[Federal Register Volume 70, Number 229 (Wednesday, November 30, 2005)]
[Proposed Rules]
[Pages 71892-71948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23312]



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Part II





Department of Health and Human Services





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42 CFR Parts 70 and 71



Control of Communicable Diseases; Proposed Rule

  Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Parts 70 and 71

RIN 0920-AA03


Control of Communicable Diseases

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: CDC is committed to protecting the health and safety of the 
American public by preventing the introduction of communicable disease 
into the United States. Having updated regulations in place is an 
important measure to ensure swift response to public health threats. 
CDC proposes to update existing regulations related to preventing the 
introduction, transmission, or spread of communicable diseases from 
foreign countries into the U.S. and from one State or possession into 
another.

DATES: Written comments must be received on or before January 30, 2006. 
Written comments on the proposed information collection requirements 
should also be submitted on or before January 30, 2006. Comments 
received after January 30, 2006 will be considered to the extent 
practicable.

ADDRESSES: You may submit written comments to the following address: 
Centers for Disease Control and Prevention, Division of Global 
Migration and Quarantine, ATTN: Q Rule Comments, 1600 Clifton Road, 
NE., (E03), Atlanta, GA 30333. Comments will be available for public 
inspection Monday through Friday, except for legal holidays, from 9 
a.m. until 5 p.m. at 1600 Clifton Road, NE., Atlanta, GA 30333. Please 
call ahead to 1-866-694-4867 and ask for a representative in the 
Division of Global Migration and Quarantine to schedule your visit. 
Comments also may be viewed at http://www.cdc.gov/ncidod/dq. You may 
submit written comments electronically via the Internet at http://www.regulations.gov or via e-mail to [email protected]. To 
download an electronic version of the rule, you may access http://www.regulations.gov.
    Mail written comments on the proposed information collection 
requirements to the following address: Office of Information and 
Regulatory Affairs, OMB, New Executive Office Building, 725 17th 
Street, NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for 
CDC.

FOR FURTHER INFORMATION CONTACT: Jennifer Brooks, Centers for Disease 
Control and Prevention, Division of Global Migration and 
Quarantine,1600 Clifton Road, NE., (E03), Atlanta, GA 30333; telephone 
(404) 498-2395.

SUPPLEMENTARY INFORMATION: The Preamble to this notice of proposed 
rulemaking is organized as follows:

I. Legal Authority
II. Background and Purpose
III. Legal Basis of Federal Quarantine Authority
IV. Summary of Proposed Changes to 42 CFR Part 70
V. Summary of Proposed Changes to 42 CFR Part 71
VI. Required Regulatory Analyses Under Executive Order 12866, the 
Unfunded Mandates Reform Act, and the Regulatory Flexibility Act
    A. Objectives and Basis for the Proposed Regulation
    B. The Nature of the Impacts
    C. Need for the Rule
    D. Baseline
    E. Alternatives
    F. Cost Analysis of Proposed Option and Alternatives
    G. Impacts on Industry
    H. Benefits
    I. Comparison of Costs and Benefits
    J. Regulatory Flexibility Analysis
    K. References for Part VI
VII. Other Administrative Requirements
    A. Executive Order 13045: Protection of Children from 
Environmental Health and Safety Risks
    B. Paperwork Reduction Act of 1995
    C. Environmental Assessment
    D. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    E. Executive Order 12630: Governmental Actions and Interference 
With Constitutionally Protected Property Rights
    F. Executive Order 13132: Federalism
    G. Executive Order 13211: Energy Effects
    H. National Technology Transfer and Advancement Act
    I. Family Policy Analysis
    J. Executive Order 12988: Civil Justice Reform
    K. Plain Language
VIII. Solicitation of Comments

I. Legal Authority

    These regulations are proposed under the authority of 25 U.S.C. 
198, 231, and 1661; 42 U.S.C. 243, 248, 249, 264-272, and 2001.

II. Background and Purpose

    The primary authorities supporting this rulemaking are Sec. Sec.  
361-368 of the Public Health Service Act (42 U.S.C. 264-271). Section 
361 authorizes the Secretary to make and enforce regulations as are 
necessary to prevent the introduction, transmission or spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another.
    Recent experiences with emerging infectious diseases such as West 
Nile Virus, SARS, and monkeypox have illustrated the rapidity with 
which disease may spread throughout the world and the impact 
communicable diseases, when left unchecked, may have on the global 
economy. As noted by the Institute of Medicine, National Academy of 
Sciences in a recent study, ``Whether naturally occurring or 
intentionally inflicted, infections can cause illness, disability, and 
death in persons while disrupting whole populations, economies, and 
governments. And because national borders offer trivial impediment to 
such threats, especially in the highly interconnected and readily 
traversed ``global village'' of our time, one nation's problem soon 
becomes every nation's problem.'' (Microbial Threats to Health: 
Emergence, Detection and Response'', Institute of Medicine, March, 
2003). As diseases evolve naturally or as a result of human 
intervention, it is important to ensure that containment procedures 
reflect new threats and uniform ways to respond to them.
    Stopping an outbreak--whether it is naturally occurring or 
intentionally caused--requires the use of the most rapid and effective 
public health tools available. These tools include basic public health 
practices such as disease reporting requirements and identification and 
notification of contacts who may have been exposed to a communicable 
disease so that they may receive preventive measures. Quarantine is 
defined as the restriction of the movement of persons exposed to 
infection to prevent them from infecting others, including family 
members, friends, and neighbors. Quarantine of exposed persons may be 
the best initial way to prevent the uncontrolled spread of highly 
dangerous biologic agents such as smallpox, plague, and Ebola fever--
especially when combined with other health strategies such as 
vaccination, prophylactic drug treatment, patient isolation, and other 
appropriate infection control measures. Quarantine may be particularly 
important if a biologic agent has been rendered contagious, drug-
resistant, or vaccine-resistant through bioengineering, making other 
disease control measures less effective.
    The Secretary's authority to quarantine persons is limited to those 
communicable diseases published in an Executive Order of the President. 
This list currently includes cholera, diphtheria, infectious 
tuberculosis, plague, smallpox, yellow fever, and viral hemorrhagic 
fevers, such as

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Marburg, Ebola and Congo-Crimean, Severe Acute Respiratory Syndrome, 
and influenza caused by novel or reemergent influenza viruses that are 
causing or have the potential to cause a pandemic (see Executive Order 
13295, as amended by Executive Order 13375 on April 1, 2005).
    Regulations that implement federal quarantine authority are 
currently promulgated in 42 CFR parts 70 and 71. Part 71 deals with 
foreign arrivals and part 70 deals with interstate matters. The 
Secretary has delegated to the Director of the Centers for Disease 
Control and Prevention the authority for implementing 42 CFR part 71, 
which was last substantively updated in 1985. On August 16, 2000, the 
Secretary transferred the authority for interstate quarantine over 
persons from FDA to CDC, which became 42 CFR part 70. FDA retained, 
pursuant to 21 CFR part 1240, regulatory authority over animals and 
other products that may transmit or spread communicable diseases. The 
Secretary took this action in order to consolidate regulations designed 
to control the spread of communicable diseases, thereby increasing the 
agencies' efficiency and effectiveness. This proposed rule is not 
intended to have any effect upon FDA's authority in 21 CFR part 1240. 
In 2003, in response to the emergence of Severe Acute Respiratory 
Syndrome (SARS), Health and Human Services (HHS) amended 42 CFR 70.6 
and 71.3 to incorporate by reference the Executive Order listing the 
communicable diseases subject to quarantine, thereby eliminating the 
administrative delay involved in separately publishing the list of 
diseases through rulemaking. Also in 2003, CDC published an interim 
final rule that added Sec.  71.56 African rodents and other animals 
that may carry the monkeypox virus. Finally, on January 25, 2005, the 
Secretary added section 70.9 to establish vaccination clinics and a 
user fee in connection with administration of vaccine services and 
vaccine.
    The intent of the proposed updates to 42 CFR parts 70 and 71 is to 
clarify and strengthen existing procedures to enable CDC to respond 
more effectively to current and potential communicable disease threats.

III. Legal Basis of Federal Quarantine Authority

    The primary statutory authority to enact regulations for the 
purpose of communicable disease control is found at section 361 (42 
U.S.C. 264) of the Public Health Service Act. Section 361 is divided 
into four subsections. Subsection (a) authorizes the Secretary \1\ to 
make and enforce such regulations ``as in his judgment are necessary to 
prevent the introduction, transmission, and spread of communicable 
diseases'' from foreign countries and from one state or possession into 
any other state or possession. Subsection (a) also authorizes a variety 
of public health measures, including destruction of articles determined 
to be sources of communicable disease. Subsection (b) authorizes the 
``apprehension, detention, or conditional release'' of individuals to 
prevent the spread of communicable diseases as specified in Executive 
Orders of the President. Subsection (c) provides the basis for foreign 
quarantine of persons, while subsection (d) provides the basis for 
interstate quarantine of persons.
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    \1\ The Office of the Surgeon General was abolished by section 3 
of the 1966 reorganization plan, effective June 25, 1966, 31 FR 
8855. Accordingly, statutory references to the Surgeon General 
should be understood as referring to the Secretary.
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    As prescribed in 42 U.S.C. 271 and 18 U.S.C. 3559 and 3571(c), 
criminal sanctions exist for violating regulations enacted under 
section 361. Specifically, individuals in violation of such regulations 
are subject to a fine of no more than $250,000 or one year in jail, or 
both. Violations by organizations are currently subject to a fine no 
greater than $500,000 per event. Federal district courts also have 
jurisdiction to enjoin individuals and organizations from violating 
regulations implemented under section 361. See 28 U.S.C. 1331. 
Furthermore, section 311 (42 U.S.C. 243) of the PHSA, authorizes the 
Secretary to accept state and local assistance in the enforcement of 
quarantine regulations and to assist states and their political 
subdivisions in the control of communicable diseases.
    Prevention of communicable diseases has long been the subject of 
federal regulation. In 1796, Congress enacted the first federal 
quarantine law in response to a yellow fever epidemic, which gave 
federal officials the authority to assist states in the enforcement of 
quarantine laws. In 1799, Congress repealed the 1796 Act and replaced 
it with one establishing the first federal inspection system for 
maritime quarantines. In 1878, Congress amended the Quarantine Act to 
assign responsibilities to the Marine Hospital Service, which had been 
established in 1798 to provide for the health needs of merchant seaman. 
The 1878 Quarantine Act, however, was extremely limited and provided 
that federal quarantine regulations could not conflict with those of 
state or municipal authorities.
    In 1893, Congress expanded the role of the Marine Hospital Service 
by enacting ``An Act Granting Additional Quarantine Powers and Imposing 
Additional Duties upon the Marine Hospital Service.'' See Compagnie 
Francaise de Navigation a Vapeur v. State Board of Health, Louisiana, 
186 U.S. 380, 395-96 (1902). While the 1893 Act did not abrogate the 
role of the states, it nonetheless granted the Secretary of the 
Treasury the authority to enact additional rules and regulations to 
prevent the introduction of diseases, both foreign and interstate, 
where state and municipal ordinances were deemed insufficient. Id. at 
396. The Act also authorized direct federal enforcement of communicable 
disease regulations where state and municipal authorities refused to 
act. Id. Section 361 was enacted in 1944, and last amended in 2002.
    Acknowledging the critical importance of protecting the public's 
health, long-standing court decisions uphold the ability of Congress 
and the States to enact quarantine and other public health laws, and to 
have them executed by public health officials. United States v. 
Shinnick, 219 F.Supp.789 E.D.N.Y. (1963). Kroplin v. Truax, 165 N.E. 
498 (1929); Jacobson v. Massachusetts, 197 U.S. 11 (1905); North 
American Cold Storage Co. v. City of Chicago, 211 U.S. 306 (1908); 
Compagnie Francaise de Navigation a Vapeur v. Board of Health, 186 U.S. 
380 (1902). Whereas the States derive public health authorities from 
the police power reserved to them by the 10th Amendment to the U.S. 
Constitution, the authority of the federal government to enact 
quarantine rules and regulations is based on the Commerce Clause, which 
grants to Congress the exclusive authority to regulate foreign and 
interstate commerce. See U.S. Const. Art. I, section 8, cl.3 (granting 
to Congress the power ``to regulate Commerce with foreign Nations, and 
among the several States, and with the Indian Tribes.'').
    In addition to Congress' authority to regulate foreign commerce, 
the U.S. Supreme Court has identified three broad categories of 
interstate activity that Congress may regulate under its Commerce 
Clause authority: (1) The use of the channels of interstate commerce 
(e.g., prohibitions on the shipment in interstate commerce of noxious 
articles or kidnapped persons); (2) the instrumentalities of interstate 
commerce, or persons or things in interstate commerce, even though the 
threat to interstate commerce may come only from intrastate activities 
(e.g., regulations on railway rates); and (3)

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activities that substantially affect interstate commerce (e.g., labor 
standards). United States v. Lopez, 514 U.S. 549, 558-559 (1995). The 
proposed regulation is consistent with the scope of the federal 
government's commerce power because it seeks to regulate the uses of 
the channels of foreign and interstate commerce (i.e., by protecting 
against the introduction, transmission, and spread of communicable 
diseases) and the instrumentalities of foreign and interstate commerce 
(e.g., airlines with flights arriving into the U.S. or traveling from 
one state or possession into another).
    The proposed regulation also is consistent with the ``search and 
seizure'' requirements of the Fourth Amendment. Authority to ``search 
and seize'' in the form of inspections, detentions, and quarantine has 
long existed under the Public Health Service Act and the current 
regulations. The Fourth Amendment to the U.S. constitution provides 
that ``[t]he right of the people to be secure in their persons, houses, 
papers, and effects, shall not be violated, and no warrants shall 
issue, but upon probable cause. * * *'' Courts have held, however, that 
not all types of searches and seizures necessarily require probable 
cause and a warrant. Searches and seizures conducted with the consent 
of an authorized person and those searches and seizures that are 
conducted to avert an imminent threat to health or safety do not run 
afoul of the Fourth Amendment even when conducted without probable 
cause and a warrant. See Lenz v. Winburn, 51 F.3d 1540, 1548 (11th Cir. 
1995) (``Anyone who possesses common authority over or other sufficient 
relationship to the premises or effects sought to be inspected may 
consent to the search of another's property.'') (internal quotations 
marks omitted); North American Cold Storage, 211 U.S. at 315 (upholding 
seizure of food unfit for human consumption). Similarly, individuals at 
points of entry and who are in transit have a substantially reduced 
expectation of privacy concerning their persons and effects and thus 
courts have not required that searches and seizures be conducted 
pursuant to probable cause and a warrant. See United States v. 
McDonald, 100 F.3d 1320, 1324-25 (7th Cir. 1996) (noting that it is 
generally recognized that people who are in transit on common 
thoroughfares, i.e., on a bus, train, or airplane, have a substantially 
reduced expectation of privacy compared to persons in a fixed 
dwelling); United States v. Berisha, 925 F.2d 791, 795 (5th Cir. 1991) 
(noting that both incoming and outgoing border searches have features 
in common including the need to protect U.S. citizens, the likelihood 
of smuggling contraband, and the fact that individuals are placed on 
notice that their privacy may be invaded when they cross the border).
    The U.S. Supreme Court has also recognized a reduced expectation of 
privacy concerning commercial industries that are ``closely regulated'' 
and thus searches and seizures of such commercial industries do not 
require probable cause and a warrant. See New York v. Burger, 482 U.S. 
691, 702 (1987) (noting that the warrant and probable-cause 
requirements of the Fourth Amendment have lessened application in this 
context); Lesser v. Espy, 34 F.3d 1301, 1308 (1994) (upholding 
warrantless inspections of rabbit farms by the Animal Plant Health 
Inspection Program pursuant to the Animal Welfare Act). Specifically, 
warrantless inspections of ``closely regulated'' businesses are deemed 
reasonable provided that (1) there is a substantial government interest 
that informs the regulatory scheme pursuant to which the inspection is 
made; (2) the warrantless inspection is necessary to further the 
regulatory scheme; and (3) the inspection program, in terms of the 
certainty and regularity of its application, provides an adequate 
substitute for a warrant. Burger, 482 U.S. at 702-703.
    Section 361(a) of the PHS Act (42 U.S.C. 264(a)) provides that 
regulations enacted by the Secretary may provide for inspection, 
fumigation, disinfection, sanitation, pest extermination, destruction 
of animals or articles found to be so infected or contaminated to be 
sources of dangerous infection to human beings, and other measures that 
in the Secretary's judgment may be necessary to prevent the 
introduction, transmission, or spread of communicable diseases from 
foreign countries into the United States or from one state or 
possession into another. The statute also authorizes the apprehension, 
detention, and conditional release of persons reasonably believed to be 
infected with specified communicable diseases and arriving into the 
United States or traveling from one state into another. In carrying out 
this statutory authority, the proposed regulations authorize the 
Director to detain and inspect carriers and articles on board carriers 
for purposes of determining whether they may require the application of 
sanitary measures to prevent the introduction, transmission, or spread 
of communicable diseases.
    The Director's delegated authority under section 361 is distinct 
from legal authority afforded to other federal agencies, such as USDA, 
which, among other things, includes the legal authority to prohibit or 
restrict the importation or entry of any animal, article, or means of 
conveyance, or the use of any means of conveyance or facility, if the 
USDA Secretary determines that the prohibition or restriction is 
necessary to prevent the introduction into or dissemination within the 
United States of any pest or disease of livestock. See 7 U.S.C. 8303. 
In implementing measures necessary to prevent the introduction, 
transmission, and spread of communicable diseases that affect both 
human and livestock health, e.g., avian influenza, CDC would work 
collaboratively with USDA.
    As previously noted, there are circumstances where courts have held 
that the Fourth Amendment does not require probable cause and a 
warrant, including searches conducted upon the consent of the 
individual and those necessary to avert an imminent threat to human 
health or safety. Inspections conducted by quarantine officers at ports 
of entry and other locations will most often fall into one of these two 
categories. In addition, under the proposed regulations, the Director 
may compel inspections of carriers and the application of sanitary 
measures through written order. Furthermore, the proposed regulations 
provide the owners with an opportunity for a written appeal in the 
event that the Director orders the detention of a carrier or the 
destruction of animals, articles, or things, on board the carrier. 
Regarding individuals, the proposed regulation authorizes the 
provisional quarantine of persons arriving into the United States 
reasonably believed to be infected with or exposed to a quarantinable 
disease and persons who the Director reasonably believes to be in the 
qualifying stage of a quarantinable disease and traveling from one 
state into another or who are a probable source of infection to others 
who may be traveling from one state into another.
    The routine inspection of persons or property for purposes of 
determining the presence of communicable disease is authorized by 
statute and does not run afoul of the Fourth Amendment because of the 
reduced expectation of privacy inherent in travel and at border 
crossings. See United States v. Flores-Montano, 541 U.S. 149, 152 
(2004) (noting that the Government's interest in preventing the entry 
of unwanted persons and effects is at its zenith at the international 
border and that border searches conducted pursuant to the

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longstanding right of the sovereign to protect itself by stopping and 
examining persons and property crossing into this country are 
reasonable simply by virtue of the fact that they occur at the border); 
McDonald, 100 F.3d at 1324 n.5 (``This diminished interest derives 
from, among other factors, the myriad legitimate safety concerns that 
pertain to those who travel by common carrier.''). Air travel and 
shipping are also closely regulated industries in the United States 
because these industries must comply with myriad regulatory 
requirements relating to safety, immigration, and homeland security. 
See United States v. Dominguez-Prieto, 923 F.2d 464, 468 (6th Cir. 
1991) (holding that common carriers in the trucking industry are 
pervasively regulated industries for purposes of warrantless 
inspections because of extensive federal and state regulations). Courts 
have also long recognized a substantial government interest in 
preventing the introduction, transmission, and spread of communicable 
diseases. See Jacobson, 197 U.S. at 11. Unsanitary carriers, as well as 
contaminated goods, may pose a threat to human health or safety, as 
well as lead to further contamination of other articles, if not 
immediately inspected and sanitized. The issuance of a written order by 
the Director, when necessary to compel compliance, accompanied by an 
opportunity for a written appeal, in the case of carriers ordered 
detained or animals, articles, or things ordered destroyed, also 
provides protections analogous to those of a warrant. See Burger, 482 
U.S. at 711 (ruling that the administrative inspection program provided 
an adequate substitute for a warrant because it placed appropriate 
restraints on the discretion of the inspecting officers).
    It is well recognized that freedom from physical restraint is a 
``liberty'' interest protected by the Due Process Clause of the 14th 
Amendment to the U.S. Constitution. See Kansas v. Hendricks, 521 U.S. 
346, 356 (1997) (noting that while freedom from physical restraint is 
at the core of the liberty protected by the Due Process Clause, that 
liberty interest is not absolute). In circumstances where due process 
is required, courts determine the process that is due by balancing the 
private interest affected by the official action against the 
government's asserted interest and the burdens that the government 
would face in providing greater process. See Hamdi v. Rumsfeld, 124 
S.Ct. 2633, 2646 (2004) (relying on Mathews v. Eldridge, 424 U.S. 319, 
335 (1976)). Due process is a flexible concept requiring that the level 
of process granted be commensurate with the degree of deprivation and 
the circumstances of the event. See Parham v. J.R., 442 U.S. 584, 608 
(1979) (``What process is constitutionally due cannot be divorced from 
the nature of the ultimate decision that is being made.''). 
Furthermore, due process does not always require judicial-type hearings 
or quasi-criminal proceedings before curtailing an individual's 
physical liberty for public health purposes. See id. at 609 (``Although 
we acknowledge the fallibility of medical and psychiatric diagnosis, we 
do not accept the notion that the shortcomings of specialists can 
always be avoided by shifting the decision from a trained specialist 
using the traditional tools of medical science to an untrained judge or 
administrative hearing officer after a judicial-type hearing.'') 
(internal citation omitted); Addington v. Texas, 441 U.S. 418, 431 
(1979) (holding that states need not apply the strict criminal standard 
of proof beyond a reasonable doubt before committing the mentally ill); 
Morales v. Turman, 562 F.2d 993, 998 (5th Cir. 1977) (noting in dicta 
that ``[a] state should not be required to provide the procedural 
safeguards of a criminal trial when imposing a quarantine to protect 
the public against a highly communicable disease.''). The basic 
elements of due process include: Reasonable and adequate notice of the 
action that the government is purporting to take (typically through a 
written order); an opportunity to be heard in a reasonable time and 
manner; access to legal counsel; and review of the government's actions 
by an impartial decision-maker. See Goldberg v. Kelly, 397 U.S. 254, 
267-268 (1970) (discussing due process in the context of terminating 
welfare benefits). Because quarantine implicates an individual's 
liberty interest to remain free from physical restraint, CDC in 
carrying out quarantine actions is obliged to act in a manner 
consistent with these basic elements of due process.
    The proposed regulation establishes administrative procedures that 
afford individuals with due process commensurate with the degree of 
deprivation and the circumstances of controlling the spread of 
communicable disease. CDC quarantine officers are typically the first 
line of defense in preventing the importation of communicable diseases 
into the United States. Quarantine officers routinely conduct rapid 
assessments of ill passengers at airports and other ports of entry to 
assess the presence of communicable disease. Such assessments generally 
occur on a voluntary basis with the consent of the ill passenger. Where 
the quarantine officer reasonably believes that an ill passenger has a 
quarantinable disease, and the passenger is otherwise non-compliant, 
the quarantine officer may order the provisional quarantine of the 
passenger by serving the passenger with a written order, verbally 
ordering that the passenger be provisionally quarantined, or by 
ordering that actual restrictions be placed on a non-compliant 
passenger. The quarantine officer's reasonable belief would be informed 
by objective scientific evidence such as clinical criteria indicative 
of one of the specified quarantinable diseases, e.g., high fever, 
respiratory distress, and/or chills, accompanied by epidemiologic 
criteria such as travel to or from an affected area and/or contact with 
known cases. Provisionally quarantined individuals are provided with a 
written order in support of the agency's determination at the time that 
provisional quarantine commences or as soon thereafter as the 
circumstances reasonably permit. The written provisional quarantine 
order provides the individual with notice regarding the legal and 
scientific basis for their provisional quarantine, the location of 
detention, and the suspected quarantinable disease. Under the proposed 
regulations, CDC may provisionally quarantine an individual for up to 
three business days unless the Director determines that the individual 
should be released or served with a quarantine order. CDC does not 
intend to provide individuals with administrative hearings during this 
initial three-day period of provisional quarantine, but rather will 
afford an opportunity for a full administrative hearing in the event 
that the individual or group of individuals is served with a quarantine 
order, which potentially would involve a longer period of detention.
    While there are no federal cases establishing a specific time 
period for holding persons in quarantine-type detentions, there are 
several analogous federal cases dealing with ``alimentary canal'' 
smugglers, i.e., persons who smuggle drugs in their intestines by 
swallowing balloons. In United States v. Montoya de Hernandez, 473 U.S. 
531 (1985), the U.S Supreme Court analogized holding a suspected 
alimentary canal smuggler to detaining someone for suspected 
tuberculosis, noting that ``both are detained until their bodily 
processes dispel the suspicion that they will introduce a harmful agent 
into this country.''

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Federal courts have upheld detention periods ranging from 16 hours to 
20 days based on ``reasonable suspicion'' for suspected alimentary 
canal smugglers. CDC believes that the provisional quarantine of 
individuals for up to three business days without an administrative 
hearing is reasonable because such a time frame is necessary to 
determine whether the individual has one of the specified quarantinable 
diseases. A provisional quarantine order is likely to be premised on 
the need to investigate based on reasonable suspicion of exposure or 
infection, whereas a quarantine order is more likely to be premised on 
a medical determination that the individual actually has one of the 
quarantinable diseases. Thus, during this initial three business day 
period, there may be very little for a hearing officer to review in 
terms of factual and scientific evidence of exposure or infection. 
Three business days may be necessary to collect medical samples, 
transport such samples to laboratories, and conduct diagnostic testing, 
all of which would help inform the Director's determination that the 
individual is infected with a quarantinable disease and that further 
quarantine is necessary. In addition, because provisional quarantine 
may last no more than three business days, allowing for a full hearing, 
with witnesses, almost guarantees that no decision on the provisional 
quarantine will actually be reached until after the provisional period 
has ended, thus making such a hearing virtually meaningless in terms of 
granting release from the provisional quarantine. In the event that 
further quarantine or isolation is necessary, the Director would issue 
an additional order based on scientific principles such as clinical 
manifestations, diagnostic or other medical tests, epidemiologic 
information, laboratory tests, physical examination, or other available 
evidence of exposure or infection. The length of quarantine or 
isolation would not exceed the period of incubation and communicability 
for the communicable disease as determined by the Director.
    Under 28 U.S.C. 2241, an opportunity for judicial review of the 
agency's decision exists via the filing of a petition for a writ of 
habeas corpus. This judicial review mechanism affords individuals under 
quarantine with the full panoply of due process rights typical of a 
court hearing. A petition for a writ of habeas corpus is the 
traditional mechanism by which individuals may contest their detention 
by the federal government. See Hamdi, 124 S.Ct. at 2644 (noting that 
absent suspension, the writ of habeas corpus remains available to all 
individuals detained within the United States); United States v. 
Shinnick, 219 F.Supp.789 (E.D.N.Y. 1963) (upholding the U.S. Public 
Health Service's medical isolation of an arriving passenger because she 
had been in Stockholm, Sweden, a city declared by the World Health 
Organization to be a smallpox infected local area and could not show 
proof of vaccination).
    In addition to this judicial review mechanism, as previously 
mentioned, the proposed regulations establish a procedure for 
individuals under quarantine to request an administrative hearing. The 
purpose of the administrative hearing is not to review any legal or 
constitutional issues that may exist, but rather only to review the 
factual and scientific evidence concerning the agency's decision, e.g., 
whether the individual has been exposed to or infected with a 
quarantinable disease. Such an administrative hearing would comport 
with the basic elements of due process. Under the proposed regulations, 
the Director would notice the hearing and designate a hearing officer 
to review the available evidence of exposure or infection and make 
findings as to whether the individual should be released or remain in 
quarantine. The proposed regulations authorize the Director to take 
such measures as the Director determines to be reasonably necessary to 
allow an individual in quarantine to communicate with their authorized 
representative to participate in the hearing.
    In addition to section 361 of the PHS Act (42 U.S.C. 264), HHS also 
relies on the following legal authorities with respect to this notice 
of proposed rulemaking: 25 U.S.C. 198, 231, and 1661; 42 U.S.C. 243, 
248, 249, 265-272, and 2001. 25 U.S.C. 198, 231, 1661 and 42 U.S.C. 
2001 contain legal authorities primarily relevant to public health 
measures taken with respect to Indian country. 42 U.S.C. 265-272 
contain legal authorities primary relevant to HHS operations and 
activities with respect to quarantine and other public health measures. 
These authorities are discussed in depth in Section IV.

IV. Summary of Proposed Changes to 42 CFR Part 70

    Several new sections have been added to 42 CFR Part 70. Most of 
these sections are provided to update and streamline practices to 
reflect modern quarantine practice. Imposition of quarantine needs to 
be based on clear legal authorities and applied safely and effectively 
while according respect to the individual.
    The following is a section-by-section analysis:

Section 70.1 Scope and Definitions

    Section 70.1 is renamed scope and definitions. Section 70.1 
explains that, except where otherwise stated, regulations to prevent 
the spread of disease among possessions or from a possession to a State 
are contained in 42 CFR Part 71.
    A number of terms have been added or modified to be consistent with 
modern quarantine concepts and current medical principles and practice. 
Specifically, definitions for ``aircraft commander,'' ``airline,'' 
``airline agent,'' ``business day,'' ``carrier,'' ``detention,'' 
``emergency contact information,'' ``flight information,'' ``hearing 
officer,'' ``Indian country,'' ``Indian tribe,'' ``infectious agent,'' 
``interstate traffic,'' ``medical monitoring,'' ``military service,'' 
``possession,'' ``provisional quarantine'', ``public health 
emergency,'' ``qualifying stage,'' ``quarantine,'' ``quarantinable 
disease,'' ``sanitary measure,'' ``Secretary,'' ``State'' and 
``vector'' have been added or modified. The definition of an ill person 
has been modified to include the signs or symptoms commonly associated 
with diseases for which provisional quarantine or quarantine may be 
necessary. This definition is of particular importance because it 
determines the scope of the reporting requirement specified in Sec.  
70.2. Because reporting is dependent on recognition of an ill passenger 
by non-medical personnel and without the benefit of a medical 
examination, such as by the flight crew, this definition relies on 
descriptive terms that are overt and commonly understood by lay 
persons. The definition is broad by design for two reasons: (1) To 
ensure that all situations for which the Director must take action in 
order to prevent the introduction and spread of communicable diseases 
are reported, and (2) the reporting of ill passengers relies on 
personnel without medical training. While a narrower definition might 
reduce the number of situations reported for which action by the 
Director is unnecessary, such a definition would necessarily include 
findings or terms that cannot be accurately assessed by those without 
medical training. Moreover, a narrower definition would likely exclude 
situations of public health significance thus circumventing the very 
purpose for which the reporting requirement is designed. Therefore, the 
more prudent course has been chosen, whereby reporting is required for 
a broad range of signs and symptoms, allowing the

[[Page 71897]]

Director to use her professional judgment to determine which situations 
require additional action.

Section 70.2 Report of Death or Illness on Board Flights

    As noted previously, the Director has a responsibility to prevent 
the spread of communicable diseases between states. The purpose of the 
disease reporting requirement is to ensure that CDC can mobilize 
appropriate personnel to respond efficiently to the arrival of an ill 
person with a communicable disease. This response may require 
evaluation of the ill passenger by trained medical personnel, 
evaluation of other passengers who may have been exposed to the disease 
en route, and secure transport of individuals to a designated isolation 
facility where they may receive appropriate care while minimizing the 
risk of transmission to others. Because the entire panel of responders 
may not be onsite at the airport it is imperative that notification be 
received by CDC as soon as the illness is identified and, whenever 
possible, at least one hour prior to arrival.
    Under current regulations (Sec.  70.4), the person in charge of any 
carrier engaged in interstate traffic on which a case or suspected case 
of a communicable disease develops, as soon as practicable, is required 
to notify the local health authorities at the next port of call, 
station, or stop and take such measures as the local health authority 
directs. Paragraph (a) of Sec.  70.2 in the proposed revision 
eliminates the requirement that carriers report to local health 
authorities, requiring instead that reports be made to the Director. By 
providing a single point of contact for disease reports, the burden on 
carriers to identify and maintain points of contact with local health 
authorities is significantly reduced. The Director would assume 
responsibility for notifying local health authorities as indicated. It 
is common, but not universal, that FAA officials (e.g., air traffic 
control) are included among those notified by the airline of an ill 
passenger. Current CDC procedure dictates that FAA personnel and other 
emergency response personnel are notified by Quarantine Station staff 
of the impending arrival of a plane carrying a passenger with other 
than routine illness. However, this notification is contingent on CDC 
awareness of the situation prior to flight arrival, as this provision 
requires.
    The regulation was drafted to afford the carrier maximum 
flexibility in establishing a system to ensure that the advance 
reporting requirement is met. We do not intend to mandate a particular 
pathway of communication as long as a report is made by the designated 
airline official within the specified time frames. Individuals 
typically involved in the notification process include the crew, 
including the pilot or captain, flight operations on the ground, air 
traffic controllers, other ground personnel, and other airline 
representatives.
    Paragraph (b) of this section enables the Director to order 
airlines engaged in interstate traffic to distribute to passengers and 
crew, at a time specified by the Director, public health notices and 
other materials that describe recommended measures for preventing 
spread of communicable diseases. During SARS and in the time since the 
outbreak was controlled, CDC has distributed Health Alert Notices to 
advise passengers on international flights who may have been exposed to 
a communicable disease as to how to monitor their health and how to 
proceed should certain symptoms develop. These notices were an 
important component of the CDC response to SARS. The effectiveness of 
this measure, however, was limited by CDC's inability to ensure that 
all passengers received the notices, a goal that was particularly 
difficult if distribution occurred after passengers already had entered 
the terminal and were focused on getting to distant gates or their 
final destinations. The routine delay in passenger dispersal following 
disembarkation that accompanies international arrivals (i.e., while 
they undergo immigration and customs processing) is absent from 
interstate arrivals, thereby making distribution of this information 
post-disembarkation even more challenging. By requiring airline staff 
to distribute these materials prior to disembarkation, for example, 
Director can better ensure that potentially exposed passengers have 
access to information critical to maintaining their own health and to 
preventing spread in the community. CDC expects to exercise this 
requirement in situations where a significant outbreak of a 
quarantinable disease is detected abroad and there is the potential for 
exposure among interstate travelers. CDC might also require airlines to 
distribute notices in the period between the outbreak of a new 
communicable disease and the addition of the disease to the list of 
quarantinable diseases.

Section 70.3 Written Plan for Reporting of Deaths or Illness on Board 
Flights and Designation of an Airline Agent

    In order to ensure that all parties are aware of the appropriate 
lines of communication between airlines and CDC for reporting, and that 
policies and procedures are in place to facilitate such communication, 
this section requires airlines engaged in interstate travel to develop 
a written plan sufficient to ensure the reporting of ill passengers and 
deaths on board flights and submit it to the Director within 90 days of 
the final publication of this rule. Airlines that intend to commence 
operation of flights in interstate traffic after this effective date 
shall submit a written plan to the Director before commencing 
operations.
    The plan may be submitted electronically to an e-mail address or 
permanent address that will be provided in the final rule. This plan 
would identify the designated airline ``point of contact'' or ``agent'' 
for issues related to reporting of any deaths or ill passengers. In 
addition, the plan would identify the members of the flight team (e.g., 
cabin crew, captain, airline flight operations, flight controllers, or 
other airline-designated agent for reporting) who will be responsible 
for making the required report to the Director.
    The plan must be implemented within 180 days of the final 
publication of the rule. CDC believes that a 90-day time frame for 
development of a written plan and an additional 90 days for 
implementation to be appropriate because airlines should already have 
such procedures in place to satisfy the existing ill passenger 
reporting requirement currently contained in 42 CFR 70.4. Airlines 
commencing operations after the rule is in effect must implement their 
written plans by the later of the following: 180 days after the final 
publication of the rule or upon commencement of operations. CDC 
solicits comment on whether these timeframe are appropriate. During the 
phase-in period established in this section, airlines are still 
expected to comply with the reporting requirements contained in current 
Sec.  70.4.
    Airlines are required to review the plan one year after 
implementation and annually thereafter and make revisions as necessary. 
Airlines that have not reported ill passengers or deaths on board a 
flight under the requirements in 70.2 in the prior 365 days are 
required to conduct drills or exercises to test and evaluate the 
effectiveness of the plan. Any revisions as a result of the annual 
review or the drills or exercises must be

[[Page 71898]]

submitted to the Director within 60 days.

Section 70.4 Passenger Information

    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. 
Public health authorities may then offer these individuals treatment, 
vaccination, or other preventive measures as may be available. These 
treatments, by preventing the development or progress of the disease, 
serve the dual purpose of providing direct benefit to those exposed 
along with benefit to the community at large by preventing further 
person-to-person spread. Thus, in order to carry out her delegated 
responsibility to control spread of communicable diseases between 
states, the Director must, for a limited time, be able to efficiently 
identify and locate persons who may have been exposed to a communicable 
disease during travel. The identification and notification of those 
exposed is an essential first step in providing the exposed access to 
potentially life-saving medical follow-up and disease prevention 
measures, including vaccination. Preventing secondary cases among 
contacts, in turn, helps prevent further propagation and spread of 
disease within the community. As such, travelers and the public at 
large derive direct benefit from a system, such as is proposed, that 
ensures that, if an exposure has occurred, affected passengers can be 
identified, located, and notified within the incubation period of the 
disease. If notification does not occur by the conclusion of the 
incubation period, the effectiveness of medical follow-up and disease 
prevention measures and, therefore, the benefit to the public is 
severely reduced.
    The worldwide outbreak of SARS, an illness that was originally 
reported in Asia in late 2002 and quickly spread to North America and 
Europe, provided a clear example of the rapidity with which an 
infectious disease may spread through air travel, while exposing clear 
limitations in the current system of identifying and notifying those 
who may have been exposed during travel. During this outbreak, CDC 
attempted to gather contact information on persons exposed and received 
significant cooperation from the airlines. CDC met flights containing 
suspected contagious passengers and obtained location and contact data 
from both passengers and crew members before disembarkation. Ill 
passengers on planes from affected areas were met by CDC staff members 
for evaluation and referred for medical care when appropriate. However, 
if a suspected case of SARS was identified after disembarkation, CDC 
staff had to manually gather, compile, and process data from flight 
manifests, customs declarations, and any other available sources 
relevant to the case.
    Utilizing this manual process, CDC staff encountered the following 
difficulties:
     Manifests provided by carriers contained only the name and 
the seat number.
     Custom declarations were completed by the passenger by 
hand and were often illegible.
     Names on the customs declarations did not necessarily 
match those on the manifests.
     Phone numbers were not included on customs forms, and only 
one customs form was filled out per family.
    Since the data gathered from manifests and customs declarations 
were only available in hard copy, it often took several days to obtain. 
Photocopies were sent by express mail to CDC where the data were keyed 
into a database. Entering the data and verifying the addresses usually 
took several more days. The time required to track passengers was 
routinely longer than the incubation period of the SARS virus.
    While CDC received good cooperation from the industry, the primary 
responsibility for locating passengers rests with public health 
authorities as recognized by International Air Transport Association 
(IATA) Recommended Practices 1788, as shown in the following excerpts:

    When a Member is advised by a health authority that it may have 
transported a passenger with an infectious disease, it shall co-
operate with such health authority, with the understanding that it 
is not the Member's responsibility to trace and notify other 
passengers who may have been exposed to the infectious disease.
    If the health authority requests a list of other passengers who 
may have been exposed to the infectious disease, the health 
authority should be advised to first utilize immigration records of 
the arriving passengers, such as landing cards, in order to 
determine the names and addresses of such passengers. If the health 
authority advises the Member that it was unable to determine from 
immigration records, the names of other passengers who may have been 
exposed to the infectious disease, the Member should ask the health 
authority to make a formal request for a list of passengers.

