[Federal Register Volume 91, Number 94 (Friday, May 15, 2026)] [Notices] [Pages 27964-27968] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-09804] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0906- 0110--Revision AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than July 14, 2026. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 13N82, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Samantha Miller, the HRSA Information Collection Clearance Officer, at (301) 443-3983. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110--Revision 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 HRSA's oversight, 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 official federal approval. Need and Proposed Use of the Information: HRSA and the OPTN BOD use data to develop transplant, procurement, and allocation policies; to determine whether institutional members are complying with OPTN policies and HHS regulations; to determine member-specific performance; to ensure patient safety; and to fulfill the requirements of the HHS OPTN regulations at 42 CFR 121. In addition, the regulatory authority in 42 CFR 121.11 (https://www.ecfr.gov/current/title-42/section-121.11) requires the OPTN to maintain certain records and to make OPTN data available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of 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. The 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 requests making the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements: 1. Add two data collection forms from the OPTN Computer System (UNet platform) to the existing OMB-approved information collection. a. The Patient Safety Contact Management form is used by OPTN members to identify the OPTN member organization's primary and secondary patient safety contact who fulfills the duties as outlined in OPTN policy 15.1. b. The Patient Transfer form is used by transplant centers to facilitate the transfer of patients to another transplant center after transplant and throughout the annual follow-up periods. 2. Remove vascularized composite allografts (VCA) Transplant Candidate Registration. With the implementation of new VCA waitlist registration forms in the OPTN Waiting List system (in UNet), OPTN members will no longer need to validate the data on the form. The form is now read only. All changes and validations will be performed directly on the new waitlist registration forms. 3. The OPTN BOD-approved additional revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance. [[Page 27965]] Likely Respondents: Transplant Centers, Organ Procurement Organizations (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. The total burden hours in the OMB inventory increased by 58,975.02 hours from the previously OMB-approved data collection package. This increase included 3,310.46 hours from the addition of two new data collection forms, an increase of 1,031.03 hours due to OPTN BOD- approved data collection changes, and an increase of 54,633.53 hours from updating the number of respondents and total responses using actual OPTN data from 2025. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total Form No. Form name respondents responses per responses response burden respondent (in hours) hours * ---------------------------------------------------------------------------------------------------------------- 1.................. Deceased Donor 55 452.40 24,882 0.48 11,943.36 Registration. 2.................. Living Donor 209 31.45 6,573 2.2 14,460.71 Registration. 3.................. Living Donor Follow- 209 100.325 20,968 1.52 31,871.25 up. 4.................. Donor 137 178.555 24,462 0.15 3,669.31 Histocompatibility. 5.................. Recipient 137 323.81 44,362 0.32 14,195.83 Histocompatibility. 6.................. Heart Transplant 149 40.87 6,090 0.9 5,481.67 Candidate Registration. 