Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Proposed Rules 75939 

responsibilities among the various 

levels of government.’’ 

H. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS/CDC has 

attempted to use plain language in 

promulgating this rule consistent with 

the Federal Plain Writing Act and 

requests public comment on this effort. 

List of Subjects in 42 CFR Part 70 

Communicable diseases, CDC, 

Isolation, Public health, Quarantine, 

Quarantinable Communicable Disease. 

Proposed Text 

For the reasons discussed in the 

preamble, the Centers for Disease 

Control and Prevention proposes to 

amend 42 CFR part 70 as follows: 

PART 70—INTERSTATE QUARANTINE 

1. The authority citation for part 70 

continues to read as follows: 

Authority: Secs. 215 and 311 of the Public 

Health Service (PHS) Act, as amended (42 

U.S.C. 216, 243); section 361–369, PHS Act, 

as amended (42 U.S.C. 264–272); 31 U.S.C. 

9701. 

2. Amend § 70.1 as follows: 

a. Remove paragraph designations (a), 

(b), (c), (d), (e), (f), and (g). 

b. Add in alphabetical order 

definitions of CDC, Conditional release, 

Director, Isolation, Master or Operator, 

Quarantine, Quarantinable 

communicable disease, and U.S. 

Territory. 

c. Revise the definitions of Possession 

and State. The revisions and additions 

read as follows: 

§ 70.1 General definitions. 

* * * * * 

CDC means the Centers for Disease 

Control and Prevention, Department of 

Health and Human Services. 

* * * * * 

Conditional release means 

‘‘surveillance’’ as that term is defined in 

42 CFR 71.1. 

* * * * * 

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 of HHS. 

* * * * * 

Isolation means the separation of an 

individual or group reasonably believed 

to be infected with a quarantinable 

communicable disease from those who 

are healthy to prevent the spread of the 

quarantinable communicable disease. 

Master or Operator means the aircrew 

or sea crew member with responsibility 

respectively for aircraft or vessel 

operation and navigation, or a similar 

individual with responsibility for a 

conveyance. 

Possession means U.S. Territory. 

Quarantine means the separation of 

an individual or group reasonably 

believed to have been exposed to a 

quarantinable communicable disease, 

but who are not yet ill, from others who 

have not been so exposed, to prevent the 

possible spread of the quarantinable 

communicable disease. 

Quarantinable communicable 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 

communicable 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. 

State means any of the 50 states, plus 

the District of Columbia. 

U.S. Territory means any territory 

(also known as possessions) of the 

United States, including American 

Samoa, Guam, the Northern Mariana 

Islands, the Commonwealth of Puerto 

Rico, and the U.S. Virgin Islands. 

* * * * * 

3. Revise § 70.6 to read as follows: 

§ 70.6 Apprehension and detention of 

persons with specific diseases. 

Regulations prescribed in this part 

authorize the detention, isolation, 

quarantine, or conditional release of 

individuals, for the purpose of 

preventing the introduction, 

transmission, and spread of the 

communicable diseases listed in an 

Executive Order setting out a list of 

quarantinable communicable diseases, 

as provided under section 361(b) 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 

communicable diseases, and may be 

obtained at http://www.cdc.gov/ 

quarantine and http:// 

www.archives.gov/federal_register. If 

this Order is amended, HHS will 

enforce that amended order 

immediately and update its Web site. 

Dated: December 13, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–30726 Filed 12–21–12; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. CDC–2012–0017] 

RIN 0920–AA12 

Control of Communicable Diseases: 

Foreign; Scope and Definitions 

AGENCY: Centers for Disease Control and 

Prevention (HHS/CDC), Department of 

Health and Human Services (HHS). 

ACTION: Notice of Proposed Rulemaking 

and request for comments. 

SUMMARY: Through this Notice of 

Proposed Rulemaking (NPRM), the 

Centers for Disease Control and 

Prevention (CDC), located within the 

Department of Health and Human 

Services (HHS) is proposing to update 

and reorganize the Scope and 

Definitions for foreign quarantine 

regulations and add a new section to 

contain definitions for Importations. 

This NPRM proposes to update the 

Scope and Definitions to reflect modern 

terminology and plain language used 

globally by industry and public health 

partners. As part of the proposed 

updates, we are updating five existing 

definitions; adding thirteen new 

definitions to help clarify existing 

provisions; creating a new scope and 

definitions section for Importations 

under a new section by reorganizing 

existing definitions into this new 

section; and updating regulations to 

reflect the language used by the most 

recent Executive Order regarding 

quarantinable communicable diseases. 

DATES: Submit written or electronic 

comments by January 25, 2013. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA12’’: by any 

of the following methods: 

• Internet: Access the Federal 

e-Rulemaking Portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Global Migration 

and Quarantine, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE., MS–03, Atlanta, Georgia 

30333, ATTN: Part 71 NPRM. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 


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relevant comments will be posted 

without change to http:// 

regulations.gov, including any personal 

information provided. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, please go to 

http://www.regulations.gov. Comments 

will also be available for public 

inspection Monday through Friday, 

except for legal holidays, from 9 a.m. 

until 5 p.m., Eastern Standard Time, at 

1600 Clifton Road NE., Atlanta, Georgia 

30333. Please call ahead to 1–866–694– 

4867 and ask for a representative in the 

Division of Global Migration and 

Quarantine (DGMQ) to schedule your 

visit. To download an electronic version 

of the rule, access http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning this notice of 

proposed rulemaking: Ashley A. 

Marrone, JD, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop E–03, Atlanta, Georgia 30333; 

telephone 404–498–1600. 

