S.Amdt. 1811
What it does: Adds Sec. 7__. Notwithstanding any other provision of this Act, none of the funds appropriated or otherwise made available under this Act may be used to carry out activities, including the review or approval of clinical trial protocols or special protocol assessments that would permit placebo-only or no-treatment-only concurrent controls, in any clinical investigation conducted with respect to any serious or life-threatening condition or disease, where reasonably effective alternative therapies that have been approved or cleared by the Secretary of Health and Human Services for the specific indications under investigation exist on page 173, line 24
Sen. Sam Brownback (R-KS)What it changes
1 change to H.R. 2744
Adds Sec. 7__. Notwithstanding any other provision of this Act, none of the funds appropriated or otherwise made available under this Act may be used to carry out activities, including the review or approval of clinical trial protocols or special protocol assessments that would permit placebo-only or no-treatment-only concurrent controls, in any clinical investigation conducted with respect to any serious or life-threatening condition or disease, where reasonably effective alternative therapies that have been approved or cleared by the Secretary of Health and Human Services for the specific indications under investigation exist on page 173, line 24
Adds a sectionPrinted pageInserted: Sec. 7__. Notwithstanding any other provision of this Act, none of the funds appropriated or otherwise made available under this Act may be used to carry out activities, including the review or approval of clinical trial protocols or special protocol assessments that would permit placebo-only or no-treatment-only concurrent controls, in any clinical investigation conducted with respect to any serious or life-threatening condition or disease, where reasonably effective alternative therapies that have been approved or cleared by the Secretary of Health and Human Services for the specific indications under investigation exist.
Original wording
On page 173, after line 24, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 1811. Mr. BROWNBACK submitted an amendment intended to be proposed by him to the bill H.R. 2744, making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for the fiscal year ending September 30, 2006, and for other purposes; which was ordered to lie on the table; as follows:
On page 173, after line 24, insert the following:
Sec. 7__. Notwithstanding any other provision of this Act, none of the funds appropriated or otherwise made available under this Act may be used to carry out activities, including the review or approval of clinical trial protocols or special protocol assessments that would permit placebo-only or no-treatment-only concurrent controls, in any clinical investigation conducted with respect to any serious or life-threatening condition or disease, where reasonably effective alternative therapies that have been approved or cleared by the Secretary of Health and Human Services for the specific indications under investigation exist.
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Senate amendment submitted
September 21, 2005