[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Rules and Regulations]
[Pages 55106-55110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26972]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 52a and 54a
RIN 0905-AE00
National Institutes of Health Center Grants
AGENCY: Public Health Service, Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: The National Institutes of Health (NIH) is amending its center
grants regulations in order to incorporate changes necessitated by
enactment of the ADAMHA Reorganization Act and the National Institutes
of Health Revitalization Act of 1993, and is merging the regulations
governing its grants for national alcohol research centers with its
center grant regulations in accordance with the goals of the
President's Regulatory Reinvention Initiative.
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 1B25, 31 Center Dr., MSC 2075, Bethesda, MD
20892-2075, telephone (301) 496-4606 (not a toll-free number). For
program information contact the Office of Extramural Research, National
Institutes of Health, Shannon Building, Room 144, One Center Dr., MSC
0152, Bethesda, MD 20892-0152, telephone (301) 496-1096 (not a toll-
free number).
SUPPLEMENTARY INFORMATION: On July 10, 1992, the Alcohol, Drug Abuse,
and Mental Health Administration (ADAMHA) Reorganization Act, Public
Law 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 122 of that Act transferred Public Health Service
(PHS) Act section 511, ``National Alcohol Research Center,'' to title
IV, part C, subpart 14 of the Act, and redesignated the section as PHS
Act section 464J. Under section 464J, the Secretary, acting through
NIAAA, may designate National Alcohol Research Centers for the purpose
of interdisciplinary research relating to alcoholism and other
biomedical, behavioral and social issues related to alcoholism and
alcohol abuse, and shall make annual grants to the Centers, including a
grant to a designated Center for research on the effects of alcohol on
the elderly.
Additionally, 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
[[Page 55107]]
Director of NIDA is authorized to make annual grants to these Centers.
Subsequently, the National Institutes of Health Revitalization Act
of 1993, Public Law 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 Public Law 103-43, authorizes centers for breast
cancer research; section 417A of the PHS Act, as added by section 402
of Public Law 103-43, authorizes prostate cancer research and
demonstration centers; section 422 of the PHS Act, as amended by
section 502 of Public Law 103-43, authorizes centers for the study of
pediatric cardiovascular diseases; section 431 of the PHS Act, as
amended by section 601 of Public Law 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 Public
Law 103-43, authorizes research centers regarding chronic fatigue
syndrome; section 452A of the PHS Act, as added by section 1001 of the
Public Law 103-43, authorizes research centers with respect to
contraception and infertility; and section 452C of the PHS Act, as
added by section 1021 of Public Law 103-43, authorizes child health
research centers.
NIH published proposed amendments to its center grant regulations
codified at 42 CFR part 52a, in a notice of proposed rule making (NPRM)
published in the Federal Register February 17, 1995 (60 FR 9560). NIH
also published another NPRM in the Federal Register August 19, 1994 (59
FR 42793), in which it published proposed amendments to the regulations
codified at 42 CFR part 54a governing grants for national alcohol
research centers in order to set forth changes necessitated by
enactment of the ADAMHA Reorganization Act.
Subsequently, in March 1995, the President announced the
Administration's plan for reform of the Federal regulatory system. In
accordance with the goals of the President's Regulatory Reform
Initiative, part of the President's Reinventing Government effort, NIH
decided to merge the regulations governing grants for national alcohol
research centers with the center grants regulations, thereby creating a
single uniform set of rules governing all of its center grant programs
set forth in title IV of the PHS Act.
Accordingly, the authority citation of part 52a is revised to
include the U. S. Code citations for the new center grant authorities
set forth in PHS Act sections 417, 417A, 422, 431, 447, 452A, 452C, and
464N, and for the authority pertaining to grants for national alcohol
research centers set forth in PHS Act section 464J. Part 54a, entitled,
``Grants For Alcohol Abuse And Alcoholism Prevention, Treatment, And
Rehabilitation Services And National Alcohol Research Centers,'' is
removed from the Code of Federal Regulations.
Section 52a.1 is amended by adding language reflecting the
applicability of part 52a to these new center grant programs and the
grants for national alcohol research centers program, and is
restructured for improved clarity into three separate paragraphs.
Language is added in the first paragraph to clarify that center grants
awarded under sections 441, 464C, and 2316 of the PHS Act include
payments for alteration, remodeling, improvement, expansion, and repair
of existing buildings, and the provision of equipment necessary to make
them suitable for use as a center.