7.................. Heart Transplant 149 30.78 4,586 1.96 8,988.99 Recipient Registration. 8.................. Heart Transplant 149 28.51 4,248 0.4 1,699.20 Recipient Follow Up (6 Month). 9.................. Heart Transplant 149 122.62 18,270 0.9 16,443.34 Recipient Follow Up (1-5 Year). 10................. Heart Transplant 149 202.66 30,196 0.5 15,098.17 Recipient Follow Up (Post 5 Year). 11................. Heart Post-Transplant 149 14.584 2,173 0.9 1,955.71 Malignancy Form. 12................. Lung Transplant 77 51.26 3,947 0.95 3,749.67 Candidate Registration. 13................. Lung Transplant 77 45.34 3,491 1.14 3,979.95 Recipient Registration. 14................. Lung Transplant 77 41.34 3,183 0.5 1,591.59 Recipient Follow Up (6 Month). 15................. Lung Transplant 77 147.70 11,373 1.1 12,510.19 Recipient Follow Up (1-5 Year). 16................. Lung Transplant 77 162.26 12,494 0.6 7,496.41 Recipient Follow Up (Post 5 Year). 17................. Lung Post-Transplant 77 22.73 1,750 0.4 700.08 Malignancy Form. 18................. Heart/Lung Transplant 75 1.03 77 1.16 89.61 Candidate Registration. 19................. Heart/Lung Transplant 75 0.80 60 2.09 125.40 Recipient Registration. 20................. Heart/Lung Transplant 75 0.75 56 0.8 45.00 Recipient Follow Up (6 Month). 21................. Heart/Lung Transplant 75 2.69 202 1.1 221.93 Recipient Follow Up (1-5 Year). 22................. Heart/Lung Transplant 75 3.64 273 0.6 163.80 Recipient Follow Up (Post 5 Year). 23................. Heart/Lung Post- 75 0.20 15 0.4 6.00 Transplant Malignancy Form. 24................. Liver Transplant 144 112.48 16,197 0.8 12,957.70 Candidate Registration. 25................. Liver Transplant 144 85.715 12,343 1.2 14,811.55 Recipient Registration. 26................. Liver Transplant 144 384.50 55,368 1 55,368.00 Recipient Follow Up (6 Month-5 Year). 27................. Liver Transplant 144 466.79 67,218 0.5 33,608.88 Recipient Follow Up (Post 5 Year). 28................. Liver Recipient 144 7.806 1,124 0.6 674.44 Explant Pathology Form. 29................. Liver Post-Transplant 144 27.19 3,915 0.8 3,132.29 Malignancy Form. 30................. Intestine Transplant 17 6.76 115 1.3 149.40 Candidate Registration. 31................. Intestine Transplant 17 5.18 88 1.8 158.51 Recipient Registration. 32................. Intestine Transplant 17 23.29 396 1.5 593.90 Recipient Follow Up (6 Month-5 Year). 33................. Intestine Transplant 17 52.35 890 0.4 355.98 Recipient Follow Up (Post 5 Year). 34................. Intestine Post- 17 0.35 6 1 5.95 Transplant Malignancy Form. 35................. Kidney Transplant 232 225.83 52,393 0.8 41,914.05 Candidate Registration. 36................. Kidney Transplant 232 118.935 27,593 1.2 33,111.50 Recipient Registration. 37................. Kidney Transplant 232 610.616 141,663 0.9 127,496.62 Recipient Follow Up (6 Month-5 Year). 38................. Kidney Transplant 232 617.823 143,335 0.5 71,667.47 Recipient Follow Up (Post 5 Year). 39................. Kidney Post- 232 31.573 7,325 0.8 5,859.95 Transplant Malignancy Form. 40................. Pancreas Transplant 127 2.20 279 0.6 167.64 Candidate Registration. 41................. Pancreas Transplant 127 0.84 107 1.2 128.02 Recipient Registration. 42................. Pancreas Transplant 127 4.20 533 0.5 266.70 Recipient Follow Up (6 Month-5 Year). 43................. Pancreas Transplant 127 15.71 1,995 0.5 997.59 Recipient Follow Up (Post 5 Year). 44................. Pancreas Post- 127 0.724 92 0.6 55.17 Transplant Malignancy Form. 45................. Kidney/Pancreas 127 13.35 1,695 0.6 1,017.27 Transplant Candidate Registration. 46................. Kidney/Pancreas 127 6.34 805 1.2 966.22 Transplant Recipient Registration. 