Department of Health
and Human Services (HHS)
and Human Services (HHS)
March 31, 2021
None
National Institute of Allergy and Infectious Diseases (NIAID)
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 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 Omnibus BAA is governed by Federal Acquisition Regulation (FAR) 6.102(d)(2) and FAR 35.016, as well as the NIH Policy Manual, Manual Chapter 6035, Broad Agency Announcements. A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and that part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature, identifying areas of research interest, and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.
Offers submitted in response to this BAA will be required to present separate detailed technical and business proposals designed to meet the Technical Objectives described for each Research Area proposed. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Offeror, not the Government.
Proposals received in response to this BAA are NOT evaluated against each other since they are not submitted in accordance with a common SOW issued by the Government. Instead, Research and Technical Objectives will be provided in the BAA that describe individual Research Areas in which the Government is interested. Proposals received in response to the BAA will be evaluated in accordance with the Evaluation Factors for Award specified in the announcement. The Government reserves the right to conduct discussions with all, some, one, or none of the proposals received in response to this BAA. If discussions are conducted, the Government reserves the right to suggest modifying, adding or deleting milestones, decision points, research plans, processes, schedules, budget or product. The Government also reserves the right to make awards without discussions. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award. Multiple awards are anticipated. Selection for award under this BAA will be based upon the evaluation factors, importance to the agency programs, and the availability of funds.
The Research Areas included in this NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2021-1, as well as the projected amounts of available funding, are discussed below.
DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEAES (DMID), NIAID, NIH
Research Area 001: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases.
The objective of Research Area 001 is to advance vaccine technologies and platforms that have sufficient proof of concept data and/or clinical data to support vaccine development through manufacturing, toxicology testing, and testing in phase 1 or 2 clinical trials. The goal of Research Area 001 is to advance vaccine technologies and platforms which could be deployed against agents important for biodefense and/or emerging pathogens to protect human health and well-being. The development of these platforms and technologies to rapidly progress into Phase 1 clinical trials will provide critical data to reduce the risk for future development of these technologies into approved therapies and vaccines.
Solicited products are anticipated to include: Vaccines for Anti-Microbial Resistant (AMR) Organisms and Vaccines for Pandemic Preparedness and Emerging Infectious Diseases.
NIAID estimates that three (3) or more awards may be issued across this Research Area and the next Research Area entitled “Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases” for a total cost of up to $11 million for the non-severable base work (direct and indirect costs combined) across all contracts. The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. The total performance period comprised of the base and any options proposed by an Offeror shall not exceed five (5) years.
Research Area 002: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases.
The objective of Research Area 002 is the development of promising new therapeutics to address infections caused by NIAID Category A, B, and C priority pathogens and select bacterial and fungal infections identified in the 2019 CDC Antibiotic Resistance Threats Report https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf. For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident. For the purposes of this solicitation, a therapeutic candidate refers to an advanced lead series, optimized leads, or product candidate, and is either a small molecule (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins).
Solicited products are anticipated to include: Antimicrobial Therapeutics; Antiviral Therapeutics; and Anti-toxin Therapeutics.
NIAID estimates that three (3) or more awards may be issued across this Research Area and the preceding Research Area entitled “Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases” for a total cost of up to $11 million for the non-severable base work (direct and indirect costs combined) across all contracts. The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. The total performance period comprised of the base and any options proposed by an Offeror shall not exceed five (5) years.
Research Area 003: Advanced Development of Sequencing-Based Diagnostics for Biothreats and Emerging Infectious Diseases
The objective of Research Area 003 is to advance the research and development of nucleic acid and protein sequencing solutions on established commercial platforms for the targeted and agnostic detection of bio-threat and naturally emerging infectious pathogens.
Solicited products are anticipated to include: Early through late-stage development for a sequencing-based diagnostic test that supports biodefense and naturally emerging and re-emerging infectious pathogen preparedness. Diagnostic must detect one of the following agents:
NIAID estimates that one (1) or more awards may be issued across this Research Area for a total cost of up to $4 million for the non-severable base work (direct and indirect costs combined) across all contracts. The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. The total performance period comprised of the base and any options proposed by an Offeror shall not exceed five (5) years.
Contract Proposal Receipt Date:
Proposals submitted in response to the BAA Solicitation must be received by 3:00 p.m. Eastern Time, May 24, 2021.
Any responsible offeror may submit a proposal which shall be considered by the Agency. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."
Primary Contact:
Alexandra Buck
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5174
Email: [email protected]
Secondary Contact:
Brian Madgey
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3712
Email: [email protected]