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§12.45. Notice of participation. — Inbound Citations

21 C.F.R. § 12.45

Cited by 8 regulations in release Current.

Citations to 21 C.F.R. § 12.45 as a whole

  • (4) All notices of participation filed under § 12.45;
  • (ii) A notice of participation under § 12.45 should be filed; and
  • (7) The time within which notices of participation should be filed under § 12.45.
  • (a) A person who has filed a notice of participation under § 12.45 may appear in person or by counsel or other representative in any hearing and, subject to § 12.89, may be heard concerning all relevant issues.
  • (1) To expedite the hearing, participants are encouraged to prepare in advance for the prehearing conference. Participants should cooperate with each other, and request information and begin preparation of testimony at the earliest possible time. Failure of a participant to appear at the prehearing conference or to raise matters that could reasonably be anticipated and resolved at that time will not delay the progress of the hearing, and constitutes a waiver of the rights of the participant regarding such matters as objections to the agreements reached, actions taken, or rulings issued by the presiding officer and may be grounds for striking the participation under § 12.45.

Citations to §12.45(a)

  • (8) The date, time, and place of the prehearing conference, or a statement that the date, time, and place will be announced in a later notice. The pre-hearing conference may not commence until after the time expires for filing the notice of participation required by § 12.45(a).

Citations to §12.45(e)