71892 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 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 

qrulepubliccomments@cdc.gov. 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 §§ 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 vaccineresistant 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 

Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 71893 

1The 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. 

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 § 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. 

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) 

71894 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 probablecause 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. FloresMontano, 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 

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

71896 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 § 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 

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

71898 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 

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

Data elements required by CDC NPRM Currently collected by airlines 

Required by 

DHS/APIS for 

international 

flights 

Name ........................................................................................... Yes ............................................................................................ Yes. 

Emergency contact ..................................................................... Intermittent to rarely for domestic flights, more frequently for 

international flights.

No. 

Flight information ........................................................................ Yes ............................................................................................ Yes. 

Phone number ............................................................................ Intermittent ................................................................................ No. 

Email address ............................................................................. Intermittent—usually only for Internet, phone, or travel agent 

reservations.

No. 

Current home address ................................................................ Intermittent—usually only for Internet or travel agent reservations.No. 

Passport or travel document number and country (for foreign 

nationals for domestic and international flights).

Only for international flights ...................................................... Yes. 

Traveling companions ................................................................. No .............................................................................................. No. 

Returning flight information ......................................................... Usually only if booked at same time or with same airline ........ No. 

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 § 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 

71900 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 § 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 § 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 § 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 

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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 

§ 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: § 70.6(a) (travel permits 

requirements relating to carriers), 

§ 70.11 (sanitary measures), and § 70.12 

(detention of carriers affecting interstate 

commerce). A limited exemption is also 

created with respect to § 70.6(c) (travel 

permit requirements relating to persons 

who know that they are in the 

qualifying stage of a quarantinable 

disease) and § 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 § 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 (§ 70.2 

& § 70.3) and passenger information 

(§ 70.4 & § 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 § 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 § 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.’’

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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 §§ 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 § 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. 

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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 organismspecific 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 §§ 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 § 70.21. 

Paragraph (f) explains that nothing in 

§ 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 § 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 

71904 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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: 

Disease Incubation period following exposure Period of communicability following onset of illness 

Cholera ................................. Few hours—5 days ......................................................... 7–14 days. 

Diphtheria ............................. 2–5 days .......................................................................... 30 days. 

Infectious Tuberculosis ........ Primary: 4–6 weeks; Secondary: variable ...................... 14–60 days. 

Influenza ............................... 1–4 days .......................................................................... 5–14 days. 

Plague .................................. Pneumonic: 1–7 days (usually 2–4) ............................... 48 hours–14 days. 

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 

§ 70.16 shall be construed to limit the 

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

71906 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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. 

Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 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 § 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 § 70.14 

and § 70.15, quarantine under § 70.16–

§ 70.18, § 70.20, and medical 

examination and monitoring under 

§ 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 

71908 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 inadequate local control ....................... 70.2 Report of death or illness 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; special requirements ................ 70.7 Responsibility with respect to minors, wards, and patients. 

70.6 Apprehension and detention of persons with specific diseases ... 70.8 Military services. 

70.7 Responsiblity with respect to minors, wards, and patients. .......... 70.9(new) Vaccination clinics. 

70.8 Members of military and naval forces ........................................... 70.10(new) Establishment of 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. 

Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 71909 

TABLE IV–1.—SECTIONS UPDATED AND/OR RECODIFIED IN 42 CFR PART 70—Continued 

Current regulation Proposed regulation 

Section Section 

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 

§ 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 § 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 § 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 § 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 

§ 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 § 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. 

71910 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 § 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 § 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 § 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 § 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 

§ 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 § 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 § 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 § 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 

§ 70.11. 

Section 71.14 Detention of Carriers 

This section contains provisions 

comparable to those contained in 

§ 70.12 and current § 71.31(b). 

Section 71.15 Carriers of U.S. Military 

Services 

This section carries over provisions 

contained in current § 71.34. 

Section 71.16 Screenings to Detect Ill 

Persons 

This section contains procedures 

comparable to those contained in 

§ 70.13 at U.S. ports. 

Section 71.17 Provisional Quarantine 

of Arriving Persons 

This section contains procedures 

comparable to those contained in 

§ 70.14. 

Section 71.18 Provisional Quarantine 

Orders 

This section contains procedures 

comparable to those in § 70.15. 

Section 71.19 Quarantine 

This section contains procedures 

comparable to those in § 70.16. 

Section 71.20 Content of Quarantine 

Order 

This section contains procedures 

comparable to those in § 70.17. 

Section 71.21 Service of Quarantine 

Order 

This section contains procedures 

comparable to those in § 70.18. 

§ 71.22 Medical Examination and 

Monitoring 

This section contains provisions 

comparable to those contained in 

§ 70.19. 

Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 71911 

Section 71.23 Hearings 

This section contains procedures 

comparable to those in § 70.20. 

Section 71.24 Care and Treatment of 

Arriving Persons 

This section contains provisions 

comparable to those contained in 

§ 70.21. 

Section 71.25 Arriving Foreign 

Nationals 

This section contains provisions 

comparable to those contained in 

§ 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 § 70.23. 

