Interim Final Rule

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 71
[CDC Docket No. CDC–2020–0013]
RIN 0920–AA75

Control of Communicable Diseases;
Foreign Quarantine
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Interim final rule with request
for comments.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS) is issuing this interim
final rule to amend its Foreign
Quarantine regulations, to enable CDC
to require airlines to collect, and
provide to CDC, certain data regarding
passengers and crew arriving from
foreign countries for the purposes of
health education, treatment,
prophylaxis, or other appropriate public
health interventions, including travel
restrictions.
DATES:
Effective date: This interim final rule
is effective on February 7, 2020.
Comment date: Written comments are
invited and must be submitted on or
before March 13, 2020.
Expiration date: Unless extended after
consideration of submitted comments,
this interim final rule will cease to be
in effect on the earlier of (1) the date
that is two incubation periods after the
last known case of 2019–nCoV, or (2)
when the 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: Written comments may be
submitted to the Department of Health
and Human Services as specified below.
Any comment that is submitted will be
made available to the public. Comments
must be identified by RIN 0920–AA75.
Because of staff and resource
limitations, comments must be
submitted electronically to
www.regulations.gov. 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

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SUMMARY:

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received, as they are public records.
Comments may be submitted
anonymously.
Comments: You may submit
electronic comments on this interim
final rule to http://www.regulations.gov.
Follow the ‘‘Submit a comment’’
instructions.
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. Before or after the close of
the comment period, CDC will post all
comments that were received before the
end of the comment period on
www.regulations.gov. Follow the search
instructions on that website to view the
public comments.
FOR FURTHER INFORMATION CONTACT:
Christopher De La Motte Hurst, Health
Scientist, Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS H16–4, Atlanta, GA
30329; Telephone: 404–498–1600;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Current Outbreak of 2019–nCoV
On December 31, 2019, the People’s
Republic of China (China) notified the
World Health Organization (WHO) of
pneumonia cases of an unknown cause
in Wuhan, China. The United States
now has confirmed cases of individuals
who have this severe acute respiratory
illness caused by a novel (new)
coronavirus (‘‘2019–nCoV’’) (‘‘the
virus’’) first detected in Wuhan, Hubei
Province, China. On January 30, 2019,
the World Health Organization (WHO)
declared the outbreak of the 2019–nCoV
virus in China a Public Health
Emergency of International Concern.1
WHO indicated that it is expected that
further international exportation of
cases may appear in any country, and
that countries should place particular
emphasis on reducing human infection,
prevention of secondary transmission,
and international spread of the disease.
As of February 1, 2020, Chinese health
officials have reported approximately
11,953 confirmed cases of infections
with 2019–nCoV in China, with an
additional 15,238 suspected cases.2
China now has more confirmed cases of
1 Under the International Health Regulations, a
public health emergency of international concern is
‘‘an extraordinary event’’ that constitutes a ‘‘public
health risk to other States through international
spread of disease and to potentially require a
coordinated international response.’’
2 Suspected cases as of January 31, 2020.

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2019–nCOV than it had of severe acute
respiratory syndrome (‘‘SARS’’) in
2002–2003. As of February 1, 2020, the
virus has killed at least 259 people, all
in China.
Outside of China, there are
approximately 164 confirmed cases as of
February 1, 2020. In one day, the total
number of confirmed cases around the
world rose from 9,707 to 11,953—an
increase of nearly 20 percent. The virus
was discovered in China in December
2019. There are now reports of infected
people in 28 countries, including those
who have not visited China. Those
individuals are in Germany, Japan,
Taiwan, and Vietnam, among other
countries. As of February 1, 2020, there
were 8 confirmed cases in the United
States.
The 2019–nCoV
Coronaviruses are a large family of
viruses. Some cause illness in people
and others circulate among animals,
including camels, cats, and bats. Animal
coronaviruses are capable of evolving
and infecting people and then spreading
between people, as occurred with
Middle East respiratory syndrome
(MERS) and SARS.
Coronaviruses can cause illnesses
ranging in severity from mild upper
respiratory symptoms, similar to the
common cold, to severe illnesses, such
as those caused by SARS and MERS.
Signs and symptoms of 2019–nCoV
include fever, cough, and difficulty
breathing. The virus has the potential to
cause severe illness and death—with
persons that have underlying health
conditions possibly at higher risk.
However, many with the virus
experience mild symptoms. U.S. and
international health officials are
continuing to study the virus to
determine its characteristics, including
its transmissibility and fatality rate, and
to develop diagnostic tests, vaccines,
and therapeutics.
Outbreaks of novel virus infections
among people are always of public
health concern. Older adults and people
with underlying health conditions may
be at increased risk.
As noted, public health experts are
still in the process of studying the virus,
including the severity of the virus. The
cases that have been identified skew to
the severe, including patients who are
older or have other illnesses. Experts are
working to understand the incubation
period. The incubation period for
coronaviruses varies; known
coronaviruses have incubation periods
ranging anywhere from 2 to 14 days. But
that period could be higher or lower for
this virus. China and Germany have

