FILING OBJECTIONS AND REQUESTS FOR A HEARING ON A REGULATION OR ORDER -- 21 CFR PART 12

ICR 199305-0910-003

OMB: 0910-0184

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0184 199305-0910-003
Historical Active 199003-0910-001
HHS/FDA
FILING OBJECTIONS AND REQUESTS FOR A HEARING ON A REGULATION OR ORDER -- 21 CFR PART 12
Extension without change of a currently approved collection   No
Regular
Approved without change 08/06/1993
Retrieve Notice of Action (NOA) 05/04/1993
  Inventory as of this Action Requested Previously Approved
08/31/1996 08/31/1996 07/31/1993
60 0 60
1,200 0 1,200
0 0 0

TO FACILITATE RULING ON OBJECTION TO AGENCY ACTION AND REQEST FOR A HEARING, FDA REQUIRES THAT EACH OBJECTION BE SEPARATELY NUMBERED AND, IF A HEARING IS REQUESTED ON IT, ACCOMPANIED BY A DETAILED DESCRIPTION AND ANALYSIS OF FACTUAL INFORMATION TO BE PRESENTED IN SUPPORT OF THE OBJECTION.

None
None


No

1
IC Title Form No. Form Name
FILING OBJECTIONS AND REQUESTS FOR A HEARING ON A REGULATION OR ORDER -- 21 CFR PART 12

  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 60 60 0 0 0 0
Annual Time Burden (Hours) 1,200 1,200 0 0 0 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.
05/04/1993


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