[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]


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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.

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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\
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    \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.
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    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