[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Proposed Rules]
[Pages 59478-59483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-23484]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 84
RIN 0945-AA27
Nondiscrimination on the Basis of Disability in Programs or
Activities Receiving Federal Financial Assistance
AGENCY: Office for Civil Rights (OCR), Office of the Secretary,
Department of Health and Human Services.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Department of Health and Human Services (HHS or
Department) issues this Notice of Proposed Rulemaking (NPRM) to revise
45 CFR 84.4(g) in the regulation implementing section 504 of the
Rehabilitation Act of 1973 (section 504) as it applies to recipients of
HHS funding (entitled ``Nondiscrimination on the Basis of Disability in
Programs or Activities Receiving Federal Financial Assistance,'' 89 FR
40066 (``2024 Final Rule'')), published on May 9, 2024. This rule
clarifies that the Department interprets the statutory exclusion of
``gender identity disorders not resulting from physical impairments''
from the definitions of ``individual with a disability'' and
``disability'' set forth at 29 U.S.C. 705(9) & (20)(F)(i), 42 U.S.C.
12211(b), to encompass ``gender dysphoria not resulting from a physical
impairment'' for purposes of part 84. This clarification is necessary
to resolve ambiguity introduced in the preamble to the 2024 Final Rule
and to ensure compliance with the best reading of the plain language of
the governing statute.
DATES: Comments: Submit comments on or before January 20, 2026.
ADDRESSES: You may submit comments to this proposed rule, identified by
RIN Number 0945-AA27, by any of the following methods. Please do not
submit duplicate comments.
Federal eRulemaking Portal: You may submit electronic comments at
https://regulations.gov by searching for the Docket ID number XXXXX.
Follow the instructions for submitting electronic comments. If you are
submitting comments electronically, the department strongly encourages
you to submit any comments or attachments in Microsoft Word format. If
you must submit a comment in Adobe Portable Document Format (PDF), the
Department strongly encourages you to convert the PDF to ``print-to-
PDF'' format, or to use some other commonly used searchable text
format. Please do not submit the PDF in scanned format. Using a print-
to-PDF allows the Department to electronically search and copy certain
portions of your submissions to assist in the rulemaking process.
Regular, Express, or Overnight Mail: You may mail written comments
to the following address only: U.S. Department of Health and Human
Services, Office for Civil Rights, Attention: Disability NPRM, RIN
0945-AA27, Hubert H. Humphrey Building, Room 509F, 200 Independence
Avenue SW, Washington, DC 20201.
All comments received by the methods and due date specified above,
or officially post marked by the due date above, will be posted without
change to content to https://www.regulations.gov, including any
personal information provided, and such posting may occur after the
closing of the comment period.
However, the Department may redact certain non-substantive content
from comments before posting, including threats, hate speech,
profanity, graphic images, or individually identifiable information
about an individual third-party other than the commenter. In addition,
comments or material designated as confidential or not to be disclosed
to the public will not be accepted. Comments may be redacted or
rejected as described above without notice to the commenter, and the
Department will not consider in rulemaking any redacted or rejected
content that would not be made available to the public as part of the
administrative record. Because of the large number of public comments
normally received on Federal Register documents, the Office for Civil
Rights is not able to provide individual acknowledgements of receipt.
Please allow sufficient time for mailed comments to be timely
received in the event of delivery or security delays.
Please note that comments submitted by fax or email and those
submitted or postmarked after the comment period will not be accepted.
Docket: For a plain language summary of the proposed rule and
complete access to background documents or posted comments, go to
https://www.regulations.gov and search for Docket ID number XXXXX.
FOR FURTHER INFORMATION CONTACT: John Thompson, Office for Civil
Rights, Department of Health and Human Services at (202) 545-4884 or
(800) 537-7697 (TDD), or via email at [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
a. Statutory Framework
b. Medical Diagnostic History of ``Gender Dysphoria''
c. Fourth Circuit Interpretation and Litigation
II. Legal Authority
III. Reasons for the Proposed Rulemaking
IV. Alternatives Considered
V. Executive Order 12866 and Related Executive Orders on Regulatory
Review
a. Executive Order 12866 Determination
b. Executive Order 12250 on Leadership and Coordination of
Nondiscrimination
c. Regulatory Flexibility Analysis--Initial Small Entity
Analysis
d. Executive Order 13132: Federalism
e. Executive Order 13175: Tribal Consultation
f. Paperwork Reduction Act
g. Executive Order 14192: Deregulation
VI. Request for Comment
Background
Statutory Framework
Section 504 of the Rehabilitation Act of 1973, codified at 29
U.S.C. 794, prohibits discrimination on the basis of disability in
federally assisted and federally conducted programs and activities.
