HHS Request for Information on Deregulation

Content

ACTION:

Notice; request for information.

SUMMARY:

To implement the President's Deregulatory Initiatives, including Department of Government Efficiency Deregulatory Agenda,
and to better promote the health and well-being of the American people, the U.S. Department of Health and Human Services (HHS)
is planning the largest deregulatory effort in the history of the Department. To facilitate this effort, HHS seeks input from
all interested parties on how to dramatically deregulate across all areas the Department touches. HHS also welcomes other
submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed.

DATES:

To be assured consideration, comments must be received no later than 11:59 p.m. Eastern Time (ET) on July 14, 2025. HHS will
not reply individually to responders but will consider all comments submitted by the deadline.

ADDRESSES:

RFI Docket: You may examine the RFI docket at regulations.gov under Docket ID. AHRQ-2025-0001. The docket contains this RFI and all comments received to date. To submit a response, click
the “Comment” button inside Docket: AHRQ-2025-0001 and follow all instructions.

Regulations.gov: The public can also send HHS-specific deregulatory submissions for publication in the
Federal Register
at the following site: https://www.regulations.gov/deregulation.

FOR FURTHER INFORMATION CONTACT:

For additional information, direct questions to Jennifer Burnszynski or Laina Bush in the HHS Office of the Assistant Secretary
for Planning and Evaluation at osaspeinfo@hhs.gov or (202) 690-7858.

SUPPLEMENTARY INFORMATION:

Background: The President has issued two major, cross government Deregulatory Initiatives. First, on January 31, 2025, he issued E.O.
14192, “Unleashing Prosperity Through Deregulation” (90 FR 9065; February 6, 2025). This E.O. directs agencies to eliminate
10 regulations for each new regulation issued (“10-for-1”), as well as the direction that deregulation leads to significant
cost savings. In addition, on February 19, 2025, the President issued Executive Order 14219, “Ensuring Lawful Regulation and
Implementing the President's ‘Department of Government Efficiency’ Deregulatory Agenda” (90 FR 10583; February 25, 2025).
That order stated the policy of the Trump Administration is to focus the executive branch's limited enforcement resources
on regulations squarely authorized by constitutional Federal statutes and commence the deconstruction of the overbearing and
burdensome administrative state.

To implement the President's Deregulatory Initiatives, and to better promote the health and well-being of the American people,
HHS is planning the largest deregulatory effort in its history. However, HHS cannot accomplish this feat alone. As Secretary,
I believe that an important component of Making America Healthy Again is making sure that providers and caretakers can focus
on preventing and treating chronic diseases instead of having to do unnecessary or burdensome paperwork and otherwise comply
with Administrative burdensome requirements with no clear health benefit. As such, HHS is seeking input from the American
public on how to dramatically deregulate across all the areas the Department touches. Specifically, HHS welcomes submissions
explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed. Those submissions
may be entered in response to this RFI.

Ensuring Lawful Regulation

Pursuant to E.O.14219, agencies are required to identify and report to the Office of Information and Regulatory Affairs (OIRA)
within the Office of Management and Budget on regulations in one or more of the following categories:

(i) Unconstitutional regulations and regulations that raise serious constitutional difficulties, such as exceeding the scope
of the power vested in the Federal Government by the Constitution;

(ii) Regulations that are based on unlawful delegations of legislative power;

(iii) Regulations that are based on anything other than the best reading of the underlying statutory authority or prohibition;

(iv) Regulations that implicate matters of social, political, or economic significance that are not authorized by clear statutory
authority;

(v) Regulations that impose significant costs upon private parties that are not outweighed by public benefits;

(vi) Regulations that harm the national interest by significantly and unjustifiably impeding technological innovation, infrastructure
development, disaster response, inflation reduction, research and development, economic development, energy production, land
use, and foreign policy objectives; and

(vii) Regulations that impose undue burdens on small business and impede private enterprise and entrepreneurship.

After receiving this report, OIRA is instructed to consult with agency heads to develop a Unified Regulatory Agenda to rescind
or modify identified regulations as appropriate and consider these factors when evaluating potential new regulations.

Unleashing Prosperity Through Deregulation

Pursuant to E.O. 14192, agencies have been charged with the following requirements:

(a) Unless prohibited by law, whenever an agency proposes for notice and comment or otherwise promulgates a new regulation,
it shall identify at least 10 existing regulations to be repealed.

(b) For fiscal year 2025, all agencies must ensure that the total incremental cost of all new regulations, including repealed
regulations, being finalized is significantly less than zero, as determined by the Director of the Office of Management and
Budget (OMB), unless otherwise required by law or instructions from OMB.

