02-28292. National Institutes of Health Center Grants

AGENCY:

National Institutes of Health, Department of Health and Human Services.

ACTION:

Notice of proposed rulemaking.

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 [phone]) or email [e-mail].

FOR FURTHER INFORMATION CONTACT:

Jerry Moore at the address above or telephone [phone], 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 § 52a.1, § 52a.2, and § 52a.3 of the regulations governing NIH center grants to reflect these new authorities. Additionally, we are proposing to amend § 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.

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:

§ 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:

§ 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 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:

§ 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:

§ 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 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 [phone] (not a toll-free number) to obtain references to the current version and any amendments.)