Summary

Requires the HHS Secretary (through the FDA Commissioner) to publish an interim final rule within one year to change certain regulatory wording to explicitly refer to “nonclinical tests, data, studies, models, and research.” The rule must insert a statutory definition of “nonclinical test” into several CFR definitions, replace general references to “tests, data, studies, models, and research” with the phrase prefixed by “nonclinical” in specified parts of Title 21 CFR, and perform a technical renumbering in the FD&C Act. The interim final rule becomes effective immediately upon publication, and the Secretary is allowed to make any additional changes needed to fully implement those replacements.

Key Points

• Directs FDA to publish an interim final rule within one year to update regulatory language to reference “nonclinical” tests and related items.
• Requires inserting a statutory definition of “nonclinical test” into multiple CFR definition sections.
• Mandates textual replacements across specified parts of Title 21 CFR, changing general references to explicitly read “nonclinical tests, data, studies, models, and research.”
• Includes a technical renumbering in section 505 of the FD&C Act.
• The interim final rule is effective immediately upon publication.
• Secretary may make additional implementing changes as needed to complete the replacements.
• The change is limited to regulatory text and definitions—no new testing protocols or funding are created by the provision itself.
• Regulated entities (drug/device sponsors, labs, CROs) and FDA staff will need to interpret and apply the updated regulatory language.

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