Adverse Experience Reporting for Licensed Biological Product; and General Records

ICR 200807-0910-007

OMB: 0910-0308

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-07-14
ICR Details
0910-0308 200807-0910-007
Historical Active 200505-0910-001
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 09/23/2008
Retrieve Notice of Action (NOA) 07/21/2008
  Inventory as of this Action Requested Previously Approved
09/30/2011 36 Months From Approved 09/30/2008
98,732 0 22,324
895,663 0 493,522
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 licensed 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.

US Code: 42 USC 262 Name of Law: PHS Act
  
None

Not associated with rulemaking

  73 FR 8881 02/25/2008
73 FR 28486 05/16/2008
No

  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 98,732 22,324 0 54,536 21,872 0
Annual Time Burden (Hours) 895,663 493,522 0 0 402,141 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The estimated total annual burden for this information collection was 493,522 hours in 2005. The current increase to 895,639 burden hours is mostly attributed to the increase in the number of reports (total annual responses) submitted under 21 CFR 600.80.

$12,500,958
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
07/21/2008


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