SUPPLEMENTARY INFORMATION: HHS/CDC 

is simultaneously publishing a 

companion direct final rule (DFR) in the 

Federal Register that proposes identical 

updates because we believe that these 

requirements are non-controversial and 

unlikely to generate significant adverse 

comment. If HHS/CDC does not receive 

any significant adverse comments on 

the DFR within the specified comment 

period, we will publish a document in 

the Federal Register withdrawing this 

NPRM and confirming the effective date 

of the DFR within 30 days after the 

public comment period on the DFR 

ends. If HHS/CDC receives any timely 

significant adverse comment, we will 

withdraw the DFR in part or in whole 

by publication of a document in the 

Federal Register within 30 days after 

the comment period ends. If the DFR is 

withdrawn, we will carefully consider 

all public comments before proceeding 

with any subsequent final rule based on 

the NPRM. A significant adverse 

comment is one that explains: (1) why 

the DFR is inappropriate, including 

challenges to the rule’s underlying 

premise or approach; or (2) why the 

DFR will be ineffective or unacceptable 

without a change. 

This preamble is organized as follows: 

I. Public Participation 

II. Authority for These Regulations 

III. Proposed Updates to 42 CFR 71.1, 

71.32(a) and 71.50 

IV. Proposed Scope and Definitions for 

Section 71.1 

A. Definitions Updated Under Section 71.1 

B. Definitions Added to Section 71.1 

V. Proposed Update of Section 71.32(a) 

VI. Proposed Scope and Definitions for 

Section 71.50 

A. Definitions Added to Section 71.50 

VII. Alternatives Considered 

VIII. Required Regulatory Analysis 

A. Required Regulatory Analyses Under 

Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Small Business Regulatory Enforcement 

Fairness Act of 1996 

D. The Paperwork Reduction Act of 1995 

E. National Environmental Policy Act 

(NEPA) 

F. Civil Justice Reform (Executive Order 

12988) 

G. Executive Order 13132 (Federalism) 

H. Plain Language Act of 2010 

I. Public Participation 

Interested persons are invited to 

participate in this rulemaking by 

submitting written views, opinions, 

recommendations, and data. Comments 

received, including attachments and 

other supporting materials, are part of 

the public record and subject to public 

disclosure. Do not include any 

information in your comment or 

supporting materials that you do not 

wish to be disclosed publicly. 

Comments are invited on any topic 

related to this NPRM. 

II. Authority for These Regulations 

The primary authority supporting this 

rulemaking is section 361 of the Public 

Health Service Act (42 U.S.C. § 264). 

Section 361 authorizes the Secretary of 

HHS to make and enforce regulations as 

in the Secretary’s judgment are 

necessary to prevent the introduction, 

transmission, or spread of 

communicable diseases from foreign 

countries into the states or possessions 

of the United States and from one state 

or possession into any other state or 

possession. Regulations that implement 

federal quarantine authority are 

currently promulgated in 42 CFR Parts 

70 and 71. Part 71 contains regulations 

to prevent the introduction, 

transmission, and spread of 

communicable diseases into the states 

and possessions of the United States, 

while Part 70 contains regulations to 

prevent the introduction, transmission, 

or spread of communicable diseases 

from one state into another. CDC is 

proposing to update the term 

‘‘possession’’ to ‘‘territory.’’ The U.S. 

Department of the Interior’s Office of 

Insular Affairs, the lead federal agency 

on issues involving the territories, no 

longer uses the term ‘‘possession’’ to 

refer to the insular areas. Therefore, 

CDC is adopting the predominant term 

‘‘territory’’ consistent with how other 

federal agencies use this term. The 

Secretary has delegated to the Director 

of the Centers for Disease Control and 

Prevention the authority for 

implementing these regulations. 

Authority for carrying out most of 

these functions has been delegated to 

HHS/CDC’s Division of Global 

Migration and Quarantine (DGMQ). The 

Secretary’s authority to apprehend, 

examine, detain, and conditionally 

release individuals is limited to those 

quarantinable communicable diseases 

published in an Executive Order of the 

President. This list currently includes 

cholera, diphtheria, infectious 

tuberculosis (TB), plague, smallpox, 

yellow fever, and viral hemorrhagic 

fevers, such as Marburg, Ebola, and 

Crimean-Congo hemorrhagic fever 

(CCHF), Severe Acute Respiratory 

Syndrome (SARS), and influenza caused 

by novel or re-emergent 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). 

III. Updates to 42 CFR 71.1, 71.32(a) 

and 71.50 

Through this Notice of Proposed 

Rulemaking (NPRM), HHS/CDC 

proposes to update the Scope and 

Definitions for 42 CFR Part 71 under 

section 71.1 and adding a new section 

71.50, to reflect modern terminology 

and plain language commonly used by 

global private sector industry and public 

health partners. Specifically, we are 

updating five existing definitions, 

adding thirteen new definitions to help 

clarify existing provisions, and creating 

a new scope and definitions section 

within Part 71, under subpart F for 

Importations, by reorganizing certain 

existing definitions. In updating the 

definitions in Part 71, it became evident 

to us that certain definitions pertain 

more directly to Importations under 

subpart F than to Part 71 in general; 

therefore, we have decided to reorganize 

the existing definitions by creating a 

new section 71.50 for this subpart to 

contain these definitions to better clarify 

the terms for importers. We are also 

adding new definitions for section 71.50 

to clarify the intent of certain provisions 

under subpart F. 

Finally, as part of the proposed 

changes to definitions, we are also 

updating section 71.32(a) incorporate 

the most recent listing of quarantinable 

communicable diseases under Executive 

Order 13295, of April 4, 2003, as 

amended by Executive Order 13375 of 


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April 1, 2005. These proposed changes 

are not substantive and will not affect 

current practices. 

