[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)] [Notices] [Pages 48743-48745] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2021-18688] ----------------------------------------------------------------------- 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. 0915- 0157--Revision AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for the 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 November 1, 2021. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 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 Lisa Wright- Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. 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 Act requires that the Secretary, by contract, provide for the establishment and operation of a private, non-profit entity: The Organ Procurement and Transplantation Network (OPTN). The data collected pursuant to the OPTN's regulatory authority in 42 CFR 121.11 of the OPTN Final Rule is collected through OMB approved data collection forms. Therefore, data approved for collection by the OPTN Board of Directors are submitted by HRSA for OMB approval under the Paperwork Reduction Act of 1995. This is a request for revising the current OPTN data collection associated with an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant to include data collection forms in the OPTN Organ Labeling, Packaging, and Tracking System, the OPTN Kidney Paired Donation Pilot Program (KPDPP), and the OPTN Patient Safety Reporting Portal (PSRP). This revision also includes OPTN Board of Directors approved changes to the existing OMB data collection forms. These specific data elements of the OPTN data system are collected from transplant hospitals, organ procurement organizations, and histocompatibility laboratories. The information is used 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 and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; (5) perform transplantation-related public health surveillance including the possible transmission of donor disease. HRSA is submitting the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements. All of these proposed changes have been approved by the OPTN Board of Directors. (1) Adding two data collection forms for the OPTN Organ Labeling, Packaging, and Tracking System to the existing OMB approved Data System for Organ Procurement and Transplantation Network. The system has two forms that are used through mobile and web-based applications to ensure the correct organ is transplanted into the correct patient, minimize labeling and transport errors, accelerate organ information transfer, [[Page 48744]] and capture data regarding organ procurement. OPTN Organ Labeling, Packaging, and Tracking System is comprised of two data collection forms: Organ labeling and packaging, and organ tracking and validating. (2) Adding data collection forms for the OPTN KPDPP to the existing OMB approved Data System for Organ Procurement and Transplantation Network. Kidney paired donation is a transplant option for those patients waiting for a kidney transplant who have a willing living donor who is medically able but cannot donate a kidney to their intended candidate because they are incompatible. OPTN KPDPP matches living donors, and their intended candidates with other living donors or intended candidate pairs when the living donors cannot donate to the person(s) they initially hoped would receive their kidney. OPTN KPDPP is comprised of three data collection forms: Candidate registration, donor registration, and match offer management. (3) Adding data collection forms in the OPTN PSRP to the existing OMB approved Data System for Organ Procurement and Transplantation Network. OPTN PSRP allows the OPTN to collect reports on any event or process variance that could cause concerns from transplantation, donation, safety, or quality perspective. OPTN PSRP is comprised of four data collection forms: Disease transmission event, living donor event, safety situation, and potential disease transmission. (4) Additional revisions to existing data collection forms were made based on the OPTN Board of Directors-approved changes to improve organ matching, allocation, and OPTN policy compliance. Need and Proposed Use of the Information: Data are used to develop transplant, donation, 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 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 members of the public for evaluation, research, patient information, and other important purposes. Likely Respondents: Transplant programs, Organ Procurement Organizations, 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 to collect, validate, and verify information, process and maintain information, and disclose and provide information; to train personnel and 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. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total per response Total burden respondents respondent * responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- Deceased Donor Registration..... 57 188.26 10,731 1.10 11,804 Living Donor Registration....... 300 22.85 6,855 2.19 \a\ 15,012 Living Donor Follow-up.......... 300 62.23 18,669 1.53 \b\ 28,564 Donor Histocompatibility........ 147 123.99 18,227 0.20 3,645 Recipient Histocompatibility.... 147 225.10 33,090 0.40 13,236 Heart Transplant Candidate 140 33.69 4,717 0.90 4,245 Registration................... Heart Recipient Registration.... 140 24.33 3,406 1.20 4,087 Heart Follow Up (6 Month)....... 