Week of March 29, 2021
- The new fee rates are for the period from October 1, 2020, through September 30, 2021.
FDA (or the Agency) is announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. On March 27, 2020, new provisions were added to the FD&C Act by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. FDA refers to the OTC Monograph Drug user fee program as “OMUFA” throughout this document. This notice publishes the OMUFA fee rates for FY 2021.
Fee Category FY 2021 Fee Rates:
Tier 1 $500,000
Tier 2 $100,000
The CPSC (or Commission) is announcing the availability of a document titled, “Proposed Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.” The Commission requests comments on the proposed guidance.
Regulatory Information/Comment Opportunities
The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
AHRQ Surveillance Report Now Available:
Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain – Quarterly Progress Report: February 2021 (Surveillance Report, released on March 24, 2021) (Drugs/Dietary Supplements)
This is the second progress report for an ongoing living systematic review on plant-based treatments for chronic pain. The ensuing systematic review will synthesize evidence on the benefits and harms of cannabinoids and other plant-based compounds (PBCs) such as kratom used to treat chronic pain, addressing the impact on pain and function, as well as concerns about adverse effects, abuse, misuse, dependence, and addiction.
Click here to view a select list of relevant Federal Register notices for the OTC, dietary supplement, and consumer medical device industries.