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Showing 51–92 of 92 regulations
License Application Procedures
14 CFR Part 413 establishes procedures for obtaining licenses and experimental permits for commercial space transportation activities, including launching vehicles and operating launch or reentry sites in the United States or internationally. The regulation requires applicants to consult with the FAA before submission and specifies who must obtain licenses based on citizenship, entity organization, and controlling interest.
Compliance and Enforcement
14 CFR Part 405 establishes FAA compliance and enforcement procedures for licensed and permitted launch and reentry activities. The regulation grants federal officers access to observe launch/reentry sites and related facilities, authorizes the FAA to modify, suspend, or revoke licenses and permits for non-compliance or safety concerns, and permits the Associate Administrator to immediately terminate operations when they pose risks to public health, safety, property, or national security.
Safety Element Approvals
14 CFR Part 414 establishes FAA procedures for obtaining, renewing, and transferring safety element approvals. These approvals certify that specific launch/reentry vehicles, components, safety systems, processes, or qualified personnel will not jeopardize public health, safety, or property when used within defined parameters. Eligibility includes vehicle designers/manufacturers/operators, safety system developers, and personnel performing safety-critical functions. Applicants must consult with the FAA before submission and may apply separately or concurrently with vehicle operator license applications.
Investigations, Enforcement, and Administrative Review
14 CFR Part 406 establishes FAA procedures for investigations, enforcement, and administrative review of commercial space launch licenses, permits, and payload actions. It specifies hearing rights for applicants, licensees, and permittees; sets civil penalty liability at up to $299,772 per violation; and outlines the process for notice, response, and administrative law judge review leading to final Associate Administrator decision.
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.
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.
Section 804 Importation Program
Section 804 Importation Program establishes FDA procedures for time-limited programs permitting importation of eligible prescription drugs from Canada. The rule defines eligible drugs as FDA-approved medications available in the U.S. that also meet Canadian regulatory requirements, excluding controlled substances, biologics, and certain high-risk formulations like injectables and inhaled drugs. Importers must follow specified compliance, labeling, and adverse event reporting requirements.
Renewable Energy Production Incentives
10 CFR Part 451 establishes Department of Energy incentive payment procedures for qualified renewable energy facilities owned by states, political subdivisions, not-for-profit cooperatives, public utilities, Indian tribes, or Native corporations. Eligible renewable sources include solar, wind, ocean, geothermal, and biomass energy. Payments are based on net electric energy generated and sold, with facility eligibility determined by date of first use and permit receipt.
Standby Mandatory International Oil Allocation
This regulation implements U.S. obligations under the International Energy Program (IEP) to enable mandatory international oil allocation during energy supply emergencies. It applies to firms engaged in producing, transporting, refining, distributing or storing oil under U.S. jurisdiction. The rule remains on standby status and activates only when the President determines allocation is necessary to fulfill IEP obligations and notifies Congress; it reverts to standby within 60 days of emergency deactivation.
Administrative Procedures and Sanctions
10 CFR Part 501 establishes administrative procedures for Department of Energy proceedings under parts 500-508, including provisions for prepetition conferences, petition filing and acceptance, and service of documents. Powerplant owners and operators may request conferences to discuss exemption petitions under fuel use regulations (parts 503-504), with OFE required to notify petitioners of acceptance or rejection within 30 days and allowing amendment of rejected petitions within 90 days.
Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended
10 CFR Part 170 establishes fees charged by the Nuclear Regulatory Commission for licensing services, inspection services, and special projects under the Atomic Energy Act of 1954. The regulation applies to applicants and holders of various nuclear licenses and approvals, including byproduct material licenses, source material licenses, special nuclear material licenses, power reactor operating licenses, spent fuel storage facilities, and import/export licenses, as well as fees for reactor operator examinations, inspections, and preapplication reviews.
Administrative Procedures with Respect to the Import and Export of Natural Gas
Establishes administrative procedures and rules for obtaining Department of Energy authorizations to import or export natural gas under the Natural Gas Act. Defines key terms including "natural gas," "contested proceedings," "interested persons," and procedural roles for decisional employees and the Assistant Secretary for Fossil Energy. Implements delegated authority from the DOE Act to regulate natural gas trade.
International Voluntary Agreements
This regulation establishes standards and procedures for persons in the petroleum industry (producers, transporters, refiners, distributors, and storage operators) to develop voluntary agreements implementing the International Energy Program's information and allocation provisions during international energy supply emergencies, with meetings chaired by DOE and antitrust exemptions provided under the Energy Policy and Conservation Act.
Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274
This regulation defines exemptions and regulatory authority under Section 274 of the Atomic Energy Act for Agreement States and offshore waters. It establishes the scope of NRC oversight for byproduct material, source material, and special nuclear material in quantities insufficient to form critical mass, and clarifies that Agreement States have limited authority while the NRC retains jurisdiction over specified activities.
