[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Rules and Regulations]
[Pages 34144-34148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
42 CFR Part 136
RIN 0917-AA24
Removal of Outdated Regulations
AGENCY: Indian Health Service, Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: The Indian Health Service (IHS) of the Department of Health
and Human Services (HHS or ``the Department'') is issuing this final
rule to remove outdated regulations that do not align with the current
statutory text.
DATES: This final rule is effective May 30, 2024.
FOR FURTHER INFORMATION CONTACT: Joshuah Marshall, Senior Advisor to
the Director, Indian Health Service, 5600 Fishers Lane, Rockville, MD
20857, email: [email protected], telephone: 301-443-7252.
SUPPLEMENTARY INFORMATION:
I. Background
On January 27, 1982, the IHS published regulations imposing
restrictions on the use of Federal funding for certain abortions,
currently codified at 42 CFR 136.51 through 136.57.\1\ These
regulations implementing IHS program authority pursuant to 25 U.S.C. 13
and 42 U.S.C. 2001 allowed the use of IHS funds for abortions only when
a physician certified that ``the life of the mother would be endangered
if the fetus were carried to term.'' This restriction was to be
consistent with a provision in the annual appropriations legislation
for the Departments of Labor, Health and Human Services, and Education,
sometimes referred to as the ``Hyde Amendment,'' that restricted the
use of Federal funds for certain abortions, which did not automatically
apply to IHS funding.\2\ The purpose of these IHS regulations was
specifically ``to conform IHS practice to that of the rest of the
Department [of Health and Human Services] in accordance with the
applicable congressional guidelines.'' \3\ In 1988, Congress enacted 25
U.S.C. 1676, explicitly extending any limitations on the use of funds
included in HHS appropriations laws with respect to the performance of
abortions to apply to funds appropriated to IHS. As such, IHS became
subject to the Hyde Amendment as included in annual appropriations
legislation.
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\1\ Final Rule, Provision of Abortion Services by the Indian
Health Service, 47 FR 4016 (Jan. 27, 1982).
\2\ Continuing Appropriations for FY 1981, Public Law 96-369
(1980); Continuing Appropriations Act for FY 1982, Public Law 97-92
(1981).
\3\ Final Rule, Provision of Abortion Services by the Indian
Health Service, 47 FR 4016 (Jan. 27, 1982).
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Since the IHS promulgated these regulations in 1982, Congress has
repeatedly revised annual restrictions related to the use of Federal
funds for certain abortions. In fiscal year 1994, for instance,
Congress revised the Hyde Amendment to include additional exceptions to
the general prohibition on the use of Federal funds for abortions,
including in instances in which a pregnancy is the result of an act of
rape or incest.\4\ Similarly, in fiscal year 1998, Congress also
altered the standards for when the ``life of the mother'' may be
considered an exception.\5\ As relevant here, the Hyde Amendment
currently provides that no covered funds ``shall be expended for any
abortion'' or ``for health benefits coverage that includes coverage of
abortion,'' except ``if the pregnancy is the result of an act of rape
or incest; or . . . in the case where a woman suffers from a physical
disorder, physical injury, or physical illness, including a life-
endangering physical condition caused by or arising from the pregnancy
itself, that would, as certified by a physician, place the woman in
danger of death unless an abortion is performed.'' \6\
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\4\ Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 1994, Public Law
103-112, 509, 107 Stat. 1082, 1113 (1993).
\5\ Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 1998, Public Law
105-78, 509(b), 111 Stat. 1467, 1516 (1997).
\6\ Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 2024, Public Law
118-47, secs. 506-507, title V of Division D, 138 Stat. 703 (2024).
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The current IHS regulations do not align with the current text of
the Hyde Amendment or with 25 U.S.C. 1676. The IHS has complied with,
and will continue to comply with, the statutory exceptions; has
clarified its compliance with the statutory limitations through policy
directives; \7\ and now removes these outdated regulations in their
entirety.\8\ Doing so will eliminate any potential confusion regarding
these outdated regulations and will ensure alignment with the
applicable congressional restrictions governing HHS given Congress's
enactment of 25 U.S.C. 1676, which independently aligns relevant
restrictions applicable to the IHS and HHS. Regulations on this subject
are not necessary to implement the IHS's authority. Nor are they
necessary to comply with statutory directives. Moreover, amending the
regulations to reflect the current Hyde Amendment could cause
additional confusion in the future if Congress changes the annual
appropriations language, as it has in the past.
