عرض 301–350 من أصل 648 لائحة
Information Security Program
14 CFR Part 1203 establishes NASA's Information Security Program governing the classification, protection, and safeguarding of national security information and classified material. The regulation derives authority from Executive Orders 13526 and 10865, and the National Aeronautics and Space Act, requiring NASA to protect classified information in contracts and releases to industry while enabling public access to unclassified information and Congressional oversight.
Privacy Act—NASA Regulations
NASA regulation implementing the Privacy Act of 1974, establishing procedures for individuals to access their records held by NASA, request amendments, and file administrative appeals. Applies to all NASA Headquarters, Field Centers, and Component Installations. Defines key terms including individual, record, system of records, and routine use, and outlines processes for requesting access to Privacy Act records either in person, in writing, or electronically.
Duty-Free Entry of Space Articles
14 CFR Part 1217 establishes NASA's procedures for certifying duty-free entry of space articles into the United States. This includes articles to be launched into space, spare parts, ground support equipment, and uniquely associated equipment for NASA's own use or for implementing NASA international programs and launch service agreements. Articles brought back from space or foreign countries as part of NASA programs are not subject to import duties or customs entry requirements.
Procedures for Disclosure of Records Under the Freedom of Information Act (FOIA)
NASA establishes procedures for disclosing Agency records under the Freedom of Information Act (FOIA). The regulation requires NASA to make available all Agency records under its jurisdiction to the public upon request to the fullest extent practicable, and specifies which records must be published in the Federal Register, including descriptions of NASA offices, procedural rules, substantive regulations, and final opinions or orders from case adjudications.
Equal Access to Justice Act in Agency Proceedings
This NASA regulation (14 CFR Part 1262) implements the Equal Access to Justice Act, establishing procedures for awarding attorney fees and other expenses to eligible parties who prevail in adversary adjudications before NASA. Eligible parties may receive awards unless NASA's position was substantially justified, the party unreasonably protracted proceedings, or special circumstances make an award unjust. The rule defines covered proceedings, eligible parties, and the standards and procedures NASA will apply when determining awards.
Tracking and Data Relay Satellite System (TDRSS)
14 CFR Part 1215 establishes NASA's policy for providing Tracking and Data Relay Satellite System (TDRSS) services to non-U.S. Government users. The regulation defines user eligibility, service offerings (tracking, data acquisition, command transmission), required support activities, and reimbursement requirements compliant with OMB Circular A-25. Services are provided to low-Earth orbit spacecraft and terrestrial users, with data delivery at specified ground stations (WSC or GRGT). Users cannot transfer or assign TDRSS services to third parties and must contract directly with NASA's Associate Administrator for Space Operations.
Standards of Conduct
14 CFR Part 1207 establishes standards of conduct for NASA employees, requiring compliance with executive branch-wide ethical conduct standards. It prohibits employees from participating in matters where they have a financial interest that could directly affect that interest, and establishes procedures for requesting and granting waivers of this prohibition through designated NASA officials based on employee position and location.
New Restrictions on Lobbying
14 CFR Part 1271 restricts the use of appropriated federal funds by recipients of contracts, grants, loans, and cooperative agreements to pay for lobbying activities directed at federal officials or members of Congress. Recipients must certify compliance and disclose any payments made with non-appropriated funds that would otherwise be prohibited. The rule applies to federal loan insurance and guarantee commitments.
Inventions and Contributions
This regulation establishes NASA's procedure for awarding monetary recognition to individuals and entities for scientific and technical contributions with significant value to aeronautical and space activities. Eligible contributions include innovations, inventions, and software meeting commercial quality standards. Awards are determined by the Inventions and Contributions Board based on contribution value, development costs, prior compensation, and other material factors.
Human Space Flight Requirements
14 CFR Part 460 establishes crew qualification and training requirements for human spaceflight operations under FAA licensing and permitting. Crew members must complete training on their assigned roles in nominal and emergency conditions, demonstrate ability to withstand space flight stresses, and maintain current medical certificates. Pilots and remote operators must hold FAA pilot certificates with instrument ratings and receive vehicle-specific training through simulation, comparable aircraft, flight testing, or equivalent methods approved by the FAA. Operators must maintain training records, document lessons learned, and ensure recurrent training schedules keep all crew qualifications current before launch and reentry.
