10656 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 

Wynkoop Street, Denver, Colorado 

80202–1129, 303–312–6145, 

morrison.kendra@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

‘‘Rules and Regulations’’ section of this 

Federal Register, EPA is publishing 

these negative declarations as a direct 

final rule without prior proposal 

because the Agency views this as a 

noncontroversial action and anticipates 

no adverse comments. A detailed 

rationale for publication is set forth in 

the preamble to the direct final rule. If 

EPA receives no adverse comments, 

EPA will not take further action on this 

proposed rule. If EPA receives adverse 

comments, EPA will withdraw the 

direct final rule and it will not take 

effect. EPA will address all public 

comments in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period 

on this action. Any parties interested in 

commenting must do so at this time. 

Please note that if EPA receives adverse 

comment on an amendment, paragraph, 

or section of this rule and if that 

provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. See the information provided 

in the Direct Final action of the same 

title which is located in the Rules and 

Regulations Section of this Federal 

Register. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: January 30, 2015. 

Debra H. Thomas, 

Acting Regional Administrator, Region 8. 

[FR Doc. 2015–03921 Filed 2–26–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 73 

[Docket No. CDC–2015–0006] 

RIN 0920–AA59 

Possession, Use, and Transfer of 

Select Agents and Toxins; Biennial 

Review 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Advance notice of proposed 

rulemaking and request for comments. 

SUMMARY: In accordance with the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

Subtitle A (Department of Health and 

Human Services) of Title II (Enhancing 

Controls on Dangerous Biological 

Agents and Toxins) of Public Law 107– 

188 (June 12, 2002) (the Bioterrorism 

Response Act), the Centers for Disease 

Control and Prevention (CDC) located 

within the Department of Health and 

Human Services (HHS) has initiated the 

review of the HHS list of biological 

agents and toxins that have the potential 

to pose a severe threat to public health 

and safety. We are considering whether 

to propose amending the HHS list by 

removing six biological agents. 

DATES: Comments should be received on 

or before April 28, 2015. 

ADDRESSES: You may submit comments, 

identified by Regulation Identifier 

Number (RIN), 0920–AA59 or Docket 

Number CDC–2015–0006 in the heading 

of this document by any of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Centers for Disease Control 

and Prevention, Select Agent Program, 

1600 Clifton Road NE., Mailstop A–46, 

Atlanta, Georgia 30329, ATTN: RIN 

0920–AAxx. 

Instructions: All submissions received 

must include the agency name and RIN 

for this rulemaking. All relevant 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. 

Docket Access: For access to the 

docket to read background documents 

or comments received or to download 

an electronic version of the ANPRM, 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. at 1600 Clifton Road NE., 

Atlanta, GA 30329. Please call ahead to 

1–866–694–4867 and ask for a 

representative in the Division of Select 

Agents and Toxins to schedule your 

visit. Please be aware that comments 

and other submissions from members of 

the public are made available for public 

viewing without changes. 

FOR FURTHER INFORMATION CONTACT: 

Robbin Weyant, Director, Division of 

Select Agents and Toxins, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., Mailstop A–46, 

Atlanta, Georgia 30329. Telephone: 

(404) 718–2000. 

SUPPLEMENTARY INFORMATION: The 

Preamble to this notice of proposed 

rulemaking is organized as follows: 

I. Public Participation 

II. Background 

III. Changes to 42 CFR Part 73, Modifications 

to the List of Select Agents and Toxins 

Being Considered 

A. Coxiella burnetii 

B. Rickettsia prowazekii 

C. Bacillus anthracis Pasteur strain 

D. Brucella abortus, B. melitensis, and B. 

suis 

IV. References 

I. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

recommendations, and data. Comments 

are invited on any topic related to this 

rulemaking. 

In addition, HHS/CDC invites 

comments specifically as to whether 

there are biological agents or toxins that 

should be added or removed from the 

HHS list of select agents and toxins 

based on the following criteria, or any 

other appropriate criteria: 

(1) The effect on human health of 

exposure to the agent or toxin; 

(2) The degree of contagiousness of 

the agent or toxin and the methods by 

which the agent or toxin is transferred 

to humans; and 

(3) The availability and effectiveness 

of pharmacotherapies and 

immunizations to treat and prevent any 

illness resulting from infection by the 

agent or exposure to the toxin. 

(4) The needs of children and other 

vulnerable populations. 

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 consider confidential or 

inappropriate for public disclosure. 

HHS/CDC will carefully consider all 

comments submitted in preparation of a 

proposed final rule. 

