Browse regulations

This regulation establishes the classification framework for cardiovascular devices, determining which require premarket approval and which have exemptions. It defines class III devices requiring FDA approval, class II devices with special controls, and class I devices with exemptions, while providing procedures for substantial equivalence determination and grandfathering provisions for devices in commercial distribution before 1976.

This regulatory framework creates excessive barriers to medical innovation, increases healthcare costs through compliance burdens, and protects established manufacturers from competition. The FDA's premarket approval process delays life-saving devices from reaching patients, while the substantial equivalence standard prevents truly innovative designs from entering the market. Medical device safety is better achieved through market competition, professional liability, and voluntary certification rather than federal micromanagement.

FDA regulation establishing procedures for creating, amending, and revoking performance standards for medical devices to ensure safety and effectiveness through testing, certification, and labeling requirements.

Creates excessive regulatory burden on medical device innovation, increases costs for patients, and protects incumbent manufacturers from competition through complex compliance requirements that slow technological advancement in healthcare.

FDA regulation establishing procedures for clinical investigations of medical devices, including requirements for investigational device exemptions (IDEs), informed consent, IRB oversight, and data reporting to ensure patient safety while allowing scientific research on potentially beneficial devices.

This regulation protects patient safety in medical device research while enabling scientific advancement. Without it, there would be no standardized oversight of clinical trials, increasing risks of harm from untested devices and reducing public trust in medical research.

Federal regulations establishing informed consent requirements for clinical investigations involving human subjects, including provisions for waivers in emergency situations and specific military/national security contexts.

Americans would be worse off if this regulation was deleted because it protects vulnerable research subjects from exploitation and ensures ethical standards in medical research. The informed consent framework prevents coercion, provides transparency about risks, and maintains public trust in the clinical trial system that is essential for medical advancement.

Establishes detailed medical standards for adjudicating black lung disability claims, including specific protocols for X-rays, pulmonary function tests, blood-gas studies, biopsies, and physical examinations; requires adherence to external standards incorporated by reference; defines pneumoconiosis broadly; sets presumptions based on employment duration.

Massive compliance costs for medical providers, bureaucratic overhead, moral hazard via automatic presumptions after 10 years employment, federal overreach into state workers' compensation domain, and distortion of medical practice to regulatory compliance rather than patient care. The unseen costs include reduced provider participation, higher healthcare prices, and inefficiency that burden taxpayers and miners.

Establishes eligibility requirements for Social Security benefits including insured status, quarters of coverage, and disability determination procedures.

This regulation creates a massive bureaucratic entitlement system that forces Americans to participate in a government-run retirement and disability program, violating principles of individual liberty and free choice. The administrative costs and compliance burden far exceed any benefits, while creating dependency on government and crowding out private retirement planning alternatives.

Regulation sets procedures for the Federal Reserve Board to comply with court orders garnishing employee wages for child support and alimony, defining remuneration, specifying service requirements, limiting garnishment to 65% of pay, and providing liability protections.

Deletion would undermine enforcement of court-ordered child support and alimony from Federal Reserve employees, directly harming children and spouses who rely on these payments. The regulation provides clear, standardized processes that ensure timely compliance while safeguarding employee rights and government operations, avoiding ad hoc, inconsistent handling.

Regulation establishes a claims process for Railroad Retirement Board employees to seek compensation for damage or loss of personal property incident to their service, defining eligible property, filing requirements, and settlement authority.

Unnecessary government entitlement program that creates moral hazard, distorts employee incentives, and uses taxpayer funds for non-core functions better handled by private insurance markets.

Section 504 of the Rehabilitation Act implementing regulations requiring recipients of TVA financial assistance to provide equal access and non-discrimination for qualified handicapped persons in programs, employment, facilities, and services, with specific requirements for reasonable accommodation, accessibility, and complaint procedures.

These regulations impose substantial compliance costs on recipients through mandatory building alterations, reasonable accommodation requirements, and administrative burdens. The federal government lacks constitutional authority to mandate such detailed disability accommodation requirements on private entities receiving TVA assistance - this represents regulatory overreach beyond Commerce Clause powers. Small businesses face disproportionate compliance costs that create barriers to entry and protect established firms from competition.

Federal program providing financial assistance to states for comprehensive water management planning, requiring coordination between federal, state, and local entities to address water quantity, quality, groundwater, and instream values.

Federal overreach into state water management creates bureaucratic overhead, distorts local priorities, and imposes compliance costs on states that should manage their own water resources under the Tenth Amendment.

