Amendment 1 - HHS-NIH-NIAID-BAA2022-1.pdf

HHS-NIH-NIAID-BAA2022-1

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2022 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2022-1

Solicitation Amendment (One) 1

Issuing Office:

Solicitation Number:

Date of Solicitation Issuance:

Date of Amendment One Issuance

Number of Pages:

Proposal Due Dates:

OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D39, MSC 9821 Bethesda, MD 20892-9821

HHS-NIH-NIAID-BAA2022-1

January 18, 2022

February 14, 2022

Ten (10) pages

The hour and date specified for receipt of offers for each Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE PROPOSALS DUE*

001 DMID

Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

April 18, 2022

002 DMID

Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

April 18, 2022

003 DMID

The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

March 18, 2022

004 DMID

Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

April 18, 2022

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein.

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Contracting Office Points of Contact:

Primary Contact:

Julie Rodriguez, Contracting Officer Email: julie.rodriguez@nih.gov Phone: 301-761-7735

Secondary Contact:

Brian Madgey, Contracting Officer Email: brian.madgey@nih.gov Phone: 240-627-3712

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. 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.

2. Provide a cut-off date of March 1, 2022 for questions from potential offerors under Research Area 003.

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: Can additional data be submitted after the BAA submission due date?

RESPONSE: No. Once a proposal has been submitted for the BAA by the due date, the proposal is considered complete for peer review.

• QUESTION 2: Must I submit an Intent letter to apply to the BAA?

RESPONSE: For planning purposes, it is requested that potential offerors submit a notice of intent. The notice of intent is strongly suggested but not required. Please refer to Section 4.3.2.1.4 of the BAA.

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• QUESTION 3: In the BAA, it states that for FY 23 funding is for the non-severable Base period (direct and indirect costs combined) only. What does non-severable mean?

RESPONSE: “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 4: Budget and Award Information, the BAA mentions the total performance period will consist of the base period and options. What is the length of Base and Options?

RESPONSE: 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 on the scope of the project and technical objectives. In proposing performance periods for the base and each option, the Offeror should make a reasonable estimate of the time in months needed to complete the activities under the base and each option. The total performance period comprised of the combined base period and all options proposed by an Offeror shall not exceed five (5) years.

• QUESTION 5: Can a company apply for funding to develop a product that is also receiving other NIH funding, such as SBIR funding, if the two awards would fund different areas of development? Does the same hold true for funding from other government agencies, e.g., BARDA, or funding from government-supported entities, e.g., CARB-X?

RESPONSE: If the specific goals and objectives differ, an award can be made to an offeror that has ongoing support from other NIH, or government agency, or government-supported sources.

The NIAID will withdraw any application that overlaps with research that is underway, completed, or under peer review.

• QUESTION 6: Uniform Cost Assumptions in 3.4.5b says, “Cost will not be allowed for the purchase of any equipment…” Please confirm that we will not be permitted to use the award funds to purchase any equipment even with a COA request.

RESPONSE: Confirmed. In accordance with 3.4.5.b. of the Broad Agency Announcement, “Cost will NOT be allowed for the purchase of any equipment, hardware, or software under this contract.”

• QUESTION 7: Section 3.2 states that the NIAID estimates a total FY23 budget of up to $12.8 million for the non-severable base work (direct and indirect costs combined) across all contracts in Research Areas 001, 002 and 004, depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds. Does that mean that there is up to $12.8M for each award, or does it mean that there is up to $12.8M to be divided between all awards?

RESPONSE: The NIAID estimates a budget of up to $12.8 million to be divided between the non-severable base periods of all contract awards for Research Areas 001, 002 & 004, depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds.

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• QUESTION 8: Who is eligible to submit a proposal? Are academic groups or academic/industry collaborations able to apply? Are you targeting start-up companies, small businesses, or established large companies? Are foreign companies eligible for award?

RESPONSE: This BAA is being competed using full and open competition. All responsible offerors not otherwise prohibited by law are eligible to submit a proposal in response to this BAA Solicitation.

• QUESTION 9: If proposing CROs, do they need to be USA domestic?

RESPONSE: No. All responsible offerors, including foreign entities, not otherwise prohibited by law, are eligible to respond to this BAA. If successful, clearance by the State Department will be obtained prior to awarding a foreign contract, a foreign subcontract, or a domestic contract with a foreign component.

• QUESTION 10: Could a clinical trial be carried out in a foreign country by a subcontractor? Are there any budget limitations with respect to how much of the award could be subcontracted out?

RESPONSE: The same full and open principal applies to the clinical trial sites; non-US organizations may be included in a proposal if they are not a prohibited source identified in FAR

25.7. Offerors should carefully review the content of the BAA to ensure compliance with all requirements of proposing subcontractors. The BAA does not specify budget limitation with respect to how much of award could be subcontracted, but Offerors are encouraged to review FAR 52.215-23 Limitations on Pass-Through Charges.

