TRANSMITTAL OF PERIODIC REPORTS FOR DRUGS FOR HUMAN USE

ICR 198207-0910-005

OMB: 0910-0017

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
165352 Migrated
ICR Details
0910-0017 198207-0910-005
Historical Active 197905-0910-001
HHS/FDA
TRANSMITTAL OF PERIODIC REPORTS FOR DRUGS FOR HUMAN USE
No material or nonsubstantive change to a currently approved collection   No
Emergency 07/16/1982
Approved with change 07/16/1982
Retrieve Notice of Action (NOA) 07/16/1982
  Inventory as of this Action Requested Previously Approved
06/30/1984 06/30/1984 06/30/1984
3,500 0 3,500
48,744 0 1,750
0 0 0

REPORTS ARE REVIEWED BY FDA TO DETERMINE IF ACTION TO CHANGE APPROVAL STATUS AND/OR LABELING OF A DRUG IS WARRANTED.

None
None


No

1
IC Title Form No. Form Name
TRANSMITTAL OF PERIODIC REPORTS FOR DRUGS FOR HUMAN USE FD-2252

  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 3,500 3,500 0 0 0 0
Annual Time Burden (Hours) 48,744 1,750 0 0 46,994 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.
07/16/1982


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