Filing Objections and Requests for a Hearing on a Regulation or Order

ICR 200212-0910-005

OMB: 0910-0184

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0184 200212-0910-005
Historical Active 200002-0910-004
HHS/FDA
Filing Objections and Requests for a Hearing on a Regulation or Order
Extension without change of a currently approved collection   No
Regular
Approved without change 02/03/2003
Retrieve Notice of Action (NOA) 12/23/2002
  Inventory as of this Action Requested Previously Approved
02/28/2006 02/28/2006 03/31/2003
10 0 60
200 0 1,200
0 0 0

Section 12.22 (21 CFR 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 Sec. 12.20(d)(21 CFR 12.20(d)). Objections and requests must be submitted within the time specified in Sec. 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.

None
None


No

1
IC Title Form No. Form Name
Filing Objections and Requests for a Hearing on a Regulation or Order

  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 10 60 0 0 -50 0
Annual Time Burden (Hours) 200 1,200 0 0 -1,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
12/23/2002


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