IV. Proposed Scope and Definitions for 

Section 71.1 

Proposed section 71.1(a) has been 

updated to include the current interstate 

quarantine regulations administered by 

HHS/CDC found at ‘‘42 CFR part 70’’ to 

the existing cross-reference citing ‘‘21 

CFR parts 1240 and 1250.’’ 

On August 16, 2000, the Secretary 

transferred certain authority for 

interstate control of communicable 

disease, including the authority to 

apprehend, examine, detain, and 

conditionally release individuals 

moving from one state into another from 

HHS/Food and Drug Administration 

(FDA) to HHS/CDC, which became 42 

CFR Part 70. As part of this transfer, 

FDA retained regulatory authority over 

animals and other products that may 

transmit or spread communicable 

disease. These other regulations may be 

found at 21 CFR parts 1240 and 1250. 

This rule has no effect upon FDA’s 

regulatory authority. Accordingly, the 

proposed scope reads: ‘‘The provisions 

of this part contain the regulations to 

prevent the introduction, transmission, 

and spread of communicable disease 

from foreign countries into the States or 

territories (also known as possessions) 

of the United States. Regulations 

pertaining to preventing the interstate 

spread of communicable diseases are 

contained in 21 CFR parts 1240 and 

1250 and 42 CFR part 70.’’ 

Current section 71.1 (b) Definitions 

contains definitions of terms used in the 

current CFR. The NPRM proposes new 

or updated definitions for clarification 

and to be consistent with current 

industry and public health principles 

and practice. 

Table 1 lists the definitions found in 

the current 42 CFR part 71, subpart A, 

and compares them with the updated 

definitions in this NPRM. 

TABLE 1—SUBPART A—FOREIGN QUARANTINE

DEFINITIONS AND CORRESPONDING CHANGES IN DEFINITIONS IN THE NPRM 

Existing definitions in Part 42 CFR 71.1 Corresponding, new or updated definition in NPRM 

Carrier ....................................................................................................................... No Change. 

Commander. 

Communicable disease ............................................................................................. No Change. 

Contamination ........................................................................................................... No Change. 

Controlled Free Pratique ........................................................................................... No Change. 

Deratting Certificate .................................................................................................. No Change. 

Deratting Exemption Certificate ................................................................................ No Change. 

Detention ................................................................................................................... No Change. 

Director ...................................................................................................................... No Change. 

Disinfection ................................................................................................................ No Change. 

Disinfestation ............................................................................................................. No Change. 

Disinsection ............................................................................................................... No Change. 

Educational Purpose ................................................................................................. Moved to new 71.50. 

Exhibition Purpose .................................................................................................... Moved to new 71.50. 

Ill person .................................................................................................................... No Change. 

International Health Regulations ............................................................................... Updated. 

International voyage .................................................................................................. No Change. 

Isolation ..................................................................................................................... Updated. 

Military Services ........................................................................................................ No Change 

Quarantine. 

Quarantinable Communicable disease. 

Possession. 

Scientific Purpose ..................................................................................................... Moved to new 71.50. 

Surveillance ............................................................................................................... Updated. 

U.S. port .................................................................................................................... No Change. 

U.S. Territory. 

United States ............................................................................................................. Updated. 

Vector ........................................................................................................................ Updated. 

A. Definitions Updated Under Section 

71.1 

International Health Regulations or 

IHR. This NPRM defines International 

Health Regulations or IHR as the 

International Health Regulations of the 

World Health Organization (WHO), 

adopted by the 58th World Health 

Assembly in 2005, as may be further 

amended, and subject to the United 

States’ reservation and understandings. 

The NPRM proposes to update the 

current CFR’s definition to reflect that 

the 1969 IHR, as amended in 1973 and 

1981 by the World Health Assembly, 

has been superseded by the 2005 IHR 

currently in place. This definition also 

reflects that the United States accepted 

the IHR with the reservation that it will 

implement them in line with U.S. 

principles of federalism. In addition, the 

United States submitted three 

understandings, setting forth its views 

that: (1) incidents that involve the 

natural, accidental or deliberate release 

of chemical, biological or radiological 

materials are notifiable under the IHR; 

(2) countries that accept the IHR are 

obligated to report potential public 

health emergencies that occur outside 

their borders to the extent possible; and 

(3) the IHR do not create any separate 

private right to legal action against the 

federal government. 

Isolation. The NPRM proposes to 

update the term ‘‘isolation’’ to mean the 

separation of an individual or group of 

individuals who are reasonably believed 

to be infected with a quarantinable 

communicable disease from others who 

are healthy in such a manner as to 

prevent the spread of the quarantinable 

communicable disease. The current 

definition of ‘‘isolation,’’ when applied 

to an individual or group of individuals 

is stated as ‘‘the separation of that 

person or group of persons from other 

persons, except the health staff on duty, 

in such a manner necessary as to 

prevent the spread of infection.’’ Not 

only does the updated definition help to 

clarify the distinction between 


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quarantine and isolation, but it removes 

the current reference to ‘‘health staff on 

duty’’ to which the separation does not 

apply. HHS/CDC believes that the 

reference to ‘‘health staff on duty’’ is 

unnecessary and outmoded because, in 

practice, a patient may have his or her 

needs attended to by a variety of 

individuals. The new definition focuses 

on the measures used to prevent the 

spread of infection and not on the types 

of individuals who may attend to the 

patient. This is not a substantive change 

from current practice. 

