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Showing 101–150 of 256 regulations
Disclosure of Change-of-Gauge Services
This regulation requires US air carriers and ticket agents to disclose change-of-gauge services (flights requiring an aircraft change en route despite a single flight number) to consumers through written and electronic schedule information, oral notice before booking, and written notice at the time of sale or check-in. The disclosure requirement became effective August 25, 1999, to prevent unfair or deceptive practices in air transportation marketing.
Rules of Practice in Informal Nonpublic Investigations
14 CFR Part 305 establishes procedural rules governing informal nonpublic investigations conducted by the DOT's Office of the Assistant General Counsel for Aviation Enforcement and Proceedings to determine whether violations of aviation statutes and regulations have occurred. The rules authorize investigation attorneys and administrative law judges to compel disclosure of information through witness testimony and subpoenas, require testimony to be recorded and transcribed, entitle witnesses to legal representation and copies of documents, and maintain the confidential nature of proceedings.
Submission of Audit Reports
This regulation requires U.S. air carriers subject to Part 241 to submit annual audit reports of their books, records, and accounts to the Bureau of Transportation Statistics' Office of Airline Information within 15 days after the due date of their BTS Form 41 Report. Carriers must file complete copies of independent auditor reports including all schedules and exhibits, or submit a statement if no audit was performed. Reports may be withheld from public disclosure if requested by the carrier.
Reports by Air Carriers on Incidents Involving Animals During Air Transport
This regulation requires U.S. air carriers operating scheduled domestic and international passenger service with aircraft designed for more than 60 seats to report incidents involving loss, injury, or death of animals during air transport. Reports must be submitted within 15 days of month-end to DOT's Aviation Consumer Protection Division and include incident details, cause descriptions, and corrective actions. Carriers must also submit annual summaries by December 31 with total incident counts and total animals transported.
Airline Service Quality Performance Reports
Part 234 establishes mandatory reporting requirements for U.S. airlines to submit service quality performance data to the Department of Transportation and computer reservation systems. Airlines must track and disclose metrics including on-time arrival performance, flight cancellations, diversions, and mishandled baggage to enable consumer access to air carrier service quality information.
Uniform System of Accounts and Reports for Large Certificated Air Carriers
14 CFR Part 241 establishes a uniform system of accounts and reports for large certificated air carriers operating aircraft with more than 60 passenger seats or 18,000 pounds payload capacity, or conducting operations outside the 50 states. The regulation defines key accounting and operational terms including air carrier classifications, cargo and ticket agencies, property acquisitions, and aircraft assignment metrics for financial reporting purposes.
Direct Airport-to-Airport Mileage Records
14 CFR Part 247 establishes the official direct airport-to-airport mileage records maintained by the Department of Transportation's Office of Airline Information. These mileages must be used whenever determining direct distances between airports under federal aviation regulations and transportation law.
Reporting Tarmac Delay Data
14 CFR Part 244 establishes reporting requirements for tarmac delay data by U.S. and foreign air carriers operating scheduled passenger service with aircraft seating 30+ passengers. The regulation defines key terms including covered carriers, tarmac delays exceeding three hours (domestic) or four hours (international), gate arrival/departure times, and airport hub classifications, creating a framework for tracking and reporting excessive delays to improve passenger protections.
Passenger Manifest Information
This regulation requires covered airlines (certificated and foreign air carriers) to collect and maintain passenger manifest information for covered flight segments (those operating to or from the United States). Airlines must collect full names of U.S. citizen passengers and solicit emergency contact information. The requirement ensures the U.S. government has prompt access to passenger data in case of aviation disasters including crashes, fires, collisions, sabotage, or acts of air piracy.
Electronic Airline Information Systems
14 CFR Part 256 establishes requirements for electronic airline information systems (GDSs, corporate booking tools, internet flight search tools) displaying flight schedules, fares, and availability. The regulation prohibits undisclosed display bias and requires systems to present flight options objectively based on user-selected search criteria without giving any carrier preference based on identity unless prominently disclosed.
