Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal, 51465 [2018-22098]

Download as PDF 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]


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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.

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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