Regulatory Guidance Processes:

Selected Departments Could Strengthen Internal Control and Dissemination Practices

GAO-15-368: Published: Apr 16, 2015. Publicly Released: May 18, 2015.

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What GAO Found

The four departments—Agriculture (USDA), Education (Education), Health and Human Services (HHS), and Labor (DOL)—and their selected components used guidance for multiple purposes, such as clarifying or interpreting regulations and providing grant administration information. The terminology used for agency guidance varied and agency components issued varying amounts of guidance, ranging from about 10 to over 100 guidance documents each year. The key criterion used when deciding whether to issue a regulation or guidance was whether it needed to be binding; in such cases agencies proceeded with regulation. Officials reported that they routinely consulted with legal counsel when making these choices. Departments typically identified few of their guidance documents as “significant,” generally defined by the Office of Management and Budget (OMB) as guidance with a broad and substantial impact on regulated entities.

All four departments identified standard practices to follow when developing guidance. They addressed OMB's requirements for significant guidance to varying degrees and could strengthen internal controls for issuing guidance. Education and USDA had written departmental procedures for approval of significant guidance as required by OMB. DOL's procedures were not available to staff and required updating. HHS had no written procedures. Ensuring these procedures are available could better ensure that components consistently follow OMB's requirements. In the absence of specific government standards for non-significant guidance—the majority of issued guidance—the application of internal control standards is particularly important. The 25 components GAO reviewed addressed some control standards more regularly than others. For example, few components had written procedures to ensure consistent application of guidance processes. All components could describe standard review practices and most used tools to document management approval of draft guidance. Of the 25 components, 15 cited examples in which they conferred with external nonfederal stakeholders while developing guidance and nearly half did not regularly evaluate whether issued guidance remained current and effective.

Components used different strategies to disseminate guidance and all relied primarily on posting the guidance on their websites. As such, components should follow applicable requirements for federal websites. One of these requirements—easy access to current and relevant guidance—could also facilitate opportunities for affected parties and stakeholders to provide feedback on those documents. USDA, DOL, and Education posted their significant guidance on a departmental website as directed by OMB; HHS did not. Components used several strategies—including organizing guidance by audience or topic and highlighting new or outdated guidance—to facilitate access. However, GAO identified factors that hindered online access, including long lists of guidance and documents dispersed among multiple web pages. All components GAO studied collected web metrics and many used them to evaluate online guidance dissemination. However, many of these components did not use metrics to improve how they disseminated guidance through their websites. Beyond their websites, components found other ways to disseminate and obtain feedback on issued guidance, including focus groups, surveys, and direct feedback from the public at conferences, webinars, and from monitoring visits.

Why GAO Did This Study

Agencies rely on guidance to clarify regulatory text or statutes, to respond to the questions of affected parties in a timely way, and to inform the public about complex policy implementation topics. Unlike regulations, guidance is not legally binding.

GAO was asked to examine guidance processes at four departments. This report reviews how (1) agencies use guidance and decide to issue guidance rather than regulations; (2) follow applicable criteria and leading practices in their policies, procedures, and practices for producing guidance; and (3) agencies disseminate guidance to ensure public access and feedback. GAO reviewed guidance processes at all 25 components in the four departments that (1) were within the requesting committee's jurisdiction, and (2) engaged in regulatory or grant activities. GAO reviewed relevant requirements, written procedures, guidance and websites, and interviewed agency officials.

What GAO Recommends

GAO is recommending that HHS and DOL ensure consistent application of OMB requirements for significant guidance. GAO also recommends that USDA, Education, HHS, and DOL strengthen the use of internal controls in guidance production processes and improve online guidance dissemination. USDA, Education, HHS and DOL generally agreed with the recommendations.

For more information, contact Michelle Sager at (202) 512-6806 or sagerm@gao.gov.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In comments printed in the April 2015 final report, HHS concurred with the recommendation and stated that it would explore the best mechanism for distributing written procedures for approval of significant guidance. In June 2019, Department of Health and Human Services (HHS) officials provided GAO with an update on the status of their response to this recommendation. They identified departmental documents issued in 2018 that address the two elements of OMB's Final Bulletin for Agency Good Guidance Practices relevant to this recommendation-that each agency develop or have written procedures for the internal clearance of significant guidance documents and that those procedures should ensure that issuance of significant guidance documents is approved by appropriate agency officials. The primary relevant document is an updated Guide to Document Preparation (Guide) issued by the Office of the Secretary in 2018. They noted that this document provides guidance for all divisions of the department about preparing documents for leadership and is available on the department's Intranet. The clearance process for guidance documents is addressed in several places within the Guide. The updated Guide also includes within its appendices a HHS Clearances Overview Table that identifies by document type who is responsible for coordinating clearances at HHS. The table specifies that the Executive Secretariat in the Office of the Secretary is responsible for coordinating clearances of guidance documents requiring HHS review. The officials also identified two 2018 HHS memoranda related to the collection and review of guidance documents issued by the divisions of the department. A February 2018 memo reiterated a request by the Administrator of OMB's Office of Information and Regulatory Affairs that all Regulatory Reform Officers pay close attention to guidance documents and that senior agency officials have visibility into each agency's use of guidance, particularly but not exclusively with regard to "significant guidance" as that term was defined by OMB in the Final Bulletin for Agency Good Guidance Practices. A June 2018 memo requires divisions to submit all new guidance documents to Guidance@hhs.gov for review. This process is required for all new guidance regardless of whether there was departmental clearance of the document(s). In addition, the officials noted that divisions are reminded about the clearance process for guidance in meetings with executive secretariats throughout the department.

