This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information in this notice. Proposals are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price order as a result of this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-07 dated August 11, 2021. The associated North American Industrial Classification System (NAICS) code for this procurement is 611430 – Professional and Management Development, with an associated size standard of 1,000 employees. This propose simplified acquisition combined synopsis/solicitation is for services; the Government is soliciting only to after exclusion of sources. Interested parties may identify their interests and capabilities to respond to the requirement within seven (7) days after the publication of this notice. A determination by the Government not to reissue and recompete this proposed simplified acquisition based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct another competitive requirement. No further solicitation is available. FDA will consider all responses received prior to the closing date of this notice and will use responses in determining, whether it is necessary to use full and open competition for this requirement. Responses shall be emailed to Natapol Sirikhan,
[email protected], by July 14, 2022, 2:00 PM EST. Introduction: In accordance with the FDA Reauthorization Act of 2017, which includes the reauthorization of our user fee program, and the MDUFA IV Commitment Letter, it is mission critical for CBER staff to receive instruction on the process improvement and updated guidance for writing well-constructed deficiencies using four-part harmony that includes a statement for the basis for the deficiencies (e.g., a specific reference to applicable section of a rule, final guidance, recognized standard unless the entire or most of document is applicable). In the instance when the deficiency cannot be traced in the manner above and relates to a scientific or regulatory issue pertinent to the determination, FDA will cite the specific scientific issue and the information to support its position. All deficiency letters will undergo supervisory review prior to issuance to ensure the deficiencies cited are relevant to a marketing authorization decision (e.g., 510(k) clearance, PMA approval, and de novo classification). How to write clear and concise reviews and deficiencies will provide review staff with classroom training on the basic elements of plain writing and how to apply those elements to write lucid, logical technical documents relevant to the review of biological and related products regulated by CBER. This classroom training fosters a baseline of knowledge throughout the Center’s review staff and consistency in the review process. Objective: CBER requires a commercial vendor to deliver a tailored off-the-shelf, technical writing course that teaches staff how to write clear and concise technical documents using Plain Language. The course must be tailored to include examples of effectively written deficiencies to manufactures using four-part harmony to ensure consistency and to improve the manufacture’s comprehension of FDA’s analysis of the review. CBER additionally requires both initial and refresher classroom training for CBER personnel as well as tailored training specifically for supervisors. The classroom training will help ensure that CBER supervisors and personnel provide clear and concise written deficiencies to request information required to complete their reviews on manufacturer submissions. The course will need to be provided to the CBER population in the following number of iterations. Scope : The contractor will provide an off-the-shelf, CBER tailored course and refresher that covers writing clear and concise reviews that highlight deficiencies to provide CBER employees with tools and techniques on how to write clear and concise technical and regulatory documents using Plain Writing and Four-Part Harmony. Performance Requirements: Training Requirements Class Materials Training Instructor Qualifications Training Facilities Training Requirement: The contractor will be responsible for working with CBER assigned subject matter experts (SME)/Project Officer(s) to tailor the contractors off-the-shelf training using the ADDIE model to make the content applicable to the CBER environment by using real examples drawn from FDA deficiency letters. The contractor shall provide a full day workshop that covers writing clear and concise reviews highlighting deficiencies to provide CBER employees with tools and techniques on how to write clear and concise technical and regulatory documents using Plain English and Four-Part Harmony. The workshop will include time for one-on-one advice that distinguishes these workshops from other training programs while encouraging participants to provide follow up questions and feedback to the instructor. Upon completion participants shall be able to: Apply a consistent style, and approach to writing and proofreading to produce well written reviews that are identical in content, tone and style. Discuss the common vocabulary for talking about writing with peers and colleagues, which speeds collaborative writing projects and the editing process Review the three causes of writer’s block and how to prevent them. Outline when and how to apply writing rules Provide individual feedback and one-on-one advice after each workshop Class Materials: The Contractor shall be responsible for providing each student a student guide/manual, which shall follow the outline of the course. The student guide/manual shall include a syllabus as well as copies of the graphics shown in the class with note-taking space. Student Guides shall include Terminal Learning Objectives (TLOs) and the Enabling Learning Objectives (ELOs). All material given to students must reflect the most current writing samples, tools and techniques. Other material to be included in the guide/manual is at the Contractor’s discretion but shall be supportive of the learning objectives. The student guides/manuals will be retained by each student when the training concludes. The contractor shall provide the COR with the following training materials (if applicable to the course): syllabus, lesson plans, objectives, common terms study sheets, acronyms study sheets, and hands on exercises. The Contractor shall provide all necessary materials such as books, handouts, slides, and test. All student guides and training materials shall be provided to the COR for approval at least fifteen (15) business days prior to the training start date. The Contractor shall be responsible for ensuring all course materials arrive to the training location, virtually or physically, before each training course begins. The Contractor shall provide the COR with a complete and current set of all course related materials, tests, and test answers at least fifteen (15) business days prior to the training start date. Course related materials provided to the COR will be kept on file in CBER/OCOD/DMAT. The COR will make the final determination on the appropriateness and quality of all training material. Training Instructor Qualifications: Contractor personnel assigned to teach a course shall have five (5) or more years of professional experience publishing on public health policy and expertise in the subject area. Personnel instructors should have at 10 years of communication training experience and possess current instructional experience defined as experience in training government personnel within the last three (3) years and be proficient in English. All instructors shall understand all the requirements and tasks as they relate to security, classroom preparation, and course materials. Instructors shall be familiar with all initial presentation and remediation procedures, training aids, and devices and equipment associated with the course. Instructors shall be proficient in performance-based practical exercises, if any, that shall be included for each block of instruction. Instructors shall exhibit behavior conducive to a favorable learning environment to foster high student morale and motivation. Instructors shall abide by any FDA guidelines regarding integrity, grooming, conduct, speech, and fraternization. The Contractor shall ensure that: The instructor(s) are in the classroom/virtual classroom in enough time for the classroom, materials, and equipment to be ready and operational to begin the class at the appointed class start time. The instructor(s) are prepared to teach the class at the required level associated with the subject matter. An instructor may be deemed unprepared to teach with frequent occurrences of reading the overheads/graphics without substantive elaboration of material, failure to provide value-added insight to written materials, or an inability to deliver the material in a professional manner consistent with adult learning methodologies and professional level platform skills. The instructor(s) employ an organized manner of delivery, utilizing good time management, logical sequencing of course materials, following an established course agenda/syllabus, and the ability to provide materials in such a way as to avoid student confusion. Instructor(s) are able to answer student questions consistent with the subject matter being taught thereby demonstrating knowledge of familiarity with course materials. Instructor(s) provide instruction consistent with the course agenda/syllabus and do not alter the proposed course schedule. Training Facilities: The Contractor shall be required to report to the Food and Drug Administration, White Oak campus or other approved provided classroom settings. Provided virtual settings will be managed by FDA Training Coordinators. In-person classrooms will include standard audiovisual equipment (overhead projector, screen, flipcharts, and projection systems for computer generated graphics) and computers required for the training course. Virtual classrooms will have the ability to accommodate break out rooms, polling questions and white board options. The Contractor shall submit any additional requirements to the COR for approval prior to confirming a course date. Place of Performance: Unless otherwise specified, all meetings between the Contractor and FDA/BCER/OCOD/DMAT will be held either virtually or on the White Oak Campus, located at 10903 New Hampshire Avenue (Building 71), Silver Spring, MD. Virtual meetings will be held via Microsoft Teams with advanced notification from the Contracting Officer Representative or Contractor.