[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59103-59105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21119]


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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 (HHS).

ACTION: Notice.

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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 [email protected] or by mail to 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 Samantha Miller, 
the HRSA Information Collection Clearance Officer at (301) 443-9094.

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:

[[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:

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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         243.560          13,883            1.09          15,132
Living Donor Registration.......             216          28.106           6,071            2.19          13,295
Living Donor Follow-up..........             216          90.550          19,559            1.52          29,730
Donor Histocompatibility........             141         149.184          21,035            0.20           4,207
Recipient Histocompatibility....             141         264.950          37,358            0.40          14,943
Heart Transplant Candidate                   145          34.586           5,015            0.90           4,514
 Registration...................
Heart Transplant Recipient                   145          26.324           3,817            1.40           5,344
 Registration...................
Heart Transplant Recipient                   145          24.400           3,538            0.40           1,415
 Follow-Up (6 Months)...........
Heart Transplant Recipient                   145         104.140          15,100            0.90          13,590
 Follow-Up (1-5 Years)..........
Heart Transplant Recipient                   145         171.100          24,810            0.50          12,405
 Follow-Up (Post 5 Year)........
Heart Post-Transplant Malignancy             145          13.170           1,910            0.90           1,719
 Form...........................
Lung Transplant Candidate                     72          42.970           3,094            0.90           2,785
 Registration...................
Lung Transplant Recipient                     72          35.010           2,521            1.20           3,025
 Registration...................
Lung Transplant Recipient Follow-             72          33.630           2,421            0.50           1,211
 Up (6 Months)..................
Lung Transplant Recipient Follow-             72         139.940          10,076            1.10          11,084
 Up (1-5 Years).................
Lung Transplant Recipient Follow-             72         136.280           9,812            0.60           5,887
 Up (Post 5 Year)...............
Lung Post-Transplant Malignancy               72          22.630           1,629            0.40             652
 Form...........................
Heart/Lung Transplant Candidate               70           0.960              67            1.10              74
 Registration...................
Heart/Lung Transplant Recipient               70           0.640              45            1.30              59
 Registration...................
Heart/Lung Transplant Recipient               70           0.600              42            0.80              34
 Follow-Up (6 Months)...........
Heart/Lung Transplant Recipient               70           2.100             147            1.10             162
 Follow-Up (1-5 Years)..........
Heart/Lung Transplant Recipient               70           3.360             235            0.60             141
 Follow-Up (Post 5 Year)........
Heart/Lung Post-Transplant                    70           0.290              20            0.40               8
 Malignancy Form................
Liver Transplant Candidate                   143          96.920          13,860            0.80          11,088
 Registration...................
Liver Transplant Recipient                   143          64.580           9,235            1.20          11,082
 Registration...................
Liver Transplant Recipient                   143         320.266          45,798            1.00          45,798
 Follow-Up (6 Month-5 Year).....
Liver Transplant Recipient                   143         384.320          54,958            0.50          27,479
 Follow-Up (Post 5 Year)........
Liver Recipient Explant                      143           7.300           1,044            0.60             626
 Pathology Form.................
Liver Post-Transplant Malignancy             143          19.060           2,726            0.80           2,181
Intestine Transplant Candidate                21           6.860             144            1.30             187
 Registration...................
Intestine Transplant Recipient                21           4.570              96            1.80             173
 Registration...................
Intestine Transplant Recipient                21          20.050             421            1.50             632
 Follow-Up (6 Month-5 Year).....
Intestine Transplant Recipient                21          40.190             844            0.40             338
 Follow-Up (Post 5 Year)........
Intestine Post-Transplant                     21           0.620              13            1.00              13
 Malignancy Form................
Kidney Transplant Candidate                  234         177.000          41,418            0.80          33,134
 Registration...................
Kidney Transplant Recipient                  234         105.397          24,663            1.20          29,596
 Registration...................
Kidney Transplant Recipient                  234         517.124         121,007            0.90         108,906
 Follow-Up (6 Month-5 Year).....
Kidney Transplant Recipient                  234         525.103         122,874            0.50          61,437
 Follow-Up (Post 5 Year)........
Kidney Post-Transplant                       234          24.474           5,727            0.80           4,582
 Malignancy Form................
Pancreas Transplant Candidate                120           2.650             318            0.60             191
 Registration...................
Pancreas Transplant Recipient                120           1.190             143            1.20             172
 Registration...................

[[Page 59105]]

 
Pancreas Transplant Recipient                120           6.680             802            0.50             401
 Follow-Up (6 Month-5 Year).....
Pancreas Transplant Recipient                120          17.820            2138            0.50           1,069
 Follow-Up (Post 5 Year)........
Pancreas Post-Transplant                     120           1.060             127            0.60              76
 Malignancy Form................
Kidney/Pancreas Transplant                   120          12.450           1,494            0.60             896
 Candidate Registration.........
Kidney/Pancreas Transplant                   120           6.840             821            1.20             985
 Recipient Registration.........
Kidney/Pancreas Transplant                   120          39.440           4,733            0.50           2,367
 Recipient Follow-Up (6 Month-5
 Year)..........................
Kidney/Pancreas Transplant                   120          69.410           8,329            0.60           4,997
 Recipient Follow-Up (Post 5
 Year)..........................
Kidney/Pancreas Post-Transplant              120           2.490             299            0.40             120
 Malignancy Form................
VCA Transplant Candidate                      21           0.330               7            0.40               3
 Registration...................
VCA Transplant Recipient                      21           0.190               4            1.36               5
 Registration...................
VCA Transplant Recipient Follow               21           1.000              21            1.31              28
 Up.............................
Organ Labeling and Packaging....              57         247.720          14,120            0.18           2,542
Organ Tracking and Validating...             308          19.487           6,002            0.08             480
Kidney Paired Donation Candidate             159           1.200             191            0.29              55
 Registration...................
Kidney Paired Donation Donor                 159           1.560             248            1.08             268
 Registration...................
Kidney Paired Donation Match                 159           1.520             242            0.67             162
 Offer Management...............
Disease Transmission Event......             308           1.810             557            0.62             345
Living Donor Event..............             251           0.155              39            0.56              22
Safety Situation................             449           0.600             269            0.56             151
Potential Disease Transmission..              57           8.720             497            1.27             631
Request to Unlock Form..........             449          42.399          19,037            0.02             381
Initial Donor Registration......              57         335.720          19,136            3.00          57,408
OPO Notification Limit                        57           0.490              28            0.17               5
 Administration.................
Potential Transplant Recipient..             308       4,718.480       1,453,292            0.05          72,665
Death Notification Registration.              57         185.770          10,589            0.42           4,447
Deceased Donor Death Referral...              57          53.840           3,069            0.50           1,535
Donor Hospital Registration.....              57           0.040               2            0.08               0
Donor Organ Disposition.........              57         335.720          19,136            0.17           3,253
Transplant Center Contact                    251         637.500         160,013            0.06           9,601
 Management.....................
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    Total = 70 forms............           9,146  ..............       2,352,736  ..............         643,929
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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 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.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-21119 Filed 9-28-22; 8:45 am]
BILLING CODE 4165-15-P