N62645-PA-19-1 Questions and Answers.docx

Please note that the N62645-PA-19-1 Program Announcement has been revised under Section IV. EVALUATION INFORMATION, 1. Review and Selection Process:

The second paragraph of this section has been revised from:

The first tier is a completeness review that ensures that the application provides support of all three research focus areas. Failure of an application to document support of all three research focus areas may (at the discretion of the Grants Officer) cause an application to not be forwarded for the peer and programmatic reviews and therefore, not be eligible to be funded.

To

The first tier is a completeness review that ensures that the application provides support of all areas outlined in the Program Announcement. Failure of an application to document support of all areas outlined in the Program Announcement may (at the discretion of the Grants Officer) cause an application to not be forwarded for the peer and programmatic reviews and therefore, not be eligible to be funded.

Please note that the N62645-PA-19-1 Program Announcement has been revised under Section VI. OTHER INFORMATION, 6. Organizational Conflicts of Interest:

The paragraph of this section has been revised from:

All Applicants and proposed sub-awardees must affirm whether they are providing scientific, engineering, and technical assistance (SETA) or similar assistance to any NMRC technical office(s) through an active contract or subcontract. All affirmations must state which office(s) the applicant assists and identify the corresponding, prime assistance agreement/contract numbers. Affirmations shall be furnished at the time of application submission. All facts relevant to the existence or potential existence of organizational conflicts of interest (2 CFR 200.112) must be disclosed. The disclosure shall include a description of the action the applicant has taken or proposes to take to avoid, neutralize, or mitigate such conflict. Applications that fail to fully disclose potential conflicts of interests or do not have acceptable plans to mitigate identified conflicts will be rejected without technical evaluation and withdrawn from further consideration for award. If a prospective applicant believes that any conflict of interest exists or may exist (whether organizational or otherwise), the applicant should promptly raise the issue with NMLC by sending his/her contact information and a summary of the potential conflict by e-mail to the Business Point of Contact in Section I, item 10 above, before time and effort are expended in preparing an application and mitigation plan. If, in the sole opinion of the Grants Officer after full consideration of the circumstances, any conflict situation cannot be effectively avoided or mitigated, the application may be rejected without evaluation and withdrawn from further consideration for award under this funding opportunity.

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All Applicants and proposed sub-awardees must affirm whether they are providing Systems Engineering and Technical Assistance (SETA) or similar assistance to any NMRC technical office(s) through an active contract or subcontract. All affirmations must state which office(s) the applicant assists and identify the corresponding, prime assistance agreement/contract numbers. Affirmations shall be furnished at the time of application submission. All facts relevant to the existence or potential existence of organizational conflicts of interest (2 CFR 200.112 and 2 CFR 200.318(c)) must be disclosed. The disclosure shall include a description of the action the applicant has taken or proposes to take to avoid, neutralize, or mitigate such conflict. Applications that fail to fully disclose potential conflicts of interests or do not have acceptable plans to mitigate identified conflicts will be rejected without technical evaluation and withdrawn from further consideration for award. If a prospective applicant believes that any conflict of interest exists or may exist (whether organizational or otherwise), the applicant should promptly raise the issue with NMLC by sending his/her contact information and a summary of the potential conflict by e-mail to the Business Point of Contact in Section I, item 10 above, before time and effort are expended in preparing an application and mitigation plan. If, in the sole opinion of the Grants Officer after full consideration of the circumstances, any conflict situation cannot be effectively avoided or mitigated, the application may be rejected without evaluation and withdrawn from further consideration for award under this funding opportunity.

Answers to Applicant Questions:

(Please note that italicized text is from the Program Announcement or Application Instructions).

Q1. Do I need to submit a Pre‐Application, Letter of Intent, or White paper?

A: Pre‐Application, Letter of Intent, or White paper is not requested and will not be accepted. Please refer to the N62645-PA-19-1 Application Instructions for further information.

Q2. I am from the XYZ Government Research Lab, we are Capital Work funded. Am I eligible to submit as a PI? Can I also include XYZ Government agency as a collaborator?

A: Please note the revised text under Program Announcement Section IV. EVALUATION INFORMATION, 1. Review and Selection Process: The first tier is a completeness review that ensures that the application provides support of all areas outlined in the Program Announcement. Failure of an application to document support of all areas outlined in the Program Announcement may (at the discretion of the Grants Officer) cause an application to not be forwarded for the peer and programmatic reviews and therefore, not be eligible to be funded.

Please note the text under Program Announcement Section ii. Award Description: The intent of this award is to fund an organization that can continue serving as the integrating coordinator for ACESO and work closely with NMRC to develop and implement scientific efforts of the consortium. The award is designed to maintain a hub that can bring together the expertise of military research laboratories with relevant accomplished civilian scientists (i.e., from the fields of infectious disease, critical care, computational biology, systems biology, and global health) at outstanding organizations and with appropriate patient populations in resource-limited and resource-replete settings.

