2019 NIAID Omnibus Broad Agency Announcement

NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2019-1

1. This broad agency announcement (BAA) will be 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.

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.

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.

2. 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 Allergy, Immunology, and Transplantation (DAIT), and the Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH.

The Research Areas included in this NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2019-1, as well as the projected amounts of available funding, are discussed below. Dates for receipt of proposals are identified separately for EACH Research Area within the solicitation.

DIVISION OF ALLERGY, IMMUNOLOGY, AND TRANSPLANTATION (DAIT), NIAID, NIH

Research Area Title: Development of Radiation/Nuclear Medical Countermeasures

Total Available Funding: $4M per year for all awards
Anticipated Number of Awards: 1-2
The goal of this research is to support the development of safe and effective Medical Countermeasures (MCMs) to mitigate and/or treat tissue injuries exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in radiation-associated morbidities and mortalities. Given the extent of damage sustained after a mass casualty incident, drugs are not expected to be mobilized from the Strategic National Stockpile (SNS) before 24 hours, hence the need for MCMs that are efficacious 24 hours or later post-exposure.

DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID), NIAID, NIH

NIAID estimates that two or more awards may be issued for the Research Areas identified below, for a total estimated funding amount up to $10 million for non-severable base contract work across all contracts (direct and indirect costs combined.) 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 should not exceed five (5) years.

Research Area Title: Development of Therapeutic Products for Antibiotic Resistant Bacteria

The objective of this Research Area is the development of therapeutics to address antibiotic resistant bacteria. 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 lead series/lead/candidate therapeutic products.

Solicited products are anticipated to include: Therapeutics for Antibiotic Resistant Bacteria - Lead series/lead/candidates must address infections caused by one or more bacterial pathogens listed in the 2013 CDC Antibiotic Resistance Threats in the United States report.

Research Area Title: Advanced Development of Vaccine Candidates for Antibiotic Resistant Bacteria

The objective of this Research Area is the development of vaccines to address antibiotic resistant bacteria. 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. Novel delivery platforms that reduce logistical requirements or provide other benefits may be components of the candidate product to be developed as well. Cross-cutting technologies applicable to more than one vaccine component are also of interest.

Solicited Products are anticipated to include: Vaccines for Antibiotic Resistant Bacteria. Antibiotic resistance is rendering many current countermeasures ineffective and increasingly challenges the development of effective new antimicrobials for many priority pathogens, described in the CDC antibiotic resistant threat list. Antibiotic resistance represents a serious threat to public health and the economy. As more bacterial strains become resistant to an ever-increasing number of antibiotics, drug choices will become increasingly limited and expensive and, in some cases, nonexistent. For the many antibiotic resistant pathogens, there are currently no licensed vaccines. The development of vaccines against these microorganisms is critical since vaccines reduce the need to use antimicrobials and antibiotics, and therefore reduce the threat of antibiotic resistance.

3. Any responsible offeror may submit a proposal which shall be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

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/NIAID and then click on "How to Submit."

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