Regulacje i polityka gospodarcza · 09/12/2015

Pandemic Influenza Medical Countermeasures-Amendment

The Secretary is amending the declarations issued on October 10, 2008 (73 FR 61861), as amended June 11, 2009 (74 FR 29213); December 17, 2008 (73 FR 78362); and February 29, 2012 (77 FR 13329), pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: Cover vaccines, antivirals, diagnostics and devices used against pandemic influenza A viruses in a single declaration; extend coverage to additional antivirals and devices and to biologics and other drugs; simplify descriptions of covered diagnostics and devices; clarify the disease threat and description of pandemic influenza A viruses and influenza A viruses with pandemic potential; include coverage for countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); extend the effective time period of the prior declarations; reformat the declarations for antivirals and for diagnostics and devices; modify or clarify terms of the declarations; and republish the prior declarations as a single declaration in its entirety, as amended.