S.Amdt. 1003
What it does: Adds SEC. 211A. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY after section 211
Sen. Chuck Grassley (R-IA)What it changes
1 change to S. 1082 · shown in the bill's text
Adds SEC. 211A. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY after section 211
Adds a sectionIn S. 1082 · Reported to Senate
"(d) Permanence of Committee.--Section 14 of the Federal Advisory Committee Act shall not apply to the Committee established under this section.".
Inserted: SEC. 211A. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.
Inserted: 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:
Inserted: "SEC. 567. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.
Inserted: "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.".
Original wording
After section 211 of the bill, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
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.”.
Legislative Activity
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Senate amendment submitted
May 1, 2007