    In the aftermath of SARS, CDC has continued to enjoy good overall 
cooperation from airline industry partners. However, citing information 
privacy concerns, some airlines have increasingly required that CDC 
accompany its request for passenger information with a written order 
explaining CDC's legal authority for requesting such information.
    In November 2003, the University of Louisville School of Medicine 
prepared a report entitled ``Quarantine and Isolation: Lessons Learned 
from SARS,'' that recommended:

    In the event that an international traveler develops an 
infectious disease, there is an urgent need to be able to locate 
crew members and other passengers from the same flight or ship. 
Public health officials must have immediate access to passenger 
manifests or be able to require all arriving passengers to complete 
a public health form containing, for example, the individual's 
health status, seat number, countries visited, and contact 
information. This information must be in electronic form.

    Collection of this information 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, 
finds 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.
    In its April 2004 report on Emerging Diseases, GAO-04-564, the U.S. 
Government Accountability Office concluded:

    The Centers for Disease Control and Prevention * * * tried to 
contact passengers from flights and ships on which a traveler was 
diagnosed with SARS after arriving in the United States. However, 
these efforts were hampered by airline concerns and procedural 
issues.

    On the basis of that conclusion, the GAO recommended that the

    Secretary of HHS complete steps to ensure that the agency can 
obtain passenger contact information in a timely manner, including, 
if necessary, the promulgation of specific regulations.

    This provision seeks to address this recommendation by GAO.
    As stated previously, under 42 U.S.C. 264, the Secretary of HHS is 
authorized to make and enforce regulations necessary to prevent the 
introduction, transmission, and spread of communicable diseases from 
foreign countries into the United States and from one state or 
possession into another. The Director has been delegated the 
responsibility for carrying out these regulations. The Director's 
authority to investigate suspected cases

[[Page 71899]]

and potential spread of communicable disease among foreign and 
interstate travelers is thus not limited to those known or suspected of 
having a quarantinable disease (any of the communicable diseases listed 
in an Executive Order, as provided under Section 361 of the Public 
Health Service Act (42 U.S.C. 264). Executive Order 13295, of April 4, 
2003, as amended by Executive Order 13375 of April 1, 2005, contains 
the current revised list of quarantinable diseases, and may be obtained 
at http://www.cdc.gov and http://www.archives.gov/federal_register). 
Rather, the authority encompasses all communicable diseases that may 
necessitate a public health response. An order for transmission of 
passenger information is more likely to follow exposure to a non-
quarantinable communicable disease than to one listed as quarantinable 
under the current Executive Order as the former occur much more 
commonly. Examples of situations where manifest data may be requested 
for communicable diseases would be following exposure to an individual 
with suspected measles or bacterial meningitis. When to order 
transmission of data from airlines would, by necessity, have to be 
decided on a case-by-case basis depending on the facts and 
circumstances of the particular disease occurrence. However, any order 
to transmit passenger information to CDC would be done so when 
necessary for the protection of the vital interests of an individual or 
other persons, in regard to significant health risks.
    The proposed regulation requires that airlines operating interstate 
flights arriving in or departing from any of the airports listed in 
Appendix A to request certain information from passengers, maintain it 
in an electronic database for 60 days from the end of the flight, and 
transmit the information to CDC within 12 hours of a request. This 
information includes, as specified in paragraph (e), full name (first, 
last, middle initial, suffix); current home address (street, apartment 
number, city, state/province, postal code); at least one of the 
following current phone numbers in order of preference: (mobile, home, 
pager, or work ); e-mail address; passport or travel document, 
including the issuing country or organization; traveling companions or 
group; flight information; returning flight (date, airline number, and 
flight number); and emergency contact information as defined in Sec.  
70.1. The following table summarizes the data elements that would be 
collected under the proposed NPRM, those items currently collected by 
airlines and the frequency of collection, and items which the 
Department of Homeland Security collects under its Advanced Passenger 
Information System (APIS). Based on CDC's experience with previous 
contact tracing efforts using passenger data, the data elements are 
ordered according to the relative utility of each piece of data with 
respect to contract tracing.

------------------------------------------------------------------------
                                                        Required by DHS/
 Data elements required by CDC  Currently collected by      APIS for
             NPRM                      airlines           international
                                                             flights
------------------------------------------------------------------------
Name..........................  Yes...................  Yes.
Emergency contact.............  Intermittent to rarely  No.
                                 for domestic flights,
                                 more frequently for
                                 international flights.
Flight information............  Yes...................  Yes.
Phone number..................  Intermittent..........  No.
Email address.................  Intermittent--usually   No.
                                 only for Internet,
                                 phone, or travel
                                 agent reservations.
Current home address..........  Intermittent--usually   No.
                                 only for Internet or
                                 travel agent
                                 reservations.
Passport or travel document     Only for international  Yes.
 number and country (for         flights.
 foreign nationals for
 domestic and international
 flights).
Traveling companions..........  No....................  No.
Returning flight information..  Usually only if booked  No.
                                 at same time or with
                                 same airline.
------------------------------------------------------------------------

    The data are to be collected from each crewmember and passenger or 
head of household if the passenger is a minor and must be maintained by 
the airline for 60 days from the end of the voyage. Upon request of the 
Director, the data are to be transmitted to CDC within 12 hours. This 
time period is considered longer than will actually be necessary once 
the plan for data transmission developed pursuant to Sec.  70.5 has 
been implemented. In addition, paragraph (f) enables the Director to 
compel, through order, transmittal of additional information in the 
airline's possession that may be necessary to prevent the introduction, 
transmission, or spread of communicable diseases. For example, 
information regarding the airline's food service provider may be 
relevant to an investigation of a foodborne outbreak on board an 
airline.
    The provision does not require airlines to verify the accuracy of 
the information collected from passengers. Airlines, however, are 
expected to accurately transmit information collected from passengers. 
Based in part on data from a public opinion survey, it is believed 
likely that passengers will voluntarily provide this information so 
that CDC could contact the passenger in the case of that passenger's 
exposure to a communicable disease. However, passengers who decline to 
provide contact information will not be prohibited from traveling.
    CDC invites comments on any and all aspects of this data 
collection. Specifically, CDC solicits comments on the following 
subjects:
     Although we assume travelers will be willing to provide 
accurate information in the interest of being contacted for public 
health reasons, we are interested in further strategies that may 
increase the likelihood of receiving accurate information from 
travelers
     Whether a shorter list of contact data would improve the 
willingness to provide information or the accuracy of the information 
provided.
     The degree to which airlines and shiplines currently 
collect each proposed data element, the feasibility and cost of 
collecting each data element, and the extent that the additional data 
collection would require changes in IT systems or operating procedures.
     The utility of each proposed data element for the purposes 
of contact tracing.
    Information and records provided to CDC will be maintained and 
stored in accordance with HHS and CDC policies and in accordance with 
Privacy Act (5 U.S.C. 552a) and its implementing regulations (45 CFR 
Part 5b), which

[[Page 71900]]

require that the records only be used for authorized purposes by 
authorized personnel. Paper records will be kept in locked storage 
containers and access will only be allowed for authorized personnel; 
electronic records will be inaccessible to all CDC employees except 
those that are authorized to use them in accordance with Federal law. 
After the legal retention period for these records has expired, they 
will be destroyed (shredding or maceration for paper files; wiping of 
electronic files) to ensure that the information is not recoverable and 
to ensure the privacy and confidentiality of those involved. CDC has a 
long history of managing sensitive data in a manner that protects the 
confidentiality and privacy of the public. This positive track record 
will continue with the management of these records.
    The Federal Records Management retention guidelines require that we 
develop a specific approved records control schedule through the 
established records disposition process. CDC intends to propose a 
records control schedule for these records that would establish a legal 
retention period of one year. This would allow CDC to properly respond 
to outbreaks, and to ensure the health of airline passengers and the 
American public. The review process (as defined in 36 CFR part 1228) 
will involve significant internal CDC review (including substantive 
legal review), a review by HHS and the National Archives and Records 
Administration (NARA), and finally the publishing of a proposed 
retention schedule for these records in the Federal Register for public 
comment. CDC anticipates that this process will take 12-18 months. We 
are confident that after this process all relevant interests and 
concerns from health, privacy and legal perspectives, and those 
representing the interests of passengers, the airline industry, and the 
general public will be taken into consideration. Current standard 
records retention policy requires that we keep data for 10 years. Until 
we can create a new records schedule for these data, CDC will follow 
this policy.
    Airlines are expected to safeguard the confidentiality of the 
information collected. Under the proposed regulation, information 
collected solely in order to comply with this rule may only be used for 
the purposes for which it is collected. Airlines shall ensure that 
passengers are informed of the purposes of this information collection 
at the time passengers arrange their travel. CDC solicits comments on 
the privacy aspects of collecting information to be used solely in 
order to comply with this rule, including the practicality of informing 
passengers of the purposes of the information collection and the 
safeguarding of passenger information.
    The airports listed in Appendix A are derived from a list that the 
Federal Aviation Administration uses to apportion its Airport 
Improvement Program grants base. As part of this program, FAA assigns 
the status of airport hubs based upon that airport's passenger 
boardings as a percent of total U.S. passenger boardings. CDC has 
listed in Appendix A the 67 large and medium hubs assigned by FAA in 
2004, which is the latest list published by FAA. CDC is focusing upon 
the 67 large and medium hubs because this captures a majority 
(approximately 90%) of annual passenger boardings without burdening 
airlines that operate only in small hubs where passenger boardings are 
considerably lighter. CDC may revise this list in the future through 
notice and comment rulemaking.

Section 70.5 Written Plan for Passenger Information and Designation of 
an Airline Agent

    This provision as outlined in paragraph (a) requires airlines 
engaged in interstate commerce to designate an agent as a CDC single 
point of contact for communications related to passenger manifests. In 
addition, airlines must develop, within six months of the final 
publication of this rule, a written plan sufficient to ensure the 
electronic transmission to the Director of data that are collected from 
passengers and crew pursuant to Sec.  70.4. Paragraph (f) explains that 
airlines meeting the provisions in (a) that intend to commence 
operations after the effective date in (a) shall submit a written plan 
to the Director prior to commencing operations.
    The plan may be submitted electronically to an e-mail address or 
permanent address that will be provided in the final rule. The written 
plan must include policies and procedures for the transmission of the 
data in an electronic format available to both the airline and the 
Director using industry standards for data encoding, transmission, and 
security. Airlines are required to submit their written plans for 
transmission of passenger manifest information to the Director and 
implement the plan within 2 years of the final publication of this 
rule. Airlines commencing operations after the effective date in (a) 
are required to implement the plan on the later of these two dates: 2 
years after the final publication of this rule or upon commencement of 
operations. CDC is soliciting comments specifically in regard to these 
timeframes.
    Upon implementation of the plan, airlines are required to conduct 
drills or exercises to test and evaluate the effectiveness of the plan. 
Airlines are required to review the plan one year after implementation 
and annually thereafter. The review shall include drills or exercises 
to test and evaluate the effectiveness of the written plan unless the 
airline has transmitted passenger and crewmember information under 
Sec.  70. 4 in the prior 365 days. Airlines shall make revisions as 
necessary as result of the review and submit them to the Director 
within 60 days.

Section 70.6 Travel Permits

    This provision requires any person who knows that he or she is in 
the qualifying stage, as defined in Sec.  70.1, of any quarantinable 
disease to obtain a travel permit from the Director if he/she intends 
to travel in interstate traffic or from one state or possession into 
any other state or possession.
    Section 70.6 prohibits interstate carriers from knowingly 
transporting or accepting for transport any person in the qualifying 
stage of a quarantinable disease without a travel permit issued by the 
Director. If a person possesses a travel permit, the carrier is 
required to take all steps necessary to prevent spread of the disease 
during transport.
    Persons who know that they are in the qualifying stage of a 
quarantinable disease are prohibited from traveling in interstate 
traffic or from one state or possession into another without a permit 
issued by the Director. The person issued a permit is required to 
maintain possession of the permit at all times during travel, and to 
comply with its conditions. Persons whose application for a travel 
permit has been denied may submit a written appeal within two business 
days in accordance with 70.31.
    An order of the CDC Director is not necessary for travel permits to 
be required under this section, rather these are ongoing requirements. 
CDC expects that the need to issue a travel permit will arise 
infrequently. CDC envisions that the circumstances under which the use 
of travel permits would be necessary include (1) to prevent spread of 
quarantinable disease in interstate traffic or from one state or 
possession into any other state or possession; (2) upon request of a 
health authority; and (3) in the event of inadequate local control. The 
requirement of travel permits pertains to individuals who know they are 
in the qualifying stage of quarantinable disease and thus requires 
actual knowledge of one's condition. Similarly, section 70.6 provides 
that a

[[Page 71901]]

carrier may not knowingly transport a traveler in the qualifying stage 
of a quarantinable disease without a permit.
    The Director may additionally apply the provisions of this section 
to persons and carriers traveling entirely within the boundaries of a 
state or possession upon the request of a cognizant health authority or 
in the event of inadequate local control if the Director determines 
that such persons' travel or the operations of the carrier have an 
effect on interstate commerce. In such cases, the Director will issue 
an order advising persons of the application of this provision to 
intrastate traffic that affects interstate commerce. CDC believes that 
travel permits may be an important public health tool in the event of a 
public health emergency that necessitates the control of intrastate 
movement or the orderly evacuation of infected individuals to other 
locations within a state or possession.

Section 70.7 Responsibility With Respect to Minors, Wards, and Patients

    This section clarifies that parents, guardians, physicians, nurses, 
and other persons may not procure transportation for children, wards, 
or patients whom they know to be in the qualifying stage of a 
quarantinable disease without obtaining a travel permit from the 
Director if such a permit is required under this part. Because minor 
children, wards, and hospitalized persons may not be able to procure 
transportation on their own, the responsibility for obtaining the 
travel permit falls to their guardians and/or other persons in whom 
their care is entrusted. This provision is a carryover from existing 
Sec.  70.7, with the exception that the provision has been changed to 
specifically reference travel permits. Persons whose application for a 
travel permit has been denied may submit a written appeal within two 
business days in accordance with 70.31.

Section 70.8 Military Services

    Under section 361 of the PHS Act (42 U.S.C. 264), the HHS Secretary 
has broad authority to enact regulations to prevent the introduction, 
transmission, and spread of communicable diseases. This is a statute of 
general applicability and thus applies to the military and its service 
members traveling on military carriers. Section 70.8, however, exempts 
the military services and their members traveling on military carriers 
from certain provisions of Part 70. Specifically, the military services 
and their members traveling on military carriers are exempt from the 
following provisions: Sec.  70.6(a) (travel permits requirements 
relating to carriers), Sec.  70.11 (sanitary measures), and Sec.  70.12 
(detention of carriers affecting interstate commerce). A limited 
exemption is also created with respect to Sec.  70.6(c) (travel permit 
requirements relating to persons who know that they are in the 
qualifying stage of a quarantinable disease) and Sec.  70.7 
(Responsibility with respect to minors, wards, and patients), provided 
that the person authorizing the service member's travel on a military 
carrier takes measures consistent with those prescribed by the Director 
to prevent the possible transmission of infection to others during 
travel. This section is largely carried over from existing Sec.  70.8. 
Furthermore, while not specifically exempt, carriers belonging to the 
military services are not subject to requirements relating to reporting 
of deaths or illness on board flights (Sec.  70.2 & Sec.  70.3) and 
passenger information (Sec.  70.4 & Sec.  70.5) because aircraft 
operated by the military services do not operate ``commercially.'' 
These exemptions exist because the U.S. military has established 
mechanisms to prevent disease spread on board its carriers and among 
its personnel. HHS also wishes to minimize any potential disruption of 
military activities.

Section 70.9 Vaccination Clinics

    This provision replaces current Sec.  70.9, recently promulgated as 
an interim final rule. The current section authorizes the Director to 
establish vaccination clinics and to charge persons not enrolled in 
Medicare Part B a user fee to cover costs associated with 
administration of vaccine. The proposed regulation contains similar 
authority, and additionally requires vaccination clinics to comply with 
recordkeeping and other instructions issued by the Director to ensure 
safe administration, handling, monitoring and storage of vaccines. 
These requirements include collection and maintenance of information on 
vaccine recipients including age, gender, date of vaccination, vaccine 
lot number, prior vaccination, concurrent vaccinations, Vaccine Adverse 
Events Reporting System Report/Adverse Event Report Number (if 
applicable), and verification that the vaccination conferred immunity. 
In addition, the reason for vaccination (e.g. post exposure, pre-
exposure prophylaxis, military, administrative requirement [pre-
employment, school entry], member of high risk group, pre-travel, 
general vaccination, or other reason) must be stated. The Director may 
waive or modify these requirements in the event of a public health 
emergency.

Section 70.10 Establishment of Institutions, Hospitals and Stations

    This provision authorizes the Director to enter into voluntary 
agreements with public or private institutions for the purpose of 
establishing places for care and treatment. This provision is based 
upon legal authority provided in 42 U.S.C. 267. With the approval of 
the Secretary, the Director may select suitable sites for the 
establishment of quarantine stations and places for care and treatment. 
Additional legal authorities relevant to the control, management, and 
control of institutions, hospitals, and stations established by the 
Secretary are also contained in 42 U.S.C. 248.

Section 70.11 Sanitary Measures

    Section 361(a) of the PHS Act (42 U.S.C. 264(a)) provides that in 
carrying out regulations, the Secretary

may provide for such inspection, fumigation, disinfection, 
sanitation, pest extermination, destruction of animals or articles 
found to be so infected or contaminated as to be sources of 
dangerous infection to human beings, and other measures, as in his 
judgment may be necessary.

    Section Sec.  70.11 implements this statutory provision by 
authorizing the Director, in consultation with other Federal agencies 
as appropriate, to inspect and order the application of such sanitary 
measures (as that term is defined) to any carrier affecting interstate 
commerce or to things on board the carrier that the Director reasonably 
believes to be infected or contaminated by a communicable disease.
    Paragraph (a) updates, consolidates and makes applicable to 
interstate situations the ``disinfection,'' ``disinfestations,'' 
``disinsection,'' and other provisions contained in current 42 CFR Part 
71. It explains that the Director, in consultation with other federal 
agencies as appropriate, may inspect and order the carrier, or other 
entity specified in the order, as the party responsible for applying 
such measures as the Director deems necessary to prevent the 
introduction, transmission, or spread of communicable diseases.
    Paragraph (b) explains that CDC shall not bear the expense of 
applying the sanitary measure or, expenses related to things on board. 
While the preceding paragraph states that CDC shall not bear related 
expenses, paragraph (c) indicates that CDC does not intend to prevent 
an entity conducting sanitary measures required by the Director from 
seeking reimbursement ``through contractual arrangements or other 
available means from entities other than the CDC.''

[[Page 71902]]

    A written order to the carrier operator or owner of the cargo would 
be one method that CDC could use for ordering the application of 
sanitary measures, but would not be the exclusive method. Depending on 
the circumstances of the disease, CDC, for example, could notify 
carrier operators through publication in the Federal Register when the 
occurrence of a communicable disease outbreak in a foreign country 
increases the likelihood of the importation of infected persons or 
goods into the United States, and thus may affect interstate travel. In 
time-sensitive situations that present an imminent threat to human 
health and require the immediate application of sanitary measures, a 
CDC quarantine officer could also verbally order that such measures be 
carried out. Typically, an order to carry out sanitary measures would 
explain the risk to human health posed by the infected or contaminated 
carrier or article and contain instructions on which measures should be 
employed to abate the human health risk. Which sanitary measures should 
be employed in a given circumstance would be determined based on 
scientific and public health principles applicable to the threat to 
human health.
    Under paragraph (c), the Director may apply sanitary measures to 
persons who are not in the qualifying stage of a quarantinable disease. 
Provisions specifically dealing with respect to persons who may be in 
the qualifying stage of a quarantinable disease may be found in 
Sec. Sec.  70.6, and 70.14 through 70.24. When applied to a person or 
group of persons, a sanitary measure involves the application or direct 
exposure to such chemical, physical, or other processes that are 
designed to destroy the presence of infectious agents that may be 
outside the body. Under paragraph (c), such procedures may be carried 
out only with the consent of the person. Sanitary measures applied to a 
person or group of persons are intended to kill agents (or vectors 
capable of conveying infectious agents) outside the body by direct 
exposure to a chemical, physical or other process designed to destroy 
such infectious agents or vectors. During an outbreak of avian 
influenza, for example, persons exiting a farm containing infected 
birds would have all visible organic matter removed from their shoes 
with disposable towels. Those persons would then transit through a foot 
bath containing an effective virucidal solution. As an additional 
example, persons infected with body lice during an outbreak of epidemic 
typhus would be treated with appropriate antibiotics and an effective 
topical pediculocidal agent, and would have their clothing washed in 
hot water and detergent. The sanitary measures applicable to carriers, 
animals or things include detention, destruction, seizure, 
disinfection, disinfestations, disinsection and any other measures 
deemed necessary to prevent the introduction, transmission or spread of 
communicable diseases. If the Director orders the destruction or export 
of animals, articles, or things in accordance with this section, the 
owner of such animals, articles, or things may appeal the measure, 
within two business days, in accordance with Section 70.31.
    CDC invites comments on any and all aspects of the proposed process 
for issuing orders to conduct sanitary measures and the appeals 
process.

Section 70.12 Detention of Carriers Affecting Interstate Commerce

    In addition to the provisions listed in Section 70.11, this 
provision further authorizes the Director, in consultation with such 
other federal agencies as appropriate, to detain a carrier until the 
necessary measures outlined in Section 70.11 have been completed. The 
expense of applying sanitary measures and detention shall not be borne 
by CDC. If the Director orders the detention of a carrier in accordance 
with this section, the carrier owner may appeal the detention, within 
two business days, in accordance with Section 70.31.
    CDC invites comments on any and all aspects of the proposed process 
for issuing orders to conduct sanitary measures and the appeals 
process.

Section 70.13 Screenings to Detect Ill Persons

    This section authorizes the Director at airports and other 
locations to conduct screenings to detect the presence of ill persons. 
The definition of ``ill persons'' appears in the definitions section. 
Methods of screening may include visual inspection, electronic 
temperature monitors, and other methods determined appropriate by the 
Director to detect the presence of ill persons.

Section 70.14 Provisional Quarantine

    Quarantine officers routinely conduct short term examinations of 
ill passengers at airports and other ports of entry to assess the 
presence of disease. Such examinations generally occur on a voluntary 
basis with the consent of the ill passenger. In situations where a 
passenger withholds his or her consent though those situations are few 
in number, the Director may nevertheless need to detain that person to 
determine whether the person may be in the qualifying stage of a 
quarantinable disease. This section is primarily intended to deal with 
those situations.
    Section 361(b) of the Public Health Service Act (42 U.S.C. 264(b)) 
authorizes the ``apprehension, detention, or conditional release'' of 
persons to prevent the introduction, transmission, and spread of 
specified communicable diseases from foreign countries into the United 
States and from one State or possession into another. Section 70.1 3(a) 
authorizes the Director to provisionally quarantine a person or group 
of persons believed to be in the qualifying stage of a quarantinable 
disease. Ordinarily, provisional quarantine will be ordered by the 
quarantine officer at the port of entry, but may also be ordered by 
other authorized agents of the Director. In accordance with sections 
311 and 365 of the PHS Act (42 U.S.C. 243 and 268), the Director may 
seek the assistance of state and local authorities and of U.S. Customs 
and Coast Guard officials, respectively, in the enforcement of 
quarantine rules and regulations.
    Under Sec.  70.14, paragraph (b), provisional quarantine commences 
on the occurrence of any one of three events: (i) Service of a written 
provisional quarantine order on the person or group of persons; (ii) a 
verbal order from an authorized party (typically the quarantine officer 
at the port of entry) that the person or group of persons are being 
provisionally quarantined; or (iii) placement of actual movement 
restrictions on the person or group of persons. ``Actual movement 
restrictions'' occur when, as determined by the Director, a person 
under the same circumstances would understand that he or she is being 
detained and thus is not free to leave. In most circumstances, 
provisional quarantine is a brief detention lasting only as long as 
necessary for the quarantine officer (or other authorized agent) to 
ascertain whether the person or groups of persons are a possible 
carrier of disease. Under paragraph (c), however, provisional 
quarantine may continue for up to three business days, provided that 
persons subject to provisional quarantine may be released sooner if the 
Director determines that detention is no longer necessary. In the event 
it is necessary to quarantine an individual beyond three business days, 
the Director will serve the individual with a quarantine order.
    A time frame of up to three business days for provisional 
quarantine is necessary to confirm whether certain disease-causing 
microorganisms are present in samples that may be obtained from ill or 
deceased persons.

[[Page 71903]]

Confirmation generally requires in vitro cultivation of the organism 
followed by identification, direct visualization of the organism in 
tissue samples, amplification of organism-specific nucleic acid 
sequences (e.g. PCR confirmation), or detection of organism-specific 
antibodies generated in response to the infection. Before these tests 
can be performed, samples must be collected and shipped to CDC, a 
process likely to take 24 hours. Once received, completion of culture 
and identification of bacteria requires a minimum of 24-48 hours. 
Direct visualization in tissue samples typically requires 12-24 hours. 
Quicker methods (amplification or antibody detection) may be available 
for some diseases. Even under optimal circumstances, however, the most 
modern testing methods require a minimum of 12 hours. In addition to 
the time required for sample collection, shipping and testing, the 
Director may need up to an additional 24 hours to assimilate test 
results with the findings of other investigations before arriving at a 
well-informed determination on the need for a quarantine order.
    A time frame of up to three business days comports with the 
requirements of due process. While there are no federal cases 
establishing a bright line for quarantine-type detentions, there are 
several federal cases dealing with ``alimentary canal'' smugglers, 
i.e., persons who smuggle drugs in their intestines by swallowing 
balloons. In United States v. Montoya de Hernandez, 473 U.S. 531 
(1985), the U.S Supreme Court analogized holding a suspected alimentary 
canal smuggler to detaining someone for suspected tuberculosis, noting 
that ``both are detained until their bodily processes dispel the 
suspicion that they will introduce a harmful agent into this country.'' 
Federal courts have upheld detention periods ranging from 16 hours to 
20 days based on ``reasonable suspicion'' for suspected alimentary 
canal smugglers. Accordingly, provisionally quarantining a person 
suspected of carrying a specified communicable disease and affording 
that individual an opportunity for an administrative hearing during 
that period is consistent with due process requirements. Under 
paragraph (d), in the event that the Director determines that it is 
necessary to continue to detain such persons beyond three business 
days, the Director may serve the person or group of persons with a 
quarantine order in accordance with Sec. Sec.  70.16-70.18.
    Under paragraph (e), persons subject to provisional quarantine may 
be offered medical treatment, prophylaxis, or vaccination as the 
Director deems necessary to prevent the transmission or spread of 
disease. Medical treatment, prophylaxis, or vaccination will typically 
occur in a hospital setting, but may occur in other settings as the 
Director deems necessary. Medical treatment, prophylaxis, or 
vaccination shall occur on a voluntary basis, provided that persons who 
refuse remain subject to provisional quarantine. Medical treatment, 
prophylaxis, or vaccination may be provided in accordance with the 
provisions set forth in Sec.  70.21.
    Paragraph (f) explains that nothing in Sec.  70.14 shall be 
construed to limit the Director's ability to detain a person or group 
of persons on a voluntary basis or offer such persons medical 
treatment, prophylaxis, or vaccination on a voluntary basis.

Section 70.15 Provisional Quarantine Orders

    This section explains the content of a provisional quarantine order 
issued in accordance with Sec.  70.11 and the process for serving an 
order on a person or group of persons. Paragraph (a) explains that the 
provisional quarantine order shall be served by the Director at the 
time that provisional quarantine commences or as soon thereafter as the 
Director determines that the circumstances reasonably permit. Service 
will typically occur through personal service, for example, by the 
quarantine officer or another authorized representative serving the 
person or group of persons with a copy of the provisional quarantine 
order at the port of entry or hospital facility, but may also occur 
through other methods of personal service. Due process requires that 
the method of serving the order in any case be reasonably designed to 
accomplish actual service. Because personal service may be 
impracticable or undesirable in certain circumstances, for example, 
when it is necessary to provisionally quarantine a large group of 
persons on a very short time-frame, paragraph (b) authorizes service 
through posting or publishing the order in a conspicuous location when 
the Director deems it necessary. Under paragraph (c), in circumstances 
where the Director deems public posting or publishing necessary or 
desirable, the Director may omit the names and/or identities of the 
persons and take other measures respecting the privacy of persons, for 
example, using initials, instead of full names, or other pseudonyms.
    Paragraph (d) describes the information contained in the 
provisional quarantine order and states that the order shall be in 
writing and signed by the Director. While due process is a flexible 
concept that varies depending upon the particular circumstances of the 
event, a key element of due process is a written order that provides 
sufficient notice to the person of the actions that the government 
proposes to take and describes how to contest the government's 
decision. In order to comply with this fundamental concept of due 
process, paragraph (d) requires that the order advise the person or 
group of persons of the following:
     The Director's reasonable belief that the person or group 
of persons is in the qualifying stage of a quarantinable disease based 
on information available to the Director at the time, such as travel 
history, clinical manifestations, or any other evidence of infection or 
exposure;
     The Director's reasonable belief that either: (i) the 
person or group of persons is moving or about to move from a State to 
another State; or (ii) is a probable source of infection to persons who 
will be moving from a State to another State;
     The suspected quarantinable disease;
     That the person or group of persons may be provisionally 
quarantined for three business days and that at the end of such period 
the person or group shall be released or, if determined by the 
Director, served with a quarantine order;
     That the person or group of persons may be released 
earlier if the Director determines that provisional quarantine is no 
longer warranted;

Section 70.16 Quarantine

    The Director has historically recommended medical isolation and/or 
home quarantine of persons with suspected quarantinable diseases. 
Isolation and quarantine have generally been carried out with the 
consent of persons or their authorized representatives. This section is 
primarily intended to deal with the small number of situations where 
the person refuses to comply on a voluntary basis with the Director's 
instructions, or in situations where the Director otherwise believes 
that the mandatory quarantine is necessary. It describes the Director's 
authority to quarantine persons that the Director believes are in the 
qualifying stage of a quarantinable disease.
    The quarantine of persons believed to be infected with communicable 
diseases is a prevention measure that has been used effectively to 
contain the spread of disease. Quarantine differs from provisional 
quarantine in its potentially longer duration, generally determined by 
the disease's periods of incubation and communicability. Under 
paragraph (a), the Director may issue a quarantine

[[Page 71904]]

order whenever the Director reasonably believes that a person or group 
of persons are in the qualifying stage of a quarantinable disease. In 
general, the Director's belief that a person is in the qualifying stage 
of a quarantinable disease will be based on scientific principles such 
as clinical manifestations, diagnostic tests or other medical tests, 
epidemiologic information, laboratory tests, physical examination, or 
other available evidence of exposure or infection. For interstate 
quarantine only, the Director will make an additional determination 
that either (i) the person or group of persons are moving or about to 
move from a State to another State; or (ii) that the person or group of 
persons are a probable source of infection to persons who will be 
moving from a State to another State.
    Under paragraphs (b), (c), and (d), as with provisional quarantine, 
the Director may offer medical treatment, prophylaxis, or vaccination 
to persons subject to quarantine as the Director deems necessary to 
prevent the transmission or spread of disease. Medical treatment, 
prophylaxis, or vaccination may occur in a hospital or other settings, 
including homes, as the Director deems necessary. Medical treatment, 
prophylaxis, or vaccination will occur on a voluntary basis, provided 
that persons who refuse remain subject to quarantine until the period 
of incubation and communicability have passed. In the event such 
persons are quarantined, they may request an administrative hearing.
    Under paragraph (d), the Director may also order quarantine where 
examination, medical treatment, prophylaxis, or vaccination is 
medically contra-indicated or not reasonably available.
    Under paragraph (e), the length of quarantine shall not exceed the 
period of incubation and communicability, as determined by the 
Director, for the quarantinable disease. While flexibility regarding 
the length of quarantine must be maintained by the Director in order to 
allow for the possibility of new variant or bioengineered strains of 
specified communicable diseases, in general the periods of incubation 
and communicability are as follows:

------------------------------------------------------------------------
                                                          Period of
                                Incubation period      communicability
           Disease             following exposure    following onset of
                                                           illness
------------------------------------------------------------------------
Cholera.....................  Few hours--5 days...  7-14 days.
Diphtheria..................  2-5 days............  30 days.
Infectious Tuberculosis.....  Primary: 4-6 weeks;   14-60 days.
                               Secondary: variable.
Influenza...................  1-4 days............  5-14 days.
Plague......................  Pneumonic: 1-7 days   48 hours-14 days.
                               (usually 2-4).
Yellow Fever................  3-14 days...........  Viremia documented
                                                     as long as 14 days
                                                     into illness.
SARS........................  2-10 days...........  21 days.
Marburg.....................  2-16 days...........  60-90 days.
Ebola.......................  2-21 days...........  60 days.
Crimean-Congo...............  2-12 days...........  12 days.
Smallpox....................  7-17 days...........  10 days.
------------------------------------------------------------------------

    The periods of incubation and communicability are intended to 
provide an estimate of the time an individual might be placed in 
quarantine or isolation, respectively. These time frames are based on 
accepted medical facts related to these diseases and would be 
considered part of the basic knowledge possessed by physicians familiar 
with the diagnosis and treatment of these diseases. For many of the 
diseases, such as tuberculosis and viral hemorrhagic fever, the range 
of possible periods of incubation and communicability, based on 
published individual case reports, is significantly longer. To provide 
a more realistic sense of the time during which isolation or quarantine 
may be necessary, CDC listed ranges that, in the opinion of subject 
matter experts, encompass the vast majority of cases of these diseases. 
In all cases, the listed ranges are shorter than the upper limit of 
documented periods of incubation or communicability.
    For this purpose, it is important to distinguish between the two 
terms: Quarantine and isolation. Quarantine refers to the restriction 
of movement of persons who have been exposed to a communicable disease, 
but have not yet become ill or able to transmit that disease to others. 
Isolation, on the other hand, is the restriction of movement of persons 
ill with a communicable disease in a stage where transmission is 
possible. In general, when a person is exposed to one of the diseases 
listed in this table, existing authority allows the Director to place 
that person under quarantine up to the length of time listed under the 
incubation period for each disease. If, during the time of quarantine, 
the person becomes ill, the authorities allow for them to be isolated 
for a period up to that listed under period of communicability.
    For example, a person with a potential exposure to SARS could be 
under quarantine for up to 10 days. However, if that person became ill, 
he or she would no longer be in quarantine, but would be isolated for 
the duration of illness or period of communicability (up to 21 days). 
If the person under quarantine for the incubation period did not become 
ill within 10 days of the time the exposure was thought to have 
occurred, he or she would be released.
    An opportunity to request an administrative hearing for purposes of 
reviewing the quarantine order is provided for under these regulations. 
The person or group may also seek judicial review of the quarantine 
order through a petition for writ of habeas corpus pursuant to 28 
U.S.C. 2241. Habeas corpus is the traditional legal mechanism for 
contesting detention by the government. See Hamdi, 124 S.Ct. at 2644. 
There is one litigated case involving the exercise of federal 
quarantine authority to quarantine an exposed person, United States v. 
Shinnick, 219 F.Supp.789 (E.D.N.Y. 1963).
    In Shinnick, the U.S. Public Health Service medically isolated an 
arriving passenger in a hospital for 14 days because she had been in 
Stockholm, Sweden, a city that the World Health Organization had 
declared to be a smallpox-infected local area. The patient, moreover, 
could not show proof of vaccination. The district court upheld the 
detention, finding that health authorities had acted in good faith 
because there had been an opportunity for exposure while the patient 
had been in Stockholm. The court further noted that there was no way of 
determining for 14 days whether the patient was actually infected with 
smallpox and that she was especially susceptible to infection because 
there was a history of unsuccessful vaccinations.
    Paragraph (g) explains that nothing in Sec.  70.16 shall be 
construed to limit the

[[Page 71905]]

Director's ability to quarantine a person or group of persons on a 
voluntary basis.

Section 70.17 Content of Quarantine Order

    This section requires that quarantine orders issued by CDC be 
signed by the Director and describes the content of the order. A 
written order that provides sufficient notice to the person of the 
actions that the government proposes to take and describes how to 
contest the government's decision is a key element of due process. In 
order to comply with this fundamental concept of due process and the 
requirements of Section 361 of the Public Health Service Act (42 U.S.C. 
264), this section requires that the quarantine order contain the 
following information:
     The identity of the person or group of persons to be 
quarantined, if known;
     The location where such person or group of persons is to 
be quarantined;
     The date and time at which quarantine commences and ends;
     The suspected quarantinable disease;
     A statement that the Director reasonably believes that (i) 
such person or group of persons is in the qualifying stage of a 
quarantinable disease; and that either (ii) such person or group of 
persons will move or is about to move from one State to another State; 
or (iii) is a probable source of infection to persons who will be 
moving from a State to another State;
     A statement regarding the basis for the Director's belief 
that such person or group of persons is in the qualifying stage of a 
quarantinable disease, e.g., clinical manifestations, physical 
examination, laboratory tests, diagnostic tests or other medical tests, 
epidemiologic information, or other evidence of exposure or infection 
available to the Director at the time;
     A statement that persons shall comply with conditions of 
quarantine, including, but not limited to, examination, medical 
monitoring, medical treatment, prophylaxis, or vaccination, or other 
conditions of quarantine deemed by the Director to be necessary to 
prevent the transmission or spread of communicable disease;
     A statement that persons may refuse examination, medical 
monitoring, medical treatment, prophylaxis, or vaccination, but that if 
they choose to do so they remain subject to quarantine;
     A statement that persons under quarantine, any time while 
the quarantine order is in effect, may request that the Director hold a 
hearing to review the quarantine order.

Section 70.18 Service of Quarantine Order

    This section explains the process for serving a quarantine order on 
a person or group of persons. Paragraph (a) explains that a copy of the 
quarantine order shall be served at the time that quarantine commences 
or as soon thereafter as the Director determines that the circumstances 
reasonably permit. Service will typically occur through personal 
service, for example, by an agent authorized to enforce quarantine 
serving the person or group of persons with a copy of the quarantine 
order at home or at a hospital or other quarantine facility, but may 
also occur through other methods of service. Because personal service 
may be impracticable in certain circumstances, for example, when it is 
necessary to quarantine a large group of persons, paragraph (b) also 
authorizes service through posting or publishing the order in a 
conspicuous location when the Director deems it necessary or desirable. 
In any case, due process requires that the method of serving the order 
be reasonably designed to accomplish actual service. Under paragraph 
(b), in circumstances where the Director deems public posting or 
publishing necessary or desirable, the Director may omit the names and/
or identities of the persons and take other measures respecting the 
privacy of persons, for example, using initials, instead of full names, 
or pseudonyms.

Section 70.19 Medical Examination and Monitoring

    This provision authorizes the Director to order medical examination 
or monitoring of persons believed to be in the qualifying stage of a 
quarantinable disease. Production of information concerning familial 
and social contacts, travel itinerary, medical history, place of work 
and vaccination status may also be ordered by the Director. This 
information will permit determinations to be made concerning the scope 
of potential exposure, the identity of those in recent contact with the 
person, and the potential vulnerability of the person to the disease. 
Persons may refuse medical examination and monitoring, but remain 
subject to provisional quarantine or quarantine. In the event that 
persons who refuse medical examination or monitoring are served with a 
quarantine order, they may request an administrative hearing.

