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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, email 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)—[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 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.

The OPTN is recommending addition of a new Liver Explant Pathology form to the OPTN data system. This new form was developed by the OPTN Liver and Intestinal Organ Transplantation Committee and will be used to collect pathology data on liver transplant recipients who received waitlist exception points as a result of a diagnosis of hepatocellular carcinoma. Existing OPTN policy requires submission of post-transplant pathology reports by fax transmission, and the proposed form will provide standardized collection of this already-required information.

There are also minor revisions to the existing data collection forms; the added fields were inadvertently left off of the forms at the time of the initial submission. Several of these fields are “read only” and are included on the forms for information purposes only. One field is proposed to be removed as it represented duplicative information.

The annual estimate of burden is as follows:Start Printed Page 73651

FormNumber of respondentsResponses per respondentsTotal responsesHours per responseTotal burden hours
Deceased Donor Registration5822813,2240.75009918.00
Death Referral Data581269610.00006,960.00
Death Notification Referral—Eligible5814584100.50004205.00
Death Notification Referral—Imminent5812471920.50003596.00
Living Donor Registration3112371530.65004649.45
Living Donor Follow-up3117824,2580.500012,129.00
Donor Histocompatibility1589414,8520.10001,485.20
Recipient Histocompatibility15817127,0180.20005,403.60
Heart Candidate Registration131273,5370.50001,768.50
Lung Candidate Registration664127060.50001353.00
Heart/Lung Candidate Registration501500.500025.00
Thoracic Registration1313444540.75003340.50
Thoracic Follow-up13127736,2870.650023,586.55
Kidney Candidate Registration23915436,8060.500018,403.00
Kidney Registration2397217,2080.750012,906.00
Kidney Follow-up *239693165,6270.550091,094.85
Liver Candidate Registration1329812,9360.50006,468.00
Liver Registration132486,3360.65004,118.4
Liver Explant Pathology132111,4520.3400493.68
Liver Follow-up13245960,5880.500030,294.00
Kidney/Pancreas Candidate Registration144111,5840.5000792.00
Kidney/Pancreas Registration14468640.9000777.60
Kidney/Pancreas Follow-up1447510,8000.85009180.00
Pancreas Candidate Registration14445760.5000288.00
Pancreas Islet Candidate Registration2351150.500057.50
Pancreas Registration14422880.7500216.00
Pancreas Follow-up1442333120.65002152.80
Intestine Candidate Registration4352150.5000107.50
Intestine Registration4331290.9000116.10
Intestine Follow-up432510750.8500913.75
Post Transplant Malignancy6891175790.20001515.80
*Includes an estimated 2,430 kidney transplant patients transplanted prior to the initiation of the data system.

Email comments to or mail to 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: November 23, 2011.

Reva Harris,

Acting Director, Division of Policy and Information Coordination.

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[FR Doc. 2011-30779 Filed 11-28-11; 8:45 am]