H.R. 3448 -- The Public Health Security and Bioterrorism Preparedness and Response Act Conference Report

Summary

• The bill authorizes more than $1.5 BILLION in grants to states, local governments and other public and private health care facilities and other entities to improve planning and preparedness activities, enhance laboratory capacity, educate and train health care personnel, and to develop new drugs, therapies and vaccines.

• The bill authorizes $300 MILLION for the Centers for Disease Control and Prevention to upgrade and renovate their facilities to deal with public health threats and additional sums, as needed, to improve CDC capabilities.

• The bill authorizes more than $1.15 BILLION for the Secretary of Health and Human Services to expand our current national stockpiles of medicines and other supplies, including the purchase of additional small pox vaccines.

• To help prevent bioterrorism and to establish a national database of dangerous pathogens, the bill requires the HHS Secretary to impose new registration requirements on all possessors of the 36 biological agents and toxins most dangerous to humans and mandates tough new safety and security requirements. The bill also grants authority to USDA to similarly regulate those agents that are most devastating to crops and livestock. Additionally, the bill creates tough new criminal penalties to enforce both of these important new regulatory regimes.

• To further protect America's food and drug supply, as well as to enhance agricultural security, the bill authorizes $545 MILLON for FDA and USDA to hire hundreds of new inspectors at our borders, develop new methods to detect contaminated foods, work with state food safety regulators and to protect crops and livestock. The bill also provides new regulatory powers to FDA to detain suspicious foods for inspection, to require prior notice of all food imports, to improve access to records to investigate the source of contamination and to require foreign and domestic food facilities to register with the FDA. These new resources and authorities will substantially improve the Secretary's ability to ensure the safety of America's food supply.

• To help bring safer, more-effective medicines to market, the bill reauthorizes the Prescription Drug User Fees Act (PDUFA) through FY 2007, authorizes additional funding for FDA’s Office of Drug Safety, the Office of Generic Drugs and the Division of Drug Marketing, Advertising and Communications. Additionally, the bill provides FDA the authority to notify physicians when clinical studies of new drugs have not been completed.

• And finally, in order to better protect against chemical, biological or radiological attacks on America’s drinking water supplies, the bill authorizes over $100 MILLION for the development of vulnerability analyses and emergency response plans for drinking water systems.