[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
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 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)_________________________________________________________________

[[Page 121]]

 (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]