non-human data

(3) Hearings; judicial review (A) In general Only a person who participated in each stage of formal dispute resolution under subclause (III) of paragraph (2)(A)(iv) of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug. If a hearing is sought, such person must submit a request for a hearing, which shall be based solely on information in the administrative record, to the Secretary not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure. (B) No hearing required with respect to orders relating to certain drugs (i) In general The Secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph (2)(A)(iv) if the final administrative order involved relates to a drug— (I) that is described in subsection (a)(3)(A); and (II) with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug. (ii) Human data studies and non-human data defined In this subparagraph: (I) The term “human data studies” means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies. (II) The term “non-human data” means data from testing other than with human subjects which provides information concerning safety or effectiveness. (C) Hearing procedures (i) Denial of request for hearing If the Secretary determines that information submitted in a request for a hearing under subparagraph (A) with respect to a final administrative order issued under paragraph (2)(A)(iv) does not identify the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies. (ii) Single hearing for multiple related requests If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate. (iii) Presiding officer The presiding officer of a hearing requested under subparagraph (A) shall— (I) be designated by the Secretary; (II) not be an employee of the Center for Drug Evaluation and Research; and (III) not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order. (iv) Rights of parties to hearing The parties to a hearing requested under subparagraph (A) shall have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties. Where appropriate, the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication. (v) Final decision (I) At the conclusion of a hearing requested under subparagraph (A), the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law. The decision of the presiding officer shall be final. (II) The final decision may not take effect until the period under subparagraph (D)(ii) for submitting a request for judicial review of such decision expires. (D) Judicial review of final administrative order (i) In general The procedures described in section 355(h) of this title shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the United States in lieu of the appellate courts specified in such section. (ii) Period to submit a request for judicial review A person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than 60 calendar days after the latest of— (I) the date on which notice of such order is published; (II) the date on which a hearing with respect to such order is denied under subparagraph (B) or (C)(i); (III) the date on which a final decision is made following a hearing under subparagraph (C)(v); or (IV) if no hearing is requested, the date on which the time for requesting a hearing expires.


21 USC § 355h(b)(3)

Scoping language

In this subparagraph
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