Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal, 44888 [2018-19066]

Download as PDF 44888 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 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/ CardiovascularandRenalDrugsAdvisory Committee/ucm094743.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: August 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–19067 Filed 8–31–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3123] Advisory Committee; Endocrinologic and Metabolic 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 Endocrinologic and Metabolic 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 Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2020. DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory Committee will expire on August 27, 2020, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:54 Aug 31, 2018 Jkt 244001 Silver Spring, MD 20993–0002, 301– 796–9001, email: EMDAC@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 Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The 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 data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders, and makes appropriate recommendations to the Commissioner. The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of endocrinology, metabolism, 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/ EndocrinologicandMetabolicDrugs AdvisoryCommittee/ucm100261.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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: August 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–19066 Filed 8–31–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3037] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the creation of a new collection of information entitled ‘‘Generic Clearance for Quantitative Testing for the Development of FDA Communications.’’ DATES: Submit either electronic or written comments on the collection of information by November 5, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 5, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Page 44888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3123]


Advisory Committee; Endocrinologic and Metabolic 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 Endocrinologic and Metabolic 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 
Endocrinologic and Metabolic Drugs Advisory Committee for an additional 
2 years beyond the charter expiration date. The new charter will be in 
effect until August 27, 2020.

DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory 
Committee will expire on August 27, 2020, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, 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 Endocrinologic and Metabolic Drugs Advisory Committee 
(the Committee). The Committee is a discretionary Federal advisory 
committee established to provide advice to the Commissioner.
    The 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 data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of endocrine and metabolic disorders, and makes 
appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of endocrinology, metabolism, 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/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm100261.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: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19066 Filed 8-31-18; 8:45 am]
 BILLING CODE 4164-01-P


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