[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)] [Notices] [Pages 43776-43777] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-21730] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration 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, 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 (301)-443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Organ Procurement and Transplantation Network (OPTN) Data System (OMB No. 0915-0157)--Extension and Revision--The data collection system of the OPTN and Scientific Registry provides for collection of data on organ transplantation, including heart, kidney, liver, heart-lung, pancreas and small intestine transplants. The OPTN data collection is required under Section 372 of the Public Health Service Act and includes data on pre-transplant activities. This includes cadaveric and live donor characteristics, and histocompatibility testing that is used in the matching of donor organs with recipients. Section 373 of the Public Health Service act requires the Scientific Registry to collect, analyze and report on clinical and scientific data of importance to post-transplant graft and patient function. This involves a routine, periodic, submission of data for each organ transplant patient at the time of transplant, one-year (or six months for heart transplant patients), and annually post-transplant until graft failure or patient death. Information and data collected by the OPTN and Scientific Registry are used primarily to match donor organs with recipients, analyze policies for the allocation of donor organs, and assess the clinical outcomes of transplantation. The data are also used by the committees and Board of Directors of the OPTN for developing and reviewing policies related to allocation, patient listing criteria, optimal organ preservation times, and infectious disease screening. Respondents include organ procurement organizations (for cadaveric donor data), histocompatibility laboratories (for tissue typing data), and transplant hospitals (for pre- and post-transplant data on recipients). The data are used to issue two key reports--the Annual Data Report and the Report of Patient and Graft Survival Rates (issued biennially). HRSA proposes to make only minor changes to the data elements, to obtain more detailed information on transplant patients and their post- clinical course. For example, additional categories will be added to several items on the forms. The estimated annual response burden is as follows: [[Page 43777]] ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Hours per Total Form type respondents per responses response burden respondent hours ---------------------------------------------------------------------------------------------------------------- Cadaver Donor Registration/Referral........... 69 217 15,000 0.2 3,000 Living Donor Registration..................... 69 54 3,700 0.2 740 Donor Histocompatibility...................... 51 196 10,000 0.1 1,000 Potential Recipient Form...................... 69 275 19,000 0.1 1,900 Recipient Histocompatibility.................. 51 392 20,000 0.1 2,000 Transplant Candidate Registration............. 69 638 44,000 0.1 4,400 Thoracic Registration......................... 166 21 3,500 0.3 1,050 Thoracic Follow-Up............................ 166 101 16,800 0.2 3,360 Kidney Registration........................... 248 49 12,200 0.2 2,440 Kidney Follow-Up.............................. 248 448 111,000 0.1 11,100 Liver Registration............................ 119 34 4,000 0.4 1,600 Liver Follow-Up............................... 119 176 21,000 0.3 6,300 Pancreas Registration......................... 120 8 1,000 0.2 200 Pancreas Follow-Up............................ 120 34 4,100 0.2 820 Intestine Registration........................ 26 4 100 0.2 20 Intestine Follow-Up........................... 26 8 200 0.2 40 ----------------------------------------------------------------- Total................................... 799 357 285,600 0.14 39,970 ---------------------------------------------------------------------------------------------------------------- Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Allison Eydt, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, D.C. 20503. Dated: August 19, 1996. J. Henry Montes, Associate Administrator for Policy Coordination. [FR Doc. 96-21730 Filed 8-23-96; 8:45 am] BILLING CODE 4160-15-P