Broad Agency Announcement (BAA) for Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

This amendment extends the Deadline for Submission to November 30, 2017.

This contract is for the development of Zika IgM and Zika IgG automated immunoassays. The overall objective of this contract is to advance the development of two laboratory-based in vitro diagnostic (IVD) assays: one to detect Zika IgM antibodies and the other to detect Zika IgG antibodies in human patient serum, to be used together for the diagnostic detection and identification of Zika virus infection.

This contract is for the development of the OraQuick Zika Point-of-Care Test to detect infection from the Zika virus in multiple matrices which may include whole blood (venous whole blood and finger-stick whole blood), oral fluid, serum, plasma, urine, and seminal fluid.

Synopsis:
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 Chemical, Biological, Radiological and Nuclear (CBRN) agents in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the 2014 PHEMCE Implementation Plan for CBRN Threats. The Implementation Plan is located on the ASPR website: http://www.phe.gov/Preparedness/mcm/phemce/Documents/2014-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-109publ417.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-113publ5.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 BAA is to solicit proposals that focus on one or more of the following area of interest as listed here and further described in Part I.

Development Areas of Interest:
Area of Interest #1: Platform Technologies to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

BARDA anticipates that research and development activities awarded from this Broad Agency Announcement (BAA) will serve to advance the knowledge and scientific understanding of candidates' platform technologies submitted for consideration under this Area of Interest should fully describe all aspects of the platform and supportive technologies and should include a statement of work that applies the platform to a known pathogen or disease, as an example, to demonstrate the capabilities of the platform and allow evaluation of its feasibility and performance.
The Government intends to have a full & open competition for this requirement in the form of a BAA. This synopsis is not a BAA; a BAA itself is anticipated to be posted on or about October 13, 2015. The Government expects to make 1 or more awards, subject to the availability of funds. The open period of the BAA will be specified in the BAA itself.

Contact Information:
Technical Point of Contact: Mark Craven; mark.craven@hhs.gov

Comments to this announcement, referencing synopsis BAA- 16-100-SOL-00003 may be submitted to the following email address: SST-BAA@hhs.gov

Contracting Office Address:

Department of Health & Human Services (DHHS)
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Acquisition Management Contracts & Grants (AMCG)
330 Independence Ave., S.W., Room G-644
Washington, D.C. 20201
The Government intends to promote and provide for full & open competition under this requirement through the use of this BAA. The Government expects to make 1 or more awards, subject to the availability of funds. This advertisement does not commit the Government to award a contract.

Pre-proposal Conference:

A Multi-BAA Pre-Proposal Conference is scheduled for October 14-16, 2015 in Washington, D.C. Advance registration is required. For additional information, and to register, please visit: https://www.medicalcountermeasures.gov/federal-initiatives/public-meetings-and-conferences/barda-industry-day-2015