Professional training services to facilitate two (2) Technical Writing courses for CDER employees.

Notice of Intent to Sole Source – Professional training services to facilitate two (2) Technical Writing courses for CDER employees. 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 the Center for Drug Evaluation and Research intends to sole source to: Graham Consulting Associates, Inc. Address: 9117 Saranac Ct, Fairfax, VA 22032 Phone: (703) 978-0122 in accordance with the authority under FAR Part 13.501(a). This procurement is being conducted under simplified acquisition procedures in accordance with FAR Parts 12 and 13, including subpart 13.5. The NAICS code is 611430 – Professional and Management Development Training. The purpose of this acquisition is intended to acquire professional services to facilitate two (2) CDER essential customized training courses titled Technical Writing for CDER Reviewers and Technical Writing for CDER Staff. These courses provide critical writing skills needed for CDER employees to communicate complex scientific and regulatory information to audiences which include: internal, external, Congress, and drug manufactures and fulfil essential, core competency skills required for all CDER employees. Graham Associates, Inc. designed, developed, and delivers these customized courses under an agreement with CDER. A copywrite process is used throughout the course which forms the foundation for all CDER written communications. This course is mandatory for all CDER Medical Officers, Reviewers, and Review Project Managers and is included in CDER employee competencies. These courses are especially important in meeting increased hiring levels needed to meet User Fee commitments (PDUFA, GDUGA, BSUFA), and the Accelerated Approval, Fast Track, Breakthrough Therapy, and Priority Review drug development designations. The CDER Technical Writing curriculum developed by Graham Consulting Associates, Inc. uses a proven and copyrighted writing system. These courses teach a system of proven techniques that writers use to produce better regulatory review documents by organizing information according to readers' needs and editing for coherence, clarity, economy and readability. Techniques in the Graham writing system teach participants how to use the system to act as error traps to catch problems and expose gaps early in the review documentation process. The courses include experiential learning exercises where participants utilize real-life review work to practice skills and receive on-the-spot writing assistance/coaching. To successfully execute the technical writing training courses, explicit or tacit knowledge is needed to fully understand written communications within the regulatory framework required for reporting on drug reviews. This notice is not a request for competitive quotes. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response, i.e. capability statement, which clearly supports and demonstrates its ability to perform the requirements. Any response shall be received by the response date and time of this notice. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government. Response Date: 12:00 p.m. ET on January 23, 2020. Responses must be emailed to [email protected].