National Institutes of Health Center Grants

Part VIII

Department of Health and Human Services

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Public Health Service

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42 CFR Part 52a

National Institutes of Health Center Grants; Proposed Rule

Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 52a

RIN 0905-AE00

National Institutes of Health Center Grants

AGENCY: Public Health Service, Department of Health and Human Services.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to amend its

center grant regulations in order to incorporate changes necessitated

by enactment of the ADAMHA Reorganization Act and the National

Institutes of Health Revitalization Act of 1993.

DATES: Comments must be received on or before April 18, 1995. The final

rule would become effective 30 days following its publication in the

Federal Register.

ADDRESSES: Comments should be sent to Mr. Jerry Moore, NIH Regulatory

Affairs Officer, National Institutes of Health, Building 31, Room 1B25,

31 DR MSC 2075, 9000 Rockville Pike, Bethesda, Maryland 20892-2340.

FOR FURTHER INFORMATION CONTACT: Mr. Jerry Moore, at the address above,

or telephone (301) 496-4606. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: On July 10, 1992, the Alcohol, Drug Abuse,

and Mental Health Administration (ADAMHA) Reorganization Act, Pub. L.

102-321, was enacted. That Act restructured the Alcohol, Drug Abuse,

and Mental Health Administration (ADAMHA) by transferring the National

Institute on Alcohol Abuse and Alcoholism (NIAAA), the National

Institute on Drug Abuse (NIDA), and the National Institute of Mental

Health (NIMH) to NIH, effective October 1, 1992, and provided for the

administration of treatment and service programs under a newly created

Substance Abuse and Mental Health Services Administration (SAMHSA)

h Administration (ADAMHA) by transferring the National

Institute on Alcohol Abuse and Alcoholism (NIAAA), the National

Institute on Drug Abuse (NIDA), and the National Institute of Mental

Health (NIMH) to NIH, effective October 1, 1992, and provided for the

administration of treatment and service programs under a newly created

Substance Abuse and Mental Health Services Administration (SAMHSA).

Section 123 of the ADAMHA Reorganization Act added a new section 464N

to the PHS Act which authorizes the Director of NIDA to designate

National Drug Abuse Research Centers for the purpose of

interdisciplinary research relating to drug abuse and other biomedical,

behavioral, and social issues related to drug abuse. Under section

464N, the Director of NIDA is authorized to make annual grants to these

Centers.

Subsequently, the National Institutes of Health Revitalization Act

of 1993, Pub. L. 103-43, was enacted on June 10, 1993. Provisions of

that Act authorized several new center grant programs that should be

covered by part 52a. Specifically, section 417 of the PHS Act, as added

by section 401 of Pub. L. 103-43, authorizes centers for breast cancer

research; section 417A of the PHS Act, as added by section 402 of Pub.

L. 103-43, authorizes prostate cancer research and demonstration

centers; section 422 of the PHS Act, as amended by section 502 of Pub.

L. 103-43, authorizes centers for the study of pediatric cardiovascular

diseases; section 434 of the PHS Act, as added by section 601 of Pub.

L. 103-43, authorizes centers for research and training regarding

nutritional disorders including obesity; section 447 of the PHS Act, as

added by section 902 of Pub. L. 103-43, authorizes research centers

regarding chronic fatigue syndrome; section 452A of the PHS Act, as

added by section 1001 of the Pub. L. 103-43; authorizes research

centers with respect to contraception and infertility; and section 452C

of the PHS Act, as added by section 1021 of Pub. L

nutritional disorders including obesity; section 447 of the PHS Act, as

added by section 902 of Pub. L. 103-43, authorizes research centers

regarding chronic fatigue syndrome; section 452A of the PHS Act, as

added by section 1001 of the Pub. L. 103-43; authorizes research

centers with respect to contraception and infertility; and section 452C

of the PHS Act, as added by section 1021 of Pub. L. 103-43, authorizes

child health research centers.

