Agency Information Collection Activities: Proposed Collection: Comment Request

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