[Federal Register Volume 60, Number 59 (Tuesday, March 28, 1995)]
[Rules and Regulations]
[Pages 15870-15871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7574]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization

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 from the Commissioner of Food 
and Drugs to reflect recent changes to organizational structures within 
FDA; to update the titles of certain officials; and to reflect changes 
in the location and numbering of certain statutory provisions.
EFFECTIVE DATE: March 28, 1995.

FOR FURTHER INFORMATION CONTACT: Edna Morgan, 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 certain regulations for 
delegations of authority in 21 CFR part 5 to reflect recent changes to 
organizational structures within FDA. This document removes obsolete 
titles and adds new titles of certain officials in various regions, 
districts, etc., as well as the Center for Veterinary Medicine (CVM) 
under the new organizational structure. The document also reflects the 
changes in the location and numbering of certain statutory provisions. 
The sections affected are as follows:
     Section 5.36  Certification following inspections (21 CFR 5.36); 
Sec. 5.37  Issuance of reports of minor violations (21 CFR 5.37); and 
Sec. 5.63  Detention of meat, poultry, eggs, and related products (21 
CFR 5.63).
    In Sec. 5.36, FDA is deleting the Director, St. Louis Branch from 
those FDA officials authorized to issue certificates of sanitation. In 
Sec. 5.37(a)(4)(iii), FDA is deleting the Deputy Director, Division of 
Compliance, Office of Surveillance and Compliance, Center for 
Veterinary Medicine, from the list of officials authorized to issue 
certain written notices or warnings. In Sec. 5.37(a)(6) and (b)(5), FDA 
is adding the Directors of the Northeast Regional Laboratory, Southeast 
Regional Laboratory, Winchester Engineering and Analytical Center, and 
National Forensic Chemistry Center to authorize these officials to 
issue certain written notices [[Page 15871]] or warnings. Finally, in 
Sec. 5.63, FDA is deleting the Director, St. Louis Branch from those 
FDA officials authorized to perform and to designate other officials to 
perform all of the functions of the Commissioner of Food and Drugs 
relating to detention of meat, poultry, eggs, and related products.
    In Sec. 5.37(a), FDA is changing the reference to ``section 306'' 
of the Federal Food, Drug, and Cosmetic Act to read, ``section 309'' to 
reflect renumbering accomplished by Pub. L. 102-282. In Sec. 5.37(b), 
FDA is changing the reference to ``section 360C(d) of the Public Health 
Service Act'' to read ``section 539(d) of the Federal Food, Drug, and 
Cosmetic Act'' to reflect a redesignation accomplished by Pub. L. 101-
629.
    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.

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 5.36 is revised to read as follows:


Sec. 5.36   Certification following inspections.

    Regional Food and Drug Directors and District Directors are 
authorized to issue certificates of sanitation under Sec. 1240.20 of 
this chapter.

     3. Section 5.37 is amended by revising the introductory text of 
paragraph (a), by revising paragraph (a)(4)(iii), by adding new 
paragraphs (a)(6)(v) through (a)(6)(viii), by revising the introductory 
text of paragraph (b), and by revising the introductory text of 
paragraph (b)(5) to read as follows:


Sec.  5.37  Issuance of reports of minor violations.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 309 of 
the Federal Food, Drug, and Cosmetic Act regarding the issuance of 
written notices or warnings:
 * * * * *
    (4) *   *   *
    (iii) The Director, Division of Compliance, Office of Surveillance 
and Compliance, CVM.
 * * * * *
    (6) *  *  *
    (v) The Director, Northeast Regional Laboratory, Northeast Region.
    (vi) The Director, Southeast Regional Laboratory, Southeast Region.
    (vii) The Director, Winchester Engineering and Analytical Center.
    (viii) The Director, National Forensic Chemistry Center.
    (b) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 539(d) of 
the Federal Food, Drug, and Cosmetic Act regarding the issuance of 
written notices or warnings:
 * * * * *
    (5) Regional Food and Drug Directors; District Directors; the 
Director, St. Louis Branch; the Director, Northeast Regional 
Laboratory, Northeast Region; the Director, Southeast Regional 
Laboratory, Southeast Region; the Director, Winchester Engineering and 
Analytical Center; and the Director, National Forensic Chemistry 
Center, when such functions relate to:
 * * * * *

    4. Section 5.63 is amended by revising the introductory text to 
read as follows:


Sec. 5.63  Detention of meat, poultry, eggs, and related products.

    The Regional Food and Drug Directors and District Directors are 
authorized to perform and to designate other officials to perform all 
of the functions of the Commissioner of Food and Drugs under:
* * * * *

    Dated: March 17, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-7574 Filed 3-27-95; 8:45 am]
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