirements of 
paragraph (d)(2) of this section.
    (c) Criteria for certification under paragraph (b)(1) of this 
section. A facility may qualify for certification under paragraph (b)(1) 
of this section if it met the criteria of either paragraph (c)(1) or 
paragraph (c)(2) of this section for the fiscal year preceding the 
request for certification. A facility that seeks certification under 
paragraph (c)(2) of this section must also meet the requirements of 
paragraph (c)(2)(i) or

[[Page 834]]

paragraph (c)(2)(ii) of this section during each year of certification.
    (1)(i) For facilities that are nursing homes: It received no monies 
directly from patients with incomes up to triple the current poverty 
line issued by the Secretary pursuant to 42 U.S.C. 9902, exclusive of 
amounts charged or received for purposes of claiming reimbursement under 
third party insurance or governmental programs, such as Medicaid or 
Medicare deductible or co-insurance amounts.
    (ii) For all other facilities. It received no monies directly from 
patients with incomes up to double the current poverty line issued by 
the Secretary pursuant to 42 U.S.C. 9902, exclusive of amounts charged 
or received for purposes of claiming reimbursement under third party 
insurance or governmental programs, such as Medicaid or Medicare 
deductible or coinsurance amounts.
    (2) It received at least 10 percent of its total operating revenue 
(net patient revenue plus other operating revenue, exclusive of any 
amounts received, or if not received, claimed, as reimbursement under 
Medicaid or Medicare) from philanthropic sources to cover operating 
deficits attributable to the provision of discounted services. 
Philanthropic sources include private trusts, foundations, churches, 
charitable organizations, state and/or local funding, and individual 
donors; and either--
    (i) Provides health services without charge or at a substantially 
reduced rate (exclusive of amounts charged or received for purposes of 
claiming reimbursement under third party insurance or governmental 
programs, such as Medicaid or Medicare deductible or coinsurance 
amounts) to persons who are determined by the facility to qualify for 
such reduced charges under a program of discounted health services. A 
``program of discounted health services'' must provide for financial and 
other objective eligibility criteria and procedures, including notice 
prior to nonemergency service, that assure effective opportunity for all 
persons to apply for and obtain a determination of eligibility for such 
services, including a determination prior to service where requested; or
    (ii) Makes all services of the facility available to all persons at 
no more than a nominal charge, exclusive of amounts charged or received 
for purposes of claiming reimbursement under third party insurance or 
governmental programs, such as Medicaid or Medicare deductible or 
coinsurance amounts.
    (d) Procedures for certification--(1) Certification under paragraph 
(b)(1) of this section. To be certified under paragraph (b)(1) of this 
section, a facility must submit to the Secretary, in addition to other 
materials that the Secretary may from time to time require, copies of 
the following:
    (i) An audited financial statement for the fiscal year preceding the 
request or other documents prescribed by the Secretary, sufficient to 
show that the facility meets the criteria of paragraph (c)(1) or (c)(2) 
of this section, as applicable;
    (ii) Where a facility claims qualification under paragraph (c)(2)(i) 
of this section, a complete description, and documentation where 
requested, of its program of discounted health services, including 
charging and collection policies of the facility, and eligibility 
criteria and notice and determination procedures used under its 
program(s) of discounted health services;
    (iii) Where the facility claims qualification under paragraph (c)(1) 
or paragraph (c)(2)(ii) of this section, a complete description, and 
documentation where requested, of its admission, charging, and 
collection policies.
    (2) Provisional certification under paragraph (b)(2) of this 
section. (i) In order to receive a provisional certification under 
paragraph (b)(2) of this section, prior to the beginning of the fiscal 
year for which provisional certification will be sought, the facility 
must submit to the Secretary an assurance, together with such 
documentation and in such form and manner as the Secretary may require, 
that it will operate during the fiscal year a program that qualifies for 
certification under paragraph (b)(1) of this section.

[[Page 835]]

    (ii) No later than 90 days following the end of the fiscal year in 
which a facility has operated a provisionally certified program, the 
facility must submit to the Secretary, the documentation required, as 
applicable, under paragraph (d)(1) of this section.
    (e) Period of effectiveness--(1) Certification under paragraph 
(b)(1) of this section. A certification by the Secretary under paragraph 
(b)(1) of this section remains in effect until withdrawn. The Secretary 
may disallow credit under this subpart when the Secretary determines 
that there has been a material change in any factor upon which 
certification was based or substantial noncompliance with this section. 
The Secretary may withdraw certification where the change or 
noncompliance has not been, in the Secretary's judgment, adequately 
remedied or otherwise continues.
    (2) Provisional certification under paragraph (b)(2) of this 
section. Where the Secretary is satisfied, based on the documentation 
submitted by the facility in accordance with paragraph (d)(2)(ii) of 
this section and any other information available to the Secretary, that 
the facility has complied with the terms of its provisional 
certification under paragraph (b)(2) of this section, the Secretary 
shall certify the facility under paragraph (b)(1) of this section. If 
the Secretary finds that the facility has not complied with the terms of 
its provisional certification under paragraph (b)(2) of this section, 
the facility will receive no credit towards its uncompensated services 
obligation during the fiscal year of provisional certification.
    (f) Deficits--(1) Title VI-assisted facilities--(i) Title VI-
assisted facilities with assessed deficits. Where a facility assisted 
under title VI of the Act has been assessed as having a deficit under 
Sec.  124.503(b) that has not been made up prior to certification under 
paragraph (b)(1) of this section, the facility may make up that deficit 
by either--
    (A) Demonstrating to the Secretary's satisfaction that it met the 
applicable requirements of paragraph (c) of this section for each year 
in which a deficit was assessed; or
    (B) Providing an additional period of service under this section on 
the basis of one year (or portion of a year) of certification for each 
year (or portion of a year) of deficit assessed. The period of 
obligation applicable to the facility under Sec.  124.501(b) shall be 
extended until the deficit is made up in accordance with the preceding 
sentence.
    (ii) Title VI-assisted facilities with unassessed deficits. Where 
any period of compliance under this subpart of a facility assisted under 
title VI of the Act has not been assessed, the facility will be presumed 
to have no allowable credit for the unassessed period. The facility may 
either--
    (A) Make up such deficit in accordance with paragraph (f)(1)(i) of 
this section; or
    (B) Submit an independent certified audit, conducted in accordance 
with procedures specified by the Secretary, of the facility's records 
maintained pursuant to Sec.  124.510. If the audit establishes to the 
Secretary's satisfaction that no, or a lesser, deficit exists for the 
period in question, the facility will receive credit for the period so 
justified. Any deficit which the Secretary determines still remains must 
be made up in accordance with paragraph (f)(1)(i)(B) of this section.
    (2) Title XVI-assisted facilities--(i) Title XVI-assisted facilities 
with assessed deficits. A facility assisted under title XVI of the Act 
which has an assessed deficit which was not made up prior to 
certification under paragraph (b)(1) of this section shall make up that 
deficit in accordance with paragraph (f)(1)(i) of this section. If it 
cannot make the showing required by that paragraph, it shall make up the 
deficit when its certification under paragraph (b)(1) of this section is 
withdrawn.
    (ii) Title XVI-assisted facilities with unassessed deficits. Where 
any period of compliance under this subpart of a facility assisted under 
title XVI of the Act has not been assessed, the facility will be 
presumed to have no allowable credit for the unassessed period. The 
facility may either--
    (A) Make up such deficit in accordance with paragraph (f)(1)(i) of 
this section; or
    (B) Submit an independent certified audit, conducted in accordance 
with procedures specified by the Secretary, of the facility's records 
maintained

[[Page 836]]

pursuant to Sec.  124.510. If the audit establishes to the Secretary's 
satisfaction that no, or a lesser, deficit exists for the period in 
question, the facility will receive credit for the period so justified. 
Any deficit which the Secretary determines still remains must be made up 
in accordance with paragraph (f)(2)(i) of this section.

[66 FR 49267, Sept. 26, 2001]



Sec.  124.517  Unrestricted availability compliance alternative 
for Title VI-assisted facilities.

    (a) Effect of certification. The Secretary may certify a Title VI-
assisted facility which meets the requirements of paragraph (b) of this 
section and the applicable requirements of this subpart as an 
unrestricted availability facility. A facility which is so certified is 
not required to comply with the requirements of this subpart, except as 
provided in this section or elsewhere in this subpart.
    (b) Criteria for qualification. A facility may qualify for 
certification under this section if, for any fiscal year for which 
certification is sought, it operates a compliant, fully expanded 
uncompensated services program. Such a program must meet the following 
criteria:
    (1) It makes all services of the facility available without charge 
to all persons requesting uncompensated services from the facility who 
are eligible under Sec.  124.505, including all persons coming within 
Category B and, if applicable, Category C.
    (2) It complies with the notice and allocation plan requirements of 
Sec. Sec.  124.504 and 124.506, except that all notices published or 
provided must describe an allocation plan and program consistent with 
paragraph (b)(1) of this section.
    (3) It makes written determinations in accordance with Sec.  
124.507, except that all favorable determinations must indicate that the 
facility will provide uncompensated services at no charge.
    (4) It provides uncompensated services consistent with the 
requirements of this section for the entire fiscal year for which 
certification is sought, except that a facility may
    (i) Cease providing such services and still receive credit, 
calculated in accordance with paragraph (d) of this section, where--
    (A) The facility has completed its total uncompensated services 
obligation, including making up any deficit; or
    (B) The facility determines, and submits documentation which the 
Secretary finds, taking into account the factors identified in Sec.  
124.511(c), sufficient to establish that it is financially unable to 
continue to meet the requirements of this section for the remainder of 
the fiscal year; and
    (ii) Receive a portion of a year's credit for the first partial year 
in which it began operating a fully expanded program, as long as it 
continued to operate the fully expanded program in subsequent years.
    (c) Period of effectiveness. A certification by the Secretary under 
this section remains in effect until withdrawn. The Secretary may 
withdraw certification under this section where the Secretary determines 
the facility is in substantial noncompliance with the requirements of 
paragraph (b) of this section and has not adequately remedied or 
otherwise continues such noncompliance. Where the Secretary withdraws 
certification for part or all of a fiscal year or years, no credit may 
be granted for the period of unremedied substantial noncompliance.
    (d) Deficits. (1) Where a Title VI-assisted facility has been 
assessed as having a deficit under Sec.  124.503(b) that has not been 
made up prior to certification under this section, the facility may make 
up the deficit by providing uncompensated services in accordance with 
this section. The facility shall receive credit towards its deficit on 
the basis of one year, or part thereof, of credit towards each ``deficit 
year'' for each year, or part thereof, of operation in compliance with 
this section and the applicable requirements of this subpart.
    (2) The number of ``deficit years'' of a facility shall be 
calculated as follows:
    (i) Determine the number of years in the facility's total period of 
obligation pursuant to Sec.  124.501;
    (ii) Subtract the number of years in which the facility operated in 
compliance with this section and the applicable requirements of this 
subpart from the number of years derived under paragraph (d)(2)(i) of 
this section;

[[Page 837]]

    (iii) For all years in which the facility did not operate in 
compliance with this section, determine the ratio of the total 
compliance levels applicable under Sec.  124.503(a) to the facility's 
total deficit under Sec.  124.503(b);
    (iv) Multiply the percentage derived under paragraph (d)(2)(iii) of 
this section by the number of years under obligation pursuant to Sec.  
124.501 but for which the facility did not operate in compliance with 
this section;
    (v) Subtract the number derived under paragraph (d)(2)(iv) of this 
section from the number of years derived under paragraph (d)(2)(ii) of 
this section;
    (vi) If the facility is still within the period described in Sec.  
124.501(b)(1), add the number of years derived under paragraph (d)(2)(v) 
of this section to the end of the period of obligation, or if the 
facility is beyond the period described in Sec.  124.501(b)(1), add the 
number of years derived under paragraph (d)(2)(v) of this section to the 
last year the facility operated in compliance with this section.

[66 FR 49268, Sept. 26, 2001]



Sec.  124.518  Agreements with State agencies.

    (a) Where the Secretary finds that it will promote the purposes of 
this subpart and the State agency is able and willing to do so, the 
Secretary may enter into an agreement with an agency of a State to 
assist in administering this subpart in the State. An agreement may be 
terminated by the Secretary or the State agency on 60 days notice.
    (b) Under an agreement the State agency will provide any assistance 
the Secretary requests in any one or more of the following areas, as set 
out in the agreement:
    (1) Investigation of complaints regarding noncompliance;
    (2) Monitoring compliance of facilities with the requirements of 
this subpart;
    (3) Review of reports submitted under Sec.  124.509, including 
affirmative action plans;
    (4) Making initial decisions for the Secretary with respect to 
compliance, subject to appeal by any party to the Secretary, or review 
by the Secretary on the Secretary's initiative; and
    (5) Application of any sanctions available to it under State law 
(such as license revocation or termination of State assistance) against 
facilities determined to be out of compliance with the requirements of 
this subpart.
    (c) Nothing in this subpart precludes any State from taking any 
action authorized by State law regarding the provision of uncompensated 
services by facilities in the State as long as the action taken does not 
prevent the Secretary from enforcing the requirements of this subpart.

[52 FR 46031, Dec. 3, 1987. Redesignated at 59 FR 44639, Aug. 30, 1994]



                       Subpart G_Community Service

    Authority: Secs. 215, 1525, 1602(6), Public Health Service Act as 
amended; 58 Stat 690, 88 Stat. 2249, 2259; 42 U.S.C. 216, 300m-4, 300o-
1(6).

    Source: 44 FR 29379, May 18, 1979, unless otherwise noted.



Sec.  124.601  Applicability.

    The provisions of this subpart apply to any recipient of Federal 
assistance under title VI or XVI of the Public Health Service Act that 
has given an assurance that it would make the facility or portion 
thereof assisted available to all persons residing (and, in the case of 
title XVI assisted applicants, employed), in the territorial area it 
serves. This assurance is referred to in this subpart as the ``community 
service assurance.''



Sec.  124.602  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Facility means the an entity that received assistance under title VI 
or title XVI of the Act and provided a community service assurance.
    Fiscal year means facility's fiscal year.
    Secretary means the Secretary of Health and Human Services or his 
delegatee.
    Service area means the geographic area designated as the area served 
by the facility in the most recent State

[[Page 838]]

plan approved by the Secretary under title VI, except that, at the 
request of the facility, the Secretary may designate a different area 
proposed by the facility when he determines that a different area is 
appropriate based on the criteria.
    State agency means the agency of a state fully or conditionally 
designated by the Secretary as the State health planning and development 
agency of the State under section 1521 of the Act.

[44 FR 29379, May 18, 1979, as amended at 85 FR 72909, Nov. 16, 2020]



Sec.  124.603  Provision of services.

    (a) General. (1) In order to comply with its community service 
assurance, a facility shall make the services provided in the facility 
or portion thereof constructed, modernized, or converted with Federal 
assistance under title VI or XVI of the Act available to all persons 
residing (and, in the case of facilities assisted under title XVI of the 
Act, employed) in the facility's service area without discrimination on 
the ground of race, color, national origin, creed, or any other ground 
unrelated to an individual's need for the service or the availability of 
the needed service in the facility. Subject to paragraph (b) (concerning 
emergency services) a facility may deny services to persons who are 
unable to pay for them unless those persons are required to be provided 
uncompensated services under the provisions of Subpart F.
    (2) A person is residing in the facility's service area for purposes 
of this section if the person:
    (i) Is living in the service area with the intention to remain there 
permanently or for an indefinite period;
    (ii) Is living in the service area for purposes of employment; or
    (iii) Is living with a family member who resides in the service 
area.
    (b) Emergency services. (1) A facility may not deny emergency 
services to any person who resides (or, in the case of facilities 
assisted under title XVI of the Act, is employed) in the facility's 
service area on the ground that the person is unable to pay for those 
services.
    (2) A facility may discharge a person that has received emergency 
services, or may transfer the person to another facility able to provide 
necessary services, when the appropriate medical personnel determine 
that discharge or transfer will not subject the person to a substantial 
risk of deterioration in medical condition.
    (c) Third party payor programs. (1) The facility shall make 
arrangements, if eligible to do so, for reimbursement for services with:
    (i) Those principal State and local governmental third-party payors 
that provide reimbursement for services that is not less than the actual 
costs, as determined in accordance with accepted cost accounting 
principles; and
    (ii) Federal governmental third-party programs, such as medicare and 
medicaid.
    (2) The facility shall take any necessary steps to insure that 
admission to and services of the facility are available to beneficiaries 
of the governmental programs specified in paragraph (c)(1) of this 
section without discrimination or preference because they are 
beneficiaries of those programs.
    (d) Exclusionary admissions policies. A facility is out of 
compliance with its community service assurance if it uses an admission 
policy that has the effect of excluding persons on a ground other than 
those permitted under paragraph (a) of this section. Illustrative 
applications of this requirement are described in the following 
paragraphs:
    (1) A facility has a policy or practice of admitting only those 
patients who are referred by physicians with staff privileges at the 
facility. If this policy or practice has the effect of excluding persons 
who reside (or for title XVI facilities, are employed) in the community 
from the facility because they do not have a private family doctor with 
staff privileges at the facility, the facility would not be in 
compliance with its assurance. The facility is not required to abolish 
its staff physician admissions policy as a usual method for admission. 
However, to be in compliance with its community service assurance it 
must make alternative arrangements to assist area residents who would 
otherwise be unable to gain admission to obtain services available in 
the facility. Examples of alternative arrangements a facility might use 
include:

[[Page 839]]

    (i) Authorizing the individual's physician, if licensed and 
otherwise qualified, to treat the patient at the facility even though 
the physician does not have staff privileges at the facility;
    (ii) For those patients who have no physician, obtaining the 
voluntary agreement of physicians with staff privileges at the facility 
to accept referrals of such patients, perhaps on a rotating basis;
    (iii) If an insufficient number of physicians with staff privileges 
agree to participate in a referral arrangement, requiring acceptance of 
referrals as a condition to obtaining or renewing staff privileges;
    (iv) Establishing a hospital-based primary care clinic through which 
patients needing hospitalization may be admitted; or
    (v) Hiring or contracting with qualified physicians to treat 
patients who do not have private physicians.
    (2) A facility, as required, is a qualified provider under the title 
XIX medicaid program, but few or none of the physicians with staff 
privileges at the facility or in a particular department or sub-
department of the facility will treat medicaid patients. If the effect 
is that some medicaid patients are excluded from the facility or from 
any service provided in the facility, the facility is not in compliance 
with its community service assurance. To be in compliance a facility 
does not have to require all of its staff physicians to accept medicaid. 
However, it must take steps to ensure that medicaid beneficiaries have 
full access to all of its available services. Examples of steps that may 
be taken include:
    (i) Obtaining the voluntary agreement of a reasonable number of 
physicians with staff privileges at the facility and in each department 
or sub-department to accept referral of medicaid patients, perhaps on a 
rotating basis;
    (ii) If an insufficient number of physicians with staff privileges 
agree to participate in a referral arrangement, requiring acceptance of 
referrals as a condition to obtaining or renewing staff privileges;
    (iii) Establishing a clinic through which medicaid beneficiaries 
needing hospitalization may be admitted; or
    (iv) Hiring or contracting with physicians to treat medicaid 
patients.
    (3) A facility requires advance deposits (pre-admission or pre-
service deposits) before admitting or serving patients. If the effect of 
this practice is that some persons are denied admission or service or 
face substantial delays in gaining admission or service solely because 
they do not have the necessary cash on hand, this would constitute a 
violation of the community service assurance. While the facility is not 
required to forego the use of a deposit policy in all situations, it is 
required to make alternative arrangements to ensure that persons who 
probably can pay for the services are not denied them simply because 
they do not have the available cash at the time services are requested. 
For example, many employed persons and persons with other collateral do 
not have savings, but can pay hospital bills on an installment basis, or 
can pay a small deposit. Such persons may not be excluded from admission 
or denied services because of their inability to pay a deposit.



Sec.  124.604  Posted notice.

    (a) The facility shall post notices, which the Secretary supplies in 
English and Spanish, in appropriate areas of the facility, including but 
not limited to the admissions area, the business office and the 
emergency room.
    (b) If in the service area of the facility the ``usual language of 
households'' of ten percent or more of the population, according to the 
most recent figures published by the Bureau of the Census, is other than 
English or Spanish, the facility shall translate the notice into that 
language and post the translated notice on signs substantially similar 
in size and legibility to, and posted with, those supplied under 
paragraph (a) of this section.
    (c) The facility shall make reasonable efforts to communicate the 
contents of the posted notice to persons who it has reason to believe 
cannot read the notice.



Sec.  124.605  Reporting and record maintenance requirements.

    (a) Reporting requirements--(1) Timing of reports. (i) A facility 
shall submit to

[[Page 840]]

the Secretary a report to assist the Secretary in determining compliance 
with this subpart once every three fiscal years, on a schedule to be 
prescribed by the Secretary. The report required by this section shall 
be submitted not later than 90 days after the end of the fiscal year, 
unless a longer period is approved by the Secretary for good cause 
shown.
    (ii) A facility shall also submit the required report whenever the 
Secretary determines, and so notifies the facility in writing, that a 
report is needed for proper administration of the program. In this 
situation the facility shall submit the report specified in this section 
for the filing of reports, within 90 days after receiving notice from 
the Secretary, or within 90 days after the close of the fiscal year, 
whichever is later.
    (2) Content of report. The report must be submitted on a form 
prescribed by the Secretary and must include information that the 
Secretary prescribes to permit a determination of whether a facility has 
met its obligations under this subpart.
    (3) The facility shall provide a copy of any report to the HSA for 
the area when submitting it to the Secretary.
    (4) Institution of suit. Not later than 10 days after being served 
with a summons or complaint, the applicant shall notify the Regional 
Health Administrator for the Region of HHS in which it is located of any 
legal action brought against it alleging that it has failed to comply 
with the requirements of this subpart. \1\
---------------------------------------------------------------------------

    \1\ The addresses of the Regional Office of HHS are set out in 45 
CFR 5.31.
---------------------------------------------------------------------------

    (b) Record maintenance requirements. (1) A facility shall maintain, 
make available for public inspection consistent with personal privacy, 
and provide to the Secretary on request, any records necessary to 
document its compliance requirements of this subpart in any fiscal year, 
including documents from which information required to be reported under 
paragraph (a) of this section was obtained. A facility shall maintain 
these records until 180 days following the close of the Secretary's 
investigation under Sec.  124.606(a).



Sec.  124.606  Investigation and enforcement.

    (a) Investigations. (1) The Secretary periodically investigates the 
compliance of facilities with the requirements of this subpart, and 
investigates complaints.
    (2)(i) A complaint is filed with the Secretary on the date on which 
the following information is received in the Office of the Regional 
Health Administrator for the Region of HHS in which the facility is 
located:
    (A) The name and address of the person making the complaint or on 
whose behalf the complaint is made;
    (B) The name and location of the facility;
    (C) The date or approximate date on which the event complained of 
occurred, and
    (D) A statement of what actions the complainant considers to violate 
the requirements of this subpart.
    (ii) The Secretary promptly provides a copy of the complaint to each 
facility named in the complaint.
    (3) When the Secretary investigates a facility, the facility shall 
provide to the Secretary on request any documents, records and other 
information concerning its operations that relate to the requirements of 
this subpart.
    (4) The Act provides that if the Secretary dismisses a complaint or 
the Attorney General has not brought an action for compliance within six 
months from the date on which the complaint is filed, the person filing 
it may bring a private action to effectuate compliance with the 
assurance. If the Secretary determines that he will be unable to issue a 
decision on a complaint or otherwise take appropriate action within the 
six month period, he may, based on priorities for the disposition of 
complaints that are established to promote the most effective use of 
enforcement resources, or on the request of the complainant, dismiss the 
complaint without a finding as to compliance prior to the end of the six 
month period, but no earlier than 45 days after the complaint is filed.
    (b) Enforcement. (1) If the Secretary finds, based on his 
investigation under paragraph (a) of this section, that a facility did 
not comply with the requirements of this subpart, he may take any

[[Page 841]]

action authorized by law to secure compliance, including but not limited 
to voluntary agreement or a request to the Attorney General to bring an 
action against the facility for specific performance.
    (2) If the Secretary finds, based on his investigation under 
paragraph (a) of this section, that a facility has limited the 
availability of its services in a manner proscribed by this subpart, he 
may, in addition to any other action that he is authorized to take in 
accordance with the Act, require the facility to establish an effective 
affirmative action plan that in his judgment is designed to insure that 
its services are made available in accordance with the requirements of 
this subpart.



Sec.  124.607  Agreements with State agencies.

    (a) Where the Secretary finds that it will promote the purposes of 
this subpart, and the State agency is able and willing to do so, he may 
enter into an agreement with the State agency for the State agency to 
assist him in administering this subpart in the State.
    (b) Under an agreement, the State agency will provide the Secretary 
with any assistance he requests in any one or more of the following 
areas, as set out in the agreement:
    (1) Investigation of complaints of noncompliance;
    (2) Monitoring the compliance of facilities with the requirements of 
this subpart;
    (3) Review of affirmative action plans submitted under Sec.  
124.606(b);
    (4) Review of reports submitted under Sec.  124.605;
    (5) Making initial decisions for the Secretary with respect to 
compliance, subject to appeal by any party to the Secretary or review by 
the Secretary on his own initiative; and
    (6) Application of any sanctions available to it under State law 
(such as license revocation or termination of State assistance) against 
facilities determined to be out of compliance with the requirements of 
this subpart.
    (c) A State agency may use funds received under section 1525 of the 
Act to pay for expenses incurred in the course of carrying out this 
agreement.
    (d) Nothing in this subpart precludes any State from taking any 
action authorized by State law regarding the provision of services by 
any facility in the State as long as the action taken does not prevent 
the Secretary from enforcing the requirements of this subpart.



Sec. Appendix to Subpart G of Part 124--Interim Procedures and Criteria 
for Review by Health Systems Agencies of Applications Under Section 1625 
                    of the Public Health Service Act

    In performing reviews under section 1513 (e) of the Public Health 
Service Act (42 U.S.C. 3001-2(c)) of applications for grants under 
section 1625 of the Act, health systems agencies shall use the 
procedures and criteria stated below. A health systems agency may not 
conduct such reviews until the procedures and criteria to be used in 
conducting the reviews have been adopted by the agency and published in 
newspapers of general circulation within the health service area or 
other public information channels.

                               procedures

    The procedures adopted and utilized by a health systems agency for 
conducting reviews of applications for grants under section 1625 of the 
Act shall include at least the following: 1. Except as provided below, 
notification of the beginning of a review within seven days of the 
receipt by the health systems agency of the application. Where the 
application was received by the health systems agency prior to 
publication of this subpart in the Federal Register, notification must 
be made within seven days of the date on which the health systems agency 
adopts its procedures and criteria. The notification shall include the 
proposed schedule for the review, the period within which a public 
hearing during the course of the review may be requested (which must be 
a reasonable period from the transmittal of the written notification 
required above), and the manner in which notification will be provided 
of the time and place of any hearings so requested. Written notification 
to members of the public may be provided through newspapers of general 
circulation in the area and public information channels. Notification to 
the applicant whose application is being reviewed and all other 
applicants for assistance under section 1625 of the Act providing health 
service in the health service area shall be by mail (which may be as 
part of a newsletter). The health systems agency must simultaneously 
notify the Federal funding agency of the beginning of the review.

[[Page 842]]

    2. Schedules for reviews which provide that such reviews shall not 
exceed 60 days from the date of notification made in accordance with 
paragraph 1 of this section to the date of the written findings made in 
accordance with paragraph 4 of this section. This does not preclude a 
health systems agency from conducting its review in less than 60 days.
    3. Provision for applicants to submit to the health systems agency 
(in such form and manner as the agency shall require) such information 
as the agency deems necessary in order to conduct its review.
    4. Written findings which state the basis for the approval or 
disapproval of the application by the health systems agency. Such 
findings shall be sent to the applicant, the State health planning and 
development agency (or agencies), and the Secretary, and shall be 
available to other upon request.
    5. Access by the general public to all such applications reviewed by 
the health systems agency and to all other written materials pertinent 
to the agency review.
    6. Public hearings in the course of agency review, if requested by 
one or more persons directly affected by the review. For purposes of 
this paragraph, a ``person directly affected by the review'' is as 
defined in 42 CFR 122.306 (a)(7).

                                criteria

    The specific criteria adopted and utilized by a health systems of 
this agency to conduct reviews of applications for grants under section 
1625 of the Act shall include at least the following:
    1. The relationship of the health services of the facility to the 
applicable health systems plan and annual implementation plan.
    2. The relationship of the health services of the facility to the 
long-range development plan (if any) of the applicant.
    3. The need that the population served or to be served by the 
facility has for the health services of such facility.
    4. The availability of alternative, less costly, or more effective 
methods of providing the health services which the facility provides.
    5. The relationship of the health services provided by the facility 
to the existing health care system of the area.
    6. The availability of resources (including health manpower, 
management personnel, and funds for capital and operating needs) for the 
provision of services by the facility and the availability of 
alternative uses of such resources for the provision of other health 
services.
    7. The special needs and circumstances of those entities which 
provide a substantial portion of their services or resources, or both, 
to individuals not residing in the health service area in which the 
entities are located or in adjacent health service areas. Such entities 
may include medical and other health professions schools, 
multidisciplinary clinics, and other speciality centers.
    8. The special needs and circumstances of health maintenance 
organizations for which assistance may be provided under title XIII.
    9. The costs and methods of the proposed construction or 
modernization, including the costs and methods of energy provision.
    10. The probable impact of the project reviewed on the applicant's 
costs of providing health services.



                    Subpart H_Recovery of Grant Funds

    Authority: Secs. 609 and 1622 of the Public Health Service Act as 
amended 98 Stat. 112 (42 U.S.C. 291i and 300s-1a).

    Source: 51 FR 7939, Mar. 7, 1986, unless otherwise noted.



Sec.  124.701  Applicability.

    The provisions of this subpart apply to facilities with respect to 
which grant funds were paid for construction or modernization--
    (a) Under title VI or XVI of the Public Health Service Act; or
    (b) Pursuant to the authority of the Secretary under any of the 
following statutes:
    (1) The Public Works Acceleration Act of 1962, Pub. L. 87-658 (42 
U.S.C. 2641 et seq.);
    (2) The District of Columbia Medical Facilities Construction Act of 
1968, 82 Stat. 631 (Pub. L. 90-457);
    (3) The Appalachian Regional Development Act of 1965, as amended (40 
U.S.C. App.).



Sec.  124.702  Definitions.

    As used in this subpart--
    Act means the Public Health Service Act.
    Department means the Department of Health and Human Services.
    Expected useful life means the period of time during which the 
structure may reasonably be expected to perform the function for which 
it was designed or intended.
    Facility means a facility with respect to which grant funds were 
paid under any of the authorizations listed in Sec.  124.701.
    Fiscal year means the facility's fiscal year.

[[Page 843]]

    Nonprofit, as applied to any facility, means a facility that is 
owned and operated by one or more nonprofit corporations or associations 
no part of the net earnings of which inures, or may lawfully inure, to 
the benefit of any private shareholder or individual.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    State agency means (1) in the case of a facility with respect to 
which a grant was made under title VI of the Public Health Service Act 
or any of the statutes listed in Sec.  124.701(b), the State agency 
designated pursuant to section 604 of the Public Health Service Act or 
its successor agency, and (2) in the case of a facility with respect to 
which a grant was made under title XVI of the Public Health Service Act, 
the State health planning and development agency designated pursuant to 
title XV of the Public Health Service Act.
    Then value means the value of the facility on the date the facility 
is sold, transferred or ceases to be used for a permissible use as 
described in Sec.  124.704.



Sec.  124.703  Federal right of recovery.

    (a) If any facility is at any time within 20 years after the 
completion of the grant-assisted construction or modernization sold or 
transferred to any entity which is either not qualified for a grant 
under the statute pursuant to which the grant was awarded or not 
approved as a transferee by the State agency, the United States shall be 
entitled to recover on the basis of joint and several liability from any 
transferor, transferee, or successive transferee of the facility an 
amount determined in accordance with this subpart.
    (b) If any facility at any time within 20 years after the completion 
of the grant-assisted construction or modernization ceases to be a 
public or other non-profit facility that would have been eligible for a 
grant under the statute pursuant to which the grant was awarded, the 
United States shall be entitled to recover from the owners of the 
facility an amount determined in accordance with this subpart.



Sec.  124.704  Notification of sale, transfer, or change of use.

    (a) The transferor of a facility that is sold or transferred as 
described in Sec.  124.703(a), or the owner of a facility which ceases 
to be a public or other nonprofit facility as described in Sec.  
124.703(b), shall provide the Secretary written notice of such sale, 
transfer, or other change not later than 10 days after the date on which 
the sale, transfer, or change occurs.
    (1) Transfer. For purposes of this subpart, a transfer occurs when a 
facility is conveyed to another entity through lease, merger, 
bankruptcy, foreclosure, or other arrangement.
    (2) Cease to be. For purposes of this subpart,
    (i) A facility ``ceases to be'' a facility for which a grant could 
have been made under the statute pursuant to which the grant was awarded 
when it is no longer operated as such a facility; and
    (ii) A facility ``ceases to be a public or nonprofit facility'' when 
an entity that is not a public or other non-profit corporation or 
association assumes management responsibilities with respect to the 
facility which, in the Secretary's judgment, are so pervasive as to 
constitute operation of the facility. The manager will not be deemed to 
be the operator of the facility if the management agreement contains 
both of the following provisions:

    The Board of Directors of the facility retains authority to 
terminate the agreement at any time upon reasonable notice to the 
contractor.
    No employee of the contractor may be a member of the facility's 
Board of Directors.


In the absence of either of these provisions the Secretary will consider 
the degree of control granted to the managing organization over patient 
admission, determination of what services will be provided, and charges 
for services provided in the facility.
    (b) Content of Notice. The notice required by paragraph (a) of this 
section shall be sent to the Secretary by certified mail, and shall 
contain or be accompanied by
    (1) The date of the sale, transfer, or other event that gives rise 
to the notice;

[[Page 844]]

    (2) Copies of any sales contracts, lease agreements, management 
contracts or other documents pertinent to the event giving rise to the 
notice;
    (3) Estimates of current assets, current liabilities, book value of 
equipment, the expected value of land on the new owner's books, and the 
remaining depreciation for all fixed assets involved in the transaction 
calculated on a straight line basis using commonly adopted expected 
useful lifetimes.
    (c) Failure to provide notice. Failure to provide the information 
required by paragraph (b) of this section, will be considered failure to 
provide the notice required by this section. In any case in which such 
information has not been provided, the Secretary will, promptly upon 
receiving an incomplete notice or otherwise discovering that a sale, 
transfer or other event giving rise to a recovery may have occurred, 
send a letter to the owner of the facility requesting the information 
needed to calculate a recovery amount.

(Approved by the Office of Management and Budget under control number 
0915-0099)



Sec.  124.705  Amount of recovery.

    (a) Except as provided in Sec.  124.706, the amount that the United 
States shall be entitled to recover under this subpart is that amount 
bearing the same ratio to the then value of so much of the facility as 
constituted an approved project (or projects) as the amount of Federal 
participation bore to the cost of the construction or modernization 
under such project (or projects).
    (b) The then value of the facility will be based on:
    (1) The transaction value in the case of an arms-length sale or 
transfer, or
    (2) A depreciated reproduction value in the absence of an arms-
length sale or transfer or if the buyer fails to provide, within 60 days 
after the date of the Secretary's letter described in Sec.  124.704(c), 
the information which, in the judgment of the Secretary, is necessary to 
establish, adjust, and apportion a transaction value. As used in this 
section, ``transaction value'' means in the case of a sale, the sale 
price, and in the case of a lease, the value of the lease plus the 
residual value of the facility at the termination of the lease (i.e., 
the reproduction value or, if appropriate, an alternative use value).
    (c) The transaction value will be adjusted to account for the 
purchase or lease of other assets and the assumption of liabilities 
associated with the transaction. To determine the amount of Federal 
recovery, the adjusted value will be apportioned to the grant-aided 
assets by the ration of the remaining useful lifetime values of those 
assets to the sum of the remaining useful lifetime values of all assets 
not previously accounted for in adjusting the transaction value.
    (d) A depreciated reproduction value will be established by 
calculating a reproduction value using construction cost indexes or 
current costs per square foot for construction, depending on which is 
more relevant to the type of construction associated with the grant. 
This reproduction value will then be adjusted by the ratio of the 
remaining useful life to the total useful life for the assets involved.
    (e) In calculating the recovery amount, the Secretary will include 
as Federal participation any grant assistance received by the facility 
under an authority listed in Sec.  124.701 and any assistance 
supplementary to that assistance received for the construction or 
modernization of the facility under the Public Works and Economic 
Development Act of 1965 (42 U.S.C. 3121, et seq.) or the Local Public 
Works Capital Development Act of 1976 (Pub. L. 94-369).



Sec.  124.706  Calculation of interest.

    (a) In addition to the amount of recovery calculated under Sec.  
124.705, the United States shall be entitled to recover interest on such 
amount in accordance with this section at the rate determined by the 
Secretary based on the average of the bond equivalent of the weekly 
ninety-day U.S. Treasury bill auction rate for the quarter previous to 
the quarter in which interest begins to accrue under this section.
    (1) Change of status before July 18, 1984. For facilities that were 
sold or transferred or which ceased to be public or other nonprofit 
facilities before July 18, 1984, interest will be charged beginning 
August 17, 1984, or 180 days after the date of such sale, transfer or 
other, whichever is later, and ending

[[Page 845]]

on the date the amount the United States is entitled to recover is 
collected.
    (2) Change of status after July 17, 1984. For facilities that are 
sold or transferred or which cease to be public or other nonprofit 
facilities after July 17, 1984, interest will be charged beginning 180 
days after receipt by the Department of the notice required under Sec.  
124.704; Provided, That if such notice is not provided as prescribed, 
interest will be charged beginning on the date of the sale, transfer, or 
change of use, and ending on the date the amount which the United States 
is entitled to recover is collected.
    (b) The Secretary may waive interest charges that result from delays 
caused solely by the Department.



Sec.  124.707  Waiver of recovery where facility is sold 
or transferred to a proprietary entity.

    (a) Conditions of the waiver. The Secretary may waive the recovery 
rights of the United States arising under Sec.  124.703(a) if the entity 
to which the facility was sold or transferred:
    (1) Has filed a written request for the waiver within the time 
limits prescribed by this section;
    (2) Has established an irrevocable trust in accordance with this 
section, in an amount equal to the greater of the amount that would 
otherwise have been recovered pursuant to Sec.  124.705 (including 
accrued interest as calculated under Sec.  124.706) or twice the cost of 
the remaining uncompensated services obligation of the facility as of 
the date of the change of status, that will be used by the entity only 
to provide services to those unable to pay in accordance with the 
requirements of subpart F of this part; and
    (3) Has agreed to comply with the community service regulations set 
out in subpart G of this part.
    (b) Procedures for obtaining waiver. (1) Within 30 days after the 
date of receipt of the information described in Sec.  124.704(b), the 
Secretary will send a letter to the new owner of the facility advising 
of the United States' right of recovery and the opportunity to obtain a 
waiver. For the purpose of advising the new owner of the amount to be 
placed in the irrevocable trust should the owner wish to obtain a 
waiver, the letter will also state the dollar amount of the remaining 
uncompensated care obligation and the amount that would be due under 
Sec.  124.705, computed as follows:
    (i) Computation of uncompensated care obligation. (A) For a facility 
which changes status before the date that subpart F of this part is 
effective for the facility, the remaining uncompensated services 
obligation is zero.
    (B) For a facility which changes status after the date that subpart 
F of this part is effective for the facility, the Secretary will 
multiply the annual compliance level, computed under the 10% method 
specified in 42 CFR 124.503(a)(1)(ii), for the fiscal year in which the 
change of status occurs times the number of years remaining in the 
facility's uncompensated services obligation. From this amount, the 
Secretary will subtract amounts of excess or add amounts of deficit for 
each fiscal year prior to the change of status for which the Secretary 
has previously conducted an audit of uncompensated services accounts. 
Excess and deficits will be adjusted by the percent change in the 
National Consumer Price Index for Medical Care between the year in which 
the excess or deficit occurred and the year in which the status change 
occurred. For each fiscal year prior to the change of status which the 
Secretary has not audited, the Secretary will add to the remaining 
obligation an amount equal to the annual compliance level in each such 
year adjusted by the percent change in the National Consumer Price Index 
for Medical Care between that year and the year of the status change. 
The amount computed as the total remaining obligation will then be 
multiplied by two. If the transferee chooses to accept the Secretary's 
calculation, no further assessments will be made of uncompensated care 
provided prior to the change of status date. If the transferee does not 
accept the calculation, the transferor or transferee may hire, and may 
charge against the irrevocable trust established under this section, an 
independent auditor to certify the compliance level and any excess or 
deficit for the period from May 18, 1979, up to and

[[Page 846]]

including the date of the change of status, using standard Departmental 
procedures supplemented with instructions provided by the Secretary, and 
submit the results in accordance with paragraph (b)(2)(ii) of this 
section. The audit may be conducted for any years not included in a 
previous site assessment conducted by the Department. If the Secretary 
agrees that a change is appropriate, the Secretary will use this 
information to adjust the calculation as set out in paragraph (b)(3) of 
this section. If the independent auditor certifies that qualified care 
was rendered either at the facility or at a replacement facility 
operated by the transferee between the date of the change of status and 
the date of establishment of the trust, and the Secretary agrees, the 
post transfer level of care shall not affect the calculation of the 
total remaining uncompensated care obligation to be doubled, but instead 
shall be recognized as a credit to be drawn from the trust as provided 
in paragraph (c)(1)(ii) of this section. In the case of a facility with 
respect to which a grant was made under title XVI of the Act, the 
remaining period of obligation will be the remainder of the expected 
useful life of the facility, as follows: 40 years for buildings, 30 
years for additions, 20 years for building renovations, 20 years for 
fixed equipment and 12 years for major movable equipment.
    (ii) Computation of recovery amount. The Secretary will determine 
the recovery amount as provided in Sec.  124.705.
    (2) Within 60 days following the date of the Secretary's letter 
provided pursuant to paragraph (b)(1) of this section, the owner of the 
facility shall notify the Secretary in writing that it either:
    (i) Accepts the trust fund amount for the waiver as offered by the 
Secretary;
    (ii) Provides a detailed statement of an alternative determination 
of the recovery amount or an independent audit of the remaining 
uncompensated services obligation as described in paragraph (b)(1)(i) of 
this section; or
    (iii) Does not seek a waiver under Sec.  124.707. Failure to provide 
a timely response to the Secretary under this subparagraph will be 
considered an election not to seek the waiver.
    (3) Within 30 days following the receipt of the owner's views 
concerning the calculation, and after considering those views, the 
Secretary will send a final letter providing the Secretary's 
determination of twice the remaining uncompensated care obligation and 
the recovery amount under Sec.  124.705. The amount to be placed in the 
irrevocable trust will be the higher of those two figures. (See 
paragraph (a)(2) of this section.)
    (4) Within 30 days of the date of the final letter, the owner of the 
facility shall notify the Secretary in writing whether or not it accepts 
the terms of the waiver. Failure to provide timely notice to the 
Secretary under this subparagraph will be considered an election not to 
accept the waiver.
    (c) Establishment of the trust. (1) Within 60 days of the date of 
its acceptance of a waiver under paragraph (b)(2) or (b)(4) of this 
section, the owner shall begin delivering services to those unable to 
pay in accordance with subpart F of this part under an irrevocable trust 
established in the amount calculated pursuant to paragraph (b) of this 
section. Provided, That
    (i) The owner shall provide a copy of the trust documents to the 
Secretary and no trust shall be considered established until the trust 
documents have been approved by the Secretary; and
    (ii) The owner may credit against the trust any uncompensated 
services provided in accordance with subpart F of this part between the 
date of the change of status of the facility and the establishment of 
the trust. For an owner to receive the credit before the establishment 
of the trust and deposit of funds therein, the auditor's report covering 
the post-transfer period shall be submitted with the notification of 
acceptance of the waiver, and in any event, not later than 30 days from 
the date of the Secretary's final letter described in paragraph (b)(3) 
of this section. Within 30 days following the receipt of the auditor's 
report, the Secretary will notify the owner of the allowable credit, if 
any. If the auditor's report is not timely submitted, the trust must be 
established and fully funded, in accordance with the time limits imposed 
by paragraph (c)(1) of

[[Page 847]]

this section, and the Secretary will notify the owner of the allowable 
credit, if any, within 30 days of the date of the establishment of the 
trust or within 30 days of the receipt of the report, whichever is 
later.
    (2) The trust shall be administered by a Trustee who is neither an 
employee of the transferee nor an employee of a subsidiary or of the 
parent institution of the transferee.
    (3) The trust shall provide that the trust corpus and income may be 
invested only in U.S. Government or U.S. Government insured securities.
    (d) Use of the trust. The corpus and income of the irrevocable trust 
shall be used to pay for the costs of uncompensated services, which may 
include reasonable costs of establishing and administering the trust and 
the cost of the independent audit described in paragraph (b)(1)(i) of 
this section, until the trust is exhausted.

(Approved by the Office of Management and Budget under control number 
0915-0099)



Sec.  124.708  Waiver of recovery--good cause for other use of facility.

    The Secretary may for good cause waive the recovery rights of the 
United States arising under Sec.  124.703(b). In determining whether 
there is good cause under this section for releasing the applicant or 
other owner of the facility from its obligation, the Secretary will take 
into consideration the extent to which:
    (a) The facility will be devoted by the applicant or other owner to 
use for another public or nonprofit purpose whch will promote the 
purpose of the Act;
    (b) There are reasonable assurances that for the remainder of the 
20-year period other public or nonprofit facilities not previously 
utilized for the purpose for which the facility was constructed will be 
so utilized and are substantially equivalent in nature and purpose.
    (c) The facility has been acquired from an agency of the United 
States (e.g., the Federal Housing Administration under its mortgage 
insurance commitment program) which has made a reasonable effort to 
dispose of it for operation as a public or nonprofit health care 
facility.

[51 FR 7939, Mar. 7, 1986, as amended at 57 FR 8272, Mar. 9, 1992]



Sec.  124.709  Withdrawal of waiver.

    (a) Any waiver granted under this subpart is conditioned upon the 
recipient of the waiver carrying out the obligations imposed by Sec.  
124.707 or Sec.  124.708 as applicable.
    (b) The Secretary will monitor compliance with the community service 
and uncompensated care obligations of any entity that receives a waiver.
    (c) Should a recipient of a waiver fail to comply with the 
applicable conditions, the Secretary will withdraw the waiver and seek 
recovery based on the value of the facility on the date the right of 
recovery first arose under Sec.  124.703.
    (d) No waiver will be withdrawn until the recipient has been 
notified in writing by the Secretary of the noncompliance and has failed 
to take corrective action within 90 days after the date of such notice.
    (e) Should the waiver be withdrawn, the amount of the Government's 
recovery will be the amount set out in the Secretary's determination 
letter as described in Sec.  124.707 (b)(1) or (b)(3) as applicable plus 
interest from the date of the notification sent in accordance with 
paragraph (d) of this section.

                        PARTS 125	129 [RESERVED]

[[Page 848]]



                   SUBCHAPTER L_COMPASSIONATE PAYMENTS



                        PARTS 131	135 [RESERVED]

[[Page 849]]



   SUBCHAPTER M_INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES





PART 136_INDIAN HEALTH--Table of Contents



                    Subpart A_Purpose and Definitions

Sec.
136.1 Definitions.
136.2 Purpose of the regulations.
136.3 Administrative instructions.

