05-1621. National Institutes of Health Training Grants

AGENCY:

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

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The National Institutes of Health (NIH) proposes to amend the existing regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training.

DATES:

Comments must be received on or before March 29, 2005, in order to assure that NIH will be able to consider all comments when preparing the final rule.

ADDRESSES:

You may submit comments, identified by RIN number 0925-AA28, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• E-mail: [e-mail]. Include RIN number 0925-AA28 in the subject line of the message.
• Fax: [phone].
• Mail: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892.
• Hand Delivery/Courier: 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892.

FOR FURTHER INFORMATION CONTACT:

Jerry Moore at the address above, or telephone [phone] (not a toll-free number).

SUPPLEMENTARY INFORMATION:

On October 17, 2000, Congress enacted the Children's Health Act of 2000, Public Law 106-310. Title X, section 1002, of this law amended the Public Health Service (PHS) Act by adding section 452G (42 U.S.C. 285g-10). Section 452G directs the Director of the National Institute of Child Health and Human Development, after consultation with the Administrator of the Health Resources and Services Administration, to support activities to provide for and increase in the number and size of institutional training grants to institutions supporting pediatric training. We propose to amend the present regulations codified at 42 CFR part 63a, National Institutes of Health Training Grants, to implement this pediatric research training grants authority. More specifically, we propose to amend part 63a to reference section 452G of the PHS Act in the authority section and in paragraph (2) of § 63a.1 of the regulations, and update information in unnumbered paragraphs 17 and 18 of § 63a.11.

The purpose of this notice is to invite public comment on this proposed action. We provide the following as public information.

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, prepublication review by the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) is necessary. The OIRA reviewed this proposed rule under Executive Order 12866 and deemed it not a significant regulatory action as defined by the Executive Order.

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 of Health and Human Services (Secretary) certifies that any final rule resulting from this proposed rule will not have 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 Secretary reviewed the proposed rule as required under the Executive Order and determined that it does not have federalism implications. The Secretary certifies that this proposed rule will not have an effect on the States, or on the distribution of power and responsibilities among the various levels of government.

Paperwork Reduction Act

This proposed rule does not contain information collection requirements which are subject to Office of Management and Budget (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 numbered program affected by the proposed regulation is: 93.865.

List of Subjects in 42 CFR Part 63a

• Grant programs—health
• Health-medical research

Dated: May 27, 2004.

Elias A. Zerhouni,

Director, National Institutes of Health.

Approved: January 14, 2005.

Tommy G. Thompson,

Secretary.

For the reasons set forth in the preamble, we propose to amend chapter 1 of title 42 of the Code of Federal Regulations as set forth below.

PART 63a—NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS

1. The authority citation of part 63a would be revised to read as follows:

Authority: 42 U.S.C. 216, 242 l (b)(3), 284(b)(1)(C), 285g-10, 287c(b), 300cc-15(a)(1), 300cc-41(a)(3)(C), 7403(h)(2).

2. Section 63a.1 would be amended by revising paragraph (a)(2) to read as follows:

§ 63a.1

To what programs do these regulations apply?

* * * * *

(a) * * *

(1) * * *

(2) Grants awarded by NIH for research training with respect to the human diseases, disorders, or other aspects of human health or biomedical research for which the institute or other awarding component was established, for which fellowship support is not provided under section 487 of the Act and which is not residency training of physicians or other health professionals, as authorized by sections 405(b)(1)(C), 452G, 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and

* * * * *

3. Section 63a.11 would be amended by revising the 17th and 18th undesignated paragraphs to read as follows:

§ 63a.11

Other HHS regulations and policies that apply.

* * * * *

“NIH Grants Policy Statement,” NIH Publication No. 99-8 (October 1998). (NOTE: this policy is subject to change, and interested persons should contact the Extramural Outreach and Information Resources Office (EOIRO), Office of Extramural Research, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, Maryland 20892-7910, telephone [phone] (not a toll-free number), to obtain references to the current version and any amendments. Information may also be obtained by contacting the EOIRO via e-mail address ([e-mail]) and browsing the NIH Home Page site on the World Wide Web (http://www.nih.gov).)

“Public Health Service Policy on Humane Care and Use of Laboratory Animals,” Office of Laboratory Animal Welfare (Amended August, 2002). (NOTE: This policy is subject to change, and interested persons should contact the Office of Laboratory Animal Welfare, 6705 Rockledge Drive, Suite 360, MSC 7982, Bethesda, Maryland 20892-7982, telephone [phone] (not a toll-free number), to obtain references to the current version and any amendments. Information may also be obtained by browsing the Office of Laboratory Animal Welfare Home Page site on the World Wide Web (http://www.grants.nih.gov/​grants/​olaw/​olaw.htm).)