Rule2026-10543
Control of Communicable Diseases; Foreign Quarantine
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 27, 2026
Effective
May 22, 2026
Issuing agencies
Health and Human Services Department
Abstract
The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) issues this interim final rule with request for comments to amend its Foreign Quarantine Regulations. This interim final rule provides a procedure for the Secretary acting through the CDC Director or other delegate to suspend the introduction of persons from designated countries or places, if required, in the interest of public health.
Full Text
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[Federal Register Volume 91, Number 101 (Wednesday, May 27, 2026)]
[Rules and Regulations]
[Pages 31362-31368]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10543]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[Docket No. CDC-2026-0991]
RIN 0920-AA88
Control of Communicable Diseases; Foreign Quarantine
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Interim final rule.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the U.S. Department of Health and Human Services (HHS) issues this
interim final rule with request for comments to amend its Foreign
Quarantine Regulations. This interim final rule provides a procedure
for the Secretary acting through the CDC Director or other delegate to
suspend the introduction of persons from designated countries or
places, if required, in the interest of public health.
DATES:
Effective date: This interim final rule is effective on May 22,
2026.
Comment date: Comments must be received by June 26, 2026.
Expiration date: Unless extended after consideration of submitted
comments, this interim final rule will cease to be in effect on the
earlier of (1) six months from the publication of this interim final
rule, or (2) when the HHS Secretary determines there is no longer a
need for this interim final rule. The Secretary will publish a document
in the Federal Register announcing the expiration date.
ADDRESSES: You may submit comments, identified by CDC-2026-0991, by the
following method:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name
and docket number or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
<a href="http://regulations.gov">http://regulations.gov</a>, including any personal information provided.
For access to the docket to read background documents or comments
received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Any comment that is submitted will be shared with the Department of
Homeland Security and the Department of State and will also be made
available to the public. Comments must be identified by CDC-2026-0991.
Because of staff and resource limitations, all comments must be
submitted electronically to <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
Warning: Do not include any personally identifiable information
(such as name, address, or other contact information) or confidential
business information that you do not want publicly disclosed. All
comments may be posted on the internet and can be retrieved by most
internet search engines. No deletions, modifications, or redactions
will be made to comments received.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including personally identifiable or confidential business information
that is included in a comment.
FOR FURTHER INFORMATION CONTACT: Division of Global Migration Health,
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-
H16-4, Atlanta, Georgia 30329. Telephone: 1-800-232-4636.
SUPPLEMENTARY INFORMATION: The IFR is organized as follows:
Table of Contents
I. Background
II. Statutory Authority
III. Provisions of Amended Sec. 71.40(f)
IV. Rationale for Issuance of an Interim Final Rule With Immediate
Effectiveness
V. Request for Comment
VI. Regulatory Impact Analysis
I. Background
The Centers for Disease Control and Prevention (CDC), a component
of the U.S. Department of Health and Human Services (HHS), is amending
the regulations that implement section 362 of the Public Health Service
(PHS) Act, 42 U.S.C. 265, as amended, as part of its response to the
2026 Ebola Disease Outbreak in the Democratic Republic of Congo (DRC),
Uganda, and South Sudan. Section 362 provides that if the Secretary
``determines that by reason of the existence of any communicable
disease in a foreign country there is serious danger of the
introduction of
[[Page 31363]]
such disease into the United States, and that this danger is so
increased by the introduction of persons or property from such country
that a suspension of the right to introduce such persons and property
is required in the interest of the public health,'' he has the
authority, in accordance with regulations approved by the President,
``to prohibit, in whole or in part, the introduction of persons and
property from such countries or places as he shall designate in order
to avert such danger, and for such period of time as he may deem
necessary for such purpose.'' PHS Act 362, 42 U.S.C. 265. Pursuant to a
delegation of the Secretary's authority, the CDC Director has
promulgated regulations under section 362 to suspend the introduction
of persons and property into the United States. Current regulations,
however, provide an exception to the suspension of introduction into
the United States for lawful permanent residents (LPR) (42 CFR
71.40(f))
CDC's experience with Ebola disease is that the disease is a severe
and often fatal illness caused by viruses in the Ebola family. Ebola
disease outbreaks occur mainly in parts of sub-Saharan Africa and can
spread rapidly in communities with limited healthcare resources. The
particular Ebola disease at issue in this outbreak, the Bundibugyo
virus, is a rare form of Ebola first identified during an outbreak in
Bundibugyo District, Uganda, in 2007. Bundibugyo virus is one of
several species within the orthoebolavirus family and causes symptoms
similar to other forms of Ebola, including fever, weakness, vomiting,
diarrhea, and, in severe cases, hemorrhagic complications and organ
failure. The disease spreads through direct contact with infected
bodily fluids or contaminated materials.
