Comment-Letter_Advocacy-Comments-to-HHS-Deregulatory-RFI

Sep 21, 2026

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Letter dated July 14, 2025 from the U.S. Department of Health and Human Services Office of Advocacy responding to the agency’s request for information on deregulating health-related rules. It explains the Office of Advocacy’s role under the Regulatory Flexibility Act and SBREFA, emphasizing minimizing economic impacts and avoiding unnecessary burdens on small entities. It summarizes the outreach used to gather small business perspectives and supports HHS efforts to identify deregulatory opportunities for regulatory relief to small businesses.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages60

Reading Time2 h 31 min

AccessFree to download

Background

The Office of Advocacy

HHS’ Request for Information (RFI)

Advocacy’s Small Business Concerns

July 14, 2025 VIA ELECTRONIC SUBMISSION The Honorable Robert F. Kennedy, Jr. Secretary U.S. Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: Health and Human Services’ Request for Information: Ensuring Lawful Regulation and Unleashing Innovation to Make American Healthy Again, Docket No. 2025-08384. Dear Secretary Kennedy: On May 14, 2025, the United States Department of Health and Human Services (HHS) published a request for information on the deregulation of its rules and policies to increase efficiency and reduce burden on the healthcare system. 1 This letter constitutes the Office of Advocacy’s (Advocacy) public comments to the agency’s solicitation which identify rules for consideration to be revised or repealed that are of interest to affected small entities. Advocacy supports HHS’ efforts to identify opportunities to reduce regulatory burdens throughout all sectors ofthe economy. The Regulatory Flexibility Act (RFA)2 directs Advocacy to work with federal agencies to minimize the economic impacts of regulations on small entities. HHS’ request for information aligns with Advocacy’s mission and will help identify deregulatory opportunities designed to provide regulatory relief to small businesses. Advocacy encourages HHS to prioritize responses on any deregulatory ideas proposed by small entities. I. Background A. The Office of Advocacy Congress established the Office of Advocacy under Pub. L. 94-305 to represent the views of small entities before federal agencies and Congress. Advocacy is an independent office within the U.S. Small Business Administration (SBA) that seeks to ensure small business concerns are heard in the federal regulatory process. Advocacy also works to ensure that regulations do not 1 90 Fed. Reg. 20478 (May 14, 2025) . 2 Regulatory Flexibility Act, Pub. L. No. 96-354, 94 Stat. 1164 (1980) (codified at 5 U. S.C. §§ 601-612) . unduly inhibit the ability of small entities to compete, innovate, or comply with federal laws. The views expressed by Advocacy do not necessarily reflect the views ofthe SBA or the Administration. The RFA, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), 3 gives small entities a voice in the rulemaking process. For all rules that are expected to have a significant economic impact on a substantial number of small entities, the RFA requires federal agencies to assess the impact of the proposed rule on small entities and to consider less burdensome alternatives.4 If a rule is not expected to have a significant economic impact on a substantial number of small entities, agencies may certify it as such and submit a statement of the factual basis for such a determination that adequately supports its certification.5 The Small Business Jobs Act of 2010 requires agencies to give every appropriate consideration to comments provided by Advocacy.6 The agency must include a response to these written comments in any explanation or discussion accompanying the final rule’s publication in the Federal Register, unless the agency certifies that the public interest is not served by doing so.7 Advocacy’s comments are consistent with Congressional intent underlying the RFA, that“[w]hen adopting regulations to protect the health, safety, and economic welfare of the nation, federal agencies should seek to achieve statutory goals as effectively and efficiently as possible without imposing unnecessary burdens on the public.”8 B. HHS’ Request for Information (RFI) HHS is seeking “to address regulations that are unnecessary, inconsistent with the law, overly burdensome, outdated, out of alignment with current Executive Orders (EO), or are otherwise unsound.” Specifically, HHS is seeking input from a full range of stakeholders, including healthcare providers and suppliers; state, local, territorial, and Tribal governments; health and drug plans and payers; human service

FAQs

What is the purpose of this letter to HHS?

The letter provides the Office of Advocacy’s public comments in response to HHS’s request for information on deregulating rules and policies to increase efficiency and reduce burdens on the healthcare system.

How does the Regulatory Flexibility Act affect Advocacy’s work?

The RFA directs the Office of Advocacy to work with federal agencies to minimize the economic impacts of regulations on small entities and to consider less burdensome alternatives in rulemaking.

What kinds of stakeholders does HHS seek input from in its RFI?

HHS seeks input from a wide range of healthcare and community stakeholders, including providers, suppliers, government entities, payers, public health organizations, long-term care facilities, patient advocacy groups, researchers, health technology organizations, farmers and food producers, and other businesses.

Sep 21, 2026

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