[Federal Register: November 12, 2002 (Volume 67, Number 218)]
[Proposed Rules]
[Page 68548-68551]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no02-24]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 52a
RIN 0925-AA24
National Institutes of Health Center Grants
AGENCY: National Institutes of Health, Department of Health and Human
Services.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The National Institutes of Health (NIH) is proposing to amend
its regulations governing center grants to reflect their applicability
to several new grant programs including, research on autism,
Alzheimer's disease research, fragile X disease research, and minority
health disparities research and other health disparities research.
DATES: Comments must be received on or before January 13, 2003, in
order to ensure that NIH will be able to consider the comments in
preparing the final rule.
ADDRESSES: Comments should be sent to Jerry Moore, NIH Regulations
Officer, Office of Management Assessment, NIH, 6011 Executive
Boulevard, Room 601, MSC 7669, Rockville, MD 20892, Comments may also
be sent electronically by FAX (301-402-0169) or email jm40z@nih.gov.
FOR FURTHER INFORMATION CONTACT: Jerry Moore at the address above or
telephone (301-496-4607, not a toll-free number).
SUPPLEMENTARY INFORMATION: On October 17, 2000, the United States
Congress enacted the Children's Health Act of 2000 (Pub. L. 106-310).
Section 101 of Public Law 106-310 amended the PHS Act by adding a new
section 409C (42 U.S.C. 284g) concerning research on autism. Section
409C authorizes the Director of the National Institutes of Health,
through the Director of the National Institute of Mental Health, to
make awards of grants and contracts to public or nonprofit private
entities to pay all or part of the costs of planning, establishing,
improving, and providing basic operating support for centers of
excellence regarding research on autism.
On November 13, 2002, the United States Congress enacted the Public
Health Improvement Act (Pub. L. 106-505). Section 801 of Public Law
106-505 amended the PHS Act by adding a new section 445I (42 U.S.C.
285e-10a) concerning Alzheimer's clinical research and training awards.
More specifically, section 445I authorizes the Director of the National
Institute on Aging to establish and maintain a program to enhance and
promote the translation of new scientific knowledge into clinical
practice related to the diagnosis, care and treatment of individuals
with Alzheimer's disease. Amounts made available under the program must
be directed to the support of promising clinicians through awards for
research, study, and practice at centers of excellence in Alzheimer's
disease research and treatment in environments of demonstrated
excellence in neuroscience, neurobiology, geriatric medicine, and
psychiatry.
Additionally, section 201 of Public Law 106-310 amended the PHS Act
by adding a new section 452E (42 U.S.C. 285g-9) concerning research on
the disease known as fragile X. Section 201 authorizes the Director of
the National Institute of Child Health and Human Development to make
grants or enter into contracts for the development and operation of
centers to conduct research for the purposes of improving the diagnosis
and treatment of, and finding the cure for, fragile X.
On November 22, 2000, the United States Congress enacted the
Minority Health and Health Disparities Research and Education Act of
2000 (Pub. L. 106-525). Section 102 of Public Law 106-525 amended the
PHS Act by adding a new section 485F (42 U.S.C. 287c-32) concerning
centers for minority health and health disparities related-research,
education and training. Section 485F authorizes the Director of the
National Center on Minority Health and Health Disparities to make
awards of grants or contracts to designated biomedical and behavioral
research institutions or consortia for the purpose of assisting the
institutions in supporting programs of excellence in biomedical and
behavioral research training for individuals who are members of
minority health disparity populations or other health disparity
populations. The grants must be expended to train members of minority
health disparity populations or other health disparity populations as
professionals in the area of biomedical or behavioral research or both;
or to expand, remodel, renovate, or alter existing research facilities
or construct new research facilities for the purpose of conducting
minority health disparities research and other health disparities
research.
We propose to amend Sec. 52a.1, Sec. 52a.2, and Sec. 52a.3 of
the regulations governing NIH center grants to reflect these new
authorities. Additionally, we are proposing to amend Sec. 52a.8 to
update the organizational reference for the Public Health Service
Policy on Humane Care and Use of Laboratory Animals. We provide the
following information for the public.
Executive Order 12866
Executive Order 12866, Regulatory Planning and Review, 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, review by the Office of Management and
Budget's (OMB) Office of Information and Regulatory Affairs (OIRA)
prior to publication is necessary. The OIRA reviewed this proposed rule
under Executive Order 12866 and deemed it not significant.
