§13.20. Submissions to a Board. — Inbound Citations
21 C.F.R. § 13.20
Statutory Authority
Cited by 3 regulations in release Current.
Citations to 21 C.F.R. § 13.20 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.
-
(e) Within the time specified by the Board after its first hearing, participants may submit written rebuttal information and views in accordance with § 13.20. The Chariman will then schedule a second hearing, if requested and justified by a participant. A second hearing, and any subsequent hearing, will be called only if the Chairman concludes that it is needed to fully and fairly present information that cannot otherwise adequately be considered and to properly resolve the issues. Notice of the time and location of any hearing is to be published at least 15 days in advance. The hearing is open to the public.
-
(2) All written submissions under § 13.20.