> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-226/
- Published: 2019-06-02T12:00:00.000Z
- Updated: 2026-09-15T01:30:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144245

[**Info Collection Extension on Supplement Notifications**](https://www.fdaweb.com/info-collection-extension-on-supplement-notifications/)  
*Federal Register* notice: FDA submits to OMB an information collection extension entitled “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93.” 05/31/2019

[**Comments Sought on Opioid Unit-of-Use Packaging**](https://www.fdaweb.com/comments-sought-on-opioid-unit-of-use-packaging/)  
*Federal Register* notice: FDA seeks public comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain opioid analgesics be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing. 05/31/2019

[**Study Risk-Based Monitoring Approaches Workshop**](https://www.fdaweb.com/study-risk-based-monitoring-approaches-workshop/)  
*Federal Register* notice: FDA announces a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.” 05/31/2019

[**Lupron Not Withdrawn Due to Safety/Efficacy: FDA**](https://www.fdaweb.com/lupron-not-withdrawn-due-to-safety-efficacy-fda/)  
*Federal Register* notice: FDA determines that AbbVie’s Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of safety or effectiveness. 05/30/2019

[**Correction on OTC Maximal Usage Trials Docket**](https://www.fdaweb.com/correction-on-otc-maximal-usage-trials-docket/)  
*Federal Register* notice correction: FDA corrects the docket number on a 5/10 notice entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” 05/29/2019

[**Info Collection on OTC Drug Labeling**](https://www.fdaweb.com/info-collection-on-otc-drug-labeling/)  
*Federal Register* notice: FDA submits to OMB an information collection extension entitled “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” 05/29/2019

[**Info Collection on FDA Adverse Event Reporting**](https://www.fdaweb.com/info-collection-on-fda-adverse-event-reporting/)  
*Federal Register* notice: FDA submits to OMB an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540,329.100,514.80, 600.80, 1271.350, and Part 803.” 05/28/2019

[**Comments Extended on Device Inspection Standards**](https://www.fdaweb.com/comments-extended-on-device-inspection-standards/)  
*Federal Register* notice: FDA extends the comment period on a draft guidance entitled “Review and Update of Device Establishment Inspection Processes and Standards.” 05/28/2019

[**Regulatory Review Period for Edwards Aortic Valve**](https://www.fdaweb.com/regulatory-review-period-for-edwards-aortic-valve/)  
*Federal Register* notice: FDA determines that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days. 05/24/2019