The incubation period for Ebola disease caused by the Bundibugyo
virus is typically between 2 and 21 days, with most people developing
symptoms within 4 to 10 days after exposure. During this incubation
period, infected individuals do not spread the virus until symptoms
begin. Screening for Ebola disease caused by Bundibugyo virus focuses
on identifying symptoms and possible exposure history, such as recent
travel to affected areas or contact with infected individuals.
Suspected patients are evaluated for symptoms including fever,
weakness, vomiting, diarrhea, and bleeding, and laboratory confirmation
is performed using specialized tests such as PCR (polymerase chain
reaction) to detect the virus in blood and other body fluid samples.
Health authorities also use temperature checks, contact tracing, and
isolation procedures to prevent transmission.
There are currently no widely approved vaccines or specific
antiviral treatments for the Bundibugyo virus that causes Ebola
disease. Treatment mainly consists of supportive care, including
intravenous fluids, electrolyte replacement, oxygen support, pain and
fever management, and treatment of secondary infections. Early medical
care significantly improves survival chances. Robust public health
measures such as early detection, rapid isolation, strong infection
prevention measures (i.e., use of personal protective equipment (PPE)),
and monitoring of contacts are critical to controlling outbreaks and
reducing deaths. Given the complexities of global disease outbreaks,
including the current Ebola disease outbreak in the DRC, Uganda and
South Sudan, the logistics of trying identify cases at the numerous
ports of entry (POE) of the United States (air, land, and sea), and the
fact that there are no approved vaccines or specific antiviral
treatments for this strain of Ebola disease, CDC needs a more efficient
regulatory mechanism to exercise its section 362 authority and suspend
the introduction of persons other than U.S. Citizens and U.S. Nationals
who would otherwise pose a serious danger of introduction of Ebola
disease into the United States.
Past Experience With Migration and Communicable Disease
International travel and migration play a significant role in the
global transmission of infectious biological agents or their toxic
products that pose risks for vulnerable populations. Travelers can
serve as unwitting vectors of disease and thereby increase the risk of
communicable disease transmission and of the introduction of
quarantinable communicable disease into the United States. The risk
increases when travelers are in congregate settings, such as carriers
(i.e., ships, aircraft, trains, and road vehicles) or terminals with
shared sitting, sleeping, eating, or recreational areas, all of which
are conducive to disease transmission.
The speed and far reach of global travel were factors in prior
outbreaks that expanded to numerous continents. Examples include: The
H1N1 influenza pandemic in 2009; severe acute respiratory syndrome
(SARs) coronavirus in 2003; tuberculosis; measles; Middle East
Respiratory Syndrome (MERS-CoV) in 2012; Ebola Virus Disease in 2014
and 2018, and COVID-19 in 2020. All these high-consequence diseases
posed significant public health risks, especially given the compressed
timeframes in which the outbreaks initially occurred.
In addition, global travel has increased dramatically since prior
infectious disease outbreaks. In 2025, international visitations to the
U.S. totaled over 68 million; in 2020 when this regulation was amended
to introduce the suspension of introduction of persons into the United
States, that number totaled only 19.8 million. The dramatic increase in
global travel to the United States, likely spurred by individuals
having the freedom to travel again following the COVID-19 pandemic,
make the availability of the most efficient and comprehensive mechanism
for exercising the section 362 authority all the more important to the
protection of the public health going forward.
The Current Outbreak of Ebola Disease
Presently, there is a confirmed ongoing outbreak of Ebola disease
caused by the Bundibugyo virus in DRC and Uganda. The current outbreak
is centered in eastern DRC's Ituri Province, where hundreds of
suspected cases and dozens of deaths have been reported. Conflict, weak
health infrastructure, and relatively porous borders in the region are
complicating containment efforts.
