Advisory Committee; Oncologic Drugs Advisory Committee; Renewal, 46959 [2018-20108]
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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices
We base our estimate of the average
burden per response on review activities
familiar to the Agency. Noting that 2
hours per response is a significant
amount of time, we are particularly
interested in feedback regarding this
estimate, including comments regarding
how an alternative estimate might be
derived.
Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20091 Filed 9–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3236]
[FR Doc. 2018–20092 Filed 9–14–18; 8:45 am]
Advisory Committee; Oncologic Drugs
Advisory Committee; Renewal
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice; renewal of advisory
committee.
ACTION:
Food and Drug Administration
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:
ODAC@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
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.
SUMMARY:
[Docket No. FDA–2018–N–3431]
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Anesthetic and Analgesic Drug
Products Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments’’ that
appeared in the Federal Register of
September 11, 2018. The document
announced a forthcoming public
advisory committee meeting of the
Anesthetic and Analgesic Drug Products
Advisory Committee and establishment
of a public docket for comments. The
document was published with the
incorrect docket number. This
document corrects that error.
SUMMARY:
Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of Tuesday, September
11, 2018 (83 FR 45941), in FR Doc.
2018–19667, on page 45941, the
following correction is made:
On page 45941, in the first column, in
the header of the document, and also in
the third column under Instructions,
‘‘Docket No. FDA–2018–N–3276’’ is
corrected to read ‘‘Docket No. FDA–
2018–N–3431’’.
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SUPPLEMENTARY INFORMATION:
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46959
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0001]
Pathogen Reduction Technologies for
Blood Safety; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Pathogen Reduction Technologies for
SUMMARY:
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
