S. 15 · 108th Congress

Vaccine Compensation bill

Stage
Signed by the president
Sponsor
Judd Gregg
Introduced
2003-03-11
Latest action
2004-07-21 · Signed by President.

Summary

Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act to declare that the National Institute of Allergy and Infectious Diseases shall be the lead institute for performing, administering, or supporting biomedical countermeasure research and development. Defines a biomedical countermeasure as a drug, biological product, or device that is used to treat, identify, or prevent harm from: (1) a biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or (2) a potentially harmful condition arising from the administering of a drug, biological product, or device in response to such an agent.Grants the Secretary of Health and Human Services (the Secretary): (1) expedited procurement authority regarding property or services for use in performing, administering, or supporting biomedical countermeasure research or development; (2) the authority to expedite peer review under this section as deemed necessary to obtain a likely contribution to the field of biomedical countermeasure research; and (3) the authority to secure the personal services of experts or consultants with relevant qualifications for the purpose of performing, administering, and supporting biomedical countermeasure research and development.Classifies a person carrying out a contract under this section, and an officer, employee, or governing board member of such person, to be deemed an employee of the Department of Health and Human Services for purposes of claims under specified law for money damages for personal injury, including death.(Sec. 3) Directs the Secretary of Homeland Security, on an ongoing basis, to assess threats of use of chemical, biological, radiological, and nuclear agents and determine which threats pose a material risk of use against the United States population. Requires the Secretary of Homeland Security to assess the public health consequences of such potential uses and to determine the agents for which countermeasures are necessary to protect the public health. Authorizes the Secretary and the Secretary of Homeland Security to jointly submit to the President for approval proposals to call for needed countermeasures. Directs the Secretaries to inform persons who may respond to each approved call. Requires the Secretary, in consultation with the Secretary of Homeland Security, to determine countermeasures appropriate for procurement and inclusion in the stockpile under the Public Health and Bioterrorism Preparedness and Response Act of 2002. Directs the Secretary to annually determine and report to the President whether there is a significant commercial market for products identified as appropriate for procurement other than as biomedical countermeasures. Directs the Secretary to procure countermeasures that have been approved by the President.Authorizes appropriations.(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 or device intended solely for use in an emergency. Directs the Secretary to impose requirements on the authorization to ensure 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. Imposes civil monetary penalties for violation of this section. Allows the President, under specified circumstances in cases involving the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure. Applies record keeping requirements under the Act to products authorized under this Act for use in emergencies.(Sec. 5) Amends Public Health Service Act provisions concerning the administration of smallpox countermeasures by health professionals, including to modify the definitions of covered countermeasure, covered person, and qualified person.(Sec. 6) Directs the Comptroller General to report to Congress regarding this Act.