[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.34]

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                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
              Subpart B--General Redelegations of Authority
 
Sec. 5.34  Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

    (a) The Director, the Deputy Director, and the Associate Director 
for Regulatory Policy, Center for Drug Evaluation and Research, the 
Director and Deputy Director, Center for Veterinary Medicine, and the 
Director and Deputy Directors, Center for Biologics Evaluation and 
Research are authorized to issue the following notices and make all 
findings required in relation to these notices under section 306 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a) which 
relate to the assigned functions of their organizations:
    (1) Notices of opportunity for hearing on proposals for mandatory or 
permissive debarment.
    (2) Notices ordering debarment when opportunity for a hearing has 
been waived.
    (3) Notices ordering debarment where the person notifies the agency 
that the person consents to debarment under section 306(c)(2)(B) of the 
act (21 U.S.C. 335a(c)(2)(B)).
    (4) Notices of opportunity for hearing on proposals denying an 
application to terminate debarment under section 306(d)(3) of the act 
(21 U.S.C. 335u(d)(3)).
    (5) Orders denying an application to terminate debarment under 
section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for 
a hearing has been waived.
    (b) These officials may not further redelegate these authorities.

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