108th Congress

Project BioShield Act of 2004

P.L. 108-276 (S. 15, H.R. 2122)

Impact of Public Law

P.L. 108-276, the Project BioShield Act of 2004, provides authorities for expedited procurement, streamlined personnel appointments, expedited peer review, biomedical countermeasures procurement, smallpox vaccine development for the National Stockpile, and other authorities relevant to biodefense activities. Among its research-related provisions, the Act:

• Authorizes the Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health (NIH), to employ expedited peer-review procedures as deemed appropriate to obtain an assessment of the scientific and technical merit and contribution to the relevant field of a grant, contract, or cooperative agreement for qualified countermeasure research. This expedited peer review will replace the normal peer-review process without regard to any prior peer-review procedures used for the same grant, contract, or cooperative agreement.
• Authorizes the Director of NIH, acting through the Director of the National Institute of Allergy and Infectious Diseases, to award grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities. For relevant activities, such sums as may be necessary are authorized for fiscal years 2004 and 2005.
• Authorizes the Secretary to appoint professional and technical employees, not to exceed 30 at one time, to positions at NIH to perform, administer, or support qualified countermeasure research and development

Legislative History

In his 2003 State of the Union Message, President George W. Bush announced Project BioShield, a comprehensive project with the stated goals of speeding development and availability of modern, effective drugs, vaccines, and other countermeasures against biological and chemical weapons and providing incentives to private companies in order to encourage development of vaccines for diseases that pose a potentially significant bioterrorism threat. In response, the House and the Senate introduced versions of Project BioShield legislation.

S. 15, originally entitled the Biodefense Improvement and Treatment for America Act, was introduced by Senator Judd Gregg (R-NH) on March 11, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions. Project BioShield provisions were included in Title II of the Act. On March 19, the measure was marked up and ordered to be reported out with amendments, and on March 25, the measure was reported out of the Senate Committee on Health, Education, Labor and Pensions. Although scheduled for floor debate on May 6, 2003, the measure was not considered in the Senate until May 19, 2004. At that time, the Senate agreed to two amendments by Senator Gregg, one of which substituted the text of the original S. 15 with text more similar but not identical to a version of the legislation passed by the House. The Senate agreed to the amended S. 15 by a vote of 99 to 0. The measure was sent to the House on May 20 and passed on July 14 by a vote of 414 to 2. The measure was signed by the President on July 21 as P.L. 108-276.

H.R. 2122 was introduced by Representative W.J. “Billy” Tauzin (R-LA) on May 15, 2003, and was referred to the House Committees on Energy and Commerce and on Government Reform and the House Select Committee on Homeland Security. The measure was marked up and ordered to be reported out as amended by those Committees on May 15, May 22, and June 26, respectively. The measure was also sequentially referred to the House Committee on Armed Services on June 11 and discharged by that Committee on the same day. On July 16, an amendment in the nature of a substitute was adopted and the measure was passed by a vote of 421 to 2. H.R. 2122 was sent to the Senate on July 17 and placed on the Senate Calendar. No further action occurred on this legislation.