[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Rules and Regulations]
[Pages 75880-75884]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30729]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 70

[Docket No. CDC-2012-0016]
RIN 0920-AA22


Control of Communicable Diseases: Interstate; Scope and 
Definitions

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

ACTION: Direct Final Rule and request for comments.

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SUMMARY: In this Direct Final Rule, the Centers for Disease Control and 
Prevention (CDC), located within the Department of Health and Human 
Services (HHS) is proposing to update the definitions for interstate 
quarantine regulations to reflect modern terminology and plain language 
used by private industry and public health partners. These updates will 
not affect current practices. As part of the update, we are updating 
two existing definitions and adding eight new definitions to clarify 
existing provisions, as well as updating regulations to reflect the 
most recent Executive Order addressing quarantinable communicable 
diseases.

[[Page 75881]]


DATES: The DFR is effective on February 25, 2013 unless significant 
adverse comment is received by January 25, 2013. If we receive no 
significant adverse comments within the specified comment period, we 
intend to publish a document confirming the effective date of the final 
rule in the Federal Register within 30 days after the comment period on 
this DFR ends. If we receive any timely significant adverse comment, we 
will withdraw this DFR in part or in whole by publication of a document 
in the Federal Register within 30 days after the comment period ends.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA22'' 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 70 DFR.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All 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 be available for public inspection Monday through Friday, except 
for legal holidays, from 9 a.m. until 5 p.m., Eastern 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 direct 
final rule: 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 publishing a DFR because it does 
not expect to receive any significant adverse comments and believes 
that updating definitions to add clarity to the regulations is non-
controversial. However, in this Federal Register, HHS/CDC is 
simultaneously publishing a companion notice of proposed rulemaking 
(NPRM) that proposes identical modifications. If HHS/CDC does not 
receive any significant adverse comments on this DFR within the 
specified comment period, we will publish a document in the Federal 
Register confirming the effective date of this final rule within 30 
days after the comment period on the DFR ends and withdraw the NPRM. 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. HHS/
CDC will carefully consider all public comments received 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. Rationale for DFR
IV. Updates to Section 70.1
    A. Definitions Updated Under Section 70.1
    B. Definitions Added to Section 70.1
V. Rationale for Updates Under Section 70.6
VI. Alternatives Considered
VII. Required Regulatory Analyses
    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 DFR.

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. 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. Rationale for DFR

    Through this DFR, HHS/CDC is updating definitions to Part 70 to 
reflect modern science and current practices. HHS/CDC has chosen to 
publish a DFR because we view this as a non-controversial action and 
anticipate no significant adverse comment. This DFR does not create any 
additional requirements or burden upon the regulated community, nor 
does it affect the current practices of HHS/CDC. A significant adverse 
comment is one that explains: (1) Why the DFR is inappropriate, 
including challenges to

[[Page 75882]]

the rule's underlying premise or approach; or (2) why the DFR will be 
ineffective or unacceptable without a change. In determining whether a 
comment necessitates withdrawal of the DFR, HHS/CDC will consider 
whether it warrants a substantive response in a notice and comment 
process. If we receive significant adverse comment on this DFR, we will 
publish a timely withdrawal in the Federal Register informing the 
public that the amendment in this rule will not take effect. If this 
DFR is withdrawn, we will carefully consider all public comments before 
proceeding with any subsequent final rule based on the NPRM which is 
being published simultaneously in the Federal Register.

IV. Updates to Section 70.1

    Regulations that implement federal authority for interstate 
quarantine are currently promulgated in 42 CFR part 70. The Secretary 
of HHS has delegated to the Director of the Centers for Disease Control 
and Prevention the authority for implementing 42 CFR part 70.
    Through this DFR, HHS/CDC proposes to update the Definitions for 42 
CFR part 70, under section 70.1, to reflect modern terminology and 
plain language commonly used by private sector industry and public 
health partners, as well as clarify the intent of the provisions that 
follow. Specifically, we are updating two existing definitions and 
adding eight new definitions to clarify existing provisions, as well as 
updating 70.6 to reflect the language of the most recent Executive 
Order concerning quarantinable communicable diseases.
    Section 70.1(b) contains the definitions used in this DFR. The DFR 
proposes new or updated definitions to be consistent with modern 
quarantine concepts and current medical and public health principles 
and practice. Table 1 lists the current definitions found in 42 CFR 
part 70 and the definitions proposed in this DFR.

