Browse regulations

This regulation implements Section 504 of the Rehabilitation Act to prohibit discrimination against individuals with disabilities in federal agency programs and activities, establishing definitions, accessibility requirements, auxiliary aids, employment protections, and complaint procedures.

Americans would be worse off if this regulation was deleted because it ensures equal access to federal programs for millions of people with disabilities, providing legal protections that enable participation in education, employment, and public services that would otherwise be inaccessible. The regulation creates enforceable standards that private markets and voluntary compliance alone have historically failed to provide.

Establishes privacy protection policies for the African Development Foundation, governing record maintenance, access, disclosure, and amendment procedures under the Privacy Act of 1974, including safeguards against unauthorized disclosure and mechanisms for individual access and correction.

Americans would be worse off without federal privacy protections for government-held personal information. These safeguards prevent unauthorized disclosure, ensure accuracy of records affecting individuals, and provide legal recourse for violations, which would be difficult to replicate through market mechanisms or state-level protections.

Federal regulation implementing Section 504 of the Rehabilitation Act, prohibiting disability discrimination in federal programs and requiring accessibility accommodations, auxiliary aids, and complaint procedures.

Americans would be worse off without these protections - federal programs would revert to excluding individuals with disabilities, denying them equal access to government services, employment opportunities, and public accommodations that are essential for participation in civic life.

Governmentwide system for debarment and suspension from federal nonprocurement programs, implementing Executive Order 12549 to exclude persons convicted of fraud, criminal offenses, or other serious misconduct from federal contracts, grants, and benefits.

Creates a massive administrative bureaucracy that imposes compliance costs on all businesses, disproportionately harms small firms, and represents federal overreach into areas better handled by market forces and civil courts. The system's complexity and governmentwide scope create unnecessary barriers to entry and competition.

This regulation establishes procedures for USAID employees and former employees when served with subpoenas or other legal demands for agency-related information. It requires immediate notification to the General Counsel, who determines whether and how to respond based on factors including privilege, classified information, trade secrets, foreign policy interests, and ongoing investigations. The rule provides a centralized approval process and instructs employees to respectfully decline demands if the court does not stay them pending review.

It protects sensitive national security, foreign policy, and proprietary information from inappropriate disclosure while ensuring coordinated legal responses. Deleting it would risk unauthorized releases of classified data, trade secrets, and information that could harm ongoing investigations or foreign assistance programs. The minimal procedural burden on employees is outweighed by these critical protections, which serve legitimate government interests without imposing costs on the public or private enterprise.

This regulation establishes standard terms and conditions for housing guaranty agreements between the U.S. Agency for International Development (A.I.D.) and international lenders, providing federal guarantees for loans to foreign borrowers in exchange for compensation when defaults occur.

This regulation represents federal overreach into international finance and development assistance, distorting market mechanisms and creating moral hazard by using taxpayer funds to guarantee foreign loans. The federal government has no constitutional authority to guarantee international development loans, and these guarantees create perverse incentives for both lenders and borrowers while exposing American taxpayers to unnecessary financial risk.

Regulates disposition of personal property by U.S. diplomatic and consular personnel and their families overseas, requiring pre-approval for sales and prohibiting retention of profits from sales to non-exempt persons, aiming to prevent abuse of diplomatic import/tax exemptions.

Imposes prior restraint and profit confiscation on a small group for a privilege that could be policed through simpler means, creating bureaucratic overhead and infringing economic liberty without clear necessity given host country laws and existing disciplinary mechanisms.

Regulation designates the Office of Children's Issues as U.S. Central Authority under the Hague Convention on International Child Abduction, outlining its duties to locate and return abducted children, coordinate with foreign and state authorities, process applications fee-free, and maintain case records.

Deletion would leave U.S. parents with no official channel to recover internationally abducted children, violating treaty obligations and harming families. The centralized authority achieves this outcome efficiently—a mechanism difficult to replicate through states or private actors, with minimal administrative costs relative to the humanitarian benefits.

Establishes eligibility criteria and benefit calculations for former spouses of Foreign Service employees under FSRDS and FSPS. Defines key terms, grants a share of the principal's annuity (50% or pro rata), provides survivor benefits (55%), includes COLA adjustments, and sets application procedures.