Section 71.27 Food, Potable Water, 

and Waste: U.S. Seaports and Airports 

This section carries over provisions 

contained in current § 71.45. 

Section 71.28 Health Documents in 

International Traffic 

This section carries over provisions 

contained in current § 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 § 70.10. 

Section 71.31 Penalties 

The penalties listed in this section are 

the same as those listed in § 70.29. 

Section 71.32 Implementation 

Through Order 

This section contains measures 

comparable to those in § 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 

71912 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

TABLE V–1.—SECTIONS UPDATED AND/OR RECODIFIED IN 42 CFR PART 71 

Current regulation Proposed regulation 

Subpart A—Definitions and General Provisions Proposed Regulation A. Subpart A—General 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 vaccination centers; Validation 

stamps.

71.3 (new) Vaccination clinics. 

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 surveillance ............................................. 71.15 (modified) Carriers of U.S. military services. 

71.34 Carriers of U.S. military services ................................................. 71.16 (new) Screenings to detect ill persons. 

71.35 Report of death or illness on carrier during stay in port ............. 71.17 (new) Provisional 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: U.S. seaports and airports ...... 71.29 (modified) Special provisions relating to airports: Office, examination, and quarantine facilities. 

71.30 (new) Establishment of institutions, hospitals and stations. 

71.46 Issuance of deratting certificates and deratting exemption certificates.71.31 (new) Penalties. 

71.47 Special provisions relating to airports: Office and isolation facilities.71.32 (new) Implementation through order. 

71.48 Carriers in intercoastal and interstate traffic ................................ 71.33 (new) Appeals of actions 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 vectors ......................................... 71.54 Etiological agents, hosts, and vectors. 

71.55 Dead bodies ................................................................................. 71.55 (modified) Dead bodies. 

71.56 African rodents and other animals that may carry monkey pox 

virus.

71.56 African rodents and other 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, 

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

71914 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 

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

Airline type Number 

Passengers 

(millions) 

Flights 

(thousands) Revenue ($ 

millions) 

Net income ($ 

millions) Total Average Total Average 

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 

71916 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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

Number of 

cruise lines Foreign or domestic 

Total Average 

Ships Passengers Revenues 

($ millions) 

Ships per 

line 

Berths per 

ship 

Revenues 

per line ($ 

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. 

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

71918 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

TABLE VI.F–3A.—ESTIMATED ANNUALIZED NATIONAL COSTS FOR THE POINT OF SALE SCENARIO

[$ millions, 2004] 

Affected entity 

Option 1: 

International 

only 

Option 2: 

International 

plus large and 

medium hubs 

Option 3: 

International 

plus all 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] 

Affected entity 

Option 1: 

International 

only 

Option 2: 

International 

plus large and 

medium hubs 

Option 3: 

International 

plus all 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 outbreakrelated 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 outbreakcaused 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 

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

Outcome Base case Earlier 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] 

Outcome 

Option 1: 

International 

only 

Option 2: 

International 

plus medium 

and large hubs 

Option 3: 

International 

plus all 

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 

71920 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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

Parameter 

Option 1: International only 

Option 2: International plus 

medium and large hubs 

Option 3: International 

plus all domestic 

Total cost 

and benefit 

Incremental 

net benefit 

Total cost 

and benefit 

Incremental 

net benefit 

Total cost 

and benefit 

Incremental 

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

Parameter 

Option 1: International only 

Option 2: International plus 

medium and large hubs 

Option 3: International 

plus all domestic 

Total cost 

and benefit 

Incremental 

net benefit 

Total cost 

and benefit 

Incremental 

net benefit 

Total cost 

and benefit 

Incremental 

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) 

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

Parameter 

Option 1: International only 

Option 2: International plus 

medium and large hubs 

Option 3: International 

plus all domestic 

Total cost 

and benefit 

Incremental 

net benefit 

Total cost 

and benefit 

Incremental 

net benefit 

Total cost 

and benefit 

Incremental 

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] 

Option 

Annualized 

cost 

($ millions) 

QALYs 

Incremental 

cost 

($ millions) 

Incremental 

QALYs 

Average 

cost effectiveness 

($/QALY) 

Incremental 

cost effectiveness 

($/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] 

Option 

Annualized 

cost 

($ millions) 

QALYs 

Incremental 

cost 

($ millions) 

Incremental 

QALYs 

Average 

cost effectiveness 

($/QALY) 

Incremental 

cost effectiveness 

($/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 

71922 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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] 

Option 

Annualized 

cost 

($ millions) 

QALYs 

Incremental 

cost 

($ millions) 

Incremental 

QALYs 

Average 

cost effectiveness 

($/QALY) 

Incremental 

cost effectiveness 

($/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

Annualized 

costs 

($ millions, 

2004) 

Number of 

outbreaks in 

10 years for 

benefits to 

equal costs 

Frequency 

of outbreaks 

to 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 

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

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 

71924 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 § 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: 

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

CFR Section Number of 

respondents 

Annual 

frequency per 

response 

Total number 

of responses 

Hours per 

response 

(in minutes) 

Total hours 

42 CFR 70.2 ........................................................................ 1,549 1 1,549 2/60 52 

42 CFR 70.3 and 42 CFR 71.7 (first year) .......................... 217 1 217 60/60 217 

42 CFR 70.3 and 42 CFR 71.7 (subsequent years) ........... 217 1 217 10/60 36 

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 

71926 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 

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

§ 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 

§ 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 § 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 § 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 

71928 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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: 

—§ 70.3 Reporting of death or illness, 

plan and implementation. 