  Table 1--Definitions and Corresponding Changes in Definitions in the
                               Final Rule
------------------------------------------------------------------------
 Existing  definitions in  42 CFR part    Corresponding, new or updated
                   70                           definition in DFR
------------------------------------------------------------------------
                                         CDC.
Communicable diseases..................  No Change.
Communicable period....................  No Change.
                                         Conditional release.
Conveyance.............................  No Change,
                                         Director.
Incubation period......................  No Change.
Interstate traffic.....................  No Change.
                                         Isolation.
                                         Master or Operator.
Possession.............................  Updated.
                                         Quarantine.
                                         Quarantinable communicable
                                          disease.
State..................................  Updated.
                                         U.S Territory.
Vessel.................................  No Change.
------------------------------------------------------------------------

A. Definitions Updated Under Section 70.1

    Possession. To best add clarity to part 70, we have updated the 
term ``possession'' to mean ``U.S. Territory'' and defined 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.
    State. To best add clarity to the regulations of part 70, 
specifically where roles and responsibilities are outlined, we have 
included a definition of ``state'' to mean any of the 50 states within 
the United States, plus the District of Columbia.

B. Definitions Added to Section 70.1

    CDC. We have defined ``CDC'' to mean the Centers for Disease 
Control and Prevention within the Department of Health and Human 
Services to clarify the provisions under part 70.
    Conditional release. We have defined ``conditional release'' to 
have the same meaning as ``surveillance,'' as that term is defined in 
42 CFR Part 71. We have included this definition to best add clarity to 
the provisions and practices under part 70, specifically section 70.6, 
as well as to ensure that conditional release and surveillance are both 
used consistently in both parts 70 and 71.
    Director. To clarify the provisions under part 70, we have defined 
``Director'' to mean 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. In this DFR, ``isolation'' is defined as 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. This DFR 
clarifies the distinction between quarantine and isolation by 
separately defining ``quarantine'' and ``isolation'' to distinguish 
these common public health measures. Isolation, as currently used in 42 
CFR 71.1, applies to both persons and groups of persons. Thus, CDC is 
changing the definition in part 70 so that the term is used 
consistently in both part 70 and 71. Applying isolation measures to 
groups of individuals is consistent with CDC's current practice and 
does not constitute a substantive change.
    Master or Operator. This DFR defines ``Master'' or ``Operator'' as 
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. We have included this definition 
to better identify and assign responsibilities under this subpart 
(according to current practices).
    Quarantine. This DFR defines ``quarantine'' as the separation of an 
individual or group reasonably believed to have been exposed to a 
quarantinable communicable disease, but not yet ill,

[[Page 75883]]

from others who have not been so exposed, to prevent the possible 
spread of the quarantinable communicable disease. In this DFR, HHS/CDC 
is separately defining quarantine and isolation to distinguish these 
common public health measures. Applying quarantine measures to groups 
of individuals is consistent with HHS/CDC's current practice and does 
not constitute a substantive change.
    Quarantinable communicable disease. Under this DFR, ``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 
found at http://www.cdc.gov/quarantine and in the docket as 
supplemental documents. If this Executive Order is amended, HHS/CDC 
will enforce the amended order immediately and update its Web site. The 
definition for ``quarantinable communicable disease'' is being added to 
Part 70 through this DFR to reflect the most recent Executive Order 
regarding quarantinable communicable disease. This addition does not 
reflect a substantive change from current practice.
    U.S. Territory. Under this DFR, ``U.S. Territory'' means 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 cognizant agency for U.S. territories, no longer uses the 
term ``possession'' to refer to these jurisdictions. Consequently, HHS/
CDC is adding a new definition for U.S. territory consistent with 
current federal usage.

