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

HHS-NIH-NIAID-BAA2020-1 Page 1 of 8

Amendment Two (2)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT TWO (2)

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 Two (2) Issuance: January 21, 2020

Number of Pages: 8

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 mailto:liem.nguyen@nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 2 of 8

Phone: 240-669-5144

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 Two is to:

I) Revise Section 3.1.2.1.2 – Technical Objectives (page 6) of Research Area 001.

II) Revise Section 3.2.1 – Background (page 17), Section 3.2.2.2.3 – Technical Approach (pages 20 and

21) of Research Area 003, and Section 3.2.2.3.2 – Technical Objectives (page 22) and Section 3.2.2.3.3

– Technical Approach (page 24) of Research Area 004.

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

HHS-NIH-NIAID-BAA2020-1 Page 3 of 8 responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

REVISIONS TO HHS-NIH-NIAID-BAA2020-1 (highlighted in red):

I. Division of Allergy, Immunology, and Transplantation (DAIT)

Section 3.1.2.1.2 – Technical Objectives (page 6) – paragraph two is hereby revised to read as follows:

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 enhance survival or prevent major morbidity by mitigating and/or treating acute or delayed radiation injury.

II. Division of Microbiology and Infectious Diseases (DMID)

Section 3.2.1 – Background (page 17) – paragraph one is hereby revised to read as follows:

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. NIAID also has a key role in the development of new medical countermeasures (MCMs) against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases. Through a variety of research grants and contracts, NIAID’s Division of Microbiology and Infectious Diseases (DMID) supports basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics targeting multiple pathogens, including NIAID Category A, B, and C priority pathogens

(https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). NIAID/DMID intends to use this Broad Agency Announcement to help address goals articulated in a number of strategic plans. The National Biodefense Strategy (https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf) articulates the need to enhance preparedness through medical countermeasures, including vaccines, therapeutics and diagnostics.

The World Health Organization (WHO) has prioritized diseases with epidemic potential and for which there are no or insufficient countermeasures (https://www.who.int/blueprint/priority-diseases/en/), as well as bacteria for which new antibiotics are urgently needed (https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed). Similarly, CDC has highlighted antimicrobial resistance threats in a recently released report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf).

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

Infectious Diseases https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf https://www.who.int/blueprint/priority-diseases/en/ https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf

HHS-NIH-NIAID-BAA2020-1 Page 4 of 8

Section 3.2.2.2.3 – Technical Approach:

Vaccines for Antibiotic Resistant Bacteria (page 20) – this paragraph is hereby revised to read as follows:

Antimicrobial resistance is rendering many current countermeasures ineffective and increasingly challenges the development of effective new antimicrobials for many priority pathogens. This Broad Agency Announcement seeks to support vaccine development directed at a subset of bacterial agents that are of interest to both biodefense and the general public. The initial list focuses on gram negative bacteria including, but not limited to, Burkholderia spp., Pseudomonas aeruginosa, Francisella tularensis, Yersinia pestis, and E. coli. This Broad Agency Announcement excludes gram positive bacteria.

Vaccines for Pandemic Preparedness (page 21) – this paragraph is hereby revised to read as follows:

Multiple organizations are funding vaccines and vaccine platforms to expedite responses to pandemic outbreaks. This Broad Agency Announcement seeks to support vaccine development for pandemics that have not been funded by other governmental and non-governmental funding agencies. Based on an internal landscape analysis, this Broad Agency Announcement seeks to support unfunded and/or under-funded vaccine development for disease such as Rift Valley Fever and Candida auris. Vaccines for the following diseases may be supported in future Broad Agency Announcements but the following vaccine candidates will be excluded from this Broad Agency Announcement: Filoviruses, Lassa, MERS, and Nipah.

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

(AMR) Infections and Emerging Infectious Diseases

Section 3.2.2.3.2 – Technical Objectives (page 22) – paragraph one is hereby revised to read as follows:

The objective of Research Area 004 is the development of promising new therapeutics to address infections caused by NIAID Category A, B, and C priority pathogens and select bacterial and fungal infections identified in the 2019 CDC Antibiotic Resistance Threats Report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf). 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. For the purposes of this solicitation, a therapeutic candidate is either a lead series, lead, or product candidate, and is either a drug (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins).