• QUESTION 11: Does the Offeror need multiple CRO bids/budgets in the proposal or would this be an activity to take place during a negotiation phase?

RESPONSE: As referenced in the Solicitation, offerors proposing subcontracts and/or consultants to perform portions of the proposed work should clearly identify the specific tasks for which they plan to utilize subcontractors and/or consultants, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors and/or consultants, and the expected advantages of such an approach. Processes for subcontractor and consultant identification, selection, management and evaluation should be described in the proposal. An offeror’s initial proposal should contain the offeror’s best terms from a price and technical standpoint.

• QUESTION 12: Section 3.4.2 Work Plan requests that a task-linked budget (item c) be included.

Can an example of a task-linked budget be provided?

RESPONSE: Please find attached an example of a task-linked budget as part of a Work Plan.

This example is intended to be a guide and the description of Base and Options will be dependent upon the specifics of the product development plan. Note that the Statement of Work (SOW) is requested to include base and options, milestones, and deliverables. These items can be used to populate the task-linked budget. Please include duration for base and each option, deliverables, direct costs, and total costs (direct costs, indirect costs, fees, etc.) for the base and each option.

For the Work Plan, a high-level budget is requested.

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• QUESTION 13: Does the Broad Agency Announcement apply only to vaccines, therapeutics, and diagnostics for human use?

RESPONSE: Yes. The goal of the DMID Omnibus BAA is to advance vaccines, therapeutics, and diagnostics which could be deployed against biodefense and/or emerging pathogens to protect human health and well-being, i.e., vaccines, therapeutics, and diagnostics for human use.

• QUESTION 14: Do you have any example submissions you could share?

RESPONSE: Due to the competitive nature of the BAA, we are not able to share a sample proposal. Please refer to the BAA solicitation for all available information about proposal requirements.

• QUESTION 15: I noticed the recently published NIAID BAA does not contain a whitepaper/preproposal process prior to full proposal submissions. Was that an oversight or intentional?

RESPONSE: There is no whitepaper review process for this acquisition.

• QUESTION 16: We would like to have a phone call with you to discuss our project.

RESPONSE: Due to the competitive nature of this acquisition, we cannot provide feedback regarding the desirability of any particular scientific approach. Any questions should be submitted by e-mail to the Contracting Officer Point of Contact listed on page 4 of the Solicitation, and all responses will be publicly posted in a Q&A amendment.

II. RESEARCH AREA SPECIFIC QUESTIONS

1) RESEARCH AREA 001:

• QUESTION 1: Is a clinical trial required for Research Area 001?

RESPONSE: A clinical trial is not required but is strongly encouraged. The scope of support differs depending on the stage of the project being proposed.” If Offerors plan to conduct a clinical trial in the awarded contract, please submit a clinical trial plan.

• QUESTION 2: We would like to request funding for Phase I clinical trials. Is it expected, or desirable, to use the NIH VTEU network for this? Or should we partner with a Phase I CRO for this component of the application?

RESPONSE: While the conduct of a clinical trial is within scope for this BAA, Offerors shall not propose the use of the NIAID/DMID or the VTEU funding mechanism. The conduct and structure of the clinical trial is the responsibility of the offeror, whether the offeror has the capability or subcontracts to another organization.

2) RESEARCH AREA 002:

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• QUESTION 1: Mucormycosis has been listed on the NIAID website as an emerging disease since 2014, but it is not necessarily listed under the A, B, and C priority category organisms.

RESPONSE: Mucormycosis is an emerging infectious disease pathogen (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) and is eligible for consideration under Research Area 002. Refer to Sections 3.3.2.1 and 3.3.2.2 for pathogen and therapeutic priorities.

• QUESTION 2: Does Research Area 002 encompass an oral therapy for complicated UTI including ESBLs and CRE?

RESPONSE: Proposals are encouraged for the development of broad-spectrum therapeutics as well as limited spectrum therapeutic candidates that target high-priority pathogens for which inadequate standard clinical treatment exist or for which drug resistance poses a significant public health concern.

• QUESTION 3: Does Research Area 002 include host-targeted therapeutics, or is it aimed solely at antimicrobials, antivirals, and anti-toxin therapies?

RESPONSE: Please refer to Section 3.3.2.1 – Technical Objectives: “Proposals on non-traditional therapeutics and anti-toxins are encouraged, provided they have demonstrated therapeutic activity in invitro and in vivo models when used alone or in combination with an existing licensed product.

