Source: https://www.federalregister.gov/articles/2009/01/21/E9-937/draft-guidance-for-industry-on-citizen-petitions-and-petitions-for-stay-of-action-subject-to-section
Timestamp: 2014-04-19 14:30:12
Document Index: 574907449

Matched Legal Cases: ['§ 10', '§ 10', '§ 10', '§ 10', '§ 10', '§ 10', '§ 10']

Federal Register | Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability
Dates: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance, including comments regarding the proposed collection of information, by March 23, 2009.
-3614 (4 pages)
Document Number: E9-937
Shorter URL: https://federalregister.gov/a/E9-937 Regulations.gov Docket Info
Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
FDA currently has OMB approval for the collection of information entitled, “General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions” (OMB Control Number 0910-0183). This collection of information includes, among other things: (1) The format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (21 CFR 10.20), a citizen petition requesting the Commissioner of Food and Drugs (Commissioner) to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action (§ 10.30(b) (21 CFR 10.30(b))); (2) the submission of written comments on a filed citizen petition (§ 10.30(d)); (3) the submission of a supplement or amendment to or a letter to withdraw a filed citizen petition (§ 10.30(g)); (4) the format and procedures by which an interested person may request, in accordance with § 10.20, the Commissioner to stay the effective date of any administrative action (§ 10.35(b) (21 CFR 10.35(b))); and (5) the submission of written comments on a filed petition for administrative stay of action (§ 10.35(c)). This information collection includes citizen petitions, petitions for administrative stay of action, comments to petitions, supplements to citizen petitions, and letters to withdraw a citizen petition, as described above, that are subject to section 505(q) of the act and described in the draft guidance.
Based on FDA's knowledge of citizen petitions and petitions for stay of agency action subject to section 505(q) of the act that have been submitted since September 27, 2007, as well as the agency's familiarity with the time needed to prepare a certification and a verification, our estimates for this information collection are as follows:
Certification for citizen petitions
Certification for petitions for stay of agency action
Verification for comments to citizen petitions
Verification for comments to petitions for stay of agency action
Verification for supplements to citizen petitions
Supplements to petitions for stay of agency action and the verification for the supplement
Letter withdrawing a petition for stay of agency action