[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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