Title 21

SECTION 12.22

12.22 Filing objections and requests for a hearing on a regulation or order.

§ 12.22 Filing objections and requests for a hearing on a regulation or order.

(a) Objections and requests for a hearing under § 12.20(d) must be submitted to the Division of Dockets Management and will be accepted for filing if they meet the following conditions:

(1) They are submitted within the time specified in § 12.20(e).

(2) Each objection is separately numbered.

(3) Each objection specifies with particularity the provision of the regulation or proposed order objected to.

(4) Each objection on which a hearing is requested specifically so states. Failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection.

(5) Each objection for which a hearing is requested includes a detailed description and analysis of the factual information to be presented in support of the objection. Failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under § 12.24, and do not limit the evidence that may be presented if a hearing is granted.

(i) A copy of any report, article, survey, or other written document relied upon must be submitted, except if the document is -

(a) An FDA document that is routinely publicly available; or

(b) A recognized medical or scientific textbook that is readily available to the agency.

(ii) A summary of the nondocumentary testimony to be presented by any witnesses relied upon must be submitted.

(b) Requests for hearing submitted under § 12.21 will be submitted to the Division of Dockets Management and will be accepted for filing if they meet the following conditions:

(1) They are submitted on or before the 30th day after the date of publication of the notice of opportunity for hearing.

(2) They comply with §§ 314.200, 514.200, or 601.7(a).

(c) If an objection or request for a public hearing fails to meet the requirements of this section and the deficiency becomes known to the Division of Dockets Management, the Division of Dockets Management shall return it with a copy of the applicable regulations, indicating those provisions not complied with. A deficient objection or request for a hearing may be supplemented and subsequently filed if submitted within the 30-day time period specified in § 12.20(e) or § 12.21(b).

(d) If another person objects to a regulation issued in response to a petition submitted under § 12.20(a)(2), the petitioner may submit a written reply to the Division of Dockets Management.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10, 1999]

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