Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee, Renewal, 11802 [2019-05985]
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Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Notices
II. Topics for Discussion at the Public
Meeting
FDA Center Directors will hold a
panel discussion on pressing FDA
initiatives suitable for Public-Private
Partnerships. Panelists will include Drs.
Janet Woodcock, Peter Marks, and
Jeffrey Shuren. The panel moderator
will be Michael McCaughan, CoFounder of Prevision Policy. Find the
meeting page at https://reaganudall.org/
2019-annual-public-meeting-0.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website to register: https://reaganudall.
salsalabs.org/2019AnnualMeeting/
index.html. Persons interested in
attending this public meeting must
register online by April 30, 2019, at 5
p.m. Eastern Time.
If you need special accommodations
due to a disability, please contact Kelly
Catterton (see FOR FURTHER INFORMATION
CONTACT) no later than April 30, 2019,
at 5 p.m. Eastern Time.
Requests for Oral Presentations:
Interested persons may present
comments at the public meeting.
Comments will be scheduled to begin
approximately at 11:45 a.m. Time
allotted for comments is limited to 3
minutes per speaker. Those desiring to
make oral comments should notify Kelly
Catterton (see FOR FURTHER INFORMATION
CONTACT) by April 30, 2019, at 5 p.m.
Eastern Time. Please include a brief
statement of the general nature of the
comments you wish to present along
with your name, address, telephone
number, and email address. The contact
person will notify individuals regarding
their request to speak by May 1, 2019.
Dated: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05944 Filed 3–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0428]
amozie on DSK9F9SC42PROD with NOTICES
Advisory Committee; Cellular, Tissue
and Gene Therapies Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
VerDate Sep<11>2014
18:57 Mar 27, 2019
Jkt 247001
renewal of the Cellular, Tissue and Gene
Therapies Advisory Committee
(Committee) by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until
October 28, 2020.
DATES: Authority for the Cellular, Tissue
and Gene Therapies Advisory
Committee will expire on October 28,
2018, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6306, Silver Spring,
MD 20993; 240–402–8006, email:
Prabhakara.atreya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of 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 which provides scientific
support for the regulation of these
products, and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of thirteen 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
PO 00000
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Fmt 4703
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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 four years.
Almost all non-Federal members of this
Committee serve as Special Government
Employees. 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 consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Blood
VaccinesandOtherBiologics/Cellular
TissueandGeneTherapiesAdvisory
Committee/default.htm 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 document 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: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05985 Filed 3–27–19; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Page 11802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0428]
Advisory Committee; Cellular, Tissue and Gene Therapies Advisory
Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cellular, Tissue and Gene Therapies Advisory Committee
(Committee) by the Commissioner of Food and Drugs (the Commissioner).
The Commissioner has determined that it is in the public interest to
renew the Committee for an additional 2 years beyond the charter
expiration date. The new charter will be in effect until October 28,
2020.
DATES: Authority for the Cellular, Tissue and Gene Therapies Advisory
Committee will expire on October 28, 2018, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6306, Silver Spring, MD 20993; 240-402-8006, email:
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of 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 which provides scientific support
for the regulation of these products, and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core of thirteen 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 four years. Almost all non-Federal members of this
Committee serve as Special Government Employees. 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 member who is
identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/default.htm 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 document 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: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05985 Filed 3-27-19; 8:45 am]
BILLING CODE 4164-01-P
