Amendment 4 - HHS-NIH-NIAID-BAA2024-1.pdf

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2024 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2024-1

Solicitation Amendment (4) Four

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 February 23, 2024

Number of Pages: Nine 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

*PLEASE NOTE: The due date for the submission of questions in response to this BAA closed on February 19, 2024. One final amendment will be issued to address any remaining questions not included in this amendment that were previously received by February 19, 2024.

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 #4

The purpose of Amendment #4 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: Please provide clarification regarding submitting a Small Business Subcontracting Plan in the SBCX system.

RESPONSE: Please refer to Section 4.3.3.1.6 for additional instructions. The following link is for this BAA Solicitation in the SBCX system. Please note, the link below will take offerors directly to the login screen. Once logged in, the system will walk offerors through the process. If you experience any issues, please utilize the Help link at the top of the screen in the SBCX system which provides articles for assistance, including “Getting Started” and “User Guide” articles for assistance, or contact their office directly with questions. Any technical questions regarding the use of the SBCX system may be submitted via e-mail message to the SBCX help desk at client.support@apexlogic.com.

https://osdbu.hhs.gov/subcontracting/0fce753d-2cdb-44d0-b71c-5ba24d3397ca

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QUESTION 2: Can you confirm whether the non-US company can only apply for NIAID through SAM and if D&B DUNS, and NCAGE are needed for that?

RESPONSE: Please refer to the BAA Solicitation including the proposal instructions which requires registration on www.sam.gov and a UEI number for all offerors, domestic or foreign, in addition to other requirements.

QUESTION 3: I was informed that select agent authorization will not be completed until June 2023. Will this affect our ability to submit our proposal to the DMID program, as the deadline is March 12Th.

RESPONSE: Please carefully read all of sections 4.3.2.6 - “Possession, Use and Transfer of Select Biological Agents or Toxins” and 5.45 - “Possession use and transfer of select biological agents or toxins”. No NIH funds can be used for research involving Select Agents or Toxins until approval is granted, either by CDC for domestic sites or NIAID for foreign sites.

QUESTION 4: My PI has informed me of having a subrecipient on the project (No. HHS-NIH-NIAID- BAA2024-1) and I am not sure where to include the subrecipient documents on behalf of the other institution.

RESPONSE: Please review the entire solicitation including the technical and business instructions contained therein. The Business Proposal typically contains the subcontractor documentation although please ensure everything that is required to be documented or included in the Technical Proposal is covered as well.

QUESTION 5: For HHS-NIH-NIAID-BAA2024-1 should the budget be organized by Base/Option delineated by tasks OR should the budget be delineated by calendar year. The template provided in the RFP includes a budget organized by calendar year, but the RFP appears to indicate budgets should be separated by Base/Option.

RESPONSE: Please refer to the instructions noted in the BAA Solicitation including Section 4.3.3 and complete the budget organized by Base/Option and the proposed applicable dates for the Base and any options. Additionally, 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. Base and options may overlap.

QUESTION 6: Section 3.2 describes the “The total performance period comprising the combined Base Requirement and all Options proposed by an Offeror shall not exceed an estimated 5 years.” and “$16 million for the award of 5 cost reimbursement type base contracts across all three Research Areas (001, 002 & 003).” Would NIAID please clarify whether $16 million is the total amount available for all 5 expected awards over the 5 year contract period?

RESPONSE: This question was previously addressed in Solicitation Amendment #1 posted on www.sam.gov .

QUESTION 7: Section 4.3.3.1.6 - Are foreign companies, which are classed as small businesses in their own country, exempt from completing a Small Business Subcontracting Plan?

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RESPONSE: The requirement to submit a subcontracting plan does not apply to contracts to be performed entirely outside of the United States.

QUESTION 8: As part of our proposal in response to HHS-NIH-NIAID-BAA2024-1, our company would like to utilize government resources, specifically by working with a NIAID laboratory.

RESPONSE: Please note, NIAID cannot fund intramural Government labs with extramural dollars (i.e., BAA funding), not even through an Interagency Agreement.

QUESTION 9: I’m writing to confirm whether the sample SOW for Research Areas 001 and 002 at the bottom of page 43 of the solicitation has been inadvertently cut off or if the additional sections are missing.

RESPONSE: Additional sections are not missing. Please see the next page (pg. 44) of the BAA Solicitation. The sample SOW does extend through page 44 of the current solicitation and ends with the breakout for the Base and Options. The chart is also included below for your reference.

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Period Tasks Duration Budget

Base Prerequisite: Award Description of Base Task 1 (description)

Subtask 1.1. description Subtask 1.2. description

Milestones

Task 2 (description) Subtask 2.1. description Subtask 2.2. description

Milestones

XX months $0,000,000

Option 1 Prerequisite: Criteria 1, 2, 3 Description of Option 1 Task 3

Subtask 3.1 Subtask 3.2

Milestones

Option 2 Task 4

More Options…

II. SPECIFIC RESEARCH AREA QUESTIONS:

A. RESEARCH AREA 001

QUESTION 1: Our goal is to develop a combination vaccine (for two separate viruses). If we possess a lead vaccine candidate for each individual vaccine but have not yet run the in-vivo studies for proof-of-concept data for the combination of the two vaccines, does our application align with the eligibility criteria of the NIAID BAA? Would you suggest applying now, or should we wait until we have proof of concept for the combined administration of the two vaccines?

