[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Rules and Regulations]
[Pages 7874-7880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02731]
[[Page 7874]]
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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
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Interim final rule with request for comments.
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SUMMARY: 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 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 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.
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\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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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
[[Page 7875]]
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 inter-province 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 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.
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
[[Page 7876]]
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 attempts at compliance of any airline which may
have difficulty in 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 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.
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\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 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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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;
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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 passenger information to the minimum
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, sanitation,
pest extermination, destruction of animals or articles found 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
[[Page 7878]]
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.
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 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-and-
comment 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 (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
[[Page 7879]]
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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\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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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 ``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 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 foreign-based 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
[[Page 7880]]
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
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. 71.4 by adding new paragraphs (d) and (e) to read as
follows:
Sec. 71.4 Requirements relating to the transmission of airline
passenger, crew, and flight information for public health purposes.
* * * * *
(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
(5) Email address.
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