Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Process Data for Organ Procurement and Transplantation Network, 87592-87593 [2024-25522]
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Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices
available a draft guidance for FDA staff
entitled ‘‘Sec. 540.525 Scombrotoxin
(Histamine)-forming Fish and Fishery
Products—Decomposition and
Histamine (CPG 7108.24)’’ and gave
interested parties an opportunity to
submit comments by February 25, 2022,
for us to consider before beginning work
on the final version of the guidance. In
the Federal Register of March 15, 2022
(87 FR 14538), in response to a request
from stakeholders, we reopened the
comment period until April 14, 2022.
We received comments on the draft
guidance and have modified the final
guidance where appropriate. Changes to
the guidance include the addition of a
detailed explanation for our revisions to
the histamine levels set forth in the
guidance. The guidance announced in
this notice finalizes the draft guidance
dated December 2021.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
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to find the most current version of the
guidance.
Dated: October 22, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–25315 Filed 11–1–24; 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: Process Data
for Organ Procurement and
Transplantation Network
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
lotter on DSK11XQN23PROD with NOTICES1
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
SUMMARY:
VerDate Sep<11>2014
17:28 Nov 01, 2024
Jkt 265001
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
and any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than January 3, 2025.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, MD 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 paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance Officer
at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Process Data for Organ Procurement and
Transplantation Network, OMB No.
0906–xxxx—New.
Abstract: Section 372 of the Public
Health Service Act requires that the
Secretary of HHS, by awards, provide
for the establishment and operation of
the Organ Procurement and
Transplantation Network (OPTN),
which, under oversight of the HRSA,
operates the U.S. procurement and
transplantation system. The Secretary
and/or HRSA may direct the collection
of data in accordance with the
regulatory authority in 42 CFR 121.11 of
the OPTN Final Rule. HRSA, in
alignment with the Paperwork
Reduction Act of 1995, submits data
elements for collection to OMB for
official federal approval.
Need and Proposed Use of the
Information: HRSA and the OPTN
Board of Directors use data to develop
transplant, procurement, and allocation
policies; to determine whether
institutional members are complying
with policy; to determine memberspecific performance; to ensure patient
safety, and to fulfill the requirements of
the OPTN Final Rule. The regulatory
authority in 42 CFR 121.11 of the OPTN
Final Rule allows the Secretary of HHS
to prescribe data collection. This
regulatory authority requires OPTN data
to be made available, consistent with
applicable laws, for use by OPTN
members, the Scientific Registry of
Transplant Recipients, and members of
the public for evaluation, research,
patient information, and other purposes.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
This is a request to expand the current
OPTN data collection, approved under
OMB No. 0915–0157. HRSA is
submitting this new data collection,
separate from OMB No. 0915–0157,
since it includes new forms developed
in response to an HHS Secretarial Data
Directive that are not in use by OPTN.
HRSA believes that separating these
data collections will minimize
confusion, increase clarity among OPTN
members and stakeholders, and enable
more direct feedback on the new forms.
Both data collections include timesensitive, life-critical data on transplant
candidates and potential organ donor
patients, the organ matching process,
histocompatibility results, organ
labeling and packaging, and pre-and
post-transplantation data on recipients
and donors. The OPTN collects these
specific data elements from transplant
centers.
HRSA and the OPTN use 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, procurement, 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.
This new collection consists of three
new data forms as directed by the HHS
Secretary, which were developed to
improve the OPTN organ matching and
allocation process and OPTN member
compliance with OPTN requirements:
• One new form will collect data from
the point of referral of a patient to an
organ procurement organization (OPO)
for potential deceased organ donation.
These data will provide a more objective
source of information on procurement
practices, the management of donor
patients, and how these practices inform
the supply of deceased donor organs
available for transplant. These data may
also help to improve monitoring of OPO
performance and would facilitate
quality assurance and performance
improvement efforts to reduce the
variation in the quality-of-care OPOs
provide to donors and donor families.