Disclosure of Code-Sharing Arrangements and Long-Term Wet Leases
14 CFR Part 257 requires U.S. air carriers, foreign air carriers, and ticket agents to clearly disclose code-sharing arrangements and long-term wet leases to consumers. Carriers must identify the actual operating carrier in flight itineraries, schedules, and computer reservation systems, with prominent disclosure of the transporting carrier's name to prevent unfair and deceptive practices in scheduled passenger air transportation sales.
Regulation (EU) 2026/1030 of the European Parliament and of the Council of 29 April 2026 on the greenhouse gas emissions accounting of transport services (Text with EEA relevance)
EU regulation requiring transport operators, service organizers, and hub operators to calculate and publicly disclose greenhouse gas emissions from transport services using standardized methodologies. Aims to reduce SME compliance burdens while providing comparable emissions data to incentivize sustainable transport choices and support climate neutrality by 2050.
Regulation (EU) 2026/1030 of the European Parliament and of the Council of 29 April 2026 on the greenhouse gas emissions accounting of transport services (Text with EEA relevance)
EU regulation establishing standardised greenhouse gas emissions accounting and disclosure requirements for transport operators, service organisers, and hub operators. Creates comparable methodologies for calculating GHG emissions from transport services to incentivise sustainable transport choices, reduce SME compliance burdens, and support EU climate neutrality by 2050.
Carbon budget and growth delivery plan
The Carbon Budget and Growth Delivery Plan sets out how the government meets its statutory carbon budgets and secure the benefits of this transition for people and businesses.
Water supply asset discharges: consents, permits and risk assessments
When you need consent or permit to discharge from water supply assets to surface waters. How to carry out a risk assessment and how to apply.
General Requirements
14 CFR Part 402 establishes general requirements prohibiting falsification, reproduction, alteration, or material omission of documents submitted to or kept for compliance with FAA regulations. Violations can result in denial, suspension, modification, or revocation of permits, licenses, authorizations, or approvals, and civil penalties.
UK Emissions Trading Scheme for maritime: how to comply
Guidance to help maritime operators understand and meet their compliance obligations under the UK Emissions Trading Scheme (UK ETS).
Formal Evidentiary Public Hearing
This FDA regulation (21 CFR Part 12) establishes procedural rules for formal evidentiary public hearings before the FDA Commissioner. It covers initiation of proceedings for issuing, amending, or revoking regulations and orders related to food additives, color additives, drugs, medical devices, and biologics. The regulation specifies timelines for submitting petitions, objections, and hearing requests (typically 30 days), notification requirements, and incorporation of the Equal Access to Justice Act procedures for expense reimbursement.
Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
21 CFR Part 99 establishes requirements for manufacturers disseminating information about unapproved or new uses of FDA-approved drugs, biologics, and devices to healthcare practitioners, pharmacy benefit managers, health insurers, group health plans, and government agencies. The regulation defines key terms including health care practitioners, manufacturers, and new uses, and specifies that unsolicited requests from healthcare providers are exempted from these dissemination requirements.
Emergency Permit Control
21 CFR Part 108 establishes emergency permit control procedures for food manufacturers, processors, and packers. The FDA Commissioner may issue temporary emergency permits when a facility fails to meet mandatory conditions of applicable food safety regulations. The rule specifies procedures for permit determination, including notification, objection filing within 3 working days, expedited hearings for imminent health hazards, and permit revocation once compliance is demonstrated. Permits remain valid only as long as necessary to protect public health.
Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
21 CFR Part 106 establishes current good manufacturing practice (cGMP), quality control, and quality factor requirements for infant formula manufacturers under the Federal Food, Drug, and Cosmetic Act. Manufacturers must comply with processing standards, quality factors, and record-keeping procedures; non-compliance renders formula adulterated. The regulation mandates manufacturer registration, submission, and notification to the FDA.
