Notice ID: FDA_1238717 Notice of Intent to Sole Source with vendor EVIDENCE AND EPIDEMIOLOGY CONSULTING, LLC Title: Introduction to Systematic Review and Meta-Analysis Training Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS)/Food and Drug Administration (FDA) on behalf of Office of Applied Research and Safety Assessment (OARSA), Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration (OARSA/CFSAN) intends to sole source to: EVIDENCE AND EPIDEMIOLOGY CONSULTING, LLC 2019 Pawnee Trail Okemos, MI 48864 1. Purpose The purpose of this requirement is to acquire Introduction to Systematic Reviews and Meta-Analysis Training to support the Center for Food Safety and Applied Nutrition (CFSAN), Office of Applied Research and Safety Assessment (OARSA) strategic plan and research direction. 2. Background The OARSA provides Center and Agency leadership in toxicology: reproductive toxicology, neurotoxicology, immunotoxicology, molecular toxicology, and in vitro toxicology with special emphasis on developing higher throughput methods in hepatotoxicity, neurotoxicity, renal toxicity, cardiotoxicity, dermal and nanoparticle toxicity; microbiology, which includes foodborne parasites and viruses, and molecular biology: genetic and biomarkers, microbial genetics, including molecular epidemiology and molecular virology, and foodborne allergens and glutens. We work with the program offices, Office of Food and Veterinary Medicine (OFVM) and the field labs Office of Regulatory Affairs (ORA) to meet their needs and help achieve their goals as established through the research prioritization process. The challenge for the research offices within CFSAN is to identify the regulatory-driven needs for the program offices as well as determine the public health impact of the research. Evidence-based approaches are emerging analytical tools to identify medical or regulatory priority questions, data gaps, and focused research. Systematic reviews (SR) are common in clinical and public health and increasingly used in risk assessment in food safety and production, and this requirement will give the Food and Drug Administration (FDA) staff hands on/interactive sessions to enable participants to practice the concepts. FDA has received prior training for the past two years. The prior year training was for systematic reviews, methodology and scoping exercises. This new requirement builds off the prior year, to continue learning with updated techniques and practical/software sessions. 3. Objectives The objective of this requirement to acquire systematic reviews and meta-analysis training for CFSAN/OARSA. More specifically, the contractor shall provide two (2) sessions, of three full training days, one for Microbiology and one for Toxicology, to 1) introduce the conduct of systematic reviews and meta-analysis as it relates to food and feed regulations, 2) prepare individuals to manage potential issues when they arise, or even before they arise, by sharing the most up-to-date scientific knowledge, 3) provide a unique training experience for OARSA investigators, 4) provide a framework and case study for FDA-wide training on systematic review and scoping exercises and 5) develop a framework for identifying and prioritizing specific research gaps. NAICS code is 611430 – Professional and Management Development Training. and/or NAICS Code: 541990 All Other Professional, Scientific, and Technical Services PSC Code: U010 Certifications/Accreditations This notice is not a request for competitive proposals. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. It is anticipated that an award will be issued to EVIDENCE AND EPIDEMIOLOGY CONSULTING, LLC , within approximately 15 days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement. Response Date: 10:00 p.m. ET on March 31, 2021. Please email Sharon Masciana at
[email protected]. All responses are due by the response date noted above. Please provide your responses in MS Word and PDF formats. A determination not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Contact Information: Primary point of contact: Sharon Masciana
[email protected] 240-402-7631