Revisions to the General Safety Requirements for Biological Products

ICR 200303-0910-001

OMB: 0910-0504

Federal Form Document

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ICR Details
0910-0504 200303-0910-001
Historical Active
HHS/FDA
Revisions to the General Safety Requirements for Biological Products
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/09/2003
Retrieve Notice of Action (NOA) 03/05/2003
Approved. FDA shall monitor use of this process over the next 3 years to better estimate the burden in its next submission.
  Inventory as of this Action Requested Previously Approved
04/30/2006 04/30/2006
10 0 0
400 0 0
0 0 0

FDA is revising the administrative procedure to obtain an exemption because the General Safety Test (GST) may not be relevant or necessary for all biological products. FDA anticipate that manufacturers requesting exemptions would have a demonstrated record of GST compliance supported by long-term compliance with current good manufacturing procedures, well-documented in-process safety controls, and use of sophisticated analytical techniques to adequately characterize the final products and validate its safety. The Director, CBER, may grant the exemption if its determined that...

None
None


No

1
IC Title Form No. Form Name
Revisions to the General Safety Requirements for Biological Products

  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 10 0 0 10 0 0
Annual Time Burden (Hours) 400 0 0 400 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.
03/05/2003


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