Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation, OMB No. 0906-0034-Extension, 80318-80319 [2023-25368]
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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
has verified the applicant’s claims that
the new drug application (NDA) for
ROZLYTREK CAPSULES (NDA 212726)
was initially submitted on December 18,
2018.’’
Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–25489 Filed 11–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Scientific
Registry of Transplant Recipients
Information Collection Effort for
Potential Donors for Living Organ
Donation, OMB No. 0906–0034—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than January 16, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
SUMMARY:
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 945–0232.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Scientific Registry of Transplant
Recipients Information Collection Effort
for Potential Donors for Living Organ
Donation, OMB No. 0906–0034—
Extension.
Abstract: The Scientific Registry of
Transplant Recipients (SRTR) is
administered under contract with
HRSA, an agency within HHS. HHS is
authorized to establish and maintain
mechanisms to evaluate the long-term
effects associated with living organ
donations (42 U.S.C. 273a) and is
required to submit to Congress an
annual report on the long-term health
effects of living donation (42 U.S.C.
273b). In 2018, the SRTR contractor
implemented a pilot living donor
registry in which transplant programs
registered all potential living organ
donors who provided informed consent
to participate in the pilot registry. The
Organ Procurement and Transplantation
Network final rule, 42 CFR part 121,
requires organ procurement
organizations and transplant hospitals,
‘‘as specified from time to time by the
Secretary,’’ to submit to the SRTR, as
appropriate, information regarding
‘‘donors of organs’’ and ‘‘other
information that the Secretary deems
appropriate.’’ 42 CFR 121.11(b)(2).
In 2018, a pilot living donor registry
was implemented by the SRTR, and
each participating transplant program
registered all potential candidates for
living donation who provided informed
consent to enroll. In 2019, an updated
version of the data collection instrument
was approved, followed by the latest
data collection forms which were
approved on February 26, 2021. These
data collection modifications were
intended to improve the quality of the
data and reduce the administrative
burden for respondents. This Federal
Register notice requests an extension of
the last approved data collection forms
(February 2021) with no changes to the
total estimated annualized burden
hours.
Need and Proposed Use of the
Information: The transplant programs
submit health information collected at
the time of donation evaluation through
a secure web-based data collection tool
developed by the SRTR contractor. The
SRTR contractor maintains contact with
registry participants and collects data on
long-term health outcomes through
surveys. The data collection includes
outcomes of evaluation, including
reasons for non-donation. The living
donor registry is an ongoing effort, and
the goal is to continue to collect data on
living organ donor transplant programs
in the United States over time.
Monitoring and reporting of long-term
health outcomes of living organ donors
post-donation will continue to provide
useful information to transplant
programs for their future donor
selection process and to aid potential
living organ donors in their decision to
pursue living donation.
Likely Respondents: Potential and
actual living donors, transplant
programs, medical and scientific
organizations, and public organizations,
including patient advocacy groups.
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
khammond on DSKJM1Z7X2PROD with NOTICES
Potential Living Donor Registration form .............................................
Potential Living Donor Follow-up form ................................................
Reasons Did not Donate form (liver or kidney) ...................................
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
Average
number of
responses per
respondent
Number of
respondents
Form name
PO 00000
Frm 00050
Fmt 4703
a 16
b 754
a 16
Sfmt 4703
112
1
106
E:\FR\FM\17NON1.SGM
Total
number of
responses
1,792
754
1,696
17NON1
Average
burden per
response
(in minutes)
0.27
0.50
0.23
Total
burden
hours
484
377
390
80319
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total ..............................................................................................
a Number
Average
number of
responses per
respondent
Number of
respondents
Form name
786
........................
Total
number of
responses
I
4,242
Average
burden per
response
(in minutes)
I ........................
Total
burden
hours
1,251
of respondents is based on the current number of transplant programs and is likely to increase as additional programs decide to par-
ticipate.
b Number of living organ donor candidates submitting follow-up forms in 2019.
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. 2023–25368 Filed 11–16–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Intent To Establish
Federal Advisory Committee on Long
COVID
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services announces the intent to
establish an Advisory Committee on
Long COVID and invites nominations
for the Committee.
DATES: Nominations must be submitted
by 11:59 p.m. eastern time on January
16, 2024.
ADDRESSES: Nominations may be
submitted by email to LongCOVID@
hhs.gov and addressed to Allison
O’Donnell. 202–690–7694.
FOR FURTHER INFORMATION CONTACT:
Allison O’Donnell at 202–690–7694 or
LongCOVID@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Committee is authorized under 42
U.S.C. 217a, section 222 of the Public
Health Service Act, as amended. The
Committee is governed by the
provisions of the Federal Advisory
Committee Act, Public Law 92–463, as
amended (5 U.S.C. chapter 10), which
sets forth standards for the formation
and use of advisory committees.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
The April 5, 2022, Memorandum
(https://www.whitehouse.gov/briefingroom/presidential-actions/2022/04/05/
memorandum-on-addressing-the-longterm-effects-of-covid-19/) on Addressing
the Long-term Effects of COVID–19
charged the Secretary of Health and
Human Services (Secretary) with
coordinating a Government-wide
response to the longer-term effects of
COVID–19. The Secretary named the
Assistant Secretary for Health to
coordinate the U.S. Government
response to Long COVID. The
Memorandum specified development
and publication of two reports that were
published August 3, 2022. One of the
reports, the National Research Action
Plan on Long COVID (https://
www.covid.gov/assets/files/NationalResearch-Action-Plan-on-Long-COVID08012022.pdf), called for the
establishment of a Secretary’s Advisory
Committee on Long COVID. The
Committee will bring perspectives from
outside the Government to help inform
action of the Executive Branch on Long
COVID and associated conditions, with
a focus on health equity. Numerous
entities across the U.S. Government
fund and conduct research and use
external advisory bodies. This Federal
Advisory Committee does not replace or
supersede the ongoing work of these
advisory bodies.
