[Federal Register Volume 59, Number 160 (Friday, August 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20359]
[[Page Unknown]]
[Federal Register: August 19, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 54a
RIN 0905-AE08
Grants for National Alcohol Research Centers
agency: National Institutes of Health, Public Health Service, HHS.
action: Notice of proposed rulemaking.
-----------------------------------------------------------------------
summary: The National Institutes of Health (NIH) proposes to amend the
current regulations governing grants for alcohol abuse and alcoholism
prevention, treatment, and rehabilitation services and National Alcohol
Research Centers to set forth changes necessitated by enactment of the
Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
Reorganization Act, and to make other changes necessary to update the
regulations.
dates: Comments concerning the regulations must be received on or
before October 18, 1994 in order to ensure that NIH will be able to
consider the comments in preparing the final rule.
addresses: Comments should be sent to Jerry Moore, Regulatory Affairs
Officer, National Institutes of Health, Building 31, Room 3B-11, 9000
Rockville Pike, Bethesda, Maryland 20892-0001.
for further information contact: Jerry Moore at the address above, or
telephone (301) 496-4606 (not a toll-free number).
supplementary information: Section 122 of the ADAMHA Reorganization
Act, Public Law 102-321, which was enacted on July 10, 1992,
transferred Public Health Service (PHS) Act section 511, National
Alcohol Research Center, to Title IV, Part C, Subpart 14 of the Act,
and redesignated the section as PHS Act section 464J. Under PHS Act
section 464J, the Secretary, acting through the National Institute on
Alcohol Abuse and Alcoholism (NIAAA), may designate National Alcohol
Research Centers for the purpose of interdisciplinary research relating
to alcoholism and other biomedical, behavioral and social issues
related to alcoholism and alcohol abuse, and shall make annual grants
to the Centers, including a grant to a designated Center for research
on the effects of alcohol on the elderly. The NIH proposes to amend the
current regulations governing these grants by revising the ``Table of
Contents'' section, removing reserved sections 54a.508 and 54a.509, and
redesignating section 54a.510 as 54a.508, revising the authority
citation and ``Applicability'' section to show the changes necessitated
by enactment of the ADAMHA Reorganization Act, providing additional
definitions, replacing the language in section 54a.504 with non-
specific language which will eliminate the need to seek OMB regulatory
review for future changes in the grant application form, and revise
section 54a.506(c) by removing the $1 million limitation on grant
awards to conform to Public Law 98-24 which eliminated the $1 million
cap. Additionally, NIH proposes to add a new section 54a.509 to the
current regulations setting forth other HHS policies and regulations
that apply to grants awarded under subpart E. The purpose of this
notice is to invite public comment on these proposed changes. The
following statements are provided for the information of the public.
Regulatory Impact Statement
Because this rule merely makes minor changes in grant application
practices and conforms grant awards to the current statute, it will
have no consequential effects on the economy or small entities.
Therefore the Secretary has determined that this rule is not
significant within the definition of Executive Order 12866, and the
Secretary certifies that this rule will not have a significant impact
on a substential number of small entities.
Paperwork Reduction Act
This proposed rule does not contain any information collection
requirements which are subject to Office of Management and Budget (OMB)
review and approval under the Paperwork Reduction Act of 1980 (44
U.S.C. chapter 35).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance (CFDA) numbered program
affected by the regulations is 93.981.
List of Subjects in 42 CFR Part 54a
Alcohol abuse; Alcoholism; Grant programs--Health.
Dated: December 17, 1993.
Philip R. Lee,
Assistant Secretary for Health.
Approved: August 5, 1994.
Donna E. Shalala,
Secretary.
For reasons set out in the preamble, it is proposed to amend part
54a, subpart E, of title 42 of the Code of Federal Regulations, to read
as set forth below.
PART 54a--GRANTS FOR ALCOHOL ABUSE AND ALCOHOLISM PREVENTION,
TREATMENT, AND REHABILITATION SERVICES AND NATIONAL RESEARCH
CENTERS
Subparts A--D [Reserved]
Subpart E--Grants for National Alcohol Research Centers
1. The authority citation for subpart E would be revised to read as
follows:
Authority: 42 U.S.C. 216, 285n-2.
2. and 3. Section 54a.501 would be revised to read as follows:
Sec. 54a.501 To which programs do these regulations apply?
The regulations in this subpart apply to grants to develop,
establish, and support centers for interdisciplinary research relating
to alcoholism and other alcohol problems as authorized by section 464J
of the Act (42 U.S.C. 285n-2).
4. Section 54a.502 would be revised to read as follows:
Sec. 54a.502 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
HHS means the Department of Health and Human Services.
National Alcohol Research Center or Center means an institution
engaged in long-term interdisciplinary research relating to alcoholism
and other alcohol problems.
