[Federal Register Volume 68, Number 240 (Monday, December 15, 2003)]
[Rules and Regulations]
[Pages 69619-69622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30757]


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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: Final rule.

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SUMMARY: The National Institutes of Health (NIH) is amending its 
regulations

[[Page 69620]]

governing center grants to reflect their applicability to several new 
grant programs, including research on autism, Alzheimer's disease, 
fragile X disease, and minority health disparities and other types of 
health disparities.

EFFECTIVE DATE: This final rule is effective 30 days from the date of 
publication.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
NIH, Office of Management Assessment, 6011 Executive Boulevard, Room 
601, MSC 7669, Rockville MD, 20892, by e-mail ([email protected]), by fax 
301-402-0169, or by 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 (Public Law 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 (Public Law 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 452E 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 (Public Law 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 are amending 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 amending Sec.  52a.8 to update the 
organizational reference for the Public Health Service Policy on Humane 
Care and Use of Laboratory Animals.
    We announced our plans to amend the current regulations in a notice 
of proposed rulemaking (NPRM) published in the Federal Register, 
November 12, 2002 (67 FR 68548-68551). The NPRM provided for a sixty-
day comment period. We received no comments. Consequently, except for 
various editorial changes, the final rule is the same as the proposed 
rule published in November 2002.
    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 rule under 
Executive Order 12866 and deemed it not significant.

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 this rule 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 this rule as required under the Order and determined that it 
does not have any federalism implications. The Secretary certifies that 
the 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 rule does not contain any information collection requirements 
that are subject to OMB approval under the Paperwork Reduction Act of 
1995, as amended (44 U.S.C. chapter 35).

Catalogue of Federal Domestic Assistance

    The Catalogue of Federal Domestic Assistance (CFDA) numbered 
programs affected by this 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

[[Page 69621]]

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.

    Dated: May 9, 2003.
Elias A. Zerhouni,
Director, National Institutes of Health.
    Approved: September 16, 2003.
Tommy G. Thompson,
Secretary.

0
For the reasons set forth in the preamble, subchapter D, chapter 1 of 
title 42 of the Code of Federal Regulations is amended as set forth 
below.

PART 52a--NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

0
1. The authority citation of part 52a is 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.


0
2. Section 52a.1 is 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 and/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 section 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 (AIDS) 
research, as authorized by section 2316 of the Act (42 U.S.C. 300cc-
16).
* * * * *
    3. Section 52a.2 is 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, 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

[[Page 69622]]

research into arthritis and musculosketal diseases; and 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 conducts 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 conducts 
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) Have 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) Have been effective in assisting such students of the 
institution to complete the program of education or training and 
receive the degree involved;
    (3) Have 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) Have 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 (AIDS).

0
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 
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.
* * * * *

0
5. Section 52a.8 is amended by revising unnumbered paragraphs 21 and 22 
to read as follows:


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

* * * * *
    Public Health Service Policy on Humane Care and Use of Laboratory 
Animals, Office of Laboratory Animal Welfare, Office of 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 of 
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. 03-30757 Filed 12-12-03; 8:45 am]
BILLING CODE 4140-01-P