Questions and Responses - 30 Jan 20.pdf

Questions and Responses Page 1 of 7 75N93019R00028 30 January 2020

QUESTIONS & RESPONSES:

NIAID CENTERS OF EXCELLENCE FOR INFLUENZA RESEARCH AND RESPONSE

75N93019R00028

1. QUESTION: Can you clarify whether NIAID estimates the average annual total costs to be $20M per award or for all awards combined?

RESPONSE: NIAID estimates that the average annual total cost (direct and indirect costs combined) is $20M for all awards combined. However, it is anticipated that the total cost for the award(s), including Options, may vary depending upon the scope of the project, technical objectives of the award(s), and availability of funds.

2. QUESTION: Are non-U.S. companies eligible to respond to this solicitation?

RESPONSE: Yes, this solicitation is for full and open competition.

3. QUESTION: One of our international sites has three affiliated medical centers within their area and I am wondering how we shall budget for travel within the sites? I know that contracts have restricted travel and that programmatic meeting travel anticipated is spelled out in the BAA, but what isn’t clear is whether or not we can budget for travel to patients or between medical institutions for clinical related reasons?

RESPONSE: These travel costs may be proposed.

4. QUESTION: In the previous CEIRS solicitation, proposals were expected to include Options. These Options made up a large portion of the budget. In the CEIRR solicitation, I only saw one reference to Options in Attachment 7: “Each Option must be budgeted separately within the Business Proposal to conform with the proposal submission of the Statement of Work”. I could not find a reference to Options in the Technical Proposal. I did find a reference to a pilot research program in the Leadership and Project management section of Attachment 4 (pg. 1).

Should options/pilot research projects be proposed in the technical application (in addition to the items listed)?

RESPONSE: Proposals only need to identify a process for selecting pilot research programs. Only elective components should be identified and budgeted separately.

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5. QUESTION: Can you provide clarification on the number of required surveillance sites? The phrase beginning “proposals must” within Part A, Attachment 4, page 3 seems to contradict information in Attachment 6, Section 4.A., Paragraph 2.

RESPONSE: As stated in Attachment 6, Section 4.A., Paragraph 2, offerors may:

carry out a minimum of two (2) and maximum of four (4) projects from the activities described in Part A only, Part B only, or on both Parts A and B of Attachment 3.

If offering Part A only or on both Parts A and B: proposals must include a minimum of one site in the US and a minimum of two international sites in Asia, Africa and Latin America (as stated in Attachment 4, page 3).

If offering Part B only: proposals must include one site in the US and one international site (as stated in Attachment 6, Section 4.A., Paragraph 2).

6. QUESTION: Would a reagent core that generates reverse genetics plasmids be considered responsive to the (optional) request for reagent cores? Page 1 of Attachment 7 implies that monoclonal antibodies, antisera and recombinant proteins are sought. Are these simply examples given for budgeting purposes?

RESPONSE: Page 1 of Attachment 7 lists reagent examples for budgeting purposes.

A Reagent core that generates reverse genetics plasmids would be considered responsive.

7. QUESTION: Does NIH have a recommended escalation rate to use in budgets? Or should there not be an escalation rate?

RESPONSE: Utilize your organizational policies in regards to escalation rates.

8. QUESTION: Are publication costs allowed in the budget?

RESPONSE: No, publication costs are not allowed.

9. QUESTION: Is a hard copy or compact disc submission (i.e. a mailed copy) required or is only eCPS submission required per Attachment 1?

RESPONSE: Please see page Attachment 1, Section I, Subsection A, Statements 1

Questions and Responses Page 3 of 7 and 2. Proposals will only be accepted through eCPS.

10. QUESTION: Attachment 4, Page 3: For required activities under #3 (Influenza Surveillance, Risk Assessment and Response Research), Part A notes that "Proposals must include a minimum of one site in the US and a minimum of two international sites in Asia, Africa or Latin America."

However, Attachment 6, page 4 notes, "Proposals must include a minimum of one site in the US and one international site" (under section A2). Is one or two international surveillance sites required? Or is one site required in Asia, Africa or Latin America and a second can be in Europe or Australia/Oceania?

RESPONSE: As stated in Attachment 6, Section 4.A., Paragraph 2, offerors may:

carry out a minimum of two (2) and maximum of four (4) projects from the activities described in Part A only, Part B only, or on both Parts A and B of Attachment 3.

If offering Part A only or on both Parts A and B: proposals must include a minimum of one site in the US and a minimum of two international sites in Asia, Africa and Latin America (as stated in Attachment 4, page 3). Sites in Europe or Australia/Oceania may be offered in addition to the two sites in Asia, Africa and Latin America.

If offering Part B only: proposals must include one site in the US and one international site (Attachment 6, Section 4.A., Paragraph 2).

International sites may be located anywhere outside the United States.

11. QUESTION: Does the maximum of 4 projects under Attachment 6, page 4, section A2 include Longitudinal Human Influenza Studies from #2 if they fulfill Part B or can total projects exceed 4 if they include Longitudinal Human Influenza Studies?

RESPONSE: If an aspect of Longitudinal Human Influenza studies (Attachment 4, Section B.2.) would also fulfill part B of Influenza Surveillance, Risk Assessment and Response Research (Attachment 4, Section B.3.), it would count as a project as listed in Attachment 6, Section A.2., page 4.

12. QUESTION: Attachment 4: For required activities, under #3, Part A international surveillance sites are restricted to Asia, Africa, and Latin America. Are International Longitudinal Human Influenza Studies under #2 similarly restricted or are sites in Europe or Australia/Oceania permitted and considered responsive to the BAA?

