Grants for Research Projects

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