[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: 21CFR12.22]
[Page 115-116]
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. 12.22 Filing objections and requests for a hearing on a regulation or order.
(a) Objections and requests for a hearing under Sec. 12.20(d) must
be submitted to the Division of Dockets Management and will be accepted
for filing if they meet the following conditions:
(1) They are submitted within the time specified in Sec. 12.20(e).
(2) Each objection is separately numbered.
(3) Each objection specifies with particularity the provision of the
regulation or proposed order objected to.
(4) Each objection on which a hearing is requested specifically so
states. Failure to request a hearing on an objection constitutes a
waiver of the right to a hearing on that objection.
[[Page 116]]
(5) Each objection for which a hearing is requested includes a
detailed description and analysis of the factual information to be
presented in support of the objection. Failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection. The description and analysis may be used only
for the purpose of determining whether a hearing has been justified
under Sec. 12.24, and do not limit the evidence that may be presented
if a hearing is granted.
(i) A copy of any report, article, survey, or other written document
relied upon must be submitted, except if the document is--
(a) An FDA document that is routinely publicly available; or
(b) A recognized medical or scientific textbook that is readily
available to the agency.
(ii) A summary of the nondocumentary testimony to be presented by
any witnesses relied upon must be submitted.
(b) Requests for hearing submitted under Sec. 12.21 will be
submitted to the Division of Dockets Management and will be accepted for
filing if they meet the following conditions:
(1) They are submitted on or before the 30th day after the date of
publication of the notice of opportunity for hearing.
(2) They comply with Sec. Sec. 314.200, 514.200, or 601.7(a).
(c) If an objection or request for a public hearing fails to meet
the requirements of this section and the deficiency becomes known to the
Division of Dockets Management, the Division of Dockets Management shall
return it with a copy of the applicable regulations, indicating those
provisions not complied with. A deficient objection or request for a
hearing may be supplemented and subsequently filed if submitted within
the 30-day time period specified in Sec. 12.20(e) or Sec. 12.21(b).
(d) If another person objects to a regulation issued in response to
a petition submitted under Sec. 12.20(a)(2), the petitioner may submit
a written reply to the Division of Dockets Management.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 69190, Dec. 10, 1999]
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