Notice2023-12719
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
Primary source
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Published
June 14, 2023
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 114 (Wednesday, June 14, 2023)</title>
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[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38873-38876]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#eb9b8a9b8e999c849980ab8399988ac58c849d"><span class="__cf_email__" data-cfemail="7a0a1b0a1f080d1508113a1208091b541d150c">[email protected]</span></a> 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
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