Preparation for International Cooperation on Cosmetics Regulation Twelfth Annual Meeting; Public Meeting, 15576-15577 [2018-07416]

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 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices associations and public advocacy groups. Currently, the ICCR members are: The Brazilian Health Surveillance Agency; Health Canada; the European Commission Directorate-General for Internal Market, Industry, Entrepreneurship, and Small and Medium-sized Enterprises; the Ministry of Health, Labor, and Welfare of Japan; and FDA. All decisions are made by consensus and will be compatible with the laws, policies, rules, regulations, and directives of the respective administrations and governments. Members will implement and/or promote actions or documents within their own jurisdictions and seek convergence of regulatory policies and practices. Successful implementation will need input from stakeholders. II. Topics for Discussion at the Public Meeting We will make the agenda for the public meeting available on the internet at https://www.fda.gov/Cosmetics/ InternationalActivities/ICCR/ default.htm. Depending on the number of requests for oral presentations, we intend to have an agenda available by May 31, 2018. III. Participating in the Public Meeting Registration: To register for the public meeting, send registration information (including your name, title, affiliation, address, email, and telephone), to Jonathan Hicks by May 24, 2018 (see FOR FURTHER INFORMATION CONTACT). If you would like to listen to the meeting by phone, please submit a request for a dial-in number by May 24, 2018. If you need special accommodations due to a disability, please contact Jonathan Hicks by May 31, 2018. Requests for Oral Presentations: If you wish to make an oral presentation, you should notify Jonathan Hicks by May 24, 2018, and submit a brief statement of the general nature of the evidence or arguments that you wish to present, your name, title, affiliation, address, email, and telephone, and indicate the approximate amount of time you need to make your presentation. You may present proposals for future ICCR agenda items, data, information, or views, in person or in writing, on issues pending at the public meeting. There will be no presentations by phone. Time allotted for oral presentations may be limited to 10 minutes or less for each presenter, depending on the number of requests received. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20850. Dated: April 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–07416 Filed 4–10–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ACTION: 15577 Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: Approval is withdrawn as of May 11, 2018. DATES: FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993–0002, 240–402–7945, Trang.Tran@fda.hhs.gov. The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2018–N–1336] Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. Application No. Drug Applicant ANDA 040252 ........ Carisoprodol and Aspirin Tablets USP, 200 milligrams (mg)/ 325 mg. Carisoprodol, Aspirin, and Codeine Phosphate Tablets USP, 200 mg/325 mg/16 mg. Tetracycline Hydrochloride (HCl) Capsules USP, 250 mg and 500 mg. Tetracycline HCl Tablets, 500 mg .......................................... Oxford Pharmaceuticals, LLC, 301 Leaf Lake Pkwy., Birmingham, AL 35211. Do. ANDA 040283 ........ ANDA 061214 ........ ANDA 061682 ........ ANDA 062212 ........ ANDA 062654 ........ amozie on DSK30RV082PROD with NOTICES ANDA 062680 ........ Totacillin (ampicillin/ampicillin trihydrate) Capsules, Equivalent to (EQ) 250 mg base and EQ 500 mg base. Rocephin (ceftriaxone sodium) for Injection, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial. Oxacillin Sodium for Injection (Pharmacy Bulk Package) ..... ANDA 065124 ........ Cefotaxime for Injection USP, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial. ANDA 065263 ........ Ceftriaxone for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package). Diltiazem HCl Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg. ANDA 074845 ........ VerDate Sep<11>2014 17:17 Apr 10, 2018 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228. Mylan Pharmaceuticals Inc., P.O. Box 4293, Morgantown, WV 26505. GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709. Hoffman La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way, MS 241B, South San Francisco, CA 94080. ACS Dobfar S.p.A., c/o Interchem Corp., 120 Route 17 North, Paramus, NJ 07653. Lupin Ltd., c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 24th Floor, Baltimore, MD 21202. Do. Biovail Corp. International, Subsidiary of Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. E:\FR\FM\11APN1.SGM 11APN1

Agencies

[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15576-15577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07416]


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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.

-----------------------------------------------------------------------

SUMMARY: 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.

ADDRESSES: 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, [email protected], 240-402-1375.

SUPPLEMENTARY INFORMATION:

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

[[Page 15577]]

associations and public advocacy groups. Currently, the ICCR members 
are: The Brazilian Health Surveillance Agency; Health Canada; the 
European Commission Directorate-General for Internal Market, Industry, 
Entrepreneurship, and Small and Medium-sized Enterprises; the Ministry 
of Health, Labor, and Welfare of Japan; and FDA. All decisions are made 
by consensus and will be compatible with the laws, policies, rules, 
regulations, and directives of the respective administrations and 
governments. Members will implement and/or promote actions or documents 
within their own jurisdictions and seek convergence of regulatory 
policies and practices. Successful implementation will need input from 
stakeholders.

II. Topics for Discussion at the Public Meeting

    We will make the agenda for the public meeting available on the 
internet at https://www.fda.gov/Cosmetics/InternationalActivities/ICCR/default.htm. Depending on the number of requests for oral 
presentations, we intend to have an agenda available by May 31, 2018.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, send registration 
information (including your name, title, affiliation, address, email, 
and telephone), to Jonathan Hicks by May 24, 2018 (see FOR FURTHER 
INFORMATION CONTACT). If you would like to listen to the meeting by 
phone, please submit a request for a dial-in number by May 24, 2018. If 
you need special accommodations due to a disability, please contact 
Jonathan Hicks by May 31, 2018.
    Requests for Oral Presentations: If you wish to make an oral 
presentation, you should notify Jonathan Hicks by May 24, 2018, and 
submit a brief statement of the general nature of the evidence or 
arguments that you wish to present, your name, title, affiliation, 
address, email, and telephone, and indicate the approximate amount of 
time you need to make your presentation. You may present proposals for 
future ICCR agenda items, data, information, or views, in person or in 
writing, on issues pending at the public meeting. There will be no 
presentations by phone. Time allotted for oral presentations may be 
limited to 10 minutes or less for each presenter, depending on the 
number of requests received.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20850.

    Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07416 Filed 4-10-18; 8:45 am]
 BILLING CODE 4164-01-P

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