Specifically, 29 U.S.C. 794(a) provides: ``No otherwise qualified
individual with a disability in the United States, as defined in
section 705(20) of this title, shall, solely by reason of his or her
disability, be excluded from the participation in, be denied the
benefits of, or be subjected to discrimination under any program or
activity receiving Federal financial assistance or under any program or
activity conducted by any Executive agency[.]'' The HHS Office for
Civil Rights (OCR) enforces section 504 as well as other statutes that
prohibit discrimination on the basis of disability. Although the
Rehabilitation Act predates the Americans with Disabilities Act of 1990
(ADA), Congress subsequently amended the Rehabilitation Act, through
the Rehabilitation Act Amendments of 1992 (Pub. L. 102-569, sec. 102,
106 Stat 4344), to align key definitions in the Rehabilitation Act with
key definitions in the ADA. Under these amendments, the term
``individual with a disability'' ``does not include an individual on
the basis of . . . transvestism, transsexualism, pedophilia,
exhibitionism, voyeurism, gender
[[Page 59479]]
identity disorders not resulting from physical impairments, or other
sexual behavior disorders.'' 29 U.S.C. 705(20)(F)(i).
Congress amended the Rehabilitation Act again, in the ADA
Amendments Act of 2008 (Pub. L. 110-325, sec. 7, 122 Stat 3553), to
further align the Rehabilitation Act definitions with the ADA.
Specifically, 29 U.S.C. 705(9)(B) states: ``The term `disability' means
. . . for purposes of [section 504], the meaning given it in section
12102 of [the ADA].'' In addition, the definition of ``individual with
a disability'' at 29 U.S.C. 705(20)(B) was revised for purposes of
section 504 to mean ``any person who has a disability as defined in
section 12102 of [the ADA].'' Under the ADA, 42 U.S.C. 12102(1),
``disability'' means: ``(A) a physical or mental impairment that
substantially limits one or more major life activities of such
individual; (B) a record of such an impairment; or (C) being regarded
as having such an impairment.'' The ADA, at 42 U.S.C. 12211(b),
explicitly excludes certain conditions from the definition of
``disability.'' Specifically, 42 U.S.C. 12211(b)(1) states that,
``under this Chapter,'' on Equal Opportunity for Individuals with
Disabilities,''[t]he term `disability' shall not include (1)
transvestism, transsexualism, pedophilia, exhibitionism, voyeurism,
gender identity disorders not resulting from physical impairments, or
other sexual behavior disorders[.]'' Thus, any regulatory
interpretation of section 504 must adhere to these identical statutory
exclusions from the definitions of ``individual with a disability'' and
``disability.''
Relevant Medical Diagnostic History of ``Gender Dysphoria''
At the time Congress passed the ADA, the American Psychiatric
Association's Diagnostic and Statistical Manual (DSM), third edition
(1987) (``DSM-III-R'') described a set of disorders as ``gender
identity disorders.'' DSM-III-R at 71-78. This set of disorders
included ``Gender Identity Disorder of Childhood,'' ``Transsexualism,''
``Gender Identity Disorder of Adolescence or Adulthood, Nontranssexual
Type (GIDAANT),'' and ``Gender Identity Disorder Not Otherwise
Specified.'' Id. As described in DSM-III-R, the ``essential feature of
the disorders included in this subclass [Gender Identity Disorders] is
an incongruence between assigned sex (i.e., the sex that is recorded on
the birth certificate) and gender identity.'' Id. at 71.
The descriptions for each of the disorders within the DSM-III-R's
set of ``Gender Identity Disorders'' tracked this essential feature.
``Gender Identity Disorder of Childhood'' was marked by ``persistent
and intense distress in a child about his or her assigned sex and the
desire to be, or insistence that he or she is, of the other sex.'' Id.
at 71. An ``essential feature[ ]'' of ``transsexualism'' included ``a
persistent discomfort and sense of inappropriateness about one's
assigned sex in a person who has reached puberty.'' Id. at 74. GIDAANT
similarly included ``a persistent or recurrent discomfort and sense of
inappropriateness about one's assigned sex[.]'' Id. at 76. Finally,
``Gender Identity Disorder Not Otherwise Specified'' served as a catch-
all for ``[d]isorders in gender identity that are not classifiable as a
specific Gender Identity Disorder.'' Id. at 77. The conditions were
associated with symptoms such as anxiety and depression. Id. at 72, 74,
76.
The DSM-III-R was in effect at the time Congress passed the
exclusionary language at issue. Later, the diagnostic framework in the
DSM-III-R was revised in the DSM fourth edition (1994) (``DSM-IV'') to
describe a singular condition, ``Gender Identity Disorder.'' DSM-IV at
532-38.\1\ The DSM-IV's description of ``Gender Identity Disorder''
included a diagnostic criterion that the condition ``causes clinically
significant distress or impairment in social, occupational, or other
important areas of functioning.'' DSM-IV at 538.
