General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions

ICR 200904-0910-002

OMB: 0910-0183

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0183 200904-0910-002
Historical Active 200602-0910-002
General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
Extension without change of a currently approved collection   No
Approved without change 05/29/2009
Retrieve Notice of Action (NOA) 04/02/2009
  Inventory as of this Action Requested Previously Approved
05/31/2012 36 Months From Approved 05/31/2009
510 0 516
6,084 0 6,108
0 0 0

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. Sectrion 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20) (submission of documents to the Dockets Management Branch), a citizen petition requesting the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.

US Code: 5 USC 553 Name of Law: Administrative Procedures Act
   US Code: 5 USC 552 Name of Law: Administrative Procedures Act

Not associated with rulemaking

  73 FR 79885 12/30/2008
74 FR 10255 03/10/2009

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 510 516 0 0 -6 0
Annual Time Burden (Hours) 6,084 6,108 0 0 -24 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Jonnalynn Capezzuto 3018274659


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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