  Subpart B_What Services Are Available and Who Is Eligible To Receive 
                                  Care

136.11 Services available.
136.12 Persons to whom services will be provided.
136.13 [Reserved]
136.14 Care and treatment of ineligible individuals.

                   Subpart C_Contract Health Services

136.21 Definitions.
136.22 Establishment of contract health service delivery areas.
136.23 Persons to whom contract health services will be provided.
136.24 Authorization for contract health services.
136.25 Reconsideration and appeals.

   Subpart D_Limitation on Charges for Services Furnished by Medicare-
                   Participating Hospitals to Indians

136.30 Payment to Medicare-participating hospitals for authorized 
          Contract Health Services.
136.31 Authorization by urban Indian organization.
136.32 Disallowance.

                   Subpart E_Preference in Employment

136.41 Definitions.
136.42 Appointment actions.
136.43 Application procedure for preference eligibility.

   Subpart F_Abortions and Related Medical Services in Indian Health 
          Service Facilities and Indian Health Service Programs

136.51 Applicability.
136.52 Definitions.
136.53 General rule.
136.54 Life of the mother would be endangered.
136.55 Drugs and devices and termination of ectopic pregnancies.
136.56 Recordkeeping requirements.
136.57 Confidentiality.

                        Subpart G_Residual Status

136.61 Payor of last resort.

    Subpart H_Grants for Development, Construction, and Operation of 
                         Facilities and Services

136.101 Applicability.
136.102 Definitions.
136.103 Eligibility.
136.104 Application.
136.105 Project elements.
136.106 Grant award and evaluation.
136.107 Use of project funds.
136.108 [Reserved]
136.109 Availability of appropriations.
136.110 Facilities construction.
136.111 Interest.
136.112 Additional conditions.
136.113 Fair and uniform provision of services.
136.114 Applicability of other Department regulations.
136.115 Rescission of grants.
136.116 Reports.
136.117 Amendment of regulations.
136.118 Effect on existing rights.
136.119 Penalties.
136.120 Use of Indian business concerns.
136.121 Indian preference in training and employment.

 Subpart I_Limitation on Charges for Health Care Professional Services 
                       and Non-Hospital-Based Care

136.201 Applicability.
136.202 Definitions.
136.203 Payment for provider and supplier services purchased by Indian 
          health programs.
136.204 Authorization by urban Indian organizations.

          Subpart J_Indian Health Care Improvement Act Programs

    Subdivision J-1--Provisions of General and Special Applicability

136.301 Policy and applicability.
136.302 Definitions.
136.303 Indians applying for scholarships.
136.304 Publication of a list of allied health professions.
136.305 Additional conditions.

   Subdivision J-2--Health Professions Recruitment Program for Indians

136.310 Health professions recruitment grants.

[[Page 850]]

136.311 Eligibility.
136.312 Application.
136.313 Evaluation and grant awards.
136.314 Use of funds.
136.315 Publication of list of grantees and projects.
136.316 Other HHS regulations that apply.

Subdivision J-3--Health Professions Preparatory Scholarship Program for 
                                 Indians

136.320 Preparatory scholarship grants.
136.321 Eligibility.
136.322 Application and selection.
136.323 Scholarship and tuition.
136.324 Availability of list of recipients.

           Subdivision J-4--Indian Health Scholarship Program

136.330 Indian health scholarships.
136.331 Selection.
136.332 Service obligation.
136.333 Distribution of scholarships.
136.334 Publication of a list of recipients.

            Subdivision J-5--Continuing Education Allowances

136.340 Provision of continuing education allowances.

       Subdivision J-6--Contracts With Urban Indian Organizations

136.350 Contracts with Urban Indian organizations.
136.351 Application and selection.
136.352 Fair and uniform provision of services.
136.353 Reports and records.

               Subdivision J-7--Leases With Indian Tribes

136.360 Leases with Indian tribes.

Subdivision J-8--Health Professions Pregraduate Scholarship Program for 
                                 Indians

136.370 Pregraduate scholarship grants.
136.371 Eligibility.
136.372 Application and selection.
136.373 Scholarship and tuition.
136.374 Availability of list of recipients.

    Subpart K_Indian Child Protection and Family Violence Prevention

136.401 Purpose.
136.402 Policy.
136.403 Definitions.
136.404 What does the Indian Child Protection and Family Violence 
          Prevention Act require of the Indian Health Service and Indian 
          Tribes or Tribal organizations receiving funds under the 
          ISDEA?
136.405 What are the minimum standards of character for individuals 
          placed in, or applying for, a position that involves regular 
          contact with or control over Indian children?
136.406 Under what circumstances will the minimum standards of character 
          be considered to be met?
136.407 Under what circumstances should a conviction, or plea of nolo 
          contendere or guilty to, be considered if there has been a 
          pardon, expungement, set aside, or other court order of the 
          conviction or plea?
136.408 What are other factors, in addition to the minimum standards of 
          character, that may be considered in determining placement of 
          an individual in a position that involves regular contact with 
          or control over Indian children?
136.409 What positions require a background investigation and 
          determination of eligibility for employment or retention?
136.410 Who conducts the background investigation and prepares 
          determinations of eligibility for employment?
136.411 Are the requirements for Indian Health Service adjudication 
          different from the requirements for Indian Tribes and Tribal 
          organizations?
136.412 What questions must the IHS ask as part of the background 
          investigation?
136.413 What protections must the IHS and Tribes or Tribal organizations 
          provide to individuals undergoing a background investigation?
136.414 How does the IHS determine eligibility for placement or 
          retention of individuals in positions involving regular 
          contact with Indian children?
136.415 What rights does an individual have during this process?
136.416 When should the IHS deny employment or dismiss an employee?
136.417 May the IHS hire individuals pending completion of a background 
          investigation?
136.418 What should the IHS do if an individual has been charged with an 
          offense but the charge is pending or no disposition has been 
          made by a court?

    Authority: 25 U.S.C. 13; sec. 3, 68 Stat. 674 (42 U.S.C., 2001, 
2003); Sec. 1, 42 Stat. 208 (25 U.S.C. 13); 42 U.S.C. 2001, unless 
otherwise noted.



                    Subpart A_Purpose and Definitions

    Source: 64 FR 58319, Oct. 28, 1999, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002



Sec.  136.1  Definitions.

    When used in this part:

[[Page 851]]

    Bureau of Indian Affairs (BIA) means the Bureau of Indian Affairs, 
Department of the Interior.
    Indian includes Indians in the Continental United States, and 
Indians, Aleuts and Eskimos in Alaska.
    Indian health program means the health services program for Indians 
administered by the Indian Health Service within the Department of 
Health and Human Services.
    Jurisdiction has the same geographical meaning as in Bureau of 
Indian Affairs usage.
    Service means the Indian Health Service.



Sec.  136.2  Purpose of the regulations.

    The regulations in this part establish general principles and 
program requirements for carrying out the Indian health programs.



Sec.  136.3  Administrative instructions.

    The service periodically issues administrative instructions to its 
officers and employees, which are primarily found in the Indian Health 
Service Manual and the Area Office and program office supplements. These 
instructions are operating procedures to assist officers and employees 
in carrying out their responsibilities, and are not regulations 
establishing program requirements which are binding upon members of the 
general public.



  Subpart B_What Services Are Available and Who Is Eligible To Receive 
                                  Care?

    Source: 64 FR 58319, Oct. 28, 1999, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



Sec.  136.11  Services available.

    (a) Type of services that may be available. Services for the Indian 
community served by the local facilities and program may include 
hospital and medical care, dental care, public health nursing and 
preventive care (including immunizations), and health examination of 
special groups such as school children.
    (b) Where services are available. Available services will be 
provided at hospitals and clinics of the Service, and at contract 
facilities (including tribal facilities under contract with the 
Service).
    (c) Determination of what services are available. The Service does 
not provide the same health services in each area served. The services 
provided to any particular Indian community will depend upon the 
facilities and services available from sources other than the Service 
and the financial and personnel resources made available to the Service.



Sec.  136.12  Persons to whom services will be provided.

    (a) In general. Services will be made available, as medically 
indicated, to persons of Indian descent belonging to the Indian 
community served by the local facilities and program. Services will also 
be made available, as medically indicated, to a non-Indian woman 
pregnant with an eligible Indian's child but only during the period of 
her pregnancy through postpartum (generally about 6 weeks after 
delivery). In cases where the woman is not married to the eligible 
Indian under applicable state or tribal law, paternity must be 
acknowledged in writing by the Indian or determined by order of a court 
of competent jurisdiction. The Service will also provide medically 
indicated services to non-Indian members of an eligible Indian's 
household if the medical officer in charge determines that this is 
necessary to control acute infectious disease or a public health hazard.
    (2) Generally, an individual may be regarded as within the scope of 
the Indian health and medical service program if he/she is regarded as 
an Indian by the community in which he/she lives as evidenced by such 
factors as tribal membership, enrollment, residence on tax-exempt land, 
ownership of restricted property, active participation in tribal 
affairs, or other relevant factors in keeping with general Bureau of 
Indian Affairs practices in the jurisdiction.
    (b) Doubtful cases. (1) In case of doubt as to whether an individual 
applying for care is within the scope of the program, the medical 
officer in charge shall obtain from the appropriate BIA officials in the 
jurisdiction information

[[Page 852]]

that is pertinent to his/her determination of the individual's 
continuing relationship to the Indian population group served by the 
local program.
    (2) If the applicant's condition is such that immediate care and 
treatment are necessary, services shall be provided pending 
identification as an Indian beneficiary.
    (c) Priorities when funds, facilities, or personnel are insufficient 
to provide the indicated volume of services. Priorities for care and 
treatment, as among individuals who are within the scope of the program, 
will be determined on the basis of relative medical need and access to 
other arrangements for obtaining the necessary care.



Sec.  136.13  [Reserved]



Sec.  136.14  Care and treatment of ineligible individuals.

    (a) In case of an emergency, as an act of humanity, individuals not 
eligible under Sec.  136.12 may be provided temporary care and treatment 
in Service facilities.
    (b) Charging ineligible individuals. Where the Service Unit Director 
determines that an ineligible individual is able to defray the cost of 
care and treatment, the individual shall be charged at rates approved by 
the Assistant Secretary for Health and Surgeon General published in the 
Federal Register. Reimbursement from third-party payors may be arranged 
by the patient or by the Service on behalf of the patient.

[64 FR 58319, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



                   Subpart C_Contract Health Services

    Source: 64 FR 58320, Oct. 28, 1999, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



Sec.  136.21  Definitions.

    (a) Alternate resources is defined in Sec.  136.61 of subpart G of 
this part.
    (b) Appropriate ordering official means, unless otherwise specified 
by contract with the health care facility or provider, the ordering 
official for the contract health service delivery area in which the 
individual requesting contract health services or on whose behalf the 
services are requested, resides.
    (c) Area Director means the Director of an Indian Health Service 
Area designated for purposes of administration of Indian Health Service 
programs.
    (d) Contract health service delivery area means the geographic area 
within which contract health services will be made available by the IHS 
to members of an identified Indian community who reside in the area, 
subject to the provisions of this subpart.
    (e) Contract health services means health services provided at the 
expense of the Indian Health Service from public or private medical or 
hospital facilities other than those of the Service.
    (f) Emergency means any medical condition for which immediate 
medical attention is necessary to prevent the death or serious 
impairment of the health of an individual.
    (g) Indian tribe means any Indian tribe, band, nation, group, 
Pueblo, or community, including any Alaska Native village or Native 
group, which is federally recognized as eligible for the special 
programs and services provided by the United States to Indians because 
of their status as Indians.
    (h) Program Director means the Director of an Indian Health Service 
``program area'' designated for the purposes of administration of Indian 
Health Service programs.
    (i) Reservation means any federally recognized Indian tribe's 
reservation. Pueblo, or colony, including former reservations in 
Oklahoma, Alaska Native regions established pursuant to the Alaska 
Native Claims Settlement Act (43 U.S.C. 1601 et seq.), and Indian 
allotments.
    (j) Secretary means the Secretary of Health and Human Services to 
whom the authority involved has been delegated.
    (k) Service means the Indian Health Service.
    (l) Service Unit Director means the Director of an Indian Health 
Service ``Service unit area'' designated for purposes of administration 
of Indian Health Service programs.

[64 FR 58320, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002]

[[Page 853]]



Sec.  136.22  Establishment of contract health service delivery areas.

    (a) In accordance with the congressional intention that funds 
appropriated for the general support of the health program of the Indian 
Health Service be used to provide health services for Indians who live 
on or near Indian reservations, contract health service delivery areas 
are established as follows:
    (1) The State of Alaska;
    (2) The State of Nevada;
    (3) the State of Oklahoma;
    (4) Chippewa, Mackinac, Luce, Alger, Schoolcraft, Delta, and 
Marquette Counties in the State of Michigan;
    (5) Clark, Eau Claire, Jackson, La Crosse, Monroe, Vernon, Crawford, 
Shawano, Marathon, Wood, Juneau, Adams, Columbia, and Sauk Counties in 
the State of Wisconsin and Houston County in the State of Minnesota;
    (6) With respect to all other reservations within the funded scope 
of the Indian health program, the contract health services delivery area 
shall consist of a county which includes all or part of a reservation, 
and any county or counties which have a common boundary with the 
reservation.
    (b) The Secretary may from time to time, redesignate areas or 
communities within the United States as appropriate for inclusion or 
exclusion from a contract health service delivery area after 
consultation with the tribal governing body or bodies on those 
reservations included within the contract health service delivery area. 
The Secretary will take the following criteria into consideration:
    (1) The number of Indians residing in the area proposed to be so 
included or excluded;
    (2) Whether the tribal governing body has determined that Indians 
residing in the area near the reservation are socially and economically 
affiliated with the tribe;
    (3) The geographic proximity to the reservation of the area whose 
inclusion or exclusion is being considered; and
    (4) The level of funding which would be available for the provision 
of contract health services.
    (c) Any redesignation under paragraph (b) of this section shall be 
made in accordance with the procedures of the Administrative Procedure 
Act (5 U.S.C. 553).



Sec.  136.23  Persons to whom contract health services will be provided.

    (a) In general. To the extent that resources permit, and subject to 
the provisions of this subpart, contract health services will be made 
available as medically indicated, when necessary health services by an 
Indian Health Service facility are not reasonably accessible or 
available, to persons described in and in accordance with Sec.  136.12 
of this part if those persons:
    (1) Reside within the United States and on a reservation located 
within a contract health service delivery area; or
    (2) Do not reside on a reservation but reside within a contract 
health service delivery area and:
    (i) Are members of the tribe or tribes located on that reservation 
or of the tribe or tribes for which the reservation was established; or
    (ii) Maintain close economic and social ties with that tribe or 
tribes.
    (b) Students and transients. Subject to the provisions of this 
subpart, contract health services will be made available to students and 
transients who would be eligible for contract health services at the 
place of their permanent residence within a contract health service 
delivery area, but are temporarily absent from their residence as 
follows:
    (1) Student--during their full-time attendance at programs of 
vocational, technical, or academic education, including normal school 
breaks (such as vacations, semester or other scheduled breaks occurring 
during their attendance) and for a period not to exceed 180 days after 
the completion of the course of study.
    (2) Transients (persons who are in travel or are temporarily 
employed, such as seasonal or migratory workers) during their absence.
    (c) Other persons outside the contract health service delivery area. 
Persons who leave the contract health service delivery area in which 
they are eligible for contract health service and are neither students 
nor transients will be eligible for contract health service for a period 
not to exceed 180 days from such departure.

[[Page 854]]

    (d) Foster children. Indian children who are placed in foster care 
outside a contract health service delivery area by order of a court of 
competent jurisdiction and who were eligible for contract health 
services at the time of the court order shall continue to be eligible 
for contract health services while in foster care.
    (e) Priorities for contract health services. When funds are 
insufficient to provide the volume of contract health services indicated 
as needed by the population residing in a contract health service 
delivery area, priorities for service shall be determined on the basis 
of relative medical need.
    (f) Alternate resources. The term ``alternate resources'' is defined 
in Sec.  136.61(c) of subpart G of this part.

[64 FR 58319, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



Sec.  136.24  Authorization for contract health services.

    (a) No payment will be made for medical care and services obtained 
from non-Service providers or in non-Service facilities unless the 
applicable requirements of paragraphs (b) and (c) of this section have 
been met and a purchase order for the care and services has been issued 
by the appropriate ordering official to the medical care provider.
    (b) In nonemergency cases, a sick or disabled Indian, an individual 
or agency acting on behalf of the Indian, or the medical care provider 
shall, prior to the provision of medical care and services notify the 
appropriate ordering official of the need for services and supply 
information that the ordering official deems necessary to determine the 
relative medical need for the services and the individual's eligibility. 
The requirement for notice prior to providing medical care and services 
under this paragraph may be waived by the ordering official if:
    (1) Such notice and information are provided within 72 hours after 
the beginning of treatment or admission to a health care facility; and
    (2) The ordering official determines that giving of notice prior to 
obtaining the medical care and services was impracticable or that other 
good cause exists for the failure to provide prior notice.
    (c) In emergency cases, a sick or disabled Indian, or an individual 
or agency acting on behalf of the Indian, or the medical care provider 
shall within 72 hours after the beginning of treatment for the condition 
or after admission to a health care facility notify the appropriate 
ordering official of the fact of the admission or treatment, together 
with information necessary to determine the relative medical need for 
the services and the eligibility of the Indian for the services. The 72-
hour period may be extended if the ordering official determines that 
notification within the prescribed period was impracticable or that 
other good cause exists for the failure to comply.



Sec.  136.25  Reconsideration and appeals.

    (a) Any person to whom contract health services are denied shall be 
notified of the denial in writing together with a statement of the 
reason for the denial. The notice shall advise the applicant for 
contract health services that within 30 days from the receipt of the 
notice the applicant:
    (1) May obtain a reconsideration by the appropriate Service Unit 
Director of the original denial if the applicant submits additional 
supporting information not previously submitted; or
    (2) If no additional information is submitted, may appeal the 
original denial by the Service Unit Director to the appropriate Area or 
program director. A request for reconsideration or appeal shall be in 
writing and shall set forth the grounds supporting the request or 
appeal.
    (b) If the original decision is affirmed on reconsideration, the 
applicant shall be so notified in writing and advised that an appeal may 
be taken to the Area or program director within 30 days of receipt of 
the notice of the reconsidered decision. The appeal shall be in writing 
and shall set forth the grounds supporting the appeal.
    (c) If the original or reconsidered decision is affirmed on appeal 
by the Area or program director, the applicant shall be so notified in 
writing and advised that a further appeal may be taken to the Director, 
Indian Health Service, within 30 days of receipt of the notice. The 
appeal shall be in writing and shall set the grounds supporting

[[Page 855]]

the appeal. The decision of the Director, Indian Health Service, shall 
constitute final administrative action.



   Subpart D_Limitation on Charges for Services Furnished by Medicare-
                   Participating Hospitals to Indians

    Source: 72 FR 30710, June 4, 2007, unless otherwise noted.



Sec.  136.30  Payment to Medicare-participating hospitals 
for authorized Contract Health Services.

    (a) Scope. All Medicare-participating hospitals, which are defined 
for purposes of this subpart to include all departments and provider-
based facilities of hospitals (as defined in sections 1861(e) and (f) of 
the Social Security Act) and critical access hospitals (as defined in 
section 1861(mm)(1) of the Social Security Act), that furnish inpatient 
services must accept no more than the rates of payment under the 
methodology described in this section as payment in full for all items 
and services authorized by IHS, Tribal, and urban Indian organization 
entities, as described in paragraph (b) of this section.
    (b) Applicability. The payment methodology under this section 
applies to all levels of care furnished by a Medicare-participating 
hospital, whether provided as inpatient, outpatient, skilled nursing 
facility care, as other services of a department, subunit, distinct 
part, or other component of a hospital (including services furnished 
directly by the hospital or under arrangements) that is authorized under 
part 136, subpart C by a contract health service (CHS) program of the 
Indian Health Service (IHS); or authorized by a Tribe or Tribal 
organization carrying out a CHS program of the IHS under the Indian 
Self-Determination and Education Assistance Act, as amended, Pub. L. 93-
638, 25 U.S.C. 450 et seq.; or authorized for purchase under Sec.  
136.31 by an urban Indian organization (as that term is defined in 25 
U.S.C. 1603(h)) (hereafter ``I/T/U'').
    (c) Basic determination. (1) Payment for hospital services that the 
Medicare program would pay under a prospective payment system (PPS) will 
be based on that PPS. For example, payment for inpatient hospital 
services shall be made per discharge based on the applicable PPS used by 
the Medicare program to pay for similar hospital services under 42 CFR 
part 412. Payment for outpatient hospital services shall be made based 
on a PPS used in the Medicare program to pay for similar hospital 
services under 42 CFR part 419. Payment for skilled nursing facility 
(SNF) services shall be based on a PPS used in the Medicare program to 
pay for similar SNF services under 42 CFR part 413.
    (2) For Medicare participating hospitals that furnish inpatient 
services but are exempt from PPS and receive reimbursement based on 
reasonable costs (for example, critical access hospitals (CAHs), 
children's hospitals, cancer hospitals, and certain other hospitals 
reimbursed by Medicare under special arrangements), including provider 
subunits exempt from PPS, payment shall be made per discharge based on 
the reasonable cost methods established under 42 CFR part 413, except 
that the interim payment rate under 42 CFR part 413, subpart E shall 
constitute payment in full for authorized charges.
    (d) Other payments. In addition to the amount payable under 
paragraph (c)(1) of this section for authorized inpatient services, 
payments shall include an amount to cover: The organ acquisition costs 
incurred by hospitals with approved transplantation centers; direct 
medical education costs; units of blood clotting factor furnished to an 
eligible patient who is a hemophiliac; and the costs of qualified non-
physician anesthetists, to the extent such costs would be payable if the 
services had been covered by Medicare. Payment under this subsection 
shall be made on a per discharge basis and will be based on standard 
payments established by the Centers for Medicare & Medicaid Services 
(CMS) or its fiscal intermediaries.
    (e) Basic payment calculation. The calculation of the payment by I/
T/Us will be based on determinations made under paragraphs (c) and (d) 
of this section consistent with CMS instructions to its fiscal 
intermediaries at the time the claim is processed. Adjustments will be

[[Page 856]]

made to correct billing or claims processing errors, including when 
fraud is detected. I/T/Us shall pay the providing hospital the full PPS 
based rate, or the interim reasonable cost rate, without reduction for 
any co-payments, coinsurance, and deductibles required by the Medicare 
program from the patient.
    (f) Exceptions to payment calculation. Notwithstanding paragraph (e) 
of this section, if an amount has been negotiated with the hospital or 
its agent by the I/T/U, the I/T/U will pay the lesser of: The amount 
determined under paragraph (e) of this section or the amount negotiated 
with the hospital or its agent, including but not limited to capitated 
contracts or contracts per Federal law requirements;
    (g) Coordination of benefits and limitation on recovery. If an I/T/U 
has authorized payment for items and services provided to an individual 
who is eligible for benefits under Medicare, Medicaid, or another third 
party payor--
    (1) The I/T/U shall be the payor of last resort under Sec.  136.61;
    (2) If there are any third party payers, the I/T/U will pay the 
amount for which the patient is being held responsible after the 
provider of services has coordinated benefits and all other alternative 
resources have been considered and paid, including applicable co-
payments, deductibles, and coinsurance that are owed by the patient; and
    (3) The maximum payment by the I/T/U will be only that portion of 
the payment amount determined under this section not covered by any 
other payor; and
    (4) The I/T/U payment will not exceed the rate calculated in 
accordance with paragraph (e) of this section or the contracted amount 
(plus applicable cost sharing), whichever is less; and
    (5) When payment is made by Medicaid it is considered payment in 
full and there will be no additional payment made by the I/T/U to the 
amount paid by Medicaid (except for applicable cost sharing).
    (h) Claims processing. For a hospital to be eligible for payment 
under this section, the hospital or its agent must submit the claim for 
authorized services--
    (1) On a UB92 paper claim form (until abolished, or on an officially 
adopted successor form) or the HIPAA 837 electronic claims format ANSI 
X12N, version 4010A1 (until abolished, or on an officially adopted 
successor form) and include the hospital's Medicare provider number/
National Provider Identifier; and
    (2) To the I/T/U, agent, or fiscal intermediary identified by the I/
T/U in the agreement between the I/T/U and the hospital or in the 
authorization for services provided by the I/T/U; and
    (3) Within a time period equivalent to the timely filing period for 
Medicare claims under 42 CFR 424.44 and provisions of the Medicare 
Claims Processing Manual applicable to the type of item or service 
provided.
    (i) Authorized services. Payment shall be made only for those items 
and services authorized by an I/T/U consistent with part 136 of this 
title or section 503(a) of the Indian Health Care Improvement Act 
(IHCIA), Public Law 94-437, as amended, 25 U.S.C. 1653(a).
    (j) No additional charges. A payment made in accordance with this 
section shall constitute payment in full and the hospital or its agent 
may not impose any additional charge--
    (1) On the individual for I/T/U authorized items and services; or
    (2) For information requested by the I/T/U or its agent or fiscal 
intermediary for the purposes of payment determinations or quality 
assurance.



Sec.  136.31  Authorization by urban Indian organization.

    An urban Indian organization may authorize for purchase items and 
services for an eligible urban Indian (as those terms are defined in 25 
U.S.C. 1603(f) and (h)) according to section 503 of the IHCIA and 
applicable regulations. Services and items furnished by Medicare-
participating inpatient hospitals shall be subject to the payment 
methodology set forth in Sec.  136.30.



Sec.  136.32  Disallowance.

    (a) If it is determined that a hospital has submitted inaccurate 
information for payment, such as admission, discharge or billing data, 
an I/T/U may as appropriate--

[[Page 857]]

    (1) Deny payment (in whole or in part) with respect to any such 
services, and;
    (2) Disallow costs previously paid, including any payments made 
under any methodology authorized under this subpart. The recovery of 
payments made in error may be taken by any method authorized by law.
    (b) For cost based payments previously issued under this subpart, if 
it is determined that actual costs fall significantly below the computed 
rate actually paid, the computed rate may be retrospectively adjusted. 
The recovery of overpayments made as a result of the adjusted rate may 
be taken by any method authorized by law.



                   Subpart E_Preference in Employment

    Authority: 25 U.S.C. 44, 45, 46 and 472; Pub. L. 83-568, 68 Stat 
674, 42 U.S.C. 2003.

    Source: 64 FR 58321, Oct. 28, 1999, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



Sec.  136.41  Definitions.

    For purposes of making appointments to vacancies in all positions in 
the Indian Health Service, a preference will be extended to persons of 
Indian descent who are:
    (a) Members of any recognized Indian tribe now under Federal 
jurisdiction;
    (b) Descendants of such members who were, on June 1, 1934, residing 
within the present boundaries of any Indian reservation;
    (c) All others of one-half or more Indian blood of tribes indigenous 
to the United States;
    (d) Eskimos and other aboriginal people of Alaska; or
    (e) Until January 4, 1990, or until the Osage Tribe has formally 
organized, whichever comes first, a person of at least one-quarter 
degree Indian ancestry of the Osage Tribe of Indians, whose rolls were 
closed by an act of Congress.



Sec.  136.42  Appointment actions.

    (a) Preference will be afforded a person meeting any one of the 
definitions of Sec.  136.41 whether the placement in the position 
involves initial appointment, reappointment, reinstatement, transfer, 
reassignment, promotion, or any other personnel action intended to fill 
a vacancy.
    (b) Preference eligibles may be given a schedule A excepted 
appointment under 5 CFR 213.3116(b)(8). If the individuals are within 
reach on a Civil Service Register, they may be given a competitive 
appointment.

[64 FR 58321, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



Sec.  136.43  Application procedure for preference eligibility.

    To be considered a preference eligible, the person must submit with 
the employment application a Bureau of Indian Affairs certification that 
the person is an Indian as defined by Sec.  136.41 except that an 
employee of the Indian Health Service who has a certificate of 
preference eligibility on file in the Official Personnel Folder is not 
required to resubmit such proof but may instead include a statement on 
the application that proof of eligibility is on file in the Official 
Personnel Folder.

[64 FR 58319, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



   Subpart F_Abortions and Related Medical Services in Indian Health 
          Service Facilities and Indian Health Service Programs

    Authority: Sec. 1, 42 Stat. 208, (25 U.S.C. 13); sec. 1, Stat. 674, 
(42 U.S.C. 2001); sec. 3, 68 Stat. 674, (42 U.S.C. 2003).

    Source: 64 FR 58322, Oct. 28, 1999, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



Sec.  136.51  Applicability.

    This subpart is applicable to the use of Federal funds in providing 
health services to Indians in accordance with the provisions of subparts 
A, B, and C of this part.



Sec.  136.52  Definitions.

    As used in this subpart:
    Physician means a doctor of medicine or osteopathy legally 
authorized to

[[Page 858]]

practice medicine and surgery at an Indian Health Service or tribally 
run facility, or by the state in which he or she practices.



Sec.  136.53  General rule.

    Federal funds may not be used to pay for or otherwise provide for 
abortions in the programs described in Sec.  136.51, except under the 
circumstances described in Sec.  136.54.

[64 FR 58322, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



Sec.  136.54  Life of the mother would be endangered.

    Federal funds are available for an abortion when a physician has 
found and so certified in writing to the appropriate tribal or other 
contracting organization, or Service Unit or Area Director, that ``on 
the basis of my professional judgment the life of the mother would be 
endangered if the fetus were carried to term.'' The certification must 
contain the name and address of the patient.



Sec.  136.55  Drugs and devices and termination of ectopic pregnancies.

    Federal funds are available for drugs or devices to prevent 
implantation of the fertilized ovum, and for medical procedures 
necessary for the termination of an ectopic pregnancy.



Sec.  136.56  Recordkeeping requirements.

    Documents required by Sec.  136.54 must be maintained for three 
years pursuant to the retention and custodial requirements for records 
at 45 CFR part 75.361.

[64 FR 58322, Oct. 28, 1999. Redesignated and amended at 67 FR 35342, 
May 17, 2002; 81 FR 3010, Jan. 20, 2016]



Sec.  136.57  Confidentiality.

    Information which is acquired in connection with the requirements of 
this subpart may not be disclosed in a form which permits the 
identification of an individual without the individual's consent, except 
as may be necessary for the health of the individual or as may be 
necessary for the Secretary to monitor Indian Health Service program 
activities. In any event, any disclosure shall be subject to appropriate 
safeguards which will minimize the likelihood of disclosures of personal 
information in identifiable form.



                        Subpart G_Residual Status



Sec.  136.61  Payor of last resort.

    (a) The Indian Health Service is the payor of last resort for 
persons defined as eligible for contract health services under the 
regulations in this part, notwithstanding any State or local law or 
regulation to the contrary.
    (b) Accordingly, the Indian Health Service will not be responsible 
for or authorize payment for contract health services to the extent 
that:
    (1) The Indian is eligible for alternate resources, as defined in 
paragraph (c) of this section, or
    (2) The Indian would be eligible for alternate resources if he or 
she were to apply for them, or
    (3) The Indian would be eligible for alternate resources under State 
or local law or regulation but for the Indian's eligibility for contract 
health services, or other health services, from the Indian Health 
Service or Indian Health Service funded programs.
    (c) Alternate resources means health care resources other than those 
of the Indian Health Service. Such resources include health care 
providers and institutions, and health care programs for the payment of 
health services including but not limited to programs under titles XVIII 
or XIX of the Social Security Act (i.e., Medicare, Medicaid), State or 
local health care programs, and private insurance.

[64 FR 58322, Oct. 28, 1999]



    Subpart H_Grants for Development, Construction, and Operation of 
                         Facilities and Services

    Authority: Secs. 104, 107, 25 U.S.C. 450h(b), 450k; Sec. 3, Pub. L. 
83-568, 42 U.S.C. 2003.

    Source: 40 FR 53143, Nov. 14, 1975, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



Sec.  136.101  Applicability.

    The regulations of this subpart are applicable to grants awarded 
pursuant to section 104(b) of Pub. L. 93-638, 25

[[Page 859]]

U.S.C. 450h(b) for (a) projects for development including feasibility 
studies, construction, operation, provision, or maintenance of services 
and facilities provided to Indians and, (b) for projects for planning, 
training, evaluation or other activities designed to improve the 
capacity of a tribal organization to enter into a contract or contracts 
pursuant to section 103 of the Act. Such grants may include the cost of 
training personnel to perform grant related activities.



Sec.  136.102  Definitions.

    As used in this subpart:
    (a) Act means Title I of the Indian Self-Determination and Education 
Assistance Act, Pub. L. 93-638 (88 Stat. 2203).
    (b) Indian means a person who is a member of an Indian tribe.
    (c) Indian tribe means any Indian tribe, band, nation, rancheria, 
Pueblo, colony or community, including any Alaska Native Village or 
regional or village corporation as defined in or established pursuant to 
the Alaska Native Claims Settlement Act, Pub. L. 92-203 (85 Stat. 688 
which is recognized as eligible by the United States Government for the 
special programs and services provided by the United States to Indians 
because of their status as Indians.
    (d) Tribal organization means:
    (1) The recognized governing body of any Indian tribe; or
    (2) Any legally established organization of Indians which is:
    (i) Controlled, sanctioned or chartered by such governing body or 
bodies; or
    (ii) Democratically elected by the adult members of the Indian 
community to be served by such organization and which includes the 
maximum participation of Indians in all phases of its activities.
    (e) Secretary means the Secretary of the Department of Health and 
Human Services and any other officer or employee of the Department of 
Health and Human Services to whom the authority involved has been 
delegated.
    (f) Grantee means the tribe or tribal organization that receives a 
grant under section 104(b) of the Act and this subpart and assumes the 
legal and financial responsibility for the funds awarded and for the 
performance of the grant supported activity in accordance with the Act 
and these regulations.
    (g) Indian owned economic enterprise means any commercial, 
industrial, or business activity established or organized for the 
purpose of profit which is not less than 51 percent Indian owned.



Sec.  136.103  Eligibility.

    Any Indian tribe or tribal organization is eligible to apply for a 
grant under this subpart.



Sec.  136.104  Application.

    (a) Forms for applying for grants are governed by 45 CFR 75.206.
    (b) In addition to such other pertinent information as the Secretary 
may require, the application for a grant under this subpart shall 
contain the following:
    (1) A description of the applicant including an indication whether 
the applicant is a Tribe or tribal organization, and if the latter:
    (i) The legal and organizational relationship of the applicant to 
the Indians in the Area to be served or effected by the project.
    (ii) A description of the current and proposed participation of 
Indians in the activities of applicant.
    (iii) Whether applicant is controlled, sanctioned or chartered by 
the governing body of the Indians to be served, and if so, evidence of 
such fact.
    (iv) If elected, a description of the election process, voting 
criteria, and extent of voter participation in the election designating 
the organization.
    (2) A narrative description of the project including its goals and 
objectives and the manner in which the proposed project is compatible 
with published Indian Health Service statements of availability of 
funds, the manner in which those goals and objectives are to be 
attained, and a work and time schedule which will be utilized to 
accomplish each goal and objective.
    (3) A description of applicant's staff, present or proposed, 
including their qualifications, academic training, responsibilities and 
functions.
    (4) A description of the manner in which the staff is or will be 
organized

[[Page 860]]

and supervised to carry out proposed activities.
    (5) A description of training to be provided as part of the proposed 
project.
    (6) A description of the administrative, managerial, and 
organizational arrangements and resources to be utilized to conduct the 
proposed project.
    (7) An itemized budget for the budget period (normally 12 months) 
for which support is sought and justification of the amount of grant 
funds requested.
    (8) The intended financial participation, if any, of the applicant, 
specifying the type of contributions such as cash or services, loans of 
full or part-time staff, equipment, space materials or facilities, or 
other contributions.
    (9) Where health services are to be provided, a description of the 
nature of the services to be provided and the population to be served.
    (10) A description of the Federal property, real and personal, 
equipment, facilities and personnel which applicant proposes to utilize 
and a description of the arrangements which applicant has made or will 
make to assume responsibility for the operation and management of those 
facilities.
    (c) The application shall contain assurances satisfactory to the 
Secretary that the applicant will:
    (1) Where applicant is providing services, provide such services at 
a level and range which is not less than that provided by the Indian 
Health Service or that identified by the Service after negotiation with 
the applicant, as an appropriate level, range and standard of care.
    (2) Where providing services, provide services in accordance with 
law and applicable Indian Health Service policies and regulations.
    (3) Where providing services, provide services in a fair and uniform 
manner, consistent with medical need, to all Indian people.

(Approved by the Office of Management and Budget under control number 
0915-0045)

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1853, Jan. 14, 1985; 81 
FR 3010, Jan. 20, 2016]



Sec.  136.105  Project elements.

    A project supported under this subpart must:
    (a) Have sufficient, adequately trained staff in relation to the 
scope of the project.
    (b) Maintain a mechanism for dealing with complaints regarding the 
delivery of health services or performance of project activities.
    (c) Hold confidential all information obtained by the personnel of 
the project from participants in the project related to their 
examination, care, and treatment, and shall not release such information 
without the individuals' consent except as may be required by law, as 
may be necessary to provide service to the individual, or as may be 
necessary to monitor the operations of this program or otherwise protect 
the public health. Information may be disclosed in a form which does not 
identify particular individuals.
    (d) Operate with the approval, support, and involvement of the 
tribe, tribes, or Indian communities in the area served by the local 
facility and program.
    (e) Keep in force adequate liability insurance in accordance with 
the approved application unless the Secretary, for good cause shown, has 
determined that such insurance was not obtainable or appropriate or has 
determined that such insurance may be permitted to expire or lapse. The 
insurance shall provide that prior to cancellation the Secretary must be 
notified and must further provide that for each such policy of insurance 
the carrier shall waive any right it may have to raise as a defense the 
tribe's sovereign immunity from suit but such waiver shall extend only 
to claims the amount and nature of which are within the coverage and 
limits of the policy and shall not authorize or empower the insurance 
carrier to waive or otherwise limit the tribe's sovereign immunity 
outside or beyond the coverage and limits of the policy of insurance.

    Note: This provision is excepted from application of 45 CFR 75.304 
by section 103(c) of Pub. L. 93-638.

    (f) Provide services at a level and range which is not less than 
that provided by the Indian Health Service or

[[Page 861]]

that identified by the Service as an appropriate level, range, and 
standard of care.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1854, Jan. 14, 1985; 81 
FR 3010, Jan. 20, 2016]



Sec.  136.106  Grant award and evaluation.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants whose project will, in the judgment of the 
Secretary, best promote the purposes of the Act, and the regulations of 
this subpart, taking into account:
    (1) The apparent capability of the applicant to organize and manage 
the proposed project successfully considering, among other things the 
adequacy of staff, management systems, equipment and facilities.
    (2) The soundness of the applicant's plan for conducting the project 
and for assuring effective utilization of grant funds.
    (3) The adequacy of the budget in relation to the scope of the 
project and available funds.
    (4) The relative effectiveness of the applicant's plan, as set forth 
in the application, to carry out each of the requirements Sec.  136.105.
    (5) The compatibility of the proposed project with the published 
goals and responsibilities of the IHS in carrying out its statutory 
mission.
    (b) The Notice of Grant Awards specifies how long the Secretary 
intends to support the project period without requiring the project to 
re-compete for funds. This period, called the project period, will 
usually be for one to two years. The total project period comprises the 
original project period and any extension. Generally the grant will be 
for a one-year budget period, any subsequent award will also be a one-
year budget period. A grantee must submit a separate application for 
each subsequent year. Decisions regarding continuation awards and the 
funding level of such awards will be made after consideration of such 
factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, awards require a determination by 
the Secretary that funding is in the best interest of the Federal 
Government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation or other award with respect to 
any approved application or portion of an approved application.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1854, Jan. 14, 1985. 
Redesignated and amended at 67 FR 35342, May 17, 2002]



Sec.  136.107  Use of project funds.

    (a) A grantee shall only spend funds it receives under this subpart 
according to the approved application and budget, the regulations of 
this subpart, the terms and conditions of the award and the applicable 
cost principles prescribed in 45 CFR part 75, subpart E.
    (b) The provisions of any other Act notwithstanding, any funds made 
available to a tribal organization under grants pursuant to section 
104(b) of the Act may be used as matching shares for any other Federal 
grant programs which contribute to the purposes for which grants under 
this section are made.

    Note: This provision is excepted from application of 45 CFR 75.306 
by section 104(c) of Pub. L. 93-638.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1854, Jan. 14, 1985; 81 
FR 3010, Jan. 20, 2016]



Sec.  136.108  [Reserved]



Sec.  136.109  Availability of appropriations.

    The Secretary will from time to time publish a notice in the Federal 
Register indicating by areas the allotment of funds and categories of 
activities for which awards may be made under this subpart. The 
Secretary may revise such allotments and categories from time to time 
and will promptly publish a notice of such revisions in the Federal 
Register.



Sec.  136.110  Facilities construction.

    In addition to other requirements of this subpart:
    (a) An applicant for a construction grant to build, renovate, 
modernize, or

[[Page 862]]

remodel a hospital, clinic, health station or quarters for housing 
personnel associated with such facilities, must in its application:
    (1) Provide its assessment of the environmental impact of the 
project as called for by section 102(2)(c) of the National Environmental 
Policy Act of 1969 (42 U.S.C. 4332(c)).
    (2) Furnish its evaluation of the project site in accordance with 
the terms and conditions of E.O. 11296, 31 FR 10663 (August 10, 1966) 
relating to the evaluation of flood hazards in locating federally owned 
or financed facilities.
    (b) The following requirements are applicable to each construction 
grant to build, renovate, modernize, or remodel a hospital, clinic, 
health station or quarters for housing personnel associated with such 
facilities.
    (1) Competitive bids. The approval of the Secretary shall be 
obtained before the project is advertised or placed on the market for 
bidding. The approval shall include a determination by the Secretary 
that the final plan and specifications conform to the minimum standards 
of construction and equipment specified in the grant award or in HHS 
documents specified in the grant award.
    (2) There will be no preference given to local contractors or 
suppliers over non-local contractors or suppliers, except as otherwise 
provided in these regulations.
    (3) Construction contracts and subcontracts under this program are 
subject to the Davis-Bacon Act (40 U.S.C. 276a et seq.). For 
requirements that grantees must observe for enforcing compliance by 
contractors and subcontractors, see the section on contract provisions 
in the procurement standards for HHS grantees made applicable by 45 CFR 
75.326 through 75.340.
    (4) Minimum standards of construction and equipment. The plans and 
specifications for the project will conform to the minimum standards of 
construction and equipment specified in the grant award or in HHS 
documents specified in the grant award.
    (5) The following provision must be included in all construction 
contracts let by the grantee: ``The Secretary of the Department of 
Health and Human Services shall have access at all reasonable times to 
work wherever it is in preparation or progress, and the contractor shall 
provide proper facilities for such access and inspection.''

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1854, Jan. 14, 1985; 81 
FR 3010, Jan. 20, 2016]



Sec.  136.111  Interest.

    Tribes and Tribal organizations shall not be held accountable for 
interest earned on grant funds, pending disbursement by such 
organization.

    Note: This provision is excepted from application of 45 CFR 
75.305(b)(9) by section 106(b) of Pub. L. 93-638.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1854, Jan. 14, 1985; 81 
FR 3010, Jan. 20, 2016]



Sec.  136.112  Additional conditions.

    The Secretary may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in his judgment 
such conditions are necessary to assure or protect advancement of the 
approved project, the interests of public health, or the conservation of 
grant funds.



Sec.  136.113  Fair and uniform provision of services.

    Services provided pursuant to a grant under this subpart shall be 
provided by the Grantee in a fair and uniform manner to all participants 
in the project consistent with their medical need, the policies and 
regulations of the Indian Health Service, and the Act.



Sec.  136.114  Applicability of other Department regulations.

    Several other regulations apply to grants under this subpart. These 
include to the extent applicable but are not limited to:

42 CFR part 50, subpart D, Public Health Service grant appeals procedure
45 CFR part 16, Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 84, Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance

[[Page 863]]

45 CFR part 86, Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91, Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

    Note: To the extent they provide special benefits to Indians, grants 
under this subpart are exempted from the requirements of section 601 of 
the Civil Rights Act of 1964 [42 U.S.C. 200d], prohibiting 
discrimination on the basis of race, color or national origin, by 
regulation at 45 CFR 80.3(d) which provides, with respect to Indian 
health services, that, ``An individual shall not be deemed subjected to 
discrimination by reasons of his exclusion from the benefits of a 
program limited by Federal law to individuals of a particular race, 
color, or national origin different from his.

[50 FR 1854, Jan. 14, 1985, as amended at 81 FR 3010, Jan. 20, 2016]



Sec.  136.115  Rescission of grants.

    (a) When the Secretary determines that the performance of a grantee 
under these regulations involves (1) the violation of the rights or 
endangerment of the health, safety, or welfare of any persons, or (2) 
gross negligence or the mismanagement in the handling or use of funds 
under the grant, the Secretary will, in writing, notify the grantee of 
such determination and will request that the grantee take such 
corrective action, within such period of time, as the Secretary may 
prescribe.
    (b) When the Secretary determines that a grantee has not taken 
corrective action (as prescribed by him under paragraph (a) of this 
section) to his satisfaction, he may, after providing the grantee an 
opportunity for a hearing in accordance with paragraph (c) of this 
section, rescind the grant in whole or in part and if he deems it 
appropriate, assume or resume control or operation of the program, 
activity, or service involved.
    (c) When the Secretary has made a determination described in 
paragraph (b) of this section, he shall in writing notify the grantee of 
such determination and of the grantee's right to request a review of 
such determination (and of the determination described in paragraph (a) 
of this section) under the Public Health Service Grant Appeals Procedure 
(42 CFR part 50, subpart D). Such notification by the Secretary shall 
set forth the reasons for the determination in sufficient detail to 
enable the grantee to respond and shall inform the grantee of its 
opportunity for review under such subpart D. If the review held under 
subpart D results in a response adverse to the grantee's position, the 
grantee shall be informed of its right to have a hearing before the 
Department Grant Appeals Board, pursuant to 45 CFR part 16.
    (d) Where the Secretary determines that a grantee's performance 
under a grant awarded under this subpart poses an immediate threat to 
the safety of any person, he may immediately rescind the grant in whole 
or in part and if he deems it appropriate, assume or resume control or 
operation of the program, activity, or service involved. Upon such 
recission he will immediately notify the grantee of such action and the 
basis or reasons therefor; and offer the grantee an opportunity for a 
hearing to be held within 10 days of such action. If the grantee 
requests such a hearing, the Secretary will designate three officers or 
employees of the Department to serve as a hearing panel. No officer or 
employee from the immediate office of the official who made the decision 
to rescind the grant under this paragraph may be designated to serve on 
the hearing panel.
    (1) The hearing shall be commenced within 10 days after the 
recission of the grant, shall be held on the record and shall afford the 
grantee the right:
    (i) To notice of the issues to be considered;
    (ii) To be represented by counsel;
    (iii) To present witnesses on grantee's behalf; and
    (iv) To cross-examine other witnesses either orally or through 
written interrogatories.
    (2) The hearing panel shall, within 25 days after the conclusion of 
the hearing, notify all parties in writing of its decision.
    (3) Such decision shall not be subject to further hearing under 42 
CFR part 50, subpart D or 45 CFR part 16.
    (e) In any case where the Secretary has rescinded a grant under 
paragraph (b) or (d) of this section, he may decline to enter into a new 
grant agreement with the grantee until such time

[[Page 864]]

as he is satisfied that the basis for the recission has been corrected. 
Nothing in this section shall be construed as contravening the 
Occupational Safety and Health Act of 1970 (84 Stat. 1590), as amended 
(29 U.S.C. 651).
    (f) In any case where the Secretary has rescinded a grant for the 
delivery of health services under this subpart, the grantee shall, upon 
the request of the Secretary, transfer to the Secretary all medical 
records compiled in the operation of the supported project.