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\1\ The DSM-IV also included a category for ``Gender Identity
Disorder Not Otherwise Specified'' that was ``included for coding
disorders in gender identity that are not classifiable as a specific
Gender Identity Disorder,'' and which could be used, for example,
``for individuals who have a gender identity problem with a
concurrent congenital intersex condition.'' DSM-IV at 537, 538.
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In 2013, the American Psychiatric Association revised its
terminology in the DSM fifth edition (``DSM-5''), replacing the section
on ``Gender Identity Disorder'' with a section on ``Gender Dysphoria.''
DSM-5 at 451-59. In DSM-5, ``[g]ender dysphoria refers to the distress
that may accompany the incongruence between one's experienced or
expressed gender and one's assigned gender.'' Id. at 451. The DSM-5
explained that the terminology change was because ``[t]he current term
is more descriptive than the previous DSM-IV term gender identity
disorder and focuses on dysphoria as the clinical problem, not identity
per se.'' Id.
The diagnostic criteria for ``gender dysphoria'' remained
functionally similar to the criteria for gender identity disorder(s) in
previous versions of the DSM. To qualify for a diagnosis of gender
dysphoria under DSM-5, a person must exhibit a ``marked incongruence
between one's experienced/expressed gender and assigned gender'' ``of
at least six months' duration,'' as manifested through specific urges
or convictions. Id. at 452. ``The condition is associated with
clinically significant distress or impairment in social, occupational,
or other important areas of functioning.'' Id. at 452-53. Importantly,
the American Psychiatric Association explicitly acknowledged that this
was not the creation of a new diagnosis, but rather a reframing of the
same condition: ``This diagnosis is a revision of DSM-IV's criteria for
gender identity disorder and is intended to better characterize the
experiences of affected children, adolescents, and adults.'' \2\
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\2\ Am. Psychiatric Ass'n, Gender Dysphoria (2013), https://www.psychiatry.org/file%20library/psychiatrists/practice/dsm/apa_dsm-5-gender-dysphoria.pdf (emphasis added).
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Fourth Circuit Interpretation and Litigation
The Rehabilitation Act and the ADA expressly exclude ``gender
identity disorders not resulting from physical impairments'' from the
definition of ``disability.'' As noted above, this exclusion was
enacted in the ADA in 1990 and has never been amended by Congress.
While this seems straightforward, in recent years, Federal district
courts have split on whether ``Gender Dysphoria'' falls within the
ADA's exclusion for gender identity disorders not resulting from
physical impairments.\3\ The Fourth Circuit's decision in Williams v.
Kincaid, 45 F.4th 759 (4th Cir. 2022), cert. denied, 600 U.S. (2023),
represents the only appellate review of this issue on the merits under
the ADA and the Rehabilitation Act.
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\3\ See, e.g., the following cases determining that gender
dysphoria is subject to the ADA's gender identity disorder
exclusion: Duncan v. Jack Henry & Assocs., Inc., 617 F. Supp. 3d
1011, 1055-57 (W.D. Mo. 2022); Lange v. Houston Cnty., 608 F. Supp.
3d 1340, 1361-63 (M.D. Ga. 2022); Doe v. Northrop Grumman Sys.
Corp., 418 F. Supp. 3d 921, 930 (N.D. Ala. 2019); Parker v. Strawser
Constr. Inc., 307 F. Supp. 3d 744, 754-55 (S.D. Ohio 2018); Gulley-
Fernandez v. Wis. Dep't of Corr., No. 15-CV-995, 2015 WL 7777997, at
*3 (E.D. Wis. Dec. 1, 2015); but see Guthrie v. Noel, No. 1:20-CV-
02351, 2023 WL 8115928, at *13 (M.D. Pa. Sept. 11, 2023); Kozak v.
CSX Transportation, Inc., No. 20-CV-184S, 2023 WL 4906148, at *4-7
(W.D.N.Y. Aug. 1, 2023); Doe v. Mass. Dep't of Corr., No. 17-12255-
RGS, 2018 WL 2994403, at *6-7 (D. Mass. Jun. 14, 2018); Blatt v.
Cabela's Retail, Inc., No. 5:14-cv-04822, 2017 WL 2178123, at *3-4
(E.D. Pa. May 18, 2017).
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In Williams the court concluded, in a 2-1 decision, that gender
dysphoria is not excluded from the ADA's definition
[[Page 59480]]
of ``disability.'' Williams, 45 F.4th at 769, 773-74. The majority
reasoned that gender dysphoria, as clinically classified, is distinct
from ``gender identity disorders not resulting from physical
impairments'' excluded by the ADA in 42 U.S.C. 12211(b)(1). Id.
