Bill summaries are authored by CRS.

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Passed House amended (07/16/2003)

Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.

Makes biocontainment laboratories and specialized research facilities available as needed to the Secretary of Health and Human Services (the Secretary) in public health emergencies affecting national security if the owners of such a facility have entered into a grant, contract, or cooperative agreement with the Secretary under the provisions of this Act pertaining to biomedical countermeasure research and development.

Grants the Secretary certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer review authority; (3) authority for personal services contracts; and (4) streamlined personnel authority. Defines a qualified countermeasure as a priority countermeasure that affects national security.

(Sec. 3) Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) review and revise the contents of the stockpile on a regular basis; (2) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (3) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary. Permits the Secretary and the Secretary of Homeland Security to jointly submit to the President proposals for the development of needed security countermeasures. Defines security countermeasures as priority countermeasures against a chemical, biological, radiological, or nuclear agent that meet one of certain criteria (including having been approved or cleared under the Federal Food, Drug, and Cosmetic Act as countermeasures against a chemical, biological, radiological, or nuclear agent).

Amends the Homeland Security Act of 2002 to authorize appropriations for: (1) the procurement of security countermeasures; (2) the carrying out of terror threat assessment responsibilities; and (3) the acquisition and deployment of secure intelligence sharing facilities.

(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug, device, or biological product intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, with regard to the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure if complying with such requirement is: (1) not feasible; (2) contrary to the best interests of such individuals; or (3) not in the interests of national security. Allows the Secretary to withhold from members of the Armed Forces information about the benefits and risks of a countermeasure and alternatives to its use if such information is provided to such individuals within 30 days of the administration of the countermeasure and is recorded in the medical records of such members.

Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office.

(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving other underrepresented populations, are meaningfully aware of research, contracts, cooperative agreements, and development grants and procurements conducted under this Act.

(Sec. 7) Directs the Secretary to determine whether, for any grant, contract, or cooperative agreement awarded under this Act for the research, development, or procurement of a qualified countermeasure or a security countermeasure, the countermeasure involved is subject to existing export-related controls. Allows the Secretary to make a recommendation to the appropriate agency or agencies that a countermeasure should be subject to such controls if it is not already.

(Sec. 8) Directs the Secretary, the Secretary of Homeland Security, and the Secretary of Defense to ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs designed to protect the homeland from biological, chemical, radiological, and nuclear agents. Directs such Secretaries to each appoint an official to coordinate such programs for their respective Departments.