Federal Register (FR) Notices, October 10, 2022

Summary Excerpts from Select Federal Register Notices for CHPA Weekly Voice

Week of October 10, 2022

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Drugs

Guidance (Draft/Final)

FDA Providing Over-the-Counter Monograph Submissions in Electronic Format; Draft Guidance for Industry; Availability; Notice of availability

Comments due to FDA by November 28, 2022, to ensure consideration before work begins on the final version of the guidance.
Draft Guidance
Note: Please contact Barb Kochanowski if you have questions or input on this draft guidance. CHPA will be submitting comments to the draft guidance so watch for further information.

FDA Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability; Notice of availability

Comments due to FDA by January 4, 2023, to ensure consideration before work begins on the final version of the guidance.
Draft Guidance

FDA Generic Drug User Fee Rates for Fiscal Year 2023; Notice

These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.

Regulatory Information/Comment Opportunities

FDA Prescription Drug User Fee Rates for Fiscal Year 2023; Notice

These fees apply to the period from October 1, 2022, through September 30, 2023.
FDA is announcing the rates for prescription drug user fees for FY2023. The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2023.

Dietary Supplements

Rulemaking

FDA Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”; Proposed rule

e-Comments will be accepted by FDA until 11:59 pm ET at the end of December 28, 2022. Late, untimely filed comments will not be considered.
FDA (or we) is proposing to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This action, if finalized, will revise the requirements for when the term “healthy” can be used as an implied claim in the labeling of human food products to indicate that a food’s level of nutrients may help consumers maintain healthy dietary practices by helping them achieve a total diet that conforms to dietary recommendations.