Uganda has confirmed imported cases linked to travel from DRC,
including one case detected in Kampala, imported from a traveler from
DRC. Ugandan authorities have activated emergency response systems,
expanded surveillance, and strengthened screening at borders and health
facilities. Uganda has significant prior experience managing Ebola
disease outbreaks, including the Sudan virus strain outbreak in 2025,
which improved preparedness and response capacity.
South Sudan has not reported confirmed cases in the current
outbreak, but it is considered at high risk because of its close border
with affected areas in eastern DRC and Uganda, limited healthcare
infrastructure, and cross-border population movement. Regional and
international agencies, including WHO and Africa CDC, are supporting
preparedness measures, surveillance, and coordination among the three
countries to prevent wider spread. Despite these efforts there is a
risk that the outbreak could spread beyond these three countries, and
ultimately reach the United States, through international travel by
infected individuals during the virus's incubation period, when they
have been exposed but are not yet showing symptoms. Travelers moving
between affected countries and major international transit hubs could
[[Page 31364]]
unknowingly carry the virus before becoming ill.
DRC, Uganda, and South Sudan are connected to the global aviation
network through a series of regional and international transit hubs
that provide pathways into the United States. Travelers departing from
outbreak-affected regions frequently transit through densely populated
metropolitan airports such as Addis Ababa Bole International Airport
(ADD), Jomo Kenyatta International Airport (NBO) in Nairobi, Hamad
International Airport (DOH) in Doha, Dubai International Airport (DXB),
and Istanbul Airport (IST), all of which maintain extensive passenger
connectivity to major U.S. gateway airports including John F. Kennedy
International Airport (JFK), Washington Dulles International Airport
(IAD), Hartsfield-Jackson Atlanta International Airport (ATL), Chicago
O'Hare International Airport (ORD), and Los Angeles International
Airport (LAX). These international transportation corridors support
continuous movement of travelers between Central and East Africa and
major U.S. metropolitan centers, increasing the likelihood that
individuals exposed to Ebola virus disease could enter the United
States before symptoms become apparent. Complex multi-leg itineraries
and the rapid pace of international travel create substantial
challenges for identifying potentially infected travelers before
arrival.
The risk of Bundibugyo virus disease introduction into the United
States is heightened by the virus's incubation period, which can extend
up to 21 days, allowing infected individuals to travel internationally
while asymptomatic and therefore unlikely to be detected through
routine symptom-based screening measures. A traveler infected in
outbreak regions of DRC and Uganda may transit through multiple
countries and major international airports before developing fever or
other clinical signs of disease. Upon arrival in major U.S.
metropolitan areas, travelers who become symptomatic could interact
with crowded airport environments, domestic transportation systems,
healthcare facilities, hotels, or community settings prior to diagnosis
and isolation. Because modern aviation networks enable rapid movement
from outbreak zones to the United States within one to two days, even a
limited number of infected travelers could create significant public
health response demands, particularly if exposure events occur in high-
density urban environments. The interconnected nature of global air
travel therefore presents a credible pathway for Bundibugyo virus
disease importation into the United States, underscoring the importance
of aggressive surveillance, traveler monitoring, airport screening,
healthcare preparedness, and rapid containment capabilities.
Travelers utilizing air transit pathways originating in or passing
through DRC, Uganda, and South Sudan include non-U.S. citizens, foreign
contract workers, humanitarian personnel, business travelers, students,
refugees, and third-country nationals moving through international
aviation hubs in Africa, the Middle East, and Europe. Many travelers
entering U.S.-bound itineraries from these pathways may do so under
temporary visas, refugee or asylum processing mechanisms, international
organizational travel, or multi country itineraries that obscure their
original point of departure. As a result, public health screening and
border security systems face heightened operational complexity in
identifying travelers with recent exposure histories linked to Ebola-
affected regions, particularly when travelers originate from or transit
through multiple jurisdictions prior to arrival at major U.S.
metropolitan airports.
On May 18, 2026, the Director General of WHO declared that the
outbreak of Ebola Disease caused by the Bundibugyo virus is a Public
Health Emergency of International Concern under the International
Health Regulations. Also on May 18, 2026, the CDC issued an initial
order suspending the entry of covered aliens into the United States
pursuant to section 362 (42 U.S.C. 265) of the Public Health Service
Act, as amended, and 42 CFR part 71.40.