Statement of Organization and General Information
This regulation establishes NASA's organizational structure and authority under the National Aeronautics and Space Act. It defines NASA's purpose to conduct aeronautical and space research, develop and operate space vehicles and systems, and explore space using manned and unmanned vehicles. The regulation outlines NASA's governance structure including the Administrator and Deputy Administrator, headquarters in Washington DC, nine field centers, the Jet Propulsion Laboratory, and establishes permanent boards including the Contract Adjustment Board and Inventions and Contributions Board.
Experimental Permits
14 CFR Part 437 establishes requirements for obtaining and maintaining experimental permits to launch or reenter reusable suborbital vehicles. Permits authorize research and development, compliance demonstrations, or crew training activities and remain valid for one year with renewal options. The FAA may modify permit terms to ensure safety compliance, and permits include pre- and post-flight ground operations at U.S. launch sites.
Nondiscrimination on the Basis of Age in Programs or Activities Receiving Federal Financial Assistance
NASA regulations implementing the Age Discrimination Act of 1975, establishing policies and procedures to prohibit discrimination on the basis of age in programs or activities receiving federal financial assistance from NASA. The regulations define key terms, specify applicability to NASA recipients and their federally-assisted programs, and outline exemptions for certain age distinctions in federal, state, or local statutes and employment practices.
Release of Information to News and Information Media
14 CFR Part 1213 establishes NASA's policy for releasing public information to news and media outlets. The regulation requires timely, accurate, and equitable dissemination of information about NASA activities and results while maintaining a culture of openness. It applies to NASA Headquarters, Centers, and Component Facilities, excluding the Office of Inspector General. The policy does not authorize disclosure of classified, procurement-sensitive, privacy-protected, or otherwise legally restricted information.
Organization and Definitions
14 CFR Part 401 establishes the organizational structure and definitions governing commercial space transportation regulation in the United States. The Office of Commercial Space Transportation, located within the Federal Aviation Administration, is headed by an Associate Administrator responsible for licensing, permitting, and regulating commercial space launch and reentry activities. The regulation provides standard definitions for key terms used throughout commercial space transportation regulations, including crew, payload, flight safety systems, abort procedures, and casualty areas, establishing the foundational terminology for FAA oversight of the commercial space industry.
Space Flight
14 CFR Part 1214 establishes policy and procedures governing International Space Station crewmembers provided by NASA, including U.S. employees, military personnel, U.S. citizens, and foreign nationals. The regulation sets forth standards of conduct and Code of Conduct requirements for all NASA-provided ISS crew, mandated by the 1998 intergovernmental agreement governing civil ISS cooperation among Canada, ESA member states, Japan, Russia, and the United States.
Protection of Human Subjects
This regulation establishes the applicability of federal human subjects protection policy to research conducted, supported, or regulated by federal departments and agencies. It requires compliance with institutional review board standards and the Belmont Report principles, applies to domestic and international research, and allows department heads to approve alternative procedures in foreign countries or grant waivers when consistent with ethical standards.
The NASA Seal and Other Devices, and the Congressional Space Medal of Honor
This regulation establishes policies governing the use of NASA's official seals, insignia, logotypes, program identifiers, and flags. It prohibits unauthorized use of these devices and requires compliance with NASA's Graphics Standards Manual and visual communications guidelines. Misuse is subject to statutory penalties and must be reported.
Financial Responsibility
14 CFR Part 440 establishes financial responsibility and risk allocation requirements for entities conducting FAA-licensed or permitted launch and reentry activities. It defines key terms including bodily injury, liability, maximum probable loss (with distinct thresholds for third parties and government personnel), and various participant categories (licensees, customers, contractors). The regulation ensures that launch and reentry operators maintain adequate financial capability to satisfy liability obligations arising from their operations.