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reported that there may be evidence of
asymptomatic transmission.
Travel Restrictions
In light of the rapid spread of the
virus, Chinese authorities have imposed
strict travel restrictions in the area
around Wuhan. China has taken
unprecedented steps to help control the
virus. Currently, there are at least 16
cities in China that are under travel
restrictions and 26 of China’s
provincial-level jurisdictions are on
high health alert. Beijing city
government has suspended all interprovince bus service.
But these precautions have not
stopped the virus from spreading to
areas of China outside of Hubei
Province, as well as to other countries.
As many as 5 million individuals are
reported to have left Wuhan prior to the
imposition of intra-China travel
restrictions. Neighboring countries have
taken swift action to protect their
citizens by restricting travel between
their countries and China.
On January 29, President Trump
designated the Secretary of Health and
Human Services to lead an interagency
task force on the novel coronavirus. On
January 30, 2020, the U.S. Department
of State issued a ‘‘Level 4: Do Not
Travel’’ travel advisory for China, its
highest level of caution over the rapidly
spreading virus. Other countries have
taken additional measures, including
prohibiting foreign nationals traveling
from China from entering or transiting
their borders and quarantining citizens
returning from China. Such sustained
human-to-human viral transmission in
the United States could have cascading
public health, economic, and societal
consequences.
While the risk of infection for
Americans remained low, on January
31, 2020, the Secretary determined that,
as of January 27, 2020, a public health
emergency has existed in the United
States as a result of confirmed cases of
2019–nCoV under section 319 of the
Public Health Service Act. As part of the
public health response, the President
authorized temporary measures to
increase the U.S. government’s ability to
detect and contain 2019–nCoV
beginning at 5:00 p.m. EST on Sunday,
February 2, 2020. Amongst these
measures, U.S. citizens (and certain
classes of aliens) returning to the United
States who have been in Hubei Province
in the previous 14 days will be subject
to up to 14 days of mandatory
quarantine to ensure that they received
appropriate medical screening—have
not contracted the virus and do not pose
a public health risk—or receive proper
medical care. U.S. citizens (and certain

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classes of foreign nationals) returning to
the United States who have been in the
rest of mainland China within the
previous 14 days will undergo proactive
entry health screening at a select
number of ports of entry and up to 14
days of monitoring to ensure they have
not contracted the virus and do not pose
a public health risk. Pursuant to the
President’s proclamation, with certain
exceptions, the entry of aliens who were
physically present within China
(excluding the Special Administrative
Regions of Hong Kong and Macau)
during the 14-day period preceding
their entry or attempted entry into the
United States has been temporarily
suspended.
The CDC is closely monitoring the
situation in the United States for
person-to-person transmissions in the
United States, is conducting enhanced
entry screening at the U.S airports
where travelers from China are arriving,
and is enhancing its general illness
response capacity at the 20 ports of
entry where CDC quarantine stations are
located. CDC is also supporting States in
conducting contact investigations of
confirmed 2019–nCoV cases identified
in the United States. As of January 31,
2020, there has been at least one case of
person-to-person transmission in the
United States.
During Fiscal Year 2019, an average of
more than 14,000 people traveled to the
United States from China each day, via
both direct and indirect flights. With
such numbers, it would put a severe
strain on the CDC to require it to both
actively monitor all of these travelers
and actively contain and arrange care
for individuals at risk in the United
States. This continues to be the case,
even with the temporary travel
restrictions, given the scope of the
public health response in which CDC is
engaged. The virus has spread to 28
countries, including Germany, Japan,
Taiwan, and Vietnam, among other
countries, and as of February 1, 2020,
there were 8 confirmed cases in the
United States.
II. Newly Required Data Reporting
By this interim final rule, CDC
requires airlines to collect, and within
24 hours of an order by the Director of
CDC, submit to CDC certain data
regarding passengers and crew arriving
from foreign countries for the purposes
of health education, treatment,
prophylaxis, or other appropriate public
health interventions, including travel
restrictions.

