S.Amdt. 996

SA 996. Mr. GRASSLEY submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the end of section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by section 251 of the bill, add the following:

“(r) Certification of Information.--When submitting information in support of a new drug application or a supplemental new drug application, the sponsor shall certify, in writing, that all clinical trials, federally or privately funded, whether conducted within or outside the United States, related to the safety or efficacy of the drug under review, have been submitted to the Food and Drug Administration.”.