• QUESTION 4: Section 3.3.2.1 states, "…therapeutic candidates that target high-priority pathogens for which inadequate standard clinical treatment exists or for which drug resistance poses a significant public health concern are eligible…", while page 13, Section 3.3.2.4 states that contract awards under this Research Area will not support "development of candidates/products or lead series that have not demonstrated therapeutic activity in a relevant animal model of disease OR have not demonstrated drug development stage appropriate pharmacokinetics".

RESPONSE: Section 3.3.2.1 of the BAA specifies that proposals are eligible under this solicitation for therapeutics with a limited spectrum of activity if they target high-priority pathogens for which inadequate standard clinical treatment exists or for which drug resistance poses a significant public health concern. Section 3.3.2.4 specifies that, for a contract to be awarded, the development candidate must have demonstrated therapeutic activity in a relevant animal model of disease and drug development stage appropriate pharmacokinetics.

• QUESTION 5: Our proposal to this BAA includes FDA required in-vitro and in-vivo antiviral studies needed for an IND application. Are there any additional requirements for Research Area 002?

RESPONSE: Section 3.3.2.3 specifies that the offeror of the proposed therapeutic lead series/ lead/product candidate must demonstrate phase appropriate evidence of all the following characteristics: i. Chemical structure and if appropriate, relevant structure activity relationships to support lead optimization, ii. Synthesis/manufacturing feasibility, iii. Drug development stage appropriate invitro and invivo efficacy, and iv.Drug development stage appropriate in vitro and in vivo pharmacokinetic and toxicology. These characteristics must be reflected in the draft Target Product Profile.

https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens

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• QUESTION 6: We have a novel series of antibacterials based on a natural product with demonstrated in vivo activity against a Category A pathogen and in vitro potency against another Category A and a CDC AR high threat organism. The putative mechanism of action is novel but not completely elucidated. Is this considered a lead optimization stage candidate for this BAA?

RESPONSE: Please review section 3.3.2.1 for details describing the development phases in-scope of Research Area 002, and Sections 3.3.2.2 and 3.3.2.3 for priority pathogens/therapeutics and additional entry requirements.

• QUESTION 7: Does the NIAID consider a de novo designed minibinder anti-viral protein targeting SARS-CoV-2 Spike to be the same as a "monoclonal antibody"?

RESPONSE: For the purposes of this solicitation, minibinder proteins are not considered monoclonal antibodies. Refer to section 3.3.2.1 for details describing the development phases in-scope of Research Area 002, and section 3.3.2.3 for additional entry requirements. For non-monoclonal antibody therapeutics like these, please consider if they are suitable for Research Area 003 (See details in sections 3.3.3.1 - 3.3.3.4).

• QUESTION 8: We work on multiple bacterial pathogens as a goal for broad spectrum agents. Is development of a broad spectrum therapeutic of interest or should we focus on a single pathogen?

RESPONSE: Please refer to Section 3.3.2.1. Proposals are encouraged for the development of broad-spectrum therapeutics with extended therapeutic activity over more than one pathogen.

Refer to Section 3.3.2.2 for pathogen priorities. Due to the competitive nature of the BAA, the NIAID is unable to offer advice or feedback regarding a specific technical approach.

• QUESTION 9: We work on host-directed therapeutics as potentiating agents as well as small molecule antimicrobials. Is one area more preferable or would co-administration of both be preferable?

RESPONSE: Please refer to Section 3.3.2.2. Due to the competitive nature of the BAA, the NIAID is unable to offer advice or feedback regarding a specific technical approach.

• QUESTION 10: We work with lead and clinical phase drugs as well as a focus on the host-pathogen interactions. Are molecules this advanced beyond the Technical Readiness Level (TRL) for this BAA?

RESPONSE: Research Area 002 will support lead optimization, pre-clinical (IND enabling) studies and clinical trials that include Phase 1 and Phase 2 studies or confirmatory trials no greater than 120 subjects. The scope of support differs depending on the stage of the project being proposed. Refer to section 3.3.2.1 – Technical Objectives for details describing the development phases in-scope of Research Area 002.

• QUESTION 11: We are working on antivirals active against one or several viruses classified as NIAID Emerging Infectious Diseases/Pathogens including Category A, B, or C viral threat agents (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). Should we apply in Research Area 002 or Research Area 003?

RESPONSE: Please review inclusion and exclusion of antivirals in Research Area 002 (Sections

3.3.2.2 and 3.3.2.4) and antivirals eligible for Research Area 003 (Sections 3.3.3.1 - 3.3.3.4).

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Research Area 002 excludes Research Area 003-eligible antiviral candidates with attributes specified in Section 3.3.3.1.

• QUESTION 12: Are small molecule inhibitors of category B protozoan pathogens) excluded from the relevant infectious diseases solicited for Research Area 002?