NIH proposes to amend center grant regulations at 42 CFR part 52a

to incorporate these new authorities. Specifically, the authority

citation would be revised to include the U. S. Code citations of the

additional center grant authorities set forth in PHS Act sections 417,

417A, 422, 434, 447, 452A, 452C, and 464N. Section 52a.1 would be

amended by adding language specifying the applicability of part 52a to

these additional center grant programs, and Sec. 52a.2 would be amended

by adding a definition for the term ``Director'' and a definition of

the term ``Center'' for each new type of center. Section 52a.3 would be

amended by adding references to PHS Act sections 417, 417A, 434, 447,

452A and 452C in paragraph (a) and adding a reference to PHS Act

section 464N in paragraph (b). The title of Sec. 52a.8 would be revised

to add the word ``policies.'' Section 52a.8 would be amended by

revising the sixteenth and seventeenth paragraphs and adding a new

paragraph referencing the NIH Guidelines on the Inclusion of Women and

Minorities as Human Subjects in Clinical Research.

Further, PHS strongly encourages all grant recipients to provide a

smoke-free workplace and to promote the nonuse of all tobacco products,

and Pub. L. 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.

The purpose of this notice is to invite public comment on these

proposed actions

e a

smoke-free workplace and to promote the nonuse of all tobacco products,

and Pub. L. 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.

The purpose of this notice is to invite public comment on these

proposed actions. The following statements are provided as information

for the public.

Regulatory Impact Statement

Executive Order 12866 of September 30, 1993, Regulatory Planning

and Review, requires us to prepare an analysis for any rule that meets

one of the E. O. 12866 criteria for a significant regulatory action;

that is that may--

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;

Create a serious inconsistency or otherwise interfere with an

action taken or planned by another agency;

Materially alter the budgetary impact of grants, user fees, or loan

programs or the rights and obligations of recipients thereof; or

Raise novel legal or policy issues arising out of legal mandates,

the President's priorities, or the principles set forth in E.O. 12866.

In addition, we generally prepare a regulatory flexibility

analysis, in accordance with the Regulatory Flexibility Act of 1980 (5

U.S.C. chapter 6), if the rule is expected to have a significant impact

on a substantial number of small entities.

For the reasons outlined below, we do not believe this rule is

economically significant, nor do we believe that it will have a

significant impact on a substantial number of small entities. In

addition, this rule is not inconsistent with the actions of any other

agency

f 1980 (5

U.S.C. chapter 6), if the rule is expected to have a significant impact

on a substantial number of small entities.

For the reasons outlined below, we do not believe this rule is

economically significant, nor do we believe that it will have a

significant impact on a substantial number of small entities. In

addition, this rule is not inconsistent with the actions of any other

agency.

This proposed rule would extend current policies and procedures

governing the award and administration of discretionary grants to

eligible institutions to support NIH center grant programs authorized

by sections 417, 417A, 422, 434, 447, 452A, 452C, and 464N of the PHS

Act. While these centers benefit those segments of the public afflicted

by the health problems addressed by the centers, and physicians and

other health professionals who receive training in those health areas,

the centers do not have a significant economic or policy impact on a

broad cross-section of the public. Furthermore, this proposed rule

would only affect those few institutions interested in obtaining

financial assistance to carry out a center's authorized programs,

subject to the normal accountability requirements for

grant funds. No entity is obligated to apply for grant

support.

For these same reasons, we certify this rule will not have a

significant economic impact on a substantial number of small entities,

and that a regulatory flexibility analysis is not required.

Paperwork Reduction Act

This NPRM does not contain information collection requirements

which are subject to Office of Management and Budget approval under the

Paper Reduction Act of 1980 (44 U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance numbered programs

affected by this proposed rule are:

latory flexibility analysis is not required.

Paperwork Reduction Act

This NPRM does not contain information collection requirements

which are subject to Office of Management and Budget approval under the

Paper Reduction Act of 1980 (44 U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance numbered programs

affected by this proposed rule are:

93.173 Multipurpose Deafness and Other Communication Disorders

Centers

93.279 Drug Abuse Research Programs

93.397 Cancer Centers Support

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 Metabolism Research

93.848 Digestive Diseases and Nutrition Research

93.849 Kidney Diseases, Urology and Hematology Research

93.855 Allergy, Immunology, and Transplantation Research

93.856 Microbiology and Infectious Diseases Research

93.864 Population Research

93.865 Research for Mothers and Children

93.866 Aging Research

List of Subjects in 42 CFR Part 52a

Grant programs--Health; Medical research.

Dated: November 15, 1994.

Philip R. Lee, M.D.,

Assistant Secretary for Health.