Surveillance. Under this NPRM, HHS/ 

CDC is proposing to define 

‘‘surveillance’’ as the temporary 

supervision by a public health official 

(or designee) of an individual or group, 

who may have been exposed to a 

quarantinable communicable disease, to 

determine the risk of disease spread. We 

are proposing to update the term 

‘‘surveillance’’ to more accurately reflect 

current practice and to clarify that, just 

as with quarantine and isolation, this 

public health measure is applicable to 

individuals and groups of individuals. 

United States. We are proposing to 

update the definition of ‘‘United States’’ 

to mean the 50 States, the District of 

Columbia, and the territories (also 

known as possessions) of the United 

States, including American Samoa, 

Guam, the Northern Mariana Islands, 

the Commonwealth of Puerto Rico, and 

the U.S. Virgin Islands. We are 

proposing this action to better clarify 

the authority of provisions within Part 

71. The current definition includes the 

Trust Territory of the Pacific Islands, 

which have not been administered by 

the United States since 1986. 

Vector. We propose to update the 

term ‘‘vector’’ to be defined as any 

animals (vertebrate or invertebrate) 

including arthropods or any 

noninfectious self-replicating system 

(e.g., plasmids or other molecular 

vector) or animal products that are 

known to transfer, or are capable of 

transferring, an infectious biological 

agent to a human. To provide further 

clarity, we have defined the term 

‘‘animal products’’ in subpart F. This 

revision more adequately reflects 

modern science and current practice 

which are focused on protecting public 

health. 

B. Definitions Added to Section 71.1 

Commander. Consistent with current 

industry practice, this NPRM proposes 

to define ‘‘commander’’ as the aircrew 

member with responsibility for the 

aircraft’s operations and navigation. 

Quarantine. HHS/CDC is proposing to 

separately define ‘‘quarantine’’ as the 

separation of an individual or group of 

individuals who are reasonably believed 

to have been exposed to a quarantinable 

communicable disease, who are not ill, 

from others who have not been so 

exposed, in such a manner as to prevent 

the possible spread of the quarantinable 

communicable disease. HHS/CDC is 

separately defining quarantine, 

isolation, and surveillance, and is using 

these terms in a manner that is 

consistent with public health practice. 

In current practice, quarantine, 

isolation, and surveillance may apply 

either to individuals or groups of 

individuals. Indeed, the current 

definition of Isolation in 42 CFR 71.1 

applies to ‘‘a person or group of 

persons.’’ HHS/CDC is clarifying that 

quarantine and surveillance are public 

health practices that may also be 

applied to groups of individuals. This is 

not a substantive change, but rather 

consistent with CDC’s current practice. 

Quarantinable communicable 

disease. Under the proposed definition, 

‘‘quarantinable communicable disease’’ 

means 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 

communicable diseases, and may be 

obtained at http://www.cdc.gov/ 

quarantine and http:// 

www.archives.gov/federal_register. If 

this Order is amended, HHS/CDC will 

enforce that amended order 

immediately and update its appropriate 

Web site. A proposed definition for 

‘‘quarantinable communicable disease’’ 

is being added to Part 71 through this 

NPRM to incorporate the most recent 

applicable Executive Order. The 

addition of this proposed definition will 

also be reflected in section 71.32(a), 

Persons, carriers and things. 

Possession. To best add clarity to Part 

71 and to align this Part with 42 CFR 

Part 70, we propose to update the term 

‘‘possession’’ to mean ‘‘U.S. territory’’ 

and define U.S. territory to include 

American Samoa, Guam, the 

Commonwealth of the Northern Mariana 

Islands, the Commonwealth of Puerto 

Rico, and the U.S. Virgin Islands. 

Currently, only Puerto Rico and the 

Virgin Islands are explicitly listed in the 

definition. Thus, CDC is updating this 

provision to explicitly list the other U.S. 

jurisdictions to which this part applies. 

U.S. territory. Consistent with current 

practice, this NPRM includes a 

proposed definition of ‘‘U.S. territory’’, 

to mean any territory (also known as 

possessions) of the United States 

including American Samoa, Guam, the 

Commonwealth of the Northern Mariana 

Islands, the Commonwealth of Puerto 

Rico, and the U.S. Virgin Islands. The 

Department of the Interior’s Office of 

Insular Affairs, the federal government’s 

lead agency for U.S. territories, no 

longer uses the term ‘‘possession’’ to 

refer to these jurisdictions. 

Consequently, HHS/CDC is proposing to 

add a new definition for U.S. territory 

consistent with current federal usage. 

V. Proposed Update of Section 71.32(a) 

In 2003, in response to the emergence 

of Severe Acute Respiratory Syndrome 

(SARS), the HHS amended 42 CFR 70.6 

and 71.32 to incorporate by reference 

the Executive Order listing the 

quarantinable communicable diseases 

subject to detention, isolation, 

quarantine, or conditional release, 

thereby eliminating the administrative 

delay involved in separately publishing 

the list of diseases through rulemaking. 

Section 71.32(a), Persons, carriers, 

and things, contains the general 

authority for the Director to take 

measures to protect public health 

against ‘‘any of the communicable 

diseases listed in an Executive Order, as 

provided under section 361(b) of the 

Public Health Service Act.’’ The current 

§ 71.32(a) lists Executive Order (E.O) 

13295, of April 4, 2003. The subpart 

states that ‘‘If this Order is amended, 

HHS will enforce that amended order.’’ 

On April 1, 2005, the existing 

Executive Order was amended by 

Executive Order 13375. Therefore, as 

part of the non-controversial proposed 

changes to in this NPRM, we are also 

updating section 71.32(a) to reflect the 

most recent Executive Order that lists 

the ‘‘Quarantinable Communicable 

Diseases,’’ which we have also defined. 

