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, 38873-38876 [2023-12719]
Download as PDF
<![CDATA[
38873
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
procedure that requires significant
support before, during, and after the
procedure. Many patients experience
barriers that impede access to HCT.
Barriers to HCT-related care and
educational information are multifactorial. The NMDP/Be The Match PSC
offers many programs and services to
support patients, caregivers, and family
members throughout their HCT journey.
Feedback from recipients of NMDP
services is essential to understand the
changing needs for services and
information as well as to demonstrate
the effectiveness of existing services.
The primary use for information
gathered through the survey is to
determine the helpfulness of
participants’ initial contact with the
PSC patient navigators and to identify
areas for improvement in the delivery of
services. Patient navigators are trained
lay or licensed clinical patient
navigators, who respond to requests for
information and support. Program
managers and NMDP leadership use this
evaluation data to share patients’
experiences as well as make program
and resource allocation decisions.
Web-based surveys will be
administered to all participants
(patients, caregivers, and family
members) who have contact with the
PSC. All participants for whom an email
address is known will be invited to
complete the survey online. Survey
respondents will be notified via email
invitation and in the survey instructions
that participation is voluntary, and
responses will be kept confidential. A
follow-up invitation will be sent within
2 weeks to non-respondents.
The survey will include these items to
measure: (1) their experience, (2) if the
contact helped the participant feel more
confident in coping with treatment, (3)
if the contact helped the participant feel
more hopeful, (4) if the contact helped
the participant feel less alone, (5)
increased awareness of available
resources, (6) if the contact helped the
participant feel more informed about
treatment options, (7) if their questions
were answered, and (8) types of
challenges faced by the participant. The
survey data will be analyzed quarterly
and annually, and results will be shared
with program managers. Feedback
indicating a need for improvement will
be reviewed by program managers
biannually and implementation of
resulting program changes or additions
will be documented.
Likely Respondents: Respondents will
include all patients, caregivers, and
family members who have contact with
the Patient Support Center via phone or
email for HCT navigation services and
support (advocacy). The decision to
survey all participants was made based
on the historically low response rate
(∼20 percent) to this survey due to
patients’ frequent transitions in health
status as well as transfer between home
and the hospital for initial treatment
and care for complications. Participants
will receive the survey once in a 1-year
cycle. If a participant contacts the
Patient Support Center one or more
years after the initial contact, they will
receive a second survey. This is because
it is anticipated that the participants’
needs will likely change during the time
lapse.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Be The Match® Patient Support Center Survey ..................
900
1
900
0.17
153
Total ..............................................................................
900
1
900
0.17
153
The total respondent burden for the
customer satisfaction surveys is
estimated to be 153 hours. HRSA
expects a total of 900 respondents to
complete the Be The Match® Patient
Support Center Survey.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–12666 Filed 6–13–23; 8:45 am]
BILLING CODE 4165–15–P
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
SUMMARY:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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.
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 www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
DATES:
E:\FR\FM\14JNN1.SGM
14JNN1
38874
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
Public Comments’’ or by using the
search function.
To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov 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,
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
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 OMBapproved 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,
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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 OMBapproved 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
E:\FR\FM\14JNN1.SGM
14JNN1
38875
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
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
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Form name
Deceased Donor Registration ..............................................
Living Donor Registration ....................................................
Living Donor Follow-up ........................................................
Donor Histocompatibility ......................................................
Recipient Histocompatibility .................................................
Heart Transplant Candidate Registration ............................
Heart Transplant Recipient Registration ..............................
Heart Transplant Recipient Follow Up (6 Month) ................
Heart Transplant Recipient Follow Up (1–5 Year) ..............
Heart Transplant Recipient Follow Up (Post 5 Year) ..........
Heart Post-Transplant Malignancy Form .............................
Lung Transplant Candidate Registration .............................
Lung Transplant Recipient Registration ..............................
Lung Transplant Recipient Follow Up (6 Month) .................
Lung Transplant Recipient Follow Up (1–5 Year) ...............
Lung Transplant Recipient Follow Up (Post 5 Year) ...........
Lung Post-Transplant Malignancy Form ..............................
Heart/Lung Transplant Candidate Registration ...................
Heart/Lung Transplant Recipient Registration .....................
Heart/Lung Transplant Recipient Follow Up (6 Month) .......
Heart/Lung Transplant Recipient Follow Up (1–5 Year) .....
Heart/Lung Transplant Recipient Follow Up (Post 5 Year)
Heart/Lung Post-Transplant Malignancy Form ....................
Liver Transplant Candidate Registration .............................
Liver Transplant Recipient Registration ...............................
Liver Transplant Recipient Follow Up (6 Month—5 Year) ..
Liver Transplant Recipient Follow Up (Post 5 Year) ...........
Liver Recipient Explant Pathology Form .............................
