Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group; Amendment, 38912 [2017-17323]

Download as PDF 38912 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 2016, requesting that Upsher-Smith provide the requested bioequivalence data within 30 calendar days or voluntarily seek withdrawal of ANDA 078706 under section 314.150(d) (21 CFR 314.150(d)). In a letter dated September 15, 2016, Upsher-Smith informed FDA that it did not intend to submit the requested bioequivalence data and requested that the Agency withdraw approval of ANDA 078706 for ZALEPLON Capsules under section 314.150(d). In that letter, Upsher-Smith also waived any opportunity for a hearing otherwise provided under section 314.150(a). Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and 314.150(d), approval of ANDA 078706, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: August 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–17301 Filed 8–15–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group; Amendment Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice; amendment. AGENCY: A notice was published in the Federal Register on Monday, July 17, 2017 (Vol. 82, No. 135, pages 32711– 32712), to solicit nominations of individuals who are interested in being considered for appointment to the TickBorne Disease Working Group (Working Group). The nomination period is scheduled to end close of business on August 16, 2017. The notice is being amended to extend the solicitation period for one week to allow more time for interested individuals to submit nominations. asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: The solicitation period has been extended. All nominations are due to be submitted on or before August 23, 2017. ADDRESSES: All nominations should be sent to: CAPT Richard Henry; Office of VerDate Sep<11>2014 18:33 Aug 15, 2017 Jkt 241001 Dated: August 10, 2017. Donald Wright, Acting Assistant Secretary for Health. [FR Doc. 2017–17323 Filed 8–15–17; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on Combating AntibioticResistant Bacteria Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the Web site https://www.hhs.gov/ash/ carb/ and must be completed by September 5, 2017; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https:// www.hhs.gov/ash/carb/ on the Meetings page. DATES: The meeting is scheduled to be held on September 13, 2017, from 9:00 a.m. to 5:00 p.m. ET, and September 14, 2017, from 9:00 a.m. to 3:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the Web site for the Advisory SUMMARY: BILLING CODE 4164–01–P DATES: the Assistant Secretary for Health; Department of Health and Human Services; 330 C Street SW., Suite L100, Washington, DC 20024. Nomination materials, including attachments, also may be submitted electronically to tickbornedisease@hhs.gov. FOR FURTHER INFORMATION CONTACT: CAPT Richard Henry, Office of the Assistant Secretary for Health; Department of Health and Human Services; Telephone: (202) 795–7615; Email address: richard.henry@hhs.gov. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Council at https://www.hhs.gov/ash/ carb/ when this information becomes available. Pre-registration for attending the meeting in person is required to be completed no later than September 5, 2017; public attendance at the meeting is limited to the available space. ADDRESSES: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW., Washington, DC 20201. The meeting can also be accessed through a live webcast on the day of the meeting. For more information, visit https://www.hhs.gov/ash/carb/. FOR FURTHER INFORMATION CONTACT: Jomana Musmar, Acting Designated Federal Officer, Presidential Advisory Council on Combating AntibioticResistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. Phone: (202) 690–5566; email: CARB@ hhs.gov. SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92–463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees. The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Advisory Council shall function solely for advisory purposes. In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibioticresistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Page 38912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17323]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Nominations for Appointment to the Tick-Borne 
Disease Working Group; Amendment

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice; amendment.

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SUMMARY: A notice was published in the Federal Register on Monday, July 
17, 2017 (Vol. 82, No. 135, pages 32711-32712), to solicit nominations 
of individuals who are interested in being considered for appointment 
to the Tick-Borne Disease Working Group (Working Group). The nomination 
period is scheduled to end close of business on August 16, 2017. The 
notice is being amended to extend the solicitation period for one week 
to allow more time for interested individuals to submit nominations.

DATES: The solicitation period has been extended. All nominations are 
due to be submitted on or before August 23, 2017.

ADDRESSES: All nominations should be sent to: CAPT Richard Henry; 
Office of the Assistant Secretary for Health; Department of Health and 
Human Services; 330 C Street SW., Suite L100, Washington, DC 20024. 
Nomination materials, including attachments, also may be submitted 
electronically to tickbornedisease@hhs.gov.

FOR FURTHER INFORMATION CONTACT: CAPT Richard Henry, Office of the 
Assistant Secretary for Health; Department of Health and Human 
Services; Telephone: (202) 795-7615; Email address: 
richard.henry@hhs.gov.

    Dated: August 10, 2017.
Donald Wright,
Acting Assistant Secretary for Health.
[FR Doc. 2017-17323 Filed 8-15-17; 8:45 am]
 BILLING CODE 4150-28-P
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