[Federal Register Volume 62, Number 118 (Thursday, June 19, 1997)]
[Rules and Regulations]
[Page 33349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16065]


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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 (ASH), Office of Public Health and 
Science (OPHS), Office of the Secretary (OS), to the Commissioner of 
Food and Drugs (the Commissioner), delegating all the authorities 
vested in the Secretary under section 601 of Effective Medication 
Guides of the Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies Appropriations Act of 1997, as 
amended hereafter. The delegation excludes the authority to issue 
reports to Congress.

EFFECTIVE DATE: June 19, 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 October 7, 1996, the Secretary of Health 
and Human Services delegated to the ASH, OPHS, with authority to 
redelegate as appropriate, the authorities vested in the Secretary 
under section 601 of Effective Medication Guides of the Agriculture, 
Rural Development, Food and Drug Administration, and Related Agencies 
Appropriations Act of 1997 (Pub. L. 104-180), as amended hereafter. In 
a memorandum dated January 27, 1997, the ASH delegated to the 
Commissioner all of the authorities delegated to the ASH under section 
601 of Effective Medication Guides of the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Act of 1997 (Pub. L. 104-180), as amended hereafter.
    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 a new paragraph (a)(39) to 
read as follows:

    (a) * * *
    (39) Functions vested in the Secretary under section 601 of 
Effective Medication Guides of the Agriculture, Rural Development, Food 
and Drug Administration, and Related Agencies Appropriations Act of 
1997 (Pub. L. 104-180), as amended hereafter. The delegation excludes 
the authority to issue reports to Congress.
* * * * *

    Dated: June 12, 1997.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
[FR Doc. 97-16065 Filed 6-18-97; 8:45 am]
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