[Federal Register Volume 62, Number 77 (Tuesday, April 22, 1997)]
[Rules and Regulations]
[Page 19493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending regulations 
for delegations of authority to allow the Director of the Center for 
Drug Evaluation and Research (CDER) and the Director of the Office of 
Compliance, CDER, to grant or deny a request, submitted in the form of 
a citizen petition under its pertinent regulations, for an exception or 
alternative to applicable current good manufacturing practice (CGMP) 
requirements for positron emission tomography (PET) drug products. This 
action is necessary to allow CDER to be able to grant an exception or 
alternative to applicable CGMP requirements for PET drug products when 
the request is made in a citizen petition.

EFFECTIVE DATE: April 28, 1997.

FOR FURTHER INFORMATION CONTACT: 
    Robert K. Leedham, Center for Drug Evaluation and Research (HFD-
343), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1026, 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: A final rule providing the Director and the 
Director of the Office of Compliance, CDER, with the authority to grant 
requested exceptions and alternatives to requirements in 21 CFR part 
211 pertaining to CGMP's for PET radiopharmaceutical drug products is 
published elsewhere in this issue of the Federal Register. This 
delegation allows these two agency officials to grant or deny such 
requests when submitted in the form of a citizen petition under 21 CFR 
10.30.
    Further redelegation of the authorities delegated is authorized. 
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 under 
authority of 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 5.31 is amended by adding new paragraph (h) to read as 
follows:

Sec. 5.31  Petitions under part 10.

* * * * *
    (h) The Director and the Director of the Office of Compliance, 
CDER, are each authorized to grant or deny citizen petitions submitted 
under Sec. 10.30 of this chapter requesting an exception or alternative 
to any requirement in part 211 of this chapter pertaining to current 
good manufacturing practice for positron emission tomography 
radiopharmaceutical drug products.

    Dated: April 15, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-10340 Filed 4-21-97; 8:45 am]
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