83 FR 46959 - Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 180 (September 17, 2018)

Page Range		46959-46959
FR Document		2018-20108

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.

Federal Register, Volume 83 Issue 180 (Monday, September 17, 2018)

[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Page 46959]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices 46959

We base our estimate of the average Dated: September 11, 2018. The committee shall consist of a core
burden per response on review activities Leslie Kux, of 13 voting members including the
familiar to the Agency. Noting that 2 Associate Commissioner for Policy. Chair. Members and the Chair are
hours per response is a significant [FR Doc. 2018–20091 Filed 9–14–18; 8:45 am] selected by the Commissioner or
amount of time, we are particularly BILLING CODE 4164–01–P designee from among authorities
interested in feedback regarding this knowledgeable in the fields of general
estimate, including comments regarding oncology, pediatric oncology,
how an alternative estimate might be DEPARTMENT OF HEALTH AND hematologic oncology, immunology
derived. HUMAN SERVICES oncology, biostatistics, and other related
Dated: September 11, 2018. professions. Members will be invited to
Food and Drug Administration serve for overlapping terms of up to 4
Leslie Kux,
[Docket No. FDA–2018–N–3236] years. Almost all non-Federal members
Associate Commissioner for Policy.
of this committee serve as Special
[FR Doc. 2018–20092 Filed 9–14–18; 8:45 am]
Advisory Committee; Oncologic Drugs Government Employees. The core of
BILLING CODE 4164–01–P voting members may include one
Advisory Committee; Renewal
technically qualified member, selected
AGENCY: Food and Drug Administration, by the Commissioner or designee, who
DEPARTMENT OF HEALTH AND HHS.
is identified with consumer interests
HUMAN SERVICES ACTION:Notice; renewal of advisory and is recommended by either a
committee. consortium of consumer-oriented
Food and Drug Administration
SUMMARY: The Food and Drug organizations or other interested
Administration (FDA) is announcing the persons. In addition to the voting
[Docket No. FDA–2018–N–3431]
renewal of the Oncologic Drugs members, the committee may include
Anesthetic and Analgesic Drug Advisory Committee by the one non-voting member who is
Products Advisory Committee; Notice Commissioner of Food and Drugs (the identified with industry interests.
of Meeting; Establishment of a Public Commissioner). The Commissioner has Further information regarding the
Docket; Request for Comments; determined that it is in the public most recent charter and other
Correction interest to renew the Oncologic Drugs information can be found at https://
Advisory Committee for an additional 2 www.fda.gov/AdvisoryCommittees/
AGENCY: Food and Drug Administration, years beyond the charter expiration CommitteesMeetingMaterials/Drugs/
HHS. date. The new charter will be in effect OncologicDrugsAdvisoryCommittee/
until September 1, 2020. ucm107395.htm or by contacting the
ACTION: Notice; correction. Designated Federal Officer (see FOR
DATES: Authority for the Oncologic
Drugs Advisory Committee will expire FURTHER INFORMATION CONTACT). In light
SUMMARY: The Food and Drug on September 1, 2020, unless the of the fact that no change has been made
Administration is correcting a notice Commissioner formally determines that to the committee name or description of
entitled ‘‘Anesthetic and Analgesic Drug renewal is in the public interest. duties, no amendment will be made to
Products Advisory Committee; Notice of 21 CFR 14.100.
FOR FURTHER INFORMATION CONTACT:
Meeting; Establishment of a Public This document is issued under the
Lauren Tesh, Center for Drug Evaluation
Docket; Request for Comments’’ that Federal Advisory Committee Act (5
and Research, Food and Drug
appeared in the Federal Register of U.S.C. app.). For general information
Administration, 10903 New Hampshire
September 11, 2018. The document related to FDA advisory committees,
Ave., Bldg. 31, Rm. 2417, Silver Spring,
announced a forthcoming public please check https://www.fda.gov/
MD 20993–0002, 301–796–9001, email:
advisory committee meeting of the AdvisoryCommittees/default.htm.
ODAC@fda.hhs.gov.
Anesthetic and Analgesic Drug Products Dated: September 11, 2018.
SUPPLEMENTARY INFORMATION: Pursuant
Advisory Committee and establishment
of a public docket for comments. The to 41 CFR 102–3.65 and approval by the Leslie Kux,
document was published with the Department of Health and Human Associate Commissioner for Policy.
Services pursuant to 45 CFR part 11 and [FR Doc. 2018–20108 Filed 9–14–18; 8:45 am]
incorrect docket number. This
by the General Services Administration,
document corrects that error. BILLING CODE 4164–01–P
FDA is announcing the renewal of the
FOR FURTHER INFORMATION CONTACT: Lisa Oncologic Drugs Advisory Committee.
Granger, Office of Policy and Planning, The committee is a discretionary DEPARTMENT OF HEALTH AND
Food and Drug Administration, 10903 Federal advisory committee established HUMAN SERVICES
New Hampshire Ave., Bldg. 32, Rm. to provide advice to the Commissioner.
3330, Silver Spring, MD 20993–0002, The Oncologic Drugs Advisory Food and Drug Administration
301–796–9115. Committee advises the Commissioner or
[Docket No. FDA–2018–N–0001]
designee in discharging responsibilities
SUPPLEMENTARY INFORMATION: In the as they relate to helping to ensure safe
Federal Register of Tuesday, September Pathogen Reduction Technologies for
and effective drugs for human use and, Blood Safety; Public Workshop
11, 2018 (83 FR 45941), in FR Doc. as required, any other product for which
2018–19667, on page 45941, the FDA has regulatory responsibility. AGENCY: Food and Drug Administration,
daltland on DSKBBV9HB2PROD with NOTICES

following correction is made: The committee reviews and evaluates HHS.
On page 45941, in the first column, in data concerning the safety and ACTION: Notice of public workshop.
the header of the document, and also in effectiveness of marketed and
the third column under Instructions, investigational human drug products for SUMMARY: The Food and Drug
‘‘Docket No. FDA–2018–N–3276’’ is use in the treatment of cancer and Administration (FDA) is announcing the
corrected to read ‘‘Docket No. FDA– makes appropriate recommendations to following public workshop entitled
2018–N–3431’’. the Commissioner. ‘‘Pathogen Reduction Technologies for

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Document Created: 2018-09-15 01:37:05
Document Modified: 2018-09-15 01:37:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
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.
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]
FR Citation		83 FR 46959

83 FR 46959 - Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 180 (September 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration