[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]


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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]]



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                                                              Number of                                         
                                                 Number of    responses      Total       Hours per      Total   
                   Form type                    respondents      per       responses     response       burden  
                                                              respondent                                hours   
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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
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      Total...................................          799          357      285,600          0.14       39,970
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    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