Adverse Experience Reporting for Licensed Biological Product; and General Records

ICR 200303-0910-003

OMB: 0910-0308

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
0910-0308 200303-0910-003
Historical Active 200012-0910-005
HHS/FDA
Adverse Experience Reporting for Licensed Biological Product; and General Records
Extension without change of a currently approved collection   No
Regular
Approved without change 05/02/2003
Retrieve Notice of Action (NOA) 03/14/2003
Approved for two years (change will be required for finalization of SADR rule) consistent with clarification in FDA memo of 4-29- 03.
  Inventory as of this Action Requested Previously Approved
07/31/2005 07/31/2005 05/31/2003
24,720 0 17,406
576,593 0 268,803
0 0 0

The AER requirements enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensedx biological products. The recordkeeping requirements serve preventative and remedial purposes by requesting accountability and traceability in each step from the manufacture to distribution and recall of products and by enabling FDA to perform meaningful inspections. Respondents to this collection of information are manufacturers of biological products.

None
None


No

1
IC Title Form No. Form Name
Adverse Experience Reporting for Licensed Biological Product; and General Records

  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 24,720 17,406 0 0 7,314 0
Annual Time Burden (Hours) 576,593 268,803 0 0 307,790 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.
03/14/2003


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