An amendment to prohibit the use of funds from being made available to keep in effect an exemption for a clinical trial that concerns a life-threatening disease or condition and is not included in the registry of such trials. Amendment also seeks to prohibit the use of funds to approve certain applications.

1. Adds Sec. 7__. None of the funds made available in this Act may be used by the Secretary of Health and Human Services to keep in effect an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act for a clinical trial that concerns a serious or life-threatening disease or condition and is not included in the registry of such trials under section 402(j) of the Public Health Service Act on page 83, line 19

   Adds a sectionPrinted page

   Inserted: Sec. 7__. None of the funds made available in this Act may be used by the Secretary of Health and Human Services to keep in effect an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act for a clinical trial that concerns a serious or life-threatening disease or condition and is not included in the registry of such trials under section 402(j) of the Public Health Service Act.

   Inserted: Sec. 7__. None of the funds made available in this Act may be used by the Secretary of Health and Human Services to approve an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act that--

   Inserted: (1) is for a drug for a serious or life-threatening disease or condition; and

   Inserted: (2) is under subparagraph (A) of such section supported by a clinical trial that--

   Inserted: (A) has received an exemption under section 505(i) of such Act; and

   Inserted: (B) is not included in the registry of clinical trials under section 402(j) of the Public Health Service Act.

   Original wording

   Page 83, after line 19, insert the following sections:

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As printed