Department of Health and Human Services August 16, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group; Amendment
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.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
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.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Determination That CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that CORDARONE (amiodarone hydrochloride) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for ZALEPLON Capsules, 5 milligrams (mg) and 10 mg, held by Upsher-Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee
The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces the inaugural meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC will meet on August 31, 2017, from 9:00 a.m. to 5:00 p.m., Eastern Time. The meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. The meeting will include information on federal advances related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss workgroups, future meetings, and the Report to Congress. Members of the public can attend the meeting via telephone or webcast. The meeting can be accessed via webcast at www.hhs.gov/live. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register at the SAMHSA Advisory Committees Web site at https://www.samhsa.gov/about-us/advisory-councils/smi-committ ee or contact Pamela Foote, Designated Federal Official (see contact information below). Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written statements should be submitted to the DFO on or before August 24, 2017. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the DFO on or before August 24, 2017. Two minutes will be allotted for each presentation. Substantive meeting information and a roster of Committee members is available at the Committee's Web site https://www.samhsa.gov/about- us/advisory-councils/smi-committee or by contacting Pamela Foote, DFO. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee Dates/Time/Type: August 31, 2017/9:00 a.m.5:00 p.m./OPEN Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. Webcast and teleconference (see information above). DFO: Pamela Foote, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, 14E53C, Rockville, MD 20857; telephone: 240-276-1279; email: pamela.foote@samhsa.hhs.gov
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