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Need for Contact Data for Public Health
Follow-Up
Among the fundamental components
of the public health response to the
report of a person with a communicable
disease is the identification and
evaluation of those who may have been
exposed. Thus, in order to control the
introduction, transmission, and spread
of communicable diseases into the
United States, such as 2019–nCoV, CDC
must be able to identify and locate
persons arriving in the United States
from a foreign country who may have
been exposed to a communicable
disease abroad. Another fundamental
component of a public health response
is identifying and contacting those
individuals who may have come in
contact with a person with a
communicable disease and who may be
at risk of contracting the disease as a
result of their interactions with such
affected persons. The identification and
notification of those exposed is an
essential first step in providing the
exposed access to potentially life-saving
medical screening, follow-up, disease
prevention measures, including
vaccination and other preventive
treatments, and medical treatment and
supportive care. Preventing secondary
cases among contacts, in turn, helps
prevent the propagation and spread of
disease within the community.
Therefore, travelers and the public at
large derive direct benefit from a system
that ensures that, if an exposure has
occurred, health authorities can
identify, locate, and notify affected
passengers and those individuals who
came into contact with them within the
incubation period of the disease.
Contact tracing is effective at reducing
cases of communicable disease at the
early stages of a potential outbreak if the
contacts are notified as soon after initial
exposure as possible. If an efficient
contact system is not in place when the
first ill passengers arrive, the benefits of
the contact tracing are greatly
diminished.
CDC, in partnership with State, local,
and international public health partners,
frequently conducts contact
investigations for diseases such as
tuberculosis, measles, meningitis,
rubella, and viral hemorrhagic fevers.
The delays experienced by CDC in
collecting, analyzing, processing, and
sending information related to ill and
exposed travelers to State and local
partners have at times been significant,
sometimes over several days. Such
delays may prevent CDC and State and
local partners from providing timely
public health interventions designed to
educate travelers and prevent additional

