Control of Communicable Diseases; Foreign Quarantine, 7874-7880 [2020-02731]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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]



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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 https://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

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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 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

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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 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