[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.21]
[Page 115]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart B Initiation of Proceedings
Sec. 12.21 Initiation of a hearing involving the issuance, amendment, or
revocation of an order.
(a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3)
or (4), of section 515(g)(1) of the act, or section 351(a) of the Public
Health Service Act, may be initiated--
(1) By the Commissioner on the Commissioner's own initiative;
(2) By a petition in the form specified elsewhere in this chapter,
e.g., Sec. 314.50 for new drug applications, Sec. 514.1 for new animal
drug applications, Sec. 514.2 for applications for animal feeds, or
Sec. 601.3 for licenses for biologic products; or
(3) By a petition under Sec. 10.30.
(b) A notice of opportunity for hearing on a proposal to deny or
revoke approval of all or part of an order will be published together
with an explanation of the grounds for the proposed action. The notice
will describe how to submit requests for hearing. A person subject to
the notice has 30 days after its issuance to request a hearing. The 30-
day period may not be extended.
(c) The Commissioner may use an optional procedure specified in
Sec. 10.30(h) to consider issuing, amending, or revoking an order.
(d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e)
of the act in which a party wishes to apply for reimbursement of certain
expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504
note), FDA will follow the Department of Health and Human Services'
regulations in 45 CFR part 13.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982;
54 FR 9035, Mar. 3, 1989]
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