Attachment One - Statement of Work.docx

STATEMENT OF WORK

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

MINDFULNESS COACHING SERVICES

Contents

Background 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 FDA’s Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH is the component of the FDA responsible for approving and monitoring medical devices and radiological activities. CDRH assures 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.

To support the organization’s implementation of the 2022-2025 CDRH Strategic Priorities, CDRH has committed to enhancing the employee experience and promoting employee wellness at the individual, interpersonal and organizational level through implementation of gold standards and best practices.

Launched in 2021, the CDRH Wellness Center offers a holistic approach for promoting employee wellness, including, but not limited to, providing both center-wide and intimate small-group opportunities for combat isolation in the workplace, manage stress, enhance performance through mind-body medicine practices, and promote psychological safety, mindfulness, and resilience.

The Wellness Center provides individual wellness consults tailored to assist staff and managers in identifying and developing personal wellness strategies. Office-level consults are also available, which allow wellness presentations to be tailored to meet the unique needs of individual offices.

Objective The CDRH Wellness Center is seeking evidence-based mindfulness training and coaching services designed to enhance personal psychological health and performance of CDRH employees.

Scope CDRH seeks to partner with a vendor utilizing substantiated training services designed to enhance the personal psychological health and performance of CDRH employees. The vendor will be expected to provide mindfulness programs that have been proven to enhance operational performance and personal mental wellness. These evidence-based programs should help develop greater focus and concentration, tap into the power of “flow states,” learning how to be present with emotionally difficult experiences, and leverage personal strengths. In the complex work environment faced by CDRH employees, attending to the constant activity of the mind for a few brief minutes can yield powerful results.

The vendor will provide mindfulness coaching services to create a customized program within the CDRH community through a variety of modalities.

This requirement is to provide:

Minimum: 3 staff participants

Minimum: 3 staff participants

Tasks The CDRH requires contractor support to provide an empirically backed, performance-based mindfulness plan tailored to the innovative, high-performing culture of CDRH. This program will support CDRH’s mission of assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices, while also ensuring the mental and physical well-being of CDRH staff. CDRH is requesting mindfulness training for stress reduction, as well as a proactive performance plan for operating under pressure, which would provide tailored, scalable, and sustainable solutions for dealing with stress in workplace settings. All training must be FDA Hosted ZOOM sessions on the ZOOM for government platform. Training for Tasks 4.2 and 4.3 may be recorded for future viewing by the CDRH Community.

The following is a list of tasks that must be performed in the contract:

4.1 Task One: 12-week mindfulness coaching cohorts:

Mindfulness Coaching Cohorts are designed to be an experiential opportunity for small groups of CDRH staff members, not to exceed 25 participants, to develop a regular mindfulness meditation practice over the span of 12 weeks via zoom that are relevant to the needs of CDRH. This is a safe space for CDRH employees to receive coaching on mindfulness principles and strategies (with a new topic presented each week), share the challenges and successes of their mindfulness practices, and engage in guided meditation exercises. This task includes four (4) cohorts (each with a maximum of 25 participants and minimum of three (3) participants), which will meet for 50-minutes sessions weekly for 12 weeks. The contractor will be expected provide measures to assess behavioral change for participants, provide marketing materials, weekly reviews of new mindfulness principles and strategies, weekly guided meditation, and coaching to support the establishment and/or maintenance of individual mindfulness practices.

4.2 Task Two: Mindfulness Workshops

Mindfulness Workshops are designed to be one-off, 50-minute workshops with an additional 25 minutes of Q&A following the formal 50-minute event (total of 75 minutes). These workshops will be specifically designed to cater to the needs of CDRH employees and topics will be identified at the direction of the CDRH Wellness Team to ensure topics align with the CDRH Voice. Example topics include Mindfulness for Sleep, Leadership, Parenting, Performance Enhancement, etc). A total of six (6) customized workshops via zoom is required with a variable number of participants varying based on the specific topic. Some topics may have larger groups (i.e. 200 participants), whereas other topics may be tailored to smaller groups (i.e. 20 participants). Final products of these workshops include marketing materials, customized presentations and delivery for each topic is required. These workshops may be recorded for future viewing for CDRH employees.