II. Background 

The Bioterrorism Response Act 

requires the HHS Secretary to establish 

by regulation a list of biological agents 

and toxins that have the potential to 

pose a severe threat to public health and 

safety. In determining whether to 

include an agent or toxin on the list, the 

HHS Secretary considers criteria such as 

the effect on human health of exposure 

to an agent or toxin; the degree of 

contagiousness of the agent and the 

methods by which the agent or toxin is 

transferred to humans; the availability 

and effectiveness of pharmacotherapies 

and immunizations to treat and prevent 

illnesses resulting from an agent or 

toxin; and the needs of children and 

other vulnerable populations. The 

current list of HHS select agents and 

toxins can be found at 42 CFR 73.3 

(HHS select agents and toxins) and 42 

CFR 73.4 (Overlap select agents and 

toxins). The list of HHS and Overlap 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10657 

select agents and toxins is available at: 

http://www.selectagents.gov/

Select%20Agents%20and%20Toxins

%20List.html. 

The HHS Secretary last republished 

the list of HHS select agents and toxins 

in the Federal Register on October 5, 

2012 (77 FR 61084). The list of HHS 

select agents and toxins is divided into 

two sections. The select agents and 

toxins listed in § 73.3 (HHS select agents 

and toxins) are those regulated only by 

HHS under the authority of the 

Bioterrorism Response Act (42 U.S.C. 

262a). The select agents and toxins 

listed in § 73.4 (Overlap select agents 

and toxins) are those regulated by HHS 

under the authority of the Bioterrorism 

Response Act and regulated by the U.S. 

Department of Agriculture under the 

authority of the Agricultural 

Bioterrorism Protection Act of 2002 

(7 U.S.C. 8401). 

The Bioterrorism Response Act 

requires the HHS Secretary to review 

and republish the list of select agents 

and toxins on at least a biennial basis. 

Using government subject matter 

experts, HHS/CDC conducts the 

biennial review process in consultation 

with the HHS/CDC Intragovernmental 

Select Agents and Toxins Technical 

Advisory Committee (ISATTAC). The 

ISATTAC recommends changes to the 

list of HHS select agents and toxins. The 

ISATTAC is comprised of Federal 

government employees from CDC, 

Biomedical Advanced Research and 

Development Authority (BARDA) 

within the Office of the Assistant 

Secretary for Preparedness and 

Response, the National Institutes of 

Health (NIH), the Food and Drug 

Administration (FDA), the Department 

of Homeland Security (DHS), the 

Department of Defense (DOD), the 

USDA/Animal and Plant Health 

Inspection Service (APHIS), USDA/

Agricultural Research Service (ARS), 

and USDA/CVB (Center for Veterinary 

Biologics). Based on the criteria 

outlined in the Bioterrorism Response 

Act, the ISATTAC used the following 

measures in its review: the degree of 

pathogenicity (ability of an organism to 

cause disease), communicability (ability 

to spread from infected to susceptible 

hosts), ease of dissemination, route of 

exposure, environmental stability, ease 

of production, ability to genetically 

manipulate or alter, long-term health 

effects, acute morbidity (illness), acute 

mortality (death), available treatment, 

status of host immunity, vulnerability of 

special populations, and the burden or 

impact on the health care system. 

III. Proposed Changes to 42 CFR Part 

73, Modifications to the List of Select 

Agents and Toxins Being Considered 

The purpose of this advanced notice 

of proposed rulemaking is to seek public 

comment on the appropriateness of the 

current list of HHS and Overlap select 

agents and toxins. Specifically, we are 

providing an opportunity for interested 

persons to submit comments, research 

data, and other information that will 

better inform us as to whether: (1) There 

are any other biological agents or toxins 

that should be added to the list because 

they have the potential to pose a severe 

threat to public health and safety; (2) 

there are any other biological agents or 

toxins currently on the list that should 

be removed because they no longer have 

the potential to pose a severe threat to 

public health and safety, and/or (3) the 

biological agents specifically listed in 

the following paragraphs should be 

removed or remain on the list. 

HHS/CDC is also seeking comments 

on the following considerations 

regarding the list of HHS and Overlap 

select agents: 

A. Coxiella burnetii 

Coxiella burnetii causes a disease 

called Q fever. Q fever is an acute febrile 

rickettsial disease that varies in severity 

and duration. Should Coxiella burnetii 

be removed or retained as a HHS select 

agent? Are there other reasons or 

research data to support the removal 

besides the following reasons? 

• It is not easily transmitted from 

person to person (1); 

• It has a low mortality rate with 

antibiotic treatment (2); and 

• There is an investigational new 

drug (IND) vaccine available for at-risk 

personnel (3). 