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transmission. This interim final rule
will enable CDC to receive the most
useful forms of data in a more timely
manner and enable it to more effectively
provide critical public health services.
Based on CDC’s experience, in order
to conduct effective contact tracing of
individuals who may be arriving in the
United States from abroad, it is critical
to have the person’s full name, address
in the U.S., one or two phone numbers,
and email address. In the past, CDC has
reviewed the effectiveness of different
means of contacting a person. If public
health authorities had a valid phone
number, the contact rate is between 91
and 100 percent. With only the address,
the contact rate plummets to 44 percent.
With only the name—currently, a
common situation—the contact rate is
only eight percent. HHS and CDC have
found that a phone number will allow
rapid contact with an individual and
can substantially improve the public
health response to an outbreak. Two
phone numbers increase the chance of
contacting an individual, even when he
or she is traveling. HHS and CDC
believe that collecting email addresses
will further increase the chance of
contacting a person when he or she is
traveling. Moreover, especially in an
outbreak where CDC and its public
health partners will need to conduct a
significant amount of contact tracing as
quickly as possible, it is critical for CDC
to receive the information in a usable
electronic form, so that it is easy to
process, analyze, and, as necessary,
transmit to its public health partners at
the State and local levels of government.
By this interim final rule, CDC
requires airlines to collect and submit
via electronic means to CDC, beginning
within 24 hours of an order from the
Director, certain data regarding
passengers and crew arriving on flights
arriving in the United States from
foreign countries. CDC believes that this
is the only mechanism by which it can
efficiently obtain the information it
needs for a public health response to
outbreaks of communicable disease and
that current regulatory requirements are
not sufficient, especially in public
health emergencies. CDC will exercise
enforcement discretion where
appropriate. We note that
implementation of this interim final rule
will entail technical and logistical
difficulties for airlines. We are confident
that all airlines will make every effort to
comply with it. CDC, and the
Department of Health and Human
Services (HHS) more broadly, will in the
exercise of its enforcement discretion
take into account the good faith
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implementing the interim final rule in a
timely fashion.
Currently, 42 CFR 71.20 permits the
Director to require individuals to
provide contact information as part of
public health prevention measures.
However, while 42 CFR 71.20 provides
the Department with what in many
instances are useful authorities, it is not
in all cases adequate to address public
health emergencies: It would require
collection of the information from a
large number of individuals, and it does
not require a format. Hence, the
information may be effectively
unusable—thousands of pages of paper
documents in non-standardized formats.
Thus, it would be inefficient and
cumbersome to obtain, organize, review,
and appropriately disseminate such
information from thousands of
individuals, particularly during a public
health emergency when time is of the
essence. It is more efficient to collect
such information from airline carriers,
whose numbers are more limited.
Moreover, while it might be
theoretically possible to collect contact
information directly from airline
passengers, such a collection—unless
conducted at all times for all
passengers—would inevitably mean that
CDC would not have information to
conduct contact tracing and public
health follow-ups for those individuals
who were on flights at the beginning of
or before an outbreak.
In an outbreak, paper records (such as
those collected during public health
screening programs at ports of entry)
and paper customs declarations are
inadequate for contact tracing or public
health follow-ups. Moreover, customs
declarations are not being collected and
stored consistently for all travelers at
this time, and in some airports they are
not required for U.S. travelers. As it is
impossible to predict outbreaks, and
given that the information from the
earliest affected flights would be
critical, the ability to obtain information
that is continuously collected in an
electronic format is extremely useful for
responding to the ever-changing disease
threat.
CDC’s current regulations at 42 CFR
71.4, relating to the transmission of
airline passenger, crew, and flight
information for public health purposes,
specify that airlines ‘‘must provide
certain information to CDC to the extent
that such data are already available and
maintained [. . .].’’ 42 CFR 71.4(a)
(emphasis added).3 However, such data
3 These data elements are (1) full name (last, first,
and, if available, middle or others); (2) date of birth;
(3) sex; (4) country of residence; (5) if a passport
is required, passport number, passport country of

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are not always ‘‘already available and
maintained.’’ Accordingly, even with
the current requirements, CDC
sometimes receives information that is
not timely, complete, or accurate. The
Department of Homeland Security has
attempted to help CDC fill the gaps in
these data in order to try and make
contact with exposed travelers in a
timely manner. However, even with this
assistance, gaps can still remain and
acquiring contact information for large
numbers of incoming travelers, as
needed during the current response to
2019–nCoV, can rapidly become
impracticable.
Under this interim final rule, CDC
envisions that information will be
provided by carriers and shared with
CDC using the procedures currently in
effect with respect to data that is
provided to CDC pursuant to 42 CFR
71.4. Specifically, DHS will assist HHS
in facilitating the transmission of the
requested information using the existing
data-sharing infrastructure in place
between HHS and DHS. These
infrastructures already have
operationalized safeguards for data
privacy and security. And CDC will
hold any received data under current
protocols for data privacy and security
for information obtained under 42 CFR
71.4(a) and (b).
Provisions of the Interim Final Rule
Given the limitations associated with
the current regulatory requirements,
CDC is exercising its statutory authority
to require any airline with a flight
arriving into the United States,
including any intermediate stops
between the flight’s origin and final
destination, to collect and, within 24
hours of an order by the CDC Director,
transmit to CDC the following five data
elements with respect to each passenger
and crew member who may be at risk
of exposure to a communicable disease,
to the extent that such information
exists for the individual, and in a format
acceptable to the Director:
1. Full name;
2. Address while in the United States;
3. Email address;
issuance, and passport expiration date; (6) if a travel
document other than a passport is required, travel
document type, travel document number, travel
document country of issuance and travel document
expiration date; (7) address while in the United
States (number and street, city, State, and zip code),
except that U.S. citizens and lawful permanent
residents will provide address of permanent
residence in the U.S. (number and street, city, State,
and zip code); (8) primary contact phone number
to include country code; (9) secondary contact
phone number to include country code; (10) email
address; (11) airline name; (12) flight number; (13)
city of departure; (14) departure date and time; (15)
city of arrival; (16) arrival date and time; and (17)
seat number. 42 CFR 71.4(b).

