75880 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

This section only applies to the volume 

of diesel fuel produced from transmix 

by a transmix processor using these 

processes, and to the diesel fuel volume 

produced by a pipeline operator from 

transmix. This section does not apply to 

any diesel fuel volume produced by the 

blending of blendstocks. 

* * * * * 

(d) From June 1, 2010 through May 

31, 2014, NRLM diesel fuel produced by 

a transmix processor or a pipeline 

facility that produces diesel fuel from 

transmix is subject to the standards 

under § 80.510(a). This paragraph (d) 

does not apply to NRLM diesel fuel that 

is sold or intended for sale in the areas 

listed in § 80.510(g)(1) or (g)(2). 

(e) From June 1, 2014 and beyond, 

NRLM diesel fuel produced by a 

transmix processor and a pipeline 

facility that produces diesel fuel from 

transmix is subject to the standards of 

§ 80.510(c). 

(f) From February 25, 2013 through 

May 31, 2014, LM diesel fuel produced 

by a transmix processor or a pipeline 

facility that produces diesel fuel from 

transmix that is sold or intended for sale 

in the area listed in § 80.510(g)(1) is 

subject to the standards of § 80.510(a) 

provided that the conditions in 

paragraph (h) of this section are 

satisfied. Diesel fuel produced from 

transmix that does not meet the 

conditions in paragraph (h) of this 

section is subject to the sulfur standard 

in § 80.510(c). 

(g) Beginning June 1, 2014, LM diesel 

fuel produced by a transmix processor 

or a pipeline facility that produces 

diesel fuel from transmix is subject to 

the sulfur standard of § 80.510(a), 

provided that the conditions in 

paragraph (h) of this section are 

satisfied. Diesel fuel produced from 

transmix that does not meet the 

conditions in paragraph (h) of this 

section is subject to the sulfur standard 

in § 80.510(c). 

(h) The following conditions must be 

satisfied to allow the production of 500 

ppm LM under paragraphs (f) and (g) of 

this section. 

(1) The fuel must be produced from 

transmix. 

(2) The fuel must not be sold or 

intended for sale in the area listed in 

§ 80.510(g)(2) (i.e., Alaska). 

(3) A facility producing 500 ppm LM 

diesel fuel must obtain approval from 

the Administrator for a compliance 

plan. The compliance plan must detail 

how the facility will segregate any 500 

ppm LM diesel fuel produced subject to 

the standards under § 80.510(a) from the 

producer through to the ultimate 

consumer from fuel having other 

designations. The compliance plan must 

demonstrate that the end users of 500 

ppm LM will also have access to 15 

ppm diesel fuel for use in those engines 

that require the use of 15 ppm diesel 

fuel. The compliance plan must identify 

the entities that handle the 500 ppm LM 

through to the ultimate consumer. No 

more than 4 separate entities shall 

handle the 500 ppm LM between the 

producer and the ultimate consumer. 

The compliance plan must also identify 

all ultimate consumers to whom the 

refiner supplies the 500 ppm LM diesel 

fuel. The compliance plan must detail 

how misfueling of 500 ppm LM into 

vehicles or equipment that require the 

use of 15 ppm diesel fuel will be 

prevented. 

(i) Producers of 500 ppm LM diesel 

fuel must be registered with EPA under 

§ 80.597 prior to the distribution of any 

500 ppm LM diesel fuel. 

(ii) Producers of 500 ppm LM must 

initiate a PTD that meets the 

requirements in paragraph (h)(3)(iii) of 

this section. 

(iii) All transfers of 500 ppm LM 

diesel fuel must be accompanied by a 

PTD that clearly and accurately states 

the fuel designation; the PTD must also 

meet all other requirements of § 80.590. 

(iv) Batches of 500 ppm LM may be 

shipped by pipeline provided that such 

batches do not come into physical 

contact in the pipeline with batches of 

other distillate fuel products that have 

a sulfur content greater than 15 ppm. 

(v) The volume of 500 ppm LM 

shipped via pipeline under paragraph 

(h)(3)(iv) of this section may swell by no 

more than 2% upon delivery to the next 

party. Such a volume increase may only 

be due to volume swell due to 

temperature differences when the 

volume was measured or due to normal 

pipeline interface cutting practices 

notwithstanding the requirement under 

paragraph (h)(3)(iv) of this section. 

(vi) Entities that handle 500 ppm LM 

must calculate the balance of 500 ppm 

LM received versus the volume 

delivered and used on an annual basis. 

(vii) The records required in this 

section must be maintained for five 

years, by each entity that handles 500 

ppm LM and be made available to EPA 

upon request. 

(4) All parties that take custody of 500 

ppm LM must segregate the product 

from other fuels and observe the other 

requirements in the compliance plan 

approved by EPA pursuant to paragraph 

(h)(3) of this section. 

■ 4. Section 80.572 is amended by 

revising the section heading and 

paragraph (d) to read as follows: 

§ 80.572 What labeling requirements apply 

to retailers and wholesale purchaserconsumers of Motor Vehicle, NR, LM and 

NRLM diesel fuel and heating oil beginning 

June 1, 2010? 

* * * * * 

(d) From June 1, 2010 through 

September 30, 2012 and from February 

25, 2013 and thereafter, for pumps 

dispensing LM diesel fuel subject to the 

500 ppm sulfur standard of § 80.510(a): 

LOW SULFUR LOCOMOTIVE AND 

MARINE DIESEL FUEL (500 ppm Sulfur 

Maximum) 

WARNING 

Federal law prohibits use in nonroad 

engines or in highway vehicles or 

engines. 

* * * * * 

■ 5. Section 80.597 is amended by 

adding paragraph (d)(3)(ii) to read as 

follows: 

§ 80.597 What are the registration 

requirements? 

* * * * * 

(d) * * * 

(3) * * * 

(ii) Fuel designated as 500 ppm LM 

diesel fuel. 

* * * * * 

[FR Doc. 2012–30960 Filed 12–21–12; 4:15 pm] 

BILLING CODE P 

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. 

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. 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 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 erulemaking 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 noncontroversial 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 


tkelley on DSK3SPTVN1PROD with 
75882 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

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 70 

Corresponding, new or updated 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, 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 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 noncontroversial 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: 

D 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; 

D Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

D Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

obligations of recipients; or, 

D 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 foreignbased companies in domestic and 

export markets. 


tkelley on DSK3SPTVN1PROD with 
75884 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

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 

■ 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. 2012–30729 Filed 12–21–12; 4:15 pm] 

BILLING CODE 4163–18–P 


tkelley on DSK3SPTVN1PROD with