Amendment 1 - HHS-NIH-NIAID-BAA2024-1.pdf

HHS-NIH-NIAID-BAA2024-1 Page 1 of 5 Amendment One (1)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2024 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2024-1

Solicitation Amendment (One) 1

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D39, MSC 9821 Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2024-1

Date of Solicitation Issuance: December 13, 2023

Date of Amendment One Issuance December 29, 2023

Number of Pages: Five pages

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

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Vaccine Candidates

March 12, 2024

Therapeutic Candidates

In Vitro Diagnostics

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

Please see the Proposal Submission Instructions (Section 4.3.2.1) for more information. For planning purposes, the Government requests potential Offerors to submit a Notice of Intent.

Please see Notice of Intent (Section 4.3.2.1.4) for more information.

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Contracting Office Points of Contact:

Alexandra J. Buck, JD Contracting Officer *Email: NIAID_DMIDOmnibusBAAQuestions@nih.gov

*As a reminder, any correspondences regarding the BAA solicitation, including business and/or technical questions in addition to Notice of Intent letters, must be directed to the Contracting Officer in writing via the following Omnibus BAA email address:

NIAID_DMIDOmnibusBAAQuestions@nih.gov.

Due to the competitive nature of the Broad Agency Announcement, NIAID is unable to offer advice or feedback regarding an offeror’s technical approach.

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

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

PURPOSE OF SOLICITATION AMENDMENT #1

The purpose of Amendment One is to 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.

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

GOVERNMENT’S RESPONSES:

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

I. GENERAL QUESTIONS - APPLICABLE TO ALL RESEARCH AREAS:

QUESTION 1: Is the BAA a limited submission?

RESPONSE: No, this is not a limited submission. Please refer to page 3 of the Solicitation.

QUESTION 2: Who is eligible to submit a proposal? Are academic groups or academic/industry collaborations able to apply? Are you targeting start-up companies, small businesses, or established large companies?

RESPONSE: This BAA is being competed using full and open competition. All responsible offerors not otherwise prohibited by law are eligible to submit a proposal in response to this BAA Solicitation.

QUESTION 3: Are foreign entities eligible to submit a proposal?

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RESPONSE: Yes, as stated in the BAA Solicitation, all offerors, including foreign entities not otherwise prohibited by law, are eligible to respond to this BAA. If successful, clearance by the State Department will be obtained prior to awarding a foreign contract, a foreign subcontract, or a domestic contract with a foreign component.

QUESTION 4: I have a question about foreign involvement. Specifically, could a trial be carried out in a foreign country by a subcontractor? Are there any budget limitations with respect to how much of the award could be subcontracted out to an organization?

RESPONSE: The same full and open principal applies with regard to the clinical sites: the solicitation is considered full and open competition; thus non-US organizations may be included in a proposal as long as they are not a prohibited source identified in FAR 25.7. Please also refer to Sections 4 and 5 of the BAA regarding Human Subjects, Human Research and Clinical Trials.

Offerors should carefully review the content of the BAA to ensure compliance with all requirements of proposing subcontractors. The BAA does not specify budget limitation with respect to how much of award could be subcontracted, but offerors are encouraged to review FAR 52.215-23 Limitations on Pass-Through Charges.

QUESTION 5: Based on my reading of the BAA, the awards will not be made until May 2025 at the earliest and activities before that would not be part of the award. Should we focus the submission on where we expect to be in May 2025 and the activities for the 3-5 year period after that time? Also, does “At the discretion of the Government, awards may be streamlined to meet agency needs” mean that NIAID can award contracts associated with this BAA prior to May 2025?

RESPONSE: As stated in Section 3.2 Funding and Award Information, contracts resulting from this BAA Solicitation shall not reimburse costs incurred in connection with work performed outside the contract’s period of performance. Any costs incurred before the contract’s effective date or after its completion date are unallowable and cannot be charged to the contract. For Research Areas 001, 002, and 003, all awards are anticipated to be made in or around May 2025 with the same proposal due date (March 12, 2024) for each Research Area.

For all Research Areas, the total duration of a proposed contract should be consistent with the nature and complexity of the Offeror’s proposed research and may vary depending upon the scope of the project and the technical objectives. The total performance period comprising the combined Base Requirement and all Options proposed by an Offeror shall not exceed an estimated 5 years.