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4. Primary phone number; and
5. Secondary phone number.
These are the pieces of data most
useful for CDC and provide the agency
and its partners with a capability to
provide critical public health services.
In order for CDC to perform its critical
public health functions with respect to
an outbreak of a communicable disease,
the timely provision of information from
the airlines is critical. But the airlines
currently do not always provide such
information in a timely fashion. For
routine contact investigations performed
during business hours without CDC
surge staff, CDC experience suggests
that, following a flight, it takes airlines
up to seven days to respond to a single
request for passenger manifest
information currently collected. In
addition, there is significant time and
labor needed (typically several business
days) for CDC to obtain additional
information and process the received
information into a format suitable for
distribution to local health authorities
in the U.S. As a result, obtaining contact
information after a flight—assuming the
information is available and recognizing
its limitations—leads to a delay of
nearly two weeks before health
authorities can make the first contact.
Two weeks is ample time for travelers
to be lost to follow-up, or become
symptomatic or infectious. The time
required and costs incurred increase
exponentially with multiple requests.
The required collection of this
information by the airlines finds strong
support in public opinion. While a
significant number of air passengers
expressed concerns with increased
reservation or check-in time, a Harvard
School of Public Health study, Project
on the Public and Biological Security,
found that 94% of air travelers would
want public health authorities to contact
them if they might have been exposed
to a serious contagious disease on an
airplane. In addition, 93% of domestic
air travelers and 89% of international
air travelers expressed a willingness to
provide some type of contact
information.
HHS and CDC acknowledge that
coordination with other agencies
reduces duplication, increases
passengers’ willingness to provide the
information, and reduces costs to travel
providers. HHS and CDC will work with
all relevant departments and agencies to
ensure that this process eliminates
duplication with other programs and
imposes the lowest cost possible on
travelers and travel providers. By
relying on the existing data collection
and collection methods, HHS and CDC
have trimmed the additional required
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needed for an effective public health
response. All of the data that this
interim final rule requires airlines to
collect and submit to CDC are data
elements that the airlines are already
required to submit to CDC, provided
they are ordered to do so, if the data are
already available and maintained. HHS
and CDC also acknowledge that airlines
may not currently collect all of these
data and may not keep such data as they
do collect in the form in which CDC
would prefer to receive it. They also
recognize that a certain amount of
modification to airlines’ information
systems will be necessitated by the
requirement to collect any data elements
that the airlines do not currently collect
from all international passengers.
During this transition period, CDC
anticipates working with airlines on an
individual basis to ensure they are
capable and able to meet the
requirements of this interim final rule.
Although CDC is issuing this interim
final rule, CDC continue to work with
its partners to explore all avenues to
obtain the information needed for a
public health response to the outbreak
of a communicable disease, such as
2019–nCOV.
III. Statutory Authority
The primary legal authority
supporting this rulemaking is section
361 of the Public Health Service Act, 42
U.S.C. 264. Section 361, among other
things, authorizes the Secretary of HHS
to make and enforce such regulations as
in the Secretary’s judgment are
necessary to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the states or possessions
of the United States and from one state
or possession into any other state or
possession.
Section 361(a), 42 U.S.C. 264(a), states
that the Secretary may make and enforce
regulations as necessary to prevent the
introduction, transmission, and spread
of ‘‘communicable diseases’’ from
foreign countries into the United States
or from one state or possession (U.S.
territory) into any other state or
possession (U.S. territory). By its terms,
subsection (a) does not seek to limit the
types of communicable diseases for
which regulations may be enacted, but
rather applies to all communicable
diseases that may impact human health.
Section 361(a) further authorizes the
Secretary to promulgate and enforce a
variety of public health regulations to
prevent the spread of these
communicable diseases, including
inspection, fumigation, disinfection,
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destruction of animals or articles found

