Request for Samples and Protocols

ICR 200908-0910-001

OMB: 0910-0206

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-07-16
IC Document Collections
ICR Details
0910-0206 200908-0910-001
Historical Active 200607-0910-001
HHS/FDA
Request for Samples and Protocols
Extension without change of a currently approved collection   No
Regular
Approved without change 09/15/2009
Retrieve Notice of Action (NOA) 08/05/2009
  Inventory as of this Action Requested Previously Approved
09/30/2012 36 Months From Approved 09/30/2009
6,314 0 4,930
19,155 0 15,019
0 0 0

FDA may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot with the protocols showing the results of the applicable tests prior to distributing 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 of lot-to-lot variability of a product produced from living organisms.

US Code: 42 USC 262 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  74 FR 9820 03/06/2009
74 FR 37714 07/29/2009
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 6,314 4,930 0 0 1,384 0
Annual Time Burden (Hours) 19,155 15,019 0 0 4,136 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$871,332
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
08/05/2009


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