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[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Notices]
[Pages 21198-21199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11599]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Health Resources and Services 
Administration (HRSA) will publish periodic summaries of proposed 
projects being developed for submission to 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 
instruments, call the HRSA Reports Clearance Officer on (301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (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 Projects

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 analyze policies for the allocation of donor 
organs, and to 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. HRSA invites comments on these and other 
possible changes to the OPTN and Scientific Registry datasets.
    The estimated annual response burden is as follows:

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                                                                No. of                                          
                                                 Number of    responses      Total       Hours per      Total   
                   Form Type                    respondents      per       responses     response       burden  
                                                              respondent                                hours   
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1. Cadaver Donor Registration/Referral........           69          217       15,000       \1\ 0.2        3,000
2. Living Donor Registration..................           69           54        3,700           0.2          740
3. Donor Histocompatibility...................           51          196       10,000           0.1        1,000
4. Potential Recipient Form...................           69          275       19,000           0.1        1,900
5. Recipient Histocompatibility...............           51          392       20,000           0.1        2,000
6. Transplant Candidate Registration..........           69          638       44,000           0.1        4,400
7. Thoracic Registration......................          166           21        3,500           0.3        1,050
8. Thoracic Follow-Up.........................          166          101       16,800           0.3        5,040
9. Kidney Registration........................          248           49       12,200           0.3        3,660
10. Kidney Follow-Up..........................          248          399      111,000       \2\ 0.2       22,200
11. Liver Registration........................          119           34        4,000           0.4        1,600
12. Liver Follow-Up...........................          119          176       21,000           0.4        8,400
13. Pancreas Registration.....................          120            8        1,000           0.2          200
14. Pancreas Follow-Up........................          120           34        4,100           0.2          820
15. Intestine Registration....................           26            4          100           0.2           20
16. Intestine Follow-Up.......................           26            8          200           0.2           40
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Total.........................................          799          357      285,600          20        56,070 
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\1\ It is estimated that 15,000 of these forms will be completed each year but approximately 9,500 will be      
  referrals only. For those patients, only the first page of the form and one question on the second page will  
  be completed. The average completion time for all 14,000 forms is 0.2 hours.                                  
\2\ Includes an estimated 20,000 kidney transplant patients, transplanted prior to the initiation of the data   
  system, October 1, 1987.                                                                                      

[[Page 21199]]

    Send comments to Patricia Royston, HRSA Reports Clearance Officer, 
Room 14-36, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments should be received within 60 days of this notice.

    Dated: May 3, 1996.
J. Henry Montes,
Associate Administrator for Policy Coordination.
[FR Doc. 96-11599 Filed 5-8-96; 8:45 am]
BILLING CODE 4160-15-P
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