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, email firstname.lastname@example.org 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: Data System for Organ Procurement and Transplantation Network and Associated Forms (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.
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:
|Form||Number of respondents||Responses per
respondents||Total responses||Hours per response||Total burden hours|
|Deceased Donor Registration||58||228||13,224||0.7500||9,918.00|
|Death referral data||58||12||696||10.0000||6,960.00|
|Death Notification Referral—Eligible||58||145||8410||0.5000||4,205.00|
|Death Notification Referral—Imminent||58||124||7192||0.5000||3,596.00|
|Living Donor Registration||311||23||7153||0.6500||4,649.45|
|Living Donor Follow-up||311||78||24,258||0.5000||12,129.00|
|Heart Candidate Registration||131||27||3,537||0.5000||1,768.50|
|Lung Candidate Registration||66||41||2706||0.5000||1,353.00|
|Heart/Lung Candidate Registration||50||1||50||0.5000||25.00|
|Kidney Candidate Registration||239||154||36,806||0.5000||18,403.00|
|Kidney Follow-up *||239||693||165,627||0.5500||91,094.85|
|Liver Candidate Registration||132||98||12,936||0.5000||6,468.00|
|Liver Explant Pathology||132||11||1,452||0.3400||493.68|
|Kidney/Pancreas Candidate Registration||144||11||1,584||0.5000||792.00|
|Pancreas Candidate Registration||144||4||576||0.5000||288.00|
|Pancreas Islet Candidate Registration||23||5||115||0.5000||57.50|
|Intestine Candidate Registration||43||5||215||0.5000||107.50|
|Post Transplant Malignancy||689||11||7579||0.2000||1,515.80|
|* Includes an estimated 2,430 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 email 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.”
Dated: January 12, 2012.
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-954 Filed 1-18-12; 8:45 am]
BILLING CODE 4165-15-P