These proposed changes are not 

substantive and will not affect current 

practices. 

VI. Proposed Scope and Definitions for 

Section 71.50 

This NPRM proposes to move certain 

definitions from section 71.1 to new 

section 71.50, because these definitions 

only apply to the regulations found in 

subpart F, Importations. Subpart F, 

Importations, contains the restrictions 

on importations of nonhuman primates; 

certain kinds of animals; etiological 

agents, hosts, and vectors; and dead 

bodies. The proposed addition of 

§ 71.50 Scope and Definitions is not a 

substantive change. To clarify the 

regulations for the reader, the terms 

used only in subpart A through subpart 

G are found in § 71.1, while the terms 

used only in subpart F, have been 

moved to new § 71.50. We also propose 

separate definitions for quarantine and 


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isolation to reflect current practices as 

they apply to individuals (71.1) and 

animals (71.50). 

Proposed section 71.50(a) Scope 

under subpart F—Importations, clarifies 

that HHS/CDC also has the statutory 

authority to prevent the introduction, 

transmission, and spread of 

communicable human diseases resulting 

from importations of various animal 

hosts, product, vectors, or other 

etiological agents that pose a threat to 

human health. 

Proposed section 71.50 (b) Definitions 

contains updated definitions used in the 

current CFR. The NPRM promulgates 

new and updated definitions to be 

consistent with current medical and 

public health principles and practice. 

Table 2 lists the definitions found in 

the current 42 CFR part 71, subpart A, 

and the corresponding new or updated 

proposed definitions in this NPRM. 

TABLE 2—SUBPART F—IMPORTATIONS

Definitions and Corresponding Changes in Definitions in the NPRM 

Existing definitions in 42 CFR Part 71.1 Corresponding, new and modified definition in proposed 42 CFR 71.50 

Animal product or Product. 

Educational purpose ................................................................................................................................ No Change. 

Exhibition purpose .................................................................................................................................... No Change. 

In transit. 

Isolation, when applied to animals. 

Licensed Veterinarian. 

Person. 

Quarantine, when applied to animals. 

Rendered Noninfectious. 

Scientific purpose ..................................................................................................................................... No Change. 

You or Your. 

A. Definitions Added to Section 71.50 

Animal product or Product. We have 

defined the term ‘‘animal product’’ or 

‘‘product’’ to describe those items that 

are known to transfer, or are capable of 

transferring, an infectious biological 

agent to a human and that are 

prohibited from entering the United 

States unless accompanied by a permit 

or rendered noninfectious. For the 

purposes of this NPRM, ‘‘animal 

product’’ or ‘‘product’’ means the hide, 

hair, skull, teeth, bones, claws, blood, 

tissue, or other biological samples from 

an animal, including trophies, mounts, 

rugs, or other display items. We have 

proposed this definition, which is used 

in subpart F, to best describe the current 

prohibition on animal products that are 

known to transfer, or are capable of 

transferring, an infectious biological 

agent to a human and that as a condition 

of entry into the United States must be 

accompanied by a permit or rendered 

noninfectious. 

In transit. In this NPRM, we are 

proposing to define ‘‘in transit’’ as 

animals that are located within the 

United States, including animals whose 

presence is anticipated, scheduled, or 

otherwise, as part of the movement of 

those animals between a foreign country 

of departure and foreign country of final 

destination without clearing customs 

and officially entering the United States. 

As part of modern global trade and 

travel practices, animals commonly pass 

through the United States without being 

formally admitted into this country. 

These animals pose a potential risk to 

U.S. public health where the improper 

handling of these shipments during 

exchange of cargo could introduce 

zoonotic diseases into the United States. 

We note that the term ‘‘in-transit’’ is 

currently only found in section 71.51 

relating to the importation of dogs and 

cats and we believe it is useful to add 

clarity to this section by defining to 

what is meant by this term. 

Isolation, when applied to animals. 

We have proposed a definition of 

‘‘isolation’’ under this subpart to mean 

the separation of an ill animal or ill 

group of animals from individuals, other 

animals, or vectors of disease in such a 

manner as to prevent the spread of 

infection. We have proposed a separate 

definition under this subpart to 

distinguish the concept of isolation for 

individuals from isolation of animals, 

Licensed Veterinarian. We have 

proposed defining ‘‘licensed 

veterinarian’’ to mean an individual 

who has obtained both an advanced 

degree and a valid license to practice 

animal medicine. This new definition 

best describes the intent of provisions of 

this subpart. 

Person. We have proposed to define 

‘‘person’’ to mean any individual or 

partnership, firm, company, 

corporation, association, organization, 

or similar legal entity, including those 

that are not-for-profit. With the 

exception of 42 CFR section 71.55, 

which refers to the imported remains of 

a natural person, this definition is 

intended to clarify the relevant import 

prohibitions applicable to individuals 

and organizations under this subpart. 

Quarantine, when applied to animals. 

We have proposed defining 

‘‘quarantine’’ as it applies to animals as 

the practice of separating live animals 

that are reasonably believed to have 

been exposed to a communicable 

disease, but are not yet ill, in a setting 

where the animal can be observed for 

evidence of disease, and where 

measures are in place to prevent 

transmission of infection to humans or 

animals. This new definition best 

clarifies the current public health 

measure of quarantining animals, and it 

distinguishes it from public health 

practice of isolation when applied to 

animals. 

Render Noninfectious. In this NPRM, 

we have proposed ‘‘render 

noninfectious’’ to mean treating an 

animal product (e.g., by boiling, 

irradiating, soaking, formalin fixation, 

or salting) in such a manner renders the 

product incapable of transferring an 

infectious biological agent to a human. 

