[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Notices]
[Pages 1151-1153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00239]



[[Page 1151]]

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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.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
has 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 February 
9, 2022.

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 
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 acting 
HRSA Information Collection Clearance Officer at <a href="/cdn-cgi/l/email-protection#aadacbdacfd8ddc5d8c1eac2d8d9cb84cdc5dc"><span class="__cf_email__" data-cfemail="780819081d0a0f170a1338100a0b19561f170e">[email protected]</span></a> or 
call (301) 443-9094.

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, 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 
will be 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.
    A 60-day notice was published in the Federal Register, 86 FR 48743 
(Aug. 31, 2021). One comment was received. The commenter supported the 
necessity and utility of the proposed information collection and the 
use of automated collection techniques. The commenter recommended that 
HRSA account for anticipated increased staff hours and recommended 
emphasizing collecting data pertaining to race, ethnicity, social 
determinants of health, and any other characteristics that will help 
achieve equity in organ donation and transplantation. HRSA appreciates 
all feedback, and we will continue to review and evaluate all data 
collection efforts going forward in consultation with the OPTN.
    The 60-day notice proposed data collection changes to existing data 
collection forms related to Vascularized Composite Allograft (VCA) 
transplantation, to implement policies approved by the OPTN Board of 
Directors. The OPTN expects to make additional changes to these VCA 
data collection forms in the near future so implementation of data 
collection changes has been postponed. These data collection changes 
are not included in this 30-day notice and will be included for review 
in a future submission.
    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.
    This is a request to revise 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 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, 
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.

[[Page 1152]]

    (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) Adding a request to unlock form
    (5) 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.
    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 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 burden hours in the OMB inventory increased by 4,337 
hours from the previously OMB-approved data collection package from 
August 25, 2020. This increase is due to including new data collection 
forms and additional data to existing data collection forms. However, 
the total burden hours of this request is less than the total burden 
hours presented in the 60-day notice, because of the removal of the 
proposed data collection changes associated with implementing the 
``Modify Data Collection on VCA Living Donors'' and ``Programming VCA 
Allocation in UNet'' policies.

                                    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            1.80      \a\ 12,339
Living Donor Follow-up..........             300           62.23          18,669            1.30      \b\ 24,270
Donor Histocompatibility........             147          123.99          18,226            0.20           3,645
Recipient Histocompatibility....             147          225.10          33,090            0.40          13,236
Heart Candidate Registration....             140           33.69           4,717            0.90           4,245
Heart Recipient Registration....             140           24.33           3,406            1.20           4,087
Heart Follow Up (6 Month).......             140           22.01           3,081            0.40           1,232
Heart Follow Up (1-5 Year)......             140           90.61          12,685            0.90          11,417
Heart Follow Up (Post 5 Year)...             140          153.97          21,556            0.50          10,778
Heart Post-Transplant Malignancy             140           12.77           1,788            0.90           1,609
 Form...........................
Lung Candidate Registration.....              71           45.21           3,210            0.90           2,889
Lung Recipient Registration.....              71           35.66           2,532            1.20           3,038
Lung Follow Up (6 Month)........              71           32.35           2,297            0.50           1,148
Lung Follow Up (1-5 Year).......              71          118.85           8,438            1.10           9,282
Lung Post-Transplant Malignancy               71           19.72           1,400            0.40             560
 Form...........................
Heart/Lung Candidate                          69            0.97              67            1.10              74
 Registration...................
Heart/Lung Recipient                          69            0.46              32            1.30              42
 Registration...................
Heart/Lung Follow Up (6 Month)..              69            0.45              31            0.80              25
Heart/Lung Follow Up (1-5 Year).              69            1.14              79            1.10              87
Heart/Lung Follow Up (Post 5                  69            3.30             228            0.60             137
 Year)..........................
Heart/Lung Post-Transplant                    69            0.30              21            0.40               8
 Malignancy Form................
Liver Candidate Registration....             146           90.29          13,182            0.80          10,546
Liver Recipient Registration....             146           56.55           8,256            1.20           9,907
Liver Follow-up (6 Month-5 Year)             146          266.57          38,919            1.00          38,919
Liver Follow-up (Post 5 Year)...             146          316.61          46,225            0.50          23,113
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 Candidate Registration              20            6.95             139            1.30             181
Intestine Recipient Registration              20            5.20             104            1.80             187
Intestine Follow Up (6 Month-5                20           26.20             524            1.50             786
 Year)..........................
Intestine Follow Up (Post 5                   20           37.20             744            0.40             298
 Year)..........................
Intestine Post-Transplant                     20            2.10              42            1.00              42
 Malignancy Form................
Kidney Candidate Registration...             237          168.77          39,998            0.80          31,998
Kidney Recipient Registration...             237           89.43          21,195            1.20          25,434
Kidney Follow-up (Post 5 Year)..             237          449.40         106,508            0.50          53,254
Kidney Post-Transplant                       237           22.64           5,366            0.80           4,292
 Malignancy Form................
Pancreas Candidate Registration.             133            2.77             368            0.60             221
Pancreas Recipient Registration.             133            1.46             194            1.20             233
Pancreas Follow-up (6 Month-5                133            7.87           1,047            0.50             524
 Year)..........................
Pancreas Follow-up (Post 5 Year)             133           15.93           2,119            0.50           1,060
Pancreas Post-Transplant                     133            0.73              97            0.60              58
 Malignancy Form................
Kidney/Pancreas Candidate                    133            9.75           1,297            0.60             778
 Registration...................
Kidney/Pancreas Recipient                    133            7.73           1,028            1.20           1,234
 Registration...................
Kidney/Pancreas Follow-up (6                 133           32.80           4,362            0.50           2,181
 Month-5 Year)..................
Kidney/Pancreas Follow-up (Post              133           57.80           7,687            0.60           4,612
 5 Year)........................

[[Page 1153]]

 
Kidney/Pancreas Post-Transplant              133            2.20             293            0.40             117
 Malignancy Form................
VCA Candidate Registration......              27            0.89              24            0.40              10
VCA Recipient Registration......              27            1.59              43            1.30          \c\ 56
VCA Recipient Follow Up.........              27            0.67              18            1.00          \d\ 18
Organ Labeling and Packaging                  57          208.25          11,870            0.18           2,137
 System.........................
Organ Tracking and Validating                 34          169.06           5,748            0.08             460
 System.........................
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...............
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
 Report.........................
Request to Unlock Form..........             450           39.22          17,649            0.02             353
                                 -------------------------------------------------------------------------------
    Total.......................           8,290  ..............         604,519  ..............         430,267
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* The Number of Reponses per Respondent was calculated by dividing the Total Responses by the Number of
  Respondents and rounding to the nearest tenth.
\a\ \b\ \c\ \d\ Total burden hours in these forms decreased from estimates provided in the 60-day Notice due to
  the removal of the proposed data collection changes associated with implementing the ``Modify Data Collection
  on VCA Living Donors'' and ``Programming VCA Allocation in UNet'' policies.

    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. 2022-00239 Filed 1-7-22; 8:45 am]
BILLING CODE 4165-15-P


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