Section 52a.2 is amended by adding definitions of the terms
``Director'', ``Grant(s)'', and ``Project period'', and revising the
definition of the term ``Center'' to include each new type of center
and the national alcohol research centers.
Section 52a.3 is amended by adding references to PHS Act sections
417, 417A, 431, 447, 452A, 452C, and 464J in paragraph (a) and adding a
reference to PHS Act section 464N in paragraph (b).
Section 52a.7 is amended to correct the reference to 45 CFR part
74.
In section 52a.8, the references to 45 CFR part 74, the guidelines
for research involving recombinant DNA and the PHS policy on the care
and use of laboratory animals are amended to reflect Federal Register
format requirements, and references to the regulations to ensure
objectivity in PHS-funded research at 42 CFR part 50, subpart F, and
the NIH Guidelines on the Inclusion of Women and Minorities as Human
Subjects in Clinical Research are added. The title of Sec. 52a.8 is
amended to reflect that policies, as well as regulations, are
referenced.
Finally, the Department 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.
Pursuant to section 553 of the Administrative Procedure Act (5
U.S.C. 553), we have concluded that the publication of another NPRM is
unnecessary because the changes to merge the national alcohol research
centers regulations with the center grants regulations are technical in
nature and do not require any substantive changes in the center grants
regulations or the national alcohol research centers regulations, as
they were proposed. Only one comment was received concerning the
previously published NPRMs. That comment indicated support for the
proposed changes to the center grant regulations. No comments were
received concerning the proposed changes to the national alcohol
research centers regulations.
The following statements are provided as information for the
public.
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 Management and Budget's Office of
Information and Regulatory Affairs (OIRA) is necessary. This rule was
reviewed under Executive Order 12866 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.
I certify that this final rule does 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 final rule does not contain information collection
requirements which are subject to Office of Management and Budget
approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter
35).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbered programs
affected by this final rule are:
93.173 Multipurpose Deafness and Other Communication Disorders Centers
93.279 Drug Abuse Research Programs
93.397 Cancer Centers Support
[[Page 55108]]
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
42 CFR Part 52a
Grant programs--health; Medical research.
42 CFR Part 54a
Alcohol abuse, Grant programs--health, Medical research.
Dated: July 16, 1996.
Harold Varmus,
Director, NIH.
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.
1. Under the authority of 42 U.S.C. 216, part 54a is removed.
PART 52a--NATIONAL INSTITUTES OF HEALTH CENTER GRANTS
1a. The authority citation of part 52a is revised to read as
follows:
Authority: 42 U.S.C. 216, 285a-3, 285a-6(c)(1)(E), 285a-
7(c)(1)(G), 285b-4, 285c-5, 285d-6, 285e-2, 285e-3, 285f-1, 285g-5,
285g-7, 285m-3, 285n-2, 285o-2, 300cc-16.
2. Section 52a.1 is revised 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, strengthening or 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, but not including the acquisition of land),
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, but not including the acquisition of land), as authorized
by section 422 of the Act; research and training centers in diabetes
mellitus and related endocrine and metabolic diseases (including
digestive, kidney, and urologic diseases), and research and training
centers regarding nutritional disorders, including obesity, as
authorized by section 431 of the Act; multipurpose arthritis and
musculoskeletal diseases centers (including payments for alteration,
remodeling, improvement, expansion, and repair of existing buildings,
and the provision of equipment necessary to make them suitable for use
as a center, 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 of the Act;
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 (including payments for
alteration, remodeling, improvement, expansion, and repair of existing
buildings, and the provision of equipment necessary to make them
suitable for use as a center, but not construction), as authorized by
section 464C of the Act; national alcohol research centers, as
authorized by section 464J of the Act; national drug abuse research
centers, as authorized by section 464N of the Act; and centers for
acquired immunodeficiency syndrome research (including payments for
renovation and leasing of existing buildings, and the provision of
equipment necessary to make them suitable for use as a center, but not
construction), as authorized by section 2316 of the Act.
(b) This part does not apply to:
(1) Grants for construction (see 42 CFR part 52b), except as noted
in paragraph (a) of this section;
(2) Grants covered by 42 CFR part 52 (grants for research
projects); or
(3) Grants for general research support under section 301(a)(3) of
the Act (42 U.S.C. 241(a)(3)).
