(b) A request for an informal hearing may be denied, in whole or in part, if the presiding officer determines that no genuine and substantial issue of material fact has been raised by the material submitted. If the presiding officer determines that a hearing is not justified, written notice of the determination will be given to the owner, operator, or agent in charge of the facility explaining the reason for the denial.
SEC 507.73 Requirements applicable to an informal hearing.
If the owner, operator, or agent in charge of the facility requests an informal hearing, and FDA grants the request:
(a) The hearing will be held within 10 calendar days after the date the appeal is filed or, if applicable, within a timeframe agreed upon in writing by the owner, operator, or agent in charge of the facility and FDA.
(b) The presiding officer may require that a hearing conducted under this subpart be completed within 1 calendar day, as appropriate.
(c) FDA must conduct the hearing in accordance with part 16 of this chapter, except that:
(1) The order withdrawing an exemption under SUBSEC 507.62 and 507.65, rather than the notice under SEC 16.22(a) of this chapter, 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.
(2) A request for a hearing under this subpart must be addressed to the
(3) Section 507.75, rather than SEC 16.42(a) of this chapter, describes the FDA employees who preside at hearings under this subpart.
(4) 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.
(5) 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.
(6) No party shall have the right, under SEC 16.119 of this chapter to petition the Commissioner for reconsideration or a stay of the presiding officer's final decision.
(7) 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 of this chapter, 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 of this chapter, the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.
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