REQUEST FOR CERTIFICATION OR TESTING OF AN ANTIBIOTIC BATCH

ICR 198108-0910-005

OMB: 0910-0007

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
0910-0007 198108-0910-005
Historical Active 197911-0910-008
HHS/FDA
REQUEST FOR CERTIFICATION OR TESTING OF AN ANTIBIOTIC BATCH
Revision of a currently approved collection   No
Regular
Approved without change 10/20/1981
Retrieve Notice of Action (NOA) 08/28/1981
Approved for a limited time in order to permit OMB to undertake a more thorough review of existing requirements.
  Inventory as of this Action Requested Previously Approved
05/31/1982 05/31/1982 09/30/1981
18,000 0 22,000
18,000 0 11,000
0 0 0

USED FOR REQUESTING CERTIFICATION OR RELEASE OF AN ANTIBIOTIC BATCH. CERTIFICATION OR RELEASE IS MANDATED FOR EVERY SUCH BATCH BY THE FD&C ACT UNLESS THE PRODUCT IS EXEMPTED BY REGULATION.

None
None


No

1
IC Title Form No. Form Name
REQUEST FOR CERTIFICATION OR TESTING OF AN ANTIBIOTIC BATCH FD 1677

  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 18,000 22,000 0 2,286 -6,286 0
Annual Time Burden (Hours) 18,000 11,000 0 -4,000 11,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes

$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.
08/28/1981


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