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\7\ Indian Health Service Circular No. 22-15, Use of Indian
Health Service Funds for Abortions (Jun. 30, 2022), https://www.ihs.gov/ihm/circulars/2022/use-of-indian-health-service-funds-for-abortions/.
\8\ The regulations also speak to recordkeeping requirements and
confidentiality of information. However, these provisions are
unnecessary to maintain, because recordkeeping and confidentiality
of information are independently required by other laws and
regulations that will remain in effect. See, e.g., 45 CFR parts 160,
164 (Standards for Privacy of Individually Identifiable Health
Information (The Privacy Rule)).
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II. Development of Rule
The IHS published a notice of proposed rulemaking in the Federal
Register on January 8, 2024 (89 FR 896), with a sixty-day comment
period, which closed on March 8, 2024. Notification regarding a Tribal
consultation session was sent via a Dear Tribal Leader Letter on
January 17, 2024. The consultation session was conducted virtually on
February 27, 2024. The IHS has reviewed public comments it received and
addresses them below.
III. Comments
The IHS received six written comments.\9\ Two of the written
comments were generally in favor of the removal. These two written
comments were submitted by: (1) an individual and (2) a group of 20
individuals and advocacy organizations. Four of the written comments
were generally opposed to the removal. These four comments were
submitted by advocacy organizations. At the Tribal Consultation
session, the IHS received three oral comments from representatives of
Indian Tribes. Each of these three oral comments were generally in
favor of the removal or non-germane to the removal.
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\9\ See generally, public comments posted in response to Docket
ID # IHS-2024-0001, https://www.regulations.gov/document/IHS-2024-0001-0001/comment.
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After reviewing both written comments and those comments received
orally through the Tribal consultation session, the IHS is finalizing
this rule as proposed. Accordingly, this final rule will remove the
current IHS Hyde regulations in their entirety, by removing and
reserving subpart F, consisting of 42 CFR 136.51 through 136.57. Below,
IHS summarizes and
[[Page 34145]]
addresses all substantive topics raised in comments.
A. Comments Supporting the Removal
One commenter in the consultation session supported removal of the
regulations. That commenter additionally suggested as a policy matter
that the IHS consider allowing a nurse practitioner or licensed
practitioner other than a physician to certify an abortion in cases in
which certification is required. Under the current version of the Hyde
Amendment, the IHS cannot make the requested change.
The current version of the Hyde Amendment, made applicable to IHS
funding by 25 U.S.C. 1676(a), includes an exception in cases ``where a
woman suffers from a physical disorder, physical injury, or physical
illness, including a life-endangering physical condition caused by or
arising from the pregnancy itself, that would, as certified by a
physician, place the woman in danger of death unless an abortion is
performed.'' Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 2024, Public Law
118-47, secs. 506-507, title V of Division D, 138 Stat. 703 (2024)
(emphasis added). The IHS' removal of the outdated regulations cannot
affect the separate statutory requirement that the certification be
made by a physician. Therefore, the IHS has not made changes based on
this comment.
Another commenter in the consultation session supported removal of
the regulations and asked the IHS whether it intends to replace these
regulations at a later time. While the IHS appreciates this question,
regulations on this subject are not necessary to implement IHS'
authority, nor are they necessary to comply with statutory directives.
Moreover, amending the regulations to reflect the current Hyde
Amendment could cause additional confusion in the future if Congress
changes the annual appropriations language, as it has in the past.
Therefore, the IHS has not made changes based on this comment. However,
the IHS retains the discretion to promulgate regulations at a later
date.
The IHS received an additional comment during the consultation
session about what Tribes are permitted to do with their own, non-
Federal funds. While the IHS appreciates the comment, it is outside the
scope of this action. The regulations at issue apply only to IHS'
operations as a healthcare provider and payer. Therefore, the IHS has
not made changes based on this comment.
One commenter \10\ supported removal of the regulations, based on
the justifications provided in the notice of proposed rulemaking. The
commenter opined that it was common sense to eliminate the regulations,
since the IHS is required by 25 U.S.C. 1676 to follow the Hyde
Amendment. The commenter also believes that removal would reduce
confusion. In addition to agreeing with the justifications provided in
the notice of proposed rulemaking, this commenter explained that the
outdated regulations could lead to violations of the Equal Protection
Clause of the Constitution if enforced. The commenter argued that if
the regulation were enforced, American Indian and Alaska Native (AI/AN)
people seeking abortions funded by the IHS would be treated differently
than other individuals seeking abortions funded by HHS in other
circumstances because only the second group would be able to take
advantage of all of the exceptions included in the current Hyde
Amendment. This comment requires no change to the proposed rule.
