21 C.F.R. Subpart E—Administrative Record and Decision
Title 21 - Food and Drugs
(a) The administrative record of the regulatory hearing consists of the following: (1) The notice of opportunity for hearing and the response. (2) All written information and views submitted to the presiding officer at the hearing or after if specifically permitted by the presiding officer. (3) Any transcript of the hearing. (4) The presiding officer's report of the hearing and comments on the report under §16.60(e). (5) All letters and memoranda of meetings or communications between participants and the presiding officer or the Commissioner referred to in §16.44(c). (b) The record of the regulatory hearing is closed to the submission of information and views, at the close of the hearing, unless the presiding officer specifically permits additional time for a further submission. Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a regulatory hearing. (a) With respect to a regulatory hearing at the Commissioner's initiative under §16.1(a), the Commissioner shall consider the administrative record of the hearing specified in §16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form. (b) With respect to a regulatory hearing required by the act or a regulation under §16.1(b)— (1) The administrative record of the hearing specified in §16.80(a) constitutes the exclusive record for decision; (2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and (3) For purposes of judicial review under §10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.
Title 21: Food and Drugs
PART 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
Subpart E—Administrative Record and Decision
§ 16.80 Administrative record of a regulatory hearing.
§ 16.85 Examination of administrative record.
§ 16.95 Administrative decision and record for decision.
