SOLICITATION NOTICE
A -- 2020 NIAID Omnibus Broad Agency Announcement
- Notice Date
- 12/11/2019 7:13:48 AM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID-BAA2020-1
- Archive Date
- 01/31/2020
- Point of Contact
- Swee L. Teo, Phone: 240-669-5173, Brian Madgey, Phone: 240-627-3712
- E-Mail Address
-
teosl@niaid.nih.gov, brian.madgey@nih.gov
(teosl@niaid.nih.gov, brian.madgey@nih.gov)
- Description
- 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 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 Research Areas included in this NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2020-1, as well as the projected amounts of available funding, are discussed below. Dates for receipt of proposals will be identified separately for EACH Research Area within the solicitation.Description:DIVISION OF ALLERGY, IMMUNOLOGY AND TRANSPLANTATION (DAIT), NIAID, NIHResearch Area Title: Development of Radiation/Nuclear Medical Countermeasures (MCMs)The objective of this Research Area is to advance the development of candidate medical countermeasures (MCM) to reduce mortality and/or major morbidities associated with exposure to radiation from a radiological or nuclear incident. This Research Area will advance lead candidate MCMs toward eventual FDA approval or licensure to mitigate or treat radiation-induced injuries and thereby improve survival following a radiological event. It is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs or biologics that are already licensed or approved for other indications).NIAID estimates one or two cost-reimbursement, completion type contracts may be awarded for this Research Area for an average annual total cost (direct and indirect costs combined) of up to $2 million for a non-severable base and option periods. It is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed 3 years.DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID), NIAID, NIHResearch Area Title: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis (AFM) Associated with Enterovirus D68The objective of this Research Area is to support the development of a candidate vaccine for EV D68 associated AFM. The primary vaccine candidate requested is an inactivated EV D68 vaccine; however, other technologies to develop a non-replicating EV D68 vaccine will be considered (e.g., VLP). Proposed inactivated EV D68 vaccines most likely will require an adjuvant using either a single vaccine vial format or a combination two vial antigen plus adjuvant format that uses bedside mixing. The preference is to use adjuvants that minimize regulatory concerns and expedite vaccine development into a Phase I clinical trial. Solicited products are anticipated to include: Development of inactivated EV D68 vaccines through a Phase I clinical trial. The Phase 1 clinical trial start date is targeted for 2021 while interim data assessment and/or completion of the clinical trial with draft data assessment is targeted prior to Aug 2022. NIAID estimates that one or more awards may be issued for this Research Area for a total cost of up to $3 million for the non-severable base 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 which includes stability studies. Research Area Title: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious DiseasesOne objective of this Research Area is to develop vaccines to address antibiotic resistant gram-negative bacteria focusing on, but not limited to, Burkholderia spp., Pseudomonas aeruginosa, Francisella tularensis, Yersinia pestis, and E. coli. A second objective is to support development of vaccines for emerging viruses and pandemic preparedness that includes but is not limited to alphaviruses (for example Eastern Equine Encephalitis (EEE)) and bunyaviruses (for example Rift Valley Fever Virus (RVFV)). NIAID seeks to focus this BAA on pathogens that have not recently received funding from NIAID, other agencies, or organizations. As a result, NIAID will exclude - specifically for this BAA - the following pathogens: Filoviruses, Lassa, MERS, Chikungunya, Zika and Nipah. Solicited products are anticipated to include: Lead candidate vaccines that have sufficient proof of concept data and/or clinical data to support vaccine development through manufacturing, toxicology testing, and testing in phase I/II clinical trials.NIAID estimates that three or more awards may be issued across this Research Area and the next Research Area title “Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases” for a total cost of up to $11.5 million for the non-severable base 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 Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious DiseasesThe objective of this Research Area is the development of promising new therapeutics to address infections caused by NIAID Category A, B, and C priority pathogens. For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident. For the purposes of this solicitation, a therapeutic candidate is either a lead series, lead, or product candidate, and is either a drug (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins). This Research Area support lead optimization, pre-clinical (IND enabling) and clinical trials that include Phase 1 and Phase 2 studies.Solicited products are anticipated to include: Therapeutic lead series/lead/product candidate must address infections caused by one or more pathogens listed among NIAID Category A, B, and C priority pathogens,NIAID estimates that three or more awards may be issued across this Research Area and the preceding Research Area title “Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases” for a total cost of up to $11.5 million for the non-severable base 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: Advanced Development of Diagnostics for Biothreats and Emerging Infectious DiseasesThe objective of this Research Area is to advance the development of novel, rapid sample-to-answer candidate diagnostic products that will address biodefense and pandemic preparedness. Initial proof-of-concept demonstration that diagnostic method can detect a biological component (eg., pathogen, protein, nucleic acid, etc), preferable in a relevant clinical matrix (e.g., blood, urine, swab, etc) is required for preliminary data.Solicited products are anticipated to include: Early through late-stage diagnostics to address biodefense and pandemic preparedness. Diagnostic must detect one of the following agents: Bacillus anthracis and must phenotypically determine its antibiotic susceptibility Yersinia pestis and must phenotypically determine its antibiotic susceptibility Francisella tularemia and must phenotypically determine its antibiotic susceptibility Burkholderia sp. and must phenotypically determine its antibiotic susceptibility Botulinum toxin and must identify and distinguish relevant serotypes Lassa virus Nipah virus Rift Valley Fever virus Enterovirus D68 virus Zika virus Candida auris Coccidioides sp.NIAID estimates that one or more awards may be issued for this Research Area for a total cost of up to $2 million for the non-severable base 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. 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.Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on or about December 31, 2019 and may be accessed through Beta Sam: https://beta.sam.gov/. 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 and then click on "How to Submit."
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/304049d7d6dc4f33802704eca1f3aad3/view)
- Record
- SN05513822-F 20191213/191211230303 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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