[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38873-38876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12719]


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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; 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.

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SUMMARY: In compliance with of 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.

DATES: Comments on this ICR should be received no later than July 14, 
2023.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for

[[Page 38874]]

Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Samantha Miller, the HRSA 
Information Collection Clearance Officer, at [email protected] or call 
(301) 443-3983.

SUPPLEMENTARY INFORMATION: 
    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 of HHS, by contract, provide for the establishment 
and operation of a private, non-profit entity the Organ Procurement and 
Transplantation Network (OPTN), which on behalf of HRSA, operates the 
U.S. donation and transplantation system. The OPTN Board of Directors 
(BOD) determines what data must be collected to appropriately fulfill 
the OPTN responsibilities pursuant to the 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.
    A 60-day notice published in the Federal Register on September 29, 
2022, vol. 87, No. 188; pp. 59103-59105. HRSA received one comment. The 
commenter supported the necessity and utility of the proposed 
information collection and the accuracy of the estimated burden. 
However, the commenter recommended that HRSA consider enhancements to 
the `currently-used United Network for Organ Sharing data system' 
including the need for more real-time data for Organ Procurement 
Organizations (OPO) and a more advanced application programming 
interface which integrates with OPO's electronic medical record 
platforms. Since the requested changes were to the `OPTN data system' 
and not the forms themselves, HRSA is not making any changes to the 
information collection request as a result of this comment. However, 
HRSA appreciates all public feedback and will consider data system 
changes in consultation with the OPTN members and the public.
    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, OPOs, 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 OPO 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: initial 
donor registration, OPO 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, 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 estimated burden hours for this collection increased by 
217,361.30 hours from the previously OMB-approved data collection 
package from March 22, 2022. This increase is for the most part 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 increases from the Potential Transplant Recipient form. 
While the data fields collected on the Potential Transplant Recipient 
form are limited, the volume of organ offer

[[Page 38875]]