RESPONSE: Category B protozoan pathogens (Toxoplasma, Cryptosporidium and Cyclospora) are included in Research Area 002. Please refer to Section 3.3.2.2 for more information on the development of broad-spectrum and limited-spectrum therapeutics against diseases/pathogens.

• QUESTION 13: Please clarify if the following two projects are responsive to the current BAA announcement – Research Area 002: (1) Further development of a lead immunotherapeutic against AMR Neisseria gonorrhoeae that will be delivered to women through intravaginal rings (IVRs) to prevent gonorrhea, and (2) development of a fully humanized monoclonal as a therapeutic against gonorrhea.

RESPONSE: Due to the competitive nature of this acquisition, we cannot provide specific feedback regarding the desirability of any particular scientific approach. However, drug resistant Neisseria gonorrhoeae is an urgent threat bacterium listed in the CDC 2019 report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf).

Therefore, as stated on page 11 of the BAA solicitation, development of limited spectrum candidates for it is eligible for award under Research Area 002.

• QUESTION 14: Our antibacterial research program for a new class of antibiotics covers “Urgent/Serious” priority pathogens on the CDC 2019 list but not listed on the NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens. Does the “and” really mean “or”? That is, if our program covers priority pathogens on the CDC list, but not on the NIAID then we would qualify, correct?

RESPONSE: Section 3.3.2.2 – Technical Approach may be interpreted as follows:

Proposals are encouraged for the development of broad-spectrum therapeutics with extended therapeutic activity over more than one pathogen in the list of NIAID Emerging Infectious Diseases/Pathogens including Category A, B, and C priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens), and/or infectious pathogens listed in the 2019 CDC Antibiotic Resistance Threats in the United States Report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf).

3) RESEARCH AREA 003:

• QUESTION 1: Are the due date and award date for proposals in Research Area 003 earlier than those for the other Research Areas?

RESPONSE: Yes, the proposal due date for Research Area 003 is March 18, 2022 and awards are anticipated in or around November 2022. The proposal due date for the other Research Areas (001, 002, and 004) is April 18, 2022 and awards are anticipated in or around May 2023.

• QUESTION 2: What are antivirals eligible under the Research Area 003?

https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf

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RESPONSE: Sections 3.3.3.1 states the development of antivirals that “Directly block viral targets and function, AND active against RNA viruses of pandemic potential (Coronaviridae, Bunyavirales, Filoviridae, Flaviviridae, Paramyxoviridae, Picornaviridae, and Togaviridae), AND are new chemical entities which include small molecules and small biotherapeutics (e.g.

nucleic acids or peptides) that are directly acting against viral targets and functions (not through the modulation of the host responses) AND have suitable routes of administration (e.g. oral or intranasal) and safety profiles for broad use in the outpatient setting to treat early stages of infection by reducing viral burden.

• QUESTION 3: What is the minimal data package to qualify as a lead op candidate (or later)?

Can we submit multiple leads programs with an attrition schedule that leads to IND & clinical trials (portfolio-based approach), or is each project intended to be a single asset? Do we need an industry partner?

RESPONSE: Lead optimization needs to be one lead program and a full package identifying medicinal chemistry strategy to optimize, including structure activity relationships that support the strategy. An industry partner is not required, but an Offeror must have a development pathway.

4) RESEARCH AREA 004:

• QUESTION 1: In Research Area 004, objective 2, does a rapid test in development need to target a protein antigen, or can it target a nucleic acid or other biomolecule from the pathogen?

RESPONSE: Rapid test development may target any biomolecule that is pathogen-associated.

Host-response targets are not responsive.

• QUESTION 2: Can engineered living biological modalities (e.g. mammalian cells), that may not be used as point of care but could be used for testing in a qualified laboratory, be responsive to the BAA for Research Area 004?

RESPONSE: In Research Area 004, the third Diagnostics development objective, Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization, does not require development of a point of care system; therefore, if the proposed “engineered living biological modalities (mammalian cells)” are intended to develop a system for bacterial ID and phenotypic antimicrobial resistance characterization, then this is responsive. If, however, the system is an improved rapid antigen test detection system (objective number 2 in Research Area 004), then this would be not responsive.

• QUESTION 3: Can a test that focuses on antibacterial susceptibility only (not bacterial ID) be considered responsive to Area of Research 004, objective 3?

RESPONSE: A test that solely focuses on antibacterial susceptibility testing is responsive.

• QUESTION 4: Is there a minimal TRL that a development program must have achieved to qualify for funding for Research Area 004?

RESPONSE: There is no TRL measurement associated with the evaluation of submissions;

therefore, there is no minimal TRL required.

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• QUESTION 5: Does funding support the development of a test intended to submit for FDA

EUA?

RESPONSE: Funding will not support development specifically towards EUA submission.

Submission for an EUA can be undertaken by the developer, but it cannot be part of the awarded activities funded in the contract.