R--Advisory and Assistance Services on Human Studies

The United States Environmental Protection Agency (US EPA) intends to award a sole source firm fixed price/performance based contract to the National Research Council (NRC) of the National Academy of Sciences (NAS) to develop a committee report advising the EPA on the consideration of and reliance on data from certain types of studies conducted with human subjects. The anticipated contract will have an estimated period of performance of 17 months and an estimated price of $850,000.00. The proposed contract with the NRC/NAS is to form and manage a committee of nationally recognized individuals with expertise in a wide range of relevant disciplines who will develop a written report containing advice on the full range of issues raised in the public debate about the acceptance, review, and reliance on third party, human toxicity research. The committee will be overseen by the NRC's Science, Technology, and Law Program. The committee will not develop EPA policy; rather, EPA will consider the committee's advice in developing Agency policy on these issues. The anticipated contract will have five distinct tasks: 1. Establishment of a committee of national experts in the range of disciplines relevant to the issues concerning the conduct and use of data from third party research with human subjects. 2. A range of activities to assure that the committee process is unbiased and transparent and affords opportunities for public participation. 3. Information collection and solicitation of public views. 4. Preparation and submission to EPA of a draft committee report. 5. Preparation and submission to EPA of a final committee report. The NRC/NAS is uniquely qualified to develop the advice required in the report. The NRC/NAS were established by Congress to provide independent advice to the Federal Government on critical matters of science, technology and medicine by enlisting the participation of the nation's top scientists, doctors and other experts. See note 22.