By Jeffrey H. Brochin, J.D.
Proposed HHS regulations governing the agency’s release and maintenance of guidance documents would help 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.
HHS has issued a notice of proposed rulemaking described as a good guidance practices rule which is one component of the department’s broader regulatory reform initiative. The proposed rule is designed to increase accountability, improve the fairness of guidance issued by the department, guard against unlawful regulation through guidance, and safeguard the important principles underlying the United States administrative law system (Notice, 85 FR 51396, August 20, 2020).
Statutory and regulatory background. Subject to certain exceptions, the Administrative Procedure Act (APA), mandates that rules imposing new obligations on regulated parties must go through notice-and comment rulemaking. The mandate applies regardless of whether agencies frame those rules as sub-regulatory guidance, and the APA’s procedural requirements are deemed to comport with notions of good governance. Notwithstanding the APA mandate, agencies can generally issue interpretive rules and statements of policy without conducting notice and comment rulemaking, although such sub-regulatory guidance lacks the force and effect of law and cannot bind regulated parties.
Not applicable to the FDA. The proposed rule states explicitly that the regulations setting forth good guidance practices would apply to all divisions of HHS other than the FDA, due to the fact that the FDA currently operates under a set of good guidance practices regulations as required by the Federal Food, Drug, and Cosmetic Act (FDC Act); however, no other division within HHS operates under a similar set of regulations.
The FDA will be proposing amendments to its own good guidance practices regulations, which would revise the requirements at 21 CFR 10.115 and incorporate the directives of Executive Order 13891.
Defining "guidance documents." The proposed rule, if finalized, would apply to guidance documents (including those deemed significant documents") issued by the department. HHS proposes to define "guidance document" as any department statement of general applicability which is intended to have future effect on the behavior of regulated parties and which sets forth a policy on a statutory, regulatory, or technical or scientific issue, or an interpretation of a statute or regulation. Therefore, the contents of a transmission, rather than its format, would dictate whether it would constitute a guidance document, and guidance would not need to be in the form of a formal written document to constitute a "guidance document" under the proposed rule. Furthermore, guidance may exist in a variety of forms, including, but not limited to, letters, memoranda, circulars, bulletins, advisories, and preambles and may include video, audio, and Web-based formats.
"Significant guidance documents." HHS proposes to define "significant guidance document" as a guidance document that is likely to lead to 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 or obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles of Executive Order 12866, ‘‘Regulatory Planning and Review.’’
To calculate whether a guidance document is likely to have an annual effect on the economy of $100 million or more, HHS would be required to assess the benefits, costs, or transfer impacts imposed by that guidance document; as part of this analysis, any benefit, cost or transfer occurring in any consecutive twelvemonth period would be compared against the $100 million threshold. Future cost savings would not be used to offset upfront costs.
Requirements after effective date. HHS proposes to require that each guidance document issued by it or any component after the effective date of the proposed rule, if finalized, must also include the following information: (1) The activities to which and the persons to whom the guidance applies; (2) the date HHS issued the guidance document; (3) a unique agency identifier; (4) a statement indicating whether the guidance document replaces or revises a previously issued guidance document and, if so, identifying the guidance document that it replaces or revises; (5) a citation to the statutory provision(s) and/or regulation(s) (in Code of Federal Regulations format) that the guidance document is interpreting or applying; and (6) a short summary of the subject matter covered in the guidance document.
For guidance documents issued before the implementation date of the rule, HHS would not retrospectively revise those guidance documents to include the information listed in the foregoing paragraph. Any guidance document issued in conjunction with one or more other agencies would nonetheless be required to comply with all requirements that would be applicable if the guidance document were issued solely by HHS.
In order for the public’s comments to be assured consideration, comments must be received at one of the addresses listed in the Federal Register Notice, no later than 11:59 p.m. on September 16, 2020.
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