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to be sources of dangerous infection to
human beings, and other measures.
In addition to section 361, HHS
believes that the following Public
Health Service Act sections are also
relevant with respect to this rulemaking:
Section 311, 42 U.S.C. 243; section 362,
42 U.S.C. 265; 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 365
provides that it shall be the duty of
customs officers (e.g., U.S. Customs and
Border Protection officers) and of U.S.
Coast Guard officers to aid in the
enforcement of quarantine rules and
regulations. Section 367 authorizes the
application of certain sections of the
Public Health Service 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.
As prescribed in section 368, 42
U.S.C. 271, and under 18 U.S.C. 3559
and 3571(c), criminal sanctions exist for
violating regulations enacted under
sections 361 and 362, 42 U.S.C. 264 and
265. 18 U.S.C. 3559 defines an offense
(not otherwise classified by letter grade)
as a ‘‘Class A misdemeanor’’ if the
maximum term of imprisonment is ‘‘one
year or less but more than six months.’’
18 U.S.C. 3571 provides that individuals
found guilty of an offense may be
sentenced to a fine. Specifically, an
individual may be fined ‘‘not more than
the greatest of’’—(1) the amount
specified in the law setting forth the
offense; or (2) for a misdemeanor
resulting in death, not more than
$250,000; or (3) for a Class A
misdemeanor that does not result in
death, not more than $100,000.
Similarly, an organization found guilty
of an offense may be fined ‘‘not more
than the greatest of’’—(1) the amount
specified in the law setting forth the
offense; or (2) for a misdemeanor
resulting in a death, not more than
$500,000; or (3) for a Class A
misdemeanor that does not result in
death, not more than $200,000. 42
U.S.C. 271 sets forth statutory penalties
of up to 1 year in jail and a fine of
$1,000. Therefore, it is classified as a
Class A misdemeanor under 18 U.S.C.
3559. Because the alternate fines set
forth under 18 U.S.C. 3571 are greater
than the $1,000 set forth under 42
U.S.C. 271 (which sets a maximum
penalty of not more than $1,000 or one

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year of jail, or both for violation of
quarantine laws), and because 42 U.S.C.
271 does not exempt its lower penalties
from 18 U.S.C. 3571(e), the greater
penalties of 18 U.S.C. 3571(b)(5) and
(c)(5) apply.

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IV. Request for Comment
HHS and CDC request 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
71.4. They are particularly interested in
comments on:
• The extent to which airlines
currently collect, with respect to
passengers on inbound international
flights, the data elements that this
interim final rule requires airlines to
collect and submit to CDC.
• When reporting is required, the
time period within which airlines
should be required to report such data,
and whether that time period should be
measured from the published time of
departure or of arrival.
• Whether the Director’s authority to
require the reporting of the data
elements listed in paragraph (e) should
be limited to circumstances in which
the Secretary has determined, under
section 319 of the Public Health Service
Act, 42 U.S.C. 247d, that a public health
emergency exists, or some other public
health determination. If so, should the
regulation authorize the Director to
require the submission of data for
persons on inbound international flights
that were completed prior to the
issuance of the directive? If so, to what
period of time prior to the directive
should the Director be able to reach
with this data submission requirement?
Any comments submitted in response
to this interim final rule will be
considered in the preparation of a final
rule.
V. 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, the Department 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

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agency, for ‘‘good cause,’’ finds that
notice and public comment thereon are
impracticable, unnecessary, or contrary
to the public interest.
As noted above, although China has
taken unprecedented steps to help
control the virus, these steps have not
stopped the virus from spreading
outside of China into other countries,
including the United States. During
Fiscal Year 2019, an average of more
than 14,000 people traveled to the
United States from China each day, via
both direct and indirect flights. That
travel has decreased since the onset of
the 2019–nCoV outbreak in China, and
the U.S. government has taken steps to
limit travel to the United States from
China by aliens. Nevertheless, given the
demands on its resources by the public
health response to the current outbreak,
CDC is experiencing difficulty in both
actively monitoring travelers from
China, and other countries with
individuals infected with 2019–nCoV,
and actively containing and arranging
care for individuals at risk in the United
States. The virus has caused severe
illness and sustained person-to-person
spread in China, and the United States
reported the first confirmed instance of
person-to-person spread with this virus
on January 30, 2020. The goal of the
ongoing U.S. public health response is
to contain this outbreak and prevent
sustained spread of 2019–nCoV in this
country. HHS and CDC have determined
that, given the exigent and rapidly
emerging circumstances associated with
the 2019–nCoV outbreak, it would be
impracticable and contrary to the public
health and, thus, to the public interest,
to delay putting these provisions in
place until a full public notice-andcomment process is completed.
Pursuant to 5 U.S.C. 553(b)(3)(B), and
for the reasons stated above, HHS and
CDC therefore conclude 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
and CDC have 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.
VII. 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

