Inactive Total Small Business Set-Aside (FAR 19.5)

The U.S. Foods and Drug Administration (FDA) is charged with protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and me... The U.S. Foods and Drug Administration (FDA) is charged with protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products. As part of FDA, the Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. FDA has a unique responsibility to provide education to a variety of constituents, to include FDA staff, clinical investigators, the public, medical professionals, healthcare professionals, industry, consumers, and academia. Education and training are of the highest priority to FDA, and FDA continues to be responsive to the needs of these stakeholders by offering training opportunities leveraging various forums and formats. The Office of Executive Programs (OEP) oversees a variety of Center-wide programs, including executive project management, the Center’s executive secretariat function, scientific advisory committees, training and development, CDER’s ombudsman, and the program and administrative management. Within OEP, the Division of Learning and Organizational Development (DLOD) exists. DLOD is an educational resource for scientific, regulatory and leadership training in support of CDER’s mission. DLOD provides a wide range of learning opportunities, educational activities, and professional development through a variety of instructional methods to best prepare CDER staff to meet the organization’s mission. With the disruption of COVID -19 limiting in-person gathering across the United States and any unforeseen future circumstances, FDA needs remote alternatives to facilitate courses. DLOD requires professional services support to facilitate specific training paths or individual courses to ensure CDER staff are well prepared to address mission critical objectives. This acquisition is to continue delivery of a Mutual Learning Approach via core classes and infusing Mutual Learning throughout CDER in its leadership programs. Currently, the Mutual Learning Approach delivered at FDA is comprised of the courses entitled “Introduction to Mutual Learning” and “Smart Leaders, Smarter Teams,” provided by Roger Schwarz & Associates (RSA) (contract # 75F40120C00169). The courses focus simultaneously on all the elements needed to create the change in CDER to a mutual learning culture: 1) team mindset (core values and assumptions); 2) behaviors; and 3) team structures and processes. RSA has developed and employs proprietary models and approaches for creating this change. Furthermore, the textbook, Smart Leaders, Smarter Teams, written by Roger Schwarz of RSA, together with the course workbook, job aides, and other proprietary materials comprise this instruction. All training materials utilized in the training are copyrighted by RSA. The Government expects to achieve the following: Equip CDER Staff with the necessary skillsets for leading and working with others. Comprehensive facilitation of the training course(s) as detailed further in the SOW. Scope FDA seeks the full professional and technical services necessary to facilitate, educate, and instruct the Mutual Learning Approach for individuals and the Mutual Learning Approach for Effective Leadership and Team Development. Introduction to Mutual Learning The Contractor shall facilitate, educate, and instruct the Introduction to Mutual Learning training course for registered CDER staff. The FDA expects participants to achieve the following objectives upon conclusion of the course: Demonstrate a mutual learning approach that simultaneously captures elements that result in sustainable change to the organization’s culture. A mutual learning approach alignment with CDER Civility Initiative in developing a shared vision for a civil CDER. Increase understanding of the role and benefits of leaders in promoting workplace civility in alignment with a mutual learning approach. A mutual learning approach that supplements the CDER civility activities which promote awareness and the practice of civil behaviors. Realizing/creating an understanding of the role CDER staff plays in practicing a mutual learning approach and promoting civility to drive positive change throughout CDER. The Contractor shall leverage the existing training materials and/or provide relevant training materials necessary to effectively facilitate and conduct the training. The Contractor shall conduct the following activities: Coordinate with COR or designee on time, location, and technical requirements specific to the training course (e.g., audio/visual needs, meeting space configuration, post assessment/evaluation for future improvement …etc.) Ensure appropriate and qualified resources are available for training facilitation; for instructor-led virtual delivery, contractor shall provide meeting platform and staff to manage meeting issues and needs. Facilitate 1-day Instructor Led Training (ILT) face-to-face session or equivalent Instructor Led Training (ILT) virtual session for Introduction to Mutual Learning. Up to six (6) sessions shall be offered during the base year and up to six (6 