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\10\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0003,
https://www.regulations.gov/comment/IHS-2024-0001-0003.
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One comment,\11\ submitted on behalf of a group of individuals,
supported the removal but recommended that the IHS address disparate
reproductive health outcomes for AI/AN people, including in urban
areas, through activities outside of this rulemaking. The comment also
recommended that the IHS improve its capacity for abortions consistent
with the Hyde Amendment, and provide additional information, education,
and engagement with AI/AN people about permitted abortions. This
comment also discussed the commenters' opposition to the scope and
impact of the Hyde Amendment itself. These comments are outside of the
scope of the rulemaking.
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\11\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0007,
https://www.regulations.gov/comment/IHS-2024-0001-0007.
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B. Comments Recommending Retaining the Regulations as Written
Several commenters asked that the IHS retain the regulations as
written, specifically 42 CFR 136.53 and 136.54 (the two sections that
describe the limitations on the use of IHS funding for abortions).
These commenters stated that the Hyde Amendment does not require, only
permits, the use of IHS funding for abortion in cases of rape or
incest. Therefore, the commenters opined that the IHS regulations are
not outdated or in conflict with the current law, and also expressed
their belief that abortions should not be provided when a pregnancy is
the result of rape or incest. One commenter \12\ also expressed concern
that, should the Hyde Amendment not be included in the annual
appropriations act and these regulations are removed, the IHS would be
able to further expand access to abortions.
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\12\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0005,
https://www.regulations.gov/comment/IHS-2024-0001-0005.
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Congress has intentionally broadened the exceptions to the
limitation on the use of Federal funds for abortion to include
instances of rape or incest, and has specifically made the current
scope of the Hyde Amendment applicable to IHS, via 25 U.S.C. 1676(a).
Removing the outdated and unnecessary provisions of 42 CFR 136.53 and
136.54 simply aligns IHS regulations with congressional action.
Comments about the substance and application of the Hyde Amendment
itself are outside of the scope of this rulemaking.
Should Federal law regarding the use of Federal funds for abortion
change in the future, the IHS could consider whether regulatory
provisions should be proposed. But this final rule will ensure that the
IHS follows applicable statutory provisions at any given time.
Therefore, the IHS has not made changes based on these comments.
Two commenters \13\ stated that removing the regulations is
inconsistent with the IHS mission and authority under the Snyder Act,
25 U.S.C. 13, to provide care and assistance for the ``conservation of
health,'' claiming that providing abortions in the case of rape or
incest is not healthcare, and that abortion in general does not
conserve the health of the fetus. The IHS has determined that removing
42 CFR 136.53 and 136.54 clearly aligns with congressional action, and
this regulatory action simply removes outdated and unnecessary
regulations. Comments about the substance and application of the Hyde
Amendment itself are outside of the scope of this rulemaking.
Therefore, the IHS has not made changes based on these comments.
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\13\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0005,
https://www.regulations.gov/comment/IHS-2024-0001-0005, Comment ID #
IHS-2024-0001-0006, https://www.regulations.gov/comment/IHS-2024-0001-0006.
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One commenter \14\ stated that providing abortions in the cases of
rape or incest is not consistent with the trust relationship between
the Federal Government and Tribes, and asserted that it infringes on
Tribal sovereignty. The IHS has determined that removing 42 CFR 136.53
and 136.54 clearly aligns with congressional action, and this
[[Page 34146]]
regulatory action simply removes outdated and unnecessary regulations.
Comments about the substance of the Hyde Amendment itself are outside
of the scope of this rulemaking. The use of IHS funds for certain
abortions does not infringe on Tribal sovereignty. The IHS' clinicians
and patients work together to determine the most appropriate treatment
in an individual case. Moreover, this action does not affect a Tribe's
right to self-determination or self-governance, nor does it impact any
Tribe's choice to administer IHS health care programs itself. This
action applies only to IHS operations as a healthcare provider and
payer. The current regulations also do not reflect a determination that
considerations surrounding Tribal sovereignty or the trust relationship
forecloses funding for abortions in cases of rape or incest. See 46 FR
22617; 47 FR 4017-18. Therefore, the IHS has not made changes based on
this comment.