Section 70.20 Hearings

    This section describes the procedures for an administrative hearing 
relating to a quarantine order. An administrative review by the agency 
is in addition to and apart from any judicial review of the Director's 
determination that may be available, for example, through the filing of 
a petition for a writ of habeas corpus under 28 U.S.C. 2241. The 
opportunity to contest the government's actions in a meaningful time, 
place, and manner is a fundamental element of due process. An 
administrative hearing under this section is an informal proceeding 
conducted by the agency where the hearing officer reviews the 
determination to quarantine a person or group of persons. Under 
paragraph (a), a person or group of persons (or an authorized 
representative) must specifically request that the CDC Director hold an 
administrative hearing. The CDC Director will then schedule the 
administrative hearing to take place within one business day of the 
request for a hearing. As part of the quarantine order, the CDC 
Director will provide the person or group with information concerning 
how to request an administrative hearing, e.g., contact information, 
telephone numbers as stated in paragraph (c). Typically, requests can 
be made by informing the quarantine officer, either verbally or in 
writing, or by calling a telephone number established by the CDC 
Director for that purpose. Notice of the administrative hearing will be 
provided to the person or group of persons under quarantine (or to an 
authorized representative) through any method the CDC Director 
determines to be reasonably designed to provide notice that the 
administrative hearing has been scheduled. The method may include, for 
example, e-mail, telephone, or written notice.
    Under paragraph (d), the CDC Director may designate a hearing 
officer to review the available medical or other evidence of exposure 
or infection available and make findings as to whether the person or 
group of persons are in the qualifying stage of a quarantinable disease 
and recommendations as to whether the person or group of persons should 
be released or remain in quarantine. Under section 369 of the Public 
Health Service Act (42 U.S.C. 272), medical officers of the United 
States, when performing duties as quarantine officers at any port or 
place within the U.S., are authorized to take declarations and 
administer oaths in matters pertaining to the administration of 
quarantine laws and regulations.
    The hearing officer may be someone within the agency, but will not 
be the same person who ordered the quarantine. While the hearing 
officer retains ultimate discretion regarding

[[Page 71906]]

matters to be heard, the hearing will be limited to genuine and 
substantial issues of fact, e.g., regarding whether the person or group 
of persons is in the qualifying stage of a quarantinable disease and 
whether the person or group should be released or remain in quarantine. 
Matters not subject to a hearing may include questions relating to the 
legality or constitutionality of statutes or regulations and matters 
that are neither genuine nor substantial, e.g., quality of food, 
availability of entertainment.
    The administrative hearing will ordinarily be closed to the public 
to protect the medical privacy of the person or group of persons under 
quarantine, unless the person or group of persons request that the 
hearing be open. The hearing officer, however, may record the hearing 
through transcription, audio or video tape, summary notes of the 
proceeding, or other means. At the discretion of the hearing officer, 
the administrative hearing may be based on written submission. A 
hearing involving live testimony should, to the extent practicable, 
provide opportunity for participation via telephone or other remote 
means. Under paragraph (e), a person or group of persons in quarantine 
may authorize a representative to appear at the hearing. Under 
paragraph (f), the CDC Director shall take such measures as the CDC 
Director determines to be reasonably necessary to allow a person or 
group of persons under quarantine to communicate with their authorized 
representatives. Measures may, for example, include establishment of 
video-conferencing facilities, e-mail terminals, telephone or cellular 
phone services, and other similar devices or technologies.
    During the administrative hearing, the person or group of persons 
subject to quarantine will be given an opportunity to call witnesses 
and present testimony. Within the discretion of the hearing officer, 
administrative hearings may be consolidated when the number of persons 
or other factors renders individual participation impracticable or when 
factual issues affecting the group are typical of those affecting the 
individual. The hearing officer retains ultimate discretion to 
determine the conduct of hearings, but will generally follow these 
procedures:
     The hearing officer will ask the parties if they wish to 
make a short statement outlining their concerns and desired outcomes. 
This is not part of the testimony, but a summary preview of the 
testimony and evidence for the hearing officer;
     The hearing officer will ask the parties to present 
evidence to support their positions and desired outcomes of the 
hearing. Witnesses may be called and the parties may ask questions. The 
hearing officer will swear in any witnesses offering testimony;
     The hearing officer will ask each party for comments 
regarding the evidence or testimony presented by the other party and 
for a short summary of reasons for the desired outcome;
     The hearing officer will inform the parties that a report 
and recommendation outlining the hearing officer's findings regarding 
the evidence of exposure or infection will be presented to the CDC 
Director for final agency determination.
    Under paragraph (g), the hearing officer may order a medical 
examination of the person or group of persons under quarantine when a 
medical examination would assist in reasonably determining whether the 
person or group is in the qualifying stage of a quarantinable disease. 
Persons requested to undergo a medical examination by the hearing 
officer may refuse, but remain subject to quarantine.
    Under paragraph (h), at the conclusion of the administrative 
hearing, the hearing officer will, based upon his or her review of the 
evidence of exposure or infection made available to the hearing 
officer, make findings and a written recommendation to the CDC Director 
whether the person or group of persons should be released or remain in 
quarantine. The hearing officer will provide the CDC Director with the 
hearing report and recommendation as soon as possible after the 
conclusion of the hearing. Under paragraph (h), the CDC Director, based 
upon the hearing officer's findings and written recommendation and the 
administrative record, shall within one business day after the 
conclusion of the hearing, order the release or continued quarantine of 
the person or group of persons. The CDC Director's order will be 
carried out without delay. Furthermore, because it is difficult to 
foresee all of the circumstances under which persons may request to be 
heard, paragraph (h)(2) permits the CDC Director to issue additional 
instructions and guidelines considered necessary to govern the conduct 
of hearings.
    Paragraph (k) states that the quarantine order will be deemed final 
administrative action either when the Director has accepted or rejected 
the hearing officer's written recommendation or three business days 
after the request for a hearing, whichever comes first.

Section 70.21 Care and Treatment of Persons

    Under section 322(a) of the PHS Act (42 U.S.C. 249) persons 
detained in accordance with quarantine laws may be treated and cared 
for by HHS. Such persons may receive care and treatment at the expense 
of HHS at a public or private medical or hospital facility, when 
authorized by the officer in charge of the quarantine station at which 
the application is made. CDC, in its sole discretion and subject to 
available appropriations, is authorized to pay, as a payer of last 
resort, expenses of care and treatment for persons detained in 
accordance with quarantine laws. For quarantinable diseases, eligible 
expenses are limited to those for costs and items reasonable and 
necessary for the care and treatment of the person from the time the 
person is referred to a hospital or other medical facility for 
treatment until the time that quarantine expires. For other diseases, 
eligible expenses are limited to those associated with services and 
items relating to care and treatment prior to diagnosis; expenses 
associated with care and treatment following diagnosis will not be paid 
by CDC.

Section 70.22 Foreign Nationals

    This section sets forth procedures for notifying consular offices 
of the provisional quarantine or quarantine of their foreign nationals. 
These procedures are consistent with requirements found in the Vienna 
Convention on Consular Relations regarding consular notification. In 
general, U.S. government requirements regarding the detention of 
foreign nationals may be accessed at: http://travel.state.gov/law/consular/consular_636.html.

Section 70.23 Administrative Record

    Another key element of due process is the existence of a record 
describing the agency's actions for a court to review. This section 
describes the content of a person's administrative record. An 
administrative record will consist of the following, where applicable:
     Provisional quarantine and/or quarantine order;
     Any medical, laboratory, epidemiologic, or other 
information in support thereof;
     Evidence submitted by the person under provisional 
quarantine and/or quarantine;
     Written findings and recommendation of the hearing 
officer; and
     Hearing transcript, if any, or summary notes of the 
hearing.

[[Page 71907]]

Section 70.24 Requests by State (including political subdivisions 
thereof), Possession, or Tribal Health Authorities

    This provision authorizes the Director to take whatever steps 
necessary to prevent the introduction, transmission or spread of 
communicable diseases upon the request of a health authority. Expressly 
referred to in the provision are requests for issuance of a provisional 
quarantine order or a quarantine order. Under section 311 of the PHS 
Act (42 U.S.C. 243), the Secretary is authorized to cooperate with and 
aid states and local authorities in the enforcement of their quarantine 
and other health regulations. Paragraph (c) clarifies that nothing in 
this section is intended to impose a condition or limit the ability of 
the Director to exercise any of the public health measures provided for 
in part 70, or in the case of possessions, part 71.

Section 70.25 Measures in the Event of Inadequate Local Control

    This section is a carryover from existing Sec.  70.2 which 
authorizes the CDC Director to take measures to prevent the spread of 
communicable diseases between States or between States and possessions 
whenever the Director determines that the measures taken by any State 
or possession (including political subdivisions) are insufficient. 
Under Section 361(a) of the PHS Act, the measures that the Director may 
take include inspection, fumigation, disinfection, sanitation, pest 
extermination, and destruction of animals or articles believed to be 
sources of infection, and other measures. The proposed regulatory 
language is consistent with that appearing in Section 361(a) of the PHS 
Act. The proposed section also makes clear that the Director may make a 
determination of inadequate local control with respect to public health 
measures taken by Indian Tribes in Indian country. While a 
determination of inadequate local control under this section does not 
require the concurrence of the IHS Director, to the extent practicable, 
when taking actions in Indian Country the Director will consult with 
the IHS Director prior to such action and once a determination has been 
made, the Director will send notification to both the Director, IHS and 
to the Tribe or tribes affected.

Section 70.26 Federal Facilities

    This section clarifies that, in addition to the public health 
measures outlined in part 70, the Director may take whatever further 
public health measures or combination of measures the Director deems 
necessary with respect to facilities owned or operated by the federal 
government. The federal government has a variety of different 
jurisdictional and proprietary arrangements with State and local 
governments, as well as with private entities, concerning federal 
facilities. In some cases, the federal government maintains exclusively 
federal campuses, while in other cases, jurisdiction with respect to 
activities occurring on federal facilities is shared with State and 
local governments. This section simply clarifies that the Director may 
take public health measures with respect to federal facilities. 
Pursuant to 42 U.S.C. 243, the Director may request the assistance of 
State and local authorities in enforcing federal quarantine rules and 
regulations. Paragraph (b) clarifies that this section does not 
preclude the Director from requesting such assistance with respect to 
facilities owned or operated by the federal government.

Section 70.27 Indian Country

    This section is intended to implement provisions appearing in 25 
U.S.C. 198 and 231; 25 U.S.C. 1661; and 42 U.S.C. 2001.
    Pursuant to 25 U.S.C. 198, the Secretary of the Interior may 
quarantine any Indian found to be afflicted with ``tuberculosis, 
trachoma, or other contagious or infectious disease.'' The Secretary of 
the Interior, through 25 U.S.C. 231, may also permit State agents and 
employees to enter upon Tribal lands for the purposes of making 
inspections of health and educational conditions and enforcing 
sanitation and quarantine regulations.
    42 U.S.C. 2001 transferred all functions, responsibilities, 
authorities, and duties relating to the conservation of the health of 
Indians, including 25 U.S.C. 198 and 231, from the Secretary of the 
Interior to the Secretary of HHS, which were redelegated to the 
Director of the Indian Health Service (IHS) by 25 U.S.C. 1661. Any 
action the Director of CDC takes under these sections must be in 
concurrence with the Director of IHS after consultation with the 
affected Tribe or Tribes.
    The grant of authority in 25 U.S.C. 198 and 231 is in addition to 
the Director's authority under 42 U.S.C. 264, and this section of the 
proposed rule supplements the Director's authority to impose public 
health measures to prevent interstate disease transmission. In other 
words, with respect to carriers in Indian country, the Director may 
apply any of the public health measures appearing in this part if such 
carriers have an effect on interstate commerce. Similarly, with respect 
to a person or group of persons in Indian country, the Director may 
exercise public health measures appearing in this part provided that 
such person or group of persons is in the qualifying stage of a 
quarantinable disease and either (i) moving or about to move from a 
State to another State; or (ii) a probable source of infection to 
persons who will be moving from a State to a State.
    Under this section, the Director, with the concurrence of the IHS 
Director and after consulting with the affected Tribes or Tribes may 
enter onto Indian country for the purpose of enforcing federal 
quarantine rules and regulations. This section provides that, in 
addition to the public health measures outlined in Part 70, the 
Director may impose public health measures with regard to provisional 
quarantine under Sec.  70.14 and Sec.  70.15, quarantine under Sec.  
70.16-Sec.  70.18, Sec.  70.20, and medical examination and monitoring 
under Sec.  70.19, in Indian country without making a finding that such 
person or group of persons is moving or about to move from a State to 
another State or is a probable source of infection to persons who will 
be moving from a State to another State. In such circumstances, a 
finding that such persons are in the ``qualifying stage of a 
quarantinable disease'' would be required.
    Paragraph (b) provides that any quarantine authorized by paragraph 
(a) must take place in a hospital or other place for treatment and that 
any person who is subject to provisional quarantine or quarantine may 
refuse medical examination, monitoring, treatment, prophylaxis, or 
vaccination, but remain subject to provisional quarantine or 
quarantine. Paragraph (c) further explains that any person who is the 
subject of a provisional quarantine order or quarantine order 
authorized by paragraph (a) has the same rights as provided for 
elsewhere in this part.
    Furthermore, under paragraph (d), the Director, with the 
concurrence of the IHS Director and after consulting with the affected 
Tribes or Tribes, may authorize agents and employees of any State to 
enter Indian country for the sole purpose of enforcing federal 
quarantine rules and regulations. This authority is subject to any 
rules or regulations the IHS Director may choose to promulgate under 25 
U.S.C. 231.

Section 70.28 Special Powers in Time of War

    This section implements statutory authority contained in section 
363 of the PHS Act (42 U.S.C. 266). Under this authority, the Director, 
in consultation

[[Page 71908]]

with the Secretary of the Department of Defense or his/her designee and 
without making a finding of interstate movement, may, in time of war, 
apprehend, detain, or conditionally release persons: (1) In the 
qualifying stage of a quarantinable disease; and (2) to be a probable 
source of infection to members of the military services or to 
individuals engaged in the production or transportation of arms, 
munitions, ships, food, clothing, or other supplies for the military 
services. Any person who is the subject of a provisional quarantine 
order or quarantine order authorized under this section has the same 
rights as provided for provisional quarantine or quarantine elsewhere 
in this part.

Section 70.29 Penalties

    This section describes the penalties for violating federal 
quarantine rules and regulations. Under 42 U.S.C. 271, criminal 
penalties exist for violating regulations enacted under the authority 
of Section 361 of the PHS Act (42 U.S.C 264). Under the sentencing 
classification provisions of 18 U.S.C. 3559 and 3571, violations of the 
quarantine regulations, classified as Class A misdemeanors, are subject 
to greater penalties. Violation by an individual is punishable by a 
fine of up to $250,000 or one year in jail, or both. Organizations may 
be fined up to $500,000 per violation.

Section 70.30 Implementation Through Order

    This section explains that the Director may implement any of the 
provisions of this part through an order issued and signed by the 
Director. In the recent past, the Director has issued a variety of 
orders to deal with urgent public health threats, including: Notice of 
embargo of civets (January 13, 2004); Notice of embargo of birds 
(Class: Aves) from specified Southeast Asian countries (February 4, 
2004); Order lifting the ban of bird and bird products from specified 
Southeast Asian countries (March 10, 2004), and Joint Order (issued 
with the FDA) prohibiting transportation or distribution of certain 
rodents associated with the monkeypox outbreak (June 11, 2003) followed 
by promulgation of an Interim Final Rule (November 4, 2003). This 
section codifies the preexisting practice of the agency with respect to 
implementation through an order.

Section 70.31 Appeals of Actions Required Pursuant to 70.6, 70.7, 70.11 
or 70.12

    A new 70.31 would allow a written appeal to the Director within two 
business days in the event that the Director denies an application for 
a travel permit pursuant to 70.6 or 70.7, orders the destruction of 
animals, articles, or things, pursuant to 70.11, or the detention of a 
carrier pursuant to 70.12. The Director may nevertheless immediately 
implement the actions allowed in 70.6, 70.7, 70.11 and 70.12.
    Following is a summary of changes to the current regulations:

Sections Cancelled:
70.3 All communicable diseases
70.6 Apprehension and detention of persons with specific diseases
Sections Moved:
70.2 Measures in the event of inadequate local control moved to
70.22
Sections Added:
70.4 Passenger information
70.5 Written plan for passenger information and designation of an 
airline agent
70.6 Travel permits
70.9 Vaccination clinics
70.10 Establishment of institutions, hospitals and stations
70.11 Sanitary measures
70.12 Detention of carriers affecting interstate commerce
70.13 Screenings to detect ill persons
70.14 Provisional quarantine
70.15 Provisional quarantine orders
70.16 Quarantine
70.17 Content of quarantine order
70.18 Service of quarantine order
70.19 Medical examination and monitoring
70.20 Hearings
70.21 Care and treatment of persons
70.22 Foreign nationals
70.23 Administrative record
70.24 Requests by State (including political subdivisions thereof), 
possession, or tribal health authorities
70.25 Measures in the event of inadequate local control
70.26 Federal facilities
70.27 Indian country
70.28 Special powers in time of war
70.29 Penalties
70.30 Implementation through order
70.31 Appeals of actions required pursuant to 70.6, 70.7, 70.11 or 
70.12

    Table IV-1.--Sections Updated and/or Recodified in 42 CFR Part 70
------------------------------------------------------------------------
           Current regulation                  Proposed regulation
------------------------------------------------------------------------
                Section                              Section
------------------------------------------------------------------------
70.1 General definitions...............  70.1 Scope and definitions.
70.2 Measures in the event of            70.2 Report of death or illness
 inadequate local control.                on board flights.
                                         70.3(new) Written plan for
                                          reporting of deaths or illness
                                          on board flights and
                                          designations of an airline
                                          agent.
70.3 All communicable diseases.........  70.4(new) Passenger
                                          information.
                                         70.5(new) Written plan for
                                          passenger information and
                                          designation of an airline
                                          agent.
70.4 Report of disease.................  70.6(new) Travel permits.
70.5 Certain communicable diseases;      70.7 Responsibility with
 special requirements.                    respect to minors, wards, and
                                          patients.
70.6 Apprehension and detention of       70.8 Military services.
 persons with specific diseases.
70.7 Responsiblity with respect to       70.9(new) Vaccination clinics.
 minors, wards, and patients..
70.8 Members of military and naval       70.10(new) Establishment of
 forces.                                  institutions, hospitals and
                                          stations.
                                         70.11(new) Sanitary measures.
                                         70.12(new) Detention of
                                          carriers affecting interstate
                                          commerce.
                                         70.13(new) Screenings to detect
                                          ill persons.
                                         70.14(new) Provisional
                                          quarantine.
                                         70.15(new) Provisional
                                          quarantine orders.
                                         70.16(new) Quarantine.
                                         70.17(new) Content of
                                          quarantine order.
                                         70.18(new) Service of
                                          quarantine order.
                                         70.19(new) Medical examination
                                          and monitoring.
                                         70.20(new) Hearings.

[[Page 71909]]

 
                                         70.21(new) Care and treatment
                                          of persons.
                                         70.22(new) Foreign nationals.
                                         70.23(new) Administrative
                                          record.
                                         70.24(new) Requests by State
                                          (including political
                                          subdivisions thereof),
                                          possession or tribal health
                                          authorities.
                                         70.25 Measures in the event of
                                          inadequate local control.
                                         70.26 Federal facilities.
                                         70.27 Indian country.
                                         70.28 Special powers in time of
                                          war.
                                         70.29 Penalties.
                                         70.30(new) Implementation
                                          through order.
                                         70.31 Appeals of actions
                                          required pursuant to 70.6,
                                          70.7, 70.11 or 70.12.
------------------------------------------------------------------------

V. Summary of Proposed Changes to 42 CFR Part 71

    The foreign quarantine regulations are used to control and prevent 
the introduction, transmission, or spread of communicable diseases from 
foreign countries into the United States. Sections of this regulation 
are used in the day-to-day activities of quarantine officers. The 
proposed rule reduces the number of subparts from six to two. Many of 
the new sections further clarify current activities. Proposed subpart 
B, Importations, contains the restrictions on importation of nonhuman 
primates, certain kinds of animals, etiological agents, hosts, and 
vectors, and dead bodies. CDC proposes to change only Sec.  71.55 in 
subpart B.
    The following is a section-by-section analysis:

Subpart A--Definitions and General Provisions

Section 71.1 Scope and Definitions

    This section explains that 42 CFR Part 71 contains regulations to 
prevent the introduction, transmission, and spread of communicable 
diseases from foreign countries into the United States. This part also 
contains the regulations to prevent the spread of disease among 
possessions of the United States and from a possession into a State. 
The definitions contained in this part are comparable to those 
appearing in Part 70. The following definitions have been added or 
modified to be consistent with modern quarantine concepts and current 
medical principles and practice: ``airline,'' ``airline agent,'' 
``business day,'' ``bill of health,'' ``commander,'' ``deratting 
certificate,'' ``deratting exemption certificate,'' ``detention,'' 
``Director,'' ``emergency contact information'', ``flight 
information,'' ``hearing officer,'' ``ill person,'' ``infectious 
agent,'' ``International Health Regulations,'' ``medical monitoring,'' 
``military services,'' ``possession,'' ``provisional quarantine,'' 
``quarantine,'' ``quarantinable disease,'' ``sanitary measures,'' 
``State,'' ``ship,'' ``shipline,'' ``shipline's agent,'' and ``United 
States.''
    The definition of an ill person as it applies to this part was 
modified to be consistent to that which applies to Part 70.
    In contrast with the requirement in Section 361(d)(1) (42 U.S.C. 
264(d)(1)) of the PHS Act that the Director make findings under Part 70 
that a person is (1) in a qualifying stage of a quarantinable disease 
and (2) is moving or about to move from a State to another State or who 
is a probable source of infection to persons so moving or about to 
move, there are no such requirements when a person is entering the 
United States from a foreign country or a possession of the United 
States.

Section 71.2 Designation of Yellow Fever Vaccination Centers; Yellow 
Fever or Other Validation Stamps

    This section contains provisions comparable to those contained in 
current Sec.  71.3.
    According to Annex 7 of the WHO International Health Regulations, 
member states must designate yellow fever vaccination centers 
authorized to administer yellow fever vaccine. Licensed medical 
providers become certified as centers through issuance of a Uniform 
Stamp Number by a designated health authority. CDC, pursuant to current 
Sec.  71.3, delegated this authority to state and territorial health 
departments (SHDs). SHDs file duplicate listings of all certified 
vaccination centers with CDC. The authorization requirements and 
certification processes are determined by each SHD, and are not the 
same in every State.
    Upon certification, the SHD sends a notice of the new certification 
to the vaccine manufacturer and to CDC. Upon receipt, CDC sends a 
letter to the new center, confirming contact information and offering 
inclusion on CDC's secure Web-based registry of certified vaccination 
centers. The Web site is maintained by CDC and SHDs, and is updated 
upon notice of certification termination or changes in contact 
information. Several SHDs now file duplicated listings via the website.

Section 71.3 Vaccination Clinics

    This section contains provisions comparable to those contained in 
Sec.  70.9.

Section 71.4 Bills of Health

    Section 366 of the PHS Act (42 U.S.C. 269) provides that, except as 
otherwise prescribed in regulations, any vessel at any foreign port or 
place clearing or departing for any port or place in a State or 
possession shall be required to obtain from the consular officer of the 
United States, Public Health Service officer, or other medical officer 
of the U.S., a bill of health setting forth the sanitary history of the 
vessel. Under existing Sec.  71.11, carriers at any foreign port 
clearing or departing for any U.S. port are not required to obtain or 
deliver a bill of health. Under proposed Sec.  71.4, the Director, to 
the extent permitted by law and in consultation with such other federal 
agencies as the Director may deem necessary, may require a carrier at 
any foreign port clearing or departing for any U.S. port to obtain a 
bill of health. While the Director does not intend to require a bill of 
health for carriers engaged in routine traffic, concern over 
bioterrorism and rapidly emerging infectious diseases makes inclusion 
of this important public health tool imperative.

[[Page 71910]]

Section 71.5 Suspension of Entries and Imports from Designated Places

    This section implements statutory authority contained in section 
362 of the PHS Act (42 U.S.C. 265). Under this authority, the Director, 
to the extent permitted by law and in consultation with such other 
federal agencies as the Director may deem necessary, may prohibit, in 
whole or in part, the introduction of persons and property from foreign 
countries or places whenever the Director determines that the risk of 
introduction of a disease into the United States is increased by the 
introduction of persons or property from such foreign countries or 
places. In carrying out this section, the Director, through order, 
would designate the persons and property from the foreign countries or 
places subject to the prohibition on introduction, as well as the 
period of time that such prohibition would remain in effect.

Section 71.6 Report of Death or Illness on Board Flights

    This section contains provisions applicable to airlines operating 
flights on an international voyage, destined for a U.S. port, 
comparable to those established for airlines engaged in interstate 
traffic under Sec.  70.2.

Section 71.7 Written Plan for Reporting of Deaths or Illness on Board 
Flights and Designation of an Airline Agent

    This section contains provisions applicable to airlines operating 
flights on an international voyage, destined for a U.S. port, 
comparable to those established for airlines engaged in interstate 
traffic under Sec.  70.3

Section 71.8 Report of Death or Illness on Board Ships

    Paragraph (a) of this section establishes requirements applicable 
to a shipline operating ships on an international voyage comparable to 
the requirements applicable to airlines in section 71.6. Ships 
operating between Canadian ports and ports on the Puget Sound or on the 
Great Lakes and connected waterways are not covered by this section.
    Paragraphs (b)-(e) of this section require any shipline operating 
ships on an international voyage destined for a U.S. port to report to 
the quarantine station nearest the port of arrival any death or ill 
person as soon as made known to the ship's commander and, where 
possible, at least 24 hours before arrival. The shipline shall also 
report any deaths or ill persons onboard ships during the 15-day period 
prior to expected arrival, or since departure from a U.S. port 
(whichever period of time is shorter). Cases or suspected cases of 
communicable disease during an international voyage from one U.S. port 
to another are required to be reported to the quarantine station, and 
the ship must take measures to prevent spread of the disease as 
directed by the Director. Any death or ill person during a stay in port 
must be reported. The number of cases (including zero) of diarrhea, 
febrile respiratory disease, febrile rash illness, or febrile 
neurologic illness during an international voyage must be reported 
through a method designated in the shipline's written plan under Sec.  
71.9.
    Paragraph (f) enables the Director to order shiplines with ships on 
an international voyage destined for a U.S. port to disseminate to 
passengers and crew public health notices and other information deemed 
necessary to prevent the introduction, transmission, or spread of 
communicable diseases. This provision is comparable to that described 
for airlines on in international voyage in Sec.  71.6.

Section 71.9 Written Plan for Reporting of Deaths or Illness on Board 
Ships and Designation of a Shipline's Agent

    This provision creates a requirement for shiplines with ships on an 
international voyage destined for a U.S. port comparable to that 
created for airlines on an international voyage in Sec.  71.7. Ships 
operating between Canadian ports and ports on the Puget Sound or on the 
Great Lakes and connected waterways are not covered by this section. 
CDC believes that a 90-day time frame for development of a written plan 
and an additional 90 days for implementation after the final 
publication of this rule to be appropriate because ships should already 
have such procedures in place. CDC is soliciting comment on whether 
this timeframe is appropriate. During the phase-in period established 
by new Sec.  71.7, ships are still expected to comply with the 
reporting requirements contained in current 71.21(a) and (c) (Radio 
report of death or illness) and 71.35 (Report of death or illness on 
carrier during stay in port).

Section 71.10 Passenger Information

    This section contains provisions comparable to those contained in 
Sec.  70.4, except that this section is also applicable to ships on an 
international voyage. Ships operating between Canadian ports and ports 
on the Puget Sound or on the Great Lakes and connected waterways are 
not covered by this section.

Section 71.11 Written Plan for Passenger Information and Designation of 
an Airline or Shipline Agent

    This section contains provisions comparable to those contained in 
Sec.  70.5, except that this section is also applicable to shiplines 
operating ships on an international voyage destined for a U.S. port. 
Ships operating between Canadian ports and ports on the Puget Sound or 
on the Great Lakes and connected waterways are not covered by this 
section.

Section 71.12 Inspections

    This section consolidates provisions contained in current 42 CFR 
Part 71.

Section 71.13 Sanitary Measures

    This section contains provisions comparable to those contained in 
Sec.  70.11.

Section 71.14 Detention of Carriers

    This section contains provisions comparable to those contained in 
Sec.  70.12 and current Sec.  71.31(b).

Section 71.15 Carriers of U.S. Military Services

    This section carries over provisions contained in current Sec.  
71.34.

Section 71.16 Screenings to Detect Ill Persons

    This section contains procedures comparable to those contained in 
Sec.  70.13 at U.S. ports.

Section 71.17 Provisional Quarantine of Arriving Persons

    This section contains procedures comparable to those contained in 
Sec.  70.14.

Section 71.18 Provisional Quarantine Orders

    This section contains procedures comparable to those in Sec.  
70.15.

Section 71.19 Quarantine

    This section contains procedures comparable to those in Sec.  
70.16.

Section 71.20 Content of Quarantine Order

    This section contains procedures comparable to those in Sec.  
70.17.

Section 71.21 Service of Quarantine Order

    This section contains procedures comparable to those in Sec.  
70.18.

Sec.  71.22 Medical Examination and Monitoring

    This section contains provisions comparable to those contained in 
Sec.  70.19.

[[Page 71911]]

Section 71.23 Hearings

    This section contains procedures comparable to those in Sec.  
70.20.

Section 71.24 Care and Treatment of Arriving Persons

    This section contains provisions comparable to those contained in 
Sec.  70.21.

Section 71.25 Arriving Foreign Nationals

    This section contains provisions comparable to those contained in 
Sec.  70.22. In general, U.S. government requirements regarding the 
detention of foreign nationals may be accessed at: http://travel.state.gov/law/consular/consular_636.html.

Section 71.26 Administrative Record

    This section contains procedures comparable to those in Sec.  
70.23.

Section 71.27 Food, Potable Water, and Waste: U.S. Seaports and 
Airports

    This section carries over provisions contained in current Sec.  
71.45.

Section 71.28 Health Documents in International Traffic

    This section carries over provisions contained in current Sec.  
71.46.

Section 71.29 Special Provisions Relating to Airports: Office, 
Examination, and Quarantine Facilities

    Under 8 CFR 234.4, in order to be designated an ``international 
airport,'' an airport must fulfill requirements established by the 
Secretaries of Commerce, Transportation, Health and Human Services, and 
Homeland Security. The list of airports designated as ``international 
airports'' may be found at 19 CFR 122.13. The proposed section carries 
over existing authority requiring each U.S. airport which receives 
international traffic to provide, without cost to the Government, 
suitable office, isolation, and other exclusive space for carrying out 
the federal responsibilities under this part. The proposed section also 
adds a new provision requiring U.S. airports receiving international 
traffic to provide suitable quarantine space. The specifications for 
space requirements to carry out quarantine activities are incorporated 
into the Federal Inspection Service manual. In carrying out this 
provision, CDC intends to collaborate closely with the U.S. Department 
of Homeland Security.

Section 71.30 Establishment of Institutions, Hospitals and Stations

    This section contains provisions comparable to those in Sec.  
70.10.

Section 71.31 Penalties

    The penalties listed in this section are the same as those listed 
in Sec.  70.29.

Section 71.32 Implementation Through Order

    This section contains measures comparable to those in Sec.  70.30.

Section 71.33 Appeals of Actions Required Pursuant to 71.13 or 71.14

    A new 71.33 would allow a written appeal to the Director within 2 
business days in the event that the Director orders the export or 
destruction of animals, articles, or things, pursuant to 71.13 or the 
detention of a carrier pursuant to 71.14. The Director may nevertheless 
immediately implement the actions provided in 71.13 and 71.14.

Subpart B--Importations

Section 71.51 Dogs and Cats

    This section remains unchanged. The text has been set out for the 
convenience of the reader, however, CDC does not invite comments on 
this section.

Section 71.52 Turtles, Tortoises, and Terrapins

    This section remains unchanged. The text has been set out for the 
convenience of the reader, however, CDC does not invite comments on 
this section.

Section 71.53 Nonhuman Primates

    This section remains unchanged. The text has been set out for the 
convenience of the reader, however, CDC does not invite comments on 
this section.

Section 71.54 Etiological Agents, Hosts, and Vectors

    This section remains unchanged. The text has been set out for the 
convenience of the reader, however, CDC does not invite comments on 
this section.

Section 71.55 Dead Bodies

    Embalming is no longer an option for avoiding a permit when 
importing dead bodies. Additionally, the Director can impose additional 
conditions.

Section 71.56 African Rodents and Other Animals that May Carry the 
Monkeypox Virus

    This section remains unchanged. The text has been set out for the 
convenience of the reader, however, CDC does not invite comments on 
this section.
    Following is a summary of changes to the current regulations:

Sections cancelled:
71.3 Designation of yellow fever vaccination centers: Validation stamps
71.21 Radio report of death or illness
71.27 Issuance of Deratting Certificates and Deratting Exemption 
Certificates
71.33 Persons: isolation and surveillance
71.35 Report of death or illness on carrier during stay in port
71.41 General provisions
71.42 Disinsection of imports
71.43 Exemption for mails
71.44 Disinsection of aircraft
71.48 Carriers in intercoastal and interstate traffic
Sections modified:
71.1 Scope and definitions
71.4 Bills of health
71.29 Special provisions relating to airports: Office, examination, and 
quarantine facilities
71.31 Penalties
71.55 Dead bodies
Sections redesignated:
71.14 Carriers of U.S. military services
71.26 Food, potable water, and waste: U.S. seaports and airports
Sections added:
71.2 Designation of yellow fever vaccination centers; Yellow fever or 
other validation stamps
71.3 Vaccination clinics
71.5 Suspension of entries and imports from designated places
71.6 Report of death or illness on board flights
71.7 Written plan for reporting of deaths or illness on board flights 
and designation of an airline agent
71.8 Report of death or illness on board ships
71.9 Written plan for reporting of deaths or illness on board ships and 
designation of a shipline agent
71.10 Passenger information
71.11 Written plan for passenger information and designation of an 
airline or shipline agent
71.12 Inspections
71.13 Sanitary measures
71.14 Detention of carriers
71.16 Screenings to detect ill persons
71.17 Provisional quarantine of arriving persons
71.18 Provisional quarantine orders
71.19 Quarantine
71.20 Content of quarantine order
71.21 Service of quarantine order
71.22 Medical examination and monitoring
71.23 Hearings
71.24 Care and treatment of arriving persons
71.25 Arriving foreign nationals
71.26 Administrative record
71.28 Health documents in international traffic
71.30 Establishment of institutions, hospitals and stations
71.32 Implementation through order
71.33 Appeals of actions required pursuant to 71.13 or 71.14

[[Page 71912]]



    Table V-1.--Sections Updated and/or Recodified in 42 CFR Part 71
------------------------------------------------------------------------
           Current regulation                  Proposed regulation
------------------------------------------------------------------------
   Subpart A--Definitions and General         A. Subpart A--General
     Provisions Proposed Regulation                 Provisions
 
71.1 Scope and definitions.............  71.1 Scope and definitions.
71.2 Penalties.........................  71.2 (modified) Designation of
                                          yellow fever vaccination
                                          centers; yellow fever or other
                                          validation stamps.
71.3 Designation of yellow fever         71.3 (new) Vaccination clinics.
 vaccination centers; Validation stamps.
                                         71.4 Bills of health.
                                         71.5 (new) Suspension of
                                          entries and imports from
                                          designated places.
                                         71.6 (new) Report of death or
                                          illness on board flights.
                                         71.7 (new) Written plan for
                                          reporting of deaths or illness
                                          on board flights and
                                          designation of an airline
                                          agent.
 
  Subpart B--Measures at Foreign Ports
 
71.11 Bills of Health..................  71.8 (new) Report of death or
                                          illness on board ships.
                                         71.9 (new) Written plan for
                                          reporting of deaths or illness
                                          on board ships and designation
                                          of a shipline's agent.
 
   Subpart C--Notice of Communicable
        Disease Prior to Arrival
 
71.21 Radio report of death or illness.  71.10 (new) Passenger
                                          information.
                                         71.11 (new) Written plan for
                                          passenger information and
                                          designation of an airline or
                                          shipline agent.
 
   Subpart D--Health Measures at U.S.
      Ports: Communicable Diseases
 
                                         71.12 (new) Inspections.
71.31 General provisions...............  71.13 (new) Sanitary measures.
71.32 Persons, carriers, and things....  71.14 (new) Detention of
                                          carriers.
71.33 Persons: isolation and             71.15 (modified) Carriers of
 surveillance.                            U.S. military services.
71.34 Carriers of U.S. military          71.16 (new) Screenings to
 services.                                detect ill persons.
71.35 Report of death or illness on      71.17 (new) Provisional
 carrier during stay in port.             quarantine of arriving
                                          persons.
                                         71.18 (new) Provisional
                                          quarantine orders.
 
Subpart E--Requirements Upon Arrival at
    U.S. Ports: Sanitary Inspections
 
                                         71.19 (new) Quarantine.
                                         71.20 (new) Content of
                                          quarantine order.
                                         71.21 (new) Service of
                                          quarantine order.
                                         71.22 (new) Medical examination
                                          and monitoring.
                                         71.23 (new) Hearings.
71.41 General provisions...............  71.24 (new) Care and treatment
                                          of arriving persons.
                                         71.25 (new) Arriving foreign
                                          nationals.
71.42 Disinsection of imports..........  71.26 (new) Administrative
                                          record.
71.43 Exemption for mails..............  71.27 Food, potable water, and
                                          waste: U.S. seaports and
                                          airports.
71.44 Disinsection of aircraft.........  71.28 (new) Health documents in
                                          international traffic.
71.45 Food, potable water, and waste:    71.29 (modified) Special
 U.S. seaports and airports.              provisions relating to
                                          airports: Office, examination,
                                          and quarantine facilities.
                                         71.30 (new) Establishment of
                                          institutions, hospitals and
                                          stations.
71.46 Issuance of deratting              71.31 (new) Penalties.
 certificates and deratting exemption
 certificates.
71.47 Special provisions relating to     71.32 (new) Implementation
 airports: Office and isolation           through order.
 facilities.
71.48 Carriers in intercoastal and       71.33 (new) Appeals of actions
 interstate traffic.                      required pursuant to 71.13 or
                                          71.14.
 
        Subpart F--Importations              Subpart B--Importations
 
71.51 Dogs and cats....................  71.51 Dogs and cats.
71.52 Turtles, tortoises, and terrapins  71.52 Turtles, tortoises, and
                                          terrapins.
71.53 Nonhuman primates................  71.53 Nonhuman primates.
71.54 Etiological agents, hosts, and     71.54 Etiological agents,
 vectors.                                 hosts, and vectors.
71.55 Dead bodies......................  71.55 (modified) Dead bodies.
71.56 African rodents and other animals  71.56 African rodents and other
 that may carry monkey pox virus.         animals that may carry monkey
                                          pox virus.
------------------------------------------------------------------------

VI. Required Regulatory Analyses Under Executive Order 12866, the 
Unfunded Mandates Reform Act, and the Regulatory Flexibility Act

    We have examined the impacts of the proposed regulation under 
Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et 
seq.). Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages, distributive impacts, and equity). Unless we 
certify that the rule is not expected to have a significant economic 
impact on a substantial number of small entities, the Regulatory 
Flexibility Act,

[[Page 71913]]

as amended by the Small Business Regulatory Flexibility Act (SBREFA), 
requires agencies to analyze regulatory options that would minimize any 
significant economic impact of a rule on small entities. Section 202 of 
UMRA requires that agencies prepare a written statement of anticipated 
costs and benefits before proposing any rule that may result in an 
expenditure by State, local, and tribal governments in the aggregate, 
or by the private sector, of $100 million in any one year (adjusted 
annually for inflation). We have conducted analyses of the proposed 
rule, and have determined that the rule is consistent with the 
principles set forth in the Executive Order and in these statutes.
    We believe that the proposed regulation is a significant regulatory 
action under the Executive Order. We also believe that it is a major 
rule under the Congressional Review Act. At this time we are not 
certifying that the proposed rule would not have a significant impact 
on a substantial number of small entities under the Regulatory 
Flexibility Act and have prepared an Initial Regulatory Flexibility 
Analysis, as required.
    A ``significant regulatory action'' is defined in the Executive 
Order in the relevant part as:

    Any regulatory action that is likely to result in a rule that 
may have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities.

