[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]


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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.

ACTION: Notice.

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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
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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          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
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    Total.......................           8,290  ..............         604,519  ..............         437,240
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* 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