2022-21119. 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  

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    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 November 28, 2022.

    ADDRESSES:

    Submit your comments to paperwork@hrsa.gov or by mail to the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857.

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    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 paperwork@hrsa.gov or call Samantha Miller, the HRSA Information Collection Clearance Officer at (301) 443-9094.

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    SUPPLEMENTARY INFORMATION:

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

    Information Collection Request Title: Data System for Organ Procurement and Transplantation Network (OPTN), OMB No. 0915-0157—Revision.

    Abstract: Section 372 of the Public Health Service Act requires that the Secretary of HHS, by contract, provide for the establishment and operation of a private, non-profit entity the OPTN, which on behalf of HRSA, oversees the U.S. donation and transplantation system. The OPTN Board of Directors (BOD) determines what data must be collected to appropriately fulfill their responsibilities pursuant to their regulatory authority in 42 CFR 121.11 of the OPTN Final Rule. HRSA, on behalf of the OPTN BOD and in alignment with the Paperwork Reduction Act of 1995, submits OPTN 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, 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. In addition, the regulatory authority in 42 CFR 121.11 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 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. The OPTN uses 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 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 OPTN BOD-approved changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements:

    (1) Adding data collection forms from the OPTN donor management and organ matching system to the existing OMB-approved information collection. The system allows an organ procurement organization to add donors, run the donor/potential transplant recipients matches, and place a donated organ(s) with a computer-matched potential transplant recipient. Transplant centers will access the system to view posted donor information to assist them with accepting decisions, along with other donor/potential transplant recipient functions such as entering offer responses and verifying organ offer refusals. The OPTN donor management and organ matching system is comprised of eight data collection forms: Start Printed Page 59104 initial donor registration, organ procurement organization notification limit administration, potential transplant recipient, death notification registration, deceased donor death referral, donor hospital registration, donor organ disposition, and transplant center contact management.

    (2) The OPTN BOD-approved additional revisions to existing data collection forms to improve organ matching, allocation, and OPTN policy compliance.

    (3) Existing OPTN data collection forms that collect a single race and ethnicity variable will be revised to collect separate race and ethnicity variables, following the minimum standards for collecting and presenting data on race and ethnicity for all federal reporting found within Revisions of Standards for the Classification of Federal Data on Race and Ethnicity, OMB Statistical Policy Directive No. 15 in Federal Register , 62 FR 58782 (Oct. 30, 1997). Improving data collection around race and ethnicity information of donors and candidates aligns with Executive Order 13985, which calls on agencies to advance equity through identifying and addressing barriers to equal opportunity that underserved communities may face due to government policies and programs.

    Likely Respondents: Transplant programs, organ procurement organizations (OPO), 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 estimated total estimated burden hours for this collection increased by 213,662 hours from the currently approved ICR package. This increase is due to the addition of eight collection forms from the OPTN donor management and organ matching system to this data collection package, specifically the burden increase from the Potential Transplant Recipient form. While the data fields collected on the Potential Transplant Recipient form are limited, the volume of organ offer responses is significant due to the large number of potential transplant recipients shown on the organ match run results. The organ match run results produce thousands of potential transplant recipients that require responses from OPOs and transplant hospitals. This volume of candidates significantly impacts the total burden hours for this form.

    Total Estimated Annualized Burden Hours:

    Form nameNumber of respondents *Number of responses per respondentTotal responsesAverage burden per response (in hours)Total burden hours
    Deceased Donor Registration57243.56013,8831.0915,132
    Living Donor Registration21628.1066,0712.1913,295
    Living Donor Follow-up21690.55019,5591.5229,730
    Donor Histocompatibility141149.18421,0350.204,207
    Recipient Histocompatibility141264.95037,3580.4014,943
    Heart Transplant Candidate Registration14534.5865,0150.904,514
    Heart Transplant Recipient Registration14526.3243,8171.405,344
    Heart Transplant Recipient Follow-Up (6 Months)14524.4003,5380.401,415
    Heart Transplant Recipient Follow-Up (1-5 Years)145104.14015,1000.9013,590
    Heart Transplant Recipient Follow-Up (Post 5 Year)145171.10024,8100.5012,405
    Heart Post-Transplant Malignancy Form14513.1701,9100.901,719
    Lung Transplant Candidate Registration7242.9703,0940.902,785
    Lung Transplant Recipient Registration7235.0102,5211.203,025
    Lung Transplant Recipient Follow-Up (6 Months)7233.6302,4210.501,211
    Lung Transplant Recipient Follow-Up (1-5 Years)72139.94010,0761.1011,084
    Lung Transplant Recipient Follow-Up (Post 5 Year)72136.2809,8120.605,887
    Lung Post-Transplant Malignancy Form7222.6301,6290.40652
    Heart/Lung Transplant Candidate Registration700.960671.1074
    Heart/Lung Transplant Recipient Registration700.640451.3059
    Heart/Lung Transplant Recipient Follow-Up (6 Months)700.600420.8034
    Heart/Lung Transplant Recipient Follow-Up (1-5 Years)702.1001471.10162
    Heart/Lung Transplant Recipient Follow-Up (Post 5 Year)703.3602350.60141
    Heart/Lung Post-Transplant Malignancy Form700.290200.408
    Liver Transplant Candidate Registration14396.92013,8600.8011,088
    Liver Transplant Recipient Registration14364.5809,2351.2011,082
    Liver Transplant Recipient Follow-Up (6 Month-5 Year)143320.26645,7981.0045,798
    Liver Transplant Recipient Follow-Up (Post 5 Year)143384.32054,9580.5027,479
    Liver Recipient Explant Pathology Form1437.3001,0440.60626
    Liver Post-Transplant Malignancy14319.0602,7260.802,181
    Intestine Transplant Candidate Registration216.8601441.30187
    Intestine Transplant Recipient Registration214.570961.80173
    Intestine Transplant Recipient Follow-Up (6 Month-5 Year)2120.0504211.50632
    Intestine Transplant Recipient Follow-Up (Post 5 Year)2140.1908440.40338
    Intestine Post-Transplant Malignancy Form210.620131.0013
    Kidney Transplant Candidate Registration234177.00041,4180.8033,134
    Kidney Transplant Recipient Registration234105.39724,6631.2029,596
    Kidney Transplant Recipient Follow-Up (6 Month-5 Year)234517.124121,0070.90108,906
    Kidney Transplant Recipient Follow-Up (Post 5 Year)234525.103122,8740.5061,437
    Kidney Post-Transplant Malignancy Form23424.4745,7270.804,582
    Pancreas Transplant Candidate Registration1202.6503180.60191
    Pancreas Transplant Recipient Registration1201.1901431.20172
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    Pancreas Transplant Recipient Follow-Up (6 Month-5 Year)1206.6808020.50401
    Pancreas Transplant Recipient Follow-Up (Post 5 Year)12017.82021380.501,069
    Pancreas Post-Transplant Malignancy Form1201.0601270.6076
    Kidney/Pancreas Transplant Candidate Registration12012.4501,4940.60896
    Kidney/Pancreas Transplant Recipient Registration1206.8408211.20985
    Kidney/Pancreas Transplant Recipient Follow-Up (6 Month-5 Year)12039.4404,7330.502,367
    Kidney/Pancreas Transplant Recipient Follow-Up (Post 5 Year)12069.4108,3290.604,997
    Kidney/Pancreas Post-Transplant Malignancy Form1202.4902990.40120
    VCA Transplant Candidate Registration210.33070.403
    VCA Transplant Recipient Registration210.19041.365
    VCA Transplant Recipient Follow Up211.000211.3128
    Organ Labeling and Packaging57247.72014,1200.182,542
    Organ Tracking and Validating30819.4876,0020.08480
    Kidney Paired Donation Candidate Registration1591.2001910.2955
    Kidney Paired Donation Donor Registration1591.5602481.08268
    Kidney Paired Donation Match Offer Management1591.5202420.67162
    Disease Transmission Event3081.8105570.62345
    Living Donor Event2510.155390.5622
    Safety Situation4490.6002690.56151
    Potential Disease Transmission578.7204971.27631
    Request to Unlock Form44942.39919,0370.02381
    Initial Donor Registration57335.72019,1363.0057,408
    OPO Notification Limit Administration570.490280.175
    Potential Transplant Recipient3084,718.4801,453,2920.0572,665
    Death Notification Registration57185.77010,5890.424,447
    Deceased Donor Death Referral5753.8403,0690.501,535
    Donor Hospital Registration570.04020.080
    Donor Organ Disposition57335.72019,1360.173,253
    Transplant Center Contact Management251637.500160,0130.069,601
    Total = 70 forms9,1462,352,736643,929
    * The numbers of respondents and the numbers of total responses in the burden table were updated with 2021 OPTN data and reflect increases in the number of organ transplants and changes in the number of respondents (Transplant Hospitals, OPO, and Histocompatibility Labs).

    HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's and the OPTN'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.

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    Maria G. Button,

    Director, Executive Secretariat.

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    [FR Doc. 2022-21119 Filed 9-28-22; 8:45 am]

    BILLING CODE 4165-15-P

Document Information

Published:
09/29/2022
Department:
Health Resources and Services Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2022-21119
Dates:
Comments on this ICR should be received no later than November 28, 2022.
Pages:
59103-59105 (3 pages)
PDF File:
2022-21119.pdf