Section 3.2.2.3.3 – Technical Approach (page 24) – paragraph one and item 1.a. are hereby revised to read as follows:

Solicited Products:

Therapeutic lead series/lead/product candidate must address infections caused by one or more pathogens listed among NIAID Category A, B, and C priority pathogens or in the 2019 CDC Antibiotic

Resistance Threats Report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-

508.pdf), with an emphasis on the following:

https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens

HHS-NIH-NIAID-BAA2020-1 Page 5 of 8

1. Antimicrobial Therapeutics

a. Must demonstrate activity against the effects of one or more of the urgent or serious drug-resistant bacterial threats or urgent fungal threat (Candida auris) listed in the 2019 CDC Antibiotic Resistance Threats Report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf); AND/OR

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

GENERAL QUESTIONS

Question 1: Can you please confirm that foreign institutions are eligible to submit proposals in response to this BAA?

Response: All 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 or subcontract with a foreign component.

Question 2: Are DoD/US government investigators eligible to be included as key personnel and/or contribute to the technical volume for this opportunity if they are partnering with a non-profit organization?

Response: The United States Government (USG) resources, such as personnel, laboratories, etc, that are included in one offeror’s proposal must be made available to all potential offerors. Therefore, USG resources that are not available to the public should not be included in the proposal.

A USG resource, such as DoD personnel, whose services are publicly available is eligible. Please clearly identify in the proposal if the institution uses USG resources. In the event a proposal includes costs for a

USG entity, the decision to use an Interagency Agreement (IAA) would be dictated by the specific authority under which appropriated funds are transferred between Government Agencies, and the specific funding authority granted to the entity in question.

SPECIFIC RESEARCH AREA QUESTIONS

Division of Allergy, Immunology and Transplantation (DAIT)

Question 1: Is cutaneous radiation injury considered a major morbidity of radiation injury?

Response: Cutaneous injury caused by radiation would be considered a major morbidity.

Question 2: Is Research Area 001 for advanced development, i.e. large animal models preferred?

Response: Under “Non-Clinical Research and Development”, Section 3.1.2.1.3 – Technical Approach

(page 7), the BAA covers animal model development, efficacy studies, mechanism studies, and

HHS-NIH-NIAID-BAA2020-1 Page 6 of 8 pharm/tox studies for a lead candidate. The animal models to be used are not specified. The lead candidate must have evidence of efficacy and a favorable safety profile and a path to approval under the

FDA Animal Rule.

Question 3: Are prior FDA communications regarding licensure required for submission?

Response: Under Section 3.1.3.1. – Experimental Plan (page 9), the BAA states that the Experimental

Plan must include “Details of the critical path to licensure for the proposed product, based on current data and/or discussions with the FDA.” Offeror can use current data or FDA discussions, or both, if available, to support the critical path.

Division of Microbiology and Infectious Diseases (DMID)

Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis

Associated with Enterovirus D68

Question 1: Under technical objectives, the start and completion dates of the Phase I clinical trial are reported. The start of the Phase I clinical trial is in 2021 and completion of the trial in August 2022. From our experience these timelines are quit challenging, also considering the start date of the project. Are these dates fixed?

Response: The dates provided by NIAID are preferred target dates and NIAID understands that they are quite challenging. The offerors should provide their best dates and include brief rationale to justify their proposed schedule.

Question 2: We have both an inactivated and EV-D68 vectored based concept in development. The primary vaccine candidate requested is based on an inactivated (and adjuvanted) strategy, what will be the requirements/selection criteria for NIH to allow a live-vectored EV-D68-VLP concept to be granted?

Response: As described in Section 3.2.2.1.2 - Technical Objectives of this BAA (page 18), “The primary vaccine candidate requested is an inactivated EV D68 vaccine; however, other technologies to develop a non-replicating EV D68 vaccine will be considered (e.g., VLP).” Therefore, technologies other than an inactivated (and adjuvanted) vaccine may be proposed.

Question 3: From the website we learned there has been a pre-solicitation round in December 2019.

Were institutes selected in that round for writing a full proposal in the current round?

Response: The Pre-solicitation notice posted to Beta Sam on December 11, 2019 was to inform offerors that a solicitation will follow; it was not a request for proposal. Therefore, there were no pre-selection of offers in response to the Pre-solicitation notice.

Question 4: Currently we are not registered (our registration was outdated in 2019) to submit a NIH grant application. We need to re-apply to complete registration. Due to the strict timelines of the proposal (February 28th) this may be a risk for our application, since it is advised to plan six weeks for the registration process (https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply.htm). Can the registration be fast-tracked? Would you be able to send us prior to registration the template needed for grant application, so we could start writing on the project in advance?

https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply.htm https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply.htm

HHS-NIH-NIAID-BAA2020-1 Page 7 of 8

Response: You will need to contact System for Award Management (SAM) helpdesk regarding expedited registration. This BAA is a contract solicitation; it is not a grant. There is no template for the proposal. An offeror should carefully review the content of the BAA for information regarding the technical objective of each Research Area of this omnibus BAA, instructions regarding the proposal submission, and a description of the evaluation and award process; and exercise its professional judgement in compiling its proposal.

