S.Amdt. 1012
What it does: Adds SEC. __. AUTHORIZATION OF APPROPRIATIONS FOR THE OFFICE OF GENERIC DRUGS wherever appropriate
Sen. David Vitter (R-LA)What it changes
1 change to S. 1082
Adds SEC. __. AUTHORIZATION OF APPROPRIATIONS FOR THE OFFICE OF GENERIC DRUGS wherever appropriate
Adds a sectionInserted: SEC. __. AUTHORIZATION OF APPROPRIATIONS FOR THE OFFICE OF GENERIC DRUGS.
Inserted: Notwithstanding section 736(b) of the Federal Food, Drug, and Cosmetic Act (as amended by section 103(b) of this Act), the Secretary of Health and Human Services shall allocate $20,000,000 of the user fees generated by section 736(a) of the Federal Food, Drug, and Cosmetic Act (as amended by section 103(a) of this Act), for each fiscal year beginning with fiscal year 2009 and ending with fiscal year 2012, to the Office of Generic Drugs of the Food and Drug Administration, for the sole purpose of reviewing and approving abbreviated new drug applications.
The amendment doesn't say where this goes; the clerk decides.
Original wording
At the appropriate place, insert the following:
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As printed
SA 1012. Mr. VITTER 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. __. AUTHORIZATION OF APPROPRIATIONS FOR THE OFFICE OF GENERIC DRUGS.
Notwithstanding section 736(b) of the Federal Food, Drug, and Cosmetic Act (as amended by section 103(b) of this Act), the Secretary of Health and Human Services shall allocate $20,000,000 of the user fees generated by section 736(a) of the Federal Food, Drug, and Cosmetic Act (as amended by section 103(a) of this Act), for each fiscal year beginning with fiscal year 2009 and ending with fiscal year 2012, to the Office of Generic Drugs of the Food and Drug Administration, for the sole purpose of reviewing and approving abbreviated new drug applications.
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Senate amendment submitted
May 2, 2007