(c) Any new incremental costs associated with new regulations must, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least 10 prior regulations. Further, Executive Order 14192 requires that for fiscal year
2026, and each fiscal year thereafter, the head of each agency identify, on an aggregated basis, for regulations that increase
incremental cost, offsetting regulations and provide the agency's best approximation of the total costs or savings associated
with each new regulation or repealed regulation. During the Presidential budget process, the Director of the Office of Management
and Budget will identify for each agency a total amount of incremental costs that will be allowed for such agency in issuing
new regulations and repealing regulations for each fiscal year after fiscal year 2025. No regulations exceeding the agency's
total incremental cost allowance will be permitted in that fiscal year, unless required by law or approved in writing by the
Director. The total incremental cost allowance may allow an increase or require a reduction in total regulatory cost. Subsequent
OMB Guidance Implementing section 3 of Executive Order 14192 provides the following definitions:

An “E.O. 14192 regulatory action” is: (i) A significant regulatory action as defined in section 3(f) of E.O. 12866 that has
been finalized and that imposes total costs greater than zero; or (ii) A significant guidance document, broadly conceived,
(e.g., significant interpretive guidance) reviewed by OIRA under the procedures of E.O. 12866 that has been finalized and that imposes
total costs greater than zero. For example, E.O. 14192 regulatory actions include negotiated rulemakings that are significant
as defined in section 3(f) of E.O. 12866, that have been finalized, and that impose total costs greater than zero.

An “E.O. 14192 deregulatory action” is an action that has been finalized and has total costs less than zero. An E.O. 14192
deregulatory action qualifies as both: (1) one of the actions used to satisfy the provision to repeal or revise

  at least 10 existing regulations for each regulation issued, and (2) a cost savings for purposes of the total incremental
  cost allowance. E.O. 14192 deregulatory actions are not limited to those defined as significant under E.O. 12866 or OMB's *Final Bulletin on Good Guidance Practices.* An E.O. 14192 deregulatory action may be issued in the form of an action in a wide range of categories of actions, including,
  but not limited to: Informal, formal, and negotiated rulemaking; Guidance and interpretive/interpretative documents; Some
  actions related to international regulatory cooperation; and Information collection requests that repeal or streamline recordkeeping,
  reporting, or disclosure requirements. Significant proposed rules issued before noon on January 20, 2025, that are formally
  withdrawn by notice in the 
  Federal Register
  and removed from the *Unified Agenda of Regulatory and Deregulatory Actions* may also qualify as repeal actions, but do not qualify for cost savings.

Request for Information

During President Trump's first administration, HHS undertook nearly 400 deregulatory actions to increase efficiency and reduce
burden on the healthcare system. These efforts were facilitated by public comment received in response to HHS's Regulatory
Relief To Support Economic Recovery; RFI (85 FR 75720, November 25, 2020) and HHS's RFI on Redundant, Overlapping, or Inconsistent
Regulations (85 FR 76003, November 27, 2020).

Although that was a good start, HHS intends to dramatically expand its deregulatory efforts. The public should help HHS identify
any opportunities to produce cost savings, increase efficiency, and stoke health and economic innovation through deregulation.

HHS's goal is to address regulations that are unnecessary, inconsistent with the law, overly burdensome, outdated, out of
alignment with current Executive orders, or otherwise unsound. Consistent with Secretary Kennedy's commitment to radical transparency,
HHS will involve the public in this process and values the perspectives and knowledge of those outside of the Federal Government,
particularly those served by HHS and those who help carry out its mission. As HHS conducts a thorough review of all regulations
in its purview pursuant to the Executive orders described above, HHS is seeking input from a full range of stakeholders, including
health care providers and suppliers; State, local, territorial, and Tribal governments; health and drug plans and payers;
human services agencies; public health agencies; community- and faith-based organizations; long term care facilities; pharmacist
and pharmacy associations; health and human services professional organizations; farmers and food producers; patient advocacy
groups and organizations; people living with chronic disease and their family members; researchers; health technology organizations;
and other businesses.

The most helpful submissions are those that HHS can publish in the
Federal Register
with minimal revision—whether as notices of proposed rulemaking (NPRMs), direct final rules (DFRs), or other notices—rescinding
previous rulemakings or provisions in the Code of Federal Regulations. These submissions should be entered at https://www.regulations.gov/deregulation.

