Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal, 7985-7986 [2023-02499]
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Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
to provide assent (5 minutes per
response) for FU2 and complete the
survey (30 minutes per response). For
these youth respondents, we will ask
the parent/guardian to provide
permission (5 minutes per response) for
the youth to participate in the study.
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Follow-Up 3
We estimate that we will retain 80
percent of the sample from FU2 and
collect data from 4,800 respondents at
FU3. We do not intend to replenish the
sample at FU3. These 4,800 youth
respondents are estimated to provide
assent (5 minutes per response) for FU2
and complete the survey (30 minutes
per response). For these youth
respondents, we will ask the parent/
guardian to provide permission (5
minutes per response) for the youth to
participate in the study.
Supplemental Data Collection
In addition to the main data
collection, we intend to collect data
from subpopulations shown to be at
higher risk of initiating use of cigarettes
and ENDS products, such as youth who
identify as LGBTQ+ and youth who
have a mental health disorder. Data
collection will consist of online selfadministered surveys of participants
recruited through social media
advertisements. The recruitment sample
for this data collection will be youth
ages 14 to 20 who meet the
subpopulation criteria. We intend to
collect data at baseline from 1,500
respondents. We anticipate that we will
need to screen 5,000 respondents (5
minutes per response) to obtain a
baseline sample of 1,500 respondents
who meet the subpopulation criteria. At
baseline, we plan to collect data from
approximately 1,500 respondents
identified as eligible through screening.
These 1,500 youth respondents are
estimated to provide assent (5 minutes
per response) and complete the survey
(30 minutes per response). We estimate
that we will lose approximately 20
percent of the original baseline sample
at each FU wave; therefore, estimating
1,200 respondents at FU1, 960
respondents at FU2, and 768
respondents at FU3. For the FU
samples, youth will provide assent (5
minutes per response) and complete the
survey (30 minutes per response).
We made several minor edits from the
60-day Federal Register notice to the
30-day Federal Register notice. These
edits consisted of (a) minor revisions for
clarity (e.g., indicating that self-report
exposure is a measures of awareness
rather than a unique outcome); (b)
removing text alluding to using multiple
methods to understand the campaign
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impact (because the proposed study is
just one method); and (c) removing
bullets on two outcomes related to
perceived norms of tobacco use, as the
ads that will be on air at the time of data
collection are not attempting to change
those particular outcomes so they are
not relevant to assess in the study.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02501 Filed 2–6–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Advisory Committee; Cellular, Tissue,
and Gene Therapies Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Cellular, Tissue, and
Gene Therapies Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Cellular, Tissue,
and Gene Therapies Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
October 28, 2024, expiration date.
DATES: Authority for the Cellular,
Tissue, and Gene Therapies Advisory
Committee will expire on October 28,
2024, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1244, Silver Spring, MD 20993–0002,
240–402–8054, Christina.Vert@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Cellular, Tissue, and
Gene Therapies Advisory Committee
(the Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
SUMMARY:
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7985
to the Commissioner. The Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies, and
xenotransplantation products which are
intended for transplantation,
implantation, infusion, and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair, or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program that provides scientific support
for the regulation of these products, and
makes appropriate recommendations to
the Commissioner.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of cellular
therapies, tissue transplantation, gene
transfer therapies and
xenotransplantation (biostatistics,
bioethics, hematology/oncology, human
tissues and transplantation,
reproductive medicine, general
medicine, and various medical
specialties, including surgery and
oncology, immunology, virology,
molecular biology, cell biology,
developmental biology, tumor biology,
biochemistry, rDNA technology, nuclear
medicine, gene therapy, infectious
diseases, and cellular kinetics).
Members will be invited to serve for
overlapping terms of up to 4 years. NonFederal members of this committee will
serve as Special Government
Employees, representatives, or ExOfficio members. Federal members will
serve as Regular Government Employees
or Ex-Officios. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, who is
identified with consumer interests and
is recommended by either a consortium
of consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
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Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
blood-vaccines-and-other-biologics/
cellular-tissue-and-gene-therapiesadvisory-committee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02499 Filed 2–6–23; 8:45 am]
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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; Optimizing Virtual Care Grant
Program Performance Measures, OMB
No. 0906–0075—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Comments on this ICR should be
received no later than March 9, 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
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance
Officer, at paperwork@hrsa.gov or call
(301) 443–9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Optimizing Virtual Care Grant Program
Performance Measures OMB No. 0915–
0075—NEW.
Abstract: The Health Center Program
and supplemental awards for health
centers are authorized by section 330 of
the Public Health Service Act (42 U.S.C.
254b). HRSA is authorized to make
supplemental awards for health centers
to ‘‘implement evidence-based models
for increasing access to high-quality
primary care services, which may
include models related to expanding the
use of telehealth and technologyenabled collaborative learning and
DATES:
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capacity building models.’’ 42 U.S.C.
