[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83246-83250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27959]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Privacy Act of 1974; System of Records Notice

AGENCY: Department of Health and Human Services (HHS), Office of the 
Secretary (OS)

ACTION: Notice to establish a new system of records, and to delete 
related systems.

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

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, as amended, HHS is establishing a new, department-wide system of 
records, System No. 09-90-1601 ``Outside Experts Recruited for Non-FACA 
Activities,'' and deleting four related systems of records that are 
obsolete or that will be rendered duplicative by the new system. The 
new system will cover recruitment and other administrative records 
about individuals outside the HHS workforce who serve or are considered 
for service on HHS mission-related committees and other assignments 
requiring specific outside expertise or experience (excluding those 
that are subject to the Federal Advisory Committee Act (FACA), which 
are covered under System No. 09-90-0059). The new department-wide 
System No. 09-90-1601 and the related system deletions are more fully 
explained in the Supplementary Information section of this Notice.

DATES: The new system of records established in this Notice is 
effective upon publication, with the exception of the routine uses. The 
routine uses will be effective 30 days after publication of this 
Notice, unless comments are received that warrant a revision to this 
Notice. Written comments on the Notice should be submitted within 30 
days. The deletion of System Numbers 09-20-0168, 09-30-0049, 09-37-
0022, and 09-90-0080 will be effective 30 days after publication of 
this Notice.

ADDRESSES: The public should address written comments to: Beth Kramer, 
HHS Privacy Act Officer, FOIA/PA Division, Hubert H. Humphrey 
Building--Suite 729H, 200 Independence Avenue SW., Washington, DC 
20201, [email protected].

FOR FURTHER INFORMATION CONTACT: Beth Kramer, HHS Privacy Act Officer, 
FOIA/PA Division, Hubert H. Humphrey Building--Suite 729H, 200 
Independence Avenue SW.,

[[Page 83247]]

Washington, DC 20201, [email protected].

SUPPLEMENTARY INFORMATION:

I. Explanation of New System No. 09-90-1601

    The records to be covered in the new system of records are similar 
in type and function to the records covered in System No. 09-90-0059, 
which pertain to individuals who serve or are considered for service on 
committees that are subject to the Federal Advisory Committee Act 
(FACA), 5 U.S.C. App., et seq.; the key difference is that they will be 
about outside individuals serving or considered for service on mission-
related committees and other activities that are not subject to FACA. 
Following are the non-FACA-related programs at HHS that recruit and 
utilize individuals with outside expertise or experience and maintain 
records about the outside individuals in systems that retrieve the 
records by personal identifier:
     Curricula Vitae of Consultants to the National Center for 
Health Statistics (NCHS) within the Centers for Disease Control and 
Prevention (CDC) (formerly covered under SORN 09-20-0168). This program 
maintains records about individuals with special expertise, training, 
and professional experience who may be enlisted to assist CDC/NCHS as 
consultants. The records are used by CDC/NCHS to select individuals to 
participate in assignments such as: planning and conducting surveys, 
studies, statistical reporting programs, and statistical analyses of 
data; providing training and technical assistance; and planning and 
conducting conferences. These records currently are covered under SORN 
No. 09-20-0168, which is being deleted and subsumed under the new 
department-wide SORN No. 09-90-1601.
     The Food and Drug Administration (FDA) Patient 
Representative Program. This program enlists individuals with patient 
advocacy experience to serve as patient representatives on both FACA 
committees and non-FACA assignments. For example, patient 
representatives may provide input that is used in making decisions to 
approve devices or drugs, or may contribute to discussions at 
presentations and conferences. Records about patient representatives 
are retrieved by the representatives' names, and will be covered under 
either SORN No. 09-90-0059 or the new department-wide SORN No. 09-90-
1601, depending on whether the records pertain to service on a FACA 
committee or service on a non-FACA assignment.
     Peer Review Programs at the Administration for Children 
and Families (ACF), Health Resources and Services Administration 
(HRSA), and Substance Abuse and Mental Health Services Administration 
(SAMHSA) that recruit and use outside individuals to serve on peer 
review committees formed to review applications for grants and 
cooperative agreements. These programs exist in several HHS components, 
but only ACF, HRSA, and SAMHSA sometimes use a personal identifier 
(i.e., name) to retrieve administrative records about the outside 
individuals they recruit and use. Other components (including the 
Office of the Assistant Secretary for Health (OASH), Centers for 
Medicare & Medicaid Services (CMS), and National Institutes of Health 
(NIH)) use only non-personal identifiers (e.g., expertise type, or 
funding opportunity announcement number) for retrieval.
     Consultants on Other SAMHSA Projects (formerly covered 
under SORN 09-30-0049). SAMHSA contractors arrange for outside 
consultants to be used in other SAMHSA programs (besides peer review 
programs) when technical assistance is needed in conferences, meetings, 
and evaluation projects that involve a specialized area of research, 
review, or advice.
    A report on the new system of records has been sent to Congress and 
OMB in accordance with 5 U.S.C. 552a(r).