47................. Kidney/Pancreas 127 35.55 4,515 0.5 2,257.43 Transplant Recipient Follow Up (6 Month-5 Year). [[Page 27966]] 48................. Kidney/Pancreas 127 68.19 8,660 0.6 5,196.08 Transplant Recipient Follow Up (Post 5 Year). 49................. Kidney/Pancreas Post- 127 2.315 294 0.4 117.60 Transplant Malignancy Form. 50................. VCA Transplant 23 0.39 9 1.36 12.20 Recipient Registration. 51................. VCA Transplant 23 2.91 67 1.31 87.68 Recipient Follow Up. 52................. Organ Labeling and 55 308.47 16,966 0.18 3,053.85 Packaging. 53................. Organ Tracking and 306 18.68 5,716 0.08 457.29 Validating. 54................. Kidney Paired 155 0.40 62 0.26 16.12 Donation Candidate Registration. 55................. Kidney Paired 155 0.74 115 1.08 123.88 Donation Donor Registration. 56................. Kidney Paired 155 0.86 133 0.67 89.31 Donation Match Offer Management. 57................. Disease Transmission 306 2.958 905 0.6 543.09 Event. 58................. Living Donor Event... 209 0.24 50 0.56 28.09 59................. Safety Situation..... 443 1.325 587 0.24 140.87 60................. Potential Disease 55 14.78 813 1.27 1,032.38 Transmission Report. 61................. Request to Unlock 443 156.156 69,177 0.02 1,383.54 Form. 62................. Initial Donor 55 453.870 24,963 4.75 118,573.54 Registration. 63................. OPO Notification 55 0.16 9 0.17 1.50 Limit Administration. 64................. Potential Transplant 306 5332.24 1,631,665 0.05 81,583.27 Recipient. 65................. Death Notification 55 227.35 12,504 0.42 5,251.79 Registration. 66................. Deceased Donor Death 55 61.80 3,399 0.5 1,699.50 Referral. 67................. Donor Hospital 55 0.07 4 0.08 0.31 Registration. 68................. Donor Organ 55 453.87 24,963 0.17 4,243.68 Disposition. 69................. Transplant Center 251 863.462 216,729 0.06 13,003.74 Contact Management. 70................. Adult Kidney 232 227.927 52,879 0.52 27,497.11 Candidate Listing Registration. 71................. Pediatric Kidney 103 11.66 1,201 0.47 564.46 Candidate Listing Registration. 72................. Adult Kidney Pancreas 127 13.32 1,692 0.37 625.91 Candidate Listing Registration. 73................. Pediatric Kidney 29 0.10 3 0.3 0.87 Pancreas Candidate Listing Registration. 74................. Adult Pancreas 127 15.27 1,939 0.38 736.93 Candidate Listing Registration. 75................. Pediatric Pancreas 30 1.17 35 0.38 13.34 Candidate Listing Registration. 76................. Adult Pancreas Islet 18 4.44 80 0.38 30.37 Listing Registration. 77................. Pediatric Pancreas 18 0.00 0 0.33 0.00 Islet Listing Registration ***. 78................. Adult Liver Candidate 144 107.35 15,458 0.32 4,946.69 Listing Registration. 79................. Pediatric Liver 59 12.51 738 0.4 295.24 Candidate Listing Registration. 80................. Adult Intestine 17 4.53 77 0.38 29.26 Candidate Listing Registration. 81................. Pediatric Intestine 17 2.24 38 0.43 16.37 Candidate Listing Registration. 82................. Adult Heart Candidate 149 36.52 5,441 0.83 4,516.43 Listing Registration. 83................. Pediatric Heart 63 10.30 649 0.58 376.36 Candidate Listing Registration. 84................. Adult HeartLung 75 0.96 72 0.85 61.20 Candidate Listing Registration. 85................. Pediatric HeartLung 25 0.20 5 0.93 4.65 Candidate Listing Registration. 86................. Adult Lung Candidate 77 50.77 3,909 1.01 3,948.38 Listing Registration. 87................. Pediatric Lung 45 0.84 38 0.84 31.75 Candidate Listing Registration. 88................. Candidate 251 305.653 76,719 0.18 13,809.40 Registration Listing Removal. 89................. VCA Abdominal Wall 8 0.00 0 0.33 0.00 Candidate Listing Registration ***. 