Restricting entry of LPRs, in addition to other non-U.S. citizens,
who originate from or have recently traveled through DRC, Uganda, and
South Sudan would reduce the volume of higher-risk international
arrivals requiring public health monitoring and follow-up. Limiting the
number of potentially exposed travelers entering through major U.S.
ports of entry, federal, state, and local public health authorities
could concentrate finite surveillance, screening, contact tracing,
quarantine management, and medical monitoring resources on returning
U.S. citizens. Such an approach would reduce operational strain on
airport screening systems, CDC quarantine stations, public health
laboratories, and healthcare facilities, many of whom may not have
experience treating highly pathogenic diseases, responsible for
evaluating suspected Bundibugyo virus disease cases. It would also
improve the ability of authorities to conduct detailed exposure
assessments, ensure compliance with monitoring requirements during the
21-day incubation period, rapidly identify symptomatic individuals, and
allocate specialized isolation and treatment capacity more effectively.
In the context of a rapidly evolving Bundibugyo virus disease outbreak
with significant international mobility, prioritizing surveillance
efforts toward a smaller and more traceable traveler population would
strengthen the overall effectiveness of U.S. disease containment and
border health security operations.
Travelers Health Notices (THNs) and Health Alert Network notices
(HANs) have also been issued by the CDC with respect to travel from or
through the affected countries.
This outbreak continues to highlight why CDC needs an efficient and
comprehensive regulatory mechanism to suspend the introduction of all
persons who would otherwise increase the serious danger of the
introduction of a quarantinable communicable disease into the United
States. Section 362 currently provides the authority to prohibit the
``introduction'' of persons into the United States, while the
implementing regulations found at 42 CFR part 71.40 provide exceptions
to that authority. Despite continued attempts to mitigate and end the
outbreak, cases and deaths have rapidly propagated and multiplied,
crossing international borders with ease. In the immediate term, given
what is currently known about the outbreak, persons traveling from
other foreign countries and jurisdictions, including LPRs, may increase
the opportunity for introduction of Ebola disease into the United
States.
At this time, there is no approved vaccine or therapeutic for the
Bundibugyo virus causing the current outbreak of Ebola disease. The
Secretary acting through the CDC Director or other delegate needs a
robust, efficient, and comprehensive mechanism for exercising its
authority under section 362 and other applicable authorities to suspend
the introduction of persons into the United States, including LPRs,
should the public health require it. In issuing orders pursuant to this
interim final rule, the Secretary acting through the CDC Director or
other delegate would coordinate with the Secretary of State in order to
ensure compliance with the international legal obligations of the
United States and to take due account of U.S. national and security
interests. CDC would also coordinate
[[Page 31365]]
with the Department of Homeland Security to operationalize and
implement the order.
Other Public Health Risks
The suspension authority is also critical to CDC because there is
always a risk of another emerging, or re-emerging, quarantinable
communicable disease that may harm the American public. Currently, CDC
is responding to multiple outbreaks of quarantinable communicable
disease: Andes virus, a strain of Hantavirus, and now the Ebola
disease. Another continuous risk of quarantinable communicable disease
comes in the form of pandemic influenza (as opposed to seasonal
influenza), which occurs when a novel, or new, influenza virus strain
spreads over a wide geographic area and affects an exceptionally high
proportion of the population. In such circumstances, the strain of
virus is new, there is usually no available vaccine, and humans do not
typically have immunity to the virus, often resulting in a more severe
illness. The severity and unpredictable nature of an influenza pandemic
require public health systems to prepare constantly for the next
occurrence. Whenever a new strain of influenza virus appears, or a
major change to a preexisting virus occurs, individuals may have little
or no immunity, which can lead to a pandemic when the virus passes
easily from human to human and causes serious illness or death. The
most recent influenza pandemics include H1N1 in 2009-2010, the 1968-
1969 Hong Kong Flu, the 1957-1958 Asian Flu, and the 1918-1919 Spanish
Flu.
