[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]
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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.
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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
