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May 8, 2007, 12:00 am ET - Amendment SA 998 proposed by Senator Brown for Senator Grassley.
May 9, 2007, 12:00 am ET - Considered by Senate.
May 9, 2007, 12:18 pm ET - Grassley Amdt. No. 998

Full Text of this Amendment

SA 998. 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 appropriate place in section 505(o) of the Federal, Food, Drug, and Cosmetic, as added by section 202, insert the following:
``(9) CIVIL MONETARY PENALTY.--Notwithstanding any other provision of this Act, an applicant (as such term is defined for purposes of this section) that knowingly fails to comply with a requirement of an approved risk evaluation and mitigation strategy under this subsection shall be subject to a civil money penalty of $250,000 for the first 30-day period that the applicant is in noncompliance, and such amount shall double for every 30-day period thereafter that the requirement is not
complied with, not to exceed $2,000,000.''.


(As printed in the Congressional Record for the Senate on May 1, 2007.)