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Federal forms, ICRs, and supporting documents

Information Collection Request

Request for Samples and Protocols

ICR 201509-0910-008 · OMB 0910-0206 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-09-21
IC Document Collections
IC ID
Document
Title
Status
43599
Modified
190202
Modified
190201
Modified
190200
Modified
ICR Details
0910-0206 201509-0910-008
Historical Active 201207-0910-005
HHS/FDA CBER
Request for Samples and Protocols
Extension without change of a currently approved collection   No
Regular
Approved without change 12/09/2015
Retrieve Notice of Action (NOA) 09/24/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2015
6,217 0 6,827
18,692 0 20,572
0 0 0
Samples and protocols are required by FDA to help ensure the safety, purity, and potency of a product because of the potential lot-to-lot variability of a product produced from living organisms. In cases of certain biological products (e.g., Albumin, Plasma Protein Fraction, and therapeutic biological products) that are known to have lot-to-lot consistency, official lot release is not normally required. However, submissions of samples and protocols of these products may still be required for surveillance, licensing, and export purposes, or in the event that FDA obtains information that the manufacturing process may not result in consistent product quality. The written protocols are reviewed by FDA scientists and other staff with expertise in the appropriate product and scientific area. FDA tests samples to verify the manufacturer's test results. A manufacturer may not distribute a product until FDA gives the official release for the lot.
US Code: 42 USC 262 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  80 FR 16393 03/27/2015
80 FR 57194 09/22/2015
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 6,217 6,827 0 0 -610 0
Annual Time Burden (Hours) 18,692 20,572 0 0 -1,880 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The previous burden estimate was 20,572 hours. The current decrease to 18,692 hours (-1,880 hours) is mostly due to a decrease in the total annual responses under section 610.2 (~600 responses). The slight decrease in burden is attributed to the normal variation in the submission of samples and protocols to FDA.
$932,550
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
  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.
09/24/2015