Well-Characterized Biotechnology Products, Elimination of

ICR 199704-0910-005

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
IC ID
Document
Title
Status
37630
Migrated
ICR Details
0910-0316 199704-0910-005
Historical Active 199601-0910-004
HHS/FDA
Well-Characterized Biotechnology Products, Elimination of
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 04/23/1997
Retrieve Notice of Action (NOA) 04/23/1997
  Inventory as of this Action Requested Previously Approved
04/30/1997 04/30/1997 03/31/1999
15 0 15
600 0 600
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

  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 15 0 0 0 0
Annual Time Burden (Hours) 600 600 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.
04/23/1997


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