The purpose of this special notice is to obtain information via White Papers from both MCDC members and other interested industry/academia partners in response to the novel Coronavirus (2019-nCoV) pandemic in the United States (U.S.). The Government is requesting White Papers with a focus on the following areas:
- Diagnostics/Monitoring: Medical diagnostic devices, with specific emphasis on Point-of-Care diagnostics (e.g. CLIA waived), under development and capable of diagnosing 2019- SARS-CoV-2, and achieving Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) within the next one to four (1-4) months.
- Surveillance: Surveillance methods and associated devices for 2019-SARS-CoV-2 screening. Any technology that can enhance the understanding of disease progression in COVID-19 infected patients is also of interest, including physiologic monitoring and other vital signs indicators, portable technology that enhances patient care in non-hospital settings, and technology that improves sample collection.
Note: Offerors can consider pursuing Assay and/or Device development efforts that could be used for health surveillance, medical diagnostics, or potentially both. Medical diagnostics efforts need to ensure that they meet required regulatory pathways.
- Information systems and technology the Government can use in a handheld Point-of-Care device to collect, screen, collate, report, and monitor disease infection and pandemic spread on a micro and macro level.
- Therapeutics: Drugs and/or drug/device combinations, or platforms currently under development demonstrating efficacy in post-exposure, pre- and post-symptomatic studies for any CoV strain, and capable of achieving EUA from the FDA within the next three (3) months for this ongoing SARS-CoV-2 pandemic. Antibody technologies, accelerating the discovery, development, manufacturing, and prediction of success for these technologies, can also be considered.
- Prophylactics: Drugs or vaccines currently under development demonstrating pre-exposure in vivo efficacy or in vitro activity against any or all strains of CoV. Antibody technology, accelerating the discovery, development, manufacturing and prediction of success for these technologies can be considered.
- Clinical Trials: Opportunities to expeditiously conduct clinical trials for any technology that will require evaluation for FDA approval, will be considered.
Entities are encouraged to provide innovative products and technologies that in the short term (1-6 months), can be rapidly deployed to combat the current pandemic. Long-term solutions (6 months and beyond) are not requested at this time.
It is expected the proposed solutions will be submitted to, and receive FDA EUA.
By submission of a White Paper in response to this request, the offeror agrees that even if marked as proprietary information in the White Paper, the Government has full authority to distribute the White Paper to any other Government agency requesting it. The proprietary information will be handled accordingly. White Papers will not be returned to the member and may be retained indefinitely by the Government. The White Papers will not be subjected to a source selection review process, therefore, no White Paper Feedback will be provided.
MCDC Membership: The OTA Consortium model allows for increased, streamlined collaboration between the Government and Consortium membership. The OTA Consortium model is a unique acquisition tool that allows for more open communication and emphasizes engaging a diversified range of membership – from academia to industry suppliers. The MCDC Consortium model operates via a single set of terms and conditions through the single-point contracting agent for the Consortium, or Consortium Management Firm (CMF). As a result, the OTA process decreases acquisition time and cost, enabling rapid technology and prototype solutions. Membership in the MCDC Consortium allows for networking with stakeholders including Government, Industry, and Academia.
Interested parties can be directed to https://www.medcbrn.org/how-to-join/ to obtain information on membership. Companies that are part of the Academia, US Defense Industrial Base, as well as new and emerging non-traditional defense contractors, are encouraged to join the MCDC and participate in Federally-funded R&D projects. Any questions should be addressed to the CMF, Advanced Technology International (ATI), at MCDC@ati.org.
For this request, submission is open to all entities of the US Defense Industrial Base, not just MCDC members. Should a non-MCDC member be selected for award, that entity would be required to join the MCDC prior to award execution.
Considering the urgency to find solutions, offerors are highly encouraged to respond within 48 hours of the issuance of this RFI. However, responses received beyond the 48 hour window will also be reviewed by the Government. Once responses are submitted, they cannot be updated. It is anticipated this Special Pandemic Response RFI will remain open through May 31, 2020, and may be extended if needed.
URL for more information:
White Papers must be submitted using the BIDS portal at the link provided below:
- Please visit this site to register if you have not already. Registration is required before submission.
- Upon WP submission, a receipt confirmation, including a unique reference number, will be provided by email. The email will come from firstname.lastname@example.org(check your spam folder if you do not receive notification).
Filed Under: Funding Opportunities