Agency guidance documents are not legally binding. Guidance documents are considered “significant” when they have a broad and  substantial impact on regulated entities, on the public or on other federal agencies. In  1997, Congress established certain aspects of FDA’s guidance processes  as law and directed the agency to evaluate the effectiveness of its  practices and develop and issue regulations specifying its procedures.FDA’s Good Guidance regulations define the subset of guidance that  must be published in the Federal Register.internal policies and practices to ensure appropriate adherence to their  good guidance practices, including a written process to document  decisions about the appropriate level of review for each guidance  document. Departments and Components Used Guidance for Multiple Purposes and Weighed Various Factors when Deciding whether to Issue Regulations or Guidance

		Components Issued a Wide Variety of Guidance Serving Multiple Purposes

Component officials used guidance for multiple purposes, including  interpreting regulations, disseminating suggested practices, and providing  grant administration information. Agency Guidance Processes Differed and Could Be Strengthened by Enhanced Internal Controls

		Two of Four Selected Departments Had Written Procedures for Significant Guidance as Directed by OMB’s Good Guidance Practices

What are the OMB Good Guidance  Practices for Approval of Significant  Guidance? However, without written procedures or wide  knowledge of these procedures—a basic internal control standard—HHS  and DOL may be unable to ensure that their components consistently  follow other requirements of the OMB bulletin, such as required standard  elements for significant guidance, and cannot ensure consistency in their  processes over time. In the Absence of Specific Government-Wide Standards for Non- significant Guidance, Components Could Strengthen Application of Internal Controls

As previously discussed, the Administrative Procedures Act does not  establish standards for the production of guidance. Officials told us that feedback from external  nonfederal stakeholders often served as the impetus for the initiation  of guidance, and 15 of the 25 selected components cited examples in  which they conferred with external nonfederal stakeholders during the  guidance development process. We found that Education, USDA, and DOL consistently  applied OMB Bulletin requirements for public access and feedback for  significant guidance while HHS did not. Highlighted new or important guidance. Easy access to current and relevant  guidance could also facilitate opportunities for affected parties and  stakeholders to provide feedback on those documents. However, many  components did not use web metrics to improve how they disseminated  guidance through their websites (see table 4). Because all components we studied primarily relied on their  websites to disseminate guidance, there is an opportunity for them to  build on their use of web metrics to improve how they disseminate  guidance online. Further, officials reported receiving useful feedback directly  from the public at conferences, webinars, stakeholder/grantee meetings,  or from monitoring visits. Education and USDA had  written departmental procedures for the approval of significant guidance,  as directed by the OMB bulletin. Further,  not all components documented approval for guidance clearance and  nearly half of them did not regularly evaluate whether issued guidance  was effective and up to date. Education stated that it will review  components’ procedures for guidance development and production and  develop and provide to its components standard protocols they can use to  clarify management roles, document management review and approval of  guidance, and review posted guidance to ensure it is current and  accessible to the public. USDA generally concurred with  our recommendations. For this report, we reviewed how the Departments  of Agriculture, Education, Health and Human Services, and Labor and  selected subagencies or components at these four departments (1) use  guidance and the processes and criteria they use to determine whether to  issue guidance or undertake rulemaking; (2) follow applicable criteria and  leading practices in their policies, procedures, and practices for producing  guidance; and (3) ensure they follow dissemination requirements and  facilitate end users’ access to and comment on documents. The scope of review included the 25 selected subagencies, or  components, in the four selected departments that (1) were within the  requesting committee’s jurisdiction, and (2) engaged in regulatory or  grantmaking activities, as the components engaged in these activities  were likely to issue guidance interpreting regulations or other  requirements to external parties (in contrast to agencies that issue only  informational guidance or other resources). Agency Use of Guidance. Used web metrics to evaluate  online guidance dissemination? Typically, it decided to issue guidance in close  consultation with the department’s Office of the General Counsel (OGC). OLMS had no written  procedures for the guidance production process.
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 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.

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.