FDA Medical Countermeasures

Initiative Update

Public comment period open

On March 11, 2016, FDA released for public comment a draft environmental assessment (EA) (PDF, 33 MB) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida.

Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. FDA is also releasing a preliminary finding of no significant impact (FONSI) (PDF, 148 KB) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment. Comment by April 13, 2016.

Image: Female Ae. aegypti mosquito (Credit: CDC/ Paul I. Howell, MPH; Prof. Frank Hadley Collins)

Related information

Federal Register notice, including how to comment
Oxitec Mosquito
Investigational products (Zika)

Zika workshop: Register by Friday, March 18

Zika Virus in the Americas: An HHS Expert Consultation to Accelerate the Development of Countermeasures

March 28-29, 2016 - North Bethesda, MD + webinar now available

The workshop will review current information about the virus’ epidemiology (including potential link to microcephaly) and clinical manifestations and pathogenesis of Zika virus. There will also be discussion of strategies to accelerate the development of vaccines, diagnostics, therapeutics and novel vector control methods and ensure blood supply safety.

This consultation is supported by NIAID, NICHD, ASPR/BARDA, CDC and FDA within the U.S. Department of Health and Human Services.

View the draft agenda

Register to attend in-person

Register to attend via webinar

Zika guidances & Q&A

On March 11, 2016, FDA issued a new guidance (Q&A) Questions and Answers Regarding - Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF, 310 KB).

This Q&A provides answers to common questions from blood establishments asked in response toguidance (PDF, 111 KB) issued February 16, 2016.

Related information

Zika virus response updates from FDA
FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue products (FDA news release, March 1, 2016)
Safety of the blood supply, with regard to Zika virus
About regulation of the blood supply

News updates

More events:

April 13-14, 2016: Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies(Bethesda, MD and webcast) - the purpose of this workshop is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies (Federal Register notice)

April 14, 2016: Update on FDA’s Role in Regulatory Oversight of LDTs (webinar), hosted by the Association of Public Health Laboratories and the American Society for Clinical Laboratory Science - Alberto Gutierrez, PhD, Director of the FDA Office of In VitroDiagnostics and Radiological Health, will discuss FDA’s latest thoughts on laboratory-developed tests (LDTs) regulatory oversight (fee)

April 14-15, 2016: Public Workshop: Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification, (Bethesda, MD) co-hosted by FDA and the National Institutes of Health Biomarkers Consortium - there is no fee to attend the workshop, but attendees must register by April 1, 2016 (Federal Register notice) - register by April 7, 2016

April 19-22, 2016: Preparedness Summit (Dallas, TX), hosted by the National Association of County and City Health Officials (NACCHO) (fee) - includes a Medical Countermeasures Link workshop to provide federal updates for state strategic national stockpile and local MCM coordinators

View more events on the frequently updated MCMi News and Events page

Guidance and information for industry:

Also see Zika guidances and Q&A above

FDA is seeking comments related to a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. Comment by May 3, 2016.

Guidance for Industry - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (PDF, 392 KB) (Federal Register notice)

Draft Guidance for Industry - Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans (PDF, 408 KB) (Federal Register notice) - comment by May 9, 2016

CDRH invites medical device industry, academia, and health care facilities to participate in its 2016 Experiential Learning Program, designed to provide medical device review staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. Submit requests to participate by April 11, 2016.

How to submit comments

Emergency Use Authorization (EUA) updates:

FDA is announcing that a proposed collection of information, Guidance: Emergency Use Authorization of Medical Product, has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Fax written comments on the collection of information by April 11, 2016. (March 10, 2016)

FDA issued an EUA to authorize emergency use of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. Additional technical information (March 4, 2016)

Determination and declaration regarding emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection - more Zika virus EUA information (March 2, 2016)

More information and all current EUAs

Funding opportunities and deadline reminders:

FDA is backing long-term improvements to national integrated food safety through a cooperative grant program for State-level Food Protection Rapid Response Teams (RRTs).Submit letters of intent by March 30, 2016.

On Rare Disease Day 2016 (February 29) FDA announced the launch of the Orphan Products Natural History Study Grants Program, funding much-needed natural history studies to facilitate product development for rare diseases. FDA intends to commit approximately $2 million and award 2-5 grants in Fiscal Year 2017 (October 1, 2016-September 30, 2017).

More funding opportunities (bottom of page)

In case you missed it:

HHS ships blood products to Puerto Rico in response to Zika outbreak - HHS is arranging and funding shipments of blood products from the continental United States to Puerto Rico to ensure an adequate supply of safe blood for island residents as the Commonwealth of Puerto Rico experiences active mosquito-borne Zika transmission. The first batch of blood products arrived in Puerto Rico on Saturday, March 5. Also see Safety of the Blood Supply(March 7, 2016)

FDA’s Commissioner’s Fellowship Program is accepting applications for the Class of 2016 from April 1 - May 12, 2016. FDA invites outstanding health care professionals, scientists, and engineers to apply to its two-year fellowship program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior scientist.