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U.S. Department of Health and Human Services

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Summary: Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products

This rule finalizes the interim rule published in 2001 (66 FR 20589 at 20596, April 24, 2001) to bring FDA regulations into compliance with provisions of the Children’s Health Act of 2000 (the Children’s Health Act).  The Children’s Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research.

Regulatory Impact Analysis