II. Deletion of Four Related Systems of Records

    The following systems of records are being deleted as duplicative 
of new department-wide System No. 09-90-1601:

 09-20-0168 Curricula Vitae of Consultants to the National 
Center for Health Statistics
 09-30-0049 Consultant Records Maintained by SAMHSA Contractors
    The following system of records is being deleted as duplicative of 
System No. 09-90-0059 Federal Advisory Committee Membership Files as to 
files that pertain to candidates for FACA committees, and as 
duplicative of new department-wide System No. 09-90-1601 as to files 
that pertain to candidates for non-FACA committees and other 
activities:

 09-90-0080 The Secretary's Advisory Committee Candidate Files

The following system of records is being deleted because it is obsolete 
and the records no longer exist:

 9-37-0022 Records of Health Experts Maintained by the Office 
of International Health

III. The Privacy Act

    The Privacy Act (5 U.S.C. 552a) governs the means by which the U.S. 
Government collects, maintains, and uses information about individuals 
in a system of records. A ``system of records'' is a group of any 
records under the control of a federal agency from which information 
about an individual is retrieved by the individual's name or other 
personal identifier. The Privacy Act requires each agency to publish in 
the Federal Register a system of records notice (SORN) identifying and 
describing each system of records the agency maintains, including the 
purposes for which the agency uses information about individuals in the 
system, the routine uses for which the agency discloses such 
information outside the agency, and how individual record subjects can 
exercise their rights under the Privacy Act.

    Dated: November 1, 2016.
Beth Kramer,
Privacy Act Officer, FOIA/Privacy Act Division, Assistant Secretary for 
Public Affairs, Department of Health and Human Services.

Notice of Deletion of Related Systems

    The following systems of record are deleted, effective 30 days 
after publication of this Notice:

1. 09-20-0168 Curricula Vitae of Consultants to the National Center for 
Health Statistics
2. 09-30-0049 Consultant Records Maintained by SAMHSA Contractors
3. 09-90-0080 The Secretary's Advisory Committee Candidate Files
4. 09-37-0022 Records of Health Experts Maintained by the Office of 
International Health
SYSTEM NUMBER:
    09-90-1601

SYSTEM NAME:
    Outside Experts Recruited for Non-FACA Activities

SECURITY CLASSIFICATION:
    Unclassified.

