S.Amdt. 1030

SA 1030. Mr. SANDERS 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:

On page 171, between lines 18 and 19, insert the following:

“(C) Additional certification.--At the time of the submission of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of such Act, section 520(m) of such Act or section 351 of the Public Health Service Act, or submission of a report under section 510(k) of such Act, such application or submission shall be accompanied by a certification that all applicable requirements of sections 201 through 212 of title 35, United States Code, and any other provision of Federal law relating to Federal rights in patented inventions made with Federal Government assistance, have been met, including, where applicable, the requirement under section 201(f) of such title that the benefits of such inventions be made available to the public on reasonable terms, including price.”.