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Full Text of this Amendment

SA 1002. 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, insert the following:
SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 251, is further amended by adding at the end the following:
``(r) Requirement to Document Contact With Drug Sponsor.--Each employee of the Food and Drug Administration shall document, in writing, each communication or contact, and the purpose of such communication or contact, that such official has with a sponsor of a drug for which an application is filled pursuant to subsection (b) or (j).''.


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