21 CFR §12.45

1. (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 Dockets Management Staff under § 10.20 a notice of participation in the following form:
2. (b)An amendment to a notice of participation should be filed with the Dockets Management Staff and served on all participants.
3. (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.
4. (d)The presiding officer may permit the late filing of a notice of participation upon a showing of good cause.
5. (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.