[[Page 68549]]
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that
regulatory proposals be analyzed to determine whether they create a
significant impact on a substantial number of small entities. The
Secretary certifies that any final rule resulting from this proposal
will not have any such impact.
Executive Order 13132
Executive Order 13132, Federalism, requires that Federal agencies
consult with State and local government officials in the development of
regulatory policies with federalism implications. The NIH Director
reviewed the proposed rule as required under the Order and determined
that it does not have any federalism implications. The Secretary
certifies that the proposed rule will not have an effect on the States
or on the distribution of power and responsibilities among various
levels of government.
Paperwork Reduction Act
This proposed rule does not contain any information collection
requirements that are subject to OMB approval under the Paperwork
Reduction Act of 1995 (44 U.S.C. chapter 35).
Catalogue of Federal Domestic Assistance
The Catalogue of Federal Domestic Assistance (CFDA) numbered
programs affected by this proposed rule are:
93.173 Multipurpose Deafness and Other Communication Disorders
Centers
93.242 Mental Health Research Grants
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
93.981 Alcohol Research Center Grants
List of Subjects in 42 CFR Part 52a
Grant programs--health; Medical research.
Dated: August 12, 2002.
Elias A. Zerhouni,
Director, National Institutes of Health.
Approved: October 30, 2002.
Tommy G. Thompson,
Secretary.
For the reasons set forth in the preamble, subchapter D, chapter I
of title 42 of the Code of Federal Regulations is amended 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, 284g, 285a-6(c)(1)(E), 285a-
7(c)(1)(G), 285b-4, 285c-5, 285c-8, 285d-6, 285e-2, 285e-3, 285e-
10a, 285f-1, 285g-5, 285g-7, 285g-9, 285m-3, 285o-2, 286a-
7(c)(1)(G), 287c-32(c), 300cc-16.
2. Section 52a.1 would be amended by revising paragraph (a) 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 an/or multipurpose centers in health fields described in
this paragraph. Specifically, these regulations apply to:
(1) National Institute of Mental Health centers of excellence with
respect to research on autism, as authorized by section 409C of the Act
(42 U.S.C. 284g);
(2) National cancer research and demonstration centers (including
payments for construction, as authorized by section 414 of the Act (42
U.S.C. 285a-3);
(3) National cancer research and demonstration centers with respect
to breast cancer, as authorized by section 417 of the Act (42 U.S.C.
285a-6);
(4) National cancer and demonstration centers with respect to
prostate cancer, as authorized by section 417A of the Act (42 U.S.C.
285a-7);
(5) 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 422 of the Act (42 U.S.C. 485b-4);
(6) Research and training centers (including diabetes mellitus, and
digestive, endocrine, metabolic, kidney and urologic diseases), as
authorized by section 431 of the Act (42 U.S.C. 285c-5);
(7) Research and training centers regarding nutritional disorders,
as authorized by section 434 of the Act (42 U.S.C. 285c-8);
(8) Multipurpose arthritis and musculoskeletal diseases centers
(including payments for alteration, but not construction), as
authorized by section 441 of the Act (42 U.S.C. 285d-6);
(9) Alzheimer's disease centers, as authorized by section 445 of
the Act (42 U.S.C. 285e-2);
(10) Claude D. Peppers Older Americans Independence Centers, as
authorized by section 445A of the Act (42 U.S.C. 285e-3);
(11) Centers of excellence in Alzheimer's disease research and
treatment, as authorized by section 445I of the Act (42 U.S.C. 285e-
10a);
(12) Research centers regarding chronic fatigue syndrome, as
authorized by section 447 of the Act (42 U.S.C. 285f-1);
(13) Research centers with respect to contraception and
infertility, as authorized by section 452A of the Act (42 U.S.C. 285g-
5);
(14) Child health research centers, as authorized by section 452C
of the Act (42 U.S.C. 285g-7);
(15) Fragile X research centers, as authorized by 452E of the Act
(42 U.S.C. 285g-9);
(16) Multipurpose deafness and other communication disorders
centers, as authorized by section 464C of the Act (42 U.S.C. 285m-3);
(17) National drug abuse research centers, as authorized by section
464N of the Act (42 U.S.C. 285o-2);
(18) Centers of excellence in biomedical and behavioral research
training for individuals who are members of minority health disparity
populations or other health disparity populations, as authorized by
section 485F of the Act (42 U.S.C. 287c-32); and
(19) Centers for acquired immunodeficiency syndrome research, as
authorized by section 2316 of the Act (42 U.S.C. 300cc-16).
