On the recordJuly 11, 2001
Amendment No. 4 offered by Mr. Allen: At the end of title VII, insert after the last section (preceding any short title) the following section: Sec. 7____. None of the amounts made available in this Act for the Food and Drug Administration may be expended to approve any application for a new drug submitted by an entity that does not, before completion of the approval process, provide to the Secretary of Health and Human Services a written statement specifying the total cost of research and development with respect to such drug, by stage of drug development, including a separate statement specifying the portion paid with Federal funds and the portion paid with State funds.
Source
govinfo.gov




