[Federal Register Volume 59, Number 147 (Tuesday, August 2, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18651]


[[Page Unknown]]

[Federal Register: August 2, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 52

RIN 0905-AC02

 

Grants for Research Projects

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to revise 
regulations governing Public Health Service (PHS) grants for research 
projects to: accommodate changes necessitated by enactment of various 
statutes governing research project grant programs administered by the 
PHS; update references to statutes and regulations; and cover all 
research project grant programs administered by the PHS, so the 
regulations will not have to be amended each time a new research 
project grant program is established by statute or administrative 
action.

DATES: Comments must be received on or before October 3, 1994 in order 
to ensure that NIH will be able to consider the comments in preparing 
the final rule. The final rule would become effective 30 days after its 
publication in the Federal Register.

ADDRESSES: Comments should be sent to Mr. Jerry Moore, NIH Regulatory 
Affairs Officer, Division of Management Policy, National Institutes of 
Health, Building 31, Room 3B11, Bethesda, Maryland 20892-0001.

FOR FURTHER INFORMATION CONTACT:
Mr. Jerry Moore, NIH Regulatory Affairs Officer, National Institutes of 
Health, Building 31, Room 3B11, Bethesda, Maryland 20892-0001, 
telephone (301) 496-4606 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: The regulations at 42 CFR part 52 governing 
PHS grants for research projects were last amended on September 27, 
1984 (49 FR 38110). Since the, Congress has enacted a number of 
statutes establishing research grant programs similar to those listed 
in Sec. 52.1 of the regulation. In the past, new statutory authority 
would have been implemented by adding the new programs to the list of 
programs in Sec. 52.1.
    However, after considering the long list of programs to be added 
and the very limited number of substantive changes necessitated by the 
new statues, we have decided to propose deletion of the listing of 
research project grant programs in Sec. 52.1, and references to that 
listing in other sections. The regulations would be amended to apply to 
all research project grant programs administered by the PHS. Thus, it 
will not be necessary to include a long list of programs in the 
regulations or to go through the lengthy process of amending the 
regulations in order for them to apply to a newly established program.
    The PHS and/or its components that award research project grants 
will, as stated in proposed Sec. 52.1, periodically publish a list of 
all the research project grant programs to which the regulations apply 
and the applicability of the regulations to new programs will be 
announced as PHS components initiate those programs. Under Sec. 52.1, 
the regulations clearly apply to all research project grants 
administered by the PHS; thus, the lists described above are provided 
for the convenience of interested members of the public, rather than 
serving as a substantive notice of the applicability of the 
regulations. A list of the current research project grant authorities 
implemented by the regulations follows:
    (1) Research into the cause, diagnosis, treatment, control, or 
prevention of the physical or mental diseases, injuries, or impairments 
to human life, as authorized by sections 301 and 303 related provisions 
of the Public Health Service Act (Act) (42 U.S.C. 241, 242a);
    (2) Electronic product radiation control research programs designed 
to protect the public health and safety from electronic product 
radiation, as authorized by section 532 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ii);
    (3) Research on health related educational technologies, medical 
library science and related activities, and for the development or 
dissemination of new knowledge, techniques, systems, and equipment for 
processing, storing, retrieving, and distributing information 
pertaining to health sciences, as authorized by section 473 of the Act 
(42 U.S.C. 286b-4);
    (4) Research on the social, behavioral, and biomedical etiology, 
mental and physical health consequences, and social and economic 
consequences of alcohol abuse and alcoholism, as authorized by section 
464H of the Act (42 U.S.C. 285n);
    (5) Research on the causes, consequences and approaches of coping 
with adolescent sexual relations, contraceptive use, pregnancy, and 
parenthood, as authorized by section 2008 of the Act (42 U.S.C. 300z-
7);
    (6) Health services research activities, as authorized by section 
301 and 464H of the Act (42 U.S.C. 241 and 285n) and defined in section 
409 of the Act (42 U.S.C. 284d);
    (7) Biomedical research in areas relating to Alzheimer's disease 
and related dementias, as authorized by section 445B of the Act (42 
U.S.C. 285e-4);
    (8) Research relating to medical rehabilitation, as authorized by 
section 452 of the Act (42 U.S.C. 285g-4);
    (9) Basic research to identify, characterize, and quantify risks to 
human health from air pollutants, as authorized by section 103 of the 
Clean Air Act (42 U.S.C. 7403);
    (10) Research relating to the evaluation of drug treatments for 
AIDS not approved by the Commissioner of the Food and Drug 
Administration, as authorized by section 2314 of the Act (42 U.S.C. 
300cc-14);
    (11) Research under the Medication Development Program to encourage 
and promote the development and use of medications to treat drug 
addiction; and collect, analyze, and disseminate data, as authorized by 
