Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020 - Federal Register
AGENCY: Bureau of Industry and Security, Office of Strategic Industries and Economic Security, U.S. Department of Commerce.
ACTION: Notice.
SUMMARY: This notice defines the pharmaceutical products and lists the jurisdictions that are eligible to receive an ad valorem tariff rate of zero pursuant to Presidential Proclamation 11020 of April 2, 2026, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States,” (Proclamation 11020). These pharmaceutical products include drugs and associated ingredients where all approved indications are designated as orphan; nuclear medicines; plasma derived therapies; fertility drugs; cell therapy product; gene therapy product; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; and animal health. Proclamation 11020 states that such products and associated ingredients receive the Section 232 zero tariff rate if they are products of a jurisdiction that has a current or forthcoming trade and security framework agreement or if they meet an urgent U.S. health need. This notice also includes procedures for the public to submit information for the Department of Commerce's (Commerce) approval to determine if imports of the pharmaceutical products and associated ingredients meet an urgent U.S. health need. This notice also issues five technical corrections to Annex I and one technical correction to Annex IV of the Proclamation.
DATES: Submission of information will be received on an ongoing basis starting September 23, 2026.
ADDRESSES: Information requesting Commerce's approval for pharmaceutical products that meet an urgent U.S. health need must be submitted electronically to: pharma232@bis.doc.gov.
FOR FURTHER INFORMATION CONTACT: Stephen Astle, Director, Defense Industrial Base Division, Office of Strategic Industries and Economic Security, Bureau of Industry and Security, U.S. Department of Commerce (202) 482-2533, pharma232@bis.doc.gov.
SUPPLEMENTARY INFORMATION:
________________________________________________________________________________
Limitations of Duty-Free Imports of Apparel Articles Assembled in Beneficiary Sub-Saharan African Countries From Regional and Third-Country Fabric - Federal Register
AGENCY: Committee for the Implementation of Textile Agreements (CITA)
ACTION: Publishing the New Quantitative Limit on Duty-Free Benefits for Certain Apparel Assembled in Sub-Saharan Africa
DATES: The new limitations became effective October 1, 2026.
FOR FURTHER INFORMATION CONTACT: Thomas Newberg, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-7578.
SUPPLEMENTARY INFORMATION:
Authority: Title I, Section 112(b)(3) of the Trade and Development Act of 2000
(TDA 2000), Public Law (Pub. L.) 106-200, as amended by Division B, Title XXI, section 3108 of the Trade Act of 2002, Public Law 107-210; Section 7(b)(2) of the AGOA Acceleration Act of 2004, Public Law 108-274; Division D, Title VI, section 6002 of the Tax Relief and Health Care Act of 2006 (TRHCA 2006), Public Law 109-432, and section 1 of The African Growth and Opportunity Amendments (Pub. L. 112-163), August 10, 2012; Presidential Proclamation 7350 of October 2, 2000 (65 FR 59321); Presidential Proclamation 7626 of November 13, 2002 (67 FR 69459); Title I, Section 103(b)(2) and (3) of the Trade Preferences Extension Act of 2015, Public Law 114-27, June 29, 2015; Division I, Section 5019 of the Consolidated Appropriations Act, 2026 (Pub. L. 119-75); and Division B, Section 2008 of the Continuing Appropriations and Extensions Act, 2027 (Pub. L. 119-103).
Title I of TDA 2000 provides for duty-free treatment for certain textile and apparel articles imported from designated beneficiary sub-Saharan African countries. Section 112(b)(3) of TDA 2000 provides duty-free treatment for apparel articles wholly assembled in one or more beneficiary sub-Saharan African countries from fabric wholly formed in one or more beneficiary sub-Saharan African countries from yarn originating in the United States or one or more beneficiary sub-Saharan African countries or former beneficiary sub-Saharan African countries, subject to quantitative limitations. This preferential treatment is also available for apparel articles assembled in one or more lesser-developed beneficiary sub-Saharan African countries, regardless of the country of origin of the fabric used to make such articles, subject to quantitative limitation. Public Law 119-103 extended preferential treatment under these programs through December 31, 2028.
