Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Health Resources and Services Administration</SUBAGY> <SUBJECT>Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments on this ICR should be received no later than July 25, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to <E T="03">www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> To request a copy of the clearance requests submitted to OMB for review, email Samantha Miller, HRSA Information Collection Clearance Officer, at <E T="03">paperwork@hrsa.gov</E> or call (301) 443-3983. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Information Collection Request Title:</E> Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157—Revision. <E T="03">Abstract:</E> Section 372 of the Public Health Service Act requires that the Secretary of HHS, by award, provide for the establishment and operation of the Organ Procurement and Transplantation Network (OPTN), which, under oversight of the HRSA, operates the U.S. Organ Procurement and Transplantation system. HRSA, in alignment with the Paperwork Reduction Act of 1995, submits OPTN Board of Directors (BOD)-approved data elements for collection to OMB for approval. A 60-day notice was published in the <E T="04">Federal Register</E> on November 1, 2024, Vol. 89, No. 212, pp. 87380-85. There were six comments, including feedback from OPTN Members and Transplant Centers. Public comments raised concerns about the financial burden of additional data collection. The commenters called for greater collaboration between transplant professionals, HRSA, and the Scientific Registry of Transplant Recipients to eliminate redundancies and improve efficiency. Commenters expressed concern that changes were communicated via the <E T="04">Federal Register</E> instead of the OPTN public comment process, limiting input from the transplant community. Additionally, the commenters sought clarification on discrepancies regarding which forms were designated as new, and they requested access to the data collection plans and draft instruments. HRSA carefully reviewed all public feedback submitted during the 60-day comment period. Through its policy development process, OPTN had previously solicited input on each of the data collection instruments through four channels: (1) Targeted outreach to relevant stakeholder organizations, including transplant professionals and patient groups. (2) Comments submitted by other OPTN committees. (3) In-person meetings across 11 OPTN regions. (4) An online OPTN public comment forum open to all on the OPTN website. HRSA welcomes participation from all interested individuals. HRSA seeks input from transplant candidates directly affected by policy changes and strongly encourages transplant professionals to provide input on the potential financial impacts of proposals. HRSA values all feedback and remains committed to reviewing and refining data collection efforts in collaboration with the OPTN. Finally, in response to commenter concerns regarding potential burden, the OPTN contract requires the OPTN Contractor to implement a direct electronic data submission plan and supplement official OPTN data with external sources. This approach aims to reduce the burden of data collection on OPTN members. <E T="03">Need and Proposed Use of the Information:</E> HRSA and the OPTN BOD 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 ( <E T="03">https://www.ecfr.gov/current/title-42/section-121.11</E> ) of the OPTN Final Rule requires the OPTN data to be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, HHS, and members of the public for evaluation, research, patient information, and other important purposes. This is a request to revise the current OPTN data collection, which includes time-sensitive, life-critical data on transplant candidates and potential organ donors, the organ matching process, histocompatibility results, organ labeling and packaging, and pre- and post-transplantation data on recipients and donors. This revision also includes OPTN BOD-approved changes to the existing OMB data collection forms. OPTN collects these specific data elements from transplant hospitals, organ procurement organizations, and histocompatibility laboratories. 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. HRSA is requesting to make the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements: (1) Adding data collection forms for candidates listed in the OPTN organ transplant waiting list to the existing OMB-approved information collection. These forms allow a transplant center to add, change, or remove candidates from the OPTN waiting list after a transplant center completes the patient evaluation. These forms contain information that the OPTN electronic organ matching system uses to match potential organ recipients with available deceased donor organs. There are 83 new data collection forms: candidate listing registration forms of all organs, candidate status justification forms of all applicable organs, Model for End-Stage Liver Disease or Pediatric End-Stage Liver Disease (MELD/PELD) score exception and extension forms, and other forms. (2) OPTN BOD-approved revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance. <E T="03">Likely Respondents:</E> Transplant Centers, Organ Procurement Organizations (OPO), and Histocompatibility Laboratories. <E T="03">Burden Statement:</E> 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. The estimated burden hours for this collection increased by 203,937.21 hours from the currently approved ICR package. This increase includes 96,148.84 hours due to adding 83 new data collection forms for the OPTN waiting list and 107,788.37 hours due to OPTN BOD-approved data collection changes to existing forms and the number of respondents. <GPOTABLE COLS="7" OPTS="L2,nj,i1" CDEF="xs36,r50,10,15,12,10,10"> <TTITLE>Total Estimated Annualized Burden—Hours</TTITLE> <CHED H="1">Form No.</CHED> <CHED H="1">Form name</CHED> <ENT>414.71</ENT> <ENT>23,223.76</ENT> <ENT>0.48</ENT> <ENT>11,147.40</ENT> </ROW> <ROW> <ENT I="01">2</ENT> <ENT>Living Donor Registration</ENT> <ENT>207</ENT> <ENT>33.42</ENT> <ENT>6,917.94</ENT> <ENT>2.19</ENT> <ENT>15,150.29</ENT> </ROW> <ROW> <ENT I="01">3</ENT> <ENT>Living Donor Follow-up</ENT> <ENT>207</ENT> <ENT>94.86</ENT> <ENT>19,636.02</ENT> <ENT>1.52</ENT> <ENT>29,846.75</ENT> </ROW> <ROW> <ENT I="01">4</ENT> <ENT>Donor Histocompatibility</ENT> <ENT>138</ENT> <ENT>173.31</ENT> <ENT>23,916.78</ENT> <ENT>0.20</ENT> <ENT>4,783.36</ENT> </ROW> <ROW> <ENT I="01">5</ENT> <ENT>Recipient Histocompatibility</ENT> <ENT>138</ENT> <ENT>307.09</ENT> <ENT>42,378.42</ENT> <ENT>0.40</ENT> <ENT>16,951.37</ENT> </ROW> <ROW> <ENT I="01">6</ENT> <ENT>Heart Transplant Candidate Registration</ENT> <ENT>149</ENT> <ENT>38.50</ENT> <ENT>5,736.50</ENT> <ENT>0.90</ENT> <ENT>5,162.85</ENT> </ROW> <ROW> <ENT I="01">7</ENT> <ENT>Heart Transplant Recipient Registration</ENT> <ENT>149</EN ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 40k characters. 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