[Federal Register Volume 90, Number 92 (Wednesday, May 14, 2025)]
[Notices]
[Pages 20478-20481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08384]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Request for Information (RFI): Ensuring Lawful Regulation and
Unleashing Innovation To Make American Healthy Again
AGENCY: Department of Health and Human Services.
ACTION: Notice; request for information.
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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be repealed.
[[Page 20479]]
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
[email protected] 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
[[Page 20480]]
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
[[Page 20481]]
2. 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?
3. 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?
4. 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?
5. 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?
6. 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]
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