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\14\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0005,
https://www.regulations.gov/comment/IHS-2024-0001-0005.
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One commenter \15\ suggested that an exception to provide abortions
in the cases of rape or incest is inappropriate. Removing the outdated
regulations, however, would merely align IHS policy, via 25 U.S.C.
1676, with whatever limitations Congress has imposed at any given time,
and with that of the rest of HHS. Comments about the substance of the
Hyde Amendment itself are outside of the scope of this rulemaking.
Therefore, the IHS has not made changes based on this comment.
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\15\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0006,
https://www.regulations.gov/comment/IHS-2024-0001-0006.
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C. Comments recommending amending the regulations
Several commenters suggested, as an alternative to retaining the
regulations as written, that the IHS consider amending 42 CFR 136.54.
Two commenters \16\ suggested amending 42 CFR 136.54 to align with the
Hyde Amendment. One of these commenters \17\ recommended options to
incorporate a reference to the Hyde Amendment, or to include a
qualifier that, if the limitations in the Hyde Amendment change, the
regulations will as well, or to cross reference the Hyde Amendment
without describing the exceptions currently contained in that language.
One of these commenters \18\ explained its view that removing the
regulations would cause more confusion to providers, and described
problematic historical practices as an example of why clear IHS rules
are needed. The IHS finds that these recommendations would merely
restate Federal law, and are therefore unnecessary. The IHS disagrees
that removal will cause more confusion. To the contrary, amending the
regulations to reflect the current Hyde Amendment could cause
additional confusion in the future if Congress changes the annual
appropriations language, as it has in the past. Since 25 U.S.C. 1676
already applies the Hyde Amendment to IHS by law, regulations
reflecting the Hyde Amendment are superfluous. The IHS has also
clarified its compliance with the statutory limitations through policy
directives and will continue to provide clear guidance to its staff.
Therefore, the IHS has not made changes based on these comments.
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\16\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0004,
https://www.regulations.gov/comment/IHS-2024-0001-0004; Comment ID #
IHS-2024-0001-0006, https://www.regulations.gov/comment/IHS-2024-0001-0006.
\17\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0006,
https://www.regulations.gov/comment/IHS-2024-0001-0006.
\18\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0004,
https://www.regulations.gov/comment/IHS-2024-0001-0004.
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One commenter \19\ recommended amending 42 CFR 136.54 to state that
Federal funds are available when a physician has found and certified
that, on the basis of his or her professional judgment, ``a statutory
condition for such funding, referenced in 25 U.S.C. 1676, is
satisfied.'' The IHS does not view this change as necessary, since 25
U.S.C. 1676 is applicable to the IHS as a matter of law. In addition,
the language recommended by the commenter is unclear, because there are
no statutory conditions in 25 U.S.C. 1676 itself. This statute instead
applies certain other Federal limitations on the use of funds for the
performance of abortions to the IHS. Therefore, the IHS has not made
changes based on this comment.
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\19\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002.
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One commenter \20\ stated that the IHS must publish a supplemental
notice of proposed rulemaking to explain why it is removing and not
replacing the regulations. The IHS clearly outlined its reasoning for
removing the regulations in the proposed rule.\21\ Therefore, the IHS
has not made changes based on this comment.
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\20\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0004,
https://www.regulations.gov/comment/IHS-2024-0001-0004.
\21\ 89 FR 896 at 897.
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One commenter \22\ also offered edits to 42 CFR 136.55 (``Drugs and
devices and termination of ectopic pregnancies'') to suggest that
Federal funds cannot be used for some treatments for ectopic pregnancy.
The IHS does not agree and, consistent with these regulations that are
now being withdrawn, reaffirms the policy stated in current 42 CFR
136.55 that Federal funds are available for medical procedures
necessary for the termination of an ectopic pregnancy. The IHS has
existing broad authority under 25 U.S.C. 13 and 42 U.S.C. 2001 to
provide healthcare. Accordingly, a regulation stating that funds are
available for medical treatments for ectopic pregnancy is unnecessary
and the IHS has not made changes based on this comment.
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\22\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002.
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One commenter \23\ stated that the certification requirement in 42
CFR 136.54 should be retained, even if other portions were changed or
moved, to ensure compliance with Congress's funding limitations. The
IHS believes retaining this section of the regulation is unnecessary.