Specifically, the court emphasized that gender dysphoria involves
clinically significant distress and functional impairments, and that,
thus, the diagnostic criteria under the DSM-5 differ from those of the
gender identity disorders referenced in the DSM-III-R when the ADA was
enacted in 1990. Williams, 45 F.4th at 767-68. The majority interpreted
the ADA in light of what it viewed as evolving medical concepts.
The Supreme Court subsequently denied certiorari in Kincaid v.
Williams, 600 U.S., __143, S. Ct. 2414 (2023), leaving the Fourth
Circuit's judgment intact. As a result, Williams remains binding
precedent within Maryland, North Carolina, South Carolina, Virginia,
and West Virginia, but it does not constitute controlling authority
elsewhere.\4\ See Maryland v. Balt. Radio Show, Inc., 338 U.S. 912, 919
(1950) (Frankfurter, J., respecting denial of certiorari) (noting that
denial of certiorari ``does not remotely imply approval . . . of what
was said by [the lower court]'').
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\4\ The factual basis of Kincaid's 2022 holding has since been
called into doubt. The majority opinion relied in part on the
applicability of the seventh edition of the World Professional
Association for Transgender Health Standards of Care (``WPATH
Standards'') to interpret the gender identify disorder exclusion.
Kincaid, 45 F.4th at 764, 769; id. at 782 (Quattlebaum, J.,
dissenting) (recognizing the majority's reliance on WPATH
Standards). Since that opinion, the basis for the WPATH standards
have been undermined. See Eknes Tucker v. Governor, 114 F.4th 1241,
1261 (11th Cir. 2024) (Lagoa, J., concurring in denial of rehearing
en banc) (``recent revelations indicate that WPATH's lodestar is
ideology, not science''); see also Statement of Interest of the
United States, Fuller v. Georgia Dep't of Corr., N.D. Ga., 25-cv-
246, Apr. 25, 2025.
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Relevant Regulatory History and Related Lawsuits
On May 9, 2024, the Department issued the 2024 Final Rule modifying
its regulations implementing section 504. As relevant here, the
preamble to the 2024 Final Rule discussed whether ``gender dysphoria
may constitute a disability under section 504.'' 89 FR at 40069. The
2024 Final Rule concluded, in its preamble, that ``gender dysphoria
does not fall with the statutory exclusions for gender identity
disorders.'' Id. The codified regulatory text merely cross-referenced
the statutory exclusion in 29 U.S.C. 705(20)(F). See 45 CFR 84.4(g).
The 2024 Final Rule, including its preamble language, spawned
litigation. In Texas v. Becerra, No. 5:24-cv-00225 (N.D. Tex.),
seventeen States filed suit challenging the 2024 Final Rule, arguing,
among other things, that the preamble's reference to gender dysphoria
unlawfully expands the definition of ``disability'' beyond the scope
authorized by 29 U.S.C. 705(20)(F) and 42 U.S.C. 12211(b).\5\
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\5\ Litigation also has been filed in the Western District of
Louisiana similarly challenging the section 504 preamble reference
to gender dysphoria. Rapides Parish Sch. Bd. v. U.S. Dep't of Health
& Hum. Servs., et al, 1:25-cv-70 (W.D. La.).
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In response to the litigation, the Department published a notice in
the Federal Register (90 FR 15412 (Apr. 11, 2025)). The notice
highlights the Department's concern that ``there has been significant
confusion about the preamble language referencing gender dysphoria in
the'' 2024 Final Rule. Id. at 15412. The notice stated: ``It is well-
established that where, as here, the language included in the
regulatory text itself is clear, statements made in the preamble to a
final rule published in the Federal Register, lack the force and effect
of law and are not enforceable.''
This NPRM reaffirms the statutory exclusion of 29 U.S.C. 705(20)(F)
in unambiguous terms for section 504 coverage and makes clear that the
Department interprets the exclusionary language ``gender identity
disorders not resulting from physical impairments'' to encompass gender
dysphoria that does not result from physical impairment.
Legal Authority
The Department has legal authority under the Rehabilitation Act to
promulgate regulations ``as may be necessary to carry out [section
504].'' 29 U.S.C. 794(a). Indeed, since 1977, the year the Department
(then, the Department of Health Education and Welfare) issued the
implementing regulation for section 504 Part 84, the Department has
exercised this authority to interpret the requirements of 29 U.S.C.
