108th Congress

Biological, Chemical, Radiological, and Nuclear Defense

S. 15/S. 1504, S. 666, H.R. 2122

Background

Having received considerable attention in the 107th Congress, the potential for biological, chemical, radiological, and nuclear attacks on the United States and the Nation's response to such threats continue to be of interest to the 108th Congress. As a result, a number of bills related to bioterrorism and biodefense issues have been introduced. Four of those bills contain provisions specific to the National Institutes of Health's (NIH) research on countermeasures to protect the populace. Three of these bills are related, although not identical; one of the three is a replacement measure.

Provisions of the Legislation/Impact on NIH

S. 15—Biodefense Improvement and Treatment for America Act/S. 1504—Project BioShield Act of 2003

S. 15, the Biodefense Improvement and Treatment for America Act, which contained Project BioShield provisions, has been replaced by S. 1504, the Project BioShield Act of 2003. In addition to research-related provisions, this most recent version of the legislation contains revised vaccine injury compensation provisions related to smallpox that were deleted from S. 15 during Senate Committee on Health, Education, Labor and Pensions action. The Project BioShield provisions of S. 1504, like those of S. 15, would provide the Secretary of Health and Human Services (HHS) with authorities for expedited procurement and peer review related to biomedical, chemical, radiological, and nuclear countermeasures research and for securing the services of experts or consultants with relevant expertise. The National Institute of Allergy and Infectious Diseases (NIAID) would be designated as the lead Institute for biological countermeasures research at NIH.

As introduced, provisions of S. 1504 relevant to NIH would:

• Require the Secretary of HHS to carry out biomedical countermeasures research and development activities through the Director of NIH
• Mandate NIAID as the lead Institute for performing, administering, and supporting such research and authorize the Director of NIH to delegate the necessary authorities to the Director of NIAID
• Authorize the Director of NIH to carry out chemical, radiological, or nuclear countermeasures research through the other national research institutes
• Authorize expedited procurement procedures for relevant property or services
• Authorize expedited peer review in place of peer-review and advisory council review procedures as the Secretary of HHS, in consultation with the Director of NIH, deems appropriate, including consultation with appropriate scientific experts
• Authorize the Secretary of HHS to appoint professional and technical employees to positions at NIH as deemed necessary to carry out countermeasures research and development, without regard to Title 5, U.S. Code
• Authorize the Secretary of HHS to require that grant or cooperative agreement recipients make their laboratories available as needed to respond to public health emergencies affecting national security

S. 1504 would also provide for a technical amendment to Section 481A of the Public Health Service Act to authorize NIAID to modernize and construct necessary facilities.

S. 666—Biological, Chemical, and Radiological Weapons Countermeasures Research Act

S. 666 would authorize the Director of NIH to award partnership challenge grants to promote joint ventures between the Agency, its grantees, and for-profit biotechnology, pharmaceutical, and medical device industries for the development of biological, chemical, radiological, and nuclear countermeasures and research tools. The Director would be required to issue regulations within 90 days of the enactment of the bill to implement the awarding of these grants. S. 666 would also authorize $200 million for each of the fiscal years (FYs) 2004 through 2008. In addition to NIH-related provisions, the bill would provide a number of incentives, tax credits, antitrust exemptions, and exclusive licensing protections to encourage industry to engage in countermeasures research and development.

H.R. 2122—Project BioShield Act of 2003

H.R. 2122 would also provide the Secretary of HHS with authorities for the expedited procurement and peer review related to biomedical, chemical, radiological, and nuclear countermeasures research and for securing the services of experts or consultants with relevant expertise. With respect to research-related provisions, this measure is similar, although not identical, to S. 1504. Specifically, H.R. 2122, as passed by the House, would:

• Authorize the Secretary of HHS to carry out biomedical countermeasures research and development activities if the activities concern qualified countermeasures defined in the bill. However, no reference is made to these activities being carried out through NIH, nor is NIAID designated as the lead Institute for biological countermeasures research.
• Authorize expedited procurement procedures for relevant property or services
• Authorize expedited peer review in place of peer-review and advisory council review procedures as the Secretary of HHS, in consultation with the Director of NIH, deems appropriate, including consultation with appropriate scientific experts
• Authorize the Secretary of HHS to appoint professional and technical employees to positions at NIH as deemed necessary to carry out countermeasures research and development, without regard to Title 5, U.S. Code; however, compensation to any such expert or consultant would be limited to no more than the daily equivalent of the annual rate of pay of the President.
• Authorize the Secretary of HHS to enter into interagency agreements and collaborations with other Federal agencies; however, provisions would prevent such other agencies from exercising the authorities provided to the Secretary of HHS.
• Authorize the Secretary of HHS to require that grant or cooperative agreement recipients make their laboratories available as needed to respond to public health emergencies affecting national security

Like S. 1504, H.R. 2122 also contains a technical amendment that would authorize NIAID to modernize and construct necessary facilities. The measure also authorizes such sums as may be necessary for FYs 2003 and 2004. Such authorization is not included in S. 1504.

Status and Outlook

S. 15 was introduced on March 11, 2003, by Senator Judd Gregg (R-NH) and was referred to the Senate Committee on Health, Education, Labor and Pensions. On March 19, the Committee reported out an amended S. 15, the Project BioShield Act of 2003, which did not include the smallpox vaccine compensation provisions. These provisions are addressed in replacement legislation, S. 1504. No further action is expected on this legislation.

S. 1504 was introduced on July 30, 2003, by Senator Gregg and was placed on the Union Calendar. No further action has occurred on this legislation.

S. 666 was introduced on March 19, 2003, by Senator Joseph I. Lieberman (D-CT) and was referred to the Senate Committee on Finance. No further action has occurred on this legislation.

H.R. 2122 was introduced on May 15, 2003, by Representative W.J. "Billy" Tauzin (R-LA) and was referred to the House Committees on Energy and Commerce and on Government Reform and the Select Committee on Homeland Security. The measure was marked up and reported out, as amended by each of these committees, on May 15, May 22, and June 26, respectively. The amended H.R. 2122 was considered in the House on July 16 and passed. The Senate received the measure on July 17 and placed it on the calendar. No further action has occurred on this legislation.