FDA publishes final rule regarding 21 CFR Parts 50 and 56 regulating clinical trials and children

The FDA published a final amended rule in the Federal Register on 02/28/2013 concerning 21 CFR Parts 50 and 56.  The effective date of this rule will be March 28th, 2013.

From the posting:


The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 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. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.

 Highlights of the Final Rule

 This final rule adopts the safeguards described in HHS subpart D for children participating in clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C 355(i) and 360j(g)), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including human drug and biological products; medical devices for human use; foods, including dietary supplements, that bear a nutrient content claim or health claim; infant formula; food and color additives; and electronic products. (See § 50.1) These safeguards are intended to ensure  that the rights and welfare of children who participate in clinical investigations are adequately protected. Nothing in these regulations is intended to preempt any applicable Federal, State, or local laws that require additional  safeguards for children participating in clinical investigations.  The final rule brings FDA’s regulations into compliance with HHS subpart D, as directed by Congress, with some changes reflecting differences between FDA’s and HHS’s regulatory authority and other changes made for clarification. In the preamble to the interim rule, we provided a detailed explanation of the provisions of the rule. In the final rule, we respond to comments received on the interim rule.

 Four substantive changes have been made to the codified section of the final rule: (1) The definition of guardian has been modified, (2) the definition of permission has been modified, (3) paragraph (a) has been added to § 50.51 to require, consistent with § 46.404 of HHS subpart D, that IRBs assess the level of risk to children in clinical investigations subject to § 50.51, and (4) a phrase has been added to § 50.55(e) to make it clear that the exception for emergency research described in § 50.24 applies to research in children.  In addition, we have made changes on our own initiative for the purposes of clarity and consistency. In addition to modifying the definitions of guardian and permission, changes to the following sections were made in order to be more consistent with HHS 45 CFR part 46, subpart D: 1) Changing ‘‘may’’ to ‘‘should’’ in the definition of assent (§ 50.3(n)); (2) deleting ‘‘and documents’’ from §§ 50.51 to 50.54; and (3) deleting ‘‘if consistent with State law’’ from § 50.55(e)(1).


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