Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal, 51465 [2018-22098]
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51465
Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
Title of collection
New Animal Drugs for Investigational Use ..............................................................................................................
Guidance for Industry and FDA Staff, Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle .........................................................................................
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements ...
Prescription Drug Advertisements ...........................................................................................................................
Survey of the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products .................
Food and Cosmetic Export Certificate Applications Process ..................................................................................
Guidance for Industry: Medical Product Communications That are Consistent With the Food and Drug Administration Required Labeling—Questions and Answers ........................................................................................
Guidance for Industry: Drug and Device Manufacturer Communications with Payors, Formulary Committees,
and Similar Entities Questions and Answers .......................................................................................................
Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear
Pharmacies, Federal Facilities, and Certain Other Entities .................................................................................
Drug Supply Chain Security Act Pilot Program .......................................................................................................
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional and Retail Food Stores
and Facility Types (2015–2025) ..........................................................................................................................
Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22101 Filed 10–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3323]
Advisory Committee; Antimicrobial
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Antimicrobial 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 Antimicrobial
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until October 7, 2020.
DATES: Authority for the Antimicrobial
Drugs Advisory Committee will expire
on October 7, 2018, 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,
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:54 Oct 10, 2018
Jkt 247001
MD 20993–0002, 301–796–9001, email:
AMDAC@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
Antimicrobial Drugs Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Antimicrobial 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
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
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 infectious
disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Date
approval
expires
0910–0117
8/31/2021
0910–0594
8/31/2021
0910–0608
0910–0686
0910–0744
0910–0759
0910–0793
8/31/2021
8/31/2021
8/31/2021
8/31/2021
8/31/2021
0910–0856
8/31/2021
0910–0857
8/31/2021
0910–0858
0910–0859
8/31/2021
8/31/2021
0910–0799
9/30/2021
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented 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/
Anti-InfectiveDrugsAdvisoryCommittee/
ucm094132.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: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22098 Filed 10–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Secretary’s
Advisory Committee on Human
Research Protections
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Page 51465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3323]
Advisory Committee; Antimicrobial 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 Antimicrobial 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 Antimicrobial
Drugs Advisory Committee for an additional 2 years beyond the charter
expiration date. The new charter will be in effect until October 7,
2020.
DATES: Authority for the Antimicrobial Drugs Advisory Committee will
expire on October 7, 2018, 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 Antimicrobial Drugs Advisory Committee. The committee is
a discretionary Federal advisory committee established to provide
advice to the Commissioner.
The Antimicrobial 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 the Food and Drug Administration has regulatory
responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of infectious diseases and disorders
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
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 infectious disease, internal medicine, microbiology,
pediatrics, epidemiology or statistics, and related specialties.
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/Anti-InfectiveDrugsAdvisoryCommittee/ucm094132.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: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22098 Filed 10-10-18; 8:45 am]
BILLING CODE 4164-01-P