    Note: This section is an exception to 45 CFR 75.371 through 75.385 
required by section 109 of Pub. L. 93-638.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1855, Jan. 14, 1985; 81 
FR 3010, Jan. 20, 2016]



Sec.  136.116  Reports.

    In addition to the reporting and information requirements provided 
in 45 CFR 75.341 through 75.360 made applicable to grants under this 
subpart by Sec.  136.114, each recipient of Federal financial assistance 
shall make such reports and information available to the Indian people 
served or represented by such recipient as and in a manner determined by 
the Secretary to be adequate.

    Note: This section is a requirement in addition to 45 CFR part 75 
and is required by section 5(c) of Pub. L. 93-638.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1855, Jan. 14, 1985. 
Redesignated and amended at 67 FR 35342, May 17, 2002; 81 FR 3010, Jan. 
20, 2016]



Sec.  136.117  Amendment of regulations.

    Before revising or amending the regulations in this subpart, the 
Secretary shall take the following actions:
    (a) Consult with Indian Tribes and national and regional Indian 
organizations to the extent practicable about the need for revision or 
amendment and consider their views in preparing the proposed revision or 
amendment.
    (b) Present the proposed revision or amendment to the Committees on 
Interior and Insular Affairs of the United States Senate and House of 
Representatives.
    (c) Publish the proposed revisions or amendments in the Federal 
Register as proposed rulemaking to provide adequate notice to receive 
comments from, all interested parties.
    (d) After consideration of all comments received, publish the 
regulations in the Federal Register in final form not less than 30 days 
before the date they are made effective.



Sec.  136.118  Effect on existing rights.

    The regulations in this part are not meant to and do not:
    (a) Affect, modify, diminish, or otherwise impair the sovereign 
immunity from suit enjoyed by an Indian tribe;
    (b) Authorize, require or permit the termination of any existing 
trust responsibility of the United States with respect to the Indian 
people;
    (c) Permit significant reduction in services to Indian people as a 
result of this subpart.



Sec.  136.119  Penalties.

    Section 6 of Pub. L. 93-638, 25 U.S.C. 450(d) provides:

    Whoever, being an officer, director, agent, or employee of, or 
connected in any capacity with, any recipient of a contract, 
subcontract, grant, or subgrant pursuant to this Act or the Act of April 
16, 1934 (48 Stat. 596), as amended, embezzles, willfully misapplies, 
steals, or obtains by fraud any of the money, funds, assets, or property 
which are the subject of such a grant, subgrant, contract, or 
subcontract, shall be fined not more than $10,000 or imprisoned for not 
more than two years, or both, but if the amount so embezzled, 
misapplied, stolen, or obtained by fraud does not exceed $100, he shall 
be fined not more than $1,000 or imprisoned not more than one year, or 
both.



Sec.  136.120  Use of Indian business concerns.

    Grants awarded pursuant to this subpart will incorporate the 
following:
    Use of Indian business concerns.
    (a) As used in this clause, the term ``Indian organizations of an 
Indian-owned economic enterprise'' as defined in section 102(g) of this 
subpart.
    (b) The grantee agrees to give preference to qualified Indian 
business concerns in the awarding of any contracts, subcontracts or 
subgrants entered into under the grant consistent with the efficient 
performance of the grant. The grantee shall comply with any preference 
requirements regarding Indian business concerns established by the

[[Page 865]]

tribe(s) receiving services under the grant to the extent that such 
requirements are consistent with the purpose and intent of this 
paragraph.

    Note: This section is an exception to 45 CFR part 75, required by 
section 7(b) of Pub. L. 93-638.

[40 FR 53143, Nov. 14, 1975, as amended at 50 FR 1855, Jan. 14, 1985; 81 
FR 3011, Jan. 20, 2016]



Sec.  136.121  Indian preference in training and employment.

    (a) Any grant made under this subpart, or a contract or subgrant 
made under such a grant shall require that, to the greatest extent 
feasible preferences and opportunities for training and employment in 
connection with the administration of such grant, or contract or 
subgrant made under such grant, shall be given to Indians.
    (b) The grantee shall include the requirements of paragraph (a) of 
this section in all contracts and subgrants made under a grant awarded 
under this subpart.



 Subpart I_Limitation on Charges for Health Care Professional Services 
                       and Non-Hospital-Based Care

    Source: 81 FR 14982, Mar. 21, 2016, unless otherwise noted.



Sec.  136.201  Applicability.

    The requirements of this Subpart shall apply to:
    (a) Health programs operated by the Indian Health Service (IHS).
    (b) Health programs operated by an urban Indian organization through 
a contract or grant under Title V of the Indian Health Care Improvement 
Act (IHCIA), Public Law 94-437, as amended.
    (c) Health programs operated by an Indian Tribe or Tribal 
organization pursuant to a contract or compact with the IHS under the 
Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et 
seq.), provided that the Indian Tribe or Tribal organization has agreed 
in such contract or compact to be bound by this Subpart pursuant to 25 
U.S.C. 450l and 458aaa-16(e), as applicable.



Sec.  136.202  Definitions.

    For purposes of this subpart, the following definitions apply.
    Notification of a claim means, for the purposes of part 136, and 
also 25 U.S.C. 1621s and 1646, the submission of a claim that meets the 
requirements of 42 CFR 136.24.
    (1) Such claims must be submitted within the applicable time frame 
specified by 42 CFR 136.24, or if applicable, 25 U.S.C. 1646, and 
include information necessary to determine the relative medical need for 
the services and the individual's eligibility.
    (2) The information submitted with the claim must be sufficient to:
    (i) Identify the patient as eligible for IHS services (e.g., name, 
address, home or referring service unit, Tribal affiliation),
    (ii) Identify the medical care provided (e.g., the date(s) of 
service, description of services), and
    (iii) Verify prior authorization by the IHS for services provided 
(e.g., IHS purchase order number or medical referral form) or exemption 
from prior authorization (e.g., copies of pertinent clinical information 
for emergency care that was not prior-authorized).
    (3) To be considered sufficient notification of a claim, claims 
submitted by providers and suppliers for payment must be in a format 
that complies with the format required for submission of claims under 
title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) or 
recognized under section 1175 of such Act (42 U.S.C. 1320d-4).
    Provider, as used in this subpart only, means a provider of services 
not governed by or subject to 42 CFR part 136 subpart D, and may 
include, but not limited to, a skilled nursing facility, comprehensive 
outpatient rehabilitation facility, home health agency, or hospice 
program.
    Referral means an authorization for medical care by the appropriate 
ordering official in accordance with 42 CFR part 136 subpart C.
    Repricing agent means an entity that offers an IHS, Tribe or Tribal 
organization, or urban Indian organization (I/T/U) discounted rates from 
non-I/T/U public and private providers as a result of existing contracts 
that the non-I/T/U public or private provider may have

[[Page 866]]

within the commercial health care industry.
    Supplier, as used in this subpart only, means a physician or other 
practitioner, a facility, or other entity (other than a provider) not 
already governed by or subject to 42 CFR part 136 subpart D, that 
furnishes items or services under this Subpart.



Sec.  136.203  Payment for provider and supplier services 
purchased by Indian health programs.

    (a) Payment to providers and suppliers not covered by 42 CFR part 
136 subpart D, for any level of care authorized under part 136, subpart 
C by a Purchased/Referred Care (PRC) program of the IHS; or authorized 
by a Tribe or Tribal organization carrying out a PRC program of the IHS 
under the Indian Self-Determination and Education Assistance Act, as 
amended, Public Law 93-638, 25 U.S.C. 450 et seq.; or authorized for 
purchase under Sec.  136.31 by an urban Indian organization (as that 
term is defined in 25 U.S.C. 1603(h)) (hereafter collectively ``I/T/
U''), shall be determined based on the applicable method in this 
section:
    (1) If a specific amount has been negotiated with a specific 
provider or supplier or its agent by the I/T/U, the I/T/U will pay that 
amount, provided that such amount is equal to or better than the 
provider or supplier's Most Favored Customer (MFC) rate, as evidenced by 
commercial price lists or paid invoices and other related pricing and 
discount data to ensure that the I/T/U is receiving a fair and 
reasonable price. The MFC rate limitation shall not apply if:
    (i) The prices offered to the I/T/U are fair and reasonable, as 
determined by the I/T/U, even though comparable discounts were not 
negotiated; and
    (ii) The award is otherwise in the best interest of the I/T/U, as 
determined by the I/T/U.
    (2) If an amount has not been negotiated in accordance with 
paragraph (a)(1) of this section, the I/T/U will pay the lowest of the 
following amounts:
    (i) The applicable Medicare payment amount, including payment 
according to a fee schedule, a prospective payment system or based on 
reasonable cost (``Medicare rate'') for the period in which the service 
was provided, or in the event of a Medicare waiver, the payment amount 
will be calculated in accordance with such waiver.
    (ii) An amount negotiated by a repricing agent if the provider or 
supplier is participating within the repricing agent's network and the 
I/T/U has a pricing arrangement or contract with that repricing agent.
    (iii) An amount not to exceed the provider or supplier's MFC rate, 
as evidenced by commercial price lists or paid invoices and other 
related pricing and discount data to ensure that the I/T/U is receiving 
a fair and reasonable price, but only to the extent such evidence is 
reasonably accessible and available to the I/T/U.
    (3) In the event that a Medicare rate does not exist for an 
authorized item or service, and no other payment methodology provided 
for in paragraph (a)(1) or (2) of this section are accessible or 
available, the allowable amount shall be deemed to be 65% of authorized 
charges.
    (b) Coordination of benefits and limitation on recovery: If an I/T/U 
has authorized payment for items and services provided to an individual 
who is eligible for benefits under Medicare, Medicaid, or another third 
party payer--
    (1) The I/T/U is the payer of last resort under 25 U.S.C. 1623(b);
    (2) If there are any third party payers, the I/T/U will pay the 
amount for which the patient is being held responsible after the 
provider or supplier of services has coordinated benefits and all other 
alternate resources have been considered and paid, including applicable 
co-payments, deductibles, and coinsurance that are owed by the patient;
    (3) The maximum payment by theI/T/U will be only that portion of the 
payment amount determined under this section not covered by any other 
payer;
    (4) The I/T/U payment will not exceed the rate calculated in 
accordance with paragraph (a) of this section (plus applicable cost 
sharing); and
    (5) When payment is made by Medicaid it is considered payment in 
full and there will be no additional payment made by the I/T/U to the 
amount paid by Medicaid.

[[Page 867]]

    (c) Authorized services: Payment shall be made only for those items 
and services authorized by an I/T/U consistent with this part 136 or 
section 503(a) of the IHCIA, Public Law 94-437, as amended, 25 U.S.C. 
1653(a).
    (d) No additional charges:
    (1) If an amount has not been negotiated under paragraph (a)(1) of 
this section, the health care provider or supplier shall be deemed to 
have accepted the applicable payment amount under paragraph (a)(2) of 
this section as payment in full if:
    (i) The services were provided based on a Referral, as defined in 
Sec.  136.202; or,
    (ii) The health care provider or supplier submits a Notification of 
a Claim for payment to the I/T/U; or
    (iii) The health care provider or supplier accepts payment for the 
provision of services from the I/T/U.
    (2) A payment made and accepted in accordance with this section 
shall constitute payment in full and the provider or its agent, or 
supplier or its agent, may not impose any additional charge--
    (i) On the individual for I/T/U authorized items and services; or
    (ii) For information requested by the I/T/U or its agent or fiscal 
intermediary for the purposes of payment determinations or quality 
assurance.
    (e) IHS will not adjudicate a notification of a claim that does not 
contain the information required by Sec.  136.24 with an approval or 
denial, except that IHS may request further information from the 
individual, or as applicable, the provider or supplier, necessary to 
make a decision. A notification of a claim meeting the requirements 
specified herein does not guarantee payment.
    (f) No service shall be authorized and no payment shall be issued in 
excess of the rate authorized by this section.



Sec.  136.204  Authorization by an urban Indian organization.

    An urban Indian organization may authorize for purchase items and 
services for an eligible urban Indian as those terms are defined in 25 
U.S.C. 1603(f) and (h) according to section 503 of the IHCIA and 
applicable regulations. Services and items furnished by physicians and 
other health care professionals and non-hospital-based entities shall be 
subject to the payment methodology set forth in Sec.  136.203.



          Subpart J_Indian Health Care Improvement Act Programs

    Authority: Secs. 102, 103, 106, 502, 702, and 704 of Pub. L. 94-437 
(25 U.S.C. 1612, 1613, 1615, 1652, 1672 and 1674); sec. 338G of the 
Public Health Service Act, 95 Stat. 908 (42 U.S.C. 254r).

    Source: 42 FR 59646, Nov. 18, 1977, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.

    Subdivision J-1--Provisions of General and Special Applicability



Sec.  136.301  Policy and applicability.

    (a) Policy. (1) It is the policy of the Secretary to encourage 
Indians to enter the health professions and to ensure the availability 
of Indian health professionals to serve Indians. The recruitment and 
scholarship programs under this subpart will contribute to this 
objective.
    (2) The regulations of this subpart are intended to be consistent 
with principles of Indian self-determination and to supplement the 
responsibilities of the Indian Health Sevice for Indian health manpower 
planning and for assisting Indian tribes and tribal organizations in the 
development of Indian manpower programs.
    (b) Applicability. The regulations of this subpart are applicable to 
the following activities authorized by the Indian Health Care 
Improvement Act:
    (1) The award of health professions recruitment grants under section 
102 of the Act to recruit Indians into the health professions 
(Subdivision J-2);
    (2) The award of preparatory scholarship grants and pregraduate 
scholarship grants under section 103 of the Act, as amended, to Indians 
undertaking compensatory and preprofessional education (Subdivisions J-3 
and J-8);
    (3) The award of Indian Health Scholarship grants pursuant to 
section 338G of the Public Health Service Act (42 U.S.C. 254r) to Indian 
or other students in health professions schools (Subdivision J-4):

[[Page 868]]

    (4) The provision of continuing education allowances to health 
professionals employed by the Service under section 106 of the Act 
(Subdivision J-5);
    (5) Contracts with urban Indian organizations under section 502 of 
the Act to establish programs in urban areas to make health services 
more accessible to the urban Indian population (Subdivision J-6); and
    (6) Leases with Indian tribes under section 704 of the Act 
(Subdivision J-7).

[42 FR 59646, Nov. 18, 1977, as amended at 49 FR 7381, Feb. 29, 1984; 50 
FR 1855, Jan. 14, 1985]



Sec.  136.302  Definitions.

    As used in this subpart: (a) Act means the Indian Health Care 
Improvement Act, Pub. L. 94-437 (25 U.S.C. 1601 et seq.).
    (b) Academic year means the traditional approximately 9 month 
September to June annual session, except for students who attend summer 
session in addition to the traditional academic year during a 12 month 
period, for whom the academic year will be considered to be of 
approximately 12 months duration.
    (c) [Reserved]
    (d) Compensatory preprofessional education means any preprofessional 
education necessary to compensate for deficiencies in an individual's 
prior education in order to enable that individual to qualify for 
enrollment in a health professions school.
    (e) Health or educational entity means an organization, agency, or 
combination thereof, which has the provision of health or educational 
programs as one of its major functions.
    (f) Health professions school means any of the schools defined in 
paragraphs (m), (n), or (o) of this section.
    (g) Hospital means general, tuberculosis, mental, and other types of 
hospitals, and related facilities such as laboratories, outpatient 
departments, extended care facilities, facilities related to programs 
for home health services, self-care units, education or training 
facilities for health professions personnel operated as an integral part 
of a hospital, and central services facilities operated in connection 
with hospitals, but does not include any hospital providing primarily 
domicillary care.
    (h) Indian or Indians means, for purposes of Subdivisions J-2, J-3, 
J-4, and J-8 of this subpart, any person who is a member of an Indian 
tribe, as defined in parargraph (i) of this section or any individual 
who (1), irrespective of whether he or she lives on or near a 
reservation, is a member of a tribe, band or other organized group 
terminated since 1940 and those recognized now or in the future by the 
State in which they reside, or who is the natural child or grandchild of 
any such member, or (2) is an Eskimo or Aleut or other Alaska Native, or 
(3) is considered by the Secretary of the Interior to be an Indian for 
any purpose, or (4) is determined to be an Indian under regulations 
promulgated by the Secretary.
    (i) Indian health organization means a nonprofit corporate body 
composed of Indians which provides for the maximum participation of all 
interested Indian groups and individuals and which has the provision of 
health programs as its principal function.
    (j) Indian tribe means any Indian tribe, band, nation, or other 
organized group or community, including any Alaska native village or 
group or regional or village corporation as defined in or established 
pursuant to the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et 
seq.), which is recognized as eligible for the special programs and 
services provided by the United States to Indians because of their 
status as Indians.
    (k) Nonprofit as applied to any private entity means that no part of 
the net earnings of such entity inures or may lawfully inure to the 
benefit of any private shareholder or individual.
    (l) [Reserved]
    (m) School of allied health professions means a junior college, 
college, or university--
    (1) Which provides, or can provide, programs of education leading to 
a certificate, or to an associate or baccalaureate degree (or the 
equivalent or either), or to a higher degree for preparing personnel 
with responsibilities for supporting, complementing, or supplementing 
the professional functions of physicians, dentists, and other health 
professionals in the delivery of

[[Page 869]]

health care to patients or assisting environmental engineers and others 
in environmental health control and preventive medicine activities.
    (2) Which, if in a college or univerisity which does not include a 
teaching hospital or in a junior college, is affiliated through a 
written agreement with one or more hospitals which provide the hospital 
component of the clinical training required for completion of such 
programs of education. The written agreement shall be executed by 
individuals authorized to act for their respective institutions and to 
assume on behalf of their institution the obligations imposed by such 
agreement. The agreement shall provide:
    (i) A description of the responsibilities of the school of allied 
health professions, the responsibilities of the hospital, and their 
joint responsibilities with respect to the clinical components of such 
programs of education; and
    (ii) A description of the procedure by which the school of allied 
health professions and the hospital will coordinate the academic and 
clinical training of students in such programs of education; and
    (iii) That, with respect to the clinical component of each such 
program of education, the teaching plan and resources have been jointly 
examined and approved by the appropriate faculty of the school of allied 
health professions and the staff of the hospital.
    (3) Which is accredited or assured accreditation by a recognized 
body or bodies approved for such purpose by the Commissioner of 
Education of the Department of Health and Human Services.
    (n) School of medicine, school of dentistry, school of osteopathy, 
school of pharmacy, school of optometry, school of podiatry, school of 
veterinary medicine, and school of public health means a school which 
provides training leading, respectively, to a degree of doctor of 
medicine, a degree of doctor of dental surgery or an equivalent degree, 
a degree of doctor of osteopathy, a degree of bachelor of science in 
pharmacy or an equivalent degree, a degree of doctor of podiatry or an 
equivalent degree, and graduate degree in public health, and including 
advanced training related to such training provided by any such school, 
and is accredited or assured accreditation by a recognized body or 
bodies approved for such purpose by the Commissioner of Education of the 
Department of Health and Human Services.
    (o) School of nursing means a collegiate, associate degree, or 
diploma school of nursing, as those terms are defined below:
    (1) The term collegiate school of nursing means a department, 
division, or other administrative unit in a college or university which 
provides primarily or exclusively a program of education in professional 
nursing and allied subjects leading to the degree of bachelor of arts, 
bachelor of science, bachelor of nursing, or to an equivalent degree, or 
to a graduate degree in nursing, and including advanced training related 
to such program of education provided by such school, but only if such 
program, or such unit, college or university is accredited;
    (2) The term associated degree school of nursing means a department, 
division, or other administrative unit in a junior college, community 
college, college, or university which provides primarily or exclusively 
a two-year program of education in professional nursing and allied 
subjects leading to an associate degree in nursing or to an equivalent 
degree, but only if such program, or such unit, college or university is 
accredited;
    (3) The term diploma school of nursing means a school affiliated 
with a hospital or university, or an independent school, which provides 
primarily or exclusively a program of education in professional nursing 
and allied subjects leading to a diploma or to equivalent indicia that 
such program has been satisfactorily completed, but only if such 
program, or such affiliated school or such hospital or university or 
such independent school is accredited.
    (4) The term accredited as used in this subsection when applied to 
any program of nurse education means a program accredited or assured 
accreditation by a recognized body or bodies, or by a State agency, 
approved for such purpose by the Commissioner of Education of the 
Department of Health and Human Services and when applied to a hospital, 
school, college, or university

[[Page 870]]

(or a unit thereof) means a hospital, school, college, or university (or 
a unit thereof) which is accredited or assured accreditation by a 
recognized body or bodies, or by a State agency, approved for such 
purpose by the Commissioner of Education of the Department of Health and 
Human Services.
    (p) Secretary means the Secretary of Health and Human Services and 
any other Officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (q) Service means the Indian Health Service.
    (r) State or local government means any public health or educational 
entity which is included within the definition of State or local 
government in 45 CFR 75.2 and Indian tribes or tribal organizations.
    (s) Tribal organization means the elected governing body of any 
Indian tribe or any legally established organization of Indians which is 
controlled by one or more such bodies or by a board of directors elected 
or selected by one or more such bodies (or elected by the Indian 
population to be served by such organization) and which includes the 
maximum participation of Indians in all phases of its activities.
    (t) Urban center means any city, with a population of 10,000 or more 
as determined by the United States Census Bureau, which the Secretary 
determines has a sufficient urban Indian population with unmet health 
needs to warrant assistance under title V of the Act.
    (u) Urban Indian means any individual who resides in an urban 
center, as defined in paragraph(s) of this section, and who meets one or 
more of the four criteria in paragraphs (h) (1) through (4) of this 
section.
    (v) Urban Indian organization means a nonprofit corporate body 
situated in an urban center which:
    (1) Is governed by an Indian controlled board of directors:
    (2) Has the provision of health programs as:
    (i) Its principal function, or
    (ii) One of its major functions and such health progams are 
administered by a distinct organizational unit within the organization.
    (3) Provides for the maximum participation of all interested Indian 
groups and individuals; and
    (4) Is capable of legally cooperating with other public and private 
entities for the purpose of performing the activities described in Sec.  
36.350(a) of Subdivision J-6 of this subpart. Except, that criteria (2) 
and (3) of this subsection shall not apply to an organization 
administering an urban Indian health project under a contract with the 
Secretary prior to October 1, 1977, for the period of such contract or 
until July 1, 1978, whichever is later.

[42 FR 59646, Nov. 18, 1977, as amended at 49 FR 7381, Feb. 29, 1984; 50 
FR 1855, Jan. 14, 1985; 81 FR 3011, Jan. 20, 2016]



Sec.  136.303  Indians applying for scholarships.

    (a) For purposes of scholarship grants under Subdivisions J-3 and J-
4 of this subpart, Indian applicants must submit evidence of their 
tribal membership (or other evidence that that applicant is an Indian as 
defined in paragraph (h) of Sec.  136.302 of this subdivision) 
satisfactory to the Secretary.
    (b) Where an applicant is a member of a tribe recognized by the 
Secretary of the Interior, the applicant must submit evidence of his or 
her tribal membership, such as:
    (1) Certification of tribal enrollment by the Secretary of the 
Interior acting through the Bureau of Indian Affairs (BIA); or
    (2) In the absence of such BIA certification, documentation that the 
applicant meets the requirements of tribal membership as prescribed by 
the charter, articles of incorporation or other legal instrument of the 
tribe and has been officially designated a tribal member by an 
authorized tribal official; or
    (3) Other evidence of tribal membership satisfactory to the 
Secretary.
    (c) Where the applicant is a member of a tribe terminated since 1940 
or a State recognized tribe, the applicant must submit documentation 
that the applicant meets the requirements of tribal membership as 
prescribed by the charter, articles of incorporation or other legal 
instrument of the tribe and has been officially designated a tribal

[[Page 871]]

member by an authorized tribal official; or other evidence, satisfactory 
to the Secretary, that the applicant is a member of the tribe. In 
addition, if the terminated or State recognized tribe of which the 
applicant is a member is not on a list of such tribes published by the 
Secretary in the Federal Register. the applicant must submit 
documentation as may be required by the Secretary that the tribe is a 
tribe terminated since 1940 or is recognized by the State in which the 
tribe is located in accordance with the law of that State.
    (d) An applicant who is not a tribal member, but who is a natural 
child or grandchild of a tribal member as defined in paragraph (h) of 
Sec.  36.302 of this subdivision must submit evidence of such fact which 
is satisfactory to the Secretary, in addition to evidence of his or her 
parent's or grandparent's tribal membership in accordance with 
paragraphs (b) and (c) of this section.

[42 FR 59646, Nov. 18, 1977. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



Sec.  136.304  Publication of a list of allied health professions.

    The Secretary, acting through the Service, shall publish from time 
to time in the Federal Register a list of the allied health professions 
for consideration for the award of preparatory and Indian Health 
scholarships under subdivisions J-3 and J-4 of this Subpart, based upon 
his determination of the relative needs of Indians for additional 
service in specific allied health professions. In making that 
determination, the needs of the Service will be given priority 
consideration.



Sec.  136.305  Additional conditions.

    The Secretary may, with respect to any grant award under this 
subpart, impose additional conditions prior to or at the time of any 
award when in his judgment such conditions are necessary to assure or 
protect advancement of the approved project, the interests of the public 
health, or the conservation of grant funds.

    Note: Nondiscrimination. Grants and contracts under this subpart are 
exempted from the requirements of section 601 of the Civil Rights Act of 
1964 (42 U.S.C. 2000d), prohibiting discrimination on the basis of race, 
color or national origin, by regulation at 45 CFR 80.3(d) which 
provides, with respect to Indian Health Services, that ``An individual 
shall not be deemed subjected to discrimination by reason of his 
exclusion from the benefits of a program limited by Federal law to 
individuals of a particular race, color, or national origin different 
from his.''

[42 FR 59646, Nov. 18, 1977, as amended at 50 FR 1855, Jan. 14, 1985]

   Subdivision J-2--Health Professions Recruitment Program for Indians



Sec.  136.310  Health professions recruitment grants.

    Grants awarded under this subdivision, in accordance with section 
102 of the Act, are for the purpose of assisting in meeting the costs of 
projects to:
    (a) Identify Indians with a potential for education or training in 
the health professions and encouraging and assisting them (1) To enroll 
in schools of medicine, osteopathy, dentistry, veterinary medicine, 
optometry, podiatry, pharmacy, public health, nursing, or allied health 
professions; or (2), if they are not qualified to enroll in any such 
school, to undertake such post-secondary education or training as may be 
required to qualify them for enrollment;
    (b) Publicize existing sources of financial aid available to Indians 
enrolled in any school referred to in paragraph (a)(1) of this section 
or who are undertaking training necessary to qualify them to enroll in 
any such school; or
    (c) Establish other programs which the Secretary determines will 
enhance and facilitate the enrollment of Indians, and the subsequent 
pursuit and completion by them of courses of study, in any school 
referred to in paragraph (a)(1) of this section.



Sec.  136.311  Eligibility.

    Any Indian tribe, tribal organization, urban Indian organization, 
Indian health organization or any public or other nonprofit private 
health or educational entity is eligible to apply for a health 
professions recruitment grant under this subdivision.

[[Page 872]]



Sec.  136.312  Application.

    (a) Forms for applying for grants are governed by 45 CFR 75.206 \1\
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the 
appropriate Indian Health Service Area or Program Office or by writing 
the Director, Indian Health Service, Room 5A-55, 5600 Fishers Lane, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    (b) In addition to such other pertinent information as the Secretary 
may require, the application for a health professions recruitment grant 
shall contain the following:
    (1) A description of the legal status and organization of the 
applicant;
    (2) A description of the current and proposed participation of 
Indians (if any) in the applicant's organization.
    (3) A description of the target Indian population to be served by 
the proposed project and the relationship of the applicant to that 
population;
    (4) A narrative description of the nature, duration, purpose, need 
for and scope of the proposed project and of the manner in which the 
applicant intends to conduct the project including:
    (i) Specific measurable objectives for the proposed project;
    (ii) How the described objectives are consistent with the purposes 
of section 102 of the Act;
    (iii) The work and time schedules which will be used to accomplish 
each of the objectives;
    (iv) A description of the administrative, managerial, and 
organizational arrangements and the facilities and resources to be 
utilized to conduct the proposed project;
    (v) The name and qualifications of the project director or other 
individual responsible for the conduct of the project; the 
qualifications of the prinicipal staff carrying out the project; and a 
description of the manner in which the applicant's staff is or will be 
organized and supervised to carry out the proposed project;
    (5) An itemized budget for the budget period (normally 12 months) 
for which support is sought and justification of the amount of grant 
funds requested:
    (6) The intended financial participation, if any, of the applicant 
in the proposed project specifying the type of contributions such as 
cash or services, loans of full or part-time staff, equipment, space, 
materials or facilities or other contributions;
    (7) When the target population of a proposed project includes a 
particular Indian tribe or tribes, an official document in such form as 
is prescribed by the tribal governing body of each such tribe indicating 
that the tribe or tribes will cooperate with the applicant.
    (c) In the case of proposed projects for identification of Indians 
with a potential for education or training in the health professions, 
applications must include a method of assessing the potential of 
interested Indians for undertaking necessary education or training in 
the health professions. Proposed projects may include, but are not 
limited to, the following activities:
    (1) Identifying Indian elementary and secondary school students 
through observations, aptitude or other testing, academic performance, 
performance in special projects and activities, and other methods as may 
be designed or developed;
    (2) Identifying Indians in college or university programs, related 
employment, upward mobility programs or other areas of activity 
indicative of interest and potential;
    (3) Review of the upward mobility plans, skills, banks etc. of 
organizations employing Indians to identify individuals with appropriate 
career orientations, expression of interest, or recognized potential;
    (4) Conducting workshops, health career days, orientation projects 
or other activities to identify interested Indians at any age level;
    (5) Performing liaison activities with Indian professional 
organizations, Indian education programs (including adult education), 
Indian school boards, Indian parent, youth recreation or community 
groups, or other Indian special interest or activity groups;
    (6) Identifying those Indians with an interest and potential who 
cannot undertake compensatory education or training in the health 
professions because of financial need.
    (d) Proposed projects designed to encourage and assist Indians to 
enroll in health professions schools; or, if not

[[Page 873]]

qualified to enroll, to undertake postsecondary education or training 
required to qualify them for enrollment may include, but are not limited 
to, the following activities:
    (1) Providing technical assistance and counseling to encourage and 
assist Indians identified as having a potential for education or 
training in the health professions--
    (i) To enroll in health professions schools.
    (ii) To undertake any post-secondary education and training required 
to qualify them to enroll in health professions schools, and
    (iii) To obtain financial aid to enable them to enroll in health 
professions schools or undertake post-secondary education or training 
required to qualify them to enroll in such schools;
    (2) Conducting programs to (i) identify factors such as deficiencies 
in basic communication, research, academic subject matter (such as 
science, mathematics, etc.), or other skills which may prevent or 
discourage Indians from enrolling in health professions schools or 
undertaking the post-secondary education or training required to qualify 
them to enroll, and (ii) provide counseling and technical assistance to 
Indians to assist them in undertaking the necessary education, training 
or other activities to overcome such factors.
    (e) Proposed projects to publicize existing kinds of financial aid 
available to Indians enrolled in health professions schools or to 
Indians undertaking training necessary to qualify them to enroll in such 
schools may include, but are not limited to, the following activities:
    (1) Collecting information on available sources of financial aid and 
disseminating such information to Indian students, Indians, recruited 
under programs assisted by grants under this subdivision and to Indian 
tribes, tribal organizations, urban Indian organizations, Indian health 
organizations and other interested groups and communities throughout the 
United States;
    (2) Providing information on available sources of financial aid 
which can be utilized by programs and counselors assisting Indians to 
obtain financial aid.
    (f) Proposed projects for establishment of other programs which will 
enhance or facilitate enrollment of Indians in health professions 
schools and the subsequent pursuit and completion by them of courses of 
study in such schools may include, but are not limited to, the following 
activities:
    (1) Compilation and dissemination of information on--
    (i) Health professions education or training programs and the 
requirements for enrollment in such programs; and
    (ii) Post-secondary education or training curricula and programs 
designed to qualify persons for enrollment in health professions 
schools;
    (2) Developing and coordinating career orientation programs in local 
schools (including high schools) and colleges and universites;
    (3) Developing programs to enable Indians to gain exposure to the 
health professions such as arranging for (i) visits to health care 
facilities and programs and meetings or seminars with health 
professionals, (ii) part-time summer or rotating employment in health 
care facilities, programs, or offices of health professionals, (iii) 
volunteer programs, or (iv) other means of providing such exposure;
    (4) Developing programs which relate tribal culture and tradition, 
including native medicine, to careers in the health professions; and
    (5) Developing programs to make Indians aware of projected health 
manpower needs, expected employment opportunities in the health 
professions, and other factors in order to orient and motivate Indians 
to pursue careers in the health professions.

[42 FR 59646, Nov. 18, 1977, as amended at 50 FR 1855, Jan. 14, 1985; 81 
FR 3011, Jan. 20, 2016]



Sec.  136.313  Evaluation and grant awards.

    (a) Within the limits of funds available for such purpose, the 
Secretary, acting through the Service, may award health professions 
recruitment grants to those eligible applicants whose proposed projects 
will in his judgment best promote the purposes of section 102 of the 
Act, taking into consideration:

[[Page 874]]

    (1) The potential effectiveness of the proposed project in carrying 
out such purposes;
    (2) The capability of the applicant to successfully conduct the 
project;
    (3) The accessibility of the applicant to target Indian communities 
or tribes, including evidence of past or potential cooperation between 
the applicant and such communities or tribes;
    (4) The relationship of project objectives to known or anticipated 
Indian health manpower deficiencies;
    (5) The soundness of the fiscal plan for assuring effective 
utilization of grant funds;
    (6) The completeness of the application.
    (b) Preference shall be given to applicants in the following order 
or priority: (1) Indian tribes, (2) tribal organizations, (3) urban 
Indian organizations and other Indian health organizations, and (4) 
public and other nonprofit profit private health or educational 
entities.
    (c) The Notice of Grant Awards specifies how long the Secretary 
intends to support the project period without requiring the project to 
re-compete for funds. This period, called the project period, will 
usually be for one to two years. The total project period comprises the 
original project period and any extension. Generally the grant will be 
for a one year budget period, any subsequent award will also be a one 
year budget period. A grantee must submit a separate application for 
each subsequent year. Decisions regarding continuation awards and the 
funding level of such awards will be made after consideration of such 
factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, awards require a determination by 
the Secretary that funding is in the best interest of the Federal 
Government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.

[42 FR 59646, Nov. 18, 1977, as amended at 50 FR 1855, Jan. 14, 1985]



Sec.  136.314  Use of funds.

    A grantee shall only spend funds it receives under this subpart 
according to the approved application and budget, the regulations of 
this subpart, the terms and conditions of the award, and the applicable 
cost principles prescribed in 45 CFR part 75, subpart E.

[50 FR 1855, Jan. 14, 1985, as amended at 81 FR 3011, Jan. 20, 2016]



Sec.  136.315  Publication of list of grantees and projects.

    The Secretary acting through the Service shall publish annually in 
the Federal Register a list of organizations receiving grants under this 
subdivision including for each grantee:
    (a) The organization's name and address;
    (b) The amount of the grant;
    (c) A summary of the project's purposes and its geographic location.



Sec.  136.316  Other HHS regulations that apply.

    Several other regulations apply to grants under this subdivision. 
These include but are not limited to:

42 CFR part 50, subpart D, Public Health Service grant appeals procedure
42 CFR part 16, Procedures of the Departmental Grant Appeals Board
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards
45 CFR part 84, Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86, Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91, Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[50 FR 1855, Jan. 14, 1985, as amended at 81 FR 3011, Jan. 20, 2016]

Subdivision J-3--Health Professions Preparatory Scholarship Program for 
                                 Indians



Sec.  136.320  Preparatory scholarship grants.

    Scholarship grants may be awarded under this subdivision and section 
103 of the act for the period (not to exceed

[[Page 875]]

two academic years) necessary to complete a recipient's compensatory 
preprofessional education to enable the recipient to qualify for 
enrollment or re-enrollment in a health professions school. Examples of 
individuals eligible for such grants are the individual who:
    (a) Has completed high school equivalency and needs compensatory 
preprofessional education to enroll in a health professions school;
    (b) Has a baccalaureate degree and needs compensatory 
preprofessional education to qualify for enrollment in a health 
professions school; or
    (c) Has been enrolled in a health professions school but is no 
longer so enrolled and needs preprofessional education to qualify for 
readmission to a health professions school.



Sec.  136.321  Eligibility.

    To be eligible for a preparatory scholarship grant under this 
subdivision an applicant must:
    (a) Be an Indian;
    (b) Have successfully completed high school education or high school 
equivalency;
    (c) Have demonstrated to the satisfaction of the Secretary the 
desire and capability to successfully complete courses of study in a 
health professions school;
    (d) Be accepted for enrollment in or be enrolled in any compensatory 
preprofessional education course or curriculum meeting the criteria in 
Sec.  136.320 of this subdivision; and
    (e) Be a citizen of the United States.

[42 FR 59646, Nov. 18, 1977. Redesignated and amended at 67 FR 35342, 
May 17, 2002]



Sec.  136.322  Application and selection.

    (a) An application for a preparatory scholarship grant under this 
subdivision shall be submitted in such form and at such time as the 
Secretary acting through the Service may prescribe. \1\ However, an 
application must indicate:
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the 
appropriate Indian Health Service Area or Program Office.
---------------------------------------------------------------------------

    (1) The health profession which the applicant wishes to enter, and
    (2) Whether the applicant intends to provide health services to 
Indians upon completion of health professions education or training by 
serving as described in Sec.  136.332 or otherwise as indicated on the 
application.
    (b) Within the limits of funds available for the purpose, the 
Secretary, acting through the Service, shall make scholarship grant 
awards for a period not to exceed two academic years of an individual's 
compensatory preprofessional education to eligible applicants taking 
into consideration:
    (1) Academic performance;
    (2) Work experience;
    (3) Faculty recommendations;
    (4) Stated reasons for asking for the scholarship; and
    (5) The relative needs of the Service and Indian health 
organizations for persons in specific health professions.

[42 FR 59646, Nov. 18, 1977, as amended at 49 FR 7381, Feb. 29, 1984. 
Redesignated and amended at 67 FR 35342, May 17, 2002]]



Sec.  136.323  Scholarship and tuition.

    (a) Scholarship grant awards under this subdivision shall consist 
of:
    (1) A stipend of $400 per month adjusted in accordance with 
paragraph (c) of this section; and
    (2) An amount determined by the Secretary for transportation, 
tuition, fees, books, laboratory expenses, and other necessary 
educational expenses.
    (b) The portion of the scholarship for the costs of tuition and fees 
as indicated in the grant award will be paid directly to the school upon 
receipt of an invoice from the school. The stipend and remainder of the 
scholarship grant award will be paid monthly to the grantee under the 
conditions specified in the grant award.
    (c) The amount of the monthly stipend specified in paragraph (a)(1) 
of this section shall be adjusted by the Secretary for each academic 
year ending in a fiscal year beginning after September 30, 1978, by an 
amount (rounded down to the next lowest multiple of $1) equal to the 
amount of such stipend multiplied by the overall percentage (as set 
forth in the report transmitted to the Congress under section 5305 of 
title 5, United States Code) of the adjustment in the rates of pay under 
the General Schedule made effective in the

[[Page 876]]

fiscal year in which such academic year ends.

[42 FR 59646, Nov. 18, 1977, as amended at 49 FR 7381, Feb. 29, 1984]



Sec.  136.324  Availability of list of recipients.

    The Indian Health Service will provide to any persons requesting it 
a list of the recipients of scholarship grants under this subdivision, 
including the school attended and tribal affiliation of each recipient.

[49 FR 7381, Feb. 29, 1984]

           Subdivision J-4--Indian Health Scholarship Program



Sec.  136.330  Indian health scholarships.

    Indian Health Scholarships will be awarded by the Secretary pursuant 
to 338A through 339G of the Public Health Service Act, and such 
implementing regulations as may be promulgated by the Secretary except 
as set out in this subdivision for the purpose of providing scholarships 
to Indian and other students at health professions schools in order to 
obtain health professionals to serve Indians.

[42 FR 59646, Nov. 18, 1977, as amended at 50 FR 1855, Jan. 14, 1985]



Sec.  136.331  Selection.

    (a) The Secretary, acting through the Service, shall determine the 
individuals who receive Indian Health Scholarships.
    (b) Priority shall be given to applicants who are Indians.



Sec.  136.332  Service obligation.

    The service obligation provided in section 338G(b)(2) of the Public 
Health Service Act shall be met by the recipient of an Indian Health 
Scholarship by service in:
    (a) The Indian Health Service.
    (b) An urban Indian organization assisted under Subdivision J-6.
    (c) In private practice of his or her profession if, the practice 
(1) is situated in a health manpower shortage area, designated under 
section 332 of the Public Health Service Act and (2) addresses the 
health care needs of a substantial number of Indians as determined by 
the Secretary in accordance with guidelines of the Service.

[42 FR 59646, Nov. 18, 1977, as amended at 50 FR 1855, Jan. 14, 1985]



Sec.  136.333  Distribution of scholarships.

    The Secretary, acting through the Service, shall determine the 
distribution of Indian Health Scholarships among the health professions 
based upon the relative needs of Indians for additional service in 
specific health professions. In making that determination the needs of 
the Service will be given priority consideration. The following factors 
will also be considered:
    (a) The professional goals of recipients of scholarships under 
section 103 of the Indian Health Care Improvement Act; and
    (b) The professional areas of study of Indian applicants.



Sec.  136.334  Publication of a list of recipients.

    The Secretary, acting through the Service, will publish annually in 
the Federal Register a list of recipients of Indian Health Scholarships, 
including the name of each recipient, tribal affiliation if applicable, 
and school.

            Subdivision J-5--Continuing Education Allowances



Sec.  136.340  Provision of continuing education allowances.

    In order to encourage physicians, dentists and other health 
professionals to join or continue in the Service and to provide their 
services in the rural and remote areas where a significant portion of 
the Indian people reside, the Secretary, acting through the Service, may 
provide allowances to health professionals, employed in the Service in 
order to enable them to leave their duty stations for not to exceed 480 
hours of professional consultation and refresher training courses in any 
one year.

       Subdivision J-6--Contracts With Urban Indian Organizations



Sec.  136.350  Contracts with Urban Indian organizations.

    (a) The Secretary, acting through the Service, to the extent that 
funds are

[[Page 877]]

available for the purpose, shall contract with urban Indian 
organizations selected under Sec.  36.351 of this subdivision to carry 
out the following activities in the urban centers where such 
organizations are situated:
    (1) Determine the population of urban Indians which are or could be 
recipients of health referral or care services;
    (2) Identify all public and private health service resources within 
the urban center in which the organization is situated which are or may 
be available to urban Indians;
    (3) Assist such resources in providing service to such urban 
Indians;
    (4) Assist such urban Indians in becoming familiar with and 
utilizing such resources;
    (5) Provide basic health education to such urban Indians;
    (6) Establish and implement manpower training programs to accomplish 
the referral and education tasks set forth in paragraphs (a)(3) through 
(5) of this section;
    (7) Identify gaps between unmet health needs of urban Indians and 
the resources available to meet such needs;
    (8) Make recommendations to the Secretary and Federal, State, local, 
and other resource agencies on methods of improving health service 
programs to meet the needs of urban Indians; and
    (9) Prove or contract for health care services to urban Indians 
where local health delivery resources are not available, not accessible, 
or not acceptable to the urban Indians to be served.
    (b) Contracts with urban Indian organizations pursuant to this title 
shall be in accordance with all Federal contracting laws and regulations 
except that, in the discretion of the Secretary, such contracts may be 
negotiated without advertising and need not conform to the provisions of 
the Act of August 24, 1935 as amended, (The Miller Act, 40 U.S.C. 270a 
et seq. which is concerned with bonding requirements).
    (c) Payments under contracts may be made in advance or by way of 
reimbursement and in such installments and on such conditions as the 
Secretary deems necessary to carry out the purposes of title V of the 
Act.
    (d) Notwithstanding any provision of law to the contrary, the 
Secretary may, at the request or consent of an urban Indian 
organization, revise or amend any contract made by him with such 
organization pursuant to this subdivision as necessary to carry out the 
purposes of title V of this Act: Provided, however, that whenever an 
urban Indian organization requests retrocession of the Secretary for any 
such contract, retrocession shall become effective upon a date specified 
by the Secretary not more than one hundred and twenty days from the date 
of the request by the organization or at such later date as may be 
mutually agreed to by the Secretary and the organization.
    (e) In connection with any contract made pursuant to this 
subdivision, the Secretary may permit an urban Indian organization to 
utilize, in carrying out such contract, existing facilities owned by the 
Federal Government within his jurisdiction under such terms and 
conditions as may be agreed upon for their use and maintenance.



Sec.  136.351  Application and selection.

    (a) Proposals for contracts under this subdivision shall be 
submitted in such form and manner and at such time as the Secretary 
acting through the Service may prescribe.
    (b) The Secretary, acting through the Service shall select urban 
Indian organizations with which to contract under this subdivision whose 
proposals will in his judgment best promote the purposes of title V of 
the Act taking into consideration the following factors:
    (1) The extent of the unmet health care needs of the urban Indians 
in the urban center involved determined on the basis of the latest 
available statistics on disease incidence and prevalence, life 
expectancy, infant mortality, dental needs, housing conditions, family 
income, unemployment statistics, etc.
    (2) The urban Indian population which is to receive assistance in 
the following order of priority:
    (i) 9,000 or more;
    (ii) 4,500 to 9,000;
    (iii) 3,000 to 4,500;
    (iv) 1,000 to 3,000;
    (v) Under 1,000.

[[Page 878]]

    (3) The relative accessibility which the urban Indian population to 
be served has to health care services, in the urban center. Factors to 
be considered in determining relative accessibility include:
    (i) Cultural barriers;
    (ii) Discrimination against Indians;
    (iii) Inability to pay for health care;
    (iv) Lack of facilities which provide free care to indigent persons;
    (v) Lack of state or local health programs;
    (vi) Technical barriers created by State and local health agencies;
    (vii) Availability of transportation to health care services;
    (viii) Distance between Indian residences and the nearest health 
care facility.
    (4) The extent to which required activities under Sec.  136.350(a) 
of this subdivision would duplicate any previous or current public or 
private health services projects in the urban center funded by another 
source. Factors to be considered in determining duplication include:
    (i) Urban Indian utilization of existing health services funded by 
other sources;
    (ii) Urban Indian utilization of existing health services delivered 
by an urban Indian organization funded by other sources.
    (5) The appropriateness and likely effectiveness of the activities 
required in Sec.  136.350(a) of this subdivision in the urban center 
involved.
    (6) The capability of the applicant urban Indian organization to 
perform satisfactorily the activities required in Sec.  136.350(a) of 
this subdivision and to contract with the Secretary.
    (7) The extent of existing or likely future participation in the 
activities required in Sec.  136.350(a) of this subdivision by 
appropriate health and health related Federal, State, local, and other 
resource agencies.
    (8) Whether the city has an existing urban Indian health program.
    (9) The applicant organization's record of performance, if any, in 
regard to any of the activities required in Sec.  136.350(a) of this 
subdivision.
    (10) Letters demonstrating local support for the applicant 
organization from both the Indian and non-Indian communities in the 
urban center involved.

[42 FR 59646, Nov. 18, 1977; 42 FR 61861, Dec. 7, 1977. Redesignated and 
amended at 67 FR 35342, May 17, 2002]



Sec.  136.352  Fair and uniform provision of services.

    Contracts with urban Indian organizations under this subdivision 
shall incorporate the following clause:
    The Contractor agrees, consistent with medical need, and the 
efficient provision of medical services to make no discriminatory 
distinctions against Indian patients or beneficiaries of this contract 
which are inconsistent with the fair and uniform provision of services.



Sec.  136.353  Reports and records.

    For each fiscal year during which an urban Indian organization 
receives or expends funds pursuant to a contract under this title, such 
organization shall submit to the Secretary a report including 
information gathered pursuant to Sec.  136.350(a) (7) and (8) of this 
subdivision, information on activities conducted by the organization 
pursuant to the contract, an accounting of the amounts and purposes for 
which Federal funds were expended, and such other information as the 
Secretary may request. The reports and records of the urban Indian 
organization with respect to such contract shall be subject to audit by 
the Secretary and the Comptroller General of the United States.

[42 FR 59646, Nov. 18, 1977. Redesignated and amended at 67 FR 35342, 
May 17, 2002]

               Subdivision J-7--Leases With Indian Tribes



Sec.  136.360  Leases with Indian tribes.

    (a) Any land or facilities otherwise authorized to be acquired, 
constructed, or leased to carry out the purposes of the Act may be 
leased or subleased from Indian tribes for periods not in excess of 
twenty years.
    (b) Leases entered into pursuant to paragraph (a) shall be subject 
to the requirements of section 322 of the Economy Act (40 U.S.C. 278a), 
which limits expenditures for rent and alterations,

[[Page 879]]

improvements and repairs on leased buildings.

Subdivision J-8--Health Professions Pregraduate Scholarship Program for 
                                 Indians

    Source: 49 FR 7381, Feb. 29, 1984, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



Sec.  136.370  Pregraduate scholarship grants.

    (a) Pregraduate scholarship grants may be awarded under this 
subdivision and section 103 of the Act for the period (not to exceed 
four academic years) necessary to complete a recipient's pregraduate 
education leading to a baccalaureate degree in a premedicine, 
preoptometry, predentistry, preosteopathy, preveterinary medicine, or 
prepodiatry curriculum or equivalent.
    (b) Students enrolled in accredited health professional or allied 
health professional programs which lead to eligibility for licensure, 
certification, registration or other types of credentials required for 
the practice of a health or allied health profession are ineligible for 
scholarships under this subdivision. Examples of health professions and 
allied health professions that will not be considered for funding 
include but are not limited to: nursing, audiology, medical technology, 
dental hygiene, dental technicians, engineering, radiologic technology, 
dietitian, nutritionist, social work, health education, physical 
therapy, occupational therapy and pharmacy. Scholarships for students in 
these programs are provided under Subdivision J-4 of this subpart.



Sec.  136.371  Eligibility.

    To be eligible for a pregraduate scholarship grant under this 
subdivison an applicant must:
    (a) Be an Indian;
    (b) Have successfully completed high school education or high school 
equivalency;
    (c) Have demonstrated to the satisfaction of the Secretary the 
desire and capability to successfully complete courses of study in a 
pregraduate education program meeting the criteria in Sec.  136.370;
    (d) Be accepted for enrollment in or be enrolled in any accredited 
pregraduate education curriculum meeting the criteria in Sec.  136.370 
of this subdivision; and
    (e) Be a citizen of the United States.

[49 FR 7381, Feb. 29, 1984. Redesignated and amended at 67 FR 35342, May 
17, 2002]



Sec.  136.372  Application and selection.

    (a) An application for a pregraduate scholarship grant under this 
subdivision shall be submitted in such form and at such time as the 
Secretary may prescribe. However, an application must indicate:
    (1) The pregraduate program in which the applicant is or wishes to 
enter, and
    (2) Whether the applicant intends to provide health services to 
Indians upon completion of health professions education or training by 
serving as described in Sec.  136.332 or otherwise as indicated on the 
application.
    (b) Within the limits of available funds, the Director, IHS, shall 
make pregraduate scholarship grant awards for a period not to exceed 
four academic years of an individual's pregraduate education to eligible 
applicants taking into consideration:
    (1) Academic performance;
    (2) Work experience;
    (3) Faculty or employer recommendation;
    (4) Stated reasons for asking for the scholarship; and
    (5) The relative needs of the IHS and Indian health organizations 
for persons in specific health professions.

(Approved by the Office of Management and Budget under control number 
0915-0080)

[49 FR 7381, Feb. 29, 1984. Redesignated and amended at 67 FR 35342, May 
17, 2002]



Sec.  136.373  Scholarship and tuition.

    (a) Scholarship grant awards under this subdivision shall consist 
of:
    (1) A stipend of $400 per month adjusted in accordance with 
paragraph (c) of this section; and
    (2) An amount determined by the Secretary for transportation, 
tuition, fees, books, laboratory expenses and other necessary 
educational expenses.
    (b) The portion of the scholarship for the costs of tuition and fees 
as indicated in the grant award will be paid

[[Page 880]]

directly to the school upon receipt of an invoice from the school. The 
stipend and remainder of the scholarship grant award will be paid 
monthly to the grantee under the conditions specified in the grant 
award.
    (c) The amount of the monthly stipend specified in paragraph (a)(1) 
of this section shall be adjusted by the Secretary for each academic 
year ending in a fiscal year beginning after September 30, 1978, by an 
amount (rounded down to the next lowest multiple of $1) equal to the 
amount of such stipend multiplied by the overall percentage (as set 
forth in the report transmitted to the Congress under section 5305 of 
title 5, United States Code) of the adjustment in the rates of pay under 
the General Schedule made effective in the fiscal year in which such 
academic year ends.



Sec.  136.374  Availability of list of recipients.

    The IHS will provide to any person requesting it a list of the 
recipients of scholarship grants under this subdivision, including the 
school attended and tribal affiliation of each recipient.



    Subpart K_Indian Child Protection and Family Violence Prevention

    Source: 67 FR 59467, Sept. 23, 2002, unless otherwise noted.



Sec.  136.401  Purpose.

    (a) The purpose of the regulations in this subpart is to establish 
minimum standards for Federal employees working in the Indian Health 
Service (IHS), including standards of character to ensure that 
individuals having regular contact with or control over Indian children 
have not been convicted of certain types of crimes as mandated by 
section 408 of the Indian Child Protection and Family Violence 
Prevention Act (the ``Act''), Public Law (Pub. L.) 101-630, 104 Stat. 
4544, 25 U.S.C. 3201-3211, as amended by section 814 of the Native 
American Laws Technical Corrections Act of 2000. In order to implement 
these minimum standards of character, these regulations also address:
    (1) The efficiency standards to ensure that individuals are 
qualified for the positions they hold or seek, as mandated by Section 
408 of the Act.
    (2) Fitness standards to ensure child care service employees are fit 
to have responsibility for the safety and well-being of children, as 
mandated by Section 231 of the Crime Control Act of 1990, Pub. L. 101-
647, 42 U.S.C. 13041.
    (3) Suitability standards to ensure that individuals have not acted 
in a manner that places others at risk or raised questions about their 
trustworthiness, as mandated by 5 CFR part 731.
    (b) The Act requires that Tribes or Tribal organizations who receive 
funds under the Indian Self-Determination and Education Assistance Act 
(ISDEA), Pub. L. 93-638, employ individuals in positions involving 
regular contact with or control over Indian children only if the 
individuals meet standards of character no less stringent than those 
prescribed under these regulations. Thus, the minimum standards of 
character as defined in these regulations will become the basis for 
Tribes or Tribal organizations to use when developing their own minimum 
standards of character that cannot be less stringent than as prescribed 
herein.



Sec.  136.402  Policy.

    In enacting the Indian Child Protection and Family Violence 
Prevention Act, (the ``Act'') the Congress recognized there is no 
resource more vital to the continued existence and integrity of Indian 
Tribes than their children and that the United States has a direct 
interest, as trustee, in protecting Indian children who are members of, 
or are eligible for membership in, an Indian Tribe. The minimum 
standards of character as prescribed by the regulations in this subpart 
are intended to ensure that Indian children are protected.



Sec.  136.403  Definitions.

    Crimes against Persons means a crime that has as an element the use, 
attempted use, or threatened use of physical force or other abuse of a 
person and includes, but is not limited to, homicide; assault; 
kidnapping; false imprisonment; reckless endangerment;

[[Page 881]]

robbery; rape; sexual assault, molestation, exploitation, contact, or 
prostitution; and other sexual offenses. In determining whether a crime 
falls within this category, the applicable Federal, State, or Tribal law 
under which the individual was convicted or pleaded guilty or nolo 
contendere shall be controlling.
    Crimes of violence means a crime that has as an element the use, 
attempted use, or threatened use of physical force against the person or 
property of another, or any other crime that is a felony and that, by 
its nature, involves substantial risk that physical force against the 
person or property of another may be used in the course of committing 
the crime. In determining whether a crime falls within this category, 
reference may be made to the applicable Federal, State, or Tribal law 
under which the individual was convicted or pleaded guilty or nolo 
contendere.
    Indian means any individual who is a member of an Indian Tribe, as 
defined below.
    Indian child means any unmarried person under the age of eighteen 
who is either a member of an Indian Tribe or eligible for membership in 
an Indian Tribe and is the biological child of a member of an Indian 
Tribe.
    Indian Tribe means any Indian Tribe, band, nation, or other 
organized group or community, including any Alaska Native village or 
regional or village corporation as defined in or established pursuant to 
the Alaska Native Claims Settlement Act, 43 U.S.C. 1601 et seq., which 
is recognized as eligible for the special programs and services provided 
by the United States to Indians because of their status as Indians.
    Individuals means persons with duties and responsibilities that 
involve regular contact with or control over Indian children and 
includes but is not limited to the following:
    (a) Persons in the competitive or excepted service (including 
temporary employment), the Commissioned Corps, or the Senior Executive 
Service in the IHS;
    (b) Persons who perform service for or under the supervision of the 
IHS while being permanently assigned to another IHS office or to another 
organization, such as a Federal agency, State, or Tribe;
    (c) Persons who volunteer to perform services in IHS facilities;
    (d) Persons who contract with the IHS to perform services in IHS 
facilities.
    Must or shall indicates a mandatory or imperative act or 
requirement.
    Offenses against children means any felonious or misdemeanor crime 
under Federal, State, or Tribal law committed against a victim that has 
not attained the age of eighteen years. In determining whether a crime 
falls within this category, the applicable Federal, State, or Tribal law 
under which the individual was convicted or pleaded guilty or nolo 
contendere shall be controlling.
    Regular contact with or control over an Indian child means 
responsibility for an Indian child(ren) within the scope of the 
individual's duties and responsibilities or contact with an Indian 
child(ren) on a recurring and foreseeable basis.
    Tribal Organization as defined in the ISDEA, means the recognized 
governing body of any Indian Tribe or any legally established 
organization of Indians which is controlled, sanctioned, or chartered by 
such governing body or which is democratically elected by the adult 
members of the Indian community to be served by such organization and 
which includes the maximum participation of Indians in all phases of its 
activities.



Sec.  136.404  What does the Indian Child Protection and Family Violence 
Prevention Act require of the IHS and Indian Tribes or Tribal organizations 
receiving funds under the ISDEA?

    (a) The IHS must compile a list of all authorized positions with 
duties and responsibilities that involve regular contact with or control 
over Indian children; investigate the character of each individual who 
is employed or is being considered for employment in such a position; 
and prescribe minimum standards of character that each individual must 
meet to be appointed or employed in such positions.
    (b) All Indian Tribes or Tribal organizations receiving funds under 
the authority of the ISDEA must identify

[[Page 882]]

those positions that permit regular contact with or control over Indian 
children; conduct an investigation of the character of each individual 
who is employed or is being considered for employment in a position that 
involves regular contact with or control over Indian children; and 
employ only individuals who meet standards of character that are no less 
stringent than those prescribed by regulations in this subpart.



Sec.  136.405  What are the minimum standards of character for individuals 
placed in, or applying for, a position that involves regular contact with 
or control over Indian children?

    The minimum standards of character shall mean a benchmark of moral, 
ethical, and emotional strengths established by character traits and 
past conduct to ensure that the individual is competent to complete his/
her job without harm to Indian children. In order to protect Indian 
children, the IHS has established minimum standards of character 
requiring completion of a satisfactory background investigation that 
ensures that no individuals who have been found guilty of, or entered a 
plea of nolo contendere or guilty to, any felonious offense or any of 
two or more misdemeanor offenses under Federal, State, or Tribal law 
involving crimes of violence; sexual assault, molestation, exploitation, 
contact, or prostitution; crimes against persons; or offenses committed 
against children, are placed in positions involving regular contact with 
or control over Indian children.



Sec.  136.406  Under what circumstances will the minimum standards 
of character be considered to be met?

    The minimum standards of character shall be considered met only 
after the individual has been the subject of a satisfactory background 
investigation. The background investigation shall include a review of:
    (a) The individual's trustworthiness, through inquiries with the 
individual's references and places of employment and education;
    (b) A criminal history background check, which includes a 
fingerprint check through the Criminal Justice Information Services 
Division of the Federal Bureau of Investigation (FBI), under procedures 
approved by the FBI, and inquiries to State and Tribal law enforcement 
agencies for the previous five years of residence listed on the 
individual's application; and
    (c) A determination as to whether the individual has been found 
guilty of or entered a plea of nolo contendere or guilty to any 
felonious offense or any of two or more misdemeanor offenses under 
Federal, State, or Tribal law involving crimes of violence; sexual 
assault, molestation, exploitation, contact, or prostitution; crimes 
against persons; or offenses committed against children.



Sec.  136.407  Under what circumstances should a conviction, 
or plea of nolo contendere or guilty to, be considered if there has been 
a pardon, expungement, set aside, or other court order 
of the conviction or plea?

    All convictions or pleas of nolo contendere or guilty to should be 
considered in making a determination unless a pardon, expungement, set 
aside or other court order reaches the plea of guilty, plea of nolo 
contendere, or the finding of guilt.



Sec.  136.408  What are other factors, in addition to the minimum standards 
of character, that may be considered in determining placement 
of an individual in a position that involves regular contact with 
or control over Indian children?

    (a) All Federal employees are subject to suitability criteria 
contained in 5 CFR part 731 as a condition of employment.
    (b) Section 231 of the Crime Control Act of 1990, Pub. L. 101-647, 
42 U.S.C. 13041, provides that an individual may be disqualified from 
consideration or continuing employment if such individual has been 
convicted of a sex crime, an offense involving a child victim or a drug 
felony, or any other crime if such conviction bears on an individual's 
fitness to have responsibility for the safety and well-being of 
children.
    (c) Tribes or Tribal organizations may but are not required to apply 
additional criteria in determining whether

[[Page 883]]

an individual is suitable for a position with duties and 
responsibilities that involve regular contact with or control over 
Indian children. Any additional suitability criteria established by 
Tribes or Tribal organizations beyond the minimum standards of character 
described in Sec.  136.405 and Sec.  136.406 would be determined by each 
individual Tribe or Tribal organization in accordance with its own 
personnel policies and procedures.



Sec.  136.409  What positions require a background investigation 
and determination of eligibility for employment or retention?

    (a) All positions that allow an individual regular contact with or 
control over Indian children are subject to a background investigation 
and determination of eligibility for employment. The IHS has compiled a 
list of positions within the agency in which the duties and 
responsibilities could involve regular contact with or control over 
Indian children. The list will be periodically updated and made 
available at all IHS Personnel Offices upon request. Positions should be 
reviewed on a case-by-case basis to determine whether the individual in 
that position has regular contact with or control over Indian children.
    (b) Tribes and Tribal organizations may use the list compiled by the 
IHS or develop their own procedures to determine within their program 
those positions that involve regular contact with or control over Indian 
children.



Sec.  136.410  Who conducts the background investigation and prepares 
determinations of eligibility for employment?

    (a) The IHS must use the Office of Personnel Management (OPM) to 
conduct background investigations for Federal employees. The IHS must 
designate qualified security personnel to adjudicate the results of 
background investigations.
    (b) Indian Tribes and Tribal organizations may conduct their own 
background investigations, contract with private firms, or may request 
that a Federal or State agency conduct investigations. (FBI criminal 
history record information, however, may only be received or evaluated 
by governmental agencies, including Tribes or Tribal organizations as 
defined in these regulations at Sec.  136.403, and may not be 
disseminated to private entities.)



Sec.  136.411  Are the requirements for IHS adjudication different 
from the requirements for Indian Tribes and Tribal organizations?

    Yes, in conducting background investigations and adjudicating 
eligibility for employment in Tribal positions that allow regular 
contact with or control over Indian children, Indian Tribes or Tribal 
organizations may, but are not required to, adopt portions of the rules 
in this subpart that are specifically applicable to employment with the 
IHS.



Sec.  136.412  What questions must the IHS ask as part of 
the background investigation?

    (a) Applications for employment with the IHS must include the 
following questions:
    (1) Has the individual been arrested or charged with a crime 
involving a child? If yes, the individual must provide the date, 
explanation of the violation, disposition of the arrest or charge, place 
of occurrence, and the name and address of the police department or 
court involved.
    (2) Has the individual ever been found guilty of, or entered a plea 
of nolo contendere or guilty to, any felonious or misdemeanor offense, 
under Federal, State, or Tribal law involving crimes of violence; sexual 
assault, molestation, exploitation, contact, or prostitution; crimes 
against persons; or offenses committed against children? If yes, the 
individual must provide an explanation of the violation, place of 
occurrence, date and disposition of the court proceeding, and the name 
and address of the police department or court involved.
    (b) The IHS must require that the individual sign, under penalty of 
perjury, a statement verifying the truth of all information provided in 
the employment application and acknowledging that knowingly falsifying 
or concealing a material fact is a felony that may result in fines up to 
$10,000 or five years imprisonment, or both.
    (c) The IHS must inform the individual that a criminal history 
record

[[Page 884]]

check is a condition of employment and require the individual to consent 
in writing to a criminal history record check.



Sec.  136.413  What protections must the IHS and Tribes 
or Tribal organizations provide to individuals undergoing 
a background investigation?

    (a) The IHS must comply with all policies, procedures, criteria, and 
guidance contained in other appropriate guidelines, such as the OPM 
policies, procedures, criteria, and guidance. Questions asked in Sec.  
136.412 will be added as an addendum to item 16 of the OPM Optional 
Form 306, ``Declaration for Federal Employment.'' The information is 
collected as part of the OPM Optional Form 306 and is safeguarded in 
accordance with Privacy Act provisions.
    (b) Indian Tribes and Tribal organizations must comply with the 
privacy requirements of the Federal, State, or other Tribal agency 
providing the background investigations. Indian Tribes and Tribal 
organizations may establish their own procedures that safeguard 
information derived from background investigations.



Sec.  136.414  How does the IHS determine eligibility for placement 
or retention of individuals in positions involving regular contact 
with Indian children?

    (a) Adjudication is the process IHS uses to determine eligibility 
for placement or retention of individuals in positions involving regular 
contact with Indian children. The adjudication process protects the 
interests of the employer and the right of applicants and employees. 
Adjudication requires uniform evaluation to ensure fair and consistent 
judgment.
    (b) Each case is judged on its own merits. All available 
information, both favorable and unfavorable, should be considered and 
assessed in terms of accuracy, completeness, relevance, seriousness, 
overall significance, and how similar cases have been handled in the 
past.
    (c) The adjudicating official who conducts the adjudication must 
first have been the subject of a favorable background investigation.
    (d) Each adjudicating official must be thoroughly familiar with all 
laws, regulations, and criteria involved in making a determination for 
eligibility.
    (e) The adjudicating official must review the background 
investigation to determine the character, reputation, and 
trustworthiness of the individual. At a minimum, the background 
investigation must:
    (1) Review each security investigation form and employment 
application and compare the information provided.
    (2) Review the results of written record searches requested from 
local law enforcement agencies, former employers, former supervisors, 
employment references, and schools.
    (3) Review the results of the fingerprint charts maintained by the 
FBI or other law enforcement information maintained by other agencies.
    (4) Review any other information obtained through a background 
investigation, including the results of searches by State human services 
agencies, the OPM National Agency Check and Inquiries, the OPM Security/
Suitability Investigations Index, and the Defense Clearance and 
Investigations Index.
    (5) Determine whether the individual has been found guilty of, or 
entered a plea of nolo contendere or guilty to, any felonious offense, 
or any of two or more misdemeanor offenses under Federal, State, or 
Tribal law, involving crimes of violence; sexual assault, molestation, 
exploitation, contact, or prostitution; crimes against persons; or 
offenses committed against children.
    (f) After an opportunity has been afforded the individual to 
respond, pursuant to Sec.  136.415, and it is adjudicated that the 
individual has been found guilty of or entered a plea of nolo contendere 
or guilty to an enumerated offense under paragraph (e)(5) of this 
section, that individual shall not be placed or retained in a position 
involving regular contact with or control over Indian children.
    (g) For individuals who have been determined to be ineligible for 
employment in positions having regular contact with or control over 
Indian children, the IHS may use Federal adjudicative standards to 
certify that an individual is suitable for employment in a position, if 
available, that does not

[[Page 885]]

involve regular contact with or control over Indian children. The 
adjudicating official must determine that the individual's prior conduct 
will not interfere with the performance of duties and will not create a 
potential risk to the safety and well-being of any Indian children after 
consideration of the following factors:
    (1) The nature and seriousness of the conduct in question.
    (2) The recency and circumstances surrounding the conduct in 
question.
    (3) The age of the individual at the time of the incident.
    (4) Societal conditions that may have contributed to the nature of 
the conduct.
    (5) The probability that the individual will continue the type of 
behavior in question.
    (6) The individual's commitment to rehabilitation and a change in 
the behavior in question.
    (7) The degree of public trust and the possibility the public would 
be placed at risk if the individual is appointed to the position.



Sec.  136.415  What rights does an individual have during this process?

    (a) The individual must be provided an opportunity to explain, deny, 
or refute unfavorable and incorrect information gathered in an 
investigation, before the adjudication is final. He/she should receive a 
written summary of all derogatory information and be informed of the 
process for explaining, denying, or refuting unfavorable information.
    (b) The adjudicating officials must not release the actual 
background investigative report to an individual. However, they may 
issue a written summary of the derogatory information.
    (c) The individual who is the subject of a background investigation 
may request, to the extent permissible by law, a copy of the reports 
from the originating (Federal, State, or other Tribal) agency and 
challenge the accuracy and completeness of any information maintained by 
that agency.
    (d) The results of an investigation cannot be used for any purpose 
other than to determine eligibility for employment in a position that 
involves regular contact with or control over Indian children.
    (e) Investigative reports contain information of a highly personal 
nature and must be maintained confidentially and secured in locked 
files. Investigative reports must be seen only by those officials who, 
in performing their official duties, need to know the information 
contained in the report.



Sec.  136.416  When should the IHS deny employment or dismiss an employee?

    The IHS must deny employment to an individual or dismiss an 
employee, when the duties and responsibilities of the position the 
individual person would hold or holds involve regular contact with or 
control over Indian children, and it has been adjudicated, pursuant to 
Sec.  136.414 and Sec.  136.415, that the individual has been found 
guilty of, or entered a plea of guilty or nolo contendere to, any 
felonious offense, or any of two or more misdemeanor offenses, under 
Federal, State or Tribal law involving a crime of violence; sexual 
assault, molestation, exploitation, contact, or prostitution; crimes 
against persons; or offenses committed against children. The IHS has the 
discretion to place such an individual in a position, if available, that 
does not involve regular contact with or control over Indian children, 
if a determination has been made that such placement would not put 
Indian children at risk and the individual would be able to perform the 
duties and responsibilities of this position.



Sec.  136.417  May the IHS hire individuals pending completion 
of a background investigation?

    Pursuant to section 231 of the Crime Control Act of 1990, Pub. L. 
101-647, 42 U.S.C. 13041, as amended by Pub. L. 102-190, the IHS may 
hire provisionally individuals as defined in these regulations, prior to 
the completion of a background investigation if, at all times prior to 
receipt of the background investigation during which children are in the 
care of the individual, the individual is within the sight and under the 
supervision of a

[[Page 886]]

staff person and a satisfactory background investigation has been 
completed on that staff person.



Sec.  136.418  What should the IHS do if an individual has been charged with 
an offense but the charge is pending or no disposition has been 
made by a court?

    (a) The IHS may deny the applicant employment until the charge has 
been resolved.
    (b) The IHS may deny the employee any on-the-job contact with 
children until the charge is resolved.
    (c) The IHS may detail or reassign the employee to other duties that 
do not involve regular contact with children.
    (d) The IHS may place the employee on indefinite suspension, in 
accordance with statutory and regulatory requirements, until the court 
has disposed of the charge.



PART 136a_INDIAN HEALTH--Table of Contents



                            Subpart A_Purpose

Sec.
136a.1 Purpose of the regulations.
136a.2 Administrative instructions.

  Subpart B_What Services Are Available and Who Is Eligible To Receive 
                                  Care?

136a.10 Definitions.
136a.11 Services available.
136a.12 Persons to whom health services will be provided.
136a.13 Authorization for contract health services.
136a.14 Reconsideration and appeals.
136a.15 Health Service Delivery Areas.
136a.16 Beneficiary Identification Cards and verification of tribal 
          membership.

Subpart C [Reserved]

                     Subpart D_Transition Provisions

136a.31 Transition period.
136a.32 Delayed implementation.
136a.33 Grace period.
136a.34 Care and treatment of people losing eligibility.

                   Subpart E_Preference in Employment

136a.41 Definitions.
136a.42 Appointment actions.
136a.43 Application procedure for preference eligibility.

   Subpart F_Abortions and Related Medical Services in Indian Health 
          Service Facilities and Indian Health Service Programs

136a.51 Applicability.
136a.52 Definitions.
136a.53 General rule.
136a.54 Life of the mother would be endangered.
136a.55 Drugs and devices and termination of ectopic pregnancies.
136a.56 Recordkeeping requirements.
136a.57 Confidentiality.

                        Subpart G_Residual Status

136.61 Payor of last resort.

    Authority: Sec. 3, 68 Stat. 674; 42 U.S.C. 2003, 42 Stat. 208, sec. 
1, 68 Stat. 674; 25 U.S.C. 13, 42 U.S.C. 2001, unless otherwise noted.

    Source: 64 FR 58318, 58319, Oct. 28, 1999, unless otherwise noted. 
Redesignated at 67 FR 35342, May 17, 2002.



                            Subpart A_Purpose



Sec.  136a.1  Purpose of the regulations.

    These regulations establish general principles and program 
requirements for carrying out the Indian health program.

[46 FR 40692, Aug. 11, 1981. Redesignated at 52 FR 35048, Sept. 16, 
1987]



Sec.  136a.2  Administrative instructions.

    The Service periodically issues administrative instructions to its 
officers and employees which are primarily found in the Indian Health 
Service Manual and the Area Office and Program Office supplements. These 
instructions are operating procedures to assist officers and employees 
in carrying out their responsibilities, and are not regulations 
establishing program requirements which are binding upon members of the 
general public.

[46 FR 40692, Aug. 11, 1981. Redesignated at 52 FR 35048, Sept. 16, 
1987]



  Subpart B_What Services Are Available and Who Is Eligible To Receive 
                                  Care?



Sec.  136a.10  Definitions.

    As used in this subpart:

[[Page 887]]

    Appropriate ordering official means, unless otherwise specified by 
contract with the health care facility or provider or by a contract with 
a tribe or tribal organization, the ordering official for the Service 
Unit in which the individual requesting contract health services or on 
whose behalf the services are requested, resides.
    Area Director means the Director of an Indian Health Service Area 
Office designated for purposes for administration of Indian Health 
Service Programs.
    Contract health services means health services provided at the 
expense of the Indian Health Service from public or private medical or 
hospital facilities other than those of the Service or those funded by 
the Service.
    Emergency means any medical condition for which immediate medical 
attention is necessary to prevent the death or serious impairment of the 
health of an individual.
    Health Service Delivery Area means a geographic area designated 
pursuant to Sec.  36.15 of this subpart.
    Indian tribe means any Indian tribe, band, nation, or other 
organized group or community, including any Alaska Native village or 
regional or village corporation as defined in or established pursuant to 
the Alaska Native Claims Settlement Act, 43 U.S.C. 1601 et. seq., which 
is recognized as eligible for the special programs and services provided 
by the United States to Indians because of their status as Indians.
    Reservation means any Federally recognized Indian tribe's 
reservation, Pueblo, or colony, including former reservations in 
Oklahoma, Alaska Native regions established pursuant to the Alaska 
Native Claims Settlement Act (43 U.S.C. 1601 et seq.), and Indian 
allotments if considered reservation land by the Bureau of Indian 
Affairs.
    Reside means living in a locality with the intent to make it a fixed 
and a permanent home. The following persons will be deemed residents of 
the Health Service Delivery Area:
    (1) Students who are temporarily absent from the Health Service 
Delivery Area during full time attendance at programs of vocational, 
technical, or academic education including normal school breaks;
    (2) Persons who are temporarily absent from the Health Service 
Delivery Area for purposes of travel or employment (such as seasonal or 
migratory workers);
    (3) Indian children placed in foster care outside the Health Service 
Delivery Area by order of a court of competent jurisdiction and who were 
residents within the Health Service Delivery Area at the time of the 
court order.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    Service means the Indian Health Service.
    Service Unit Director means the Director of Indian Health Service 
programs for a designated geographical or tribal area of responsibility 
or the equivalent official of a contractor administering an IHS program.

[52 FR 35048, Sept. 16, 1987, as amended at 55 FR 4609, Feb. 9, 1990]



Sec.  136a.11  Services available.

    (a) Type of services that may be available. Services for the Indian 
community served by the local facilities and program may include 
hospital and medical care, dental care, public health nursing and 
preventive care including immunizations, and health examination of 
special groups such as school children.
    (b) Where services are available. Available services will be 
provided at hospitals and clinics of the Service, and at contract 
facilities (including tribal facilities under contract with the 
Service).
    (c) Determination of what services are available. The Service does 
not provide the same health services in each area served. The services 
provided to any particular Indian community will depend upon the 
facilities and services available from sources other than the Service 
and the financial and personnel resources made available to the Service.
    (d) Priorities when funds, facilities, or personnel are insufficient 
to provide the indicated volume of services. Priorities for care and 
treatment, as among individuals who are within the scope of the

[[Page 888]]

program, will be determined on the basis of relative medical need and 
access to other arrangements for obtaining the necessary care.

[46 FR 40692, Aug. 11, 1981, as amended at 52 FR 35048, Sept. 16, 1987]



Sec.  136a.12  Persons to whom health services will be provided.

    (a) Subject to the requirements of this subpart, the Indian Health 
Service will provide direct services at its facilities, and contract 
health services, as medically indicated, and to the extent that funds 
and resources allocated to the particular Health Service Delivery Area 
permit, to persons of Indian or Alaska Native descent who:
    (1) Are members of a federally recognized Indian tribe; and
    (2) Reside within a Health Service Delivery Area designated under 
Sec.  36a.15; or
    (3) Are not members of a federally recognized Indian tribe but are 
the natural minor children (18 years old or under) of a member of a 
Federally recognized tribe and reside within a Health Service Delivery 
Area designated under Sec.  36a.15.
    (b) Subject to the requirements of this subpart, the Indian Health 
Service will also provide direct services at its facilities and, except 
where otherwise provided, contract health services, as medically 
indicated and to the extent that funds and resources allocated to the 
particular Health Service Delivery Area permit, to people in the 
circumstances listed below:
    (1) To persons who meet the eligibility criteria in paragraph (a) of 
this section except for the residency requirement, who formerly resided 
within a Health Service Delivery area designated under Sec.  36a.15, and 
who present themselves to any Indian Health Service or Indian Health 
Service funded facility (and to minor children of such persons if the 
children meet the eligibility criteria in paragraph (a) of this section 
except for the residency requirement). Contract health services may not 
be authorized for these individuals;
    (2) To a non-Indian woman pregnant with an eligible Indian's child 
but only during the period of her pregnancy through post-partum 
(generally about 6 weeks after delivery). In cases where the woman is 
not married to the eligible Indian under applicable state or tribal law, 
paternity must be acknowledged in writing by the Indian or determined by 
order of a court of competent jurisdiction;
    (3) To non-Indian members of an eligible Indian's household if the 
medical officer in charge determines that the health services are 
necessary to control acute infectious disease or a public health hazard; 
and
    (4) To an otherwise eligible person for up to 90 days after the 
person ceases to reside in a Health Service Delivery Area when the 
Service Unit Director has been notified of the move.
    (c) Contract health services will not be authorized when and to the 
extent that Indian Health Service or Indian Health Service funded 
facilities are available to provide the needed care. When funds are 
insufficient to provide the volume of contract health services needed by 
the service population, the Indian Health Service shall determine 
service priorities on the basis of medical need.
    (d) The Indian Health Service may provide direct services at its 
facilities on a fee-for-service basis to persons who are not 
beneficiaries under paragraphs (a) and (b) of this section under a 
number of authorities including the following:
    (1) In emergencies under section 322(b) of the Public Health Service 
Act, 42 U.S.C. 249(b), and 42 CFR 32.111 of the regulations;
    (2) To Public Health Service and other Federal beneficiaries under 
Economy Act (31 U.S.C. 1535) arrangements to the extent that providing 
services does not interfere with or restrict the provision of services 
to Indian and Alaska Native beneficiaries; and
    (3) To non-beneficiaries residing within the Health Service Delivery 
Area when approved by the tribe or tribes located on the reservation but 
only to the extent that providing services does not interfere with or 
restrict

[[Page 889]]

the provision of services to Indian and Alaska Native beneficiaries.

(Approved by the Office of Management and Budget under control number 
0915-0107)

[52 FR 35048, Sept. 16, 1987, as amended at 55 FR 4609, Feb. 9, 1990; 65 
FR 53914, Sept. 6, 2000]



Sec.  136a.13  Authorization for contract health services.

    (a) No payment will be made for medical care and services obtained 
from non-Service providers or in non-Service facilities unless the 
applicable requirements of paragraphs (b) and (c) below have been met 
and a purchase order for the care and services has been issued by the 
appropriate ordering official to the medical care provider.
    (b) In non-emergency cases, a sick or disabled Indian, or an 
individual or agency acting on behalf of the Indian, or the medical care 
provider shall, prior to the provision of medical care and services, 
notify the appropriate ordering official of the need for services and 
supply information that the ordering official deems necessary to 
determine the relative medical need for the services and the 
individual's eligibility. The requirement for notice prior to providing 
medical care and services under this paragraph may be waived by the 
ordering official if:
    (1) Such notice and information is provided within 72 hours after 
the beginning of treatment or admission to a health care facility; and
    (2) The ordering official determines that giving of notice prior to 
obtaining the medical care and services was impracticable or that other 
good cause exists for the failure to provide prior notice.
    (c) In emergency cases, a sick or disabled Indian, or an individual 
or agency acting on behalf of the Indian, or the medical care provider 
shall, within 72 hours after the beginning of treatment for the 
condition or after admission to a health care facility notify the 
appropriate ordering official of the fact of the admission or treatment, 
together with information necessary to determine the relative medical 
need for the services and the eligibility of the Indian for the 
services. The 72-hour period may be extended if the ordering official 
determines that notification within the prescribed period was 
impracticable or that other good cause exists for the failure to comply.

[43 FR 34654, Aug. 4, 1978. Redesignated at 52 FR 35048, Sept. 16, 1987]



Sec.  136a.14  Reconsideration and appeals.

    (a) Any person who has applied for and been denied health services 
or eligibility by the Indian Health Service or by any contractor 
contracting to administer an Indian Health Service program or portion of 
a program, including tribes and tribal organizations contracting under 
the Indian Self-Determination Act, shall be notified of the denial in 
writing together with a statement of all the reasons for the denial. The 
notice shall advise the applicant that within 30 days from the receipt 
of the notice the applicant.
    (b) If the original decision is affirmed on reconsideration, the 
applicant shall be so notified in writing and advised that an appeal may 
be taken to the area or program director within 30 days of receipt of 
the notice of the reconsidered decision. The appeal shall be in writing 
and shall set forth the grounds supporting the appeal.
    (c) If the original or reconsidered decision is affirmed on appeal 
by the area or program director, the applicant shall be so notified in 
writing and advised that a further appeal may be taken to the Director, 
Indian Health Service, within 30 days of receipt of the notice. The 
appeal shall be in writing and shall set forth the grounds supporting 
the appeal. The decision of the Director, Indian Health Service, shall 
constitute final administrative action.

(Approved by the Office of Management and Budget under control number 
0915-0107)

[43 FR 34654, Aug. 4, 1978. Redesignated and amended at 52 FR 35048, 
35049, Sept. 16, 1987]



Sec.  136a.15  Health Service Delivery Areas.

    (a) The Indian Health Service will designate and publish as a notice 
in the Federal Register specific geographic areas within the United 
States including Federal Indian reservations and areas surrounding those 
reservations as Health Service Delivery Areas.
    (b) The Indian Health Service may, after consultation with all the 
Indian

[[Page 890]]

tribes affected, redesignate the boundaries of any Health Service 
Delivery Area followed by publication of a notice in the Federal 
Register. Any redesignation of a Health Service Delivery area will 
include the reservation, and those areas close to the reservation 
boundaries which can reasonably be considered part of the reservation 
service area based on consideration of the following factors:
    (1) The number of persons residing in the off-reservation area who 
would be eligible under Sec.  36a.12(a) (1) and (3).
    (2) The number of persons residing in the off-reservation area who 
have traditionally received health services from the Indian Health 
Service and whose eligibility for services would be affected;
    (3) The geographic proximity of the off-reservation area to the 
reservation; and
    (4) Whether the Indians residing in the off-reservation area can be 
expected to need and to use health services provided by the Indian 
Health Service given the alternate resources (health facilities and 
payment sources) available and accessible to them.
    (c) Notwithstanding paragraphs (a) and (b) of this section, the 
Indian Health Service may designate States, subdivisions of States such 
as counties or towns, or other identifiable geographic areas such as 
census divisions or zip code areas, as Health Service Delivery Areas 
where reservations are nonexistent, or so small and scattered and the 
eligible Indian population so widely dispersed that it is inappropriate 
to use reservations as the basis for defining the Health Service 
Delivery Area.
    (d) Any Indian tribal government may request a change in the 
boundaries of the Health Service Delivery Area. Such a request should be 
supported by documentation related to the factors for consideration set 
out in paragraph (b) of this section and shall include documentation of 
any consultation with or notification of other affected or nearby 
tribes. The request shall be submitted to the appropriate Area 
Director(s) who shall afford all Indian tribes affected the opportunity 
to express their views orally and in writing. The Area Director(s) shall 
then submit the request, including all comments, together with the 
Area's recommendation and independent findings or verification of the 
factors set out in paragraph (b) of this section, to the Indian Health 
Service Director or to the Director's designee for the Indian Health 
Service decision. The decision of the Indian Health Service Director or 
the Director's designee shall constitute final agency action on the 
tribe's request. Changes in the boundaries of Health Service Delivery 
Areas will be published in the Federal Register.

(Approved by the Office of Management and Budget under control number 
0915-0107)

[52 FR 35049, Sept. 16, 1987, as amended at 65 FR 53914, Sept. 6, 2000]



Sec.  136a.16  Beneficiary Identification Cards and verification 
of tribal membership.

    (a) The Indian Health Service will issue Beneficiary Identification 
Cards as evidence of beneficiary status to persons who are currently 
eligible for services under Sec.  36a.12(a). Persons requesting 
Beneficiary Identification Cards must submit or have on file evidence 
satisfactory to the Indian Health Service of tribal membership and 
residence within a Health Service Delivery Area. The absence of a 
Beneficiary Identification Card will not preclude an otherwise eligible 
Indian from obtaining services though it may delay the administrative 
determination that an individual is eligible for services on a no charge 
basis.
    (b) For establishing eligibility or obtaining a Beneficiary 
Identification Card, applicants must demonstrate that they are members 
of a federally recognized tribe. Membership in a federally recognized 
tribe is to be determined by the individual tribe or the Bureau of 
Indian Affairs. Therefore, the Indian Health Service will recognize two 
methods of demonstrating tribal membership:
    (1) Documentation that the applicant meets the requirements of 
tribal membership as prescribed by the charter, articles of 
incorporation, or other legal instruments or traditional processes of 
the tribe and has been officially designated a tribal member by an 
authorized tribal official or body; or

[[Page 891]]

    (2) Certification of tribal enrollment or membership by the 
Secretary of the Interior acting through the Bureau of Indian Affairs.
    (c) Demonstrating membership in a federally recognized tribe is the 
responsibility of the applicant. However, the Indian Health Service may 
consult with the appropriate tribe or the Bureau of Indian Affairs on 
outstanding questions regarding an applicant's tribal membership if the 
Indian Health Service has some documentation that it believes may be 
helpful to the tribe or the Bureau of Indian Affairs in making their 
determination.

(Approved by the Office of Management and Budget under control number 
0915-0107)

[50 FR 35050, Sept. 16, 1987, as amended at 65 FR 53914, Sept. 6, 2000]

Subpart C [Reserved]



                     Subpart D_Transition Provisions

    Source: 52 FR 35050, Sept. 16, 1987, unless otherwise noted.



Sec.  136a.31  Transition period.

    (a) The transition period for full implementation of the new 
eligibility regulations consists of three parts;
    (1) A six month delayed implementation;
    (2) A six month grace period; and
    (3) A health care continuity period determined by medical factors.



Sec.  136a.32  Delayed implementation.

    (a) The eligibility requirements in subparts A and B of this part 
become effective March 16, 1988.
    (b) During the six month delayed implementation period the former 
eligibility regulations will apply.



Sec.  136a.33  Grace period.

    (a) Upon the effective date referred to in Sec.  36a.32(a), 
individuals who would lose their eligibility under the new eligilibity 
regulations published on September 16, 1987, and who have made use of an 
Indian Health Service of Indian Health Service funded service within 
three years prior to September 16, 1987 (date of publication of the new 
eligibility regulations) shall retain their eligibility for a six month 
grace period ending September 16, 1988. During this grace period such 
individual's eligibility will continue to be determined under the former 
regulations except that the new residency requirements established by 
subparts A and B must be met for the individual to be eligible.
    (b) All individuals who receive services during the grace period 
based on paragraph (a) of this section and whose eligibility will 
terminate on September 16, 1988, shall be notified in writing that after 
September 16, 1988 they will no longer the eligible for services as 
Indian Health Service beneficiaries. Such written notice should include 
an explanation of their appeal rights as provided in Sec.  36a.14 of the 
part. These patients shall be offered assistance in locating other 
health care providers and medical assistance programs.

[52 FR 35050, Sept. 16, 1987, as amended at 65 FR 53914, Sept. 6, 2000]



Sec.  136a.34  Care and treatment of people losing eligibility.

    (a) Individuals who lose their eligibility on September 16, 1988, 
(end of the grace period) and on that date are actively undergoing 
treatment may still be provided services for a limited period in the 
following circumstances;
    (1) Inpatients in IHS and IHS funded facilities and those receiving 
inpatient care under contract, including contract health services, may 
continue to receive such care and necessary follow-up services at Indian 
Health Service expense until the need for hospitalization and follow-up 
services has ended as determined by the responsible Indian Health 
Service or tribal physician, all other conditions being met including 
medical priorities;
    (2) Those actively undergoing a course of outpatient treatment 
either in Indian Health Service and Indian Health Service funded 
facilities or through contract health services, termination of which 
would impair the health of the individual patient, may continue to 
receive the treatment at Indian Health Service expense for a reasonable 
length of time, until the course of treatment reaches a point where it 
may safely be terminated or the patient transferred to other providers 
as determined by the responsible

[[Page 892]]

Indian Health Service or tribal physician, all other conditions being 
met including medical priorities.
    (3) Those under treatment for chronic degenerative conditions may be 
provided additional treatment at Indian Health Service expense for no 
longer than 1 year beyond the end of the grace period notwithstanding 
any determination that it was otherwise safe to transfer treatment to 
other providers, all other conditions being met including medical 
priorities.
    (b) All patients receiving care under paragraph (a) of this section 
shall be notified in writing that, after discharge from care provided 
under any of the above circumstances, they will no longer be eligible 
for services as Indian Health Service beneficiaries. Such notice shall 
include an explanation of their appeal rights as provided in Sec.  
36a.14 of this part. These patients shall be offered assistance in 
locating other health care providers and medical assistance programs.

[52 FR 35050, Sept. 16, 1987, as amended at 65 FR 53914, Sept. 6, 2000]



                   Subpart E_Preference in Employment

    Authority: 25 U.S.C. 44, 45, 46 and 472; Pub. L. 83-568, 42 U.S.C. 
2003.



Sec.  136a.41  Definitions.

    For purposes of making appointments to vacancies in all positions in 
the Indian Health Service a preference will be extended to persons of 
Indian descent who are:
    (a) Members of any recognized Indian tribe now under Federal 
jurisdiction;
    (b) Descendants of such members who were, on June 1, 1934, residing 
within the present boundaries of any Indian reservation;
    (c) All others of one-half or more Indian blood of tribes indigenous 
to the United States;
    (d) Eskimos and other aboriginal people of Alaska; or
    (e) Until January 4, 1990 or until the Osage Tribe has formally 
organized, whichever comes first, a person of at least one-quarter 
degree Indian ancestry of the Osage Tribe of Indians, whose rolls were 
closed by an act of Congress.

[43 FR 29783, July 11, 1978, as amended at 54 FR 48246, Nov. 22, 1989]



Sec.  136a.42  Appointment actions.

    (a) Preference will be afforded a person meeting any one of the 
definitions of Sec.  36a.41 whether the placement in the position 
involves initial appointment, reappointment, reinstatement, transfer, 
reassignment, promotion, or any other personnel action intended to fill 
a vacancy.
    (b) Preference eligibles may be given a schedule A excepted 
appointment under 5 CFR 213.3116(b)(8). If the individuals are within 
reach on a Civil Service Register, they may be given a competitive 
appointment.

[43 FR 29783, July 11, 1978, as amended at 65 FR 53914, Sept. 6, 2000]



Sec.  136a.43  Application procedure for preference eligibility.

    To be considered a preference eligible, the person must submit with 
the employment application a Bureau of Indian Affairs certification that 
the person is an Indian as defined by Sec.  36a.41 except that an 
employee of the Indian Health Service who has a certificate of 
preference eligibility on file in the Official Personnel Folder is not 
required to resubmit such proof but may instead include a statement on 
the application that proof of eligibility is on file in the Official 
Personnel Folder.

