TRANSMITTAL OF LABELS AND CIRCULARS

ICR 198506-0910-004

OMB: 0910-0039

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
109438 Migrated
ICR Details
0910-0039 198506-0910-004
Historical Active 198206-0910-001
HHS/FDA
TRANSMITTAL OF LABELS AND CIRCULARS
Revision of a currently approved collection   No
Regular
Approved without change 08/20/1985
Retrieve Notice of Action (NOA) 06/26/1985
  Inventory as of this Action Requested Previously Approved
08/31/1988 08/31/1988 08/31/1985
2,940 0 3,000
490 0 500
0 0 0

LABELS AND CIRCULARS FOR BIOLOGICAL PRODUCTS MUST BE REVIEWED AND APPROVED BY THE OFFICE OF BIOLOGICS RESEARCH AND REVIEW PRIOR TO MARKETING OF THE LICENSED PRODUCT.

None
None


No

1
IC Title Form No. Form Name
TRANSMITTAL OF LABELS AND CIRCULARS FD 2567

  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 2,940 3,000 0 0 -60 0
Annual Time Burden (Hours) 490 500 0 0 -10 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.
06/26/1985


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