section 464P of the Act (42 U.S.C. 285o-4);
    (12) International research relating to the development and 
evaluation of vaccines and treatments for AIDS, as authorized by 
section 2315 of the Act (42 U.S.C. 300cc-15);
    (13) Long-term research into treatments for AIDS, as authorized by 
section 2320 of the Act (42 U.S.C. 300cc-20);
    (14) Research relating to AIDS conducted outside of the United 
States by qualified foreign professionals and collaborative research 
involving American and foreign participants, as authorized in section 
2351 of the Act (42 U.S.C. 300cc-41);
    (15) Research in the biomedical, contraceptive development, 
behavioral, and program implementation fields related to family 
planning and population, as authorized by section 1004 of the Act (42 
U.S.C. 300a-2);
    (16) Research on occupational safety and health problems in 
industry, as authorized by section 20(a) of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 669a) and section 501 of the Federal Coal 
Mine Health and Safety Act of 1969, as amended (30 U.S.C. 951);
    (17) Injury prevention and control research, as authorized by 
section 391 of the Act (42 U.S.C. 280b);
    (18) Research into the prevention and control of childhood lead 
poisoning, as authorized by section 301 of the Act (42 U.S.C. 241);
    (19) Investigation to identify strategies for prevention of 
childhood deaths from diarrhea, as authorized by sections 301 and 
317(k)(3) of the Act (42 U.S.C. 241, 247b(k)(3));
    (20) Support for radiation studies and research, as authorized 
under section 301 of the Act (42 U.S.C. 241) and section 20(a) of the 
Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a));
    (21) Ecological and epidemiological research studies in Lyme 
disease, including disease surveillance, development and evaluation of 
prevention and control studies, and development of improved diagnostic 
tests, as authorized by section 301 of the Act (42 U.S.C. 241);
    (22) Surveillance and epidemiologic studies for the prevention of 
infectious diseases and injuries in children in child day care 
settings, as authorized by sections 301, 317(k)(3), and 391 of the Act 
(42 U.S.C. 241, 247b(k)(3), 280b);
    (23) Research into prevention and control of tuberculosis, 
especially research concerning strains of tuberculosis resistant to 
drugs and research concerning cases of tuberculosis that affect certain 
populations, as authorized by section 317(k) of the Act (42 U.S.C. 
247b(k));
    (24) Research to stimulate health-related technological innovation 
especially through the use of small business, minority and 
disadvantaged firms and increased private sector commercialization of 
innovations derived from Federal research and development, as 
authorized by section 301 of the Act, (42 U.S.C. 241), in accordance 
with the procedures prescribed pursuant to the Small Business 
Innovation Development Act of 1982 (15 U.S.C. 638);
    (25) Epidemiological studies, and state-based research capacity 
building projects for the prevention of primary and secondary 
disabilities; as authorized by section 301 of the Act (42 U.S.C. 241);
    (26) Research for the development of knowledge and approaches to 
the epidemiology, etiology, diagnosis, treatment, control and 
prevention of narcotic addition, intravenous (IV)-related, AIDS and 
drug abuse, as authorized by sections 301 and 405 of the Act (42 U.S.C. 
241, 284);
    (27) HIV/AIDS surveillance, HIV serosurveillance surveys and 
studies, and epidemiologic research studies of AIDS and HIV infection, 
as authorized by sections 301 and 317(k)(3) of the Act (42 U.S.C. 241 
and 247b(k)(3));
    (28) Research into areas where a microgravity environment may 
contribute to significant progress in the understanding and treatment 
of diseases and other medical conditions, as authorized by section 603 
of the National Aeronautics and Space Administration Authorization Act, 
Fiscal Year 1993 (42 U.S.C. 2487b);
    (29) Research on clinical and health services on eye care and 
diabetes, as authorized by section 456 of the Act (42 U.S.C. 285i-1);
    (30) Research on multiple sclerosis, especially research on the 
effects of genetics and hormonal changes on the progress of the 
disease, as authorized by section 460 of the Act (42 U.S.C. 285j-3); 
and
    (31) Research on osteoporosis, paget's disease and related bone 
disorders, as authorized by section 409A of the Act (42 U.S.C. 284e).
    A more detailed listing of the programs to be implemented by the 
regulations, as listed in the Catalog of Federal Domestic Assistance, 
appears at the end of this preamble.
    In addition to the actions noted above, NIH proposes to limit the 
citation of authority for issuance of the regulations to the 
Secretary's general statutory authority for the issuance of regulations 
set forth in section 215 of the PHS Act, rather than citing the 
statutory authority for each research project grant program. The latter 
provisions do not require or explicitly authorize the issuance of 
regulations and thus 1 CFR part 21, subpart B, does not require 
inclusion of those statutes in the authority citation. It is also 
proposed to make minor changes required by new statutory authority, 
simplify the language in Secs. 52.2-4 and 52.6, update PHS Act section 
numbers referenced in part 52 as necessitated by enactment of 
legislation, and update the listing of HHS policies and regulations in 
Sec. 52.8. The purpose of this notice is to invite public comment on 
these proposed changes. The following statements are provided for the 
information of the public.

