BARDA D-COHRe Questions and Answers_21Jul23.pdf

Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership Solicitation Questions Received & BARDA Answers 21 July 2023

# Solicitation Section Reference

Question BARDA Answer

1 General Can Respondents submit multiple proposals from the same organization?

The solicitation does not expressly prohibit the submission of more than one proposal.

However, it is the preference of BARDA that respondents submit only one proposal.

Each proposal will be evaluated in accordance with the evaluation criteria explained in Section 5 of the solicitation.

Further the language of Section 6 allows for certain aspects to be addressed during negotiations prior to award: "Following its evaluation of a proposal, a respondent whose proposal appears to offer the best value to the USG will be invited to enter into negotiations with an intent to reach and execute an Agreement. Negotiations may address the following, but not limited to, eligibility requirements, the proposed work statement, terms and conditions (including data rights, intellectual property rights), teaming arrangements, or pricing."

2 General As this is an expected 5-year commitment, what are the terms and policies if the partner wishes to suspend the relationship prior to completing the 5-year agreement?

As stated in Section 3.1 of the solicitation, “partners should anticipate maintaining a readiness capability to conduct clinical studies that integrates with the business model of their organization for the entire period of performance of the OT award.”

The period of performance for the OT award is explain in Section 2.2:

“Each agreement under the OTA will have a 5-year Base period of performance, with multiple Option line items. Each Option line item will have a period of performance of up to 5-years and will support continued activities for capability growth as well as the execution of clinical research studies, based on the availability of funds. Overall period of performance may be revised by mutual agreement.”

Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership Solicitation

21 July 2023

By being awarded an OT agreement the Respondent is committing to a minimum five-year relationship with BARDA, or possibly longer based on the terms of the agreement.

3 General If the Respondent submits after the July 25th deadline, what is the next scheduled award date?

At this time, there is no definitive timeline. Awards may be executed on a rolling basis. Aside from the intent we noted to execute an award this fiscal year, we intend to proceed with successful proposals as soon as funding is made available funding in the next fiscal year.

Please keep in mind that the government’s current fiscal year ends September 30, 2023.

4 Section 2.1 Eligibility Requirements

Are we a good fit for the D- COHRe solicitation?

What if we are a [med] company developing a technology?

Everyone who believes they meet the Eligibility Requirements from Section 2.1 may apply.

We recommend the Respondent read the full solicitation and pay attention to Section

3.1 Technical Overview: “BARDA is committed to jointly working with D-COHRe partners to clinically evaluate products and their adoption into healthcare models nationwide. These partners are expected to have current or planned capabilities to conduct decentralized clinical research.”

It is also helpful to carefully read Table 2. Requirements, Minimum Acceptable Capabilities, as well as Appendix B. Example Studies, to see if those examples align with the Respondent’s business and capabilities.

As the solicitation states, this opportunity is not intended for companies seeking to develop their own technologies/platforms.

We recommend the Respondent review BARDA’s open programs to see if there is alignment with their technology. If so, one option is requesting a TechWatch meeting with BARDA in which the Respondent could be invited to present their technology to a

Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership Solicitation

21 July 2023 panel of experts to see if there might be alignment with another program within BARDA or across government:

https://medicalcountermeasures.gov/request-barda-techwatch-meeting/

5 Section 2.3 Submission Overview & Instructions

Where do we submit our proposal?

The email for D-COHRe proposal submission is LaunchOfficeContracting@hhs.gov, as stated in Section 2.3 Submission Overview & Instructions.

6 Section 7 Special Considerations

Can you describe the regulatory oversight that would be in process?

Please refer to Section 7 Special Considerations in the solicitation.

Protection of Human Subjects.

“All research...must... comply with 42 U.S.C. § 300v-1(b), 32 CFR 219, and, as applicable, 21 CFR Parts 11, 50, 54, 56, 312)(45 CFR Part 46) and the ICH as well as other applicable federal and state regulations.”

“The Good Clinical Practice Regulations (GCP)(21 CFR Parts 50, 54, 56 312)(45 CFR Part 46)(ICH E6) as well as other applicable federal and state regulations will be standards that apply for use of human subject and/or human specimens in clinical studies.”

Inspection of Facilities “Respondents selected for negotiations may be subject to inspections of their facilities and Quality Assurance or Quality Control capabilities, Regulatory or Quality Management, FDA submissions or meetings, and Audits or Site Visits may also be discussed during negotiations. The decision to inspect facilities will be made by the OTAO in coordination with the OTTR, or other USG representative.”

https://medicalcountermeasures.gov/request-barda-techwatch-meeting/