Amendment 2 - HHS-NIH-NIAID-BAA2024-1.pdf

HHS-NIH-NIAID-BAA2024-1 Page 1 of 8 Amendment One (2)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2024 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2024-1

Solicitation Amendment (Two) 2

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 January 19, 2024

Number of Pages: Eight 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 #2

The purpose of Amendment One is to provide the NIAID’s response to questions received regarding the solicitation and provide further clarification regarding Section 3.3.1.1 – Research Area 001. 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: Will any of the awards be expedited under the three Research Areas?

RESPONSE: Proposals for all 3 Research Areas are due by 3:00 p.m. EDT on March 12, 2024. As referenced in the BAA solicitation, May 2025 is the earliest anticipated contract award date for all three Research Areas.

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QUESTION 2: For proposers other than small business concerns, if the proposed contract exceeds a total estimated cost of $750,000 for the entire period of performance, the offeror is required to submit a "Small Business Subcontracting Plan" through SBCX by the proposal submission deadline. Does this also apply to subcontractors that aren't small business concerns who are proposing over $750,000 or just to the offeror?

RESPONSE: If applicable, only offerors (prime contractors) need to submit their Small Business Subcontracting Plan in the SBCX system by the proposal submission deadline. Please note, although subcontractors proposing over $750,000 that are not small business concerns need to submit Subcontracting Plans, they will be requested during negotiations if your organization is selected.

QUESTION 3: If awarded a contract, would it be FAR-based and subject to cost accounting standards (CAS)? We would potentially be interested in responding to this BAA, but only if the Government would consider awarding an OTA. We are a non-traditional government contractor and have not performed contracts subject to CAS.

RESPONSE: Any resulting contract award would be FAR-based and subject to CAS unless explicitly exempt under the FAR. Section 4.3.3.1.2 Item #8 requires offerors to clearly indicate on their Business Proposal Cover Sheet whether your organization is subject to cost accounting standards in addition to other pertinent CAS information. Additionally, please refer to Section 4.2.3.2. and 4.3.3.1.14 of the

BAA.

4.2.3.2 - FAR 16.301-3

The FAR limits the use of any contract type, other than firm-fixed price, to a contractor whose accounting system is adequate for determining costs applicable to the contract. To be considered for an award under this solicitation, the Offeror is required to certify, in its Business Proposal, the adequacy of its accounting system. See the paragraph entitled, Adequate Accounting System in Section 4.3.3 - Business Proposal Instructions, in this solicitation for additional information about this certification.

4.3.3.1.14 - Adequate Accounting System FAR Part 16 sets forth the requirements and limitations for consideration of contract type. As stated in Section 4, Instructions, Conditions, and Notices to Offerors, of this solicitation, the resultant contract will not be Firm-Fixed Price. Therefore, the offeror's/contractor's accounting system and practices must be adequate and suitable for accumulating costs under government contracts.

QUESTION 4: Would it be possible to get an advance copy of the contract template that you would provide to us should we apply for and be offered the grant?

RESPONSE: Please note, the BAA solicitation will result in contract awards, not grants. As referenced in Section 4.2.3.1, any resultant contract shall include the clauses applicable to the selected offeror's organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract.

Additionally, Section 5 identifies Special Contract Requirements that may be applicable to an offeror’s proposed project and reiterates that any resultant contract will include provisions applicable to the selected offeror’s organization and the specific scope of activities awarded, as required by Public Law, Executive Order, Regulation, or Policy in effect at the time of execution of the proposed contract.

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The following website also contains reference material for prospective offerors and contractors including options to view general contract clauses including FAR clauses and clauses for negotiated cost-reimbursement contracts with various entities.

https://oamp.od.nih.gov/nih-document-generation-system/reference-material-prospective-offerors-and-contractors/general-clause-listing

QUESTION 5: After going through the solicitation, we noted that the technical proposal length has been reduced to 75 pages. We thank NIAID for providing page limit guidance on Sections 2-9 of the technical proposal, which adds up to the 75-page limit.

However, we noted that we also need to include several other sections in the technical proposal that were not included in page limit guidance. Additional sections for Human Subjects, Vertebrate Animal Sections (VAS), and a bibliography will also be needed. Can NIAID provide a suggested page limit for the Human Subjects and bibliography sections? NIAID did suggest 1-2 pages for the VAS, but I do not believe that was factored into the page guidance given for Sections 2-9 as Sections 2-9 total 75 pages.

RESPONSE: If an offeror proposes human, animal studies and/or clinical trials, the Vertebrate Animal Section and/or Human Subjects requirements as well as references are included in the 75-page limitation for the Technical Proposal. Pages in excess of this 75-page limitation will be removed from the proposal.

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.

