Solicitation Amendment 1 - HHS-NIH-NIAID-BAA2026-1.pdf

HHS-NIH-NIAID-BAA2026-1 Page 1 of 7 Amendment One (1)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2027 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2026-1

Solicitation Amendment (One) 1

Requiring Office: National Institute of Allergy and Infectious Diseases

5601 Fishers Lane, MSC 9821, Bethesda, MD 20892-9821

Issuing Office: National Institutes of Health

NIH OD/OA/R&D Division A-3, OALM 6701 Rockledge Drive, RKL2, 4th Floor

Bethesda, MD 20817

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

Solicitation Number: HHS-NIH-NIAID-BAA2026-1

Date of Solicitation Issuance: October 9, 2026

Date of Amendment One Issuance November 4, 2026

Number of Pages: Seven pages

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

Research Area remains unchanged:

RESEARCH

AREA

TITLE SOLICITATION

PAGE NO.

PROPOSALS

DUE*

Vaccine Candidates

December 8, Therapeutic Candidates

In Vitro Diagnostics

HHS-NIH-NIAID-BAA2026-1 Page 2 of 7 Amendment One (1)

* Proposals must be received before 3:00 PM Eastern Standard 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.

Offers will be valid for 240 days unless a different period is specified by the Offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043”.

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.

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:

1) Provide the NIAID’s response to questions received regarding the solicitation and

2) Provide a due date of December 2, 2026 for questions from potential offerors.

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 there a due date for the submission of business or technical questions in response to the solicitation?

Response: December 2, 2026 is the last day to submit any questions regarding the BAA Solicitation.

Offerors are encouraged to submit their questions timely.

Question 2: Can an offeror be granted a time extension to submit their proposal?

Response: Due to the competitive nature of the BAA solicitation for proposed contract awards, we are unable to authorize an extension for individual offerors. There may be instances where a time extension is authorized for all offerors under a solicitation. If a time extension was authorized for all offerors, this would be communicated in a solicitation amendment on www.sam.gov and made available to all offerors.

Timely submission of proposals are strongly encouraged as late submissions will not be considered.

https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sam.gov%2F&data=05%7C02%7CNIAID_DMIDOmnibusBAAQuestions%40niaid.nih.gov%7C148b7b0f0c5b42111f3608df35220873%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C639288092412892429%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=o7uuC9AAm0OZweE37mf90PtN%2BszfdqJeJysl6idYog8%3D&reserved=0

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Question 3: Similar to a BARDA Tech Watch meeting, is there a mechanism to meet with NIAID staff prior to our submission to get feedback on the feasibility and programmatic fit of our planned proposal?

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 or programmatic fit. Please review sections 3.3.1.1 and 3.3.1.3 (e.g., vaccine candidates). Each Research Area identifies both the technical objectives and the types of activities that are not supported by this BAA solicitation.

Question 4: Page 4 of the BAA states "For Fiscal Year (FY) 27, NIAID estimates up to $16 million for the award of up to 4 cost reimbursement completion type contracts." If we were to propose a 3 year period of performance (BASE period yr1, followed by two OPTION periods of 1 yr each), does the cost of the three year development program have to be covered by the above mentioned FY27 funds or does NIAID anticipate additional funding in FY 28 and FY29 to cover OPTION periods?

Response: The total estimated award amount of up to $16 million is for the non-severable BASE requirement to be divided among all contract awards for the three research areas. NIAID estimates awarding up to 4 cost reimbursement type contracts; however, the number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

Offerors should propose a budget that is aligned with the Statement of Work proposed. The total cost for each award (Base and options) may vary depending upon the scope of the project and the technical objectives of the award. The Base will be fully funded at time of award, and each non-severable Option, if proposed, will be fully funded when it is exercised at the discretion of the Government. For example, if the Base performance period is two (2) years, the contract will be fully funded for two (2) years at time of award.

Base and options need not be proposed as consecutive one-year periods. Additionally, options are not required to follow sequentially from the Base or a previous option. Rather, each option should reflect a logically coherent set of tasks whose requirement is defined by certain prerequisites having been met during contract execution. It is possible for multiple options and/or base to be concurrent depending on the proposed design of the development program. It is permissible that a proposal includes only a Base period. The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. The total performance period comprised of the Base and any options proposed by an Offeror should not exceed five (5) years.

In proposing the total cost and performance periods for the Base and each option, the Offeror should use its professional judgement in estimating its best offer and make a reasonable estimate of the time in months that would be needed to complete the activities under the Base and each option.

“Non-severable” means work resulting in a final product or end-item and for which benefit is received only when the project is complete, such as process development activities resulting in a product development report or efficacy studies sufficient to submit for regulatory approval of a candidate to enter clinical trials.

Question 5: What is the amount of funding for each applicant in the BAA and how many years?

Response: Offerors should propose a budget that is aligned with their proposed Statement of Work.

