countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents.
As the expiration of some of these authorities approaches, Congress is considering whether these
authorities have sufficiently contributed to national preparedness to merit extension.
The Project BioShield Act provides three main authorities: (1) guaranteeing a federal market for
new CBRN medical countermeasures, (2) permitting emergency use of countermeasures that are
either unapproved or have not been approved for the intended emergency use, and (3) relaxing
regulatory requirements for some CBRN terrorism-related spending. The Department of Health
and Human Services (HHS) has used each of these authorities. The HHS obligated approximately
$2.5 billion to guarantee a government market for countermeasures against anthrax, botulism,
radiation, and smallpox. The HHS allowed the emergency use of several unapproved products,
including during the 2009 H1N1 influenza pandemic. The HHS used expedited review authorities
to approve contracts and grants related to CBRN countermeasure research and development.