Existing Powerplants
10 CFR Part 504 establishes regulations for prohibitions on the use of petroleum and natural gas as primary energy sources in existing powerplants. The Office of Fossil Fuels may issue prohibition orders based on owner/operator certifications demonstrating technical capability and financial feasibility to convert to coal or alternate fuels, subject to compliance schedules and permitting requirements.
Ophthalmic Devices
21 CFR Part 886 establishes the FDA regulatory framework for ophthalmic devices intended for human use in commercial distribution. The regulation sets forth device classifications, premarket notification requirements under part 807, and premarket approval (PMA) procedures for class III devices. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA approval before commercial distribution, with specific grace periods and effective dates specified for different device categories introduced before or after May 28, 1976.
Hematology and Pathology Devices
21 CFR Part 864 establishes the regulatory framework for hematology and pathology devices intended for human use in commercial distribution. It outlines classification requirements, premarket approval timelines for Class III devices, and exemptions from premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act. Manufacturers must demonstrate substantial equivalence to existing devices and comply with applicable FDA guidance.
Quotas
This regulation establishes procedures for DEA quotas on Schedule I and II controlled substances. It defines three quota types—aggregate production, individual manufacturing, and procurement—and five subcategories covering commercial sale, transfers, product development, and replacement of disposed material. Quotas limit the total and per-manufacturer quantities of controlled substance APIs that may be produced or procured annually for pharmaceutical manufacturing.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
Cardiovascular Devices
21 CFR Part 870 establishes FDA classification and regulatory requirements for cardiovascular devices intended for human use. The regulation outlines premarket approval (PMA) requirements for Class III devices, substantially equivalent device determinations under 510(k) submissions, and effective dates for compliance. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA premarket approval before commercial distribution, with grace periods specified for devices classified before May 28, 1976.
Orthopedic Devices
21 CFR Part 888 establishes FDA classification and regulatory requirements for orthopedic devices intended for human use in commercial distribution. Devices classified as Class III require premarket approval (PMA) or completed product development protocol (PDP) before marketing, with specific effective dates and grace periods outlined. Manufacturers must demonstrate substantial equivalence to existing devices via premarket notification submissions.
Radiology Devices
21 CFR Part 892 establishes the regulatory framework for radiology devices intended for human use in commercial distribution. The regulation sets out device classification requirements, premarket approval procedures, and exemption limitations. Manufacturers must demonstrate substantial equivalence to existing devices and comply with FDA approval requirements based on device class, with specific grace periods and effective dates governing commercial distribution of new or substantially altered radiology devices.
Anesthesiology Devices
21 CFR Part 868 establishes the FDA classification framework for anesthesiology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements for Class III devices, defines substantial equivalence standards for premarket notification submissions, and specifies effective dates for FDA approval orders. Manufacturers must demonstrate substantial equivalence to existing devices or obtain premarket approval (PMA) or product development protocol (PDP) clearance before commercial distribution.
Importation and Exportation of List I and List II Chemicals
21 CFR Part 1313 establishes procedures for importing, exporting, transshipping and in-transit shipment of List I and List II chemicals under the Chemical Diversion and Trafficking Act. Importers and exporters must notify the DEA at least 15 days before importing chemicals meeting threshold quantities, file declarations on DEA Form 486/486A, establish documented business relationships with customers, and maintain required records including supplier information and transaction frequency.
Immunology and Microbiology Devices
21 CFR Part 866 establishes the regulatory classification framework for immunology and microbiology devices intended for human use in commercial distribution. The regulation defines scope, premarket approval requirements, and effective dates for Class III devices, requiring FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976.
Importation and Exportation of Controlled Substances
21 CFR Part 1312 establishes procedures for importation, exportation, and transshipment of controlled substances. Importers must obtain DEA authorization through registration and permits (for Schedules I-II and certain Schedule III-V substances) or import declarations (for other Schedule III-V substances). Each shipment requires separate authorization, and applicants must submit detailed information including drug names, dosage forms, NDC numbers, and quantities on DEA Form 357 through the DEA Diversion Control Division secure network.
Neurological Devices
21 CFR Part 882 establishes the FDA regulatory framework for neurological devices intended for human use in commercial distribution. The regulation sets forth device classification requirements and premarket approval procedures, specifying that class III neurological devices require FDA premarket approval (PMA) or completed product development protocol (PDP) before commercial distribution, with grace periods for devices marketed before May 28, 1976, but not for new devices introduced after that date.
