Request for Information.docx

Request for Information (RFI) for Extended Reality/Reality Simulation Capability for Office of Inspections and Investigations - Training & Development Program

RFI Number:

Send date: 12/23/2024 Project Name/Number: OII-Extended Reality/Reality Simulation Training & Development Capability Response Deadline: 1/2/2025 Statement of Purpose This Request for Information (RFI) is being issued by the Food and Drug Administration (FDA) in accordance with Federal Acquisition Regulations (FAR) Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the FDA or its Centers.

The purpose of this RFI is to broaden FDA’s understanding of current market capability on Artificial Intelligence-powered Extended Reality (XR) reality simulation tools such as Augmented Reality (AR) or Virtual Application (VR) training platforms to provide the next generation immersive learning, experiential learning, and microlearning opportunities for FDA regulatory inspection/investigation workforce.

FDA will not award a contract based on responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Information obtained because of this notice may be used by the FDA for program planning on a non‐attribution basis. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Responses will be reviewed only by FDA personnel and will be held in a confidential manner.

Program Overview The Office of Inspections and Investigations (OII) is responsible for the operational activities of FDA through the work of its headquarters and field staff across the United States and Puerto Rico. OII inspects regulated products and manufacturers, conducts sample analyses of regulated products, and reviews imported products offered for entry into the United States.

Currently, FDA/OII and partnering organizations access FDA-provide training courses through OII’s LearnED Training System, a cloud-based, learning management system (LMS) that provides both synchronous and asynchronous learning platforms. LearnED has over 13,284 active users from a wide-variety occupational roles, including but not limited to, regulators, scientists, program/management analysts, and supervisors that come from offices across FDA, State, Local, Tribal, Territorial (SLLT), Military, and academia. Furthermore, LearnED is accessed by FDA offshore offices and non-FDA partners around the world.

OII’s Office of Training Education and Development (OTED) manages over 225 standard instructor-led training courses and over 490 asynchronous on-line training courses. OTED provides on-the-job high quality learning opportunities to OII and its partners through timely, cost-effective learning products that support FDA’s mission and strategic goals. Furthermore, OTED strives to meet current training and development needs for OII personnel, state and local regulatory officials, and other stakeholders and is committed to modernizing its training programs in a phased approach. OTED’s vision is to be a modern innovative leader and trusted partner in public health education, effectively delivering training in a global world. This includes employing modern learning modalities with immersive learning capabilities using technology-driven environments to simulate real world scenarios, thus, allowing learners to fully engage the training material through experiential learning. Moreover, incorporate microlearning modalities to help learners absorb information quickly and effectively catering to modern attention span and busy schedules.

Currently, OTED is looking to utilize innovative technologies in an effort modernize its training offerings outside of the standard classroom model. OTED envisions a training platform/solution that leverages AR/VR to modernize the training experience. The AR/VR tools would allow the FDA to simulate a real-world environment in which students would be able to conduct training activities similar to those experienced during the performance of work duties. This will also offer OTED the opportunity to assess performance-based learning objectives outside of the classroom environment.

Scope of Service

· Provide for digital engineering, modelling and simulation via augmented reality and virtual reality service to FDA inspection personnel.

· Provide AI-powered extended reality, reality simulation capability such as augmented reality and virtual reality (AR/VR), specifically, focusing on enhancing the effectiveness of training through adaptive gamified learning environments that are tailorable to improve the learners’ performance and proficiencies levels in complex virtual environments.

· Adopt a dynamic and customizable learning interface to enable a personalized and adaptable training, rapid changes to scenarios focusing on areas that are identified for improvement which are specific to the individual or to the discipline and can change as skills are improved.

· Foster a learning environment that incorporate multi-users with varying capabilities to simulate a team learning environment where training modules are developed utilizing COTS products that enable simulation and gamification capabilities.

· Develop a complete, pre-packaged and validated scenario-based AR or VR training system for inspectors.

· Training solutions shall provide multiple and varied immersive scenarios.

· Training solutions shall integrate with agency learning management systems (LMS) to track training and record progress.

· Include built-in features for real-time feedback on learning progress

Anticipated High-level Capabilities/Future State

Implementing simulation-based training solutions in FDA/OII is anticipated to transform various aspects of our training program to help improve operations, efficiency and training experience to the workforce.

