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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-33/
- Published: 2021-03-14T12:00:00.000Z
- Updated: 2026-09-14T16:50:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148772

**7 NADAs Withdrawn Over Reporting Requirements**  
*Federal Register* notice: FDA is amending its animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications for lack of compliance with regulation-reporting requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-23/pdf/2021-03251.pdf?ref=fdaweb.com). 3/12/2021

**Info Collection on Humanitarian Use Devices**  
*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Humanitarian Use Devices (HUD) — 21 CFR Part 814” (OMB Control Number 0910-0332). The collection is intended to assist FDA in making determinations on the following: (**1**) Whether to grant HUD designation of a medical device; (**2**) whether to exempt an HUD from the effectiveness requirements under sections 514 and 515 of the FD&C Act, and (**3**) whether to grant marketing approval for the HUD. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-24/pdf/2021-03746.pdf?ref=fdaweb.com). 3/12/2021

**Info Collection on Single-use Device Labeling**  
*Federal Register* notice: FDA is seeking comments on an information collection entitled “Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices” (OMB Control Number 0910-0577). The collection is related to Section 502 of the Federal Food, Drug, and Cosmetic Act that establishes requirements that a label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-24/pdf/2021-03748.pdf?ref=fdaweb.com). 3/11/2021

**Guide on Testing Alcohols for Methanol**  
*Federal Register* notice: FDA has made available a final guidance entitled *Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (Covid–19*). The document is intended to alert pharmaceutical manufacturers and pharmacists in state- licensed pharmacies or federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-23/pdf/2021-03548.pdf?ref=fdaweb.com). 3/11/2021

**Info Collection on Biologic Adverse Event Reports**  
*Federal Register* notice: FDA has submitted to OMB an information collection extension for “Adverse Experience Reporting for Licensed Biological Products and General Records — 21 CFR Part 600” (OMB Control Number 0910-0308). Agency regulation requires licensed manufacturers or any person whose name appears on the label of a licensed biological product to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the licensed manufacturer. These reports are known as postmarketing 15-day Alert reports. They also require licensed manufacturers to submit any follow-up reports within 15 calendar days of receipt of new information or as requested by FDA, and if additional information is not obtainable, to maintain records of the unsuccessful steps taken to seek additional information. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-23/pdf/2021-03541.pdf?ref=fdaweb.com). 3/10/2021

**Info Collection of Device Shortages Data**  
*Federal Register* notice: FDA is seeking comments on an information collection extension for “Shortages Data Collections” (OMB Control Number 0910-0491). The agency’s regulations give CDRH authority to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand and/or would be vulnerable to shortages in specific disaster/emergency situations or following specific regulatory actions. Such data could support prospective risk assessment, help inform risk mitigation strategies, support real-time decision making by HHS during actual emergencies or emergency preparedness exercises, and mitigate or prevent harm to the public health. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-02-23/pdf/2021-03630.pdf?ref=fdaweb.com). 3/10/2021