QUESTION 6: In addition to the Technical and Business Proposals, all Offerors must complete Attachment 14, the “PHS Human Subjects and Clinical Trials Information Form" (BAA page 41). For Research Area 001, human subjects information is also included in the Technical Proposal in a separate section (BAA page 48, under 4.3.2.3). The Human Subjects section of the BAA (starting on page 48) discusses some items that would be uploaded as part of Attachment 14 but the statement that a separate human subjects section is required in the Technical Proposal makes it sound like all items listed in that section of the BAA need to be addressed as part of the separate “Human Subjects” section of the Technical Proposal. Are the attachments to Attachment 14 excluded from the Technical Proposal page limit and may the Technical Proposal refer to Attachment 14 rather than include the same information in two places?

RESPONSE: If an offeror proposes human, animal studies and/or clinical trials, the Vertebrate Animal Section and/or Human Subjects requirements as well as references are included in the 75-page limitation for the Technical Proposal. Pages in excess of this 75-page limitation will be removed from the proposal. 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.

QUESTION 7: As we design the proposal it is important for us to understand who will be holding the IND and data management. In prior studies we have conducted with DMID or DAIDS as the sponsor, DMID/DAIDS have been the IND sponsor.

RESPONSE: It is DMID’s expectation that the awardee will hold the IND. However, upon completion of protocol development, DMID will determine if the offeror will hold the IND and conduct the clinical trial—please refer to Section 3.4.1 of the BAA--CLINICAL TRIAL PROTOCOL DEVELOPMENT AND IMPLEMENTATION. The Contractor shall develop a protocol and all associated documents for each clinical trial and submit drafts for review as well as all final protocols and protocol amendments for

HHS-NIH-NIAID-BAA2024-1 Page 5 of 8 Amendment One (2) approval by DMID. Associated documents include a Data Management Plan. Please refer to Section

3.5.1 of the BAA - Reporting Requirements, Subsection I--. Draft and Final Clinical Trial Protocols.

QUESTION 8: Will the maximum participant number of 120 for the phase II trial also include participants who are only part of the phase I work?

RESPONSE: The trial objective and number of participants for all clinical trials should be well justified;

120 is given as an example on how to limit the size and therefore costs of Phase 2 trials. Whether participants count in both Phase 1 and Phase 2 depends on how the trial(s) are designed and the Offeror should use their best judgment.

QUESTION 9: One of my faculty plans to submit to HHS-NIH-NIAID-BAA2024-1 for the March 12 deadline. She has continuous submission privileges due to study section service. If this BAA eligible for continuous submission?

RESPONSE: This does not apply to the contract funding mechanism in the BAA. All offerors must submit their proposals by the due date in the solicitation. Please refer to the following site which is applicable to grants only: https://public.csr.nih.gov/FAQs/ApplicantsFAQs/ContinuousSubmission#1 .

QUESTION 10: Is the omnibus BAA posted on December 22nd, 2023 (https://grants.nih.gov/grants/guide/notice-files/NOT-AI-24-014.html) the correct BAA for this work?

RESPONSE: Yes, this is the correct link for the NIH Guide Notice. However, please ensure to review the entire BAA Solicitation & Solicitation Amendments to date posted on www.SAM.gov before preparing and submitting a Business Proposal, Technical Proposal, and a Small Business Subcontracting Plan (if applicable). Please note, the Small Business Subcontracting Plan must be submitted separately by the proposal due date in the SBCX System, not in the eCPS system which is solely designated for the Business & Technical Proposals.

II. SPECIFIC RESEARCH AREA QUESTIONS:

A. RESEARCH AREA 001

QUESTION 1: I noted that Research Area 001 - Vaccine Candidates indicated an interest in approaches against pathogens listed on the NIAID Emerging Pathogens List with a special interest on B. pertussis, V.

cholerae, and Valley Fever. I was wondering if the “special interest” list excludes other members of the Emerging Pathogens List such as Chlamydia psittaci (Psittacosis). Would you entertain a proposal for a vaccine approach against C. psittaci or would that be out of scope.

RESPONSE: Any pathogen listed in the NIAID Emerging Infectious Diseases/Pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) is responsive to this solicitation.

QUESTION 2: Our organization is interested in submitting a proposal for Solicitation HHS-NIH- NIAID-BAA2024-1. Could we get clarification on the pathogens of interest for this solicitation? Can you clarify whether any pathogen listed in Categories A-C are responsive to this solicitation? Or are B.

pertussis, Vibrio cholerae, and Coccidioidomycosis the only pathogens responsive to this solicitation?

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For Research Area 001 Vaccine Candidates, on pp. 5-6, the solicitation indicates:

“This research area is restricted to the following:

1. NIAID Emerging Infectious Diseases/Pathogens listed in Categories A-C (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens), with selected pathogens of special interest:

a. Improved vaccines for B. pertussis

b. Next generation vaccines for Vibrio cholerae.

c. Valley Fever (Coccidioidomycosis)”

RESPONSE: Any pathogen listed in NIAID Emerging Infectious Diseases/Pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) is responsive to this solicitation.

QUESTION 3: For this research area, would you include the pathogens from the NIAID Emerging Infectious Diseases listed in Categories A-C or only for those in the special interest group – B. pertussis, Vibrio Cholerae and Valley fever?

RESPONSE: Any pathogen listed in NIAID Emerging Infectious Diseases/Pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) is responsive to this solicitation.