Administrative Practices and Procedures
21 CFR Part 10 establishes administrative practices and procedures governing petitions, hearings, and administrative proceedings conducted by the FDA under the Federal Food, Drug, and Cosmetic Act and related laws. It defines key terms such as administrative action, administrative file, ex parte communication, and participant, and clarifies the applicability and scope of FDA administrative proceedings and related regulatory sections.
Financial Disclosure by Clinical Investigators
FDA regulation requiring disclosure of financial interests and compensation arrangements between clinical investigators and study sponsors for drugs and medical devices. Investigators must disclose equity interests, proprietary interests in tested products, and compensation affected by study outcomes to minimize potential bias in clinical data submitted for FDA marketing applications.
Shell Eggs
21 CFR Part 115 establishes refrigeration requirements for shell eggs held for retail distribution in the United States. Shell eggs must be promptly placed under refrigeration and maintained at or below 7.2°C (45°F) while held at retail establishments, with exemptions for eggs processed to destroy viable Salmonella. The regulation empowers FDA to order diversion or destruction of non-compliant eggs and allows states and localities to assist in enforcement through inspections and administrative remedies.
Public Hearing Before a Public Advisory Committee
This regulation (21 CFR Part 14) establishes procedures for public hearings before FDA advisory committees. It applies when the FDA Commissioner determines it is in the public interest, or when required by statute for specific matters including electronic product radiation safety, color additives, prescription and over-the-counter drugs, medical devices, and device manufacturing standards. The rule defines advisory committees, distinguishes between standing and ad hoc committees, and specifies when groups do not qualify as advisory committees.
Public Hearing Before a Public Board of Inquiry
This regulation establishes procedures for public hearings before a Public Board of Inquiry under FDA jurisdiction. It defines the scope of when such boards are established, requires Federal Register notice of hearings with specified information, and sets qualifications and nomination procedures for board members, who must be free from conflicts of interest and possess relevant medical, technical, or scientific expertise.
Regulatory Hearing Before the Food and Drug Administration
21 CFR Part 16 establishes procedures for regulatory hearings before the FDA when the Commissioner considers regulatory actions affecting drugs, devices, food, cosmetics, and tobacco products. Hearings are available under specific statutory provisions including premarket approval withdrawals, device bans, mandatory recalls, investigational device exemptions, and tobacco product orders. The procedures apply when the Commissioner discretionarily offers a hearing or when statutory provisions mandate one, but exclude informal presentations and certain admission refusals.
General Administrative Rulings and Decisions
21 CFR Part 2 establishes FDA administrative procedures for declaring imminent hazards to public health and conducting examination and investigation samples of foods, drugs, and cosmetics. An imminent hazard exists when evidence shows a product poses significant health threat requiring immediate correction. FDA officers collecting official samples must gather at least twice the estimated quantity needed for analysis, with exceptions for limited availability, cost exceeding $150, or samples from importers or labeled manufacturers. The regulation governs sample handling, preservation, and evidentiary retention for enforcement actions under the Federal Food, Drug, and Cosmetic Act.
Public Hearing Before the Commissioner
This regulation establishes procedures for public hearings before the FDA Commissioner. It applies when the Commissioner determines it is in the public interest to hold a hearing, when an act or regulation specifically provides for one, or when a person waives a formal evidentiary hearing and requests one instead. The Commissioner must publish notice in the Federal Register detailing the hearing's purpose, subject matter, date, time, and location. Participants must file notices of participation with specified information, and the Commissioner determines time allocations for presentations.
Public Information
21 CFR Part 20 establishes FDA procedures for public disclosure of agency records and governs employee testimony. It requires FDA employees to decline testimony unless authorized by the Commissioner, allows written requests for testimony to be evaluated based on public interest, and mandates that record requests follow established procedures under the regulation's subparts addressing confidentiality, trade secrets, and privacy protections.