794(a) and provide certainty to recipients of Department financial
assistance that they are in compliance with section 504. For example,
in Alexander v. Choate, the Supreme Court relied on the general
nondiscrimination requirements in HHS' section 504 implementing
regulations in Part 84 when determining whether limitations on Medicaid
benefits amounted to discrimination under section 504.\6\
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\6\ See Alexander v. Choate, 469 U.S. 287, 304 (1985).
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As stated in Loper Bright v. Raimondo, ``when a particular statute
delegates authority to an agency consistent with constitutional limits,
courts must respect the delegation, while ensuring the agency acts
within it.'' \7\ While courts must respect that Congress delegated
authority to HHS to implement regulations for section 504 and interpret
the nondiscrimination requirements of the statute, the preamble to the
2024 Final Rule went beyond the statutory limits when it interpreted
the definition of disability in a manner that included a condition
excluded by Congress.
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\7\ Loper Bright Enters. v. Raimondo, 603 U.S. 369, 413 (2024).
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Administrative agencies must act within the limits of authority
delegated to them by Congress. As the Supreme Court has made clear,
``[a]n agency literally has no power to act . . . unless and until
Congress confers power upon it.'' Louisiana Public Service Commission
v. FCC, 476 U.S. 355, 374 (1986). Agencies may not expand their
authority or reframe statutory provisions based on policy preferences.
See Alexander v. Sandoval, 532 U.S. 275, 291 (2001) (stating that
agencies cannot through rulemaking ``conjure up a [right] that has not
been authorized by Congress. Agencies may play the sorcerer's
apprentice but not the sorcerer himself'').
The definition of ``individual with a disability'' in section 504
and the definition of ``disability'' that applies to both section 504
and the ADA do not cover ``transvestism, transsexualism, pedophilia,
exhibitionism, voyeurism, gender identity disorders not resulting from
physical impairments, or other sexual behavior disorders.'' 29 U.S.C.
705(9) & (20)(F)(i), 42 U.S.C. 12211(b)(1). As neither section 504 nor
the ADA define ``gender identity disorders,'' the term must be given
the ``ordinary meaning'' it had at the time of its adoption. See Niz-
Chavez v. Garland, 593 U.S. 155, 160 (2021) (``When called on to
resolve a dispute over a statute's meaning, this Court normally seeks
to afford the law's terms their ordinary meaning at the time Congress
adopted them.''). Given the history of the terms ``gender identity
disorders'' and ``gender dysphoria'' referenced above, under the
ordinary meaning of the term as used in the DSM-III-R, gender identity
disorder, as a category, includes gender dysphoria.
In the 1990s, gender identity disorders were understood to be a
family of conditions which shared the same ``essential feature'': an
individual experiencing ``incongruence between assigned sex (i.e., the
sex that is recorded on the birth certificate) and gender.'' DSM-III-R
at 71. The DSM-
[[Page 59481]]
III-R noted that an individual with even mild incongruence could feel
``discomfort and a sense of inappropriateness about the[ir] assigned
sex.'' Id. at 77. The distress resulting from the discomfort could also
manifest as ``[a]nxiety and depression.'' Id. at 76. Not all
individuals with gender incongruence can fit squarely within a
subcategory due to a variation of symptoms. However, even if an
individual does not fit within a specific subcategory, the individual
would have a ``Gender Identity Disorder Not Otherwise Specified'' Id.
at 77-78.
A later update of the DSM published in 1994 clarified that distress
was part and parcel of a gender identity disorder. To make a gender
identity disorder diagnosis, ``there must be evidence of clinically
significant distress or impairment in social, occupational, or other
important areas of functioning.'' DSM-IV at 533 (emphasis added).
The DSM-5 switched from using the term ``gender identity
disorders'' to ``gender dysphoria.'' But the difference is merely
linguistic. Gender dysphoria specifically ``refers to the distress that
may accompany the incongruence between one's experienced or expressed
gender and one's assigned gender.'' DSM-5 at 451. To be diagnosed with
gender dysphoria, an individual must show the hallmark of a gender
identity disorder--gender incongruence. See DSM-5 at 452-53. Then,
because of that incongruence, they must also have ``clinically
significant distress or impairment.'' See id. In other words, gender
dysphoria is gender identity disorder where the person has specifically
had ``clinically significant distress.''
While the American Psychiatric Association and the medical
profession may have changed how they conceptualize gender identity
disorders by focusing on the distress rather than on the incongruence,
they do not have the authority to redefine the meaning of statutes. See
id. at 451 (explaining that change in conceptualizing gender identity
disorders); As Judge Quattlebaum wrote in his opinion in Williams,
``linguistic drift cannot alter the meaning of the words in the ADA
when it was enacted.'' Williams, 45 F.4th at 780; see also Loper Bright
Enters. v. Raimondo, 603 U.S. 369, 400 (2024) (``[E]very statute's
meaning is fixed at the time of enactment.'' (quotation omitted)).