Question 5: Do we need a partner institute from the USA to be eligible to this grant?

Response: You do not need a partner institute from the USA to be eligible to respond to this BAA.

Question 6: Will the Phase I study be executed in the USA?

Response: Section 3.2.2.1.3 – Technical Approach of this BAA (page 18) identifies the requirements for clinical trial management. Phase I study can be executed within the USA and/or globally.

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

(AMR) Infections and Emerging Infectious Diseases

Question 1: Does discovering and developing novel antibiotics against multidrug-resistant Enterobacteriaceae and multidrug-resistant P. aeruginosa fall under this program?

Response: As described in Section 3.2.1 - Background of the BAA (page 17), NIAID uses this funding to support product development targeting NIAID Category A, B, and C priority pathogens, as well as to help address goals articulated in a number of strategic plans to target WHO’s prioritized diseases and CDC’s drug resistant microbial threats. Multidrug-resistant Enterobactericeae and P. aeruginosa are examples of such drug resistant bacterial pathogens on NIAID and CDC’s lists, and thus are within the scope of this BAA, as well as the emphasis of this BAA, as indicated further in Section 3.2.2.3.3 - Technical Approach of the BAA (page 24).

Question 2: Would NIAID consider Candida auris as a pathogen of concern for this BAA?

Response: As described in Section 3.2.1 - Background of the BAA (page 17), NIAID uses this funding to support product development targeting NIAID Category A, B, and C priority pathogens, as well as to help address goals articulated in a number of strategic plans to target WHO’s prioritized diseases and CDC’s drug resistant microbial threats. Candida auris is an urgent threat on the CDC’s “antibiotic Resistance Threats in the United states, 2019” referenced in Section 3.2.2.3.3 – Technical Approach of the Revisions to HHS-NIH-NIAID-BAA2020-1 above, and thus is within the scope of this BAA.

Questions 3: We are advancing the development of a broad spectrum antimicrobial with activity against both gram(-) and gram(+) MDR bacteria. Does this fall within the scope for Research Area 004?

Response: As described in Section 3.2.1 Background of the BAA (page 17), NIAID uses this funding to support product development targeting NIAID Category A, B, and C priority pathogens, as well as to help address goals articulated in a number of strategic plans to target WHO’s prioritized diseases and CDC’s drug resistant microbial threats. For broad spectrum antimicrobial with activity against a broad range of bacterial pathogens, if the proposed indication(s) of the candidate product is aiming at one or more of those pathogens emphasized under Section 3.2.2.3.3 - Technical Approach (page 24), it is within the scope of this Research Area.

HHS-NIH-NIAID-BAA2020-1 Page 8 of 8

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

Question 1: Other than cost and length of award, how is this Omnibus Solicitation different (or perhaps it's not) from the PHS 2019-02 Omnibus Solicitation SBIR [R43/R44]?

Response: R43/R44 is a grant. This BAA is a contract solicitation. Please see Section 1. Broad Agency Announcement Information (page 3).

Question 2: If significantly different from the 2019-02 Omnibus Solicitation described above, are small businesses allowed/encouraged to apply?

Response: This BAA is being solicited using full and open competition. All offerors, including small businesses, not otherwise prohibited by law are eligible to respond.

Question 3: What is the (approximate) payline? You mentioned it being highly competitive, how many applications do you expect?

Response: NIAID estimates that one or more awards may be issued across Research Area 005 for a total cost of up to $2 million for the non-severable base work across all contracts (direct and indirect costs combined), depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds. The total cost for each award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). Please see Section 3.2.2.4.1. – Budget and Award Information (page 35). This BAA is being solicited using full and open competition; the Government cannot estimate nor provide the number of proposals received.

Question 4: What are some of the highest priority emerging infectious diseases NIAID would like to target with regard to Research Area 005 - Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases? Essentially category A pathogens?

Response: As is specified in Section 3.2.2.4.3 – Technical Approach of this BAA (page 36), the proposed diagnostic must detect one of the following agents:

o Bacillus anthracis and must phenotypically determine its antibiotic susceptibility o Yersinia pestis and must phenotypically determine its antibiotic susceptibility o Francisella tularemia and must phenotypically determine its antibiotic susceptibility o Burkholderia sp. and must phenotypically determine its antibiotic susceptibility o Botulinum toxin and must identify and distinguish relevant serotypes o Lassa virus o Nipah virus o Rift Valley Fever virus o Enterovirus D68 virus o Zika virus o Candida auris o Coccidioides sp.

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