Proposed SEC 507.73(b) would establish that the presiding officer may require that a hearing conducted under this subpart E be completed within 1 calendar day, if appropriate. The Agency tentatively concludes that, if it grants a request for an informal hearing, limiting the time for the hearing itself to be completed within 1 calendar day is appropriate for purposes of the efficient adjudication of the appeal of a withdrawal order and would provide reasonable due process that would come to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if the Agency denies the appeal.
Proposed SEC 507.73(c)(1) through (c)(7) would establish that, if the owner, operator or agent in charge of the facility requests an informal hearing, and FDA grants the request, FDA must conduct the hearing in accordance with part 16, except that:
* The order withdrawing an exemption under SUBSEC 507.62 and 507.65, rather than the notice under SEC 16.22(a), provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under SEC 16.80(a) of this chapter.
* A request for a hearing under this subpart D must be addressed to the
* Section 507.75, rather than SEC 16.42(a), describes the FDA employees who preside at hearings under this subpart.
* Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 2 calendar days of issuance of the report. The presiding officer will then issue the final decision.
* Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this subpart. The presiding officer's report of the hearing and any comments on the report by the hearing participant under SEC 507.73(c)(4) are part of the administrative record.
* No party shall have the right, under SEC 16.119 of this chapter to petition the Commissioner of Food and Drugs for reconsideration or a stay of the presiding officer's final decision.
* If FDA grants a request for an informal hearing on an appeal of an order withdrawing an exemption, the hearing must be conducted as a regulatory hearing under part 16, except that SEC 16.95(b) does not apply to a hearing under this subpart. With respect to a regulatory hearing under this subpart, the administrative record of the hearing specified in SUBSEC 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 507.73(c)(5) constitutes the exclusive record for the presiding officer's final decision. For purposes of judicial review under SEC 10.45 (21 CFR 10.45), the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.
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