Establishes procedures for the U.S. Water Resources Council to implement Exec. Orders 11988 (Floodplain Management) and 11990 (Wetlands Protection) in its water resources planning assistance activities. Requires avoidance of floodplain/wetland impacts where practicable, minimization when unavoidable, public involvement, and integration with NEPA. Applies to Level A/B regional planning, not site-specific Level C planning.

Adds bureaucratic overhead and delays to federal water resources planning, centralizing authority that belongs to states under the Tenth Amendment. Increases compliance costs and may block beneficial projects by rigidly prioritizing avoidance over cost-benefit analysis. Unseen costs include higher infrastructure expenses, reduced flexibility, and slower responses to local needs; these outweigh marginal environmental gains achievable via property rights and state-level regulation.

This regulation establishes the Federal Energy Regulatory Commission's internal organization, emergency succession procedures, and continuity of operations plan. It defines the chain of command, delegates authority during emergencies affecting the National Capital Region, sets procedures for activating the Continuity of Operations Plan, and provides mechanisms for tolling deadlines and suspending certain requirements during crises.

Americans would be worse off if this was deleted: During emergencies (cyberattacks, natural disasters, etc.), FERC's continued oversight of critical energy infrastructure—dam safety, LNG facility incidents, grid reliability—requires clear, predetermined lines of authority. Without these procedural rules, regulatory gaps could threaten public safety, energy security, and timely responses to incidents at jurisdictional facilities. The minimal administrative burden this imposes is necessary to ensure the commission can continue essential functions when most needed.

This regulation establishes the administrative and procedural framework for the Federal Energy Regulatory Commission (FERC), including office locations, business hours, meeting procedures (open/closed meetings, quorum requirements, public announcements), official seal design, delegation of authority to staff officials, and filing requirements. It contains sunset provisions set to expire on December 5, 2026, unless extended after public input.

These are purely procedural, bureaucratic housekeeping rules that impose compliance costs on regulated entities through complex filing requirements, meeting notices, and authentication procedures while delivering no meaningful consumer or competitive benefit. The detailed specifications (seal design, office hours, physical filing locations) create unnecessary administrative burden that could be handled through internal agency guidance. The sunset provisions acknowledge these are temporary administrative matters, not substantive regulations necessary for energy market oversight. Americans would be better off with streamlined processes and FERC focusing on its core statutory mission rather than regulating its own administrative minutiae.

This regulation implements PURPA's requirement that electric utilities purchase power from 'qualifying facilities' - small power production or cogeneration facilities meeting size (≤80 MW), fuel (75%+ renewable/biomass/waste), and efficiency standards. It defines terms, establishes certification procedures (self-certification or FERC review), sets rules for site aggregation, waste definitions, and power classifications (supplementary, backup, interruptible, maintenance). The rule mandates utilities buy from certified facilities at 'avoided cost' rates.

This regulation imposes heavy compliance costs and market distortions. It mandates utilities to purchase from designated facilities at government-set 'avoided costs' rather than allowing voluntary negotiations, creating artificial barriers to entry. The complex certification process (self-certification, protests, FERC review) favors large incumbents and disadvantages small producers. The 'avoided cost' pricing mechanism invites manipulation and distorts investment signals. Definitions like 'waste' and site aggregation rules create regulatory arbitrage opportunities. The regulation violates federalism by federalizing energy policy that should be state/local. It epitomizes unintended consequences: higher electricity costs for consumers, misallocation of capital, reduced competition, and regulatory capture by special interests. If renewable/cogeneration technologies are economically viable, they will thrive without government mandates.

This FERC regulation requires public utilities to annually file lists of their largest non-resale electricity purchasers, and requires individuals holding executive positions at both utilities and certain related entities (financial firms, suppliers, underwriters) to file annual disclosure statements about these corporate interlocks. It defines 'control' broadly with a 10% ownership presumption and exempts certain utility types like RTOs and cooperatives.

The compliance burden exceeds any transparency benefits. The filing requirements impose significant annual administrative costs on utilities and individuals to disclose business relationships that are already visible through corporate records and securities filings. The regulation assumes interlocks are inherently problematic despite no evidence of harm, creating a chilling effect on board service. Market competition and existing antitrust laws already address anti-competitive coordination without this intrusive reporting regime. Rural electric cooperative exemptions further demonstrate regulatory arbitrariness. The unseen costs include diverted legal resources, privacy invasion, and deterrent effects on business relationships that could otherwise enhance efficiency.