Well-Characterized Biotechnology Products, Elimination of Establishment License Application

ICR 199601-0910-004

OMB: 0910-0316

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0316 199601-0910-004
Historical Active
HHS/FDA
Well-Characterized Biotechnology Products, Elimination of Establishment License Application
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/22/1996
Retrieve Notice of Action (NOA) 01/24/1996
OMB approves this package contingent upon FDA making the changes outlined in the correspondence of March 20, 1996. In addition, OMB notes that FDA is in the process of consolidating approximately 20 forms, including this form, into one, and that the estimated timeline for this consolidation is presented in the correspondence of March 22, 1996. OMB will review the FDA form consolidation package and expects FDA to shift the burden numbers associated with each individual form to the consolidation package to avoid double-counting and to permit the greatest flexibility.
  Inventory as of this Action Requested Previously Approved
03/31/1999 03/31/1999
15 0 0
600 0 0
0 0 0

FDA is proposing to amend the biologics regulations to eliminate the establishment license application requirement for well-characterized biotechnology products licensed under the Public Health Service Act.

None
None


No

1
IC Title Form No. Form Name
Well-Characterized Biotechnology Products, Elimination of Establishment License Application

  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 15 0 0 15 0 0
Annual Time Burden (Hours) 600 0 0 600 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.
01/24/1996


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