On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 55235). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS’s guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more.
On August 20, 2020, HHS published a Notice of Proposed Rulemaking that proposes to issue regulations governing the agency’s release and maintenance of guidance documents. See 85 FR 51396. These regulations should, if finalized, help to ensure that the public receives appropriate notice of new guidance and that the Department’s guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them. HHS has issued a Request for Information soliciting comments relating to the Department’s current compliance with Executive Order 13891, and in particular, seeks specific feedback about potential opportunities to improve and ensure the Department’s compliance with, and best practices relating to, the legal obligations governing the appropriate issuance of guidance. Comments are due on October 12, 2020 and should be submitted electronically to GuidanceRFI@hhs.gov.
DISCLAIMER: Please note, the contents of this database do not have the force and effect of law and are not meant to bind the public in any way. These documents are intended only to provide clarity to the public regarding existing requirements under the law or HHS policies.