[Federal Register Volume 59, Number 221 (Thursday, November 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28323]


[[Page Unknown]]

[Federal Register: November 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 52e

RIN 0905-AE25

 

National Heart, Lung, and Blood Institute Grants for Prevention 
and Control Projects

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Final rule.

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SUMMARY: The National Institutes of Health (NIH) is amending the 
regulations governing grants awarded by the National Heart, Lung, and 
Blood Institute (NHLBI) for prevention and control projects in order to 
conform the regulations to minor changes made to the NHLBI authority by 
the NIH Revitalization Act of 1993 and add a reference to the NIH 
policy on the inclusion of women and minorities as subjects in clinical 
research.

EFFECTIVE DATE: This amendment is effective on November 17, 1994.

FOR FURTHER INFORMATION CONTACT:
Mr. Jerry Moore, Regulatory Affairs Officer, National Institutes of 
Health, Building 31, Room 3B11, 9000 Rockville Pike, Bethesda, Maryland 
20892-0001, telephone (301) 496-2832 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: Section 419 of the PHS Act authorizes NHLBI 
to make prevention and control grants. Section 505 of the NIH 
Revitalization Act of 1993, which was enacted on June 10, 1993, amended 
section 419 of the Public Health Service (PHS) Act by making minor 
changes to the NHLBI Prevention and Control authority. The NIH 
Revitalization Act of 1993 also added section 492B to the PHS Act which 
requires the Director of NIH, in conjunction with the Director of the 
Office of Research on Women's Health and the Director of the Office of 
Research on Minority Health, to establish guidelines on the inclusion 
of women and minorities as subjects in clinical research supported by 
NIH. In a notice published in the Federal Register of March 28, 1994 
(59 FR 14508), NIH announced the establishment of those guidelines. 
Additionally, in a notice published in the Federal Register of March 7, 
1994 (59 FR 10648), the Assistant Secretary for Health enunciated PHS 
policy concerning the establishment and maintenance of a smoke-free 
workplace and the promotion of the non-use of tobacco products by 
recipients of PHS grants. Further, Public Law 103-227, enacted on March 
31, 1994, prohibits smoking in certain facilities in which minors will 
be present. The Department of Health and Human Services is now 
preparing to implement the provisions of that law. Until those 
implementation plans are in place, PHS continues to strongly encourage 
all grant recipients to provide a smoke-free workplace and promote the 
nonuse of all tobacco products.
    We are amending regulations at 42 CFR part 52e governing grants for 
prevention and control projects to refer to the NIH policy on the 
inclusion of women and minorities as subjects in clinical research, and 
to make minor changes in the NHLBI Prevention and Control authority. 
Specifically, we are amending Sec. 52.8 by adding the word ``policies'' 
to the heading and amending the text of Sec. 52e.8 by adding reference 
to the new NIH guidelines on the inclusion of women and minorities as 
subjects in clinical research. We are also revising paragraphs (a)(1) 
and (b) of Sec. 52e.1 to conform them to amended section 419 of the PHS 
Act.
    Notice, public comment, and delayed effective date procedures are 
being waived for this amendment based on a finding of good cause. These 
procedures for ensuring public participation in the rulemaking process 
and time for compliance are unnecessary because the substantive changes 
have already been made by the NIH Revitalization Act and this technical 
amendment changes the regulation to conform with the statutory changes. 
Similarly, the addition of a reference to a recently issued policy does 
not impose any new substantive requirements upon applicants.
    The following statements are provided for information of the 
public.

Regulatory Impact Statement

    Executive Order 12866 of September 30, 1993, Regulatory Planning 
and Review, requires us to prepare an analysis for any rule that meets 
one of the E.O. 12866 criteria for a significant regulatory action; 
that is, that may--
    Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal, governments, or 
communities;
    Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    Materially alter the budgetary impact of grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or
    Raise novel legal or policy issues arising out of legal mandates, 
the President's priorities, or the principles set forth in E.O. 12866.
    In addition, we prepare a regulatory flexibility analysis, in 
accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
chapter 6), if the rule is expected to have a significant impact on a 
substantial number of small entities.
    For the reasons outlined below, we do not believe this rule is 
economically significant nor do we believe that it will have a 
significant impact on a substantial number of small entities. In 
addition, this rule is not inconsistent with the actions of any other 
agency.
    This rule makes minor changes to conform existing regulations to 
the current statute and to refer to a recently issued NIH policy. While 
these grants benefit those segments of the public afflicted by heart, 
blood vessel, lung, and blood diseases, and community-based and 
population-based programs carried out in cooperation with other Federal 
agencies, with public health agencies of State or local governments, 
with nonprofit private entities that are community-based health 
agencies, or with other appropriate public or non-profit private 
entities, these grants do not have a significant economic or policy 
impact on a broad cross-section of the public. Furthermore, this rule 
would only affect those few institutions interested in obtaining 
financial assistance to carry out authorized prevention and control 
projects, subject to the normal accountability requirements for grant 
funds. No entity is obligated to apply for grant support.
    For these same reasons, we certify this rule will not have a 
significant economic impact on a substantial number of small entities, 
and that a regulatory flexibility analysis is not required.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbered programs 
affected by this rule are:

93.837--Heart and Vascular Diseases Research
93.838--Lung Diseases Research
93.839--Blood Diseases and Resources Research

List of Subjects in 42 CFR Part 52e

    Grant programs--Health; Health; Medical research.

    Dated: October 28, 1994.
Philip R. Lee,
Assistant Secretary for Health.
    Approved: November 8, 1994.
Donna E. Shalala,
Secretary.

    For the reasons set forth in the preamble, part 52e of title 42 of 
the Code of Federal Regulations is amended to read as set forth below.

PART 52e--NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR 
PREVENTION AND CONTROL PROJECTS

    1. The authority citation for part 52e continues to read as 
follows:

    Authority: 42 U.S.C. 216, 285b-1.

    2. In Sec. 52e.1 paragraphs (a)(1) and (b) are revised to read as 
follows:


Sec. 52e.1  To what programs do these regulations apply?

    (a) * * *
    (1) Demonstrate and evaluate the effectiveness of new techniques or 
procedures for the prevention and control of heart, blood vessel, lung, 
and blood diseases, with special consideration given to the prevention 
and control of these diseases in children, and in populations that are 
at increased risk with respect to such diseases;
    (2) * * *
    (3) * * *
    (b) For purposes of this part, prevention and control projects 
shall include community-based and population-based programs carried out 
in cooperation with other Federal agencies, with public health agencies 
of State or local governments, with nonprofit private entities that are 
community-based health agencies, or with other appropriate public or 
nonprofit private entities.
    3. Section 52e.8 is amended by adding the words ``and policies'' to 
the heading following the word ``regulations'' and, immediately after 
the reference to the PHS Policy on Humane Care and Use of Laboratory 
Animals, by adding as the last item a reference to the NIH Guidelines 
on the Inclusion of Women and Minorities as Human Subjects in Clinical 
Research, to read as follows:


Sec. 52e.8  Other HHS regulations and policies that apply.

* * * * *
    59 FR 14508 (as republished March 28, 1994), as may be amended, or 
its successor--NIH Guidelines on the Inclusion of Women and Minorities 
as Subjects in Clinical Research.

[FR Doc. 94-28323 Filed 11-16-94; 8:45 am]
BILLING CODE 4140-01-M