Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices

Solicitation Notice Information

Introduction

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, Division of Allergy, Immunology and Transplantation has been charged by the DHHS with developing products for the mitigation and/or treatment of radiation injuries resulting from a nuclear and radiological attack to the stage where products are eligible for advanced product development by the Biomedical Advanced Research and Development Authority (BARDA) or acquisition under the Project BioShield Act of 2004.

Description

National Institute of Allergy and Infectious Diseases intends to solicit proposals for contracts entitled "Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Biomarkers/Devices" to advance the development of candidate medical countermeasures (MCM) or biodosimetry biomarkers/devices to assess and reduce mortality and/or major morbidities associated with exposure to radiation from a radiological or nuclear incident. NIAID anticipates that research and development studies supported by this BAA will advance lead candidate MCM or lead biomarkers/devices toward eventual FDA approval or licensure to assess/mitigate/treat radiation-induced injuries and thereby improve survival following a radiological event. For this Broad Agency Announcement, it is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs/devices or biologics that are already licensed or approved for other indications), so the offeror is expected to provide a Statement of Work based on the stage of the candidate and the work that needs to be performed to advance the MCM/biomarker/device.

Proposals will be evaluated on the extant, underlying data supporting the amelioration of radiation-induced tissue damage and reduction of mortality and/or major morbidities, and the comprehensiveness, soundness, adequacy and suitability of the proposed scientific approach and methodology used to support the advancement of the candidate MCM/biomarker/devices for the assessment, mitigation or treatment of Acute Radiation Syndrome (ARS) towards FDA approval or licensure under the FDA Animal Rule. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, (GLP, cGMP compliance) and project management.

It is anticipated that up to 4 cost reimbursement, completion type contracts will be awarded for a 3-year period of performance beginning on or about December 1, 2016. 

NIAID estimates that the average annual total cost (direct and indirect costs combined) is $1-2million per contract award per year. However, 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 three years.

Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about December 28, 2015 , and may be accessed through 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, NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

Presolicitation Notice Information

Introduction

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, Division of Allergy, Immunology and Transplantation has been charged by the DHHS with developing products for the mitigation and/or treatment of radiation injuries resulting from a nuclear and radiological attack to the stage where products are eligible for advanced product development by the Biomedical Advanced Research and Development Authority (BARDA) or acquisition under the Project BioShield Act of 2004.

Description

National Institute of Allergy and Infectious Diseases intends to solicit proposals for contracts entitled "Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Biomarkers/Devices" to advance the development of candidate medical countermeasures (MCM) or biodosimetry biomarkers/devices to assess and reduce mortality and/or major morbidities associated with exposure to radiation from a radiological or nuclear incident. NIAID anticipates that research and development studies supported by this BAA will advance lead candidate MCM or lead biomarkers/devices toward eventual FDA approval or licensure to assess/mitigate/treat radiation-induced injuries and thereby improve survival following a radiological event. For this Broad Agency Announcement, it is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs/devices or biologics that are already licensed or approved for other indications), so the offeror is expected to provide a Statement of Work based on the stage of the candidate and the work that needs to be performed to advance the MCM/biomarker/device.

Proposals will be evaluated on the extant, underlying data supporting the amelioration of radiation-induced tissue damage and reduction of mortality and/or major morbidities, and the comprehensiveness, soundness, adequacy and suitability of the proposed scientific approach and methodology used to support the advancement of the candidate MCM/biomarker/devices for the assessment, mitigation or treatment of Acute Radiation Syndrome (ARS) towards FDA approval or licensure under the FDA Animal Rule. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, (GLP, cGMP compliance) and project management.

It is anticipated that up to 4 cost reimbursement, completion type contracts will be awarded for a 3-year period of performance beginning on or about December 1, 2016. 

NIAID estimates that the average annual total cost (direct and indirect costs combined) is $1-2million per contract award per year. However, 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 three years.

Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about December 28, 2015 , and may be accessed through 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, NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."