Quantifiable benefits of this proposed rule are cost savings that come from reducing the burden of submitting investigational new drug applications (INDs) to the Food and Drug Administration (FDA) for clinical investigations to evaluate a drug use of a product that is lawfully marketed as a food for human consumption (including both conventional foods and dietary supplements) or as a cosmetic. The proposed rule would have a one-time, upfront cost for current and future sponsors and sponsor-investigators who would have to read the rule. In addition, there would be costs to FDA associated with a new type of IND-related submission, a request for an FDA-determined exemption. The impact of this new submission is analyzed in section II.E, “Benefits of the Proposed Rule,” as a partial offset to the cost savings of the rule. Discounted over 10 years, the total net benefit of the rule is estimated to be $33 million at a 3% discount rate and $27 million at a 7% discount rate.

Regulatory Impact Analysis: Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic Preliminary Regulatory Impact Analysis (PDF - 311KB)

Federal Register: 87 FR 75536, December 9, 2022

Docket:  FDA–2019–N–2650