Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal, 15576 [2018-07437]

Download as PDF 15576 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices amozie on DSK30RV082PROD with NOTICES Dated: March 16, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: April 5, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. 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 on the safety and effectiveness of marketed and investigational human [FR Doc. 2018–07410 Filed 4–10–18; 8:45 am] drug products for use in the practice of BILLING CODE 4120–01–P osteoporosis and metabolic bone disease, obstetrics, gynecology, urology, and related specialties, and makes DEPARTMENT OF HEALTH AND appropriate recommendations to the HUMAN SERVICES Commissioner. Food and Drug Administration The Committee shall consist of a core of 11 voting members including the [Docket No. FDA–2017–N–4561] Chair. Members and the Chair are selected by the Commissioner or Advisory Committee; Bone, Reproductive and Urologic Drugs designee from among authorities Advisory Committee, Renewal knowledgeable in the fields of osteoporosis and metabolic bone AGENCY: Food and Drug Administration, disease, obstetrics, gynecology, urology, HHS. pediatrics, epidemiology, or statistics ACTION: Notice; renewal of advisory and related specialties. Members will be committee. invited to serve for overlapping terms of up to 4 years. Almost all non-Federal SUMMARY: The Food and Drug Administration (FDA) is announcing the members of this committee serve as Special Government Employees. The renewal of the Bone, Reproductive and core of voting members may include one Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs technically qualified member, selected (the Commissioner). The Commissioner by the Commissioner or designee, who has determined that it is in the public is identified with consumer interests interest to renew the Bone, and is recommended by either a Reproductive and Urologic Drugs consortium of consumer-oriented Advisory Committee for an additional 2 organizations or other interested years beyond the charter expiration persons. In addition to the voting date. The new charter will be in effect members, the Committee may include until March 23, 2020. one non-voting member who is DATES: Authority for the Bone, identified with industry interests. Reproductive and Urologic Drugs Further information regarding the Advisory Committee will expire on most recent charter and other March 23, 2020, unless the information can be found at https:// Commissioner formally determines that www.fda.gov/AdvisoryCommittees/ renewal is in the public interest. CommitteesMeetingMaterials/Drugs/ FOR FURTHER INFORMATION CONTACT: ReproductiveHealthDrugs Kalyani Bhatt, Division of Advisory AdvisoryCommittee/ucm107572.htm or Committee and Consultant by contacting the Designated Federal Management, Center for Drug Officer (see FOR FURTHER INFORMATION Evaluation and Research, Food and CONTACT). In light of the fact that no Drug Administration, 10903 New change has been made to the committee Hampshire Ave., Bldg. 31, Rm. 2417, name or description of duties, no Silver Spring, MD 20993–0002, 301– 796–9001, email: BRUDAC@fda.hhs.gov. amendment will be made to 21 CFR 14.100. SUPPLEMENTARY INFORMATION: Pursuant This document is issued under the to 41 CFR 102–3.65 and approval by the Federal Advisory Committee Act (5 Department of Health and Human Services pursuant to 45 CFR part 11 and U.S.C. app.). For general information by the General Services Administration, related to FDA advisory committees, please check https://www.fda.gov/ FDA is announcing the renewal of the Bone, Reproductive and Urologic Drugs AdvisoryCommittees/default.htm. Advisory Committee (the Committee). Dated: April 5, 2018. The Committee is a discretionary Leslie Kux, Federal advisory committee established Associate Commissioner for Policy. to provide advice to the Commissioner. [FR Doc. 2018–07437 Filed 4–10–18; 8:45 am] The Committee advises the Commissioner or designee in BILLING CODE 4164–01–P VerDate Sep<11>2014 17:17 Apr 10, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0981] Preparation for International Cooperation on Cosmetics Regulation Twelfth Annual Meeting; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ‘‘International Cooperation on Cosmetics Regulation (ICCR)—Preparation for ICCR–12 Meeting.’’ The purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR–12 meeting that will be held July 10 to 12, 2018, in Tokyo, Japan. DATES: The public meeting will be held on June 7, 2018, from 2 p.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. SUMMARY: The public meeting will be held at the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., Wiley Auditorium (first floor), College Park, MD 20740. FOR FURTHER INFORMATION CONTACT: Jonathan Hicks, Office of Cosmetics and Colors, Food and Drug Administration, 5001 Campus Dr. (HFS–125), College Park, MD 20740, jonathan.hicks@ fda.hhs.gov, 240–402–1375. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background The intention of the ICCR multilateral framework is to pave the way for the removal of regulatory obstacles to international trade while maintaining global consumer protection. The purpose of the meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR–12 meeting that will be held July 10 to 12, 2018, in Tokyo, Japan. ICCR is a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, the European Union, Japan, and the United States of America. These regulatory authority members will engage in constructive dialogue with their relevant cosmetics industry trade E:\FR\FM\11APN1.SGM 11APN1

Agencies

[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4561]


Advisory Committee; Bone, Reproductive and Urologic 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 Bone, Reproductive and Urologic 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 Bone, Reproductive and Urologic Drugs Advisory Committee for an 
additional 2 years beyond the charter expiration date. The new charter 
will be in effect until March 23, 2020.

DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory 
Committee will expire on March 23, 2020, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Division of Advisory 
Committee and Consultant Management, 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 Bone, Reproductive and Urologic 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 FDA 
has regulatory responsibility.
    The Committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drug products for 
use in the practice of osteoporosis and metabolic bone disease, 
obstetrics, gynecology, urology, and related specialties, 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 osteoporosis and metabolic bone disease, obstetrics, 
gynecology, urology, 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/ReproductiveHealthDrugsAdvisoryCommittee/ucm107572.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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07437 Filed 4-10-18; 8:45 am]
 BILLING CODE 4164-01-P


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