[Federal Register Volume 59, Number 180 (Monday, September 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23036]


[[Page Unknown]]

[Federal Register: September 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

 

Delegations of Authority and Organization; Counterfeit Drugs 
Enforcement Activities

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 enforcement 
activities. The amendment designates FDA officers or employees who have 
been issued official credential FDA-200D to administer oaths and 
affirmations for use in any prosecution or proceeding under or in the 
enforcement of any law enforced by FDA.

EFFECTIVE DATE: September 19, 1994.

FOR FURTHER INFORMATION CONTACT: John L. Paolino, Jr., Office of 
Criminal Investigations (HFC-300), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-294-4030, or 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 for 
delegations of authority for Sec. 5.35 Enforcement activities (21 CFR 
5.35) by designating FDA officers and employees who have been issued 
official credential FDA-200D, Special Authority for Criminal 
Investigators, the authority to administer oaths and affirmations for 
use in any prosecution or proceeding under or in the enforcement of any 
law enforced by FDA. This authority is the same as that delegated to 
holders of FDA-200A and FDA-200B credentials. This authority may not be 
redelegated.

 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 5.35 is amended by adding new paragraph (b)(3) to read 
as follows:


Sec. 5.35  Enforcement activities.

 * * * * *
     (b)(3) To administer oaths and affirmations under section 1 of the 
act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of 
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization 
Plan No. 1 of 1953, effective April 11, 1953.
 * * * * *

    Dated: September 9, 1994.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-23036 Filed 9-16-94; 8:45 am]
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