Deleting this rule would eliminate the predictable, uniform framework for distributing already-authorized retirement benefits to former spouses, leading to arbitrary agency decisions, increased litigation, and potential injustice. It ensures consistent entitlement administration that would be costly and inefficient to replicate case by case.

This regulation establishes classification rules for radiology devices intended for human use, defining categories of devices and their regulatory requirements including premarket approval, exemptions, and special controls based on risk levels and intended use.

Americans would be worse off if this regulation was deleted because it ensures medical imaging devices are properly classified by risk level, provides clear pathways for market entry, and maintains safety standards that prevent dangerous or ineffective radiological equipment from harming patients through radiation exposure or misdiagnosis.

The regulation classifies general and plastic surgery devices (e.g., prostheses, mesh, tissue adhesives) into Class I (general controls), Class II (special controls), or Class III (premarket approval) and specifies associated regulatory pathways, exemptions, and requirements for substantial equivalence and transitional devices.

The regulation imposes burdensome compliance costs, creates regulatory barriers that protect incumbents and stifle innovation, and exceeds constitutional authority under the Tenth Amendment. Unseen consequences include delayed access to medical devices, reduced competition, higher healthcare prices, and bureaucratic capture. Market-driven safety via liability, reputation, and private certification can achieve desired outcomes more efficiently.

FDA regulations for in vitro diagnostic products including Antibody to Hepatitis B Surface Antigen and Blood Grouping Reagents. Establishes manufacturing standards, potency requirements (specific titer values), labeling specifications, sample submission protocols, and mandatory FDA review and release procedures before commercial distribution.

These are high-stakes medical diagnostic products where failure can cause death (transfusion reactions) or severe health harm (missed hepatitis B diagnosis). The extreme information asymmetry between manufacturers and end-users (hospitals, labs) creates a classic market failure. End-users cannot credibly assess product quality before use, and the consequences of error are catastrophic. While compliance costs are substantial, they are justified to prevent loss of life and preventable disease transmission. Private alternatives like tort law and professional accreditation are insufficient post-hoc mechanisms for products that must be consistently reliable at the point of manufacture.

This FDA regulation (21 CFR Part 349) establishes monographs for over-the-counter ophthalmic drug products, defining permissible active ingredients, concentrations, labeling requirements, warnings, and directions for various categories including astringents, demulcents, emollients, hypertonicity agents, vasoconstrictors, and eyewashes.

This regulation represents federal overreach into low-risk consumer products that could be safely regulated by states or markets. The monograph system creates barriers to entry, stifles innovation, and inflates costs through rigid pre-approval requirements. Small businesses face disproportionate compliance burdens while established manufacturers benefit from regulatory capture. Eye products pose minimal risk when properly manufactured; existing tort law, state consumer protection, and private certifications (e.g., USP) can ensure safety without a centralized federal monopoly on formulations. The unseen costs—reduced competition, higher prices, delayed access to improved formulations—outweigh any marginal safety benefits.

This regulation establishes safety and labeling requirements for over-the-counter stimulant drug products containing caffeine. It defines stimulants as drugs that restore mental alertness during fatigue, sets dosage limits of 100-200mg every 3-4 hours for adults and children over 12, and mandates specific labeling including indications, warnings about caffeine content and side effects, age restrictions, and usage directions.

Americans would be worse off if this regulation was deleted because it provides essential consumer protection for widely used stimulant products. The regulation ensures accurate labeling about caffeine content, prevents dangerous overconsumption through dosage limits, warns about side effects like nervousness and rapid heartbeat, restricts use by children, and clarifies that stimulants are not substitutes for sleep. Without these protections, consumers would lack critical information about what they're ingesting and face increased health risks from improper use of these common products.

FDA procedures for implementing patent term restoration under 35 U.S.C. 156, compensating drug/device innovators for time lost during regulatory review by extending patent terms up to 5 years. Sets detailed rules for calculating review periods, eligibility verification, and due diligence challenges via petition and hearing processes.

Extends government-granted monopolies on lifesaving products, directly raising consumer prices and delaying generic competition. Creates a perverse subsidy that reduces pressure to streamline FDA's own regulatory bottlenecks rather than eliminating costly approval delays. The unseen cost: fewer affordable treatment options for patients, especially the poor.