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

HHS-NIH-NIAID-BAA2025-1

Page 1 of 4 Amendment Five (5)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2026 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2025-1

Solicitation Amendment Five (5)

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 Five Issuance January 10, 2025

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 Five (5)

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 FIVE (5)

The purpose of Amendment Five (5) 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: Can you confirm that contract research organizations should be treated as subcontractors for the purposes of this application? If so, is there a list of accepted vendors for which additional documentation (e.g. facilities, floorplan etc.) may not be required? Are there any restrictions on activities which a CRO can perform?

Response: Yes. If the contract research organizations will be performing some activities proposed in the Statement of Work, they will be considered subcontractors. FAR 52.244-2 defines subcontract as any contract entered into by a subcontractor to furnish supplies or services for performance of the prime contract or a subcontract. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

The Government does not have an accepted list of vendors nor have restrictions for the CRO’s activities. It is the responsibility of the Offeror to propose a subcontractor(s) to perform the proposed activities and provide the necessary documentation. See Section 4 and 6 of the solicitation. Nonetheless, if selected for an award, a Contracting Officer’s Authorization will be required for each subcontractor prior to initiation of any work.

Question 2: The formatting guidelines on Page 42 of the BAA state that all margins must be at least 1-inch on all sides (g.). However, the NIH Biosketch format on the same page (a.) has a

0.5 inch margin – based on NIH’s own template. Are Biosketches an exception to the 1-inch

Page 3 of 4 Amendment Five (5) margin requirement or should the Biosketch template be reformatted to also have the requested

1-inch margin?

Response: You may use the NIH Biosketch template as is.

B. RESEARCH AREA SPECIFIC QUESTIONS:

1. RESEARCH AREA 001

a) Topic A

Question 3: Should results from supporting preliminary studies/work be included in the proposal? If so, are illustrative figures and tables acceptable?

Response: Results from supporting preliminary studies/work should be included to support the proposed research, and illustrative figures and tables are acceptable.

Question 4: For details within the technical proposal, if methods cannot be referenced due to in house development of assays, will a short description of said methods suffice?

Response: A short description of the in-house developed assay can be added to the technical proposal, including any relevant data appropriate for the proposed research.

Question 5: We have demonstrated in vitro activity against both bacterial and yeast

AMR infectious agents of interest and are very interested in the Topic 1 of the grant.

However, our lead active is a full-length protein (not antibody) and we are interested why this type of therapeutic is explicitly excluded from the grant and if there is any way we could still apply.

Response: This BAA covers antibody, and full-length protein is excluded based on our programmatic needs. See Section 3.3.1.1.1 - Technical Objectives “The following are not included: proteins, other biological entities, and conjugates of such entities (except monoclonal antibodies, nanobodies and bacteriophages).” Please understand that this

BAA will result in a contract and not a grant.

2. RESEARCH AREA 002

Question 6: If we are only proposing Pre-clinical and clinical stage activities (that is, not lead optimization), does a TPP need to be provided by the Offeror in the proposal? There is no mention of the TPP in the Description of Activities for those stages (see pages 14-15) of the

BAA.

Response: Stage-appropriate TPP needs to be provided as described in Section 3.3.2.2 -

Technical Approach and Section 3.3.2.3 – Additional Requirements.

Question 7: Section 5. SOW states the following: “The SOW table should be accompanied by a corresponding Gantt chart that clearly indicates the projected temporal relationships of performance periods, tasks and subtasks.” NIAID wants the Gantt chart in the SOW section?

Or should it be in Section 6?

Page 4 of 4 Amendment Five (5)

Response: See response to Question 1 of Amendment Two. The Gantt chart can be in Section 6.