QUESTION 6: In the funding information section, can you please clarify whether NIAID intends to award 15 awards in total (i.e., 5 for each Research Area) or a total of 5 awards?

RESPONSE: NIAID intends to award up to five contracts in total across all three Research Areas, not five awards for each Research Area.

QUESTION 7: In a previous SBIR application for an Omnibus phase I, we were limited by a ~$300,000 maximum budget. Is that the case for this solicitation? What is the maximum budget?

RESPONSE: This acquisition is for the Omnibus Broad Agency Announcement which is separate and distinct from an SBIR solicitation along with its own requirements and specific instructions contained within the BAA Solicitation.

Regarding the budget, as stated in Section 3.2 Funding and Award Information, NIAID estimates a budget of up to $16 million for the award of up to 5 cost reimbursement type base contracts across all

HHS-NIH-NIAID-BAA2024-1 Page 4 of 5 Amendment One (1) three Research Areas. The estimated FY25 funding is for the non-severable Base Requirement (direct and indirect costs combined) to be divided between all contract awards for Research Areas 001, 002, and 003, depending on the number of technically meritorious proposals, agency priorities, and availability of funds. If options are proposed by an Offeror, they will be evaluated in accordance with Section 6 of the

BAA.

QUESTION 8: Can the timeframe of the Base & Options overlap?

RESPONSE: Yes.

II. SPECIFIC RESEARCH AREA QUESTIONS:

RESEARCH AREA 002

QUESTION 1: Under Research Area 002, are therapeutic proposals to include only Pseudomonas aeruginosa-directed efforts or are proposals which include Category A, B, and C priority Pathogens with multidrug resistance (such as Burkholderia pseudomallei or Burkholderia mallei) also included under this

BAA?

RESPONSE: Please refer to 3.3.2.1 - Technical Objectives bullet #3.

QUESTION 2: Please clarify what MERS-CoV experimental data the scientific reviewers of the BAA require to meet the definition of pan-coronavirus therapeutic.

RESPONSE: The definition of pan-coronavirus activity includes: in vivo efficacy against the primary coronavirus for the proposed program and then robust in vitro activity against SARS-CoV-1, SARS-CoV- 2 and MERS-CoV.

QUESTION 3: One of the requirements for Research Area #2 is “In vivo efficacy data consistent with the TPP and demonstrating therapeutic efficacy is provided.” (see checklist on p. 128). For submissions proposing a pan-coronavirus therapeutic: is in vivo efficacy data required for all three coronaviruses of interest (i.e., SARS-CoV-1, SARS-CoV-2, and MERS-CoV)? Or is it sufficient to have in vivo efficacy data for one virus (e.g., SARS-CoV-2), plus robust in vitro data for the other two viruses?

RESPONSE: The definition of pan-coronavirus activity includes: in vivo efficacy against the primary coronavirus for the proposed program and then robust in vitro activity against SARS-CoV-1, SARS-CoV- 2 and MERS-CoV.

QUESTION 4: Are preclinical studies acceptable? Can a drug-repurposing strategy be used?

RESPONSE: Please refer to section 3.3.2.4.

QUESTION 5: Are cell based therapies eligible to submit a proposal?

RESPONSE: Per section 3.3.2.1 of the BAA Solicitation, the following are not included: proteins, monoclonal antibodies, other biologic entities (except bacteriophages), and conjugates of such entities.

QUESTION 6: Can you please confirm that direct killing of the pathogen is required vs diminishing its damaging effect in vivo?

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RESPONSE: Please refer to section 3.3.2.1 - Important notice to Offerors: Research Area 002 only supports development of therapeutic products. “Therapeutic” activity refers to elimination or substantial reduction of infective pathogens by administration of a pharmaceutical agent after challenge.

QUESTION 7: Where can we find more information regarding our eligibility if proposing lead optimization and what is the budget limit?

RESPONSE: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding an offeror’s technical approach. Please refer to Section 3.2 for funding information and the funding question/response stated in this Solicitation Amendment. For lead optimization, please refer to Section 3.3.2.2 - Technical Approach/Lead Optimization. Regarding the budget limit, please see the response to General Question #7 above.