2010-25843. Agency Information Collection Activities: Proposed Collection: Comment Request

In compliance with the requirement for opportunity for public comment on proposed data collection projects under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [e-mail] or call the HRSA Reports Clearance Officer at [phone].

Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Proposed Project: Data System for Organ Procurement and Transplantation Network (42 CFR Part 121, OMB No. 0915-0184): Extension

The operation of the Organ Procurement and Transplantation Network (OPTN) necessitates certain recordkeeping and reporting requirements in order to perform the functions related to organ transplantation under contract to the Department of Health and Human Services (HHS). This is a request for an extension of the current recordkeeping and reporting requirements associated with the OPTN. These data will be used by HRSA in monitoring the contracts for the OPTN and the Scientific Registry of Transplant Recipients (SRTR) and in carrying out other statutory responsibilities. Information is needed to match donor organs with recipients, to monitor compliance of member organizations with OPTN rules and requirements, to ensure that all qualified entities are accepted for membership in the OPTN, and to ensure patient safety.

Estimated Annual Reporting and Recordkeeping Burden

Section and activity	Number of respondents	Responses per respondent	Total responses	Hours per response	Total burden hours
121.3(b)(2) OPTN membership and application requirements	40	3	120	15	1, 800
121.3(b)(4) Appeal for OPTN membership	2	1	2	3	6
121.6(c) (Reporting) Submitting criteria for organ acceptance	900	1	900	0.5	450
121.6(c) (Disclosure) Sending criteria to OPOs	900	1	900	0.5	450
121.7(b)(4) Reasons for Refusal	900	38	34,200	0.5	17,100
121.7(e) Transplant to prevent organ wastage	260	1.5	390	0.5	195
121.9(b) Designated Transplant Program Requirements	10	1	10	5.0	50
121.9(d) Appeal for designation	2	1	2	6	12
Total	3,014		36,524		20,063

E-mail comments to [e-mail] or mail the HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: October 7, 2010.

Wendy Ponton,

Director, Office of Management.