Request for Samples and Protocols, Official Release -- 21 CFR 610.2

ICR 199709-0910-006

OMB: 0910-0206

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
0910-0206 199709-0910-006
Historical Active 199509-0910-011
HHS/FDA
Request for Samples and Protocols, Official Release -- 21 CFR 610.2
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 11/19/1997
Retrieve Notice of Action (NOA) 09/25/1997
This collection expired in 3/96. Therefore, any collections since that date have been in violation of the Paperwork Reduction Act of 1995.
  Inventory as of this Action Requested Previously Approved
11/30/2000 11/30/2000
6,500 0 0
19,500 0 0
0 0 0

This regulation requests samples and protocols of biological products and allows official release of such. The regulations are designed to assure safety, purity, and potency of such products and to assure that licenses for new products are only issued when a product meets the standards.

None
None


No

1
IC Title Form No. Form Name
Request for Samples and Protocols, Official Release -- 21 CFR 610.2

  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 6,500 0 0 6,500 0 0
Annual Time Burden (Hours) 19,500 0 0 19,500 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.
09/25/1997


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