Security Programs; Arrest Authority and Use of Force by NASA Security Force Personnel
This regulation establishes guidelines for NASA and NASA contractor security force personnel authorized to exercise arrest authority and use physical force, including deadly force. Personnel must complete accredited training and receive written certification before exercising arrest authority on NASA facilities. The regulation defines conditions for warrantless arrests, protocols for announcing authority, searching arrestees, and transferring custody to appropriate law enforcement, with restrictions on the use of non-deadly physical force limited to what is reasonable and necessary.
Care and Use of Animals in the Conduct of NASA Activities
NASA regulation 14 CFR Part 1232 establishes policies for the care and use of vertebrate animals in NASA activities, including those conducted at NASA facilities, spacecraft, and through contracts with external entities. The regulation requires compliance with the Animal Welfare Act of 1966 and implements minimum standards of care and treatment for animals used in NASA research, testing, teaching, and hardware development.
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.
Cross-Waiver of Liability
14 CFR Part 1266 establishes cross-waiver of liability requirements for NASA agreements involving International Space Station (ISS) activities and NASA science or space exploration launches. The regulation implements Article 16 of the intergovernmental ISS agreement, requiring NASA to include reciprocal liability waivers in contracts with related entities (contractors, subcontractors, users, customers) to encourage participation in outer space exploration and use through the ISS.
Implementation of the Program Fraud Civil Penalties Act of 1986
This NASA regulation implements the Program Fraud Civil Remedies Act of 1986, establishing administrative procedures for imposing civil penalties and assessments against persons who submit false, fictitious, or fraudulent claims or written statements to NASA. It defines key terms, specifies the roles of Administrative Law Judges and reviewing officials, and outlines hearing and appeal rights for defendants.
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.
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.
Administrative Authority and Policy
14 CFR Part 1204 establishes NASA's administrative authority and small business policy, enabling equitable participation by small businesses, minority-owned enterprises, and educational institutions in NASA procurement and contracts. The regulation delegates responsibilities to the Office of Small Business Programs and NASA Centers to coordinate small business acquisitions, establish specialist roles, and maintain liaison with the Small Business Administration.
Protection of Privacy
21 CFR Part 21 implements the Privacy Act of 1974 by establishing procedures for the FDA to manage, protect, and control access to records about individuals maintained in Privacy Act Record Systems. The regulation defines scope, exemptions, and key terms; limits disclosure to the individuals who are subjects of records, their legal representatives, or those with consent; and excludes certain records such as those anticipated for litigation and personnel records managed by the Division of Human Resources Management.
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.
Civil Money Penalties Hearings
21 CFR Part 17 establishes procedures for FDA administrative hearings on civil money penalties for violations of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Penalties apply to violations involving prescription drug marketing, medical devices, pesticide residues, clinical trials, direct-to-consumer drug advertising, biologics, electronic products, mammography standards, vaccine record falsification, and tobacco products.
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.
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR Part 111 establishes Current Good Manufacturing Practice (CGMP) requirements for dietary supplement manufacturers, packagers, labelers, and distributors in the US. The regulation applies to all entities manufacturing or importing dietary supplements, with exemptions for retail-only storage. Key definitions include batch/lot identification, component specifications, in-process materials, and microorganism standards to ensure product identity, purity, strength, and composition.
Institutional Review Boards
21 CFR Part 56 establishes standards for Institutional Review Boards (IRBs) that oversee clinical investigations of FDA-regulated products including drugs, medical devices, biological products, foods, dietary supplements, and electronic products. The regulation defines the composition, operation, and responsibilities of IRBs to protect the rights and welfare of human research subjects.
Common or Usual Name for Nonstandardized Foods
This FDA regulation establishes requirements for the common or usual names of nonstandardized foods. Names must accurately describe the basic nature and characterizing properties of foods in simple, direct terms and be uniform across identical products. When characterizing ingredients materially affect price or consumer perception, their percentage must be declared on the principal display panel in specified font sizes and format. Presence or absence of key ingredients must also be disclosed when it could mislead consumers about the product's composition.
General Enforcement Regulations
General enforcement regulations under the Federal Food, Drug, and Cosmetic Act establishing that FDA regulations apply to causing prohibited acts, defining key terms like labeling and label, and clarifying the agency's statutory authorities for food, drug, and cosmetic regulation including provisions on package labeling and net quantity declarations.
