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Agency Information Collection Activities: Proposed Collection: Comment Request

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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 the Office of Management and Budget (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, e-mail or call the HRSA Reports Clearance Officer at (301) 443-1129.

Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (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: Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System (OMB No. 0915-0157)—Extension

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 system 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 indicate the disease severity of transplant candidates, 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 to develop transplant, donation and allocation policies, to determine if institutional members are complying with policy, to determine member specific performance, to ensure patient safety and to fulfill the requirements of the OPTN Final Rule. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, 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.

No revisions of the 26 data collection forms are proposed at this time; however, the OPTN is currently undergoing a review of the forms and expects to submit proposed revisions within the next year.

The annual estimate of burden is as follows:

FormNumber of respondentsResponses per respondentsTotal responsesHours per responseTotal burden hours
Deceased Donor Registration5821612,5280.75009,396.00
Death referral data581269610.00006,960.00
Death Notification Referral—Eligible5816193380.20001,867.60
Death Notification Referral—Imminent5816897440.50004,872.00
Living Donor Registration3083912,0120.65007,807.80
Living Donor Follow-up3085015,4000.50007,700.00
Donor Histocompatibility15613120,4360.10002,043.60
Recipient Histocompatibility15619630,5760.20006,115.20
Heart Candidate Registration127354,4450.50002,222.50
Lung Candidate Registration68422,8560.50001,428.00
Heart/Lung Candidate Registration5121020.500051.00
Thoracic Registration127364,5720.75003,429.00
Thoracic Follow-up12732040,6400.650026,416.00
Kidney Candidate Registration24118344,1030.500022,051.50
Kidney Registration2418320,0030.750015,002.25
Kidney Follow-up *241742178,8220.550098,352.10
Liver Candidate Registration12910914,0610.50007,030.50
Liver Registration129587,4820.65004,863.30
Liver Follow-up12951966,9510.500033,475.50
Kidney/Pancreas Candidate Registration143142,0020.50001,001.00
Kidney/Pancreas Registration14371,0010.9000900.90
Kidney/Pancreas Follow-up1438512,1550.850010,331.75
Pancreas Candidate Registration14371,0010.5000500.50
Pancreas Registration14334290.7500321.75
Pancreas Follow-up143202,8600.65001,859.00
Intestine Candidate Registration4473080.5000154.00
Intestine Registration4452200.9000198.00
Intestine Follow-up44281,2320.85001,047.20
Post Transplant Malignancy684106,8400.20001,368.00
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* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data system.

E-mail comments to or mail the HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

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Dated: May 25, 2010.

Sahira Rafiullah,

Director, Division of Policy and Information Coordination.

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[FR Doc. 2010-12964 Filed 5-27-10; 8:45 am]