QUESTION 4 – Regarding the Clinical trial plan, are you looking for the offeror to actually do the clinical trials? Or work with a CRO / subcontractor who will do the clinical trials? Or do you want a written plan on how we would do a clinical trial including details about what population we will target or exclude?

RESPONSE: A clinical trial plan must be included in the proposal. Please refer to Section 3.3.1.2. – Technical Approach of the BAA. It is up to the offeror to decide whether or not the clinical trials will be conducted using a CRO / subcontractor.

B. RESEARCH AREA 002

QUESTION 1: My question pertains to how the BAA defines regarding lead optimization. How early in the usual sequence of lead optimization will this BAA still regard as lead optimization?

RESPONSE: In the Solicitation, Section 3.3.2.3 bullet 1 states “Stage-appropriate data must be provided. For proposals that include Lead Optimization, stage-appropriate data demonstrates achievement or near-achievement of preclinical candidate selection criteria by exemplars of the proposed lead series.

For all other proposals, a single entity, the proposed preclinical candidate, or product to be developed under the contract, must demonstrate achievement or potential to achieve all minimally acceptable criteria of the TPP.”

QUESTION 2: Reading the description for this funding opportunity it seems like you are primarily interested in late stage optimization programs that have likely already demonstrated efficacy in vivo. Is that correct? We are just trying to understand whether we would be responsive to this application with what we currently have in hand.

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RESPONSE: Please refer to Sections 3.3.2.3 and 3.3.2.4 in addressing responsiveness to the solicitation. Per section 3.3.2.4 bullet points # 2 (referring back to section 3.3.2.3) and #4 detail the requirements for responsiveness to the BAA.

C. RESEARCH AREA 003

QUESTION 1: Is a digital platform in scope for Research Area 003? Our proposal would focus on the acquisition of condition/disease specific cough samples to train, test, and validate our AI models. If not in scope, are there opportunities to present our capabilities to NIAID?

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

3.3.3.4 for out-of-scope topics including item #4. Additional funding announcements and solicitations can be found on www.sam.gov .

QUESTION 2: In Section 3.3.3.1, you list 3 areas of interest. We are interested in Area 3: Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization. Per our understanding of your description here, our proposal would be consistent with your Area 3.

In Section 3.3.3.2- Technical Approach: Priority Pathogen and Resistance Targets, you describe your targets, and stipulate that "Diagnostic test system must detect one of the following agents or markers":

Taking the first item in this list as an example, you list: ESKAPE+ pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp, Escherichia coli), including genotypic resistance markers. Per this description, you would exclude any approaches that had a phenotypic approach to resistance, but did not have a genotypic resistance marker characterization, which is not consistent with the guidance you provide in Section

3.3.3.1. None of your other examples include the possibility of any phenotypic resistance characterization. Can you please clarify?

RESPONSE: Test platforms developing phenotypic antibacterial susceptibility testing are in scope, and indeed preferred, as noted in Section 3.3.3.1. Some genotypic resistance marker testing is in scope as well, as noted in Section 3.3.3.2.

III. Clarification regarding language in Research Area 001 - 3.3.1.1 (Bullet Point #1)

NOTE: Due to the number of clarification questions received regarding Section 3.3.1.1, please see the BOLDED TEXT on the next page which clarifies the scope for Bullet Point #1 (originally pages 5-6 of the BAA solicitation).

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Original BAA Solicitation language – Pages 5 & 6 of the BAA Solicitation

3.3.1.1 – Technical Objectives

The goal of Research Area 001 is to protect human health and well-being by advancing specific vaccine candidates that utilize technology platforms that ideally elicit a rapid onset of immunity following a single dose, provide a durable response and are readily adaptable to multiple emerging pathogens. These vaccine technologies and platforms may include, but are not limited to, any of the following: novel adjuvant vaccine formulations, delivery platforms that are scalable or produce mucosal immunity, nucleic acid-based platforms, viral vectors, and nanoparticle/VLP approaches.

This research area is restricted to the following:

1. NIAID Emerging Infectious Diseases/Pathogens listed in Categories A-C

(https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens), with selected pathogens of special interest:

a. Improved vaccines for B. pertussis

c. Valley Fever (Coccidioidomycosis)

Clarification Language for BAA Solicitation (originally pages 5-6 of the BAA)

3.3.1.1 – Technical Objectives

The goal of Research Area 001 is to protect human health and well-being by advancing specific vaccine candidates that utilize technology platforms that ideally elicit a rapid onset of immunity following a single dose, provide a durable response and are readily adaptable to multiple emerging pathogens. These vaccine technologies and platforms may include, but are not limited to, any of the following: novel adjuvant vaccine formulations, delivery platforms that are scalable or produce mucosal immunity, nucleic acid-based platforms, viral vectors, and nanoparticle/VLP approaches.

1. While all NIAID Emerging Infectious Diseases/Pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) are within scope, there is special interest in:

a. Improved vaccines for B. pertussis

c. Valley Fever (Coccidioidomycosis)”