General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling; and Revocation and Suspension

ICR 200206-0910-007

OMB: 0910-0338

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0338 200206-0910-007
Historical Active 200002-0910-002
HHS/FDA
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling; and Revocation and Suspension
Extension without change of a currently approved collection   No
Regular
Approved with change 08/20/2002
Retrieve Notice of Action (NOA) 06/19/2002
Approved consistent with clarifications and changes in FDA memos of 8-9-02 and 8-16-02 and revised 83-I and supporting statement attached.
  Inventory as of this Action Requested Previously Approved
09/30/2005 09/30/2005 03/31/2003
5,715 0 21,252
301,752 0 602,856
349,000 0 0

The PHS Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. Manufacturers must also submit to FDA supplementals to an approved application, and advertising and promotional labeling. There are also requirements regarding suspension and revocation of a license.

None
None


No

1
IC Title Form No. Form Name
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling; and Revocation and Suspension FDA-2567, FDA-356H

  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 5,715 21,252 0 0 -15,537 0
Annual Time Burden (Hours) 301,752 602,856 0 0 -301,104 0
Annual Cost Burden (Dollars) 349,000 0 0 349,000 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.
06/19/2002


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