The exclusions from the definition of ``disability'' applicable to
the ADA and section 504 and from the definition of ``individual with a
disability'' applicable in section 504, cannot be circumvented through
renaming or redefining the conditions that are excluded in the law.
Gender identity disorders were understood to encompass conditions where
the person was suffering from gender incongruence and the accompanying
distress. Gender dysphoria falls squarely within this framework.
Here, the Rehabilitation Act and the ADA expressly exclude ``gender
identity disorders not resulting from physical impairments'' from the
definitions of ``disability'' and ``individual with a disability.'' 29
U.S.C. 705(9) & (20)(F)(i); 42 U.S.C. 12211(b)(1). OCR does not have
the authority to broaden or narrow these statutory exclusions through
agency rulemaking. Deviation from the statute Congress enacted would be
legally vulnerable under the Administrative Procedure Act, which
requires federal courts to ``hold unlawful and set aside'' agency
actions taken ``in excess of statutory jurisdiction, authority, or
limitations.'' 5 U.S.C. 706(2)(C).
While Williams framed its analysis in terms of evolving medical
classifications, such reliance on post-enactment developments in the
DSM-5 raises serious concerns under established canons of statutory
construction. Instead, one must look to the DSM-III-R, in place in
1990, which provides that, even in mild cases, gender identity
disorders involve ``discomfort and a sense of the inappropriateness
about the assigned sex.'' DSM-III-R at 71. It even lists such distress
as the first diagnostic criteria for gender identity disorder. Id. at
73, 77. This language makes clear that gender identity disorders, as
understood in 1990, included distress and discomfort from identifying
as a gender different from the sex assigned at birth and thus
encompasses ``gender dysphoria.'' See Williams, 45 F.4th at 784
(Quattlebaum, J. dissenting); see also Kincaid, 600 U.S .,143 S.Ct. at
2417 (Alito, J. dissenting from denial of certiorari) (noting that the
``broad brush used by Congress'' in crafting the language of Section
12211(b)(1) suggests Congressional intent to ``prohibit the ADA's
application to conditions that are sufficiently similar to the more
specific categories of conditions'' identified). Several federal courts
agree with this interpretation. See, e.g., Parker v. Strawser Constr.,
Inc., 307 F. Supp. 3d 744, 754 (S.D. Ohio 2018) (surveying cases and
finding that ``[t]he majority of federal cases have concluded'' that
the ADA excludes from its protection ``both disabling and non-disabling
gender identity disorders that do not result from a physical
impairment''); Duncan v. Jack Henry Assocs., Inc., 617 F. Supp. 3d
1011, 1056-57 (W.D. Mo. 2022) (concluding that ADA's exclusion of
gender identity disorders ``encompass[ed] Plaintiff's diagnosis of
gender dysphoria''); Lange v. Houston Cnty., Georgia, 608 F. Supp. 3d
1340, 1361-63 (M.D. Ga. 2022) (holding that gender dysphoria not
resulting from physical impairment is subject to the gender identity
disorder exclusion); Doe v. Northrop Grumman Sys. Corp., 418 F. Supp.
3d 921, 930 (N.D. Ala. 2019) (same).
Accordingly, under a review of the definition of disability as
written in 29 U.S.C. 705(20)(A) and (F)(i), independent of HHS' 2024
Final Rule and preamble, many courts have reached the conclusion that
the best reading of the statute is that ``disability'' does not include
gender dysphoria not resulting from physical impairments. Even if a
court considers there to be ambiguity as to whether gender identity
disorders not resulting from physical impairments includes gender
dysphoria not resulting from physical impairments, ``there is a best
reading all the same--`the reading the court would have reached' if no
agency were involved.'' \8\ This proposed rulemaking rectifies the
overreach committed by the 2024 Final Rule preamble and recognizes the
the interpretation of ``disability'' set by Congress and the courts as
required by the Administrative Procedures Act.\9\
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\8\ Loper Bright Enters. v. Raimondo, 603 U.S. 369, 400 (2024).
\9\ See 5 U.S.C. 706.
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Reasons for the Proposed Rulemaking
The Department is issuing this NPRM to address a targeted but
consequential gap in regulatory clarity created by the 2024 Final
Rule's preamble. Although the operative regulation at 45 CFR 84.4(g)
cross-references the statutory exclusion for ``gender identity
disorders not resulting from physical impairments,'' the preamble's
general discussion of gender dysphoria introduced interpretative
confusion regarding how the exclusion applies to that condition. The
Department has determined that this ambiguity warrants regulatory
resolution.