Regulatory Impact Statement

    The Secretary has reviewed this proposed rule in accordance with 
the requirements of Executive Order 12866, Regulatory Planning and 
Review, and has determined that it will not: (1) Have an annual effect 
on the economy of $100 million or more or adversely affect in a 
material way the economy, a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, or tribal governments or communities; (2) create a serious 
inconsistency or otherwise interfere with an action taken or planned by 
another agency; (3) materially alter the budgetary impact of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raise novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in Executive Order No. 12866. Therefore, the 
Secretary has determined that the proposed rule does not require: (1) 
An assessment of benefits anticipated from the proposed amendments; (2) 
an assessment of costs anticipated from the proposed amendments; or (3) 
an assessment of costs and benefits of potentially effective and 
reasonably feasible alternative to the proposed amendments.

Regulatory Flexibility Act

    Because of the nonsubstantive nature of the proposed amendments, 
the Secretary certifies that the proposed regulations will not have a 
significant economic impact on a substantial number of small entities, 
and therefore, a regulatory flexibility analysis, as defined under the 
Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6), is not 
required.

Paperwork Reduction Act

    The proposed regulations do not contain information collection 
requirements subject to review and approval by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1980 (44 U.S.C. 
chapter 35).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance (CFDA) numbered programs 
affected by the regulations are:

93.113--Biological Response to Environmental Health Hazards
93.114--Applied Toxicological Research and Testing
93.115--Biometry and Risk Estimation--Health Risks from 
Environmental Exposures
93.118--Acquired Immunodeficiency Syndrome (AIDS) Activity
93.121--Oral Diseases and Disorders Research
93.135--Centers for Research and Demonstration for Health Promotion 
and Disease Prevention
93.136--Injury control Research Projects
93.154--Special International Postdoctoral Research Program in 
Acquired Immunodeficiency Syndrome
93.173--Biological Research Related to Deafness and Communicative 
Disorders
93.184--Disabilities Prevention
93.198--Biological Models and Materials Resources Program
93.242--Mental Health Research Grants
93.262--Occupational Safety and Health Research Grants
93.271--Alcohol Scientist Development Award; Scientist Development 
Award for Clinicians; and Research Scientist Award
93.273--Alcohol Research Programs
93.277--Drug Abuse Scientist Development Award for Clinicians, and 
Scientist Development Awards
93.279--Drug Abuse Research Programs
93.281--Mental Health Research Scientist Development Award, Research 
Scientist Development Award for Clinicians, and Research Scientist 
Award
93.283--Centers for Disease Control-Investigation and Technical 
Assistance
93.306--Comparative Medicine Program (formerly called Laboratory 
Animal Sciences and Primate Research)
93.333--General Clinical Research Centers
93.361--Nursing Research
93.371--Biomedical Research Technology
93.389--Research Centers in Minority Institutions
93.390--Academic Research Enhancement Award
93.393--Cancer Cause and Prevention Research
93.394--Cancer Detection and Diagnosis Research
93.395--Cancer Treatment Research
93.396--Cancer Biology Research
93.821--Biophysics and Physiological Sciences Research
93.837--Heart and Vascular Diseases Research
93.838--Lung Diseases Research
93.839--Blood Diseases and Resources Research
93.846--Arthritis, Musculoskeletal and Skin Diseases Research
93.847--Diabetes, Endocrinology and Metabolic Research
93.848--Digestive Diseases and Nutrition Research
93.849--Kidney Diseases, Urology and Hematology Research
93.853--Clinical Research Related to Neurological Disorders
93.854--Biological Basis Research in the Neurosciences
93.855--Allergy, Immunology, and Transplantation Research
93.856--Microbiology and Infectious Diseases Research
93.859--Pharmacological Sciences
93.862--Genetics Research
93.863--Cellular and Molecular Basis of Disease Research
93.864--Population Research
93.865--Research for Mothers and Children
93.866--Aging Research
93.867--Vision Research
93.879--Medical Library Assistance
93.929--Center for Medical Rehabilitation Research
93.934--Fogarty International Research Collaboration Award
93.939--Blood Diseases and Resources Research
93.941--HIV Demonstration, Research, Public and Professional 
Education Projects
93.942--Research, Treatment and Education Programs on Lyme Disease 
in the United States
93.943--Epidemiologic Research Studies of Acquired Immunodeficiency 
Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection in 
Selected Population Groups
93.947--Tuberculosis Demonstration, Research, Public and 
Professional Education

List of Subjects in 42 CFR Part 52

    Grant programs--health; Medical research; Occupational safety and 
health.

    Dated: May 31, 1994.
Philip R. Lee,
Assistant Secretary for Health.

    Approved: July 25, 1994.
Donna E. Shalala,
Secretary.

    For reasons set out in the preamble, it is proposed to amend part 
52 of title 42 of the Code of Federal Regulations to read as set forth 
below.

PART 52--GRANTS FOR RESEARCH PROJECTS

    1. and 2. The authority citation for part 52 would be revised to 
read as follows:

    Authority: 42 U.S.C. 216.

    3. Section 52.1 would be revised to read as follows:


Sec. 52.1  To which programs do these regulations apply?

    (a) General. The regulations of this part apply to all health-
related research project grants administered by the PHS or its 
components. 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.

    4. Section 52.2 would be revised to read as follows:


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.).
    Department means the Department of Health and Human Services (HHS).
    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.
    Principal investigator means a single individual designated by the 
grantee in the grant application and approved by the Secretary, who is 
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 (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.

    5. Section 52.3 would be revised to read as follows:


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 (e.g., only Diabetes Eye 
Research Institutions are eligible for research project grants on eye 
care and diabetes under section 456 of the PHS Act);
    (2) Federal agencies or institutions, unless specifically 
authorized by law to receive the grant;
    (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, 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.

    6. Section 52.4 would be revised to read as follows:


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.

    7. Section 52.6 would be amended as follows:

    In paragraph (a) the first sentence would be revised to read as set 
forth below; paragraphs (b), (c), (d) and (e) would be redesignated 
(c), (d), (e) and (f), respectively; new paragraph (b) would be added, 
and paragraphs (c)(2) and (d) would be revised to read as follows:


Sec. 52.6  Grant awards.

    (a) Within the limits of funds available for such 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.* * 
*
    (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 the Commissioner of the 
Food and Drug Administration, 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) * * *
    (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) * * *
    (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 awards pursuant to two or more concurrent 
applications, each dealing with one or more specified aspects of the 
project.
* * * * *
    8. Section 52.8 would be revised to read as follows:


Sec. 52.8  Other HHS policies and regulations 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
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--Proteciton of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
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 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
51 FR 16958 (May 7, 1986), as may be amended, or its 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), as may be amended, or its successor.


Sec. 52.9  [Amended]

    9. The heading of Sec. 52.9 would be revised to read ``Additional 
conditions.''

[FR Doc. 94-18651 Filed 8-1-94; 8:45 am]
BILLING CODE 4140-01-M