Administrative guidance

Last updated March 06, 2019

Administrative guidance is non-binding advice given by an administrative agency to the public regarding how best to comply with a particular law or regulation. It may also be referred to by terms such as "advice" or "recommendation." Guidance is often used to explain the objective or interpretation of a vague or nonspecific law or requirement.

Advice is a form of relating personal or institutional opinions, belief systems, values, recommendations or guidance about certain situations relayed in some context to another person, group or party often offered as a guide to action and/or conduct. Put a little more simply, an advice message is a recommendation about what might be thought, said, or otherwise done to address a problem, make a decision, or manage a situation.

In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources.

Types of guidance documents

While guidance documents are not usually enforceable rules or requirements by themselves, they often define standards or expectations which are part of a rule or requirement. For example, a regulation might require adequate testing for relevant microorganisms in sterile containers and a guidance document would be used to explain what testing is adequate and which organisms are relevant.

Guidance documents are also used to explain internal policies or practices to simplify an organization's interactions with other parties. For example, a guidance document could explain how to prepare a report or what information should be gathered before submitting a complaint.

Japan

Administrative guidance(行政指導,gyōsei shidō) is a Japanese government practice defined under Article 2 of the Administrative Procedure Act of 1993 as "guidance, recommendations, advice, or other acts by which an Administrative Organ may seek, within the scope of its duties or affairs under its jurisdiction, certain action or inaction on the part of specified persons in order to realize administrative aims, where such acts are not Dispositions."^[1]

Japan is an island country in East Asia. Located in the Pacific Ocean, it lies off the eastern coast of the Asian continent and stretches from the Sea of Okhotsk in the north to the East China Sea and the Philippine Sea in the south.

The Administrative Procedure Act, enacted in 1993, governs general functions of government agencies in Japan.

Historically, the government of Japan employed this practice in imposing its policies on individuals and organizations, implying poorer treatment for those who failed to comply with its non-binding advice.

The government of Japan is a constitutional monarchy in which the power of the Emperor is limited and is relegated primarily to ceremonial duties. As in many other states, the Government is divided into three branches: the Legislative branch, the Executive branch, and the Judicial branch.

The Act of 1993 was the first statute to specifically regulate the practice of administrative guidance. Under the Act:

A statute is a formal written enactment of a legislative authority that governs a city, state, or country. Typically, statutes command or prohibit something, or declare policy. Statutes are rules made by legislative bodies; they are distinguished from case law or precedent, which is decided by courts, and regulations issued by government agencies.

A government agency may not treat a person in an adverse manner solely because that person failed to follow administrative guidance (article 32.2).
Administrative guidance may not be used to pressure a petitioner into withdrawing or modifying a petition once they have indicated an intent not to do so (article 33).
The content of administrative guidance and the identity of the official responsible must be made clear to the counterparty (article 35.1).
Verbal administrative guidance must be followed by a summary in writing if the counterparty demands it (article 35.2).

United States

In United States law, although administrative guidance is not generally binding on the public as a whole, it may serve as persuasive authority regarding the correct interpretation of the law.^[2] Additionally, if guidance has been voluntarily sought by a member of the public, it may be binding on the person who sought it.^[2]

The United States of America (USA), commonly known as the United States or America, is a country composed of 50 states, a federal district, five major self-governing territories, and various possessions. At 3.8 million square miles, the United States is the world's third or fourth largest country by total area and is slightly smaller than the entire continent of Europe's 3.9 million square miles. With a population of over 327 million people, the U.S. is the third most populous country. The capital is Washington, D.C., and the largest city by population is New York City. Forty-eight states and the capital's federal district are contiguous in North America between Canada and Mexico. The State of Alaska is in the northwest corner of North America, bordered by Canada to the east and across the Bering Strait from Russia to the west. The State of Hawaii is an archipelago in the mid-Pacific Ocean. The U.S. territories are scattered about the Pacific Ocean and the Caribbean Sea, stretching across nine official time zones. The extremely diverse geography, climate, and wildlife of the United States make it one of the world's 17 megadiverse countries.

Good guidance practice

In the United States, guidance documents published by federal agencies are required to follow a set of requirements to ensure that the documents they publish are useful and accurate.^[3] These rules are referred to as "good guidance practice" (GGP) and require specific controls. For example, agencies have to ask for public comment before publishing major guidance documents, similar to the requirements for new rules and regulations.

The Federal Government of the United States is the national government of the United States, a federal republic in North America, composed of 50 states, a federal district, five major self-governing territories, and several island possessions. The federal government is composed of three distinct branches: legislative, executive, and judicial, whose powers are vested by the U.S. Constitution in the Congress, the President, and the federal courts, respectively. The powers and duties of these branches are further defined by acts of congress, including the creation of executive departments and courts inferior to the Supreme Court.

GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.

Related Research Articles

Administrative law is the body of law that governs the activities of administrative agencies of government. Government agency action can include rule making, adjudication, or the enforcement of a specific regulatory agenda. Administrative law is considered a branch of public law. As a body of law, administrative law deals with the decision-making of the administrative units of government that are part of a national regulatory scheme in such areas as police law, international trade, manufacturing, the environment, taxation, broadcasting, immigration and transport. Administrative law expanded greatly during the twentieth century, as legislative bodies worldwide created more government agencies to regulate the social, economic and political spheres of human interaction.

The Sarbanes-Oxley Act of 2002, also known as the "Public Company Accounting Reform and Investor Protection Act" and "Corporate and Auditing Accountability, Responsibility, and Transparency Act" and more commonly called Sarbanes–Oxley, Sarbox or SOX, is a United States federal law that set new or expanded requirements for all U.S. public company boards, management and public accounting firms. A number of provisions of the Act also apply to privately held companies, such as the willful destruction of evidence to impede a federal investigation.

A directive is a legal act of the European Union which requires member states to achieve a particular result without dictating the means of achieving that result. It can be distinguished from regulations, which are self-executing and do not require any implementing measures. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on their subject matter.

The Securities Act of 1933, also known as the 1933 Act, the Securities Act, the Truth in Securities Act, the Federal Securities Act, and the '33 Act, was enacted by the United States Congress on May 27, 1933, during the Great Depression, after the stock market crash of 1929. Legislated pursuant to the Interstate Commerce Clause of the Constitution, it requires every offer or sale of securities that uses the means and instrumentalities of interstate commerce to be registered with the SEC pursuant to the 1933 Act, unless an exemption from registration exists under the law. The term "means and instrumentalities of interstate commerce" is extremely broad and it is virtually impossible to avoid the operation of the statute by attempting to offer or sell a security without using an "instrumentality" of interstate commerce. Any use of a telephone, for example, or the mails would probably be enough to subject the transaction to the statute.

A notice of proposed rulemaking (NPRM) is a public notice issued by law when one of the independent agencies of the United States government wishes to add, remove, or change a rule or regulation as part of the rulemaking process. It is an important part of United States administrative law which facilitates government by typically creating a process of taking of public comment. This nomenclature is also utilized at the state level.

The National Environmental Policy Act (NEPA) is a United States environmental law that promotes the enhancement of the environment and established the President's Council on Environmental Quality (CEQ). The law was enacted on January 1, 1970. To date, more than 100 nations around the world have enacted national environmental policies modeled after NEPA.

Delegated legislation is law that is not passed by an Act of Parliament but by a government minister, a delegated person or an entity in the United Kingdom. Delegated legislation is used for a wide variety of purposes such as fixing the date on which an Act of Parliament will come into force; setting fees for a public service; or establishing the details of an Act of Parliament. Delegated legislation is dependent on its Parent Act which proscribes its parameters and procedures. Although a large volume of delegated legislation is written without close parliamentary scrutiny, there are Statutory Instruments to prevent its misuse.

United States federal administrative law encompasses statutes, common law, and directives issued by the Office of Information and Regulatory Affairs in the Executive Office of the President, that together define the extent of powers and responsibilities held by administrative agencies of the United States Government. The executive, legislative, and judicial branches of the U.S. federal government cannot always directly perform their constitutional responsibilities. Specialized powers are therefore delegated to an agency, board, or commission. These administrative governmental bodies oversee and monitor activities in complex areas, such as commercial aviation, medical device manufacturing, and securities markets.

Know your customer, alternatively known as know your client or simply KYC, is the process of a business verifying the identity of its clients and assessing potential risks of illegal intentions for the business relationship. The term is also used to refer to the bank regulations and anti-money laundering regulations which govern these activities. Know your customer processes are also employed by companies of all sizes for the purpose of ensuring their proposed agents, consultants, or distributors are anti-bribery compliant. Banks, insurers and export creditors are increasingly demanding that customers provide detailed anti-corruption due diligence information.

The UK's Building regulations are statutory instruments that seek to ensure that the policies set out in the relevant legislation are carried out. Building regulations approval is required for most building work in the UK. Building regulations that apply across England and Wales are set out in the Building Act 1984 while those that apply across Scotland are set out in the Building (Scotland) Act 2003. The Act in England and Wales permits detailed regulations to be made by the Secretary of State. The regulations made under the Act have been periodically updated, rewritten or consolidated, with the latest and current version being the Building Regulations 2010. The UK Government is responsible for the relevant legislation and administration in England, the Welsh Government is the responsible body in Wales, the Scottish Government is responsible for the issue in Scotland, and the Northern Ireland Executive has responsibility within its jurisdiction. There are very similar Building Regulations in the Republic of Ireland.

