[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: 21CFR12.28]
[Page 117-118]
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. 12.28 Denial of hearing in whole or in part.
If the Commissioner determines upon review of the objections or
requests for hearing that a hearing is not justified, in whole or in
part, a notice of the determination will be published.
(a) The notice will state whether the hearing is denied in whole or
in part. If the hearing is denied in part, the notice will be combined
with the notice of hearing required by Sec. 12.35, and will specify the
objections and requests for hearing that have been granted and denied.
(1) Any denial will be explained. A denial based on an analysis of
the information submitted to justify a hearing will explain the
inadequacy of the information.
(2) The notice will confirm or modify or stay the effective date of
the regulation or order involved.
(b) The record of the administrative proceeding relating to denial
of a public hearing in whole or in part on an objection or request for
hearing consists of the following:
(1) If the proceeding involves a regulation--
(i) The documents specified in Sec. 10.40(g);
(ii) The objections and requests for hearing filed by the Division
of Dockets Management;
(iii) If the proceeding involves a color additive regulation
referred to an advisory committee in accordance with
[[Page 118]]
section 721(b)(5)(C) of the act, the committee's report and the record
of the committee's proceeding; and
(iv) The notice denying a formal evidentiary public hearing.
(2) If the proceeding involves an order--
(i) The notice of opportunity for hearing;
(ii) The requests for hearing filed by the Division of Dockets
Management;
(iii) The transcripts, minutes of meetings, reports, Federal
Register notices, and other documents constituting the record of any of
the optional procedures specified in Sec. 12.24(c) used by the
Commissioner, but not the transcript of a closed portion of a public
advisory committee meeting; and
(iv) The notice denying the hearing.
(c) The record specified in paragraph (b) of this section is the
exclusive record for the Commissioner's decision on the complete or
partial denial of a hearing. The record of the proceeding will be closed
as of the date of the Commissioner's decision unless another date is
specified. A person who requested and was denied a hearing may submit a
petition for reconsideration under Sec. 10.33 or a petition for stay of
action under Sec. 10.35. A person who wishes to rely upon information
or views not included in the administrative record shall submit them to
the Commissioner with a petition under Sec. 10.25(a) to modify the
final regulation or order.
(d) Denial of a request for a hearing in whole or in part is final
agency action reviewable in the courts, under the statutory provisions
governing the matter involved, as of the date of publication of the
denial in the Federal Register.
(1) Before requesting a court for a stay of action pending review, a
person shall first submit a petition for a stay of action under Sec.
10.35.
(2) Under 28 U.S.C. 2112(a), FDA will request consolidation of all
petitions on a particular matter.
(3) The time for filing a petition for judicial review of a denial
of a hearing on an objection or issue begins on the date the denial is
published in the Federal Register, (i) When an objection or issues
relates to a regulation, if a hearing is denied on all objections and
issues concerning a part of the proposal the effectiveness of which has
not been deferred pending a hearing on other parts of the proposal; or
(ii) when an issue relates to an order, if a hearing is denied on all
issues relating to a particular new drug application, new animal drug
application, device premarket approval application or product
development protocol, or biologics license. The failure to file a
petition for judicial review within the period established in the
statutory provision governing the matter involved constitutes a waiver
of the right to judicial review of the objection or issue, regardless
whether a hearing has been granted on other objections and issues.
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