Tick-borne disease experts needed (Jan. 2 deadline)

Tick-borne disease experts needed

Nominate an expert or apply by January 2, 2018

HHS seeks highly qualified individuals (federal employees and members of the public) to serve on subcommittees to its new Tick-Borne Disease Working Group. Subcommittees include: Disease Vectors, Surveillance and Prevention Pathogenesis, Transmission, and Treatment Testing and Diagnostics Access to Care Services and Support to Patients Vaccine and Therapeutics Other Tick-Borne Diseases and Co-infections The primary purpose of the subcommittees is to gather information, conduct research, or analyze relevant issues and facts in preparation for meetings by the Working Group, or to draft position papers for deliberation by the Working Group. Image: A male adult dog tick (credit: NIAID)

PHEMCE updates

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has released the PHEMCE Strategy and Implementation Plan and the PHEMCE Multiyear Budget.  The 2017-2018 PHEMCE Strategy and Implementation Plan (PDF, 986 KB) provides the blueprint for the PHEMCE to enhance national security through the development, procurement, and planning for effective use of critical medical countermeasures (MCMs).  The PHEMCE Multiyear Budget (PDF, 1.8 MB) shows how much HHS agencies are spending or plan to spend over a five-year period to develop, review, and stockpile medical countermeasures.  FDA-specific information begins on page 36.

Zika update for HCT/P establishments

Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission in Hidalgo County, Texas On December 19, 2017, CDC added new epidemiological information on its Blood and Tissue Safety webpageused to communicate epidemiological information about Zika virus (ZIKV) to the blood and tissue collection community. Specifically, CDC reported that local, mosquito-borne transmission of ZIKV began in Hidalgo County, Texas on September 1, 2017. Related information: Important additional information for HCT/P establishments Zika virus response updates from FDA Zika remains a research and public health challenge, say NIAID scientists

Events January 8, 2018: Webinar for industry - CLIA Waiver Applications Draft Guidance Documents, 3:00 - 4:30 p.m. ET  January 10, 2018: Webinar for industry  - Technical Considerations for Additive Manufactured Medical Devices, 1:00 - 2:30 p.m. ET January 11, 2018: Antimicrobial Drugs Advisory Committee public meeting (Hyattsville, MD) - The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. New! January 11, 2018: FDA Grand Rounds - Ethnicity- and Gender-related Differences in Alzheimer’s Disease, presented by Sherry Ferguson, PhD, Research Psychologist and Vijayalakshmi Varma, PhD, Research Biologist, FDA National Center for Toxicological Research (NCTR) - CE credit available January 30-31, 2018: Public workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program (Bethesda, MD and webcast) - register by 4:00 p.m. ET January 18, 2018  February 7-8, 2018: Tenth Annual Sentinel Initiative Public Workshop (Bethesda and Silver Spring, MD, and 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 2by February 6, 2018. To attend both days, please register separately for each. New! April 17-20, 2018: Preparedness Summit (Atlanta, GA) - The theme for the conference is Strengthening National Health Security: Mastering Ordinary Responses, Building Resilience for Extraordinary Events. Registration is now open. (fee) April 23-27, 2018: Achieving Data Quality and Integrity in Maximum Containment Laboratories course (Bethesda, MD) - Registration opens January 8, 2018.

Information for industry MERS-CoV diagnostic update: FDA granted a de novo request (PDF, 226 KB) from BioFire Diagnostics, LLC for its FilmArray Respiratory Panel 2 plus (RP2plus), a multiplexed nucleic acid test intended for use with FilmArray 2.0 or FilmArray Torch systems for the simultaneous qualitative detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple common viral and bacterial respiratory pathogens. This assay is intended to test nasopharyngeal swabs obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria; if patients do not meet these criteria, this test should not be used.  Existing MERS-CoV diagnostic Emergency Use Authorizations (EUAs) remain in effect. (November 24, 2017) FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 2017. This applies to drug listings that were not initially listed or updated during the current calendar year. This is the first deadline of the annual certification requirement under Part 207 of Title 21 of the Code of Federal Regulations. Draft guidance - Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases (PDF, 117 KB) to provide clarity for industry on orphan drug designation requirements. Comment by January 19, 2018. Also see: FDA takes step to close orphan drug loophole that let drug developers sidestep pediatric studies Draft guidance - Drug Products, Including Biological Products, that Contain Nanomaterials (PDF, 235 KB), to provide recommendations to industry engaged in developing human drug products in which a nanomaterial is present in the finished dosage form, including recommendations regarding investigational, premarket, and postmarket submissions for these products. Comment by March 19, 2018. (December 18, 2017) Reminder: 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 science: Results of FDA study supports development of high throughput (next-generation) sequencing for viral safety evaluation of biologic materials (December 12, 2017) FDA Voice on antimicrobial susceptibility testing: Treating Infections – FDA is Forging a More Efficient Path to Help Healthcare Providers Treat their Patients (December 13, 2017)  What is gene therapy and how does it work? Scientists have been working on the process for decades. Now this research on gene therapy is finally paying off with FDA approving three gene therapy products, the first of their kind, in 2017. Video - 1:30 (December 19, 2017) How does FDA protect public health? Take this training course to learn about the drug regulatory process and earn free CE. 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. CBER is also hiring a Principal Investigator: Molecular Virologist Senior Staff Fellow/Visiting Scientist to develop an independent research program on molecular virology with emphasis on hepatitis viruses and other emerging blood viruses that present a risk to blood supply. From NIH - NIH Lifts Funding Pause on Gain-of-Function Research - NIH announced that it is lifting a funding pause dating back to October 2014 on gain-of-function (GOF) experiments involving influenza, SARS, and MERS viruses. GOF research is important in helping identify, understand, and develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health. The funding pause was lifted in response to release of the HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework) (PDF, 718 KB). (December 19, 2017)