Further, per section 3.2, Funding and Award Information, the total performance period including the Base Requirement plus all Options proposed by an Offeror shall not exceed an estimated 5 years.

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The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. In proposing performance periods for the base and each option, the Offeror should make a reasonable estimate of the time in months that would be needed to complete the activities under the base and each option. However, the total performance period comprised of the base and any options proposed by an Offeror shall not exceed five (5) years.

For further information, please review the response to Question #4 above.

Question 6: I am interested in applying for the following grant. As NIH limits the maximum number of grants a PI can apply to 6 per calendar year, I want to check with you whether this application will count as one grant application.

Response: The Broad Agency Announcement (BAA) is for a contract award, not a grant. There are no formal stipulations regarding the number of contract awards to a particular organization. However, offerors should be sure to include all relevant information in Attachment #4, “Summary of Related Activities”, key personnel (including the Principal Investigator) must be named in the contract award and must not exceed 100% effort, inclusive of contracts and grants. Additionally, offerors must provide evidence that they have sufficient staffing and resources to deliver the stated contract requirements.

Question 7: Who is eligible to submit a proposal? Are academic groups, academic/industry collaborations, and FFRDCs able to apply? Is NIAID targeting start-up companies, small businesses, or established large companies?

Response: This BAA is being competed using full and open competition for proposed contract awards, not grants. All responsible offerors not otherwise prohibited by law are eligible to submit a proposal in response to this BAA Solicitation. Additionally, review Section 4.2 for general information and submission requirements, including registering for all Government awards in www.sam.gov and completion of the electronic Representation and Certifications, including the applicable NAICS code and size standard.

Question 8: We noticed that for the 2027 NIAID DMID Omnibus BAA, NIAID anticipates awarding “cost reimbursement completion type contracts.” Could you please let us know what funding mechanism/s you anticipate using and whether a mechanism such as an interagency agreement (IAA) could be considered?

Response: The purpose of the BAA solicitation is to issue cost reimbursement contract awards. An IAA cannot be used as a mechanism to issue a contract award under this BAA Solicitation. Also, please refer to Question 7 regarding eligibility of offerors and Section 4.2 for submission requirements, including registering for all Government awards in www.sam.gov and completion of the electronic Representation and Certifications, including the applicable NAICS code and size standard.

Question 9: Can a foreign entity/organization serve as prime contractor or as a subcontractor for this solicitation?

Response: The BAA is being solicited using full and open competition. Thus, all offerors not otherwise prohibited by law, including foreign entities, are eligible to respond. Additionally, please refer to Section 3.4.1, as there is some discussion regarding the process for proposed foreign awards or domestic contracts with a foreign subcomponent/subcontract. Foreign contractors and collaborators will need to go through NIH Internal Review. Additionally, foreign organizations are eligible to serve as prime contractors for an award from this solicitation as long as they are not a U.S. restricted entity. NIH does not have a list of http://www.sam.gov/ http://www.sam.gov/

HHS-NIH-NIAID-BAA2026-1 Page 5 of 7 Amendment One (1) restricted entities, though the National Science Foundation maintains a website listing this information for multiple agencies. Note that restricted entities may not be the prime nor a subcontractor. Please note, there may also be restrictions on a foreign entity’s subsidiaries, including its subsidiaries based in the United States.” For more information, please refer to the following site for general guidance.

https://www.nsf.gov/funding/information/dcl-prohibition-collaborations-entities-us-prohibited-party.

Question 10: In Section 3.7.4. Uniform Cost Assumptions, it was stated that costs will not be allowed for the purchase of any equipment, hardware or software. If our project were to require the purchase of new hardware/equipment would include that in the PDP and technical documents but omit from the financials or just have a subsection that would demonstrate that we would purchase the equipment?

Response: Offerors should include any planned purchase of equipment in the required Product Development Plan (PDP) and technical documents to clearly justify the need to the Government and not expect reimbursement under the contract award. There should be no costs associated with the equipment proposed in the budget.

II. SPECIFIC RESEARCH AREA - TECHNIAL QUESTIONS:

1) Research Area 1 – Vaccine Candidates:

Question 1: We have a question regarding the following statement on page 5 of the BAA document.

Regarding proposed adjuvants, the BAA states:

• Adjuvant(s) must have been used in a prior Phase 1 clinical trial and demonstrated safety

We are wondering whether the prior Phase 1 clinical trial in which the adjuvant was tested needs to be via the same route of administration as is proposed here or does demonstration of safety of the adjuvant in a Phase 1 clinical trial via any route of administration meet the criteria listed above? In other words, if Adjuvant X demonstrated safety in a Phase 1 clinical trial via intramuscular administration, is it acceptable to propose using Adjuvant X via intranasal administration in response to this BAA?

