Source: https://www.federalregister.gov/documents/2012/03/16/2012-6392/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-11-24 00:42:34
Document Index: 514672075

Matched Legal Cases: ['§\u200910', '§\u200910', '§\u200910', '§\u200910', '§\u200910', '§\u200910', '§\u200910']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
Fax written comments on the collection of information by April 16, 2012.
77 FR 15762
2012-6392
FDA-2011-N-0627
https://www.federalregister.gov/d/2012-6392 https://www.federalregister.gov/d/2012-6392
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0183. Also include the FDA docket number found in brackets in the heading of this document.
The Administrative Procedures Act (5 U.S.C. 553(e)), provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (21 CFR 10.20) (submission of documents to Division of Dockets Management), a citizen petition requesting the Commissioner of FDA (the Commissioner) to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.
The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33) issued under section 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under 21 CFR 10.25 (initiation of administrative proceedings). A petition for reconsideration must contain a full statement in a well-organized format of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 days after the decision involved. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant the petition for reconsideration. Respondents to this collection of information are individuals of households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions who are requesting from the Commissioner a reconsideration of a matter.
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the FD&C Act, sets forth 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.
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the FD&C Act sets forth the format and procedures by which an interested person may request, in accordance with § 10.20, an advisory opinion from the Commissioner on a matter of general applicability. An advisory opinion represents the formal position of FDA on a matter of general applicability. When making a request, the petitioner must provide a concise statement of the issues and questions on which an opinion is requested, and a full statement of the facts and legal points relevant to the request. Respondents to this collection of information are interested persons seeking an advisory opinion from the Commissioner on the Agency's formal position for matters of general applicability.
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the Federal Register of September 7, 2011 (76 FR 55396), to which the Agency received one comment. However, this comment did not address the information collection.
The burden estimates for this collection of information are based on Agency records and experience over the past 3 years. In 2010, FDA received approximately 207 petitions (§ 10.30), 4 administrative reconsiderations of action (§ 10.33), 5 administrative stays of action (§ 10.35), and 4 advisory opinions (§ 10.85).
[FR Doc. 2012-6392 Filed 3-15-12; 8:45 am]