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(including potential economic,
environmental, and public health and
safety effects; distributive impacts; and
equity). Executive Order 13563
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 has been
determined to be significant for the
purposes of Executive Orders 12866 and
13563, and has been reviewed by the
Office of Management and Budget.
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). The
requirement 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.’’ Id. section
605(b). The agency must, however,
publish the certification in the Federal
Register at the time of publication of the

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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).4 For the reasons
set forth in this document pertaining to
the outbreak and rapid spread of the
2019–nCoV, 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. HHS and
CDC will assess the potential economic
effects of this action on all small
entities. Based on that assessment, HHS
and CDC will either certify that the rule
will not have a significant economic
impact on a substantial number of small
entities or publish a final regulatory
flexibility analysis.

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Executive Order 13771
The White House issued Executive
Order 13771 on Reducing Regulation
and Controlling Regulatory Costs on
January 30, 2017. Section 2(a) of
Executive Order 13771 requires an
agency, unless prohibited by law, to
identify at least two existing regulations
to be repealed when the agency publicly
proposes for notice and comment or
otherwise promulgates a new regulation.
In furtherance of this requirement,
section 2(c) of Executive Order 13771
requires that the new incremental costs
associated with new regulations shall, to
the extent permitted by law, be offset by
the elimination of existing costs
associated with at least two prior
regulations. This rule is not subject to
Executive Order 13771, because it
relates to a national security function of
the United States as defined in OMB M–
17–21, Guidance Implementing
Executive Order 13771, Titled
4 An agency head may delay the completion of
the regulatory impact analysis requirements for a
period of not more than 180 days after the date of
publication in the Federal Register of a final rule
by publishing in the Federal Register, not later than
such date of publication, a written finding, with
reasons therefor, that the final rule is being
promulgated in response to an emergency that
makes timely compliance with such requirements
impracticable. If the agency has not prepared a final
regulatory analysis within 180 days from the date
of publication of the final rule, the RFA provides
that the rule shall lapse and have no effect and shall
not be repromulgated until a final regulatory
flexibility analysis has been completed by the
agency. 5 U.S.C. 608(b).

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‘‘Reducing Regulation and Controlling
Regulatory Costs’’.
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 $154 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. The Department
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, of
$154 million or more in any one year.
Accordingly, the Department has not
prepared a budgetary impact statement
or specifically addressed the regulatory
alternatives considered.
National Environmental Policy Act
(NEPA)
The Department 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
The Department has reviewed this
rule under Executive Order 12988 on
Civil Justice Reform and determines that
this final rule meets the standard in the
Executive Order.
Executive Order 13132
This 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.
Additionally, there are no provisions in
this regulation that impose direct
compliance costs on State and local
governments. Therefore, the Department

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believes that the 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
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
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 foreignbased enterprises in domestic and
export markets.’’ 5 U.S.C. 804(2). OIRA
has determined that this interim final
rule is not likely to result in an annual
effect of $100,000,000 or more and is
not otherwise a major rule for purposes
of 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. The Department
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
CDC currently has an approved
Airline Traveler Information Collection
(42 CFR part 71) (0920–1180 expires 05/
31/2020), which covers its current
collection of information from airlines
under 42 CFR 71.4(a). The Office of
Management and Budget has
determined there is no new information
collection requiring a submission of a

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new information collection request
under the Paperwork Reduction Act, (44
U.S.C. Chapter 35).
List of Subjects in 42 CFR Part 71
Apprehension, Communicable
diseases, Conditional release, CDC, 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
1. The authority citation for part 71
continues to read as follows:

■

Dated: February 6, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–02731 Filed 2–7–20; 8:45 am]
BILLING CODE 4163–18–P

FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 19–3; FCC 19–127; FRS
16411]

Reexamination of the Comparative
Standards and Procedures for
Licensing Noncommercial Educational
Broadcast Stations and Low Power FM
Stations
Federal Communications
Commission.
ACTION: Final rule.

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).

AGENCY:

2. Amend § 71.4 by adding new
paragraphs (d) and (e) to read as follows:

SUMMARY:

■

§ 71.4 Requirements relating to the
transmission of airline passenger, crew,
and flight information for public health
purposes.

*

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(5) Email address.