    Recommendation: To better ensure the adherence to requirements for approval and public access to and feedback on significant guidance in accordance with OMB's Final Bulletin for Agency Good Guidance Practices (M-07-07), the Secretary of HHS should develop written procedures for the approval of significant guidance documents.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: In a May 2016 update on the status of this recommendation, Department of Labor officials stated that the Department had reviewed and updated its written procedures for approval of significant guidance, disseminated the procedures, and made the procedures available to all staff by disseminating them through its Regulatory Council and via the Department's Intranet on December 31, 2015. The updated written procedures address the definition of significant guidance, how significance determinations are to be made, and the steps to be followed for clearance of significant guidance.

    Recommendation: To better ensure the adherence to requirements for approval of significant guidance in accordance with OMB's Final Bulletin for Agency Good Guidance Practices (M-07-07), the Secretary of Labor should review and update the department's written procedures for approval of significant guidance and make them available to appropriate component staff.

    Agency Affected: Department of Labor

  3. Status: Closed - Implemented

    Comments: In 2016, the Food and Nutrition Service (FNS) adopted an Instruction prescribing FNS's process for development and clearance of non-significant guidance.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should strengthen their selected components' application of internal controls to guidance processes by adopting, as appropriate, practices developed by other departments and components, such as assessment of risk; written procedures and tools to promote the consistent implementation and communication of management directives; and ongoing monitoring efforts to ensure that guidance is being issued appropriately and has the intended effect. Examples of practices that could be adopted more widely include (1) written procedures for guidance production to, among other things, clearly define management roles; (2) improved communication tools, such as routing slips to document management review; and (3) consistent and ongoing monitoring to determine if guidance is being accessed and having the intended effect.

    Agency Affected: Department of Agriculture

  4. Status: Closed - Implemented

    Comments: In February 2017, Education reported that they had (1) summarized the guidance development, clearance, and monitoring processes for each Education component agency, (2) studied the guidance development, clearance, and monitoring processes of other agencies reviewed by GAO, and (3) identified best practices based on both studies, and developed and finalized written protocols for the development of guidance. The new written protocols identify the responsibilities of various officials in the guidance production process, directions for gathering external input on guidance documents, standard elements for guidance documents, and assert a system for clearance of the guidance document. The written procedures also encourage offices to solicit external feedback, use web analytics to evaluate whether their dissemination methods are effective, and to periodically review their non-significant guidance documents.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should strengthen their selected components' application of internal controls to guidance processes by adopting, as appropriate, practices developed by other departments and components, such as assessment of risk; written procedures and tools to promote the consistent implementation and communication of management directives; and ongoing monitoring efforts to ensure that guidance is being issued appropriately and has the intended effect. Examples of practices that could be adopted more widely include (1) written procedures for guidance production to, among other things, clearly define management roles; (2) improved communication tools, such as routing slips to document management review; and (3) consistent and ongoing monitoring to determine if guidance is being accessed and having the intended effect.

    Agency Affected: Department of Education

  5. Status: Closed - Implemented

    Comments: In June and July 2019, Department of Health and Human Services (HHS) officials provided GAO an update on the status of their response to this recommendation. They identified documents addressing this recommendation issued by the two components of HHS that GAO reviewed for GAO-15-368, the Administration for Children and Families (ACF) and the Administration for Community Living (ACL). To strengthen their selected components' application of internal controls to guidance processes, both of these administrations developed written procedures for guidance production. The purpose of the "ACF Policy for Clearance of Guidance Documents" is to provide clear and consistent guidance on the development and clearance of all guidance documents that ACF offices plan to release. Among other things, this document defines three distinct categories of sub-regulatory guidance documents, according to the type of information they contain, and identifies the development and review process that should be followed for each category. ACF established this review process to: (1) comply with OMB requirements; (2) enhance ACF's ability to identify when guidance from one part of ACF has implications for other parts of the organization; (3) ensure leadership visibility on ACF program activities and improve ACF's ability to inform others outside ACF, as appropriate; and (4) offer technical assistance when needed. ACL's "Issuing Policy Guidance: ACL Clearance and Standardization Processes" is intended to ensure consistency and help program managers determine and take into account the appropriate internal clearance process for any given document. The ACL document identifies the appropriate internal clearance processes to be followed, their expected timeframes, and the parties who should clear and/or have the opportunity to review and offer input regarding three categories of documents: (1) formal policy guidance and products, (2) informal guidance and products, and (3) communication products.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should strengthen their selected components' application of internal controls to guidance processes by adopting, as appropriate, practices developed by other departments and components, such as assessment of risk; written procedures and tools to promote the consistent implementation and communication of management directives; and ongoing monitoring efforts to ensure that guidance is being issued appropriately and has the intended effect. Examples of practices that could be adopted more widely include (1) written procedures for guidance production to, among other things, clearly define management roles; (2) improved communication tools, such as routing slips to document management review; and (3) consistent and ongoing monitoring to determine if guidance is being accessed and having the intended effect.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: In a May 2016 update on the status of this recommendation, Department of Labor officials stated that the Department had convened an internal working group meeting to share best practices on the application of internal control standards. To assist agencies in their development of internal controls, the Department also developed and disseminated a checklist for their consideration as they develop new non-significant guidance documents. The checklist includes sections on the reason for issuing guidance, analysis and engagement that should take place during guidance development, how the guidance should be cleared, and what should be considered for the rollout of the guidance.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should strengthen their selected components' application of internal controls to guidance processes by adopting, as appropriate, practices developed by other departments and components, such as assessment of risk; written procedures and tools to promote the consistent implementation and communication of management directives; and ongoing monitoring efforts to ensure that guidance is being issued appropriately and has the intended effect. Examples of practices that could be adopted more widely include (1) written procedures for guidance production to, among other things, clearly define management roles; (2) improved communication tools, such as routing slips to document management review; and (3) consistent and ongoing monitoring to determine if guidance is being accessed and having the intended effect.

