[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)]
[Rules and Regulations]
[Pages 24766-24767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11525]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority to the Commissioner of Food and Drugs

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 [[Page 24767]] by adding a new 
authority delegation from the Assistant Secretary for Health to the 
Commissioner of Food and Drugs for certain authorities delegated to the 
Assistant Secretary for Health under the Controlled Substances Act (as 
amended). The delegation excludes the authority to submit reports to 
Congress.

EFFECTIVE DATE: May 10, 1995.

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: On June 22, 1993, the Secretary of Health 
and Human Services delegated to the Assistant Secretary for Health 
authorities vested in the Secretary under the Controlled Substances Act 
(Title II of the Comprehensive Drug Abuse Prevention and Control Act of 
1970 (21 U.S.C. 811(h)(4)), as amended). On May 16, 1994, the Assistant 
Secretary for Health delegated to the Commissioner of Food and Drugs 
these same authorities. These authorities concern providing responses 
to the Drug Enforcement Administration's temporary scheduling notices 
made under the Controlled Substances Act, as amended. This delegation 
excludes the authority to submit reports to Congress.
    Further redelegation of the authority delegated may only be 
authorized with the Commissioner's approval. 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 the 
Public Health Service 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 5.10 is amended by adding new paragraph (a)(37) to read 
as follows:


Sec.  5.10  Delegations from the Secretary, the Assistant Secretary for 
Health, and Public Health Service Officials.

    (a) * * *
    (37) Functions vested in the Secretary under section 811(h)(4) of 
the Controlled Substances Act (Title II of the Comprehensive Drug Abuse 
Prevention and Control Act of 1970, as amended) to provide responses to 
the Drug Enforcement Administration's temporary scheduling notices. The 
delegation excludes the authority to submit reports to Congress.
* * * * *

    Dated: May 2, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-11525 Filed 5-9-95; 8:45 am]
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