[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Proposed Rules]
[Pages 4080-4081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1621]


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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: Notice of proposed rulemaking.

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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: [email protected]. Include RIN number 0925-AA28 in the 
subject line of the message.
     Fax: 301-402-0169.
     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 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 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 Sec.  63a.1 of the regulations, and update information 
in unnumbered paragraphs 17 and 18 of Sec.  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

[[Page 4081]]

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, 242l(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:


Sec.  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:


Sec.  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 301-435-0714 
(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 ([email protected]) 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 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. 05-1621 Filed 1-27-05; 8:45 am]
BILLING CODE 4140-01-P