[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Page 46959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20108]


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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 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 September 1, 2020.

DATES: Authority for the Oncologic Drugs Advisory Committee will expire 
on September 1, 2020, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Lauren Tesh, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, 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 Oncologic Drugs Advisory Committee. The committee is a 
discretionary Federal advisory committee established to provide advice 
to the Commissioner.
    The Oncologic Drugs Advisory 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. 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/Drugs/OncologicDrugsAdvisoryCommittee/ucm107395.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 check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20108 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P