Acceptable methods of rendering a 

product noninfectious typically include 

the following: 

(1) Boiling in water to ensure that any 

matter other than bone, horns, hooves, 

claws, antlers, or teeth is removed, 

(2) Irradiating with gamma irradiation 

at a dose of at least 20 kilogray at room 

temperature (20 °C or higher), 

(3) Soaking, with agitation, in a 4 

percent (weight/volume) solution of 

washing soda (sodium carbonate, 

Na2CO3) maintained at pH 11.5 or above 

for at least 48 hours, 

(4) Soaking, with agitation, in a formic 

acid solution (100 kg salt [sodium 

chloride, NaCl] and 12 kg formic acid 

per 1,000 liters water) maintained at 

below pH 3.0 for at least 48 hours; 


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wetting and dressing agents may be 

added. 

(5) In the case of raw hides, salting for 

at least 28 days with sea salt containing 

2 percent washing soda (sodium 

carbonate, Na2CO3). 

(6) Formalin fixation. 

(7) Another method approved by 

HHS/CDC. 

Through this definition within the 

NPRM, HHS/CDC is proposing to better 

clarify and explain existing practices 

that limit limiting the importation of 

animal products that are known to 

transfer, or are capable of transferring, 

an infectious biological agent to a 

human. Such products must be 

accompanied by an HHS/CDC import 

permit or rendered noninfectious as a 

condition of entry into the United 

States. Items that have been rendered 

noninfectious, as described in this 

subpart, may be imported without an 

HHS/CDC permit. 

You or your. To best identify and 

assign responsibilities under this 

subpart, we have defined the terms 

‘‘you’’ or ‘‘your’’ to mean an importer, 

owner, or an applicant. 

VII. Alternatives Considered 

Under Executive Order 13563 

agencies are asked to consider all 

feasible alternatives to current practice 

and the rule as proposed. HHS/CDC 

notes that the main impact of the 

proposed rule is to clarify the current 

practices and intent of HHS/CDC 

updating and defining terms used in the 

existing 42 CFR Part 71. As explained in 

Section III. ‘‘Rationale for Updates to 42 

CFR 71.1, 71.32(a) and 71.50,’’ through 

this NPRM, HHS/CDC proposes to 

update the Scope and Definitions for 42 

CFR Part 71 under sections 71.1 and add 

new section 71.50, to reflect modern 

terminology and plain language 

commonly used by global private sector 

industry and public health partners. By 

clarifying and explaining the provisions 

within part 71, HHS/CDC hopes to assist 

the regulated community in complying 

with the provisions to best protect 

public health. HHS/CDC believes that 

this rulemaking complies with the spirit 

of the Executive Order; updating 

definition and clarifying language 

provides good alternatives to the current 

regulation. 

VIII. Required Regulatory Analyses 

A. Required Regulatory Analyses Under 

Executive Orders 12866 and 13563 

Under Executive Order 12866 (EO 

12866), Regulatory Planning and Review 

(58 FR 51735, October 4, 1993) HHS/ 

CDC is required to determine whether 

this regulatory action would be 

‘‘significant’’ and therefore subject to 

review by the Office of Management and 

Budget (OMB) and the requirements of 

the Executive Orders. This order defines 

‘‘significant regulatory action’’ 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; 

• Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

• Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

obligations of recipients; or, 

• Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in EO 12866. 

Executive Order 13563 (EO 13563), 

Improving Regulation and Regulatory 

Review, (76 FR 3821, January 21, 2011), 

updates some of the provisions of EO 

12866 in order to promote more 

streamlined regulatory actions. This EO 

charges, in part, that, while protecting 

‘‘public health, welfare, safety, and our 

environment’’ that regulations must also 

‘‘promote predictability and reduce 

uncertainty’’ in order to promote 

economic growth. Further, regulations 

must be written in common language 

and be easy to understand. In the spirit 

of EO 13563, this NPRM enhances 

definitions related to control of 

communicable diseases and adds more 

recent medical information where 

appropriate. HHS/CDC has determined 

that this NPRM is an update of 

definitions and compliant with the 

spirit of EO 13563. Further, HHS/CDC 

has determined that this NPRM is not a 

significant regulatory action as defined 

in EO 12866 because the NPRM is 

definitional and does not change the 

baseline costs for any of the primary 

stakeholders. 

B. Regulatory Flexibility Act 

We have examined the impacts of the 

proposed rule under the Regulatory 

Flexibility Act (5 U.S.C. 601–612). 

Unless we certify that the proposed rule 

is not expected to have a significant 

economic impact on a substantial 

number of small entities, the Regulatory 

Flexibility Act (RFA), as amended by 

the Small Business Regulatory 

Enforcement Fairness Act (SBREFA), 

requires agencies to analyze regulatory 

options that would minimize any 

significant economic impact of a rule on 

small entities. We certify that this 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

This regulatory action is not a major 

rule as defined by Sec. 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This proposed rule 

will not result in an annual effect on the 

economy of $100,000,000 or more; a 

major increase in cost or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

D. The Paperwork Reduction Act of 

1995 

HHS/CDC has determined that the 

Paperwork Reduction Act does apply to 

the date collection and record keeping 

requirements of 42 CFR Part 71 and has 

obtained approval by the Office of 

Management and Budget (OMB) under 

OMB Control No. 0920–0134, expiration 

07/31/2015. The updates proposed in 

this rule do not impact the data 

collection and record keeping 

requirements already approved by OMB. 

