Q. What is a regulation?
A. A regulation is a general statement issued by an agency, board, or commission that has the force and effect of law. Congress often grants agencies the authority to issue regulations. Sometimes Congress requires agencies to issue a regulation; sometimes Congress grants agencies the discretion to do so. Many laws passed by Congress give Federal agencies some flexibility in deciding how best to implement those laws. Federal regulations specify the details and requirements necessary to implement and to enforce legislation enacted by Congress.
Q. What is the rulemaking process?
A. Federal regulations are created through a process known as "rulemaking," which is governed by the Administrative Procedure Act (APA) (5 U.S.C. Chapter 5). Click here for a graphical illustration of this process.
Once an agency decides that a regulatory action is necessary or appropriate, it develops and typically publishes a proposed rule in the Federal Register, soliciting comments from the public on the regulatory proposal. After the agency considers this public feedback and makes changes where appropriate, it then publishes a final rule in the Federal Register with a specific date upon which the rule becomes effective and enforceable. In issuing a final rule, the agency must describe and respond to the public comments it received.
Q. What is the Administrative Procedure Act and why is it important?
A. The APA governs the process by which Federal agencies propose and establish new regulations. The APA generally requires agencies to provide public notice and seek comment prior to enacting new regulations. The APA also lays out the process for judicial review of rules in federal court.
Q. Does Congress have a role in rulemaking?
A. Yes. Congress enacts the legislation that mandates or authorizes agencies to issue regulations. Through the APA and other laws, Congress also establishes the procedures that govern agency rulemaking. Congress may use a variety of processes as part of its oversight of agency action, including holding hearings or informal meetings, issuing reports, or adopting legislation. In addition, Congress, through the Congressional Review Act (CRA) (5 U.S.C. Chapter 8), may review and choose to reject new regulations issued by Federal agencies. The CRA requires Federal agencies to submit all new final rules to both the House and Senate. After submission, Congress may begin a process to reconsider and vote to overturn the rule.
Q. What is the Federal Register?
A. The Federal Register is the official daily publication for agency rules, proposed rules, and notices of Federal agencies and organizations, as well as for Executive Orders and other presidential documents. The Federal Register is published by the Office of the Federal Register within the National Archives and Records Administration (NARA). To learn more, visit the Federal Register website at: https://www.federalregister.gov.
Q. What is OIRA?
A. The Office of Information and Regulatory Affairs (OIRA, pronounced "oh-eye-ruh") is a Federal office that Congress established in the 1980 Paperwork Reduction Act (44 U.S.C Chapter 35). OIRA is part of the Office of Management and Budget (OMB), which is an agency within the Executive Office of the President. In addition to reviewing government collections of information from the public under the Paperwork Reduction Act, OIRA reviews draft proposed and final regulations under Executive Order 12866 and develops and oversees the implementation of government-wide policies in the areas of information policy, privacy, and statistical policy. OIRA also oversees agency implementation of the Information Quality Act, including the peer review practices of agencies.
To learn more information about OIRA and its role click here: https://www.whitehouse.gov/omb/information-regulatory-affairs/.
Q. Who is the current OIRA leadership?
A. The Office of the Administrator was created by Congress when it established OIRA in the Paperwork Reduction Act of 1980. The Administrator is nominated by the President and confirmed by the Senate.
Q. What is Executive Order 12866?
A. Executive Order 12866, "Regulatory Planning and Review," issued by President Clinton on September 30, 1993, establishes and governs the process under which OIRA reviews agency draft and proposed final regulatory actions. The objectives of the Executive Order are to enhance planning and coordination with respect to both new and existing regulations; to reaffirm the primacy of Federal agencies in the regulatory decision-making process; to restore the integrity and legitimacy of regulatory review and oversight; and to make the process more accessible and open to the public. For all significant regulatory actions, the Executive Order requires OIRA review before the actions take effect. On the part of the agencies, Executive Order 12866 requires an analysis of the costs and benefits of rules and, to the extent permitted by law, action only on the basis of a reasoned determination that the benefits justify the costs.
