Biological Product Regulated under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License

ICR 200208-0910-006

OMB: 0910-0427

Federal Form Document

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Document
Name
Status
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ICR Details
0910-0427 200208-0910-006
Historical Active 199910-0910-006
HHS/FDA
Biological Product Regulated under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 08/30/2002
Retrieve Notice of Action (NOA) 08/30/2002
  Inventory as of this Action Requested Previously Approved
08/31/2002 08/31/2002 12/31/2002
136 0 136
96,608 0 96,608
0 0 0

The final rule amends the regulations for filing an application to market a biological product under section 601.2 to eliminate the references to establishment licenses (ELA) and product licenses (PLA) for all products regulated under the PHS Act. The final rule will require manufacturers to file a single biologics license application (BLA), rather than an ELA and PLA to market a biological product.

None
None


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 136 136 0 0 0 0
Annual Time Burden (Hours) 96,608 96,608 0 0 0 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.
08/30/2002


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