—§ 70.5 Passenger and crew 

information, plan and 

implementation. 

—§ 71.7 Reporting of death or illness 

on board flights, plan and 

implementation. 

—§ 71.9 Reporting of death or illness 

on board ship, plan and 

implementation. 

—§ 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: 

Æ § 70.4 Passenger information 

Æ § 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 (§§ 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 §§ 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 

Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 71929 

Authority: 25 U.S.C. 198, 231, and 1661; 42 

U.S.C. 243, 248, 249, 264–272, and 2001. 

§ 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° F (or 

38° 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° F (or 

38° 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° F (or 38° 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. 

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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. 

§ 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 § 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. 

§ 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 § 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 § 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. 

§ 70.4 Passenger information. 

(a) Any airline operating flights in 

interstate traffic shall, pursuant to the 

written plan required under § 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 § 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); 

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(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. 

§ 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 

§ 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 § 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 § 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 § 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 § 70.4 that may be in the 

airline’s possession. 

§ 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 

§ 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 § 70.24 or whenever 

the Director, with the concurrence of the 

Secretary, makes a determination of 

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inadequate local control in accordance 

with § 70.25. 

§ 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 § 70.31. 

§ 70.8 Military services. 

(a) The Director may exempt carriers 

belonging to the military services from 

§ 70.6(a) and §§ 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 §§ 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. 

§ 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., postexposure, 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: 

Vaccine Effective 

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. 

§ 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. 

§ 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 

§ 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. 

§ 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. 

§ 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. 

§ 70.14 Provisional quarantine. 

(a) The Director may provisionally 

quarantine a person or group of persons 

who the Director reasonably believes to 

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

§ 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. 

§ 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. 

§ 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. 

71934 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

(b) When authorized by the Director, 

quarantine orders may be issued and 

signed by electronic means. 

§ 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. 

§ 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 § 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. 

§ 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. 

§ 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 thirdparty 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 nonquarantinable disease. 

§ 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 

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

§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 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 

§§ 70.14 and 70.15; 

(2) Quarantine pursuant to §§ 70.16 

through 70.18, 70.20; and 

(3) Medical examination and 

monitoring pursuant to § 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). 

§ 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 

71936 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 

§§ 70.14 and 70.15; 

(2) Quarantine pursuant to § 70.16 

through 70.18, 70.20; and 

(3) Medical examination and 

monitoring pursuant to § 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. 

§ 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. 

§ 70.30 Implementation through order. 

The Director may implement any of 

the provisions in this part through order 

issued and signed by the Director. 

§ 70.31 Appeals of actions required 

pursuant to §§ 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 § 70.6; 

(2) A parent, guardian, physician, 

nurse, or other such person whose 

application for a travel permit has been 

denied pursuant to § 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 

§ 70.11; 

(3) The owner of a carrier to be 

detained pursuant to § 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 §§ 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 § 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 

§ 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 °F (or 

38 °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 °F (or 

38 °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 °F (or 38 °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 FiftyEighth 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, 

71938 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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. 

§ 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; 

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(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. 

§ 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., postexposure, 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. 

§ 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. 

§ 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. 

§ 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 § 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. 

§ 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 

§ 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 

§ 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. 

§ 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 

71940 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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. 

§ 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 § 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 § 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. 

§ 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 § 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 

§ 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. 

§ 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 

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

§ 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. 

§ 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 

§ 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. 

§ 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. 

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§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 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 contraindicated 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. 

§ 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; 

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(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. 

§ 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. 

§ 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 § 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. 

§ 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 videoconferencing 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. 

§ 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 thirdparty 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 

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medical facility and ends when the 

person’s condition is diagnosed, as 

determined by the Director, with a nonquarantinable disease. 

§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 71.32 Implementation through order. 

The Director may implement any of 

the provisions of this part through order 

issued and signed by the Director. 

§ 71.33 Appeals of actions required 

pursuant to §§ 71.13 or 71.14. 

If the Director requires export or 

destruction of animals, articles, or 

things pursuant to § 71.13 or detention 

of a carrier pursuant to § 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 §§ 71.13 or 71.14. 

Subpart B—Importations 

§ 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. 

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(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 § 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 rabiesfree (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. 

§ 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 

71946 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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 

§ 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. 

§ 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 

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

§ 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. 

§ 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. 

§ 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, reexported, 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 

71948 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Proposed Rules 

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