Liver Post-Transplant Malignancy .......................................
Intestine Transplant Candidate Registration .......................
Intestine Transplant Recipient Registration .........................
Intestine Transplant Recipient Follow Up (6 Month—5
Year) .................................................................................
Intestine Transplant Recipient Follow Up (Post 5 Year) .....
Intestine Post-Transplant Malignancy Form ........................
Kidney Transplant Candidate Registration ..........................
Kidney Transplant Recipient Registration ...........................
Kidney Transplant Recipient Follow Up (6 Month—5 Year)
Kidney Transplant Recipient Follow Up (Post 5 Year) ........
Kidney Post-Transplant Malignancy Form ...........................
Pancreas Transplant Candidate Registration ......................
Pancreas Transplant Recipient Registration .......................
Pancreas Transplant Recipient Follow Up (6 Month—5
Year) .................................................................................
Pancreas Transplant Recipient Follow Up (Post 5 Year) ...
Pancreas Post-Transplant Malignancy Form ......................
Kidney/Pancreas Transplant Candidate Registration ..........
Kidney/Pancreas Transplant Recipient Registration ...........
Kidney/Pancreas Transplant Recipient Follow Up (6
Month—5 Year) ................................................................
Kidney/Pancreas Transplant Recipient Follow Up (Post 5
Year) .................................................................................
Kidney/Pancreas Post-Transplant Malignancy Form ..........
Vascularized Composite Allograft (VCA) Transplant Candidate Registration ...........................................................
VCA Transplant Recipient Registration ...............................
VCA Transplant Recipient Follow Up ..................................
Organ Labeling and Packaging ...........................................
Organ Tracking and Validating ............................................
Kidney Paired Donation Candidate Registration .................
Kidney Paired Donation Donor Registration ........................
Kidney Paired Donation Match Offer Management .............
Disease Transmission Event ...............................................
Living Donor Event ..............................................................
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
PO 00000
Frm 00067
Fmt 4703
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
57
216
216
141
141
145
145
145
145
145
145
72
72
72
72
72
72
70
70
70
70
70
70
143
143
143
143
143
143
21
21
243.56
28.11
90.55
149.18
264.95
34.59
26.32
24.40
104.14
171.10
13.17
42.97
35.01
33.63
139.94
136.28
22.63
0.96
0.64
0.60
2.10
3.36
0.29
96.92
64.58
320.27
384.32
7.30
19.06
6.86
4.57
13,883
6,072
19,559
21,034
37,358
5,016
3,816
3,538
15,100
24,810
1,910
3,094
2,521
2,421
10,076
9,812
1,629
67
45
42
147
235
20
13,860
9,235
45,799
54,958
1,044
2,726
144
96
1.20
2.19
1.52
0.20
0.40
0.90
1.96
0.40
0.90
0.50
0.90
0.90
1.20
0.50
1.10
0.60
0.40
1.10
2.15
0.80
1.10
0.60
0.40
0.80
1.20
1.00
0.50
0.60
0.80
1.30
1.80
16,659.60
13,297.68
29,729.68
4,206.80
14,943.20
4,514.40
7,479.36
1,415.20
13,590.00
12,405.00
1,719.00
2,784.60
3,025.20
1,210.50
11,083.60
5,887.20
651.60
73.70
96.75
33.60
161.70
141.00
8.00
11,088.00
11,082.00
45,799.00
27,479.00
626.40
2,180.80
187.20
172.80
21
21
21
234
234
234
234
234
120
120
20.05
40.19
0.62
177.00
105.40
517.12
525.10
24.47
2.65
1.19
421
844
13
41,418
24,664
121,006
122,873
5,726
318
143
1.50
0.40
1.00
0.80
1.20
0.90
0.50
0.80
0.60
1.20
631.50
337.60
13.00
33,134.40
29,596.80
108,905.40
61,436.50
4,580.80
190.80
171.60
120
120
120
120
120
6.68
17.82
1.06
12.45
6.84
802
2138
127
1,494
821
0.50
0.50
0.60
0.60
1.20
401.00
1,069.00
76.20
896.40
985.20
120
39.44
4,733
0.50
2,366.50
120
120
69.41
2.49
8,329
299
0.60
0.40
4,997.40
119.60
21
21
21
57
308
159
159
159
308
251
0.33
0.19
1.00
247.72
19.49
1.20
1.56
1.52
1.81
0.156
7
4
21
14,120
6,003
191
248
242
557
39
0.40
1.36
1.31
0.18
0.08
0.29
1.08
0.67
0.62
0.56
2.80
5.44
27.51
2,541.60
480.24
55.39
267.84
162.14
345.34
21.84
Sfmt 4703
E:\FR\FM\14JNN1.SGM
14JNN1
38876
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Safety Situation ....................................................................
Potential Disease Transmission ..........................................
