Development of Radiation/Nuclear Medical Countermeasures
Added: Jan 27, 2017 5:03 pm 1. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) 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 following NIAID Divisions:- Division of Allergy, Immunology, and Transplantation (DAIT), NIAID, NIH- Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2017-1 will soon be available electronically tough the Government wide point of entry (GPE): FedBizOpps.gov (www.fbo.gov). 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 the 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 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.The Research Areas anticipated to be included in the NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2017-1, 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.DIVISION OF ALLERGY, IMMUNOLOGY, AND TRANSPLANTATION (DAIT), NIAID, NIHResearch Area 001: Adjuvant Development ProgramThis Research Area is intended to advance novel adjuvants towards licensure for human use tough immunological characterization studies and lead compound optimization, up to and including IND-enabling studies.NIAID estimates up to five (5) contracts, and up to four (4) HIV envelope immunogen electives, may be issued. The average annual total cost (direct and indirect costs combined) will be approximately $2.0M per award. In addition, $500,000 total costs/award for one year will be available for an elective HIV envelope immunogen study. While the total proposed costs and the length of time for which funding is requested should be consistent with the nature and complexity of the proposed research, the total performance period proposed by an offeror should not exceed five (5) years.Research Area 002: Development of Radiation/Nuclear Medical CountermeasuresThis Research Area is intended to support the research and development of promising new approaches to mitigate and/or treat tissue injuries arising from exposure to ionizing radiation, which may include, but are not limited to: biologics, including cytokines and free radical scavengers; cellular therapies; and drugs, such as, anti-inflammatory agents, antibiotics, and anti-fibrotics.NIAID estimates that two or more awards may be issued for a total cost of up to $2 million for the non-severable base work across all contracts (direct and indirect costs combined). While 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 tee (3) years.Research Area 003: Development of Radiation/Nuclear Predictive Biomarkers and Biodosimetric DevicesThis Research Area is intended to support further development of biodosimetry biomarkers (biological indicators of radiation exposure, such as intensity of radiation-induced tissue injuries), and/or automated high-toughput diagnostic systems (devices) to rapidly assess levels and types of radiation exposure using minimally invasive biosamples (e.g., a minimum quantity of blood, hair follicles, skin swabs, saliva, serum, or urine, rather than spinal fluid or tissue biopsy samples.)NIAID estimates that two or more awards may be issued for a total cost of up to $2 million for the non-severable base work across all contracts (direct and indirect costs combined). While 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 tee (3) years.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 $18 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 004: Development of Broad-spectrum Therapeutic Products for Biodefense, Anti-Microbial Resistant Infections and Emerging Infectious DiseasesThe objective of this Research Area is the development of broad-spectrum therapeutic products for use in post-event settings following the intentional release of a NIAID Category A, B, or C Priority Pathogen, zika virus, or in response to naturally-occurring outbreaks of infectious diseases caused by these pathogens.Solicited products are anticipated to include: Antibacterial Broad-spectrum Therapeutics; Antiviral Broad-spectrum Therapeutics; and, Anti-toxin Therapeutics.Research Area 005: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious DiseasesThe objective of this Research Area is the development of vaccines for use in post-event settings following the intentional release of a NIAID Category A, B, or C Priority Pathogen, zika virus, or in response to naturally-occurring outbreaks of infectious diseases caused by these pathogens.Solicited Products are anticipated to include: Vaccines Against Antimicrobial Resistance Teats; Technology Gaps that Slow Progression to Clinical Testing; Enhanced Vaccine Performance (e.g., development of vaccine technologies, platforms, and/or formulations that minimize cold chain requirements and enhance stability); and, Novel Vaccine "Plug-and-Play" Technologies (e.g., technological solutions/platforms that improve preparedness capabilities).2. Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about February 21, 2017, and may be accessed tough FedBizOpps http://www.fedbizopps.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/NIAID and then click on "How to Submit."Contracting Office Address: Office of Acquisitions5601 Fishers LaneSuite 300, MSC 9821Bethesda, Maryland 20892-9821 HHS-NIH-NIAID-BAA2017-1 Department of Health and Human Services National Institutes of Health
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