Questions and Answers 10-14-26_ Amend 0002.pdf

BARDA Device Development for Scientists Training

Amendment 0002: Questions & Answers Solicitation BARDA-27-100227: BARDA Device Development for Scientists Training Issue Date: 14 October 2026

1. Revised Quotation Deadline

The RFQ document states quotations are due October 9, 2026 at 1:00 PM ET. The current SAM.gov opportunity record reflects a revised response deadline of October 21, 2026 at 1:00 PM ET. Please confirm that October 21, 2026 at 1:00 PM ET is the controlling quotation deadline.

Government Response: Quotations are due October 21, 2026, at 1:00 p.m. ET. The RFQ has been amended to reflect this deadline

2. Section 2 of the RFQ states that questions are due October 6, 2026, at 10:00 AM ET.

Please confirm whether this deadline remains unchanged following the modification to the quotation due date.

Government Response: The October 6, 2026, at 10:00 a.m. ET deadline for questions remains unchanged.

3. “MOU” / Method-of-Use Requirement

Section 4.1 of the PWS contains language stating: “The original requirement included Method of Use ‘MOU, target identification and validation.’ Please define ‘MOU’ and confirm whether this topic should be included.”

Government Response: MOU should be COU which means “Context of Use” (COU). It was intended to provide importance of the context of use for the overall product development strategy and the FDA regulatory strategy.

5. Please identify the audiovisual and classroom equipment available at the training location, including display/projector, computer connectivity, internet access, microphones, whiteboards/flipcharts, and IT/AV support. May instructors use personal laptops or USB media, and are there any applicable equipment or network-security restrictions?

Government Response: The room will have a large display or projector with computer connectivity and internet access. Microphones will be connected to the room’s audiovisual system. Instructors must use government-furnished equipment; personal laptops, USB drives, and other external media are not permitted. The Contracting Officer’s Representative (COR) will be identified at the time of award. Instructors shall provide presentations and other materials to the COR two (2) business days in advance so they can be loaded and tested before the session.

6. Please confirm that the Section 508 requirement applies to electronic materials delivered to the Government and identify whether any particular HHS/BARDA accessibility validation or document format is required.

Government Response: Applicable electronic course materials must comply with Section 508 accessibility requirements. The PWS does not prescribe a specific document format or validation method.

7. The RFQ identifies FAR 52.219-6 but does not expressly identify FAR 52.219-14. Please confirm whether the resulting purchase order will contain any limitation on subcontracting, minimum prime-contractor performance requirement, or restriction applicable to use of qualified subcontractor instructors.

Government Response: FAR 52.219-14 is not included in this purchase order. Qualified subcontractor instructors may be used, provided they meet the PWS requirements. The Contractor remains responsible for performance.

8. Is this a brand-new requirement or if there is no incumbent.

Government Response: This is new requirement. There is no incumbent contractor

9. May a quoter propose multiple instructors with different areas of expertise to deliver training.

Government Response: Yes. Multiple instructors are permitted, provided each proposed instructor meets the applicable in minimum qualifications the PWS.

10. What start/end times, net instructional hours, and break/lunch schedule are expected for each training day? When will the room be available for setup, equipment testing, and breakdown

Government Response: The rooms will be available 1 hour before the meeting to be set

up. The IT team at HHS will be available if there are problems during the set up or meeting.

It is at the company’s discretion to create the curriculum and propose the agenda. The training covers typical core hours are 9:30 am to 3:30 PM. It is suggested the training to be over 2 days with potentially small flexibility – for example (8:00 am to 4 pm) with lunch break.

11. Please confirm the intended depth of instruction on RAPID and TEMPO, including whether they should be addressed as distinct FDA/CMS-related initiatives. Are there specific Government reference materials or learning outcomes the contractor should use?

Government Response: The training should provide an overview of RAPID and TEMPO as distinct initiatives. For each, the instructor should explain its purpose, the types of devices that may be eligible, the relevant FDA and CMS roles, and the implications for device development and patient access. The instructor should also distinguish these initiatives from the FDA Breakthrough Devices Program and Safer Technologies Program (STeP), and explain relevant relationships among them. A detailed application workshop is not required. Instructors may use current, publicly available FDA and CMS materials; the Government will not provide required reference materials.

12. After award, what approval and supporting documentation would be required to substitute an instructor who meets the minimum qualifications? Is prior written CO approval required, and is there a minimum approval lead time?