Structure: The Committee will consist
of up to 20 members, including any
Chair, Vice Chair, or Co-Chairs. Factors
to be considered in selecting individuals
to serve on the Committee include
expertise in the issues to be examined
by the Committee, as well as statutory
obligations under FACA and desire for
a balanced and diverse membership. To
the extent possible, composition of the
Committee will reflect the experience of
an inclusive and diverse cross-section of
persons with Long COVID and
multidisciplinary expertise of those
supporting and caring for those affected
as well as specific clinical, medical,
public health, behavioral health, human
services, employment, data science, and
research expertise. The membership of
the Committee will reflect diverse
individuals or organizations including
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
underserved populations, with a focus
on health equity.
The following areas of expertise will
be considered in selecting the voting
members with the goal of achieving a
balanced membership in terms of points
of view, expertise, and groups
represented and functions to be
performed by the Committee.
Long COVID and related groups:
Representation from individuals living
with Long COVID and organizations
directly engaged in supporting people
living with Long COVID.
Professional Associations:
Representation from medical
professional, behavioral health and
human services associations
representing practitioners caring for
people with Long COVID, including
those representing the primary
healthcare system.
Disability and Chronic Illness Groups:
Representation from associations,
researchers, or organizations focused on
disability and chronic illness, and their
possible interplay with Long COVID.
Public Health and related groups:
Representation from public health
groups supporting communities in
addressing the impacts of Long COVID.
Healthcare and Social Care Providers:
Clinical care settings and health systems
involved in providing care for patients
with Long COVID, including in
underserved areas, such as rural
communities and communities
disproportionately impacted by Long
COVID.
Employee and Employer Related
Groups: Representation from employee
and employer experts, attorneys, or
organizations involved in addressing the
impacts of Long COVID in the
workplace, including discrimination.
Research: Researchers and research
institutions involved in Long COVID
and associated conditions research.
Non-voting Industry Representatives:
Those involved in, or representing those
involved in, Long COVID research and
development, including prevention,
diagnostics, and treatment will be
designated to represent the interests of
this sector.
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80318-80319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25368]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title:
Scientific Registry of Transplant Recipients Information Collection
Effort for Potential Donors for Living Organ Donation, OMB No. 0906-
0034--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than January
16, 2024.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 945-0232.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Scientific Registry of
Transplant Recipients Information Collection Effort for Potential
Donors for Living Organ Donation, OMB No. 0906-0034--Extension.
Abstract: The Scientific Registry of Transplant Recipients (SRTR)
is administered under contract with HRSA, an agency within HHS. HHS is
authorized to establish and maintain mechanisms to evaluate the long-
term effects associated with living organ donations (42 U.S.C. 273a)
and is required to submit to Congress an annual report on the long-term
health effects of living donation (42 U.S.C. 273b). In 2018, the SRTR
contractor implemented a pilot living donor registry in which
transplant programs registered all potential living organ donors who
provided informed consent to participate in the pilot registry. The
Organ Procurement and Transplantation Network final rule, 42 CFR part
121, requires organ procurement organizations and transplant hospitals,
``as specified from time to time by the Secretary,'' to submit to the
SRTR, as appropriate, information regarding ``donors of organs'' and
``other information that the Secretary deems appropriate.'' 42 CFR
121.11(b)(2).
In 2018, a pilot living donor registry was implemented by the SRTR,
and each participating transplant program registered all potential
candidates for living donation who provided informed consent to enroll.
In 2019, an updated version of the data collection instrument was
approved, followed by the latest data collection forms which were
approved on February 26, 2021. These data collection modifications were
intended to improve the quality of the data and reduce the
administrative burden for respondents. This Federal Register notice
requests an extension of the last approved data collection forms
(February 2021) with no changes to the total estimated annualized
burden hours.
Need and Proposed Use of the Information: The transplant programs
submit health information collected at the time of donation evaluation
through a secure web-based data collection tool developed by the SRTR
contractor. The SRTR contractor maintains contact with registry
participants and collects data on long-term health outcomes through
surveys. The data collection includes outcomes of evaluation, including
reasons for non-donation. The living donor registry is an ongoing
effort, and the goal is to continue to collect data on living organ
donor transplant programs in the United States over time. Monitoring
and reporting of long-term health outcomes of living organ donors post-
donation will continue to provide useful information to transplant
programs for their future donor selection process and to aid potential
living organ donors in their decision to pursue living donation.
Likely Respondents: Potential and actual living donors, transplant
programs, medical and scientific organizations, and public
organizations, including patient advocacy groups.
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
----------------------------------------------------------------------------------------------------------------
Average number Total Average burden Total
Form name Number of of responses number of per response burden
respondents per respondent responses (in minutes) hours
----------------------------------------------------------------------------------------------------------------
Potential Living Donor Registration form... \a\ 16 112 1,792 0.27 484
Potential Living Donor Follow-up form...... \b\ 754 1 754 0.50 377
Reasons Did not Donate form (liver or \a\ 16 106 1,696 0.23 390
kidney)...................................
-------------- ------------- ---------
[[Page 80319]]
Total.................................. 786 .............. 4,242 .............. 1,251
----------------------------------------------------------------------------------------------------------------
\a\ Number of respondents is based on the current number of transplant programs and is likely to increase as
additional programs decide to participate.
\b\ Number of living organ donor candidates submitting follow-up forms in 2019.
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. 2023-25368 Filed 11-16-23; 8:45 am]
BILLING CODE 4165-15-P