Non profit as applied to any institution or association means an
institution or association, no part of the net earnings of which inures
or may lawfully inure to the benefit of any private shareholder or
individual.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
5. Section 54a.503 would be amended by revising the heading and
paragraph (b) to read as follows:
Sec. 54a.503 Who is eligible to apply?
* * * * *
(b) Located in a State, the District of Columbia, Puerto Rico, the
Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor
States of the Trust Territory of the Pacific Islands (the Federated
States of Micronesia, the Republic of the Marshall Islands, and the
Republic of Palau).
6. Section 54a.504 would be revised to read as follows:
Sec. 54a.504 How to apply for a grant?
An institution interested in applying for a grant under this
subpart must submit an application at such time and in such form and
manner as the Secretary may prescribe.\1\
---------------------------------------------------------------------------
\1\Grant applications, instructions, and program guidelines may
be obtained from the Director of the National Institute on Alcohol
Abuse and Alcoholism, 5600 Fishers Lane, Rockville, Maryland 20857.
---------------------------------------------------------------------------
7. Section 54a.505 would be amended by revising paragraphs (f), (h)
and (i), and adding a new paragraph (j) to read as follows:
Sec. 54a.505 Program requirements.
* * * * *
(f) Have the capacity to conduct courses on alcohol problems and
research on alcohol problems for undergraduate students, for nursing,
social work and other specialized graduate students, and for medical
and osteopathic students and physicians;
(g) * * *
(h) Provide assurances that any significant changes in the Center's
scientific activities or other Center activities will be made only with
the prior approval of the Secretary;
(i) Establish a Program Advisory Committee, chaired by the Center
director, to review and make recommendations to the Center director on
the conduct of all activities of the Center. The Committee shall be
composed of persons who are not associated with the Center (apart from
their membership on the Committee); and
(j) Have a detailed 5-year plan for the Center program which
identifies the principal areas of research, the relationship of each
area of research to the central theme of the Center program, the
discipline involved, and plans for coordination among them.
8. Section 54a.506 would be amended by revising paragraphs (a),
(a)(8) and (c) to read as follows:
Sec. 54a.506 Grant awards.
(a) Within the limits of funds available, the Secretary, after
taking into account the comments of an appropriate peer review group,
may award grants to applicants with proposed programs which have been
recommended for approval by the council and will in his or her judgment
best promote the purposes of section 464J of the Act; taking into
consideration among other pertinent factors:
* * * * *
(8) The degree to which the application adequately provides for the
requirements of Sec. 54a.505.
(b) * * *
(c) Generally the grant will initially be for one year and
subsequent continuation awards will also be for one year at a time. A
grantee must submit a separate application at the time and in the form
and manner that the Secretary may require to have the support continued
for each subsequent year. Decisions regarding continuation awards and
the funding level of those awards will be made after consideration of
such factors as the grantee's progress and management practices, and
the availability of funds. Continuation awards require a determination
by HHS that continued funding is in the interest of the government.
* * * * *
9. Section 54a.507 would be amended by removing the footnote and
revising the last sentence of paragraph (a) to read as follows:
54a.507 Expenditure of grant funds.
(a) * * * For purposes of this paragraph, construction means the
construction of new buildings, the expansion of existing buildings, and
the acquisition, remodeling, replacement, renovation, major repair (to
the extent permitted by regulations), or alteration of existing
buildings (including architects' fees, but not including the cost of
acquisition of land or off-site improvements), and initial equipment of
new buildings and of the expanded, remodeled, repaired, renovated, or
altered part of existing buildings.
* * * * *
Sec. 54a.510 [Redesignated as 54a.508]
9. Section 54a.510 would be redesignated as 54a.508.
10. A new section 54a.509 would be added to read as follows:
Sec. 54a.509 Other HHS policies and regulations that apply.
Several other policies and regulations apply to grants under this
subpart. These include, but are not limited to:
42 CFR part 50, subpart A--Responsibilities of PHS awardee and
applicant institutions for dealing with and reporting possible
misconduct in science
42 CFR part 50, subpart D--Public Health Service grant appeals
procedures
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension
(nonprocurement) and governmentwide requirements for drug-free
workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal financial
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs
and activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
51 FR 16958 (May 7, 1986), as may be amended, or successor--NIH
Guidelines for Research Involving Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory
Animals,'' Office for Protection from Research Risks, NIH (Revised
September 1986), as may be amended, or successor
NIH Guide for the Care and Use of Laboratory Animals (Revised 1985), as
may be amended, or successor
59 FR 11146 (March 9, 1994), as may be amended, or its successor--NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research
[FR Doc. 94-20359 Filed 8-18-94; 8:45 am]
BILLING CODE 4140-01-M