[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 [email protected] 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.
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(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
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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 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)........................
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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
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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