It is difficult to predict the impact that another emerging, or re-
emerging, quarantinable communicable disease would have on the U.S.
public health system. The 2009 H1N1 pandemic caused between 100,000 and
600,000 deaths worldwide, while the 1918-1919 Spanish Flu was estimated
to have caused over 50 million deaths worldwide. The COVID-19 pandemic
from 2020-2023 caused approximately 7.11 million deaths world-wide,
disrupted the global economy, the ability to live everyday life
normally, separated families and friends for, in some cases, several
years, and caused untold harm to individual mental health. Although
advances in health care quality have greatly improved, the dramatic
increases in global mobility in the 21st century have increased the
rate at which a communicable disease can spread. Modern pandemics,
spread through international travel, can engulf the world in three
months or less. Moreover, pandemics can last from 12 to 18 months (or
longer in the case of COVID-19) and are not considered one-time events.
The introduction of another emerging, or re-emerging, quarantinable
communicable disease into the United States is always a risk. The PHS
Act section 362 suspension authority has proven critical to prior CDC
efforts, as well as those of its Federal, State, and local partners to
contain or mitigate public health risks. CDC expects to mitigate the
risk in the future by issuing a Final Rule, after considering comments,
to implement a permanent regulatory structure regarding the potential
suspension of introduction of persons, including LPRs, into the United
States in the event a serious danger of the introduction of a
quarantinable communicable disease arises in the future.
II. Statutory Authority
The primary legal authority supporting this rulemaking is section
362 of the PHS Act, which is codified at 42 U.S.C. 265. Under section
362, the Secretary has the authority--if he were to determine that the
existence of a communicable disease in a foreign country creates a
serious danger of the introduction of such disease into the United
States, and that this danger is increased by the introduction of
persons or property from such country such that suspension of
introduction is necessary to protect the public health--to suspend, in
accordance with regulations approved by the President, such period of
time as he may deem necessary for such purpose.
In addition to section 362, other sections of the PHS Act are
relevant to this rulemaking, including section 311, 42 U.S.C. 243;
section 361, 42 U.S.C. 264; section 365, 42 U.S.C. 268; and section
367, 42 U.S.C. 270. Section 311 authorizes the Secretary to accept
State and local assistance in the enforcement of quarantine rules and
regulations and to assist States and their political subdivisions in
the control of communicable diseases. Section 361 authorizes the
Secretary to make and enforce such regulations that in the Secretary's
judgment are necessary to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries into the United
States. It also permits the ``apprehension, detention, or conditional
release of individuals'' in order to prevent the ``introduction,
transmission, or spread'' of such communicable diseases as may be
specified from time to time in Executive Orders of the President upon
the recommendation of the Secretary, in consultation with the Surgeon
General. Section 365 provides that it shall be the duty of designated
customs officers and of Coast Guard officers to aid in the enforcement
of quarantine rules and regulations. Section 367 authorizes the
application of certain sections of the PHS Act and promulgated
regulations (including penalties and forfeitures for violations of such
sections and regulations) to air navigation and aircraft to such extent
and upon such conditions as deemed necessary for safeguarding public
health.
III. Provisions of Amended Sec. 71.40(f)
This interim final rule will implement amendments to section
71.40(f).
Although section 362 applies to ``persons,'' this interim final
rule does not apply to U.S. citizens or U.S. nationals consistent with
the constitutional limitations on the Federal Government's authority to
restrict the return of its own citizens and nationals. U.S. citizens
possess a fundamental constitutional right to enter the United States.
That does not render CDC without tools to address the public health
risks posed by returning U.S. citizens and U.S. nationals who may have
been exposed to quarantinable communicable diseases, including Ebola.
Congress provided CDC with the authority to prohibit the introduction
of persons who would increase a serious danger of introducing into the
United States a quarantinable communicable disease, when required in
the interest of the public health. CDC believes that, at present,
quarantine, isolation, and conditional release, in combination with
other authorities, while not perfect solutions, can mitigate any
transmission or spread of communicable diseases, including Ebola caused
by the Bundibugyo virus through the introduction of U.S. citizens into
the United States, as that population is likely to be limited, and
given the finite nature of the resources to support those actions.
Section 71.40(f) therefore states that this interim final rule shall
not apply to U.S. citizens and U.S. nationals. Determining the
appropriate protections for U.S. citizens and U.S. nationals requires a
complex balancing of numerous interests and would benefit from
additional consideration and public comment. HHS does not want such
concerns to delay the issuance of this interim final rule, which would
enable the CDC Director to issue orders that would have the effect of
slowing the introduction, transmission, and spread of quarantinable
communicable diseases, including Ebola caused by the Bundibugyo virus
in the United States.
