Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments.

We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.