REQUEST FOR SUPPLEMENTAL CERTIFICATION OF A BATCH OF ANTIBIOTIC DRUGS

ICR 198107-0910-002

OMB: 0910-0009

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
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ICR Details
0910-0009 198107-0910-002
Historical Active 197912-0910-001
HHS/FDA
REQUEST FOR SUPPLEMENTAL CERTIFICATION OF A BATCH OF ANTIBIOTIC DRUGS
No material or nonsubstantive change to a currently approved collection   No
Emergency 07/17/1981
Approved with change 07/17/1981
Retrieve Notice of Action (NOA) 07/17/1981
  Inventory as of this Action Requested Previously Approved
07/31/1984 07/31/1984 10/31/1984
150 0 150
75 0 75
0 0 0

THE SUPPLEMENTAL CERTIFICATION PROCEDURE RELIEVES ANTIBIOTIC RELABELERS FROM TESTING THE BATCHES AND FROM FDA CONFIRMATORY TESTING WHICH WOULD OTHERWISE BE NECESSARY.

None
None


No

1
IC Title Form No. Form Name
REQUEST FOR SUPPLEMENTAL CERTIFICATION OF A BATCH OF ANTIBIOTIC DRUGS FD 1679

  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 150 150 0 0 0 0
Annual Time Burden (Hours) 75 75 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.
07/17/1981


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