New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application, 32188-32189 [2017-14566]

Download as PDF 32188 Federal Register / Vol. 82, No. 132 / Wednesday, July 12, 2017 / Notices increasing the probability that customers would pay higher prices for fibre channel switches and that innovation would be lessened. asabaliauskas on DSKBBXCHB2PROD with NOTICES Entry Entry into the worldwide fibre channel switch market is not likely to occur in a timely, likely, or sufficient magnitude, character and scope to deter or counteract any anticompetitive effects created by the proposed Acquisition. Entry is unlikely in light of slowly declining demand for fibre channel switches in a mature market, customers that tend to stay with one fibre channel switch manufacturer for extended periods of time, and the significant capital costs required for entry. The Consent Agreement To remedy the alleged competitive concern stemming from Broadcom’s access to Cisco’s competitively sensitive confidential information, the consent decree prevents the Cisco information from being shared among Broadcom employees who could use such information to raise prices or lessen innovation. Pursuant to the proposed Order, only authorized individuals will have access to Cisco’s competitively sensitive confidential information that is given to the firewalled entity, which is defined as Broadcom’s business group responsible for the development, production, sale, and marketing of fibre channel ASICs for Cisco. The firewalled entity will have separate facilities and a separate information technology system with security protocols assuring access only to the authorized individuals. Furthermore, Broadcom shall require all authorized individuals to sign a nondisclosure agreement, requiring compliance with the terms of the proposed Order. Additionally, the proposed Order provides for a cooling off period whereby any authorized individual who leaves his or her position at the firewalled entity will not work in the development, production, sale, or marketing of fibre channel ASICs for Brocade’s business unit or in the development, production, sales, and marketing of fibre channel switches for twelve months. The proposed Order also requires Broadcom to use Cisco’s competitively sensitive confidential information only in furtherance of the design, manufacturing, and sale of fibre channel ASICs for Cisco. Moreover, Broadcom will be required to take all actions necessary to prevent access to, or the disclosure or use of Cisco’s competitively sensitive confidential VerDate Sep<11>2014 17:54 Jul 11, 2017 Jkt 241001 information by or to anyone who is not an authorized individual. The proposed Order also incorporates by reference non-disclosure provisions contained in four prior private Confidentiality Agreements that Broadcom, or its predecessor, signed with Cisco. To ensure compliance with the proposed Order, the Commission will appoint a Monitor to oversee Broadcom’s and Brocade’s performance of their obligations pursuant to the Consent Agreement. The Monitor will be appointed to a five-year term, but the Commission may extend or modify the term as appropriate up to a ten-year period. Further, the Consent Agreement contains appropriate reporting requirements. Opportunity for Public Comment The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement to aid the Commission in determining whether it should make the proposed Consent Agreement final. This analysis is not an official interpretation of the proposed Consent Agreement and does not modify its terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2017–14536 Filed 7–11–17; 8:45 am] BILLING CODE 6750–01–P management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Claudette Grant, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2017–14745 Filed 7–10–17; 4:15 pm] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0002] New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs). This action is being taken at the sponsor’s request because these products are no longer manufactured or marketed. SUMMARY: Withdrawal of approval is effective July 24, 2017. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Sunshine Act Meeting: Board of Scientific Counselors NCEH/ATSDR; Cancelation FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: The original Federal Register Notice for this meeting was published in the Federal Register on May 22, 2017, Volume 82, Number 2017–10333, page/s/23250–23251. PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING: 9:00 a.m.–noon, EDT, June 23, 2017. This meeting is being canceled in its entirety. CONTACT PERSON FOR MORE INFORMATION: Amanda Malasky, BS, ORISE Fellow, CDC, 4770 Buford Hwy., Atlanta, GA 30344, telephone 770–488–7699; yoo0@ cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee CHANGES IN THE MEETING: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of NADA 065–291 for bulk dihydrostreptomycin sulfate and NADA 065–324 for bulk streptomycin sulfate because the products are no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 065–291 and NADA 065–324, and all supplements and amendments thereto, is hereby withdrawn, effective July 24, 2017. As neither of these NADAs was codified, the animal drug regulations do not require amendment to reflect the voluntary withdrawal of approval of these applications. SUPPLEMENTARY INFORMATION: E:\FR\FM\12JYN1.SGM 12JYN1 Federal Register / Vol. 82, No. 132 / Wednesday, July 12, 2017 / Notices Dated: July 7, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–14566 Filed 7–11–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, July 20, 2017, 11:00 a.m. to July 20, 2017, 05:00 p.m., National Cancer Institute Shady Grove, Shady Grove, 9609 Medical Center Drive, 7W102, Rockville, MD 20850 which was published in the Federal Register on May 31, 2017, 82 FR 24983. The meeting notice is amended to change the meeting title to ‘‘Core Infrastructure & Epidemiology Cohorts’’. The meeting date has been changed to August 8, 2017 and the contact person has been changed to Shakeel Ahmad, Ph.D.; phone 240–276–6349; ahmads@ mail.nih.gov. The meeting is closed to the public. Name of Committee: National Institute on Aging Special Emphasis Panel; The Dog Aging Project. Date: August 4, 2017. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 2W200, 7201 Wisconsin Ave., Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Isis S. Mikhail, DRPH, MD, MPH, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7704, MIKHAILI@MAIL.NIH.GOV. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: July 6, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. asabaliauskas on DSKBBXCHB2PROD with NOTICES National Institutes of Health VerDate Sep<11>2014 17:54 Jul 11, 2017 Jkt 241001 BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2016–1084] Navigation and Vessel Inspection Circular (NVIC) 05–17; Guidelines for Addressing Cyber Risks at Maritime Transportation Security Act (MTSA) Regulated Facilities ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES SUMMARY: National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Name of Committee: Center for Scientific Review Special Emphasis Panel; Myocardial Ischemia and Metabolism Members Conflict. Date: August 1–2, 2017. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Abdelouahab Aitouche, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4222, MSC 7814, Bethesda, MD 20892, 301–435– 2365, aitouchea@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–14538 Filed 7–11–17; 8:45 am] AGENCY: Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. BILLING CODE 4140–01–P Dated: July 6, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P National Institute on Aging; Notice of Closed Meeting [FR Doc. 2017–14539 Filed 7–11–17; 8:45 am] 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) [FR Doc. 2017–14540 Filed 7–11–17; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Dated: July 6, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. 32189 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Coast Guard, DHS. Notice of availability and request for comments. The Coast Guard announces the availability of draft Navigation and Inspection Circular (NVIC) 05–17; Guidelines for Addressing Cyber Risks at Maritime Transportation Security Act (MTSA) Regulated Facilities, and requests public comment on the draft. This NVIC proposes to clarify the existing requirements under MTSA to incorporate analysis of computer and cyber risks and guidance for addressing those risks. This NVIC would provide guidance on incorporating cybersecurity risks into an effective Facility Security Assessment (FSA), as well as additional recommendations for policies and procedures that may reduce cyber risk to operators of maritime facilities. Operators may use this document as a benchmark to develop and implement measures and activities for effective selfgovernance of cyber risks. DATES: Comments must be submitted to the online docket via https:// www.regulations.gov, or reach the Docket Management Facility, on or before September 11, 2017. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call or email, Jason Warren, Coast Guard; telephone 202–372–1106, email Jason.S.Warren@uscg.mil or LCDR Josephine Long, Coast Guard; telephone 202–372–1109, email Josephine.A.Long@uscg.mil. ADDRESSES: You may submit comments identified by docket number USCG– 2016–1084 using the Federal eRulemaking Portal at https:// www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 82, Number 132 (Wednesday, July 12, 2017)]
[Notices]
[Pages 32188-32189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0002]


New Animal Drugs; Withdrawal of Approval of a New Animal Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADAs). This action is being taken 
at the sponsor's request because these products are no longer 
manufactured or marketed.

DATES: Withdrawal of approval is effective July 24, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis, Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of NADA 065-291 for bulk 
dihydrostreptomycin sulfate and NADA 065-324 for bulk streptomycin 
sulfate because the products are no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs, and in accordance with Sec.  514.116 Notice of withdrawal of 
approval of application (21 CFR 514.116), notice is given that approval 
of NADA 065-291 and NADA 065-324, and all supplements and amendments 
thereto, is hereby withdrawn, effective July 24, 2017.
    As neither of these NADAs was codified, the animal drug regulations 
do not require amendment to reflect the voluntary withdrawal of 
approval of these applications.


[[Page 32189]]


    Dated: July 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14566 Filed 7-11-17; 8:45 am]
BILLING CODE 4164-01-P
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