    The Regulatory Flexibility Act and the Congressional Review Act 
(Subtitle E of SBREFA) similarly define ``significant impact'' and 
``major rule,'' respectively.
    Finally, our Unfunded Mandates Reform Act analysis concludes that 
the proposed rule will not have any significant economic impact on 
State, local, or Tribal governments. However, the proposed rule would 
have a significant impact on the private sector, particularly air 
carriers. This impact is more than offset by the benefits of the 
proposed rule, which is designed to enhance our ability to effectively 
counter the threat of introduction, transmission, and spread of 
infectious disease via travel. The benefits accruing to public health 
and safety will also extend to the airline industry and the economy 
generally.
    The analyses undertaken to meet the above requirements are 
presented in detail in the report titled Regulatory Impact Analysis of 
Proposed 42 CFR part 70 and 42 CFR part 71, which can be found in the 
Rulemaking Record (CDC, 2005) (hereinafter referred to as the RIA).

A. Objectives and Basis for the Proposed Regulation

    The rule is necessary to minimize the risk of introduction, 
transmission, and spread of infectious disease via travel. In a recent 
study, the Institute of Medicine, National Academy of Sciences, found:

    Whether naturally occurring or intentionally inflicted, 
infections can cause illness, disability, and death in persons while 
disrupting whole populations, economies, and governments. And 
because national borders offer trivial impediment to such threats, 
especially in the highly interconnected and readily traversed 
``global village'' of our time, one nation's problem soon becomes 
every nation's problem (Institute of Medicine, 2003).

    Stopping an outbreak--whether it is naturally occurring or caused 
intentionally--requires the use of the most rapid and effective public 
health tools available. One of those tools is quarantine--restricting 
the movement of persons exposed to infection to prevent them from 
infecting others, including family members, friends, and neighbors. 
Quarantine of exposed persons may be the best initial way to prevent 
the uncontrolled spread of highly dangerous biologic agents such as 
smallpox, plague, and Ebola fever--especially when combined with other 
health strategies such as vaccination, prophylactic drug treatment, 
patient isolation, and other appropriate infection control measures.

B. The Nature of the Impacts

    We commissioned the Volpe National Transportation Systems Center 
(2005) to undertake a study concerning the need for access to data 
enabling us to rapidly identify and locate at-risk persons to control 
the spread of infectious diseases. In the course of the study, airlines 
expressed concern over business and cost considerations associated with 
future data sharing. We would pursue collection of this vital data with 
a commitment to minimize the effect on airline operations. Full 
advantage would be taken of the trend toward online booking and 
passenger information input. Every effort would be made to merge our 
data collection efforts with those already undertaken by the airlines 
for national security and other purposes. During the course of rule 
development, we will seek comment from the airlines and their 
passengers concerning the most efficient means of data collection.
    Failure to efficiently address the health-related effects of 
infectious disease spread through travel poses substantial adverse 
economic consequences. Reliable estimates are that the SARS' economic 
impacts in Asia in 2003 might have totaled as much as U.S. $28.4 
billion, as discussed in Fan (2003). In Toronto, after SARS was 
detected, hotel occupancy rates were cut in half, and conventions were 
cancelled. CBS News Online (2003) reported that the Canadian Government 
spent $40M (CAN) to counteract both the medical impacts (surgical 
backlogs) of SARS quarantines and the public concern about safe travel 
into Ontario. To the extent that economic activity shifts from on 
region to another, estimates of regional impacts overstate national or 
international impacts. Nevertheless, the SARS experience proves that 
fear of contagion and the reaction to that fear can have severe 
economic impacts on nations where such contagions are detected.
    Airlines were severely affected by SARS, with the St. Louis 
Business Journal (2003) stating ``the outbreak of SARS has had a 
greater impact on the global airline industry than the war in Iraq, 
according to a study by OAG, a firm that provides flight schedule 
information.''
    Since the mere threat of an outbreak can affect the public health 
system and damage the economies of affected nations and the travel 
industry, it must be contained promptly to mitigate public reaction. 
Automated tools to acquire passenger information would enable CDC to 
more effectively employ its staff in tracing and identifying travelers.
    The major impacts of this rule will fall on the airlines and the 
global distribution systems (GDSs), travel agencies, and other 
reservation booking operations to gather the data from passengers and 
submit the proposed required crew manifest and passenger data, as 
needed. It will also fall on the passengers themselves, who must take 
time to supply the information (see Sections F and G below for more 
detail). Our current belief is that any data collection-related costs 
borne by these entities will be substantially outweighed by avoidance 
of public health and economic costs associated with infectious disease 
outbreaks spread via travel.
    The other requirements of the proposed rule are primarily 
clarifications or cover tasks that are currently being performed by 
agencies at the state and local levels. In particular, for sanitary 
measures, the proposed regulation duplicates CDC regulatory language 
from 42 CFR part 71, related to international commerce in

[[Page 71914]]

part 70, which relates to interstate commerce. Although this may appear 
to be an expansion of authority, we argue that there is no economic 
impact from this change in language for two reasons. First, the 
regulation will not change historical practice during an outbreak. In 
lieu of CDC action, State and local public health authorities have the 
power to order sanitary measures or destruction of cargo to prevent the 
spread of illness. For example, during the 2003 monkeypox event, the 
state of Wisconsin banned the sale, importation, and display of prairie 
dogs to stop the spread of the disease. Thus, the additional language 
will change the authority under which sanitary measures are taken from 
State to Federal jurisdictions, but the measures would be taken in any 
event, so there is no economic effect.
    Second, the economic impact of a sanitation order may differ 
significantly depending on the circumstances. Experience shows that, in 
some cases, public health officials' sanitation orders do not generate 
costs over and above the costs that the outbreak itself creates. 
Affected markets often respond immediately to health risk information. 
For example, demand for pet prairie dogs collapsed virtually overnight 
when they were identified as potential carriers of monkeypox. Thus, the 
value of the pet prairie dog inventory was destroyed by the loss of a 
market even before health authorities sequestered them. In other cases, 
such as a sanitation order affecting a standard commodity such as 
chicken or beef, whose price would likely not collapse in the presence 
of an outbreak, the order itself may be the vehicle that destroys at 
least part of the value of the shipment. Because a sanitation order 
restricts the supply of a product, in yet other cases it may even cause 
prices to rise. Regardless, government intervention ensures that those 
with less information are not made vulnerable to the disease and can 
reestablish safe conditions and public trust in the product.
    We invite comment concerning the economic impact of this proposed 
regulation.

C. Need for the Rule

    As discussed in more detail above, we believe that the rule is 
necessary to minimize the risk of introduction, transmission, and 
spread of infectious disease via travel. The need for the regulation is 
driven by a demonstrated market failure. An externality exists when one 
person's or party's actions impose uncompensated costs to other 
parties. By exposing fellow travelers to potential illness and possible 
death, an ill traveler imposes uncompensated costs on the fellow 
travelers, travel providers, and the individuals that they, in turn, 
might expose. Due to the national and international nature of travel 
and the transmission of communicable diseases, regulation at the 
Federal level is the most appropriate mechanism for protecting public 
health.

D. Baseline

    A first step in economic analysis of a regulatory action is the 
identification of a baseline, a depiction of the world in the absence 
of any action, from which to calculate the effects of the regulation. 
In the absence of the changes proposed in this regulation, we would 
continue to use the approaches taken during the SARS outbreak. We would 
meet flights containing suspected contagious passengers and attempt to 
obtain location and contact data from both passengers and crew members 
before disembarkation. Ill passengers on planes from affected areas 
would be evaluated and referred for medical care when appropriate.
    As with SARS, data concerning cases identified after disembarkation 
would have to be manually gathered, compiled, and processed from flight 
manifests, customs declarations, and any other available sources 
relevant to the case. This manual process has the following 
shortcomings:
     Manifests contain only the passenger name and seat number.
     Custom declarations are completed by the passenger by hand 
and are often illegible.
     Names on the customs declarations do not necessarily match 
those on the manifests. Phone numbers are not included on customs 
forms, and only one customs form is filled out per family.
    Hard copy data gathered from manifests and customs declarations 
frequently takes several days to obtain. Data must then be keyed into a 
database. Entering the data and verifying addresses may take several 
more days. The time to do manual tracking of passengers could 
frequently be expected to take longer than the incubation period of 
many infectious diseases.

E. Alternatives

    Economic analysis of a regulation is based on the concept of 
incremental change: What would happen without a rule versus what would 
happen with it. The current regulatory environment provides a base case 
against which the changes in behavior precipitated by the new rule are 
compared.
    Overall, the proposed rule seeks to:
     Clarify administrative procedures to ensure due process 
rights to quarantined individuals.
     Mandate that carriers maintain and provide to CDC 
passenger information in electronic formats.
     Clarify requirements for reporting sick passengers.
     Clarify sanitary measures taken with respect to interstate 
commerce.
     Clarify coordination with state and tribal authorities.
    CDC performed a section-by-section comparison of the current and 
proposed rule. Many provisions of the proposed rule codify practices 
that have evolved over the years. As these practices are part of 
current practice at CDC and in the industry, their codification does 
not impose new costs upon society.
    The major cost component of the proposed regulation is creation and 
maintenance of a passenger information database including home address, 
emergency contact, and itinerary information. Under current 
regulations, the airlines do not typically collect this information in 
an easily accessible format, nor do they maintain it for the proposed 
60-day period. Airlines, Global Distribution Systems (GDSs), and travel 
agencies may already collect some of it, however. If the information 
can be shared, then this data collection may be relatively invisible to 
the traveler and primarily a programming problem for the airlines, 
although passengers will incur some opportunity costs of their time to 
provide information and travel agencies and similar entities will incur 
some costs to collect the data. This scenario is CDC's ``Point of 
Sale'' (POS) scenario. However, CDC also examined the situation where a 
wholly separate information collection must be undertaken at departure; 
this process could add to check-in times and entail gathering 
information that is already gathered by many travel agencies, 
generating additional real and opportunity costs for carriers and 
passengers. This is the ``Point of Departure'' (POD) scenario.
    The proposed rule defines a basic set of information to be 
collected from all passengers. The information includes permanent 
address, e-mail address, passport information, traveling companions or 
group, emergency contact information (including at least name of an 
alternate person or business and a phone number), phone number(s) for 
the passenger, itinerary, and other flight information. This set of 
data is greater than the set of information currently collected by the 
airlines, GDSs, or travel agencies. The incremental costs of 
collecting, storing, and producing this information on

[[Page 71915]]

demand in contrast with the no-action base case represent the 
compliance costs of the proposed rule.
    CDC looked at three options for the proposed rule. The first option 
(Option 1--International Only) would cover international flight 
arrivals and trips on vessels arriving from non-U.S. locations only. 
The second option would cover these international flights and vessel 
trips and would add domestic flights landing in or taking off from 
large and medium size U.S. airports specified by CDC (Option 2--
International plus Large and Medium Hubs) (see Appendix A for this 
list). The third option would also cover international flights and 
vessel trips and would add all domestic flights (Option 3--
International plus All Domestic). CDC proposes Option 2 for this 
rulemaking.
    CDC compared the estimated costs and monetized benefits associated 
with the proposed rule (Section I). CDC also examined whether any costs 
should be considered regarding sanitary measures taken with interstate 
commerce (Section B).

F. Cost Analysis of Proposed Option and Alternatives

F.1 Profile of Airline and Cruise Ship Industries
    Under the proposed rule, costs to industry will be incurred 
primarily by the airline and cruise ship industries. Additional sectors 
would also incur some costs to collect additional passenger 
information. (See the RIA [CDC, 2005] for profile information on these 
other sectors, which include travel agencies and GDSs.) Compliance 
costs can be broadly categorized into one-time costs, such as computer 
reprogramming for each airline or cruise line, and recurring costs that 
will be incurred for each passenger traveling with that carrier. 
Foreign carriers incur costs under all three options and are included 
for projecting the total cost of the proposed rule. However, the 
financial impact to carriers is projected only for U.S.-owned 
companies.
Airline Industry
    Commercial air carriers are classified according to the size of the 
aircraft and type of service provided. Airlines operating aircraft with 
more than 60 seats are classified as large certificated carriers, and 
further distinguished as major, national, and regional according to 
annual revenues. Carriers operating aircraft with 60 seats or fewer may 
be classified as small certificated carriers and commuter airlines. 
Some commercial air carriers operate under code-sharing partnerships 
with other, typically major, airlines. Generally, reservations are made 
with, and flight manifests are generated by, the parent airline, not 
the codeshare airline (Franz, 2005). We estimate that 23 codeshare 
airlines fly exclusively under other airlines' codes (RAA, 2005).
    Table VI.F-1 presents flight operation and passenger information 
for air carriers likely to be affected by the proposed rule (BTS 2005a, 
2005b, 2005c) under Option 3; that is, passenger-carrying arrivals from 
foreign countries, as well as interstate and intrastate flights within 
the U.S. This option covers 217 airlines, carrying 696 million 
passengers on 10.4 million flights. Option 1 (International Only) 
covers 184 airlines, 10 percent of Option 3 passengers, and 6 percent 
of the Option 3 flights, while Option 2 (International Only plus Large 
and Medium Hubs) covers 217 airlines, 90 percent of the Option 3 
passengers, and 77 percent of the Option 3 flights.

  Table VI.F-1.--Flights and Passengers Carried by Airlines on Routes Affected by Rule, Revenue and Net Income
                                           July 1, 2003--June 30, 2004
                          [All potentially affected international and domestic flights]
----------------------------------------------------------------------------------------------------------------
                                                        Passengers            Flights
                                                        (millions)          (thousands)      Revenue      Net
              Airline type                 Number  ----------------------------------------     ($     income ($
                                                      Total    Average    Total    Average  millions)  millions)
----------------------------------------------------------------------------------------------------------------
Major...................................        13     522.8     40.21     5,898       454     $6,857     $(357)
National................................        24     113.9      4.75     2,535       106       $512        $19
Large regional..........................        12       5.1      0.43        60         5        $87     $(0.4)
Medium regional.........................         8       2.5      0.31        71         9        $30     $(0.4)
Small/commuter..........................        47      18.9      0.40     1,579        34        $53         NA
Foreign flag............................       113      32.9      0.29       239         2         NA         NA
                                         -----------
    Total...............................       217     696.1        NA    10,382        NA         NA        NA
----------------------------------------------------------------------------------------------------------------
Source: BTS 2005a, 2005b, 2005c. Revenue for 31 small certificated carriers and commuters taken from Dun &
  Bradstreet or estimated from similar airlines based on average revenue per passenger. Carriers and commuters
  taken from Dun & Bradstreet or estimated from similar airlines based on average revenue per passenger.

Cruise Ship Industry
    The cruise ship industry provides international water 
transportation to passengers. The well-known portion of this industry 
comprises large-to-very large firms, best typified by the ``big three'' 
of the global industry: Carnival, Royal Caribbean, and Star Cruises. A 
second tier includes smaller cruise lines that serve similar markets 
and niche markets. A third, much smaller segment comprises small 
operations that provide shorter-distance international water 
transportation to passengers traveling from outside the U.S. in regions 
such as the Great Lakes and the Pacific Northwest, or from Canada and 
the Caribbean. Finally, there are also lines that own and operate 
ferries that carry passengers between, for example, Seattle, WA, and 
Vancouver, B.C., Canada, or between Ohio and Ontario, Canada.
    In theory, any vessel could be affected by the rule because ships 
are inherently mobile. Nevertheless, the general itineraries of the 
lines as currently posted on Web sites were considered the likeliest 
indicator of whether they would be affected by the proposed regulation 
in the near future. Affected cruise lines were identified on the basis 
that: (1) They serve U.S. ports, and (2) they have itineraries with at 
least one international destination.
    Most of the largest cruise lines are members of the International 
Council of Cruise Lines (ICCL); of the 16 cruise lines in this 
category, two are U.S.-owned. The second tier consists of 16 cruise or 
ferry lines that are not members of ICCL, but are considered

[[Page 71916]]

large operations under the terms of the small business analysis. One 
cruise line in this group is U.S.-owned. Small cruise lines and 
international ferry lines number 25; all of these appear to be U.S.-
owned. Table VI.F-2 summarizes relevant data for the cruise line 
industry and presents limited financial data for U.S.-owned cruise and 
ferry lines.

                               Table VI.F-2.--Available Data for U.S. Cruise Lines
----------------------------------------------------------------------------------------------------------------
                                                    Total                                 Average
                                   -----------------------------------------------------------------------------
   Number of         Foreign or                                                                        Revenues
  cruise lines        domestic         Ships      Passengers  Revenues ($   Ships per    Berths per  per line ($
                                                               millions)       line         ship      millions)
----------------------------------------------------------------------------------------------------------------
                                        Large Cruise Lines, ICCL Members
----------------------------------------------------------------------------------------------------------------
14.............  Foreign..........          112   65,997,060           NA            8        1,733           NA
2..............  USA..............            8    2,520,760         $869            4          927       $434.5
----------------
                                      Large Cruise Lines, Non-ICCL Members
----------------------------------------------------------------------------------------------------------------
15.............  Foreign..........           42    3,630,700           NA          2.8          257           NA
1..............  USA..............            3      465,120          $49            3          456          $49
----------------
                                          Small Cruise and Ferry Lines*
----------------------------------------------------------------------------------------------------------------
0..............  Foreign..........            0            0           NA            0            0           NA
25.............  USA..............           48    1,852,090         $138          3.6           76       $19.7
----------------------------------------------------------------------------------------------------------------
\*\Complete data were unavailable for small cruise lines; therefore, revenue data and averages shown are based
  on 7 of the 25 small lines.

F.2 Incremental Costs to Industry of Data Collection
Data Collection Costs
    Under the POS scenario, CDC assumed that legal and logistical 
barriers to carriers accessing DHS and GDS databases were removed, and 
therefore they could access information that passengers input directly 
into a database when they make their reservations. These databases 
might belong to DHS, the airline or a GDS. Travel agents, however, 
would need to collect additional information to complete the purchase 
of tickets. Thus, the only data collection costs to industry under this 
scenario would be borne by travel agencies. There are, however, 
opportunity costs to passengers, since passengers must devote time to 
providing additional information when they make reservations (discussed 
later in this section).
    Under the POD scenario, CDC assumed that airlines would incur the 
data gathering costs and that the amount of incremental data to be 
gathered is greater than the amount of incremental data to be gathered 
under the POS scenario. Unless a passenger is a frequent flier 
customer, much of the information that travel agencies routinely 
gather, such as home or business address and telephone number and/or e-
mail address, is not collected by the airlines routinely.
    CDC based its assumptions for incremental data collection time on 
industry estimates for and comments on DHS' proposed implementation of 
Section 231 of the Enhanced Border Security and Visa Reform Act of 
2002, and direct industry discussions (FR, 2003; IATA, 2003; Qantas, 
2003; Volpe, 2004). Providing an address, for example, is expected to 
add 45 seconds to information collection time, according to industry 
estimates. To estimate the cost of data collection by travel agents 
under the POS scenario, CDC assumed that approximately 30 percent of 
passengers will book through travel agents, and travel agents need an 
additional 45 seconds to gather information from passengers to cover 
the new data needs. Travel agencies already collect much of the 
information required, but a few pieces of information might not be 
universally collected. These might include e-mail address, passport 
information, and emergency contact information. This information was 
considered equivalent to the amount of information that would need to 
be gathered for an address. Thus 45 seconds was considered a reasonable 
estimate under the POS scenario.
    Under the POD scenario, CDC assumed that somewhat longer times, 
such as 1.5 minutes per non-frequent flier passenger, are needed to 
compile the additional information and to obtain or verify emergency 
contact information. Additionally, airlines are forecast to hire 
additional personnel to facilitate information gathering at the time of 
airport check-in. Such workers would be provided with portable 
workstations so that information could be gathered while passengers are 
waiting in line or at the departure gates. These additional workers 
would be needed to avoid excessive queuing time for passengers.
    The incremental costs for gathering information by travel agencies 
are estimated to be $5.2 million to $53.7 million yearly, depending on 
option under the POS scenario. Under the POD scenario, these costs will 
fall on the airlines and cruise lines and will total $65.1 to $316.3 
million annually, depending on the option.
Reprogramming Costs
    Each of the regulatory options also involves potentially 
substantial reprogramming by carriers so that a variety of information 
from several different databases can be linked to information compiled 
prior to or at departure and saved electronically with the manifest 
data currently collected by the airlines. Discussions with industry 
indicate that this reprogramming might cost from $5 million to $15 
million per major airline. These reprogramming costs are primarily a 
function of the need to add data fields and integrate data systems, but 
are relatively invariant with respect to the number of fields added. 
Smaller airlines appear to have IT systems that are less complex and 
more flexible than those of major airlines, so reprogramming costs 
should be substantially lower (Airline Web Sites, 2005; Delta, 2005; 
FR, 2003; Pace, 2005; Sun Country, 2005).
    CDC assumed major and foreign airlines will each incur 
reprogramming costs of $10 million. These costs are assumed to decrease 
with airline size; small certificated/commuter airlines are projected 
to incur costs of $10,000 each.

[[Page 71917]]

Although CDC spoke to airlines about what their anticipated 
reprogramming costs might be, CDC is requesting additional information 
and comment from airlines or others who might have information that 
would assist CDC in further estimating reprogramming costs, 
particularly costs for smaller airlines and cruise lines. Codeshare 
airlines will incur zero reprogramming costs because they do not have 
their own reservation systems. Large cruise lines are assigned a cost 
of $125,000, based on DHS' proposed implementation of the Enhanced 
Border Security and Visa Reform Act (FR, 2003). Costs of $10,000 are 
assigned to small cruise lines and ferries.
    In addition to air carriers and cruise lines, under the POS 
scenario (but not the POD scenario), GDS operators and travel agents 
will also incur reprogramming costs. Companies that own and operate 
GDSs will need to modify databases to accept additional fields from 
Web-based systems and travel agencies. CDC estimated that four major 
GDS systems dominate the U.S. market, and these companies will incur 
reprogramming costs on the order of $5 million each. Travel agencies 
and other tour-booking companies are assumed to incur reprogramming 
costs of $1,000 per establishment to update their Web links with the 
GDS. CDC estimates that about 18,000 establishments will incur these 
costs.
    Reprogramming costs are annualized at 7 percent over 10 years. CDC 
estimates that reprogramming will cost the airlines $105.9 million to 
$107.5 million on an annualized basis under either scenario. For cruise 
lines, the estimated costs of reprogramming total $0.6 million 
(annualized) over all options and scenarios. For travel agencies, GDSs, 
and similar entities, CDC estimates that reprogramming will cost $5.4 
million on an annualized basis over all options, which is added to the 
totals for reprogramming for airlines and cruise lines under the POS 
scenario. Total costs for reprogramming under the POS scenario range 
from $111.9 million to $113.5 million per year, depending on option. 
Under the POD scenario, because the burden of data collection shifts to 
airlines, these costs are slightly less--$106.5 million to $108.1 
million per year.
Archiving and Other Administrative Costs
    Major airlines tend to keep flight manifests in electronic format 
for only a few days because their intensive flight operations would 
otherwise result in massive storage requirements (United, 2005; Volpe, 
2004). Incremental costs will be incurred for archiving manifest and 
passenger information in electronic format up to 60 days, as well as 
administrative costs for submitting data each time CDC requests data 
and for documenting how they will collect data and submit it to CDC. 
This includes time to provide passenger lists and data for the 10-12 
times per month CDC expects to routinely request this information. It 
is assumed that, with the software modifications in place, such routine 
requests will require only a small amount of time to process and submit 
data. CDC assumed major, national, and foreign airlines would require 5 
percent of a full-time-equivalent airline database manager to handle 
these tasks, declining to 1 percent for small certificated/commuter 
airlines. For cruise lines, ICCL members are assigned 5 percent, other 
large lines are assigned 3 percent, and small lines and ferries are 
assigned 1 percent. The average wage for this occupation is taken to be 
$44.00 per hour fully loaded (BLS, 2005). CDC assumed archiving will 
occur on 50-gigabyte tapes, and airlines will need a maximum of 12 
tapes over a 3-month period. Because these tapes can be recycled and 
reused for a number of years, annualized costs of tapes are assumed 
minimal. Storage space requirements are also considered negligible. CDC 
estimated annual archiving and administrative tasks (under either 
scenario) would cost $676,000 to $710,000 for airlines, depending on 
option, and $140,000 for cruise lines across all options, for a total 
of $816,000 to $855,000 depending on option. GDSs and travel agencies 
would not have an equivalent responsibility to provide data to CDC, so 
no archiving or administrative costs are assumed for these entities.
Opportunity Costs to Passengers
    Passengers incur an opportunity cost for the time they use in 
providing additional information to the carriers or others. Under the 
POS scenario, passenger time providing information at a minimum equals 
the time travel agencies require to collect that information (45 
seconds). An additional amount of time (15 seconds) is assumed, on 
average, to allow time for those passengers using the Internet to input 
additional information into Web pages or for any passengers who must 
locate certain information, such as emergency contact telephone number 
or passport number. Thus, on average, all passengers are assumed to 
need one minute to provide additional information. (This figure has not 
been discounted to account for families and groups that may be able to 
provide the data more efficiently.) Under the POD scenario, CDC assumed 
it takes an average of 1.5 minutes for passengers to provide the 
required additional information to airlines/cruise lines.
    The opportunity cost of passenger time is set at the value of 
passenger time on air carriers recommended by FAA (FAA-APO, 2003) of 
$28.60 per hour. This same value is used for cruise line passengers. 
CDC estimates that the opportunity costs to passengers of providing 
additional data total $67.6 to $367.3 million annually under the POS 
scenario and $90.5 million to $439.9 million annually under the POD 
scenario, depending on option. The opportunity cost to passengers is a 
non-industry social cost of the rule.
F.3 Projected National Costs of the Proposed Rule
    CDC discounted future costs to their present value using the 7 
percent discount rate recommended by OMB over 10 years. Costs are 
annualized so that options with costs occurring in different years can 
be compared. Tables VI.F-3a and VI.F-3b show the annualized national 
costs of the three options under the POS and POD scenarios, 
respectively. The biggest difference in costs among the three options 
within each scenario is the opportunity cost to passengers. Costs to 
industry rise only about 42 percent from Option 1 to Option 3 and only 
38 percent from Option 1 to Option 2 under the POS scenario. Under the 
POD scenario, costs to industry more than double from Option 1 to 
Option 2, and increase slightly more for Option 3. Additionally, costs 
to the industries directly affected by the rulemaking (the rule does 
not directly affect GDSs or travel agencies) rise negligibly from one 
option to the next, with Option 1 costing about $107 million and the 
other two costing about $109 million annually under the POS scenario. 
Under the POD scenario, airlines and cruise ship industries incur all 
compliance costs as they are collecting and compiling all required 
passenger information.
    Under the alternative scenario (Point of Departure Scenario) Option 
3 would be associated with costs totaling $425.3 million to industry. 
Adding the $439.9 million opportunity costs to passengers to the 
industry costs yields a total for this scenario of $865.2 million per 
year.

[[Page 71918]]



               Table VI.F-3a.--Estimated Annualized National Costs for the Point of Sale Scenario
                                               [$ millions, 2004]
----------------------------------------------------------------------------------------------------------------
                                                                                     Option 2:       Option 3:
                                                                     Option 1:     International   International
                         Affected entity                           International  plus large and     plus all
                                                                       only         medium hubs      domestic
----------------------------------------------------------------------------------------------------------------
Airlines........................................................          $106.6          $108.2          $108.2
Cruise lines....................................................             0.8             0.8             0.8
Travel agencies.................................................             7.6            50.5            56.1
GDSs............................................................             3.0             3.0             3.0
                                                                 -----------------
    Total Industry Cost.........................................          $117.9          $162.4          $168.0
Opportunity cost to passengers..................................            67.6           332.6           367.3
                                                                 -----------------
    Total with Opportunity Cost.................................          $185.5          $495.0          $535.3
----------------------------------------------------------------------------------------------------------------


             Table VI.F-3b.--Estimated Annualized National Costs for the Point of Departure Scenario
                                               [$ millions, 2004]
----------------------------------------------------------------------------------------------------------------
                                                                                     Option 2:       Option 3:
                                                                     Option 1:     International   International
                         Affected entity                           International  plus large and     plus all
                                                                       only         medium hubs      domestic
----------------------------------------------------------------------------------------------------------------
Airlines........................................................          $133.4          $356.4          $386.3
Cruise lines....................................................            39.0            39.0            39.0
Travel agencies.................................................               0               0               0
GDSs............................................................               0               0               0
                                                                 -----------------
    Total Industry Cost.........................................          $172.4          $395.4          $425.3
Opportunity cost to passengers..................................            90.5           398.4           439.9
                                                                 -----------------
    Total with Opportunity Cost.................................          $262.9          $793.8          $865.2
----------------------------------------------------------------------------------------------------------------

G. Impacts on Industry

    Impacts on industry, including airlines, cruise lines, travel 
agencies, and GDSs, were measured using a comparison of annualized 
costs per firm to each firm's revenues, if available. Impacts were 
identified where the annualized costs exceeded 1 percent of revenues 
and/or where the annualized costs exceeded the net income of a firm 
(airlines only). For airlines, we used a second test, comparing 
annualized costs to net income (similar baseline net income figures are 
not available for the other entities). Impacts were identified where 
annualized compliance costs exceeded net income, where net income was 
currently positive.
    Under the Point of Sale scenario, CDC determined that no airlines, 
cruise lines, GDSs, or travel agencies, would experience annualized 
costs in excess of 1 percent of revenues under any of the options 
analyzed. For those airlines for which net income is available and 
positive, CDC estimates one airline would incur compliance costs 
exceeding net income.
    Under the Point of Departure scenario, CDC estimates that one 
airline would incur annualized compliance costs greater than 1 percent 
of revenues under Option 1, and two airlines would exceed the 1 percent 
level under Option 2. Four airlines are expected to incur costs 
exceeding 1 percent of revenues under Option 3. Furthermore, one 
airline would incur annualized compliance costs exceeding its baseline 
net income under all three options. There is no change to the impact 
results among the other affected entities.

H. Benefits

    As discussed above, the benefits of the proposed regulation are 
associated with the faster suppression of infectious disease outbreaks 
spread via travel. More efficient traceback of infectious individuals 
can lead to more complete and effective prophylaxis and quarantine. The 
reduction of the frequency and scale of outbreaks should result in a 
commensurate reduction in the opportunity costs of outbreak-related 
public health efforts to Federal, State, and local governments.
    In addition to the avoided illnesses and deaths from the proposed 
rule, more effective control of an outbreak will reduce the economic 
impact of infectious disease outbreaks. The SARS outbreak is estimated 
to have reduced incomes in East and Southeast Asia by $12.3 billion to 
28.4 billion (Fan, 2003). Such regional impact measurements overstate 
the global impact of disease outbreaks because they generally do not 
take into account the redirection of investment, travel, and purchasing 
from affected areas to unaffected areas. The global impact would be the 
net loss of consumer and producer surpluses (e.g., how much travelers 
might have preferred to travel to China instead of other destinations) 
due to the outbreak-caused adjustments in economic activity. 
Nevertheless, the affected nation does experience a loss. For example, 
if an outbreak of disease in the U.S. similar to the SARS outbreak in 
Toronto occurred, it could have a large negative effect on the U.S. 
economy through impacts such as those on the travel and tourism 
industries, even though the net impact, measured globally, might not be 
significant. Because forecasting such impacts for the U.S. economy is 
so speculative and unique to specific outbreaks, these types of 
benefits from net reductions in economic impacts are not estimated.
    Other potentially sizeable benefits that could not be quantified 
include reductions in stress on health care systems due to disease 
outbreaks, reductions in cases of common illnesses, such as measles, 
through an ability to rapidly contact passengers who might have been 
exposed, and reductions in anxiety among those who

[[Page 71919]]

do not become ill that are associated with fears of contracting an 
illness during an outbreak.
    The most direct effect of the CDC rule changes is improved contact 
tracing leading to better health outcomes when an outbreak threatens. 
In epidemiological models, the speed of response is often more 
important than the specific action taken (Barrett et al., 2005; 
Lipsitch, 2003). Whether the chosen action is vaccination, quarantine, 
and/or isolation, early implementation lowers the illness and death 
toll. Thus one way to quantify benefits is to compare a base case in 
which intervention proceeds using existing tools with alternatives in 
which intervention can proceed more rapidly. (The more rapid 
intervention is made possible because passenger information that 
includes contact information is readily available.) The benefits of the 
alternative are measured in terms of the number of prevented deaths and 
illnesses.
    To estimate the effect of faster contact tracing, CDC applied a 
Susceptible-Exposed-Infectious-Recovered (SEIR) epidemiological model 
that includes the effects of vaccination, quarantine, isolation, and 
asymptomatic carriers. The model forecasts the number of deaths, 
illness days, isolation days, and quarantine days given parameters that 
characterize the illness and the public health intervention. Each 
outcome measure is monetized by the public's willingness to pay (WTP) 
to avoid death and illness.
    The risks of illness and death from an infectious disease are 
similar to risks from some environmental hazards in that they are 
involuntary, pervasive, and random. Thus, we updated values from the 
Environmental Protection Agency's evaluation of the benefits of the 
Clean Air Act (Kochi, et al., 2003) to 2004 dollars as a measure of WTP 
for changes in the risk of death or value of a statistical life (VSL). 
We applied this $6.9 million to the number of deaths the SEIR model 
forecast would be avoided by faster government action. Johnson et al. 
(1997) found a WTP to avoid a day of severe cough was $56 (updated to 
2004 with CPI). In addition, the WTP for workdays lost to illness and 
recovery is measured as wages lost. CDC valued these losses using the 
median usual weekly earnings of full-time wage and salary workers, $128 
per day (BLS, 2005). Lost earnings are an element of WTP that was not 
captured by Johnson et al. (1997) so it is appropriate to add the two 
components together.
    The parameters of the model were selected to simulate the first 200 
days of a SARS-like disease spreading in a large city. In the base case 
intended to represent current practice, intervention began in the sixth 
week after introduction, isolated 40 percent of infectious patients, 
and quarantined 30 percent of contacts. To model the three options, ERG 
assumes interventions begin in the fifth week, 70 percent of infectious 
patients are isolated, and 60 percent of contacts are quarantined. 
Table VI.H-1 shows the improvement in outcomes with earlier public 
health intervention.

                           Table VI.H-1.--Outcomes in Base Case and Early Intervention
----------------------------------------------------------------------------------------------------------------
                                                                                      Earlier
                             Outcome                                 Base case     intervention     Difference
----------------------------------------------------------------------------------------------------------------
Deaths..........................................................             900              37             863
Illness days....................................................          18,075             670          17,405
Isolation days..................................................          23,753           1,000          22,753
Recovery days...................................................          14,460             536          13,924
Quarantine days.................................................         127,967           5,013         122,954
----------------------------------------------------------------------------------------------------------------

    Table VI.H-2 shows the WTP values for the deaths and days of 
incapacity avoided in a single outbreak by implementing each option. 
However, the rule will presumably be in place for many years and be 
effective in many situations. In order to show the long run benefits of 
the rule, it is necessary to forecast the frequency and scale of 
epidemic events. CDC assumed that epidemics on the scale of the modeled 
outbreak would occur once every 5 years over the 10-year planning 
horizon. Table VI.H-2 shows the WTP in current dollars as well as the 
10-year annualized discounted values at three and seven percent.

                       Table VI.H-2.--Estimated Willingness to Pay for Change in Outcomes
                                             [Million, 2004 dollars]
----------------------------------------------------------------------------------------------------------------
                                                                                     Option 2:       Option 3:
                                                                     Option 1:     International   International
                             Outcome                               International    plus medium      plus all
                                                                       only       and large hubs     domestic
----------------------------------------------------------------------------------------------------------------
Deaths Avoided..................................................        $4,999.7        $5,901.9        $5,956.1
Other Outcomes Avoided:
Illness days....................................................             2.7             3.2             3.2
Isolation days..................................................             3.5             4.2             4.2
Recovery days...................................................             1.4             1.7             1.7
Quarantine days.................................................            13.2            15.6            15.7
                                                                 -----------------
    Total.......................................................        $5,020.6        $5,926.5        $5,980.9
-----------------------------------------------------------------
                                               Annualized Benefits
----------------------------------------------------------------------------------------------------------------
7 percent discount rate.........................................        $1,069.5        $1,262.5        $1,274.1
3 percent discount rate.........................................        $1,033.3        $1,219.8        $1,231.0
----------------------------------------------------------------------------------------------------------------


[[Page 71920]]

    The effect of the earlier intervention reducing the number of 
deaths from 900 to 37 is remarkable but not inconceivable; compare the 
43 SARS deaths in Canada where preparations were made and there were 
effective public health measures with the 299 SARS deaths in Hong Kong. 
A Monte Carlo simulation demonstrated that the set of parameters used 
in the analysis yielded a benefit estimate at the 42nd percentile of a 
range of possible parameter choices. While some alternative assumptions 
could result in considerably smaller benefits estimates, many other 
alternative assumptions could result in much larger estimates. Although 
we cannot know the appropriate assumptions to model the epidemics that 
will be encountered in the future, it is not difficult to imagine 
outbreaks whose control would exceed this level of benefits. We invite 
comments on the benefits model, which is described in detail in the RIA 
(CDC, 2005).

I. Comparison of Costs and Benefits

    The primary cost impact of the proposed rule is the collection and 
maintenance of crew and passenger data. The economic analysis focused 
primarily on air and water carriers, and secondarily, under the POS 
scenario, on GDSs and travel agencies, all of which are likely to 
modify computer systems and collect passenger information in order to 
come into compliance or meet airline/cruise line requirements. Some 
data sought by CDC is already or soon may be collected by other 
government agencies (e.g., the Transportation Security Administration's 
Advanced Passenger Information System or APIS). For the purposes of the 
analysis, it is assumed CDC will not gain access to this data and will 
have to collect the data itself, either directly at departure (POD 
scenario) or indirectly, through cooperation with travel agencies and 
GDSs (POS scenario). For more discussion of the potential for data 
collection overlap, see the RIA (CDC, 2005). Potential costs savings 
may result should CDC gain access to APIS data. However, it is not 
possible to estimate those savings at this time due to multiple 
uncertainties. These uncertainties include the extent to which CDC 
would have access to such data and the list of data elements that is 
consistently collected under APIS.
    Tables VI.I-1a and VI.I-1b summarize the estimated annualized costs 
and benefits associated with the proposed rule under the POS and POD 
scenarios, respectively. Table VI.I-1c presents these same results 
assuming the actual costs are at the midpoint between the two bounding 
scenarios. The benefits of the rule are measured in terms of the number 
of deaths and illnesses prevented by rapid intervention. The costs and 
benefits of the rule are considered over a 10-year period. As the table 
shows, under all options, the benefits substantially outweigh the costs 
under either scenario and assuming actual costs are the midpoint of 
costs under the two scenarios.