*
*
*
*
(d) Notwithstanding paragraph (a) of
this section, any airline with a flight
arriving into the United States,
including any intermediate stops
between the flight’s origin and final
destination, shall collect and, within 24
hours of an order by the Director,
transmit to the Director the data
elements in paragraph (e) of this section,
in a format acceptable to the Director,
for the passengers or crew who may be
at risk of exposure to a communicable
disease, for the purposes of public
health follow-up, such as health
education, treatment, prophylaxis, or
other appropriate public health
interventions, including travel
restrictions.
(e) The data elements referred to in
paragraph (d) of this section include, to
the extent that such information exists
for the individual:
(1) Full name (last, first, and, if
available, middle or others);
(2) Address while in the United States
(number and street, city, State, and zip
code), except that U.S. citizens and
lawful permanent residents will provide
address of permanent residence in the
U.S. (number and street, city, State, and
zip code);
(3) Primary contact phone number to
include country code;
(4) Secondary contact phone number
to include country code; and

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In this document, the
Commission adopts changes to its rules
and procedures to select and license
competing applications for new
noncommercial educational (NCE)
broadcast stations and low power FM
(LPFM) stations. The changes are
designed to improve the comparative
selection procedures, reduce confusion
among future applicants, expedite the
initiation of new service to the public,
and eliminate unnecessary applicant
burdens.

Effective April 13, 2020, except
for rule changes to §§ 73.865, 73.872,
73.7002(c), 73.7003, and 73.7005. The
Commission will publish a separate
document in the Federal Register
announcing the effective date of these
rules.

DATES:

FOR FURTHER INFORMATION CONTACT:

Albert Shuldiner, Chief, Media Bureau,
Audio Division, (202) 418–2721; Lisa
Scanlan, Deputy Division Chief, Media
Bureau, Audio Division, (202) 418–
2704; Amy Van de Kerckhove, Attorney
Advisor, Media Bureau, Audio Division,
(202) 418–2726. For additional
information concerning the Paperwork
Reduction Act (PRA) information
collection requirements contained in
this document, contact Cathy Williams
at 202–418–2918, or via the internet at
[email protected].
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Report
and Order (R&O), MB Docket No. 19–3;
FCC 19–127, adopted on December 10,
2019, and released on December 11,
2019. The full text of this document is
available electronically via the FCC’s

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Electronic Document Management
System (EDOCS) website at http://
fjallfoss.fcc.gov/edocs_public/ or via the
FCC’s Electronic Comment Filing
System (ECFS) website at http://
www.fcc.gov/ecfs. (Documents will be
available electronically in ASCII,
Microsoft Word, and/or Adobe Acrobat.)
This document is also available for
public inspection and copying during
regular business hours in the FCC
Reference Information Center, which is
located in Room CY–A257 at FCC
Headquarters, 445 12th Street SW,
Washington, DC 20554. The Reference
Information Center is open to the public
Monday through Thursday from 8:00
a.m. to 4:30 p.m. and Friday from 8:00
a.m. to 11:30 a.m. The complete text
may be purchased from the
Commission’s copy contractor, 445 12th
Street SW, Room CY–B402, Washington,
DC 20554. Alternative formats are
available for people with disabilities
(braille, large print, electronic files,
audio format), by sending an email to
[email protected] or calling the
Commission’s Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
Paperwork Reduction Act of 1995
Analysis
This document contains new or
modified information collection
requirements subject to the Paperwork
Reduction Act of 1995 (PRA), Public
Law 104–13, see 44 U.S.C. 3507. The
Commission, as part of its continuing
effort to reduce paperwork burdens, will
invite the general public and the Office
of Management and Budget (OMB) to
comment on the information collection
requirements contained in this
document in a separate Federal Register
Notice, as required by the PRA. These
new or modified information collections
will become effective after the
Commission publishes a document in
the Federal Register announcing such
approval and the relevant effective date.
In addition, pursuant to the Small
Business Paperwork Relief Act of 2002,
Public Law 107–198, see 44 U.S.C.
3506(c)(4), the Commission previously
sought specific comment on how the
Commission might further reduce the
information collection burden for small
business concerns with fewer than 25
employees.
Congressional Review Act
The Commission will send a copy of
this R&O to Congress and the
Government Accountability Office
(GAO) pursuant to the Congressional
Review Act, 5 U.S.C. 801(a)(1)(A).

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