E7-23538. Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on [phone].

The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:

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 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 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 respondents	Total responses	Hours per response	Total burden hours
121.3(b)(2): OPTN membership requirements for OPOs, hospitals, and histocompatibility laboratories	40	1	40	45	1, 800
121.3: Application for Non-Institutional Members	20	1	20	10	200
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
121.3: Personnel Change Application	324	1	324	10	3,240
121.9(d): Appeal for designation	2	1	2	6	12
Total	974		39,704		23,503

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to [e-mail] or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”

Dated: November 29, 2007.

Alexandra Huttinger,

Acting Director, Division of Policy Review and Coordination.