140 22.01 3,081 0.40 1,233 Heart Transplant Recipient 140 90.61 12,685 0.90 11,417 Follow Up 1-5 Year............. Heart Transplant Recipient 140 153.97 21,556 0.50 10,778 Follow Up Post 5 Year.......... Heart Post-Transplant Malignancy 140 12.77 1,788 0.90 1,609 Form........................... Lung Transplant Candidate 71 45.21 3,210 0.90 2,889 Registration................... Lung Transplant Recipient 71 35.66 2,532 1.20 3,038 Registration................... Lung Transplant Recipient Follow 71 32.35 2,297 0.50 1,148 Up 6 Month..................... Lung Transplant Recipient Follow 71 118.85 8,438 1.10 9,282 Up 1-5 Year.................... Lung Transplant Recipient Follow 71 116.49 8,271 0.60 4,962 Up Post 5 Year................. Lung- Post-Transplant Malignancy 71 19.72 1,400 0.40 560 Form........................... Heart/Lung Transplant Candidate 69 0.97 67 1.10 74 Registration................... Heart/Lung Recipient 69 0.46 32 1.30 41 Registration................... Heart/Lung Transplant Recipient 69 0.45 31 0.80 25 Follow Up 6 Month.............. Heart/Lung Transplant Recipient 69 1.14 79 1.10 87 Follow Up 1-5 Year............. Heart/Lung Transplant Recipient 69 3.30 228 0.60 137 Follow Up Post 5 Year.......... Heart/Lung Post-Transplant 69 0.30 21 0.40 8 Malignancy Form................ Liver Transplant Candidate 146 90.29 13,182 0.80 10,546 Registration................... Liver Transplant Recipient 146 56.55 8,256 1.20 9,908 Registration................... Liver Transplant Recipient 146 266.57 38,919 1.00 38,919 Follow-Up 6 Month--5 Year...... Liver Transplant Recipient 146 316.61 46,225 0.50 23,113 Follow-up Post 5 Year.......... Liver Recipient Explant 146 10.58 1,545 0.60 927 Pathology Form................. Liver Post-Transplant Malignancy 146 16.35 2,387 0.80 1,910 Intestine Transplant Candidate 20 6.95 139 1.30 181 Registration................... Intestine Transplant Recipient 20 5.20 104 1.80 187 Registration................... Intestine Transplant Recipient 20 26.20 524 1.50 786 Follow Up 6 Month--5 Year...... Intestine Transplant Recipient 20 37.20 744 0.40 298 Follow Up Post 5 Year.......... Intestine Post-Transplant 20 2.10 42 1.00 42 Malignancy Form................ Kidney Transplant Candidate 237 168.77 39,998 0.80 31,999 Registration................... [[Page 48745]] Kidney Transplant Recipient 237 89.43 21,195 1.20 25,434 Registration................... Kidney Transplant Recipient 237 431.86 102,351 0.90 92,116 Follow-Up 6 Month--5 Year...... Kidney Transplant Recipient 237 449.40 106,508 0.50 53,254 Follow-Up Post 5 Year.......... Kidney Post-Transplant 237 22.64 5,366 0.80 4,293 Malignancy Form................ Pancreas Transplant Candidate 133 2.77 368 0.60 221 Registration................... Pancreas Transplant Recipient 133 1.46 194 1.20 233 Registration................... Pancreas Transplant Recipient 133 7.87 1,047 0.50 523 Follow-Up 6 Month--5 Year...... Pancreas Transplant Recipient 133 15.93 2,119 0.50 1,059 Follow-Up Post 5 Year.......... Pancreas Post-Transplant 133 0.73 97 0.60 58 Malignancy Form................ Kidney/Pancreas Transplant 133 9.75 1,297 0.60 778 Candidate Registration......... Kidney/Pancreas Transplant 133 7.73 1,028 1.20 1,234 Recipient Registration......... Kidney/Pancreas Transplant 133 32.80 4,362 0.50 2,181 Recipient Follow-Up 6 Month--5 Year........................... Kidney/Pancreas Transplant 133 57.80 7,687 0.60 4,612 Recipient Follow-Up Post 5 Year Kidney/Pancreas Post-Transplant 133 2.20 293 0.40 117 Malignancy Form................ VCA Transplant Candidate 27 0.89 24 0.40 11 Registration................... VCA Transplant Recipient 27 1.59 43 1.36 \c\ 58 Registration................... VCA Transplant Recipient Follow 27 0.67 18 1.31 \d\ 24 Up............................. Organ Labeling and Packaging.... 57 208.25 11,870 0.18 2,137 Organ Tracking and Validating... 34 169.06 5,748 0.08 460 Kidney Paired Donation Candidate 160 1.38 221 0.29 64 Registration................... Kidney Paired Donation Donor 160 1.46 234 1.07 250 Registration................... Kidney Paired Donation Match 160 1.51 242 0.67 162 Offer Management............... Disease Transmission Event...... 308 1.44 444 0.62 275 Living Donor Event.............. 251 0.12 30 0.56 17 Safety Situation................ 450 0.48 216 0.56 121 Potential Disease Transmission.. 57 6.88 392 1.27 498 Request to Unlock............... 450 39.22 17,649 0.02 353 ------------------------------------------------------------------------------- Total....................... 8,290 .............. 604,519 .............. 437,240 ---------------------------------------------------------------------------------------------------------------- * The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth. \a\ Total burden increased due to the approval of the ``Modify Data Collection on VCA Living Donors'' proposal approved by the OPTN Board of Directors (BOD) in December of 2020. The proposal required adding 54 new data fields onto this form and removing 1 data field from this form. \b\ Total burden increased due to the approval of the ``Modify Data Collection on VCA Living Donors'' proposal approved by the OPTN BOD in December of 2020. The proposal required adding 17 new data fields onto this form. \c\ Total burden increased due to the approval of the ``Programming VCA Allocation in UNet'' proposal approved by the OPTN BOD in December of 2020. The proposal required adding 16 new data fields onto this form and removing 10 data fields from this form. \d\ Total burden increased due to the approval of the ``Programming VCA Allocation in UNet'' proposal approved by the OPTN BOD in December of 2020. The proposal required adding 54 new data fields onto this form and removing 5 data fields from this form. 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. 2021-18688 Filed 8-30-21; 8:45 am] BILLING CODE 4165-15-P