* * * * *
3. Section 52a.2 would be amended by revising the definition of
Center to read as follows:
Sec. 52a.2 Definitions.
As used in this part:
* * * * *
Center means:
(a) For purposes of grants authorized by section 409C of the Act, a
public or nonprofit private entity which provides for planning and
conducting basic and clinical research into the cause, diagnosis, early
detection, prevention,
[[Page 68550]]
control, and treatment of autism, including the fields of developmental
neurobiology, genetics, and psychopharmacology;
(b) 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;
(c) For purposes of grants authorized by section 417 of the Act, an
agency or institution which provides for planning and conducting basic,
clinical, epidemiological, psychological, prevention and treatment
research and related activities on breast cancer;
(d) For purposes of grants authorized by section 417A of the Act,
an agency or institution which provides for planning and conducting
basic, clinical, and epidemiological, psychosocial, prevention and
control, treatment, research, and related activities on prostate
cancer;
(e) 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;
(f) 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;
(g) 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;
(h) 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 musculosketal diseases; orthopedic procedures,
training, and information programs for the health community and the
general public;
(i) For purposes of grants authorized by section 445 of the Act, a
public or private nonprofit entity (including university medical
centers) which conduct basic and clinical research (including
multidisciplinary research) into, training in, and demonstration of
advanced diagnostic, prevention, and treatment methods for Alzheimer's
disease;
(j) For purposes of grants authorized by section 445A of the Act, a
single public or private nonprofit institution or entity or a
consortium of cooperating institutions or entities which conduct
research into the aging processes and into the diagnosis and treatment
of diseases, disorders, and complications related to aging, including
menopause, which research includes research on such treatments, and on
medical devices and other medical interventions regarding such
diseases, disorders, and complications, that can assist individuals in
avoiding institutionalization and prolonged hospitalization and in
otherwise increasing the independence of the individuals.
(k) For the purposes of section 445I of the Act, a single
institution or consortium of cooperating institutions which conducts
basic and clinical research on Alzheimer's disease.
(l) 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;
(m) 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;
(n) 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;
(o) For purposes of grants authorized by section 452E of the Act, a
single institution or a consortium of cooperating institutions which
conducts research for the purposes of improving the diagnosis and
treatment of, and finding the cure for, fragile X;
(p) 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;
(q) 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,
behavioral, and social issues related to drug abuse;
(r) For purposes of grants authorized by section 485F of the Act, a
biomedical or behavioral research institution or consortia that:
(1) has a significant number of members of minority health
disparity populations or other health disparity populations enrolled as
students in the institution (including individuals accepted for
enrollment in the institution);
(2) has been effective in assisting such students of the
institution to complete the program of education or training and
receive the degree involved;
(3) has made significant efforts to recruit minority students to
enroll in and graduate from the institution, which may include
providing means-tested scholarships and other financial assistance as
appropriate; and
(4) has made significant recruitment efforts to increase the number
of minority or other members of health disparity populations serving in
faculty or administrative positions at the institution; or
(s) For the 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.
4. 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 nonprofit agency, institution, or
consortium of agencies is eligible to apply for a grant under sections
409C, 414, 417, 417A, 422, 445, 445A, 445I, 447, 452A, and 2316 of the
Act.
(b) Any public or private nonprofit or for-profit agency,
institution, or consortium of agencies is eligible to apply for a grant
under sections 428, 431, 434, 441, 452C, 452E, 464C, 464J, 464N, and
485F of the Act.
(c) * * *
5. Section 52a.8 would be amended by revising the last entry and
the Note to read as follows:
Sec. 52a.8 Other HHS regulations and policies that apply.
* * * * *
[[Page 68551]]
Public Health Service Policy on Humane Care and Use of Laboratory
Animals, Office of Laboratory Animal Welfare, Office for Extramural
Research, NIH (revised September 1986).
Note: This policy is subject to change, and interested persons
should contact the Office of Laboratory Animal Welfare, Office for
Extramural Research, NIH, Rockledge 1, 6705 Rockledge Drive, Bethesda,
Maryland 20817, telephone 301-594-2382 (not a toll-free number) to
obtain references to the current version and any amendments.)
[FR Doc. 02-28292 Filed 11-8-02; 8:45 am]
BILLING CODE 4140-01-P