E. National Environmental Policy Act 

(NEPA) 

Pursuant to 48 FR 9374 (list of HHS/ 

CDC program actions that are 

categorically excluded from the NEPA 

environmental review process), HHS/ 

CDC has determined that this action 

does not qualify for a categorical 

exclusion. In the absence of an 

applicable categorical exclusion, the 

Director, HHS/CDC, has determined that 

provisions amending 42 CFR Part 71 

will not have a significant impact on the 

human environment. Therefore, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

F. Civil Justice Reform (Executive Order 

12988) 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. Under this rule: (1) All State 

and local laws and regulations that are 

inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. 


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Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Proposed Rules 75945 

G. Executive Order 13132 (Federalism) 

HHS/CDC has reviewed this proposed 

rule in accordance with Executive Order 

13132 regarding Federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS/CDC has 

attempted to use plain language in 

promulgating this rule consistent with 

the Federal Plain Writing Act and 

requests public comment on this effort. 

List of Subjects in 42 CFR Part 71 

Communicable diseases, Isolation, In 

Transit, Public health, Quarantine, 

Quarantinable Communicable Disease, 

Render Noninfectious. 

Proposed Text 

For the reasons discussed in the 

preamble, the Centers for Disease 

Control and Prevention proposes to 

amend 42 CFR Part 71 as follows: 

PART 71—FOREIGN QUARANTINE 

1. The authority citation for part 71 

continues to read as follows: 

Authority: Secs. 215 and 311 of Public 

Health Service (PHS) Act as amended (42 

U.S.C. 216, 243); secs. 361–369, PHS Act, as 

amended (42 U.S.C. 264–272). 

2. Amend § 71.1 as follows: 

a. Revise paragraph (a). 

b. In paragraph (b), add in 

alphabetical order definitions of 

Commander, Quarantine, Quarantinable 

communicable disease, and U.S. 

territory. 

c. In paragraph (b), revise definitions 

of International Health Regulations, 

Isolation, Surveillance, United States, 

and Vector. The revisions and additions 

read as follows: 

§ 71.1 Scope and definitions. 

* * * * * 

(a) The provisions of this part contain 

the regulations to prevent the 

introduction, transmission, and spread 

of communicable disease from foreign 

countries into the States or territories 

(also known as possessions) of the 

United States. Regulations pertaining to 

preventing the interstate spread of 

communicable diseases are contained in 

21 CFR parts 1240 and 1250 and 42 CFR 

part 70. 

(b) * * * 

* * * * * 

Commander means the aircrew 

member with responsibility for the 

aircraft’s operations and navigation. 

* * * * * 

International Health Regulations or 

IHR means the International Health 

Regulations of the World Health 

Organization, adopted by the FiftyEighth World Health Assembly in 2005, 

as may be further amended, and subject 

to the United States’ reservation and 

understandings. 

* * * * * 

Isolation means the separation of an 

individual or group who is reasonably 

believed to be infected with a 

quarantinable communicable disease 

from those who are healthy to prevent 

the spread of the quarantinable 

communicable disease. 

* * * * * 

Possession means U.S. territory. 

Quarantine means the separation of 

an individual or group reasonably 

believed to have been exposed to a 

quarantinable communicable disease, 

but who is not yet ill, from others who 

have not been so exposed, to prevent the 

possible spread of the quarantinable 

communicable disease. 

Quarantinable communicable disease 

means any of the communicable 

diseases listed in an Executive Order, as 

provided under § 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 

communicable 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. 

Surveillance means the temporary 

supervision by a public health official 

(or designee) of an individual or group, 

who may have been exposed to a 

quarantinable communicable disease, to 

determine the risk of disease spread. 

* * * * * 

U.S.territory means any territory (also 

known as possessions) of the United 

States, including American Samoa, 

Guam, the Northern Mariana Islands, 

the Commonwealth of Puerto Rico, and 

the U.S. Virgin Islands. 

United States means the 50 States, 

District of Columbia, and the territories 

(also known as possessions) of the 

United States, including American 

Samoa, Guam, the Northern Mariana 

Islands, the Commonwealth of Puerto 

Rico, and the U.S. Virgin Islands. 

Vector means any animals (vertebrate 

or invertebrate) including arthropods or 

any noninfectious self-replicating 

system (e.g., plasmids or other 

molecular vector) or animal products 

that are known to transfer, or are 

capable of transferring, an infectious 

biological agent to a human. 

3. Revise § 71.32(a) to read as follows: 

§ 71.32 Persons, carriers, and things. 

(a) Whenever the Director has reason 

to believe that any arriving person is 

infected with or has been exposed to 

any of the communicable diseases listed 

in an Executive Order, as provided 

under section 361(b) of the Public 

Health Service Act, he/she may isolate, 

quarantine, or place the person under 

surveillance and may order disinfection 

or disinfestation, fumigation, as he/she 

considers necessary to prevent the 

introduction, transmission or spread of 

the listed communicable diseases. 

Executive Order 13295, of April 4, 2003, 

as provided under section 361 of the 

Public Health Service Act (42 U.S.C. 

264), and as amended by Executive 

Order 13375 of April 1, 2005, contains 

the current revised list of quarantinable 

communicable 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 

this reference. 

* * * * * 

4. Add § 71.50 to subpart F to read as 

follows: 

§ 71.50 Scope and definitions. 

(a) The purpose of this subpart is to 

prevent the introduction, transmission, 

and spread of communicable human 

disease resulting from importations of 

various animal hosts or vectors or other 

etiological agents from foreign countries 

into the United States. 

(b) In addition to terms in § 71.1, the 

terms below, as used in this subpart, 

shall have the following meanings: 

Animal product or product means the 

hide, hair, skull, teeth, bones, claws, 

blood, tissue, or other biological 

samples from an animal, including 

trophies, mounts, rugs, or other display 

items. 