V. Updates to Section 70.6

    Section 70.6, Apprehension and detention of persons with specific 
diseases, contains the general authority for the Director to take 
measures with respect to persons to protect the public's health against 
the spread of 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.'' The current 
section 71.32(a) lists Executive Order 13295, of April 4, 2003. The 
subpart states that ``If this Order is amended, HHS will enforce that 
amended order.'' On April 1, 2005, this Executive Order was amended by 
Executive Order 13375. Therefore, as part of the non-controversial 
changes in this DFR, we are also updating section 70.6 to reflect the 
most recent amendment to the Executive Order which lists the 
``quarantinable communicable disease'', which we have also defined. 
These changes are not substantive and will not affect current 
practices.

VI. 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 this proposed rule is to update 
current definitions and clarify language in the current regulation to 
reflect modern terminology and plain language commonly used by global 
private sector industry and public health partners. The intent of these 
updates is to clarify the provisions of the existing regulation to help 
the regulated community comply with current regulation and protect 
public health. HHS/CDC believes that this rulemaking complies with the 
spirit of the Executive Order; updating current definitions, clarifying 
language, and updating the referenced Executive Order provides good 
alternatives to the current regulation.

VII. 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:
    [ssquf] 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;
    [ssquf] Create a serious inconsistency or otherwise interfere with 
an action taken or planned by another agency;
    [ssquf] Materially alter the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients; or,
    [ssquf] Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
E.O. 12866.
    Executive Order 13563 (E.O. 13563), Improving Regulation and 
Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the 
provisions of E.O. 12866 in order to promote more streamlined 
regulatory actions. This E.O. 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 
E.O. 13563, this DFR enhances definitions related to the control of 
communicable diseases and add more current medical terminology where 
appropriate.
    HHS/CDC has determined that this DFR is simply an update and 
clarification of definitions and terms used in the current regulation. 
As such, the DFR complies with the spirit of E.O. 13563. Further, HHS/
CDC has determined that this DFR is not a significant regulatory action 
as defined in E.O. 12866 because the DFR 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 rule under the Regulatory 
Flexibility Act (5 U.S.C. 601-612). 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 (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 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 DFR is not a major rule as defined by Sec. 804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996. This 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 foreign-
based companies in domestic and export markets.

[[Page 75884]]

D. The Paperwork Reduction Act of 1995

    HHS/CDC has already determined that the Paperwork Reduction Act 
applies to the data collection and record keeping requirements of 42 
CFR part 70 and has obtained approval by the Office of Management and 
Budget (OMB) to collect data and require record keeping under OMB 
Control No. 0920-0488, expiration 03/31/2013. The changes in this rule 
do not impact the data collection or record keeping requirements and do 
not require revision to the approval from 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, CDC, has determined that provisions amending 
42 CFR part 70 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.

G. Executive Order 13132 (Federalism)

    HHS/CDC has reviewed this 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 Part 70

    Communicable diseases, Isolation, Public health, Quarantine, 
Quarantinable communicable disease.

Amended Text

    For the reasons discussed in the preamble, the Centers for Disease 
Control and Prevention amends 42 CFR part 70 as follows:

PART 70--INTERSTATE QUARANTINE

0
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.


0
2. Amend Sec.  70.1 as follows:
0
a. Remove paragraph designations (a), (b), (c), (d), (e), (f), and (g).
0
b. Add in alphabetical order definitions of CDC, Conditional release, 
Director, Isolation, Master or Operator, Quarantine, Quarantinable 
communicable disease, and U.S. Territory.
0
c. Revise the definitions of Possession and State. The revisions and 
additions read as follows:


Sec.  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.
* * * * *

0
3. Revise Sec.  70.6 to read as follows:


Sec.  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. 2012-30729 Filed 12-21-12; 4:15 pm]
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