When Congress clearly excluded ``gender identity disorders not
resulting from physical impairments,'' federal agencies and courts are
bound to apply that exclusion as written, unless and until Congress
amends the underlying statute. Here, the Rehabilitation Act and the ADA
expressly exclude ``gender identity disorders not resulting from
physical impairments'' from the definitions of ``disability'' and
[[Page 59482]]
``individual with a disability.'' 29 U.S.C. 705(9) & (20)(F)(i); 42
U.S.C. 12211(b)(1). OCR does not have the authority to broaden or
narrow these statutory exclusions through agency rulemaking. This is in
part because the Administrative Procedure Act requires federal courts
to ``hold unlawful and set aside'' agency actions taken ``in excess of
statutory jurisdiction, authority, or limitations.'' 5 U.S.C.
706(2)(C). Therefore, to remedy the ambiguity and reduce litigation
risk, we are issuing this proposed rule to clarify that, where ``gender
identity disorders not resulting from physical impairments'' is used in
part 84, it encompasses ``gender dysphoria not resulting from physical
impairments,'' because the statutory text states as much.
The Department maintains that the preamble language of the 2024
Final Rule lacks the force and effect of law and is not enforceable.
However, we recognize that this proposed rule comes to a different
conclusion on whether ``gender dysphoria'' not resulting from physical
impairment may be a disability under section 504 compared to that
preamble.
The Department is issuing this rule because it has reevaluated the
relevant statutory language and determined that the term ``gender
dysphoria not resulting from physical impairments'' is encompassed in
the term ``gender identity disorder not resulting from physical
impairments,'' as that term is used in the ADA and in section 504,
based on the plain language of the statutory exclusions from the
definitions of ``disability'' and ``individual with a disability'' in
the context of existing medical terminology at the time of the ADA's
enactment. The discussion in the preamble of the 2024 final rule
focused almost exclusively on the Williams majority opinion and its
determination that the current definition of gender dysphoria is not
interchangeable with the definition of gender identity disorder from
1990. 45 F.4th 759. After careful consideration, the Department
recognizes that the evolving medical classifications of gender
disorders cannot change the meaning of the statutory language.
Because the preamble lacks the force and effect of law and is not
enforceable, the Department expects that any reliance interests are
minimal. To the extent anyone relied on that language, however, they
have no legitimate reliance interests in maintaining that language, and
indeed would be harmed by its continuation. Since the preamble language
is not enforceable and lacks the force of law, no one can use it to
their benefit. Meanwhile, individuals may unintentionally believe that
the preamble language can override statutory language. By fixing the
incorrect language in the preamble, the Department is ensuing that no
one incorrectly relies on the mistaken interpretation to their
detriment.
Alternatives Considered
While the Department believes that rulemaking to clarify that the
definitions of ``disability'' and ``individual with a disability'' in
Section 504 exclude ``gender dysphoria not resulting from physical
impairments'' is the most prudent course of action, we considered a
host of alternatives.
The first alternative to rulemaking considered was to simply leave
the existing preamble language in place and maintain the Department's
position that the preamble language is not binding or legally
enforceable, as stated in the April 11, 2025 notice in the Federal
Register.\10\ While this approach would result in less rulemaking for
the Department and may ultimately result in the same outcome as this
rulemaking in hypothetical future litigation, it would do little to
rectify the ambiguity surrounding the definition of ``disability''
caused by the preamble to the 2024 Final Rule. The Department believes
that the 2024 Final Rule Preamble has generated significant confusion
and that the only way to rectify such confusion is to modify the text.
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\10\ 90 FR 15412 (Apr. 11, 2025).
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The second alternative considered was to issue guidance further
explaining to the public that the Department interpreted the exclusion
for ``gender identity disorders not resulting from physical
impairments'' to include ``gender dysphoria not resulting from physical
impairments.'' Similar to the first alternative, the Department
determined that guidance alone would be insufficient to rectify the
existing confusion, and the public would question why contradictory
preamble language still existed.
The final alternative considered was a full repeal of the 2024
Final Rule. While this method would have eliminated the confusion
caused by the preamble language, such an approach would be broader than
necessary to address the issue presented by the preamble on whether
``disability'' included or excluded ``gender dysphoria not resulting
from physical impairment.'' The Department requests comments on these
alternatives considered.
Executive Order 12866 and Related Executive Orders on Regulatory Review
Executive Order 12866 Determination
Pursuant to Executive Order 12866, this rulemaking has been
designated as a significant regulatory action under subsection 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
Executive Order 12250 on Leadership and Coordination of
Nondiscrimination
Pursuant to Executive Order 12250, the Attorney General has the
responsibility to ``coordinate the implementation and enforcement by
Executive agencies of . . . ``[a]ny other provision of Federal
statutory law which provides, in whole or in part, that no person in
the United States shall, on the ground of race, color, national origin,
handicap, religion, or sex, be excluded from participation in, be
denied the benefits of, or be subject to discrimination under any
program or activity receiving Federal financial assistance.'' Executive
Order 12250 at Sec. 1-201(d), 45 FR 72995 (Nov. 2, 1980). The NPRM was
reviewed and approved by the Attorney General.