Additionally, in the event that we were to propose a combination adjuvant, does the combination adjuvant need to have been used in a prior Phase 1 clinical trial and demonstrated safety or does demonstration of safety in separate Phase 1 clinical trials meet the criteria listed above? In other words, if Adjuvant A demonstrated safety in a Phase 1 clinical trial and Adjuvant B demonstrated safety in a different Phase 1 clinical trial, is it acceptable to propose using Adjuvant A + Adjuvant B as a combination adjuvant in response to this BAA?

Response: Prior Phase 1 data for the adjuvant does not need to be for the same route as proposed for this Broad Agency Announcement. It is acceptable to propose a combination of adjuvants where each individual adjuvant has been evaluated separately for safety in a previous Phase 1 trial, but where the combination of adjuvants has not.

Question 2: Regarding the vaccine solicitation (Research Area 001), are vaccines targeting fungal pathogens eligible under this research area?

Response: No, vaccines targeting fungal pathogens are not in scope, please review section 3.3.1.1.

https://www.nsf.gov/funding/information/dcl-prohibition-collaborations-entities-us-prohibited-party https://www.nsf.gov/funding/information/dcl-prohibition-collaborations-entities-us-prohibited-party

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2) Research Area 2 – Therapeutic Candidates:

Question 1: Are humanized monoclonal antibodies targeting a particular pathogen eligible under this BAA? From my readings, it seems that this mab is eligible for funding under this opportunity. Can you please comment on this assumption? Also, we have a dual antigen vaccine candidate, with the vaccine given through needle injection. Is this eligible for submission under Research area 001 (vaccine candidates) or Research Area 002 (e.g., as a therapeutic vaccine)?

Response: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding whether to submit a proposal. Monoclonal antibodies are within scope, please review section 3.3.2.1. under Research Area 002. Vaccines for bacterial or fungal pathogens for Research Area 001 are not in scope, please review section 3.3.1.1 for eligibility under Research Area

001. Vaccines for Research Area 002 (Therapeutic Candidates) are not in scope, please review section 3.3.2.1.

Question 2: Regarding the therapeutics solicitation (Research Area 002), is a therapeutic targeting one of the fungi mentioned (candida, Aspergillus, and/or Mucorales) responsive?

Response: Please review section 3.3.2.1, specifically 3.3.2.1.d: “At least two of the following (i.e., addressed with a broad spectrum antimicrobial): susceptible and carbapenem-resistant Enterobacteriaceae (CRE), susceptible and multidrug resistant (MDR) Pseudomonas aeruginosa, and susceptible and Carbapenem-resistant Acinetobacter (CRAB), with potential to improve patient outcomes in the clinic;

Candida auris, Cryptococcus spp., Aspergillus fumigatus, and/or Mucorales”.

Question 3: We are currently in the lead optimization phase with lead candidates for the listed viral indications. While the language in the BAA suggests that lead optimization followed by rapid progression into non-GLP IND-enabling studies and manufacturing is within scope, Attachment 17 ("Research Area 002 - Therapeutic Candidates - Technical Proposal Readiness Checklists") lists prior in vitro ADME, in vivo PK, and in vivo toxicology data as required criteria for submissions under RA002.

Could you please clarify whether proposals that include lead optimization activities are considered exempt from these checklist criteria at the time of submission?

Response: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding whether to submit a proposal. Lead optimization proposals must include in vitro ADME, in vivo PK and in vivo toxicology data that indicate there are viable candidates in the series. The offeror should review section 3.3.2.3 - Additional Requirements.

Question 4: We are considering a proposal under Research Area 002 and would appreciate clarification on the animal efficacy requirement for projects entering at the lead-optimization stage. For a lead-optimization proposal targeting one pathogen, could efficacy in a relevant model using a different pathogen satisfy the requirement in Section 3.3.2.3, with animal efficacy studies included in the proposed work, or must therapeutic efficacy against the target pathogen itself be demonstrated before submission?

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 or programmatic fit. The offeror is referred to review section 3.3.2.3.

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3) Research Area 003 – In Vitro Diagnostics:

Question 1: We would appreciate clarification regarding the preliminary data requirements described in Research Area 003 – In Vitro Diagnostics. Section 3.3.3.2 indicates that proposals should include completed foundational preliminary data beyond proof of concept, including feasibility-phase testing but I’m asking if a proposal that describes the development and feasibility testing of this new integrated diagnostic platform, supported by the team's existing technical capabilities but without full preliminary feasibility data for the proposed integrated system, be considered adequately responsive to Research Area 003 in your BAA? Does the solicitation require that the feasibility testing of the proposed diagnostic technology be complete before a proposal submission?

Response: Feasibility testing need not be fully completed at submission, but as stated in section 3.3.3.2, any feasibility-phase data that has been completed should be presented to justify maturity of the program at submission.

Question 2: We have applied for a Direct to Phase II at NIAID and the question is can we apply for this BAA to for the same virus family or apply for another family of viruses?

Response: Pathogen targets chosen for the BAA are independent of and can be the same as those chosen for SBIR applications. However, funding cannot be received from multiple sources for the same scope of work.