  Table VI.I-1a.--Annualized Discounted Value of Costs and Benefits of the POS Scenario over a 10-Year Planning
                                                     Period
----------------------------------------------------------------------------------------------------------------
                                     Option 1: International   Option 2: International   Option 3: International
                                              only              plus medium and large       plus all domestic
                                   --------------------------           hubs           -------------------------
             Parameter                                       --------------------------
                                     Total cost  Incremental   Total cost  Incremental   Total cost  Incremental
                                    and benefit  net benefit  and benefit  net benefit  and benefit  net benefit
----------------------------------------------------------------------------------------------------------------
At 7 percent discount rate:
    Costs.........................       $185.5  ...........       $495.0  ...........       $535.3  ...........
    Benefits......................        1,070  ...........        1,263  ...........        1,274  ...........
    Net Benefit...................        884.5  ...........        768.0     ($116.5)        738.7      ($29.3)
At 3 percent discount rate:
    Costs.........................       $165.7  ...........       $475.0  ...........       $515.3  ...........
    Benefits......................        1,033  ...........        1,220  ...........        1,231  ...........
    Net Benefit...................        867.3  ...........        745.0     ($122.3)        715.7      ($29.3)
----------------------------------------------------------------------------------------------------------------


  Table VI.I-1b.--Annualized Discounted Value of Costs and Benefits of the POD Scenario Over a 10-Year Planning
                                                     Period
----------------------------------------------------------------------------------------------------------------
                                     Option 1: International   Option 2: International   Option 3: International
                                              only              plus medium and large       plus all domestic
                                   --------------------------           hubs           -------------------------
             Parameter                                       --------------------------
                                     Total cost  Incremental   Total cost  Incremental   Total cost  Incremental
                                    and benefit  net benefit  and benefit  net benefit  and benefit  net benefit
----------------------------------------------------------------------------------------------------------------
At 7 percent discount rate:
    Costs.........................       $262.9  ...........       $793.8  ...........       $865.2  ...........
    Benefits......................        1,070  ...........        1,263  ...........        1,274  ...........
    Net Benefit...................        807.1  ...........        469.2     ($337.9)        408.8      ($60.4)
At 3 percent discount rate:
    Costs.........................       $244.1  ...........       $774.7  ...........        846.1  ...........
    Benefits......................        1,033  ...........        1,220  ...........        1,231  ...........
    Net Benefit...................        788.9  ...........        445.3     ($343.6)        384.9      ($60.4)
----------------------------------------------------------------------------------------------------------------


[[Page 71921]]


    Table VI.I-1c.--Annualized Discounted Value of Costs and Benefits of the Midpoint Between the POS and POD
                                     Scenario over a 10-Year Planning Period
----------------------------------------------------------------------------------------------------------------
                                     Option 1: International   Option 2: International   Option 3: International
                                              only              plus medium and large       plus all domestic
                                   --------------------------           hubs           -------------------------
             Parameter                                       --------------------------
                                     Total cost  Incremental   Total cost  Incremental   Total cost  Incremental
                                    and benefit  net benefit  and benefit  net benefit  and benefit  net benefit
----------------------------------------------------------------------------------------------------------------
At 7 percent discount rate:
    Costs.........................       $224.2  ...........       $644.4  ...........       $700.3  ...........
    Benefits......................        1,070  ...........        1,263  ...........        1,274  ...........
    Net Benefit...................        845.8  ...........        618.6     ($227.2)        573.7      ($44.9)
At 3 percent discount rate:
    Costs.........................        204.9  ...........       $624.9  ...........       $680.7  ...........
    Benefits......................        1,033  ...........        1,220  ...........        1,231  ...........
    Net Benefit...................        828.1  ...........        595.1     ($233.0)        550.3      ($44.8)
----------------------------------------------------------------------------------------------------------------

    As a second analysis, the cost effectiveness of the options was 
considered. In order to include both mortality and morbidity effects in 
a single metric for cost effectiveness analysis, these measures were 
converted to Quality Adjusted Life-Years (QALYs). (See the RIA for more 
information on how QALYs are calculated.)
    The QALY losses avoided by implementation of the proposed rule 
annualized at 7 percent are presented in Tables VI.I-2a (POS 
scenario),VI.I-2b (POD scenario), and VI.I-2c (midpoint). As with the 
dollar denominated benefit estimates, the number of deaths avoided is 
the largest component of benefits. Costs per QALY for Options 1 and 2 
are less than $300,000 under the higher-cost POD scenario.
    In the cost-effectiveness analysis, the options are ranked in order 
of ascending numbers of QALYs. The average cost effectiveness of the 
options is calculated as the cost of each option divided by the number 
of QALYs associated with each option ($/QALY). To calculate the 
incremental cost-effectiveness of each option, each option's costs and 
QALYs are first calculated as the incremental cost and incremental 
number of QALYs going from that option to the next higher option. The 
incremental cost is then divided by the incremental number of QALYs. 
This method is also used for Option 1, which is incremental to the no-
action alternative (not explicitly shown). The no-action alternative 
has zero cost and zero QALYs.
    As Tables VI.I-2a and VI.I-2b show, after Option 1 (international 
flights and cruise lines only) under either scenario, costs rise 
quickly. Option 2 (international plus large and medium hubs) is 
associated with a slightly lower average cost effectiveness value 
compared to Option 3 (international plus all domestic), but a 
significantly lower incremental cost effectiveness value compared to 
Option 3 under either scenario.

        Table VI.I-2a.--Average and Incremental Cost Effectiveness of the Options Under the POS Scenario
                                           [Ranked by number of QALYs]
                                            [7 percent discount rate]
----------------------------------------------------------------------------------------------------------------
                                                                                                    Incremental
                                 Annualized               Incremental  Incremental   Average cost       cost
            Option                cost  ($      QALYs       cost  ($      QALYs     effectiveness  effectiveness
                                 millions)                 millions)                   ($/QALY)       ($/QALY)
----------------------------------------------------------------------------------------------------------------
Option 1......................       $185.5        2,257       $185.5        2,257       $82,189        $82,189
Option 2......................        495.0        2,665        309.5          408       185,752        758,652
Option 3......................        535.3        2,689         40.3           24       199,074      1,678,333
----------------------------------------------------------------------------------------------------------------


        Table VI.I-2b.--Average and Incremental Cost Effectiveness of the Options under the POD Scenario
                                           [Ranked by number of QALYs]
                                            [7 percent discount rate]
----------------------------------------------------------------------------------------------------------------
                                                                                                    Incremental
                                 Annualized               Incremental  Incremental   Average cost       cost
            Option                cost ($       QALYs       cost ($       QALYs     effectiveness  effectiveness
                                 millions)                 millions)                   ($/QALY)       ($/QALY)
----------------------------------------------------------------------------------------------------------------
Option 1......................       $262.9        2,257       $262.9        2,257      $116,478       $116,478
Option 2......................        793.8        2,665        530.9          408       297,865      1,301,275
Option 3......................        865.2        2,689         71.4           24       321,752      2,974,167
----------------------------------------------------------------------------------------------------------------


[[Page 71922]]


 Table VI.I-2b.--Average and Incremental Cost Effectiveness of the Options at the Midpoint of Costs Between the
                                              POS and POD Scenario
                                           [Ranked by number of QALYs]
                                            [7 percent discount rate]
----------------------------------------------------------------------------------------------------------------
                                                                                                    Incremental
                                 Annualized               Incremental  Incremental   Average cost       cost
            Option                cost ($       QALYs       cost ($       QALYs     effectiveness  effectiveness
                                 millions)                 millions)                   ($/QALY)       ($/QALY)
----------------------------------------------------------------------------------------------------------------
Option 1......................       $224.2        2,257       $224.2        2,257       $99,333        $99,333
Option 2......................        644.4        2,665        420.2          408       241,809      1,029,963
Option 3......................        700.3        2,689         55.8           24       260,413      2,326,250
----------------------------------------------------------------------------------------------------------------

    In a third analysis of costs and benefits, a breakeven analysis was 
performed. In a breakeven analysis, the number of years between 
outbreaks that would need to occur for benefits to equal costs is 
calculated. The benefits of one outbreak were discounted as if the 
outbreak would occur five years in the future and annualized to be 
comparable to annualized costs. Dividing annualized costs by annualized 
benefits indicates the number of outbreaks that would need to occur 
during the planning period for benefits to equal costs. Dividing the 
planning period, 10 years, by this number shows the expected period of 
time between outbreaks. If this period is longer than the expected 
recurrence of serious outbreaks, then the expected benefits outweigh 
the expected costs.
    Table VI.I-3 shows these results for the three options considered 
under the POS and POD scenarios, as well as under a midpoint cost 
assumption. Whether or not one believes that there will be two 
outbreaks of this magnitude in the next 10 years, it may be reasonable 
to expect that there may be one such outbreak in 9 to 27 years, as 
represented for the midpoint cost assumption.

                     Table VI.I-3.--Costs in Terms of the Number and Frequency of Outbreaks
----------------------------------------------------------------------------------------------------------------
                                                                                         Number of    Frequency
                                                                            Annualized   outbreaks        of
                                                                             costs ($   in 10 years   outbreaks
                                                                            millions,       for        to equal
                                                                              2004)     benefits to     costs
                                                                                        equal costs    (years)
----------------------------------------------------------------------------------------------------------------
POS Scenario:
    Option 1.............................................................       $185.5         0.31         32.7
    Option 2.............................................................        495.0         0.82         12.3
    Option 3.............................................................        535.3         0.88         11.3
Mid-Point:
    Option 1.............................................................        224.2         0.37         27.1
    Option 2.............................................................        644.4         1.06          9.4
    Option 3.............................................................        700.3         1.15          8.7
POD Scenario:
    Option 1.............................................................        262.9         0.43         23.1
    Option 2.............................................................        793.8         1.35          7.7
    Option 3.............................................................        865.2         1.43          7.1
----------------------------------------------------------------------------------------------------------------

J. Regulatory Flexibility Analysis

    CDC considered the proposed regulation's effects on small entities, 
as required by the Regulatory Flexibility Act (RFA; 5 U.S.C. et seq.; 
Pub. L. 96-354) as amended by the Small Business Regulatory Enforcement 
Fairness Act of 1996 (SBREFA; Pub. L. 104-121). The RFA establishes, as 
a principle of regulation, that agencies should tailor regulatory and 
informational requirements to the size of entities, consistent with the 
objectives of a particular regulation and applicable statutes. The 
agency has prepared an Initial Regulatory Flexibility Analysis (IRFA). 
This analysis suggests that this rule will not have a significant 
effect on a substantial number of small businesses, small 
organizations, or small governmental jurisdictions. However, CDC is 
asking for comment on the costs and impacts of the rule on small 
entities. As required by the RFA, in the final rule, CDC will provide 
the public comments it received in response to the proposal, prepare a 
Final Regulatory Flexibility Analysis (FRFA) and make a determination 
whether a certification of no significant impact on a substantial 
number of small entities is appropriate.
    The Small Business Administration defines small airlines as those 
with fewer than 1,500 employees and small water carriers as those with 
fewer than 500 employees. Department of Transportation (DOT) data 
indicates that there are 43 airlines (NAICS 481111) with fewer than 
1,500 employees (BTS, 2005a and 2005b). Employment is not reported for 
an additional 32 airlines and another 19 airlines have no financial 
data whatsoever. We assume that all 32 with no employment data are 
small, there are 75 small airlines that might be affected by the 
proposed rule. International ownership links complicate estimation of 
the number of small cruise lines (NAICS 438112). When ferry and charter 
boat companies operating in the Great Lakes, Gulf of Mexico, Pacific 
Northwest, or Florida with foreign port itineraries are considered, we 
estimate that there are approximately 20 small firms in the cruise 
industry subject to the regulation.
    GDSs and travel agencies might also be affected by the proposed 
regulation under the POS scenario. Census Bureau data indicate there 
are 21,679 small travel agency (NAICS 561510) establishments in the 
U.S. (Census, 2004). Larger travel companies own 4,559 of these 
establishments, so we estimate that the remaining 17,120 are

[[Page 71923]]

small firms. Using similar reasoning, we estimate there are 703 small 
other reservation booking firms (not listed as travel agencies) in the 
U.S. All GDSs are considered large.
    CDC, as discussed earlier, considered three options under two 
scenarios. The first option requires information to be collected from 
passengers only for those arriving on international flights and cruise 
lines with international to domestic itineraries. Option 2 adds 
domestic flights from medium and large airports to Option 1, and Option 
3 adds all domestic flights to Option 1. The two scenarios are the 
Point of Sale scenario, under which CDC assumes that the airlines will 
be able to gain access to data collected by travel agencies and GDSs 
and will not have to collect data from passengers at the point of 
departure. In the second scenario, CDC assumes that the logistical and 
legal barriers to this information sharing are such that all 
information would need to be collected by the airlines at the point of 
departure (the Point of Departure scenario).
    CDC did consider Option 1, which represents an option for 
minimizing the number of affected small firms and their associated 
costs (since it covers fewer flights and passengers). Small firms are 
less likely to provide international flights than large firms. CDC did 
not select this option because CDC believes that Option 2 provides 
better protection of human health with only slightly greater potential 
impacts (and only under the POD scenario). Although CDC could have 
considered an option in which some or all airlines and cruise lines 
considered small by Small Business Administration Standards were 
exempted from providing data, CDC did not believe that this approach 
would adequately protect human health. Although the airlines defined as 
small carry only 5-10 percent of passengers (depending on option), this 
represents as many as 35 million passengers annually and as many as 22 
percent of flights. Furthermore, the nature of the airline industry is 
such that some of the smaller airlines, which comprise a major portion 
of the codeshare airlines, would avoid some of the major costs of the 
proposed rule. The codeshare airlines do not have their own reservation 
systems. These are managed by their larger airline partners. A 
significant cost of the proposed rule entails the reprogramming of the 
reservation system software. CDC does not believe any codeshare airline 
will share in any of these costs, since the larger airlines are very 
dependent on the codeshare airlines to fill the gaps in their itinerary 
offerings.
    CDC applied a revenue test to assess the impact of added costs on 
small businesses. Under the POS scenario, costs are less than 1 percent 
of revenues for all affected airlines and cruise lines under Option 2. 
Even among the small travel agencies, costs are less than one-half of 
one percent of small travel agencies' average revenues. These small 
businesses are estimated to incur costs of less than $700 per year per 
firm under Option 3.
    Under the Point of Departure scenario, Option 2, CDC estimates that 
two small airlines out of 91 small airlines and cruise lines analyzed 
might incur annualized compliance costs in excess of one percent of 
revenues, should the carriers themselves need to collect all of the 
passenger information required prior to passenger boarding.

K. References for Part VI

Barrett, C.L., S.G. Eubank, and J.P. Smith. 2005. If smallpox 
strikes Portland. Scientific American 292(3):55-61.
BLS (Bureau of Labor Statistics). 2005. Wages by area and 
occupation. http://www.bls.gov/bls/blswage.htm. Accessed March 7-17, 
2005.
BTS (Bureau of Transportation Statistics). 1998. Office of Airline 
Information. Air carrier financial statistics: Quarterly (Yellow 
Book). Washington, DC: U.S. Department of Transportation. June.
BTS (Bureau of Transportation Statistics). 2005a. Air carrier 
financial reports (Form 41 financial data) Schedule P-11 database. 
http://www.transtats.bts.gov/. Accessed March 14, 2005.
BTS (Bureau of Transportation Statistics). 2005b. Air carrier 
financial reports (Form 41 financial data) Schedule P-12 database. 
http://www.transtats.bts.gov/. Accessed March 14, 2005.
BTS (Bureau of Transportation Statistics). 2005b. Air carrier 
statistics (Form 41 traffic) T-100 segment database. http://www.transtats.bts.gov/. Accessed March 14, 2005. CBS News Online. 
2003. ``The Economic Impact of SARS.'' April 28. CDC. 2005. 
Regulatory Impact Analysis of Proposed 42 CFR Part 70 and 42 CFR 
Part 71.
Cruise Industry News. 2004. Market brand and growth. http://www.cruiseindustrynews.com/index.php?option=com_content&task=view&id=18&Itemid=42 Itemid=42. Spring. Accessed March 2005.
Delta. 2005. Telephone conversations between Spark Nowak and Dennis 
Stamm, Delta Airlines, and John Eyraud and Calvin Franz, ERG. March 
7 and March 9, 2005.
DOT (Department of Transportation). 2005. Telephone conversation 
between Bernie Stankus, Office of Airline Information, and Calvin 
Franz, ERG. March 16, 2005. Deutsche Bank. 2004. Cruise industry 
review: The dynamic duopoly. Global Equity Research. September 27, 
2004.
FAA-APO. 2003. ``Treatment of Passenger Time in Economic Analysis.'' 
APO Bulletin (APO-03-01). March.
Fan, E.X. 2003. SARS: Economic impacts and implications. Asian 
Development Bank, Economics and Research Department, ERD Policy 
Brief No. 15. May.
FR (Federal Register). 2003. Manifest requirements under Section 231 
of the Act. Proposed rule. Immigration and Naturalization Service, 
Department of Justice. Fed. Reg. 68(2). January 3.
Franz. 2005. Personal communications between Calvin Franz, ERG, and 
representatives of the following regional airlines: Air Wisconsin, 
Chautauqua, Comair, ExpressJet, and SkyWest. March 15, 2005.
IATA (International Air Transport Association). 2003. Comments of 
the International Air Transport Association in respect of: U.S. 
Immigration and Naturalization Service notice of proposed rulemaking 
on manifest requirements under Section 231 of the Act. Public 
Docket. February 3, 2003.
Institute of Medicine. 2003. Microbial Threats to Health: Emergence, 
Detection and Response. March
Johnson, F.R., E.E. Fries, and H.S. Banzhaf. 1997. Valuing 
morbidity: An integration of the willingness to pay and health 
status index literatures. Journal of Health Economics 16:641-665.
Kochi, I., B. Hubbell, and R. Kramer. 2003. An empirical Bayes 
approach to combining and comparing estimates of the value of a 
statistical life for environmental policy analysis. Appendix H. 
Prepared for meeting of the EPA Science Advisory Board. May 12.
Lipsitch, M., T. Cohen, B. Cooper, J.M. Robins, S. Ma, L. James, G. 
Gopalakrishna, S.K. Chew, C.C. Tan, M.H. Samore, D. Fisman, and M. 
Murray. 2003. Transmission dynamics and control of severe acute 
respiratory syndrome. Sciencexpress (May 23):1.
Pace. 2005. Telephone conversation between Harlan Cobert, Pace 
Airlines, and Calvin Franz, ERG. March 16, 2005.
RAA (Regional Airline Association). 2005. Regional Airline Code 
Sharing Partnerships as of April 2004. http://www.raa.org. Accessed 
March 10, 2005.
Sun Country. 2005. Telephone conversation between Tony Loeks, Sun 
Country Airlines, and Calvin Franz, ERG. March 15, 2005.
St. Louis Business Journal. 2003. June 12.
Qantas. 2003. Department of Justice Immigration and Naturalization 
Service 8 CFR Part 217, 231, 251 manifest requirements under Section 
231 of the Act proposed rule, comments by Qantas Airways. Public 
Docket. January 30, 2003.
United Airlines. 2005. Telephone conversations between Gary Kohn, 
United Airlines, and Calvin Franz, ERG. March 14, 2005.
USB Warburg. 2003. Your ship has come in. Global Equity Research. 
May 14.
Volpe. 2005. Real-time data for CDC location of at-risk passengers. 
Cambridge, MA: Intermodal Logistics Planning and

[[Page 71924]]

Integration Division, Volpe National Transportation Systems Center, 
U.S. Department of Transportation. June 29.
WHO (World Health Organization). 2004. Summary of probable SARS 
cases with onset of illness from 1 November 2002 to 31 July 2003. 
http://www.who.int/csr/sars/country/table2004_04_21/en/print.html. Accessed August 8, 2005.
Airline Web Sites Accessed:
Casino Express. http://www.redlioncasino.com/CasinoExpress/. 
Accessed March 16, 2005.
Miami International. http://www.miamiair.com/. Accessed March 16, 
2005.
North American. http://www.northamericanair.com/. Accessed March 16, 
2005.
Sky King. http://www.flyskyking.net/. Accessed March 16, 2005.
Trans Meridian. http://www.tmair.com/. Accessed March 16, 2005.
USA3000. http://www.usa3000airlines.com/. Accessed March 16, 2005.

VII. Other Administrative Requirements

A. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 requires HHS to determine whether the 
proposed rule is economically significant. The Executive Order further 
requires HHS to determine whether the proposed rule would create an 
environmental health or safety risk disproportionately affecting 
children. HHS has determined that this proposed rule of general 
applicability is consistent with the principles set forth in the 
Executive Order.

B. Paperwork Reduction Act of 1995

    The Centers for Disease Control and Prevention has determined that 
this notice of proposed rulemaking contains information collections 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
A description of these provisions is given below with an estimate of 
the annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information. Comments are invited on (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) ways to enhance the quality, utility, and clarity of 
the information to be collected; and (d) ways to minimize the burden of 
the collection of information on respondents, including through the use 
of automated collection techniques or other forms of information 
technology. Written comments should be received within 60 days of the 
publication of this notice. Please send written comments to Seleda 
Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, 
MS D-74, Atlanta, GA 30333.
    Proposed Project: Control of Communicable Diseases; Interstate and 
Foreign Quarantine--Revision--Division of Global Migration and 
Quarantine (DGMQ), National Center for Infectious Diseases (NCID), 
Centers for Disease Control and Prevention.
    Description: Section 361 of the Public Health Service (PHS) Act (42 
U.S.C. 264) authorizes the Secretary of Health and Human Services to 
make and enforce regulations necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the United States or from one State or possession into another. 
Legislation and existing regulations governing interstate and foreign 
quarantine activities (42 CFR Parts 70 and 71) authorize quarantine 
officers and other personnel to inspect and undertake necessary control 
measures in order to protect the public health. Currently, with the 
exception of rodent inspections and the cruise ship sanitation program, 
inspections are performed only on those vessels and aircraft which 
report illness prior to arrival or when illness is discovered upon 
arrival. Other inspection agencies assist quarantine officers in public 
health screening of persons, pets, and other importations of public 
health importance and make referrals to PHS when indicated. These 
practices and procedures ensure protection against the introduction and 
spread of communicable diseases into the United States with a minimum 
of recordkeeping and reporting as well as a minimum of interference 
with trade and travel. The information collection burden is associated 
with these recordkeeping and reporting requirements.
    At present, CDC maintains clearance to collect certain information 
and impose recordkeeping requirements related to quarantine 
responsibilities under two separate OMB control numbers: 0920-0488 for 
42 CFR Part 70 Interstate quarantine and 0920-0134 Foreign Quarantine. 
CDC proposes to revise reporting and recordkeeping requirements under 
the current OMB control numbers for sections in the rule that have been 
modified or retained. Additionally, CDC proposes to add new sections 
containing reporting and recordkeeping requirements for interstate and 
foreign quarantine to the existing 0920-0488 and 0920-0134, 
respectively.
Interstate Quarantine
    Under OMB control number 0920-0488, the following section will be 
modified: 70.6 Travel permits. CDC proposes to add the following 
sections: 70.2 Report of death or illness on board flights; 70.3 
Written plan for reporting of deaths or illness on board flights and 
designation of an airline agent; 70.4 Passenger information; 70.5 
Written plan for passenger information and designation of an airline 
agent; and, 70.19 Medical examination and monitoring.
    Control of disease transmission within the United States is largely 
considered to be the province of state and local health authorities, 
with federal assistance being sought by those authorities on a 
cooperative basis, without application of federal regulations. 
Interstate quarantine regulations administered by CDC were developed to 
facilitate federal action in the event of large outbreaks requiring a 
coordinated effort involving several states, or in the event of 
inadequate local control. While it is not known whether, or to what 
extent, situations may arise in which these regulations would be 
invoked, contingency planning for domestic emergency preparedness is 
not uncommon. Should a domestic emergency occur, the reporting and 
record keeping requirements contained in the regulations will be used 
by CDC to carry out quarantine responsibilities as required by law, 
specifically, to prevent the spread of communicable diseases from one 
state or possession into any other state or possession. The information 
would only be collected when it is required, and is the minimum 
necessary to meet statutory obligations. CDC uses one form to collect 
essential information in the following sections:
    42 CFR 70.3: All communicable diseases.
    42 CFR 70.4: Report of disease.
    42 CFR 70.5: Certain communicable diseases; special requirements.
    CDC's proposed rule cancels Sec.  70.3 and modifies 70.4 and 70.5 
into a new section 70.6. The current permit form will be modified to 
reflect that the application is now made only to the Director as set 
forth in 70.6(c)(2).
    In addition to 70.6, CDC proposes adding reporting requirements at 
the following sections:

[[Page 71925]]

    70.2 Report of death or illness on board flights. This requirement, 
currently only in the foreign quarantine regulations, now extends to 
airlines operating flights in interstate traffic in this proposed rule.
    70.3 Written plan for reporting of deaths or illness on board 
flights and designation of an airline agent. The first year in which 
the plan is required after the final rule takes effect imposes the 
largest burden. However, the time to assemble the initial plan is 
expected to be minimal as airlines are already required to have these 
procedures in place under the current regulation. In subsequent years, 
airlines are required to annually review the plan and make revisions as 
necessary. Airlines are also required to conduct drills or exercises to 
annually test and evaluate the effectiveness of the plan. Any revisions 
as a result of the annual review or the drills or exercises must be 
submitted to the Director.
    70.4 Passenger information. This is a new requirement for any 
airline operating flights in interstate traffic to collect certain 
information, including name and best contact information, from 
passengers arriving in or departing from any of the airports listed in 
Appendix A. This information will be used to notify passengers in case 
of exposure to a communicable disease. CDC recognizes that other 
federal agencies--in particular the Department of Homeland Security--
currently collects some of the information that CDC is requesting in 
the proposed rule. To that end, CDC and DHS are exploring options to 
reduce the potential burden of dual reporting.
    70.5 Written plan for passenger information and designation of an 
airline agent. The burden for this section is greatest in the first 
year. In subsequent years, airlines are required to annually review the 
plan and make revisions as necessary. Airlines are also required to 
conduct drills or exercises to annually test and evaluate the 
effectiveness of the plan. Any revisions as a result of the annual 
review or the drills or exercises must be submitted to the Director.
    70.19(b) Medical examination and monitoring. Persons believed to be 
in the qualifying stage of a quarantinable disease may be asked to 
provide the Director with information related to familial and social 
contacts, travel itinerary, medical history, place of work, and 
vaccination status.
Foreign Quarantine
    Under OMB control number 0920-0134, the following sections will be 
modified: 71.6 and 71.8. These reporting requirements currently fall 
under 71.21.
    New reporting and recordkeeping requirements proposed to be added 
to 0920-0134 include: 71.7 Written plan for reporting of deaths or 
illness on board ships and designation of an airline agent; 71.9 
Written plan for reporting of deaths or illness on board ships and 
designation of a shipline agent; 71.10 Passenger information; 71.11 
Written plan for passenger information and designation of an airline or 
shipline agent; and, 71.22 Medical examination and monitoring.
    Currently, 42 CFR Part 71 comprises the following citations that 
require reporting or recordkeeping:
    42 CFR 71.21 Radio report of death and illness.
    42 CFR 71.33(c) Report of persons held in isolation or 
surveillance.
    42 CFR 71.35 Report of death or illness on carrier during stay in 
port.
    42 CFR 71.51(b)(3) and (d) Requirements for admission of dogs and 
cats.
    42 CFR 71.52(d) Application for permits to import turtles.
    42 CFR 71.53(d) and (e) Requirements for registered importers of 
nonhuman primates.
    The proposed rule modifies these recordkeeping and reporting 
requirements as follows:

    71.6 Reports of death or illness on board flights and 71.8 Report 
of death or illness on board ships. These requirements clarify the 
current section 71.21 Radio report of death and illness.
    71.7 Written plan for reporting of deaths or illness on board 
flights and designation of an airline agent and 71.9 Written plan for 
reporting of deaths or illness on board ships and designation of a 
shipline's agent. These requirements are comparable to requirements in 
Sections 70.3.
    71.10 Passenger information. This requirement applies to any 
airline operating flights or shipline operating ships on an 
international voyage destined for a U.S. port and contains reporting 
requirements comparable to 70.4.
    71.11 Written plan for passenger information and designation of an 
airline or shipline agent. This requirement is comparable to 
requirements found in 70.5.
    71.22 Medical examination and monitoring. This section contains 
reporting requirements comparable to 70.19.
    The reporting and recordkeeping requirements in Sec.  71.51, 71.52, 
and 71.53 do not change in this proposed rule.
    Description of Respondents: Respondents may include airplane 
pilots, ships' captains, travelers, state health departments, 
territorial health departments, and airline industry personnel. The 
nature of the quarantine response would dictate which forms are 
completed by whom.

                               Table VII. B.1.--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                      Annual                         Hours per
           CFR Section               Number of     frequency per   Total number    response (in     Total hours
                                    respondents      response      of responses      minutes)
----------------------------------------------------------------------------------------------------------------
42 CFR 70.2.....................           1,549               1           1,549            2/60              52
42 CFR 70.3 and 42 CFR 71.7                  217               1             217           60/60             217
 (first year)...................
42 CFR 70.3 and 42 CFR 71.7                  217               1             217           10/60              36
 (subsequent years).............
42 CFR 70.4.....................     278,400,000               1     278,400,000            1/60       5,568,000
42 CFR 70.5 and 42 CFR 71.11....             274               1             274          600/60           2,740
42 CFR 70.6.....................           2,000               1           2,000           15/60             500
42 CFR 70.19....................              18               1              18           30/60               9
42 CFR 71.6.....................           1,549               1           1,549            2/60              52
42 CFR 71.8.....................              57              54           3,135            5/60             261
42 CFR 71.9.....................              57               1              57          180/60             171
42 CFR 71.10....................     142,213,640               1     142,213,640            1/60       2,844,273
42 CFR 71.22....................              18               1              18           30/60               9
                                 -----------------
    Total.......................  ..............  ..............  ..............  ..............       8,416,320
----------------------------------------------------------------------------------------------------------------


[[Page 71926]]

    Our estimates are based on experience to date with current 
recordkeeping and reporting requirements of 42 CFR Parts 70 and 71. In 
addition, the estimate for proposed new reporting requirements at 70.4 
Passenger Information is based on statistics from the Bureau of 
Transportation Statistics showing passengers carried by airlines 
affected by the rule for the period July 1, 2003-June 30, 2004. The 
number of passengers on domestic flights for this period was estimated 
to be 556.8 million; this number was reduced by 50% based on quarterly 
calculations from mid 2003 to mid 2004, which consistently showed that 
about 54% of domestic flights contained trip segments of 1.85 on 
average (i.e., an adjustment was made for the fact that about half of 
all domestic travel includes one or more connecting flights). Estimates 
for reporting requirements at 71.10 Passenger information were also 
obtained from the Bureau of Transportation Statistics (for 
international airline passengers) and from available data for U.S. 
cruise lines. An estimated 142,213,640 passengers on airlines and 
shiplines will report information under 71.10.
    A detailed analysis of the costs to the airline and shipline 
industries for the reporting and recordkeeping requirements of this 
propose rule, including the opportunity costs to passengers providing 
this information, can be found under Part VI of this NPRM.

C. Environmental Assessment

    The Director has determined that provisions amending 42 CFR Parts 
70 and 71 will not have a significant impact on the human environment.

D. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (published at 65 FR 67249 on November 
9, 2000), requires agencies to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' The phrase 
``policies that have tribal implications'' is defined in the Executive 
Order to include regulations and other policy statements or actions 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes.''
    This proposed rule will have a substantial direct effect as defined 
by the Executive Order requiring consultation with Tribal 
representatives and an analysis of Tribal impacts.
    Current federal law (42 U.S.C. 243, 264) gives the Secretary of 
Health and Human Services (HHS) the authority to implement disease 
control measures in situations that could impact interstate commerce, 
including quarantine of persons suspected of carrying certain 
communicable diseases who are (1) traveling from one state to another 
or (2) likely to infect others traveling from one state to another. The 
Secretary has delegated this statutory authority to the Director. Under 
current law (25 U.S.C. 198, 231, 2001), the Secretary, acting through 
the IHS Director, also has the authority to implement disease control 
measures, such as quarantine, in Indian country, if necessary. There 
are currently no federal regulations that implement the IHS Director's 
statutory authority to quarantine persons with communicable diseases.
    The federal regulations that implement CDC's statutory authorities 
for communicable disease control are in the Code of Federal 
Regulations, 42 CFR Parts 70 and 71. These regulations implement CDC's 
existing statutory authority to detain and/or quarantine persons 
suspected of carrying certain communicable diseases that pose a threat 
to the public's health. CDC's authority to quarantine persons extends 
only to the communicable diseases listed in an Executive Order of the 
President, including cholera, diphtheria, tuberculosis, plague, 
smallpox, yellow fever, viral hemorrhagic fevers, SARS, and influenza 
caused by novel or reemergent influenza viruses that are causing, or 
have the potential to cause, a pandemic.
    Under proposed section 70.24, Tribal health authorities will be 
able to ask the Director for assistance to prevent the spread of 
communicable diseases from State to State. Under proposed section 
70.25, the Director may determine that the measures taken by a Tribe 
are inadequate to prevent the spread of communicable diseases. Under 
the proposed section 70.27, the Director, with the concurrence of the 
of the IHS Director and after consulting with the affected Tribe, may 
impose provisional quarantine under 70.14-70.15, quarantine under 
70.16-70.18, 70.20 and medical examination and monitoring under 70.19 
in Indian country. The Director may act under this section without 
making a finding that the person or group of persons is moving or about 
to move from a State to another State or is a probable source of 
infection to persons who will be moving from a State to another State.
    Furthermore, under Section 70.27, subsection (d), the Director, 
with the concurrence of the Director of the Indian Health Service and 
after consulting with the affected Tribe or Tribes may authorize agents 
and employees of any State government to enter Indian country for the 
sole purpose of enforcing federal quarantine rules and regulations. 
This authority is subject to any rules or regulations the Director of 
the Indian Health Service may choose to promulgate under 25 U.S.C. 231. 
This section is intended to implement provisions appearing in 25 U.S.C. 
198 and 231, 25 U.S.C. 1661, and 42 U.S.C. 2001.
    Pursuant to 25 U.S.C. 198, the Secretary of the Interior may 
quarantine Native Americans on Tribal lands for ``tuberculosis, 
trachoma, or other contagious or infectious disease.'' Under 25 U.S.C. 
231, the Secretary of the Interior may also permit State agents and 
employees to enter upon Tribal lands for purposes of making inspection 
of health and educational conditions and enforcing sanitation and 
quarantine regulations. All Indian health programs and functions were 
transferred from the Secretary of the Interior to the Secretary of HHS 
by 42 U.S.C. 2001, and delegated to the Director of IHS by 25 U.S.C. 
1661. The authority found in 25 U.S.C. 198 and 231 supplements the 
Director's authority under section 361 of the PHS Act (42 U.S.C. 264). 
Any action the Director takes under these sections must be in 
concurrence with the Director of the Indian Health Service after 
consultation with the affected Tribe or Tribes. CDC's Division of 
Global Migration and Quarantine has technical expertise in quarantine. 
Such cooperation between the Indian Health Service and the CDC would 
potentially streamline operations and clarify procedures regarding 
quarantine on Tribal lands.
    Furthermore Indian Tribes, like States, are sovereign entities with 
police power authority to enact their own quarantine rules and 
regulations. Thus, Tribal governments are able to enforce any Tribal 
quarantine law to the extent that such laws exist. The proposed rule 
would not preempt the enactment of Tribal quarantine rules and 
regulations, to the extent that such Tribal laws do not conflict with 
the exercise of federal quarantine law under the proposed rule.
    Tribal participation in and support of planned revisions of 
regulations governing the control of communicable diseases is critical. 
HHS Tribal Consultation Policy calls for a tribal impact statement and 
appropriate

[[Page 71927]]

consultation with tribal representatives prior to promulgation of a 
regulation. This consultation process began during the FY 2005 HHS 
Regional Tribal Consultation Sessions and the HHS National Tribal 
Budget Consultations, prior to the publication of this NPRM. In order 
to ensure that all Tribes are provided every opportunity to participate 
in and comment on planned revisions of current quarantine regulations, 
CDC is also soliciting written comments in the form of a Dear Tribal 
Leader letter being sent to all Tribal leaders. The preamble for the 
final regulation resulting from this rulemaking process will contain 
the tribal summary impact statement required by the Executive Order.

E. Executive Order 12630: Governmental Actions and Interference With 
Constitutionally Protected Property Rights

    Under Executive Order 12630, if the contemplated rule would require 
a Federal taking of private property, then a takings analysis is 
required. The agency must address the merits of the rule and the 
implications for constitutionally protected property rights.
    The Fifth Amendment to the United States Constitution prohibits the 
taking of private property for public use without just compensation. 
Though courts may find that a per se taking has occurred due to 
government action requiring a property owner to sacrifice ``all 
economically beneficial use'' of the property see Lucas v. South 
Carolina Coastal Council, 505 U.S. 1003 (1992), the takings analysis 
generally used by courts is set forth in Penn Central Transportation 
Co. v. New York City, 438 U.S. 104 (1978). The Penn Central analysis 
focuses on the character of the government action and the economic 
impact on the property owner, particularly regarding the extent to 
which the regulatory action at issue interferes with the owner's 
distinct investment-backed expectations. Also, though the Lucas per se 
approach is not generally used by courts in analyzing takings cases, it 
is important to note that the decision in that case also stands for the 
proposition that a taking will be held not to have occurred if the 
affected property constitutes a nuisance.
    Goldblatt v. Hempstead, 369 U.S. 590 (1962) was cited by the Penn 
Central court as illustrative of the burdens that may be imposed upon a 
property owner in the face of regulatory action designed to serve a 
substantial public purpose. That case involved a city safety ordinance 
enacted to prohibit excavation below the water table. That prohibition 
effectively barred the property owner from further operation of a sand 
and gravel business that had been in existence for over 30 years. 
Because the restriction served a substantial public purpose, the court 
held that no taking had occurred. See also, North American Cold Storage 
Co. v. City of Chicago, 211 U.S. 306 (1908) holding that a statute 
authorizing seizure and destruction of food unfit for human consumption 
was constitutional despite the lack of notice and opportunity to be 
heard).
    Section 361(a) of the PHS Act (42 U.S.C. 264(a)) provides that in 
carrying out regulations the Secretary ``may provide for such 
inspection, fumigation, disinfection, sanitation, pest extermination, 
destruction of animals or articles found to be so infected or 
contaminated as to be sources of dangerous infection to human beings, 
and other measures, as in his judgment may be necessary.'' This 
authority was carried out in the preexisting rule in Sec.  71.32(b), 
which authorized the Director to require the application of a variety 
of measures (detention, disinfection, disinfestations, fumigation, and 
other related measures) whenever the Director had reason to believe 
that an arriving carrier or any article or thing on board the carrier 
may be infected or contaminated with a communicable disease. 
Furthermore, under preexisting Sec.  71.31(b), the Director could 
require the detention of the carrier until the completion of such 
measures. This authority is carried forward in the proposed rule in 
Sec.  71.13 (Sanitary measures) and 71.14 (detention of carriers). The 
proposed rule also makes these requirements applicable to carriers 
affecting interstate commerce or things on board such carriers in Sec.  
70.11 (Sanitary measures). These sections clarify that the expense of 
applying sanitary measures are borne by the affected carrier or, in the 
case of things on board the carrier, expenses are borne by the owners.
    Thus, the character of regulatory actions that would be taken under 
the proposed regulation is most accurately characterized as protection 
of the public health in the form of avoidance of the introduction, 
transmission or spread of infectious disease. Owners of property posing 
a threat of introduction, transmission or spread of infectious disease 
cannot have a reasonable investment-backed expectation that their 
property should move freely while posing such a threat. See B&F 
Trawlers, Inc. v. the United States, 27 Fed. Cl. 299, 306 (Ct. Fed. Cl. 
1992) (holding that U.S. Coast Guard's lawful destruction of a burning 
vessel as a danger to navigation was not a compensable taking). 
Alternatively, the presence of carriers and things on board carriers in 
interstate and foreign traffic reasonably believed by the Director to 
be sources of communicable disease qualify as nuisances because they 
directly threaten human health and safety. Accordingly, the proposed 
regulations do not constitute a taking, and compensation is not 
required under the Fifth Amendment.
    The Director's use of these regulations must, of course, be 
reasonable and based on the judgment that such steps are necessary to 
prevent the introduction, transmission or spread of communicable 
diseases. On the facts of a particular case, a court could ultimately 
find that the Director's belief was unreasonable, the steps taken were 
unnecessary, a nuisance did not exist, and a taking therefore occurred. 
Proper use, however, of the ``reasonable belief'' and ``necessity'' 
provisions contained in the proposed regulation would result in a 
finding of ``no taking'' under the requisite analysis.

