SEC. 565. [21 USC §360bbb–4] Technical Assistance

Note: revisions were posted to this section in September 2007.

The Secretary, in consultation with the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration a team of experts on manufacturing and regulatory activities (including compliance with current Good Manufacturing Practice) to provide both off-site and on-site technical assistance to the manufacturers of qualified countermeasures (as defined in section 319F-1 of the Public Health Service Act [42 USC § 247d-6a]), security countermeasures (as defined in section 319F-2 of such Act [42 USC § 247d-6b]), or vaccines, at the request of such a manufacturer and at the discretion of the Secretary, if the Secretary determines that a shortage or potential shortage may occur in the United States in the supply of such vaccines or countermeasures and that the provision of such assistance would be beneficial in helping alleviate or avert such shortage.