B. Rickettsia prowazekii 

Rickettsia prowazekii causes epidemic 

typhus. Epidemic typhus is a potentially 

lethal, louse-borne, disease caused by R. 

prowazekii. Should Rickettsia 

prowazekii be removed or retained as a 

HHS select agent? Are there other 

reasons or research data to support the 

removal besides the following reasons? 

• It is readily treatable with 

antibiotics (4); 

• The risk of mass casualties is low 

because R. prowazekii can be treated 

with a single dose of doxycycline when 

symptoms are present (4); and 

• Transmissibility from person to 

person is low due to the fact that R. 

prowazekii is usually transmitted via 

blood, although it can be spread through 

inhalation of louse feces. 

C. Bacillus anthracis Pasteur Strain 

Bacillus anthracis is the bacterium 

that causes anthrax, an acute disease in 

animals and humans. However, 

different strains of B. anthracis have 

different abilities to cause disease. The 

Pasteur strain, for example, is unable to 

produce toxic factors and is not 

considered harmful to humans. Should 

B. anthracis Pasteur strain be removed 

or retained as an Overlap select agent? 

Are there other reasons or research data 

to support the removal besides the 

following reasons? 

• B. anthracis Pasteur strain lacks the 

plasmid that encodes the toxin genes 

causing disease (6); 

• B. anthracis Sterne strain, which 

lacks the plasmid that encodes for the 

capsule, was excluded from the 

requirements of the regulations effective 

on February 27, 2003 (7–8); and 

• Historically, the B. anthracis 

Pasteur strain has been retained as a 

select agent to allow for continued 

oversight of laboratories in which the 

accidental (or intentional) combination 

of this strain with the Sterne strain 

could occur to produce de novo the 

wild type phenotype B. anthracis. 

However, a recent study indicates that 

bacterial transformation of B. subtilis 

with plasmid DNA (e.g. pXO1 into 

Bacillus anthracis Pasteur strain) is 

inefficient; indicating that 

transformation with bacteria such as B. 

anthracis would also be inefficient (9). 

D. Brucella abortus, B. melitensis, and 

B. suis 

Brucella abortus, B. melitensis, and B. 

suis bacteria cause brucellosis, a disease 

that can spread from animals to 

humans. Should B. abortus, B. 

melitensis, and B. suis be removed or 

retained as select agents? Are there 

other reasons or research data to support 

the removal besides the following 

reasons? 

• B. abortus has a low human 

mortality rate (10); 

• B. abortus, B. melitensis, and B. 

suis are readily treatable with 

antibiotics (10); and 

• Human-to-human transmission is 

extremely rare, and wildlife carriers in 

the United States often come into 

contact with humans without significant 

transmission (10). 

IV. References 

1. T.J. Marrie. Q fever. In: Marrie TJ, editor. 

Q fever. Vol. 1. Boca Raton, FL: CRC 

Press; 1990. (The disease). 

2. M. Maurin and D. Raoult. Q fever. Clin 

Microbiol Rev. Oct. 1999;12(4):518–53. 

3. Biosafety in Microbiological and 

Biomedical Laboratories (BMBL) 5th 

Edition, http://www.cdc.gov/biosafety/


tkelley on DSK3SPTVN1PROD with PROPOSALS
10658 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 

publications/bmbl5/BMBL5_sect_VIII_

d.pdf. 

4. D. Raoult, J.B. Ndihokubwayo, H. TissotDupont, V. Roux, B. Faugere, R. 

Abegbinni, and R.J. Birtles. Outbreak of 

epidemic typhus associated with trench 

fever in Burundi. The Lancet. Aug. 1998; 

352 (3125):353–358. 

5. D. Raoult, T. Woodward, and J.S. Dumler. 

The history of epidemic typhus. Infect 

Dis Clin N Am. Mar. 2004; 18(1):127– 

140. 

6. B.E. Ivins, J.W. Ezzell, J. Jemski, K.W. 

Hedlund, J.D. Ristroph, and S.H. Leppla. 

Immunization Studies with Attenuated 

Strains of Bacillus anthracis. Infection 

and Immunity. May 1986; 52(2):454–458. 

7. Centers for Disease Control and 

Prevention, National Center for Emerging 

and Zoonotic Infectious Diseases 

‘‘Anthrax Sterne strain (34F2) of Bacillus 

anthracis,’’ http://www.cdc.gov/nczved/

divisions/dfbmd/diseases/anthrax_

sterne/. 