Approved: February 9, 1995.

Donna E. Shalala,

Secretary.

For the reasons set forth in the preamble, part 52a, subchapter D,

chapter 1 of title 42 of the Code of Federal Regulations is amended to

read as set forth below.

PART 52a--NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

1. The authority citation of part 52a would be revised to read as

follows:

Authority: 42 U.S.C. 216, 285a-3, 285a-6(c)(1)(E), 285b-4, 285c-

5, 285c-8, 285d-6, 285e-2, 285e-3, 285f-1, 285g-5, 285g-7, 285m-3,

285o-2, 286a-7(c)(1)(G), 300cc-16.

2.-3. Section 52a.1 would be amended by revising paragraph (a)

introductory text, to read as follows:

Sec. 52a.1 To which programs do these regulations apply?

uthority citation of part 52a would be revised to read as

follows:

Authority: 42 U.S.C. 216, 285a-3, 285a-6(c)(1)(E), 285b-4, 285c-

5, 285c-8, 285d-6, 285e-2, 285e-3, 285f-1, 285g-5, 285g-7, 285m-3,

285o-2, 286a-7(c)(1)(G), 300cc-16.

2.-3. Section 52a.1 would be amended by revising paragraph (a)

introductory text, to read as follows:

Sec. 52a.1 To which programs do these regulations apply?

(a) The regulations of this part apply to grants by the National

Institutes of Health and its organizational components to support the

planning, establishment, expansion, and operation of research and

demonstration and/or multipurpose centers in the health fields

described in this paragraph. Specifically, these regulations apply to

National Cancer Research and Demonstration Centers (including payments

for construction), as authorized by section 414 of the Act; National

Cancer Research and Demonstration Centers with Respect to Breast

Cancer, as authorized by section 417 of the Act; National Cancer

Research and Demonstration Centers with Respect to Prostate Cancer, as

authorized by section 417A of the Act; National Research and

Demonstration Centers for Heart, Blood Vessel, Lung, and Blood

Diseases, Sickle Cell Anemia, Blood Resources and Pediatric

Cardiovascular Diseases (including payments for construction), as

authorized by section 422 of the Act; Research and Training Centers

(including diabetes mellitus, and digestive, endocrine, metabolic,

kidney and urologic diseases), as authorized by section 431 of the Act;

Research and Training Centers Regarding Nutritional Disorders, as

authorized by section 434 of the Act; Multipurpose Arthritis and

Musculoskeletal Diseases Centers (including payments for alteration,

but not construction), as authorized by section 441 of the Act;

Alzheimer's Disease Centers, as authorized by section 445 of the Act;

Claude D

diseases), as authorized by section 431 of the Act;

Research and Training Centers Regarding Nutritional Disorders, as

authorized by section 434 of the Act; Multipurpose Arthritis and

Musculoskeletal Diseases Centers (including payments for alteration,

but not construction), as authorized by section 441 of the Act;

Alzheimer's Disease Centers, as authorized by section 445 of the Act;

Claude D. Pepper Older Americans Independence Centers, as authorized by

section 445A of the Act; Research Centers Regarding Chronic Fatigue

Syndrome, as authorized by section 447; Research Centers with Respect

to Contraception and Infertility, as authorized by section 452A of the

Act; Child Health Research Centers, as authorized by section 452C of

the Act; Multipurpose Deafness and Other Communication Disorders

Centers, as authorized by section 464C of the Act; National Drug Abuse

Research Centers, as authorized by section 464N of the Act; and Centers

for Acquired Immunodeficiency Syndrome Research, as authorized by

section 2316 of the Act.

* * * * *

4. Section 52a.2 would be amended by revising the definition of

``Center'' and adding a definition of ``Director'' to read as follows:

Sec. 52a.2 Definitions.

