New Tick-Borne Diseases Working Group and Sentinel Initiative meetings

New Tick-Borne Disease Working Group

HHS announced the appointment of 14 members, and will host the first meetings December 11-12, 2017

Image: A male adult dog tick (credit: NIAID). Also see Tiny but Treacherous: Pics and Flicks Feature Disease-Bearing Ticks, from NIAID.

The U.S. Department of Health and Human Services (HHS) announced the appointment of 14 members to the new Tick-Borne Disease Working Group. The Working Group was established by the 21st Century Cures Act to improve federal coordination of efforts related to tick-borne diseases. Members will review all HHS efforts related to tick-borne diseases to provide expertise and help ensure interagency coordination and minimize overlap, examine research priorities and identify unmet needs. Captain Estella Jones, DVM, of FDA's Office of Counterterrorism and Emerging Threats, will represent FDA. The group will hold its inaugural meetings December 11-12, 2017 (Washington, DC and webcast). Related information Tick-Borne Disease Working Group website Register to attend the December 11-12 meetings by December 8, 2017 21st Century Cures Act information from FDA

FDA's Sentinel Initiative

The Sentinel Initiative is a national electronic system that monitors the safety of drugs, vaccines, biologics and medical devices on the market. Robert Ball, MD, MPH, deputy director of the FDA Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology, discusses Sentinel’s progress and future in this CDER Conversation. FDA will hold the Tenth Annual Sentinel Initiative Public Workshop on February 7-8, 2018 in Bethesda and Silver Spring, MD, and via webcast. The stakeholder community will discuss a variety of topics on active medical product surveillance. To attend in-person or via webcast, register here for Day 1 and/or here for Day 2 by February 6, 2018. To attend both days, please register separately for each.

Events November 30 - December 1, 2017: Blood Products Advisory Committee Meeting (Silver Spring, MD and webcast) - committee members will meet in open session to discuss topics including strategies to reduce the risk of transfusion-transmitted Zika virus New! December 4, 2017: CDER SBIA webinar - REMS Integration Initiative: An Overview, 2:00 - 4:00 p.m. ET - also see Approved Risk Evaluation and Mitigations Strategies (REMS) New! December 11-12, 2017: HHS Tick-Borne Disease Working Group meetings (Washington, DC and webcast) - also see New Tick-Borne Disease Working Group above New! January 8, 2018: Webinar for industry - CLIA Waiver Applications Draft Guidance Documents, 3:00 - 4:30 p.m. ET - also see Information for industry below New! February 7-8, 2018: Tenth Annual Sentinel Initiative Public Workshop (Bethesda and Silver Spring, MD, and webcast) - also see FDA's Sentinel Initiative above

Information for industry A proposed order (FDA-2017-N-4919) was published in the Federal Register to announce FDA's intent to exempt N95s from premarket notification requirements and execute a Memorandum of Understanding (MOU) between FDA and the CDC National Institute for Occupational Safety and Health (NIOSH), regarding regulatory oversight of N95s. Also see Personal Protective Equipment for Infection Control (November 30, 2017) FDA's Center for Devices and Radiological Health (CDRH) has published Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and FDA Staff (PDF, 349 KB) and Recommendations for Dual 510(k) and CLIA Waiver by Application Studies; Draft Guidance for Industry and FDA Staff (PDF, 614 KB). CDRH will host a webinar for industry on these draft guidances on January 8, 2018. (November 28, 2017) The NIAID/NIH Centers for Medical Countermeasures against Radiation Consortium (CMCRC) is accepting applications for pilot projects focused on practical approaches for radiation biodosimetry or the development of agents for the mitigation of acute or late radiation injury. Applications are due March 15, 2018.  The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) requests proposals for projects that address technology and/or workforce development issues in biomanufacturing. Only NIIMBL members may participate on proposal project teams. Organizations must provide a signed Membership Agreement by January 12, 2018 to submit a proposal or be included on a project team. Also see the full RFP (PDF, 448 KB) More: MCM-Related Guidance by Date

In case you missed it FDA's Center for Biologics Evaluation and Research (CBER) is recruiting for several scientist positions: senior staff fellow/visiting scientists for influenza vaccines and vector-borne diseases, and a staff fellow(interdisciplinary scientist). Apply by January 15, 2018.  Statement by FDA Commissioner Scott Gottlieb, MD, on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls (November 17, 2017) FDA Voice - FDA, International Regulators Look at Common Challenges, Innovation - Regulatory experts from around the world (International Coalition of Medicines Regulatory Authorities [ICMRA]), including FDA, gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified medical products. (November 28, 2017) From CDC - Up and Running Within 48hrs: Learn How Federal Medical Stations (FMSs) Help People during a Public Health Emergency - An FMS is a non-emergency medical center set up during a natural disaster to care for people with special health needs, including those with chronic health conditions (e.g., respiratory illnesses and diabetes), limited mobility, and common mental health illnesses.(November 22, 2017)