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Federal Register — Trade & Customs

Rules, proposed rules, and notices from CBP, USTR, Commerce ITA, USITC, and BIS affecting tariffs, trade remedies, anti-dumping duties, and customs regulations.

Proposed Rule2026-140732026-07-13

Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

Health and Human Services Department, Food and Drug Administration

Proposed Rule2026-120592026-06-16

Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2026-115652026-06-10

Notice of Revocation of Customs Brokers' Licenses

Homeland Security Department, U.S. Customs and Border Protection

Notice2026-104792026-05-27

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661

Health and Human Services Department, Food and Drug Administration

Notice2026-085522026-05-01

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Health and Human Services Department, Food and Drug Administration

Notice2026-066612026-04-06

Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Rule2026-043682026-03-05

Revising the National Drug Code Format and Drug Label Barcode Requirements

Health and Human Services Department, Food and Drug Administration

Notice2026-041962026-03-03

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments

Health and Human Services Department, Food and Drug Administration

Proposed Rule2025-237052025-12-23

Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

Health and Human Services Department, Centers for Medicare & Medicaid Services

Proposed Rule2025-237022025-12-23

Global Benchmark for Efficient Drug Pricing (GLOBE) Model

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2025-226812025-12-12

Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Rule2025-209072025-11-25

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots

Health and Human Services Department, Centers for Medicare & Medicaid Services,

Rule2025-197872025-11-05

Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2025-150822025-08-08

Product-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability

Health and Human Services Department, Food and Drug Administration

Notice2025-144112025-07-30

Generic Drug User Fee Rates for Fiscal Year 2026

Health and Human Services Department, Food and Drug Administration

Proposed Rule2025-133602025-07-17

Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency

Health and Human Services Department, Centers for Medicare & Medicaid Services,

Proposed Rule2025-132712025-07-16

Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2025-116052025-06-25

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

Health and Human Services Department, Food and Drug Administration

Notice2025-011512025-01-17

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting

Health and Human Services Department, Food and Drug Administration

Notice2025-011492025-01-17

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

Health and Human Services Department, Food and Drug Administration

Rule2024-302612024-12-26

Nonprescription Drug Product With an Additional Condition for Nonprescription Use

Health and Human Services Department, Food and Drug Administration

Rule2024-253822024-12-09

Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2024-284332024-12-05

Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Rule2024-212542024-09-26

Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2024-216752024-09-23

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

Health and Human Services Department, Food and Drug Administration

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