[[Page 31366]]
The interim final rule will apply to lawful permanent residents.
HHS and CDC have determined that permitting the Director of CDC or
other Secretarial delegate the discretion to prohibit entry of certain
lawful permanent residents is reasonably required in the interest of
public health. In making that determination, HHS and CDC considered
that many lawful permanent residents may maintain stronger ties to
families and communities outside the United States than do U.S.
citizens and nationals, such that prohibiting their entry is
comparatively less burdensome to lawful permanent residents than to
U.S. citizens or nationals. Moreover, lawful permanent residents may
have comparatively deeper ties to their home countries or regions than
do American citizens, whose connections to those countries or regions
may be more fleeting. And those closer connections, more frequent
visits, and additional time spent in relevant countries or region may
increase the risk of exposure to pathogens in their home countries or
regions during public health emergencies. HHS and CDC have also
considered that, conversely, U.S. citizens and nationals would be more
negatively affected by being prohibited from entering the United
States.
Furthermore, HHS and CDC have determined that the interim final
rule should apply to lawful permanent residents given resource
constraints. Containing quarantinable communicable diseases on U.S.
soil is highly resource-intensive, requiring specialized and isolated
facilities with limited capacity. In their judgment, HHS and CDC have
determined that current section 71.40 may not provide the Director of
CDC or other Secretarial Delegate the flexibility needed to manage the
influx of persons from designated foreign countries or places. Given
the above analysis of the relative burdens faced by U.S. citizens, U.S.
nationals, and lawful permanent residents, HHS and CDC have determined
that the best balance between ensuring the Director of CDC has the
ability to properly allocate resources and taking into account the
interests of persons entering the United States is to draw the line at
lawful permanent residents.
As with current section 71.40, this interim final rule only
provides discretion to the Director of CDC to suspend the entry of
covered aliens; it does not automatically prohibit the introduction of
any individua into the United States.
IV. Rationale for Issuance of an Interim Final Rule With Immediate
Effectiveness
Agency rulemaking is governed by section 553 of the Administrative
Procedure Act (APA) (5 U.S.C. 553). Section 553(b) requires that,
unless the rule falls within one of the enumerated exemptions, HHS must
publish a notice of proposed rulemaking in the Federal Register that
provides interested persons an opportunity to submit written data,
views, or arguments, prior to finalization of regulatory requirements.
Section 553(b)(3)(B) of the APA authorizes a department or agency to
dispense with the prior notice and opportunity for public comment
requirement when the agency, for ``good cause,'' finds that notice and
public comment thereon are impracticable, unnecessary, or contrary to
the public interest. In addition, because this interim final rule
represents a critical part of the dialogue between the United States
and the Governments of the affected countries, DRC, Uganda, and South
Sudan, as well as potential implementing partners Mexico and Canada, in
preventing the spread of Ebola disease caused by Bundibugyo virus, it
involves a ``foreign affairs function of the United States.'' 5 U.S.C.
553(a)(1).
As noted above, the United States and the affected countries of
DRC, Uganda, and South Sudan, along with other countries have taken
necessary measures to try to contain or slow the transmission or spread
of this Ebola disease outbreak. Such public health actions, especially
the actions by the Secretary, have been taken to attempt to slow
introduction and transmission of the disease into the United States,
which benefit the public health, preserve limited public and private
resources, particularly in the areas of quarantine and isolation, and
give the U.S. public health system additional time to implement further
measures to protect and support the public.
Nevertheless, these measures have not completely stopped (and will
not completely stop) global travelers, and other persons crossing from
one country into another country, from spreading Ebola disease caused
by the Bundibugyo virus across country boundaries. This interim final
rule's expanded discretion to exercise the suspension authority is
therefore critical to slowing the introduction of Ebola disease into
the United States. The United States is at a mitigation juncture where
suspending the introduction of persons, including LPRs, from certain
countries or places may be required in the interest of the public
health, because it could materially reduce the transmission and spread
of Ebola disease in the United States and the need for limited
resources to implement any necessary public health actions. Because
persons can have Ebola disease and be asymptomatic (although not
infectious until symptomatic) at the time of introduction into the
United States, and because specialized testing is needed to confirm
infection with the disease, it is impracticable to confirm who is
infected with Ebola disease and who is not infected with Ebola disease
as persons move into the United States. Similarly, Federal quarantines
or isolations of all such persons pending test results would be
impracticable due to the potential numbers of persons involved if this
necessary limitation is not imposed, logistical challenges, and CDC
resource and personnel constraints.
