FDA Medical Countermeasures Initiative Update
Decoding Ebola: Next-Generation Sequencing of the Ebola Genome for the FDA ARGOS Database
An MCMi Intramural Research Profile
When you need a test to confirm disease in an outbreak, you need it fast. Global public health providers need additional infrastructure and tools like rapid diagnostic tests to combat emerging threats, including Ebola and antimicrobial resistant-pathogens.
Next-generation sequencing (NGS) technologies show promise to improve rapid diagnostic tests, and have the potential to speed development of vaccines, therapeutics and diagnostic devices—all of which would enable quicker actions to protect public health.
From principal investigator Dr. Heike Sichtig: "Given the trend to make technology gadgets smaller and more portable, one can imagine NGS as an implantable or wearable device in the future. What if we could detect an infection before signs and symptoms manifest? And what if NGS could be used as a detective tool for completely unknown agents? NGS technology for infectious disease diagnostics has the potential to revolutionize the field through its foremost ability to detect emerging infectious disease agents using agnostic (metagenomics) sequencing, especially in an emergency situation." more
Related information
FDA dAtabase for Regulatory Grade micrObial Sequences (FDA-ARGOS)
About MCMi's intramural regulatory science program
MCMi extramural research funding and current projects
FDA Voice: Taking Genomic Testing to the Next Level
Image: Lab Manager Naomi Sengamalay oversees all sample extraction, library construction and sequencing activities within the University of Maryland Genomics Research Center. (Photo courtesy of the University of Maryland, Institute for Genome Sciences)
News updates
Events:
September 15, 2015: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. (Federal Register notice)
September 18, 2015: 2015 FDA Science Writers Symposium - a special event intended to engage and inform science and health journalists about how the FDA is applying scientific approaches to critical public health issues. Registration is free and open to credentialed media; register by September 14, 2015.
September 28, 2015: FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data (Silver Spring, MD and webcast) - The purpose of the workshop is to receive and discuss input from stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records. Register by September 18, 2015.
September 29, 2015: Webinar - Get to Know ClinicalTrials.gov 
hosted by the FDA Office of Minority Health - register by noon on September 21, 2015
September 29 2015: Webinar - FDA Online Drug Information Resources for Students and Clinicians - Lesley Navin RN, MSN, Advanced Practice Nurse, will present information regarding FDA databases that are of interest to students and practicing clinicians who will learn how to navigate and utilize these databases to find useful, relevant and current drug information - hosted by CDER's Office of Communication, Division of Drug Information
September 29-30, 2015: Public workshop - Medical Device Patient Labeling (Silver Spring, MD and webcast) - register to attend in person or online by September 21, 2015
September 30, 2015: Public meeting - Collecting On-Farm Antimicrobial Use and Resistance Data (Washington, DC) - register by September 18, 2015 (Federal Register notice)
View more events on the frequently updated MCMi News and Events page
Preparedness and response:
HHS ASPR posted a webinar recording - The Healthcare and Public Sector Webinar: Preparedness Grants Opportunities (August 17, 2015)
NIH has announced the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2015. The list (PDF, 322 KB) includes biodefense research priorities (see Table 5). All nominations of pediatric therapeutics for future consideration should be submitted to Dr. Perdita Taylor-Zapata at taylorpe@mail.nih.gov.(August 26, 2015)
Ebola:
FDA and the Ministry of Public Health and Hygiene of Guinea signed reciprocal agreements(PDF, 364 KB) to help facilitate communications between the two agencies on medical products used, or proposed to be used, for Ebola-related purposes as part of cooperative regulatory activities. More information about FDA’s international arrangements (September 1, 2015)
In late 2014, the U.S. Public Health Service Commissioned Corps was activated to respond to the Ebola epidemic in West Africa. Officers were pulled from many different agencies within HHS and other components of the U.S. government. Some of the deployed FDA officers share their experiences in this video, The Hope Multipliers (14:24). (August 2015)