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RESPONSE: There is no restriction of sites to Asia, Africa and Latin America.

Attachment 4, Section B.3., Part A states that “Proposals must include a minimum of one site in the US and a minimum of two international sites in Asia, Africa, or Latin America.” Sites in addition to these minimums may be proposed.

As stated in Attachment 4, Section B.2. Longitudinal human Influenza studies, “Proposals should contain at least 1 site in the US and 1 international site.” International sites may be located anywhere outside the United States.

13. QUESTION: Attachment 4: For required activities, under #3, Part A, are international surveillance sites allowed in Europe or Australia/Oceania?

RESPONSE: Yes, international sites in Europe or Australia/Oceania are allowable in addition to the minimum sites as listed.

14. QUESTION: Attachment 4: Does #4 (Pre-pandemic and pandemic emergency response) require availability of Select Agent and/or BSL3 facilities to receive and work with emerging influenza viruses?

RESPONSE: No, this is not a requirement of Attachment 4, Section B.4. Pre-pandemic and pandemic emergency response.

15. QUESTION: Under Optional Activities 4, Modeling/computational core, should the core have specific bioinformatic/modeling approaches described with a plan of using data from the required activities (#2, #3, and/or #5)?

Can this be a part of the Core proposal or should it be included as a research component under Activities #2, #3, and/or #5? Or is this not required for the core proposal?

RESPONSE: As stated in Attachment 4, Section C, Optional 4 – Modeling/computational Core, the Core “may contribute to the statistical experimental design of the research projects, meta-analyses and data integration projects, as needed.”

16. QUESTION: Can offerors be included on more than one proposal?

RESPONSE: Yes, offerors can be included on more than one proposal.

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17. QUESTION: Attachment 7, Section 3 states that the uniform cost assumptions should be broken down into the required and optional components.

However, the required component “Pathogenesis and Immune Response Research” is missing from this list. This component requires a minimum of three research projects. Are separate totals and budgets for each of these projects required?

RESPONSE: Separate totals and budgets for those projects are not required.

18. QUESTION: Attachment 1, Section 1B states that multiple Excel files may be included, as necessary. Should individual files for each component be submitted, or should only one file that includes all expenses for all components be submitted?

RESPONSE: Individual files for each component should be submitted.

19. QUESTION: Page 63 of the BAA states that the technical proposal must include direct cost and resource information.

I. Should the attachment “Technical Proposal Cost

Information/Summary of Labor and Direct Costs” be provided for each component, or only for the entire project?

II. Which section of the technical proposal should include the cost information/summary form(s)?

III. Does the form(s) count towards the 250 page limit?

IV. Should this information be referenced anywhere else in the technical proposal?

RESPONSE:

I. The cost summary form should be provided for the entire project, as a whole. Each elective component should have its own cost summary form.

II. Please incorporate the cost summary form where it makes the most sense for your technical proposal.

III. Yes, this form counts towards the 250-page limit.

IV. No, this information should not be referenced anywhere else in the technical proposal.

20. QUESTION: On page 61 it states, “It is anticipated that multiple awards will be made from this solicitation and that the awards will be made on/about 12/31/2020.” We had assumed that the start date of the awards would have been on/about 04/01/2021 as the current CEIRS program is

Questions and Responses Page 6 of 7 scheduled to end on 03/31/2021. Shall we use 12/31/2020 as the start date in our proposals related to BAA # 75N93019R00028?

RESPONSE: Please use the date listed in the BAA: 12/31/2020.

21. QUESTION: On page 2 of Attachment 3 it states, “In addition, offerors may propose to support the following Elective Components: Reagent Core, Serology Core, Translational Development Projects, Modeling/computational Core.” If we propose to support any of these elective components, shall these be included in the main technical proposal which is limited to 250 pages? If the elective components are not to be included in the main technical proposal, are there page limitations for the elective components?

RESPONSE: They do not count towards the overall 250-page limitation. Limit elective components to five pages each.

22. QUESTION: Is the intent to fund both the operational build-up required for the basic research response? Or is the operational preparedness and early response piece outside of the scope of CEIRR?

RESPONSE: NIAID does not intend to fund operational build-up required for any pandemic response. The plan should include already operational facilities ready to provide emergency response.

23. QUESTION: Human Subjects Section – Are all the human subjects’ requirements described in pages 72-87 of the BAA included in the PHS Human Subjects and Clinical Trials Information Form and its attachments? Is the list of all personnel working on human subjects’ research (p.74) included in the form? If not, does any of this information count towards the 250-page limit for the Technical Proposal?

RESPONSE: BAA Page 70, #4 states that “The following subparagraphs shall be addressed, as applicable, in a SEPARATE FILE of the Technical Proposal entitled, "HUMAN SUBJECTS."” This file should be attached to the technical proposal and will not count towards the page limitation.

24. QUESTION: Does the “Vertebrate Animals Section” count towards the technical proposal’s 250-page limit? Does the VAS worksheet count towards the page limit?

Questions and Responses Page 7 of 7

RESPONSE: No, they do not count towards the page limit.

25. QUESTION: In general, do the attachments count towards the 250-page limit?

RESPONSE: No, technical proposal attachments do not count towards the page limit.

26. QUESTION: Are computers and external hard drives allowable?

RESPONSE: No, general purpose equipment is an unallowable cost under CEIRR and should not be proposed.