Description
Update 6/4: The final vendor questions and answers have been attached. Update 6/2: Due to the amount of questions, the following deadlines are being extended: Questions now due: 3:00pm (Eastern) on Wednesday, June 3, 2020. Final Questions and Answers will now be posted by: Friday, June 5, 2020. Quotes now due: 3:00pm (Eastern) on Wednesday, June 10, 2020. The following documents have been uploaded: Questions and Answers (some Q&As still TBD) and an updated SOW (deadline changes highlighted). Update 5/29 : A live virtual teaching is an option. If so, there should be electronic (power point material perhaps) available to each attendee emailed prior to the start of class so attendees can have material available. The training should be set up via web-ex since the FDA work force uses this most frequently and is secure on our servers. Also there should be up to 90 electronic invitations and material available for more people to attend. An updated solicitation has been attached (edits highlighted). Please refer to the attached solicitation for full details. Background The Food and Drug Administration, the oldest comprehensive federal consumer protection agency, has oversight of the safety, quality, and effectiveness of a vast array of life-sustaining products that affect every citizen every day. Its expansive portfolio of responsibilities has grown for more than a century and continues to evolve. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. The Plain Writing Act of 2010 requires federal agencies to train their employees in plain writing in order to promote clear. The Plain Writing Act of 2010 (Public Law 111-274) was signed into law on October 13, 2010. The Act calls for plain writing that is clear, concise, well-organized, and consistent with other best practices appropriate to the subject or field and intended audience. It encourages writers and communicators to avoid jargon, redundancy, ambiguity, and obscurity. Experience has shown that plain writing has many benefits including: improving public understanding of government communications and requirements saving money and increasing efficiency reducing the need for public clarification reducing resources spent on enforcement increasing public understanding of agency forms and applications reducing the number of errors made and the time and effort required to fix them In short, clear and simple communication has several benefits for the reader: to find what they need, understand what they read, and and do what they need to the first time they read it Purpose A writing class is needed to teach Consumer Safety Officers how to use plain language writing within their reports and communications. Consumer Safety Officers (CSOs) are required to write FDA 483 Inspectional Observations, Establishment Inspection Reports, Memorandums, etc. as part of their daily operational functions. These scientific and technical documents are needed to be written succinctly, in plain language, and in a productive manner. There is a capability gap and a need for CSOs to be able to write in a technical and succinct manner. This class will enable them to meet this performance objective more readily. This class will also cut down in review time by the SCSO, DIB, CBR, and Center, hence increasing productivity. The capability gap needs to be bridged by September 30, 2020. Requirements The Salient characteristics of the training should include ways for employees to: write precise and concise documents write documents that are grammatically correct write documents that effectively convey the significance of the content write complex technical documents in a clear plain language write to communicate with the lay public properly organize, revise, edit, and proofread documents. Each student / attendee shall be provided the training material at class for their personal possession to refer to after the training has completed. The 2-day training class must be conducted on two (2) consecutive days, with no interruption.