{"description":"Documents matching 'product problem failure capture read'","count":5121,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=product+problem+failure+capture+read&format=json&page=2","results":[{"title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if an applicant implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a practitioner licensed by law to administer such drug. The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products and increase consumer access to appropriate, safe, and effective drug products, which could improve public health.","document_number":"2024-30261","html_url":"https://www.federalregister.gov/documents/2024/12/26/2024-30261/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-26/pdf/2024-30261.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30261.pdf?1734961513","publication_date":"2024-12-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"regarding approval of specific drug products or categories of drug products or restrict the types of drug products that FDA may consider for approval as a nonprescription drug product with an ACNU. FDA considers the specifics of each application during its review, including the potential risk for misuse of the drug product. As long as the application meets the existing evidentiary standards under the FD&C Act and current FDA regulations to demonstrate the safety and effectiveness of the drug product, and the drug product does not meet the criteria for"},{"title":"National Emission Standards for Hazardous Air Pollutants: Plywood and Composite Wood Products","type":"Rule","abstract":"The U.S. Environmental Protection Agency (EPA) is finalizing amendments to the national emissions standards for hazardous air pollutants (NESHAP) for the Plywood and Composite Wood Products (PCWP) source category. Specifically, the EPA is finalizing maximum achievable control technology (MACT) standards in the form of emission limitations and work practices as appropriate for total hazardous air pollutants (HAP) (including acetaldehyde, acrolein, formaldehyde, methanol, phenol, propionaldehyde), non-mercury (non-Hg) HAP metals, mercury (Hg), hydrogen chloride (HCl), polycyclic aromatic hydrocarbons (PAH), dioxin/furan (D/F), and methylene diphenyl diisocyanate (MDI). Sources affected by the amendments include PCWP process units and lumber kilns located at facilities that are major sources of HAP emissions. These final amendments address the 2007 partial remand and vacatur of the 2004 final rule that promulgated the PCWP NESHAP (\"2004 rule\"). The final amendments also respond to issues raised in a petition for reconsideration regarding the 2020 residual risk and technology review (RTR) and other amendments to the 2020 PCWP NESHAP.","document_number":"2026-13550","html_url":"https://www.federalregister.gov/documents/2026/07/06/2026-13550/national-emission-standards-for-hazardous-air-pollutants-plywood-and-composite-wood-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-06/pdf/2026-13550.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13550.pdf?1782996317","publication_date":"2026-07-06","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"from Plywood and Composite Wood Products Reconstituted Wood Products Presses, Tube Dryers, and Miscellaneous Coating Operations, \n available in the docket for this rulemaking.\n \n \n 1. Reconstituted Wood Product Presses \n a. What reconstituted wood product press MDI standards did we propose? \n The EPA proposed MDI emission standards for reconstituted wood product presses that produce OSB and for reconstituted wood product presses that produce particleboard or MDF (PB/MDF). We developed separate standards because product differences affect MDI emissions"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA's adverse event reports and product experience reports for FDA-regulated products.","document_number":"2025-01149","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01149/agency-information-collection-activities-proposed-collection-comment-request-food-and-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01149.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01149.pdf?1737035130","publication_date":"2025-01-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports to SRP (both questionnaires) \n 176 \n 1 \n 176 \n 0.6 (36 minutes) \n 106 \n \n \n Mandatory Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports 1114.41(a)(2) \n 3 \n 6 \n 18 \n 0.6 (36 minutes) \n 11 \n \n \n Total \n \n \n 5,924 \n \n 3,961 \n \n \n 1 \n There are no capital costs or operating and maintenance costs associated with this collection of information.