There is no general prohibition on awarding to companies located outside of the U.S.; however, please refer to the “Exclusion Criteria” in Section 3.3 Minimal Acceptable and Desired Technical Capabilities of the Solicitation:

Exclusion Criteria - Respondents that have international clinical capabilities but no ability to conduct domestic clinical studies in the United States, would be considered non-responsive. Domestic clinical capabilities are critical to represent disease burden and healthcare practices in the US.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

Partners are expected to have current or planned capabilities to conduct decentralized clinical research. This opportunity is not intended for companies seeking to develop, validate or incorporate their own technologies/platforms into clinical study sites. For additional information please see Section 3.1 Technical Overview and read Table 2 in the solicitation.

Solicitation Section Reference: Section 3.1 – Capability Building and Clinical Study Types

This announcement is open to any large or small business. Not being registered for the 541714 NAICs code does not prohibit the Respondent from responding to the Solicitation.

Solicitation Section Reference: Section 2.1 – Respondent Eligibility Requirements

Yes, it is reasonable for a Respondent to use the $2M to incorporate, build or develop a specific type of technology to improve decentralized clinical study readiness, however the Respondent’s company focus should not be focused on technology development. There is no requirement currently for any technology developed by D-COHRe partners to be open source. In your proposal you should justify how the proposed funding for the capability build will enhance innovation and the organization’s overall business model for decentralized clinical studies.

As per Section 3.3. Exclusion criteria, “Respondents interested in only advancing their own product, technology, or platform in a decentralized setting (e.g., technology developers, developers of specific MCMs, data management and integration),” would be considered non-responsive.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

No technology developers with a single product would be considered non-responsive. Respondents should be flexible in the products and technologies that they can utilize in clinical studies versus requiring the use of the product developed by the respondent. Decentralized capabilities should not be reliant on a single product.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

If this product, technology, or platform is required for your ability to conduct decentralized clinical studies than you are not eligible. Products essential to the proposer’s ability to conduct DCTs should be developed, validated, and ready for incorporation into clinical studies for wide distribution and scaling.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

The goal is for the partner/respondent to develop decentralized clinical study capabilities that can be used to conduct future clinical studies under the partnership – such as clinically validating products to support regulatory indications. In this situation, BARDA will identify the product and work with the partner to conduct the clinical study. Any technology or products (not identified by BARDA for study) that the partner will use to conduct the studies needs to be validated already for the purposes of conducting clinical studies. The proposal should reflect the respondent’s experience in conducting clinical studies to evaluate different technologies as well as incorporating technologies into clinical study design to assist with the clinical study (e.g., remote monitoring, home sample collection technologies, wearables).

Please also read Section 4.1 Technical Proposal instructions item 5b of the Solicitation.

Solicitation Section Reference: Section 1.3 – Objectives

The Footprint/Use Regions is relevant to the ability of your organization to deliver decentralized clinical care and/or conduct decentralized clinical studies in those regions. It is related to any or all of the following: access to patients, access to sites and/or licensure to treat. In your proposal, please justify the ability of your organization to deliver healthcare and conduct studies in those regions which may include but is not limited to the site capacity, patient access, personnel, medical licensure, etc.

In addition, the intent of this footprint is to have broad representation within a region, not just a singular site. Multiple decentralized sites with ability to scale within a region would be viewed more favorably than limited sites.

Solicitation Section Reference: Section 3.3 – Table 2. Requirements

Yes, Respondents can provide hourly rates across the 5-year Base Period of performance (Years 1 through 5) that include annual escalation factors. As stated in Section 4.2 Business Proposal, “The documentation provided under this part will not be binding; however, it will be used as a basis for determining budgets for future clinical study requirements.”

Solicitation Section Reference: Section 4.2. Business Proposal; Part 2: Clinical Study Pricing (Options)

Section 3.1 Capability Building and Clinical Study Types of the Solicitation states, “…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.”

Proposals are being evaluated for their capabilities across a 5-year base period. Specifically technical proposal and budget should reflect however what will be conducted in the 1-year initial capability build. Proposals detailing plans beyond 5 years is not necessary or required. However, it is of interest to understand how these capabilities will be integrated into business operations. BARDA will evaluate proposals received per Section 5 Proposal Evaluation Criteria and Section 4 Proposal Preparation of the Solicitation. The guidance for how to propose your capability growth plan is outlined in the evaluation criteria and Table 2.

Yes, the 5-year base period includes the 1-year timeframe for initial capability build.

Solicitation Section Reference: Section 2.2 – Intent to Execute Multiple Agreements; Section 3.1 – Capability Building and Clinical Study Types

There is no specific guidance or guidelines for establishing the fringe benefits, overhead, and G&A rates for the D-COHRe Business Proposal. The respondent should determine and propose indirect rates that are appropriate for their company and provide supporting documentation to justify the rates.

See Section 4.2, Business Proposal, of the Solicitation regarding indirect rates.

We will evaluate the proposed indirect rates based on the supporting documentation and address any differences during the negotiation process.

See also Bureau of Labor Statistics published a guide for Indirect Cost Determination (DCD-2-CFR-Guide.pdf (dol.gov)). The use of this guide is not required but may provide helpful information in understanding the Government’s approach to calculating indirect costs on our contracts.

Solicitation Section Reference: Section 4.2 – Business Proposal

The proposal should focus on the desired company objectives and capabilities to address the evaluation criteria in the solicitation.