[43 FR 29783, July 11, 1978, as amended at 65 FR 53914, Sept. 6, 2000]



   Subpart F_Abortions and Related Medical Services in Indian Health 
          Service Facilities and Indian Health Service Programs

    Authority: Sec. 1, 42 Stat. 208, 25 U.S.C. 13; sec. 1, 68 Stat. 674, 
42 U.S.C. 2001; sec. 3, 68 Stat. 674, 42 U.S.C. 2003.

    Source: 47 FR 4018, Jan. 27, 1982, unless otherwise noted.



Sec.  136a.51  Applicability.

    This subpart is applicable to the use of Federal funds in providing 
health

[[Page 893]]

services to Indians in accordance with the provisions of subparts A, B, 
C, H, I and J of this part.



Sec.  136a.52  Definitions.

    As used in this subpart:
    Physician means a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery at an Indian Health Service 
or tribally run facility, or by the State in which he or she practices.



Sec.  136a.53  General rule.

    Federal funds may not be used to pay for or otherwise provide for 
abortions in the programs described in Sec.  36a.51, except under the 
Circumstances discribed in Sec.  36a.54.

[47 FR 4018, Jan. 27, 1982, as amended at 65 FR 53914, Sept. 6, 2000]



Sec.  136a.54  Life of the mother would be endangered.

    Federal funds are available for an abortion when a physician has 
found and so certified in writing to the appropriate tribal or other 
contracting organization, or service unit or area director, that ``on 
the basis of my professional judgement the life of the mother would be 
endangered if the fetus were carried to term.'' The certification must 
contain the name and address of the patient.



Sec.  136a.55  Drugs and devices and termination of ectopic pregnancies.

    Federal funds are available for drugs or devices to prevent 
implantation of the fertilized ovum, and for medical procedures 
necessary for the termination of an ectopic pregnancy.



Sec.  136a.56  Recordkeeping requirements.

    Documents required by Sec.  36a.54 must be maintained for three 
years pursuant to the retention and custodial requirements for records 
at 45 CFR 74.20 et seq.

[47 FR 4018, Jan. 27, 1982, as amended at 65 FR 53914, Sept. 6, 2000]



Sec.  136a.57  Confidentiality.

    Information which is acquired in connection with the requirements of 
this subpart may not be disclosed in a form which permits the 
identification of an individual without the individual's consent, except 
as may be necessary for the health of the individual or as may be 
necessary for the Secretary to monitor Indian Health Service program 
activities. In any event, any disclosure shall be subject to appropriate 
safeguards which will minimize the likelihood of disclosures of personal 
information in identifiable form.



                        Subpart G_Residual Status



Sec.  136a.61  Payor of last resort.

    (a) The Indian Health Service is the payor of last resort of persons 
defined as eligible for contract health services under these 
regulations, notwithstanding any State or local law or regulation to the 
contrary.
    (b) Accordingly, the Indian Health Service will not be responsible 
for or authorize payment for contract health services to the extent 
that:
    (1) The Indian is eligible for alternate resources, as defined in 
paragraph (c), or
    (2) The Indian would be eligible for alternate resources if he or 
she were to apply for them, or
    (3) The Indian would be eligible for alternate resources under State 
or local law or regulation but for the Indian's eligibility for contract 
health services, or other health services, from the Indian Health 
Service or Indian Health Service funded programs.
    (c) Alternate resources means health care resources other than those 
of the Indian Health Service. Such resources include health care 
providers and institutions, and health care programs for the payment of 
health services including but not limited to programs under title XVIII 
and XIX of the Social Security Act (i.e., Medicare, Medicaid), State or 
local health care programs and private insurance.

[55 FR 4609, Feb. 9, 1990]



PART 137_TRIBAL SELF-GOVERNANCE--Table of Contents



                      Subpart A_General Provisions

Sec.
137.1 Authority, purpose and scope.
137.2 Congressional policy.
137.3 Effect on existing Tribal rights.

[[Page 894]]

137.4 May Title V be construed to limit or reduce in any way the funding 
          for any program, project, or activity serving an Indian Tribe 
          under this or other applicable Federal law?
137.5 Effect of these regulations on Federal program guidelines, manual, 
          or policy directives.
137.6 Secretarial policy.

                          Subpart B_Definitions

137.10 Definitions.

     Subpart C_Selection of Indian Tribes for Participation in Self-
                               Governance

137.15 Who may participate in Tribal Self-Governance?
137.16 What if more than 50 Indian Tribes apply to participate in self-
          governance?
137.17 May more than one Indian Tribe participate in the same compact 
          and/or funding agreement?
137.18 What criteria must an Indian Tribe satisfy to be eligible to 
          participate in self-governance?

                             Planning Phase

137.20 What is required during the planning phase?
137.21 How does an Indian Tribe demonstrate financial stability and 
          financial management capacity?
137.22 May the Secretary consider uncorrected significant and material 
          audit exceptions identified regarding centralized financial 
          and administrative functions?
137.23 For purposes of determining eligibility for participation in 
          self-governance, may the Secretary consider any other 
          information regarding the Indian Tribe's financial stability 
          and financial management capacity?
137.24 Are there grants available to assist the Indian Tribe to meet the 
          requirements to participate in self-governance?
137.25 Are planning and negotiation grants available?
137.26 Must an Indian Tribe receive a planning or negotiation grant to 
          be eligible to participate in self-governance?

                    Subpart D_Self-Governance Compact

137.30 What is a self-governance compact?
137.31 What is included in a compact?
137.32 Is a compact required to participate in self-governance?
137.33 May an Indian Tribe negotiate a funding agreement at the same 
          time it is negotiating a compact?
137.34 May a funding agreement be executed without negotiating a 
          compact?
137.35 What is the term of a self-governance compact?

                      Subpart E_Funding Agreements

137.40 What is a funding agreement?
137.41 What PSFAs must be included in a funding agreement?
137.42 What Tribal shares may be included in a funding agreement?
137.43 May a Tribe negotiate and leave funds with IHS for retained 
          services?

                      Terms in a Funding Agreement

137.45 What terms must be included in a funding agreement?
137.46 May additional terms be included in a funding agreement?
137.47 Do any provisions of Title I apply to compacts, funding 
          agreements, and construction project agreements negotiated 
          under Title V of the Act?
137.48 What is the effect of incorporating a Title I provision into a 
          compact or funding agreement?
137.49 What if a Self-Governance Tribe requests such incorporation at 
          the negotiation stage of a compact or funding agreement?

                       Term of a Funding Agreement

137.55 What is the term of a funding agreement?
137.56 Does a funding agreement remain in effect after the end of its 
          term?
137.57 How is a funding agreement amended during the effective period of 
          the funding agreement?

                  Subpart F_Statutorily Mandated Grants

137.60 May a statutorily mandated grant be added to a funding agreement?
137.65 May a Self-Governance Tribe receive statutorily mandated grant 
          funding in an annual lump sum advance payment?
137.66 May a Self-Governance Tribe keep interest earned on statutorily 
          mandated grant funds?
137.67 How may a Self-Governance Tribe use interest earned on 
          statutorily mandated grant funds?
137.68 May funds from a statutorily mandated grant be added to a funding 
          agreement be reallocated?
137.69 May a statutorily mandated grant program added to a funding 
          agreement be redesigned?
137.70 Are the reporting requirements different for a statutorily 
          mandated grant program added to a funding agreement?
137.71 May the Secretary and the Self-Governance Tribe develop separate 
          programmatic reporting requirements for statutorily mandated 
          grants?
137.72 Are Self-Governance Tribes and their employees carrying out 
          statutorily mandated grant programs added to a funding 
          agreement covered by the Federal Tort Claims Act (FTCA)?

[[Page 895]]

137.73 What provisions of Title V apply to statutorily mandated grants 
          added to the funding agreement?

                            Subpart G_Funding

                                 General

137.75 What funds must the Secretary transfer to a Self-Governance Tribe 
          in a funding agreement?
137.76 When must the Secretary transfer to a Self-Governance Tribe funds 
          identified in a funding agreement?
137.77 When must the Secretary transfer funds that were not paid as part 
          of the initial lump sum payment?
137.78 May a Self-Governance Tribe negotiate a funding agreement for a 
          term longer or shorter than one year?
137.79 What funds must the Secretary include in a funding agreement?

                              Prohibitions

137.85 Is the Secretary prohibited from failing or refusing to transfer 
          funds that are due to a Self-Governance Tribe under Title V?
137.86 Is the Secretary prohibited from reducing the amount of funds 
          required under Title V to make funding available for self-
          governance monitoring or administration by the Secretary?
137.87 May the Secretary reduce the amount of funds due under Title V in 
          subsequent years?
137.88 May the Secretary reduce the amount of funds required under Title 
          V to pay for Federal functions, including Federal pay costs, 
          Federal employee retirement benefits, automated data 
          processing, technical assistance, and monitoring of activities 
          under the Act?
137.89 May the Secretary reduce the amount of funds required under Title 
          V to pay for costs of Federal personnel displaced by contracts 
          under Title I or self-governance under Title V?
137.90 May the Secretary increase the funds required under the funding 
          agreement?

             Acquisition of Goods and Services From the IHS

137.95 May a Self-Governance Tribe purchase goods and services from the 
          IHS on a reimbursable basis?

                           Prompt Payment Act

137.96 Does the Prompt Payment Act apply to funds transferred to a Self-
          Governance Tribe in a compact or funding agreement?

                  Interest or Other Income on Transfers

137.100 May a Self-Governance Tribe retain and spend interest earned on 
          any funds paid under a compact or funding agreement?
137.101 What standard applies to a Self-Governance Tribe's management of 
          funds paid under a compact or funding agreement?

                           Carryover of Funds

137.105 May a Self-Governance Tribe carryover from one year to the next 
          any funds that remain at the end of the funding agreement?

                             Program Income

137.110 May a Self-Governance Tribe retain and expend any program income 
          earned pursuant to a compact and funding agreement?

                           Limitation of Costs

137.115 Is a Self-Governance Tribe obligated to continue performance 
          under a compact or funding agreement if the Secretary does not 
          transfer sufficient funds?

                           Stable Base Budget

137.120 May a Self-Governance Tribe's funding agreement provide for a 
          stable base budget?
137.121 What funds may be included in a stable base budget amount?
137.122 May a Self-Governance Tribe with a stable base budget receive 
          other funding under its funding agreement?
137.123 Once stable base funding is negotiated, do funding amounts 
          change from year to year?
137.124 Does the effective period of a stable base budget have to be the 
          same as the term of the funding agreement?

                          Subpart H_Final Offer

137.130 What is covered by this subpart?
137.131 When should a final offer be submitted?
137.132 How does the Indian Tribe submit a final offer?
137.133 What does a final offer contain?
137.134 When does the 45-day review period begin?
137.135 May the Secretary request and obtain an extension of time of the 
          45-day review period?
137.136 What happens if the agency takes no action within the 45-day 
          review period (or any extensions thereof)?
137.137 If the 45-day review period or extension thereto, has expired, 
          and the Tribe's offer is deemed accepted by operation of law, 
          are there any exceptions to this rule?
137.138 Once the Indian Tribe's final offer has been accepted or deemed 
          accepted by operation of law, what is the next step?

[[Page 896]]

                        Rejection of Final Offers

137.140 On what basis may the Secretary reject an Indian Tribe's final 
          offer?
137.141 How does the Secretary reject a final offer?
137.142 What is a ``significant danger'' or ``risk'' to the public 
          health'?
137.143 How is the funding level to which the Indian Tribe is entitled 
          determined?
137.144 Is technical assistance available to an Indian Tribe to avoid 
          rejection of a final offer?
137.145 If the Secretary rejects a final offer, is the Secretary 
          required to provide the Indian Tribe with technical 
          assistance?
137.146 If the Secretary rejects all or part of a final offer, is the 
          Indian Tribe entitled to an appeal?
137.147 Do those portions of the compact, funding agreement, or 
          amendment not in dispute go into effect?
137.148 Does appealing the decision of the Secretary prevent entering 
          into the compact, funding agreement or amendment?

                             Burden of Proof

137.150 What is the burden of proof in an appeal from rejection of a 
          final offer?

                             Decision Maker

137.155 What constitutes a final agency action?

                    Subpart I_Operational Provisions

                          Conflicts of Interest

137.160 Are Self-Governance Tribes required to address potential 
          conflicts of interest?

                       Audits and Cost Principles

137.165 Are Self-Governance Tribes required to undertake annual audits?
137.166 Are there exceptions to the annual audit requirements?
137.167 What cost principles must a Self-Governance Tribe follow when 
          participating in self-governance under Title V?
137.168 May the Secretary require audit or accounting standards other 
          than those specified in Sec.  137.167?
137.169 How much time does the Federal Government have to make a claim 
          against a Self-Governance Tribe relating to any disallowance 
          of costs, based on an audit conducted under Sec.  137.165?
137.170 When does the 365-day period commence?
137.171 Where do Self-Governance Tribes send their audit reports?
137.172 Should the audit report be sent anywhere else to ensure receipt 
          by the Secretary?
137.173 Does a Self-Governance Tribe have a right of appeal from a 
          disallowance?

                                 Records

137.175 Is a Self-Governance Tribe required to maintain a recordkeeping 
          system?
137.176 Are Tribal records subject to the Freedom of Information Act and 
          Federal Privacy Act?
137.177 Is the Self-Governance Tribe required to make its records 
          available to the Secretary?
137.178 May Self-Governance Tribes store patient records at the Federal 
          Records Centers?
137.179 May a Self-Governance Tribe make agreements with the Federal 
          Records Centers regarding disclosure and release of the 
          patient records stored pursuant to Sec.  137.178?
137.180 Are there other laws that govern access to patient records?

                                Redesign

137.185 May a Self-Governance Tribe redesign or consolidate the PSFAs 
          that are included in a funding agreement and reallocate or 
          redirect funds for such PSFAs?

                             Non-Duplication

137.190 Is a Self-Governance Tribe that receives funds under Title V 
          also entitled to contract under section 102 of the Act [25 
          U.S.C. 450(f)] for such funds?

                          Health Status Reports

137.200 Are there reporting requirements for Self-Governance Tribes 
          under Title V?
137.201 What are the purposes of the Tribal reporting requirements?
137.202 What types of information will Self-Governance Tribes be 
          expected to include in the reports?
137.203 May a Self-Governance Tribe participate in a voluntary national 
          uniform data collection effort with the IHS?
137.204 How will this voluntary national uniform data set be developed?
137.205 Will this voluntary uniform data set reporting activity be 
          required of all Self-Governance Tribes entering into a compact 
          with the IHS under Title V?
137.206 Why does the IHS need this information?
137.207 Will funding be provided to the Self-Governance Tribe to 
          compensate for the costs of reporting?

                                 Savings

137.210 What happens if self-governance activities under Title V reduce 
          the administrative or other responsibilities of the Secretary 
          with respect to the operation of Indian programs and result in 
          savings?
137.211 How does a Self-Governance Tribe learn whether self-governance 
          activities

[[Page 897]]

          have resulted in savings as described in Sec.  137.210.

                 Access to Government Furnished Property

137.215 How does a Self-Governance Tribe obtain title to real and 
          personal property furnished by the Federal Government for use 
          in the performance of a compact, funding agreement, 
          construction project agreement, or grant agreement pursuant to 
          section 512(c) of the Act [25 U.S.C. 458aaa-11(c)]?

              Matching and Cost Participation Requirements

137.217 May funds provided under compacts, funding agreements, or grants 
          made pursuant to Title V be treated as non-Federal funds for 
          purposes of meeting matching or cost participation 
          requirements under any other Federal or non-Federal program?

                     Federal Tort Claims Act (FTCA)

137.220 Do section 314 of Public Law 101-512 [25 U.S.C. 450f note] and 
          section 102(d) of the Act [25 U.S.C. 450f(d)] (regarding, in 
          part, FTCA coverage) apply to compacts, funding agreements and 
          construction project agreements?

                       Subpart J_Regulation Waiver

137.225 What regulations may be waived under Title V?
137.226 How does a Self-Governance Tribe request a waiver?
137.227 How much time does the Secretary have to act on a waiver 
          request?
137.228 Upon what basis may the waiver request be denied?
137.229 What happens if the Secretary neither approves or denies a 
          waiver request within the time specified in Sec.  137.227.
137.230 Is the Secretary's decision on a waiver request final for the 
          Department?
137.231 May a Self-Governance Tribe appeal the Secretary's decision to 
          deny its request for a waiver of a regulation promulgated 
          under section 517 of the Act [25 U.S.C. 458aaa-16]?

                          Subpart K_Withdrawal

137.235 May an Indian Tribe withdraw from a participating inter-Tribal 
          consortium or Tribal organization?
137.236 When does a withdrawal become effective?
137.237 How are funds redistributed when an Indian Tribe fully or 
          partially withdraws from a compact or funding agreement and 
          elects to enter a contract or compact?
137.238 How are funds distributed when an Indian Tribe fully or 
          partially withdraws from a compact or funding agreement 
          administered by an inter-Tribal consortium or Tribal 
          organization serving more than one Indian Tribe and the 
          withdrawing Indian Tribe elects not to enter a contract or 
          compact?
137.239 If the withdrawing Indian Tribe elects to operate PSFAs carried 
          out under a compact or funding agreement under Title V through 
          a contract under Title I, is the resulting contract considered 
          a mature contract under section 4(h) of the Act [25 U.S.C. 
          450b(h)]?

                         Subpart L_Retrocession

137.245 What is retrocession ?
137.246 How does a Self-Governance Tribe retrocede a PSFA?
137.247 What is the effective date of a retrocession?
137.248 What effect will a retrocession have on a retroceding Self-
          Governance Tribe's rights to contract or compact under the 
          Act?
137.249 Will retrocession adversely affect funding available for the 
          retroceded program?
137.250 How are funds distributed when a Self-Governance Tribe fully or 
          partially retrocedes from its compact or funding agreement?
137.251 What obligation does the retroceding Self-Governance Tribe have 
          with respect to returning property that was provided by the 
          Secretary under the compact or funding agreement and that was 
          used in the operation of the retroceded program?

                         Subpart M_Reassumption

137.255 What does reassumption mean?
137.256 Under what circumstances may the Secretary reassume a program, 
          service, function, or activity (or portion thereof)?
137.257 What steps must the Secretary take prior to reassumption 
          becoming effective?
137.258 Does the Self-Governance Tribe have a right to a hearing prior 
          to a non-immediate reassumption becoming effective?
137.259 What happens if the Secretary determines that the Self-
          Governance Tribe has not corrected the conditions that the 
          Secretary identified in the notice?
137.260 What is the earliest date on which a reassumption can be 
          effective?
137.261 Does the Secretary have the authority to immediately reassume a 
          PSFA?
137.262 If the Secretary reassumes a PSFA immediately, when must the 
          Secretary provide the Self-Governance Tribe with a hearing?
137.263 May the Secretary provide a grant to a Self-Governance Tribe for 
          technical assistance to overcome conditions identified under 
          Sec.  137.257?

[[Page 898]]

137.264 To what extent may the Secretary require the Self-Governance 
          Tribe to return property that was provided by the Secretary 
          under the compact or funding agreement and used in the 
          operation of the reassume program?
137.265 May a Tribe be reimbursed for actual and reasonable close out 
          costs incurred after the effective date of reassumption?

                         Subpart N_Construction

                            Purpose and Scope

137.270 What is covered by this subpart?
137.271 Why is there a separate subpart in these regulations for 
          construction project agreements?
137.272 What other alternatives are available for Self-Governance Tribes 
          to perform construction projects?
137.273 What are IHS construction PSFAs?
137.274 Does this subpart cover construction programs?
137.275 May Self-Governance Tribes include IHS construction programs in 
          a construction project agreement or in a funding agreement?

                        Construction Definitions

137.280 Construction definitions.

                              NEPA Process

137.285 Are Self-Governance Tribes required to accept Federal 
          environmental responsibilities to enter into a construction 
          project agreement?
137.286 Do Self-Governance Tribes become Federal agencies when they 
          assume these Federal environmental responsibilities?
137.287 What is the National Environmental Policy Act (NEPA)?
137.288 What is the National Historic Preservation Act (NHPA)?
137.289 What is a Federal undertaking under NHPA?
137.290 What additional provisions of law are related to NEPA and NHPA?
137.291 May Self-Governance Tribes carry out construction projects 
          without assuming these Federal environmental responsibilities?
137.292 How do Self-Governance Tribes assume environmental 
          responsibilities for construction projects under section 509 
          of the Act [25 U.S.C. 458aaa-8]?
137.293 Are Self-Governance Tribes required to adopt a separate 
          resolution or take equivalent Tribal action to assume 
          environmental responsibilities for each construction project 
          agreement?
137.294 What is the typical IHS environmental review process for 
          construction projects?
137.295 May Self-Governance Tribes elect to develop their own 
          environmental review process?
137.296 How does a Self-Governance Tribe comply with NEPA and NHPA?
137.297 If the environmental review procedures of a Federal agency are 
          adopted by a Self-Governance Tribe, is the Self-Governance 
          Tribe responsible for ensuring the agency's policies and 
          procedures meet the requirements of NEPA, NHPA, and related 
          environmental laws?
137.298 Are Self-Governance Tribes required to comply with Executive 
          Orders to fulfill their environmental responsibilities under 
          section 509 of the Act [25 U.S.C. 458aaa-8]?
137.299 Are Federal funds available to cover the cost of Self-Governance 
          Tribes carrying out environmental responsibilities?
137.300 Since Federal environmental responsibilities are new 
          responsibilities which may be assumed by Tribes under section 
          509 of the Act [25 U.S.C. 458aaa-8], are there additional 
          funds available to Self-Governance Tribes to carry out these 
          formerly inherently Federal responsibilities?
137.301 How are project and program environmental review costs 
          identified?
137.302 Are Federal funds available to cover start-up costs associated 
          with initial Tribal assumption of environmental 
          responsibilities?
137.303 Are Federal or other funds available for training associated 
          with Tribal assumption of environmental responsibilities?
137.304 May Self-Governance Tribes buy back environmental services from 
          the IHS?
137.305 May Self-Governance Tribes act as lead, cooperating, or joint 
          lead agencies for environmental review purposes?
137.306 How are Self-Governance Tribes recognized as having lead, 
          cooperating, or joint lead agency status?
137.307 What Federal environmental responsibilities remain with the 
          Secretary when a Self-Governance Tribe assumes Federal 
          environmental responsibilities for construction projects under 
          section 509 of the Act [25 U.S.C. 458aaa-8]?
137.308 Does the Secretary have any enforcement authority for Federal 
          environmental responsibilities assumed by Tribes under Section 
          509 of the Act?
137.309 How are NEPA and NHPA obligations typically enforced?
137.310 Are Self-Governance Tribes required to grant a limited waiver of 
          their sovereign immunity to assume Federal environmental 
          responsibilities under Section 509 of the Act [25 U.S.C. 
          458aaa-8]?
137.311 Are Self-Governance Tribes entitled to determine the nature and 
          scope of the

[[Page 899]]

          limited immunity waiver required under section 509(a)(2) of 
          the Act?
137.312 Who is the proper defendant in a civil enforcement action under 
          section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)]?

    Notification (Prioritization Process, Planning, Development and 
                              Construction)

137.320 Is the Secretary required to consult with affected Indian Tribes 
          concerning construction projects and programs?
137.321 How do Indian Tribes and the Secretary identify and request 
          funds for needed construction projects?
137.322 Is the Secretary required to notify an Indian Tribe that funds 
          are available for a construction project or a phase of a 
          project?

                       Project Assumption Process

137.325 What does a Self-Governance Tribe do if it wants to perform a 
          construction project under section 509 of the Act [25 U.S.C. 
          458aaa-8]?
137.326 What must a Tribal proposal for a construction project agreement 
          contain?
137.327 May multiple projects be included in a single construction 
          project agreement?
137.328 Must a construction project proposal incorporate provisions of 
          Federal construction guidelines and manuals?
137.329 What environmental considerations must be included in the 
          construction project agreement?
137.330 What happens if the Self-Governance Tribe and the Secretary 
          cannot develop a mutually agreeable construction project 
          agreement?
137.331 May the Secretary reject a final construction project proposal 
          based on a determination of Tribal capacity or capability?
137.332 On what bases may the Secretary reject a final construction 
          project proposal?
137.333 What procedures must the Secretary follow if the Secretary 
          rejects a final construction project proposal, in whole or in 
          part?
137.334 What happens if the Secretary fails to notify the Self-
          Governance Tribe of a decision to approve or reject a final 
          construction project proposal within the time period allowed?
137.335 What costs may be included in the budget for a construction 
          agreement?
137.336 What is the difference between fixed-price and cost-
          reimbursement agreements?
137.337 What funding must the Secretary provide in a construction 
          project agreement?
137.338 Must funds from other sources be incorporated into a 
          construction project agreement?
137.339 May the Self-Governance Tribe use project funds for matching or 
          cost participation requirements under other Federal and non-
          Federal programs?
137.340 May a Self-Governance Tribe contribute funding to a project?
137.341 How will a Self-Governance Tribe receive payment under a 
          construction project agreement?
137.342 What happens to funds remaining at the conclusion of a cost 
          reimbursement construction project?
137.343 What happens to funds remaining at the conclusion of a fixed 
          price construction project?
137.344 May a Self-Governance Tribe reallocate funds among construction 
          project agreements?

    Roles of Self-Governance Tribe in Establishing and Implementing 
                     Construction Project Agreements

137.350 Is a Self-Governance Tribe responsible for completing a 
          construction project in accordance with the negotiated 
          construction project agreement?
137.351 Is a Self-Governance Tribe required to submit construction 
          project progress and financial reports for construction 
          project agreements?
137.352 What is contained in a construction project progress report?
137.353 What is contained in a construction project financial report?

  Roles of the Secretary in Establishing and Implementing Construction 
                           Project Agreements

137.360 Does the Secretary approve project planning and design documents 
          prepared by the Self-Governance Tribe?
137.361 Does the Secretary have any other opportunities to approve 
          planning or design documents prepared by the Self-Governance 
          Tribe?
137.362 May construction project agreements be amended?
137.363 What is the procedure for the Secretary's review and approval of 
          amendments?
137.364 What constitutes a significant change in the original scope of 
          work?
137.365 What is the procedure for the Secretary's review and approval of 
          project planning and design documents submitted by the Self-
          Governance Tribe?
137.366 May the Secretary conduct onsite project oversight visits?
137.367 May the Secretary issue a stop work order under a construction 
          project agreement?
137.368 Is the Secretary responsible for oversight and compliance of 
          health and safety codes during construction projects being 
          performed by a Self-Governance

[[Page 900]]

          Tribe under section 509 of the Act [25 U.S.C. 488aaa-8]?

                                  Other

137.370 Do all provisions of this part apply to construction project 
          agreements under this subpart?
137.371 Who takes title to real property purchased with funds provided 
          under a construction project agreement?
137.372 Does the Secretary have a role in the fee-to-trust process when 
          real property is purchased with construction project agreement 
          funds?
137.373 Do Federal real property laws, regulations and procedures that 
          apply to the Secretary also apply to Self-Governance Tribes 
          that purchase real property with funds provided under a 
          construction project agreement?
137.374 Does the Secretary have a role in reviewing or monitoring a 
          Self-Governance Tribe's actions in acquiring or leasing real 
          property with funds provided under a construction project 
          agreement?
137.375 Are Tribally-owned facilities constructed under section 509 of 
          the Act [25 U.S.C. 458aaa-8] eligible for replacement, 
          maintenance, and improvement funds on the same basis as if 
          title to such property were vested in the United States?
137.376 Are design and construction projects performed by Self-
          Governance Tribes under section 509 of the Act [25 U.S.C. 
          458aaa-8] subject to Federal metric requirements?
137.377 Do Federal procurement law and regulations apply to construction 
          project agreements performed under section 509 of the Act [25 
          U.S.C. 458aaa-8]?
137.378 Does the Federal Davis-Bacon Act and wage rates apply to 
          construction projects performed by Self-Governance Tribes 
          using their own funds or other non-Federal funds?
137.379 Do Davis-Bacon wage rates apply to construction projects 
          performed by Self-Governance Tribes using Federal funds?

                 Subpart O_Secretarial Responsibilities

                             Budget Request

137.401 What role does Tribal consultation play in the IHS annual budget 
          request process?

                                 Reports

137.405 Is the Secretary required to report to Congress on 
          administration of Title V and the funding requirements 
          presently funded or unfunded?
137.406 In compiling reports pursuant to this section, may the Secretary 
          impose any reporting requirements on Self-Governance Tribes, 
          not otherwise provided in Title V?
137.407 What guidelines will be used by the Secretary to compile 
          information required for the report?

                            Subpart P_Appeals

137.410 For the purposes of section 110 of the Act [25 U.S.C. 450m-1] 
          does the term ``contract'' include compacts, funding 
          agreements, and construction project agreements entered into 
          under Title V?

                           Post-Award Disputes

137.412 Do the regulations at 25 CFR Part 900, Subpart N apply to 
          compacts, funding agreements, and construction project 
          agreements entered into under Title V?

                           Pre-Award Disputes

137.415 What decisions may an Indian Tribe appeal under Sec. Sec.  
          137.415 through 137.436?
137.416 Do Sec. Sec.  137.415 through 137.436 apply to any other 
          disputes?
137.417 What procedures apply to Interior Board of Indian Appeals (IBIA) 
          proceedings?
137.418 How does an Indian Tribe know where and when to file its appeal 
          from decisions made by IHS?
137.419 What authority does the IBIA have under Sec. Sec.  137.415 
          through 137.436?
137.420 Does an Indian Tribe have any options besides an appeal?
137.421 How does an Indian Tribe request an informal conference?
137.422 How is an informal conference held?
137.423 What happens after the informal conference?
137.424 Is the recommended decision from the informal conference final 
          for the Secretary?
137.425 How does an Indian Tribe appeal the initial decision if it does 
          not request an informal conference or if it does not agree 
          with the recommended decision resulting from the informal 
          conference?
137.426 May an Indian Tribe get an extension of time to file a notice of 
          appeal?
137.427 What happens after an Indian Tribe files an appeal?
137.428 How is a hearing arranged?
137.429 What happens when a hearing is necessary?
137.430 What is the Secretary's burden of proof for appeals covered by 
          Sec.  137.145?
137.431 What rights do Indian Tribes and the Secretary have during the 
          appeal process?
137.432 What happens after the hearing?
137.433 Is the recommended decision always final?
137.434 If an Indian Tribe objects to the recommended decision, what 
          will the Secretary do?
137.435 Will an appeal adversely affect the Indian Tribe's rights in 
          other compact,

[[Page 901]]

          funding negotiations, or construction project agreements?
137.436 Will the decisions on appeal be available for the public to 
          review?

    Appeals of an Immediate Reassumption of a Self-Governance Program

137.440 What happens in the case of an immediate reassumption under 
          section 507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)]?
137.441 Will there be a hearing?
137.442 What happens after the hearing?
137.443 Is the recommended decision always final?
137.444 If a Self-Governance Tribe objects to the recommended decision, 
          what action will the Secretary take?
137.445 Will an immediate reassumption appeal adversely affect the Self-
          Governance Tribe's rights in other self-governance 
          negotiations?

                    Equal Access to Justice Act Fees

137.450 Does the Equal Access to Justice Act (EAJA) apply to appeals 
          under this subpart?

    Authority: 25 U.S.C. 458 et seq.

    Source: 67 FR 35342, May 17, 2002, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  137.1  Authority, purpose and scope

    (a) Authority. These regulations are prepared, issued and maintained 
with the active participation and representation of Indian Tribes, 
Tribal organizations and inter-Tribal consortia pursuant to the guidance 
of the negotiated rulemaking procedures required by section 517 of the 
Act [25 U.S.C. 458aaa-16].
    (b) Purpose. These regulations codify rules for self-governance 
compacts, funding agreements, and construction project agreements 
between the Department of Health and Human Services (DHHS) and Self-
Governance Tribes to implement sections 2, 3, and 4 of Pub. L. 106-260.
    (c) Scope. These regulations are binding on the Secretary and on 
Indian Tribes carrying out programs, services, functions, and activities 
(or portions thereof) (PSFAs) under Title V except as otherwise 
specifically authorized by a waiver under section 512(b) of the Act [25 
U.S.C. 458aaa-11(b)].
    (d) Information collection. The information collection requirements 
have been submitted to the Office of Management and Budget (OMB) and are 
pending OMB approval.



Sec.  137.2  Congressional policy.

    (a) According to section 2 of Pub. L. 106-260, Congress has declared 
that:
    (1) The Tribal right of self-government flows from the inherent 
sovereignty of Indian Tribes and nations;
    (2) The United States recognizes a special government-to-government 
relationship with Indian Tribes, including the right of the Indian 
Tribes to self-governance, as reflected in the Constitution, treaties, 
Federal statutes, and the course of dealings of the United States with 
Indian Tribes;
    (3) Although progress has been made, the Federal bureaucracy, with 
its centralized rules and regulations, has eroded Tribal Self-Governance 
and dominates Tribal affairs.
    (4) The Tribal Self-Governance Demonstration Project, established 
under title III of the Indian Self-Determination Act (ISDA) [25 U.S.C. 
450f note] was designed to improve and perpetuate the government-to-
government relationship between Indian Tribes and the United States and 
to strengthen Tribal control over Federal funding and program 
management;
    (5) Although the Federal Government has made considerable strides in 
improving Indian health care, it has failed to fully meet its trust 
responsibilities and to satisfy its obligations to the Indian Tribes 
under treaties and other laws; and
    (6) Congress has reviewed the results of the Tribal Self-Governance 
Demonstration Project and finds that transferring full control and 
funding to Tribal governments, upon Tribal request, over decision making 
for Federal PSFAs:
    (i) Is an appropriate and effective means of implementing the 
Federal policy of government-to-government relations with Indian Tribes; 
and
    (ii) Strengthens the Federal policy of Indian self-determination.
    (b) According to section 3 of Pub. L. 106-260, Congress has declared 
its policy to:
    (1) Permanently establish and implement Tribal Self-Governance 
within the DHHS;

[[Page 902]]

    (2) Call for full cooperation from the DHHS and its constituent 
agencies in the implementation of Tribal Self-Governance to--
    (i) Enable the United States to maintain and improve its unique and 
continuing relationship with, and responsibility to, Indian Tribes;
    (ii) Permit each Indian Tribe to choose the extent of its 
participation in self-governance in accordance with the provisions of 
the ISDA relating to the provision of Federal services to Indian Tribes;
    (iii) Ensure the continuation of the trust responsibility of the 
United States to Indian Tribes and Indians;
    (iv) Affirm and enable the United States to fulfill its obligations 
to the Indian Tribes under treaties and other laws;
    (v) Strengthen the government-to-government relationship between the 
United States and Indian Tribes through direct and meaningful 
consultation with all Tribes;
    (vi) Permit an orderly transition from Federal domination of 
programs and services to provide Indian Tribes with meaningful 
authority, control, funding, and discretion to plan, conduct, redesign, 
and administer PSFAs that meet the needs of the individual Tribal 
communities;
    (vii) Provide for a measurable parallel reduction in the Federal 
bureaucracy as programs, services, functions, and activities (or portion 
thereof) are assumed by Indian Tribes;
    (viii) Encourage the Secretary to identify all PSFAs of the DHHS 
that may be managed by an Indian Tribe under this Act and to assist 
Indian Tribes in assuming responsibility for such PSFAs; and
    (ix) Provide Indian Tribes with the earliest opportunity to 
administer PSFAs from throughout the Department.
    (c) According to section 512(a) of the Act [25 U.S.C. 458aaa-11(a)], 
Congress has declared, except as otherwise provided by law, the 
Secretary shall interpret all Federal laws, Executive Orders, and 
regulations in a manner that will facilitate:
    (1) The inclusion of PSFAs and funds associated therewith, in the 
agreements entered into under this section;
    (2) The implementation of compacts and funding agreements entered 
into under this title; and
    (3) The achievement of Tribal health goals and objectives.
    (d) According to section 512(f) of the Act [25 U.S.C. 458aaa-11(f)], 
Congress has declared that each provision of Title V and each provision 
of a compact or funding agreement shall be liberally construed for the 
benefit of the Indian Tribe participating in and any ambiguity shall be 
resolved in favor of the Indian Tribe.
    (e) According to section 515(b) of the Act [25 U.S.C. 458aaa-14(b)], 
Congress has declared that nothing in the Act shall be construed to 
diminish in any way the trust responsibility of the United States to 
Indian Tribes and individual Indians that exists under treaties, 
Executive orders, or other laws and court decisions.
    (f) According to section 507(g) of the Act [25 U.S.C. 458aaa-6(g)], 
Congress has declared that the Secretary is prohibited from waiving, 
modifying, or diminishing in any way the trust responsibility of the 
United States with respect to Indian Tribes and individual Indians that 
exists under treaties, Executive orders, other laws, or court decisions.
    (g) According to section 515(c) of the Act [25 U.S.C. 458aaa-14(c)], 
Congress has declared that the Indian Health Service (IHS) under this 
Act shall neither bill nor charge those Indians who may have the 
economic means to pay for services, nor require any Tribe to do so. 
Nothing in this section shall impair the right of the IHS or an Indian 
Tribe to seek recovery from third parties section 206 of the Indian 
Health Care Improvement Act [25 U.S.C. 1621e], under section 1 of the 
Federal Medical Care Recovery Act [42 U.S.C. 2651], and any other 
applicable Federal, State or Tribal law.
    (h) According to section 507(e) of the Act [25 U.S.C. 458aaa-6(e)], 
Congress has declared that in the negotiation of compacts and funding 
agreements the Secretary shall at all times negotiate in good faith to 
maximize implementation of the self-governance policy. The Secretary 
shall carry out Title V in a manner that maximizes the policy of

[[Page 903]]

Tribal Self-Governance, and in a manner consistent with the purposes 
specified in section 3 of the Act.



Sec.  137.3  Effect on existing Tribal rights.

    Nothing in this part shall be construed as:
    (a) Affecting, modifying, diminishing, or otherwise impairing the 
sovereign immunity from suit enjoyed by Indian Tribes;
    (b) Terminating, waiving, modifying, or reducing the trust 
responsibility of the United States to the Indian Tribe(s) or individual 
Indians. The Secretary must act in good faith in upholding this trust 
responsibility;
    (c) Mandating an Indian Tribe to apply for a compact(s) or grant(s) 
as described in the Act; or
    (d) Impeding awards by other Departments and agencies of the United 
States to Indian Tribes to administer Indian programs under any other 
applicable law.



Sec.  137.4  May Title V be construed to limit or reduce in any way 
the funding for any program, project, or activity serving an Indian Tribe 
under this or other applicable Federal law?

    No, if an Indian Tribe alleges that a compact or funding agreement 
violates section 515(a) of the Act [25 U.S.C. 458aaa-14(a)], the Indian 
Tribe may apply the provisions of section 110 of the Act [25 U.S.C. 
450m-1].



Sec.  137.5  Effect of these regulations on Federal program guidelines, 
manual, or policy directives.

    Unless expressly agreed to by the Self-Governance Tribe in the 
compact or funding agreement, the Self-Governance Tribe shall not be 
subject to any agency circular, policy, manual, guidance, or rule 
adopted by the IHS, except for the eligibility provisions of section 
105(g) of the Act [25 U.S.C. 450j(g)] and regulations promulgated under 
section 517 of the Act [25 U.S.C. 458aaa-16(e)].



Sec.  137.6  Secretarial policy.

    In carrying out Tribal self-governance under Title V, the Secretary 
recognizes the right of Tribes to self-government and supports Tribal 
sovereignty and self-determination. The Secretary recognizes a unique 
legal relationship with Tribal governments as set forth in the 
Constitution of the United States, treaties, statutes, Executive Orders, 
and court decisions. The Secretary supports the self-determination 
choices of each Tribe and will continue to work with all Tribes on a 
government-to-government basis to address issues concerning Tribal self-
determination.



                          Subpart B_Definitions



Sec.  137.10  Definitions.

    Unless otherwise provided in this part:
    Act means sections 1 through 9 and Titles I and V of the Indian 
Self-Determination and Education Assistance Act of 1975, Public Law 93-
638, as amended.
    Appeal means a request by an Indian Tribe for an administrative 
review of an adverse decision by the Secretary.
    Compact means a legally binding and mutually enforceable written 
agreement, including such terms as the parties intend shall control year 
after year, that affirms the government-to-government relationship 
between a Self-Governance Tribe and the United States.
    Congressionally earmarked competitive grants as used in section 
505(b)(1) of the Act [25 U.S.C. 458aaa-4(b)(1)] means statutorily 
mandated grants as defined in this section and used in subpart H of this 
part.
    Contract means a self-determination contract as defined in section 
4(j) of the Act [25 U.S.C. 450b].
    Days means calendar days; except where the last day of any time 
period specified in these regulations falls on a Saturday, Sunday, or a 
Federal holiday, the period shall carry over to the next business day 
unless otherwise prohibited by law.
    Department means the Department of Health and Human Services.
    Director means the Director of the Indian Health Service.
    Funding agreement means a legally binding and mutually enforceable 
written agreement that identifies the PSFAs that the Self-Governance 
Tribe will carry out, the funds being transferred from the Service Unit, 
Area, and

[[Page 904]]

Headquarter's levels in support of those PSFAs and such other terms as 
are required, or may be agreed upon, pursuant to Title V.
    Gross mismanagement means a significant, clear, and convincing 
violation of a compact, funding agreement, or regulatory or statutory 
requirements applicable to Federal funds transferred to an Indian Tribe 
by a compact or funding agreement that results in a significant 
reduction of funds available for the PSFAs assumed by a Self-Governance 
Tribe.
    IHS means Indian Health Service.
    IHS discretionary grant means a grant established by IHS pursuant to 
the IHS' discretionary authority without any specific statutory 
directive.
    Indian means a person who is a member of an Indian Tribe.
    Indian Tribe means any Indian Tribe, band, nation, or other 
organized group, or community, including pueblos, rancherias, colonies, 
and any Alaska Native Village, or regional or village corporation as 
defined in or established pursuant to the Alaska Native Claims 
Settlement Act, which is recognized as eligible for the special programs 
and services provided by the United States to Indians because of their 
status as Indians; provided that in any case in which an Indian Tribe 
has authorized another Indian Tribe, an inter-Tribal consortium, or a 
Tribal organization to plan for or carry out programs, services, 
functions, or activities (or portions thereof) on its behalf under Title 
V, the authorized Indian Tribe, inter-Tribal consortium or Tribal 
organization shall have the rights and responsibilities of the 
authorizing Indian Tribe (except as otherwise provided in the 
authorizing resolution or in this part). In such event, the term 
``Indian Tribe'' as used in this part includes such other authorized 
Indian Tribe, inter-Tribal consortium, or Tribal organization.
    Indirect costs shall have the same meaning as it has in 25 CFR 900.6 
as applied to compacts, funding agreements and construction project 
agreements entered into under this part.
    Inherent Federal functions means those Federal functions which 
cannot legally be delegated to Indian Tribes.
    Inter-Tribal consortium means a coalition of two or more separate 
Indian Tribes that join together for the purpose of participating in 
self-governance, including Tribal organizations.
    OMB means the Office of Management and Budget.
    PSFA means programs, services, functions, and activities (or 
portions thereof).
    Real property means any interest in land together with the 
improvements, structures, and fixtures and appurtenances thereto.
    Reassumption means rescission, in whole or part, of a funding 
agreement and assuming or resuming control or operation of the PSFAs by 
the Secretary without consent of the Self-Governance Tribe.
    Retained Tribal share means those funds that are available as a 
Tribal share but which the Self-Governance Tribe elects to leave with 
the IHS to administer.
    Retrocession means the voluntary return to the Secretary of a self-
governance program, service, function or activity (or portion thereof) 
for any reason, before or on the expiration of the term of the funding 
agreement.
    Secretary means the Secretary of Health and Human Services (and his 
or her respective designees.)
    Self-Governance means the program of self-governance established 
under section 502 of the Act [25 U.S.C. 458aaa-1].
    Self-Governance Tribe means an Indian Tribe participating in the 
program of self-governance pursuant to section 503(a) of the Act [25 
U.S.C. 458aaa-2(a)] or selected and participating in self-governance 
pursuant to section 503(b) of the Act [25 U.S.C. 458aaa-2(b)].
    Statutorily mandated grant as used in this section and subpart F of 
this part means a grant specifically designated in a statute for a 
defined purpose.
    Title I means sections 1 through 9 and Title I of the Indian Self-
Determination and Education Assistance Act of 1975, Pub. L. 93-638, as 
amended.
    Title V means Title V of the Indian Self-Determination and Education 
Assistance Act of 1975, Pub. L. 93-638, as amended.

[[Page 905]]

    Tribal organization means the recognized governing body of any 
Indian Tribe; any legally established organization of Indians which is 
controlled, sanctioned, or chartered by such governing body or which is 
democratically elected by the adult members of the Indian community to 
be served by such organization and which includes the maximum 
participation of Indians in all phases of its activities; provided, that 
in any case where a contract or compact is entered into, or a grant is 
made, to an organization to perform services benefitting more than one 
Indian Tribe, the approval of each such Indian Tribe shall be a 
prerequisite to the entering into or making of such contract, compact, 
or grant.
    Tribal Self-Governance Advisory Committee means the Committee 
established by the Director of IHS that consists of Tribal 
representatives from each of the IHS Areas participating in Self-
Governance, and that provides advocacy and policy guidance for 
implementation of Tribal Self-Governance within IHS.
    Tribal share means an Indian Tribe's portion of all funds and 
resources that support secretarial PSFAs that are not required by the 
Secretary for the performance of inherent Federal functions.



     Subpart C_Selection of Indian Tribes for Participation in Self-
                               Governance



Sec.  137.15  Who may participate in Tribal Self-Governance?

    Those Self-Governance Tribes described in 503(a) of the Act [25 
U.S.C. 458aaa-2(a)] participating in the Title III Tribal Self-
Governance Demonstration Project and up to 50 additional Indian Tribes 
per year that meet the criteria in Sec.  137.18 may participate in self-
governance.



Sec.  137.16  What if more than 50 Indian Tribes apply to participate 
in self-governance?

    The first Indian Tribes who apply and are determined to be eligible 
shall have the option to participate in self-governance. Any Indian 
Tribe denied participation due to the limitation in number of Indian 
Tribes that may take part is entitled to participate in the next fiscal 
year, provided the Indian Tribe continues to meet the financial 
stability and financial management capacity requirements.



Sec.  137.17  May more than one Indian Tribe participate in the same compact 
and/or funding agreement?

    Yes, Indian Tribes may either:
    (a) Each sign the same compact and/or funding agreement, provided 
that each one meets the criteria to participate in self-governance and 
accepts legal responsibility for all financial and administrative 
decisions made under the compact or funding agreement, or
    (b) Authorize another Indian Tribe to participate in self-governance 
on their behalf.



Sec.  137.18  What criteria must an Indian Tribe satisfy to be eligible 
to participate in self-governance?

    To be eligible to participate in self-governance, an Indian Tribe 
must have:
    (a) Successfully completed the planning phase described in Sec.  
137.20;
    (b) Requested participation in self-governance by resolution or 
other official action by the governing body of each Indian Tribe to be 
served; and
    (c) Demonstrated, for three fiscal years, financial stability and 
financial management capability.

                             Planning Phase



Sec.  137.20  What is required during the planning phase?

    The planning phase must be conducted to the satisfaction of the 
Indian Tribe and must include:
    (a) legal and budgetary research; and
    (b) internal Tribal government planning and organizational 
preparation relating to the administration of health programs.