\n \n \n The number of respondents for the Voluntary Tobacco Product Health Problem or Product Problem"},{"title":"Energy Conservation Program: Review of DOE's Analytic Methods for Setting Energy Conservation Standards","type":"Proposed Rule","abstract":"The U.S. Department of Energy (\"DOE\" or the \"Department\") requests comment regarding the assumptions, models, and methodologies that DOE uses in setting energy conservation standards for covered products and equipment. Relatedly, DOE also requests comments on the report summarizing the work conducted by the National Academies of Sciences, Engineering, and Medicine (\"NASEM\") Committee on Review of Methods for Setting Building and Equipment Performance Standards. DOE also welcomes the submission of data, peer-reviewed studies, and other relevant information related to how DOE might implement NASEM report recommendations and to DOE's analytical methodology for evaluating energy conservation standards in general.","document_number":"2026-13673","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13673/energy-conservation-program-review-of-does-analytic-methods-for-setting-energy-conservation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13673.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13673.pdf?1783341912","publication_date":"2026-07-07","agencies":[{"raw_name":"DEPARTMENT OF ENERGY","name":"Energy Department","id":136,"url":"https://www.federalregister.gov/agencies/energy-department","json_url":"https://www.federalregister.gov/api/v1/agencies/136","parent_id":null,"slug":"energy-department"}],"excerpts":"covered products in lieu of replacing them with products that meet the minimum energy conservation standards.\n \n \n B. Modeling Retirement and Replacement \n As part of its analysis of the impact on consumer life-cycle costs and product shipments following the implementation of a new or amended efficiency standard, DOE models product lifetime using a survival function, typically based on a Weibull distribution. The survival function is calibrated using available data on average product or equipment lifetime from survey data, manufacturer product literature"},{"title":"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","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2025-11605","html_url":"https://www.federalregister.gov/documents/2025/06/25/2025-11605/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-25/pdf/2025-11605.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11605.pdf?1750769110","publication_date":"2025-06-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"remove: \n ○ Special nutritional products (dietary supplements, medical foods, infant formulas) \n ○ Food (including beverages and ingredients added to foods) \n • add: \n \n ○ If your report involves a health problem or product problem with foods or special nutritional products such as infant formulas, dietary supplements, or medical foods, go to \n https://www.safetyreporting.fda.gov \n or call 1-888-723-3366 to report.\n \n • revise: \n \n ○ “If your report involves a health problem or a product problem with a tobacco product, go to \n https://www.safetyreporting"},{"title":"Energy Conservation Program: Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Certain Commercial/Industrial Equipment","type":"Proposed Rule","abstract":"The U.S. Department of Energy (\"DOE\" or \"the Department\") proposes to update the Department's current rulemaking methodology titled, \"Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Certain Commercial/Industrial Equipment\" (\"Process Rule\"). Specifically, DOE proposes to: make Appendix A binding on DOE for certain actions; amend objectives and considerations consistent with recent Executive orders and Department policies; add a definition of \"significant energy savings\"; re-instate the comparative analysis requirement, described as a \"walk up\" approach; include certain economic thresholds; re-instate the description of clear and convincing evidence; and revert to language from the 2020 Process Rule text, with minor edits, in several sections. In addition to requesting written comments on its proposal, DOE will also hold a public meeting to discuss this proposal and obtain additional input.","document_number":"2026-13674","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13674/energy-conservation-program-procedures-interpretations-and-policies-for-consideration-of-new-or","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13674.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13674.pdf?1783341912","publication_date":"2026-07-07","agencies":[{"raw_name":"DEPARTMENT OF ENERGY","name":"Energy Department","id":136,"url":"https://www.federalregister.gov/agencies/energy-department","json_url":"https://www.federalregister.gov/api/v1/agencies/136","parent_id":null,"slug":"energy-department"}],"excerpts":"type (or class) for any group of covered products which have the same function or intended use, if the Secretary determines that covered products within such group: (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard from that which applies (or will apply) to other products within such type (or class). (42 U.S.C.6295(q)(1))"},{"title":"Prohibition on the Use of Reputation Risk by Regulators","type":"Rule","abstract":"The Office of the Comptroller of the Currency and the Federal Deposit Insurance Corporation are adopting a final rule to codify the elimination of reputation risk from their supervisory programs. Among other things, the rule prohibits the agencies from criticizing or taking adverse action against an institution on the basis of reputation risk. The rule also prohibits the agencies from requiring, instructing, or