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Bart Stupak: in all due respect, I do not require any of that. I require the Secretary of Health and Human Services to do it; not the…

On the recordJune 8, 2005
in all due respect, I do not require any of that. I require the Secretary of Health and Human Services to do it; not the FDA, not the NIH, the Secretary of Health and Human Services. These agencies, Food and Drug Administration, NIH, are underneath their jurisdiction. That is why we drafted it this way, to get around the germaneness issue. We are not requiring FDA or NIH. It is only the Secretary of HHS. As to the second part of your ruling, Mr. Chairman, you said we are creating new law. We were very careful, as I pointed out, that every word used in the proposed amendment is the same words used in the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. That is exemption, that is in both acts; registry of clinical trials, exact same words; and limits to, quote, serious or life-threatening disease or condition, again words all found in the 1997 act which we require the Secretary to do, so we do not get into this thing about putting a new requirement on FDA or NIH. The Acting CHAIRMAN. The Chair has ruled. The gentleman's comments are post-facto argument and not a proper parliamentary inquiry. Amendment Offered by Mr. Hefley
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Bart Stupak

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