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

HHS-NIH-NIAID-BAA2025-1

Page 1 of 4 Amendment Two (2)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2026 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2025-1

Solicitation Amendment Two (2)

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 Two Issuance December 11, 2024

Number of Pages: Four (4)

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

Page 2 of 4 Amendment Two (2)

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 TWO (2)

The purpose of Amendment Two (2) 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: I have a question about the intended content for Section 4 (Outline of the

Technical Plan) and how that differs from the intended content for Section 6 (SOW Technical

Discussion).

Clearly one key difference described is that Section 4 includes the summary table of contractor activities. However, I'm unclear what is meant by a 'high-level technical plan' for Section 4, and how that differs from the requirement for Section 6. I first thought that Section 4 was simply an outline, however that would appear to be the intended content for Section 5 (Statement of

Work). Can you please help clarify these issues?

Response: Section 4.3.2.2: Section 4: Outline of Technical Plan (page 43)

This section is like an executive summary for your Technical Plan.

Section 5: Statement of Work Format (page 44)

The Statement of Work should only provide an outline of tasks and subtasks (headers and sub-headers). The Statement of Work should not include detailed activities as they should be provided in Section 6: SOW Technical Discussion.

Section 4.3.2.2: Section 6: SOW Technical Discussion (page 46)

Page 3 of 4 Amendment Two (2)

This section should include detailed documentation to demonstrate how you will accomplish the work detailed in your proposed SOW.

Question 2: What is the NIAID’s official stance on female/diversity co-lead PIs?

Response: An Offeror may propose multiple Principal Investigators (PI) and will need to submit a Leadership Plan as part of the Technical Proposal. See Section 4.3.2.2, Section 7

(page 47) for additional requirement and information. Proposed co-PIs, not listed in the

Excluded Parties List System (EPLS), can include male, female, and of different diversity.

Question 3: Can you please elaborate what would be the impact on ownership of the results?

Response:

The awardee is solely responsible for the timely acquisition of all appropriate property rights, including intellectual property rights, and all materials needed for the awardee to perform the project. See Section 4.3.3.1.21 of the BAA.

A contract resulting from this BAA will incorporate general data rights and/or additional data rights for any data, including new discovery, developed under the contract. See Section 5.52

Contract Clauses for a Cost Reimbursement Research and Development Contract. Included in the list of clauses is FAR 52.227-14 Rights in Data – General (May 2014).

B. RESEARCH AREA SPECIFIC QUESTIONS:

1. RESEARCH AREA 001

a) Topic A

Question 4: Does a proposal focus on development of a marketed product for a new indication meets the eligibility criteria for evaluation?

Response: Not eligible. Please refer to Section 3.3.1.1.4 as defined under e and f.

Question 5: We are submitting a proposal for Lead Optimization only and will not include an Option for IND-enabling studies. Is this within the scope of Research Area

001, Topic A?

Response: Please refer to Section 3.3.1.1.2 – Technical Approach in the Table

(Desired End Point) "Selection of pre-clinical candidate(s) and completion of non-

Good Laboratory Practice (non-GLP) IND enabling activities with non-Good

Manufacturing Practice (non-GMP) manufacturing (3 years period of performance).”

2. RESEARCH AREA 002

Question 6: We have a lead nanobody conjugate that effectively inhibits all tested sarbecovirus strains (preclinical data). While we currently lack data on its activity against

MERS, this conjugate could be readily expanded to target MERS by substituting its warheads with those specific to MERS-conserved epitopes. Would this conjugate, which is

Page 4 of 4 Amendment Two (2) pan-sarbecovirus but not MERS-specific at this stage, qualify as a lead point of entry for further optimization under the BAA to encompass MERS?

Response: Please refer to Section 3.3.2.1 Technical Objectives, Page 13 which states

“Pan-coronavirus” activity requires demonstrated in vivo efficacy against clinical strains of SARS-CoV-2 variants and MERS-CoV.”

Question 7: Would a nanobody itself be considered responsive to the request or is it specifically looking for a nanobody-fusion product?

Response: A nanobody could be responsive if the proposed therapeutic development program achieves the Objectives described in Section 3.3.2.1 - Technical Objectives (Page

13) and stage-appropriate data is provided as described in the Section 3.3.2.3 - Additional

Requirements (Page 15)