F. Executive Order 13132: Federalism

    Under Executive Order 13132, if the contemplated rule would limit 
or preempt State authorities, then a Federalism analysis is required. 
The agency must consult with State and local officials to determine 
whether the rule would have a substantial direct effect on State or 
local governments, as well as whether it would either preempt State law 
or impose a substantial direct cost of compliance on them.
    Section 361(e) of the PHS Act (42 U.S.C. 264(e)) provides that 
``[n]othing in this section or Section 266 of this title [relating to 
special quarantine powers in time of war], or the regulations 
promulgated under such sections, may be construed as superseding any 
provision under State law (including regulations and including 
provisions established by political subdivisions of States), except to 
the extent that such a provision conflicts with an exercise of Federal 
authority under this section or Section 266 of this title.'' The 
proposed rule is consistent with this statutory provision.
    Through numerous forums such as conferences, tabletop exercises, 
response efforts, and meetings, CDC has consulted with state and local 
public health officials and health-care providers about the appropriate 
role of the federal government in exercising public health powers such 
as those described in the proposed rule. CDC seeks to continue this 
consultation through solicitation of comments from

[[Page 71928]]

state and local public health officials on all aspects of the rule.

G. Executive Order 13211: Energy Effects

    HHS is required by Executive Order 13211 to produce a statement of 
energy effects if the proposed rule is significant or economically 
significant and likely to have a significant adverse effect on the 
supply, distribution, or use of energy. HHS has determined that the 
proposed rule does not have that effect and that a statement of energy 
is therefore not required.

H. National Technology Transfer and Advancement Act

    This Act, 15 U.S.C. 272, requires adoption of technical standards 
developed or adopted by voluntary consensus standard bodies in rules 
promulgated by HHS. No voluntary consensus standards are applicable and 
feasible with regard to the proposed rule.

I. Family Policy Analysis

    Title 5 U.S.C. 601 requires agencies to determine whether a 
proposed rule would affect family well-being. Section 70.7 of the 
proposed regulation makes parents or guardians responsible for 
obtaining travel permits prior to procuring transportation for children 
or wards known by the parents or guardians to be in the qualifying 
stage of a communicable disease. While the proposed provision 
undoubtedly places responsibility on parents and guardians, it would be 
unreasonable to conclude that this responsibility adversely affects 
family well-being, particularly in view of the beneficial effects on 
families and the population as a whole associated with preventing the 
spread of infectious disease.

J. Executive Order 12988: Civil Justice Reform

    HHS has completed the required reviews and has determined that the 
proposed rule meets the standards in Executive Order 12988. The 
preemptive effect of the rule is explained in section VII.F., 
Federalism, above. The rule has no retroactive effect. With respect to 
administrative hearings, the rule allows persons or groups of persons 
made subject to a quarantine order to request a hearing to dispute the 
genuine and substantial issues of fact. The rule clearly states that 
the quarantine order is not final until the Director approves or 
rejects the hearing officer's recommendation, or 3 business days after 
the request for hearing is made.

K. Plain Language

    Executive Order 12866 requires each agency to write all rules in 
plain language. We try to write clearly. If you can suggest how to 
improve the clarity of these regulations, call or write Jennifer Brooks 
at the address listed above.

VIII. Solicitation of Comments

    CDC solicits comments on various issues specifically identified in 
the preamble as well as any other issues that are relevant to the 
proposed regulation. Specifically, CDC solicits information, data, and 
comment on the following topics:
     Whether the time frames to develop and submit the plans 
described in following sections are sufficient. and, if it is not, what 
are the difficulties in meeting each of these schedules:

--Sec.  70.3 Reporting of death or illness, plan and implementation.
--Sec.  70.5 Passenger and crew information, plan and implementation.
--Sec.  71.7 Reporting of death or illness on board flights, plan and 
implementation.
--Sec.  71.9 Reporting of death or illness on board ship, plan and 
implementation.
--Sec.  71.11 Passenger and crew information, plan and implementation.

     In addition to soliciting comment on relative merits of 
the fully analyzed alternative options presented in Section VI, CDC 
also solicits comment on regulatory options that may fall outside the 
scope of the options analyzed in the regulatory impact analysis, 
including but not limited to the scope of the passenger information 
collected and the extent of the coverage of interstate travel.
     The most efficient means of collecting accurate passenger 
contact information, particularly from airlines and passengers:
    [cir] Sec.  70.4 Passenger information
    [cir] Sec.  71.10 Passenger information
     The economic analysis in this proposal, including the 
estimated costs.
     The paperwork reduction analysis, including the accuracy 
of the burden estimates and the practical utility of the data.
     The estimated costs based on the assumption that data 
collection efforts could be coordinated with contemporary rulemaking 
efforts by other Federal agencies.
     Whether the rule, particularly those sections pertaining 
to quarantine, hearings, and appeals (Sec. Sec.  70.14-70.20; 70.31; 
71.17-71.23; 71.33), provide adequate due process to individuals and 
entities that may be affected by them.

List of Subjects

42 CFR Part 70

    Communicable diseases, Public health, Quarantine, Reporting and 
recordkeeping requirements, Travel restrictions.

42 CFR Part 71

    Airports, Animals, Communicable diseases, Harbors, Imports, 
Pesticides and pests, Public health, Quarantine, Reporting and 
recordkeeping requirements.

    For the reasons stated in the preamble, we propose to amend 42 CFR 
Parts 70 and 71 to read as follows:

CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
SERVICES

    1. Part 70 is revised to read as follows:

PART 70--INTERSTATE QUARANTINE

Sec.
70.1 Scope and definitions.
70.2 Report of death or illness on board flights.
70.3 Written plan for reporting of deaths or illness on board 
flights and designation of an airline agent.
70.4 Passenger information.
70.5 Written plan for passenger information and designation of an 
airline agent.
70.6 Travel permits.
70.7 Responsibility with respect to minors, wards, and patients.
70.8 Military services.
70.9 Vaccination clinics.
70.10 Establishment of institutions, hospitals and stations.
70.11 Sanitary measures.
70.12 Detention of carriers affecting interstate commerce.
70.13 Screenings to detect ill persons.
70.14 Provisional quarantine.
70.15 Provisional quarantine orders.
70.16 Quarantine.
70.17 Content of quarantine order.
70.18 Service of quarantine order.
70.19 Medical examination and monitoring.
70.20 Hearings.
70.21 Care and treatment of persons.
70.22 Foreign nationals.
70.23 Administrative record.
70.24 Requests by State (including political subdivisions thereof), 
possession, or tribal health authorities.
70.25 Measures in the event of inadequate local control.
70.26 Federal facilities.
70.27 Indian country.
70.28 Special powers in time of war.
70.29 Penalties.
70.30 Implementation through order.
70.31 Appeals of actions required pursuant to Sec. Sec.  70.6, 70.7, 
70.11 or 70.12
Appendix A to Part 70--Calendar Year 2004 Enplanement Data as 
Published by the Federal Aviation Agency (FAA) for Large and Medium 
U.S. Airports


[[Page 71929]]


    Authority: 25 U.S.C. 198, 231, and 1661; 42 U.S.C. 243, 248, 
249, 264-272, and 2001.


Sec.  70.1  Scope and definitions.

    (a) The purpose of this part is to prevent the introduction, 
transmission, and spread of communicable diseases from one State into 
any other State. Regulations to prevent the spread of disease from 
foreign countries into the States are contained in 42 CFR Part 71. 
Except where otherwise indicated, regulations to prevent the spread of 
disease among possessions of the United States or from a possession 
into a State are contained in 42 CFR Part 71.
    (b) As used in this part, the terms listed below in alphabetical 
order shall have the following meanings:
    Aircraft commander means any person serving on an aircraft with 
responsibility for its operation and navigation.
    Airline means any air carrier, foreign or domestic, operating 
commercial passenger flights under regular schedules within the United 
States.
    Airline agent means any person who is authorized to act for or in 
place of the owner or operator of an airline for the purposes of 
carrying out the airline's responsibilities described in this part.
    Business day means any full business day during which the Centers 
for Disease Control and Prevention is open for regular business 
(excluding Saturdays, Sundays, and legal holidays) from 9 a.m. in the 
morning to 5 p.m. in the evening, Eastern Standard Time.
    Carrier means, except where otherwise specified, a ship, shipline, 
vessel, airline, aircraft, train, road vehicle, or other means of 
transport, including military carriers.
    Communicable disease means an illness due to an infectious agent or 
its toxic products which arises through transmission of that agent or 
its products from an infected person or animal or a reservoir to a 
susceptible host, either directly or indirectly through an intermediate 
animal host, vector, or the inanimate environment.
    Detention, when applied to carriers, animals, articles, or things 
means the temporary holding on a voluntary or involuntary basis of such 
carriers, animals, articles, or things, until the completion of such 
sanitary measures as may be required under this part.
    Director means the Director, Centers for Disease Control and 
Prevention, Department of Health and Human Services, or another 
authorized representative as approved by the CDC Director or the 
Secretary.
    Disinfection means the killing of infectious agents or inactivation 
of their toxic products outside the body of a person or on the surface 
of a thing by direct exposure to chemical or physical agents.
    Disinfestation means any chemical or physical process serving to 
destroy or remove undesired small animal forms, particularly arthropods 
or rodents.
    Disinsection means the operation in which measures are taken to 
kill the insect vectors of human disease.
    Emergency contact information means the following information 
pertaining to a person (other than the passenger or crewmember) or an 
entity (such as a business) that has the ability to contact the 
passenger or crewmember on an emergency basis:
    (i) The full name (first, last, middle initial, suffix) of the 
person or business name of the entity;
    (ii) The permanent address; and
    (iii) A phone number (either home, work, or mobile).
    Flight information means for each airline operating a flight in 
interstate traffic (including any intermediate stops between the 
flight's origin and final destination) the airline name, flight number, 
city of arrival, date of arrival, date of departure, seat number for 
any passenger or crewmember, arrival gate, and arrival terminal.
    Hearing officer means a person designated by the Director or the 
Secretary to conduct administrative hearings under this part or another 
authorized representative as approved by the Director or the Secretary.
    Ill person means a person who:
    (i) Has a temperature of 100.4[deg] F (or 38[deg] C) or greater 
accompanied by one or more of the following: Rash, swelling of the 
lymph nodes or glands, headache with neck stiffness, or changes in 
level of consciousness or cognitive function; or
    (ii) Has a temperature of 100.4[deg] F (or 38[deg] C) or greater 
that has persisted for more than 48 hours; or
    (iii) Has diarrhea, defined as the occurrence in a 24-hour period 
of three or more loose stools or of stools in an amount greater than 
normal (for the person); or
    (iv) Has one or more of the following: Severe bleeding, jaundice, 
or severe, persistent cough accompanied by bloody sputum, respiratory 
distress, or a temperature of 100.4[deg] F (or 38[deg] C) or greater; 
or
    (v) Displays other symptoms or factors that are suggestive of 
communicable disease, which the Director may describe in an order as 
the Director determines necessary.
    Indian country means:
    (i) All land within the limits of any Indian reservation under the 
jurisdiction of the United States Government, notwithstanding the 
issuance of any patent, and, including rights-of-way running through 
the reservation;
    (ii) All dependent Indian communities within the borders of the 
United States whether within the original or subsequently acquired 
territory thereof, and whether within or without the limits of a state; 
and
    (iii) All Indian allotments, the Indian titles to which have not 
been extinguished, including rights-of-way running through the same.
    Indian tribe means any Indian tribe, band, nation or other 
organized group or community, including any Alaska Native village or 
regional or village corporation as defined in or established pursuant 
to the Alaska Native Claims Settlement Act which is recognized as 
eligible for the special programs and services provided by the United 
States to Indians because of their status as Indians.
    Infectious agent means an organism (e.g., bacteria, fungus, 
helminth, prion, protozoan, rickettsia, virus, or bioengineered variant 
thereof) that is capable of producing infection or infectious disease.
    Interstate traffic, except as otherwise provided in paragraph (ii) 
of this definition, means:
    (i) The movement of any carrier or the transportation of persons or 
property, including any portion of such movement or transportation that 
is entirely within a State--
    (A) From a point of origin in any State to a point of destination 
in any other State; or
    (B) Between a point of origin and a point of destination in the 
same State but through any contiguous State or foreign country.
    (ii) Interstate traffic does not include the following:
    (A) The movement of any carrier or the transportation of persons or 
property on an international voyage as defined in 42 CFR Part 71; or
    (B) The movement of any carrier which is solely for the purpose of 
its repair, reconstruction, rehabilitation, or storage.
    Medical monitoring means close medical or other supervision of a 
person or group of persons on a voluntary or involuntary basis to 
permit prompt recognition of infection or illness.
    Military service means the U.S. Air Force, U.S. Army, the U.S. 
Coast Guard, the U.S. Marine Corps, the U.S. Navy, and any National 
Defense Reserve Fleet vessels engaged in military operations at the 
direction of the U.S. Department of Defense.

[[Page 71930]]

    Possession means, in addition to Puerto Rico, any other possession 
of the United States.
    Provisional quarantine means the detention on an involuntary basis 
of a person or group of persons reasonably believed to be in the 
qualifying stage of a quarantinable disease until a quarantine order 
has been issued or until the Director determines that provisional 
quarantine is no longer warranted.
    Public health emergency, as used in this part, means:
    (i) Any disease event as determined by the Director with either 
documented or significant potential for regional, national, or 
international disease spread or with actual or potential interference 
with the free movement of people or goods between States and 
possessions within the United States or other countries or 
sovereignties; or
    (ii) Any disease event designated as a public health emergency by 
the Secretary pursuant to section 319(a) of the Public Health Service 
Act (42 U.S.C. 247d(a)).
    Qualifying stage means:
    (i) A communicable stage of the disease; or
    (ii) A precommunicable stage, if the disease would be likely to 
cause a public health emergency if transmitted to other persons.
    Quarantine means the holding on a voluntary or involuntary basis, 
including the isolation, of a person or group of persons in such place 
and for such period of time as the Director deems necessary or 
desirable to prevent the spread of infection or illness.
    Quarantinable disease means any of the communicable diseases listed 
in an Executive Order, as provided under section 361 of the Public 
Health Service Act. Executive Order 13295, of April 4, 2003, as amended 
by Executive Order 13375 of April 1, 2005, contains the current revised 
list of quarantinable diseases, and may be obtained at http://www.cdc.gov and http://www.archives.gov/federal_register. If this 
Order is amended, HHS will enforce that amended order immediately and 
update that Web site.
    Sanitary measures means:
    (i) When applied to carriers, animals, articles, or things: 
Detention; destruction of animals, articles, or things that the 
Director deems to be sources of dangerous infection to human beings; 
disinfection; disinfestations; disinsection; fumigation; pest 
extermination; seizure; or any other measure or combination of 
measures, whether voluntary or involuntary, that the Director deems 
necessary or desirable to prevent the introduction, transmission, or 
spread of communicable diseases; or
    (ii) When applied to a person or group of persons, the killing of 
infectious agents (or vectors capable of conveying infectious agents) 
outside the body by direct exposure to any chemical, physical, or other 
process designed to destroy such infectious agents.
    Secretary means the Secretary of the Department of Health and Human 
Services.
    State means in addition to the several States, only the District of 
Columbia.
    United States means the States and possessions of the United 
States.
    Vector means an animal (including insects) or thing which conveys 
or is capable of conveying infectious agents from a person or animal to 
another person or animal.


Sec.  70.2  Report of death or illness on board flights.

    (a) Any airline operating flights in interstate traffic shall, 
pursuant to the written plan required under Sec.  70.3, report any 
deaths or ill persons that occur on board to the Director as soon as 
such occurrences are made known to the aircraft commander and, where 
possible, at least one hour before arrival.
    (b) The Director, whenever necessary for purposes of preventing the 
introduction, transmission or spread of communicable diseases, may 
order airlines operating a flight in interstate traffic to disseminate 
to passengers and crew public health notices, recommended public health 
measures, and other public health information. Such information shall 
be disseminated at the time and in a manner specified in the Director's 
order.


Sec.  70.3  Written plan for reporting of deaths or illness on board 
flights and designation of an airline agent.

    (a) Within 90 days of the final publication of this rule, any 
airline operating flights in interstate traffic shall develop a written 
plan sufficient to ensure reporting of deaths or illness on board 
flights as required by Sec.  70.2.
    (b) The written plan shall include the full name (i.e., first, 
last, middle initial, suffix), official title, business telephone 
number, and e-mail address (if available), of an airline agent who 
shall serve as a point of contact between the Director and the airline 
concerning reports of deaths or ill persons.
    (c) The written plan shall include policies and procedures 
necessary to facilitate communication between the Director and the 
airline agent on a 24-hour basis, 7 days a week.
    (d) Within 90 days of the final publication of this rule, a copy of 
the written plan shall be submitted to the Director.
    (e) Airlines shall implement the written plan within 180 days of 
the final publication of this rule.
    (f) Airlines shall review the written plan one year after 
implementation and annually thereafter. The review shall include drills 
or exercises to test and evaluate the effectiveness of the written plan 
unless the airline has reported ill passengers or deaths on board a 
flight under Sec.  70.2 in the prior 365 days. Airlines shall revise 
the plan as necessary after any review. Any revisions of the written 
plan shall be submitted to the Director within 60 days.
    (g) Airlines that intend to commence operation of flights in 
interstate traffic after the effective date in paragraph (a) of this 
section shall submit a written plan meeting the requirements of this 
section to the Director before commencing operations. The airline shall 
implement the written plan by the later of the two following dates: 
Either 180 days after the final publication of this rule, or upon 
commencement of operations.


Sec.  70.4  Passenger information.

    (a) Any airline operating flights in interstate traffic shall, 
pursuant to the written plan required under Sec.  70.5, solicit from 
each passenger (or head of household if the passenger is a minor) and 
crewmember traveling on those flights in interstate traffic arriving in 
or departing from any of the airports listed in Appendix A the 
information contained in the data fields specified in paragraph (e) of 
this section.
    (b) Any information obtained by the airline pursuant to paragraph 
(a) in this section shall be maintained by the airline in an electronic 
database for 60 days from the end of the flight.
    (c) For each passenger (or head of household if the passenger is a 
minor) and crewmember traveling on an interstate flight, the airline 
may solicit the information in paragraph (e) of this section from such 
person's authorized agent.
    (d) Within 12 hours of a request by the Director to the airline's 
agent, the airline, pursuant to the written plan under Sec.  70.5, 
shall transmit to the Director in an electronic format the data fields 
specified in paragraph (e) of this section.
    (e) The data fields as applicable to the individual passenger (or 
head of household if the passenger is a minor) or crewmember, shall 
include the following:
    (1) Full name (first, last, middle initial, suffix);

[[Page 71931]]

    (2) Emergency contact information;
    (3) E-mail address;
    (4) Current home address (street, apartment , city, state/
province, postal code);
    (5) Passport number or travel document number, including the 
issuing country or organization (in the case of foreign nationals 
only);
    (6) Names of traveling companions or group;
    (7) Flight information;
    (8) Returning flight (date, airline number, and flight number);
    (9) At least one of the following current phone numbers (in order 
of preference): mobile, home, pager, or work.
    (f) In addition to data fields specified in paragraph (e) of this 
section, when necessary to prevent the introduction, transmission, or 
spread of communicable diseases, the Director through order may also 
require that airlines transmit additional information in the airline's 
possession.
    (g) Information collected solely in order to comply with this 
regulation may only be used for the purposes for which it is collected.
    (h) Airlines shall ensure that passengers are informed of the 
purposes of this information collection at the time passengers arrange 
their travel.


Sec.  70.5  Written plan for passenger information and designation of 
an airline agent.

    (a) Within six months of the final publication of this rule, any 
airline operating flights in interstate traffic shall develop a written 
plan sufficient to ensure transmission of passenger and crew 
information for those flights in interstate traffic arriving in or 
departing from any of the airports listed in appendix A to part 70 as 
required by Sec.  70.4.
    (b) The written plan shall include:
    (1) Policies and procedures for the transmission of data in an 
electronic format available to both the airline and the Director using 
industry standards for data encoding, transmission, and security;
    (2) Policies and procedures for the transmission of the data within 
12 hours of a request by the Director to the airline's agent;
    (3) The full name (i.e., first, last, middle initial, suffix), 
official title, business telephone number, and e-mail address (if 
available), of an airline agent who shall serve as a point of contact 
between the Director and the airline concerning requests for and 
transmission of passenger and crew information data;
    (4) Policies and procedures necessary to facilitate communication 
between the Director and the airline's agent on a 24-hour basis, 7 days 
a week;
    (5) Policies and procedures for soliciting the information 
contained in the data fields required by Sec.  70.4(e) from the 
passenger (or head of household if the passenger is a minor), 
crewmember, or such persons' authorized agent; and
    (6) Policies and procedures for maintaining responsive information 
obtained by the airline in an electronic database for 60 days from the 
end of the flight as required by Sec.  70.4(b).
    (c) Within six months of the final publication of this rule, a copy 
of the written plan shall be submitted to the Director.
    (d) Airlines shall implement the written plan within 2 years of the 
final publication date of this rule. Within 60 days of implementation, 
airlines shall conduct drills or exercises to test and evaluate the 
effectiveness of the written plan and revise the plan as necessary 
after any drill or exercise. Any revisions of the written plan shall be 
submitted to the Director within 60 days.
    (e) Airlines shall review the written plan one year after 
implementation and annually thereafter. The review shall include drills 
or exercises to test and evaluate the effectiveness of the written plan 
unless the airline has transmitted passenger and crewmember information 
under Sec.  70.4 in the prior 365 days. Airlines shall revise the plan 
as necessary after any review. Any revisions of the written plan shall 
be submitted to the Director within 60 days.
    (f) Airlines that intend to commence operation of flights in 
interstate traffic arriving in or departing from any of the airports 
listed in appendix A to part 70 after the effective date in paragraph 
(a) of this section shall submit a written plan meeting the 
requirements of this section to the Director before commencing 
operations. The airline shall implement the written plan by the later 
of the two following dates: either 2 years after the final publication 
of this rule, or upon commencement of operations.
    (g) Pending the development or implementation of the written plan 
as required by this section, the Director, through order, may require 
that airlines transmit to the Director, in a format available to both 
the airline and the Director, any of the information required by Sec.  
70.4 that may be in the airline's possession.


Sec.  70.6  Travel permits.

    (a) The operator of any carrier operating in interstate traffic or 
moving from one state or possession into another shall not:
    (1) Accept for transportation any person whom the operator knows to 
be in the qualifying stage of a quarantinable disease, unless such 
person presents a permit issued by the Director authorizing such 
travel; or
    (2) Transport any person whom the operator knows to be in the 
qualifying stage of a quarantinable disease in violation of any of the 
terms or conditions prescribed in the travel permit issued by the 
Director.
    (b) Whenever a carrier operating in interstate traffic or moving 
from one state or possession into another transports a person who is in 
the qualifying stage of a quarantinable disease bearing a travel permit 
issued by the Director, the operator of the carrier shall take such 
measures to prevent the spread of the disease, including submission of 
the carrier to inspection, sanitary measures and the like, as the 
Director deems necessary.
    (c) Requirements relating to travelers who know that they are in 
the qualifying stage of a quarantinable disease:
    (1) No such person shall travel in interstate traffic or from one 
state or possession to another without a written permit of the 
Director.
    (2) Application for a permit authorizing travel may be made 
directly to the Director.
    (3) Upon receipt of an application, the Director, taking into 
consideration the risk of introduction, transmission, or spread of the 
disease in interstate traffic or from one state or possession into 
another, shall reject it or issue a permit that may be conditioned upon 
compliance with such precautionary measures as the Director shall 
prescribe.
    (4) A person to whom a permit has been issued shall retain it in 
his/her possession throughout the course of his/her authorized travel 
and comply with all conditions prescribed therein, including 
presentation of the permit to the operators of carriers, as required by 
its terms.
    (5) A person who has had his/her request for a permit denied may 
submit a written appeal in accordance with Sec.  70.31.
    (d) The Director may additionally apply the provisions in 
paragraphs (a) through (c) of this section to persons and carriers 
traveling entirely within a state or possession whenever the Director 
determines that such person's travel or the carrier's operations will 
have an effect on interstate commerce upon the request of a health 
authority in accordance with Sec.  70.24 or whenever the Director, with 
the concurrence of the Secretary, makes a determination of

[[Page 71932]]

inadequate local control in accordance with Sec.  70.25.


Sec.  70.7  Responsibility with respect to minors, wards, and patients.

    (a) A parent, guardian, physician, nurse, or other such person 
shall not transport, nor procure or furnish transportation for any 
minor child or ward, patient or other such person whom they know to be 
in the qualifying stage of a quarantinable disease, without a travel 
permit issued by the Director if such a permit is required under this 
part.
    (b) A parent, guardian, physician, nurse, or other such person who 
has had his/her request for a permit denied may submit a written appeal 
in accordance with Sec.  70.31.


Sec.  70.8  Military services.

    (a) The Director may exempt carriers belonging to the military 
services from Sec.  70.6(a) and Sec. Sec.  70.11 and 70.12, provided 
that such carriers take adequate sanitary measures to prevent the 
introduction, transmission, and spread of communicable diseases.
    (b) The requirements of Sec. Sec.  70.6(c) and 70.7 shall not apply 
to members of the military service or Public Health Service, or to the 
medical care or hospital beneficiaries of the military service, 
Department of Veterans Affairs, or Public Health Service, provided 
that:
    (1) Such persons are traveling on military carriers under competent 
orders; and
    (2) The person authorizing the travel on a military carrier has 
taken public health measures consistent with those prescribed by the 
Director to prevent the introduction, transmission, or spread of 
quarantinable diseases during the travel period.


Sec.  70.9  Vaccination clinics.

    (a) The Director may establish vaccination clinics, through 
contract or otherwise, authorized to issue certificates of vaccination 
and administer vaccines and/or other prophylaxis. When authorized by 
the Director, certificates of vaccination may be issued and 
authenticated by electronic means.
    (b) A vaccination clinic established by the Director shall collect 
and maintain, for such time as determined by the Director, the 
following information from vaccine recipients:
    (1) Gender;
    (2) Age;
    (3) Vaccination date;
    (4) Vaccine lot number;
    (5) Prior vaccinations;
    (6) Reason for vaccination (e.g., post-exposure, pre-exposure, 
member of high risk group, general vaccination);
    (7) Concurrent vaccinations;
    (8) Vaccine Adverse Events Reporting System Report/Adverse Event 
Report Number; and
    (9) Verification that the vaccine conferred immunity (if 
applicable).
    (c) In addition to the requirements in paragraph (b) of this 
section, a vaccination clinic established by the Director shall comply 
with such additional recordkeeping requirements and other instructions 
that the Director may issue for the safe administration, handling, 
monitoring, and storage of vaccines.
    (d) In the event of a public health emergency, the Director may 
waive or modify any of the requirements in paragraph (b) of this 
section.
    (e) A vaccination fee may be charged for individuals not enrolled 
in Medicare Part B to cover costs associated with administration of the 
vaccine and/or other prophylaxis. Such fee is to be collected at the 
time that the vaccine is administered. The vaccination fee, if imposed, 
is shown in the following table:

------------------------------------------------------------------------
                                                Effective
                   Vaccine                        dates        Amount
------------------------------------------------------------------------
Fluarix.....................................   \1\ 1/25/05   \2\ $25.00
------------------------------------------------------------------------
\1\ Continuing for one year.
\2\ $7.00 for the vaccine and $18.00 for administration.

Sec.  70.10  Establishment of institutions, hospitals and stations.

    (a) The Director, with the approval of the Secretary, may, from 
time to time, select sites suitable for, and establish such 
institutions, hospitals, and stations in the States and possessions of 
the United States as the Director, with the approval of the Secretary, 
deems necessary or desirable for carrying out the functions in this 
part.
    (b) The Director may enter into voluntary agreements with public or 
private institutions as the Director deems necessary or desirable for 
carrying out the functions in this part.


Sec.  70.11  Sanitary measures.

    (a) Whenever the Director reasonably believes that any carrier 
affecting interstate commerce, or animal, article, or thing on board 
such carrier is or may be infected or contaminated with a communicable 
disease, the Director, may, in consultation with other federal agencies 
as appropriate:
    (1) Inspect the carrier, animal, article, or thing on board the 
carrier, and/or
    (2) Order the carrier, or other entity specified in the order, to 
apply such sanitary measures as the Director deems necessary to prevent 
the introduction, transmission, or spread of communicable diseases.
    (b) CDC shall not bear the expense of any sanitary measures 
required or ordered by the Director. The carrier or other entity 
specified in the order issued pursuant to 70.11(a) shall bear the 
responsibility for the application of such measures.
    (c) Sections 70.11(a) and 70.11(b) shall not preclude any entity 
ordered to conduct sanitary measures pursuant to Sec.  70.11(a) from 
arranging to have such measures conducted by other entities through 
contractual or other arrangements, or from seeking reimbursement for 
any costs associated with sanitary measures through contractual or 
other arrangements.
    (d) The Director may apply such sanitary measures to persons who 
are not in the qualifying stage of a quarantinable disease, with their 
consent, as may be required to destroy the presence of infectious 
agents or vectors.


Sec.  70.12  Detention of carriers affecting interstate commerce.

    (a) The Director whenever necessary to prevent the introduction, 
transmission, or spread of communicable diseases and in consultation 
with such other federal agencies as the Director deems necessary may 
require the detention of any carrier affecting interstate commerce and 
all animals, articles, or things onboard the carrier until the 
completion of the measures outlined in this part.
    (b) CDC shall not bear any expenses relating to the detention of 
the carrier; or any associated expenses related to animals, articles, 
or things on board the carrier.
    (c) Section 70.12(b) shall not preclude any entity from seeking 
reimbursement for any costs associated with detention of a carrier 
pursuant to section 70.12(a) through contractual arrangements or other 
available means from entities other than the CDC.


Sec.  70.13  Screenings to detect ill persons.

    The Director may, at airports or other locations, conduct 
screenings of persons or groups of persons to detect the presence of 
ill persons. Such screenings may be conducted through visual 
inspection, electronic temperature monitors, or other means determined 
appropriate by the Director to detect the presence of ill persons.


Sec.  70.14  Provisional quarantine.

    (a) The Director may provisionally quarantine a person or group of 
persons who the Director reasonably believes to

[[Page 71933]]

be in the qualifying stage of a quarantinable disease and:
    (1) Moving or about to move from one State to another State; or
    (2) A probable source of infection to persons who will be moving 
from a State to another State.
    (b) Provisional quarantine shall commence upon:
    (1) The service of a written provisional quarantine order;
    (2) A verbal provisional quarantine order; or
    (3) Actual movement restrictions placed on the person or group of 
persons.
    (c) Provisional quarantine shall end three business days after 
provisional quarantine commences, except that the person or group of 
persons shall be released earlier if the Director determines that 
provisional quarantine is no longer warranted.
    (d) In the event that the Director determines that it is necessary 
to provisionally quarantine a person or group of persons beyond three 
business days, then the Director shall serve the person or group of 
persons with a written quarantine order in accordance with this part.
    (e) A person or group of persons subject to provisional quarantine 
may be offered medical treatment, prophylaxis, or vaccination, as the 
Director deems necessary to prevent the introduction, transmission or 
spread of the disease; such persons may refuse such medical treatment, 
prophylaxis, or vaccination, but remain subject to provisional 
quarantine.
    (f) Nothing in this section shall be construed to limit the 
Director's ability to detain a person or group of persons on a 
voluntary basis or to offer such persons medical treatment, 
prophylaxis, or vaccination on a voluntary basis.


Sec.  70.15  Provisional quarantine orders.

    (a) Provisional quarantine orders shall be served by the Director:
    (1) At the time that provisional quarantine commences; or
    (2) As soon thereafter as the Director determines that the 
circumstances reasonably permit.
    (b) Provisional quarantine orders shall be served either through 
personal service or, in circumstances where the Director deems it 
necessary by posting or publishing the order in a conspicuous location.
    (c) In circumstances where the Director deems public posting or 
publishing necessary, the Director may omit the names and/or identities 
of persons and take other measures respecting the privacy of persons.
    (d) The provisional quarantine order shall be in writing, signed by 
the Director, and include the following information:
    (1) A statement regarding the basis for the Director's reasonable 
belief that the person or group of persons is in the qualifying stage 
of a quarantinable disease based on information available to the 
Director at the time, such as travel history, clinical manifestations, 
or any other evidence of infection or exposure;
    (2) A statement setting forth the Director's reasonable belief that 
either:
    (i) The person or group of persons is moving or about to move from 
a State to another State; or
    (ii) A probable source of infection to persons who will be moving 
from a State to another State;
    (3) The suspected quarantinable disease;
    (4) A statement advising the person or group or persons that they 
may be under provisional quarantine for three business days and that at 
the end of such period they shall be released or, if determined by the 
Director, served with a quarantine order;
    (5) A statement advising the person or group of persons that they 
may be released earlier if the Director determines that provisional 
quarantine is no longer warranted;
    (6) The location of provisional quarantine;
    (e) When authorized by the Director, provisional quarantine orders 
may be issued and signed by electronic means.


Sec.  70.16  Quarantine.

    (a) The Director may issue a quarantine order whenever the Director 
reasonably believes that:
    (1) A person or group of persons are in the qualifying stage of a 
quarantinable disease based on, but not limited to, any of the 
following: clinical manifestations, diagnostic tests or other medical 
tests, epidemiologic information, laboratory tests, physical 
examination, or other evidence of exposure or infection available to 
the Director at the time; and either
    (2) Moving or about to move from a State to another State; or
    (3) A probable source of infection to persons who will be moving 
from a State to another State.
    (b) In accordance with the Director's quarantine order, the 
Director may offer medical treatment, prophylaxis, or vaccination, as 
the Director deems necessary to prevent the introduction, transmission, 
or spread of the disease.
    (c) Persons offered medical treatment, prophylaxis, or vaccination 
may refuse, but remain subject to quarantine.
    (d) The Director's quarantine order may include the quarantine of a 
person or group of persons who refuse examination, medical treatment, 
prophylaxis, or vaccination, or for whom the Director determines that 
such examination, medical treatment, prophylaxis, or vaccination is 
medically contra-indicated or not reasonably available.
    (e) The length of quarantine shall not exceed the period of 
incubation and communicability, as determined by the Director, for the 
quarantinable disease.
    (f) Nothing in this section shall be construed to limit the 
Director's ability to quarantine a person or group of persons on a 
voluntary basis.


Sec.  70.17  Content of quarantine order.

    (a) Quarantine orders shall be in writing, signed by the Director, 
and contain the following:
    (1) The identity of the person or group of persons to be 
quarantined, if known;
    (2) The location where such person or group of persons will be 
quarantined;
    (3) The date and time at which quarantine commences and ends;
    (4) The suspected quarantinable disease;
    (5) A statement that the Director reasonably believes that:
    (i) The person or group of persons are in the qualifying stage of a 
quarantinable disease; and that either
    (ii) The person or group of persons will move or are about to move 
from one State to another State; or
    (iii) The person or group of persons are a probable source of 
infection to persons who will be moving from a State to another State;
    (6) A statement regarding the basis for the Director's reasonable 
belief that such person or group of persons are in the qualifying stage 
of a quarantinable disease, e.g., clinical manifestations, physical 
examination, laboratory tests, diagnostic tests or other medical tests, 
epidemiologic information, or other evidence of exposure or infection 
available to the Director at the time;
    (7) A statement that such persons shall comply with conditions of 
quarantine, including, but not limited to, examination, medical 
monitoring, medical treatment, prophylaxis, or vaccination, or other 
conditions of quarantine deemed by the Director to be necessary to 
prevent the introduction, transmission or spread of communicable 
disease;
    (8) A statement that such persons may refuse examination, medical 
monitoring, medical treatment, prophylaxis, or vaccination, but remain 
subject to quarantine; and
    (9) A statement that persons under quarantine, any time while the 
quarantine order is in effect, may request that the Director hold a 
hearing to review the quarantine order.

[[Page 71934]]

    (b) When authorized by the Director, quarantine orders may be 
issued and signed by electronic means.


Sec.  70.18  Service of quarantine order.

    (a) A copy of the quarantine order shall be personally served on 
the person or group of persons at the time that quarantine commences or 
as soon thereafter as the Director determines that the circumstances 
reasonably permit.
    (b) In circumstances where the Director deems it necessary, the 
quarantine order may be posted or published in a conspicuous location, 
except that the Director may omit the names and/or identities of 
persons and take other measures respecting the privacy of persons.


Sec.  70.19  Medical examination and monitoring.

    (a) The Director may order medical examination or monitoring of a 
person or group of persons that the Director reasonably believes to be 
in the qualifying stage of a quarantinable disease and:
    (1) Moving or about to move from one State to another State; or
    (2) A probable source of infection to persons who will be moving 
from a State to another State.
    (b) Persons subject to medical examination or monitoring shall 
provide the Director with such information as the Director may order, 
including, but not limited to, familial and social contacts, travel 
itinerary, medical history, place of work, and vaccination status.
    (c) Persons subject to medical monitoring shall report for such 
further medical examinations and comply with other conditions of 
monitoring as the Director orders.
    (d) Persons may refuse medical examination or monitoring, but 
remain subject to provisional quarantine or quarantine, provided that 
if quarantined such persons may request a hearing in accordance with 
Sec.  70.20.
    (e) Nothing in this section shall be construed to limit the 
Director's ability to conduct medical examinations or place persons 
under medical monitoring on a voluntary basis or from engaging in other 
methods of voluntary disease surveillance.


Sec.  70.20  Hearings.

    (a) Upon the request of a person or group of persons under 
quarantine, at any time while the quarantine order is in effect, the 
Director shall hold a hearing to review the quarantine order within one 
business day of the request.
    (b) Requests for a hearing by a person or group of persons under 
quarantine shall be limited to genuine and substantial issues of fact 
in dispute.
    (c) The Director shall provide notice of the hearing to the person 
or group of persons under quarantine through any method that the 
Director determines to be reasonably designed to notify the person or 
group of persons that such a hearing has been scheduled.
    (d) The Director shall designate a hearing officer to review the 
medical or other evidence of exposure or infection available to the 
Director and make findings as to which person or group of persons are 
in the qualifying stage of a quarantinable disease and recommendations 
concerning which person or group of persons should be released or 
remain in quarantine.
    (e) A person or group of persons in quarantine may authorize a 
representative to submit evidence concerning whether the person or 
group is in the qualifying stage of a quarantinable disease;
    (f) The Director shall take such measures that the Director 
determines to be reasonably necessary to allow a person or group of 
persons in quarantine to communicate with their authorized 
representatives. Such measures, for example, may include the 
establishment of video-conferencing facilities, e-mail terminals, 
telephone or cellular phone services, and other similar devices or 
technologies.
    (g) The hearing officer may order a medical examination of the 
person or group of persons in quarantine when, in the hearing officer's 
judgment, such a medical examination would aid in the determination of 
whether the person or group of persons are in the qualifying stage of a 
quarantinable disease, provided that such persons may refuse such 
examination.
    (h) The hearing officer shall, based upon his or her review of the 
evidence of exposure or infection made available to the hearing 
officer, make findings and a written recommendation to the Director as 
to which, if any, person or group of persons should be released or 
remain in quarantine.
    (i) The Director, based upon the hearing officer's findings and 
written recommendation and the administrative record shall within one 
business day after the conclusion of the hearing order the release or 
continued quarantine of the person or group of persons in quarantine.
    (j) The Director may issue additional instructions and guidelines 
as the Director deems necessary governing the conduct of hearings.
    (k) The quarantine order shall be deemed final either when the 
Director has accepted or rejected the hearing officer's written 
recommendation or three business days after the request for a hearing, 
whichever comes first.


