Transmittal of Labels and Circulars

ICR 199709-0910-007

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
5693 Migrated
ICR Details
0910-0039 199709-0910-007
Historical Active 199509-0910-014
HHS/FDA
Transmittal of Labels and Circulars
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 11/19/1997
Retrieve Notice of Action (NOA) 09/25/1997
This collection expired in 5/96. Therefore, any collections since that date have been in violation of the Paperwork Reduction Act. The collection is approved on the condition that FDA add a burden statement, in accordance with the Paperwork Reduction Act, to the form. FDA shall send the revised form to OMB prior to its release.
  Inventory as of this Action Requested Previously Approved
11/30/2000 11/30/2000
2,800 0 0
448 0 0
0 0 0

FDA-2567 is completed by manufacturers of biological products when applying for a license for new product, when updating labeling information on a licensed biological product, or when an amended label or package insert is generated for a licensed product.

None
None


No

1
IC Title Form No. Form Name
Transmittal of Labels and Circulars FDA-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 2,800 0 0 2,800 0 0
Annual Time Burden (Hours) 448 0 0 448 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
09/25/1997


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