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:
(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.
(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.