SYSTEM LOCATION:
    Physical locations include:
     CDC program offices that recruit consultants to assist in 
statistical projects and reporting programs conducted or sponsored by 
NCHS, in Atlanta, GA and Hyattsville, MD;
     FDA's committee management office in Silver Spring, MD;
     Program offices at ACF in Washington, DC, at HRSA in 
Rockville, MD, and at SAMHSA in Rockville, MD,

[[Page 83248]]

that recruit individuals to serve as peer reviewers; and
     Locations of SAMHSA contractors that arrange use of 
consultants on SAMHSA projects.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Records in this system pertain to individuals outside the HHS 
workforce who serve or are considered for service on HHS mission-
related committees or other assignments that require specific outside 
expertise or experience (for example, medical, scientific, or 
manufacturing expertise, or patient advocacy experience), but that are 
not subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. 
App., et seq.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The records consist of recruitment and other administrative 
records, including:
     An application and resume or curricula vitae, describing 
the individual's qualifications;
     Nomination/recommendation records, or other records used 
in evaluating an individual's qualifications and any potential 
conflicts of interest and selecting an individual for a specific 
assignment; and
     Records used to plan and arrange the individual's 
participation in the assigned activities, including scheduling records 
and records used to coordinate parking, badging, and payment of any 
stipend or honorarium.
    The records may contain these data elements:
     The individual's name and other identifying information 
(e.g., sex, place and date of birth);
     Contact information (e.g., home and business addresses, 
telephone numbers, email addresses);
     Occupation, job titles, employers, employment status and 
history, and whether currently employed by the federal government;
     Work and organizational affiliations, memberships, 
credentials, and licenses;
     Degrees held, and general educational and/or experience 
background;
     Racial classification or ethnic background;
     Areas of specialization, expertise, or experience, and 
special qualifications (e.g., language or technical skills, ability to 
drive to an assignment);
     Dates and descriptions of past assignments or past 
experience;
     Sources and references, and any information provided by 
sources/references; and
     Information about availability and any special needs.
    Any special needs, medical condition, or similar information 
contained in an individual's records is maintained and used in 
accordance with relevant provisions of the Rehabilitation Act of 1973, 
as amended, 29 U.S.C. 791 et seq., and implementing regulations at 29 
CFR parts 1614 and 1630, and the Genetic Information Nondiscrimination 
Act of 2008 at 42 U.S.C. 2000ff et seq.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    For CDC/NCHS Consultant Records: 42 U.S.C. 242b(b)(3).
    For FDA Patient Representative Records: 21 U.S.C. 360bbb-8c, 371 et 
seq., 379d-1(b)(1)(A).
    For ACF Peer Reviewer Records: 42 U.S.C. 799(f), 806(e).
    For HRSA Peer Reviewer Records: 42 U.S.C. 799(f), 806(e).
    For SAMHSA Peer Reviewer and Other Consultant Records: 42 U.S.C. 
241, 249(c), 290aa et seq., 290aa-5, 290bb et seq., 290bb-21 et seq., 
290bb-31 et seq., 5121 et seq., 10801 et seq.; 8 U.S.C. 1522 note; 
Executive Order 12341.
    See also: 5 U.S.C. 3109.

PURPOSE(S):
    The records will be used within the agency on a need-to-know basis 
for the purpose of staffing committees and other assignments and 
managing administrative matters pertaining to individuals serving on 
committees and other assignments, including to:
     Prepare reports and lists of past, present, and 
recommended members, vacancies, acceptances, and separations;
     Send recruitment notices to individual prospective 
candidates, and send informational notices to selectees;
     Identify qualified candidates and document the selections; 
and
     Manage and coordinate the selected individuals' 
participation in assignment activities (including sharing information 
within the agency to coordinate aspects such as badging, parking, 
travel, training, and payment of any stipend or honorarium).

