E6-11924. National Institutes of Health Training Grants

AGENCY:

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

ACTION:

Final rule.

SUMMARY:

The National Institutes of Health (NIH) is amending the current regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training.

DATES:

Effective Date: This final rule is effective August 25, 2006.

FOR FURTHER INFORMATION CONTACT:

Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892, 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 an increase in the number and size of institutional training grants to institutions supporting pediatric training. We are amending the current regulations codified at 42 CFR part 63a, “National Institutes of Health Training Grants,” to implement this pediatric research training grants authority. More specifically, we are amending part 63a to reference section 452G of the PHS Act in the authority section and in paragraph (a)(2) of § 63a.1 of the regulations, and update information in the 18th, 19th, and 20th undesignated paragraphs of § 63a.11.

We announced our intention to amend the training grants regulations by publishing the notice of proposed rulemaking (NPRM), “National Institutes of Health Training Grants,” in the Federal Register of January 28, 2005 (70 FR 4080-4081). The NPRM provided for a 60-day public comment period. The comment period expired on March 29, 2005. We received no comments. Therefore, the amending action reflected in this final rule is the same as what we proposed in the NPRM.

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 final 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 this final rule does 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 this final rule as required under the Executive Order and determined that it does not have federalism implications. The Secretary certifies that this final 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 final 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: April 12, 2006.

Elias A. Zerhouni,

Director, National Institutes of Health.

Approved: July 18, 2006.

Michael O. Leavitt,

Secretary.

For the reasons set forth in the preamble, we 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 is revised to read as follows:

Authority: 42 U.S.C. 216, 242 1 (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 is amended by revising paragraph (a)(2) to read as follows:

§ 63a.1

To what programs do these regulations apply?

(a) * * *

(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 is amended by revising the 18th, 19th, and 20th undesignated paragraphs to read as follows:

§ 63a.11

Other HHS regulations and policies that apply.

* * * * *

“NIH Grants Policy Statement,” (December 1, 2003). This version is located on the NIH Web site at: http://grants./​policy/​nihgps_​2003/​index.htm.

[Note:

this policy is subject to change, and interested persons should contact the Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research, NIH, 6701 Rockledge Drive, Suite 350, MSC 7974, Bethesda, Maryland 20892-7974, telephone [phone] (or toll-free 800-518-4726), to obtain references to the current version and any amendments. Information may also be obtained by contacting the OPERA Division of Grants Policy via e-mail at http://[e-mail]. Previous versions of the NIH Grants Policy Statement are archived at http://grants.nih.gov/​grantspolicy/​policy.htm.]

“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).]