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

ICR 199910-0910-006

OMB: 0910-0427

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0427 199910-0910-006
Historical Active
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
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/29/1999
Retrieve Notice of Action (NOA) 10/21/1999
This collection is approved as amended by FDA's revisions of 12/9/99.
  Inventory as of this Action Requested Previously Approved
12/31/2002 12/31/2002
136 0 0
96,608 0 0
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 0 0 136 0 0
Annual Time Burden (Hours) 96,608 0 0 96,608 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.
10/21/1999


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