encouraging an institution to close an account, to refrain from providing an account, product, or service, or to modify or terminate any product or service on the basis of a person or entity's political, social, cultural, or religious views or beliefs, constitutionally protected speech, or solely on the basis of politically disfavored but lawful business activities perceived to present reputation risk. The rule further forbids the agencies from taking any supervisory action or other adverse action against an institution, a group of institutions, or the institution-affiliated parties of any institution that is designed to punish or discourage an individual or group from engaging in any lawful political, social, cultural, or religious activities, constitutionally protected speech, or, for political reasons, lawful business activities that the agencies or its personnel disagree with or disfavor.","document_number":"2026-06947","html_url":"https://www.federalregister.gov/documents/2026/04/10/2026-06947/prohibition-on-the-use-of-reputation-risk-by-regulators","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-10/pdf/2026-06947.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06947.pdf?1775738713","publication_date":"2026-04-10","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Office of the Comptroller of the Currency","name":"Comptroller of the Currency","id":80,"url":"https://www.federalregister.gov/agencies/comptroller-of-the-currency","json_url":"https://www.federalregister.gov/api/v1/agencies/80","parent_id":497,"slug":"comptroller-of-the-currency"},{"raw_name":"FEDERAL DEPOSIT INSURANCE CORPORATION","name":"Federal Deposit Insurance Corporation","id":164,"url":"https://www.federalregister.gov/agencies/federal-deposit-insurance-corporation","json_url":"https://www.federalregister.gov/api/v1/agencies/164","parent_id":null,"slug":"federal-deposit-insurance-corporation"}],"excerpts":"condition. The OCC's analysis shows that the agency will not lose information useful to anticipate regulated institutions' failure by ceasing to produce reputation risk ratings in the Risk Assessment System (RAS) ratings system, as the RAS reputation risk ratings do not forecast failure after accounting for the CAMELS composite rating and components. Instead, only RAS ratings that assess fundamental financial risks predict failure risk once CAMELS ratings are accounted for. \n In addition, there is no evidence that ceasing to impose Matters Requiring"},{"title":"Enhanced Transparency and Public Accountability of the Supervisory Stress Test Models and Scenarios; Modifications to the Capital Planning and Stress Capital Buffer Requirement Rule, Enhanced Prudential Standards Rule, and Regulation LL","type":"Proposed Rule","abstract":"The Board is inviting public comment on the models used to conduct the Board's supervisory stress test, changes to those models to be implemented in the 2026 stress test, and proposed changes to enhance the transparency and public accountability of the Board's stress testing framework (the proposal). The proposal would amend the Policy Statement on the Scenario Design Framework for Stress Testing, including to implement guides for additional scenario variables, and the Stress Testing Policy Statement. The proposal would also codify an enhanced disclosure process under which the Board would annually publish comprehensive documentation on the stress test models, invite public comment on any material changes that the Board seeks to make to those models, and annually publish the stress test scenarios for comment. Lastly, the proposal would make changes to the FR Y-14A/Q/M to remove items that are no longer needed to conduct the supervisory stress test and to collect additional data to support the stress test models and improve risk capture.","document_number":"2025-20211","html_url":"https://www.federalregister.gov/documents/2025/11/18/2025-20211/enhanced-transparency-and-public-accountability-of-the-supervisory-stress-test-models-and-scenarios","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-18/pdf/2025-20211.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20211.pdf?1763387141","publication_date":"2025-11-18","agencies":[{"raw_name":"FEDERAL RESERVE SYSTEM","name":"Federal Reserve System","id":188,"url":"https://www.federalregister.gov/agencies/federal-reserve-system","json_url":"https://www.federalregister.gov/api/v1/agencies/188","parent_id":null,"slug":"federal-reserve-system"}],"excerpts":"selected maturities and expiration dates, which are key inputs to the pricing of interest rate derivatives; \n • Futures prices at various expiration dates for commodity products such as energy, oil, metals, and agricultural products; and \n • Credit spreads or prices for selected credit-sensitive products, including corporate bonds, credit default swaps (CDS), securitized products, sovereign debt, and municipal bonds. \n The global market shock is typically applied to positions held by the firms on a given as-of date, reflecting a hypothetical instantaneous"},{"title":"Salmonella Framework for Raw Poultry Products","type":"Proposed Rule","abstract":"FSIS is announcing