HHS Issues Proposed Rule on Guidance Documents

Situation Report | August 24, 2020

The U.S. Department of Health and Human Services (HHS) has issued a proposed regulation governing the agency’s release and maintenance of guidance documents. According to HHS, it “would 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 proposes to require that each guidance document it issues must also include certain information including: its object and audience; a date and unique agency identifier; clarification as to whether the guidance is an update or revision of previous guidance; statutory citations; and other requirements.

HHS also proposes that, prior to issuing any “significant” guidance document (defined as anticipated to lead to an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy), HHS must also offer a public notice and comment period of at least 30 days.

HHS proposes to make its guidance documents available through a fully text-searchable online repository at www.hhs.gov/guidance by November 2, 2020.