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Full Text of this Amendment

SA 1003. 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:

After section 211 of the bill, insert the following:
SEC. 211A. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by this Act, is further amended by adding at the end the following:
``SEC. 567. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.
``Not later than 5 years after the date of enactment of the Food and Drug Administration Revitalization Act, the Secretary shall ensure that any information required to be submitted to the Food and Drug Administration under section 505, 505A, 505B, 506A, 506B, 510, 512, 513, 515, 519, 520, or 526 is submitted in electronic form that is interoperable with the Food and Drug Administration's information technology systems.''.


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