CDRH Mental Health First Aid and General Wellness

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a Request for Quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 Acquisition of Commercial Items and Part 13 Simplified Acquisition Procedures. The associated North American Industry Classification System (NAICS) Code is 611430 – Professional and Management Development Training. This is a small business set-aside solicitation in accordance with FAR Subpart 19.5 Set-Asides for Small Business. The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. The CDRH assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. CDRH identified Employee Engagement, Opportunity, and Success as a Strategic Priority for 2018-2020. This goal “aims to improve our work life and work environment by reducing unnecessary burdens, promoting an environment of trust and mutual respect, facilitating open dialogue, fostering creativity and teamwork, providing a reasonable work life balance, and creating opportunities for professional growth and personal development.” The Division of the Employee Training and Development (DETD) is part of the CDRH’s Office of Communication and Education (OCE) which provides training to all Center staff including scientific, medical and administrative professionals. To help fulfil CDRH’s engagement efforts and commitment to its employees, DETD in collaboration with the Office of Management (OM) requires contractor support to offer training in Mental Health First Aid and General Wellness. This training must address the importance of wellbeing, identification of distress, and actionable measures CDRH employees can take to assist themselves or coworkers. The half-day training should be instructor led and may be provided virtually or onsite. Information from related work previously done by FDA will be shared by the COR, at least in part, with the Contractor to help facilitate completion of the requirements in this SOW. Objective The primary objective is to provide training addressing mental heal and general wellness for CDRH employees; the Contractor shall conduct up to eight (8) sessions each year (one 12-month base period and one 12-month option year, if exercised) to provide training for 120 CDRH employees, the majority of whom will be serving in management or supervisory roles. Scope The Contractor shall provide training that offers an introduction to Mental Health First Aid and General Wellness. This training must summarize potential situations of mental distress, address how to identify signs of stress, and propose methods to handle situations that could represent potential mental health crises. Additionally, the training must address support options for general wellness to negate stress or other more significant situation that may arise from mental distress. While these presentations may include statistics and definitions, the majority of the course must focus on actionable items and response plans for attendees. The Contractor shall provide an instructor-led training event focused on mental health and wellness issues. The training courses shall be 4.5-5 hours in length, including up to two (2) hours of pre-work to be completed prior to the course session. This training must inform the participants about mental health disorders and provide instruction on how CDRH managers and staff can provide an adequate “first aid” response when interacting with coworkers. Note: This instructor led training must be able to be presented both in-person and virtually considering the current complications of the COVID-19 Pandemic. Sessions are expected to be instructor led virtually until it is safe for a return to campus. At that time, future courses may be provided on-site at CDRH facilities. Within this training, the Contractor shall: Provide information and statistics regarding mental health disorders from most common to rare; Provide information on actions that participants can take to migrate stress and mental health crisis in support of general wellness, Provide instruction on identifying potential mental health issues in the workplace, Provide specific examples that relate to the training with actual events that have happened at FDA or similar workplaces such as other government agencies (as provided by the CDRH at the Kick-Off Meeting); Provide brief exercises, roleplay scenarios, case studies, and/or videos to aid class discussions; Provide instruction on appropriately reacting and responding to mental health crisis situations so attendees are prepared with actionable plans for the future. The Contractor shall provide a qualified instructor for up to eight (8) training sessions in Mental Health First Aid and General Wellness for an audience of CDRH Staff, the majority of whom serve in supervisory roles. The Contractor shall supply all necessary training materials. The training courses shall be 4.5-5 hours in length, including up to two (2) hours of pre-work for completion prior to each training session. Dates and times for training sessions shall be agreed upon in collaboration with the CDRH.