Source: https://www.federalregister.gov/documents/2005/11/16/05-22753/agency-information-collection-activities-proposed-collection-comment-request-filing-objections-and
Timestamp: 2017-08-21 11:42:10
Document Index: 157443704

Matched Legal Cases: ['art 12', 'art 12', '§\u200912', '§\u200912', '§\u200912', '§\u200912']

Submit written or electronic comments on the collection of information by January 17, 2006.
https://www.federalregister.gov/d/05-22753 https://www.federalregister.gov/d/05-22753
Under part 12 (21 CFR part 12), § 12.22, issued under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(2)), sets forth the instructions for filing objections and requests for a hearing on a regulation or order under § 12.20(d). Objections and requests must be submitted within the time specified in § 12.20(e). Each objection for which a hearing has been requested must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. 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.
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The burden estimate for this collection of information is based on past filings. Agency personnel responsible for processing the filing of objections and requests for a public hearing on a specific regulation or order estimate approximately 10 requests are received by the agency annually, with each requiring approximately 20 hours of preparation time.
[FR Doc. 05-22753 Filed 11-15-05; 8:45 am]