Government Response: Substitute instructors must meet the PWS minimum qualifications and are subject to prior written Contracting Officer approval. A resume or CV must be provided for review. No minimum lead time is required; however, requests should be submitted as soon as practicable.

14. When will the contractor receive the final participant count and relevant audience information? Who will coordinate attendance, participant communications, and day-of-training issues? Will any attendance roster, completion certificate, learning assessment, or training evaluation be required as a contractor deliverable?

Government Response: The Government (BARDA) will coordinate attendance, participant communications, and day-of-training logistics for up to 30 participants. At award, the Government will identify its point of contact. Before training, it will provide the Contractor with the final participant count and audience information, including a list of participant names and titles at least five days before the training. After the course, the Contractor shall provide participant satisfaction survey results and certificates of completion. An attendance roster and learning assessment are not required.

15. Are printed participant materials required in addition to electronic materials? If so, what quantities and format are expected, and which party handles printing/distribution?

Please confirm responsibility for stationery and exercise supplies, and whether any refreshments or meals must be included in the quotation.

Government Response: Printed participant materials are not required. The Contractor must provide the instructional materials and any supplies needed for its proposed training.

Refreshments and meals are not required.

16. Will the Government record, livestream, or otherwise distribute any portion of the training? If so, what consent, usage, accessibility, and recording-support requirements apply? Will the Government supply nonpublic examples or information requiring special handling, or should all case studies use public or sanitized information?

Government Response: The Government does not intend to record, livestream, or otherwise distribute the training. The Contractor should use publicly available or sanitized information for case studies and examples. The Government does not anticipate providing nonpublic information requiring special handling

17. What is the anticipated award date, and for how long must quotations remain valid? If award is delayed, how will the Government accommodate curriculum preparation, facility access, and advance-material deadlines

Government Response: Award is anticipated as soon as practicable after evaluation.

Quotations must remain valid for 30 days after the due date. Training is scheduled for January 11–12, 2027. The Government will coordinate any necessary schedule changes in writing; final materials remain due two business days before training.

18. Participant background and curriculum emphasis

What scientific disciplines, job functions, and levels of medical-device development experience will be represented? Are there priority device types, BARDA use cases, or prerequisite knowledge that should guide the examples and level of instruction

Government Response: Participants are expected to include scientists and technical professionals with varying levels of medical device development experience. No device type is prioritized, and no prerequisite knowledge is required. The training should cover the PWS subject areas and use examples applicable across a range of medical device development activities.

19. Please identify routine visitor-registration procedures, lead times, acceptable identification, equipment screening, loading/delivery access, and parking arrangements.

For non-U.S.-citizen instructors, when will secure vetting instructions be provided and how long does review normally take? Please confirm whether the three-business-day requirement is a submission deadline and when clearance must be confirmed

Government Response: The Government will provide facility access and security instructions after award. Non-U.S.-citizen vetting information must be submitted at least 10 business days in advance, and access must be approved before facility entry

20. What license or data-rights terms will apply to existing contractor course content and newly developed materials? Does the Government intend to share materials beyond the 30 participants, post them online, or reuse them for future training? Please identify any required scope of reuse rights so that permissions and costs can be addressed accurately

Government Response: Course materials are intended for participant reference during and after this training. The Government does not intend to post them publicly, distribute them beyond the participants, or reuse them for future training. Rights in pre-existing and newly developed materials will be governed by the terms of the resulting purchase order.

21. Who will review and accept the materials and completed training, what criteria will be used, and within what timeframe? Please clarify whether any post-training report, correction, follow-up support, or other item is required before final acceptance and invoicing

Government Response: BARDA will accept the training and required materials based on compliance with the PWS. The Contractor shall distribute a post-training survey, allow participants 15 business days to respond, and report the results. The Contractor shall provide certificates of completion for each participant within 15 business days after training and before invoicing. No follow-up support or other deliverables are required for final acceptance and invoicing.

22. The RFQ requires a master's degree or higher in a related field. Would a master's in a pharmaceutical science be considered related? Would an MBA also be accepted when combined with a B.S. in a science field and more than five years of medical device development experience?

Government Response: Each proposed instructor must have a master’s degree or higher in a field related to the course subject matter, at least five years of relevant medical device development experience, and knowledge of the PWS Section 4 topics. The Government will evaluate a master’s degree in pharmaceutical science or an MBA against these requirements using the qualifications submitted with the quotation. A bachelor’s degree and experience do not replace the master’s degree requirement.

23. The technical approach is limited to two pages. Are there any additional page limitations for other sections of the proposal.

Government Response: No page limits apply to other sections of the quotation.