[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Rules and Regulations]
[Pages 55102-55106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26976]
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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: Final rule.
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SUMMARY: The National Institutes of Health (NIH) is amending the
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; updated references to statutes and regulations; and cover all
research project grant programs administered by the PHS, except for
grants for health services research, demonstration, and evaluation
projects administered by the Agency for Health Care Policy and Research
(AHCPR), so the regulations will not have to be amended each time a new
research project grant program is established by statute or
administrative action.
EFFECTIVE DATE: This final rule is effective on November 25, 1996.
FOR FURTHER INFORMATION CONTACT:
Mr. Jerry Moore, NIH Regulatory Affairs Officer, National Institutes of
Health, Building 31, Room 1B05, 31 CENTER DR MSC 2075, BETHESDA, MD
20892-2075, 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 then, Congress enacted a number of statutes
establishing research grant programs similar to those listed in
Sec. 52.1 of the current 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 statutes, the NIH is deleting the listing of research project grant
programs in Sec. 52.1, and references to that listing in other
sections. The regulations are amended to apply to all research project
grant programs administered by the PHS, except for grants for health
services research, demonstration, and evaluation projects administered
by the AHCPR. Thus, in the future 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 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 amended regulations
clearly apply to all research project grants administered by the PHS
except for the AHCPR grants referenced above. 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
[[Page 55103]]
physical or mental diseases, injuries, or impairments to human life, as
authorized by sections 301, 303 and related provisions of the Public
Health Service Act (Act) (42 U.S.C. 241, 242a);
(2) Research into the prevention and control of childhood lead
poisoning, as authorized under section 301 of the Act (42 U.S.C. 241);
(3) Epidemiologic studies, and state-based research capacity
building projects for the prevention of primary and secondary
disabilities, as authorized under section 301 of the Act (42 U.S.C.
241);
(4) Ecological and epidemiologic research studies in Lyme disease,
including disease surveillance, development and evaluation of
prevention and control studies, and development of improved diagnostic
tests, as authorized under section 301 of the Act (42 U.S.C. 241);
(5) Investigation to identify strategies for prevention of
childhood deaths from diarrhea, as authorized under sections 301 and
317(k)(3) of the Act (42 U.S.C. 241, 247(k)(3));
(6) HIV/AIDS surveillance, HIV serosurveillance surveys and
studies, and epidemiologic research studies of AIDS and HIV infection,
as authorized under sections 301 and 317(k)(3) of the Act (42 U.S.C.
241 and 247b(k)(3));
(7) Surveillance and epidemiologic studies for the prevention of
infectious diseases and injuries in children in child day care
settings, as authorized under sections 301, 317(k)(3), and 391 of the
Act (42 U.S.C. 241, 247b(k)(3), 280b);
(8) Research for the development of knowledge and approaches to the
epidemiology, etiology, diagnosis, treatment, control and prevention of
narcotic addiction and intravenous (IV)-related AIDS and drug abuse, as
authorized under sections 301 and 405 of the Act (42 U.S.C. 241, 284);
(9) 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));
(10) Injury prevention and control research, as authorized by
section 391 of the Act (42 U.S.C. 280b);
(11) Research on osteoporosis, paget's disease and related bone
disorders, as authorized by section 409A of the Act (42 U.S.C. 284e).