Q. What is Executive Order 13563?
A. On January 18, 2011, President Obama issued Executive Order 13563, which emphasizes the importance of protecting "public health, safety and our environment while promoting economic growth, innovation, competitiveness, and job creation." Executive Order 13563 points to the need for predictability and for certainty, and for use of the least burdensome tools for achieving regulatory ends. It indicates that agencies "must take into account benefits and costs, both quantitative and qualitative." Executive 13563 reaffirms the principles, structures, and definitions in Executive Order 12866, which has long governed regulatory review. In addition, it endorses, and quotes, a number of provisions of that Executive Order that specifically emphasize the importance of considering costs. Importantly, Executive Order 13563 asks agencies "to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible." It also authorizes agencies to consider, and discuss qualitatively, "values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts."
Executive Order 13563 elaborates five new principles to guide regulatory decisionmaking. First, agencies are directed to promote public participation, in part through making relevant documents available on the regulations.gov to promote transparency and comment. It also directs agencies to engage the public, including affected stakeholders, before rulemaking is initiated. Second, agencies are directed to attempt to reduce "redundant, inconsistent, or overlapping requirements," in part by working with one another to simplify and harmonize rules. Third, agencies are directed to identify and consider flexible approaches to regulatory problems, including warnings and disclosure requirements. Such approaches may "reduce burdens and maintain flexibility and freedom of choice for the public." Fourth, agencies are directed to promote scientific integrity. Fifth, and finally, agencies are directed to produce plans to engage in retrospective analysis of existing significant regulations to determine whether they should be modified, streamlined, expanded, or repealed.
Q. What is OIRA's role in the rulemaking process?
A. Executive Order 12866 assigns OIRA the responsibility of coordinating interagency Executive Branch review of significant regulations before publication. This is to ensure agency compliance with the principles in Executive Order 12866, which include incorporating public comment, considering alternatives to the rulemaking, and analyzing both costs and benefits.
Q. What does it mean when a regulatory action is determined to be "significant?"
A. Under Executive Order 12866, OIRA is responsible for determining which agency regulatory actions are "significant" and, in turn, subject to interagency review. Significant regulatory actions are defined in the Executive Order as those that:
- Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
- Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
- Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
- Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.
Q. What does it mean when a regulation is determined to be "economically significant?"
A. These regulatory actions are a subset of those designated by OIRA as significant. A regulatory action is determined to be "economically significant" if OIRA determines that it is likely to have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. For all "economically significant" regulations, the Executive Order directs agencies to provide (among other things) a more detailed assessment of the likely benefits and costs of the regulatory action, including a quantification of those effects, as well as a similar analysis of potentially effective and reasonably feasible alternatives.
Q. Why is OIRA review needed?
A. The OIRA review process under Executive Order 12866 seeks to ensure that agencies, to the extent permitted by law, comply with the regulatory principles stated in the Executive Order and that the President's policies and priorities are reflected in agency rules. Such review also helps to promote adequate interagency review of draft proposed and final regulatory actions, so that such actions are coordinated with other agencies to avoid inconsistent, incompatible, or duplicative policies. OIRA review helps to ensure that agencies carefully consider the consequences of rules (including both benefits and costs) before they proceed.
Q. How long can OIRA take to review a draft regulation?
A. The period for OIRA review is limited by Executive Order 12866 to 90 days. There is no minimum period for review. Under the Executive Order, the review period may be extended indefinitely by the head of the rulemaking agency; alternatively, the OMB Director may extend the review period on a one-time basis for no more than 30 days.
Q. What does it mean when OIRA "returns" an agency rule?
A. During the course of OIRA's review of a draft regulation, the Administrator may decide to send a letter to the agency that returns the rule for reconsideration. Such a return may occur if the rule is not compatible with the law, if the quality of the agency's analysis is inadequate, if the regulation is not justified by the analysis, if the rule is not consistent with the regulatory principles stated in Executive Order 12866 or with the President's policies and priorities, or if the rule unnecessarily conflicts with other Executive Branch agency regulations or efforts. Such a return does not necessarily imply that either OIRA or OMB is opposed to the draft rule. The return letter merely explains why OIRA believes that the rulemaking would benefit from further consideration and review by the agency.
