[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Rules and Regulations]
[Pages 26825-26826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12398]



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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 covering the certification of 
true documents and use of the Department seal in order to update this 
authority to reflect recent changes to organizational structures within 
FDA.
EFFECTIVE DATE: May 19, 1995.

FOR FURTHER INFORMATION CONTACT: L'Tonya Barnes, 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 in Sec. 5.22 
Certification of true copies and use of Department seal (21 CFR 5.22) 
in order to update this authority to reflect recent changes to 
organizational structures within FDA. Revisions and deletions have been 
made to reflect current titles. Also, the following additions have been 
made to bring the list of officials up-to-date: the Deputy 
Commissioners; the Director, Division of Management Operations, and 
Chief, Administrative Management Branch, Office of Resource Management, 
Office of Regulatory Affairs (ORA); the Director, FDA History Staff, 
ORA; the Director, Office of Policy, Planning, and Strategic 
Initiatives, Center for Food Safety and Applied Nutrition (CFSAN); the 
Director, Office of Management Systems, CFSAN; the Director, Office of 
Cosmetics and Colors, CFSAN; the Director, Office of Plant and Dairy 
Foods and Beverages, CFSAN; the Director, Office of Seafood, CFSAN; the 
Director, Office of Special Nutritionals, CFSAN; the Director, Office 
of Special Research Skills, CFSAN; the Director, Office of Constituent 
Operations, CFSAN; the Director, Office of Field Programs, CFSAN; the 
Director, Office of Premarket Approval, CFSAN; the Director, Office of 
Scientific Analysis and Support, CFSAN; and the Director, National 
Forensic Chemistry Center.
    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 [[Page 26826]] 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 5.22 is amended by revising paragraphs (a)(1) through 
(a)(13) and by adding new paragraph (a)(14), by revising paragraphs 
(b)(1) and (b)(2), and by adding new paragraph (b)(3) to read as 
follows:


Sec. 5.22  Certification of true copies and use of Department seal.

    (a) * * *
    (1) The Deputy Commissioners.
    (2) The Associate and Deputy Associate Commissioners.
    (3)(i) The Director, Office of Executive Operations.
    (ii) The Director, Executive Secretariat.
    (iii) The Director, Program Management Staff.
    (4) The Executive Assistant to the Commissioner, Office of the 
Commissioner.
    (5)(i) The Director and Deputy Director, Office of Enforcement, 
Office of Regulatory Affairs (ORA).
    (ii) The Director and Deputy Director, Office of Regional 
Operations, ORA.
    (iii) The Director and Deputy Director, Office of Resource 
Management, ORA.
    (iv) The Director, Division of Management Operations, and Chief, 
Administrative Management Branch, Office of Resource Management, ORA.
    (v) The Director, FDA History Staff, ORA.
    (6)(i) The Director, Division of Management Systems and Policy, 
Office of Management (OM).
    (ii) The Chief, Dockets Management Branch, Division of Management 
Systems and Policy, OM.
    (7) The Director, Freedom of Information Staff, Office of Public 
Affairs.
    (8)(i) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director, Office of Management, CBER.
    (iii) The Directors and Deputy Directors of the Office of 
Compliance, CBER.
    (iv) The Director of Congressional and Public Affairs Staff, Office 
of the Center Director, CBER.
    (v) The Chief, Surveillance and Policy Branch and Consumer Safety 
Officers, Office of Compliance, CBER.
    (9)(i) The Director and Deputy Directors, Center for Food Safety 
and Applied Nutrition (CFSAN).
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Management Systems, CFSAN.
    (iv) The Director, Office of Cosmetics and Colors, CFSAN.
    (v) The Director, Office of Plant and Dairy Foods Beverages, CFSAN.
    (vi) The Director, Office of Seafood, CFSAN.
    (vii) The Director, Office of Special Nutritional, CFSAN.
    (viii) The Director, Office of Special Research Skills, CFSAN.
    (ix) The Director, Office of Constituent Operations, CFSAN.
    (x) The Director, Office of Field Programs, CFSAN.
    (xi) The Director, Office of Premarket Approval, CFSAN.
    (xii) The Director, Office of Scientific Analysis and Support, 
CFSAN.
    (10)(i) The Director and Deputy Director, Center for Devices and 
Radiological Health (CDRH).
    (ii) The Director, Office of Management Services, CDRH.
    (iii) The Director and Deputy Director, Office of Compliance, CDRH.
    (iv) The Director and Deputy Director, Division of Compliance 
Programs, CDRH.
    (v) The Director and Deputy Director, Office of Standards and 
Regulations, CDRH.
    (11)(i) The Director and Deputy Directors, Center for Veterinary 
Medicine (CVM).
    (ii) The Director and Deputy Director, Office of Management, CVM.
    (iii) The Director and Deputy Director, Office of Surveillance and 
Compliance, CVM.
    (iv) The Director, Division of Compliance, Office of Surveillance 
and Compliance, CVM.
    (v) The Chief, Case Guidance Branch, Division of Compliance, Office 
of Surveillance and Compliance, CVM.
    (12)(i) The Director and Deputy Director, National Center for 
Toxicological Research (NCTR).
    (ii) The Director, Office of Research Support, NCTR.
    (13)(i) The Director and Deputy Director, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Directors and Deputy Directors of the Offices of 
Management, Epidemiology and Biostatistics, Compliance, Drug Evaluation 
I, Drug Evaluation II, Research Resources, Generic Drugs, and Over-the-
Counter Drug Evaluation, CDER.
    (iii) The Chief and Freedom of Information Officers, Freedom of 
Information Staff, Office of Management, CDER.
    (iv) The Director, Division of Management and Budget, Office of 
Management, CDER.
    (v) The Directors of the Divisions of Drug Labeling Compliance, 
Drug Quality Evaluation, Manufacturing and Product Quality, and 
Scientific Investigations, Office of Compliance, CDER.
    (14)(i) Regional Food and Drug Directors.
    (ii) District Directors.
    (iii) The Director, St. Louis Branch.
    (iv) The Director, New York Laboratory Division, Northeast Region.
    (v) The Director, Southeast Regional Laboratory, Southeast Region.
    (vi) The Director, National Forensic Chemistry Center.
    (b) * * *
    (1) Deputy Commissioners.
    (2) The Associate and Deputy Associate Commissioners.
    (3) The Director, Office of Human Resources Management, Office of 
Management.
* * * * *

    Dated: May 9, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-12398 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-F