"For decades, presidents have said agencies should retrospectively review their regulations," HHS Secretary Alex Azar said. "Under President Trump, HHS is actually doing it. Our proposed rule is an effective way to deliver on the requirements of the Regulatory Flexibility Act, signed by President Carter and on the books since 1980.

"With HHS regulatory responsibilities as wide-ranging as food safety, drug approval, adoption and child care, and health-care financing, it's essential that we know — and inform the American people — whether we're executing on these responsibilities in a way that maximizes benefits, minimizes costs and keeps up with the times."

Under the proposed rule, any regulation issued by HHS (with certain exceptions) will cease to be effective 10 years after it is issued, unless the department performs a plenary assessment of the regulation and a more detailed review of those regulations that have a significant economic impact upon a substantial number of small entities. HHS regulations will be subject to a two-step review:

1. Assessing whether they have a significant economic impact on a substantial number of small entities, the standard set out under the RFA; and
2. If it qualifies for review under the RFA, a more detailed review that will consider the continued need for the rule, complaints about it, the rule's complexity, the extent to which it duplicates or conflicts with other rules and whether technological, economic and legal changes favor amending or rescinding the rule.

Retrospective reviews of the costs and benefits of federal regulations has long been a goal of presidents and regulatory experts across the political spectrum, according to the department. This proposed rule seeks to increase transparency, public participation and democratic accountability. As part of the review process, the public can submit comments on the impact of regulations.

The proposed rule will be subject to a public comment period, and there also will be a public hearing. Depending on the public comments, HHS could finalize a version of this rule after the public comment period concludes.

"This proposal — the boldest and most significant regulatory reform effort ever undertaken by HHS — would sunset burdensome regulations unless their necessity is publicly demonstrated to the American people," HHS Chief of Staff Brian Harrison said.

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