(c) This part also applies to cooperative agreements made to
support the centers specified in paragraph (a) of this section. When a
reference is made in this part to ``grants,'' the reference shall
include ``cooperative agreements.''
3. Section 52a.2 is amended by revising the definition of
``Center'' and adding definitions of the terms ``Director'',
``Grant(s)'', and ``Project period'' 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;
kidney and urologic diseases; or nutritional disorders, including
obesity;
(6) For purposes of grants authorized by section 441 of the Act, a
single institution or a consortium of
[[Page 55109]]
cooperating institutions which conducts basic and clinical research
into arthritis and musculoskeletal diseases and orthopedic procedures,
and provides training and information programs for health professionals
and the general public;
(7) For purposes of grants authorized by section 445 of the Act, an
entity (including a university medical center) which conducts basic and
clinical research (including multidisciplinary research) into, training
in, and demonstration of advanced diagnostic, prevention, and treatment
methods for Alzheimer's disease;
(8) For purposes of grants authorized by section 445A of the Act,
an entity which conducts research into the aging processes and into the
diagnosis and treatment of diseases, disorders, and complications
related to aging, including menopause, which includes research on the
treatments, and on medical devices and other medical interventions
regarding these diseases, disorders, and complications that can assist
individuals in avoiding institutionalization and prolonged
hospitalization and in otherwise increasing the independence of the
individuals;
(9) 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;
(10) 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;
(11) 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;
(12) 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 health professionals 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;
(13) For purposes of grants authorized by section 464J of the Act,
an entity engaged in long-term interdisciplinary research relating to
alcoholism and other alcohol problems;
(14) For purposes of grants authorized by section 464N of the Act,
an entity for interdisciplinary research relating to drug abuse and
other biomedical, behavioral, and social issues related to drug abuse;
or
(15) For purposes of grants authorized by 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.
(16) 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.
Grant(s) means, unless the context otherwise requires, an award of
funds to support a center authorized under Sec. 52a.1. The term
includes cooperative agreement(s).
* * * * *
Project period means the period of time, from one to five years,
specified in the notice of grant award that the NIH or the awarding
component intends to support a proposed center without requiring the
center to recompete for funds.
* * * * *
4. Section 52a.3 is 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
414, 417, 417A, 422, 445, 445A, 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 431, 441, 452C, 464C, 464J, and 464N of the Act.
(c) * * *
5. Section 52a.7 is revised to read as follows:
Sec. 52a.7 For what purposes may a grantee spend grant funds?
A grantee shall spend funds it receives under this part solely in
accordance with the approved application and budget, the authorizing
legislation, the regulations of this part, the terms and conditions of
the award, and the applicable cost principles prescribed in 45 CFR
74.27.
6. Section 52a.8 is amended by revising the heading; revising the
reference to 45 CFR part 74; adding references to 42 CFR part 50,
subpart F; adding an entry for ``59 FR 14508'' immediately following
the entry ``45 CFR part 93''; removing the entry ``51 FR 16958 or
successor'' and inserting in its place an entry ``59 FR 34496''; and
revising the reference to Public Health Service Policy on Humane Care
and Use of Laboratory Animals to read as follows:
Sec. 52a.8 Other HHS regulations and policies that apply.
* * * * *
42 CFR part 50, subpart F--Responsibility of applicants for
promoting objectivity in research for which PHS funding is sought
* * * * *
45 CFR part 74--Uniform administrative requirements for awards and
subawards to institutions of higher education, hospitals, other
nonprofit organizations, and commercial organizations; and certain
grants and agreements with states, local governments and Indian tribal
governments
* * * * *
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 change, and interested persons should contact the
Office of Research on Women's Health, NIH, Room 201, MSC 0161,
BETHESDA, MD 20892-0601 (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 change, and
interested persons should contact the Office of Recombinant DNA
Activities, NIH, Suite 323, 6000 Executive Boulevard, MSA 7010,
BETHESDA, MD 20892-7010 (301-496-9838; 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 change, and
interested persons should contact the Office for Protection from
Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507,
Bethesda, MD 20892-7507 (301-496-
[[Page 55110]]
7005; not a toll-free number) to obtain references to the current
version and any amendments.]
7. Section 52a.9 is 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. 96-26972 Filed 10-23-96; 8:45 am]
BILLING CODE 4140-01-P
