PREPARE Act

Summary

Pathogen Research, Emergency Preparedness and Response Efforts Act of 2001 (PREPARE Act) - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to encourage the development and manufacture of new products or new uses for products which can identify, prevent, or treat chemical or biological agents. Permits a limited antitrust exemption for the cooperative efforts of the pharmaceutical, biotechnical, medical device, and research industries when working to develop and bring such countermeasure products to market. Authorizes the Secretary to enter into contracts and provide assistance for product development, including good manufacturing practices and facility security. Requires the Secretary to ensure that medical supplies from the National Pharmaceutical Stockpile are located in appropriate proximity to the site of special events. Amends the Federal Food, Drug, and Cosmetic Act to permit: (1) fast-track designation and priority review for unapproved countermeasure products; and (2) the use of animal trials for drugs useful against lethal or disabling agents. Requires the Secretary to: (1) prohibit the unauthorized transportation of chemical or biological agents; (2) establish and maintain a list of each biological agent and toxin potentially threatening to public health and another list of those agents and toxins potentially threatening to national security; and (3) establish safety procedures for the transfer of such agents and toxins. Requires the Secretaries of Health and Human Services and Defense to coordinate the creation of a government-owned, contractor-operated vaccine production facility on a military installation.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 6 November 2001

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 6 November 2001

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• Introduced in Senate

  summary · EN · 6 November 2001

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