(12) 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);
(13) Research relating to medical rehabilitation, as authorized by
section 452 of the Act (42 U.S.C. 285g-4);
(14) 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);
(15) 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);
(16) 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);
(17) Health services research activities with respect to the
prevention of alcohol abuse and treatment of alcoholism, as authorized
by section 464H of the Act (42 U.S.C. 285n) and defined in section 409
of the Act (42 U.S.C. 284d);
(18) Research under the Medication Development Program to encourage
and promote the development and use of medications to treat drug
addiction; and to collect, analyze, and disseminate data, as authorized
by section 464P of the Act (42 U.S.C. 285o-4);
(19) 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);
(20) 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);
(21) 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);
(22) Research relating to the evaluation of drug treatments for
AIDS not approved by the Commissioner of Food and Drugs, as authorized
by section 2314 of the Act (42 U.S.C. 300cc-14);
(23) 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);
(24) Long-term research into treatments for AIDS, as authorized by
section 2320 of the Act (42 U.S.C. 300cc-20);
(25) Research relating to AIDS conducted outside the United States
by qualified foreign professionals and collaborative research involving
American and foreign participants, as authorized in section 2354 of the
Act (42 U.S.C. 300cc-41);
(26) 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);
(27) 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);
(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) Support for radiation studies and research, as authorized
under section 301 of the Act (42 U.S.C. 241) and by section 20(a) of
the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a));
(30) 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 (30 U.S.C. 951); and
(31) 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 under 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).
A more detailed listing of the programs implemented by this rule,
as listed in the Catalog of Federal Domestic Assistance, appears at the
end of this preamble.
In addition to the actions noted above, NIH is limiting 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.
[[Page 55104]]
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.
The regulations are amended by making minor changes required by new
statutory authority, simplifying the language in Secs. 52.2-52.4 and
52.6, updating PHS Act section numbers referenced in part 52 as
necessitated by enactment of legislation, and updating the listing of
HHS policies and regulations in Sec. 52.8. The NIH announced its plans
to make these changes in the notice of proposed rulemaking (NPRM) that
it published in the Federal Register of August 2, 1994 (59 FR 39312).
The NIH received no comments concerning the NPRM. Thus, no substantive
changes were made to the proposed regulations. However, language was
added to the preamble and Sec. 52.1(a) to explicitly indicate that part
52 does not apply to grants for health services research,
demonstration, and evaluation projects administered by the AHCPR.
The following statements are provided for the information of the
public.
The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and to promote the nonuse of all tobacco products,
and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Executive Order 12866
Executive Order 12866 requires that all regulatory actions reflect
consideration of the costs and benefits they generate, and that they
meet certain standards, such as avoiding the imposition of unnecessary
burdens on the affected public. If a regulatory action is deemed to
fall within the scope of the definition of the term ``significant
regulatory action'' contained in section 3(f) of the Order, pre-
publication review by the Office of the Management and Budget's Office
of Information and Regulatory Affairs (OIRA) is necessary. This rule
was reviewed under Executive Order 12866 by OIRA and was determined to
be not significant.
Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6)
requires that regulatory actions be analyzed to determine whether they
create a significant impact on a substantial number of small entities.
Because of the nonsubstantive nature of the amendments in this rule,
the Secretary certifies that this rule 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, is not required.
Paperwork Reduction Act
This rule does not contain information collection requirements
subject to review and approval by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (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: July 25, 1996.
Harold Varmus,
Director, NIH.
For reasons set out in the preamble, part 52 of title 42 of the
Code of Federal Regulations is amended as set forth below.
PART 52--GRANTS FOR RESEARCH PROJECTS
1. The authority citation for part 52 is revised to read as
follows:
[[Page 55105]]
Authority: 42 U.S.C. 216.
2. Section 52.1 is revised to read as follows:
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 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.
3. Section 52.2 is 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.).
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 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 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.
4. Section 52.3 is 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;
(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, 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.
5. Section 52.4 is 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.
6. Section 52.6 is amended as follows:
In paragraph (a) the first sentence is revised to read as set forth
below; paragraphs (b), (c), (d) and (e) are redesignated (c), (d), (e)
and (f), respectively; new paragraph (b) is added; and newly designated
paragraphs (c)(2) and (d) are revised to read as follows:
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. * *
*
(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 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) * * *
(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
[[Page 55106]]
with one or more specified aspects of the project.
* * * * *
7. Section 52.8 is 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
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 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
or 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
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.]
8. The heading of Sec. 52.9 is revised to read as follows:
Sec. 52.9 Additional conditions.
[FR Doc. 96-26976 Filed 10-23-96; 8:45 am]
BILLING CODE 4140-01-M