Given that the outbreak has been declared a public health emergency
of international concern, and that quick action is crucial to
preventing spread of the disease, it would be impracticable and
contrary to the public health--and, by extension, the public interest--
to delay the necessary changes to this implementing regulation until a
full public notice-and-comment process is completed.
Pursuant to 5 U.S.C. 553(b)(3)(B), and for the reasons stated
above, HHS therefore concludes that there is good cause to dispense
with prior public notice and the opportunity to comment on this rule
before finalizing this rule. For the same reasons, HHS has determined,
consistent with section 553(d) of the APA, that there is good cause to
make this interim final rule effective immediately upon filing at the
Office of the Federal Register.
V. Request for Comment
HHS requests comment on all aspects of this interim final rule,
including its likely costs and benefits and the impacts that it is
likely to have on the public health, as compared to the current
requirements under 42 CFR part 71.
VI. Regulatory Impact Analysis
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, and public
health and safety effects; distributive impacts; and equity). Executive
Order 13563
[[Page 31367]]
emphasizes the importance of quantifying both costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility. Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a regulation (1)
having an annual effect on the economy of $100 million or more in any
one year, or adversely and materially affecting a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or communities
(also referred to as ``economically significant''); (2) creating a
serious inconsistency or otherwise interfering with an action taken or
planned by another agency; (3) materially altering the budgetary
impacts of entitlement grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order. This
interim final rule is economically significant for the purposes of
Executive Orders 12866 and 13563. CDC, however, is proceeding under the
emergency provision at Executive Order 12866 Section 6(a)(3)(D) based
on the need to move expeditiously during the current outbreak and
public health emergency of international concern to limit the
introduction of Ebola disease into the United States.
The Regulatory Flexibility Act (RFA) generally requires that when
an agency issues a proposed rule, or a final rule pursuant to section
553(b) of the APA or another law, the agency must prepare a regulatory
flexibility analysis that meets the requirements of the RFA and publish
such analysis in the Federal Register. 5 U.S.C. 603, 604. Specifically,
the RFA normally requires agencies to describe the impact of a
rulemaking on small entities by providing a regulatory impact analysis.
Such analysis must address the consideration of regulatory options that
would lessen the economic effect of the rule on small entities. The RFA
defines a ``small entity'' as (1) a proprietary firm meeting the size
standards of the Small Business Administration (SBA); (2) a nonprofit
organization that is not dominant in its field; or (3) a small
government jurisdiction with a population of less than 50,000. 5 U.S.C.
601(3)-(6). Except for such small government jurisdictions, neither
State nor local governments are ``small entities.'' Similarly, for
purposes of the RFA, individual persons are not small entities. The
requirement to conduct a regulatory impact analysis does not apply if
the head of the agency ``certifies that the rule will not, if
promulgated, have a significant economic impact on a substantial number
of small entities.'' 5 U.S.C. 605(b). The agency must, however, publish
the certification in the Federal Register at the time of publication of
the rule, ``along with a statement providing the factual basis for such
certification.'' Id. If the agency head has not waived the requirements
for a regulatory flexibility analysis in accordance with the RFA's
waiver provision, and no other RFA exception applies, the agency must
prepare the regulatory flexibility analysis and publish it in the
Federal Register at the time of promulgation or, if the rule is
promulgated in response to an emergency that makes timely compliance
impracticable, within 180 days of publication of the final rule. 5
U.S.C. 604(a), 608(b).\[19]\
This interim final rule establishes a regulatory mechanism for the
exercise of the PHS Act section 362 suspension authority, which
directly applies against persons and not State, local, or tribal
governments, or the private sector. Accordingly, HHS and CDC certifies
that this interim final rule would likely impact only persons, and that
it would, therefore, not have a significant economic impact on a
substantial number of small entities. In addition, for the reasons set
forth in this document pertaining to the Ebola disease outbreak, the
Secretary finds that this interim final rule is being promulgated in
response to an emergency that makes timely compliance with the
provisions of section 604 impracticable.
Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (2 U.S.C. 1532) requires that covered agencies 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 in 1995 dollars, updated annually for inflation. Currently,
that threshold is approximately $193 million. If a budgetary impact
statement is required, section 205 of the Unfunded Mandates Act also
requires covered agencies to identify and consider a reasonable number
of regulatory alternatives before promulgating a rule. HHS has
determined that this interim final rule is not expected to result in
expenditures by State, local, and tribal governments, or by the private
sector, that meets or exceeds the threshold in any one year because it
only establishes a regulatory mechanism for the exercise of the PHS Act
section 362 suspension authority, which applies against persons and not
State, local, or tribal governments, or the private sector.
Accordingly, HHS has not prepared a budgetary impact statement or
specifically addressed the regulatory alternatives considered.
National Environmental Policy Act (NEPA)
HHS has determined that the amendments to 42 CFR part 71 will not
have a significant impact on the human environment. Executive Order
12988: Civil Justice Reform
HHS has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and has determined that this interim final rule meets
the standard in the Executive Order.
Executive Order 13132: Federalism
This interim final rule has been reviewed under Executive Order
13132, Federalism. Under 42 U.S.C. 264(e), Federal public health
regulations do not preempt State or local public health regulations,
except in the event of a conflict with the exercise of Federal
authority. Other than to restate this statutory provision, this
rulemaking does not alter the relationship between the Federal
government and State/local governments as set forth in 42 U.S.C. 264.
The longstanding provision on preemption in the event of a conflict
with Federal authority (42 CFR 70.2) is left unchanged by this
rulemaking. Furthermore, there are no provisions in this regulation
that impose direct compliance costs on State and local governments.
Therefore, HHS believes that the interim final rule does not warrant
additional analysis under Executive Order 13132.
Plain Language Act of 2010
Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13,
2010), executive Departments and Agencies are required to use plain
language in documents that explain to the public how to comply with a
requirement the Federal Government administers or enforces. HHS/CDC has
attempted to use plain language in promulgating this interim final
rule, consistent with the Federal Plain Writing Act guidelines.
Congressional Review Act
The Congressional Review Act defines a ``major rule'' as ``any rule
that the Administrator of the Office of Information and Regulatory
Affairs (OIRA) of the Office of Management and Budget finds has
resulted in or is likely to result in--(A) an annual effect on the
[[Page 31368]]
economy of $100,000,000 or more; (B) a major increase in costs or
prices for consumers, individual industries, Federal, State, or local
government agencies, or geographic regions; or (C) significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export
markets.'' 5 U.S.C. 804(2). This Office of Information and Regulatory
Affairs has determined that this interim final rule is a major rule for
purposes of the Congressional Review Act. As this rule is promulgated
under the ``good cause'' exemption of the Administrative Procedure Act,
there is not a delay in its effective date under the Congressional
Review Act.
Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999 requires Federal departments and agencies to determine
whether a proposed policy or regulation could affect family well-being.
If the determination is affirmative, then the Department or agency must
prepare an impact assessment to address criteria specified in the law.
HHS has determined that this interim final rule will not have an impact
on family well-being, as defined in the Act.
Paperwork Reduction Act of 1995
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
Ch. 3506; 5 CFR 1320 Appendix A.1), HHS has reviewed this interim final
rule and has determined that there are no new collections of
information contained therein.
List of Subjects in 42 CFR Part 71
Apprehension, CDC, Communicable diseases, Conditional release, Ill
person, Isolation, Non-invasive, Public health emergency, Public health
prevention measures, Qualifying stage, Quarantine, Quarantinable
communicable disease.
For the reasons set forth in the preamble, the Department of Health
and Human Services, on behalf of the Centers for Disease Control and
Prevention, amends 42 CFR part 71 as follows:
PART 71--FOREIGN QUARANTINE:
0
1. The authority citation for part 71 continues to read as follows:
Authority: Secs. 215 and 311 of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as
amended (42 U.S.C. 264-272).
0
2. Amend Sec. 71.40 by revising paragraph (f) to read as follows:
Sec. 71.40 Suspension of the right to introduce and prohibition of
the introduction of persons into the United States from designated
foreign countries or places for public health purposes.
* * * * *
(f) This section shall not apply to U.S. citizens and U.S.
nationals.
* * * * *
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-10543 Filed 5-22-26; 4:15 pm]
BILLING CODE 4163-18-P
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</html>Indexed from Federal Register on May 27, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.