The AGOA Acceleration Act of 2004 provides that the quantitative limitation will be an amount not to exceed seven percent of the aggregate square meter equivalents of all apparel articles imported into the United States in the preceding 12-month period for which data are available.
See Section 112(b)(3)(A)(ii)(I) of TDA 2000, as amended by Section 2008(b)(2) of the Continuing Appropriations and Extensions Act, 2027. Of this overall amount, apparel imported during the same period under the special rule for lesser-developed countries is limited to an amount not to exceed 3.5 percent of all apparel articles imported into the United States in the preceding 12-month period for which data are available.
See Section 112(b)(3)(B)(ii)(II) of TDA 2000, as amended by Section 2008(b)(3) of the Continuing Appropriations and Extensions Act, 2027. Presidential Proclamation 7350 of October 2, 2000 directed CITA to publish the aggregate quantity of imports allowed during each 12-month period in the Federal Register.
For the period beginning on October 1, 2026, and extending through September 30, 2027, the aggregate quantity of imports eligible for preferential treatment under these provisions is 1,690,799,016 square meters equivalent. Of this amount, 845,399,508 square meters equivalent is available to apparel articles imported under the special rule for lesser-developed countries. Apparel articles entered in excess of these quantities will be subject to otherwise applicable tariffs.
These quantities are calculated using the aggregate square meter equivalents of all apparel articles imported into the United States, derived from the set of Harmonized System lines listed in the Annex to the World Trade Organization Agreement on Textiles and Clothing (ATC), and the conversion factors for units of measure into square meter equivalents used by the United States in implementing the ATC.
________________________________________________________________________________
FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing - Food & Drug Administration
New rule supports wider use of innovative testing methods while maintaining existing safety standards for human drug development
The U.S. Food and Drug Administration today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.
The update reflects advances in science and technology that have expanded the range of testing options available in human drug development, including methods using human cells, organs-on-chips, computer models and other advanced technologies.
“This new rule supports the Trump Administration’s push to explore ways to complement, or where appropriate, replace animal studies with methods that may better predict how medicines will actually affect people,” said Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D. “It gives scientists and drug developers greater flexibility to use the testing approach that best addresses their scientific question. Our goal is not to replace one rigid approach with another. It is to support rigorous, modern science — including animal studies when they remain appropriate and validated alternatives when they can provide the evidence needed to protect patients.”
The rule replaces terms like “animal tests” and “animal studies” with the terms “nonclinical tests” and “nonclinical studies.” Related terms, including “preclinical” and “in vitro,” are also replaced. The rule defines “nonclinical test” and “nonclinical study” in line with the Food and Drug Omnibus Reform Act of 2022 (FDORA). The law recognizes newer methods that do not use animals and traditional animal studies as possible ways to provide the evidence needed to begin studies in people.
The rule removes language that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions in products intended for human use. It does not eliminate or prohibit animal studies, change evidentiary standards or impose new costs or requirements on drug developers.
To demonstrate their practical application, the FDA also launched a database featuring specific uses of New Approach Methodologies (NAMs). The initial release includes 25 examples drawn from publicly available FDA review materials.
The new rule and database are among several actions that the Department of Health and Human Services, including the FDA, is taking to advance drug development using NAMs, which are innovative testing methods that may better reflect human biology. Developers may use NAMs to generate safety information when the methods are adequately validated and appropriate for the product and regulatory question.
These actions are in line with Pillar 1 — Innovation and Global Leadership — of the FDA’s Public Health Pillars. By formally recognizing a broader range of scientific approaches, the FDA is keeping pace with emerging technologies and strengthening the agency’s leadership in regulatory science. Encouraging the use of NAMs also complements Operation TrialBlazer, the Department of Health and Human Services initiative to modernize clinical research and accelerate the development of life-saving treatments. Clearer terminology and regulatory expectations can reduce avoidable uncertainty as sponsors develop nonclinical evidence and prepare applications to begin clinical trials.
The agency is inviting the public, including clinicians, parents, caregivers, the scientific community, industry, and others, to comment on the rule.
For additional information, see the Federal Register notices announcing the direct final rule, the companion proposed rule, and the comment period. If the FDA receives significant adverse comments on the direct final rule, the agency will withdraw it and continue rulemaking through the standard notice-and-comment process using the companion proposed rule. Publishing both simultaneously ensures the rulemaking can proceed efficiently under either scenario.