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
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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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Deceased Donor Registration.....              57          243.56          13,883            1.20       16,659.60
Living Donor Registration.......             216           28.11           6,072            2.19       13,297.68
Living Donor Follow-up..........             216           90.55          19,559            1.52       29,729.68
Donor Histocompatibility........             141          149.18          21,034            0.20        4,206.80
Recipient Histocompatibility....             141          264.95          37,358            0.40       14,943.20
Heart Transplant Candidate                   145           34.59           5,016            0.90        4,514.40
 Registration...................
Heart Transplant Recipient                   145           26.32           3,816            1.96        7,479.36
 Registration...................
Heart Transplant Recipient                   145           24.40           3,538            0.40        1,415.20
 Follow Up (6 Month)............
Heart Transplant Recipient                   145          104.14          15,100            0.90       13,590.00
 Follow Up (1-5 Year)...........
Heart Transplant Recipient                   145          171.10          24,810            0.50       12,405.00
 Follow Up (Post 5 Year)........
Heart Post-Transplant Malignancy             145           13.17           1,910            0.90        1,719.00
 Form...........................
Lung Transplant Candidate                     72           42.97           3,094            0.90        2,784.60
 Registration...................
Lung Transplant Recipient                     72           35.01           2,521            1.20        3,025.20
 Registration...................
Lung Transplant Recipient Follow              72           33.63           2,421            0.50        1,210.50
 Up (6 Month)...................
Lung Transplant Recipient Follow              72          139.94          10,076            1.10       11,083.60
 Up (1-5 Year)..................
Lung Transplant Recipient Follow              72          136.28           9,812            0.60        5,887.20
 Up (Post 5 Year)...............
Lung Post-Transplant Malignancy               72           22.63           1,629            0.40          651.60
 Form...........................
Heart/Lung Transplant Candidate               70            0.96              67            1.10           73.70
 Registration...................
Heart/Lung Transplant Recipient               70            0.64              45            2.15           96.75
 Registration...................
Heart/Lung Transplant Recipient               70            0.60              42            0.80           33.60
 Follow Up (6 Month)............
Heart/Lung Transplant Recipient               70            2.10             147            1.10          161.70
 Follow Up (1-5 Year)...........
Heart/Lung Transplant Recipient               70            3.36             235            0.60          141.00
 Follow Up (Post 5 Year)........
Heart/Lung Post-Transplant                    70            0.29              20            0.40            8.00
 Malignancy Form................
Liver Transplant Candidate                   143           96.92          13,860            0.80       11,088.00
 Registration...................
Liver Transplant Recipient                   143           64.58           9,235            1.20       11,082.00
 Registration...................
Liver Transplant Recipient                   143          320.27          45,799            1.00       45,799.00
 Follow Up (6 Month--5 Year)....
Liver Transplant Recipient                   143          384.32          54,958            0.50       27,479.00
 Follow Up (Post 5 Year)........
Liver Recipient Explant                      143            7.30           1,044            0.60          626.40
 Pathology Form.................
Liver Post-Transplant Malignancy             143           19.06           2,726            0.80        2,180.80
Intestine Transplant Candidate                21            6.86             144            1.30          187.20
 Registration...................
Intestine Transplant Recipient                21            4.57              96            1.80          172.80
 Registration...................
Intestine Transplant Recipient                21           20.05             421            1.50          631.50
 Follow Up (6 Month--5 Year)....
Intestine Transplant Recipient                21           40.19             844            0.40          337.60
 Follow Up (Post 5 Year)........
Intestine Post-Transplant                     21            0.62              13            1.00           13.00
 Malignancy Form................
Kidney Transplant Candidate                  234          177.00          41,418            0.80       33,134.40
 Registration...................
Kidney Transplant Recipient                  234          105.40          24,664            1.20       29,596.80
 Registration...................
Kidney Transplant Recipient                  234          517.12         121,006            0.90      108,905.40
 Follow Up (6 Month--5 Year)....
Kidney Transplant Recipient                  234          525.10         122,873            0.50       61,436.50
 Follow Up (Post 5 Year)........
Kidney Post-Transplant                       234           24.47           5,726            0.80        4,580.80
 Malignancy Form................
Pancreas Transplant Candidate                120            2.65             318            0.60          190.80
 Registration...................
Pancreas Transplant Recipient                120            1.19             143            1.20          171.60
 Registration...................
Pancreas Transplant Recipient                120            6.68             802            0.50          401.00
 Follow Up (6 Month--5 Year)....
Pancreas Transplant Recipient                120           17.82            2138            0.50        1,069.00
 Follow Up (Post 5 Year)........
Pancreas Post-Transplant                     120            1.06             127            0.60           76.20
 Malignancy Form................
Kidney/Pancreas Transplant                   120           12.45           1,494            0.60          896.40
 Candidate Registration.........
Kidney/Pancreas Transplant                   120            6.84             821            1.20          985.20
 Recipient Registration.........
Kidney/Pancreas Transplant                   120           39.44           4,733            0.50        2,366.50
 Recipient Follow Up (6 Month--5
 Year)..........................
Kidney/Pancreas Transplant                   120           69.41           8,329            0.60        4,997.40
 Recipient Follow Up (Post 5
 Year)..........................
Kidney/Pancreas Post-Transplant              120            2.49             299            0.40          119.60
 Malignancy Form................
Vascularized Composite Allograft              21            0.33               7            0.40            2.80
 (VCA) Transplant Candidate
 Registration...................
VCA Transplant Recipient                      21            0.19               4            1.36            5.44
 Registration...................
VCA Transplant Recipient Follow               21            1.00              21            1.31           27.51
 Up.............................
Organ Labeling and Packaging....              57          247.72          14,120            0.18        2,541.60
Organ Tracking and Validating...             308           19.49           6,003            0.08          480.24
Kidney Paired Donation Candidate             159            1.20             191            0.29           55.39
 Registration...................
Kidney Paired Donation Donor                 159            1.56             248            1.08          267.84
 Registration...................
Kidney Paired Donation Match                 159            1.52             242            0.67          162.14
 Offer Management...............
Disease Transmission Event......             308            1.81             557            0.62          345.34
Living Donor Event..............             251           0.156              39            0.56           21.84

[[Page 38876]]

 
Safety Situation................             449            0.60             269            0.56          150.64
Potential Disease Transmission..              57            8.72             497            1.27          631.19
Request to Unlock Form..........             449           42.40          19,038            0.02          380.76
Initial Donor Registration......              57          335.72          19,136            3.00       57,408.00
OPO Notification Limit                        57            0.49              28            0.17            4.76
 Administration.................
Potential Transplant Recipient..             308         4718.48       1,453,292            0.05       72,664.60
Death Notification Registration.              57          185.77          10,589            0.42        4,447.38
Deceased Donor Death Referral...              57           53.84           3,069            0.50        1,534.50
Donor Hospital Registration.....              57            0.04               2            0.08            0.16
Donor Organ Disposition.........              57          335.72          19,136            0.17        3,253.12
Transplant Center Contact                    251          637.50         160,013            0.06        9,600.78
 Management.....................
Total = 70 forms................           9,146  ..............       2,352,737  ..............      647,628.30
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* 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 Programs, 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 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. 2023-12719 Filed 6-13-23; 8:45 am]
BILLING CODE 4165-15-P