Acidified Foods
21 CFR Part 114 establishes current good manufacturing practice requirements for acidified foods—low-acid foods to which acids are added to achieve a finished pH of 4.6 or below. Processors must employ quality control procedures and employ supervisory personnel trained in food handling, pH controls, and acidification. The regulation defines key terms including acidified foods, scheduled processes, and water activity, and exempts certain products like carbonated beverages, jams, and refrigerated foods from coverage.
General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
21 CFR Part 81 establishes general specifications and restrictions for provisional color additives used in foods, drugs, and cosmetics under the Color Additive Amendments of 1960. The regulation lists provisionally approved color additives, requires progress reports, and prohibits their use in eye-area products. It also documents termination of provisional listings for specific colors due to safety concerns, including Ext. D&C Yellow Nos. 9 and 10 (due to β-naphthylamine contamination) and FD&C Red No. 1 (due to demonstrated toxicity in animal feeding studies).
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.
Protection of Human Subjects
21 CFR Part 50 establishes requirements for the protection of human subjects in clinical investigations regulated by the FDA. It applies to investigations involving drugs, biological products, medical devices, food additives, dietary supplements, and related products submitted for FDA approval. The regulation defines the scope of coverage, applicable regulatory sections, and key definitions for research and marketing permit applications across multiple FDA-regulated product categories.
Infant Formula
21 CFR Part 107 establishes labeling requirements, nutrient standards, and exemption criteria for infant formula under the Federal Food, Drug, and Cosmetic Act. Manufacturers must comply with nutrient content specifications, labeling formats declaring calories and specific nutrients (vitamins, minerals, biotin, choline, inositol), and special provisions for exempt formulas designed for infants with inborn errors of metabolism or low birth weight. Non-compliance renders formulas misbranded or adulterated.
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.
Electronic Records; Electronic Signatures
21 CFR Part 11 establishes FDA criteria for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records. The regulation applies to electronic records created, modified, maintained, or transmitted under FDA regulations and those submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Electronic signatures meeting these requirements are treated as equivalent to handwritten signatures unless specifically excepted. Electronic records may replace paper records unless paper is required, and computer systems must be subject to FDA inspection.
Environmental Impact Considerations
21 CFR Part 25 establishes FDA procedures for implementing the National Environmental Policy Act (NEPA), requiring environmental impact assessments for major Federal actions related to FDA-regulated products including drugs, biologics, and medical devices. The regulation defines key NEPA terms and establishes supplemental procedures consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.
Dietary Supplements That Present a Significant or Unreasonable Risk
This regulation designates dietary supplements containing ephedrine alkaloids as adulterated products under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under recommended or ordinary conditions of use.
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.
Color Additives
21 CFR Part 70 establishes federal regulations governing color additives used in foods, drugs, and cosmetics under the Federal Food, Drug, and Cosmetic Act. The regulation defines color additives as dyes, pigments, or synthetic substances capable of imparting color when added to food, drugs, cosmetics, or the human body, and clarifies exemptions for natural food ingredients and substances where color is incidental to primary function. The FDA's Color Certification Branch administers certification procedures for regulated color additives.
Regulation of Combination Products
21 CFR Part 4 establishes current good manufacturing practice (CGMP) requirements for combination products, which are products containing two or more constituent parts (drugs, devices, or biological products). The regulation clarifies how CGMP rules apply to both co-packaged and single-entity combination products, defines key terms, and outlines the regulatory framework for designing and implementing CGMP operating systems at manufacturing facilities.
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.
Food Labeling
21 CFR Part 101 establishes federal requirements for food labeling on packaged products. It defines the principal display panel as the most prominently displayed label surface and specifies its measurement for rectangular, cylindrical, and irregularly shaped containers. The information panel must appear immediately contiguous to the principal display panel and contain required disclosures in conspicuous, legible text of at least one-sixteenth inch height. These provisions ensure consumers can readily access mandatory nutritional and ingredient information at retail.