The language in the Hyde Amendment, already made applicable to the IHS
via 25 U.S.C. 1676(a), currently contains a physician certification
requirement. Retaining that language in the regulation could cause
confusion in the future if Congress changes the annual appropriations
language, as it has in the past. Therefore, the IHS has not made
changes based on this comment.
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\23\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002.
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Some commenters also stated that the remaining sections in subpart
F should be retained. These commenters stated that the IHS did not
provide justification as to why it was removing the entire section, and
not just 42 CFR 136.54. As stated in the notice of proposed
rulemaking,\24\ the sections on recordkeeping and confidentiality of
information (42 CFR 136.56, 136.57) are unnecessary to maintain because
these requirements are independently required by other laws and
regulations that will remain in effect. See, e.g., 45 CFR parts 160,
164 (Standards for Privacy of Individually Identifiable Health
Information (The Privacy Rule)); 44 U.S.C. 31 (The Federal Records
Act).
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\24\ 89 FR 897.
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Other commenters similarly requested that the sections on
recordkeeping and confidentiality of information be maintained, stating
that doing so would ensure accountability, confidentiality, and patient
safety. The IHS agrees that recordkeeping and confidentiality
requirements serve those important purposes. However, the IHS has
sufficient safeguards in place for recordkeeping already required by
other
[[Page 34147]]
Federal laws and regulations, and therefore retaining these regulations
is unnecessary. The definition of ``physician'' in 42 CFR 136.52 is
also unnecessary as the meaning of ``physician'' is well-established in
practice and law. See, e.g., 42 U.S.C. 1395x(r).
As acknowledged by a different commenter,\25\ certain sections
(Sec. Sec. 136.51 (``Applicability''), 136.53 (``General rule'')) only
exist in relation to other sections of subpart F, and thus are
superfluous upon the removal of 42 CFR 136.54. Finally, the IHS has
existing broad authority under 25 U.S.C. 13 and 42 U.S.C. 2001 to
provide healthcare; accordingly, and as described above, 42 CFR 136.55
is unnecessary. Therefore, the IHS has not made changes based on these
comments.
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\25\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002.
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D. Other Comments
One commenter \26\ stated that, as a policy matter, the IHS should
not use Federal funds for drugs or devices to prevent implantation of
the fertilized ovum. The IHS disagrees with this assertion and the
removal of 42 CFR 136.55 makes no changes to IHS' existing authority to
use Federal funds for the purposes described in the regulatory language
being removed. The IHS' broad authority under 25 U.S.C. 13 and 42
U.S.C. 2001 authorizes the IHS to use Federal funds for necessary
medical care such as contraception and therefore the IHS does not
accept the commenter's policy suggestion to limit the use of funds for
this purpose. Therefore, the IHS has not made changes based on this
comment.
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\26\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002.
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One commenter \27\ explained its view that abortion harms AI/AN
people, and recounted some of the history of maltreatment of AI/ANs.
These comments are outside of the scope of this action, which merely
aligns IHS regulation with statutory text. Therefore, the IHS has not
made changes based on this comment.
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\27\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0005,
https://www.regulations.gov/comment/IHS-2024-0001-0005.
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One commenter \28\ made suggestions for changing IHS policy,
including statements in IHS policy about the impact of State law on IHS
activities, but recognizes that these policy matters are separate from
this rulemaking. The IHS also considers these comments outside of the
scope of the rulemaking, and therefore has not made changes based on
that discussion.
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\28\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002.
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Another commenter \29\ stated that the IHS failed to conduct a
federalism analysis pursuant to Executive Order 13132, suggesting that
IHS clarify whether ``its regulations can preempt state law and, if so,
address the federalism implications of its rule.'' The IHS complied
with the requirements of Executive Order 13132.\30\ Removing these
outdated and unnecessary regulations does not impose a substantial
direct requirement or cost on State or local governments, as they apply
only to IHS operations as a healthcare provider and payer. This action
to remove outdated and unnecessary regulations does not have any
preemptive effect. Therefore, the IHS has not made changes based on
this comment.
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\29\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0006,
https://www.regulations.gov/comment/IHS-2024-0001-0006.
\30\ See 89 FR 897-98.
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Two commenters \31\ stated that the IHS should focus its efforts on
services for victims of sexual assault, and improving maternal and
infant health, instead of removing the outdated rules. The IHS notes
that it has a detailed Sexual Assault policy and a robust Maternal and
Child Health Program, which will not be affected by the removal of the
outdated regulations. The comment is thus outside of the scope of this
action, which merely removes outdated and unnecessary regulations.
