Human Tissue Intended for Transplantation

Forms and Documents

Document Name	Status
0302 SUPPORTING STATEMENT FINAL 12-17-13.doc Supporting Statement A	2013-12-17

IC Document Collections

IC ID	Document Title	Status
5867	Written Procedures -- 1270.31(a), (b), (c), and (d)	Modified
179893	Specific Records -- 1270.35(d)	Modified
179892	Specific Records -- 1270.35(c)	Modified
179891	Records, General Requirements -- 1270.33(a), (f), and (h), and 1270.35(a) and (b)	Modified
179890	Written Procedures -- 1270.31(a) and (b)	Modified

ICR Details

OMB Control No: 0910-0302	ICR Reference No: 201312-0910-010
Status: Historical Active	Previous ICR Reference No: 201011-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 21075
Title: Human Tissue Intended for Transplantation
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: 01/27/2014
	Date Received in OIRA: 12/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	806,011	0	1,079,817
Time Burden (Hours)	806,770	0	1,080,760
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection requirements help prevent the transmission of communicable diseases through human tissue transplantation by requiring that written SOPs be prepared and followed for the following: (1) infectious disease testing; (2) determining the medical history of the donor; (3) designating and identifying quarantined tissue; and (4) preventing infectious disease contamination or cross-contamination of tissue during processing. The regulations require maintenance of records of all significant steps in the infectious disease testing, and screening, and require that these records be made available for FDA inspection. Adequate donor screening and testing must be recorded so that the suitability of the tissue can be determined. If FDA is unable to ascertain how a tissue donor was screened or tested, or if the tissue was distributed in violation of the regulations, then recall, retention, and/or destruction orders may be issued by FDA in accordance with codified administrative procedures.

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Authorizing Statute(s): US Code: 42 USC 264 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:
	78 FR 41403	07/10/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 72895	12/04/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Written Procedures -- 1270.31(a), (b), (c), and (d)
Records, General Requirements -- 1270.33(a), (f), and (h), and 1270.35(a) and (b)
Specific Records -- 1270.35(c)
Specific Records -- 1270.35(d)
Written Procedures -- 1270.31(a) and (b)

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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	806,011	1,079,817	0	0	-273,806	0
Annual Time Burden (Hours)	806,770	1,080,760	0	0	-273,990	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 in 2011 was 1,080,760 hours. The decrease in burden to 806,770 (-273,990) hours is mostly attributed to a decrease in the number of establishments and a corresponding decrease in the number of total annual records under all the listed regulations.

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Annual Cost to Federal Government: $401,850

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: 12/20/2013

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