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to the statutory disclosures of information permitted 
in the Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(11), HHS may make 
the following disclosures of information about an individual from this 
system of records to parties outside the agency without the 
individual's prior, written consent:
    1. Disclosures may be made to federal agencies and Department 
contractors that have been engaged by HHS to assist in accomplishment 
of an HHS function relating to the purposes of this system of records 
and that have a need to have access to the records in order to assist 
HHS in performing the activity. Any contractor will be required to 
comply with the requirements of the Privacy Act.
    2. Records may be disclosed to parties such as educational 
institutions, current and former employers, and qualified experts, when 
necessary to check or obtain an opinion about a candidate's 
qualifications.
    3. Records about consultants and patient advocates may be disclosed 
to parties organizing or hosting assignment activities, such as grantee 
institutions and federal, foreign, state, tribal, local, and other 
government agencies and public authorities (e.g., U.S. Embassies and 
Ministries of Health), when necessary to apprise them of an 
individual's qualifications for the assignment or coordinate the 
individual's participation in the activities.
    4. Records may be disclosed to supervisors and administrative 
assistants at the individual's place of employment, for administrative 
purposes such as coordinating the individual's participation in the 
activities.
    5. Records may be disclosed to external parties that audit 
committee or assignment activities.
    6. Relevant information will be included in any required reports to 
the President, the Office of Management and Budget (OMB), and the 
General Services Administration (GSA) about committees and other 
assignments that are mission-related.
    7. Information may be disclosed to the U.S. Department of Justice 
(DOJ) or to a court or other tribunal, when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where DOJ has agreed to represent the employee, or
    d. The United States Government, is a party to litigation or has an 
interest in such litigation and, by careful review, HHS determines that 
the records are both relevant and necessary to the litigation and that, 
therefore, the use of such records by the DOJ, court or other tribunal 
is deemed by HHS to be compatible with the purpose for which the agency 
collected the records.
    8. Records may be disclosed to student volunteers and other 
individuals performing functions for the

[[Page 83249]]

Department but technically not having the status of agency employees, 
if they need access to the records in order to perform their assigned 
agency functions.
    9. Disclosures may be made to the National Archives and Records 
Administration (NARA) and/or the General Services Administration (GSA) 
for the purpose of records management inspections conducted under 44 
U.S.C. 2904 and 2906.
    10. Information may be disclosed to a Member of Congress or a 
Congressional staff member in response to a written inquiry of the 
Congressional office made at the written request of the constituent 
about whom the record is maintained. The Congressional office does not 
have any greater authority to obtain records than the individual would 
have if requesting the records directly.
    11. Records may be disclosed to the U.S. Department of Homeland 
Security (DHS) if captured in an intrusion detection system used by HHS 
and DHS pursuant to a DHS cybersecurity program that monitors Internet 
traffic to and from federal government computer networks to prevent a 
variety of types of cybersecurity incidents.
    12. Disclosures may be made to appropriate federal agencies and 
Department contractors that have a need to know the information for the 
purpose of assisting the Department's efforts to respond to a suspected 
or confirmed breach of the security or confidentiality of information 
maintained in this system of records, when the information disclosed is 
relevant and necessary to that assistance.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM--
STORAGE:
    Records are stored in hard-copy files and electronic media.

RETRIEVABILITY:
    Records are retrieved by the individual's name.

SAFEGUARDS:
    Safeguards conform to the HHS Information Security and Privacy 
Program, http://www.hhs.gov/ocio/securityprivacy/index.html. 
Information is safeguarded in accordance with applicable laws, rules 
and policies, including the HHS Information Technology Security Program 
Handbook, all pertinent National Institutes of Standards and Technology 
(NIST) publications, and OMB Circular A-130, Management of Federal 
Resources. Records are protected from unauthorized access through 
appropriate administrative, physical, and technical safeguards. These 
safeguards include protecting the facilities where records are stored 
or accessed with security guards, badges and cameras, securing hard-
copy records in locked file cabinets, file rooms or offices during off-
duty hours, limiting access to electronic databases to authorized users 
based on roles and two-factor authentication (user ID and password), 
using a secured operating system protected by encryption, firewalls, 
and intrusion detection systems, requiring encryption for records 
stored on removable media, and training personnel in Privacy Act and 
information security requirements. Records that are eligible for 
destruction are disposed of using destruction methods prescribed by 
NIST SP 800-88.