its proposed determination that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products contaminated with certain Salmonella levels and serotypes are adulterated within the meaning of the Poultry Products Inspection Act (PPIA). The proposed determination would establish final product standards based on these Salmonella levels and serotypes and would prevent raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products that contain Salmonella at the levels and serotypes that would render them adulterated from entering commerce. FSIS is also proposing to revise the regulations that require that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation to clarify that these procedures must include a microbial monitoring program (MMP) that incorporates statistical process control (SPC) monitoring methods, to require sampling at rehang instead of pre-chill, and to require that all establishments conduct paired sampling at rehang and post-chill.","document_number":"2024-16963","html_url":"https://www.federalregister.gov/documents/2024/08/07/2024-16963/salmonella-framework-for-raw-poultry-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-07/pdf/2024-16963.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16963.pdf?1722948312","publication_date":"2024-08-07","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Food Safety and Inspection Service","name":"Food Safety and Inspection Service","id":201,"url":"https://www.federalregister.gov/agencies/food-safety-and-inspection-service","json_url":"https://www.federalregister.gov/api/v1/agencies/201","parent_id":12,"slug":"food-safety-and-inspection-service"}],"excerpts":"parts or provide a robust assessment on final product standards for turkey carcasses that FSIS could use to inform the development of final product standards for these products.\n \n \n The basis for the proposed final product standards and FSIS' proposed determination that products that contain the \n Salmonella \n levels and serotypes identified in the proposed final product standards are adulterated is discussed below.\n \n B. Pathogens as Adulterants in Raw and Not-Ready-To Eat Meat and Poultry Products \n \n Under the FMIA (21 U.S.C. 601 \n et seq. \n"},{"title":"Trade Regulation Rule Relating to Power Output Claims for Amplifiers Utilized in Home Entertainment Products","type":"Rule","abstract":"The Federal Trade Commission (\"FTC\" or \"Commission\") issues final amendments to its Trade Regulation Rule Relating to Power Output Claims for Amplifiers Utilized in Home Entertainment Products (\"Amplifier Rule\" or \"Rule\"). The amendments require sellers making power-related claims to calculate power output using uniform testing methods to allow consumers to easily compare amplifier sound quality; prescribe disclosure language that improves differentiation between power output claims that comply with the Rule's testing methods and those that do not; and modernize as well as clarify Rule language considering the foregoing modifications. Additionally, the amendments formalize prior Commission guidance on applying the Rule to multichannel amplifiers.","document_number":"2024-12744","html_url":"https://www.federalregister.gov/documents/2024/06/12/2024-12744/trade-regulation-rule-relating-to-power-output-claims-for-amplifiers-utilized-in-home-entertainment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-12/pdf/2024-12744.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-12744.pdf?1718109920","publication_date":"2024-06-12","agencies":[{"raw_name":"FEDERAL TRADE COMMISSION","name":"Federal Trade Commission","id":192,"url":"https://www.federalregister.gov/agencies/federal-trade-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/192","parent_id":null,"slug":"federal-trade-commission"}],"excerpts":"defined by 5 U.S.C. 804(2).\n \n \n List of Subjects in 16 CFR Part 432 \n Amplifiers, Home entertainment products, Trade practices. \n \n For the reasons stated above, the Commission amends 16 CFR part 432 as follows: \n \n PART 432—POWER OUTPUT CLAIMS FOR AMPLIFIERS UTILIZED IN HOME ENTERTAINMENT PRODUCTS \n \n \n 1. The authority citation for part 432 continues to read: \n \n Authority: \n 38 Stat. 717, as amended; (15 U.S.C. 41-58). \n \n \n \n 2. Revise § 432.2 to read as follows: \n \n § 432.2 \n \n Whenever any direct or indirect representation is made of the power"},{"title":"Updating Class I Rail Carrier Reporting Requirements","type":"Rule","abstract":"The Board is adopting a final rule terminating Class I carriers' supplemental reporting of certain Positive Train Control (PTC) expenditures, and it is requiring Class I carriers to report two service metrics on a weekly basis.","document_number":"2026-09189","html_url":"https://www.federalregister.gov/documents/2026/05/08/2026-09189/updating-class-i-rail-carrier-reporting-requirements","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-08/pdf/2026-09189.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09189.pdf?1778157918","publication_date":"2026-05-08","agencies":[{"raw_name":"SURFACE TRANSPORTATION BOARD","name":"Surface Transportation Board","id":481,"url":"https://www.federalregister.gov/agencies/surface-transportation-board","json_url":"https://www.federalregister.gov/api/v1/agencies/481","parent_id":null,"slug":"surface-transportation-board"}],"excerpts":"submitted to the Board.