[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8214-8215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4914]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Issuance of Notices 
Relating to Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for delegations of authority to FDA officials in the Center 
for Drug Evaluation and Research (CDER), the Center for Veterinary 
Medicine (CVM), and the Center for Biologics Evaluation and Research 
(CBER) by adding a new delegations section concerning the issuance of 
notices relating to proposals and orders for debarment and denial of an 
application to terminate debarment. Additionally, FDA is amending the 
regulations regarding petitions so that certain officials of CDER, CVM, 
and CBER are authorized to respond to petitions concerning debarment 
and refusal to terminate debarment. This action will make the process 
of issuing such notices and responses to petitions more efficient.

EFFECTIVE DATE: March 4, 1996.

FOR FURTHER INFORMATION CONTACT: 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: New section 306 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 335a), created by the Generic 
Drug Enforcement Act of 1992, authorizes the Secretary of Health and 
Human Services and, by previous delegation, the Commissioner of Food 
and Drugs (the Commissioner) to take actions relating to debarment 
proposals and orders as well as proposals and orders to deny an 
application to terminate a debarment order. Certain aspects of this 
authority are being redelegated in new Sec. 5.98 from the Commissioner 
to the Directors of CDER, CVM, and CBER, to the Deputy Directors of 
CDER and CVM, and the Associate Director for Policy Coordination and 
Public Relations, CBER, as appropriate. In addition, FDA is amending 
Sec. 5.31 (21 CFR 5.31) by delegating authority to the Directors of 
CDER, CVM, and CBER, to the Deputy Directors of CDER and CVM, and the 
Associate Director for Policy Coordination and Public Relations of CBER 
to respond to petitions concerning actions they are authorized to take 
under new Sec. 5.98. The redelegations will make the process of issuing 
such notices and responses to petitions more efficient.
    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, 

[[Page 8215]]
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 5.31 is amended by adding new paragraphs (f)(1)(vi), 
(f)(2)(x), and (f)(8) to read as follows:

Sec. 5.31  Petitions under part 10.

 * * * * *
    (f) * * *
    (1) * * *
    (vi) Section 5.98 Issuance of notices relating to proposals and 
orders for debarment and denial of an application to terminate 
debarment.
    (2) * * *
    (x) Section 5.98 Issuance of notices relating to proposals and 
orders for debarment and denial of an application to terminate 
debarment.
* * * * *
    (8) The Director and Deputy Director, CVM, are authorized to grant 
or deny citizen petitions submitted under Sec. 10.30 of this chapter 
concerning actions they are authorized to take under Sec. 5.98 Issuance 
of notices relating to proposals and orders for debarment and denial of 
an application to terminate debarment.
    3. New Sec. 5.98 is added to subpart B to read as follows:

Sec. 5.98  Issuance of notices relating to proposals and orders for 
debarment and denial of an application to terminate debarment.

    The Director and Deputy Director, Center for Drug Evaluation and 
Research (CDER), the Director and Deputy Director, Center for 
Veterinary Medicine (CVM), and the Director and Associate Director for 
Policy Coordination and Public Relations, Center for Biologics 
Evaluation and Research (CBER) are authorized to issue the following 
notices under section 306 of the Federal Food, Drug, and Cosmetic Act 
(the act) which relate to the assigned functions of their 
organizations:
    (a) Notices of opportunity for hearing on proposals for mandatory 
or permissive debarment.
    (b) Notices ordering debarment when opportunity for a hearing has 
been waived.
    (c) Notices ordering debarment where the person notifies the agency 
that the person acquiesces to debarment under section 306(c)(2)(B) of 
the act.
    (d) Notices of opportunity for hearing on proposals denying an 
application to terminate debarment under section 306(d)(3) of the act.
    (e) Orders denying an application to terminate debarment under 
section 306(d)(3) of the act when opportunity for a hearing has been 
waived.

    Dated: February 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4914 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F