Request for Samples and Protocols

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0206 9-21-2015.docx Supporting Statement A	2015-09-21

IC Document Collections

IC ID	Document Title	Status
43599	Lot Release Information Submission	Modified
190202	Lot Release Information Submission	Modified
190201	Lot Release Information Submission	Modified
190200	Lot Release Information Submission	Modified

ICR Details

OMB Control No: 0910-0206	ICR Reference No: 201509-0910-008
Status: Historical Active	Previous ICR Reference No: 201207-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Request for Samples and Protocols
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/09/2015
	Date Received in OIRA: 09/24/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	6,217	0	6,827
Time Burden (Hours)	18,692	0	20,572
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 16393	03/27/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 57194	09/22/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Lot Release Information Submission
Lot Release Information Submission
Lot Release Information Submission
Lot Release Information Submission

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $932,550

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/24/2015

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