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§12.80. Filing and service of submissions. — Inbound Citations

21 C.F.R. § 12.80

Cited by 3 regulations in release Current.

Citations to 21 C.F.R. § 12.80 as a whole

  • (6) The failure to comply with the requirements of this part or with § 12.80 or § 13.20 will result in rejection of the submission for filing or, if it is filed, in exclusion from consideration of any portion that fails to comply. If a submission fails to meet any requirement of this section and the deficiency becomes known to theDockets Management Staff, the Dockets Management Staff shall not file the submission but return it with a copy of the applicable regulations indicating those provisions not complied with. A deficient submission may be corrected or supplemented and subsequently filed. The office of the Dockets Management Staff does not make decisions regarding the confidentiality of submitted documents.
  • (2) Participants shall bring to the prehearing conference the following specific information, which will be filed with the Dockets Management Staff under § 12.80:
    (i) Any additional information to supplement the submission filed under § 12.85, which may be filed if approved under § 12.85(c).
    (ii) A list of all witnesses whose testimony will be offered, orally or in writing, at the hearing, with a full curriculum vitae for each. Additional witnesses may later be identified, with the approval of the presiding officer, on a showing that the witness was not reasonably available at the time of the prehearing conference or the relevance of the witness' views could not reasonably have been foreseen at that time.
    (iii) All prior written statements including articles and any written statement signed or adopted, or a recording or transcription of an oral statement made, by persons identified as witnesses if—
    (a) The statement is available without making request of the witness or any other person;
    (b) The statement relates to the subject matter of the witness' testimony; and
    (c) The statement either was made before the time the person agreed to become a witness or has been made publicly available by the person.
  • (a) A motion on any matter relating to the proceeding is to be filed under § 12.80, and must include a draft order, except one made in the course of an oral hearing before the presiding officer.