________________________________________________________________________________
Customs Bulletin Weekly Vol 60, September 16, 2026, No. 28
• Heightened Import Disclosures for Supply Chain Visibility
Customs Bulletin Weekly Vol 60, September 9, 2026, No. 27
• Automated Commercial Environmental (ACE) Electronic Export Manifest for Rail Cargo
________________________________________________________________________________
Federal Register Notices:
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Seamless Refined Copper Pipe and Tube From Mexico: Preliminary Results and Rescission, in Part, of Antidumping Duty Administrative Review; 2024-2025
• Welded Stainless Line and Pressure Pipe From India and the Republic of Türkiye: Postponement of Preliminary Determinations in the Countervailing Duty Investigations
• Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes From the Republic of Korea: Final Results of the Antidumping Duty Administrative Review; 2023-2024
• Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2024-2025
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Brake Drums From the People's Republic of China: Preliminary Affirmative Determination of Circumvention of the Antidumping Duty and Countervailing Duty Orders
• Forged Steel Fluid End Blocks From Italy: Final Results of Countervailing Duty Administrative Review; 2024
• Polyethylene Terephthalate Resin From the Sultanate of Oman: Amended Final Results of Antidumping Duty Administrative Review; 2023-2024; Correction
• Steel Wire Garment Hangers From the People's Republic of China and the Socialist Republic of Vietnam: Preliminary Affirmative Determination of Circumvention of the Antidumping Duty Order on Steel Wire Garment Hangers From the People's Republic of China and the Antidumping and Countervailing Duty Orders on Steel Wire Garment Hangers From the Socialist Republic of Vietnam
• Large Diameter Welded Pipe From Canada: Preliminary Results of Changed Circumstances Review
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Oil Country Tubular Goods From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2023-2024
• Tris(hydroxymethyl)aminomethane From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination, Preliminary Affirmative Determination of Critical Circumstances, in Part, and Alignment of Final Determination With Final Antidumping Duty Determination
• Certain Vertical Shaft Engines Between 99cc and 225cc, and Parts Thereof, From the People's Republic of China: Affirmative Final Determinations of Circumvention of the Antidumping and Countervailing Duty Orders-5C65M0 and BC70M0 Engines
• Common Alloy Aluminum Sheet From the People's Republic of China, Bahrain, Brazil, Croatia, Egypt, Germany, India, Indonesia, Italy, Oman, Romania, Serbia, Slovenia, South Africa, Spain, Taiwan, and the Republic of Türkiye: Final Results of Changed Circumstances Reviews and Revocation of the Antidumping and Countervailing Duty Orders, in Part
• Large Diameter Graphite Electrodes From the People's Republic of China: Preliminary Affirmative Critical Circumstances Determination in Countervailing Duty Investigation
• Certain Freight Rail Couplers and Parts Thereof From India: Final Affirmative Countervailing Duty Determination
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Superabsorbent Polymers From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2023-2024
• Large Diameter Welded Pipe From the Republic of Türkiye: Final Results of Antidumping Duty Administrative Review; 2024-2025
________________________________________________________________________________
In the News:
• Mexico pushes for lower US aluminum tariffs as trade talks advance [AL Circle]
• Great Lakes bind U.S., Canada trade imperiled by Trump tariffs [Financial Post]
• Are Truckers Going on Strike October 1? What Diesel Prices Say' [Newsweek]
• US-China Summit begins with signs that the trade truce will stay in place — for now [Yahoo Finance]
• Trump set to impose sweeping tariffs on 60 trade partners [ABC News]
________________________________________________________________________________
CPSC Continues Elimination of Outdated and Unnecessary Regulations - Consumer Product Safety Commission
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) today eliminated several obsolete and unnecessary provisions from the agency’s regulations, including requirements that have not been enforced in decades, if ever. Although these provisions no longer play a meaningful role in CPSC’s safety work, their continued presence in the Code of Federal Regulations creates unnecessary compliance burdens, confusion, and uncertainty for regulated businesses.
The action implements President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation,” while leaving existing consumer safety protections unchanged. The changes took effect today following publication of a direct final rule earlier this year.
