[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17808]


[[Page Unknown]]

[Federal Register: July 22, 1994]


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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 relating to disclosure of 
official records in order to delegate authority to certain officials 
within the agency for disclosure to foreign governments.

EFFECTIVE DATE: July 22, 1994.

FOR FURTHER INFORMATION CONTACT: Ellen R. Rawlings, Division of 
Management Systems and Policy (HFA-340), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-4976.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 19, 1993 
(58 FR 61598), FDA published a final rule amending the regulations in 
Sec. 20.89 (21 CFR 20.89), effective December 20, 1993, to provide that 
the Commissioner of Food and Drugs (the Commissioner) may designate any 
other FDA officer or employee to act on the Commissioner's behalf to 
authorize the nonpublic disclosure, under certain specified conditions, 
of confidential commercial information submitted to FDA or incorporated 
into agency-prepared records. This amendment permits such disclosure to 
foreign government officials who perform counterpart functions to FDA 
as part of cooperative law enforcement or regulatory efforts. The 
amendment also permits the disclosure of trade secret information to 
visiting foreign scientists under certain limited conditions. Section 
5.23 Disclosure of official records (21 CFR 5.23) is being revised to 
add Sec. 20.89(c) to the sections already referenced in Sec. 5.23(a), 
and to list those officials authorized to make such disclosures.
    Further redelegation of the authority delegated is not authorized. 
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, 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 5.23 is amended by revising the introductory text of 
paragraph (a) and by adding new paragraphs (a)(10)(i) through 
(a)(10)(vii) to read as follows:


Sec. 5.23  Disclosure of official records.

    (a) The following officials are authorized to make determinations 
to disclose official records and information under part 20 of this 
chapter, except that only the officials listed in paragraph (a)(1) of 
this section may disclose official records and information under 
Secs. 20.82 and 20.85 of this chapter, and only officials listed in 
paragraph (a)(10) of this section may disclose information under 
Sec. 20.89(c) of this chapter.
* * * * *
    (10)(i) The Associate Commissioner for Regulatory Affairs, Deputy 
Associate Commissioner for Regulatory Affairs, and Director, Office of 
Enforcement, FDA.
    (ii) The Director, Deputy Director, and Associate Director for 
Policy Coordination and Public Affairs, Center for Biologics Evaluation 
and Research (CBER), and Director, Division of Congressional and Public 
Affairs, CBER.
    (iii) The Director, Deputy Directors, and Associate Director for 
Science and Medical Affairs, Center for Drug Evaluation and Research 
(CDER).
    (iv) The Director and Deputy Director for Regulations and Policy, 
Center for Devices and Radiological Health (CDRH).
    (v) The Director, Center for Food Safety and Applied Nutrition 
(CFSAN), and Deputy Director for Systems and Support, CFSAN.
    (vi) The Director and Deputy Director, Center for Veterinary 
Medicine (CVM).
    (vii) The Director, Deputy Director, and Associate Director for 
Scientific Coordination, National Center for Toxicological Research 
(NCTR).
* * * * *

    Dated: July 18, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17808 Filed 7-21-94; 8:45 am]
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