Human Tissue Intended for Transplantation

Forms and Documents

Document Name	Status
0910- 0302 Supporting Statement.doc Supporting Statement A	2010-11-04

IC Document Collections

IC ID	Document Title	Status
5867	1270.31(a), (b), (c), and (d)	Modified
179893	1270.35(d)	Modified
179892	1270.35(c)	Modified
179891	1270.33(a), (f), and (h), and 1270.35(a) and (b)	Modified
179890	1270.31(a) and (b)	Modified
179889	Human Tissue Intended for Transplantation	Removed

ICR Details

OMB Control No: 0910-0302	ICR Reference No: 201011-0910-003
Status: Historical Active	Previous ICR Reference No: 200704-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 01/30/2011
	Date Received in OIRA: 11/24/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved	01/31/2011
Responses	1,079,817	0	782,562
Time Burden (Hours)	1,080,760	0	783,332
Cost Burden (Dollars)	0	0	0

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Abstract: These information collection requirements help prevent the transmission of communicable diseases through human tissue transplantation by requiring written SOPs and the maintenance of records of all significant steps in testing, processing, distribution, and final disposition of the tissue, and which FDA investigators can review to evaluate whether the SOPs are consistent with the regulations and to determine that an establishment is following the procedures documented in the SOPs. 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:
	75 FR 9226	03/01/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 45127	08/02/2010
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
1270.31(a), (b), (c), and (d)
1270.31(a) and (b)
1270.33(a), (f), and (h), and 1270.35(a) and (b)
1270.35(c)
1270.35(d)
Human Tissue Intended for Transplantation

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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	1,079,817	782,562	0	-28	297,283	0
Annual Time Burden (Hours)	1,080,760	783,332	0	-672	298,100	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The previous burden estimate was 783,332 hours. The increase in burden to 1,080,760 (~ 300,000) hours is mostly attributed to an increase in the number of establishments and number of total annual records under 1270.33 (~100,000 hours) and 1270.35 (~200,000 hours). The reduction listed as a program change is the result of an elimination of an IC. Those burden hours were transferred to another IC and do not represent a reduction in burden.

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Annual Cost to Federal Government: $367,650

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: 11/23/2010

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