[Federal Register Volume 62, Number 157 (Thursday, August 14, 1997)]
[Rules and Regulations]
[Page 43471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Center for Veterinary 
Medicine

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 to reflect a new delegation 
that authorizes the Director and Deputy Director, Center for Veterinary 
Medicine (CVM), to sign certain Federal Register documents related to 
the implementation of the Animal Medicinal Drug Use Clarification Act 
of 1994 (the AMDUCA), as amended hereinafter. This authority will 
enable the agency to issue Federal Register documents related to 
implementation of the AMDUCA more efficiently.

EFFECTIVE DATE: August 14, 1997.
FOR FURTHER INFORMATION CONTACT: 
    Richard L. Arkin, Office of Policy and Regulations (HFV-6), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855-2773, 301-594-1737, or
    Donna G. Page, Division of Management Systems and Policy (HFA-340), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-4816.

SUPPLEMENTARY INFORMATION: The regulations are being amended in subpart 
B of part 5 (21 CFR part 5) by adding a new Sec. 5.40 Issuance of 
Federal Register documents pertaining to the determination of safe 
levels, notice of need for development of an analytical method, notice 
of availability of a developed analytical method, and prohibition of 
certain extralabel drug use to reflect a new delegation that authorizes 
the Director and Deputy Director, CVM, to sign certain Federal Register 
documents related to the implementation of the AMDUCA (Pub. L. 103-
396), as amended hereinafter. This delegation will permit the efficient 
implementation of the AMDUCA which was signed into law on October 22, 
1994.
    This authority may be further redelegated by the Director and 
Deputy Director, CVM. Authority delegated to a position by title may be 
exercised by a person officially designated to serve in such a 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 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. New Sec. 5.40 is added to subpart B to read as follows:


Sec. 5.40  Issuance of Federal Register documents pertaining to the 
determination of safe levels, notice of need for development of an 
analytical method, notice of availability of a developed analytical 
method, and prohibition of certain extralabel drug use.

    The Director and Deputy Director, Center for Veterinary Medicine 
(CVM) are authorized to issue Federal Register documents pertaining to 
the determination of safe levels, notice of need for development of an 
analytical method, notice of availability of a developed analytical 
method, and prohibition of certain extralabel drug use related to 
implementation of the Animal Medicinal Drug Use Clarification Act of 
1994 (the AMDUCA) (Pub. L. 103-396). This authority may be further 
redelegated by the Director and Deputy Director, CVM.

    Dated: August 8, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-21585 Filed 8-13-97; 8:45 am]
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