RESPONSE: NIAID cannot advise on whether to submit a proposal since the Broad Agency Announcement (BAA) is a competitive acquisition. Please carefully review Section 3.3.1 including Section 3.3.1.2 criteria.

QUESTION 2: Two questions. First, are we interpreting the financial scope of the entire program to be $16M for 5-6 selected projects or is this $16M/project and ~5 will be funded. We ask because producing a GMP phase I vaccine stock for phase I testing is expensive (~$1-2 million). Second, would our four component chimeric mRNA vaccine still be considered as responsive to this program?

RESPONSE: For the first question please refer to Amendment #1 published on SAM.gov. For the second question; due to the competitive nature of the Broad Agency Announcement, NIAID is unable to offer advice or feedback on an offeror’s technical approach or advise whether to submit a proposal.

Please refer to section 3.3.1, with focus on section 3.3.1.1 of the BAA Solicitation.

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QUESTION 3: Which VPAT Template should be used for compliance with the Section 508 requirement described in 4.3.1.14 of the BAA? The link provided in Attachment 13 (https://www.section508.gov/sell/vpat/) leads to 5 different forms (https://www.itic.org/policy/accessibility/vpat).

RESPONSE: Attachment #13 of the BAA Solicitation is for the VPAT Template Form - VPAT 2.5 508 (November 2023).

QUESTION 4: Which PHS Human Subjects and Clinical Trials Information Form should be completed and how many pages is it?

RESPONSE: The PHS Form is only one page and it is also included as an Attachment to this Amendment for your reference.

QUESTION 5: Are graduate student researchers permitted to participate in the project as other personnel?

RESPONSE: Offerors must demonstrate in their proposals that they have the necessary expertise and capabilities for conducting the proposed research. The evaluation will be based on the demonstrated capabilities of the offerors in relation to the needs of the project as set forth in the BAA.

QUESTION 6: If graduate student researchers are permitted, are tuition and fees allowed?

RESPONSE: No, tuition and fees should not be included in an offeror’s budget and is not reimbursable under any contract awards for this BAA.

QUESTION 7: When does NIAID expect to begin negotiations or award contracts with selected offerors?

RESPONSE: As stated in the solicitation, the Government reserves the right to conduct discussions with all, some, one, or none of the proposals received in response to this BAA. If discussions are conducted, NIAID reserves the right to suggest modifying, adding or deleting milestones, decision points, research plans, processes, schedules, budgets or products. The Government also reserves the right to make awards without discussions. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award. As stated in the solicitation, at this time, all awards are anticipated to be made in or around May 2025.

B. Research Area 002

QUESTION 1: I was looking for the fund/grant regarding my company’s pipeline, does this help our Company’s pipeline? Also, could this project be possible to designate on the strategic national stockpile (SNS)? Meaning after all of IND, NDA, phase 1/2 support, can we possibly tryout on SNS? There are two research areas that we could apply: Vaccine candidate OR Therapeutic candidate. I would appreciate knowing which part I should apply.

RESPONSE: NIAID is unable to offer advice or feedback regarding an offeror’s technical approach.

Please carefully review Sections 3.3.1. and 3.3.2. for eligibility with a focus on sections 3.3.1.1., 3.3.2.1 and 3.3.2.4. Additionally, a BAA contract award is neither necessary nor sufficient for product entry to the Strategic National Stockpile, which is managed by ASPR/HHS, not NIAID. NIAID cannot comment on topics not directly related to this solicitation.

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QUESTION 2: We are formulating our application to address Research Area 002. Under this section, it notes: A therapeutic candidate may be a lead series, a preclinical candidate, or a clinical candidate. The product must be based on a small molecule (e.g., natural products, nucleosides, oligonucleotides or peptides) or bacteriophages. The following are not included: proteins, monoclonal antibodies, other biologic entities (except bacteriophages), and conjugates of such entities. The therapeutic candidate we have targets Pseudomonas aeruginosa. Would this candidate and our application then be responsive to the BAA solicitation?

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

3.3.2.4 – “Contracts awarded under this Research Area will NOT support the following activities (proposals containing any of these activities will be excluded from peer review and will not be considered further for award)”.

C. Research Area 003

QUESTION 1: Under section 3.6.1 – PRODUCT DEVELOPMENT PLAN (PDP) (pg.24) of the BAA, it is instructed that the PDP should include (among other requirements) "2. A description of the assay integration plan on a commercially established automated platform." If the development of the assay is for a currently in-development platform (both the platform and assay developed by the applicant company), would the application be compliant with BAA requirements?