Please note the text under Program Announcement Section 11. Funds Available and Anticipated Number of Awards: NMLC intends to award a single Cooperative Agreement for a single 60 month period to the selected ACESO Coordinator to support the ACESO Consortium. The ACESO Coordinator will provide funding support for the selected clinical study sites and Consortium partners as sub-awards.

The Program Announcement is requesting applications for an organization that can continue serving as the integrating coordinator for ACESO. The ACESO coordinator is responsible for proposing consortium partners that will comprise the consortium. The ACESO Coordinator will provide funding support for the selected clinical study sites and Consortium partners as sub-awards. NMLC is not requesting applications for individual research projects, PI’s or collaborators.

Federal partners may be proposed under the consortium.

Please note the text under Application Instruction Section 2. Content and Format of Applications:

The ACESO Coordinator designated through this award will support ACESO-related research activities of consortium partners through ACESO award funds, with the potential exception of military treatment facilities (MTF's) or other US military or US Government institutes. The ACESO Coordinator will provide management and support (e.g., research personnel, supplies) to the federal research partners through various and appropriate means; however, no direct funds will be provided to any government institution by the ACESO Coordinator.

Please note Application Instruction Section 2.B. Research & Related Budget Instructions:

Extramural and Intramural Collaboration: Research and development which involves awarding to extramural recipients (Non-Government) with collaboration in part from intramural entities (Government) shall adhere to the following guidance:

Intramural costs shall not be included and contributory to direct or total cost on proposed extramural efforts. Rather, these pieces shall be identified and broken out in separate costs within extramural application, as to avoid duplicative expenses to the Government.

The extramural portion will be funded via an assistance agreement through NMLC; the intramural portion shall be funded directly, via a Military Interdepartmental Purchase Request (MIPR) or some other type of Funding Authorization Document (FAD) between the Government entities.

The use of Cooperative Research and Development Agreements (CRADAs) as a mechanism to provide funding to Government entities in collaboration on Non-Governmental efforts will be prohibited on the award resultant from this funding opportunity, unless specified otherwise.

Direct funds will not be provided to any government institution by the ACESO Coordinator. Funding would be provided from NMRC to the Government institution via Military Interdepartmental Purchase Request (MIPR) or other approved means. If a Government Research Lab operates a Capital Work funded, it is the responsibility of that Government Research Lab to ensure that they could accept direct funding via these methods, before submitting an application.

Q3. How can I find other consortium members?

A: The applicant is responsible for proposing consortium partners as subawardees. Please note that the applicant must be able to collaborate with the Government and support all areas covered in the Program Announcement.

Failure of an application to document support of all areas outlined in the Program Announcement may (at the discretion of the Grants Officer) cause an application to not be forwarded for the peer and programmatic reviews and therefore, not be eligible to be funded.

Q4. My question pertains to the following funding opportunity: N62645‐PA‐19‐1, Austere Environment Consortium for Enhanced Sepsis Outcomes (ACESO) Award (Cooperative Agreement).

Can you please confirm that the funding opportunity will only fund an ACESO Coordinator and not research project. If this is true, can you please advise when and how Sepsis research projects, in the stated research focus areas, will be solicited.

A: The funding opportunity will fund both the ACESO Coordinator and the research to be conducted under the COA. Please refer to section 11 of the PA: Funds Available and Anticipated Number of Awards. NMLC intends to award a single Cooperative Agreement for a single 60 month period to the selected ACESO Coordinator to support the ACESO Consortium. The ACESO Coordinator will provide funding support for the selected clinical study sites and Consortium partners as sub-awards. Funding will be provided on the base award (and added incrementally) to provide for the operation of the consortium. All direct and indirect costs of any sub-award (sub-grant or sub-contract) must be included in the total direct costs of the primary award.

The applicant is encouraged to review the PA and AI as all areas of the applicants questions are covered within the two documents.

Q5: Section VI. 6 of the Program Announcement, Organizational Conflicts of Interest (OCI), invites applicants to raise questions with NMLC before time and effort are expended in preparing an application and mitigation plan. Accordingly, this offeror notes that the OCI provision requires offerors to affirm whether they are providing “scientific, engineering and technical assistance (SETA) or similar assistance to any NMRC technical office(s)….” The acronym SETA, as customarily used in the industry, refers to “Systems Engineering and Technical Assistance.” Because the government’s definition may impact an offeror’s identification of actual or potential OCIs, will the Government please confirm that the reference to “SETA” is intended to refer to “Systems Engineering and Technical Assistance” rather than “scientific, engineering and technical assistance”?

A: Please note that “scientific, engineering and technical assistance” (SETA) has been revised within the document to reference “Systems Engineering and Technical Assistance”. Please refer to language at the top of this document, which has been revised within the Program Announcement.