HHS-NIH-NIAID-BAA2025-1 - Amendment Three.pdf

HHS-NIH-NIAID-BAA2025-1

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2026 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2025-1

Solicitation Amendment Three (3)

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID)

5601 Fishers Lane, Room 3D38, MSC 9821

Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2025-1

Date of Solicitation Issuance: November 22, 2024

Date of Amendment Three Issuance December 18, 2024

Number of Pages: Six (6)

Proposal Due Dates: The hour and date specified for receipt of offers for each

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Development of Candidate

Therapeutics, Vaccines, and In Vitro

Diagnostics for Antimicrobial-Resistant

(AMR) Bacterial or Fungal Pathogens

February 21, 2025

Development of Direct Acting

Antivirals (DAA) for Viral Families of

Pandemic Potential

January 21, 2025

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein.

Contracting Office Points of Contact:

Primary Contact:

Swee L. Teo, Contracting Officer

Email: teosl@niaid.nih.gov

Phone: 240-669-5173

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

mailto:teosl@niaid.nih.gov

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Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The cut-off date for questions for each Research Area is:

• Research Area 001 – February 10, 2025

• Research Area 002 – January 10, 2025

A final Amendment will be posted within a week after each cut-off date. Questions received thereafter may not be addressed.

PURPOSE OF AMENDMENT THREE (3)

The purpose of Amendment Three (3) is to:

I. Provide the NIAID’s response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.

Due to the competitive nature of the BAA, NIAID cannot provide any technical direction or feedback regarding an offeror’s specific technical approach.

Please note, in the questions/responses below, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

I. GOVERNMENT RESPONSES:

The Government’s responses to questions received regarding this solicitation are as follows:

A. GENERAL QUESTIONS APPLICABLE TO ALL RESEARCH AREAS:

Question 1: Do we need to include Attachment 2 (Technical Proposal Cost Summary) in the technical proposal? If so, in what section of the technical proposal should this be included?

Response: Yes, your Technical Proposal must include the Technical Proposal Cost Summary.

See Section 4.3.1.2. (page 35) for additional information. You have the discretion to include this Summary in the section you deem fit in your Technical Proposal.

Question 2: The link for Attachment 14 leads to a Page Not Found. Can you provide a new link to the PHS Human Subjects and Clinical Trials Information Form?

Response: Please use this link for Attachment 14: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j. A PHS Human

Subjects and Clinical Trials Information Form is also provided in word form alongside this

Amendment.

Question 3a: To our understanding we need to create the Breakdown of Proposed Estimated

Costs (plus fee) and labor hours form. How detailed do the expenses in each category (i.e.

chemicals, bioagents, glassware, publication and facility core, glassware) need to be?

https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

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Response: A template for the Breakdown of Proposed Estimated Cost (plus fee) is provided as

Attachment 9 in Section 8 (page 126). There are 2 links – one for instructions on how to complete this template and the other is the excel spreadsheet template. Section 4.3.3 also provides additional instructions for completing this template.

Question 3b: Are quotes from venders acceptable for certification of pricing?

Response: Yes, vendors’ quotes are acceptable as supporting documentation. However, these quotes do not replace the Certified Cost or Pricing Data as it is required in your Business

Proposal in accordance with Section 4.3.3.1.3. (page 74) of the solicitation.

Question 3c: How are the expenses matched to the Gantt chart?

Response: The Gantt Chart provides the timelines for a project. For your proposed estimated costs, see response to Question 7 of Amendment One for guidance.

Question 3d: We are assuming that subcontractors (Universities) need to provide the same expense breakdown.

Response: Yes. For each subcontractor proposed, you will need to provide:

i. A Breakdown of Proposed Estimated Cost (plus fee) for cost-reimbursement type agreement;

or

ii. A quote for fixed price type agreement.

Question 3e: Is there a checklist for required documents for the budget proposal?

