Request for Samples and Protocols

ICR 200607-0910-001

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
IC ID
Document
Title
Status
43599
Migrated
ICR Details
0910-0206 200607-0910-001
Historical Active 200305-0910-003
HHS/FDA
Request for Samples and Protocols
Extension without change of a currently approved collection   No
Regular
Approved without change 09/19/2006
Retrieve Notice of Action (NOA) 07/05/2006
  Inventory as of this Action Requested Previously Approved
09/30/2009 36 Months From Approved 09/30/2006
4,930 0 6,747
15,019 0 20,588
0 0 0

The regulations require samples of biological products along with protocols showing the results of applicable tests prior to marketing the lot of the product. This information is required by FDA to help ensure the safety, purity, and potency of the product due to the potential lot-to-lot variability of product produced from living organisms.

None
None


No

1
IC Title Form No. Form Name
Request for Samples and Protocols

  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 4,930 6,747 0 0 -1,817 0
Annual Time Burden (Hours) 15,019 20,588 0 0 -5,569 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.
07/05/2006


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