National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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. NIAID is currently soliciting proposals that possess the research and development (R&D) expertise necessary for successfully carrying out research toward meeting the program objectives of the NIAID Division of Microbiology and Infectious Diseases (DMID). At publication of this notice, the BAA includes the following Research Areas:

• Research Area 001: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases
• Research Area 002: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases
• Research Area 003: Collaborative Influenza Vaccine Innovation Centers (CIVICs)

The 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. Offerors should refer to the solicitation for further details about eligibility requirements.

Research Area 001: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

The objective of Research Area 001 is the development of therapeutics for use in post-event settings following the intentional release of select pathogens, or in response to naturally-occurring outbreaks of infectious diseases caused by pathogens listed in the Technical Approach section. While proposals for the development of broad-spectrum therapeutics are encouraged, candidate therapeutics or lead series with a limited spectrum that target high-priority pathogens for which no standard clinical treatment exists or for which drug resistance poses a significant public health concern are eligible as proposed candidates/products or lead series.

Solicited Products are anticipated to include:

• Antibacterial Therapeutics
• Antiviral Therapeutics
• Anti-toxin Therapeutics

Research Area 002: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

The objective of Research Area 002 is the development of vaccines for scenarios associated with intentional release of a NIAID Category A, B, or C Priority Pathogen, or naturally-occurring outbreaks of infectious diseases caused by these pathogens or Zika virus (as a component of a multivalent vaccine for other pathogens such as a vaccine for Flavivirus family). Only proposed candidate products aimed at these pathogens are eligible. The candidate product(s) may also include an adjuvant that enhances the immune response (i.e., enhanced immunogenicity, decreased time, or reduced number of immunizations to achieve protective antibodies and/or increased efficacy). Adjuvants will be supported as components of the candidate product.

Solicited Products are anticipated to include:

• Technology Gaps that Slow Progression to Clinical Testing
• Novel Vaccine Plug-and-Play Technologies
• Enhanced Vaccine Performance
• Vaccines Against Antimicrobial Resistance Threats

Research Area 003: Collaborative Influenza Vaccine Innovation Centers (CIVICs)

The objective of Research Area 003 is to support improvements in the immunogenicity and durability of seasonal influenza vaccines, and the development of innovative influenza vaccine approaches that provide robust, durable, broadly protective mucosal and systemic anti-influenza immunity ("universal influenza vaccines"). Research Area 003 will support iterative vaccine design based on detailed immunologic assessment of influenza vaccine candidates through pre-clinical animal studies, early phase clinical trials and healthy volunteer human challenge studies to advance the most promising vaccine candidates into Phase I/II clinical trials.

NIAID will work with the Contractors to facilitate a CIVICs program that:

• Is comprised of well-integrated, multi-disciplinary teams of investigators that work collaboratively across Centers and Cores to support the research objectives of this program as guided by NIAID.
• Employs state-of-the-art, cutting-edge techniques and strategies, and bring in expertise from outside of the influenza field, to design innovative influenza vaccine approaches.
• Employs an iterative process, based on principles of influenza immunity, to achieve the desired attributes of a universal influenza vaccine.
• Works collaboratively to test novel combinations and conduct head-to-head comparisons of influenza vaccine approaches under development in order to identify, down-select and advance the most promising vaccine candidates.
• Collaborates with and leverages other NIAID extramural and intramural research programs to contribute to the development of universal and improved seasonal influenza vaccines.

General

All responsible sources may submit a proposal, which shall be considered by the Agency. NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2018 is available electronically through the Government wide point of entry (GPE): FedBizOpps.gov (www.fbo.gov). This BAA is available ONLY via electronic means. Printed copies of the announcement will not be distributed. Potential offerors are encouraged to refer frequently to the GPE for updates on the program. Any updates or corrections to the announcement will be posted there.

For this solicitation, the NIAID requires proposals to be submitted 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."

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

Inquiries

Please direct all inquiries to:

George W Kennedy
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5170
Email: kennedyg@mail.nih.gov