Antimicrobial resistance:
Announcement of Public Consultation on Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge - HHS intends to hold a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and will convene a public consultation to seek comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. Written comments can be submitted to https://www.challenge.gov/ for this competition October 1, 2015, 8:30 a.m. EDT to October 6, 2015, 5:00 p.m. EDT.(September 9, 2015)
FDA and CDC release NARMS data - FDA is publishing online data on its collection of bacteria – Salmonella, Campylobacter, E. coli, and Enterococcus – that are found in the guts of animals and humans, collected over the past 19 years as part of the National Antimicrobial Resistance Monitoring System (NARMS). CDC has also announced a new interactive tool, NARMS Now: Human Data. (August 19, 2015)
FDA released the 2012-2013 Integrated National Antimicrobial Resistance Monitoring System (NARMS) Report, including interactive data displays - report PDF (2.3 MB) (August 11, 2015)
Federally funded research:
NIH/NIAID research news - NIAID Researchers Advance Development of Universal Flu Vaccine (August 27, 2015)
NIH/NIAID research news - NIH scientists and colleagues successfully test MERS vaccine in monkeys and camels (August 19, 2015)
Development of new anthrax vaccine underway with HHS support - Project is the latest in the quest to protect health quickly (post-exposure) in a bioterrorism attack (August 17, 2015)
NIH/NIAID research news - NIH-Funded Study Establishes Genomic Data Set on Lassa Virus - Knowledge of Virus Supports Efforts to Develop Medical Countermeasures. The data set is publicly accessible at the National Center for Biotechnology Information's BioProjectwebsite under PRJNA254017. (August 13, 2015)
Guidance:
FDA Voice - Need a guidance document? We've got you covered. - Search all FDA guidance.
Final rule - HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus and other potential pandemic strains, such as H5N1 avian influenza. Also seeCountermeasures Injury Compensation Program. (August 7, 2015)
Proposed Rule - Federal Policy for the Protection of Human Subjects - The departments and agencies listed in this Federal Register notice propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Comment by December 7, 2015.(September 8, 2015)
Draft Guidance for Industry - Nonproprietary Naming of Biological Products (PDF, 111 KB,Federal Register notice) and proposed rule: Designation of Official Names and Proper Names for Certain Biological Products - submit comments on the draft guidance by October 27, 2015 and the proposed rule by November 12, 2015. Related links: FDA Biosimilars page - FDA Voice: Naming and Biological Products (August 28, 2015)
Guidance for Industry - Providing Submissions in Electronic Format--Postmarketing Safety Reports for Vaccines (PDF, 77 KB) (Federal Register notice) (August 18, 2015)
Draft guidance - Rare Diseases: Common Issues in Drug Development (PDF, 306 KB) - comment by October 16, 2015 (Federal Register notice) (August 17, 2015)
Deadline reminders:
NIH and CDC are soliciting proposals from small businesses to conduct research and development, including possible medical countermeasure-related research - respond byOctober 16, 2015.
FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects
In case you missed it:
New England Journal of Medicine Perspective - Combating Emerging Threats — Accelerating the Availability of Medical Therapies , by FDA's Luciana Borio, MD, Edward Cox, MD, MPH, and HHS ASPR Nicole Lurie, MD, MSPH (August 5, 2015)
The Drug Shortages 2 app is now available for Android devices on Google Play. Drug Shortages 2 includes an Alerts feature. You can opt in to receive notifications on your mobile device when FDA adds or updates shortage information about a drug product or one or more drugs within a selected therapeutic category. First launched March 4, 2015, the app identifies current drug shortages, resolved shortages and discontinuations of drug products. FDA is currently working on notifications for the iOS version of the mobile app. The app for Apple devices is available for free download via iTunes. (August 11, 2015)
FDA Voice - Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients (August 11, 2015)
MCMi Fiscal Year 2014 Program Update (web version) - printable PDF (1.3 MB) (June 2015)
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