Educational purpose means use in the 

teaching of a defined educational 

program at the university level or 

equivalent. 

Exhibition purpose means use as 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 


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75946 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Proposed Rules 

the general public at routinely 

scheduled hours on 5 or more days of 

each week. The trained animal act must 

be routinely schedule for multiple 

performances each week and open to 

the general public except for reasonable 

vacation and retraining periods. 

In transit means animals that are 

located within the United States, 

whether their presence is anticipated, 

scheduled, or not, as part of the 

movement of those animals between a 

foreign country of departure and foreign 

country of final destination without 

clearing customs and officially entering 

the United States. 

Isolation when applied to animals 

means the separation of an ill animal or 

ill group of animals from individuals, or 

other animals, or vectors of disease in 

such a manner as to prevent the spread 

of infection. 

Licensed veterinarian means an 

individual who has obtained both an 

advanced degree and valid license to 

practice animal medicine. 

Person means any individual or 

partnership, firm, company, 

corporation, association, organization, 

or similar legal entity, including those 

that are not-for-profit. 

Quarantine when applied to animals 

means the practice of separating live 

animals that are reasonably believed to 

have been exposed to a communicable 

disease, but are not yet ill, in a setting 

where the animal can be observed for 

evidence of disease, and where 

measures are in place to prevent 

transmission of infection to humans or 

animals. 

Render noninfectious means treating 

an animal product (e.g., by boiling, 

irradiating, soaking, formalin fixation, 

or salting) in such a manner that renders 

the product incapable of transferring an 

infectious biological agent to a human. 

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. 

You or your means an importer, 

owner, or an applicant. 

Dated: December 13, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–30725 Filed 12–21–12; 4:15 pm] 

BILLING CODE 4150–28–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 12–352; RM–11686; DA 12– 

2002]. 

Radio Broadcasting Services; Dove 

Creek, CO 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: This document sets forth a 

proposal to amend the FM Table of 

Allotments, Section 73.202(b) of the 

Commission’s rules. The Commission 

requests comment on a petition filed by 

Cochise Media Licenses, LLC, proposing 

to amend the Table of Allotments by 

allotting FM Channel 229C3 as a first 

local service at Dove Creek, Colorado. 

Channel 229C3 can be allotted at Dove 

Creek, Colorado, in compliance with the 

Commission’s minimum distance 

separation requirements, at the 

proposed reference coordinates: 37–48– 

05 North Latitude and 108–59–33 West 

Longitude. See SUPPLEMENTARY

INFORMATION infra. 

DATES: The deadline for filing comments 

is February 4, 2013. Reply comments 

must be filed on or before February 21, 

2013. 

ADDRESSES: Federal Communications 

Commission, 445 12th Street SW., 

Washington, DC 20554. In addition to 

filing comments with the FCC, 

interested parties should serve counsel 

for petitioner as follows: Susan A. 

Marshall, Esq., Anne Goodwin Crump, 

Esq., Fletcher, Heald & Hildreth, PLC, 

1300 North 17th Street, 11th Floor, 

Arlington, Virginia 22209. 

FOR FURTHER INFORMATION CONTACT: 

Deborah A. Dupont, Media Bureau (202) 

418–7072. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Notice of 

Proposed Rule Making, MB Docket No. 

12–352, adopted December 10, 2012, 

and released December 11, 2012. The 

full text of this Commission decision is 

available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center 

(Room CY–A257), 445 12th Street SW., 

Washington, DC 20554. The complete 

text of this decision may also be 

purchased from the Commission’s copy 

contractor, Best Copy and Printing, Inc., 

445 12th Street SW., Room CY–B402, 

Washington, DC 20554, (800) 378–3160, 

or via the company’s Web site, 

www.bcpiweb.com. This document does 

not contain proposed information 

collection requirements subject to the 

Paperwork Reduction Act of 1995, 

Public Law 104–13. In addition, 

therefore, it does not contain any 

proposed information collection burden 

‘‘for small business concerns with fewer 

than 25 employees,’’ pursuant to the 

Small Business Paperwork Relief Act of 

2002, Public Law 107–198, see 44 U.S.C. 

3506 (c)(4). 

The Provisions of the Regulatory 

Flexibility Act of 1980 do not apply to 

this proceeding. Members of the public 

should note that from the time a Notice 

of Proposed Rule Making is issued until 

the matter is no longer subject to 

Commission consideration or court 

review, all ex parte contacts are 

prohibited in Commission proceedings, 

such as this one, which involve channel 

allotments. See 47 CFR 1.1204(b) for 

rules governing permissible ex parte 

contacts. 

For information regarding proper 

filing procedures for comments, see 47 

CFR 1.415 and 1.420. 

List of Subjects in 47 CFR Part 73 

Radio, Radio broadcasting. 

Federal Communications Commission. 

Nazifa Sawez, 

Assistant Chief, Audio Division, Media 

Bureau. 

For the reasons discussed in the 

preamble, the Federal Communications 

Commission proposes to amend 47 CFR 

Part 73 as follows: 

PART 73—RADIO BROADCAST 

SERVICES 

1. The authority citation for Part 73 

continues to read as follows: 

Authority: 47 U.S.C. 154, 303, 334, 336 

and 339 

§ 73.202 [Amended] 

2. Section 73.202(b), the Table of FM 

Allotments under Colorado, is amended 

by adding Dove Creek, Channel 229C3. 

[FR Doc. 2012–30971 Filed 12–21–12; 4:15 pm] 

BILLING CODE 6712–01–P 


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