For more information about these letters please see: http://www.reginfo.gov/public/do/eoReturnLetters
Q. What does it mean when an agency withdraws a rule?
A. At any time during the OIRA review process, an agency may withdraw its rule from review and choose not to move forward with it or to resubmit it after further consideration. Interested parties may contact the agency directly with questions regarding specific withdrawals.
Q. Why does OIRA place so much emphasis on regulatory analysis, and what is its purpose in rulemaking?
A. Regulatory analysis is a tool that regulatory agencies use to anticipate and evaluate the likely consequences of rules (including both costs and benefits). It provides a formal means of organizing the evidence on the key effects - both good and bad - of the various alternatives that should be considered in developing regulations. Among the purposes are (1) to learn if the quantitative and qualitative benefits of an action are likely to justify the costs, (2) to promote accountability to the public, and (3) to discover which of various possible alternatives would produce the highest net-benefits. Sometimes careful analysis can show that a less stringent alternative is best; sometimes more stringency will be shown to be justified; sometimes a creative option will emerge.
As one of its regulatory principles, Executive Order 12866 states that agencies in developing a regulation "shall assess both the costs and the benefits of the intended regulation and, recognizing that some costs and benefits are difficult to quantify, propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs." In addition, other laws such as the Regulatory Flexibility Act and the Unfunded Mandates Reform Act require agencies to evaluate the costs and benefits of certain rulemakings.
Q. Does OIRA provide technical guidance to agencies on how to perform/develop good regulatory analysis?
A. Yes. OMB has long provided guidance on "best practices" for regulatory analysis. The latest such guidance is OMB's Circular A-4, "Regulatory Analysis," which was released in September 2003. This guidance was designed to assist regulatory agencies by defining good regulatory analysis and by standardizing the measurement and reporting of the benefits and costs of Federal regulatory actions. Before finalizing this Circular, OMB subjected a draft to peer review and solicited public comments.
Q. Does OIRA provide summary information on the costs and benefits of significant regulatory actions.?
A. Yes. You can find OIRA's annual report to Congress on the costs and benefits of Federal rules at: https://www.whitehouse.gov/omb/information-regulatory-affairs/reports/ .
Q. OIRA is part of the Executive Office of the President; are OIRA employees political appointees of the President?
A. No. While the Administrator is a Senate-confirmed appointee of the President, the vast majority of OIRA employees are career public servants.
Q. How large is OIRA's staff and what are their backgrounds?
A. OIRA has about 50 full-time professionals who work with agency professionals on specific issues and regulations. All OIRA professionals possess graduate level degrees and have historically come from backgrounds in economics, law, policy analysis, statistics, and information technology. With the growth of science-based regulation and information-quality issues, several staff also have expertise in public health, toxicology, epidemiology, engineering, and other technical fields.
OIRA Disclosure and its Relationship with Parties Outside the Executive Branch
Q. Does OIRA talk to or meet with particular interest groups during review of its rules?
A. OIRA's policy is to meet with any party interested in discussing issues on a rule under review, whether they are from State or local governments, small business or other business interests, or from the environmental, health, or safety communities. Under OIRA procedures, as set forth in Executive Order 12866, meetings on regulatory actions must be conducted by the OIRA Administrator or a specific designee. A log, available on Reginfo.gov, is kept of such meetings. Groups and individuals interested in meeting with OIRA regarding a rule under review should call 202-395-6880. Please provide the name of the regulatory action you or your group would like to discuss.
Q. What are OIRA's disclosure and transparency policies?
A. RegInfo.gov includes a "Regulatory Dashboard," which provides information about regulatory actions under OIRA review. Among other things, the Dashboard graphically displays regulatory actions under review by agency, length of review, economic significance, and stage of rulemaking.
The information on OIRA's website includes reports, policies, and guidance to agencies. Additionally, OIRA makes public all substantive communications with any party outside the Executive Branch concerning regulatory actions under review. If the OIRA Administrator or his/her designee meets with outside parties during a review, the subject, date, and participants of the meeting are disclosed on the OIRA website. Any written material received from outside parties on rules under review is placed on the OIRA website. After a regulatory action is published in the Federal Register, OIRA will make publicly available certain documents exchanged between OIRA and the rulemaking agency during the review period.
