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Reporting of Defects and Noncompliance
10 CFR Part 21 mandates that directors and responsible officers of nuclear licensees and vendors immediately report to the NRC any information indicating that licensed facilities, activities, or basic components fail to comply with applicable regulations or contain defects that could create substantial safety hazards, unless the Commission has already been adequately informed.
Risk-Informed, Technology-Inclusive Regulatory Framework for Commercial Nuclear Plants
10 CFR Part 53 establishes an optional, risk-informed, technology-inclusive regulatory framework for licensing, amending, renewing, and terminating commercial nuclear plants under the Atomic Energy Act. It defines key terms including anticipated event sequences, certified fuel handlers, combined licenses, and commercial nuclear reactors, and applies to all persons providing components, equipment, or services related to licensees and applicants.
Procedural Rules for the Assessment of Civil Penalties for Classified Information Security Violations
This regulation establishes procedural rules for assessing civil penalties against DOE contractors and subcontractors who violate classified information security requirements, including safeguarding of Restricted Data and national security information. Civil penalties may reach $187,668 per violation. The rules apply to entities with DOE contracts entered after October 5, 1999, but exclude individual employees and cap total penalties to annual DOE fees for certain entities.
Facility Security Clearance and Safeguarding of National Security Information and Restricted Data
10 CFR Part 95 establishes procedures for facility security clearance and safeguarding of classified National Security Information and Restricted Data in NRC-licensed activities. It defines requirements for access authorization, facility eligibility, classified material handling, storage, transmission protocols, and security procedures for NRC licensees, certificate holders, contractors, and designated parties requiring access to Secret or Confidential information.
Freedom of Information Act (FOIA)
10 CFR Part 1004 establishes Department of Energy procedures for implementing the Freedom of Information Act (FOIA), defining how DOE offices process public records requests, categorize requesters, calculate direct costs for copying and searching, and handle appeals. FERC is excluded from these regulations.
Consent for Access to Information on Department of Energy Computers
This regulation establishes minimum requirements for individuals accessing Department of Energy computers, mandating written consent acknowledging no expectation of privacy and permitting authorized investigative agency access during employment and for three years thereafter. DOE contractors must obtain and maintain written acknowledgments from employees and subcontractor employees before granting computer access.
Public Records
10 CFR Part 9 establishes the Nuclear Regulatory Commission's procedures for public records access and disclosure under the Freedom of Information Act, Privacy Act, Government in the Sunshine Act, and Social Security Number Fraud Prevention Act. It defines key terms, specifies communication procedures for FOIA and Privacy Act requests, confirms OMB approval of information collection requirements, and addresses record production in response to judicial subpoenas.
Notices, Instructions and Reports to Workers: Inspection and Investigations
10 CFR Part 19 establishes requirements for NRC licensees and regulated entities to provide notices, instructions, and reports to workers in nuclear-licensed activities. It defines worker rights and responsibilities during NRC inspections and investigations, including rules for compelled interviews under subpoena, and applies to all persons involved in NRC-licensed nuclear material, production/utilization facilities, and spent fuel storage installations.
Criteria and Procedures for Determining Eligibility for Access to Restricted Data or National Security Information or an Employment Clearance
10 CFR Part 10 establishes criteria and procedures for determining eligibility for access to Restricted Data and National Security Information for NRC employees, contractors, licensees, and applicants. The regulation implements the Atomic Energy Act and Executive Orders to ensure security of the nuclear energy program while providing administrative review opportunities for individuals seeking access authorization or employment clearance.
Records Maintained on Individuals (Privacy Act)
10 CFR Part 1008 implements the Privacy Act of 1974 for the Department of Energy, establishing procedures for maintaining and handling records about individuals across all DOE divisions, FERC personnel records maintained by DOE, and DOE contractors. The regulation defines key terms and lists DOE locations subject to these privacy requirements.
Statement of Organization and General Information
This regulation establishes the Nuclear Regulatory Commission's organizational structure, authority, and operations following its creation under the Energy Reorganization Act of 1974. It defines the Commission's composition, designates principal and regional offices, and describes how to access NRC organizational directives, meeting information, regulatory documents, and records under the Freedom of Information Act.
Identification and Protection of Unclassified Controlled Nuclear Information
10 CFR Part 1017 implements the Atomic Energy Act's section 148 to identify and protect Unclassified Controlled Nuclear Information (UCNI)—unclassified information concerning nuclear facilities, materials, and weapons. It establishes minimum physical protection standards for UCNI documents, defines who may access such information, specifies review procedures for designation, and creates enforcement mechanisms for unauthorized dissemination penalties. The regulation applies to all persons authorized or seeking access to UCNI.
