Adverse Experience Reporting for Licensed Biological Products and General Records -- 21 CFR 600

ICR 199903-0910-001

OMB: 0910-0308

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0308 199903-0910-001
Historical Active 199503-0910-002
HHS/FDA
Adverse Experience Reporting for Licensed Biological Products and General Records -- 21 CFR 600
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 05/10/1999
Retrieve Notice of Action (NOA) 03/08/1999
This collection is approved for two years on the condition that FDA continue to work with OMB and outside parties to coordinate and revise the various adverse reporting requirements.
  Inventory as of this Action Requested Previously Approved
05/31/2001 05/31/2001
3,212 0 0
342,132 0 0
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.

None
None


No

1
IC Title Form No. Form Name
Adverse Experience Reporting for Licensed Biological Products and General Records -- 21 CFR 600

  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 3,212 0 0 3,212 0 0
Annual Time Burden (Hours) 342,132 0 0 342,132 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.
03/08/1999


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