Below is an outline of anticipated capabilities and envisioned future state characterized by efficiency, experiential training, microlearning, and improved user experience. They are:

a) Immersive Training Programs

· Create highly realistic and interactive training modules.

· Enable employees practice complex procedures in a safe and controlled environment.

· Include location agnostic training capabilities.

· Reduce training time and costs while increasing retention and performance.

b) Simulation for Skill Development

· Simulate real-world scenarios for skills development and assessment.

· Provide instant feedback and analytics to improve learning outcomes.

c) Enhance Trainee Engagement and Experience

· Facilitate collaboration between geographically dispersed teams.

· Allow multiple users to interact with 3D models simultaneously in a virtual space.

d) Future State Desired Features

· Integration of digital information with current training environment,

· Wearable technology, when applicable

· Microlearning capability

· Experiential learning

· Content creation and integration with current training platform

· Collaboration with multiple users

· Recording capabilities for later review and training

· Artificial environment presented to user with user interaction (hand movements, walking around environment, etc.)

· Tethered to computer or wireless devices

· Content creation and scenario development for training

· Multi-user training applications

· Ability to scale training scenario to other programs/ discipline

e) Equipment

· Infrastructure to support multiple users that are geographical dispersed

· Scalable to increase capabilities and reach

· Portability

· VR devices

· Interoperability with current system

· Multiple operating locations

· Operability on or off network (AF network, intranet, or commercial network)

f) Support and Maintenance

· Data security and privacy

· Data accessibility

· Content updates

· Device security updates

· Device upgrades and hardware improvement

· Adding additional use cases

· Technical support (on-site, 24/7 on-call, annual training, response times, etc.)

High-Level Use Case/Requirement for Sample Collection The following is sample use case, sample collection activity, we hope a simulation tool would allow us to design and develop a training program that can simulate these activities:

· Overall inspection/investigation sample collection activity.

· Walk into a metal warehouse with a concrete floor. Go to refrigerated dock and see pallets of boxes. Not a lot of other boxes other than the following (pulled out by warehouse employee):

· Shipment of grits: 2 pallets full of 54 1-lb boxes, (stacked 6 boxes tall, 3 boxes). 972 total boxes. In every master carton, there are 9 retail units.

· Shipment of blueberries: Pallet full of 45, 10-lb boxes (stacked 5 boxes high and 3 boxes across) with a plastic liner inside, full of blueberries.

· Specifically, collect aseptic samples of blueberries and grits at an imports warehouse and prepare them for shipping. Specific steps, if any:

· Gather supplies from bag.

· Correct supplies: sterile scoops, sterile(aseptic) gloves, whirlpack bags, scale, black permanent marker, cooler, frozen ice packs, tape, box cutter knife

· Incorrect supplies: brown paper bags, thermometer, exam gloves

· Perform aseptic sampling:

· Grits (Filer BNX): given 1 retail package (1 scoop = 25 gm). Sub sample consists of 4 scoops of grits. Total sample for exercise is 2 whirlpack bags containing 4 scoops each (8 scoops grits total). Sampled with an aseptic scoop.

· Warehouse employee has pulled out pallets on refrigerated dock.

· You pull out 15 retail units. Pull 7 boxes from 1 pallet, 8 boxes from the other. From each master carton, pull out 1 retail box and open.

· Then aseptically sample from each retail unit. Take whirlpack bag first and sterile scoop. Open retail unit. Open up the sterile bag in one hand. Open up the sterile scoop in the other. Dip spoon into retail unit. Do not touch side of box. Put scoop into whirlpack bag. Repeat those steps until you reach 3.5 oz. Should have a small scale with you to measure. Twist the whirlpack bag up and seal it. Label the bag with the sample sub number using a permanent marker. Do the same thing for the remaining 14 subs.

· Once subs are marked in bag, also mark the sub on the master carton. For each of the boxes we took a box from, refill using units from the other boxes we opened. Tape boxes up to ensure integrity.

· Blueberries (Filer NM2): given approx. 50 blueberries (5 blueberries = 25 gm). Sub sample consists of 20 blueberries. Total sample for exercise is 2 whirlpack bags containing 20 blueberries each (40 blueberries total). Sampled with an aseptic glove, not scoop.

· Warehouse employee has pulled out pallets on refrigerated dock.

