On May 14, 2025, the Department of Health and Human Services (HHS) published in the Federal Register a Request for Information (RFI) on “Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again.” The RFI requests input from the public to “help HHS identify any opportunities to produce cost savings, increase efficiency, and stoke health and economic innovation through deregulation.” “HHS’s goal,” the Department explains, “is to address regulations that are unnecessary, inconsistent with the law, overly burdensome, outdated, out of alignment with current Executive orders, or otherwise unsound.” Members of the public may submit deregulatory proposals at regulations.gov/deregulation. The deadline for submissions is 11:59 p.m. ET on July 14, 2025.
Background
The RFI builds off existing deregulatory actions by the Trump Administration including:
- Executive Order 14219 “Ensuring Lawful Governance” which required agencies to identify and report to the Office of Information and Regulatory Affairs (OIRA) regulations that meet certain criteria including those that are (1) unconstitutional; (2) based on unlawful delegation of legislative power; (3) not based on the best reading of the statute; (4) implicating matters of social, political, or economic significance that are not authorized by clear statutory authority; (5) imposing significant costs upon private parties that are not outweighed by public benefits; (6) impeding technological innovation, infrastructure development, disaster response, inflation reduction, research and development, economic development, energy production, land use, and foreign policy objectives; and (7) imposing undue burdens on small business and impeding private enterprise and entrepreneurship.
- Executive Order 14192 “Unleashing Prosperity Through Deregulation” which requires that agencies proposing new regulations identify at least 10 existing regulations to be repealed. The Executive Order also imposes a “regulatory cap,” requiring that the incremental cost of all new regulations, including those repealed through regulations, be “significantly less than zero” for Fiscal Year 2025. Starting with Fiscal Year 2026 and each fiscal year thereafter, each agency head must identify offsetting regulations for each regulation that increases incremental costs.
- Guidance Implementing Section 3 of Executive Order 14192, Titled “Unleashing Prosperity Through Deregulation.” The guidance implementing EO 14192 provides additional details on the “regulatory cap” provisions, including definition of “EO 14192 regulatory action” as a “significant” regulatory action or guidance document that has been finalized that imposes total costs greater than zero. The guidance also defines an “EO 14192 deregulatory action” as “an action that has been finalized and has total costs less than zero.”
This RFI complements earlier efforts by the Administration to solicit public input on deregulatory options. On April 11, the Office of Management and Budget (OMB) issued an RFI seeking “comment from the public on regulations that are unnecessary, unlawful unduly burdensome, or unsound.” Submissions were due by May 12. On the same day, the Centers for Medicare & Medicaid Services (CMS) issued an RFI titled “Unleashing Prosperity Through Deregulation of the Medicare Program.” CMS is seeking “public input on approaches and opportunities to streamline regulations and reduce administrative burdens on providers, suppliers, beneficiaries, Medicare Advantage and Part D plans, and other stakeholders participating in the Medicare program.” Submissions are due by June 10.
Instructions for Submissions
Responses to the HHS RFI can be submitted to regulations.gov/deregulation through July 14, 2025. HHS recommends that responses include the following information:
- Details on how the recommendation would lead to cost savings including data, legal citations, and quantitative estimates, as appropriate;
- The amount of savings anticipated including, where possible, economic data to demonstrate cost savings; and
- Statutory authority that would permit CMS to act on the recommendation.
In addition, HHS includes guiding questions in the RFI to help commenters identify regulations that could be modified or repealed. These questions broadly focus on how deregulatory efforts can help accomplish the President’s deregulatory goals including the objectives of Executive Orders 14219 and 14192, how HHS can achieve similar outcomes with a lesser burden, and whether existing regulations are grounded in outdated technologies.
Opportunities and Challenges for Stakeholders
The RFI presents a new opportunity for stakeholders to identify regulations, guidance, or enforcement actions that could be rescinded or modified by the Administration. At the same time, the deregulatory agenda broadly could present challenges to life sciences companies, particularly if critical FDA or CMS regulations are identified for rescission.
Covington has been actively advising stakeholders on deregulatory options for HHS, FDA, and CMS. If you would like to discuss how the RFI affects your organization, please contact the authors of this alert.
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