[Federal Register Volume 67, Number 197 (Thursday, October 10, 2002)]
[Notices]
[Pages 63109-63110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25725]



[[Page 63109]]

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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:

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 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
----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondents      responses       response          hours
----------------------------------------------------------------------------------------------------------------
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                          81               2             162           0.3             48.60
 Registration...................
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                    138              14           1,932           0.2            386.40
 Registration...................
Kidney/Pancreas Registration                 138               7             966           0.4            386.40
 (new form).....................
Kidney/Pancreas Follow-up (new               138              51           7,038           0.3          2,111.40
 form)..........................
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                  668             259         173,012           0.025        4,325.30
 Follow-up......................
Post Transplant Malignancy......             668               8           5,344           0.05           267.20
                                 -----------------
    Total.......................             883  ..............         517,693  ..............      78,744.50
----------------------------------------------------------------------------------------------------------------
* Includes an estimated 10,000 kidney transplant patients transplanted prior to the initiation of the data
  system.


[[Page 63110]]

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
John Morrill, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC.

    Dated: October 3, 2002.
Jane M. Harrison,
Director, Division of Policy Review and Coordination.
[FR Doc. 02-25725 Filed 10-9-02; 8:45 am]
BILLING CODE 4165-15-P