Documents

Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments

Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule

Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry

Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff

Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments

Union Pacific Railroad Company's Request for Administrative Review and Hearing

Receipt of Enhancement of Survival Permit Application and Proposed Conservation Benefit Agreement for the Benefit of the Columbia Basin Pygmy Rabbit in Washington; Categorical Exclusion

Endangered and Threatened Species: Status with Section 4(d) Rule for Southern Hognose Snake

General Conservation Plan for the Alabama Beach Mouse; Categorical Exclusion; Baldwin County, AL

Notice 2026-36

Fisheries of the Caribbean, Gulf of America, and South Atlantic: Puerto Rico Fishery Management Plan