Code of Federal Regulations Title 21. Food and Drugs § 21.12.45 Notice of participation

(a) Within 30 days after publication of the notice of hearing under § 12.35, a person desiring to participate in a hearing is to file with the Division of Dockets Management under § 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)

(Street address)

(City and State)

(Telephone number)

The following statements are made as part of this notice of participation:

(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 § 12.85 or the prehearing order issued under § 12.92. Any person whose participation is stricken may petition the Commissioner for interlocutory review.