• Two new forms will expand data
collection from the point of patient
registration, referral, and evaluation at
transplant centers. These data will
enable collection of data from the point
of referral. Pre-waitlisting data will
provide insight into who gets referred
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87593
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices
and by whom, who gets evaluated, and
who gets placed on the organ
transplantation waiting list. These data
will also facilitate the OPTN’s ability to
address disparities in processes of care,
improve access to organ transplantation,
and assess overall system performance.
Once this collection is approved,
HRSA will cease the use of the Death
Notification Registration and the
Deceased Donor Death Referral forms
that are included within the existing
OMB-approved Data System for Organ
Procurement and Transplantation
Network OMB No. 0915–0157. This
decision was made to avoid unnecessary
burden and redundancy in the data
collected by this package and the
existing OMB data collection
instrument.
Likely Respondents: Transplant
Centers, 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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Pre-Waitlist Transplant Referral Form .............
Pre-Waitlist Transplant Evaluation Form .........
Ventilated Patient Form ...................................
248
248
56
1,164.68
594.22
3,292.00
288,840.64
147,366.56
184,352.00
0.35
0.40
0.50
101,094.22
58,946.62
92,176.00
..........................................................................
552
........................
620,559.20
....................
252,216.84
Form name
1 .....................
2 .....................
3 .....................
Total ........
The average burden estimates of both
new pre-waitlist forms are based on the
2023 burden estimates of existing OMBapproved Transplant Candidate
Registration forms, approved under
0915–0157. The average burden
estimate of the Ventilated Patient Form
is based on the average burden estimate
of the 2024 burden estimates of existing
OMB-approved Death Notification
Registration form with an additional
0.08 hour per collected form burden to
reflect an increase in total data fields.
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.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2024–25522 Filed 11–1–24; 8:45 am]
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BILLING CODE 4165–15–P
VerDate Sep<11>2014
Average
burden per
response
(in hours)
Number of
respondents
Form No.
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Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee to
the Director, National Institutes of
Health.
This will be a hybrid meeting held inperson and virtually and will be open to
the public as indicated below. Given the
capacity constraints of the venue, the
public is strongly encouraged to attend
virtually via NIH videocast. Individuals
who plan to attend in-person or view
the virtual meeting and need special
assistance or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting. The meeting can be
accessed from the NIH Videocast at the
following link: https://
videocast.nih.gov/.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: December 12, 2024.
Time: 9:00 a.m. to 5:45 p.m.
Agenda: NIH Director’s Report; Budget
Update; Legislative Update; RECOVER 2.0
Early Career Intramural Investigator
Highlight; ACD Working Group on Diversity
Update; Accessibility, Disability Inclusion,
and Disability Research at NIH; NExTRAC
ENGAGE Update; Scientific Management
Review Board. Other Business of the
Committee.
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Total
responses
Total
burden
hours
Date: December 13, 2024.
Time: 9:00 a.m. to 12:15 p.m.
Agenda: Cancer Moonshot Update; ABCD
Update; Alzheimer’s Update; AMP Update
Other Business of the Committee.
Place: National Institutes of Health,
Building 1, Wilson Hall, One Center Drive,
Bethesda, MD 20892.
Contact Person: Cyndi Burrus-Shaw, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 126, Bethesda, MD 20892,
301–496–2433, email: shawcy@od.nih.gov.
Any interested person may file
written comments with the committee
by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
procedures at https://www.nih.gov/
about-nih/visitor-information/campusaccess-security for entrance into oncampus and off-campus facilities. All
visitor vehicles, including taxicabs,
hotel, and airport shuttles will be
inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal
facility will be asked to show one form
of identification (for example, a
government-issued photo ID, driver’s
license, or passport) and to state the
purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
acd.od.nih.gov, where an agenda and
any additional information for the
meeting will be posted when available.
E:\FR\FM\04NON1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87592-87593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Process
Data for Organ Procurement and Transplantation Network
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 and any other aspect of the ICR.
DATES: Comments on this ICR should be received no later than January 3,
2025.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14NWH04, 5600
Fishers Lane, Rockville, MD 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) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Process Data for Organ
Procurement and Transplantation Network, OMB No. 0906-xxxx--New.
