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
- Analysis of Economic Impacts: Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products; Final Rule (PDF - 35KB)
- Federal Register: 78 FR 12937-12951, February 26, 2013
- Docket: FDA-2000-N-0009 (formerly FDA-2000-N-0074)