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Agency Information Collection Activities: Submission for OMB Review; Comment Request

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Information about this document as published in the Federal Register.

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Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), 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, e-mail paperwork@hrsa.gov or 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: 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 when no alternative sources of data exist 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 29 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 respondentTotal responsesHours per responseTotal burden hours
Deceased Donor Registration5821612,5280.75009,396.0000
Death referral data581269610.00006,960.0000
Death Notification Referral—Eligible5816193380.20001,867.6000
Death Notification Referral—Imminent5816897440.50004,872.0000
Living Donor Registration3083912,0120.65007,807.8000
Living Donor Follow-up3085015,4000.50007,700.0000
Donor Histocompatibility15613120,4360.10002,043.6000
Recipient Histocompatibility15619630,5760.20006,115.2000
Heart Candidate Registration127354,4450.50002,222.5000
Lung Candidate Registration68422,8560.50001,428.0000
Heart/Lung Candidate Registration5121020.500051.0000
Thoracic Registration127364,5720.75003,429.0000
Thoracic Follow-up12732040,6400.650026,416.0000
Kidney Candidate Registration24118344,1030.500022,051.5000
Kidney Registration2418320,0030.750015,002.2500
Kidney Follow-up*241742178,8220.550098,352.1000
Liver Candidate Registration12910914,0610.50007,030.5000
Liver Registration129587,4820.65004,863.3000
Liver Follow-up12951966,9510.500033,475.5000
Kidney/Pancreas Candidate Registration143142,0020.50001,001.0000
Kidney/Pancreas Registration14371,0010.9000900.9000
Kidney/Pancreas Follow-up1438512,1550.850010,331.7500
Pancreas Candidate Registration14371,0010.5000500.5000
Pancreas Registration14334290.7500321.7500
Pancreas Follow-up143202,8600.65001,859.0000
Intestine Candidate Registration4473080.5000154.0000
Intestine Registration4452200.9000198.0000
Intestine Follow-up44281,2320.85001,047.2000
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Post Transplant Malignancy684106,8400.20001,368.0000
Total463522,815278,765.9500
* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data system.

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”

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Dated: September 3, 2010.

Sahira Rafiullah,

Director, Division of Policy and Information Coordination.

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[FR Doc. 2010-22665 Filed 9-10-10; 8:45 am]

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