* * * * *

Center means:

(1) For purposes of grants authorized by section 414 of the Act, an

agency or institution which provides for planning and conducting basic

and clinical research into, training in, and demonstration of advanced

diagnostic, control, prevention and treatment methods for cancer;

(2) For purposes of grants authorized by section 417 of the Act, an

agency or institution which provides for planning and conducting basic,

clinical, epidemiological, psychosocial, prevention and treatment

research and related activities on breast cancer;

c

and clinical research into, training in, and demonstration of advanced

diagnostic, control, prevention and treatment methods for cancer;

(2) For purposes of grants authorized by section 417 of the Act, an

agency or institution which provides for planning and conducting basic,

clinical, epidemiological, psychosocial, prevention and treatment

research and related activities on breast cancer;

(3) For purposes of grants authorized by section 417A of the Act,

an agency or institution which provides for planning and conducting

basic, clinical, epidemiological, psychosocial, prevention and control,

treatment, research, and related activities on prostate cancer;

(4) For purposes of grants authorized by section 422 of the Act, an

agency or institution which provides for planning and basic and

clinical research into, training in, and demonstration of, management

of blood resources and advanced diagnostic, prevention, and treatment

methods (including emergency services) for heart, blood vessel, lung,

or blood diseases including sickle cell anemia;

(5) For purposes of grants authorized by section 431 of the Act, a

single institution or a consortium of cooperating institutions, which

conducts research, training, information programs, epidemiological

studies, data collection activities and development of model programs

in diabetes mellitus and related endocrine and metabolic diseases;

(6) For purposes of grants authorized by section 434 of the Act, a

single institution or a consortium of cooperating institutions, which

conducts basic and clinical research, training, and information

programs in nutritional disorders, including obesity;

(7) For purposes of grants authorized by section 441 of the Act, a

facility which conducts basic and clinical research as well as research

into arthritis and musculoskeletal diseases, orthopedic procedures,

training, and information programs for the health community and the

general public;

and clinical research, training, and information

programs in nutritional disorders, including obesity;

(7) For purposes of grants authorized by section 441 of the Act, a

facility which conducts basic and clinical research as well as research

into arthritis and musculoskeletal diseases, orthopedic procedures,

training, and information programs for the health community and the

general public;

(8) For purposes of grants authorized by section 447 of the Act, a

single institution or consortium of cooperating institutions which

conducts basic and clinical research on chronic fatigue

syndrome;

(9) For purposes of grants authorized by section 452A of the Act, a

single institution or consortium of cooperating institutions which

conducts clinical and other applied research, training programs,

continuing education programs, and information programs with respect to

methods of contraception and infertility;

(10) For purposes of grants authorized by section 452C of the Act,

an agency or institution which conducts research with respect to child

health, and gives priority to the expeditious transfer of advances from

basic science to clinical applications and improving the care of

infants and children;

(11) For purposes of grants authorized by section 464C of the Act,

a single institution or a consortium of cooperating institutions which

conducts basic and clinical research into, training in, information and

continuing education programs for the health community and the general

public about, and demonstration of, advanced diagnostic, prevention,

and treatment methods for disorders of hearing and other communication

processes and complications resulting from these disorders;

(12) For purposes of grants authorized by section 464N of the Act,

institutions designated as National Drug Abuse Research Centers for

interdisciplinary research relating to drug abuse and other biomedical,

behaviorial, and social issues related to drug abuse; or

y?

(a) Any public or private non-profit agency, institution, or

consortium of agencies is eligible to apply for a grant under sections

414, 417, 417A, 422, 434, 441, 445, 445A, 447, 452A, 452C, and 2316 of

the Act.

(b) Any public or private non-profit or for-profit agency,

institution, or consortium of agencies is eligible to apply for a grant

under sections 431, 464C, and 464N of the Act.

(c) * * *

6. Section 52a.8 would be amended by revising the heading, adding a

new paragraph referencing the NIH Guidelines on the Inclusion of Women

and Minorities as Subjects in Clinical Research, and revising the

sixteenth and seventeenth paragraphs, to read as follows:

Sec. 52a.8 Other HHS regulations and policies that apply.

* * * * *

51 FR 16958 (May 7, 1986)--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).

59 FR 14508 (as republished March 28, 1994)--NIH Guidelines on the

Inclusion of Women and Minorities as Subjects in Clinical Research .

7. Section 52a.9 would be revised to read as follows:

Sec. 52a.9 Additional conditions.

The Director may, with respect to any grant award, impose

additional conditions prior to or at the time of any award when in the

Director's judgment the conditions are necessary to assure the carrying

out of the purposes of the award, the interests of the public health,

or the conservation of grant funds.

[FR Doc. 95-3926 Filed 2-16-95; 8:45 am]

BILLING CODE 4140-01-P