Control of Communicable Diseases, 71892-71948 [05-23312]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

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



[[Page 71891]]

-----------------------------------------------------------------------

Part II





Department of Health and Human Services





-----------------------------------------------------------------------



42 CFR Parts 70 and 71



Control of Communicable Diseases; Proposed Rule

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

[[Page 71892]]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.cdc.gov/ncidod/dq. You may 
submit written comments electronically via the Internet at https://
www.regulations.gov or via e-mail to qrulepubliccomments@cdc.gov. To 
download an electronic version of the rule, you may access https://
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

[[Page 71893]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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)

[[Page 71894]]

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

[[Page 71895]]

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.''

[[Page 71896]]

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 https://www.cdc.gov and https://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