Document ID: FDA-2019-N-0428-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee, Renewal
Posted Date: 2019-03-28T04:00Z

[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.

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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: 
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 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