S.Amdt. 1002
What it does: Adds SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS wherever appropriate
Sen. Chuck Grassley (R-IA)What it changes
1 change to S. 1082
Adds SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS wherever appropriate
Adds a sectionInserted: SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS.
Inserted: 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:
Inserted: "(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).".
The amendment doesn't say where this goes; the clerk decides.
Original wording
At the appropriate place, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
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).”.
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Senate amendment submitted
May 1, 2007