RESPONSE: The Product Development Plan as stated in Section 3.6.1 should include the elements listed only AS APPLICABLE. For proposals that fall under Objective 1 in Sec. 3.3.3.1 (Untargeted and Targeted Nucleic Acid Sequencing), development should take place on commercially available instruments. For proposals that fall under Objectives 2 (Multiplex Protein or Nucleic Acid Detection) or Objective 3 (Bacterial Identification and Phenotypic Characterization), development may take place on commercial or in-development instruments.

QUESTION 2: What are NIAID’s priorities among the pathogens listed? Are they equally weighted, or are some more important than others?

RESPONSE: As stated in the BAA Solicitations, proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in Section 6. The number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

QUESTION 3: While the BAA lists the pathogens as candidates for individual assays, would a comprehensive assay that covered most or all of the pathogens be considered more responsive to the BAA than just one or a few?

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. As stated in the BAA Solicitation, proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in Section 6. The number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

QUESTION 4: Is the IVD to be developed in response to the BAA intended to be ready for FDA submission as a PMA or 510K device, or is a full submission through to an approved IVD envisioned?

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RESPONSE: Neither.

QUESTION 5: Among factors like cost, turn around time, throughput, and ability to detect any or all existing or newly emergent variants of any given pathogen, are there any that are considered more important than the others?

RESPONSE: As stated in the BAA Solicitation, proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in Section 6. The number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

QUESTION 6: Is there any specific diagnostic technology that is preferred?

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. As stated in the BAA Solicitation, proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in Section 6. The number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

QUESTION 7: Would the ability to rapidly change or update analyte content to detect new pathogens of interest be a priority?

RESPONSE: As stated in the BAA Solicitation, proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in Section 6. The number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

QUESTION 8: We intend to make an offer responsive to “2. Multiplex Protein or Nucleic Acid Detection in Near-Patient Testing Systems” but that would not be responsive to #1 or #3 in Section 3.3.3.1. Would such an offer be responsive to the government’s goals / objectives? Would you please clarify whether this intention is consistent with NIAID’s goals / objectives with this BAA?

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 advise an offeror whether to submit a proposal.

QUESTION 9: We intend to make an offer responsive to “2. Multiplex Protein or Nucleic Acid Detection in Near-Patient Testing Systems” in Section 3.3.3.1 that solely addresses the second bullet point, i.e.

“multiplex nucleic acid detection that is near-patient, rapid, low-complexity, low-cost, and sensitive for detection of sexually transmitted infections.” Would such an offer be responsive to the government’s goals/ objectives with respect to area “2. Multiplex Protein or Nucleic Acid Detection in Near-Patient Testing Systems”? Would you please clarify whether this intention is consistent with NIAID’s goals / objectives with this BAA?

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 advise an offeror whether to submit a proposal.

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QUESTION 10: With respect to the second bullet point of “2. Multiplex Protein or Nucleic Acid Detection in Near-Patient Testing Systems” the words “low-cost” are used. In some settings, low-cost is understood as < $10 in other settings it could be understood as < $100. Will NIAID please clarify what is intended as low cost as this has a critical impact on the technology we intend to offer to the government?

RESPONSE: NIAID cannot comment as low-cost is dependent on the context/situation (e.g., the protein, system, quality, etc.). NIAID does not have a specific definition or target ranges for “low-cost”.

QUESTION 11: In section 3.3.3.4, the following is written: Contracts awarded under this Research Area will NOT support the following activities; proposals containing any of these activities will be excluded from peer review and will not be considered further for award:

3. Development of diagnostics that rely solely on the detection of host-response antibodies, other proteins, or RNAs.

Is “host-response” applicable to “other proteins” and “RNAs” in item #3 above or only “antibodies”?

RESPONSE: As a grammatical clarification, in item #3 above, “host response” is applicable to all three (i.e., host-response antibodies, host-response other proteins, or host-response RNAs).

QUESTION 12: We intend to offer a diagnostic technology that detects these priority pathogens as well as other pathogens identifiable from genital ulcers. However, we do not intend to offer a diagnostic technology that detects other pathogens on the list not applicable to GUD (e.g. Nipah virus). Would NIAID please clarify whether such an offer would be responsive to and consistent with the government’s needs / objectives?

RESPONSE: Due to the competitive nature of the BAA, NIAID cannot provide advice or feedback on an offeror’s technical approach. Please review Section 3.3.3.2 in the BAA Solicitation.

QUESTION 13: Considering “2. Multiplex Protein or Nucleic Acid Detection in Near-Patient Testing Systems,” would an offer that encompasses additional specimen types / diagnostic needs (e.g. self-collected respiratory samples for respiratory detection) be considered responsive to the government’s needs under this objective?

RESPONSE: Due to the competitive nature of the BAA, NIAID cannot provide advice or feedback on an offeror’s technical approach. Please review Section 3.3.3.3 in the BAA Solicitation for Additional Requirements for applicability of specimen types.