Response: No, there is no checklist for the budget proposal. See response to Question 3a above for required budget information and Section 4.3.3 for Business Proposal Instructions.

Question 4: Are there any example applications available, similar to those provided for grants, but specifically for the BAA? If so, could you guide me on how best to access them?

Response: There is no application sample for the BAA as the Statement of Work, including the specific technical requirements and performance specification, is developed and proposed by the Offeror, not the Government. See Section 1 (page 4) of the BAA. An Offeror should carefully review the content of the BAA for information regarding the technical objectives of each Research Area and Topic #, if applicable, of this omnibus BAA (Section 3), instructions regarding the proposal submission (Sections 4 and 5), and a description of the evaluation and award process (Section 6); and exercise its professional judgement in compiling its proposal.

Please understand that this solicitation will result in a contract and not a grant.

B. RESEARCH AREA SPECIFIC QUESTIONS:

1. RESEARCH AREA 001

a) Topic B

Question 5: On pages 54 and 55 of the solicitation, do the following requirements apply only to Phase III clinical trials? Or, do these apply to Phase I trials as well?

“Also, the proposal must include one of the following plans:

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• Plans to conduct valid analysis to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR

• Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups, OR

• Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.”

Response: The specific requirements identified only apply to Phase III trials and not to

Phase I trials.

b) Topic C

Question 6: Overall, Offerors are encouraged to submit proposals for innovative solutions that significantly improve existing capabilities for direct-from-blood or other biofluid detection and identification of fungal infection with phenotypic AFST. Does this limit the sample types accepted to blood and biofluids, or are other sample types such as tissue biopsies permitted?

Response: Per Section 3.3.1.3.2, p. 12, sample collection from a relevant clinical matrix, including tissue biopsies, is permitted.

Question 7: Section 3.6 Notes that a Product Development Plan and a Work Plan are required as part of the initial submission for Topic C and are to be included in the

Technical Proposal. I could not seem to mesh this with the Technical proposal instructions laid out in Section 4. Is there a specific section of the Technical proposal that should include these documents? Do they replace an existing section, or fit in elsewhere?

Response: The Product Development Plan (PDP) and Work Plan (WP) must be included in the Technical Proposal. See Sections 3.6.1 and 3.6.2. A PDP describes the background, technical details, and plan for the proposed candidate/product while a

Work Plan describes the studies to be performed under the Base and each Option, if proposed, and flows from the Statement of Work. You have the discretion to include them in the appropriate section(s) as you deem fit in your Technical Proposal.

The Government’s suggestions:

The PDP may be included in Section 4: Outline of Technical Plan (page 43) while the

WP may be included in Section 6: SOW Technical Discussion (page 46).

Question 8: Would innovative sample collection solutions (e.g. exhaled breath collection) be in the scope of Research Area 001, Topic C or only solutions comprising a full workflow (sample collection, sample preparation and testing) are eligible?

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Response: Per Section 3.3.1.3.2, p. 12, innovative sample collection solutions from a relevant clinical matrix (e.g., exhaled breath collection) are in-scope, but should be combined in a submission with a workflow for a full IVD assay. The key and lone innovations may be the sample collection and sample type, but the proposal solution should be for complete development of an IVD assay.

Question 9: This Topic, which covers diagnostics for fungal pathogens, fits our capabilities very well, but I noticed that the BAA states the following:

c. Development of a diagnostic ID test that relies solely on host-response markers

(antibodies, other proteins, or RNA).

Our approach works based on WBC w/diff response. Based on this, do you think our work can still be responsive to the BAA l? Or am I misinterpreting the BAA?

