2023 NIAID Omnibus Broad Agency Announcement

AMENDMENT TWELVE

The purpose of Amendment Twelve 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.

________________________________________________________________________________________________________

AMENDMENT ELEVEN

The purpose of Amendment Eleven 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.

________________________________________________________________________________________________________

AMENDMENT TEN

The purpose of Amendment Ten is to:

1. As stated in Amendment One, the cut-off date for questions for Research Areas 001, 002, and 004 is March 30, 2023. The Government cannot guarantee a response for questions submitted after this date.
2. 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.

________________________________________________________________________________________________________

AMENDMENT NINE

The purpose of Amendment Nine is to:

1. Revise response to Question 5 under General Questions applicable to all Research Areas of Amendment Six.
2. 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.

________________________________________________________________________________________________________

AMENDMENT EIGHT

The purpose of Amendment Eight is to:

1. Update the “Date Offers Due” in the SAM.Gov system for Research Areas 001, 002, and 004 to April 11, 2023, 3:00pm ET. Please note that the “Date Offers Due” for Research Area 003 remains unchanged at March 13, 2023, 3:00pm ET.                                                                                                                                                                In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.  
2. 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.

_______________________________________________________________________________________________________

AMENDMENT SEVEN

The purpose of Amendment Seven 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.

_______________________________________________________________________________________________________

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT ELEVEN

The purpose of Amendment Eleven 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.

________________________________________________________________________________________________________

AMENDMENT TEN

The purpose of Amendment Ten is to:

1. As stated in Amendment One, the cut-off date for questions for Research Areas 001, 002, and 004 is March 30, 2023. The Government cannot guarantee a response for questions submitted after this date.
2. 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.

________________________________________________________________________________________________________

AMENDMENT NINE

The purpose of Amendment Nine is to:

1. Revise response to Question 5 under General Questions applicable to all Research Areas of Amendment Six.
2. 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.

________________________________________________________________________________________________________

AMENDMENT EIGHT

The purpose of Amendment Eight is to:

1. Update the “Date Offers Due” in the SAM.Gov system for Research Areas 001, 002, and 004 to April 11, 2023, 3:00pm ET. Please note that the “Date Offers Due” for Research Area 003 remains unchanged at March 13, 2023, 3:00pm ET.                                                                                                                                                                In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.  
2. 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.

_______________________________________________________________________________________________________

AMENDMENT SEVEN

The purpose of Amendment Seven 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.

_______________________________________________________________________________________________________

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT TEN

The purpose of Amendment Ten is to:

1. As stated in Amendment One, the cut-off date for questions for Research Areas 001, 002, and 004 is March 30, 2023. The Government cannot guarantee a response for questions submitted after this date.
2. 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.

________________________________________________________________________________________________________

AMENDMENT NINE

The purpose of Amendment Nine is to:

1. Revise response to Question 5 under General Questions applicable to all Research Areas of Amendment Six.
2. 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.

________________________________________________________________________________________________________

AMENDMENT EIGHT

The purpose of Amendment Eight is to:

1. Update the “Date Offers Due” in the SAM.Gov system for Research Areas 001, 002, and 004 to April 11, 2023, 3:00pm ET. Please note that the “Date Offers Due” for Research Area 003 remains unchanged at March 13, 2023, 3:00pm ET.                                                                                                                                                                In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.  
2. 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.

_______________________________________________________________________________________________________

AMENDMENT SEVEN

The purpose of Amendment Seven 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.

_______________________________________________________________________________________________________

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT NINE

The purpose of Amendment Nine is to:

1. Revise response to Question 5 under General Questions applicable to all Research Areas of Amendment Six.
2. 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.

________________________________________________________________________________________________________

AMENDMENT EIGHT

The purpose of Amendment Eight is to:

1. Update the “Date Offers Due” in the SAM.Gov system for Research Areas 001, 002, and 004 to April 11, 2023, 3:00pm ET. Please note that the “Date Offers Due” for Research Area 003 remains unchanged at March 13, 2023, 3:00pm ET.                                                                                                                                                                In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.  
2. 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.

_______________________________________________________________________________________________________

AMENDMENT SEVEN

The purpose of Amendment Seven 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.

_______________________________________________________________________________________________________

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT EIGHT

The purpose of Amendment Eight is to:

1. Update the “Date Offers Due” in the SAM.Gov system for Research Areas 001, 002, and 004 to April 11, 2023, 3:00pm ET. Please note that the “Date Offers Due” for Research Area 003 remains unchanged at March 13, 2023, 3:00pm ET.                                                                                                                                                                In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.  
2. 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.

_______________________________________________________________________________________________________

AMENDMENT SEVEN

The purpose of Amendment Seven 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.

_______________________________________________________________________________________________________

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT SEVEN

The purpose of Amendment Seven 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.

_______________________________________________________________________________________________________

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT SIX

The purpose of Amendment Six 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.

_______________________________________________________________________________________________________

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT FIVE

The purpose of Amendment Five 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.

_______________________________________________________________________________________________________

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT FOUR

The purpose of Amendment Four is to:

1. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.
2. 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.

_______________________________________________________________________________________________________ 

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT THREE

The purpose of Amendment Three is to:

1. Revise Section 3.3.3.2 – Technical Approach (page 13) of Research Area 003.
2. 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.

_______________________________________________________________________________________________________

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT TWO

The purpose of Amendment Two 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.

_______________________________________________________________________________________________________

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."

AMENDMENT ONE

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 for questions for each Research Area.

_______________________________________________________________________________________________________

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  This Broad Agency Announcement (BAA) is soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The following four (4) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2023-1, which NIAID aims to advance the R&D of promising candidate vaccines, therapeutics, and diagnostics for Biodefense, Emerging Infectious Diseases, and Pandemic Preparedness:

Research Area 001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

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. 

Research Area 002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.

Research Area 003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential

The Antiviral Program for Pandemics (APP; https://www.niaid.nih.gov/research/antivirals) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. 

Research Area 004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases

NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness.

1. Next-generation Nucleic Acid Sequencing on Portable Systems
2. Rapid Protein Detection
3. Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization.

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.

Each of the four (4) distinct Research Areas has a specified closing date and time. The proposals due date of March 13, 2023, specified in this solicitation posting, is the due date for Research Area 003 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Areas 001, 002, and 004. The proposals due date for each Research Area are identified below:

Research Area 001 - Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

Research Area 003 - The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

Proposals Due Date and Time – March 13, 2023, 3:00PM Eastern Time

Research Area 004 - Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging Infectious Diseases

Proposals Due Date and Time – April 11, 2023, 3:00PM Eastern Time

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.

For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."