“CPSC’s regulations should be clear, predictable, and focused on real safety risks,” said Acting Chairman Peter A. Feldman. “Requirements that are decades out of date or have been superseded by other requirements only create unnecessary compliance burdens. CPSC will continue its regulatory review to ensure its rules protect consumers without making it harder to manufacture or do business in America.”
The rule makes the following changes:
Bicycle helmets (16 CFR part 1203, subpart D): The rule removes an interim bicycle helmet safety standard that applied only to helmets manufactured between March 1995 and March 1999. CPSC’s permanent bicycle helmet safety standard, in effect since 1999, is unchanged and continues to apply to bicycle helmets manufactured today.
Aerosol products containing chlorofluorocarbons (16 CFR part 1401): The rule removes a 1977 point-of-purchase warning requirement for self-pressurized products containing CFCs. CFCs have been regulated by the Environmental Protection Agency for decades and have been largely phased out worldwide under the Montreal Protocol. As a result, the products subject to this CPSC requirement have effectively disappeared from the market.
CB and TV antennas (16 CFR part 1402) and coal- and wood-burning appliances (16 CFR part 1406): The rule eliminates requirements that manufacturers and importers of these products routinely submit copies of product labels, warnings, and instructions to CPSC. The agency retains its authority to obtain these materials when needed, and requirements to provide consumers with applicable safety warnings and instructions remain unchanged.
The direct final rule was published in the Federal Register on July 23, 2026, Docket No. CPSC-2026-0364. CPSC received no significant adverse comments.
________________________________________________________________________________
FTC Announces Additional Payments to Consumers Stemming from FTC’s Amazon Prime Settlement - Federal Trade Commission
The Federal Trade Commission announced today that Amazon will accelerate and expand payments to eligible consumers under last year’s $2.5 billion settlement, which resolved FTC allegations that the online retailer enrolled millions of consumers in Prime subscriptions without their consent and knowingly made it difficult for consumers to cancel.
Under the historic September 2025 settlement of the FTC’s allegations, Amazon was required to pay up to $1.5 billion in redress to consumers harmed by the company’s deceptive Prime enrollment practices in addition to a $1 billion civil penalty. As of September 2026, Amazon has issued more than $845 million in redress payments to consumers.
This week, a federal court approved a joint motion filed by the FTC and Amazon, approving measures to accelerate and expand future redress payments to consumers. Under the revised order, more consumers will now qualify for refunds from Amazon, the maximum payment cap has been raised from $51 to $200 total, and all future payments will be distributed automatically, eliminating the need for consumers to submit claims or additional paperwork to Amazon.
“The revised order will ensure more consumers who were harmed by Amazon’s deceptive enrollment and cancellation practices benefit from the FTC’s historic settlement,” said Christopher Mufarrige, Director of the FTC’s Bureau of Consumer Protection. “This action underscores the FTC’s commitment to ensuring companies return money to consumers harmed by unlawful and deceptive business practices.”
Expanded Redress: More Consumers Will Benefit
The original order required Amazon to provide refunds of up to $51 to consumers who used fewer than 10 Prime benefits during a one-year period. Under the revised order, Amazon will begin issuing automatic redress payments to millions of additional consumers who used between 11 and 20 Prime benefits during a one-year period.
These consumers were not included in the earlier redress payment phases but will now be eligible for automatic refunds starting on October 1, 2026. The payments will be made via electronic payment (Venmo or PayPal) or mailed check without requiring consumers to submit claims, respond to notices or complete any forms.
Additional Automatic Payments Up to $149
If consumer-accepted payments do not reach the required threshold by February 2027, Amazon will provide additional automatic payments to consumers who previously received refunds under the settlement. As part of the revised order, consumers who have accepted payments will be eligible to receive an additional $149, for a total of $200. This last round of supplemental payments will start by April 2027 and will also be distributed automatically.
Additional information about the refund process can be found on the FTC’s Amazon refund page. Please note that Amazon is responsible for administering the redress program. The FTC is not contacting people about refunds in the Amazon matter. If someone contacts you and claims to be with the FTC, it is likely a scam. No one from Amazon will ever ask you for money to get a refund.