Tissue and Organ Donor Epidemiology Study (TODES)

Forms and Documents

Document Name	Status
0990-TODES_OMB_SSB_8_8_2014_V_4 1_03-27-15.docx Supporting Statement B	2015-03-27
0990-TODES_OMB_SSA_8_2014_V_3 10 3-27-15.docx Supporting Statement A	2015-03-27

IC Document Collections

IC ID	Document Title	Status
214005	Eye Banks Other-survey	New
214002	OPOs Other-survey	New

ICR Details

OMB Control No: 0990-0427	ICR Reference No: 201411-0990-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Tissue and Organ Donor Epidemiology Study (TODES)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/06/2015
	Date Received in OIRA: 11/20/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved
Responses	24	0	0
Time Burden (Hours)	30	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: TODES is being conducted in order to better understand the impact of donor screening and selection procedures, and to determine the extent of donor-donation level data that are collected for organ and tissue (including ocular) donors. The data that are obtained from Organ Procurement Organizations (OPOs) and Eye Banks will provide a better characterization of the deceased donor pool; information regarding data management and storage practices; and a measure of the degree of standardization of data collected by various organizations across the U.S. TODES may provide better estimates of the risk of HIV, HBV and HCV infections associated with organ and tissue transplantation and the potential for disease transmission; illustrate differences in laboratory screening methods and the impact of protocol variations; and serve as a pilot for future studies. This retrospective study will provide a framework for future, prospective studies of organ and tissue donors that could inform policy decisions regarding donor qualification procedures and, potentially, increase the donor pool.

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Authorizing Statute(s): US Code: 42 USC 361 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:
	79 FR 51333	08/28/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 65959	11/06/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
OPOs
Eye Banks

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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	24	0	0	24	0	0
Annual Time Burden (Hours)	30	0	0	30	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This a new collection.

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Annual Cost to Federal Government: $259,512

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? Yes

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: 11/20/2014

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