Therefore, the IHS has not made changes based on these comments.
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\31\ Docket ID # IHS-2024-0001, Comment ID # IHS-2024-0001-0002,
https://www.regulations.gov/comment/IHS-2024-0001-0002; Comment ID #
IHS-2024-0001-0006, https://www.regulations.gov/comment/IHS-2024-0001-0006.
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E. Required Determinations
Executive Orders 12866, 13563, and 14094
Executive Order 12866, as amended by Executive Order 14094, and
Executive Order 13563 direct agencies to assess all costs and benefits
of available regulatory alternatives. Section 3(f) of Executive Order
12866, as amended by Executive Order 14094, defines a ``significant
regulatory action'' as any regulatory action that is likely to result
in a rule that may: (1) have an annual effect on the economy of $200
million or more (adjusted every 3 years by the Administrator of the
Office of Information and Regulatory Affairs (OIRA) for changes in
gross domestic product); or adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, territorial, or
Tribal governments or communities; (2) create a serious inconsistency
or otherwise interfere with an action taken or planned by another
agency; (3) materially alter the budgetary impact of entitlements,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or (4) raise legal or policy issues for which
centralized review would meaningfully further the President's
priorities or the principles set forth in the Executive order, as
specifically authorized in a timely manner by the Administrator of OIRA
in each case. OIRA has determined that this final rule is a significant
regulatory action as defined by Executive Order 12866, section 3(f).
Regulatory Flexibility Act
This action will not have a significant economic impact on Indian
health programs. Therefore, the regulatory flexibility analysis
provided for under the Regulatory Flexibility Act is not required.
Executive Order 13132 (Federalism)
Executive Order 13132, ``Federalism,'' 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. HHS has determined that
this final rule, which removes outdated regulations, does not impose
such costs or have any federalism implications.
Executive Order 13175
This rule does not have a substantial direct effect on one or more
Indian Tribes under Executive Order 13175, because it only removes
outdated regulations that do not align with the current statutory text
of the Hyde Amendment, with 25 U.S.C. 1676, or with current IHS
practice.
National Environmental Policy Act
HHS has determined that this final rule does not have a significant
impact on the environment.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
the IHS to consider the impact of paperwork and other information
collection burdens it imposes on the public. The IHS has determined no
new requirement for information collection is associated with this
final rule. This action does not affect any information collections.
[[Page 34148]]
Congressional Review Act
Pursuant to Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (also known as the Congressional Review Act, 5
U.S.C 801 et seq.), OIRA has determined that this rule does not meet
the criteria set forth in 5 U.S.C. 804(2).
Unfunded Mandates Reform Act of 1995
We have examined the impacts of this rule as required by section
202 of the Unfunded Mandates Reform Act of 1995 (UMRA; March 22, 1995;
Pub. L. 104-4). Section 202 of UMRA requires that a covered agency
prepare a budgetary impact statement before promulgating a rule that
includes any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100 million or more in any one year (adjusted for
inflation). In 2024, that threshold is approximately $183 million (in
2023 dollars). If a covered agency must prepare a budgetary impact
statement, section 205 further requires that it select the most cost-
effective and least burdensome alternative that achieves the objectives
of the rule and is consistent with the statutory requirements. In
addition, section 203 requires a plan for informing and advising any
small governments that may be significantly or uniquely impacted by the
rule. Based on information currently available, we expect the combined
impact on State, local, or Tribal governments and the private sector
does not meet the UMRA definition of unfunded mandate.
List of Subjects in 42 CFR Part 136
Employment, Government procurement, Healthcare, Health facilities,
Indians, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Health
and Human Services amends 42 CFR part 136 as follows:
PART 136--INDIAN HEALTH
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1. The authority citation for part 136 continues to read as follows:
Authority: 25 U.S.C. 13; sec. 3, 68 Stat. 674 (42 U.S.C., 2001,
2003); Sec. 1, 42 Stat. 208 (25 U.S.C. 13); 42 U.S.C. 2001, unless
otherwise noted.
Subpart F--[Removed and Reserved]
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2. Remove and reserve subpart F, consisting of Sec. Sec. 136.51
through 136.57.
Dated: April 24, 2024.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-09152 Filed 4-29-24; 8:45 am]
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