Instructions

Responses submitted at regulations.gov/deregulation should follow the format provided there. You may respond to one or more of the questions listed below and please include question
numbers provided in the response. Each responding entity (person or organization) is requested to submit only one response
per regulation or guidance. Unless submitted anonymously, responses should include the name(s) of the person(s) or organization(s)
submitting the comment. If a comment is submitted on behalf of an organization, the individual respondent's role in the organization
may also be provided.

In a clear and concise manner, please describe how the recommendation would lead to cost savings, how much savings are anticipated,
and the statutory authority that would permit HHS to act on the recommendation. Respondents should identify the specific regulation,
guidance, or requirement at issue along with its administering HHS division. Where practical, please also include data, legal
citations, quantitative estimates, and recommended actions. Economic data to demonstrate costs and savings are strongly encouraged,
with an emphasis on the especially ambitious deregulatory ideas that may require a stronger evidentiary basis. Analyses that
conform to OMB guidance to Federal agencies on the development of regulatory analysis, Circular A-4 (2003), and to the HHS
Guidelines for Regulatory Impact Analysis (2016), are similarly encouraged. Comments containing references, studies, research,
or other empirical data that are not widely published should include electronic links or copies of the referenced materials
attached as an appendix.

This RFI is voluntary, and responses may be submitted anonymously. Comments submitted in response to this RFI may be posted
on HHS websites or otherwise released publicly. Please do not submit proprietary, classified, confidential, or sensitive information,
to include personally identifiable (PII) or personal health information (PHI), in response to this RFI.

This RFI is for information and planning purposes only and should not be construed as a policy, solicitation for applications,
or as an obligation on the part of the government to provide support for any ideas in response to it. HHS will use the information
submitted at its discretion and will not comment on any respondent's submission. Respondents are advised that the government
is not obligated to acknowledge receipt of the information received or provide feedback to respondents concerning any information
submitted. Those submitting responses are solely responsible for all expenses associated with response preparation.

Questions

1. What HHS regulations and/or guidance meet one or more of the following seven criteria identified in E.O. 14219? Should they be modified or repealed? What would be the impact of this change, especially the costs and savings?

• Unconstitutional regulations and regulations that raise serious constitutional difficulties, such as exceeding the scope
  of the power vested in the Federal Government by the Constitution;

• Regulations that are based on unlawful delegations of legislative power;

• Regulations that are based on anything other than the best reading of the underlying statutory authority or prohibition;

• Regulations that implicate matters of social, political, or economic significance that are not authorized by clear statutory
  authority;

• Regulations that impose significant costs upon private parties that are not outweighed by public benefits;

• Regulations that harm the national interest by significantly and unjustifiably impeding technological innovation, infrastructure
  development, disaster response, inflation reduction, research and development, economic development, energy production, land
  use, and foreign policy objectives; or

• Regulations that impose undue burdens on small business and impede private enterprise and entrepreneurship

1. What regulations should we reconsider as we look to achieve some of the policy objectives outlined in Executive Order 14212,
   “Establishing the President's Make America Healthy Again Commission,” to focus on reversing chronic disease?

2. For more general deregulatory consideration under E.O. 14192, are there additional HHS regulations and/or guidance that:

• Are confusing or unnecessarily complicated;

• Require an excessive number of reports or unreasonable record keeping, or information that is not needed or used effectively;

• Impose requirements on the wrong individual or group;

• Carry excessive penalties;

• Are conflicting (examples include but are not limited to conflicts between HHS and State regulations, public and private
  sectors);

• Impede access to or delivery of care or services;

• Impede efforts to innovate

• Are obsolete; and/or

• Otherwise interfere with the public or private sector's ability to address chronic health conditions or otherwise promote
  the health and wellbeing of Americans?

Should they be modified or repealed? What would be the impact of this change, especially the costs and savings?

1. What alternative approaches could be taken to achieve or accomplish the same goal with a lesser burden? For example, are
   there less burdensome approaches that are used by other entities such as State governments or private companies that could
   be adopted by HHS to achieve its goal with less burdensome requirements? What would be the impact on costs and savings?

2. Are there HHS regulations, guidance, or reporting requirements that are rooted in outdated technology? Can new technologies
   be leveraged to allow for rescinding or updating these policies? What are the cost implications?

3. Are there HHS regulations, guidance, or reporting requirements that are inconsistent with Executive Orders 14151, 14154,
   14168, and 14213 or others issued by the President? Should they be modified or rescinded to make them consistent?

Robert F. Kennedy, Jr., Secretary, United States Department of Health and Human Services. [FR Doc. 2025-08384 Filed 5-13-25; 8:45 am] BILLING CODE 4150-05-P

Download File

Download