4.3 Task Three: Introduction to Mindfulness Seminars

Introduction to Mindfulness Seminars are designed to be one-off, 50-minute seminars with an additional 25 minutes of Q&A following the formal 50-minute event (total of 75 minutes). These seminars are designed to be for beginner and/or novice level individuals, who are interested in practicing mindfulness. Content will provide information about research on the benefits of mindfulness, introductory mindfulness exercises, and guidance on how to establish a mindfulness routine. This task must include two (2) Introduction to Mindfulness Seminars with no minimum or maximum number of participants via zoom. The vendor must provide final products including marketing materials, presentation materials and an example of a Mindfulness Practice action plan. These seminars may be recorded for future viewing for CDRH employees.

4.4 Task Four: 21-Day Meditation Challenges

21-Day Meditation Challenges are designed to offer accountability and support for those CDRH employees committed to building a consistent meditation practice. These 21-day challenges would include 30-minute sessions on Tuesdays and Thursdays (15 minutes of guided meditation and 15 minutes of discussion/coaching). This task must include two 21-Day Meditation Challenges with a maximum of 50 staff participants and a minimum of three (3) staff participants per challenge via zoom. The contractor must provide measures to assess the behavioral change for participant and provide the marketing materials as well as the guided meditations to all participants.

Deliverables

5.1 Deliverables Submission Procedure

The Contractor shall submit Deliverables, electronically to the Contracting Officer’s Representative (COR) and the Technical Point of Contact (TPOC), via email at a minimum three weeks before each task is to begin. The COR and TPOC will be responsible for the review of all draft and final deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with the requirements of the task. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. The government shall have ten (10) working days to complete the review and approve the deliverables. If deficiencies are found or areas require modification, the Contractor shall be notified via email and shall have five (5) calendar days to correct the deficiencies. Upon re-submission by the Contractor, the government will reapply the same acceptance criteria. If the deliverable does not meet the acceptance criteria a second time, the government may consider the Contractor as having deficient performance with respect to the subject task. Electronic copies of Deliverables must be in a format compatible with Office 365 and Adobe Acrobat (version 10 or later) and are required to be Section 508 compliant.

Summary of Deliverables

Four (4) Consecutive Cohorts of 25 staff members; each cohort entails a 12-week experience

To be determined at award

To be determined at award

To be determined at award

To be determined at award

Key Personnel All key personnel must have possess a training certification in Mindfulness Based Stress Reduction (MBSR) and a Doctoral degree in Psychology.

Contract Type This requirement is expected to be a Firm-Fixed Price contract.

Period Of Performance The period of performance is twelve (12) months from the date of award.

Place of Performance Services shall be provided virtually over a hosted FDA Zoom Platform. All preparations from the contractor for each session shall take place off premises.

508 Standard Requirements Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technologies (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of information and communication technology (ICT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 standards apply to this Statement of Work (SOW):

· Must meet WCAG 2.0 A and AA

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping Requirements)

· E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

· 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

· Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Government Contacts Contracting Officer:

Name: Michele Jackson

Email Address: Michele.Jackson@fda.hhs.gov

Contracting Officer’s Representative:

Name: “Will be provided at award”

Email Address: “Will be provided at award”

Technical Point of Contact:

Name: “Will be provided at award”

Email Address: “Will be provided at award”

Holidays And Government Closures The Contractor is not required to provide services on the following days that are Federal Holidays or on any other day designated as a Federal holiday, Government closure, or shutdown for the Washington, D.C. area:

· New Year's Day

· Martin Luther King Day

· President 's Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veteran 's Day

· Thanksgiving Day

· Christmas Day The Contractor shall not schedule training during federal holidays or Government closure. As necessary, training scheduled during unexpected Government closures may be rescheduled following coordination with the COR. The contractor shall not bill the Government for any training that the Contractor did not perform due to any Government closures.

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