Biological Products: Reporting of Biological Product Deviations in Manufacturing

ICR 200011-0910-001

OMB: 0910-0458

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0458 200011-0910-001
Historical Active
HHS/FDA
Biological Products: Reporting of Biological Product Deviations in Manufacturing
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 02/02/2001
Retrieve Notice of Action (NOA) 11/07/2000
  Inventory as of this Action Requested Previously Approved
02/29/2004 02/29/2004
60,751 0 0
261,648 0 0
0 0 0

FDA is requiring unlicensed registerd blood establishments and transfusion services, in addition to the current requirement for licensed manufacturers, to report all biological product deviations in manufacturing for distributed products. It provides a more accurate surveillance of the nation's blood supply, thereby enabling FDA to monitor actions taken in response to biological product deviations detected for all establishments; and facilitate a rapid response by FDA where public health may be at risk.

None
None


No

1
IC Title Form No. Form Name
Biological Products: Reporting of Biological Product Deviations in Manufacturing

  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 60,751 0 0 60,751 0 0
Annual Time Burden (Hours) 261,648 0 0 261,648 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.
11/07/2000


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