Sec.  70.21  Care and treatment of persons.

    (a) Persons subject to medical examination and monitoring, 
provisional quarantine, or quarantine in accordance with this part may 
receive care and treatment at the expense of the Director subject to 
paragraphs (b) through (f) of this section.
    (b) Payment for such expenses shall be in Director's sole 
discretion and subject to the availability of appropriations.
    (c) Any payment of expenses shall be secondary to the obligation of 
the United States or any third-party (including any State or local 
governmental entity, private insurance carrier, or employer), under any 
other law or contractual agreement, to pay for such care and treatment, 
and shall only be paid by the Director after all third-party payers 
have made payment in satisfaction of their obligations.
    (d) Payment shall be limited to those amounts the hospital or 
medical facility would customarily bill the Medicare system using the 
International Classification of Diseases, Clinical Modification (ICD-
CM), and relevant federal regulations promulgated by the Centers for 
Medicare and Medicaid Services in existence at the time of billing.
    (e) For quarantinable diseases, payment shall be limited to costs 
for services and items reasonable and necessary for the care and 
treatment of the person for the time period that begins when the 
Director refers the person to the hospital or medical facility for 
treatment and ends when, as determined by the Director, the period of 
provisional quarantine or quarantine expires.
    (f) For diseases other than those described in paragraph (e) of 
this section, such payment shall be limited to costs for services and 
items reasonable and necessary for care and treatment of the person for 
the time period that begins when the Director refers the person to the 
hospital or medical facility and ends when the person's condition is 
diagnosed, as determined by the Director, with a non-quarantinable 
disease.


Sec.  70.22  Foreign nationals.

    (a) The Director, in consultation with the U.S. Department of State 
as may be necessary, shall advise a foreign national under provisional 
quarantine or quarantine of such person's right to have the Director 
notify the consular post of the foreign state of such person's

[[Page 71935]]

provisional quarantine or quarantine and to have any communications 
forwarded to the consular post without delay. In circumstances where 
required by international legal obligation, the Director shall, in 
consultation with the U.S. Department of State as may be necessary, 
directly notify the consular post of the foreign state of its foreign 
national's provisional quarantine or quarantine.
    (b) When requested by the consular officer of the foreign state and 
in a manner that the Director determines to be practicable, the 
Director, in consultation with the U.S. Department of State as may be 
necessary, shall allow the consular officer to have access to the 
foreign national under provisional quarantine or quarantine for 
purposes of conversing and corresponding with the foreign national and 
arranging for the foreign national's legal representation.
    (c) Any foreign national subject to provisional quarantine or 
quarantine shall have the same rights as provided for other persons 
subject to provisional quarantine or quarantine elsewhere in this part.


Sec.  70.23  Administrative record.

    A person's administrative record shall, where applicable, consist 
of the provisional quarantine and/or quarantine order, and any medical, 
laboratory, epidemiologic, or other information in support thereof, 
evidence submitted by the person under provisional quarantine and/or 
quarantine, written findings and recommendation of the hearing officer, 
and the hearing transcript, if any, or summary notes of the hearing.


Sec.  70.24  Requests by State (including political subdivisions 
thereof), possession, or Tribal health authorities.

    (a) The health authority of a State (including political 
subdivisions thereof) or Indian tribe may request that the Director 
take public health measures in accordance with this part and whatever 
further public health measures that the Director, in consultation with 
the health authority, deems necessary to prevent the introduction, 
transmission, or spread of communicable diseases.
    (b) The health authority of a State (including political 
subdivisions thereof) or Indian tribe may request that the Director 
issue a provisional quarantine order or a quarantine order. Such 
requests shall set forth the health authority's reasonable belief that 
the person or group of persons to be quarantined or placed under 
provisional quarantine are in the qualifying stage of a quarantinable 
disease, and either:
    (1) Moving or about to move from a State to another State; or
    (2) A probable source of infection to persons who will be moving 
from a State to another State.
    (c) Nothing in this part shall be construed to limit the ability of 
the Director to cooperate with or aid States and their political 
subdivisions or Indian Tribes in the enforcement of their quarantine 
rules and regulations or other health rules and regulations.
    (d) The health authorities of a possession may request that the 
Director take whatever public health measures are applicable under this 
part or 42 CFR part 71 (including provisional quarantine or quarantine) 
and whatever further public health measures that the Director, in 
consultation with the health authority, deems necessary to prevent the 
introduction, transmission, or spread of communicable diseases.
    (e) A request by a health authority under this section shall not be 
deemed a condition for implementation by the Director of any of the 
public health measures in this part, or in the case of possessions, 42 
CFR part 71.
    (f) The decision to undertake any of the activities requested in 
accordance with this section is within the sole discretion of the 
Director.


Sec.  70.25  Measures in the event of inadequate local control.

    In addition to the public health measures in this part, whenever 
the Director, with the concurrence of the Secretary, determines that 
the measures taken by the health authorities of any State (including 
political subdivisions thereof), possession, or Indian Tribe are 
insufficient to prevent the spread of any communicable diseases from 
one State or possession into another, the Director may take such 
measures to prevent such spread of disease as the Director deems 
necessary including inspection, fumigation, disinfection, sanitation, 
pest extermination, destruction of animals or articles found to be so 
infected or contaminated as to be sources of dangerous infection to 
human beings, and other measures.


Sec.  70.26  Federal facilities.

    (a) In addition to the public health measures in this part, the 
Director, in consultation with the affected federal agencies, may take 
whatever further public health measures or combination of measures the 
Director deems necessary with respect to facilities owned or operated 
by the federal government in the United States.
    (b) This section does not preclude the Director from requesting the 
assistance of State or local authorities in implementing the 
regulations appearing in this part or in implementing other public 
health measures or combination of measures.


Sec.  70.27  Indian country.

    (a) In addition to the public health measures specified elsewhere 
in this part, with the concurrence of the Director of the Indian Health 
Service and after consulting with the affected Tribe or Tribes, the 
Director may impose the following public health measures with respect 
to persons in Indian country without making a finding that such person 
or group of persons are moving or about to move from a State to another 
State or are a probable source of infection to persons who will be 
moving from a State to another State:
    (1) Provisional quarantine pursuant to Sec. Sec.  70.14 and 70.15;
    (2) Quarantine pursuant to Sec. Sec.  70.16 through 70.18, 70.20; 
and
    (3) Medical examination and monitoring pursuant to Sec.  70.19.
    (b) Any provisional quarantine, quarantine, or medical examination 
and monitoring authorized by paragraph (a) of this section must take 
place in a hospital or other place for treatment, but any person who is 
subject to such provisional quarantine or quarantine may refuse 
examination, medical monitoring, medical treatment, prophylaxis, or 
vaccination, but remains subject to provisional quarantine and 
quarantine.
    (c) Any person who is the subject of a provisional quarantine order 
or quarantine order authorized by paragraph (a) of this section has the 
same rights as provided for provisional quarantine or quarantine 
elsewhere in this part.
    (d) After consulting with the affected Tribe or Tribes, the 
Director may authorize the agents and employees of any State to enter 
Indian country for the sole purpose of enforcing federal quarantine 
rules and regulations if the Director of the Indian Health Service 
concurs (such concurrence being subject to any rules and regulations 
that the Director of the Indian Health Service may prescribe).


Sec.  70.28  Special powers in time of war.

    (a) In addition to the public health measures in this part, the 
Director, in consultation with the Secretary of the U.S. Department of 
Defense or his or her designee, may, in time of war and to protect the 
military and naval forces and war workers of the United States, impose 
the following public health measures with respect to persons under 
paragraph (b) of this section without making a finding that such person 
or

[[Page 71936]]

group of persons are in the qualifying stage of a quarantinable 
disease; and moving or about to move from a State to another State or 
are a probable source of infection to persons who will be moving from a 
State to another State:
    (1) Provisional quarantine pursuant to Sec. Sec.  70.14 and 70.15;
    (2) Quarantine pursuant to Sec.  70.16 through 70.18, 70.20; and
    (3) Medical examination and monitoring pursuant to Sec.  70.19.
    (b) The persons subject to paragraph (a) of this section include 
any person that the Director reasonably believes to be:
    (1) Infected with or exposed to a quarantinable disease; and
    (2) A probable source of infection to members of the military 
services or to individuals engaged in the production or transportation 
of arms, munitions, ships, food, clothing, or other supplies for the 
military services.
    (c) Any person who is the subject of a provisional quarantine order 
or quarantine order authorized by subsection (a) has the same rights as 
provided for provisional quarantine or quarantine elsewhere in this 
part.


Sec.  70.29  Penalties.

    Persons in violation of this part are subject to a fine of no more 
than $250,000 or one year in jail, or both, or as otherwise provided by 
law. Violations by organizations are subject to a fine of no more than 
$500,000 per event or as otherwise provided by law.


Sec.  70.30  Implementation through order.

    The Director may implement any of the provisions in this part 
through order issued and signed by the Director.


Sec.  70.31  Appeals of actions required pursuant to Sec. Sec.  70.6, 
70.7, 70.11 or 70.12

    (a) The following persons may submit a written appeal in accordance 
with paragraph (b) of this section:
    (1) A person whose application for a travel permit has been denied 
pursuant to Sec.  70.6;
    (2) A parent, guardian, physician, nurse, or other such person 
whose application for a travel permit has been denied pursuant to Sec.  
70.7;
    (2) The owner of animals, articles, or things to be destroyed, if 
the Director determines that destruction is a necessary sanitary 
measure pursuant to Sec.  70.11;
    (3) The owner of a carrier to be detained pursuant to Sec.  70.12.
    (b) The appeal must be in writing and be submitted to the Director 
within 2 business days. The appeal must state the reasons for the 
appeal and show that there is a genuine and substantial issue of fact 
in dispute. The Director will issue a written response to the appeal, 
which shall constitute final agency action. This opportunity for an 
appeal shall not preclude the Director from acting immediately to 
exercise actions authorized under Sec. Sec.  70.6, 70.7, 70.11 or 
70.12.

Appendix A to Part 70--Calendar Year 2004 Enplanement Data as Published 
by the Federal Aviation Agency (FAA) for Large and Medium U.S. Airports 
\1\

Large Hubs

Hartsfield--Jackson Atlanta Intl Atlanta (ATL)
Chicago O'Hare Intl Chicago (ORD)
Los Angeles Intl Los Angeles (LAX)
Dallas/Fort Worth Intl Fort Worth (DFW)
Denver Intl Denver (DEN)
McCarran Intl Las Vegas (LAS)
Phoenix Sky Harbor Intl Phoenix (PHX)
John F Kennedy Intl New York (JFK)
Minneapolis--St Paul Intl Wold--Chamberlain Minneapolis (MSP)
George Bush Intercontinental Houston (IAH)
Detroit Metropolitan Wayne County Detroit (DTW)
Newark Liberty Intl Newark (EWR)
San Francisco Intl San Francisco (SFO)
Orlando Intl Orlando (MCO)
Miami Intl Miami (MIA)
Seattle-Tacoma Intl Seattle (SEA)
Philadelphia Intl Philadelphia (PHL)
General Edward Lawrence Logan Intl Boston (BOS)
Charlotte/Douglas Intl Charlotte (CLT)
La Guardia New York (LGA)
Washington Dulles Intl Chantilly (IAD)
Cincinnati/Northern Kentucky Intl Covington (CVG)
Baltimore-Washington Intl Glen Burnie (BWI)
Fort Lauderdale/Hollywood Intl Fort Lauderdale (FLL)
Honolulu Intl Honolulu (HNL)
Chicago Midway Intl Chicago (MDW)
Salt Lake City Intl Salt Lake City (SLC)
Tampa Intl Tampa (TPA)
San Diego Intl San Diego (SAN)
Ronald Reagan Washington National Arlington (DCA)

Medium Hubs

Metropolitan Oakland Intl Oakland (OAK)
Pittsburgh Intl Pittsburgh (PIT)
Portland Intl Portland (PDX)
Lambert-St Louis Intl St Louis (STL)
Cleveland-Hopkins Intl Cleveland (CLE)
Norman Y Mineta San Jose Intl San Jose (SJC)
Memphis Intl Memphis (MEM)
Luis Munoz Marin Intl San Juan (SJU)
Kansas City Intl Kansas City (MCI)
Louis Armstrong New Orleans Intl Metairie (MSY)
Sacramento Intl Sacramento (SMF)
John Wayne Airport--Orange County Santa Ana (SNA)
Raleigh-Durham Intl Raleigh (RDU)
Nashville Intl Nashville (BNA)
Indianapolis Intl Indianapolis (IND)
William P Hobby Houston (HOU)
Austin-Bergstrom Intl Austin (AUS)
San Antonio Intl San Antonio (SAT)
Bradley Intl Windsor Locks (BDL)
Ontario Intl Ontario (ONT)
Palm Beach Intl West Palm Beach (PBI)
General Mitchell Intl Milwaukee (MKE)
Southwest Florida Intl Fort Myers (RSW)
Albuquerque Intl Sunport Albuquerque (ABQ)
Port Columbus Intl Columbus (CMH)
Dallas Love Field Dallas (DAL)
Theodore Francis Green State Warwick (PVD)
Kahului Kahului (OGG)
Jacksonville Intl Jacksonville (JAX)
Reno/Tahoe Intl Reno (RNO)
Bob Hope Burbank (BUR)
Ted Stevens Anchorage Intl Anchorage (ANC)
Buffalo Niagara Intl Buffalo (BUF)
Manchester Manchester (MHT)
Eppley Airfield Omaha (OMA)
Norfolk Intl Norfolk (ORF)
Tucson Intl Tucson (TUS)
    \1\ (See Sec.  70.4).

    2. Part 71 is revised to read as follows:

PART 71--FOREIGN AND POSSESSIONS QUARANTINE

Subpart A--General Provisions
Sec.
71.1 Scope and definitions.
71.2 Designation of yellow fever vaccination centers: Yellow fever 
or other validation stamps.
71.3 Vaccination clinics.
71.4 Bills of health.
71.5 Suspension of entries and imports from designated places.
71.6 Report of death or illness on board flights.
71.7 Written plan for reporting of deaths or illness on board 
flights and designation of an airline agent.
71.8 Report of death or illness on board ships.
71.9 Written plan for reporting of deaths or illness on board ships 
and designation of a shipline's agent.
71.10 Passenger information.
71.11 Written plan for passenger information and designation of an 
airline or shipline agent.
71.12 Inspections.
71.13 Sanitary measures.
71.14 Detention of carriers.
71.15 Carriers of U.S. military services.
71.16 Screenings to detect ill persons.
71.17 Provisional quarantine of arriving persons.
71.18 Provisional quarantine orders.
71.19 Quarantine.
71.20 Content of quarantine order.
71.21 Service of quarantine order.
71.22 Medical examination and monitoring.
71.23 Hearings.
71.24 Care and treatment of arriving persons.
71.25 Arriving foreign nationals.
71.26 Administrative record.
71.27 Food, potable water, and waste: U.S. seaports and airports.
71.28 Health documents in international traffic.
71.29 Special provisions relating to airports: Office, examination, 
and quarantine facilities.
71.30 Establishment of institutions, hospitals and stations.

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71.31 Penalties.
71.32 Implementation through order.
71.33 Appeals of actions required pursuant to 71.13 or 71.14.
Subpart B--Importations
71.51 Dogs and cats.
71.52 Turtles, tortoises, and terrapins.
71.53 Nonhuman primates.
71.54 Etiological agents, hosts, and vectors.
71.55 Dead bodies.
71.56 African rodents and other animals that may carry the monkeypox 
virus.

    Authority: 42 U.S.C. 243, 248, 249, and 264-272.

Subpart A--General Provisions


Sec.  71.1  Scope and definitions.

    (a) The purpose of this part is to prevent the introduction, 
transmission, and spread of communicable disease from foreign countries 
into the United States. This part also contains the regulations to 
prevent the spread of communicable disease among possessions of the 
United States or from a possession into a State. Regulations to prevent 
the interstate spread of communicable diseases are contained in 42 CFR 
part 70.
    (b) As used in this part, the terms listed below in alphabetical 
order shall have the following meanings:
    Airline means any air carrier, foreign or domestic, operating 
commercial passenger flights under regular schedules arriving in or 
departing from the United States.
    Airline agent means any person who is authorized to act for or in 
place of the owner or operator of an airline for purposes of carrying 
out the airline's responsibilities described in this part.
    Business day means any full business day during which the Centers 
for Disease Control and Prevention is open for regular business 
(excluding Saturdays, Sundays, and legal holidays) from 9 a.m. in the 
morning to 5 p.m. in the evening, Eastern Standard Time.
    Bill of Health means a document, in a form prescribed by the 
Director, setting forth the sanitary history and condition of a carrier 
or the port from which the carrier departs and stating that the carrier 
has in all respects complied with the regulations prescribed in this 
part.
    Carrier means a ship, shipline, vessel, aircraft, airline, train, 
road vehicle, or other means of transport, including military carriers.
    Commander means any person serving on an aircraft or ship with 
responsibility for its operation and navigation.
    Communicable disease means an illness due to a specific infectious 
agent or its toxic products which arises through transmission of that 
agent or its products from an infected person or animal or a reservoir 
to a susceptible host, either directly or indirectly through an 
intermediate animal host, vector, or the inanimate environment.
    Controlled free pratique means permission for a carrier to enter a 
U.S. port, disembark, and begin operation under certain stipulated 
conditions.
    Detention when applied to carriers, animals, articles, or things 
means the temporary holding on a voluntary or involuntary basis of such 
carriers, animals, articles, or things, until the completion of such 
sanitary measures as may be required under this part.
    Director means the Director, Centers for Disease Control and 
Prevention, Department of Health and Human Services or another 
authorized representative as approved by the Director or the Secretary.
    Disinfection means the killing of infectious agents or inactivation 
of their toxic products outside the body of a person or on the surface 
of a thing by direct exposure to chemical or physical agents.
    Disinfestation means any chemical or physical process serving to 
destroy or remove undesired small animal forms, particularly arthropods 
or rodents.
    Disinsection means the operation in which measures are taken to 
kill the insect vectors of human disease.
    Educational purpose means use in the teaching of a defined 
educational program at the university level or equivalent.
    Exhibition purpose means use as a part of a display in a facility 
comparable to a zoological park or in a trained animal act. The animal 
display must be open to the general public at routinely scheduled hours 
on 5 or more days of each week. The trained animal act must be 
routinely scheduled for multiple performances each week and open to the 
general public except for reasonable vacation and retraining periods.
    Emergency contact information means the following information 
pertaining to a person (other than the passenger or crewmember) or an 
entity (such as a business) that has the ability to contact the 
passenger or crewmember on an emergency basis:
    (i) The full name (first, last, middle initial, suffix) of the 
person or business name of the entity;
    (ii) The permanent address; and
    (iii) A phone number (either home, work, or mobile).
    Flight information means for each airline operating a flight on an 
international voyage destined for a U.S. port (including any 
intermediate stops between the flight's origin and final destination) 
the airline name, flight number, city of arrival, date of arrival, date 
of departure, seat number for any passenger or crewmember, arrival 
gate, and arrival terminal.
    Hearing officer means a person designated by the Director or the 
Secretary to conduct administrative hearings under this part or another 
authorized representative as approved by the Director or the Secretary.
    Ill person means a person who:
    (i) Has a temperature of 100.4 [deg]F (or 38 [deg]C) or greater 
accompanied by one or more of the following: rash, swelling of the 
lymph nodes or glands, headache with neck stiffness, or changes in 
level of consciousness or cognitive function; or
    (ii) Has a temperature of 100.4 [deg]F (or 38 [deg]C) or greater 
that has persisted for more than 48 hours; or
    (iii) Has diarrhea, defined as the occurrence in a 24-hour period 
of three or more loose stools or of stools in an amount greater than 
normal (for the person); or
    (iv) Has one or more of the following: severe bleeding, jaundice, 
or severe, persistent cough accompanied by bloody sputum, respiratory 
distress; or a temperature of 100.4 [deg]F (or 38 [deg]C) or greater; 
or
    (v) Displays other symptoms or factors that are suggestive of 
communicable disease, which the Director may describe in an order as 
the Director determines necessary.
    Infectious agent means an organism (e.g., bacteria, fungus, 
helminth, prion, protozoan, rickettsia, virus, or bioengineered variant 
thereof) that is capable of producing infection or infectious disease.
    International health regulations means the International Health 
Regulations of the World Health Organization, adopted by the Fifty-
Eighth World Health Assembly in 2005, and as may be further amended and 
ratified by the United States.
    International voyage means:
    (i) In the case of a carrier, a voyage between ports or airports of 
more than one country, or a voyage between ports or airports of the 
same country if the ship or aircraft stopped in any other country on 
its voyage; or
    (ii) In the case of a person, a voyage involving entry into a 
country other than the country in which such person begins his/her 
voyage.
    Medical monitoring means close medical or other supervision of a 
person or group of persons on a voluntary or involuntary basis to 
permit prompt recognition of infection or illness.
    Military services means the U.S. Air Force, U.S. Army, the U.S. 
Coast Guard,

[[Page 71938]]

the U.S. Marine Corps, the U.S. Navy, and any National Defense Reserve 
Fleet vessels engaged in military operations at the direction of the 
Department of Defense.
    Possession means, in addition to Puerto Rico, any other possession 
of the United States.
    Provisional quarantine means the detention on an involuntary basis 
of an arriving person or group of arriving persons reasonably believed 
to be infected with or exposed to a quarantinable disease until a 
quarantine order has been issued or until the Director determines that 
provisional quarantine is no longer warranted.
    Public health emergency, as used in this part, means
    (i) Any disease event as determined by the Director with either 
documented or significant potential for regional, national, or 
international disease spread or with actual or potential interference 
with the free movement of people or goods between States and 
possessions within the United States or other countries or 
sovereignties; or
    (ii) Any disease event designated as a public health emergency by 
the Secretary pursuant to section 319(a) of the Public Health Service 
Act (42 U.S.C. 247d(a)).
    Quarantine means the holding on a voluntary or involuntary basis, 
including the isolation, of a person or group of persons in such place 
and for such period of time as the Director deems necessary to prevent 
the spread of infection or illness.
    Quarantinable disease means any of the communicable diseases listed 
in an Executive Order, as provided under section 361 of the Public 
Health Service Act. Executive Order 13295, of April 4, 2003, as amended 
by Executive Order 13375 of April 1, 2005, contains the current revised 
list of quarantinable diseases, and may be obtained at http://www.cdc.gov and http://www.archives.gov/federal_register. If this 
Order is amended, HHS will enforce that amended order immediately and 
update that Web site.
    Sanitary measures means:
    (i) When applied to carriers, animals, articles, or things: 
Detention; destruction of animals, articles, or things that the 
Director deems to be sources of dangerous infection to human beings; 
disinfection; disinfestations; disinsection; export; fumigation; pest 
extermination; seizure; or any other measure or combination of measures 
whether voluntary or involuntary that the Director deems necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases; or
    (ii) When applied to a person or group of persons, the killing of 
infectious agents (or vectors capable of conveying infectious agents) 
outside the body by direct exposure to any chemical, physical, or other 
process designed to destroy such infectious agents.
    Scientific purpose means use for scientific research following a 
defined protocol and other standards for research projects as normally 
conducted at the university level. The term also includes the use for 
safety testing, potency testing, and other activities related to the 
production of medical products.
    Ship means any ship commercially operated by a shipline, regardless 
of an individual ship's flag or registry or the shipline's principal 
place of business, that carries passengers or cargo under regular 
schedules arriving in or departing from the United States, but does not 
include ships that operate between Canadian ports and ports on Puget 
Sound or on the Great Lakes and connected waterways.
    Ship Sanitation Control Certificate means a certificate issued 
under the instructions of the Director, in the form prescribed by the 
International Health Regulations, unless the Director determines 
otherwise, recording the evidence of a public health risk found on 
board during an inspection and the successful completion of any 
sanitary measures taken.
    Ship Sanitation Control Exemption Certificate means a certificate 
issued under the instructions of the Director, in the form prescribed 
by the International Health Regulations, unless the Director determines 
otherwise, recording that the ship had been inspected and found to be 
free of infection and contamination, including vectors and reservoirs.
    Shipline means any shipline operating ships commercially, 
regardless of an individual ship's flag or registry or the shipline's 
principal place of business, carrying passengers or cargo under regular 
schedules arriving in or departing from the United States.
    Shipline's agent means any person who is authorized to act for or 
in place of the owner or operator of a ship for the purposes of 
carrying out the shipline's responsibilities described in this part.
    State means, in addition to the several States, only the District 
of Columbia.
    U.S. port means any seaport, airport, or border crossing point 
under the control of the United States.
    United States means the States and possessions of the United 
States.
    Vector means an animal (including insects) or thing which conveys 
or is capable of conveying infectious agents from a person or animal to 
another person or animal.


Sec.  71.2  Designation of yellow fever vaccination centers; Yellow 
fever or other validation stamps.

    (a) Designation of yellow fever vaccination centers. (1) The 
Director is responsible for the designation of yellow fever vaccination 
centers authorized to issue certificates of vaccination. This 
responsibility may be delegated by the Director to the health 
department of a State or possession, with their consent, with respect 
to yellow fever vaccination activities of non-Federal medical, public 
health facilities, and licensed physicians functioning within the 
respective jurisdictions of a health department of a State or 
possession. Designation may be made upon application and presentation 
of evidence satisfactory to a health department of a State or 
possession to whom such responsibility has been delegated by the 
Director that the applicant has adequate facilities and professionally 
trained personnel for the handling, storage, and administration of a 
safe, potent, and pure yellow fever vaccine. Medical facilities of 
Federal agencies are authorized to obtain yellow fever vaccine without 
being designated as a yellow fever vaccination center by the Director, 
but shall comply with instructions issued by the Director for the 
administration, handling, monitoring, recordkeeping, and storage of 
yellow fever vaccine.
    (2) A designated yellow fever vaccination center shall comply with 
instructions issued by the Director or by an officer or employee of a 
health department of a State or possession to whom such responsibility 
has been delegated by the Director for the administration, handling, 
monitoring, recordkeeping, and storage of yellow fever vaccine. If a 
designated center fails to comply with such instruction, after notice 
to such center, the Director or, for non-Federal centers, a health 
department of a State or possession may revoke designation.
    (b) Validation stamps. International Certificates of Vaccination 
against yellow fever issued for vaccinations performed in the United 
States and other validation stamps as required by the Director shall be 
validated by:
    (1) The Seal of the Public Health Service;
    (2) The Seal of the Department of State;
    (3) The stamp of the Department of Defense;
    (4) The stamp issued to the National Aeronautics and Space 
Administration;

[[Page 71939]]

    (5) The stamp issued by the health department of a State or 
possession to whom such responsibility has been delegated by the 
Director; or
    (6) An official stamp of a design and size approved by the Director 
for such purpose.
    (c) When authorized by the Director, certificates of vaccination 
and validation stamps may be issued and authenticated by electronic 
means.


Sec.  71.3  Vaccination clinics.

    (a) The Director may establish vaccination clinics, through 
contract or otherwise, authorized to issue certificates of vaccination 
and administer vaccines and/or other prophylaxis.
    (b) A vaccination clinic established by the Director shall collect 
and maintain, for such time as determined by the Director, the 
following information from vaccine recipients:
    (1) Gender;
    (2) Age;
    (3) Vaccination date;
    (4) Vaccine lot number;
    (5) Prior vaccinations;
    (6) Reason for vaccination (e.g., post-exposure, pre-exposure, 
member of high risk group, general vaccination);
    (7) Concurrent vaccinations;
    (8) Vaccine Adverse Events Reporting System Report/Adverse Event 
Report Number; and
    (9) Verification that the vaccine conferred immunity (if 
applicable).
    (c) In addition to the requirements in paragraph (b) of this 
section, a vaccination clinic established by the Director shall comply 
with such additional recordkeeping requirements and other instructions 
that the Director may issue for the safe administration, handling, 
monitoring, and storage of vaccines.
    (d) In the event of a public health emergency, the Director may 
waive or modify any of the requirements in paragraph (b) of this 
section.
    (e) When authorized by the Director, certificates of vaccination 
and validation stamps may be issued and authenticated by electronic 
means.


Sec.  71.4  Bills of health.

    The Director, to the extent permitted by law and in consultation 
with such other federal agencies as the Director may deem necessary, 
may require a carrier at any foreign port clearing or departing for any 
U.S port to obtain or deliver a bill of health from a United States 
consular or medical officer designated for such purpose.


Sec.  71.5  Suspension of entries and imports from designated places.

    Whenever the Director determines that by reason of the existence of 
any communicable disease in a foreign country there is serious danger 
of the introduction of such disease in the United States, and that this 
danger is so increased by the introduction of persons or property from 
such country that a suspension of the right to introduce such persons 
or property is required in the interest of the public health, the 
Director, to the extent permitted by law and in consultation with such 
other federal agencies as the Director may deem necessary, may 
prohibit, in whole or in part, the introduction of persons and property 
from such countries or places for such period of time as the Director 
may designate through order.


Sec.  71.6  Report of death or illness on board flights.

    (a) Any airline operating flights on an international voyage 
destined for a U.S. port shall, pursuant to the written plan required 
under Sec.  71.7, report any deaths or ill persons that occur on board 
to the Director as soon as such occurrences are made known to the 
aircraft commander and, where possible, at least one hour before 
arrival.
    (b) The Director may order airlines operating flights on an 
international voyage destined for a U.S. port to disseminate to 
passengers and crew public health notices, recommended public health 
measures, and other information that the Director deems necessary for 
the purposes of preventing the introduction, transmission, or spread of 
communicable diseases. Such information shall be disseminated at the 
time and in a manner specified in the Director's order.
    (c) The provisions of paragraphs (a) and (b) of this section shall 
also apply to airlines operating flights on an international voyage 
between airports of a possession and a State of the United States or 
among possessions of the United States.


Sec.  71.7  Written plan for reporting of deaths or illness on board 
flights and designation of an airline agent.

    (a) Within 90 days of the final publication of this rule, any 
airline operating flights on an international voyage destined for a 
U.S. port shall develop a written plan sufficient to ensure the 
reporting of any deaths or ill persons on board flights as required by 
Sec.  71.6.
    (b) The written plan shall include the full name (i.e., first, 
last, middle initial, suffix), official title, business telephone 
number, and e-mail address (if available), of an airline agent who 
shall serve as a point of contact between the Director and the airline 
concerning reports of deaths or ill persons on board flights.
    (c) The written plan shall include policies and procedures 
necessary to facilitate communication between the Director and the 
airline agent on a 24-hour basis, 7 days a week.
    (d) Within 90 days of final publication of this rule, copy of the 
written plan shall be submitted to the Director.
    (e) Airlines shall implement the written plan within 180 days of 
the final publication of this rule.
    (f) Airlines shall review the written plan one year after 
implementation and annually thereafter. The review shall include drills 
or exercises to test and evaluate the effectiveness of the written plan 
unless the airline has reported any deaths or ill persons on board 
under Sec.  71.6 in the prior 365 days. Airlines shall revise the plan 
as necessary after any review. Any revisions of the written plan shall 
be submitted to the Director within 60 days.
    (g) Airlines that intend to commence operations after the effective 
date in paragraph (a) shall submit a written plan meeting the 
requirements of this section to the Director before commencing 
operations. The airline shall implement the written plan by the later 
of the following dates: either 180 days after the publication of the 
final rule, or upon commencement of operations.
    (h) The provisions of paragraphs (a) through (g) of this section 
shall also apply to airlines operating flights on an international 
voyage between airports of a possession and a State of the United 
States or among possessions of the United States.


Sec.  71.8  Report of death or illness on board ships.

    (a) Any shipline operating ships on an international voyage 
destined for a U.S. port shall report to the quarantine station or to 
another authorized representative of the Director, at or nearest the 
port at which the ship will arrive, the occurrence, on board, of any 
death or any ill person among passengers or crew as soon as such 
occurrences are made known to the ship's commander and, where possible, 
at least 24 hours before arrival.
    (b) In addition to paragraph (a) of this section, the shipline, 
shall also report any death or any ill person among passengers or crew 
(including those who have disembarked or have been removed) on board 
ships during the 15-day period preceding the date of expected arrival 
at a U.S. port or during

[[Page 71940]]

the period since departure from a U.S. port (whichever period of time 
is shorter).
    (c) Any shipline operating ships traveling from one U.S. port to 
another while on an international voyage shall report immediately to 
the quarantine station or other authorized representative at the next 
port of call, station, or stop, the occurrence of any case or suspected 
case of a communicable disease and shall take such measures to prevent 
the spread of disease as the Director directs.
    (d) Any shipline with ships at a U.S. port shall report immediately 
to the quarantine station or other authorized representative at or 
nearest the port the occurrence, on board, of any death or any ill 
person among passengers or crew during stays in port.
    (e) In addition to paragraphs (a) through (d) of this section, the 
shipline must report to the quarantine station or other authorized 
representative 24 hours before a ship's arrival the number of cases 
(including zero) of diarrhea, febrile respiratory disease, febrile rash 
illness, or febrile neurologic illness in passengers and crew recorded 
in the ship's medical log during the current cruise. All cases of 
diarrhea that occur after the 24-hour report must also be reported at 
least 4 hours before arrival.
    (f) The Director for purposes of preventing the introduction, 
transmission, or spread of communicable diseases may order shiplines 
operating ships on an international voyage destined for a U.S. port to 
disseminate to passengers and crew public health notices, recommended 
public health measures, and other public health information. Such 
information shall be disseminated at the time and in a manner specified 
in the Director's order.
    (g) The provisions of paragraphs (a) through (f) of this section 
shall additionally apply to shiplines operating ships traveling between 
a possession and a State of the United States or among possessions of 
the United States.


Sec.  71.9  Written plan for reporting of deaths or illness on board 
ships and designation of a shipline's agent.

    (a) Within 90 days of the final publication of this rule, any 
shipline operating ships on an international voyage destined for a U.S. 
port shall develop a written plan sufficient to ensure the reporting of 
any deaths or ill persons as required by Sec.  71.8.
    (b) The written plan shall include the full name (i.e., first, 
last, middle initial, suffix), official title, business telephone 
number, and e-mail address (if available), of a shipline's agent who 
shall serve as a point of contact between the Director and the shipline 
concerning reports of deaths or ill persons on board ships.
    (c) The written plan shall include policies and procedures 
necessary to facilitate communication between the Director and the 
shipline's agent on a 24-hour basis, 7 days a week.
    (d) A copy of the written plan shall be submitted to the Director.
    (e) Within 90 days of the final publication of this rule, shiplines 
shall implement the written plan.
    (f) Shiplines shall review the written plan one year after 
implementation and annually thereafter. The review shall include drills 
or exercises to test and evaluate the effectiveness of the written plan 
unless the shipline has reported any deaths or ill passengers under 
Sec.  71.8 in the prior 365 days. Shiplines shall revise the plan as 
necessary after any review. Any revisions of the written plan shall be 
submitted to the Director within 60 days.
    (g) Shiplines that intend to commence operations after the 
effective date in paragraph (a) of this section shall submit a written 
plan meeting the requirements of this section to the Director before 
commencing operations. The shipline shall implement a written plan by 
the later of the following dates: either 180 days after final 
publication of this rule, or upon commencement of operations.
    (h) The provisions of paragraphs (a) through (g) of this section 
shall also apply to shiplines operating ships on an international 
voyage between ports of a possession of the United States or between 
ports of a possession and a State of the United States.


Sec.  71.10  Passenger information.

    (a) Any airline operating flights or shipline operating ships on an 
international voyage destined for a U.S. port shall, pursuant to the 
written plan approved under Sec.  71.11, solicit from each passenger 
(or head of household if traveling with a minor) and crewmember 
traveling on an international voyage destined for a U.S. port the 
information contained in the data fields specified in paragraph (e) of 
this section.
    (b) Any information obtained by the airline or shipline pursuant to 
paragraph (a) of this section shall be maintained by the airline or 
shipline for 60 days from the end of the voyage.
    (c) For each passenger (or head of household if traveling with a 
minor) and crewmember traveling on an international voyage destined for 
a U.S. port, the airline or shipline may solicit the information in 
paragraph (e) of this section from such person's authorized agent.
    (d) Within 12 hours of a request by the Director to the airline's 
or shipline's agent, the airline or shipline, pursuant to the written 
plan approved under Sec.  71.11, shall transmit to the Director in an 
electronic format the data fields specified in paragraph (e) of this 
section.
    (e) The data fields, as applicable to the individual passenger (or 
head of household if traveling with a minor) or crew member, shall 
include the following:
    (1) Full name (first, last, middle initial, suffix);
    (2) Emergency contact information;
    (3) E-mail address;
    (4) Current home address (street, apartment , city, state/
province, postal code);
    (5) Passport number or travel document number, including the 
issuing country or organization;
    (6) Name of traveling companions or group;
    (7) Flight information or ports of call;
    (8) Returning flight (date, airline number, and flight number) or 
returning ports of call; and
    (9) At least one of the following current phone numbers in order of 
preference: mobile, home, pager, or work.
    (f) In addition to data fields specified in paragraph (e) of this 
section, when necessary to prevent the introduction, transmission, or 
spread of communicable diseases, the Director through order may also 
require that airlines or shiplines transmit additional information in 
the airline's or shipline's possession.
    (g) The provisions of paragraphs (a) through (f) of this section 
shall also apply to airlines operating flights and shiplines operating 
ships on an international voyage between ports of a possession of the 
United States or between ports of a possession and a State of the 
United States.
    (h) Information collected solely in order to comply with this 
regulation may only be used for the purposes for which it is collected.
    (i) Airlines operating flights and shiplines operating ships on an 
international voyage destined for a U.S. port shall ensure that 
passengers are informed of the purposes of this information collection 
at the time passengers arrange their travel.


Sec.  71.11  Written plan for passenger information and designation of 
an airline or shipline agent.

