[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