BAA-16-100-SOL-00001_CBRN_Amendment_2_20160208.pdf

AMENDMENT TO

BROAD AGENCY ANNOUNCEMENT FOR THE ADVANCED RESEARCH AND DEVELOPMENT OF

CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR (CBRN)

MEDICAL COUNTERMEASURES FOR BARDA

Broad Agency Announcement Number: BAA-16-100-SOL-00001 Amendment Number: 0002

A. SUMMARY OF CHANGES

This amendment issues a new subsection to the section entitled Area of Interest #6: Clinical Diagnostics. Additionally, Christopher Houchens is the new point of contact for Area of Interest #3: Antimicrobial Therapeutics. Changes to the amended version of the Broad Agency Announcement are highlighted in yellow.

B. AMENDMENTS TO BAA

(1) The section entitled Area of Interest #6: Clinical Diagnostics in the Part entitled

Research Areas of Interest is changed by adding the following new subsection entitled

6.9 Diagnosis of Zika virus infections:

6.9.1 Point of Care (POC) assays: Development, clinical evaluation, and FDA clearance of rapid, highly sensitive, and accurate diagnostic systems for the detection of Zika virus specific IgM antibodies, or the detection and differentiation of Zika virus specific IgM and IgG antibody responses in individuals suspected of being infected with Zika virus, or a combination assay for the detection and differentiation of IgM and IgG responses resulting from infection with Zika, Dengue, or Chikungunya virus. (Assays that detect antibodies only against Dengue and/or Chikungunya virus will not be considered.) These systems should be portable and designed for ease-of-use by non-expert personnel at point-of-care (POC) settings. It is preferred that these POC systems be CLIA-waived/waive-able. Critical technology component should be at a maturity level equal to or greater than TRL-4. More mature projects will be given priority.

6.9.2 Laboratory Based assays: Development, clinical evaluation, and FDA clearance of rapid, highly sensitive, and accurate assays for use in a wide-range of laboratory settings for the detection of Zika virus specific IgM antibodies, or the detection and differentiation of Zika virus specific IgM and IgG antibody responses in individuals suspected of being infected with Zika virus, or a combination assay for the detection and differentiation of IgM and IgG responses resulting from infection with Zika, Dengue, or

Chikungunya virus. (Assays that detect antibodies only against Dengue and/or Chikungunya virus will not be considered.) Critical technology component should be at a maturity level equal to or greater than TRL-4. More mature projects will be given priority.

(2) For Area of Interest #6.9, Stage 2 Full Proposals are preferred and may be submitted for review on any day during the open period of the BAA. Offerors are required to follow proposal submission guidelines in the BARDA BAA-16-100-SOL-00001.

(3) Offerors contemplating submitting a Full Proposal are strongly encouraged to contact the appropriate technical Point of Contact (POC) at BARDA (see names and e-mail addresses listed immediately after each development area of interest).

(4) Area of Interest #3 Point of Contact on page16 of the BAA is changed to the following:

Technical Point of Contact: Dr. Christopher Houchens, Christopher.houchens@hhs.gov

[End of Amendment No. 0002] mailto:Christopher.houchens@hhs.gov