\n \n \n (i) Failure to spot a constructively placed railcar that has been ordered in by the cut-off time applicable to the customer for a planned service window shall be included as a failure in calculating the ISP metric. This includes “spot on arrival” railcars (\n i.e., \n railcars that may be placed without placement instructions) that have been constructively placed for any reason.\n \n (ii) Failure to spot a “spot on arrival” railcar for a planned service window shall be included as a failure in calculating the ISP metric if"},{"title":"Medical Devices; Radiology Devices; Classification of Blood Irradiators","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.","document_number":"2026-05320","html_url":"https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05320.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05320.pdf?1773751519","publication_date":"2026-03-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"devices as devices that require premarket notification (510(k)), with product code MOT.\n 1 \n \n FDA intends to create a separate product code for blood irradiators intended to prevent metastasis upon finalization of this classification action.\n 2 \n \n \n \n \n 1 \n FDA uses product codes to help categorize and assure consistent regulation of medical devices. A product code consists of three characters that are assigned at the time a product code is generated and is unique to a product type. The three characters carry no other significance and are not an"},{"title":"Revising the National Drug Code Format and Drug Label Barcode Requirements","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.","document_number":"2026-04368","html_url":"https://www.federalregister.gov/documents/2026/03/05/2026-04368/revising-the-national-drug-code-format-and-drug-label-barcode-requirements","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-05/pdf/2026-04368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04368.pdf?1772631910","publication_date":"2026-03-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"of years. We also decline the suggestion to expand the product code to 5 digits. A 4-digit product code accommodates up to 10,000 different product codes (0000 to 9999). Because only a very small number of manufacturers and private label distributors need more than 10,000 product codes, it would be more efficient and less burdensome to assign those manufacturers an additional labeler code when they use up all of the product codes under an existing labeler code rather than expand the product code. We disagree with the suggestion to eliminate the"},{"title":"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","type":"Rule","abstract":"This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-19787","html_url":"https://www.federalregister.gov/documents/2025/11/05/2025-19787/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-05/pdf/2025-19787.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19787.pdf?1761945018","publication_date":"2025-11-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"available skin substitute products, the sales and distribution structure for these products, and the rapidity of products changing manufacturer ownership. These industry changes are causing a significant increase in spending under Medicare Part B for skin substitute products in the non-facility setting. According to Medicare claims data, Part B spending for these products rose from approximately $250 million in 2019 to over $10 billion in 2024, a nearly 40-fold increase, while the number of patients receiving these products only doubled. Increases"},{"title":"Mandatory Toy Safety Standards: Requirements for Neck Floats","type":"Proposed Rule","abstract":"The Consumer Product Safety Improvement Act of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety standard. This toy safety standard sets forth only minimal labeling requirements for aquatic toys such as neck floats. The U.S. Consumer Product Safety Commission (CPSC or Commission) proposes to establish new performance and revised labeling requirements to address potentially deadly hazards associated with neck floats. The Commission also proposes to amend CPSC's list of notice of requirements (NORs) to include neck floats.","document_number":"2024-25446","html_url":"https://www.federalregister.gov/documents/2024/11/20/2024-25446/mandatory-toy-safety-standards-requirements-for-neck-floats","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-20/pdf/2024-25446.