REQUEST FOR CERTIFICATION OF AN INSULIN BATCH

ICR 198711-0910-006

OMB: 0910-0181

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
109784
Migrated
ICR Details
0910-0181 198711-0910-006
Historical Active 198603-0910-011
HHS/FDA
REQUEST FOR CERTIFICATION OF AN INSULIN BATCH
Revision of a currently approved collection   No
Regular
Approved without change 02/04/1988
Retrieve Notice of Action (NOA) 11/18/1987
This information collection request is approved for one year subject to the following: FDA will re-examine the need for its own duplicative batch testing and will within this time frame, initiate a rulemaking to allow batch certification by qualified manufacturers as an alternative to testing.
  Inventory as of this Action Requested Previously Approved
01/31/1990 01/31/1990 10/31/1987
426 0 3
533 0 582
0 0 0

ANALYTICAL DATA PREREQUISITE FOR BATCH CERTIFICATION WITHOUT WHICH THE BATCH CANNOT LEGALLY BE DISTRIBUTED. PROGRAM IS MANDATED BY STATUTE AND IS SELF-SUPPORTING THROUGH FEES.

None
None


No

1
IC Title Form No. Form Name
REQUEST FOR CERTIFICATION OF AN INSULIN BATCH

  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 426 3 0 0 423 0
Annual Time Burden (Hours) 533 582 0 0 -49 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.
11/18/1987


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