RETENTION AND DISPOSAL:
    Records pertaining to recruitment and use of outside peer reviewers 
are destroyed three years after final action; they are retained longer 
if required for business use (see General Records Schedule (GRS) 1.2, 
Item 010, Grant and Cooperative Agreement Program Management Records). 
Records pertaining to recruitment and use of other outside individuals 
(e.g., experts, patient advocates, and members of mission-related non-
FACA committees) are currently unscheduled. Unscheduled records must be 
retained indefinitely pending the agency's submission, and NARA's 
approval, of a disposition schedule. HHS anticipates proposing to NARA, 
as an appropriate retention period for these records, ``three years 
after final action, or longer if required for business use'' (similar 
to the period provided in GRS 1.2, Item 010) or ``when no longer needed 
for administrative purposes'' (similar to the periods applicable to 
similar records not retrieved by personal identifier which are not 
covered under this SORN; i.e.: N1-442-93-1, Item 37 for the Agency for 
Toxic Substances and Disease Registry's Curriculum Vitae Files, and 
NC1-235-82-1, Item 100-3 for the Office of the Secretary's Advisory 
Committee Candidate Resume Files).

SYSTEM MANAGER(S) AND ADDRESS(ES):
    For CDC/NCHS Consultant Records:

     Centers for Disease Control and Prevention (CDC), 
Director, National Center for Health Statistics, OPHSS, Prince George's 
Metro IV Bldg., Rm. 7209, MS P08, Centers for Disease Control and 
Prevention, 3311 Toledo Road, Hyattsville, MD 20782

    For FDA Patient Representative Records:

     Food and Drug Administration (FDA), Advisory Committee 
Oversight & Management Staff, 10903 New Hampshire Avenue, Bldg. WO32, 
Rm. 5129, Silver Spring, MD 20993-002
    For ACF Peer Reviewer Records:

     Administration for Children and Families (ACF), Privacy 
Act Contact, Office of Information Systems 330 C Street, NW., 
Washington, DC 20201

    For HRSA Peer Reviewer Records:

     Health Resources and Services Administration (HRSA), 
Chief, Policy, Analysis & Training Branch, Division of Independent 
Review, Office of Federal Assistance Management, 5600 Fishers Lane, 
Rockville, MD 20857

    For SAMHSA Peer Reviewer Records:

     Substance Abuse and Mental Health Services Administration 
(SAMHSA), Director, Division of Grant Review, 5600 Fishers lane, 
Rockville, MD 20852

    For Other Consultant Records, Maintained by SAMHSA Contractors:

     Substance Abuse and Mental Health Services Administration 
(SAMHSA), Director, Division of Contracts Management, Office of Program 
Services, 5600 Fishers Lane, Rockville, MD 20852

NOTIFICATION PROCEDURE:
    An individual who wishes to know if this system contains records 
about him or her should submit a written request to the relevant System 
Manager indicated above. The individual must verify his or her identity 
by providing either a notarization of the request or a written 
certification that the requester is who he or she claims to be and 
understands that the knowing and willful request for acquisition of a 
record pertaining to an individual under false pretenses is a criminal 
offense under the Privacy Act, subject to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:
    An individual seeking access to records about him in this system 
should submit a request following the same procedure indicated under 
``Notification Procedure.''

CONTESTING RECORD PROCEDURE:
    An individual seeking to amend the content of information about him 
or her in this system should contact the relevant System Manager 
indicated above and reasonably identify the record, specify the 
information contested, state the corrective action sought, and provide 
the reasons for the amendment, with supporting justification.

RECORD SOURCE CATEGORIES:
    Most information is obtained directly from the individual record 
subject.

[[Page 83250]]

Information pertaining to references and recommendations is obtained 
from other private individuals, educational institutions, current and 
former employers, HHS program personnel, biographical reference books, 
private organizations, Members of Congress, and other government 
sources.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    None.

[FR Doc. 2016-27959 Filed 11-18-16; 8:45 am]
BILLING CODE P