Document ID: FDA-2018-N-3236-0002
Agency: fda
Document Type: Notice
Title: Advisory Committee; Oncologic Drugs Advisory Committee; Renewal
Posted Date: 2022-12-05T05:00Z

[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Notices]
[Pages 74427-74428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26363]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3236]

Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Oncologic Drugs 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 Oncologic Drugs Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until the September 1, 2024, 
expiration date.

DATES: Authority for the Oncologic Drugs Advisory Committee will expire 
on September 1, 2024, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: She-Chia Chen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, [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 Oncologic Drugs

[[Page 74428]]

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 data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cancer 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 general oncology, pediatric oncology, hematologic oncology, 
immunology oncology, biostatistics, and other related professions. 
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.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/oncologic-drugs-advisory-committee-charter 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: November 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26363 Filed 12-2-22; 8:45 am]
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