RFA--Initial Small Entity Analysis
The Regulatory Flexibility Act (RFA), Public Law 96-354, applies to
rules for which an agency publishes a general notice of proposed
rulemaking (NPRM) pursuant to 5 U.S.C. 553(b).\11\ Because this
proposed rule would clarify a single limited aspect of the definitions
of ``disability'' and ``individual with a disability'' under section
504, any associated costs to recipients, including small entities,
would be negligible. Recipients would not have to purchase new
equipment, alter benefits, or change their practices in any way based
on this clarification. The Department certifies that this proposed rule
would not have a significant effect on small entities.
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\11\ See generally 5 U.S.C. 601, et. seq.
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Executive Order 13132: Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirement costs on State and local governments or has
federalism implications. The Department has determined that this
proposed rule does not impose such costs or have any Federalism
implications.
[[Page 59483]]
Executive Order 13175: Tribal Consultation
Executive Order 13175 requires Federal agencies to consult and
coordinate with Tribes on a government-to-government basis on policies
that have Tribal implications, including regulations, legislative
comments, proposed legislation, and other policy statements or actions
that have substantial direct effects on one or more Indian Tribes, on
the relationship between the Federal Government and Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Because this rulemaking would only
clarify whether ``gender dysphoria not resulting from physical
impairment'' may be included in the definitions of ``disability'' and
``individual with a disability'' and will not have a significant effect
on Tribal finances or the relationship between the Federal Government
and Indian Tribes, the Department has determined that this rulemaking
would not have Tribal implications that require consultation under
Executive Order 13175.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
ch. 3506; 5 CFR part 1320 appendix A.1), the Department has reviewed
this proposed rule and has determined that there are no new or modified
collections of information contained therein.
Executive Order 14192: Deregulation
Under Executive Order 14192, Unleashing Prosperity Through
Deregulation, executive agencies are required to limit the costs of
planned regulations, including by repealing existing regulations for
each newly promulgated regulation and/or prioritizing regulations with
minimal costs or burdens. This proposed rule will not impose new costs
or burdens on recipients as it will result in a clarification made
necessary by the preamble language of the 2024 Final Rule that called
into question whether gender dysphoria could be considered a
disability.
Request for Comment
The Department seeks comment on all issues raised by the proposed
rule. Additionally, the Department seeks comments on any reliance
interests that recipients of financial assistance from HHS, people with
disabilities, or other entities may have related to the gender
dysphoria discussion in the preamble of the 2024 Final Rule. The
Department is especially interested in comments indicating that an
entity has changed its policies, practices, or procedures to account
for the 2024 Final Rule gender dysphoria preamble language and how this
rulemaking would affect the entity. The Department also seeks comments
on the regulatory alternatives it considered in Section IV of this
notice of proposed rulemaking and the Department's decision to pursue
this rulemaking.
List of Subjects in 45 CFR Part 84
Adoption and foster care, Civil rights, Childcare, Child welfare,
Colleges and universities, Communications, Disabled, Discrimination,
Emergency medical services, Equal access to justice, Federal financial
assistance, Grant programs, Grant programs--health, Grant programs--
social programs, Health, Health care, Health care access, Health
facilities, Health programs and activities, Individuals with
disabilities, Integration, Long term care, Medical care, Medical
equipment, Medical facilities, Nondiscrimination, Public health.
For the reasons stated in the preamble, the Department of Health
and Human Services proposes to amend 45 CFR Subtitle A, Subchapter A,
Part 84 as set forth below:
PART 84--NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PROGRAMS
OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
0
1. The authority citation for part 84 continues to read as follows:
Authority: 29 U.S.C. 794
Subpart G is also issued under 21 U.S.C. 1174; 42 U.S.C. 4581.
0
2. Amend Sec. 84.4 by revising subsection (g) to read as follows:
Sec. 84.4 Disability
* * * * *
(g) Exclusions. The term ``disability'' does not include the
conditions set forth at 29 U.S.C. 705(20)(F), including ``transvestism,
transsexualism, pedophilia, exhibitionism, voyeurism, gender identity
disorders not resulting from physical impairments, or other sexual
behavior disorders'' under Section 705(20)(F)(i). For the purpose of
part 84, the term ``gender identity disorders not resulting from
physical impairments'' includes gender dysphoria not resulting from
physical impairments.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-23484 Filed 12-18-25; 8:45 am]
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