Ear, Nose, and Throat Devices
21 CFR Part 874 establishes FDA classification and regulatory requirements for ear, nose, and throat (ENT) medical devices intended for human use in commercial distribution. The regulation outlines premarket approval procedures, including requirements for Class III devices to obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercialization, with specified grace periods for devices marketed before May 28, 1976, and mandatory immediate approval for new or substantially altered devices.
Physical Medicine Devices
21 CFR Part 890 establishes the FDA classification framework for physical medicine devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including class III device approval timelines and substantial equivalence determinations. Manufacturers must demonstrate why their devices are substantially equivalent to existing devices and comply with applicable premarket notification procedures under 21 CFR Part 807.
General
21 CFR Part 1105 establishes FDA's premarket submission requirements for tobacco products. The regulation specifies grounds for refusing to accept applications, including submissions that lack required contact information, English translation, proper FDA forms, product identification details, environmental assessments, or a U.S. agent signature for foreign applicants. Accepted submissions receive a tracking number and processing acknowledgement.
Premarket Tobacco Product Applications
21 CFR Part 1114 establishes procedures and requirements for submitting premarket tobacco product applications (PMTAs) to the FDA, including evaluation procedures and postmarket reporting obligations. The regulation defines key terms such as tobacco product accessories, additives, adverse experiences, brand characteristics, and composition, and specifies the scope of applicability, excluding premium cigars and modified risk tobacco product applications unless they seek dual marketing orders.
General Hospital and Personal Use Devices
21 CFR Part 880 establishes the regulatory classification and premarket approval requirements for general hospital and personal use devices intended for human use in commercial distribution. The regulation defines the scope of device classification, requires manufacturers to demonstrate substantial equivalence, and specifies that Class III devices require FDA premarket approval before commercial distribution, with grace periods for devices marketed before May 28, 1976.
Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
21 CFR Part 1301 establishes registration procedures for manufacturers, distributors, dispensers, importers, and exporters of controlled substances under the Controlled Substances Act. Every person engaged in these activities must obtain DEA registration unless exempt. Online pharmacies must obtain a modified registration to dispense controlled substances via the Internet. Separate registrations are required for each principal place of business where such activities occur.
General and Plastic Surgery Devices
21 CFR Part 878 establishes the FDA classification framework for general and plastic surgery devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, particularly for Class III devices, which must obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution unless exempt or reclassified. Manufacturers must demonstrate substantial equivalence and comply with applicable regulatory submission procedures.
Medical Device Classification Procedures
21 CFR Part 860 establishes the procedures and criteria for classifying and reclassifying medical devices intended for human use into one of three regulatory control classes (I, II, or III) based on safety and effectiveness. The regulation defines classification criteria, describes the roles of advisory committees and the FDA Commissioner, and prescribes the data required to support device classification determinations. It also governs public participation and information disclosure in classification proceedings.
Gastroenterology-Urology Devices
21 CFR Part 876 establishes the classification and regulatory framework for gastroenterology-urology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including that Class III devices require FDA approval via premarket approval application (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976, and mandatory approval for new devices introduced after that date.
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR Part 807 establishes registration and device listing requirements for manufacturers and initial importers of medical devices. The regulation defines key terms including commercial distribution, establishment, manufacture, official correspondent, and initial importer. It outlines exemptions from commercial distribution requirements, including internal transfers within affiliated companies, investigational use devices, and certain pre-1976 Class III devices. Device manufacturers and importers must register establishments annually and maintain current officer/director information with the FDA.
Premarket Approval of Medical Devices
21 CFR Part 814 establishes the premarket approval (PMA) process for Class III medical devices intended for human use. The regulation defines procedures for FDA review to ensure devices are safe and effective before market introduction, applies to devices not on the market before May 1976 or those required by regulation to obtain PMA approval, and sets conditions for approval and supplemental applications.
Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
This regulation establishes registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under DEA jurisdiction. Registration is mandatory for entities handling ephedrine, pseudoephedrine, phenylpropanolamine, and other designated List I chemicals. Annual fees apply: $3,699 for manufacturers and $1,850 for distributors, importers, and exporters. Registration must be submitted online via the DEA's secure portal with payment by ACH transfer or credit card. Separate registrations are required for independent activities (manufacturing, distributing, importing, exporting).
Oil and Gas Production Safety Systems on the OCS
Production safety system requirements for offshore facilities including SCSSV, surface safety valves, and emergency shut-down systems.
Exclusions from definition of hazardous waste (RCRA Subpart A)
Defines materials excluded from RCRA Subtitle C hazardous waste regulation, including domestic sewage, certain spent caustics, and recycled materials.
Waste Prevention, Production Subject to Royalties, and Resource Conservation
Updates rules on flaring, venting, and royalty-bearing methane losses from onshore federal and tribal oil & gas leases.