A Registered Investment Adviser (RIA) is a firm that is an Investment adviser in the United States, registered as such with the Securities and Exchange Commission or a state's securities agency. The numerous references to RIAs within the Investment Advisers Act of 1940 popularized the term, which is closely associated with the term investment advisor. An investment adviser is defined by the Securities and Exchange Commission as an individual or a firm that is in the business of giving advice about securities. However, an RIA is the actual firm, while the employees of the firm are called Investment Adviser Representatives (IARs).

The Administrative Law, Process and Procedure Project is a bipartisan undertaking of the Committee on the Judiciary of the House of Representatives of the United States Congress. It consists of a comprehensive study of the state of administrative law, process and procedure in the United States. A description of the Project was included in the Judiciary Committee's Oversight Plan for the 109th Congress, as approved by the Committee on January 26, 2005. The Project will culminate with the preparation of a detailed report with recommendations for legislative proposals and suggested areas for further research and analysis to be considered by the Administrative Conference of the United States (ACUS). House Judiciary Committee Chairman F. James Sensenbrenner, Jr. (R-WI) and Ranking Member John Conyers (D-MI) requested the Congressional Research Service (CRS) to assist Representative Chris Cannon (R-UT), the Chairman of the Subcommittee on Commercial and Administrative Law (CAL), in conducting the Project.

The Judges' Rules are a set of guidelines about police and questioning and the acceptability of the resulting statements and confessions as evidence in court. Originally prepared for police in England, the Rules and their successor documents have become a part of legal procedure not just in Britain but in places as far afield as Jamaica, Zambia and Western Samoa where English law is followed.

The law of Florida consists of several levels, including constitutional, statutory, and regulatory law, as well as case law and local law. The Florida Statutes form the general statutory law of Florida.

Administrative Conference of the United States independent agency of the United States government

The Administrative Conference of the United States (ACUS) is a nonpartisan independent agency of the United States government established in 1964 by the Administrative Conference Act. The Conference's purpose is to "promote improvements in the efficiency, adequacy, and fairness of the procedures by which federal agencies conduct regulatory programs, administer grants and benefits, and perform related governmental functions."

The National Appeals Division (NAD) of USDA was established by the Department of Agriculture Reorganization Act of 1994 to consolidate and improve the hearing procedures for USDA claims and disputes. The statute and regulations provide that certain sections of the Administrative Procedure Act (APA), including the hearing requirements, do not apply to NAD proceedings. The NAD procedures govern informal and formal hearings covering appeals of decisions made by the rural development agencies, Natural Resources Conservation Service, Risk Management Agency, and the Farm Service Agency. The statute and regulations set forth the procedures for hearings, requirements for the presiding officers, requirements for communications between the decision-maker and persons interested in the matter, and other important issues. After a decision is made by an Administrative Judge, both the appellant and the agency have the right to a review by the NAD director, who then issues a final determination. The final determination of the NAD is reviewable and enforceable by the U.S. District Court in accordance with the judicial review provisions of the APA.

The Administrative Procedure Act (APA), Pub.L. 79–404, 60 Stat. 237, enacted June 11, 1946, is the United States federal statute that governs the way in which administrative agencies of the federal government of the United States may propose and establish regulations. To protect citizens, the APA also grants the judiciary oversight over all agency actions. It is one of the most important pieces of United States administrative law. The Act became law in 1946.

The German Bundesdatenschutzgesetz (BDSG) is a federal data protection act, that together with the data protection acts of the German federal states and other area-specific regulations, governs the exposure of personal data, which are manually processed or stored in IT systems.

In parliamentary systems and presidential systems of government, primary legislation and secondary legislation, the latter also called delegated legislation or subordinate legislation, are two forms of law, created respectively by the legislative and executive branches of government. Primary legislation generally consists of statutes, also known as 'acts', that set out broad outlines and principles, but delegate specific authority to an executive branch to make more specific laws under the aegis of the principal act. The executive branch can then issue secondary legislation, creating legally-enforceable regulations and the procedures for implementing them.

References

↑ "Administrative Procedure Act (Japanese/English text)" (PDF).
1 2 Aman, Alfred C. (1994). "Informal Agency Actions and U.S. Administrative Law -- Informal Procedure in a Global Era". American Journal of Comparative Law.
↑ "Final Bulletin for Agency Good Guidance Practices" (PDF). Federal Register.