Abstract: Section 372 of the Public Health Service Act requires
that the Secretary of HHS, by awards, provide for the establishment and
operation of the Organ Procurement and Transplantation Network (OPTN),
which, under oversight of the HRSA, operates the U.S. procurement and
transplantation system. The Secretary and/or HRSA may direct the
collection of data in accordance with the regulatory authority in 42
CFR 121.11 of the OPTN Final Rule. HRSA, in alignment with the
Paperwork Reduction Act of 1995, submits data elements for collection
to OMB for official federal approval.
Need and Proposed Use of the Information: HRSA and the OPTN Board
of Directors use data to develop transplant, procurement, 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 regulatory authority in 42 CFR 121.11 of the OPTN Final
Rule allows the Secretary of HHS to prescribe data collection. This
regulatory authority requires OPTN data to be made available,
consistent with applicable laws, for use by OPTN members, the
Scientific Registry of Transplant Recipients, and members of the public
for evaluation, research, patient information, and other purposes.
This is a request to expand the current OPTN data collection,
approved under OMB No. 0915-0157. HRSA is submitting this new data
collection, separate from OMB No. 0915-0157, since it includes new
forms developed in response to an HHS Secretarial Data Directive that
are not in use by OPTN. HRSA believes that separating these data
collections will minimize confusion, increase clarity among OPTN
members and stakeholders, and enable more direct feedback on the new
forms. Both data collections include time-sensitive, life-critical data
on transplant candidates and potential organ donor patients, the organ
matching process, histocompatibility results, organ labeling and
packaging, and pre-and post-transplantation data on recipients and
donors. The OPTN collects these specific data elements from transplant
centers.
HRSA and the OPTN use 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, procurement, 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.
This new collection consists of three new data forms as directed by
the HHS Secretary, which were developed to improve the OPTN organ
matching and allocation process and OPTN member compliance with OPTN
requirements:
One new form will collect data from the point of referral
of a patient to an organ procurement organization (OPO) for potential
deceased organ donation. These data will provide a more objective
source of information on procurement practices, the management of donor
patients, and how these practices inform the supply of deceased donor
organs available for transplant. These data may also help to improve
monitoring of OPO performance and would facilitate quality assurance
and performance improvement efforts to reduce the variation in the
quality-of-care OPOs provide to donors and donor families.
Two new forms will expand data collection from the point
of patient registration, referral, and evaluation at transplant
centers. These data will enable collection of data from the point of
referral. Pre-waitlisting data will provide insight into who gets
referred
[[Page 87593]]
and by whom, who gets evaluated, and who gets placed on the organ
transplantation waiting list. These data will also facilitate the
OPTN's ability to address disparities in processes of care, improve
access to organ transplantation, and assess overall system performance.
Once this collection is approved, HRSA will cease the use of the
Death Notification Registration and the Deceased Donor Death Referral
forms that are included within the existing OMB-approved Data System
for Organ Procurement and Transplantation Network OMB No. 0915-0157.
This decision was made to avoid unnecessary burden and redundancy in
the data collected by this package and the existing OMB data collection
instrument.
Likely Respondents: Transplant Centers, 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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form No. Form name respondents responses per responses response hours
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
1................... Pre-Waitlist 248 1,164.68 288,840.64 0.35 101,094.22
Transplant
Referral Form.
2................... Pre-Waitlist 248 594.22 147,366.56 0.40 58,946.62
Transplant
Evaluation Form.
3................... Ventilated 56 3,292.00 184,352.00 0.50 92,176.00
Patient Form.
-------------------------------------------------------------------------
Total........... ................ 552 .............. 620,559.20 ........... 252,216.84
----------------------------------------------------------------------------------------------------------------
The average burden estimates of both new pre-waitlist forms are
based on the 2023 burden estimates of existing OMB-approved Transplant
Candidate Registration forms, approved under 0915-0157. The average
burden estimate of the Ventilated Patient Form is based on the average
burden estimate of the 2024 burden estimates of existing OMB-approved
Death Notification Registration form with an additional 0.08 hour per
collected form burden to reflect an increase in total data fields.
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.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2024-25522 Filed 11-1-24; 8:45 am]
BILLING CODE 4165-15-P