· You pull out 30 boxes and lay them in front of you. Open up top of box, exposing the blueberries. Open whirlpack bag. Put on sterile glove aseptically on one hand. In the other hand, you will have your whirlpack bag. Using gloved hand, grab blueberries from box and drop into whirlpack bag without touching the bag with the sterile gloved hand. Put bag on scale and keep adding blueberries as described until you reach 3.5 oz. Seal up the whirlpack bag. As long as you did not contaminate the aseptic glove, you can use the same glove to continue. You label the 10 lb box with the sub number and master carton should be labeled with the same sub number. Box should then be taped shut to ensure integrity. Repeat steps starting from the opening of the box for the remaining samples. Inform warehouse personnel that you are finished collecting sample.

Response section Responses are to be submitted to Vivianna Diaz, Vivianna.diaz@fda.hhs.gov , Contract Specialist. Email is preferred. Please include the RFI number in the response. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Interested companies must submit a Capability Statement limited to 10 pages that provides responses to the following requested information. Capability statements will not be returned and will not be accepted after the due date.

Note that FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems.

Interested parties to this RFI, please respond to all questions below:

1. Describe your company’s experience on existing technology capabilities in the extended reality (XR) space in meeting the high-level requirements/scope similar to ours detailed above. Please describe how your solution specifically addresses the use case and the high-level requirement/overall scope detailed.

2. Please explain how you would recommend integrating the type of reality simulation training platform mature enough to handle the FDA use case detailed above.

3. Has your company worked on reality simulation initiatives that involved similar stakeholders (for example, other government agencies) with a similar requirement/scope and scale? Please provide examples or use cases.

4. Describe reality XR simulation tools such as AR/VR technologies your company offers and what hardware and software platforms you support.

5. Describe how your XR solution integrate with existing systems, for example with existing Learning Management Systems/tools.

6. Describe how your XR is scalable and customizable to meet specific business needs.

7. Describe the performance specification of your XR hardware, for example, resolution, field of view, tracking accuracy.

8. Describe the performance metrics you use to measure the effectiveness of your XR solutions. Please provide the reliability and stability of your solutions.

9. Describe the hardware and software platform you support for your extended reality solutions.

10. Describe the tools and support you provide for creating and managing XR content.

11. Describe what features you provide for real-time collaboration between multiple users in XR environments.

12. Describe or any known risks associated with developing and implementing XR project and how might they be mitigated. Please provide information what safeguards are in place, if any, should be anticipated to address security, confidentiality, and disaster recovery.

13. How did you monitor XR training platform quality and reliability? What metrics are considered to measure your company’s AI success?

14. Describe how your technology uses Artificial Intelligence to enhance training capabilities and user experience of XR technologies to increase personalization & adoptive learning, predictive analytics , making them more interactive and efficient.

15. Describe how you ensure the security and privacy of data within your XR solution.

16. Describe how you ensure 508 compliance requirements are met for user access to XR training platforms.

17. Describe how you go about establishing mechanisms for collecting feedback from users throughout the rollout process to identify improvement areas and promptly address any issues. Please provide details on continuous improvement through user feedback and performance data to iteratively improve XR training program, update content, refine rollout strategies as needed.

18. Describe how you ensure XR training program is scalable to accommodate a growing number of users, additional training content, and expanding training requirements over time.

19. Describe how you ensure an intuitive and accessible user experience for a diverse user group.

20. What training and onboarding support do you over to ensure smooth transition?

21. Describe your typical implementation timeline and process.

22. Describe your XR pricing models, for example, subscription, license, onetime-purchase, usage based etc.

23. How do you typically price out for the proposed solution and the labor categories that will be provided, for example, GSA Schedule, Open Market etc.?

24. How do you manage Agile implementation, techniques for release planning, plans for engaging end users, methods for capturing and applying lessons learned, testing processes, and how you will make resources available within schedule in handling critical modernization projects?

Please provide the following business information:

· Company Name

· Company Address

· Company Point of Contact, phone number, and email address.

· Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp.

· Small Business Socioeconomic program, if applicable

· Corporate structure (corporate, LLC, sole proprietorship, partnership, limited liability partnership, professional corporate, etc.)

· Current GSA Schedules appropriate to this Sources Sought

· Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the response.

· Please provide publicly posted pricing such as price catalogs accordance with FAR Part 10 or a copy of your commercial price catalog as market research as well as software solutions pricing methodology.