[Federal Register Volume 71, Number 143 (Wednesday, July 26, 2006)]
[Rules and Regulations]
[Pages 42295-42296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 63a

RIN 0925-AA28


National Institutes of Health Training 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 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 301-496-4607 (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 Sec.  63a.1 of the regulations, and update 
information in the 18th, 19th, and 20th undesignated paragraphs of 
Sec.  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

[[Page 42296]]

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.

0
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

0
1. The authority citation of part 63a is revised to read as follows:

    Authority: 42 U.S.C. 216, 2421(b)(3), 284(b)(1)(C), 285g-10, 
287c(b), 300cc-15(a)(1), 300cc-41(a)(3)(C), 7403(h)(2).

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


Sec.  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,
* * * * *

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3. Section 63a.11 is amended by revising the 18th, 19th, and 20th 
undesignated paragraphs to read as follows:


Sec.  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 301-
435-0938 (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://[email protected]. 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 
301-594-2382 (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).]

[FR Doc. E6-11924 Filed 7-25-06; 8:45 am]
BILLING CODE 4140-01-P