Sec.  137.21  How does an Indian Tribe demonstrate financial stability 
and financial management capacity?

    The Indian Tribe provides evidence that, for the three years prior 
to participation in self-governance, the Indian Tribe has had no 
uncorrected significant and material audit exceptions

[[Page 906]]

in the required annual audit of the Indian Tribe's self-determination 
contracts or self-governance funding agreements with any Federal agency.



Sec.  137.22  May the Secretary consider uncorrected significant 
and material audit exceptions identified regarding centralized financial 
and administrative functions?

    Yes, if the Indian Tribe chooses to centralize its self-
determination or self-governance financial and administrative functions 
with non-self-determination or non-self-governance financial and 
administrative functions, such as personnel, payroll, property 
management, etc., the Secretary may consider uncorrected significant and 
material audit exceptions related to the integrity of a cross-cutting 
centralized function in determining the Indian Tribe's eligibility for 
participation in the self-governance program.



Sec.  137.23  For purposes of determining eligibility for participation 
in self-governance, may the Secretary consider any other information 
regarding the Indian Tribe's financial stability 
and financial management capacity?

    No, meeting the criteria set forth in Sec. Sec.  137.21 and 137.22, 
shall be conclusive evidence of the required stability and capability to 
participate in self-governance.



Sec.  137.24  Are there grants available to assist the Indian Tribe 
to meet the requirements to participate in self-governance?

    Yes, any Indian Tribe may apply, as provided in Sec.  137.25, for a 
grant to assist it to:
    (a) Plan to participate in self-governance; and
    (b) Negotiate the terms of the compact and funding agreement between 
the Indian Tribe and Secretary.



Sec.  137.25  Are planning and negotiation grants available?

    Subject to the availability of funds, IHS will annually publish a 
notice of the number of planning and negotiation grants available, an 
explanation of the application process for such grants, and the criteria 
for award. Questions may be directed to the Office of Tribal Self-
Governance.



Sec.  137.26  Must an Indian Tribe receive a planning or negotiation grant 
to be eligible to participate in self-governance?

    No, an Indian Tribe may use other resources to meet the planning 
requirement and to negotiate.



                    Subpart D_Self-Governance compact



Sec.  137.30  What is a self-governance compact?

    A self-governance compact is a legally binding and mutually 
enforceable written agreement that affirms the government-to-government 
relationship between a Self-Governance Tribe and the United States.



Sec.  137.31  What is included in a compact?

    A compact shall include general terms setting forth the government-
to-government relationship consistent with the Federal Government's 
trust responsibility and statutory and treaty obligations to Indian 
Tribes and such other terms as the parties intend to control from year 
to year.



Sec.  137.32  Is a compact required to participate in self-governance?

    Yes, Tribes must have a compact in order to participate in self-
governance.



Sec.  137.33  May an Indian Tribe negotiate a funding agreement 
at the same time it is negotiating a compact?

    Yes, at an Indian Tribe's option, a funding agreement may be 
negotiated prior to or at the same time as the negotiation of a compact.



Sec.  137.34  May a funding agreement be executed 
without negotiating a compact?

    No, a compact is a separate document from a funding agreement, and 
the compact must be executed before or at the same time as a funding 
agreement.

[[Page 907]]



Sec.  137.35  What is the term of a self-governance compact?

    Upon approval and execution of a self-governance compact, the 
compact remains in effect for so long as permitted by Federal law or 
until terminated by mutual written agreement or retrocession or 
reassumption of all PSFAs.



                      Subpart E_Funding Agreements



Sec.  137.40  What is a funding agreement?

    A funding agreement is a legally binding and mutually enforceable 
written agreement that identifies the PSFAs that the Self-Governance 
Tribe will carry out, the funds being transferred from service unit, 
area and headquarters levels in support of those PSFAs and such other 
terms as are required or may be agreed upon pursuant to Title V.



Sec.  137.41  What PSFAs must be included in a funding agreement?

    At the Self-Governance Tribe's option, all PSFAs identified in and 
in accordance with section 505(b) of the Act must be included in a 
funding agreement, subject to section 507(c) of the Act [25 U.S.C. 
458aaa-6(c)].



Sec.  137.42  What Tribal shares may be included in a funding agreement?

    All Tribal shares identified in sections 505(b)(1) [25 U.S.C. 
458aaa-4(b)(1)] and 508(c) of the Act [25 U.S.C. 458aaa-7(c)] may be 
included in a funding agreement, including Tribal shares of IHS 
discretionary grants.



Sec.  137.43  May a Tribe negotiate and leave funds with IHS 
for retained services?

    Yes, at the discretion of the Self-Governance Tribe, Tribal shares 
may be left, in whole or in part, with IHS for certain PSFAs. These 
shares are referred to as a ``retained Tribal shares.''

                      Terms in a Funding Agreement



Sec.  137.45  What terms must be included in a funding agreement?

    A funding agreement must include terms required under section 505(d) 
of the Act [25 U.S.C. 458aaa-4(d)] and provisions regarding mandatory 
reporting and reassumption pursuant to section 507(a) of the Act [25 
U.S.C. 458aaa-6(a)], unless those provisions have been included in a 
compact.



Sec.  137.46  May additional terms be included in a funding agreement?

    Yes, at the Self-Governance Tribe's option, additional terms may be 
included as set forth in sections 506 [25 U.S.C. 458aaa-5] and 516(b) of 
the Act [25 U.S.C. 458aaa-15(b)]. In addition, any other terms to which 
the Self-Governance Tribe and the Secretary agree may be included.



Sec.  137.47  Do any provisions of Title I apply to compacts, 
funding agreements, and construction project agreements negotiated 
under Title V of the Act?

    (a) Yes, the provisions of Title I listed in section 516(a) of the 
Act [25 U.S.C. 458aaa-15(a)] and section 314 of Pub. L. 101-512, as 
amended, [25 U.S.C. 450f note] mandatorily apply to a compact, funding 
agreement and construction project agreement to the extent they are not 
in conflict with Title V. In addition, at the option of a Self-
Governance Tribe, under section 516(b) of the Act [25 U.S.C. 458aaa-
15(b)] any provisions of Title I may be included in the compact or 
funding agreement.
    (b) The provisions of Title I referenced in section 516(a) of the 
Act [25 U.S.C. 458aaa-15(a)] are sections 5 [25 U.S.C. 450c], 6 [25 
U.S.C. 450d], 7 [25 U.S.C. 450e], 102(c) and (d) [25 U.S.C. 450f(c) and 
(d)], 104 [25 U.S.C. 450i], 105(k) and (l) [25 U.S.C. 450j(k) and (l)], 
106(a) through (k) [25 U.S.C. 450j-1(a) through (k)], and 111 [25 U.S.C. 
450n] of the Act.



Sec.  137.48  What is the effect of incorporating a Title I provision 
into a compact or funding agreement?

    The incorporated Title I provision shall have the same force and 
effect as if it were set out in full in Title V.



Sec.  137.49  What if a Self-Governance Tribe requests such incorporation 
at the negotiation stage of a compact or funding agreement?

    In that event, such incorporation shall be deemed effective 
immediately and shall control the negotiation and

[[Page 908]]

resulting compact and funding agreement.

                       Term of a Funding Agreement



Sec.  137.55  What is the term of a funding agreement?

    A funding agreement shall have the term mutually agreed to by the 
parties. Absent notification from an Indian Tribe that it is withdrawing 
or retroceding the operation of one or more PSFAs identified in the 
funding agreement, the funding agreement shall remain in full force and 
effect until a subsequent funding agreement is executed.



Sec.  137.56  Does a funding agreement remain in effect 
after the end of its term?

    Yes, the provisions of a funding agreement, including all recurring 
increases received and continuing eligibility for other increases, 
remain in full force and effect until a subsequent funding agreement is 
executed. Upon execution of a subsequent funding agreement, the 
provisions of such a funding agreement are retroactive to the end of the 
term of the preceding funding agreement.



Sec.  137.57  How is a funding agreement amended during the effective period 
of the funding agreement?

    A funding agreement may be amended by the parties as provided for in 
the funding agreement, Title V, or this part.



                  Subpart F_Statutorily Mandated Grants



Sec.  137.60  May a statutorily mandated grant be added to a funding agreement?

    Yes, in accordance with section 505(b)(2) of the Act [25 U.S.C. 
458aaa-4(b)(2)], a statutorily mandated grant may be added to the 
funding agreement after award.



Sec.  137.65  May a Self-Governance Tribe receive statutorily mandated 
grant funding in an annual lump sum advance payment?

    Yes, grant funds shall be added to the funding agreement as an 
annual lump sum advance payment after the grant is awarded.



Sec.  137.66  May a Self-Governance Tribe keep interest earned 
on statutorily mandated grant funds?

    Yes, a Self-Governance Tribe may keep Interest Earned on Statutorily 
Mandated Grant Funds.



Sec.  137.67  How may a Self-Governance Tribe use interest earned 
on statutorily mandated grant funds?

    Interest earned on such funds must be used to enhance the grant 
program including allowable administrative costs.



Sec.  137.68  May funds from a statutorily mandated grant added to 
a funding agreement be reallocated?

    No, unless it is permitted under the statute authorizing the grant 
or under the terms and conditions of the grant award, funds from a 
statutorily mandated grant may not be reallocated.



Sec.  137.69  May a statutorily mandated grant program added to 
a funding agreement be redesigned?

    No, unless it is permitted under the statute authorizing the grant 
or under the terms and conditions of the grant award, a program added to 
a funding agreement under a statutorily mandated grant may not be 
redesigned.



Sec.  137.70  Are the reporting requirements different for a statutorily 
mandated grant program added to a funding agreement?

    Yes, the reporting requirements for a statutorily mandated grant 
program added to a funding agreement are subject to the terms and 
conditions of the grant award.



Sec.  137.71  May the Secretary and the Self-Governance Tribe 
develop separate programmatic reporting requirements for 
statutorily mandated grants?

    Yes, the Secretary and the Self-Governance Tribe may develop 
separate programmatic reporting requirements for statutorily mandated 
grants.

[[Page 909]]



Sec.  137.72  Are Self-Governance Tribes and their employees carrying out 
statutorily mandated grant programs added to a funding agreement
covered by the Federal Tort Claims Act (FTCA)?

    Yes, Self-Governance Tribes and their employees carrying out 
statutorily mandated grant programs are added to a funding agreement 
covered by the FTCA. Regulations governing coverage under the FTCA are 
published at 25 CFR Part 900, Subpart M.



Sec.  137.73  What provisions of Title V apply to statutorily 
mandated grants added to the funding agreement?

    None of the provisions of Title V apply.



                            Subpart G_Funding

                                 General



Sec.  137.75  What funds must the Secretary transfer to 
a Self-Governance Tribe in a funding agreement?

    Subject to the terms of any compact or funding agreement, the 
Secretary must transfer to a Tribe all funds provided for in the funding 
agreement, pursuant to section 508(c) of the Act [25 U.S.C. 458aaa-7(c)] 
and Sec.  137.80. The Secretary shall provide funding for periods 
covered by joint resolution adopted by Congress making continuing 
appropriations, to the extent permitted by such resolutions.



Sec.  137.76  When must the Secretary transfer to a Self-Governance Tribe 
funds identified in a funding agreement?

    When a funding agreement requires an annual transfer of funding to 
be made at the beginning of a fiscal year, or requires semiannual or 
other periodic transfers of funding to be made commencing at the 
beginning of a fiscal year, the first such transfer shall be made not 
later than 10 days after the apportionment of such funds by the OMB to 
the Department, unless the funding agreement provides otherwise.



Sec.  137.77  When must the Secretary transfer funds that were not paid 
as part of the initial lump sum payment?

    The Secretary must transfer any funds that were not paid in the 
initial lump sum payment within 10 days after distribution methodologies 
and other decisions regarding payment of those funds have been made by 
the IHS.



Sec.  137.78  May a Self-Governance Tribe negotiate a funding agreement 
for a term longer or shorter than one year?

    Yes, upon Tribal request, the Secretary must negotiate a funding 
agreement for a term longer or shorter than a year. All references in 
these regulations to funding agreements shall also include funding 
agreements for a term longer or shorter than one year.



Sec.  137.79  What funds must the Secretary include in a funding agreement?

    The Secretary must include funds in a funding agreement in an amount 
equal to the amount that the Self-Governance Tribe would have been 
entitled to receive in a contract under Title I, including amounts for 
direct program costs specified under section 106(a)(1) of the Act and 
amounts for contract support costs specified under section 106(a) (2), 
(3), (5), and (6) of the Act [25 U.S.C. 450j-1(a)(2), (3), (5) and (6)]. 
In addition, the Secretary shall include any funds that are specifically 
or functionally related to the provision by the Secretary of services 
and benefits to the Self-Governance Tribe or its members, all without 
regard to the organizational level within the Department where such 
functions are carried out.

                              Prohibitions



Sec.  137.85  Is the Secretary prohibited from failing or refusing 
to transfer funds that are due to a Self-Governance Tribe under Title V?

    Yes, sections 508(d)(1)(A) and (B) of the Act [25 U.S.C. 458aaa-
7(d)(1)(A) and (B)] expressly prohibit the Secretary from:
    (a) Failing or refusing to transfer to a Self-Governance Tribe its 
full share of any central, headquarters, regional, area, or service unit 
office or other

[[Page 910]]

funds due under Title V, except as required by Federal law, and
    (b) From withholding portions of such funds for transfer over a 
period of years.



Sec.  137.86  Is the Secretary prohibited from reducing the amount of funds 
required under Title V to make funding available for self-governance 
monitoring or administration by the Secretary?

    Yes, the Secretary is prohibited from reducing the amount of funds 
required under Title V to make funding available for self-governance 
monitoring or administration.



Sec.  137.87  May the Secretary reduce the amount of funds due 
under Title V in subsequent years?

    No, in accordance with section 508(d)(1)(C)(ii) of the Act [25 
U.S.C. 458aaa-7(d)(1)(C)(ii)], the Secretary is prohibited from reducing 
the amount of funds required under Title V in subsequent years, except 
pursuant to:
    (a) A reduction in appropriations from the previous fiscal year for 
the program or function to be included in a compact or funding 
agreement;
    (b) A Congressional directive in legislation or accompanying report;
    (c) A Tribal authorization;
    (d) A change in the amount of pass-through funds subject to the 
terms of the funding agreement; or
    (e) Completion of a project, activity, or program for which such 
funds were provided.



Sec.  137.88  May the Secretary reduce the amount of funds required 
under Title V to pay for Federal functions, including Federal pay costs, 
Federal employee retirement benefits, automated data processing, 
technical assistance, and monitoring of activities under the Act?

    No, the Secretary may not reduce the amount of funds required under 
Title V to pay for Federal functions, including Federal pay costs, 
Federal employee retirement benefits, automated data processing, 
technical assistance, and monitoring of activities under the Act.



Sec.  137.89  May the Secretary reduce the amount of funds required 
under Title V to pay for costs of Federal personnel displaced by contracts 
under Title I or Self-Governance under Title V?

    No, the Secretary may not reduce the amount of funds required under 
Title V to pay for costs of Federal personnel displaced by contracts 
under Title I or Self-Governance under Title V.



Sec.  137.90  May the Secretary increase the funds required 
under the funding agreement?

    Yes, the Secretary may increase the funds required under the funding 
agreement. However, the Self-Governance Tribe and the Secretary must 
agree to any transfer of funds to the Self-Governance Tribe unless 
otherwise provided for in the funding agreement.

             Acquisition of Goods and Services From the IHS



Sec.  137.95  May a Self-Governance Tribe purchase goods and services 
from the IHS on a reimbursable basis?

    Yes, a Self-Governance Tribe may choose to purchase from the IHS any 
goods and services transferred by the IHS to a Self-Governance Tribe in 
a compact or funding agreement. The IHS shall provide any such goods and 
services to the Self-Governance Tribe, on a reimbursable basis, 
including payment in advance with subsequent adjustment.

                           Prompt Payment Act



Sec.  137.96  Does the Prompt Payment Act apply to funds transferred 
to a Self-Governance Tribe in a compact or funding agreement?

    Yes, the Prompt Payment Act, 39 U.S.C. section 3901 et seq., applies 
to the transfer of all funds due under a compact or funding agreement 
authorized pursuant to Title V. See also Sec.  137.76 through 137.78 and 
137.341(f).

[[Page 911]]

                  Interest or Other Income on Transfers



Sec.  137.100  May a Self-Governance Tribe retain and spend interest earned 
on any funds paid under a compact or funding agreement?

    Yes, pursuant to section 508(h) of the Act [25 U.S.C. 458aaa-7(h)], 
a Self-Governance Tribe may retain and spend interest earned on any 
funds paid under a compact or funding agreement.



Sec.  137.101  What standard applies to a Self-Governance Tribe's 
management of funds paid under a compact or funding agreement?

    A Self-Governance Tribe is under a duty to invest and manage the 
funds as a prudent investor would, in light of the purpose, terms, 
distribution requirements, and provisions in the compact or funding 
agreement and Title V. This duty requires the exercise of reasonable 
care, skill, and caution, and is to be applied to investments not in 
isolation but in the context of the investment portfolio and as a part 
of an overall investment strategy, which should incorporate risk and 
return objectives reasonably suitable to the Self-Governance Tribe. In 
making and implementing investment decisions, the Self-Governance Tribe 
has a duty to diversify the investments unless, under the circumstances, 
it is prudent not to do so. In addition, the Self-Governance Tribe must:
    (a) Conform to fundamental fiduciary duties of loyalty and 
impartiality;
    (b) Act with prudence in deciding whether and how to delegate 
authority and in the selection and supervision of agents; and
    (c) Incur only costs that are reasonable in amount and appropriate 
to the investment responsibilities of the Self-Governance Tribe.

                           Carryover of Funds



Sec.  137.105  May a Self-Governance Tribe carryover from one year 
to the next any funds that remain at the end of the funding agreement?

    Yes, pursuant to section 508(i) of the Act, a Self-Governance Tribe 
may carryover from one year to the next any funds that remain at the end 
of the funding agreement.

                             Program Income



Sec.  137.110  May a Self-Governance Tribe retain and expend 
any program income earned pursuant to a compact and funding agreement?

    All Medicare, Medicaid, or other program income earned by a Self-
Governance Tribe shall be treated as supplemental funding to that 
negotiated in the funding agreement. The Self-Governance Tribe may 
retain all such income and expend such funds in the current year or in 
future years except to the extent that the Indian Health Care 
Improvement Act (25 U.S.C. 1601 et seq.) provides otherwise for Medicare 
and Medicaid receipts. Such funds shall not result in any offset or 
reduction in the amount of funds the Self-Governance Tribe is authorized 
to receive under its funding agreement in the year the program income is 
received or for any subsequent fiscal year.

                           Limitation of Costs



Sec.  137.115  Is a Self-Governance Tribe obligated to continue performance 
under a compact or funding agreement if the Secretary does not transfer 
sufficient funds?

    No, if a Self-Governance Tribe believes that the total amount of 
funds provided for a specific PSFA in a compact or funding agreement is 
insufficient, the Self-Governance Tribe must provide reasonable written 
notice of such insufficiency to the Secretary. If the Secretary does not 
increase the amount of funds transferred under the funding agreement in 
a quantity sufficient for the Self-Governance Tribe to complete the 
PSFA, as jointly determined by the Self-Governance Tribe and the 
Secretary, the Self-Governance Tribe may suspend performance of the PSFA 
until such time as additional funds are transferred.

                           Stable Base Budget



Sec.  137.120  May a Self-Governance Tribe's funding agreement provide 
for a stable base budget?

    Yes, at the option of a Self-Governance Tribe, a funding agreement 
may provide for a stable base budget, specifying the recurring funds to 
be transferred to a Self-Governance Tribe for a

[[Page 912]]

period specified in the funding agreement.



Sec.  137.121  What funds may be included in a stable base budget amount?

    The stable base budget amount may include, at the option of the 
Self-Governance Tribe,
    (a) Recurring funds available under section 106(a) of the Act [25 
U.S.C. 450j-1] ;
    (b) Recurring Tribal shares; and
    (c) Any recurring funds for new or expanded PSFAs not previously 
assumed by the Self-Governance Tribe.



Sec.  137.122  May a Self-Governance Tribe with a stable base budget receive 
other funding under its funding agreement?

    Yes, the funding agreement may include non-recurring funds, other 
recurring funds, and other funds the Self-Governance Tribe is entitled 
to include in a funding agreement that are not included in the stable 
base budget amount.



Sec.  137.123  Once stable base funding is negotiated, do funding amounts 
change from year to year?

    Stable base funding amounts are subject to adjustment:
    (a) Annually only to reflect changes in Congressional appropriations 
by sub-sub activity excluding earmarks;
    (b) By mutual agreement of the Self-Governance Tribe and the 
Secretary; or
    (c) As a result of full or partial retrocession or reassumption.



Sec.  137.124  Does the effective period of a stable base budget have to be 
the same as the term of the funding agreement?

    No, the Self-Governance Tribe may provide in its funding agreement 
that the effective period of the stable base budget will be either 
longer or shorter than the term of the funding agreement.



                          Subpart H_Final Offer



Sec.  137.130  What is covered by this subpart?

    This subpart explains the final offer process provided by the 
statute for resolving, within a specific timeframe, disputes that may 
develop in negotiation of compacts, funding agreements, or amendments 
thereof.



Sec.  137.131  When should a final offer be submitted?

    A final offer should be submitted when the Secretary and an Indian 
Tribe are unable to agree, in whole or in part, on the terms of a 
compact or funding agreement (including funding levels).



Sec.  137.132  How does the Indian Tribe submit a final offer?

    (a) A written final offer should be submitted:
    (1) During negotiations to the agency lead negotiator or
    (2) Thereafter to the Director.
    (b) The document should be separate from the compact, funding 
agreement, or amendment and clearly identified as a ``Final Offer.''



Sec.  137.133  What does a final offer contain?

    A final offer contains a description of the disagreement between the 
Secretary and the Indian Tribe and the Indian Tribe's final proposal to 
resolve the disagreement.



Sec.  137.134  When does the 45 day review period begin?

    The 45 day review period begins from the date the IHS receives the 
final offer. Proof of receipt may include a date stamp, or postal return 
receipt, or hand delivery.



Sec.  137.135  May the Secretary request and obtain an extension of time 
of the 45 day review period?

    Yes, the Secretary may request an extension of time before the 
expiration of the 45 day review period. The Indian Tribe may either 
grant or deny the Secretary's request for an extension. To be effective, 
any grant of extension of time must be in writing and be signed by the 
person authorized by the Indian Tribe to grant the extension before the 
expiration of the 45 day review period.

[[Page 913]]



Sec.  137.136  What happens if the agency takes no action within the 45 day 
review period (or any extensions thereof)?

    The final offer is accepted automatically by operation of law.



Sec.  137.137  If the 45 day review period or extension thereto, has expired, 
and the Tribes offer is deemed accepted by operation of law, are there any 
exceptions to this rule?

    No, there are no exceptions to this rule if the 45 day review period 
or extension thereto, has expired, and the Tribe's offer is deemed 
accepted by operation of law.



Sec.  137.138  Once the Indian Tribe's final offer has been accepted 
or deemed accepted by operation of law, what is the next step?

    After the Indian Tribe's final offer is accepted or deemed accepted, 
the terms of the Indian Tribe's final offer and any funds included 
therein, shall be added to the funding agreement or compact within 10 
days of the acceptance or the deemed acceptance.

                        Rejection of Final Offers



Sec.  137.140  On what basis may the Secretary reject 
an Indian Tribe's final offer?

    The Secretary may reject an Indian Tribe's final offer for one of 
the following reasons:
    (a) the amount of funds proposed in the final offer exceeds the 
applicable funding level to which the Indian Tribe is entitled under the 
Act;
    (b) the PSFA that is the subject of the final offer is an inherent 
Federal function that cannot legally be delegated to an Indian Tribe;
    (c) the Indian Tribe cannot carry out the PSFA in a manner that 
would not result in significant danger or risk to the public health; or
    (d) the Indian Tribe is not eligible to participate in self-
governance under section 503 of the Act [25 U.S.C. 458aaa-2].



Sec.  137.141  How does the Secretary reject a final offer?

    The Secretary must reject a final offer by providing written notice 
to the Indian Tribe based on the criteria in Sec.  137.140 not more than 
45 days after receipt of a final offer, or within a longer time period 
as agreed by the Self-Governance Tribe consistent with this subpart.



Sec.  137.142  What is a ``significant danger'' or ``risk'' 
to the public health?

    A significant danger or risk is determined on a case-by-case basis 
in accordance with section 507(c) of the Act [25 U.S.C. 458aaa-6(c)].



Sec.  137.143  How is the funding level to which the Indian Tribe 
is entitled determined?

    The Secretary must provide funds under a funding agreement in an 
amount equal to the amount that the Indian Tribe would have been 
entitled to receive under self-determination contracts under this Act, 
including amounts for direct program costs specified under section 
106(a)(1) of the Act [25 U.S.C. 450j-1(a)(1)] and amounts for contract 
support costs specified under section 106(a) (2), (3), (5), and (6) of 
the Act [25 U.S.C. 450j-1(a)(2), (3), (5) and (6)], including any funds 
that are specifically or functionally related to the provision by the 
Secretary of services and benefits to the Indian Tribe or its members, 
all without regard to the organizational level within the Department 
where such functions are carried out.



Sec.  137.144  Is technical assistance available to an Indian Tribe 
to avoid rejection of a final offer?

    Yes, upon receiving a final offer, the Secretary must offer any 
necessary technical assistance, and must share all relevant information 
with the Indian Tribe in order to avoid rejection of a final offer.



Sec.  137.145  If the Secretary rejects a final offer, is the Secretary 
required to provide the Indian Tribe with technical assistance?

    Yes, the Secretary must offer and, if requested by the Indian Tribe, 
provide additional technical assistance to overcome the stated grounds 
for rejection.

[[Page 914]]



Sec.  137.146  If the Secretary rejects all or part of a final offer, 
is the Indian Tribe entitled to an appeal?

    Yes, the Indian Tribe is entitled to appeal the decision of the 
Secretary, with an agency hearing on the record, and the right to engage 
in full discovery relevant to any issue raised in the matter. The 
procedures for appeals are found in subpart P of this part. 
Alternatively, at its option, the Indian Tribe has the right to sue 
pursuant to section 110 of the Act [25 U.S.C. 450m-1] in Federal 
district court to challenge the Secretary's decision.



Sec.  137.147  Do those portions of the compact, funding agreement, 
or amendment not in dispute go into effect?

    Yes, subject to section 507(c)(1)(D) of the Act [25 U.S.C. 458aaa-
6(c)(1)(D)].



Sec.  137.148  Does appealing the decision of the Secretary prevent 
entering into the compact, funding agreement, or amendment?

    No, appealing the decision of the Secretary does not prevent 
entering into the compact, funding agreement, or amendment.

                             Burden of Proof



Sec.  137.150  What is the burden of proof in an appeal 
from rejection of a final offer?

    With respect to any appeal, hearing or civil action, the Secretary 
shall have the burden of demonstrating by clear and convincing evidence 
the validity of the grounds for rejecting the final offer.

                             Decision Maker



Sec.  137.155  What constitutes a final agency action?

    A final agency action shall consist of a written decision from the 
Department to the Indian Tribe either:
    (a) By an official of the Department who holds a position at a 
higher organizational level within the Department than the level of the 
departmental agency in which the decision that is the subject of the 
appeal was made; or
    (b) By an administrative judge.



                    Subpart I_Operational Provisions

                          Conflicts of Interest



Sec.  137.160  Are Self-Governance Tribes required to address 
potential conflicts of interest?

    Yes, self-Governance Tribes participating in self-governance under 
Title V must ensure that internal measures are in place to address 
conflicts of interest in the administration of self-governance PSFAs.

                       Audits and Cost Principles



Sec.  137.165  Are Self-Governance Tribes required to undertake annual audits?

    Yes, under the provisions of section 506(c) of the Act [25 U.S.C. 
458aaa-5(c)], Self-Governance Tribes must undertake annual audits 
pursuant to the Single Audit Act, 31 U.S.C. 7501 et seq.



Sec.  137.166  Are there exceptions to the annual audit requirements?

    Yes, the exceptions are described in 31 U.S.C. 7502 of the Single 
Audit Act.



Sec.  137.167  What cost principles must a Self-Governance Tribe follow 
when participating in self-governance under Title V?

    A Self-Governance Tribe must apply the cost principles of the 
applicable OMB circular, except as modified by:
    (a) Section 106 (k) of the Act [25 U.S.C. 450j-1],
    (b) Other provisions of law, or
    (c) Any exemptions to applicable OMB circulars subsequently granted 
by the OMB.



Sec.  137.168  May the Secretary require audit or accounting standards 
other than those specified in Sec.  137.167?

    No, no other audit or accounting standards shall be required by the 
Secretary.

[[Page 915]]



Sec.  137.169  How much time does the Federal Government have to make a claim 
against a Self-Governance Tribe relating to any disallowance of costs, 
based on an audit conducted under Sec.  137.165?

    Any right of action or other remedy (other than those relating to a 
criminal offense) relating to any disallowance of costs is barred unless 
the Secretary provides notice of such a disallowance within 365 days 
from receiving any required annual agency single audit report or, for 
any period covered by law or regulation in force prior to enactment of 
the Single Agency Audit Act of 1984, any other required final audit 
report.



Sec.  137.170  When does the 365 day period commence?

    For the purpose of determining the 365 day period, an audit report 
is deemed received on the date of actual receipt by the Secretary, at 
the address specified in Sec.  137.172, if, within 60 days after 
receiving the audit report, the Secretary does not give notice of a 
determination by the Secretary to reject the single-agency audit report 
as insufficient due to non-compliance with chapter 75 of title 31, 
United States Code or noncompliance with any other applicable law.



Sec.  137.171  Where do Self-Governance Tribes send their audit reports?

    (a) For fiscal years ending on or before June 30, 1996, the audit 
report must be sent to: National External Audit Review Center, Lucas 
Place Room 514, 323 W. 8th St., Kansas City, MO 64105.
    (b) For fiscal years, beginning after June 30, 1996, the audit 
report must be sent to: Single Audit Clearinghouse, 1201 E. 10th St., 
Jeffersonville, IN 47132.



Sec.  137.172  Should the audit report be sent anywhere else 
to ensure receipt by the Secretary?

    Yes, the Self-Governance Tribe should also send the audit report to: 
National External Audit Review Center, Lucas Place Room 514, 323 W. 8th 
St., Kansas City, MO 64105.



Sec.  137.173  Does a Self-Governance Tribe have a right of appeal 
from a disallowance?

    Yes, the notice must set forth the right of appeal and hearing to 
the Interior Board of Contract Appeals, pursuant to section 110 of the 
Act [25 U.S.C. 450m-1].

                                 Records



Sec.  137.175  Is a Self-Governance Tribe required to maintain 
a recordkeeping system?

    Yes. Tribes are required to maintain records and provide Federal 
agency access to those records as provided in Sec.  137.177.



Sec.  137.176  Are Tribal records subject to the Freedom of Information Act 
and Federal Privacy Act?

    No, except to the extent that a Self-Governance Tribe specifies 
otherwise in its compact or funding agreement, the records of the Self-
Governance Tribe shall not be considered Federal records for purposes of 
chapter 5 of title 5, United States Code.



Sec.  137.177  Is the Self-Governance Tribe required to make its records 
available to the Secretary?

    Yes, after 30 days advance written notice from the Secretary, the 
Self-Governance Tribe must provide the Secretary with reasonable access 
to such records to enable the Department to meet its minimum legal 
recordkeeping system requirements under sections 3101 through 3106 of 
title 44 United States Code.



Sec.  137.178  May Self-Governance Tribes store patient records 
at the Federal Records Centers?

    Yes, at the option of a Self-Governance Tribe, patient records may 
be stored at Federal Records Centers to the same extent and in the same 
manner as other Department patient records in accordance with section 
105(o) of the Act [25 U.S.C. 450j(o)].

[[Page 916]]



Sec.  137.179  May a Self-Governance Tribe make agreements with 
the Federal Records Centers regarding disclosure and release 
of the patient records stored pursuant to Sec.  137.178?

    Yes, a Self-Governance Tribe may make agreements with the Federal 
Records Centers regarding disclosure and release of the patient records 
stored pursuant to Sec.  137.178.



Sec.  137.180  Are there other laws that govern access to patient records?

    Yes, a Tribe must consider the potential application of Tribal, 
Federal and state law and regulations that may apply to requests for 
access to Tribal patient records, such as the provisions 42 CFR 2.1-2.67 
pertaining to records regarding drug and/or alcohol treatment.

                                Redesign



Sec.  137.185  May a Self-Governance Tribe redesign or consolidate the PSFAs 
that are included in a funding agreement and reallocate or redirect funds
for such PSFAs?

    Yes, a Self-Governance Tribe may redesign or consolidate PSFAs 
included in a funding agreement and reallocate or redirect funds for 
such PSFAs in any manner which the Self-Governance Tribe deems to be in 
the best interest of the health and welfare of the Indian community 
being served, only if the redesign or consolidation does not have the 
effect of denying eligibility for services to population groups 
otherwise eligible to be served under applicable Federal law.

                             Non-Duplication



Sec.  137.190  Is a Self-Governance Tribe that receives funds under Title V 
also entitled to contract under section 102 of the Act [25 U.S.C. 450(f)] 
for such funds?

    For the period for which, and to the extent to which, funding is 
provided under the compact or funding agreement, the Self-Governance 
Tribe is not entitled to contract with the Secretary for the same funds 
or PSFA under section 102 of the Act [25 U.S.C. 450f]. Such Self-
Governance Tribe is eligible for new programs on the same basis as other 
Indian Tribes.

                          Health Status Reports



Sec.  137.200  Are there reporting requirements for Self-Governance Tribes 
under Title V?

    Yes, compacts or funding agreements negotiated between the Secretary 
and a Self-Governance Tribe must include a provision that requires the 
Self-Governance Tribe to report on health status and services delivery. 
These reports may only impose minimal burdens on the Self-Governance 
Tribes.



Sec.  137.201  What are the purposes of the Tribal reporting requirements?

    Tribal reports enable the Secretary to prepare reports required 
under Title V and to develop the budget request. The reporting 
requirements are not intended as a quality assessment or monitoring 
tool, although such provision may be included at the option of the Self-
Governance Tribe. Under no circumstances will the reporting requirement 
include any confidential, proprietary or commercial information. For 
example, while staffing levels may be a part of a report, pay levels for 
the staff are considered confidential between the Self-Governance Tribe 
and the employee.



Sec.  137.202  What types of information will Self-Governance Tribes 
be expected to include in the reports?

    Reports will be derived from existing minimal data elements 
currently collected by Self-Governance Tribes, and may include patient 
demographic and workload data. Not less than 60 days prior to the start 
of negotiations or a mutually agreed upon timeframe, the IHS will 
propose a list of recommended minimal data elements, along with 
justification for their inclusion, to be used as a basis for negotiating 
these requirements into the Self-Governance Tribe's compact or funding 
agreement.



Sec.  137.203  May a Self-Governance Tribe participate in a voluntary 
national uniform data collection effort with the IHS?

    Yes, in order to advance Indian health advocacy efforts, each Self-
Governance Tribe will be encouraged to participate, at its option, in 
national IHS data reporting activities such as Government Performance 
Results Act,

[[Page 917]]

epidemiologic and surveillance reporting.



Sec.  137.204  How will this voluntary national uniform data set be developed?

    IHS will work with representatives of Self-Governance Tribes, in 
coordination with the Tribal Self Governance Advisory Committee (TSGAC), 
to develop a mutually-defined annual voluntary uniform subset of data 
that is consistent with Congressional intent, minimizes reporting 
burdens, and responds to the needs of the Self-Governance Tribe.



Sec.  137.205  Will this voluntary uniform data set reporting activity 
be required of all Self-Governance Tribes entering into a compact with 
the IHS under Title V?

    No, to the extent that specific resources are available or have not 
otherwise been provided to Self-Governance Tribes for this purpose, and 
if the Self-Governance Tribes choose to participate, the IHS will 
provide resources, hardware, software, and technical assistance to the 
Self-Governance Tribes to facilitate data gathering to ensure data 
consistency and integrity under this voluntary effort.



Sec.  137.206  Why does the IHS need this information?

    This information will be used to comply with sections 513 [25 U.S.C. 
458aaa-12] and 514 [25 U.S.C. 458aaa-13] of the Act as well as to assist 
IHS in advocating for the Indian health system, budget formulation, and 
other reporting required by statute, development of partnerships with 
other organizations that benefit the health status of Indian Tribes, and 
sharing of best practices.



Sec.  137.207  Will funding be provided to the Self-Governance Tribe 
to compensate for the costs of reporting?

    Yes, reporting requirements are subject to the Secretary providing 
specific funds for this purpose in the funding agreement.

                                 Savings



Sec.  137.210  What happens if self-governance activities under Title V 
reduce the administrative or other responsibilities of the Secretary 
with respect to the operation of Indian programs and result in savings?

    To the extent that PSFAs carried out by Self-Governance Tribes under 
Title V reduce the administrative or other responsibilities of the 
Secretary with respect to the operation of Indian programs and result in 
savings that have not otherwise been included in the amount of Tribal 
shares and other funds determined under section 508(c) of the Act [25 
U.S.C. 458aaa-7(c)], the Secretary must make such savings available to 
the Self-Governance Tribes, for the provision of additional services to 
program beneficiaries in a manner equitable to directly served, 
contracted, and compacted programs.



Sec.  137.211  How does a Self-Governance Tribe learn whether self-governance 
activities have resulted in savings as described in Sec.  137.210.

    The annual report prepared pursuant to section 514(b)(2) [25 U.S.C. 
458aaa-13(b)(2)] of the Act must specifically identify any such savings.

                 Access to Government Furnished Property



Sec.  137.215  How does a Self-Governance Tribe obtain title to real 
and personal property furnished by the Federal Government for use in 
the performance of a compact, funding agreement, construction 
project agreement, or grant agreement pursuant to section 512(c) 
of the Act [25 U.S.C. 458aaa-11(c)]?

    (a) For government-furnished real and personal property made 
available to a Self-Governance Tribe, the Self-Governance Tribe must 
take title to all real or personal property unless the Self-Governance 
Tribe requests that the United States retain the title.
    (b) For government-furnished personal property made available to a 
Self-Governance Tribe:
    (1) The Secretary, in consultation with each Self-Governance Tribe, 
must develop a list of the property used in a compact, funding 
agreement, or construction project agreement.

[[Page 918]]

    (2) The Self-Governance Tribe must indicate any items on the list to 
which the Self-Governance Tribe wants the Secretary to retain title.
    (3) The Secretary must provide the Self-Governance Tribe with any 
documentation needed to transfer title to the remaining listed property 
to the Self-Governance Tribe.
    (c) For government-furnished real property made available to a Self-
Governance Tribe:
    (1) The Secretary, in consultation with the Self-Governance Tribe, 
must develop a list of the property furnished for use in a compact, 
funding agreement, or construction project agreement.
    (2) The Secretary must inspect any real property on the list to 
determine the presence of any hazardous substance activity, as defined 
in 41 CFR 101-47.202-2(b)(10).
    (3) The Self-Governance Tribe must indicate on the list to the 
Secretary any items of real property to which the Self-Governance Tribe 
wants the Secretary to retain title and those items of property to which 
the Self-Governance Tribe wishes to obtain title. The Secretary must 
take such steps as necessary to transfer title to the Self-Governance 
Tribe those items of real property which the Self-Governance Tribe 
wishes to acquire.

              Matching and Cost Participation Requirements



Sec.  137.217  May funds provided under compacts, funding agreements, 
or grants made pursuant to Title V be treated as non-Federal funds 
for purposes of meeting matching or cost participation requirements
under any other Federal or non-Federal program?

    Yes, funds provided under compacts, funding agreements, or grants 
made pursuant to Title V may be treated as non-Federal funds for 
purposes of meeting matching or cost participation requirements under 
any other Federal or non-Federal program.

                     Federal Tort Claims Act (FTCA)



Sec.  137.220  Do section 314 of Public Law 101-512 [25 U.S.C. 450f note] 
and section 102(d) of the Act [25 U.S.C. 450f(d)] (regarding, in part, 
FTCA coverage) apply to compacts, funding agreements and construction 
project agreements?

    Yes, regulations governing FTCA coverage are set out at 25 CFR Part 
900, Subpart M.



                       Subpart J_Regulation Waiver



Sec.  137.225  What regulations may be waived under Title V?

    A Self-Governance Tribe may request a waiver of regulation(s) 
promulgated under section 517 of the Act [25 U.S.C. 458aaa-16] or under 
the authorities specified in section 505(b) of the Act [25 U.S.C. 
458aaa-4(b)] for a compact or funding agreement entered into with the 
IHS under Title V.



Sec.  137.226  How does a Self-Governance Tribe request a waiver?

    A Self-Governance Tribe may request a waiver by submitting a written 
request to the Secretary identifying the applicable Federal 
regulation(s) sought to be waived and the basis for the request.



Sec.  137.227  How much time does the Secretary have to act 
on a waiver request?

    The Secretary must either approve or deny the requested waiver in 
writing within 90 days after receipt by the Secretary.



Sec.  137.228  Upon what basis may the waiver request be denied?

    A denial may be made only upon a specific finding by the Secretary 
that identified language in the regulation may not be waived because 
such waiver is prohibited by Federal law.



Sec.  137.229  What happens if the Secretary neither approves or denies 
a waiver request within the time specified in Sec.  137.227?

    The waiver request is deemed approved.

[[Page 919]]



Sec.  137.230  Is the Secretary's decision on a waiver request final 
for the Department?

    Yes, the Secretary's decision on a waiver request is final for the 
Department.



Sec.  137.231  May a Self-Governance Tribe appeal the Secretary's decision 
to deny its request for a waiver of a regulation promulgated 
under section 517 of the Act [25 U.S.C. 458aaa-16]?

    The decision may not be appealed under these regulations but may be 
appealed by the Self-Governance Tribe in Federal Court under applicable 
law.



                          Subpart K_Withdrawal



Sec.  137.235  May an Indian Tribe withdraw from a participating 
inter-Tribal consortium or Tribal organization?

    Yes, an Indian Tribe may fully or partially withdraw from a 
participating inter-Tribal consortium or Tribal organization its share 
of any PSFAs included in a compact or funding agreement.



Sec.  137.236  When does a withdrawal become effective?

    A withdrawal becomes effective within the time frame specified in 
the resolution that authorizes withdrawal from the participating Tribal 
organization or inter-Tribal consortium. In the absence of a specific 
time frame set forth in the resolution, such withdrawal becomes 
effective on
    (a) The earlier of 1 year after the date of submission of such 
request, or the date on which the funding agreement expires; or
    (b) Such date as may be mutually agreed upon by the Secretary, the 
withdrawing Indian Tribe, and the participating Tribal organization or 
inter-Tribal consortium that has signed the compact or funding agreement 
on behalf of the withdrawing Indian Tribe, inter-Tribal consortium, or 
Tribal organization.



Sec.  137.237  How are funds redistributed when an Indian Tribe fully 
or partially withdraws from a compact or funding agreement and elects 
to enter a contract or compact?

    When an Indian Tribe eligible to enter into a contract under Title I 
or a compact or funding agreement under Title V fully or partially 
withdraws from a participating inter-Tribal consortium or Tribal 
organization, and has proposed to enter into a contract or compact and 
funding agreement covering the withdrawn funds:
    (a) The withdrawing Indian Tribe is entitled to its Tribal share of 
funds supporting those PSFAs that the Indian Tribe will be carrying out 
under its own contract or compact and funding agreement (calculated on 
the same basis as the funds were initially allocated in the funding 
agreement of the inter-Tribal consortium or Tribal organization); and
    (b) the funds referred to in paragraph (a) of this section must be 
transferred from the funding agreement of the inter-Tribal consortium or 
Tribal organization, on the condition that the provisions of sections 
102 [25 U.S.C. 450f] and 105(i) of the Act [25 U.S.C. 450j], as 
appropriate, apply to the withdrawing Indian Tribe.



Sec.  137.238  How are funds distributed when an Indian Tribe fully 
or partially withdraws from a compact or funding agreement administered 
by an inter-Tribal consortium or Tribal organization serving more than 
one Indian Tribe and the withdrawing Indian Tribe elects not to enter 
a contract or compact?

    All funds not obligated by the inter-Tribal consortium or Tribal 
organization associated with the withdrawing Indian Tribe's returned 
PSFAs, less close out costs, shall be returned by the inter-Tribal 
consortium or Tribal organization to the IHS for operation of the PSFAs 
included in the withdrawal.

[[Page 920]]



Sec.  137.239  If the withdrawing Indian Tribe elects to operate PSFAs 
carried out under a compact or funding agreement under Title V 
through a contract under Title I, is the resulting contract considered 
a mature contract under section 4(h) of the Act [25 U.S.C. 450b(h)]?

    Yes, if the withdrawing Indian Tribe elects to operate PSFAs carried 
out under a compact or funding agreement under Title V through a 
contract under Title I, the resulting contract is considered a mature 
contract under section 4(h) of the Act [25 U.S.C. 450b(h)] at the option 
of the Indian Tribe.



                         Subpart L_Retrocession



Sec.  137.245  What is retrocession?

    Retrocession means the return by a Self-Governance Tribe to the 
Secretary of PSFAs, that are included in a compact or funding agreement, 
for any reason, before the expiration of the term of the compact or 
funding agreement.



Sec.  137.246  How does a Self-Governance Tribe retrocede a PSFA?

    The Self-Governance Tribe submits a written notice to the Director 
of its intent to retrocede. The notice must specifically identify those 
PSFAs being retroceded. The notice may also include a proposed effective 
date of the retrocession.



Sec.  137.247  What is the effective date of a retrocession?

    Unless the request for retrocession is rescinded, the retrocession 
becomes effective within the timeframe specified by the parties in the 
compact or funding agreement. In the absence of a specification, the 
retrocession becomes effective on:
    (a) The earlier of 1 year after:
    (1) The date of submission of the request, or
    (2) The date on which the funding agreement expires; or
    (b) Whatever date is mutually agreed upon by the Secretary and the 
retroceding Self-Governance Tribe.



Sec.  137.248  What effect will a retrocession have on a retroceding 
Self-Governance Tribe's rights to contract or compact under the Act?

    A retrocession request shall not negatively affect:
    (a) Any other contract or compact to which the retroceding Self-
Governance Tribe is a party;
    (b) Any other contracts or compacts the retroceding Self-Governance 
Tribe may request; and
    (c) Any future request by such Self-Governance Tribe or an Indian 
Tribe to compact or contract for the same program.



Sec.  137.249  Will retrocession adversely affect funding available 
for the retroceded program?

    No, the Secretary shall provide no less than the same level of 
funding that would have been available if there had been no 
retrocession.



Sec.  137.250  How are funds distributed when a Self-Governance Tribe fully 
or partially retrocedes from its compact or funding agreement?

    Any funds not obligated by the Self-Governance Tribe and associated 
with the Self-Governance Tribe's returned PSFAs, less close out costs, 
must be returned by the Self-Governance Tribe to IHS for operation of 
the PSFA's associated with the compact or funding agreement from which 
the Self-Governance Tribe retroceded in whole or in part.



Sec.  137.251.  What obligation does the retroceding Self-Governance Tribe 
have with respect to returning property that was provided by the Secretary 
under the compact or funding agreement and that was used in the operation 
of the retroceded program?