Q. How can outside parties best make their ideas about rules under review known to OIRA?
A. The best way to participate in rulemaking is to submit comments directly to the agency during the proposed rule stage. For more information on this question, you should contact the agency directly, view the Federal Register for notices seeking public comments, and/or file comments via http://www.regulations.gov. In addition to submitting comments through regulations.gov, outside parties may provide written comments to the OIRA Administrator on a regulatory action under review. Parties may also request a meeting with the Administrator.
Q. What is the best way to request a meeting with OIRA about a regulatory action under OIRA review?
A. To request a meeting regarding a rule, email Mabel_E._Echols@omb.eop.gov or call 202-395-6880. When you request a meeting you must provide the following information:
- Name of the organization requesting the meeting.
- Name of the organization's client or who the organization is representing at the meeting (if applicable).
- The name of the regulatory action on which the party would like to present its views.
- The Regulatory Identification Number (RIN) of the regulatory action on which the party would like to present its views.
Q. What is Reginfo.gov and the Regulatory dashboard and what information does it display?
A. Reginfo.gov displays regulatory actions and information collections currently at OIRA for review. The Regulatory dashboard is a component of that site that provides an up-to-date and easy-to-read graphical representation of regulatory actions currently under review. The dashboard displays these regulatory actions by agency, length of review, economic significance, and stage of rulemaking.
Q. What are the different types of significant regulatory actions currently displayed on the dashboard that undergo OIRA review?
A. They are:
- Notice - These are documents that announce new programs (such as grant programs) or agency policies.
- Pre-rule (or advance notice of proposed rulemaking) - Agencies undertake this type of action to solicit public comment on whether or not, or how best, to initiate a rulemaking. Such actions occur prior to the proposed rule stage.
- Proposed rule - This is the rulemaking stage in which an agency proposes to add to or change its existing regulations and solicits public comment on this proposal.
- Final rule - This is the last step of the rulemaking process in which the agency responds to public comment on the proposed rule and makes appropriate revisions before publishing the final rule in the Federal Register to become effective.
- Interim Final Rule - These interim rules are typically issued in conformity with statutory provisions allowing agencies to publish a final rule that becomes effective soon after publication, without going through the proposed rule stage. The "good cause" exception in the Administrative Procedure Act allows agencies to bypass public notice and comment on a rule when it would be impracticable, unnecessary, or contrary to the public interest. This process typically allows for public comment after the rule is published so that the agency still has an opportunity to consider public input and revise the rule accordingly.
- Direct Final Rule - These rules are similar to interim final rules, except that there is no comment period after publication, on the ground that they are uncontroversial. Such rules are categorized simply as "final rules" for display purposes on the dashboard.
Q. When I click on individual rules sometimes the information about them is blank. Why is that?
A. The description and abstract of the draft regulations undergoing OIRA review are provided by Federal agencies directly through bi-annual submissions of the Unified Agenda, which are published descriptions of each agency's upcoming regulatory actions. If the information about an individual rule is blank on the Regulatory dashboard, it is because the agency did not provide such descriptive information in its Unified Agenda entries.
Q. How do I see the actual documents and text for a regulatory action that is undergoing OIRA review?
A. Draft documents under review are considered deliberative and are not available for public release during review.
Q. What is the difference between the RegInfo.gov and Regulations.gov?
A. RegInfo.gov provides information about the status of agency documents undergoing OIRA review. Regulations.gov provides a government-wide portal for the public to review and comment on published regulatory actions and to view any supporting materials provided by the agency.
Q. What is a RIN?
A. A RIN, or "Regulation Identifier Number," is assigned by OMB's electronic docketing system to identify each regulatory action listed in the Unified Agenda. OMB has asked agencies to include RINs in the headings of their Rule and Proposed Rule documents when publishing them in the Federal Register, to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development.
