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HHS/FDA RIN: 0910-AH07 Publication ID: Spring 2018 
Title: Investigational New Drug Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics 
Abstract:

Researchers conducting studies of FDA-regulated products involving human subjects must, in some circumstances, meet requirements set out in FDA’s Investigational New Drug (IND) Application  regulations. The proposed rule is intended to broaden the regulatory criteria for studies exempt from IND requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review.  The proposed rule would also streamline some IND application requirements for certain studies that do not qualify for the new exemption.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 312   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 371    42 U.S.C. 262    21 U.S.C. 360bbb   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Mickey Parish
Senior Science Advisor
Department of Health and Human Services
Food and Drug Administration
5100 Campus Drive, Room 4A004,
College Park, MD 20740
Phone:240 402-1728
Email: mickey.parish@fda.hhs.gov