[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: 21CFR12.22]

[Page 126-127]
 
                        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 Dockets Management Branch 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.
    (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 Dockets Management Branch 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 Secs. 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 
Dockets Management Branch, the Dockets Management Branch shall return it 
with a copy of the applicable regulations, indicating those provisions 
not complied

[[Page 127]]

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 Dockets Management Branch.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 
FR 69190, Dec. 10, 1999]