Information Clearance Process
Q. What is the Paperwork Reduction Act?
A. The Paperwork Reduction Act (PRA), which was signed into law in 1980 and reauthorized in 1995, provides the statutory framework for the Federal government's collection, use, and dissemination of information. The goals of the PRA include (1) minimizing paperwork and reporting burdens on the American public and (2) ensuring the maximum possible utility from the information that is collected.
In support of these goals, the PRA requires Federal agencies to take specific steps before requiring or requesting information from the public. These steps include (1) seeking public comment on proposed information collections and (2) submitting proposed collections for review and approval by OMB. Within OMB, the Office of Information and Regulatory Affairs (OIRA) carries out the information collection review.
Q. What is an information collection?
A. OMB's PRA regulation defines "information" as "any statement or estimate of fact or opinion, regardless of form or format, whether in numerical, graphic, or narrative form, and whether oral or maintained on paper, electronic or other media." This definition includes:
- requests for information to be sent to agencies, such as forms (e.g., the IRS 1040), written reports (e.g., grantee performance reports), and surveys (e.g., the Census);
- recordkeeping requirements (e.g., OSHA requirements that employers maintain records of workplace accidents); and
- third-party or public disclosures (e.g., nutrition labeling requirements for food).
Q. What is an Information Collection Request (ICR)?
A. An ICR is an agency request for OMB approval of an information collection. It includes a description of the collection and its planned use as well as other information that demonstrates that the agency has met the requirements of the PRA. It may also include an information collection instrument (e.g., a form, survey, script, etc.) and supporting documentation that has been sent to OMB for review and approval under the PRA.
Q. What is OIRA's role in the review and approval of agency information collections?
A. OIRA reviews agency ICRs for approval or disapproval. When OMB approves an information collection, it assigns an OMB Control Number that the agency must display on the information collection. OMB has issued regulations and guidance, available on OIRA's website, to promote agency compliance with the PRA.
Q. What is an OMB Control Number?
A. An OMB Control Number is a unique number comprised of two four-digit codes separated by a hyphen. The first four digits identify the sponsoring agency and bureau, and the second four digits identify the particular collection. The public can find OMB's inventory of currently approved collections, with OMB Control Numbers, on Reginfo.gov. Note that it is possible for multiple information collections submitted as one ICR to have the same OMB Control Number.
Q. What actions can OIRA take on agency ICRs after reviewing them?
A. OIRA can take the following actions: Approval, Improperly Submitted, Withdrawn, and Disapproval.
OIRA can approve collections for up to three years. OMB may approve an ICR with or without change. For ICRs related to proposed rules, OMB may decide not to approve the request, and instead "file comment," in which case the agency is instructed to resubmit the ICR at the final stage of rulemaking. OIRA returns an ICR to the agency as improperly submitted if it fails to meet the procedural requirements of the PRA or OMB's PRA regulations.
At any time during the OIRA review process, an agency may request withdrawal of its ICR from review. An agency could resubmit the ICR at a later date after further consideration. Interested parties may contact the agency directly with questions about specific withdrawals.
If OIRA disapproves an information collection request, the PRA states that the agency may not proceed with the information collection and that "no person shall be subject to any penalty for failing to comply" with the information collection.
Q. How does an agency obtain OMB approval of an information collection?
A. The following process is used to obtain OMB approval for an information collection.
- The agency develops an information collection that it wishes to implement.
- The agency publishes a Federal Register notice about the proposed information collection and provides the public with 60 days to provide comment on the proposed collection.
- The agency considers the public's comments and makes changes as appropriate to address concerns raised by the public.
- The agency submits the ICR to OMB for review and publishes a second Federal Register notice announcing the start of OMB's review. The second notice provides the public with an additional 30 days to provide comments.
- After reviewing the ICR and considering public comments, OIRA concludes its review by approving the collection or taking one of the other actions noted above.
Q. What does OMB evaluate during its review of proposed collections?
A. A central goal of OMB review is to help agencies strike a balance between collecting information necessary to fulfill their statutory missions and guarding against unnecessary or duplicative information that imposes unjustified costs on the American public. In this regard, OIRA evaluates whether the collection of information by the agency:
- is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
- minimizes the Federal information collection burden, with particular emphasis on those individuals and entities most adversely affected; and
- maximizes the practical utility of and public benefit from information collected by or for the Federal Government.
