[Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
[Rules and Regulations]
[Pages 57337-57338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28149]



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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) with 
authority to perform all the functions of the Commissioner of Food and 
Drugs with respect to approval of new drug applications and supplements 
thereto on drugs for human use. This action is being taken to realign 
approval points for division-level authorities to a more reasonable and 
manageable number.

EFFECTIVE DATE: November 15, 1995.

FOR FURTHER INFORMATION CONTACT:
    Rixie L. Scott, Center for Drug Evaluation and Research (HFD-057), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-0530; or
    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) 
by revising Sec. 5.80(a)(1)(iii) and removing paragraph (a)(1)(iv) with 
the titles therein to delegate to the Director, Office of Over-the-
Counter Drugs, authority to approve new drug applications and 
supplements thereto on drugs for human use, except for those drugs 
listed in 21 CFR 314.440(b). These changes are being made to realign 
approval points for division-level authorities to a more reasonable and 
manageable number.
    Further redelegation of the authority delegated is not authorized 
at this time. 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.

[[Page 57338]]


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, 354, 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, 263b, 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 (a)(1)(iii) and by 
removing paragraph (a)(1)(iv) to read as follows:


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

    (a)(1) * * *
    (iii) The Director, Office of Over-the-Counter Drug Evaluation, 
CDER, for drugs under the Director's jurisdiction.
* * * * *

    Dated: November 2, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-28149 Filed 11-14-95; 8:45 am]
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