94-20359. Grants for National Alcohol Research Centers  

  • [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
    
    
    

Document Information

Published:
08/19/1994
Department:
Health and Human Services Department
Entry Type:
Uncategorized Document
Action:
Notice of proposed rulemaking.
Document Number:
94-20359
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.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: August 19, 1994
RINs:
0905-AE08
CFR: (8)
42 CFR 54a.501
42 CFR 54a.502
42 CFR 54a.503
42 CFR 54a.504
42 CFR 54a.505
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