Section 5 Proposal Evaluation Criteria, Evaluation Criteria B Overall Scientific and Technical Merit, states “… BARDA will give preference to respondents that can address more than one clinical study area as described in Table 1.” Your proposal should address the capability of your organization to conduct all 3 clinical studies should there be a need for BARDA to execute one of these types of studies as an option under the Agreement. See Section 4.1 Technical Proposal instructions in the Solicitation item 5b, “Clinical Studies: Please describe the organization’s current capabilities to conduct the 3 types of clinical studies described in Table 1: Product Development, Product Adoption and Utilization and Clinical Trial Innovation.”

Solicitation Section Reference: Section 3.1 – Capability Building and Clinical Study Types

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.”

Solicitation Section Reference: Section 7 –Special Considerations 

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.”

Solicitation Section Reference: Section 2.2 – Intent to Execute Multiple Agreements

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 as prime. Each proposal will be evaluated in accordance with the evaluation criteria explained in Section 5 of the solicitation. However, it may be possible that a respondent also participates as a subcontractor or teaming partner on submission by another prime.

There is no general prohibition on awarding to companies located outside of the U.S.; however, please refer to the “Exclusion Criteria” in Section 3.3 Minimal Acceptable and Desired Technical Capabilities of the Solicitation:

Exclusion Criteria - Respondents that have international clinical capabilities but no ability to conduct domestic clinical studies in the United States, would be considered non-responsive. Domestic clinical capabilities are critical to represent disease burden and healthcare practices in the US.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

Partners are expected to have current or planned capabilities to conduct decentralized clinical research. This opportunity is not intended for companies seeking to develop, validate or incorporate their own technologies/platforms into clinical study sites. For additional information please see Section 3.1 Technical Overview and read Table 2 in the solicitation.

Solicitation Section Reference: Section 3.1 – Capability Building and Clinical Study Types 

This announcement is open to any large or small business. Not being registered for the 541714 NAICs code does not prohibit the Respondent from responding to the Solicitation.

Solicitation Section Reference: Section 2.1 – Respondent Eligibility Requirements

Yes, it is reasonable for a Respondent to use the $2M to incorporate, build or develop a specific type of technology to improve decentralized clinical study readiness, however the Respondent’s company focus should not be focused on technology development. There is no requirement currently for any technology developed by D-COHRe partners to be open source. In your proposal you should justify how the proposed funding for the capability build will enhance innovation and the organization’s overall business model for decentralized clinical studies.

As per Section 3.3. Exclusion criteria, “Respondents interested in only advancing their own product, technology, or platform in a decentralized setting (e.g., technology developers, developers of specific MCMs, data management and integration),” would be considered non-responsive.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

No technology developers with a single product would be considered non-responsive. Respondents should be flexible in the products and technologies that they can utilize in clinical studies versus requiring the use of the product developed by the respondent. Decentralized capabilities should not be reliant on a single product.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

If this product, technology, or platform is required for your ability to conduct decentralized clinical studies than you are not eligible. Products essential to the proposer’s ability to conduct DCTs should be developed, validated, and ready for incorporation into clinical studies for wide distribution and scaling.

Solicitation Section Reference: Section 3.3 – Exclusion Criteria

Yes, Respondents can provide hourly rates across the 5-year Base Period of performance (Years 1 through 5) that include annual escalation factors. As stated in Section 4.2 Business Proposal, “The documentation provided under this part will not be binding; however, it will be used as a basis for determining budgets for future clinical study requirements.”

Solicitation Section Reference: Section 4.2. Business Proposal; Part 2: Clinical Study Pricing (Options)

Section 3.1 Capability Building and Clinical Study Types of the Solicitation states, “…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.”

Proposals are being evaluated for their capabilities across a 5-year base period. Specifically technical proposal and budget should reflect however what will be conducted in the 1-year initial capability build. Proposals detailing plans beyond 5 years is not necessary or required. However, it is of interest to understand how these capabilities will be integrated into business operations. BARDA will evaluate proposals received per Section 5 Proposal Evaluation Criteria and Section 4 Proposal Preparation of the Solicitation. The guidance for how to propose your capability growth plan is outlined in the evaluation criteria and Table 2.

Yes, the 5-year base period includes the 1-year timeframe for initial capability build.

Solicitation Section Reference: Section 2.2 – Intent to Execute Multiple Agreements; Section 3.1 – Capability Building and Clinical Study Types

There is no specific guidance or guidelines for establishing the fringe benefits, overhead, and G&A rates for the D-COHRe Business Proposal. The respondent should determine and propose indirect rates that are appropriate for their company and provide supporting documentation to justify the rates.

See Section 4.2, Business Proposal, of the Solicitation regarding indirect rates.

We will evaluate the proposed indirect rates based on the supporting documentation and address any differences during the negotiation process.

See also Bureau of Labor Statistics published a guide for Indirect Cost Determination (DCD-2-CFR-Guide.pdf (dol.gov)). The use of this guide is not required but may provide helpful information in understanding the Government’s approach to calculating indirect costs on our contracts.

Solicitation Section Reference: Section 4.2 – Business Proposal

The proposal should focus on the desired company objectives and capabilities to address the evaluation criteria in the solicitation.

Section 5 Proposal Evaluation Criteria, Evaluation Criteria B Overall Scientific and Technical Merit, states “… BARDA will give preference to respondents that can address more than one clinical study area as described in Table 1.” Your proposal should address the capability of your organization to conduct all 3 clinical studies should there be a need for BARDA to execute one of these types of studies as an option under the Agreement. See Section 4.1 Technical Proposal instructions in the Solicitation item 5b, “Clinical Studies: Please describe the organization’s current capabilities to conduct the 3 types of clinical studies described in Table 1: Product Development, Product Adoption and Utilization and Clinical Trial Innovation.”

Solicitation Section Reference: Section 3.1 – Capability Building and Clinical Study Types