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25446.pdf?1732023915","publication_date":"2024-11-20","agencies":[{"raw_name":"CONSUMER PRODUCT SAFETY COMMISSION","name":"Consumer Product Safety Commission","id":84,"url":"https://www.federalregister.gov/agencies/consumer-product-safety-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/84","parent_id":null,"slug":"consumer-product-safety-commission"}],"excerpts":"addressing aquatic toys. Specifically, the Commission proposes to address the following known hazards: (1) children slipping through the product due to deflation or underinflation; (2) children slipping through the product for reasons other than deflation or underinflation; (3) children slipping through the product due to a restraint system failure; and (4) children submerging in water without slipping through the product. Each of these hazard patterns presents a risk of drowning. The Commission proposes adding performance requirements to part 1250 to"},{"title":"Transport Airplane and Propulsion Certification Modernization","type":"Proposed Rule","abstract":"FAA proposes to amend various airworthiness regulations to modernize certain certification standards for transport category airplanes and propulsion systems. This rule would be both deregulatory and relieving by reducing the number of exemptions, special conditions, and equivalent level of safety findings required during the certification process. FAA expects that this proposal would reduce certification costs and time to certify new and changed products for both industry and FAA while maintaining or increasing the level of safety provided by the current regulations. FAA proposes to remove Special Federal Aviation Regulation (SFAR) No. 109 from part 25 and relocate certain of its requirements. Finally, this action would address industry and National Transportation Safety Board recommendations while also harmonizing FAA's regulations with international standards.","document_number":"2026-12922","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12922/transport-airplane-and-propulsion-certification-modernization","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12922.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12922.pdf?1782391515","publication_date":"2026-06-26","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Federal Aviation Administration","name":"Federal Aviation Administration","id":159,"url":"https://www.federalregister.gov/agencies/federal-aviation-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/159","parent_id":492,"slug":"federal-aviation-administration"}],"excerpts":"envisioned by amendment 25-87.\n \n \n \n The MSHWG and FAA reviews indicate since 1959 through 2006 there have been approximately 3,000 loss-of-cabin-pressure events. The majority of these have been caused by system failures (\n e.g., \n cabin pressurization controller failures, valve failures, etc.) and structural failures (\n e.g., \n door seal failures, etc.), which have been typically recognized at low altitude within a few minutes after takeoff.\n 143 \n Pilot error has also contributed to the number of events. The cabin pressure altitude in most events did"},{"title":"Energy Conservation Program: Energy Conservation Standards for Consumer Conventional Cooking Products","type":"Rule","abstract":"The Energy Policy and Conservation Act, as amended (\"EPCA\"), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including consumer conventional cooking products. In this direct final rule, the U.S. Department of Energy (\"DOE\") is adopting new and amended energy conservation standards for consumer conventional cooking products. DOE has determined that the new and amended energy conservation standards for these products would result in significant conservation of energy, and are technologically feasible and economically justified.","document_number":"2024-02008","html_url":"https://www.federalregister.gov/documents/2024/02/14/2024-02008/energy-conservation-program-energy-conservation-standards-for-consumer-conventional-cooking-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-14/pdf/2024-02008.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-02008.pdf?1707831913","publication_date":"2024-02-14","agencies":[{"raw_name":"DEPARTMENT OF ENERGY","name":"Energy Department","id":136,"url":"https://www.federalregister.gov/agencies/energy-department","json_url":"https://www.federalregister.gov/api/v1/agencies/136","parent_id":null,"slug":"energy-department"}],"excerpts":"conservation standard for a covered product that has two or more subcategories. A rule prescribing an energy conservation standard for a type (or class) of product must specify a different standard level for a type or class of products that has the same function or intended use if DOE determines that products within such group: (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not"},{"title":"Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability","type":"Rule","abstract":"This final rule revises standards relating to denial of coverage for failure to pay past-due premium; excludes Deferred Action for Childhood Arrivals recipients from the definition of \"lawfully present;\" establishes the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; revises the Exchange automatic reenrollment hierarchy; revises standards related to the annual open enrollment period and special enrollment periods; revises standards relating to failure to file and reconcile, income eligibility verifications for premium tax credits and cost-sharing reductions, annual eligibility redeterminations, de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements, and income-based cost-sharing reduction plan variations. This final rule also revises the premium adjustment percentage methodology and prohibits issuers of coverage subject to EHB requirements from providing coverage for specified sex-trait modification procedures as an EHB.","document_number":"2025-11606","html_url":"https://www.federalregister.gov/documents/2025/06/25/2025-11606/patient-protection-and-affordable-care-act-marketplace-integrity-and-affordability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-25/pdf/2025-11606.