Amendment Six HHS-NIH-NIAID-BAA2020-1 .pdf

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Amendment Six (6)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT SIX (6)

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-BAA2020-1

Date of Solicitation Issuance: January 3, 2020

Date of Amendment

Six (6) Issuance: February 27, 2020

Number of Pages: 5

Proposal Due Dates:

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

RESEARCH

AREA

NIAID

DIVISION

TITLE RECEIPT DATE AND

TIME

001 DAIT Development of Radiation/Nuclear Medical Countermeasures (MCMs)

3:00 PM Eastern Time, 04/09/2020

002 DMID Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68

3:00 PM Eastern Time, 02/28/2020

003 DMID Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

004 DMID Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

005 DMID Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

Points of Contact:

Division of Allergy, Immunology, and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Liem Nguyen, Contracting Officer

Email: liem.nguyen@nih.gov

Phone: 240-669-5144 mailto:liem.nguyen@nih.gov

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Division of Microbiology and Infectious Diseases (DMID)

Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68

Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging

Infectious Diseases

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant

(AMR) Infections and Emerging Infectious Diseases

Research Area 005: Advanced Development of Diagnostics for Biothreats and Emerging Infectious

Diseases

Primary Contact:

Swee L. Teo, Contracting Officer

Email: teosl@niaid.nih.gov

Phone: 240-669-5173

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

The purpose of Amendment Six is to:

I) Update the “Date Offers Due” in Beta Sam to April 9, 2020, 3:00pm EST for Research Areas 001, 003, 004, and 005. Please note that the “Date Offers Due” for Research Area 002 remains unchanged as February 28, 2020, 3:00pm EST.

II) Provide responses 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. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

mailto:teosl@niaid.nih.gov mailto:brian.madgey@nih.gov

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I. The “Date Offers Due” in Beta Sam is updated to April 9, 2020, 3:00pm EST for Research Areas

001, 003, 004, and 005. Please note that the “Date Offers Due” for Research Area 002 remains unchanged as February 28, 2020, 3:00pm EST.

II. The Government’s responses to questions received regarding this solicitation are as follows:

Division of Allergy, Immunology and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Question 1: Is there interest in continued development of the minipig model?

Response: 1: Please refer to Section 3.1.1 – Background, page 6/142, where it states the goal of this BAA is to support the development of safe and effective MCMs to mitigate and/or treat tissue injuries resulting from exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in radiation-associated morbidities and mortalities.

Question 2: Is there interest in delayed effects in the minipig model (especially lung)?

Response 2: If the minipig model is an appropriate model for development of a specific countermeasure, it would be allowed.

Question 3: Would technology development for the model be included in the funding-- especially for expanding reagents available for analysis of the model?

Response: 3: Although model development can be funded, the BAA is intended to advance specific products for which the Offeror has intellectual property protection. Here are some relevant parts from the BAA:

3.1.1

The goal of this BAA is to support the development of safe and effective MCMs to mitigate and/or treat tissue injuries resulting from exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in radiation-associated morbidities and mortalities. … The goal of this BAA is to support the development of safe and effective MCMs to mitigate and/or treat tissue injuries resulting from exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in radiation-associated morbidities and mortalities.

3.1.2.1.2

The scope of this work to be funded under this BAA is the development of MCMs.

Offerors are invited to submit proposals to advance the development of one lead candidate

MCM that has already demonstrated concept feasibility. MCM drug candidates should increase survival by mitigating and/or treating acute or delayed radiation injury.

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Proposals must include a plan to conduct translational research and development and, if applicable, provide additional information and data to support U.S. FDA approval or licensure and submission of an Investigational New Drug (IND) application. Offerors must provide a well-defined product development path towards approval following the FDA Animal Rule for mitigation or treatment of radiation-induced injury that includes IND-enabling studies that will be performed under the contract.

3.1.2.1.3

This contract will support the following activities:

1. Non-clinical Research and Development, including:

a. Development of animal models suitable for consideration under the FDA Animal Rule.

b. Reagent and assay development, including biomarkers to assess the biological effects and efficacy of the lead MCM.

c. Efficacy studies in animal models of radiation exposure to optimize the route of administration, formulation, dose, and dosing schedule when administered at least 24 hours or later after radiation exposure. Studies should be designed to be suitable (species, endpoints, measurements) for predicting future pivotal Good Laboratory Practice (GLP) efficacy studies under the FDA Animal Rule (21 CFR 314.600-314.650, 601.90- 601.95).

d. Mechanism of action studies as well as studies to identify, quantify and better understand

[secondary] radiation efficacy endpoints.

3.1.3.1

Provide an Experimental Plan that details the specific tasks and stages that the Offeror proposes to perform with contract funding that can reasonably be completed in three years.

The Experimental Plan must also include:

a. A description of how the lead MCM meets the technical requirements outlined in the Research and Technical Objectives section.

b. Documentation that the offeror has intellectual property (IP) protection and/or proprietary freedom to use all components and develop the proposed MCM, including bringing to FDA licensure and commercialization. Include letters from the IP-holder stating that they will provide the agent(s), any limitations on the studies to be performed with that agent(s), agreement about public disclosure of results (including negative results), and whether there are any agreements already in place.

Question 4: Should a model development grant include at least one countermeasure to confirm findings in another preclinical model (mice)?

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Response 4: The solicitation is not a model development grant, but the BAA could fund development of a potential medical countermeasure in a second species.

Question 5: Is it known whether a standing study section will evaluate the grants, or if a special study section will be convened?

Response 5: “Each proposal will be reviewed by a peer review group selected for their competence in relevant scientific and technical fields.” (6.1)

Division of Microbiology and Infectious Diseases (DMID)

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

Question 1: Quoting from the Research Area 004 description: "For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident." Does a therapeutic aimed at treating a severe side effect of infections (ARDS) caused by several of the priority pathogens fall under this description?

Response: Section 3.2.2.3.2 Technical Objectives (page 22) states that “…Proposals are encouraged for the development of broad-spectrum therapeutics with extended therapeutic activity over more than one pathogen...” and “…therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infections are evident..” Based on this description, product targeting the symptoms of infection caused by multiple pathogens is within the scope of this BAA.

Question 2: Section 3.2.2.3.5 - Contracts awarded under this Research Area will NOT support: It lists, “Development of licensed products as new formulations” and “Development of licensed products for additional clinical indications.”

A therapeutic that has newly discovered activity and mode of action against a pathogen from the NIAID Category A, B, and C priority list, that is an already approved drug in an unrelated indication, and that is now being reformulated to a different route of administration specifically to address a critical unmet medical need in a new patient population, is the development of this therapeutic eligible for funding?

Response: No, the development of the proposed therapeutic candidate does not meet the criteria for this research area as stated in Section 3.2.2.3.5 (page 25).

PLEASE NOTE: In the questions/responses above, specific organizational names have been removed or replaced where possible as well as other minor adjustments.