HHS-NIH-NIAID-BAA2025-1 - Amendment Four.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 Four (4)

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 Four Issuance December 27, 2024

Number of Pages: Five (5)

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 FOUR (4)

The purpose of Amendment Four (4) 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: We have found that a contract does not allow several items that we normally include in grant budgets, such as travel to meetings, publications, and tuition support for graduate students. Are these activities allowable in this type of contract?

Response: A contract is subject to the FAR Part 31 – Contract Cost Principles and Procedures while a grant does not. However, each resulting contract is also based on the solicitation requirements. For this BAA, offerors are allowed to include travel costs for audit and contract initiation and annual review meetings. See Section 3.4.3 – Uniform Cost Assumptions (page

17). However, travel costs to general scientific meetings and publication costs are unallowable as direct costs as they are not required for this solicitation. For graduate students, see FAR

31.205-44 Training and Education Costs for allowability.

Question 2: Our planned proposal budget will trigger the need for a Small Business

Subcontracting Plan (SBSP). Per the solicitation the Offeror is required to submit their SBSP electronically within the SBCX system. Our proposal also includes a planned Subcontractor that will have a budget that exceeds the $750K threshold and they will also need to include an

(SBSP).

Our question is, should the Subcontractor submit a paper copy of their SBSP to the Offeror for inclusion in their proposal submission, or will the Subcontractor be required to submit their

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SBSP within the SBCX system as well? If, the Subcontractor is also required to submit their

SBSP within the SBCX system, do they need to log in separately from the Offeror? How would the process work?

Response: Only the Offeror with a proposed budget that exceeds a total estimated cost of

$750,000 for the entire period of performance will need to submit an SBSP via SBCX. This provision does not apply to small business concerns.

If an Offeror proposes a subcontractor that has a total budget that exceeds the $750,000, the subcontractor is only required to submit the SBSP to the Offeror and not via SBCX. The

Offeror is not required to submit the subcontractor’s SBSP in its Business Proposal as the

Government does not have any contractual relationship with the subcontractor.

Nonetheless, if awarded a contract, the subcontractor is required to submit an Individual

Subcontract Report, which is reviewed and accepted/rejected by the Offeror, via eSRS.

Question 3: Is there a designated section for the bibliography, or should the bibliography for each section be included within that section? If it’s the latter, does it count toward the page limit for that section?

Response: An Offeror should use its professional judgement to include the bibliography in the appropriate section(s) it deems fit in the Technical Proposal.

Yes, the bibliography is counted towards the 75-page limit. See Section 4.3.2.1.3 – Formatting and Page limitations (page 42).

Question 4: We are currently only planning on applying for the Base period funding. Can we submit Options later (say, 6 months from now)?

Response: No. While an Offeror may propose only a Base period, the Offeror will not be able to revise their proposal, such as adding an option(s), after the closing date and time specified in the BAA. Additionally, if awarded a contract, the contract cannot be reopened for negotiations to add Option(s). As such, an Offeror must use its professional judgement and decide whether to include an option(s)in its proposal at time of proposal submission. See response to Question 7 of Amendment One for additional information.

B. RESEARCH AREA SPECIFIC QUESTIONS:

1. RESEARCH AREA 001

a) Topic A

Question 5: Our proposal involves a novel Pre-Clinical Candidate antifungal agent.

We note that the BAA supports pre-clinical Investigational New Drug (IND) enabling studies, and clinical Phase I trials of lead candidates with demonstrated therapeutic activities. Are microbiological methods (MIC) development, validation and testing such as M23 (CLSI) QC studies (Tier 1 - single lab, Tier 2 - multi-lab) for broth and disks in scope for Research Area 1, Topic A?

Response: Not eligible. Please refer to Section 3.3.1.1.4 Contracts awarded under this

Topic will NOT support the following activities defined under subsection a.

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b) Topic C

Question 6: When analyzing resistance markers, does NIAID want an assay that shows a positive signal when any resistance marker is detected, or do you want a diagnostic that identifies each separate resistance so as to inform therapeutic choices?

Response: Per Section 3.3.1.3.1, Technical Objectives, “Offerors may propose a multiplexed fungal species identification (ID) platform or a comprehensive antifungal susceptibility testing (AFST) platform or a platform that accomplishes a combination of both diagnostic functions.” Proposals, therefore, should address fungal ID and/or antifungal susceptibility testing (AFST). Part of fungal ID may include antifungal resistance marker detection. This solicitation does not distinguish between identification of any resistance marker and identification of separate specific resistance markers.

2. RESEARCH AREA 002

Question 7: We note that eligible new chemical entities include small molecules such as

"nucleosides, or peptides of </=40 amino acids." Are oligonucleotides of <25 base pairs considered eligible? If so, are oligonucleotide/small molecule conjugates eligible?

Response: Not eligible. Please refer to Section 3.3.2.1 Technical Objectives bullet 4 as well as under Important notice to Offerors describing “therapeutics” candidate. Oligonucleotide/small molecule conjugates come under other biological entities.

Question 8: Would siRNA-mediated antiviral approaches be considered eligible, assuming the new chemical entity otherwise meets eligibility requirements?

Response: Not eligible. Please refer to the response in Question 7 above.

Question 9: It states it will not support “Development of a product that is prophylactic or otherwise not 'therapeutic' as defined in Section 3.3.2.1." However, if an antiviral agent is primarily therapeutic but also has prophylactic potential, would it be acceptable to propose its development for both therapeutic and prophylactic applications?

Response: The prophylactic development is not allowed under this BAA. Please see”Therapeutic” in Section 3.3.2.1 Technical Objectives under Important notice to Offerors on page 13.

Question 10: We are currently considering presenting two projects for Lead Optimization to the NIH as part of the Base period under Research Area 002: Each project focuses on a different viral target (from the same family). We can either pitch both projects as a combination, highlighting their synergistic potential to create a unique cocktail with molecules targeting both targets, OR we can select and advance only one of these two targets.

Target 1 is a commercially validated drug target and therefore our small molecule has a higher probability of becoming a drug faster. Target 2 is a novel target, with potential to be the first-in-class therapeutic.

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We are reaching out to you to seek clarity on whether we should submit both projects to run in parallel or if there is merit in focusing on either one (if so, which one?)

Response: Due to the competitive nature of this solicitation, the Government is unable to provide any feedback regarding specific technical approach. An Offeror must use its professional judgement and decide whether to submit one or multiple proposals.

An Offeror may submit multiple proposals to various funding announcement simultaneously. If the specific goals and objectives differ, an award can be made to an Offeror that has ongoing support from other NIH, or government agency, or government-supported sources. However, NIAID will remove any portion of a proposal that overlaps with research that is underway or completed.

An Offeror may have multiple contracts awarded by NIAID; however, an Offeror should assure that the principal investigator, and all other personnel proposed, shall not be committed on federal grants and contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed employee is committed for more than 100% of his or her time, the government will require action on the part of the Offeror to correct the time commitment. See Section 4.3.2.2, Section 7 (page 48) of the BAA.