Production, Storage, and Transportation of Shell Eggs
21 CFR Part 118 establishes production, storage, and transportation requirements for shell eggs from farms with 3,000 or more laying hens. Covered producers must implement biosecurity programs to prevent Salmonella Enteritidis contamination, maintain proper refrigeration, conduct flock testing, and comply with registration requirements unless eggs receive approved antimicrobial treatment. Requirements apply to farms, shell egg processing facilities, and transporters handling eggs for the table market.
Color Additive Certification
21 CFR Part 80 establishes the FDA's color additive certification procedures and fee schedules. Manufacturers must submit certification requests with prescribed samples and fees ($0.45/lb minimum $288 for straight colors; tiered fees for repacks). Requests require duplicate submission, responsible officer signature, and advance deposit option. The regulation governs batch certification, foreign manufacturer requirements, and refund procedures for advance deposits.
Prescription Drug Advertising
Prescription drug advertising requirements under 21 CFR Part 202 establish rules for how drugs must be advertised. Key provisions include: ingredient information must appear together without intervening matter; ingredient listing order and quantities must match product labels; proprietary names cannot imply unique effectiveness for common substances; inert ingredients cannot be featured to exaggerate value; proprietary names must not create confusion with other drugs; and established names must accompany proprietary names with specified type size and placement requirements throughout advertisements.
Food Additive Petitions
21 CFR Part 171 establishes procedural requirements for petitions requesting approval of food additives under section 409(b) of the Federal Food, Drug, and Cosmetic Act. Petitioners must submit detailed information on the additive's chemical identity, composition, manufacturing process, analytical controls, stability data, and safety assessments to the FDA's Office of Food Additive Safety. Submissions must be in triplicate (or quadruplicate for meat/poultry uses) with English translations of foreign materials and supporting documentation.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
21 CFR Part 207 establishes requirements for registration and listing of domestic and foreign drug establishments manufacturing human drugs (including biologics) and animal drugs. It defines key terms including active pharmaceutical ingredients, bulk drug substances, commercial distribution, and labeling requirements for prescription drugs, OTC drugs, and animal drugs, along with establishment definitions for regulatory compliance and National Drug Code assignment.
Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study
21 CFR Part 180 establishes the regulatory framework for interim approval of food additives and food-contact substances when new safety or functionality concerns arise but evidence does not conclusively prove harm. Interim regulations permit continued use during study periods, subject to specified limitations, mandatory progress reporting every six months, and compliance with good laboratory practice standards. The FDA may revoke interim approvals if adequate studies are not initiated within 60 days or if interim results indicate health hazards.
General
21 CFR Part 200 establishes general provisions for FDA and drug manufacturers/distributors regarding communication of drug safety and labeling information. It specifies envelope formatting requirements (color-coded borders and statements) for mailing important drug warnings, prescribing information changes, and corrections to physicians and pharmacists. It also authorizes FDA inspection of contract facilities used by pharmaceutical manufacturers and permits pharmacists to receive dosage and indication data from manufacturers.
Guidelines for State Licensing of Wholesale Prescription Drug Distributors
This regulation establishes minimum standards and conditions for state licensing of wholesale prescription drug distributors operating in interstate commerce, implementing the Prescription Drug Marketing Act of 1987. It defines key terms including prescription drugs, wholesale distribution, wholesale distributors, and health care entities, while specifying exemptions from wholesale distribution requirements such as intracompany sales, emergency transfers, drug samples, and certain inter-entity transactions.
Dietary Supplements
21 CFR Part 190 establishes premarket notification requirements for dietary supplements containing new dietary ingredients not previously present in the food supply. Manufacturers or distributors must submit safety information to FDA at least 75 days before introducing such products to interstate commerce, including ingredient identification, usage conditions, safety history, and published evidence supporting safety conclusions. FDA acknowledges receipt and assigns a filing date; the product cannot be marketed during the 75-day review period unless FDA determines no safety concern exists.
Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement
21 CFR Part 209 requires authorized dispensers and pharmacies to distribute a standardized side effects statement with each dispensed prescription drug product approved under FDA section 505. The statement directs consumers to call their doctor about side effects and report adverse events to FDA at 1-800-FDA-1088. Distribution must occur with new and refill prescriptions via sticker, vial cap, separate paper, consumer medication information, or FDA-approved Medication Guide, using clear type no smaller than 6-10 points depending on format.
Prescription Drug Marketing
21 CFR Part 203 establishes procedures and requirements for the distribution of prescription drugs, including bulk drug substances and finished dosage forms, to protect public health and prevent drug diversion. It covers reimportation and wholesale distribution, sales by hospitals and charitable organizations, and distribution of drug samples, implementing the Prescription Drug Marketing Act of 1987 and related amendments.
Compliance with BAT-AELs for indirect emissions to water at chemical waste treatment installations: RPS 371
Environment Agency regulatory position on when you cannot comply with best available techniques associated emission limits (BAT-AELs) for certain substances discharged to sewer at chemical waste treatment installations.
Environment Agency suspends Chichester waste site permit
Officers found serious fire hazards and pollution risks during a site visit
Non-domestic Private Rented Sector minimum energy efficiency standards: EPC B implementation
We're seeking views on the government's proposed framework to improve implementation and enforcement of the EPC B target by 2030 for privately rented non-domestic buildings.
Bioavailability and Bioequivalence Requirements
21 CFR Part 320 establishes FDA requirements for demonstrating bioavailability and bioequivalence of drug products in new drug applications, abbreviated new drug applications, and supplemental applications. Applicants must submit evidence of in vivo bioavailability for full NDAs or demonstrate bioequivalence to a reference listed drug for abbreviated NDAs, with FDA authority to waive certain requirements or require additional study reports when concerns arise.
Drugs; Official Names and Established Names
21 CFR Part 299 establishes procedures for designating official and established names for drugs under the Federal Food, Drug, and Cosmetic Act. The regulation defines official names as those designated by the FDA Commissioner under section 508, and established names as official names, compendial names, or common/usual names. The FDA recognizes the U.S. Adopted Names Council for deriving nonproprietary drug names and generally relies on compendial or common names rather than routinely designating new official names.
Controlled Drugs
21 CFR Part 290 establishes requirements for dispensing controlled substances scheduled II–V under the Federal Controlled Substances Act. Drugs in these schedules require prescription-only dispensing unless exempted (e.g., codeine preparations ≤200 mg per 100 mL/g with non-narcotic active ingredients). Labels must carry a federal warning prohibiting unauthorized transfer. Emergency oral prescriptions of Schedule II drugs are permitted when immediate administration is medically necessary and written prescription is impractical.
General
This regulation establishes FDA policies for fixed-combination prescription drugs, prohibits chlorofluorocarbon propellants in human drugs, and requires annual reporting by manufacturers and sponsors of eligible investigational drugs supplied to eligible patients under the Right to Try Act.
Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
Part 361 establishes conditions under which radioactive drugs are considered safe and effective for basic research use in human subjects. Research must be approved by a Radioactive Drug Research Committee and meet strict limits on pharmacological dose, radiation dose, and cumulative exposure. Studies must demonstrate qualified investigators, proper licensure, informed consent, institutional review, and adverse event reporting.
Certification and Postmarketing Reporting for Designated Medical Gases
21 CFR Part 230 establishes FDA procedures for certification and postmarketing surveillance of designated medical gases. It requires applicants to submit certifications under the Federal Food, Drug, and Cosmetic Act and defines requirements for adverse event reporting, including serious adverse events. The regulation sets minimum data standards for individual case safety reports and establishes postmarketing safety monitoring systems.