> ## Content Index
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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-53/
- Published: 2021-09-06T12:00:00.000Z
- Updated: 2026-09-14T17:13:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150090

**Mammography QA Panel Renewed for 2 Years**  
*9/3/2021 Federal Register* notice: FDA has renewed its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expiration date. The new charter will be in effect until 7/7/2023\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-03/pdf/2021-19108.pdf?ref=fdaweb.com).  

**Panel to Weigh Future of Multiple Myeloma Therapy**  
*9/3/2021 Federal Register* notice: FDA has announced a 10/28 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the accelerated approval of an Oncopeptides NDA for Pepaxto (melphalan flufenamide) for injection for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. They will hear an update where a required confirmatory trial demonstrated a worse overall survival in the melphalan flufenamide treatment arm compared to the control arm. Discussions will be focused on next steps for the product including whether the indication should remain on the market while additional trials are conducted. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-03/pdf/2021-19024.pdf?ref=fdaweb.com).  

**Info Collection on Device Establishment Fees**  
*9/2/2021 Federal Register* notice: FDA has submitted to OMB an information collection revision entitled “Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a” (OMB Control Number 0910-0511). The revision adds Form FDA 3601a, which is designed to collect payments for the annual establishment registration fee for medical device establishments. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-19113.pdf?ref=fdaweb.com).  

**Drug Supply Security Info Collection**  
*Federal Register* notice: FDA is seeking comments on an information collection revision entitled “Drug Supply Chain Security Act Implementation” (OMB Control Number 0910-0806). The collection supports FDA regulations requiring drug distributors to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-19061.pdf?ref=fdaweb.com).  

**Panel to Review Prader-Willi Syndrome NDA**  
*9/2/2021 Federal Register* notice: FDA has announced an 11/4 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Levo Therapeutics NDA for carbetocin nasal spray, for the proposed treatment of hyperphagia, anxiety, and distress behaviors associated with Prader-Willi syndrome. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-01/pdf/2021-18892.pdf?ref=fdaweb.com).  

**FDA Revokes 15 EUAs Granted During Covid**  
*8/31/2021 Federal Register* notice: FDA has revoked 15 Emergency Use Authorizations (EUAs) — 12 decontamination systems for personal protective equipment, one bioburden reduction system for personal protective equipment, and two umbrella EUAs for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. The revocations for the decontamination and bioburden reduction systems for personal protective equipment were requested by each EUA holder. The agency revoked the EUAs of imported non-NIOSH approved filtering facepiece respirators because supplies of NIOSH-approved devices are sufficient at this time. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-31/pdf/2021-18777.pdf?ref=fdaweb.com).  

**2 Guides on Device Performance Based Pathway**  
*8/30/2021 Federal Register* notice: FDA has made available two draft device-specific guidance documents for the Safety and Performance Based Pathway — *Denture Base Resins: Performance Criteria for Safety and Performance Based Pathway* and *Facet Screw Systems: Performance Criteria for Safety and Performance Based Pathway*. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-30/pdf/2021-18592.pdf?ref=fdaweb.com).