[Federal Register Volume 59, Number 124 (Wednesday, June 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15749]


[[Page Unknown]]

[Federal Register: June 29, 1994]


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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 Drug 
Evaluation and Research

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 relating to the list of FDA 
officials in the Center for Drug Evaluation and Research (CDER), Office 
of Generic Drugs (OGD), with authority to perform all the functions of 
the Commissioner of Food and Drugs with respect to approval of 
supplemental applications. This action is being taken to reflect a 
reorganization in OGD and to ensure the accuracy of the regulation.

EFFECTIVE DATE: June 29, 1994.

FOR FURTHER INFORMATION CONTACT: Ellen R. Rawlings, Division of 
Management Systems and Policy (HFA-340), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-4976.

SUPPLEMENTARY INFORMATION: FDA is amending the regulations in Sec. 5.80 
Approval of new drug applications and their supplements (21 CFR 5.80) 
to change the title of Associate Director for Labeling and Professional 
Support, OGD, to Director, Division of Labeling and Program Support in 
Sec. 5.80(e). In addition, the title of Deputy Director, Division of 
Labeling and Program Support is being added to those authorized in 
Sec. 5.80(e) to carry out the Commissioner's authorities described in 
that section. These changes are being made to reflect a minor 
reorganization in OGD.
    Further redelegation of the authority delegated is not 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 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, 2125, 2127, 2128 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, 300aa-25, 300aa-27, 300aa-28); 42 U.S.C. 1395y, 3246b, 
4332, 4831(a), 10007-10008; E.O. 11490, 11921, and 12591; secs. 312, 
313, 314 of the National Childhood Vaccine Injury Act of 1986, Pub. 
L. 99-660 (42 U.S.C. 300aa-1 note).

    2. Section 5.80 is amended by revising paragraph (e) to read as 
follows:


Sec. 5.80  Approval of new drug applications and their supplements.

* * * * *
    (e) The Director and Deputy Director, Division of Labeling and 
Program Support, OGD, are authorized to perform all the functions of 
the Commissioner of Food and Drugs with respect to approval of 
supplemental applications to abbreviated new drug applications, 5S 
applications, or 505(b)(2) applications for drugs for human use that 
are described in Sec. 314.70(b)(3) and (c)(2)(i) through (c)(2)(iv) of 
this chapter. Authority to approve supplements that require in vivo 
bioavailability studies or in vivo study waiver requests is not 
included in this paragraph.
* * * * *

    Dated: June 23, 1994.
 Micheal R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-15749 Filed 6-28-94; 8:45 am]
BILLING CODE 4160-01-F