Register for the Sept. 12th Part 15 Public Hearing on FDA’s Predictive Toxicology Roadmap

FDA is holding a public hearing on Wed., Sept. 12 to get feedback from stakeholders on the Agency’s six-part Predictive Toxicology Roadmap for integrating cutting-edge predictive toxicology methods into safety and risk assessments of its products. Among other recommendations, the roadmap calls for FDA research to identify data gaps to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into the product pipeline.

Wednesday, September 12, 2018

9 a.m. to 4 p.m. EST

Register here by Wed., August 29, 2018 for webcast and in-person attendance. Continue reading

FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products

Today, the U.S. Food and Drug Administration (FDA) finalized guidance to provide information on FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.

Read more: https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm578420.htm

FDA approves first U.S. treatment for Chagas disease

The US Food and Drug Administration (FDA) announced yesterday that it has granted accelerated approval for the nation’s first treatment for Chagas disease, a parasitic infection caused by Trypanosoma cruzi spread by kissing bugs that has increasingly been found in the United States, especially in Texas’s Rio Grande Valley area.

The drug benznidazole, made by Chemo Research, SL, of Madrid, is approved for use in children ages 2 to 12 years old who have Chagas disease. Its safety and efficacy were shown in two placebo-controlled clinical trials in children 6 to 12 years old. An additional study in kids ages 2 to 12 helped set dosing recommendations. Stomach pain, rash, decreased weight, and headache were among the most common adverse reactions, and the drug was associated with some serious risks, including skin reactions, nervous system effects, and bone marrow depression.  Continue reading

Opportunity for food safety outreach grants

This grant is directed at smaller organizations, but if any of you work with people in local communities, please tell them about this grant.

In FY 2015, NIFA and FDA began funding an infrastructure of National and Regional Centers to extend food safety education, training, and technical assistance to specific audiences affected by new guidelines established under the Food Safety Modernization Act (FSMA) (7 U.S.C. 7625), specifically small and medium sized farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers. In FY 2016, the Food Safety Outreach Program at NIFA will build upon the national infrastructure, with a focus on delivery of customized training to very specific target audiences. To this end, grant applications will be solicited directly from those in local communities – to include those from community-based organizations, non-governmental organizations, food hubs, farm cooperatives, extension, and other local groups. Because the size and capabilities of applicants will vary widely, this Request for Applications (RFA) will solicit proposals for three project types: 1) Pilot Projects (awards not to exceed $50,000); 2) Community Outreach Projects (awards not to exceed $150,000); and 3) Multistate Education and Training Projects (awards not to exceed $400,000). Continue reading

Grants for Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act

(FSMA) Compliance (U01) Application Due Date(s)

April 21, 2016, by 11:59 PM Eastern Time.  https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-002.html

 Purposes and Principles

The Food and Drug Administration’s (FDA), Center for Food Safety and Applied Nutrition (CFSAN), is announcing the availability of a limited competition Cooperative Agreement.  The estimated amount of funds available for support of this cooperative agreement is $1,500,000 (direct and indirect costs) for fiscal year 2016.  It is anticipated that at least an additional two (2) years of support may be available, depending on annual appropriations and successful performance.

The intent of this cooperative agreement is to fund entities that have active working relationships with local food producers, processors, or enterprises and/or organizations that have demonstrated experience developing and providing science-based, culturally specific food safety training, education and outreach, for local food producers and processors, with an emphasis on those that are involved in diversified, sustainable, organic and identity-preserved agricultural operations; beginning and socially disadvantaged farmers; value-added farm businesses and small-size processors; and direct and intermediate supply chain participants.  Subcontracts to other organizations that meet the intent noted above are encouraged.  It is expected that applicants will specifically include collaboration between and among national and regional food safety leaders; relevant diversified, sustainable, organic and identity-preserved agricultural businesses or organizations; colleges, universities and related land grant cooperative extension programs; and  regional and local food sector organizations, among others, in order to reach the intended audience.  In addition, applicants are expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances. Extensive cooperation and coordination with FDA CFSAN and other FDA program offices, the National Coordination and Regional Centers (established under the “National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program”), and FDA’s FSMA partners at the United States Department of Agriculture (USDA) and other Federal organizations that have a vested interest in food safety among local food producer stakeholders is also expected.

The primary objective of this cooperative agreement is to develop and provide training, education, and outreach, and to facilitate identification of appropriate technical assistance resources for local food producers and processors related to applicable federal preventive controls regulations under FSMA, especially the Produce Safety and Preventive Controls for Human Food rules.  In addition, consideration should be given to local food producers not currently subject to the regulatory requirements but that have conveyed an interest in or have identified economic incentives to comply (i.e., marketplace requirements to comply or business growth outlooks) with such regulations.

Save the Date—March 9 & 30, 2016: Public Meetings on Updating the Coordinated Framework for Regulation of Biotechnology

On October 30, 2015, under the auspices of the National Science and Technology Council, the Food and Drug Administration, the Environmental Protection Agency, the United States Department of Agriculture, and the Office of Science and Technology Policy held a public meeting to discuss the memorandum entitled, “Modernizing the Regulatory System for Biotechnology Products,” issued by the Executive Office of the President in July 2015. This meeting was the first of three public engagement sessions on this topic. Continue reading