    On the effective date of any retrocession, the retroceding Self-
Governance Tribe, shall, at the option of the Secretary, deliver to the 
Secretary all requested property and equipment provided by the Secretary 
under the compact or funding agreement, to the extent used to carry out 
the retroceded PSFAs, which at the time of retrocession has a per item 
current fair market value, less the cost of improvements borne by the 
Self-Governance Tribe in

[[Page 921]]

excess of $5,000 at the time of the retrocession.



                         Subpart M_Reassumption



Sec.  137.255  What does reassumption mean?

    Reassumption means rescission by the Secretary without consent of 
the Self-Governance Tribe of PSFAs and associated funding in a compact 
or funding agreement and resuming responsibility to provide such PSFAs.



Sec.  137.256  Under what circumstances may the Secretary reassume a program, 
service, function, or activity (or portion thereof)?

    (a) Subject to the steps in Sec.  137.257, the Secretary may 
reassume a program, service, function, or activity (or portion thereof) 
and associated funding if the Secretary makes a specific finding 
relative to that PSFA of :
    (1) Imminent endangerment of the public health caused by an act or 
omission of the Self-Governance Tribe, and the imminent endangerment 
arises out of a failure to carry out the compact or funding agreement; 
or
    (2) Gross mismanagement with respect to funds transferred to the 
Self-Governance Tribe by a compact or funding agreement, as determined 
by the Secretary, in consultation with the Inspector General, as 
appropriate.
    (b) Immediate reassumption may occur under additional requirements 
set forth in Sec.  137.261.



Sec.  137.257  What steps must the Secretary take prior to 
reassumption becoming effective?

    Except as provided in Sec.  137.261 for immediate reassumption, 
prior to a reassumption becoming effective, the Secretary must:
    (a) Notify the Self-Governance Tribe in writing by certified mail of 
the details of findings required under Sec.  137.256(a)(1) and (2);
    (b) Request specified corrective action within a reasonable period 
of time, which in no case may be less than 45 days;
    (c) Offer and provide, if requested, the necessary technical 
assistance and advice to assist the Self-Governance Tribe to overcome 
the conditions that led to the findings described under (a); and
    (d) Provide the Self-Governance Tribe with a hearing on the record 
as provided under Subpart P of this part.



Sec.  137.258  Does the Self-Governance Tribe have a right to a hearing 
prior to a non-immediate reassumption becoming effective?

    Yes, at the Self-Governance Tribe's request, the Secretary must 
provide a hearing on the record prior to or in lieu of the corrective 
action period identified in Sec.  137.257(b).



Sec.  137.259  What happens if the Secretary determines that 
the Self-Governance Tribe has not corrected the conditions 
that the Secretary identified in the notice?

    (a) The Secretary shall provide a second written notice by certified 
mail to the Self-Governance Tribe served by the compact or funding 
agreement that the compact or funding agreement will be rescinded, in 
whole or in part.
    (b) The second notice shall include:
    (1) The intended effective date of the reassumption;
    (2) The details and facts supporting the intended reassumption; and
    (3) Instructions that explain the Indian Tribe's right to a formal 
hearing within 30 days of receipt of the notice.



Sec.  137.260  What is the earliest date on which a reassumption 
can be effective?

    Except as provided in Sec.  137.261, no PSFA may be reassumed by the 
Secretary until 30 days after the final resolution of the hearing and 
any subsequent appeals to provide the Self-Governance Tribe with an 
opportunity to take corrective action in response to any adverse final 
ruling.



Sec.  137.261  Does the Secretary have the authority to immediately 
reassume a PSFA?

    Yes, the Secretary may immediately reassume operation of a program, 
service, function, or activity (or portion thereof) and associated 
funding upon providing to the Self-Governance Tribe written notice in 
which the Secretary makes a finding:
    (a) of imminent substantial and irreparable endangerment of the 
public

[[Page 922]]

health caused by an act or omission of the Indian Tribe; and
    (b) the endangerment arises out of a failure to carry out the 
compact or funding agreement.



Sec.  137.262  If the Secretary reassumes a PSFA immediately, 
when must the Secretary provide the Self-Governance Tribe with a hearing?

    If the Secretary immediately reassumes a PSFA, the Secretary must 
provide the Self-Governance Tribe with a hearing under Subpart P of this 
part not later than 10 days after such reassumption, unless the Self-
Governance Tribe and the Secretary agree to an extension.



Sec.  137.263  May the Secretary provide a grant to a Self-Governance Tribe 
for technical assistance to overcome conditions identified under Sec.  137.257?

    Yes, the Secretary may make a grant for the purpose of obtaining 
technical assistance as provided in section 103 of the Act [25 U.S.C. 
458aaa-h].



Sec.  137.264  To what extent may the Secretary require 
the Self-Governance Tribe to return property that was provided 
by the Secretary under the compact or funding agreement and used in 
the operation of the reassumed program?

    On the effective date of any reassumption, the Self-Governance 
Tribe, shall, at the option of the Secretary and only to the extent 
requested by the Secretary, deliver to the Secretary property and 
equipment provided by the Secretary under the compact or funding 
agreement, to the extent the property was used to directly carry out the 
reassumed program, service, function, or activity (or portion thereof), 
provided that at the time of reassumption the property has a per item 
current fair market value, less the cost of improvements borne by the 
Self-Governance Tribe, in excess of $5,000 at the time of the 
reassumption.



Sec.  137.265  May a Tribe be reimbursed for actual and reasonable 
close out costs incurred after the effective date of reassumption?

    Yes, a Tribe may be reimbursed for actual and reasonable close out 
costs incurred after the effective date of reassumption.



                         Subpart N_Construction

                            Purpose and Scope



Sec.  137.270  What is covered by this subpart?

    This subpart covers IHS construction projects carried out under 
section 509 of the Act [25 U.S.C. 458aaa-8].



Sec.  137.271  Why is there a separate subpart in these regulations 
for construction project agreements?

    Construction projects are separately defined in Title V and are 
subject to a separate proposal and review process. Provisions of a 
construction project agreement and this subpart shall be liberally 
construed in favor of the Self-Governance Tribe.



Sec.  137.272  What other alternatives are available 
for Self-Governance Tribes to perform construction projects?

    Self-Governance Tribes also have the option of performing IHS 
construction projects under a variety of other legal authorities, 
including but not limited to Title I of the Act, the Indian Health Care 
Improvement Act, Public Law 94-437, and Public Law 86-121. This subpart 
does not cover projects constructed pursuant to agreements entered into 
under these authorities.



Sec.  137.273  What are IHS construction PSFAs?

    IHS construction PSFAs are a combination of construction projects as 
defined in Sec.  137.280 and construction programs.



Sec.  137.274  Does this subpart cover construction programs?

    No, except as provided in Sec.  137.275, this subpart does not cover 
construction programs such as the:
    (a) Maintenance and Improvement Program;
    (b) Construction program functions; and,
    (c) Planning services and construction management services.

[[Page 923]]



Sec.  137.275  May Self-Governance Tribes include IHS construction programs 
in a construction project agreement or in a funding agreement?

    Yes, Self-Governance Tribes may choose to assume construction 
programs in a construction project agreement, in a funding agreement, or 
in a combination of the two. These programs may include the following:
    (a) Maintenance and improvement program;
    (b) Construction program functions; and
    (c) Planning services and construction management services.

                        Construction Definitions



Sec.  137.280  Construction Definitions.

    ALJ means administrative law judge.
    APA means Administrative Procedures Act, 5 U.S.C. 701-706.
    Budget means a statement of the funds required to complete the scope 
of work in a construction project agreement. For cost reimbursement 
agreements, budgets may be stated using broad categories such as 
planning, design, construction, project administration, and contingency. 
For fixed price agreements, budgets may be stated as lump sums, unit 
cost pricing, or a combination thereof.
    Categorical exclusion means a category of actions that do not 
individually or cumulatively have a significant effect on the human 
environment and that have been found to have no such effect in 
procedures adopted by a Federal agency in implementation of these 
regulations and for which, therefore, neither an environmental 
assessment nor an environmental impact statement is required. Any 
procedures under this section shall provide for extraordinary 
circumstances in which a normally excluded action may have a significant 
environmental effect.
    CEQ means Council on Environmental Quality in the Office of the 
President.
    Construction management services (CMS) means activities limited to 
administrative support services; coordination; and monitoring oversight 
of the planning, design, and construction process. CMS activities 
typically include:
    (1) Coordination and information exchange between the Self-
Governance Tribe and the Federal Government;
    (2) Preparation of a Self-Governance Tribe's project agreement; and
    (3) A Self-Governance Tribe's subcontract scope of work 
identification and subcontract preparation, and competitive selection of 
construction contract subcontractors.
    Construction phase is the phase of a construction project agreement 
during which the project is constructed, and includes labor, materials, 
equipment and services necessary to complete the work, in accordance 
with the construction project agreement.
    Construction project means:
    (1) An organized noncontinuous undertaking to complete a specific 
set of predetermined objectives for the planning, environmental 
determination, design, construction, repair, improvement, or expansion 
of buildings or facilities described in a project agreement, and
    (2) Does not include construction program administration and 
activities described in sections 4(m)(1) through (3) of the Act [25 
U.S.C. 4b(m)(1) through (3)], that may otherwise be included in a 
funding agreement under section 505 of the Act [25 U.S.C. 458aaa-4].
    Construction project agreement means a negotiated agreement between 
the Secretary and a Self-Governance Tribe, that at a minimum:
    (1) Establishes project phase start and completion dates;
    (2) Defines a specific scope of work and standards by which it will 
be accomplished;
    (3) Identifies the responsibilities of the Self-Governance Tribe and 
the Secretary;
    (4) Addresses environmental considerations;
    (5) Identifies the owner and operations and maintenance entity of 
the proposed work;
    (6) Provides a budget;
    (7) Provides a payment process; and
    (8) Establishes the duration of the agreement based on the time 
necessary to complete the specified scope of work, which may be 1 or 
more years.
    Design phase is the phase of a construction project agreement during 
which project plans, specifications, and

[[Page 924]]

other documents are prepared that are used to build the project. Site 
investigation, final site selection activities and environmental review 
and determination activities are completed in this phase if not 
conducted as a part of the planning phase.
    Maintenance and improvement program:
    (1) As used in this subpart means the program that provides funds 
for eligible facilities for the purpose of:
    (i) Performing routine maintenance;
    (ii) Achieving compliance with accreditation standards;
    (iii) Improving and renovating facilities;
    (iv) Ensuring that Indian health care facilities meet existing 
building codes and standards; and
    (v) Ensuring compliance with public law building requirements.
    (2) The maintenance and improvement program is comprised of routine 
maintenance and repair funding and project funding. Typical maintenance 
and improvement projects have historically been funded out of regional 
or national project pools and may include, but are not limited to, total 
replacement of a heating or cooling system, remodel of a medical 
laboratory, removal of lead based paint, abatement of asbestos and 
abatement of underground fuel storage tanks. Maintenance and repair 
program funding provided under a funding agreement is not covered under 
this subpart.
    NEPA means the National Environmental Policy Act of 1969 [42 U.S.C. 
4321 et seq.].
    NHPA means the National Historic Preservation Act [16 U.S.C. 470 et 
seq.].
    Planning phase is the phase of a construction project agreement 
during which planning services are provided.
    Planning services may include performing a needs assessment, 
completing and/or verifying master plans, developing justification 
documents, conducting pre-design site investigations, developing budget 
cost estimates, conducting feasibility studies as needed, conducting 
environmental review activities and justifying the need for the project.
    SHPO means State Historic Preservation Officer.
    Scope of work or specific scope of work means a brief written 
description of the work to be accomplished under the construction 
project agreement, sufficient to confirm that the project is consistent 
with the purpose for which the Secretary has allocated funds.
    THPO means Tribal Historic Preservation Officer.

                              NEPA Process



Sec.  137.285  Are Self-Governance Tribes required to accept Federal 
environmental responsibilities to enter into a construction project agreement?

    Yes, under section 509 of the Act [25 U.S.C. 458aaa-8], Self-
Governance Tribes must assume all Federal responsibilities under the 
NEPA of 1969 [42 U.S.C. 4321 et seq.] and the National Historic 
Preservation Act [16 U.S.C. 470 et seq.] and related provisions of law 
that would apply if the Secretary were to undertake a construction 
project, but only those responsibilities directly related to the 
completion of the construction project being assumed.



Sec.  137.286  Do Self-Governance Tribes become Federal agencies 
when they assume these Federal environmental responsibilities?

    No, while Self-Governance Tribes are required to assume Federal 
environmental responsibilities for projects in place of the Secretary, 
Self-Governance Tribes do not thereby become Federal agencies. However, 
because Self-Governance Tribes are assuming the responsibilities of the 
Secretary for the purposes of performing these Federal environmental 
responsibilities, Self-Governance Tribes will be considered the 
equivalent of Federal agencies for certain purposes as set forth in this 
subpart.



Sec.  137.287  What is the National Environmental Policy Act (NEPA)?

    The NEPA is a procedural law that requires Federal agencies to 
follow established environmental review procedures, which include 
reviewing and documenting the environmental impact of their actions. 
NEPA establishes a comprehensive policy for protection and enhancement 
of the environment by the Federal Government; creates the Council on 
Environmental Quality

[[Page 925]]

in the Office of the President; and directs Federal agencies to carry 
out the policies and procedures of the Act. CEQ regulations (40 CFR 
1500-1508) establish three levels of environmental review: categorical 
exclusions, environmental assessments, and environmental impact 
statements.



Sec.  137.288  What is the National Historic Preservation Act (NHPA)?

    The NHPA requires Federal agencies to take into account the effects 
of their undertakings, such as construction projects, on properties 
covered by the NHPA, such as historic properties, properties eligible 
for listing on the National Register of Historic Places, or properties 
that an Indian Tribe regards as having religious and/or cultural 
importance. Section 106 of the NHPA [16 U.S.C. 470f] requires Federal 
agencies to afford the Advisory Council on Historic Preservation, acting 
through the SHPO or the THPO, a reasonable opportunity to comment on 
such undertakings.



Sec.  137.289  What is a Federal undertaking under NHPA?

    The Advisory Council on Historic Preservation has defined a Federal 
undertaking in 36 CFR 800.16(y) as a project, activity, or program 
funded in whole or in part under the direct or indirect jurisdiction of 
a Federal agency, including those carried out by or on behalf of a 
Federal agency; those carried out with Federal financial assistance; 
those requiring a Federal permit, license or approval; and those subject 
to State or local regulation administered pursuant to a delegation or 
approval by a Federal agency.



Sec.  137.290  What additional provisions of law are related to NEPA and NHPA?

    (a) Depending upon the nature and the location of the construction 
project, environmental laws related to NEPA and NHPA may include:
    (1) Archaeological and Historical Data Preservation Act [16 U.S.C. 
469];
    (2) Archeological Resources Protection Act [16 U.S.C. 470aa];
    (3) Clean Air Act [42 U.S.C. 7401];
    (4) Clean Water Act [33 U.S.C. 1251];
    (5) Coastal Barrier Improvement Act [42 U.S.C. 4028 and 16 U.S.C. 
Sec. 3501];
    (6) Coastal Barrier Resources Act [16 U.S.C. 3501];
    (7) Coastal Zone Management Act [16 U.S.C. 1451];
    (8) Comprehensive Environmental Response, Compensation, and 
Liability Act [42 U.S.C. 9601];
    (9) Endangered Species Act [16 U.S.C. 1531 et seq.];
    (10) Farmland Protection Policy Act [7 U.S.C. 4201 et seq.];
    (11) Marine Protection, Research, and Sanctuaries Act [33 U.S.C. 
1401-1445; 16 U.S.C. 1431-1447F; 33 U.S.C. 2801-2805];
    (12) National Historic Preservation Act [16 U.S.C. 470 et seq.];
    (13) National Trails System Act [16 U.S.C. 1241];
    (14) Native American Graves Protection and Repatriation Act [25 
U.S.C. 3001];
    (15) Noise Control Act [42 U.S.C.4901];
    (16) Resource Conservation and Recovery Act [42 U.S.C. 6901];
    (17) Safe Drinking Water Act [42 U.S.C. 300F];
    (18) Toxic Substance Control Act [15 U.S.C. 2601];
    (19) Wild and Scenic Rivers Act [16 U.S.C. 1271]; and
    (20) Wilderness Act [16 U.S.C. 1131].
    (b) This section provides a list of environmental laws for 
informational purposes only and does not create any legal rights or 
remedies, or imply private rights of action.



Sec.  137.291  May Self-Governance Tribes carry out construction projects 
without assuming these Federal environmental responsibilities?

    Yes, but not under section 509 of the Act [25 U.S.C. 458aaa-8]. 
Self-Governance Tribes may otherwise elect to perform construction 
projects, or phases of construction projects, under other legal 
authorities (see Sec.  137.272).



Sec.  137.292  How do Self-Governance Tribes assume environmental 
responsibilities for construction projects under section 509 
of the Act [25 U.S.C. 458aaa-8]?

    Self-Governance Tribes assume environmental responsibilities by:
    (a) Adopting a resolution or taking an equivalent Tribal action 
which:

[[Page 926]]

    (1) Designates a certifying officer to represent the Self-Governance 
Tribe and to assume the status of a responsible Federal official under 
NEPA, NHPA, and related provisions of law; and
    (2) Accepts the jurisdiction of the Federal court, as provided in 
Sec.  137.310 and Sec.  137.311 for purposes of enforcement of the 
Federal environmental responsibilities assumed by the Self-Governance 
Tribe; and
    (b) Entering into a construction project agreement under section 509 
of the Act [25 U.S.C. 458aaa-8].



Sec.  137.293  Are Self-Governance Tribes required to adopt 
a separate resolution or take equivalent Tribal action to assume 
environmental responsibilities for each construction project agreement?

    No, the Self-Governance Tribe may adopt a single resolution or take 
equivalent Tribal action to assume environmental responsibilities for a 
single project, multiple projects, a class of projects, or all projects 
performed under section 509 of the Act [25 U.S.C. 458aaa-8].



Sec.  137.294  What is the typical IHS environmental review process 
for construction projects?

    (a) Most IHS construction projects normally do not have a 
significant impact on the environment, and therefore do not require 
environmental impact statements (EIS). Under current IHS procedures, an 
environmental review is performed on all construction projects. During 
the IHS environmental review process, the following activities may 
occur:
    (1) Consult with appropriate Tribal, Federal, state, and local 
officials and interested parties on potential environmental effects;
    (2) Document assessment of potential environmental effects; (IHS has 
developed a form to facilitate this process.)
    (3) Perform necessary environmental surveys and inventories;
    (4) Consult with the Advisory Council on Historic Preservation, 
acting through the SHPO or THPO, to ensure compliance with the NHPA;
    (5) Determine if extraordinary or exceptional circumstances exist 
that would prevent the project from meeting the criteria for categorical 
exclusion from further environmental review under NEPA, or if an 
environmental assessment is required;
    (6) Obtain environmental permits and approvals; and
    (7) Identify methods to avoid or mitigate potential adverse effects;
    (b) This section is for informational purposes only and does not 
create any legal rights or remedies, or imply private rights of action.



Sec.  137.295  May Self-Governance Tribes elect to develop their own 
environmental review process?

    Yes, Self-Governance Tribes may develop their own environmental 
review process or adopt the procedures of the IHS or the procedures of 
another Federal agency.



Sec.  137.296  How does a Self-Governance Tribe comply with NEPA and NHPA?

    Self-Governance Tribes comply with NEPA and the NHPA by adopting and 
following:
    (a) their own environmental review procedures;
    (b) the procedures of the IHS; and/or
    (c) the procedures of another Federal agency.



Sec.  137.297  If the environmental review procedures of a Federal agency 
are adopted by a Self-Governance Tribe, is the Self-Governance Tribe 
responsible for ensuring the agency's policies and procedures 
meet the requirements of NEPA, NHPA, and related environmental laws?

    No, the Federal agency is responsible for ensuring its own policies 
and procedures meet the requirements of NEPA, NHPA, and related 
environmental laws, not the Self-Governance Tribe.



Sec.  137.298  Are Self-Governance Tribes required to comply with 
Executive Orders to fulfill their environmental responsibilities 
under section 509 of the Act [25 U.S.C. 458aaa-8]?

    No, but Self-Governance Tribes may at their option, choose to 
voluntarily comply with Executive Orders. For facilities where ownership 
will vest with the Federal Government upon completion of the 
construction, Tribes and the Secretary may agree to include the

[[Page 927]]

goals and objectives of Executive Orders in the codes and standards of 
the construction project agreement.



Sec.  137.299  Are Federal funds available to cover the cost 
of Self-Governance Tribes carrying out environmental responsibilities?

    Yes, funds are available:
    (a) for project-specific environmental costs through the 
construction project agreement; and
    (b) for environmental review program costs through a funding 
agreement and/or a construction project agreement.



Sec.  137.300  Since Federal environmental responsibilities 
are new responsibilities, which may be assumed by Tribes under section 509 
of the Act [25 U.S.C. 458aaa-8], are there additional funds available 
to Self-Governance Tribes to carry out these formerly inherently 
Federal responsibilities?

    Yes, the Secretary must transfer not less than the amount of funds 
that the Secretary would have otherwise used to carry out the Federal 
environmental responsibilities assumed by the Self-Governance Tribe.



Sec.  137.301  How are project and program environmental review 
costs identified?

    (a) The Self-Governance Tribe and the Secretary should work together 
during the initial stages of project development to identify program and 
project related costs associated with carrying out environmental 
responsibilities for proposed projects. The goal in this process is to 
identify the costs associated with all foreseeable environmental review 
activities.
    (b) If unforeseen environmental review and compliance costs are 
identified during the performance of the construction project, the Self-
Governance Tribe or, at the request of the Self-Governance Tribe, the 
Self-Governance Tribe and the Secretary (with or without amendment as 
required by Sec.  137.363) may do one or more of the following:
    (1) Mitigate adverse environmental effects;
    (2) Alter the project scope of work; and/or
    (3) Add additional program and/or project funding, including seeking 
supplemental appropriations.



Sec.  137.302  Are Federal funds available to cover start-up costs 
associated with initial Tribal assumption of environmental responsibilities?

    (a) Yes, start-up costs are available as provided in section 508(c) 
of the Act [25 U.S.C. 458aaa-7(c)]. During the initial year that these 
responsibilities are assumed, the amount required to be paid under 
section 106(a)(2) of the Act [25 U.S.C. 450j-1(a)(2)] must include 
startup costs consisting of the reasonable costs that have been incurred 
or will be incurred on a one-time basis pursuant to the agreement 
necessary:
    (1) To plan, prepare for, and assume operation of the environmental 
responsibilities; and
    (2) To ensure compliance with the terms of the agreement and prudent 
management.
    (b) Costs incurred before the initial year that the agreement is in 
effect may not be included in the amount required to be paid under 
section 106(a)(2) of the Act [25 U.S.C. 450j-1(a)(2)] if the Secretary 
does not receive a written notification of the nature and extent of the 
costs prior to the date on which such costs are incurred.



Sec.  137.303  Are Federal or other funds available for training 
associated with Tribal assumption of environmental responsibilities?

    Yes, Self-Governance Tribes may use construction program and project 
funds for training and program development. Training and program 
development funds may also be available from other Federal agencies, 
such as the Environmental Protection Agency and the National Park 
Service, state and local governments, and private organizations.



Sec.  137.304  May Self-Governance Tribes buy back environmental services 
from the IHS?

    Yes, Self-Governance Tribes may ``buy back'' project related 
services in their construction project agreement, including design and 
construction engineering, and environmental compliance services from the 
IHS in accordance with Section 508(f) of the Act [25 U.S.C.

[[Page 928]]

458aaa-7(f)] and Sec.  137.95, subject to the availability of the IHS's 
capacity to conduct the work.



Sec.  137.305  May Self-Governance Tribes act as lead, cooperating, 
or joint lead agencies for environmental review purposes?

    Yes, Self-Governance Tribes assuming Federal environmental 
responsibilities for construction projects under section 509 of the Act 
[25 U.S.C. 458aaa-8] are entitled to receive equal consideration, on the 
same basis as any Federal agency, for lead, cooperating, and joint lead 
agency status. For informational purposes, the terms ``lead,'' 
``cooperating,'' and ``joint lead agency'' are defined in the CEQ 
regulations at 40 CFR 1508.16, 1508.5, and 1501.5 respectively.



Sec.  137.306  How are Self-Governance Tribes recognized as having lead, 
cooperating, or joint lead agency status?

    Self-Governance Tribes may be recognized as having lead, 
cooperating, or joint lead agency status through funding or other 
agreements with other agencies. To the extent that resources are 
available, the Secretary will encourage and facilitate Federal, state, 
and local agencies to enter into agreements designating Tribes as lead, 
cooperating, or joint lead agencies for environmental review purposes.



Sec.  137.307  What Federal environmental responsibilities remain with 
the Secretary when a Self-Governance Tribe assumes Federal environmental 
responsibilities for construction projects under section 509 of the Act 
[25 U.S.C. 458aaa-8]?

    (a) All environmental responsibilities for Federal actions not 
directly related to construction projects assumed by Tribes under 
section 509 of the Act [25 U.S.C. 458aaa-8] remain with the Secretary. 
Federal agencies, including the IHS, retain responsibility for ensuring 
their environmental review procedures meet the requirements of NEPA, 
NHPA and related provisions of law, as called for in Sec.  137.297.
    (b) The Secretary will provide information updating and changing IHS 
agency environmental review policy and procedures to all Self-Governance 
Tribes implementing a construction project agreement, and to other 
Indian Tribes upon request. If a Self-Governance Tribe participating 
under section 509 of the Act [25 U.S.C. 458aaa-8] does not wish to 
receive this information, it must notify the Secretary in writing. As 
resources permit, at the request of the Self-Governance Tribe, the 
Secretary will provide technical assistance to the Self-governance tribe 
to assist the Self-governance Tribe in carrying out Federal 
environmental responsibilities.



Sec.  137.308  Does the Secretary have any enforcement authority 
for Federal environmental responsibilities assumed by Tribes 
under section 509 of the Act [25 U.S.C. 458aaa-8]?

    No, the Secretary does not have any enforcement authority for 
Federal environmental responsibilities assumed by Tribes under section 
509 of the Act [25 U.S.C. 458aaa-8].



Sec.  137.309  How are NEPA and NHPA obligations typically enforced?

    NEPA and NHPA obligations are typically enforced by interested 
parties who may file lawsuits against Federal agencies alleging that the 
agencies have not complied with their legal obligations under NEPA and 
NHPA. These lawsuits may only be filed in Federal court under the 
provisions of the APA, 5 U.S.C. 701-706. Under the APA, a Federal judge 
reviews the Federal agency's actions based upon an administrative record 
prepared by the Federal agency. The judge gives appropriate deference to 
the agency's decisions and does not substitute the court's views for 
those of the agency. Jury trials and civil discovery are not permitted 
in APA proceedings. If a Federal agency has failed to comply with NEPA 
or NHPA, the judge may grant declaratory or injunctive relief to the 
interested party. No money damages or fines are permitted in APA 
proceedings.

[[Page 929]]



Sec.  137.310  Are Self-Governance Tribes required to grant a limited waiver 
of their sovereign immunity to assume Federal environmental responsibilities 
under section 509 of the Act [25 U.S.C. 458aaa-8]?

    Yes, but only as provided in this section. Unless Self-Governance 
Tribes consent to the jurisdiction of a court, Self-Governance Tribes 
are immune from civil lawsuits. Self-Governance Tribes electing to 
assume Federal environmental responsibilities under section 509 of the 
Act [25 U.S.C. 458aaa-8] must provide a limited waiver of sovereign 
immunity solely for the purpose of enforcing a Tribal certifying 
officer's environmental responsibilities, as set forth in this subpart. 
Self-Governance Tribes are not required to waive any other immunity.



Sec.  137.311  Are Self-Governance Tribes entitled to determine the nature 
and scope of the limited immunity waiver required under section 509(a)(2) 
of the Act [25 U.S.C. 458aaa-8(a)(2)]?

    (a) Yes, Section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)] 
only requires that the waiver permit a civil enforcement action to be 
brought against the Tribal certifying officer in his or her official 
capacity in Federal district court for declaratory and injunctive relief 
in a procedure that is substantially equivalent to an APA enforcement 
action against a Federal agency. Self-Governance Tribes are not required 
to subject themselves to suit in their own name, to submit to trial by 
jury or civil discovery, or to waive immunity for money damages, 
attorneys fees, or fines.
    (b) Self-Governance Tribes may base the grant of a limited waiver 
under this subpart on the understanding that:
    (1) Judicial review of the Tribal certifying official's actions are 
based upon the administrative record prepared by the Tribal official in 
the course of performing the Federal environmental responsibilities; and
    (2) Actions and decisions of the Tribal certifying officer will be 
granted deference on a similar basis as Federal officials performing 
similar functions.



Sec.  137.312  Who is the proper defendant in a civil enforcement action 
under section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)]?

    Only the designated Tribal certifying officer acting in his or her 
official capacity may be sued. Self-Governance Tribes and other Tribal 
officials are not proper defendants in lawsuits brought under section 
509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)].

    Notification (Prioritization Process, Planning, Development and 
                              Construction)



Sec.  137.320  Is the Secretary required to consult with 
affected Indian Tribes concerning construction projects and programs?

    Yes, before developing a new project resource allocation methodology 
and application process the Secretary must consult with all Indian 
Tribes. In addition, before spending any funds for planning, design, 
construction, or renovation projects, whether subject to a competitive 
application and ranking process or not, the Secretary must consult with 
any Indian Tribe that would be significantly affected by the expenditure 
to determine and honor Tribal preferences whenever practicable 
concerning the size, location, type, and other characteristics of the 
project.



Sec.  137.321  How do Indian Tribes and the Secretary identify 
and request funds for needed construction projects?

    In addition to the requirements contained in section 513 of the Act 
[25 U.S.C. 458aaa-12], Indian Tribes and the Secretary are encouraged to 
jointly identify health facility and sanitation needs at the earliest 
possible date for IHS budget formulation. In developing budget 
justifications for specific projects to be proposed to Congress, the 
Secretary shall follow the preferences of the affected Indian Tribe(s) 
to the greatest extent feasible concerning the size, location, type, and 
other characteristics of the project.

[[Page 930]]



Sec.  137.322  Is the Secretary required to notify an Indian Tribe 
that funds are available for a construction project or a phase of a project?

    (a) Yes, within 30 days after the Secretary's allocation of funds 
for planning phase, design phase, or construction phase activities for a 
specific project, the Secretary shall notify, by registered mail with 
return receipt in order to document mailing, the Indian Tribe(s) to be 
benefitted by the availability of the funds for each phase of a project. 
The Secretarial notice of fund allocation shall offer technical 
assistance in the preparation of a construction project proposal.
    (b) The Secretary shall, within 30 days after receiving a request 
from an Indian Tribe, furnish the Indian Tribe with all information 
available to the Secretary about the project including, but not limited 
to: construction drawings, maps, engineering reports, design reports, 
plans of requirements, cost estimates, environmental assessments, or 
environmental impact reports and archeological reports.
    (c) An Indian Tribe is not required to request this information 
prior to either submitting a notification of intent or a construction 
project proposal.
    (d) The Secretary shall have a continuing responsibility to furnish 
information to the Indian Tribes.

                       Project Assumption Process



Sec.  137.325  What does a Self-Governance Tribe do if it wants to perform 
a construction project under section 509 of the Act [25 U.S.C. 458aaa-8]?

    (a) A Self-Governance Tribe may start the process of developing a 
construction project agreement by:
    (1) Notifying the Secretary in writing that the Self-Governance 
Tribe wishes to enter into a pre-agreement negotiation phase as set 
forth in section 105(m)(3) of the Act [25 U.S.C. 450j(m)(3)]; or
    (2) Submitting a proposed construction project agreement. This 
proposed agreement may be the final proposal, or it may be a draft for 
consideration and negotiation, or
    (3) A combination of the actions described in paragraphs (a)(1) and 
(2) of this section.
    (b) Upon receiving a Self-Governance Tribe's request to enter into a 
pre-negotiation phase the Secretary shall take the steps outlined in 
section 105(m)(3) of the Act [25 U.S.C. 450j(m)(3)].



Sec.  137.326  What must a Tribal proposal for a construction project 
agreement contain?

    A construction project proposal must contain all of the required 
elements of a construction project agreement as defined in Sec.  
137.280. In addition to these minimum requirements, Self-Governance 
Tribes may propose additional items.



Sec.  137.327  May multiple projects be included in a single 
construction project agreement?

    Yes, a Self-Governance Tribe may include multiple projects in a 
single construction project agreement proposal or may add additional 
approved projects by amendment(s) to an existing construction project 
agreement.



Sec.  137.328  Must a construction project proposal incorporate provisions 
of Federal construction guidelines and manuals?

    (a) No, the Self-Governance Tribe and the Secretary must agree upon 
and specify appropriate building codes and architectural and engineering 
standards (including health and safety) which must be in conformity with 
nationally recognized standards for comparable projects.
    (b) The Secretary may provide, or the Self-Governance Tribe may 
request, Federal construction guidelines and manuals for consideration 
by the Self-Governance Tribe in the preparation of its construction 
project proposal. If Tribal construction codes and standards (including 
national, regional, State, or Tribal building codes or construction 
industry standards) are consistent with or exceed otherwise applicable 
nationally recognized standards, the Secretary must accept the Tribally 
proposed standards.



Sec.  137.329  What environmental considerations must be included 
in the construction project agreement?

    The construction project agreement must include:

[[Page 931]]

    (a) Identification of the Tribal certifying officer for 
environmental review purposes,
    (b) Reference to the Tribal resolution or equivalent Tribal action 
appointing the Tribal certifying officer and accepting the jurisdiction 
of the Federal court for enforcement purposes as provided in Sec. Sec.  
137.310 and 137.311.
    (c) Identification of the environmental review procedures adopted by 
the Self-Governance Tribe, and
    (d) An assurance that no action will be taken on the construction 
phase of the project that would have an adverse environmental impact or 
limit the choice of reasonable alternatives prior to making an 
environmental determination in accordance with the Self-Governance 
Tribe's adopted procedures.



Sec.  137.330  What happens if the Self-Governance Tribe and the Secretary 
cannot develop a mutually agreeable construction project agreement?

    The Self-Governance Tribe may submit a final construction project 
proposal to the Secretary. No later than 30 days after the Secretary 
receives the final construction project proposal, or within a longer 
time agreed to by the Self-Governance Tribe in writing, the Secretary 
shall review and make a determination to approve or reject the 
construction project proposal in whole or in part.



Sec.  137.331  May the Secretary reject a final construction project proposal 
based on a determination of Tribal capacity or capability?

    No, the Secretary may not reject a final construction project 
proposal based on a determination of Tribal capacity or capability.



Sec.  137.332  On what basis may the Secretary reject a final 
construction project proposal?

    (a) The only basis for rejection of project activities in a final 
construction project proposal are:
    (1) The amount of funds proposed in the final construction project 
proposal exceeds the applicable funding level for the construction 
project as determined under sections 508(c) [25 U.S.C. 458aaa-7(c)] and 
106 of the Act [25 U.S.C. 450j-1].
    (2) The final construction project proposal does not meet the 
minimum content requirements for construction project agreements set 
forth in section 501(a)(2) of the Act [25 U.S.C. 458aaa(a)(2)]; and
    (3) The final construction project proposal on its face clearly 
demonstrates that the construction project cannot be completed as 
proposed.
    (b) For construction programs proposed to be included in a 
construction project agreement, the Secretary may also reject that 
portion of the proposal that proposes to assume an inherently Federal 
function that cannot legally be delegated to the Self-Governance Tribe.



Sec.  137.333  What procedures must the Secretary follow if the Secretary 
rejects a final construction project proposal, in whole or in part?

    Whenever the Secretary rejects a final construction project proposal 
in whole or in part, the Secretary must:
    (a) Send the Self-Governance Tribe a timely written notice of 
rejection that shall set forth specific finding(s) that clearly 
demonstrates, or that is supported by controlling legal authority 
supporting the rejection;
    (b) Within 20 days, provide all documents relied on in making the 
rejection decision to the Self-Governance Tribe;
    (c) Provide assistance to the Self-Governance Tribe to overcome any 
objections stated in the written notice of rejection;
    (d) Provide the Self-Governance Tribe with a hearing on the record 
with the right to engage in full discovery relevant to any issue raised 
in the matter and the opportunity for appeal of the decision to reject 
the final construction contract proposal, under the regulations set 
forth in subpart P of this part, except that the Self-Governance Tribe 
may, in lieu of filing an appeal, initiate an action in Federal district 
court and proceed directly under sections 511 [25 U.S.C. 458aaa-10] and 
110(a) of the Act [25 U.S.C. 450m-1(a)]. With respect to any hearing or 
appeal or civil action conducted pursuant to this section, the Secretary 
shall have

[[Page 932]]

the burden of demonstrating by clear and convincing evidence the 
validity of the grounds for rejecting the final construction project 
proposal (or portion thereof); and
    (e) Provide the Self-Governance Tribe with the option of entering 
into the severable portions of a final proposed construction project 
agreement (including a lesser funding amount) that the Secretary did not 
reject, subject to any additional alterations necessary to conform the 
construction project agreement to the severed provisions. Exercising 
this option does not affect the Self-Governance Tribe's right to appeal 
the portion of the final construction project proposal that was rejected 
by the Secretary.



Sec.  137.334  What happens if the Secretary fails to notify 
the Self-Governance Tribe of a decision to approve or reject 
a final construction project proposal within the time period allowed?

    If the Secretary fails to notify the Self-Governance Tribe of the 
decision to approve or reject within 30 days (or a longer period if 
agreed to by the Self-Governance Tribe in writing), then the proposal 
will be deemed approved by the Secretary.



Sec.  137.335  What costs may be included in the budget 
for a construction agreement?

    (a) A Self-Governance Tribe may include costs allowed by applicable 
OMB Circulars, and costs allowed under sections 508(c) [25 U.S.C. 
458aaa-7(c)], 106 [25 U.S.C. 450j-1] and 105 (m) of the Act [25 U.S.C. 
450j(m)]. The costs incurred will vary depending on which phase of the 
construction process the Self-Governance Tribe is conducting and type of 
construction project agreement that will be used.
    (b) Regardless of whether a construction project agreement is fixed 
price or cost-reimbursement, budgets may include costs or fees 
associated with the following:
    (1) Construction project proposal preparation;
    (2) Conducting community meetings to develop project documents;
    (3) Architects, engineers, and other consultants to prepare project 
planning documents, to develop project plans and specifications, and to 
assist in oversight of the design during construction;
    (4) Real property lease or acquisition;
    (5) Development of project surveys including topographical surveys, 
site boundary descriptions, geotechnical surveys, archeological surveys, 
and NEPA compliance;
    (6) Project management, superintendence, safety and inspection;
    (7) Travel, including local travel incurred as a direct result of 
conducting the construction project agreement and remote travel in 
conjunction with the project;
    (8) Consultants, such as demographic consultants, planning 
consultants, attorneys, accountants, and personnel who provide services, 
to include construction management services;
    (9) Project site development;
    (10) Project construction cost;
    (11) General, administrative overhead, and indirect costs;
    (12) Securing and installing moveable equipment, telecommunications 
and data processing equipment, furnishings, including works of art, and 
special purpose equipment when part of a construction contract;
    (13) Other costs directly related to performing the construction 
project agreement;
    (14) Project Contingency:
    (i) A cost-reimbursement project agreement budgets contingency as a 
broad category. Project contingency remaining at the end of the project 
is considered savings.
    (ii) Fixed-price agreements budget project contingency in the lump 
sum price or unit price.
    (c) In the case of a fixed-price project agreement, a reasonable 
profit determined by taking into consideration the relevant risks and 
local market conditions.



Sec.  137.336  What is the difference between fixed-price 
and cost-reimbursement agreements?

    (a) Cost-reimbursement agreements generally have one or more of the 
following characteristics:
    (1) Risk is shared between IHS and the Self-Governance Tribe;

[[Page 933]]

    (2) Self-Governance Tribes are not required to perform beyond the 
amount of funds provided under the agreement;
    (3) Self-Governance Tribes establish budgets based upon the actual 
costs of the project and are not allowed to include profit;
    (4) Budgets are stated using broad categories, such as planning, 
design, construction project administration, and contingency;
    (5) The agreement funding amount is stated as a ``not to exceed'' 
amount;
    (6) Self-Governance Tribes provide notice to the IHS if they expect 
to exceed the amount of the agreement and require more funds;
    (7) Excess funds remaining at the end of the project are considered 
savings; and
    (8) Actual costs are subject to applicable OMB circulars and cost 
principles.
    (b) Fixed Price agreements generally have one or more of the 
following characteristics:
    (1) Self-Governance Tribes assume the risk for performance;
    (2) Self-Governance Tribes are entitled to make a reasonable profit;
    (3) Budgets may be stated as lump sums, unit cost pricing, or a 
combination thereof;
    (4) For unit cost pricing, savings may occur if actual quantity is 
less than estimated; and,
    (5) Excess funds remaining at the end of a lump sum fixed price 
project are considered profit, unless, at the option of the Self-
Governance Tribe, such amounts are reclassified in whole or in part as 
savings.



Sec.  137.337  What funding must the Secretary provide 
in a construction project agreement?

    The Secretary must provide funding for a construction project 
agreement in accordance with sections 106 [25 U.S.C. 450j-1] and 508(c) 
of the Act [25 U.S.C. 458aaa-7(c)].



Sec.  137.338  Must funds from other sources be incorporated into 
a construction project agreement?

    Yes, at the request of the Self-Governance Tribe, the Secretary must 
include funds from other agencies as permitted by law, whether on an 
ongoing or a one-time basis.



Sec.  137.339  May a Self-Governance Tribe use project funds for matching 
or cost participation requirements under other Federal 
and non-Federal programs?

    Yes, notwithstanding any other provision of law, all funds provided 
under a construction project agreement may be treated as non-Federal 
funds for purposes of meeting matching or cost participation 
requirements under any other Federal or non-Federal program.



Sec.  137.340  May a Self-Governance Tribe contribute funding to a project?

    Yes, the Self-Governance Tribe and the Secretary may jointly fund 
projects. The construction project agreement should identify the 
Secretarial amount and any Tribal contribution amount that is being 
incorporated into the construction project agreement. The Self-
Governance Tribe does not have to deposit its contribution with the 
Secretary.



Sec.  137.341  How will a Self-Governance Tribe receive payment 
under a construction project agreement?

    (a) For all construction project agreements, advance payments shall 
be made annually or semiannually, at the Self-Governance Tribe's option. 
The initial payment shall include all contingency funding for the 
project or phase of the project to the extent that there are funds 
appropriated for that purpose.
    (b) The amount of subsequent payments is based on the mutually 
agreeable project schedule reflecting:
    (1) Work to be accomplished within the advance payment period,
    (2) Work already accomplished, and
    (3) Total prior payments for each annual or semiannual advance 
payment period.
    (c) For lump sum, fixed price agreements, at the request of the 
Self-Governance Tribe, payments shall be based on an advance payment 
period measured as follows:
    (1) One year; or
    (2) Project Phase(e.g., planning, , design, construction.) If 
project phase is chosen as the payment period, the full amount of funds 
necessary to perform the work for that phase of the construction project 
agreement is payable

[[Page 934]]

in the initial advance payment. For multi-phase projects, the planning 
and design phases must be completed prior to the transfer of funds for 
the associated construction phase. The completion of the planning and 
design phases will include at least one opportunity for Secretarial 
approval in accordance with Sec.  137.360.
    (d) For the purposes of payment, Sanitation Facilities Construction 
Projects authorized pursuant to Pub. L. 86-121, are considered to be a 
single construction phase and are payable in a single lump sum advance 
payment in accordance with paragraph (c)(2) of this section.
    (e) For all other construction project agreements, the amount of 
advance payments shall include the funds necessary to perform the work 
identified in the advance payment period of one year.
    (f) Any agreement to advance funds under paragraphs (b), (c) or (d) 
of this section is subject to the availability of appropriations.
    (g) (1) Initial advance payments are due within 10 days of the 
effective date of the construction project agreement; and
    (2) subsequent payments are due:
    (i) Within 10 days of apportionment for annual payments or
    (ii) Within 10 days of the start date of the project phase for phase 
payments.



Sec.  137.342  What happens to funds remaining at the conclusion 
of a cost reimbursement construction project?

    All funds, including contingency funds, remaining at the conclusion 
of the project are considered savings and may be used by the Self-
Governance Tribe to provide additional services for the purpose for 
which the funds were originally appropriated. No further approval or 
justifying documentation is required before the expenditure of the 
remaining funds.



Sec.  137.343  What happens to funds remaining at the conclusion 
of a fixed price construction project?

    (a) For lump sum fixed price construction project agreements, all 
funds remaining at the conclusion of the project are considered profits 
and belong to the Self-Governance Tribe.
    (b) For fixed price construction project agreements with unit price 
components, all funds remaining that are associated with overestimated 
unit price quantities are savings and may be used by the Self-Governance 
Tribe in accordance with section 137.342. All other funds remaining at 
the conclusion of the project are considered profit and belong to the 
Self-Governance Tribe.
    (c) At the option of the Self-Governance Tribe, funds otherwise 
identified in paragraphs (a) and (b) as ``profit'' may be reclassified, 
in whole or in part, as savings and to that extent may be used by the 
Self-Governance Tribe in accordance with section 137.142.



Sec.  137.344  May a Self-Governance Tribe reallocate funds 
among construction project agreements?

    Yes, a Self-Governance Tribe may reallocate funds among construction 
project agreements to the extent not prohibited by applicable 
appropriation law(s).

    Roles of Self-Governance Tribe in Establishing and Implementing 
                     Construction Project Agreements



Sec.  137.350  Is a Self-Governance Tribe responsible for completing 
a construction project in accordance with the negotiated 
construction project agreement?

    Yes, a Self-Governance Tribe assumes responsibility for completing a 
construction project, including day-to-day on-site management and 
administration of the project, in accordance with the negotiated 
construction project agreement. However, Self-Governance Tribes are not 
required to perform beyond the amount of funds provided. For example, a 
Self-Governance Tribe may encounter unforeseen circumstances during the 
term of a construction project agreement. If this occurs, options 
available to the Self-Governance Tribe include, but are not limited to:
    (a) Reallocating existing funding;
    (b) Reducing/revising the scope of work that does not require an 
amendment because it does not result in a significant change;
    (c) Utilizing savings from other projects;

[[Page 935]]

    (d) Requesting additional funds or appropriations;
    (e) Utilizing interest earnings;
    (f) Seeking funds from other sources; and/or
    (g) Redesigning or re-scoping that does result in a significant 
change by amendment as provided in Sec. Sec.  137.363 and 137.364.



Sec.  137.351  Is a Self-Governance Tribe required to submit 
construction project progress and financial reports 
for construction project agreements?

    Yes, a Self-Governance Tribe must provide the Secretary with 
construction project progress and financial reports semiannually or, at 
the option of the Self-Governance Tribe, on a more frequent basis. Self-
Governance Tribes are only required to submit the reports, as negotiated 
in the Construction Project Agreement, after funds have been transferred 
to the Self-Governance Tribe for a construction project. Construction 
project progress reports and financial reports are only required for 
active construction projects.



Sec.  137.352  What is contained in a construction project progress report?

    Construction project progress reports contain information about 
accomplishments during the reporting period and issues and concerns of 
the Self-Governance Tribe, if any.