    (a) Within six months of the final publication of this rule, any 
airline

[[Page 71941]]

operating flights or shipline operating ships on an international 
voyage destined for a U.S. port shall develop a written plan sufficient 
to ensure electronic transmission of passenger and crew information as 
required by Sec.  71.10.
    (b) The written plan shall include:
    (1) Policies and procedures for the transmission of data in an 
electronic format available to the airline or shipline and CDC using 
industry standards for data encoding, transmission, and security, 
within 12 hours of a request by the Director to the airline's or 
shipline's agent;
    (2) The full name (i.e., first, last, middle initial, suffix), 
official title, business telephone number, and e-mail address (if 
available), of an airline agent or shipline agent who shall serve as a 
point of contact between the Director and the airline or shipline 
concerning requests for and transmission of passenger and crew manifest 
data;
    (3) Policies and procedures necessary to facilitate communication 
between the Director and the airline's or shipline's agent on a 24-hour 
basis, 7 days a week;
    (4) Policies and procedures for soliciting the information 
contained in the data fields required by Sec.  71.10 from the passenger 
(or head of household if traveling with a minor), crewmember, or such 
persons' authorized agent; and
    (5) Policies and procedures for maintaining responsive information 
obtained by the airline or shipline in an electronic database for 60 
days from the end of the voyage as required by Sec.  71.10.
    (c) Within 180 days of final publication of this rule, a copy of 
the written plan shall be submitted to the Director.
    (d) Airlines and shiplines shall implement the written plan within 
2 years of the final publication of this rule. Within 60 days of 
submission, airlines and shiplines shall conduct drills or exercises to 
test and evaluate the effectiveness of the written plan and revise the 
plan as necessary after any drill or exercise. Any revisions to the 
written plan shall be submitted to the Director within 60 days.
    (e) Airlines and shiplines shall review the written plan one year 
after implementation and annually thereafter. The review shall include 
drills or exercises to test and evaluate the effectiveness of the 
written plan unless the airline or shipline has transmitted passenger 
and crewmember information under Sec.  71.10 in the prior 365 days. 
Airlines shall revise the plan as necessary after any review. Any 
revisions of the written plan shall be submitted to the Director within 
60 days.
    (f) Airlines and shiplines that intend to commence operations after 
the effective date in paragraph (a) of this section shall submit a 
written plan meeting the requirements of this section to the Director 
before commencing operations. The airline or shipline shall implement 
the written plan by the later of the following dates: either 2 years 
after the final publication of this rule, or upon commencement of 
operations.
    (g) Pending the development or implementation of the written plan 
as required by this section, the Director, through order, may require 
that airlines and shiplines transmit to the Director, in a format 
available to both the airline or shipline and the Director, any of the 
information required by Sec.  71.10 that may be in the airline's or 
shipline's possession.
    (h) The provisions of paragraphs (a) through (g) of this section 
shall also apply to airlines operating flights and shiplines operating 
ships on an international voyage between ports of a possession of the 
United States or between ports of a possession and a State of the 
United States.


Sec.  71.12  Inspections.

    (a) Carriers arriving at a U.S. port from a foreign country or on 
an international voyage in traffic between U.S. ports are subject to 
detention and inspection to determine the existence of any rodent, 
insect, or other vermin infestation, contaminated food or water, or 
other unsanitary conditions, that may require sanitary measures for the 
prevention of the introduction, transmission, or spread of communicable 
disease.
    (b) The Director may detain and inspect a carrier arriving at a 
U.S. port from a foreign country when the Director determines that a 
threat of introduction, transmission, or spread of communicable disease 
into the United States exists, as may occur, for instance, when the 
carrier has on board ill persons.
    (c) Carriers on an international voyage that are in traffic between 
U.S. ports shall be subject to detention and inspection when there 
occurs on board, among passengers or crew, any death, or when there is 
any ill person, or when the Director reasonably believes that illness 
may be caused by unsanitary conditions.
    (d) The provisions of paragraphs (a) through (c) of this section 
shall additionally apply to carriers traveling between a possession and 
State or among possessions of the United States.


Sec.  71.13  Sanitary measures.

    (a) Whenever the Director reasonably believes that any carrier 
arriving at a U.S. port from a foreign country or on an international 
voyage in traffic between U.S. ports or animal, article, or thing on 
board the carrier is or may be infected or contaminated with a 
communicable disease, the Director may, in consultation with such other 
federal agencies as appropriate:
    (1) Inspect the carrier, animal, article, or thing on board the 
carrier, and/or
    (2) Order the carrier, or other entity specified in the order, to 
apply such sanitary measures as the Director deems necessary to prevent 
the introduction, transmission, or spread of communicable diseases.
    (b) CDC shall not bear the expense of any sanitary measures 
required or ordered by the Director. The carrier or other entity 
specified in the order issued pursuant to 71.13(a) shall bear the 
responsibility for the application of such measures.
    (c) Sections 71.13(a) and 71.13(b) shall not preclude any entity 
ordered to conduct sanitary measures pursuant to Sec.  71.13(b) from 
arranging to have such measures conducted by other entities through 
contractual or other arrangements, or from seeking reimbursement for 
any costs associated with sanitary measures through contractual or 
other arrangements.
    (d) The Director may apply such sanitary measures to persons who 
have not been infected with or exposed to a quarantinable disease, upon 
their consent, as may be required to destroy the presence of infectious 
agents or vectors.


Sec.  71.14  Detention of carriers.

    (a) The Director, in consultation with such other federal agencies 
as the Director deems necessary, may require detention of a carrier and 
all things onboard the carrier until the completion of the measures 
outlined in this part that the Director determines to be necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases.
    (b) The owner of the carrier shall bear any expenses relating to 
the detention of the carrier; or, in the case of animals, articles, or 
things on board the carrier, such expense shall be borne by the owners 
thereof.
    (c) Director may issue a controlled free pratique to the carrier 
stipulating what sanitary measures are to be met, but such issuance 
does not prevent the periodic boarding of a carrier and the inspection 
of persons and records to verify that the conditions have been met for 
granting the pratique.

[[Page 71942]]

Sec.  71.15  Carriers of U.S. military services.

    (a) Carriers belonging to or operated by the military services of 
the United States may be exempted from detention and inspection if the 
Director is satisfied that they have complied with regulations of the 
military services which also meet the requirements of the regulations 
in this part. (For applicable regulations of the military services, see 
Army Regulation No. 40-12, Air Force Regulation No. 161-4, Secretary of 
the Navy Instruction 6210.2, and Coast Guard Commandant Instruction 
6210.2).
    (b) Notwithstanding exemption from detention and inspection of 
carriers under this section, animals, articles, or things on board 
shall be required to comply with the applicable requirements of subpart 
B of this part.


Sec.  71.16  Screenings to detect ill persons.

    The Director may at U.S. ports or other locations, conduct 
screenings of persons or group of persons to detect the presence of ill 
persons. Such screenings may be conducted through visual inspection, 
electronic temperature monitors, or other means determined appropriate 
by the Director to detect the presence of ill persons.


Sec.  71.17  Provisional quarantine of arriving persons.

    (a) The Director may provisionally quarantine an arriving person or 
group of arriving persons who the Director reasonably believes to be 
infected with or exposed to a quarantinable disease.
    (b) Provisional quarantine shall commence upon:
    (1) The service of a written provisional quarantine order;
    (2) A verbal provisional quarantine order; or
    (3) Actual movement restrictions placed on the person or group of 
persons.
    (c) Provisional quarantine shall end three business days after 
provisional quarantine commences, except that the person or group of 
persons shall be released earlier if the Director determines that 
provisional quarantine is no longer warranted.
    (d) In the event that the Director determines that it is necessary 
to provisionally quarantine a person or group of persons beyond three 
business days, then the Director shall serve the person or group of 
persons with a written quarantine order in accordance with this part.
    (e) A person or group of persons subject to provisional quarantine 
may be offered medical treatment, prophylaxis, or vaccination, as the 
Director deems necessary to prevent the transmission or spread of the 
disease; such persons may refuse such medical treatment, prophylaxis, 
or vaccination, but remain subject to provisional quarantine.
    (f) Nothing in this section shall be construed to limit the 
Director's ability to detain a person or group of persons on a 
voluntary basis or offer such persons medical treatment, prophylaxis, 
or vaccination on a voluntary basis.


Sec.  71.18  Provisional quarantine orders.

    (a) Provisional quarantine orders shall be served by the Director 
at the time that provisional quarantine commences or as soon thereafter 
as the circumstances reasonably permit either through personal service 
or, in circumstances where the Director deems it necessary or 
desirable, by posting or publishing the order in a conspicuous 
location.
    (b) In circumstances where the Director deems public posting or 
publishing necessary, the Director may omit the names and/or identities 
of persons and take other measures respecting the privacy of persons.
    (c) The provisional quarantine order shall be in writing, signed by 
the Director, and include the following information:
    (1) A statement setting forth the Director's reasonable belief that 
the arriving person or group of arriving persons is infected with or 
exposed to a quarantinable disease based on information available to 
the Director at the time, such as travel history, clinical 
manifestations, and any other evidence of infection or exposure;
    (2) The suspected quarantinable disease;
    (3) A statement advising the arriving person or group of arriving 
persons that they may be placed under provisional quarantine for three 
business days and that at the end of such period they shall be released 
or, if determined by the Director, served with a quarantine order;
    (4) A statement advising the person or group of persons that they 
shall be released earlier if the Director determines that provisional 
quarantine is no longer warranted;
    (5) The location of provisional quarantine;
    (d) When authorized by the Director, provisional quarantine orders 
may be issued and signed by electronic means.


Sec.  71.19  Quarantine.

    (a) The Director may issue a quarantine order whenever the Director 
reasonably believes that an arriving person or group of arriving 
persons is infected with or exposed to a quarantinable disease based 
on, but not limited to, any of the following: clinical manifestations, 
diagnostic tests or other medical tests, epidemiologic information, 
laboratory tests, physical examination, or other evidence of exposure 
or infection;
    (b) In accordance with the Director's quarantine order, the 
Director may offer medical treatment, prophylaxis, or vaccination, as 
the Director deems necessary to prevent the transmission or spread of 
the disease.
    (c) Persons offered treatment, prophylaxis, or vaccination may 
refuse, but remain subject to quarantine.
    (d) The Director's quarantine order may include the quarantine of 
an arriving person or group of arriving persons who refuse examination, 
medical treatment, prophylaxis, or vaccination, or for whom the 
Director determines that such examination, medical treatment, 
prophylaxis, or vaccination is medically contra-indicated or not 
reasonably available.
    (e) The length of quarantine shall not exceed the period of 
incubation and communicability, as determined by the Director, for the 
quarantinable disease.
    (f) Nothing in this section shall be construed to limit the 
Director's ability to quarantine a person or group of persons on a 
voluntary basis.


Sec.  71.20  Content of quarantine order.

    (a) Quarantine orders shall be in writing, signed by the Director, 
and contain the following:
    (1) The identity of the arriving person or group of arriving 
persons to be quarantined;
    (2) The location where the arriving person or group of arriving 
persons will be quarantined;
    (3) The date and time at which quarantine commences and ends;
    (4) The suspected quarantinable disease;
    (5) A statement that the Director reasonably believes that the 
arriving person or group of arriving persons are infected with or 
exposed to a quarantinable disease;
    (6) A statement regarding the basis for the Director's reasonable 
belief that the arriving person or group of arriving persons are 
infected with or exposed to a quarantinable disease, e.g., clinical 
manifestations, physical examination, laboratory tests, diagnostic 
tests or other medical tests, epidemiologic information, or other 
evidence of exposure or infection;
    (7) A statement that the arriving person or group of arriving 
persons shall comply with conditions of quarantine, including, but not 
limited to examination, medical monitoring, medical treatment, 
prophylaxis, or vaccination, or other conditions of quarantine deemed 
by the Director to be necessary to prevent the transmission or spread 
of communicable disease;

[[Page 71943]]

    (8) A statement that persons may refuse examination, medical 
monitoring, medical treatment, prophylaxis, or vaccination, but that 
such persons remain subject to quarantine; and
    (9) A statement that persons under quarantine, any time while the 
quarantine order is in effect, may request that the Director hold a 
hearing to review the quarantine order.
    (b) When authorized by the Director, quarantine orders may be 
issued and signed by electronic means.


Sec.  71.21  Service of quarantine order.

    (a) A copy of the quarantine order shall be personally served on 
the person or group of persons at the time that quarantine commences or 
as soon thereafter as the Director determines that the circumstances 
reasonably permit.
    (b) In circumstances where the Director deems it necessary or 
desirable, the quarantine order may be posted or published in a 
conspicuous location, except that the Director may omit the names and/
or identities of persons and take other measures respecting the privacy 
of persons.


Sec.  71.22  Medical examination and monitoring.

    (a) The Director may order medical examination or monitoring of an 
arriving person or group of arriving persons that the Director 
reasonably believes to be infected with or exposed to a quarantinable 
disease.
    (b) Arriving persons subject to medical examination or monitoring 
shall provide the Director with such information as the Director may 
order, including, but not limited to, familial and social contacts, 
travel itinerary, medical history, place of work, and vaccination 
status.
    (c) Arriving persons subject to medical monitoring shall report for 
such further medical examinations and comply with other conditions of 
monitoring as the Director orders.
    (d) Arriving persons may refuse medical examination or monitoring, 
but remain subject to provisional quarantine or quarantine provided 
that if quarantined such persons may request a hearing in accordance 
with Sec.  71.23.
    (e) Nothing in this section shall be construed to limit the 
Director's ability to conduct medical examinations or place arriving 
persons under medical monitoring on a voluntary basis or from engaging 
in other methods of voluntary disease surveillance.


Sec.  71.23  Hearings.

    (a) Upon the request of an arriving person or group of arriving 
persons under quarantine, at any time while the quarantine order is in 
effect, the Director shall hold a hearing to review the quarantine 
order within one business day of the request.
    (b) Requests for a hearing by the person or groups of persons under 
quarantine shall be limited to genuine and substantial issues of fact 
in dispute.
    (c) The Director shall provide notice of the hearing to the 
arriving person or group of arriving persons under quarantine through 
any method that the Director determines to be reasonably designed to 
notify the person or group of persons that such a hearing has been 
scheduled.
    (d) The Director shall designate a hearing officer to review the 
medical or other evidence of exposure or infection available to the 
Director and make findings as to which arriving person or group of 
arriving persons are infected with or exposed to a quarantinable 
disease and recommendations concerning which arriving person or group 
of arriving persons should be released or remain in quarantine.
    (e) An arriving person or group of arriving persons in quarantine 
may authorize a representative to submit evidence concerning whether 
the person or group is infected with or exposed to a quarantinable 
disease;
    (f) The Director shall take such measures that the Director 
determines to be reasonably necessary to allow an arriving person or 
group of arriving persons in quarantine to communicate with their 
authorized representatives. Such measures, for example, may include the 
establishment of video-conferencing facilities, e-mail terminals, 
telephone or cellular phone services, and other similar devices or 
technologies.
    (g) The hearing officer may order a medical examination of the 
arriving person or group of arriving persons in quarantine when, in the 
hearing officer's judgment, such a medical examination would be 
necessary or desirable for a determination of whether the arriving 
person or group of arriving persons are infected with or exposed to a 
quarantinable disease, provided that such arriving persons may refuse 
such examination.
    (h) The hearing officer shall, based upon his or her review of the 
evidence of exposure or infection made available to the hearing 
officer, make findings and a written recommendation to the Director as 
to which, if any, arriving person or group of arriving persons should 
be released or remain in quarantine.
    (i) The Director, based upon the hearing officer's findings and 
written recommendation the administrative record shall within one 
business day after the conclusion of the hearing order the release or 
continued quarantine of the arriving person or group of arriving 
persons in quarantine.
    (j) The Director may issue additional instructions and guidelines 
as the Director deems necessary governing the conduct of hearings.
    (k) The quarantine order shall be deemed final either when the 
Director has accepted or rejected the hearing officer's written 
recommendation or three business days after the request for a hearing, 
whichever comes first.


Sec.  71.24  Care and treatment of arriving persons.

    (a) Arriving persons subject to medical examination and monitoring, 
provisional quarantine, or quarantine in accordance with this part may 
receive care and treatment at the expense of the Director subject to 
paragraphs (b) through (f) of this section.
    (b) Payment for such expenses shall be in the Director's sole 
discretion and subject to the availability of appropriations.
    (c) Any payment of expenses shall be secondary to the obligation of 
the United States or any third-party (including any State or local 
governmental entity, private insurance carrier, or employer), under any 
other law or contractual agreement, to pay for such care and treatment, 
and shall only be paid by the Director after all third-party payers 
have made payment in satisfaction of their obligations.
    (d) Payment shall be limited to those amounts the hospital or 
medical facility would customarily bill the Medicare system using the 
International Classification of Diseases, Clinical Modification (ICD-
CM), and relevant federal regulations promulgated by the Centers for 
Medicare and Medicaid Services in existence at the time of billing.
    (e) For quarantinable diseases, payment shall be limited to costs 
for services and items reasonable and necessary for the care and 
treatment of the person for the time period that begins when the 
Director refers the person to the hospital or medical facility and ends 
when, as determined by the Director, the period of provisional 
quarantine or quarantine expires.
    (f) For diseases other than those described in paragraph (e) of 
this section, such payment shall be limited to costs for services and 
items reasonable and necessary for care and treatment of the person for 
the time period that begins when the Director refers the person to the 
hospital or

[[Page 71944]]

medical facility and ends when the person's condition is diagnosed, as 
determined by the Director, with a non-quarantinable disease.


Sec.  71.25  Arriving foreign nationals.

    (a) The Director, in consultation with the U.S. Department of State 
as may be necessary, shall advise an arriving foreign national under 
provisional quarantine or quarantine of such person's right to have the 
Director notify the consular post of the foreign state of such person's 
provisional quarantine or quarantine and to have any communications 
forwarded to the consular post without delay. In circumstances where 
required by international legal obligation, the Director shall, in 
consultation with the U.S. Department of State as may be necessary, 
directly notify the consular post of the foreign state of its arriving 
foreign nationals' provisional quarantine or quarantine.
    (b) When requested by the consular officer of the foreign state and 
in a manner that the Director determines to be practicable, the 
Director, in consultation with the U.S. Department of State as may be 
necessary, shall allow the consular officer to have access to the 
foreign national under provisional quarantine or quarantine for 
purposes of conversing and corresponding with the foreign national and 
arranging for the foreign national's legal representation.
    (c) Any foreign national subject to provisional quarantine or 
quarantine shall have the same rights as provided for other arriving 
persons subject to provisional quarantine or quarantine elsewhere in 
this part.


Sec.  71.26  Administrative record.

    A person's administrative record shall, where applicable, consist 
of the provisional quarantine and/or quarantine order, and any medical, 
laboratory, epidemiologic, or other information in support thereof, 
evidence submitted by the person under provisional quarantine and/or 
quarantine, written findings and recommendation of the hearing officer, 
and hearing transcript, if any, or summary notes of the proceeding.


Sec.  71.27  Food, potable water, and waste: U.S. seaports and 
airports.

    (a) Every seaport and airport shall have a supply of potable water 
from a watering point approved by the Commissioner of Food and Drugs, 
FDA, in accordance with standards established in 21 CFR parts 1240 and 
1250.
    (b) All food and potable water taken on board a ship or aircraft at 
any seaport or airport intended for human consumption thereon shall be 
obtained from sources approved in accordance with regulations cited in 
paragraph (a) of this section.
    (c) Aircraft inbound or outbound on an international voyage shall 
not discharge over the United States any excrement, waste water or 
other polluting materials. Arriving aircraft shall discharge such 
matter only at servicing areas approved under regulations cited in 
paragraph (a) of this section.


Sec.  71.28  Health documents in international traffic.

    (a) The Director may perform rodent infestation inspections, when 
requested by a shipline and at the shipline's own expense, and issue 
certificates, in a form prescribed by the Director, concerning the 
absence of rodents and other vermin on board ships.
    (b) Unless otherwise determined by the Director, and in accordance 
with Articles 37 and 38 of the International Health Regulations, as may 
be further amended and ratified by the United States, the Maritime 
Declaration of Health and the Health Part of the Aircraft General 
Declaration, shall not be required as a condition of arrival at a U.S. 
port.
    (c) The Director, upon the request of a shipline, may issue a Ship 
Sanitation Control Exemption Certificate or a Ship Sanitation Control 
Certificate, in accordance with Article 39 of the International Health 
Regulations, as may be further amended and ratified by the United 
States, or in another format prescribed by the Director.


Sec.  71.29  Special provisions relating to airports: Office, 
examination, and quarantine facilities.

    (a) Each U.S. airport which receives international traffic shall 
provide without cost to the Government suitable office, examination, 
quarantine and other exclusive space for carrying out the Federal 
responsibilities under this part.
    (b) Each U.S. airport which receives international traffic shall 
identify to the nearest quarantine station or other authorized 
representative on a yearly basis, or at other intervals as determined 
by the Director, space which is suitable for the quarantine of an 
arriving person or group of persons under guidelines or instructions 
issued by the Director.


Sec.  71.30  Establishment of institutions, hospitals and stations.

    (a) The Director, with the approval of the Secretary, may, from 
time to time, select sites suitable for, and establish such 
institutions, hospitals, and stations in the States and possessions of 
the United States as the Director, with the approval of the Secretary, 
deems necessary or desirable for carrying out the functions in this 
part.
    (b) The Director may enter into voluntary agreements with public or 
private institutions as the Director deems necessary or desirable for 
carrying out the functions in this part.


Sec.  71.31  Penalties.

    Persons in violation of this part are subject to a fine of no more 
than $250,000 or one year in jail, or both, or as otherwise provided by 
law. Violations by organizations are subject to a fine of no more than 
$500,000 per event or as otherwise provided by law.


Sec.  71.32  Implementation through order.

    The Director may implement any of the provisions of this part 
through order issued and signed by the Director.


Sec.  71.33  Appeals of actions required pursuant to Sec. Sec.  71.13 
or 71.14.

    If the Director requires export or destruction of animals, 
articles, or things pursuant to Sec.  71.13 or detention of a carrier 
pursuant to Sec.  71.14, the owner of the animals, articles, or things 
thereof, or, the carrier owner may appeal. The appeal must be in 
writing and be submitted to the Director within 2 business days. The 
appeal must state the reasons for the appeal and show that there is a 
genuine and substantial issue of fact in dispute. The Director will 
issue a written response to the appeal, which shall constitute final 
agency action. This opportunity for an appeal shall not preclude the 
Director from acting immediately to exercise actions authorized under 
Sec. Sec.  71.13 or 71.14.

Subpart B--Importations


Sec.  71.51  Dogs and cats.

    (a) Definitions. As used in this section the term:
    Cat means all domestic cats.
    Confinement means restriction of a dog or cat to a building or 
other enclosure at a U.S. port, en route to destination and at 
destination, in isolation from other animals and from persons except 
for contact necessary for its care or, if the dog or cat is allowed out 
of the enclosure, muzzling and keeping it on a leash.
    Dog means all domestic dogs.
    Owner means owner or agent.
    Valid rabies vaccination certificate means a certificate which was 
issued for a dog not less than 3 months of age at the time of 
vaccination and which:
    (1) Identifies a dog on the basis of breed, sex, age, color, 
markings, and other identifying information.

[[Page 71945]]

    (2) Specifies a date of rabies vaccination at least 30 days before 
the date of arrival of the dog at a U.S. port.
    (3) Specifies a date of expiration which is after the date of 
arrival of the dog at a U.S. port. If no date of expiration is 
specified, then the date of vaccination shall be no more than 12 months 
before the date of arrival at a U.S. port.
    (4) Bears the signature of a licensed veterinarian.
    (b) General requirements for admission of dogs and cats--(1) 
Inspection by Director. The Director shall inspect all dogs and cats 
which arrive at a U.S. port, and admit only those dogs and cats which 
show no signs of communicable disease as defined in Sec.  71.1.
    (2) Examination by veterinarian and confinement of dogs and cats. 
When, upon inspection, a dog or cat does not appear to be in good 
health on arrival (e.g., it has symptoms such as emaciation, lesions of 
the skin, nervous system disturbances, jaundice, or diarrhea), the 
Director may require prompt confinement and give the owner an 
opportunity to arrange for a licensed veterinarian to examine the 
animal and give or arrange for any tests or treatment indicated. The 
Director will consider the findings of the examination and tests in 
determining whether or not the dog or cat may have a communicable 
disease. The owner shall bear the expense of the examination, tests, 
and treatment. When it is necessary to detain a dog or cat pending 
determination of its admissibility, the owner shall provide confinement 
facilities which in the judgment of the Director will afford protection 
against any communicable disease. The owner shall bear the expense of 
confinement. Confinement shall be subject to conditions specified by 
the Director to protect the public health.
    (3) Record of sickness or death of dogs and cats and requirements 
for exposed animals. (i) The carrier responsible for the care of dogs 
and cats shall maintain a record of sickness or death of animals en 
route to the United States and shall submit the record to the 
quarantine station at the U.S. port upon arrival. Dogs or cats which 
have become sick while en route or are dead on arrival shall be 
separated from other animals as soon as the sickness or death is 
discovered, and shall be held in confinement pending any necessary 
examination as determined by the Director.
    (ii) When, upon inspection, a dog or cat appears healthy but, 
during shipment, has been exposed to a sick or dead animal suspected of 
having a communicable disease, the exposed dog or cat shall be admitted 
only if examination or tests made on arrival reveal no evidence that 
the animal may be infected with a communicable disease. The provisions 
of paragraph (b)(2) of this section shall be applicable to the 
examination or tests.
    (4) Sanitation. When the Director finds that the cages or other 
containers of dogs or cats arriving in the United States are in an 
insanitary or other condition that may constitute a communicable 
disease hazard, the dogs or cats shall not be admitted in such 
containers unless the owner has the containers cleaned and disinfected.
    (c) Rabies vaccination requirements for dogs. (1) A valid rabies 
vaccination certificate is required at a U.S. port for admission of a 
dog unless the owner submits evidence satisfactory to the Director 
that:
    (i) If a dog is less than 6 months of age, it has been only in a 
country determined by the Director to be rabies-free (a current list of 
rabies-free countries may be obtained from the Division of Quarantine, 
Center for Prevention Services, Centers for Disease Control, Atlanta, 
GA 30333); or
    (ii) If a dog is 6 months of age or older, for the 6 months before 
arrival, it has been only in a country determined by the Director to be 
rabies-free; or
    (iii) The dog is to be taken to a research facility to be used for 
research purposes and vaccination would interfere with its use for such 
purposes.
    (2) Regardless of the provisions of paragraph (c)(1) of this 
section, the Director may authorize admission as follows:
    (i) If the date of vaccination shown on the vaccination certificate 
is less than 30 days before the date of arrival, the dog may be 
admitted, but must be confined until at least 30 days have elapsed 
since the date of vaccination;
    (ii) If the dog is less than 3 months of age, it may be admitted, 
but must be confined until vaccinated against rabies at 3 months of age 
and for at least 30 days after the date of vaccination;
    (iii) If the dog is 3 months of age or older, it may be admitted, 
but must be confined until it is vaccinated against rabies. The dog 
must be vaccinated within 4 days after arrival at destination but no 
more than 10 days after arrival at a U.S. port. It must be kept in 
confinement for at least 30 days after the date of vaccination.
    (3) When a dog is admitted under paragraph (c)(2) of this section, 
the Director shall notify the health department or other appropriate 
agency having jurisdiction at the point of destination and shall 
provide the address of the specified place of confinement and other 
pertinent information to facilitate surveillance and other appropriate 
action.
    (d) Certification requirements. The owner shall submit such 
certification regarding confinement and vaccination prescribed under 
this section as may be required by the Director.
    (e) Additional requirements for the importation of dogs and cats. 
Dogs and cats shall be subject to such additional requirements as may 
be deemed necessary by the Director or to exclusion if coming from 
areas which the Director has determined to have high rates of rabies.
    (f) Requirements for dogs and cats in transit. The provisions of 
this section shall apply to dogs and cats transported through the 
United States from one foreign country to another, except as provided 
below:
    (1) Dogs and cats that appear healthy, but have been exposed to a 
sick or dead animal suspected of having a communicable disease, need 
not undergo examination or tests as provided in paragraph (b)(3) of 
this section if the Director determines that the conditions under which 
they are being transported will afford adequate protection against 
introduction of communicable disease.
    (2) Rabies vaccination is not required for dogs that are 
transported by aircraft or ship and retained in custody of the carrier 
under conditions that would prevent transmission of rabies.
    (g) Disposal of excluded dogs and cats. A dog or cat excluded from 
the United States under the regulations in this part shall be exported 
or destroyed. Pending exportation, it shall be detained at the owner's 
expense in the custody of the U.S. Customs Service at the U.S. port.


Sec.  71.52  Turtles, tortoises, and terrapins.

    (a) Definitions. As used in this section the term:
    Turtles includes all animals commonly known as turtles, tortoises, 
terrapins, and all other animals of the order Testudinata, class 
Reptilia, except marine species (Families Dermochelidae and 
Cheloniidae).
    (b) Importation; general prohibition. Except as otherwise provided 
in this section, live turtles with a carapace length of less than 4 
inches and viable turtle eggs may not be imported into the United 
States.
    (c) Exceptions. (1) Live turtles with a carapace length of less 
than 4 inches and viable turtle eggs may be imported into the United 
States, provided that such importation is not in connection with a 
business, and the importation is

[[Page 71946]]

limited to lots of fewer than seven live turtles or fewer than seven 
viable turtle eggs, or any combinations of such turtles and turtle eggs 
totaling fewer than seven, for any entry.
    (2) Seven or more live turtles with a carapace length of less than 
4 inches, or seven or more viable turtle eggs or any combination of 
turtles and turtle eggs totaling seven or more, may be imported into 
the United States for bona fide scientific or educational purposes or 
for exhibition when accompanied by a permit issued by the Director.
    (3) The requirements in paragraphs (c)(1) and (c)(2) of this 
section shall not apply to the eggs of marine turtles excluded from 
these regulations under Sec.  71.52(a).
    (d) Application for permits. Applications for permits to import 
turtles, as set forth in paragraph (c)(2) of this section, shall be 
made by letter to the Director, and shall contain, identify, or 
describe, the name and address of the applicant, the number of 
specimens, and the common and scientific names of each species to be 
imported, the holding facilities, the intended use of the turtles 
following their importation, the precautions to be undertaken to 
prevent infection of members of the public with Salmonella and Arizona 
bacteria, and any other information and assurances the Director may 
require.
    (e) Criteria for issuance of permits. A permit may be issued upon a 
determination that the holder of the permit will isolate or otherwise 
confine the turtles and will take such other precautions as may be 
determined by the Director to be necessary to prevent infection of 
members of the public with Salmonella and Arizona bacteria and on 
condition that the holder of the permit will provide such reports as 
the Director may require.
    (f) Interstate regulations. Upon admission at a U.S. Port, turtles 
and viable turtle eggs become subject to Food and Drug Administration 
Regulations (21 CFR 1240.62) regarding general prohibition.
    (g) Other permits. Permits to import certain species of turtles may 
be required under other Federal regulations (50 CFR parts 17 and 23) 
protecting such species.


Sec.  71.53  Nonhuman primates.

    (a) Definitions. As used in this section the term:
    Importer means any person or corporation, partnership, or other 
organization, receiving live nonhuman primates from a foreign country 
within a period of 31 days, beginning with the importation date, 
whether or not the primates were held for part of the period at another 
location. The term importer includes the original importer and any 
other person or organization receiving imported primates within the 31-
day period.
    Nonhuman primates means all nonhuman members of the Order Primates, 
including, but not limited to, animals commonly known as monkeys, 
chimpanzees, orangutans, gorillas, gibbons, apes, baboons, marmosets, 
tamarin, lemurs, and lorises.
    (b) General prohibition. No person or organization may import live 
nonhuman primates into the United States unless registered as an 
importer in accordance with applicable provisions of this section.
    (c) Uses for which nonhuman primates may be imported and 
distributed. Live nonhuman primates may be imported into the United 
States and sold, resold, or otherwise distributed only for bona fide 
scientific, educational, or exhibition purposes. The importation of 
nonhuman primates for use in breeding colonies is also permitted 
provided that all offspring will be used only for scientific, 
educational, or exhibition purposes. The maintenance of nonhuman 
primates as pets, hobby, or an avocation with occasional display to the 
general public is not a permissible use.
    (d) Registration of importers. (1) Importers of nonhuman primates 
shall register with the Director in a manner prescribed by the 
Director.
    (2) Documentary evidence that an importer will use all nonhuman 
primates solely for the permitted purposes is required.
    (3) Registration shall include certification that the nonhuman 
primates will not be shipped, sold, or otherwise transferred to other 
persons or organizations without adequate proof that the primates will 
be used only for the permitted purposes.
    (4) Registration shall be for 2 years, effective the date the 
application for registration is approved by the Director.
    (5) Registration may be renewed by filing a registration 
application form with the Director not less than 30 days nor more than 
60 days before expiration of the current registration.
    (e) Recordkeeping and reporting requirement for registered 
importers. (1) Importers shall maintain records on each shipment of 
imported nonhuman primates received. The record on each shipment shall 
include the number of primates received, species, country of origin, 
date of importation, the number of primates in the shipment that die 
within 90 days after receipt, and cause(s) of deaths. If any primates 
in the shipment are sold or otherwise distributed within 90 days after 
receipt, the record shall include the number of primates in each 
shipment or sale, the dates of each shipment or sale, and the identity 
of the recipients. In addition, the record shall contain copies of 
documents that were presented to the importer to establish that the 
recipient would use the primates solely for the permitted purposes. The 
records shall be maintained in an organized manner in a central 
location at or in close proximity to the importer's primate holding 
facility. The records shall be maintained for a period of 3 years and 
shall be available for inspection by the Director at any time.
    (2) Importers shall report to the Director by telephone within 24 
hours the occurrence of any illness in nonhuman primates that is 
suspected of being yellow fever, monkeypox, or Marburg/Ebola disease.
    (3) Importers also shall report to the Director by telephone within 
24 hours the occurrence of illness in any member of their staff 
suspected of having an infectious disease acquired from nonhuman 
primates.
    (f) Disease control measures. Upon receipt of evidence of exposure 
of nonhuman primates to a communicable disease that may constitute a 
threat to public health, the Director may provide for or require 
examination, treatment, detention, isolation, seizure, or destruction 
of exposed animals. Any measures required shall be at the owner's 
expense.
    (g) Disposal of excluded nonhuman primates. Nonhuman primate(s) 
excluded from the United States by provisions of this section shall, at 
the owner's option and expense, be exported, destroyed, or given to a 
scientific, educational, or exhibition facility under arrangements 
approved by the Director. If the owner fails to dispose of the nonhuman 
primate by one of the approved options or fails to select a method of 
disposal within 7 days, the Director will select the method of 
disposal. Pending disposal, the nonhuman primate(s) shall be detained 
at the owner's expense in custody of the U.S. Customs Service at the 
U.S. port.
    (h) Revocation of an importer's registration. (1) An importer's 
registration may be revoked by the Director, upon notice to the 
importer holding such registration, if the Director determines that the 
importer has failed to comply with any applicable provisions of this 
section. The notice shall contain a statement of the grounds upon which 
the revocation is based.
    (2) The importer may file an answer within 20 days after receipt of 
the notice. Answers shall admit or deny

[[Page 71947]]

specifically, and in detail, each allegation in the notice. Allegations 
in the notice not denied by answer shall be deemed admitted. Matters 
alleged as affirmative defenses shall be separately stated and 
numbered. Failure of the importer to file an answer within 20 days 
after receipt of the notice may be deemed an admission of all 
allegations of fact recited in the notice.
    (3) The importer shall be entitled to a hearing with respect to the 
revocation upon filing a written request, either in the answer or in a 
separate document, with the Director within 20 days after the effective 
date of revocation. Failure to request a hearing shall be deemed a 
waiver of hearing and as consent to the submission of the case to the 
Director for decision based on the written record. The failure both to 
file an answer and to request a hearing shall be deemed to constitute 
consent to the making of a decision on the basis of available 
information.
    (4) As soon as practicable after the completion of any hearing 
conducted pursuant to the provisions of this section, the Director 
shall render a final decision. A copy of such decision shall be served 
on the importer.
    (5) An importer's registration which has been revoked may be 
reinstated by the Director upon inspection, examination of records, 
conference with the importer, and receipt of information and assurances 
of compliance with the requirements of this section.
    (i) Other permits. In addition to the requirements under this 
section, permits to import certain species of nonhuman primates may 
also be required under other Federal regulations (50 CFR parts 17 and 
23) protecting such species.


Sec.  71.54  Etiological agents, hosts, and vectors.

    (a) A person may not import into the United States, nor distribute 
after importation, any etiological agent or any arthropod or other 
animal host or vector of human disease, or any exotic living arthropod 
or other animal capable of being a host or vector of human disease 
unless accompanied by a permit issued by the Director.
    (b) Any import coming within the provisions of this section will 
not be released from custody prior to receipt by the District Director 
of the U.S. Customs Service of a permit issued by the Director.


Sec.  71.55  Dead bodies.

    (a) The remains of a person who died of a communicable disease may 
not be brought into a U.S. port unless it has been:
    (1) Placed in a hermetically sealed casket;
    (2) Cremated; or
    (3) Accompanied by a permit issued by the Director.
    (b) The Director may inspect human remains brought into a U.S. port 
and condition their further importation upon such requirements that the 
Director may deem necessary through order to prevent the introduction, 
transmission, and spread of communicable diseases.


Sec.  71.56  African rodents and other animals that may carry the 
monkeypox virus.

    (a) What actions are prohibited? What animals are affected? (1) 
Except as provided in paragraphs (a)(2) and (a)(3) of this section,
    (i) You must not import or attempt to import any rodents, whether 
dead or alive, that were obtained, directly or indirectly, from Africa, 
or whose native habitat is Africa, any products derived from such 
rodents, any other animal, whether dead or alive, whose importation the 
Director has prohibited by order, or any products derived from such 
animals; and
    (ii) You must not prevent or attempt to prevent the Centers for 
Disease Control and Prevention (CDC) from causing an animal to be 
quarantined, re-exported, or destroyed under a written order.
    (2) The prohibitions in paragraph (a)(1) of this section do not 
apply if you have written permission from CDC to import a rodent that 
was obtained, directly or indirectly, from Africa, or whose native 
habitat is Africa, or an animal whose importation the Director has 
prohibited by order.
    (i) To obtain such written permission from CDC, you must send a 
written request to Division of Global Migration and Quarantine, 
National Center for Infectious Diseases, Centers for Disease Control 
and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. You may also fax 
your request to the Division of Global Migration and Quarantine (using 
the same address in the previous sentence) at 404-498-1633.
    (ii) Your request must state the reasons why you need an exemption, 
describe the animals involved, describe the number of animals involved, 
describe how the animals will be transported (including carrying 
containers or cages, precautions for handlers, types of vehicles used, 
and other procedures to minimize exposure of animals and precautions to 
prevent animals from escaping into the environment), describe any 
holding facilities, quarantine procedures, and/or veterinarian 
evaluation involved in the animals' movement, and explain why an 
exemption will not result in the spread of monkeypox within the United 
States. Your request must be limited to scientific, exhibition, or 
educational purposes.
    (iii) We will respond in writing to all requests, and we also may 
impose conditions in granting an exemption. If we deny your request, 
you may appeal that denial. Your appeal must be in writing and be 
submitted to the CDC official whose office denied your request, and you 
must submit the appeal within two business days after you receive the 
denial. Your appeal must state the reasons for the appeal and show that 
there is a genuine and substantial issue of fact in dispute. We will 
issue a written response to the appeal, which shall constitute final 
agency action.
    (3) The prohibitions in paragraph (a) of this section do not apply 
to products derived from rodents that were obtained, directly or 
indirectly, from Africa, or whose native habitat is Africa, or products 
derived from any other animal whose importation the Director has 
prohibited by order if such products have been properly processed to 
render them noninfectious so that they pose no risk of transmitting or 
carrying the monkeypox virus. Such products include, but are not 
limited to, fully taxidermied animals and completely finished trophies; 
and they may be imported without written permission from CDC.
    (b) What actions can CDC take? (1) To prevent the monkeypox virus 
from spreading and becoming established in the United States, we may, 
in addition to any other authorities under this part:
    (i) Issue an order causing an animal to be placed in quarantine,
    (ii) Issue an order causing an animal to be re-exported,
    (iii) Issue an order causing an animal to be destroyed, or
    (iv) Take any other action necessary to prevent the spread of the 
monkeypox virus.
    (2) Any order causing an animal to be quarantined, re-exported, or 
destroyed will be in writing.
    (c) How do I appeal an order? If you received a written order to 
quarantine or re-export an animal or to cause an animal to be 
destroyed, you may appeal that order. Your appeal must be in writing 
and be submitted to the CDC official whose office issued the order, and 
you must submit the appeal within 2 business days after you receive the 
order. Your appeal must state the reasons for the appeal and show that 
there is a genuine and substantial issue of fact in dispute. We will 
issue a

[[Page 71948]]

written response to the appeal, which shall constitute final agency 
action.

    Dated: November 21, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-23312 Filed 11-22-05; 11:43 am]
BILLING CODE 4163-18-U