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: Notice of proposed rulemaking.

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

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