[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Rules and Regulations]
[Page 54424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26356]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority; Associate Commissioner for Health 
Affairs

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 authority of 
the Commissioner of Food and Drugs to provide initial responses to the 
Drug Enforcement Administration's (DEA) temporary scheduling notices 
for control of hazardous substances. This redelegation of authority is 
intended to ensure the prompt and efficient transmission to the DEA of 
these responses. This authority is being redelegated from the 
Commissioner of Food and Drugs to the Associate Commissioner for Health 
Affairs under the Controlled Substances Act (as amended), which amends 
the Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended hereafter. The delegation excludes the authority to submit 
reports to Congress.

EFFECTIVE DATE: October 24, 1995.

FOR FURTHER INFORMATION CONTACT:
    Nicholas P. Reuter, Office of Health Affairs (HFY-20), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
1382, or
    Ellen Rawlings, Division of Management Systems and Policy (HFA-
305), Food and Drug Administration, 301-443-4976.

SUPPLEMENTARY INFORMATION: On May 16, 1994, the Assistant Secretary for 
Health delegated to the Commissioner of Food and Drugs authorities 
under the Controlled Substances Act, as amended (Title II of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. 
811(h)(4), as amended hereafter). These authorities concern providing 
initial responses to the DEA's temporary scheduling notices for control 
of hazardous substances. The Commissioner is further redelegating these 
authorities to the Associate Commissioner for Health Affairs to ensure 
the prompt and efficient transmission to DEA of these responses. 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. New Sec.  5.81 is added to read as follows:

Sec.  5.81   Responses to Drug Enforcement Administration temporary 
scheduling notices.

    The Associate Commissioner for Health Affairs is authorized to 
provide responses to the Drug Enforcement Administration's temporary 
scheduling notices under the Controlled Substances Act, as amended 
(Title II of the Comprehensive Drug Abuse Prevention and Control Act of 
1970, 21 U.S.C. 811(h)(4), as amended hereafter). The delegation 
excludes the authority to submit reports to Congress.

    Dated: October 10, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-26356 Filed 10-23-95; 8:45 am]
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