What the regulation does mechanically: 1 C.F.R. Part 51 sets procedures and substantive criteria that agencies must follow to incorporate external publications into the Code of Federal Regulations by reference. It requires agencies to describe and summarize the material in the preamble of a proposed rule (§51.5(a)), to request formal approval for final...

Mechanically, 2 C.F.R. Part 200 ("Uniform Guidance") consolidates definitions, administrative rules, cost principles, and audit standards that govern Federal awards to non‑Federal entities. It: (a) supplies a single set of defined terms used across the rules (e.g., ‘‘MTDC,’’ ‘‘indirect costs,’’ ‘‘subrecipient,’’ etc.) (§200.0, §200.1); (b) states which...

This instrument establishes a standardized framework for federal agencies to suspend or debar individuals and entities from participating in "nonprocurement transactions" (such as grants, cooperative agreements, loans, subsidies, and insurance). Mechanically, it creates a reciprocal exclusion system with the federal procurement system under the Federal...

Mechanically, 5 C.F.R. Part 2635 sets binding executive branch employee ethics rules: it defines covered persons and offices; enumerates prohibited behaviors (gifts, misuse of nonpublic information, using office for private gain, conflicts from outside employment or financial interests, improper use of government property/time); prescribes...

What this regulation does, mechanically: It sets uniform procedures and substantive reporting rules for executive branch public and confidential financial disclosure, prescribes how qualified blind and diversified trusts are created, approved, administered, and reported, and establishes procedures for obtaining Certificates of Divestiture to defer...

What this regulation does mechanically: It prescribes how the Environmental Protection Agency (EPA) processes Freedom of Information Act (FOIA) requests, where and how requesters must file, timelines and tracks for responses, the fee structure and fee waivers, procedures for asserting and adjudicating confidentiality claims for business information, special...

Mechanics: This regulation establishes procedural rules for Department of the Interior adjudications handled by the Office of Hearings and Appeals (OHA) and its components. It identifies who decides (OHA Director, ALJs, presiding officers, IBLA), sets filing and service channels and deadlines, allocates certain litigation costs (reporter’s fees), limits...

Mechanically, this part establishes the FAA's legal framework for Airworthiness Directives (ADs): it defines ADs, states when the FAA may issue them, describes their legal effect and what actions they may require, sets rules for alternatives and approvals, and explains publication and special permit procedures. Specifically, the rule: (a) defines ADs as...

Mechanically, this USDA regulation (1) adopts the OMB guidance in subparts A–F of 2 CFR part 200 as the Department's uniform administrative, cost, and audit rules (§400.1); (2) supplies chapter level definitions for terms used in the chapter and directs that part specific definitions take precedence and that undefined terms default to 2 CFR part 200 or the...

Mechanically, 5 C.F.R. Part 550 codifies detailed pay administration rules for covered Federal employees: it defines who is covered and excluded, prescribes how overtime, premium pay, compensatory time, lump sum leave, severance, evacuation payments, firefighter pay, travel compensatory time, and certain special programs (Civilian Service flag benefit and...

Mechanically, 24 C.F.R. Part 5 defines terms and prescribes cross‑cutting program rules that HUD offices, PHAs, owners, grantees and covered housing providers must follow. It (a) establishes uniform definitions used HUD‑wide (e.g., ‘‘1937 Act,’’ ‘‘earned income,’’ ‘‘family,’’ ‘‘advanced telecommunications infrastructure,’’ ‘‘violent criminal activity’’)...

What this regulation does mechanically: It prescribes the procedural rules for appeals to the Departmental Grant Appeals Board (the Board) for disputes arising under HHS programs listed in appendix A, supplementing 2 CFR parts 200 and 300 (§16.1). It sets eligibility gates (the dispute must arise under an eligible program, the appellant must have received a...

Mechanics: These regulations set the rules the Small Business Administration (SBA) uses to decide whether an entity is legally “small” for SBA and other federal programs. They (1) tie size standards to NAICS codes and publish a table matching codes to size thresholds (§121.101); (2) define affiliation and list when to aggregate receipts, employees, or...

What this regulation does, mechanically: It requires owners or operators of establishments that manufacture, prepare, assemble, repackage, relabel, reprocess, or otherwise process medical devices (including many IVDs) for human use to register the establishment and list the devices with FDA, generally using FDA's electronic registration and listing system...

