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

ICR 201405-0910-026

OMB: 0910-0183

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-06-05
IC Document Collections
IC ID
Document
Title
Status
5781
Modified
188665
Unchanged
188664
Unchanged
188663
Modified
ICR Details
0910-0183 201405-0910-026
Historical Active 201203-0910-006
HHS/FDA OC
General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
Revision of a currently approved collection   No
Regular
Approved without change 08/27/2014
Retrieve Notice of Action (NOA) 06/12/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2014
220 0 220
5,122 0 5,122
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. 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 Sec. 10.20 (21 CFR 10.20) (submission of documents to Division of Dockets Management), 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
  
None

Not associated with rulemaking

  79 FR 15594 03/20/2014
79 FR 32552 06/05/2014
No

4
IC Title Form No. Form Name
Citizen Petition
Administrative Reconsideration of Action
Administrative Stay of Action
Advisory Opinions

  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 220 220 0 0 0 0
Annual Time Burden (Hours) 5,122 5,122 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$247,649
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  No

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.
06/12/2014


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