# Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157, Revision > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2017-07526 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** April 14, 2017 - **Citation:** 82 FR 18001 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157, Revision AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA has 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. DATES: Comments on this ICR should be received no later than May 15, 2017. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. Information Collection Request Title: Data System for Organ Procurement and Transplantation Network. OMB No. 0915-0157—Revision Abstract: 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). This is a request for revisions to a subset of the current OPTN data collection forms associated with donor organ procurement and an individual's clinical characteristics at the time of registration, transplant, and follow-up after transplant. Need and Proposed Use of the Information: Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to facilitate organ placement and match donor organs with recipients, monitor compliance of member organizations with Federal laws and regulations and with OPTN requirements, review and report periodically to the public on the status of organ donation and transplantation in the United States, provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation, and perform transplantation-related public health surveillance including possible transmission of donor disease. This request revises a subset of the current OPTN data forms associated with donor organ procurement and an individual's clinical characteristics at the time of registration, transplant, and follow up. In 2015, the OPTN Board of Directors approved policies that necessitate the addition of new data elements to registration forms for heart, lung, heart/lung, liver, intestine, kidney, pancreas, and kidney/pancreas recipients. The OPTN also approved policies that impact the data collection for deceased donor registration, pancreas candidate registration, kidney/pancreas candidate registration, pancreas follow-up, and kidney/pancreas follow-up forms. The policy modifications necessitate changes to 17 of the 52 forms contained in this data collection. For example, the pancreas and kidney/pancreas transplant recipient registration and follow up forms were modified to be consistent with an OPTN policy change pertaining to data collected from pancreas programs for pancreas graft failure. Specifically, the “graft status” section of the pancreas forms was updated to be consistent with a new policy that helps transplant professionals identify when pancreas allograft failure has occurred and how to document the pancreas graft failure event. In addition, “drop down” menus were added to facilitate reporting of toxoplasma serology results and infectious diseases, consistent with revised scope of policy requirements for infectious disease testing and reporting. Finally, a policy modification to improve collection of information on lungs perfused prior to transplant resulted in the creation of easy-to-complete data fields on lung and heart/lung recipient registration forms. The modified forms allow transplant centers to easily provide information on lung perfusion, which contributes to improved accuracy in monitoring of lung allocation, recipient safety, and organ and patient outcomes. Likely Respondents: Transplant programs, organ procurement organizations, histocompatibility laboratories, medical and scientific organizations, and public organizations. 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 burden will decrease by approximately 3,500 hours. Total Estimated Annualized Burden—Hours Form name Number of respondents Number of responses per respondent * Total responses Average burden per response (in hours) Total burden hours Deceased Donor Registration 58 176.9 10,262 1.1 11,288.2 Living Donor Registration 304 19.5 5,936 1.8 10,684.8 Living Donor Follow-Up 304 58.2 17,686 1.3 22,991.8 Donor Histocompatibility 152 102.7 15,611 0.2 3,122.2 Recipient Histocompatibility 152 183.0 27,810 0.4 11,124.0 Heart Candidate Registration 137 32.4 4,439 0.9 3,995.1 Heart Recipient Registration 137 20.5 2.805 1.2 3,366.0 Heart Follow-Up (6 Months) 137 16.5 2,261 0.4 904.4 Heart Follow-Up (1-5 Years) 137 77.3 10,595 0.9 9,535.5 Heart Follow-Up (Post 5 Years) 137 117.4 16,085 0.5 8,042.5 Heart Post-Transplant Malignancy 137 11.8 1,623 0.9 1,460.7 Lung Candidate Registration 70 37.0 2,592 0.9 2,332.8 Lung Recipient Registration 70 29.4 2,058 1.2 2,469.6 Lung Follow-Up (6 Months) 70 25.8 1,809 0.5 904.5 Lung Follow-Up (1-5 Years) 70 99.1 6,939 1.1 7,632.9 Lung Follow-Up (Post 5 Years) 70 70.0 4,898 0.6 2,938.8 Lung Post-Transplant Malignancy 70 15.8 1,106 0.4 442.4 Heart/Lung Candidate Registration 68 0.7 46 1.1 50.6 Heart/Lung Recipient Registration 68 0.2 14 1.3 18.2 Heart/Lung Follow-Up (6 Months) 68 0.2 13 0.8 10.4 Heart/Lung Follow-Up (1-5 Years) 68 1.4 94 1.1 103.4 Heart/Lung Follow-Up (Post 5 Years) 68 2.9 199 0.6 119.4 Heart/Lung Post-Transplant Malignancy 68 0.3 21 0.4 8.4 Liver Candidate Registration 140 85.9 12,026 0.8 9,620.8 Liver Recipient Registration 140 50.9 7,125 1.2 8,550.0 Liver Follow-Up (6 Months-5 Years) 140 235.6 32,985 1 32,985.0 Liver Follow-Up (Post 5 Years) 140 279.3 39,108 0.5 19,554.0 Liver Recipient Explant Pathology 140 12.9 1,812 0.6 1,087.2 Liver Post-Transplant Malignancy 140 14.2 1,985 0.8 1,588.0 Intestine Candidate Registration 40 5.0 200 1.3 260.0 Intestine Recipient Registration 40 3.5 141 1.8 253.8 Intestine Follow-Up (6 Months-5 Years) 40 13.3 530 1.5 795.0 Intestine Follow-Up (Post 5 Years) 40 16.4 655 0.4 262.0 Intestine Post-Transplant Malignancy 40 0.6 24 1 24.0 Kidney Candidate Registration 238 151.6 36,076 0.8 28,860.8 Kidney Recipient Registration 238 75.2 17,899 1.2 21,478.8 Kidney Follow-Up (6 Months-5 Years) 238 383.3 91,234 0.9 82,110.6 Kidney Follow-Up (Post 5 Years) 238 375.9 89,453 0.5 44,726.5 Kidney Post-Transplant Malignancy 238 22.4 5,327 0.8 4,261.6 Pancreas Candidate Registration 133 2.9 389 0.6 233.4 Pancreas Recipient Registration 133 1.8 233 1.2 279.6 Pancreas Follow-Up (6 Months-5 Years) 133 9.4 1,252 0.5 626.0 Pancreas Follow-Up (Post 5 Years) 133 14.7 1,953 0.5 976.5 Pancreas Post-Transplant Malignancy 133 0.9 120 0.6 72.0 Kidney/Pancreas Candidate Registration 133 9.5 1,265 0.6 759.0 Kidney/Pancreas Recipient Registration 133 5.4 718 1.2 861.6 Kidney/Pancreas Follow-Up (6 Months-5 Years) 133 32.0 4,262 0.5 2,131.0 Kidney/Pancreas Follow-Up (Post 5 Years) 133 51.7 6,876 0.6 4,125.6 Kidney/Pancreas Post-Transplant Malignancy Form 133 2.1 283 0.4 113.2 VCA Candidate Registration 28 1.8 49 0.4 19.6 VCA Recipient Registration 28 1.8 49 1.3 63.7 VCA Recipient Follow-Up 28 1.8 49 1 49.0 Total ** 463 488,980 370,274.9 * The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth. ** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate or recipient forms based on the organ-specific programs associated with each form. Amy McNulty, Deputy Director, Division of the Executive Secretariat. [FR Doc. 2017-07526 Filed 4-13-17; 8:45 am] BILLING CODE 4165-15-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2017-07526. Public record. Not legal advice.