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11606.pdf?1750709712","publication_date":"2025-06-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"coverage under § 147.106(e), an issuer may, only at the time of coverage renewal, modify the health insurance coverage for a product offered in the individual market or small group market if the modification is consistent with State law and is effective uniformly for all individuals or group health plans with that product. To be considered a uniform modification of coverage, among other things, each plan within the product that has been modified must have the same cost-sharing structure as before the modification, except for any variation in cost"},{"title":"Safety Standard for Nursing Pillows","type":"Rule","abstract":"Pursuant to the Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), the U.S. Consumer Product Safety Commission (Commission or CPSC) is issuing this final rule establishing a consumer product safety standard for nursing pillows. CPSC is also amending its regulations regarding third party conformity assessment bodies, to include the safety standard for nursing pillows in the list of notices of requirements (NORs), along with identifying nursing pillows as a durable infant or toddler product subject to consumer registration requirements.","document_number":"2024-24403","html_url":"https://www.federalregister.gov/documents/2024/10/25/2024-24403/safety-standard-for-nursing-pillows","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-25/pdf/2024-24403.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24403.pdf?1729787533","publication_date":"2024-10-25","agencies":[{"raw_name":"CONSUMER PRODUCT SAFETY COMMISSION","name":"Consumer Product Safety Commission","id":84,"url":"https://www.federalregister.gov/agencies/consumer-product-safety-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/84","parent_id":null,"slug":"consumer-product-safety-commission"}],"excerpts":"\n \n Section 104(b) of the CPSIA, part of the Danny Keysar Child Product Safety Notification Act, requires the Commission to (1) examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts; and (2) promulgate consumer product safety standards for durable infant and toddler products. 15 U.S.C. 2056a(b)(1). Standards issued under section 104 are to"},{"title":"Recordkeeping for Custodial Accounts","type":"Proposed Rule","abstract":"The Federal Deposit Insurance Corporation (FDIC) is proposing requirements that would strengthen FDIC-insured depository institutions' (IDI) recordkeeping for custodial deposit accounts with transactional features and preserve beneficial owners' and depositors' entitlement to the protections afforded by Federal deposit insurance. The proposal is intended to promote the FDIC's ability to promptly make deposit insurance determinations and, if necessary, pay deposit insurance claims \"as soon as possible\" in the event of the failure of an IDI holding custodial accounts with transactional features. The proposed requirements also are expected to result in depositor and consumer protection benefits, such as promoting timely access by consumers to their funds, even in the absence of the failure of an IDI. The requirements described in this document would only apply to IDIs offering custodial accounts with transactional features and that are not specifically exempted as provided in this document.","document_number":"2024-22565","html_url":"https://www.federalregister.gov/documents/2024/10/02/2024-22565/recordkeeping-for-custodial-accounts","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-02/pdf/2024-22565.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-22565.pdf?1727786728","publication_date":"2024-10-02","agencies":[{"raw_name":"FEDERAL DEPOSIT INSURANCE CORPORATION","name":"Federal Deposit Insurance Corporation","id":164,"url":"https://www.federalregister.gov/agencies/federal-deposit-insurance-corporation","json_url":"https://www.federalregister.gov/api/v1/agencies/164","parent_id":null,"slug":"federal-deposit-insurance-corporation"}],"excerpts":"disruption is because of an IDI failure, or failure or operational disruption experienced by an account holder. The proposal would benefit customers by requiring that records be maintained in a standard format identifying customers and their balances and by requiring reconciliation between the records of IDIs and their associated non-bank entities. The required records and reconciliation would allow customers to have uninterrupted or near-uninterrupted access to their underlying funds in the event of an IDI failure, or failure or operational disruption"}]}