Federal Register (FR) Notices, November 7, 2022

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*Summary Excerpts from Select Federal Register Notices for CHPA Weekly Voice

Week of November 7, 2022

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Drugs 

Public Meetings

FDA Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Postponement of Meeting; Notice; postponement of meeting.    

Regulatory Information/Comment Opportunities

FDA Advancing Premarket Safety Analytics Workshop; Request for Comments; Notice; request for comment.    

  • Comments due to FDA by December 5, 2022. 

Guidances (Draft/Final)

FDA Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program; Draft Guidance for Industry; Availability; Notice of availability.    

  • Comments due to FDA by January 3, 2023, to ensure consideration before work begins on the final version of the guidance. 
  • FDA (or Agency) is announcing the availability of a draft guidance for industry entitled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.”  This guidance provides stakeholders with information regarding FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program authorized under the FD&C Act.
  • Draft Guidance
  • Note:  Please contact Barb Kochanowski if you have any questions. 

Rulemaking

https://www.govinfo.gov/content/pkg/FR-2022-11-02/pdf/2022-23844.pdf FDA Color Additive Certification; Increase in Fees for Certification Services; Proposed rule (Drugs/Dietary Supplements)

  • e-Comments will be accepted by FDA until 11:59 pm ET until the end of January 3, 2023.  Late, untimely filed comments will not be considered. 

FTC Trade Regulation Rule on the Use of Reviews and Endorsements; Advance notice of proposed rulemaking; request for public comment (Drugs/Medical Devices/Dietary Supplements).    

  • Comments due to FTC by January 9, 2023.

FTC Unfair or Deceptive Fees Trade Regulation Rule Commission Matter No. R207011; Advance notice of proposed rulemaking; request for public comment.    

  • Comments due to FTC by January 9, 2023.

 

Non-FR Info – for your awareness only   

Medical Devices

Cross-category/General Interest  

 

Click here to view a select list of relevant Federal Register notices for the OTC, dietary supplement, and consumer medical device industries.