90................. VCA External Male 2 0.00 0 0.33 0.00 Genitalia Candidate Listing Registration ***. 91................. VCA Head and Neck 9 0.11 1 0.33 0.33 Candidate Listing Registration. 92................. VCA Lower Limb 4 0.00 0 0.33 0.00 Candidate Listing Registration ***. 93................. VCA Musculoskeletal 2 0.00 0 0.33 0.00 Composite Graft Segment Candidate Listing Registration ***. 94................. VCA Other 5 0.20 1 0.33 0.33 Genitourinary Organ Candidate Listing Registration. 95................. VCA Spleen Candidate 0 0.00 0 0.33 0.00 Listing Registration ***. 96................. VCA Upper Limb 11 0.00 0 0.33 0.00 Candidate Listing Registration ***. 97................. VCA Uterus Candidate 6 1.83 11 0.33 3.62 Listing Registration. 98................. VCA Vascularized 1 0.00 0 0.33 0.00 Gland Candidate Listing Registration ***. 99................. Organ Export 55 0.29 16 0.03 0.48 Verification Form. 100................ OPTN Waiting Time 251 5.323 1,336 0.23 307.30 Transfer Form. 101................ OPTN Waiting Time 251 23.73 5,956 0.22 1,310.37 Modification Form. 102................ OPTN Renal Waiting 232 1.33 309 0.27 83.31 Time Reinstatement Form. 103................ OPTN Pancreas Waiting 127 0.04 5 0.2 1.02 Time Reinstatement Form. 104................ Intestinal Waiting 17 0.06 1 0.25 0.26 Time Reinstatement Form. 105................ Prior Living Donor 232 0.414 96 0.27 25.93 Priority. 106................ Kidney Minimum 232 0.957 222 0.3 66.61 Acceptance Criteria. 107................ Adult Liver Status 1A 144 2.125 306 0.57 174.42 Initial Justification and Extension Form. 108................ Pediatric Liver 59 3.00 177 0.57 100.89 Status 1A Initial Justification and Extension Form. [[Page 27967]] 109................ Pediatric Liver 59 7.10 419 0.47 196.88 Status 1B Initial Justification and Extension Form. 110................ Liver 144 0.83 120 0.43 51.39 Cholangiocarcinoma Initial MELD/PELD Score Exception Form. 111................ Liver 144 0.674 97 0.32 31.06 Cholangiocarcinoma MELD/PELD Score Exception Extension Form. 112................ Liver Cystic Fibrosis 144 0.08 12 0.33 3.80 Initial MELD/PELD Score Exception and Extension Form. 113................ Liver Familial 144 0.00 0 0.4 0.00 Amyloid Polyneuropathy Initial MELD/PELD Score Exception Form ***. 114................ Liver Familial 144 0.01 1 0.3 0.43 Amyloid Polyneuropathy MELD/ PELD Score Exception Extension Form. 115................ Liver Hepatic Artery 144 0.55 79 0.35 27.72 Thrombosis Initial MELD/PELD Score Exception and Extension Form. 116................ Liver Hepatocellular 144 22.18 3,194 0.47 1,501.14 Carcinoma Initial MELD/PELD Score Exception Form. 117................ Liver Hepatocellular 144 28.84 4,153 0.35 1,453.54 Carcinoma MELD/PELD Score Exception Extension Form. 118................ Liver Hepatopulmonary 144 1.424 205 0.32 65.62 Syndrome Initial MELD/PELD Score Exception Form. 119................ Liver Hepatopulmonary 144 0.806 116 0.25 29.02 Syndrome MELD/PELD Score Exception Extension Form. 120................ Liver Metabolic 144 0.84 121 0.28 33.87 Disease Initial MELD/ PELD Score Exception and Extension Form. 121................ Liver Portopulmonary 144 0.52 75 0.42 31.45 Hypertension Initial MELD/PELD Score Exception Form. 122................ Liver Portopulmonary 144 0.375 54 0.33 17.82 Hypertension MELD/ PELD Score Exception Extension Form. 123................ Liver Primary 144 0.104 15 0.35 5.24 Hyperoxaluria Initial MELD/PELD Score Exception and Extension Form. 124................ Liver Other Diagnosis 144 14.326 2,063 0.35 722.03 Initial MELD/PELD Score Exception and Extension Form. 125................ Pediatric Heart and 63 15.56 980 0.52 509.75 HeartLung Status 1A Initial Justification Form. 126................ Pediatric Heart and 63 73.57 4,635 0.47 2,178.41 HeartLung Status 1A Extension and Appeal Justification Forms. 