    Agency Affected: Department of Labor

  7. Status: Closed - Implemented

    Comments: In 2016, the Food and Nutrition Service (FNS) adopted an Instruction prescribing FNS's process for development, clearance, and online distribution of non-significant guidance. The Instruction prescribes where guidance materials will be maintained and displayed on the FNS website, including highlighting newly released guidance.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should improve the usability of selected component websites to ensure that the public can easily find, access, and comment on online guidance. These improvements could be informed by the web and customer satisfaction metrics that components have collected on their websites. Some examples of changes that could facilitate public access to online guidance include (1) improving website usability by clarifying which links contain guidance; (2) highlighting new or important guidance; and (3) ensuring that posted guidance is current.

    Agency Affected: Department of Agriculture

  8. Status: Closed - Implemented

    Comments: In February 2017, Education officials shared with us (1) their summary of online guidance practices, (2) their summary of online guidance practices at agencies within other federal departments, (3) analysis of web metrics of Education's website, and (4) Education's compiled best practices for presenting guidance online.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should improve the usability of selected component websites to ensure that the public can easily find, access, and comment on online guidance. These improvements could be informed by the web and customer satisfaction metrics that components have collected on their websites. Some examples of changes that could facilitate public access to online guidance include (1) improving website usability by clarifying which links contain guidance; (2) highlighting new or important guidance; and (3) ensuring that posted guidance is current.

    Agency Affected: Department of Education

  9. Status: Open

    Comments: In comments printed in the April 2015 final report, HHS concurred with the recommendation and stated that it would review current links to guidance documents and explore ways to enhance their visibility and usability. As of July 2019, GAO is working with HHS officials to obtain additional updates and documentation regarding the department's implementation of this recommendation.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should improve the usability of selected component websites to ensure that the public can easily find, access, and comment on online guidance. These improvements could be informed by the web and customer satisfaction metrics that components have collected on their websites. Some examples of changes that could facilitate public access to online guidance include (1) improving website usability by clarifying which links contain guidance; (2) highlighting new or important guidance; and (3) ensuring that posted guidance is current.

    Agency Affected: Department of Health and Human Services

  10. Status: Closed - Implemented

    Comments: In July 2017, Labor provided us with updates on improvements made to their websites. Officials reported that all DOL public websites have been coded to facilitate participation in the federal Digital Analytics Program and that departmental officials co-led a presentation to the agencies on how to use their web metrics to inform guidance dissemination strategies. Labor components also took steps to improve the usability of their online guidance. For example, the Employee Benefits Security Administration worked with a usability expert on usability testing. The Mine Safety and Health Administration reported that they (1) clarified which links on their website contained guidance, (2) highlighted new guidance, and (3) ensured posted guidance is current.

    Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should improve the usability of selected component websites to ensure that the public can easily find, access, and comment on online guidance. These improvements could be informed by the web and customer satisfaction metrics that components have collected on their websites. Some examples of changes that could facilitate public access to online guidance include (1) improving website usability by clarifying which links contain guidance; (2) highlighting new or important guidance; and (3) ensuring that posted guidance is current.

    Agency Affected: Department of Labor

  11. Status: Closed - Implemented

    Comments: In July 2017, HHS provided GAO with an update on their new webpage for significant guidance. In accordance with OMB's Final Bulletin for Agency Good Guidance Practices, the new webpage for significant guidance, which can be accessed directly from the department's main regulatory webpage, provides links to significant guidance at HHS agencies and provides an email address for the public to submit comments on significant guidance.

    Recommendation: To better ensure the adherence to requirements for approval and public access to and feedback on significant guidance in accordance with OMB's Final Bulletin for Agency Good Guidance Practices (M-07-07), the Secretary of HHS should ensure that the department's significant guidance is accessible online and that the public can provide comments on significant guidance documents.

    Agency Affected: Department of Health and Human Services

 

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