Public Information and Requests
10 CFR Part 1303 establishes Freedom of Information Act (FOIA) procedures for the U.S. Nuclear Waste Technical Review Board, including policies for public access to Board records, document inspection and copying procedures, designation of a FOIA Officer, and a public reading area in Arlington, Virginia. Records available for disclosure include Board rules, reports, meeting transcripts, and correspondence with Congress and DOE.
Testimony by DNFSB Employees and Production of Official Records in Legal Proceedings
10 CFR Part 1707 establishes procedures governing testimony by Defense Nuclear Facilities Safety Board (DNFSB) employees and production of official records in legal proceedings where the US or DNFSB is not a named party. The regulation aims to promote operational efficiency, maintain DNFSB impartiality, protect sensitive information and deliberative processes, and preserve sovereign immunity. It excludes testimony on matters unrelated to official duties, former employee testimony on non-involved matters, FOIA/Privacy Act requests, and Congressional demands.
Public Information and Requests
10 CFR Part 1703 implements the Freedom of Information Act for the Defense Nuclear Facilities Safety Board (DNFSB). It defines agency records, establishes FOIA request procedures, requires maintenance of an electronic reading room with regulations, policies, recommendations, hearing transcripts, Board orders and correspondence, and designates a FOIA Officer to administer record access and disclosure.
Security Requirements for Protected Disclosures Under Section 3164 of the National Defense Authorization Act for Fiscal Year 2000
This regulation establishes security procedures for Department of Energy employees and contractors to make protected whistleblower disclosures involving classified or unclassified controlled nuclear information related to defense activities. It protects disclosures of legal violations, gross mismanagement, waste, abuse of authority, or false statements to Congress, provided they follow specified security protocols and are made only to authorized recipients, with protections against employer retaliation.
Recording of Aircraft Titles and Security Documents
14 CFR Part 49 establishes procedures for recording aircraft titles and security documents with the FAA Aircraft Registry. The regulation applies to conveyances affecting title to registered aircraft, aircraft engines of 550+ rated takeoff horsepower, propellers of 750+ rated shaft horsepower, and spare parts maintained by certificated air carriers. Recording requires delivery to the Registry in acceptable form, proper signatures, and applicable fees. Conveyance validity is governed by the state law where the instrument is delivered.
Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points
This regulation designates Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points under 14 CFR Part 71. It incorporates by reference FAA Order JO 7400.11K (effective September 15, 2025–September 15, 2026) and establishes rules for aircraft position reporting, airspace overlap procedures, and ATS route classifications including jet routes, RNAV routes, and Federal airways.
Pilot Records Database
14 CFR Part 111 establishes rules governing the Pilot Records Database (PRD), a centralized system for accessing pilot employment and disciplinary records. The regulation applies to air carriers, operators of multi-aircraft businesses, fractional ownership programs, and public aircraft operators. It requires compliance by September 9, 2024, superseding the prior Pilot Records Improvement Act (PRIA). The PRD enables authorized users employed by covered operators to report and evaluate pilot records for employment screening purposes.
Testimony by Employees and Production of Records in Legal Proceedings, and Service of Legal Process and Pleadings
This FAA regulation designates officials authorized to accept legal service on behalf of the FAA and the Secretary of Transportation, and specifies procedures for employee testimony and record production in legal proceedings involving the FAA.
Reporting Traffic Statistics by Foreign Air Carriers in Civilian Scheduled, Charter, and Nonscheduled Services
14 CFR Part 217 establishes reporting requirements for foreign air carriers operating civilian scheduled, charter, and nonscheduled services in the US. The regulation defines key terms including revenue passengers (those generating commercial remuneration), nonrevenue passengers (traveling free or at discounted rates, including employees and authorized personnel), and reporting carriers (those in operational control of flights). Foreign air carriers must report traffic statistics according to these standardized definitions.
Protection of Voluntarily Submitted Information
14 CFR Part 193 establishes procedures for FAA protection of voluntarily submitted safety and security information from public disclosure. The regulation defines conditions under which the FAA may designate such information as protected, requiring findings that disclosure would inhibit future voluntary submissions and that protection is consistent with FAA safety and security responsibilities. De-identified or summarized information may be disclosed, and protection does not limit FAA enforcement action.
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.
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.
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.
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.
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.
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.
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.
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.
Preservation of Air Carrier Records
14 CFR Part 249 establishes recordkeeping requirements for US air carriers, public charter operators, and overseas military personnel charter operators. Air carriers must preserve records related to financial transactions and physical operations in paper, microfilm, or machine-readable formats for specified periods. The regulation defines records broadly to include accounting documents, memoranda, correspondence, and electronic media, with provisions allowing early destruction of paper/microfilm copies after transfer to machine-readable media upon Director approval.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.