sessions) shall be offered during each option period. Develop recommendations for revisions to training material to reflect revised or new statutory and/or regulatory mandates and guidelines; Upon approval by the COR or designee, implement recommended revisions into training material, both written and oral (e.g., training presentations, reference guides, talking points, etc.). Deliverables: ILT face-to-face or ILT virtual sessions Revised training materials Evaluation debriefs with Program Office 5.2 Mutual Learning Approach for Effective Leadership and Team Development The Contractor shall facilitate, educate, and instruct the Mutual Learning Approach training course on Effective Leadership and Team Development for registered CDER staff. The Contractor shall ensure that the training is integrated with CDERs core values and principles. The FDA expects participants to achieve the following objectives upon conclusion of the course: • Establish how CDER educates teams and individuals to operate effective teams. • Describe how the mutual learning approach leads to better performance, stronger working relationships, and increased individual well-being. • Compare how the mutual learning approach differ from those of an individual approach. • Apply a mutual learning approach to resolve real world challenges. • Ability to achieve better results in shorter time. • Ability to gain active support from team members. • Ability to create more team accountability. • Ability to be more adaptable during change. • Ability to increase individual and team innovation. • Ability to build better and more productive work relationships. The Contractor shall leverage the existing training materials and/or provide relevant training materials necessary to effectively facilitate, educate and instruct the training. The Contractor shall conduct the following activities: Coordinate with COR or designee on time, location, and technical requirements specific to the training course (e.g., audio/visual needs, meeting space configuration, …etc.) Ensure appropriate and qualified resources are available for training facilitation; for instructor-led virtual delivery, contractor shall provide meeting platform and staff to manage meeting issues and needs. Ship course materials (i.e., course workbook, textbook, job aides etc.) directly to each participant. Facilitate 4-day ILT face-to-face sessions or equivalent ILT virtual sessions for the training course. Up to four (4) sessions shall be offered during the base year and up to four (4 sessions) shall be offered during each option period. Conduct a pre-workshop session to set expectations for participants and provide pre-workshop session recording to program office. Develop recommendations for revisions to training material to reflect revised or new statutory and/or regulatory mandates and guidelines; Upon approval by the COR or designee, implement recommended revisions into training material, both written and oral (e.g., training presentations, reference guides, talking points, …etc.) Deliverables: ILT face-to-face or ILT virtual sessions Revised training materials Conduct pre-workshop sessions and provide recordings Evaluation debriefs with program office Consultive and Integration Services The Contractor shall provide expert and or professional advice to the DLOD with regard to the Mutual Learning Approach. The Contractor shall ensure integration between the Mutual Learning Approach and the CDER Dynamic Leaders Program (CDLP). Specifically, in support of integration, the Contractor shall: Review, and update CDLP content as needed (e.g., Facilitator’s Guide, Participant’s Guide, and all other training materials) to ensure consistency and congruency of the Mutual Learning Approach. Incorporate the Mutual Learning Approach into the broader CDLP existing seven (7) components and up to two (2) future components (e.g., web-based and/or instructor led learning) Provide CDER with unlimited and unrestricted use rights Deliverables: Revised CDLP content Four (4) of the seven (7) components during the base-year Remaining three (3) of the seven (7) components during option year one Two future components to be determined Optional Course Offering The Government may require the delivery of additional course offerings. The Contracting Officer may exercise the option by written notice to the Contractor within any time before the contract expires. Course Title Timeframe Introduction to Mutual Learning 1 day course Mutual Learning Approach for Effective Leadership and Team Development 4 day course Deliverables: Consistent with the deliverables itemized in sections 5.1 and 5.2 Reporting Requirements The Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed for the overall effective accomplishment of the order goals. Recommendations for actions that need to be taken by FDA staff, or other contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion. Be advised that the FDA does not accept documents which contain the use of “macros”. Document submissions required throughout the period of performance of this purchase order must not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.