[Federal Register: June 5, 2002 (Volume 67, Number 108)]
[Notices]               
[Page 38668-38669]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn02-51]                         

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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 for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes 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 draft 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 Project: Data System for Organ Procurement and 
Transplantation Network and Associated Forms (OMB No. 0915-0157): 
Revision

    Section 372 of the Public Health Service (PHS) Act requires that 
the Secretary, by contract, provide for the establishment and operation 
of an Organ Procurement and Transplantation Network (OPTN). The OPTN, 
among other responsibilities, operates and maintains a national waiting 
list of individuals requiring organ transplants, maintains a 
computerized system for matching donor organs with transplant 
candidates on the waiting list, and operates a 24-hour telephone 
service to

[[Page 38669]]

facilitate matching organs with individuals included in the list.
    Data for the OPTN data system are collected from transplant 
hospitals, organ procurement organizations, and tissue-typing 
laboratories. The information is used to match donor organs with 
recipients, to monitor compliance of member organizations with OPTN 
rules and requirements, and to report periodically on the clinical and 
scientific status of organ donation and transplantation in this 
country. Data are used in the development and revision of OPTN rules 
and requirements, operating procedures, and standards of quality for 
organ acquisition and preservation, some of which have provided the 
foundation for development of Federal regulations. The practical 
utility of the data collection is further enhanced by requirements that 
the OPTN data must be made available without restriction for use by 
OPTN members, the Scientific Registry of Transplant Recipients, the 
Department of Health and Human Services, and others for evaluation, 
research, patient information, and other important purposes.
    Revisions in the 28 data collection forms are intended to clarify 
existing questions, to provide additional detail and categories to 
avoid confusion and be more inclusive, to remove obsolete data, and to 
comply with requests for more complete and precise data.

                                                           Estimates of Annualized Hour Burden
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                                                                        Number of      Responses  per       Total          Hours  per     Total  burden
                                Form                                   respondents      respondents       responses         response          hours
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Cadaver Donor Registration.........................................               59              170           10,030              0.3         3,009.00
Death referral data................................................               59               12              708               10         7,080.00
Living Donor Registration..........................................              668               11            7,348              0.2         1,469.60
Living Donor Follow-up.............................................              668               16           10,688              0.1         1,068.80
Donor Histocompatibility...........................................              156               86           13,416              0.1         1,341.60
Recipient Histocompatibility.......................................              156              161           25,116              0.1         2,511.60
Heart Candidate Registration.......................................              140               26            3,640              0.3         1,092.00
Lung Candidate Registration........................................               75               29            2,175              0.3           652.50
Heart/Lung Candidate Registration..................................               81                2              162              0.3            48.60
Thoracic Registration..............................................              140               29            4,060              0.3         1,218.00
Thoracic Follow-up.................................................              140              168           23,520              0.2         4,704.00
Kidney Candidate Registration......................................              242              108           26,136              0.2         5,227.20
Kidney Registration................................................              242               62           15,004              0.3         4,501.20
Kidney Follow-up *.................................................              242              444          107,448              0.2        21,489.60
Liver Candidate Registration.......................................              120               97           11,640              0.2         2,328.00
Liver Registration.................................................              120               44            5,280              0.4         2,112.00
Liver Follow-up....................................................              120              276           33,120              0.3         9,936.00
Kidney/Pancreas Candidate Registration.............................              138               14            1,932              0.2           386.40
Kidney/Pancreas Registration (new form)............................              138                7              966              0.4           386.40
Kidney/Pancreas Follow-up (new form)...............................              138               51            7,038              0.3         2,111.40
Pancreas Candidate Registration....................................              138                7              966              0.2           193.20
Pancreas Registration..............................................              138                4              552              0.3           165.60
Pancreas Follow-up.................................................              138               12            1,656              0.2           331.20
Intestine Candidate Registration...................................               38                6              228              0.2            45.60
Intestine Registration.............................................               38                3              114              0.2            22.80
Intestine Follow-up................................................               38                9              342              0.2            68.40
Immunosuppression Treatment........................................              668               39           26,052            0.025           651.30
Immunosuppression Treatment Follow-up..............................              668              259          173,012            0.025         4,325.30
Post Transplant Malignancy.........................................              668                8            5,344             0.05           267.20
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    Total..........................................................              883  ...............          517,693  ...............       78,744.50
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* Includes an estimated 10,000 kidney transplant patients transplanted prior to the initiation of the data system.

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 11-05, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of this 
notice.

    Dated: May 30, 2002.
Jane M. Harrison,
Director, Division of Policy Review and Coordination.
[FR Doc. 02-14020 Filed 6-4-02; 8:45 am]
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