skip to main content

Federal Government

These resources – like the public health crisis itself – are constantly evolving and are only current as to the date of publication. This page was last updated on April 26, 2020.

We recommend that you monitor this site, as well as the sites referenced in these resources, for updates and changes as we expect the situation and solutions to change over the coming weeks and months. For information on specific programs, we encourage you to visit the websites of the organizations or government entities that are responsible for the relief.

resource search icon

Description of Program and Relief

Biomedical Advanced Research and Development Authority

This section of the CARES Act addresses proper procedures to be used by the Biomedical Advanced Research and Development Authority in implementing countermeasure research, development and procurement with respect to biodefense and infectious disease. The Act provides that, to the maximum extent possible, the Secretary shall use competitive procedures when entering into transactions that are related to a public health emergency. The Secretary of Health and Human Services is subsequently required to provide a report to Congress regarding the foregoing use of funds, including outcomes, benefits and risk analysis.

Additionally, under the Act, at the request of a sponsor intending to submit an application for approval of a new drug, the Secretary may expedite the review and development of a new drug if evidence suggests that the drug, either alone or in combination with other drugs, has the potential to prevent or treat a disease that is transmitted from animals to humans and has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases, in humans. The Secretary must make such priority designation within 60 calendar days of receipt of the request, and if such designation is made, the Secretary must take actions to expedite review.

Government or Lead Agency

U.S. Food and Drug Administration, through the Department of Health and Human Services

Dates Available

Continuously upon enactment.

Eligibility Requirements/Restrictions

The sponsor must have submitted a “human drug application” as defined in the Federal Food, Drug, and Cosmetic Act.

Application Deadlines (If Applicable)

N/A

Contact for More Information

N/A

List of Additional Information


© 2021 Paul, Weiss, Rifkind, Wharton & Garrison LLP. This does not constitute legal advice and does not create an attorney-client relationship. In some jurisdictions, this publication may be considered attorney advertising. Past representations are no guarantee of future outcomes.

© 2024 Paul, Weiss, Rifkind, Wharton & Garrison LLP

Privacy Policy