254b(d)(1)(E). Under the Optimizing
Virtual Care (OVC) grant program, 29
high-performing health centers received
2-year supplemental awards to increase
health care access and quality for
underserved populations through
virtual care such as telehealth, remote
patient monitoring, digital patient tools,
and health information technology
platforms. Specifically, award recipients
will use OVC funding to develop and
implement innovative evidence-based
strategies with the potential to be
adapted, leveraged, and scaled across
the Health Center Program to increase
access to care and improve clinical
quality by optimizing the use of virtual
care with a specific focus on
underserved communities and
vulnerable populations.
The goal of the OVC grant program is
to continue to support innovation that
began during the COVID–19 pandemic,
when health centers quickly expanded
their use of virtual care to maintain
access to essential primary care services
for underserved communities. HRSAfunded health centers serve special and
vulnerable populations facing barriers to
virtual care access, such as low digital
literacy, low connectivity capabilities,
or limited technology access. The OVC
grant recipients will serve as a model for
how to increase equitable virtual care,
generating and refining strategies that
can be adapted and scaled across the
Health Center Program.
A 60-day notice published in the
Federal Register, 87 FR 37874–37875
(June 24, 2022). HRSA received
comments from OVC grant recipients
during this public comment period. A
30-day notice published in the Federal
Register, 87 FR 64066–64067 (October
21, 2022). HRSA did not receive
comments on the 30-day notice.
However, HRSA is republishing the 30day notice with the correct information
collection instrument.
Need and Proposed Use of the
Information: The information collected
on OVC grant recipient activities and
performance will help HRSA
demonstrate, adapt, assess, and
disseminate promising practices,
strategies, and novel models of virtual
care across the nation’s health centers.
The information will support an
assessment that yields:
• Increased evidence of how to
optimize the use of virtual care in the
Health Center Program to enhance
access to care and improve clinical
quality for underserved communities
and special and vulnerable populations.
• Maximized impact of the new OVC
grant program, as a model to be adapted,
E:\FR\FM\07FEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7985-7986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02499]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0008]
Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee
by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Cellular, Tissue, and Gene Therapies Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until the October 28, 2024, expiration date.
DATES: Authority for the Cellular, Tissue, and Gene Therapies Advisory
Committee will expire on October 28, 2024, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Christina Vert, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
1244, Silver Spring, MD 20993-0002, 240-402-8054,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Cellular, Tissue,
and Gene Therapies Advisory Committee (the Committee). The Committee is
a discretionary Federal advisory committee established to provide
advice to the Commissioner. The Committee advises the Commissioner or
designee in discharging responsibilities as they relate to helping to
ensure safe and effective drugs for human use and, as required, any
other product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies, and xenotransplantation products
which are intended for transplantation, implantation, infusion, and
transfer in the prevention and treatment of a broad spectrum of human
diseases and in the reconstruction, repair, or replacement of tissues
for various conditions. The Committee also considers the quality and
relevance of FDA's research program that provides scientific support
for the regulation of these products, and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core of 13 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of cellular therapies, tissue transplantation, gene transfer
therapies and xenotransplantation (biostatistics, bioethics,
hematology/oncology, human tissues and transplantation, reproductive
medicine, general medicine, and various medical specialties, including
surgery and oncology, immunology, virology, molecular biology, cell
biology, developmental biology, tumor biology, biochemistry, rDNA
technology, nuclear medicine, gene therapy, infectious diseases, and
cellular kinetics). Members will be invited to serve for overlapping
terms of up to 4 years. Non-Federal members of this committee will
serve as Special Government Employees, representatives, or Ex-Officio
members. Federal members will serve as Regular Government Employees or
Ex-Officios. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry
interests. There may also be an alternate industry representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to
[[Page 7986]]
exceed 10 members) to serve temporarily as voting members and to
designate consultants to serve temporarily as voting members when: (1)
expertise is required that is not available among current voting
standing members of the Committee (when additional voting members are
added to the Committee to provide needed expertise, a quorum will be
based on the combined total of regular and added members) or (2) to
comprise a quorum when, because of unforeseen circumstances, a quorum
is or will be lacking. Because of the size of the Committee and the
variety in the types of issues that it will consider, FDA may, in
connection with a particular committee meeting, specify a quorum that
is less than a majority of the current voting members. The Agency's
regulations (21 CFR 14.22(d)) authorize a committee charter to specify
quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/cellular-tissue-and-gene-therapies-advisory-committee or by contacting the Designated Federal Officer (see
FOR FURTHER INFORMATION CONTACT). In light of the fact that no change
has been made to the committee name or description of duties, no
amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02499 Filed 2-6-23; 8:45 am]
BILLING CODE 4164-01-P
