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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-32/
- Published: 2021-02-21T12:00:00.000Z
- Updated: 2026-09-14T16:47:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148718

**Stakeholder Participation in Device User Fee Talks**  
*Federal Register* notice: FDA is requesting notification from public stakeholders of their intent to participate in periodic consultation meetings on reauthorizing the Medical Device User Fee Amendments (MDUFA). Agency regulations require it to hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with regulated industry. The meetings will take place virtually and will be held by Webcast only. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-19/pdf/2021-03428.pdf?ref=fdaweb.com). 2/19/2021  

**Covid-19 Guidance Documents Availability**  
*Federal Register* notice: FDA is announcing the availability of recent guidance documents related to the Covid–19 pandemic. The guidances have been implemented without prior comment, but they remain open for comment under the agency’s good guidance practices. They are available on FDA’s Web pages entitled [*COVID–19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders*](https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders?ref=fdaweb.com). 2/19/2021  

**Expedited Programs for Drugs/Biologics Info Collection**  
*Federal Register* notice: FDA has submitted to OMB an information collection extension for “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency regulations and associated guidance that establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses, especially where no satisfactory alternative therapy exists. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-18/pdf/2021-03244.pdf?ref=fdaweb.com). 2/18/2021  

**Comments Sought on WHO Drug Scheduling Recommendations**  
*Federal Register* notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. The comments received in response to the notice will be considered in preparing the U.S.’s position on these proposals for an April meeting of the United Nations Commission on Narcotic Drugs in Vienna, Austria. The following recommendations were provided by the WHO’s Expert Committee on Drug Dependence:

- Substance recommended to be added to Schedule I of the 1961 Convention — Isotonitazene
- Substances recommended to be added to Schedule II of the 1971 Convention — Cumyl-Pegaclone; MDMB-4en-Pinaca; 3-Methoxyphencyclidine, and; Diphenidine
- Substances recommended to be added to Schedule IV of the 1971 Convention: —Clonazolam; Diclazepam, and; Flubromazolam

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-18/pdf/2021-03268.pdf?ref=fdaweb.com). 2/18/2021