[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]


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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.

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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]
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