[Federal Register Volume 60, Number 33 (Friday, February 17, 1995)]
[Proposed Rules]
[Pages 9560-9562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3926]
[[Page 9559]]
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Part VIII
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
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42 CFR Part 52a
National Institutes of Health Center Grants; Proposed Rule
Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 /
Proposed Rules
[[Page 9560]]
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).
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. 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. 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.
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
[[Page 9561]] 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:
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?
(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. 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;
(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;
(8) For purposes of grants authorized by section 447 of the Act, a
single institution or consortium of cooperating institutions which
conducts basic and [[Page 9562]] 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
(13) For purposes of grants authorized in section 2316 of the Act,
an entity for basic and clinical research into, and training in,
advanced diagnostic, prevention, and treatment methods for acquired
immunodeficiency syndrome.
As provided in the section of the Act authorizing the particular
program or on the determination of the Director, a center may include
the facilities of a single institution or a consortium of cooperating
institutions and, if practical, may be part of an equitable
geographical distribution of centers with proven research capabilities.
Director means the Director of NIH or the organizational component
authorized to award grants to support centers under this part.
* * * * *
5. Section 52a.3 would be amended by revising paragraphs (a) and
(b) to read as follows:
Sec. 52a.3 Who is eligible to apply?
(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
