[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: 21CFR12.45]
[Page 120-121]
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 C Appearance and Participation
Sec. 12.45 Notice of participation.
(a) Within 30 days after publication of the notice of hearing under
Sec. 12.35, a person desiring to participate in a hearing is to file
with the Division of Dockets Management under Sec. 10.20 a
[[Page 121]]
notice of participation in the following form:
(Date)
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Notice of Participation
Docket No. ----
Under 21 CFR part 12, please enter the participation of:
(Name)_________________________________________________________________
(Street address)_______________________________________________________
(City and State)_______________________________________________________
(Telephone number)_____________________________________________________
Service on the above will be accepted by:
(Name)_________________________________________________________________
(Street address)_______________________________________________________
(City and State)_______________________________________________________
(Telephone number)_____________________________________________________
The following statements are made as part of this notice of
participation:
A. Specific interests. (A statement of the specific interest of the
person in the proceeding, including the specific issues of fact
concerning which the person desires to be heard. This part need not be
completed by a party to the proceeding.)
B. Commitment to participate. (A statement that the person will
present documentary evidence or testimony at the hearing and will comply
with the requirements of 21 CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry, with the requirements of 21 CFR
13.25.)
(Signed)_______________________________________________________________
(b) An amendment to a notice of participation should be filed with
the Division of Dockets Management and served on all participants.
(c) No person may participate in a hearing who has not filed a
written notice of participation or whose participation has been stricken
under paragraph (e) of this section.
(d) The presiding officer may permit the late filing of a notice of
participation upon a showing of good cause.
(e) The presiding officer may strike the participation of a person
for nonparticipation in the hearing or failure to comply with any
requirement of this subpart, e.g., disclosure of information as required
by Sec. 12.85 or the prehearing order issued under Sec. 12.92. Any
person whose participation is stricken may petition the Commissioner for
interlocutory review.
[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
Back to Top
© 2007 Betterchem Corp.
|