Request to Unlock Form ......................................................
Initial Donor Registration .....................................................
OPO Notification Limit Administration .................................
Potential Transplant Recipient .............................................
Death Notification Registration ............................................
Deceased Donor Death Referral .........................................
Donor Hospital Registration .................................................
Donor Organ Disposition .....................................................
Transplant Center Contact Management ............................
Total = 70 forms ..................................................................
449
57
449
57
57
308
57
57
57
57
251
9,146
Number of
responses per
respondent
0.60
8.72
42.40
335.72
0.49
4718.48
185.77
53.84
0.04
335.72
637.50
........................
Total
responses
269
497
19,038
19,136
28
1,453,292
10,589
3,069
2
19,136
160,013
2,352,737
Average
burden per
response
(in hours)
0.56
1.27
0.02
3.00
0.17
0.05
0.42
0.50
0.08
0.17
0.06
........................
Total
burden
hours
150.64
631.19
380.76
57,408.00
4.76
72,664.60
4,447.38
1,534.50
0.16
3,253.12
9,600.78
647,628.30
* 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcing the Annual Meeting of the
President’s Council on Sports, Fitness
& Nutrition
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the President’s Council on Sports,
Fitness & Nutrition (PCSFN) will hold
its annual meeting. The meeting will be
open to the public.
DATES: This meeting will be held on
June 27, 2023, from 1:30 p.m. to 5:00
p.m. ET.
ADDRESSES: The meeting will be held at
the Hubert H. Humphrey Building, 200
Independence Ave SW, Washington, DC
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
20001. The meeting will also be
accessible online via livestream and
recorded for later viewing. Registrants
will receive information on how to
access the meeting, either in-person or
via livestream, prior to the meeting.
FOR FURTHER INFORMATION CONTACT:
Designated Federal Officer for the
PCSFN, Rachel Fisher, MS, MPH, RD;
HHS/OASH/ODPHP, 1101 Wootton
Parkway, Suite 420, Rockville, MD
20852, 240–453–8257; Email fitness@
hhs.gov. Information about PCSFN,
including details about the upcoming
meeting, can be obtained at https://
health.gov/our-work/nutrition-physicalactivity/presidents-council.
SUPPLEMENTARY INFORMATION:
Authority and Purpose: The primary
functions of the PCSFN include: (1)
Advising the President, through the
Secretary, concerning the progress made
in carrying out the provisions of
Executive Order 13265, as amended by
Executive Order 14048, and
recommending to the President, through
the Secretary, actions to accelerate such
progress; (2) recommending to the
Secretary, actions to expand
opportunities at the national, state, and
local levels for participation in sports
and engagement in physical fitness and
activity (taking into account the HHS
Physical Activity Guidelines for
Americans, including consideration for
youth with disabilities); and (3)
functioning as liaisons and
spokespersons on behalf of the PCSFN
to relevant State, local, and private
entities, and sharing information about
the work of the PCSFN in order to
advise the Secretary regarding
opportunities to extend and improve
physical activity, fitness, sports, and
nutrition programs and services at the
State, local, and national levels.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Purpose of the Meeting: At the June
2023 meeting, the PCSFN will discuss
plans for future projects and programs
that may address but are not limited to:
(1) implementing the National Strategy
on Hunger, Nutrition, and Health,
including supporting the White House
Challenge to End Hunger and Build
Healthy Communities; (2) raising
awareness about the importance of
mental health as it pertains to physical
fitness and nutrition; (3) promoting the
implementation of the National Youth
Sports Strategy; (4) revitalizing the
Presidential Youth Fitness Program; and
(5), the launch of the Physical Activity
Guidelines Midcourse Report:
Implementation Strategies for Older
Adults.
Meeting Agendas: The meeting agenda
is in development and will be posted at
https://health.gov/our-work/nutritionphysical-activity/presidents-council/
council-meetings when it is finalized.
Meeting Registration: The meeting is
open to the public and the media.
Members of the public who wish to
attend the meeting are asked to preregister at https://www.eventbrite.com/
e/2023-presidents-council-on-sportsfitness-nutrition-annual-meeting-tickets642518348677. HHS will also stream the
meeting online via HHS.gov/live.
Registration for in-person public
attendance must be completed before
5:00 p.m. (ET) on Monday, June 19,
2023. Foreign nationals who wish to
attend in person should register no later
than Thursday, June 15, 2023, to ensure
sufficient time for federal building
security approval. To request a sign
language interpreter or other special
accommodations, please indicate this
when registering online or by notifying
E:\FR\FM\14JNN1.SGM
14JNN1
]]>Agencies
[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38873-38876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12719]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 www.reginfo.gov/public/do/PRAMain. 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 [email protected] 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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration..... 57 243.56 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
----------------------------------------------------------------------------------------------------------------
* 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
