Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Process Data for Organ Procurement and Transplantation Network

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the information collection request title for reference.

Information Collection Request Title: Process Data for Organ Procurement and Transplantation Network, OMB No. 0906-xxxx—New.

Abstract: Section 372 of the Public Health Service Act requires that the Secretary of HHS, by awards, provide for the establishment and operation of the Organ Procurement and Transplantation Network (OPTN), which, under oversight of the HRSA, operates the U.S. procurement and transplantation system. The Secretary and/or HRSA may direct the collection of data in accordance with the regulatory authority in 42 CFR 121.11 of the OPTN Final Rule. HRSA, in alignment with the Paperwork Reduction Act of 1995, submits data elements for collection to OMB for official federal approval.

Need and Proposed Use of the Information: HRSA and the OPTN Board of Directors use data to develop transplant, procurement, and allocation policies; to determine whether 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 regulatory authority in 42 CFR 121.11 of the OPTN Final Rule allows the Secretary of HHS to prescribe data collection. This regulatory authority requires OPTN data to be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, and members of the public for evaluation, research, patient information, and other purposes.

This is a request to expand the current OPTN data collection, approved under OMB No. 0915-0157. HRSA is submitting this new data collection, separate from OMB No. 0915-0157, since it includes new forms developed in response to an HHS Secretarial Data Directive that are not in use by OPTN. HRSA believes that separating these data collections will minimize confusion, increase clarity among OPTN members and stakeholders, and enable more direct feedback on the new forms. Both data collections include time-sensitive, life-critical data on transplant candidates and potential organ donor patients, the organ matching process, histocompatibility results, organ labeling and packaging, and pre-and post-transplantation data on recipients and donors. The OPTN collects these specific data elements from transplant centers.

HRSA and the OPTN use this information to: (1) facilitate organ placement and match donor organs with recipients; (2) monitor compliance of member organizations with federal laws and regulations and with OPTN requirements; (3) review and report periodically to the public on the status of organ donation, procurement, and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; and (5) perform transplantation-related public health surveillance, including the possible transmission of donor disease.

This new collection consists of three new data forms as directed by the HHS Secretary, which were developed to improve the OPTN organ matching and allocation process and OPTN member compliance with OPTN requirements:

• One new form will collect data from the point of referral of a patient to an organ procurement organization (OPO) for potential deceased organ donation. These data will provide a more objective source of information on procurement practices, the management of donor patients, and how these practices inform the supply of deceased donor organs available for transplant. These data may also help to improve monitoring of OPO performance and would facilitate quality assurance and performance improvement efforts to reduce the variation in the quality-of-care OPOs provide to donors and donor families.
• Two new forms will expand data collection from the point of patient registration, referral, and evaluation at transplant centers. These data will enable collection of data from the point of referral. Pre-waitlisting data will provide insight into who gets referred and by whom, who gets evaluated, and who gets placed on the organ transplantation waiting list. These data will also facilitate the OPTN's ability to address disparities in processes of care, improve access to organ transplantation, and assess overall system performance.

Once this collection is approved, HRSA will cease the use of the Death Notification Registration and the Deceased Donor Death Referral forms that are included within the existing OMB-approved Data System for Organ Procurement and Transplantation Network OMB No. 0915-0157. This decision was made to avoid unnecessary burden and redundancy in the data collected by this package and the existing OMB data collection instrument.

Likely Respondents: Transplant Centers, OPOs, and Histocompatibility Laboratories.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.