[Federal Register Volume 61, Number 18 (Friday, January 26, 1996)]
[Rules and Regulations]
[Page 2414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1322]



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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 redelegations of authority from the Commissioner of 
Food and Drugs to other officers of FDA in order to give the Associate 
Commissioner for Policy Coordination, Office of Policy, authority to 
issue Federal Register notices and proposed and final regulations for 
FDA. This action is being taken in order to hasten the process of 
issuing such notices and proposed and final regulations. This authority 
may not be further redelegated at this time.

EFFECTIVE DATE: January 26, 1996.
FOR FURTHER INFORMATION CONTACT: Ellen 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. 5.20 
General redelegations of authority from the Commissioner to other 
officers of the Food and Drug Administration (21 CFR 5.20) in order to 
add the title of Associate Commissioner for Policy Coordination to 
those authorized to issue Federal Register notices and proposed and 
final regulations for FDA. This action is being taken in order to 
hasten the process of issuing such notices and proposed and final 
regulations.
    Further redelegation of these authorities 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.

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 5.20 is amended by revising paragraph (f)(1) to read as 
follows:


Sec. 5.20  General redelegations of authority from the Commissioner to 
other officers of the Food and Drug Administration.

* * * * *
    (f)(1) The Deputy Commissioner for Policy and the Associate 
Commissioner for Policy Coordination are authorized to perform any of 
the functions of the Commissioner of Food and Drugs with respect to the 
issuance of Federal Register notices and proposed and final regulations 
of the Food and Drug Administration.
* * * * *

    Dated: January 19, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-1322 Filed 1-25-96; 8:45 am]
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