Sec.  137.353  What is contained in a construction project financial report?

    Construction project financial reports contain information regarding 
the amount of funds expended during the reporting period, and financial 
concerns of the Self-Governance Tribe, if any.

  Roles of the Secretary in Establishing and Implementing Construction 
                           Project Agreements



Sec.  137.360  Does the Secretary approve project planning 
and design documents prepared by the Self-Governance Tribe?

    The Secretary shall have at least one opportunity to approve project 
planning and design documents prepared by the Self-Governance Tribe in 
advance of construction if the Self-Governance Tribe is required to 
submit planning or design documents as a part of the scope of work under 
a construction project agreement.



Sec.  137.361  Does the Secretary have any other opportunities 
to approve planning or design documents prepared by the Self-Governance Tribe?

    Yes, but only if there is an amendment to the construction project 
agreement that results in a significant change in the original scope of 
work.



Sec.  137.362  May construction project agreements be amended?

    Yes, the Self-Governance Tribe, at its discretion, may request the 
Secretary to amend a construction project agreement to include 
additional projects. In addition, amendments are required if there is a 
significant change from the original scope of work or if funds are added 
by the Secretary. The Self-Governance Tribe may make immaterial changes 
to the performance period and make budget adjustments within available 
funding without an amendment to the construction project agreement.



Sec.  137.363  What is the procedure for the Secretary's review 
and approval of amendments?

    (a) The Secretary shall promptly notify the Self-Governance Tribe in 
writing of any concerns or issues that may lead to disapproval. The 
Secretary shall share relevant information and documents, and make a 
good faith effort to resolve all issues and concerns of the Self-
Governance Tribe. If, after consultation with the Self-Governance Tribe, 
the Secretary intends to disapprove the proposed amendment, then the 
Secretary shall follow the procedures set forth in Sec.  137.330 through 
137.334.
    (b) The time allowed for Secretarial review, comment, and approval 
of amendments is 30 days, or within a longer time if agreed to by the 
Self-Governance Tribe in writing. Absence of a written response by the 
Secretary within 30 days shall be deemed approved.
    (c) The timeframe set forth in paragraph (b) of this section is 
intended to

[[Page 936]]

be the maximum time and may be reduced based on urgency and need, by 
agreement of the parties. If the Self-Governance Tribe requests reduced 
timeframes for action due to unusual or special conditions (such as 
limited construction periods), the Secretary shall make a good faith 
effort to accommodate the requested timeframes.



Sec.  137.364  What constitutes a significant change 
in the original scope of work?

    A significant change in the original scope of work is:
    (a) A change that would result in a cost that exceeds the total of 
the project funds available and the Self-Governance Tribe's contingency 
funds; or
    (b) A material departure from the original scope of work, including 
substantial departure from timelines negotiated in the construction 
project agreement.



Sec.  137.365  What is the procedure for the Secretary's review 
and approval of project planning and design documents submitted 
by the Self-Governance Tribe?

    (a) The Secretary shall review and approve planning documents to 
ensure compliance with planning standards identified in the construction 
project agreement. The Secretary shall review and approve design 
documents for general compliance with requirements of the construction 
project agreement.
    (b) The Secretary shall promptly notify the Self-Governance Tribe in 
writing of any concerns or issues that may lead to disapproval. The 
Secretary shall share relevant information and documents, and make a 
good faith effort to resolve all issues and concerns of the Self-
Governance Tribe. If, after consultation with the Self-Governance Tribe, 
the Secretary intends to disapprove the documents, then the Secretary 
shall follow the procedures set forth in Sec.  137.333.
    (c) The time allowed for Secretarial review, comment, and approval 
of planning and design documents is 21 days, unless otherwise agreed to 
by the Self-Governance Tribe in writing. Absence of a written response 
by the Secretary within 21 days shall be deemed approved.



Sec.  137.366  May the Secretary conduct onsite project oversight visits?

    Yes, the Secretary may conduct onsite project oversight visits 
semiannually or on an alternate schedule negotiated in the construction 
project agreement. The Secretary must provide the Self-Governance Tribe 
with reasonable advance written notice to assist the Self-Governance 
Tribe in coordinating the visit. The purpose of the visit is review the 
progress under the construction project agreement. At the request of the 
Self-Governance Tribe, the Secretary must provide the Self-Governance 
Tribe a written site visit report.



Sec.  137.367  May the Secretary issue a stop work order 
under a construction project agreement?

    No, the Secretary has no role in the day-to-day management of a 
construction project.



Sec.  137.368  Is the Secretary responsible for oversight and compliance 
of health and safety codes during construction projects being performed by 
a Self-Governance Tribe under section 509 of the Act [25 U.S.C. 488aaa-8]?

    No, the Secretary is not responsible for oversight and compliance of 
health and safety codes during construction projects being performed by 
a Self-Governance Tribe under section 509 of the Act [25 U.S.C. 488aaa-
8].

                                  Other



Sec.  137.370  Do all provisions of this part apply to 
construction project agreements under this subpart?

    Yes, to the extent the provisions are not inconsistent with the 
provisions in this subpart. Provisions that do not apply include: 
programmatic reports and data requirements; reassumption; compact and 
funding agreement review, approval, and final offer process; and compact 
and funding agreement contents.



Sec.  137.371  Who takes title to real property purchased with funds 
provided under a construction project agreement?

    The Self-Governance Tribe takes title to the real property unless 
the

[[Page 937]]

Self-Governance Tribe requests that the Secretary take title to the 
property.



Sec.  137.372  Does the Secretary have a role in the fee-to-trust process 
when real property is purchased with construction project agreement funds?

    No, the Secretary does not have a role in the fee-to-trust process 
except to provide technical assistance if requested by the Self-
Governance Tribe.



Sec.  137.373  Do Federal real property laws, regulations and procedures 
that apply to the Secretary also apply to Self-Governance Tribes 
that purchase real property with funds provided under a construction 
project agreement?

    No, unless the Self-Governance Tribe has requested the Secretary to 
take fee title to the property.



Sec.  137.374  Does the Secretary have a role in reviewing or monitoring 
a Self-Governance Tribe's actions in acquiring or leasing real property 
with funds provided under a construction project agreement?

    No, unless the Self-Governance Tribe has requested the Secretary 
take fee title to the property. The Self-Governance Tribe is responsible 
for acquiring all real property needed to perform a construction project 
under a construction project agreement, not the Secretary. The Secretary 
shall not withhold funds or refuse to enter into a construction project 
agreement because of a disagreement between the Self-Governance Tribe 
and the Secretary over the Self-Governance Tribe's decisions to purchase 
or lease real property.



Sec.  137.375  Are Tribally-owned facilities constructed under section 509 
of the Act [25 U.S.C. 458aaa-8] eligible for replacement, maintenance, 
and improvement funds on the same basis as if title to such property 
were vested in the United States?

    Yes, Tribally-owned facilities constructed under section 509 of the 
Act [25 U.S.C. 458aaa-8] are eligible for replacement, maintenance, and 
improvement funds on the same basis as if title to such property were 
vested in the United States.



Sec.  137.376  Are design and construction projects performed by 
Self-Governance Tribes under section 509 of the Act [25 U.S.C. 458aaa-8] 
subject to Federal metric requirements?

    No, however, the Self-Governance Tribe and the Secretary may 
negotiate the use of Federal metric requirements in the construction 
project agreement when the Self-Governance Tribe will design and/or 
construct an IHS facility that the Secretary will own and operate.



Sec.  137.377  Do Federal procurement laws and regulations apply to 
construction project agreements performed under section 509 
of the Act [25 U.S.C. 458aaa-8]?

    No, unless otherwise agreed to by the Tribe, no provision of the 
Office of Federal Procurement Policy Act, the Federal Acquisition 
Regulations issued pursuant thereto, or any other law or regulation 
pertaining to Federal procurement (including Executive Orders) shall 
apply to any construction project conducted under section 509 of the Act 
[25 U.S.C. 458aaa-8]. The Secretary and the Self-Governance Tribe may 
negotiate to apply specific provisions of the Office of Federal 
Procurement and Policy Act and Federal Acquisition Regulations to a 
construction project agreement or funding agreement. Absent a negotiated 
agreement, such provisions and regulatory requirements do not apply.



Sec.  137.378  Do the Federal Davis-Bacon Act and wage rates apply to 
construction projects performed by Self-Governance Tribes using 
their own funds or other non-Federal funds?

    No, the Federal Davis-Bacon Act and wage rates do not apply to 
construction projects performed by Self-Governance Tribes using their 
own funds or other non-Federal funds.



Sec.  137.379  Do Davis-Bacon wage rates apply to construction projects 
performed by Self-Governance Tribes using Federal funds?

    Davis-Bacon Act wage rates only apply to laborers and mechanics 
employed by the contractors and subcontractors (excluding Indian Tribes,

[[Page 938]]

inter-Tribal consortia, and Tribal organizations) retained by Self-
Governance Tribes to perform construction. The Davis-Bacon Act and wage 
rates do not apply when Self-Governance Tribes perform work with their 
own employees.



                 Subpart O_Secretarial Responsibilities

                             Budget Request



Sec.  137.401  What role does Tribal consultation play in the IHS 
annual budget request process?

    The IHS will consult with Tribes on budget issues consistent with 
Administration policy on Tribal consultation.

                                 Reports



Sec.  137.405  Is the Secretary required to report to Congress 
on administration of Title V and the funding requirements 
presently funded or unfunded?

    Yes, no later than January 1 of each year after the date of 
enactment of the Tribal Self-Governance Amendments of 2000, the 
Secretary shall submit to the Committee on Indian Affairs of the Senate 
and the Committee on Resources of the House of Representatives a written 
report regarding the administration of Title V. The report shall include 
a detailed analysis of the funding requirements presently funded or 
unfunded for each Indian Tribe or Tribal organization, either directly 
by the Secretary, under self-determination contracts under Title I, or 
under compacts and funding agreements authorized under Title V.



Sec.  137.406  In compiling reports pursuant to this section, 
may the Secretary impose any reporting requirements on Self-Governance Tribes, 
not otherwise provided in Title V?

    No, in compiling reports pursuant to this section, the Secretary may 
not impose any reporting requirements on Self-Governance Tribes, not 
otherwise provided in Title V.



Sec.  137.407  What guidelines will be used by the Secretary 
to compile information required for the report?

    The report shall be compiled from information contained in funding 
agreements, annual audit reports, and data of the Secretary regarding 
the disposition of Federal funds. The report must identify:
    (a) The relative costs and benefits of self-governance, including 
savings;
    (b) With particularity, all funds that are specifically or 
functionally related to the provision by the Secretary of services and 
benefits to Self-Governance Tribes and their members;
    (c) The funds transferred to each Self-Governance Tribe and the 
corresponding reduction in the Federal bureaucracy;
    (d) The funding formula for individual Tribal shares of all 
headquarters' funds, together with the comments of affected Self-
Governance Tribes, developed under Sec.  137.405 of this subpart; and
    (e) Amounts expended in the preceding fiscal year to carry out 
inherent Federal functions, including an identification of those 
functions by type and location.



                            Subpart P_Appeals



Sec.  137.410  For the purposes of section 110 of the Act [25 U.S.C. 450m-1] 
does the term contract include compacts, funding agreements, 
and construction project agreements entered into under Title V?

    Yes, for the purposes of section 110 of the Act [25 U.S.C. 450m-1] 
the term ``contract'' includes compacts, funding agreements, and 
construction project agreements entered into under Title V.

                           Post-Award Disputes



Sec.  137.412  Do the regulations at 25 CFR Part 900, Subpart N apply 
to compacts, funding agreements, and construction project agreements 
entered into under Title V?

    Yes, the regulations at 25 CFR Part 900, Subpart N apply to 
compacts, funding agreements, and construction project agreements 
entered into under Title V.

[[Page 939]]

                           Pre-Award Disputes



Sec.  137.415  What decisions may an Indian Tribe appeal 
under Sec.  137.415 through 137.436?

    An Indian Tribe may appeal:
    (a) A decision to reject a final offer, or a portion thereof, under 
section 507(b) of the Act [25 U.S.C. 458aaa-6(b)];
    (b) A decision to reject a proposed amendment to a compact or 
funding agreement, or a portion thereof, under section 507(b) of the Act 
[25 U.S.C. 458aaa-6(b)];
    (c) A decision to rescind and reassume a compact or funding 
agreement, in whole or in part, under section 507(a)(2) of the Act [25 
U.S.C. 458aaa-6(a)(2)], except for immediate reassumptions under section 
507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)];
    (d) A decision to reject a final construction project proposal, or a 
portion thereof, under section 509(b) of the Act [25 U.S.C. 458aaa-8(b)] 
and subpart N of this part; and
    (e) For construction project agreements carried out under section 
509 of the Act [25 U.S.C. 458aaa-8], a decision to reject project 
planning documents, design documents, or proposed amendments submitted 
by a Self-Governance Tribe under section 509(f) of the Act [25 U.S.C. 
458aaa-8(f)] and subpart N of this part.



Sec.  137.416  Do Sec. Sec.  137.415 through 137.436 apply to 
any other disputes?

    No, Sec. Sec.  137.415 through 137.436 only apply to decisions 
listed in Sec.  137.415. Specifically, Sec. Sec.  137.415 through 
137.436 do not apply to any other dispute, including, but not limited 
to:
    (a) Disputes arising under the terms of a compact, funding 
agreement, or construction project agreement that has been awarded;
    (b) Disputes arising from immediate reassumptions under section 
507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)] and Sec.  137.261 
and 137.262, which are covered under Sec.  137.440 through 137.445.
    (c) Other post-award contract disputes, which are covered under 
Sec.  137.412.
    (d) Denials under the Freedom of Information Act, 5 U.S.C. 552, 
which may be appealed under 45 CFR part 5.
    (e) Decisions relating to the award of grants under section 503(e) 
of the Act [25 U.S.C. 458aaa-2(e)], which may be appealed under 45 CFR 
part 5.



Sec.  137.417  What procedures apply to Interior Board of Indian Appeals 
(IBIA) proceedings?

    The IBIA may use the procedures set forth in 43 CFR 4.22-4.27 as a 
guide.



Sec.  137.418  How does an Indian Tribe know where and when to file its appeal 
from decisions made by IHS?

    Every decision in any of the areas listed in Sec.  137.415 must 
contain information which shall tell the Indian Tribe where and when to 
file the Indian Tribe's appeal. Each decision shall include the 
following statement:

    Within 30 days of the receipt of this decision, you may request an 
informal conference under 42 CFR 137.421, or appeal this decision under 
42 CFR 137.425 to the Interior Board of Indian Appeals (IBIA). Should 
you decide to appeal this decision, you may request a hearing on the 
record. An appeal to the IBIA under 42 CFR 137.425 shall be filed with 
the IBIA by certified mail or by hand delivery at the following address: 
Board of Indian Appeals, U.S. Department of the Interior, 801 North 
Quincy St., Suite 300, Arlington, VA 22203. You shall serve copies of 
your Notice of Appeal on the Secretary and on the official whose 
decision is being appealed. You shall certify to the IBIA that you have 
served these copies.

[67 FR 35342, May 17, 2002, as amended at 80 FR 64353, Oct. 23, 2015]



Sec.  137.419  What authority does the IBIA have under Sec. Sec.  137.415 
through 137.436?

    The IBIA has the authority:
    (a) to conduct a hearing on the record;
    (b) to permit the parties to engage in full discovery relevant to 
any issue raised in the matter;
    (c) to issue a recommended decision; and
    (d) to take such action as necessary to insure rights specified in 
Sec.  137.430.



Sec.  137.420  Does an Indian Tribe have any options besides an appeal?

    Yes, the Indian Tribe may request an informal conference. An 
informal conference is a way to resolve issues as quickly as possible, 
without the need for a formal hearing. Or, the Indian

[[Page 940]]

Tribe may, in lieu of filing an administrative appeal under this subpart 
or upon completion of an informal conference, file an action in Federal 
court pursuant to section 110 of the Act [25 U.S.C. 450m-1].



Sec.  137.421  How does an Indian Tribe request an informal conference?

    The Indian Tribe must file its request for an informal conference 
with the office of the person whose decision it is appealing, within 30 
days of the day it receives the decision. The Indian Tribe may either 
hand-deliver the request for an informal conference to that person's 
office, or mail it by certified mail, return receipt requested. If the 
Indian Tribe mails the request, it will be considered filed on the date 
the Indian Tribe mailed it by certified mail.



Sec.  137.422  How is an informal conference held?

    (a) The informal conference must be held within 30 days of the date 
the request was received, unless the Indian Tribe and the authorized 
representative of the Secretary agree on another date.
    (b) If possible, the informal conference will be held at the Indian 
Tribe's office. If the meeting cannot be held at the Indian Tribe's 
office and is held more than fifty miles from its office, the Secretary 
must arrange to pay transportation costs and per diem for incidental 
expenses to allow for adequate representation of the Indian Tribe.
    (c) The informal conference must be conducted by a designated 
representative of the Secretary.
    (d) Only people who are the designated representatives of the Indian 
Tribe, or authorized by the Secretary are allowed to make presentations 
at the informal conference. Such designated representatives may include 
Office of Tribal Self-Governance.



Sec.  137.423  What happens after the informal conference?

    (a) Within 10 days of the informal conference, the person who 
conducted the informal conference must prepare and mail to the Indian 
Tribe a written report which summarizes what happened at the informal 
conference and a recommended decision.
    (b) Every report of an informal conference must contain the 
following language:

    Within 30 days of the receipt of the recommended decision from the 
informal conference, you may file an appeal of the initial decision of 
the DHHS agency with the Interior Board of Indian Appeals (IBIA) under 
42 CFR 137.425. You may request a hearing on the record. An appeal to 
the IBIA under 42 CFR 137.425 shall be filed with the IBIA by certified 
mail or hand delivery at the following address: Board of Indian Appeals, 
U.S. Department of the Interior, 801 North Quincy St., Suite 300, 
Arlington, VA 22203. You shall serve copies of your Notice of Appeal on 
the Secretary and on the official whose decision is being appealed. You 
shall certify to the IBIA that you have served these copies. 
Alternatively you may file an action in Federal court pursuant to 
section 110 of the Act. [25 U.S.C. 450m-1].

[67 FR 35342, May 17, 2002, as amended at 80 FR 64353, Oct. 23, 2015]



Sec.  137.424  Is the recommended decision from the informal conference 
final for the Secretary?

    No. If the Indian Tribe is dissatisfied with the recommended 
decision from the informal conference, it may still appeal the initial 
decision within 30 days of receiving the recommended decision and the 
report of the informal conference. If the Indian Tribe does not file a 
notice of appeal within 30 days, or before the expiration of the 
extension it has received under Sec.  137.426 , the recommended decision 
of the informal conference becomes final for the Secretary and may be 
appealed to Federal court pursuant to section 110 of the Act [25 U.S.C. 
450m-1].



Sec.  137.425  How does an Indian Tribe appeal the initial decision 
if it does not request an informal conference or if it does not agree with 
the recommended decision resulting from the informal conference?

    (a) If the Indian Tribe decides to appeal, it must file a notice of 
appeal with the IBIA within 30 days of receiving either the initial 
decision or the recommended decision from the informal conference.
    (b) The Indian Tribe may either hand-deliver the notice of appeal to 
the

[[Page 941]]

IBIA, or mail it by certified mail, return receipt requested. If the 
Indian Tribe mails the Notice of Appeal, it will be considered filed on 
the date the Indian Tribe mailed it by certified mail. The Indian Tribe 
should mail the notice of appeal to: Board of Indian Appeals, U.S. 
Department of the Interior,801 North Quincy St., Suite 300, Arlington, 
VA 22203.
    (c) The Notice of Appeal must:
    (1) Briefly state why the Indian Tribe thinks the initial decision 
is wrong;
    (2) Briefly identify the issues involved in the appeal; and
    (3) State whether the Indian Tribe wants a hearing on the record, or 
whether the Indian Tribe wants to waive its right to a hearing.
    (d) The Indian Tribe must serve a copy of the notice of appeal upon 
the official whose decision it is appealing. The Indian Tribe must 
certify to the IBIA that it has done so.
    (e) The authorized representative of the Secretary will be 
considered a party to all appeals filed with the IBIA under the Act.
    (f) In lieu of filing an administrative appeal an Indian Tribe may 
proceed directly to Federal court pursuant to section 110 of the Act [25 
U.S.C. 450m-1].

[67 FR 35342, May 17, 2002, as amended at 80 FR 64353, Oct. 23, 2015]



Sec.  137.426  May an Indian Tribe get an extension of time to file 
a notice of appeal?

    Yes, if the Indian Tribe needs additional time, the Indian Tribe may 
request an extension of time to file its Notice of Appeal with the IBIA 
within 60 days of receiving either the initial decision or the 
recommended decision resulting from the informal conference. The request 
of the Indian Tribe must be in writing, and must give a reason for not 
filing its notice of appeal within the 30-day time period. If the Indian 
Tribe has a valid reason for not filing its notice of appeal on time, it 
may receive an extension.



Sec.  137.427  What happens after an Indian Tribe files an appeal?

    (a) Within 5 days of receiving the Indian Tribe's notice of appeal, 
the IBIA will decide whether the appeal falls under Sec.  137.415. If 
so, the Indian Tribe is entitled to a hearing.
    (b) If the IBIA cannot make that decision based on the information 
included in the notice of appeal, the IBIA may ask for additional 
statements from the Indian Tribe, or from the appropriate Federal 
agency. If the IBIA asks for more statements, it will make its decision 
within 5 days of receiving those statements.
    (c) If the IBIA decides that the Indian Tribe is not entitled to a 
hearing or if the Indian Tribe has waived its right to a hearing on the 
record, the IBIA will dismiss the appeal and inform the Indian Tribe 
that it is not entitled to a hearing or has waived its right to a 
hearing.



Sec.  137.428  How is a hearing arranged?

    (a) If a hearing is to be held, the IBIA will refer the Indian 
Tribe's case to the Hearings Division of the Office of Hearings and 
Appeals of the U.S. Department of the Interior. The case will then be 
assigned to an Administrative Law Judge (ALJ), appointed under 5 U.S.C. 
3105.
    (b) Within 15 days of the date of the referral, the ALJ will hold a 
pre-hearing conference, by telephone or in person, to decide whether an 
evidentiary hearing is necessary, or whether it is possible to decide 
the appeal based on the written record. At the pre-hearing conference 
the ALJ will provide for:
    (1) A briefing and discovery schedule;
    (2) A schedule for the exchange of information, including, but not 
limited to witness and exhibit lists, if an evidentiary hearing is to be 
held;
    (3) The simplification or clarification of issues;
    (4) The limitation of the number of expert witnesses, or avoidance 
of similar cumulative evidence, if an evidentiary hearing is to be held;
    (5) The possibility of agreement disposing of all or any of the 
issues in dispute; and
    (6) Such other matters as may aid in the disposition of the appeal.
    (c) The ALJ shall order a written record to be made of any 
conference results that are not reflected in a transcript.

[[Page 942]]



Sec.  137.429  What happens when a hearing is necessary?

    (a) The ALJ must hold a hearing within 90 days of the date of the 
order referring the appeal to the ALJ, unless the parties agree to have 
the hearing on a later date.
    (b) At least 30 days before the hearing, the Secretary must file and 
serve the Indian Tribe with a response to the notice of appeal.
    (c) If the hearing is held more than 50 miles from the Indian 
Tribe's office, the Secretary must arrange to pay transportation costs 
and per diem for incidental expenses to allow for adequate 
representation of the Indian Tribe.
    (d) The hearing shall be conducted in accordance with the 
Administrative Procedure Act, 5 U.S.C. 556.



Sec.  137.430  What is the Secretary's burden of proof for appeals 
covered by Sec.  137.415?

    As required by section 518 of the Act [25 U.S.C. 458aaa-17], the 
Secretary must demonstrate by clear and convincing evidence the validity 
of the grounds for the decision made and that the decision is fully 
consistent with provisions and policies of the Act.



Sec.  137.431  What rights do Indian Tribes and the Secretary have 
during the appeal process?

    Both the Indian Tribe and the Secretary have the same rights during 
the appeal process. These rights include the right to:
    (a) Be represented by legal counsel;
    (b) Have the parties provide witnesses who have knowledge of the 
relevant issues, including specific witnesses with that knowledge, who 
are requested by either party;
    (c) Cross-examine witnesses;
    (d) Introduce oral or documentary evidence, or both;
    (e) Require that oral testimony be under oath;
    (f) Receive a copy of the transcript of the hearing, and copies of 
all documentary evidence which is introduced at the hearing;
    (g) Compel the presence of witnesses, or the production of 
documents, or both, by subpoena at hearings or at depositions;
    (h) Take depositions, to request the production of documents, to 
serve interrogatories on other parties, and to request admissions; and
    (i) Any other procedural rights under the Administrative Procedure 
Act, 5 U.S.C. 556.



Sec.  137.432  What happens after the hearing?

    (a) Within 30 days of the end of the formal hearing or any post-
hearing briefing schedule established by the ALJ, the ALJ shall send all 
the parties a recommended decision, by certified mail, return receipt 
requested. The recommended decision must contain the ALJ's findings of 
fact and conclusions of law on all the issues. The recommended decision 
shall also state that the Indian Tribe has the right to object to the 
recommended decision.
    (b) The recommended decision shall contain the following statement:

    Within 30 days of the receipt of this recommended decision, you may 
file an objection to the recommended decision with the Secretary under 
42 CFR 137.43. An appeal to the Secretary under 42 CFR 137.43 shall be 
filed at the following address: Department of Health and Human Services, 
200 Independence Ave. S.W., Washington, DC, 20201. You shall serve 
copies of your notice of appeal on the official whose decision is being 
appealed. You shall certify to the Secretary that you have served this 
copy. If neither party files an objection to the recommended decision 
within 30 days, the recommended decision will become final.



Sec.  137.433  Is the recommended decision always final?

    No, any party to the appeal may file precise and specific written 
objections to the recommended decision, or any other comments, within 30 
days of receiving the recommended decision. Objections must be served on 
all other parties. The recommended decision shall become final for the 
Secretary 30 days after the Indian Tribe receives the ALJs recommended 
decision, unless a written statement of objections is filed with the 
Secretary during the 30-day period. If no party files a written 
statement of objections within 30 days, the recommended decision shall 
become final for the Secretary.

[[Page 943]]



Sec.  137.434  If an Indian Tribe objects to the recommended decision, 
what will the Secretary do?

    (a) The Secretary has 45 days from the date it receives the final 
authorized submission in the appeal to modify, adopt, or reverse the 
recommended decision. The Secretary also may remand the case to the IBIA 
for further proceedings. If the Secretary does not modify or reverse the 
recommended decision or remand the case to the IBIA during that time, 
the recommended decision automatically becomes final.
    (b) When reviewing the recommended decision, the Secretary may 
consider and decide all issues properly raised by any party to the 
appeal, based on the record.
    (c) The decision of the Secretary must:
    (1) Be in writing;
    (2) Specify the findings of fact or conclusions of law that are 
modified or reversed;
    (3) Give reasons for the decision, based on the record; and
    (4) State that the decision is final for the Department.



Sec.  137.435  Will an appeal adversely affect the Indian Tribe's rights 
in other compact, funding negotiations, or construction project agreement?

    No, a pending appeal will not adversely affect or prevent the 
negotiation or award of another compact, funding agreement, or 
construction project agreement.



Sec.  137.436  Will the decisions on appeal be available 
for the public to review?

    Yes, all final decisions must be published for the Department under 
this subpart. Decisions can be found on the Department's website.

    Appeals of an Immediate Reassumption of a Self-Governance Program



Sec.  137.440  What happens in the case of an immediate reassumption 
under section 507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)]?

    (a) The Secretary may, upon written notification to the Self-
Governance Tribe, immediately reassume operation of a program, service, 
function, or activity (or portion thereof) if:
    (1) The Secretary makes a finding of imminent substantial and 
irreparable endangerment of the public health caused by an act or 
omission of the Self-Governance Tribe; and
    (2) The endangerment arises out of a failure to carry out the 
compact or funding agreement.
    (b) When the Secretary advises a Self-Governance Tribe that the 
Secretary intends to take an action referred to in paragraph (a) of this 
section, the Secretary must also notify the Deputy Director of the 
Office of Hearings and Appeals, Department of the Interior, 801 North 
Quincy St., Suite 300, Arlington, VA 22203.

[67 FR 35342, May 17, 2002, as amended at 80 FR 64353, Oct. 23, 2015]



Sec.  137.441  Will there be a hearing?

    Yes, unless the Self-Governance Tribe waives its right to a hearing 
in writing. The Deputy Director of the Office of Hearings and Appeals 
must appoint an Administrative Law Judge to hold a hearing,
    (a) The hearing must be held within 10 days of the date of the 
notice referred to in Sec.  137.440 unless the Self-Governance Tribe 
agrees to a later date.
    (b) If possible, the hearing will be held at the office of the Self-
Governance Tribe. If the hearing is held more than 50 miles from the 
office of the Self-Governance Tribe, the Secretary must arrange to pay 
transportation costs and per diem for incidental expenses. This will 
allow for adequate representation of the Self-Governance Tribe.



Sec.  137.442  What happens after the hearing?

    (a) Within 30 days after the end of the hearing or any post-hearing 
briefing schedule established by the ALJ, the ALJ must send all parties 
a recommended decision by certified mail, return receipt requested. The 
recommended decision shall contain the ALJs findings of fact and 
conclusions of law on all the issues. The recommended decision must also 
state that the Self-Governance Tribe has the

[[Page 944]]

right to object to the recommended decision.
    (b) The recommended decision must contain the following statement:

    Within 15 days of the receipt of this recommended decision, you may 
file an objection to the recommended decision with the Secretary under 
Sec.  137.443. An appeal to the Secretary under 25 CFR 900.165(b) shall 
be filed at the following address: Department of Health and Human 
Services, 200 Independence Ave. SW., Washington, DC 20201. You shall 
serve copies of your notice of appeal on the official whose decision is 
being appealed. You shall certify to the Secretary that you have served 
this copy. If neither party files an objection to the recommended 
decision within 15 days, the recommended decision will become final.



Sec.  137.443  Is the recommended decision always final?

    No, any party to the appeal may file precise and specific written 
objections to the recommended decision, or any other comments, within 15 
days of receiving the recommended decision. The objecting party must 
serve a copy of its objections on the other party. The recommended 
decision will become final 15 days after the Self-Governance Tribe 
receives the ALJs recommended decision, unless a written statement of 
objections is filed with the Secretary during the 15-day period. If no 
party files a written statement of objections within 15 days, the 
recommended decision will become final.



Sec.  137.444  If a Self-Governance Tribe objects to the recommended decision, 
what action will the Secretary take?

    (a) The Secretary has 15 days from the date the Secretary receives 
timely written objections to modify, adopt, or reverse the recommended 
decision. If the Secretary does not modify or reverse the recommended 
decision during that time, the recommended decision automatically 
becomes final.
    (b) When reviewing the recommended decision, the Secretary may 
consider and decide all issues properly raised by any party to the 
appeal, based on the record.
    (c) The decision of the Secretary must:
    (1) Be in writing;
    (2) Specify the findings of fact or conclusions of law that are 
modified or reversed;
    (3) Give reasons for the decision, based on the record; and
    (4) State that the decision is final for the Secretary.



Sec.  137.445  Will an immediate reassumption appeal adversely affect 
the Self-Governance Tribe's rights in other self-governance negotiations?

    No, a pending appeal will not adversely affect or prevent the 
negotiation or award of another compact, funding agreement, or 
construction project agreement.

                    Equal Access to Justice Act Fees



Sec.  137.450  Does the Equal Access to Justice Act (EAJA) apply to appeals 
under this subpart?

    Yes, EAJA claims against the Department will be heard pursuant to 25 
CFR 900.177.

                        PARTS 138	199 [RESERVED]



                       CHAPTERS II	III [RESERVED]



[[Page 945]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 947]]



                    Table of CFR Titles and Chapters




                     (Revised as of October 1, 2022)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 948]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 949]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 950]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Parts 10100--10199)
       CII  U.S. Office of Special Counsel (Parts 10200--10299)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)

[[Page 951]]

        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 952]]

         L  Rural Business-Cooperative Service, and Rural 
                Utilities Service, Department of Agriculture 
                (Parts 5000--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999) [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 953]]

        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)

[[Page 954]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
        XV  Office of the Under-Secretary for Economic Affairs, 
                Department of Commerce (Parts 1500--1599)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 955]]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

[[Page 956]]

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799) 
                [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]

[[Page 957]]

        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)

[[Page 958]]

        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance

[[Page 959]]

         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. Lawrence Seaway Development 
                Corporation, Department of Transportation (Parts 
                400--499)

[[Page 960]]

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)

[[Page 961]]

       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)

[[Page 962]]

       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Federal Acquisition Supply Chain Security
       201  Federal Acquisition Security Council (Parts 201-1--
                201-99)
            Subtitle E [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 963]]

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

[[Page 964]]

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)

[[Page 965]]

        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)

[[Page 966]]

        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 967]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of October 1, 2022)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 968]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Affairs, Office of the Under-          15, XV
       Secretary for
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I

[[Page 969]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Office of the Under-Secretary   15, XV
     for
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV

[[Page 970]]

Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Acquisition Security Council              41, 201
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102

[[Page 971]]

  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes St. Lawrence Seaway Development       33, IV
     Corporation
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
   Secretary
[[Page 972]]

Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Environmental Enforcement, Bureau    30, II
       of
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29

[[Page 973]]

  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II

[[Page 974]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of          32, XXIV; 47, II
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6

[[Page 975]]

Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Great Lakes St. Lawrence Seaway Development     33, IV
       Corporation
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
U.S. Office of Special Counsel                    5, CII
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 977]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2017 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2017

42 CFR
                                                                   82 FR
                                                                    Page
Chapter I
2 Revised...........................................................6115
    Regulation at 82 FR 6115 eff. date delayed to 3-21-17..........10863
10 Revised..........................................................1229
    Regulation at 82 FR 1229 eff. date delayed to 3-21-17..........12508
    Regulation at 82 FR 1229 eff. date further delayed to 5-22-17 
                                                                   14332
    Regulation at 82 FR 1229 eff. date further delayed to 10-1-17 
                                                                   22893
    Regulation at 82 FR 1229 eff. date further delayed to 7-1-18 
                                                                   45511
70.1 Amended........................................................6968
    Regulation at 82 FR 6968 eff. date delayed to 3-21-17..........10718
70.5 Revised........................................................6970
    Regulation at 82 FR 6970 eff. date delayed to 3-21-17..........10718
70.6 Revised........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.10 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.11 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.12 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.13 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.14 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.15 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.16 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.17 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
70.18 Added.........................................................6971
    Regulation at 82 FR 6971 eff. date delayed to 3-21-17..........10718
71.1 Amended........................................................6973
    Regulation at 82 FR 6973 eff. date delayed to 3-21-17..........10718
71.2 Revised........................................................6975
    Regulation at 82 FR 6975 eff. date delayed to 3-21-17..........10718
71.4 Added..........................................................6975
    Regulation at 82 FR 6975 eff. date delayed to 3-21-17..........10718
    Heading and (c) amended........................................31728
71.5 Added..........................................................6975
    Regulation at 82 FR 6975 eff. date delayed to 3-21-17..........10718
    Heading revised................................................31728

[[Page 978]]

71.20 Added.........................................................6975
    Regulation at 82 FR 6975 eff. date delayed to 3-21-17..........10718
71.21 Heading revised..............................................31728
    (c) revised....................................................31729
71.29 Added.........................................................6975
    Regulation at 82 FR 6975 eff. date delayed to 3-21-17..........10718
71.30 Added.........................................................6975
    Regulation at 82 FR 6975 eff. date delayed to 3-21-17..........10718
71.33 (a) and (c) revised...........................................6976
    Regulation at 82 FR 6976 eff. date delayed to 3-21-17..........10718
71.36 Added.........................................................6976
    Regulation at 82 FR 6976 eff. date delayed to 3-21-17..........10718
71.37 Added.........................................................6976
    Regulation at 82 FR 6976 eff. date delayed to 3-21-17..........10718
71.38 Added.........................................................6976
    Regulation at 82 FR 6976 eff. date delayed to 3-21-17..........10718
71.39 Added.........................................................6976
    Regulation at 82 FR 6976 eff. date delayed to 3-21-17..........10718
71.63 Added.........................................................6978
    Regulation at 82 FR 6976 eff. date delayed to 3-21-17..........10718
73.1 Amended........................................................6290
    Regulation at 82 FR 6290 eff. date delayed to 3-21-17..........10864
73.3 (d)(3), (4) and (5) redesignated as (d)(7), (8) and (12); 
        (b), (d)(2), new (7) introductory text and (i) revised; 
        (c)(2) and (f)(3)(i) amended; new (d)(3) through (6), (9), 
        (10), (11) and (e)(3) added.................................6290
    Regulation at 82 FR 6290 eff. date delayed to 3-21-17..........10864
    Regulation at 81 FR 63143 confirmed............................17569
73.4 (b), (d)(2) revised; (c)(2) amended; (d)(3) redesignated as 
        (d)(9); new (d)(3) through (8) and (e)(3) added.............6291
    Regulation at 82 FR 6291 eff. date delayed to 3-21-17..........10864
73.5 (a)(3) redesignated as (a)(4); (a)(1) and new (4) revised; 
        new (a)(3) added; (a)(3)(i) amended.........................6292
    Regulation at 82 FR 6292 eff. date delayed to 3-21-17..........10864
73.6 (a)(3) redesignated as (a)(4); new (a)(3) added; new (a)(4) 
        revised.....................................................6292
    Regulation at 82 FR 6292 eff. date delayed to 3-21-17..........10864
73.7 (b) through (k) redesignated as (c) through (l); new (b) 
        added.......................................................6292
    Regulation at 82 FR 6292 eff. date delayed to 3-21-17..........10864
73.9 (a)(6) amended; (a)(7), (8) and (9) added; (c)(1) amended......6292
    Regulation at 82 FR 6292 eff. date delayed to 3-21-17..........10864
73.10 (e) amended...................................................6293
    Regulation at 82 FR 6293 eff. date delayed to 3-21-17..........10864
73.11 (c)(5) and (h) amended; (d)(7)(vi) added......................6293
    Regulation at 82 FR 6293 eff. date delayed to 3-21-17..........10864
73.12 (a) revised; (c)(2) removed; (c)(3) redesignated as new 
        (c)(2); new (c)(2) and (e) amended..........................6293
    Regulation at 82 FR 6293 eff. date delayed to 3-21-17..........10864
73.13 (a)(2) amended; CFR correction...............................13259
73.14 (a) and (f) amended...........................................6293
    Regulation at 82 FR 6293 eff. date delayed to 3-21-17..........10864
73.15 (a) revised; (e) added........................................6293
    Regulation at 82 FR 6293 eff. date delayed to 3-21-17..........10864
73.16 (l)(1) revised................................................6294
    Regulation at 82 FR 6294 eff. date delayed to 3-21-17..........10864
73.17 (a)(1)(iii) and (3)(v) amended; (a)(1)(v), (b) and (c) 
        revised; (a)(8) added.......................................6294
    Regulation at 82 FR 6294 eff. date delayed to 3-21-17..........10864
100.3 Revised.......................................................6299
    Regulation at 81 FR 6299 eff. date delayed to 3-21-19..........11321
192 Policy Statement...............................................17152

                                  2018

42 CFR
                                                                   83 FR
                                                                    Page
Chapter I
2.15 (a)(1) amended..................................................251
2.32 Revised.........................................................251
2.33 Revised.........................................................251
2.35 (a)(2) revised..................................................251

[[Page 979]]

2.53 (a) introductory text, (1)(i), (ii), (2), (b) introductory 
        text, (2)(i), (ii), (c)(5), and (d) revised..................252
5a Removed.........................................................30080
10 Regulation at 82 FR 1229 eff. 1-1-19............................61563
10 Regulation at 82 FR 1229 eff. date further delayed to 7-1-19....25943
23.21--23.35 (Subpart B) Removed...................................30081
23.41 (Subpart C) Removed..........................................30081
71.5 Heading revised...............................................24672
130 Removed........................................................30082

                                  2019

42 CFR
                                                                   84 FR
                                                                    Page
Chapter I
22.1 Removed.......................................................27969
32 Removed.........................................................27969
59 Authority citation revised.......................................7786
59 Technical correction............................................14313
59.1 Revised........................................................7786
    (b) amended....................................................14313
59.2 Amended........................................................7787
    Introductory text, (2), and section amended....................14313
59.3 Revised........................................................7787
59.5 (a)(1), (5), (b)(1), and (8) revised; (a)(10)(i) removed; 
        (a)(10)(ii) redesignated as (a)(10); (a)(12), (13), and 
        (14) added..................................................7787
59.7 (a) revised; (b) and (c) redesignated as (d) and (e); new (b) 
        and (c) added...............................................7788
59.11 Revised.......................................................7788
59.13 Added.........................................................7788
59.14 Added.........................................................7788
59.15 Added.........................................................7788
    Introductory text amended......................................14313
59.16 Added.........................................................7788
59.17 Added.........................................................7788
59.18 Added.........................................................7788
59.19 Added.........................................................7788
    (a), (b), and (c) amended......................................14313
60 Removed.........................................................27970
81.4 (l) removed; (g) through (k) redesignated as (h) through new 
        (l); new (g) added; (s) amended; interim...................37590
81.5 (a) and (c) through (f) amended; (b) revised; interim.........37590
81.21 Revised; interim.............................................37590
81.23 (a) revised; interim.........................................37590
81.24 (a) revised; interim.........................................37591
81.25 Footnote 4 redesignated as footnote 3; interim...............37591
84.70 (a) removed; (b) through (e) redesignated as new (a) through 
        (d)........................................................16412
84.301 Revised.....................................................16412
84.310 (c) revised; (d) removed; (e), (f), and (g) redesignated as 
        new (d), (e), and (f)......................................16412
88 Actions on petitions............................................49954

                                  2020

42 CFR
                                                                   85 FR
                                                                    Page
Chapter I
2.11 Amended.......................................................43036
2.12 (a)(1) introductory text, (ii), (e)(3), and (4) revised; 
        (d)(2)(i)(A) amended; (d)(2)(ii) added.....................43036
2.13 (d) introductory text, (2) introductory text, and (3) revised
                                                                   43037
2.31 (a)(4) revised................................................43037
2.32 (a)(1) revised................................................43037
2.33 (b) revised...................................................43037
2.34 (b) revised; (d) redesignated as (e); new (d) added...........43038
2.36 Added.........................................................43038
2.51 (a) revised...................................................43038
2.52 (a) revised...................................................43038
2.53 (a)(1)(ii) and (b)(2)(ii) revised; (c) and (d) redesignated 
        as (e) and (f); (a) introductory text, (b)(1)(iii), new 
        (e)(1) introductory text, new (iii), new (3)(ii)(F), new 
        (4), new (5), new (6), and new (f) amended; (a)(1)(iii), 
        (b)(2)(iii), new (c), new (d), and (g) added...............43039
2.63 (a)(2) removed................................................80632
2.67 (d)(2) revised................................................43039
9.2 Amended........................................................54273
9.3 (a)(2)(ix), (8), and (b)(2) amended............................54273
9.4 (a) amended....................................................54273
9.5 (c)(4), (d)(2), and (e) amended................................54273
9.6 (d)(2) amended.................................................54273
9.9 (a) amended....................................................54273
9.12 (a) and (b) amended...........................................54273
10.3 Amended.......................................................80644
10.20--10.21 (Subpart C) Added.....................................80644
23.9 (c)(1) revised................................................72908

[[Page 980]]

24 Revised.........................................................21781
51 Technical correction............................................81781
51c Authority citation revised.....................................83830
51c.107 (b)(5) amended.............................................72908
51c.303 (w) added..................................................83830
51c.303 (f) amended................................................72908
52i.11 (b) through (d) amended.....................................72908
56 Technical correction............................................81781
56.108 Amended.....................................................72908
56.303 (f) amended.................................................72908
56.303 Correction: (f) instruction amended.........................81781
56.603 Amended.....................................................72908
56.603 Correction: (e) instruction amended.........................81781
57.1505 (a)(1) amended.............................................72908
63.2 Amended.......................................................72909
63.9 (b) amended...................................................72909
71 Order...........................................................16567
71.4 (d) and (e) added; interim.....................................7880
71.40 Added; interim...............................................16566
71.40 Revised; eff. 10-13-20.......................................56458
71.50 (b) amended..................................................42741
71.55 Revised......................................................42741
81 Appendix A removed...............................................5332
84.2 Amended; interim..............................................20607
84.2 Regulation at 85 FR 20607 comment period extended.............52488
84.60 (a) amended; interim.........................................20607
84.60 Regulation at 85 FR 20607 comment period extended............52488
84.63 (a), (b), and (c) amended; interim...........................20607
84.63 Regulation at 85 FR 20607 comment period extended............52488
84.64 (b) amended; interim.........................................20607
84.64 Regulation at 85 FR 20607 comment period extended............52488
84.65 (a) amended; interim.........................................20607
84.65 Regulation at 85 FR 20607 comment period extended............52488
84.125 Amended; interim............................................20607
84.125 Regulation at 85 FR 20607 comment period extended...........52488
84.126 (f) added; interim..........................................20607
84.126 Regulation at 85 FR 20607 comment period extended...........52488
84.170--84.181 (Subpart K) Revised; interim........................20607
84.170--84.181 Regulation at 85 FR 20608 comment period extended 
                                                                   52488
84.206 (b) amended; interim........................................20607
84.206 Regulation at 85 FR 20607 comment period extended...........52488
84.207 (h) added; interim..........................................20607
84.207 Regulation at 85 FR 20607 comment period extended...........52488
84.1100--84.1158 (Subpart KK) Removed; interim.....................20611
121 Authority citation revised.....................................59444
121.1 Revised; eff. 10-22-20.......................................59444
121.14 Added; eff. 10-22-20........................................59444
124.511 Amended....................................................72909
124.602 Amended....................................................72909

                                  2021

42 CFR
                                                                   86 FR
                                                                    Page
Chapter I
1 Added.............................................................5752
1 Regulation at 86 FR 5752 eff. date delayed to 3-22-22............15404
37.201 Revised.....................................................24338
37.202 Revised.....................................................24339
37.203 Revised.....................................................24339
37.204 Revised.....................................................24339
51c Authority citation revised.....................................54396
51c.303 Regulation at 85 FR 83830 delayed to 3-22-21................7059
51c.303 Regulation at 85 FR 83830 eff. date delayed to 6-20-21.....15423
51c.303 (w) removed................................................54396
59.1--59.11 (Subpart A) Revised....................................56177
73.3 (b) amended; interim..........................................64081
73.13 (a)(3) added; interim........................................64081
84 Appendix A amended; CFR correction..............................53228
100.3 (a) revised; (c)(10), (13), and (e)(8) removed................6267
100.3 Regulation at 86 FR 6267 eff. date delayed to 4-23-21........10835
100.3 Regulation at 86 FR 6267 withdrawn...........................21208
100.3 (a) table amended............................................68427
110.100 (b) introductory text and (c) revised; (d) added...........45657

                                  2022

  (Regulations published from January 1, 2022, through October 1, 2022)

42 CFR
                                                                   87 FR
                                                                    Page
Chapter I
1 Regulation at 86 FR 5751 eff. date further delayed to 9-22-22....12399

[[Page 981]]

1 Regulation at 86 FR 5752 withdrawn...............................32246
73 Policy statement................................................53679


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