Mechanically, 45 C.F.R. Part 160 sets definitions, applicability, administrative procedures, enforcement tools, and penalty rules that implement the administrative‑simplification provisions of the Social Security Act and related statutes (claims the regulation at §160.101). It specifies which entities are covered (health plans, health care clearinghouses,...

What this regulation does mechanically: 21 C.F.R. Part 10 sets the procedural framework FDA uses to receive, docket, process, and decide petitions and other administrative matters; to conduct and limit hearings and ex parte communications; to promulgate regulations and guidance; to manage administrative records and internal review; and to govern media...

Mechanically, 36 C.F.R. Part 800 prescribes the procedural steps that Federal agencies and designated agency officials must follow to satisfy the procedural requirements of Section 106 of the National Historic Preservation Act: determine whether a proposed Federal action is an "undertaking" (§ 800.3), identify historic properties within the area of...

Mechanics: This regulation (Part 401) establishes the legal scope, general definitions, and cross‑cutting procedural rules that apply to effluent limitations guidelines, standards of performance for new sources, and pretreatment standards implemented in parts 402–699 of this subchapter. It requires that point sources comply with applicable regulations and...

This regulatory text (45 C.F.R. Part 46) sets the federal baseline rules for research involving human subjects whenever a Federal department or agency elects to make the policy applicable to the research it conducts, supports, or regulates (coverage mechanics: §46.101(a); §46.103(a)). It establishes (1) who must comply and when (institutions, IRBs, and...

What the rule does mechanically: 45 C.F.R. Part 80 conditions the approval, continuation, and use of any HHS authorized Federal financial assistance on nondiscrimination on the basis of race, color, or national origin (§80.1; §80.2; §80.3). Applicants and recipients must provide written assurances of compliance as a condition of receiving funds;...

Mechanically, 7 C.F.R. Part 11 creates and prescribes the USDA National Appeals Division (NAD) administrative appeals system: it defines covered agencies and parties (§11.1), requires participants to seek NAD review (and in many cases informal agency review or mediation first) before judicial review (§11.2(b), §11.5), sets filing deadlines and...

Mechanically, 21 C.F.R. Part 820 requires manufacturers of finished medical devices intended for human use to establish, document, and maintain a quality management system (QMS) that complies with ISO 13485 and other applicable provisions of this part (§ 820.10(a); § 820.7). The rule applies to finished devices manufactured in or imported into the United...

Mechanics: This part implements the HIPAA Privacy and Security rules for "covered entities" and, where specified, their "business associates." It prescribes (a) who is covered and when (§§164.102, 164.104); (b) organizational requirements for hybrid entities and affiliated covered entities and recordkeeping of those designations (§164.105); (c) baseline...

What this regulation does mechanically: 40 C.F.R. Part 403 establishes federal regulatory requirements for pretreatment of non domestic wastewater introduced into publicly owned treatment works (POTWs). It (a) prohibits discharges that cause “Pass Through” or “Interference” with POTW operation and lists specific forbidden discharges (e.g., flammables,...

What this regulation does, mechanically: This subpart of 21 C.F.R. Part 20 sets the FDA's internal procedures and rules for responding to public records requests and for handling requests for employee testimony (see §§ 20.1, 20.2, 20.23–20.41, 20.45–20.46). It (1) centralizes FOIA request intake and logging with the Division of Freedom of Information and...

This regulatory subchapter sets rules for federal adverse personnel actions (suspensions, removals, furloughs, reductions in grade or pay, and related procedures) by defining who is covered, the legal standard for taking action, required procedures, appeal rights, and recordkeeping. Mechanically, it: (1) specifies coverage categories and exclusions for...

What this instrument does mechanically: It implements section 504 of the Rehabilitation Act for Department of Health and Human Services (HHS) recipients and sets substantive, procedural, and technical requirements that recipients of HHS federal financial assistance must meet to avoid disability based discrimination. Key mechanical changes and requirements...

Mechanically, 49 C.F.R. Part 24 implements the Uniform Relocation Assistance and Real Property Acquisition Policies Act (Uniform Act) by prescribing: definitions; procedures for notifying owners and occupants; appraisal, valuation, and offer rules for acquisitions; methods and caps for relocation and replacement housing payments; staff qualifications,...