Response: Per Section. 3.3.1.3.3. (c) p. 12, test that relies solely on host-response markers (antibodies, other proteins, or RNA) will be excluded from peer review and will not be considered further for award. This exclusion includes host cells as the host-response markers,

2. RESEARCH AREA 002

Question 10: The solicitation specifies that eligible therapeutic candidates include nanobody conjugates or fusion products but excludes proteins, monoclonal antibodies, and their conjugates. Our approach is based on a DNA construct encoding a pan-targeting CRISPR-Cas with multiplexed guide RNAs designed to target all viruses that acts a direct anti-viral for the entire viral family. Is this approach a suitable therapeutic candidate as applies to this solicitation?

Response: This approach is not supported. Please refer to Section 3.3.2.1 technical Objectives

“nanobody conjugates/fusion products that are directly acting on viral targets and functions

(not through the modulation of the host responses)”.

Question 11: Under the 3.3.2.2 Technical Approach of the BAA, it states that “Research Area

0002 will support lead optimization, pre-clinical (IND enabling) studies, and/or Phase 1 clinical trials.” It is our understanding that the technology can have an entry point of the proposal in

“Lead Optimization” (3 yr POP) and can then transition to “Pre-Clinical Candidate” efforts for a combined POP of 5 years. Have I interpreted this correctly? The alternative is that one can have either an entry point of “Lead Optimization” or “Pre-Clinical Candidate” or “Clinical

Candidate.” Can you please clarify?

Response: The proposal can have one entry point of Lead Optimization (3-year period) or

“Pre-Clinical Candidate (3-5 year period) or Clinical Candidate (3-year period). Please refer to the Table under the 3.3.2.2 Technical Approach Section that defines the entry point to the contract and desired endpoints for each. Your period of performance depends on the entry point of the contract points for each.

Question 12: Can non-human primate work be subcontracted to NIAID for this application?

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Response: No. Offerors should not propose the use of NIAID or NIAID programs/services, such as Preclinical Models of Infectious Diseases, In Vitro Assessments of Antiviral Activity, etc, to complete any tests/studies in their Technical Proposals.

Question 13: Is it correct that preclinical projects are limited to a maximum duration of three years?

Response: For Lead Optimization, which includes the selection of pre-clinical candidate(s) and completion of non-GLP IND enabling activities with non-GMP manufacturing, the period of performance should not exceed 3 years. Please refer to Section 3.3.2.2 Technical Approach in the table that provides the desired endpoint for each type of entry point of the proposal.

Question 14a: We plan to propose a lead optimization entry point of the proposal, which according to the table on page 14 has a 'desired end point' of selection of pre-clinical candidate and completion of non-GLP IND enabling activities and non-GMP manufacturing. We assume this means that we cannot propose GLP IND enabling and GMP manufacturing, but the word

'desired' suggests this is not firm. Please confirm.

Response: See the response to Question 11 above.

Question 14b: Is 3 years the maximum contract length for a lead optimization entry?

Response: If the proposal is entering the Lead Optimization Stage, the period of performance should not exceed 3 years per Section 3.3.3.3 Technical approach.

Question 15: Does the award date of November 2025 occur after negotiations, so this would be when funding and activities would start?

Response: Proposals received in response to the BAA must be evaluated in accordance with the

Evaluation Factors for Award specified in Section 6. If a proposal is technically acceptable and selected for discussions/negotiations, the Government reserves the right to conduct discussions/negotiations about all, some, one, or none of the proposals received in response to this BAA. The Government also reserves the right to make awards without discussions/negotiations. The selection for award under this BAA will be based upon the evaluation factors, agency priorities, and the availability of funds. See Section 1 (page 4) for additional information and Section 6 (page 117) – Evaluation Factors for Award for the process and evaluation factors.

If awarded a contract, the Base contract will be fully funded at time of award, which is anticipated to be made in or around November 2025. The awardee can start working on the project on the effective date of the contract. Please note that contracts resulting from this BAA shall not reimburse costs incurred in connection with work performed outside the contract’s period of performance. Costs incurred before the contract’s effective date or after its completion date are unallowable and cannot be charged to the contract. See Section 3.2 (page

5) of the BAA.