Q. How can I participate in the information collection review process?
A. Members of the public are encouraged to monitor the sponsoring agency's Federal Register notices seeking comments on information collections, and to provide feedback on any that interest them. The ICR Dashboard now provides an easy way to see what collections are under review at OMB.
At any point, members of the public may also submit comments to the sponsoring Federal agencies and OIRA about any currently approved information collections. Such comments may involve, for example, the need for the information and the reporting burdens involved.
Q. How do I submit comments on an information collection?
A. The Federal Register notices seeking comment on the information collection will provide a means to submit comments. Interested parties should contact the specific agency to submit comments outside the time frame of the Federal Register comment process.
Q. Does OIRA evaluate agency performance in minimizing paperwork burdens?
A. Yes. The PRA requires OMB to report annually to Congress on Federal information collection activities under its purview. The Information Collection Budget (ICB) is OMB's annual report on the PRA. The ICB offers a great deal of information about existing paperwork and reporting burdens; it also reports on government progress in reducing burdens and in making information collection more efficient and effective. The ICB often focuses on recent burden reduction initiatives. The annual ICBs are available here on OIRA's website.
Q. Where can I learn more about information collection under the PRA?
A. More detailed information about the scope and requirements of the PRA are provided in OMB's PRA "Primer." OMB sent this memorandum to agencies on April 7, 2010, to explain the central requirements of the PRA and to increase transparency and openness. The memorandum answers such questions as: What does and does not count as information under the PRA? What are the public notice and comment requirements for information collection requests? What does OMB evaluate during its review of proposed collections?
Q. What is the ICR Dashboard?
A. The ICR Dashboard is a component of Reginfo.gov that provides an up-to-date and easy-to-follow graphical representation of information collections currently under review. The ICR Dashboard displays these information collections by agency, length of review, and type of ICR.
Q. What are the different types of information collection requests displayed on the ICR Dashboard?
A. Seven types of information collection requests are displayed on the ICR Dashboard:
- New collection - This is an agency request for a new information collection and OMB Control Number.
- Revision - This is an agency request for OMB approval of a substantive revision to a currently approved information collection. Such revisions are generally a result of changes required by statute or of agency action. To ensure that the public record is accurate, agencies must submit, and OMB must review, documentation of all proposed revisions to a currently approved collection before those revisions may be implemented. If the agency is considering significant or substantive revisions to the collection, it must provide the public with an opportunity to comment on the proposed revisions, as it would with a new collection.
- Extension without change - This is an agency request for OMB to extend approval of an existing collection. The PRA requires that agencies use the Federal Register notice-and-comment process to extend OMB's approval at least every three years.
- Reinstatement without change - This is an agency request for OMB approval of an information collection for which the agency previously obtained OMB approval, but which the agency subsequently decided to discontinue. This request allows the agency to use the same collection under the OMB Control Number provided with the original approval.
- Reinstatement with change - This is an agency request for OMB approval of an information collection for which the agency previously obtained OMB approval, but which the agency subsequently decided to discontinue. This request allows the agency to use a revised version of the same information collection under the OMB Control Number provided with the original approval.
- Existing collection in use without OMB Control Number - This is an agency request for OMB approval of an information collection that an agency has begun.
- Discontinue - This is an agency request that OMB discontinue its approval of an information collection. In most cases, this request is a result of an agency decision that an information collection is no longer necessary.
Q. What information can I see about information collections currently under review?
A. When viewing an information collection on Reginfo.gov, you can see basic information, such as the title and burden hours. You can also click on either the OMB Control Number or the ICR Reference Number to learn more. When you click on the OMB Control Number, you will see the OMB review history of the information collection. When you click on the ICR Reference Number, you will have the option to see more detailed information on the ICR, such as the actual collection instruments (e.g., forms or surveys) and supporting documentation that lays out the need for the collection under the PRA. An exception to this is when an ICR is created or revised due to an associated proposed or final regulation. The contents of these ICRs are not made public until OMB's review is completed and the rules are published in the Federal Register.
OIRA Privacy Role