[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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