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Office of Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
The Office of Acquisitions Management, Contracts, and Grants (AMCG) on behalf of the Office of Biomedical Advanced Research and Development Authority (BARDA) solicits proposals for the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological and nuclear
(CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U. S. civilian population.
BARDA anticipates that Research and Development (R&D) activities awarded under this BAA will serve to advance candidate medical countermeasures towards licensure or approval by the U. S. Food and Drug Administration (FDA).
This BAA will also serve to advance the knowledge and scientific understanding of candidates’ platform technologies, modeling and forecasting, and visual analytics.BARDA encourages the advanced research, development, and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of CBRN agents, emerging infectious diseases, and pandemic influenza.
These efforts are in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the 2016 PHEMCE Implementation Plan for CBRN Threats.
The Implementation Plan is located on the ASPR website:
https://www.phe.gov/Preparedness/mcm/phemce/Documents/2016-phemce-sip.pdf.The Pandemic and All Hazard Preparedness Act Pub.
L.
No.
109-417, 42 U.S.C.
§ 241 et seq.
(PAHPA:
http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ41 7. pdf) and The Pandemic and All Hazard Preparedness Reauthorization Act Pub.
L.
No.
113-5, (PAHPRA:
http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ 5. pdf) authorizes BARDA to (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development.Areas of Interest:
The purpose of this Broad Agency Announcement (BAA) is to solicit proposals that focus on one or more of the following areas of interest as listed here and further described in Part I.Research and Development Areas of Interest:
1. CBRN Vaccines 2. Antitoxins and Therapeutic Proteins 3. Antibacterials 4. Radiological/Nuclear Threat Medical Countermeasures 5. Chemical Threat Medical Countermeasures 6. Burn Medical Countermeasures 7. Diagnostics 8. Influenza and Emerging Infectious Diseases (IEID) Vaccines 9. Influenza and Emerging Infectious Diseases (IEID) Therapeutics 1 0. Respiratory Protective Devices1 1. Ventilators1 2. MCM Production Platform Systems1 3. Modeling as an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats1 4. Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN ThreatsThe Government intends to have a full & open competition for this requirement in the form of a BAA.
The Government expects to make one or more awards, subject to the availability of funds.
Anticipated funding for the program is subject to congressional appropriations.
The program funding is subject to change due to government discretion and funding availability.
(CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U. S. civilian population.
BARDA anticipates that Research and Development (R&D) activities awarded under this BAA will serve to advance candidate medical countermeasures towards licensure or approval by the U. S. Food and Drug Administration (FDA).
This BAA will also serve to advance the knowledge and scientific understanding of candidates’ platform technologies, modeling and forecasting, and visual analytics.BARDA encourages the advanced research, development, and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of CBRN agents, emerging infectious diseases, and pandemic influenza.
These efforts are in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the 2016 PHEMCE Implementation Plan for CBRN Threats.
The Implementation Plan is located on the ASPR website:
https://www.phe.gov/Preparedness/mcm/phemce/Documents/2016-phemce-sip.pdf.The Pandemic and All Hazard Preparedness Act Pub.
L.
No.
109-417, 42 U.S.C.
§ 241 et seq.
(PAHPA:
http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ41 7. pdf) and The Pandemic and All Hazard Preparedness Reauthorization Act Pub.
L.
No.
113-5, (PAHPRA:
http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ 5. pdf) authorizes BARDA to (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development.Areas of Interest:
The purpose of this Broad Agency Announcement (BAA) is to solicit proposals that focus on one or more of the following areas of interest as listed here and further described in Part I.Research and Development Areas of Interest:
1. CBRN Vaccines 2. Antitoxins and Therapeutic Proteins 3. Antibacterials 4. Radiological/Nuclear Threat Medical Countermeasures 5. Chemical Threat Medical Countermeasures 6. Burn Medical Countermeasures 7. Diagnostics 8. Influenza and Emerging Infectious Diseases (IEID) Vaccines 9. Influenza and Emerging Infectious Diseases (IEID) Therapeutics 1 0. Respiratory Protective Devices1 1. Ventilators1 2. MCM Production Platform Systems1 3. Modeling as an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats1 4. Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN ThreatsThe Government intends to have a full & open competition for this requirement in the form of a BAA.
The Government expects to make one or more awards, subject to the availability of funds.
Anticipated funding for the program is subject to congressional appropriations.
The program funding is subject to change due to government discretion and funding availability.
Related Programs
Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure De
Department of Health and Human Services
Agency: Department of Health and Human Services
Office: Assistant Secretary for Preparedness and Response
Estimated Funding: $25,284
Office: Assistant Secretary for Preparedness and Response
Estimated Funding: $25,284
Who's Eligible
Obtain Full Opportunity Text:
Fedbizop
Additional Information of Eligibility:
Eligible Offerors:This BAA is open to ALL responsible sources.
Offerors may include single entities or teams from private sector organizations, Government laboratories, and academic institutions.To be eligible for award, a prospective recipient must meet certain minimum standards pertaining to financial resources, ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment.Federally Funded Research and Development Centers (FFRDCs) and Government entities (Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they address the following conditions.
FFRDCs must clearly demonstrate that the proposed work is not otherwise available from the private sector AND must provide a letter on letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to government solicitations and compete with industry, and compliance with the associated FFRDC sponsor agreement and terms and conditions.
This information is required for FFRDCs proposing to be primes or subcontractors.
Government entities must clearly demonstrate that the work is not otherwise available from the private sector and provide written documentation citing the specific statutory authority (as well as, where relevant, contractual authority) establishing their ability to propose to government solicitations.
Specific supporting regulatory guidance, together with evidence of agency approval will be required to establish eligibility.
BARDA will consider eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the Proposer.Historically Black Colleges and Universities (HBCU), Minority Institutions (MI), Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUB Zone Small Business concerns are encouraged to submit proposals and to join other entities as team members in submitting proposals.In accordance with federal statutes, regulations, and U. S. Department of Health and Human Services (HHS) policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving financial assistance from the HHS.
Full Opportunity Web Address:
https://www.fbo.gov/spg/HHS/OOS/OASPHEP/BAA-18-100-SOL-00003/listing.html
Contact:
Agency Email Description:
Please contact if you have difficulty accessing the full announcement electronically
Agency Email:
Date Posted:
2017-11-16
Application Due Date:
Archive Date:
2019-11-29
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