127................ Pediatric Heart and 63 7.05 444 0.42 186.54 HeartLung Status 1B Initial Justification Form. 128................ Adult Heart and 149 161.57 24,074 0.32 7,703.66 HeartLung Status 1-6 Justification Form Demographic Data. 129................ Adult Heart and 149 161.57 24,074 0.72 17,333.23 HeartLung Status 1-6 Justification Form Risk Stratification Data. 130................ Adult Heart and 149 8.315 1,239 0.58 718.58 HeartLung Status 1 Initial Justification Form Medical Urgency Data. 131................ Adult Heart and 149 1.10 164 0.33 54.09 HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data. 132................ Adult Heart and 149 0.87 130 0.53 68.70 HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data. 133................ Adult Heart and 149 28.644 4,268 0.8 3,414.36 HeartLung Status 2 Initial Justification Form Medical Urgency Data. 134................ Adult Heart and 149 19.987 2,978 0.33 982.76 HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data. 135................ Adult Heart and 149 0.013 2 0.42 0.81 HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data. 136................ Adult Heart and 149 5.54 825 0.63 520.04 HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data. 137................ Adult Heart and 149 1.87 279 0.6 167.18 HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data. 138................ Adult Heart and 149 11.25 1,676 0.63 1,056.04 HeartLung Status 3 Initial Justification Form Medical Urgency Data. 139................ Adult Heart and 149 7.497 1,117 0.33 368.63 HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data. 140................ Adult Heart and 149 0.544 81 0.32 25.94 HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data. 141................ Adult Heart and 149 0.04 6 0.48 2.86 HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data. 142................ Adult Heart and 149 23.41 3,488 0.5 1,744.05 HeartLung Status 4 Initial Justification Form Medical Urgency Data. [[Page 27968]] 143................ Adult Heart and 149 2.17 323 0.25 80.83 HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data. 144................ Adult Heart and 149 0.78 116 0.4 46.49 HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data. 145................ Adult and Pediatric 149 2.785 415 0.75 311.22 Lung and HeartLung Goal Exception Form. 146................ Pediatric Lung 45 0.53 24 0.33 7.87 Priority 1 Status Justification Form. 147................ Review Board Voter 251 24.745 6,211 0.23 1,428.53 Form. 148................ Living Donor Feedback 209 38.856 8,121 0.13 1,055.72 Form. 149................ Extra Vessels 251 59.28 14,879 0.03 446.38 Reporting Form. 150................ Non-US Transplants 232 0.00 0 0.03 0.00 Reporting Form ***. 151................ Discrepant HLA 137 1.27 174 5.17 899.53 Typings Reporting Form. 152................ Interim Event 251 88.454 22,202 0.06 1,332.12 Reporting Form. 153................ Patient Safety 306 42.20 12,913 0.14 1,807.85 Contact Management Form **. 154................ Patient Transfer Form 251 15.35 3,853 0.39 1,502.61 **. --------------------------------------------------------------------- Total............... 19,424 .............. 3,101,339 ........... 910,553.02 ---------------------------------------------------------------------------------------------------------------- * Note: Totals for responses and burden hours may reflect minor discrepancies due to rounding; however, these rounding adjustments do not affect the overall burden estimates presented. ** New forms. *** If a form has 0.00 under the average number of responses, this is an indicator that there were no submissions in calendar year 2025. HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2026-09804 Filed 5-14-26; 8:45 am] BILLING CODE 4165-15-P