97-13826. Delegations of Authority and Organization; Office of the Commissioner  

  • [Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
    [Rules and Regulations]
    [Page 28628]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-13826]
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 5
    
    
    Delegations of Authority and Organization; Office of the 
    Commissioner
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The Food and Drug Administration (FDA) is amending the 
    regulations for delegations of authority by adding a new authority from 
    the Assistant Secretary for Health to the Commissioner of Food and 
    Drugs (the Commissioner) for all the authorities delegated to the 
    Assistant Secretary for Health under the Safe Medical Devices Act of 
    1990 (the SMDA), as amended. The delegation excludes the authority to 
    submit reports to Congress.
    
    EFFECTIVE DATE: May 27, 1997.
    
    FOR FURTHER INFORMATION CONTACT: Loretta W. Davis, Division of 
    Management Systems and Policy (HFA-340), Food and Drug Administration, 
    5600 Fishers Lane, Rockville, MD 20857, 301-827-4809.
    
    SUPPLEMENTARY INFORMATION: On February 10, 1994, the Secretary of 
    Health and Human Services delegated to the Assistant Secretary for 
    Health all of the authorities vested in the Secretary under the SMDA 
    (Pub. L. 101-629), as amended, including any section not amending the 
    Food, Drug, and Cosmetic Act. On February 23, 1994, the Assistant 
    Secretary for Health delegated to the Commissioner all the authorities 
    delegated to the Assistant Secretary for Health under the SMDA, as 
    amended.
        FDA is amending 21 CFR 5.10 by adding a new paragraph (a)(38) to 
    reflect the new authority.
        Further redelegation of the authority delegated may only be 
    authorized with the Commissioner's approval. Authority delegated to a 
    position by title may be exercised by a person officially designated to 
    serve in such position in an acting capacity or on a temporary basis.
    
    List of Subjects in 21 CFR Part 5
    
        Authority delegations (Government agencies), Imports, Organization 
    and functions (Government agencies).
        Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
    Public Health Service Act and under authority delegated to the 
    Commissioner of Food and Drugs, 21 CFR part 5 is amended as follows:
    
    PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION
    
        1. The authority citation for 21 CFR part 5 continues to read as 
    follows:
    
        Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
    U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging 
    and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
    149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
    Food, Drug and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
    secs. 301, 302, 303, 307, 310, 311, 351, 352, 361, 362, 1701-1706, 
    2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a, 
    242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1); 42 
    U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921, 
    and 12591.
    
        2. Section 5.10 is amended by adding new paragraph (a)(38) to read 
    as follows:
    
    Sec. 5.10  Delegations from the Secretary, the Assistant Secretary for 
    Health, and Public Health Service Officials.
    
        (a) * * *
        (38) Functions vested in the Secretary under the Safe Medical 
    Devices Act of 1990 (Pub. L. 101-629), as amended. The delegation 
    excludes the authority to submit reports to Congress.
    * * * * *
    
        Dated: May 15, 1997.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 97-13826 Filed 5-23-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
5/27/1997
Published:
05/27/1997
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-13826
Dates:
May 27, 1997.
Pages:
28628-28628 (1 pages)
PDF File:
97-13826.pdf
CFR: (1)
21 CFR 5.10