8. Federal Select Agent Program, ‘‘Select 

Agents and Toxins Exclusions,’’ http://

www.selectagents.gov/

SelectAgentsandToxinsExclusions.html. 

9. C. Johnston, B. Martin, G. Fichant, P. 

Polard, and J.P. Claverys. Bacterial 

transformation: distribution, shared 

mechanisms and divergent control. 

Nature Rev. Microbiol. 2014; 12: 181– 

196. 

10. Center for Food Security and Public 

Health, ‘‘Brucellosis Technical fact 

sheet,’’ http://www.cfsph.iastate.edu/

Factsheets/pdfs/brucellosis.pdf. 

Dated: February 5, 2015. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2015–04169 Filed 2–26–15; 8:45 am] 

BILLING CODE 4163–18–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 54 

[WC Docket No. 10–90, 14–259; DA 15–140; 

DA 15–158] 

Wireline Competition Bureau Seeks 

Comment More Generally on Letter of 

Credit Proposals for Connect America 

Phase II Competitive Bidding Process 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In these documents, the 

Wireline Competition Bureau seeks 

comment more generally on letter of 

credit proposals raised by several 

petitions for waiver and their potential 

applicability to the Phase II competitive 

bidding process. 

DATES: Comments are due on or before 

March 30, 2015 and reply comments are 

due on or before April 13, 2015. 

ADDRESSES: You may submit comments, 

identified by WC Docket Nos. 10–90 and 

14–259, by any of the following 

methods: 

• Electronic Filers: Comments may be 

filed electronically using the Internet by 

accessing the ECFS: http://

fjallfoss.fcc.gov/ecfs2/. 

• People with Disabilities: Contact the 

FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by email: FCC504@fcc.gov 

or phone: 202–418–0530 or TTY: 202– 

418–0432. 

For detailed instructions for 

submitting comments and additional 

information on the rulemaking process, 

see the SUPPLEMENTARY INFORMATION

section of this document. 

FOR FURTHER INFORMATION CONTACT: 

Heidi Lankau, Wireline Competition 

Bureau at (202) 418–7400 or TTY (202) 

418–0484. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Wireline Competition 

Bureau’s Public Notices (Notices) in WC 

Docket No. 10–90, 14–259; DA 15–140, 

released January 30, 2015 and DA 15– 

158, released February 4, 2015. The 

complete text of these documents are 

available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center, 

Portals II, 445 12th Street SW., Room 

CY–A257, Washington, DC 20554. The 

document may also be purchased from 

the Commission’s duplicating 

contractor, Best Copy and Printing, Inc., 

445 12th Street SW., Room CY–B402, 

Washington, DC 20554, telephone (800) 

378–3160 or (202) 863–2893, facsimile 

(202) 863–2898, or via Internet at 

http://www.bcpiweb.com. 

I. Introduction 

1. On January 27, 2015, the Alliance 

of Rural Broadband Applicants filed a 

petition for limited waiver of certain 

letter of credit (LOC) requirements 

applicable to the rural broadband 

experiments. On February 3, 2015, 

NTCA—The Rural Broadband 

Association filed an emergency petition 

for limited waiver of the LOC bank 

eligibility requirements applicable to 

the rural broadband experiments. On 

January 21, 2015, the National Rural 

Utilities Cooperative Finance 

Corporation and its affiliate, the Rural 

Telephone Finance Cooperative, also 

filed a petition for waiver of one aspect 

of the Commission’s LOC bank 

eligibility requirements. 

2. The Bureau notes that these 

petitions for waiver raise issues that 

may be relevant to broader pending 

questions regarding possible LOC 

requirements for recipients of funding 

awarded through the Phase II 

competitive bidding process. Thus, 

during the comment period established, 

the Bureau encourages parties to 

comment on the petitions’ LOC 

proposals more generally and their 

potential applicability to the Phase II 

competitive bidding process. 

3. In order to develop a complete 

record on the issues presented in the 

waiver petition, the request for more 

general comment will be treated, for ex 

parte purposes, as ‘‘permit-but-disclose’’ 

in accordance with section 1.1200(a) of 

the Commission’s rules, subject to the 

requirements under section 1.1206(b). 

II. Procedural Matters 

1. Initial Regulatory Flexibility Act 

Analysis 

4. The USF/ICC Transformation Order 

and FNPRM included an Initial 

Regulatory Flexibility Analysis (IRFA) 

pursuant to 5 U.S.C. 603, exploring the 

potential impact on small entities of the 

Commission’s proposal. We invite 

parties to file comments on the IRFA in 

light of this additional notice. 

2. Initial Paperwork Reduction Act of 

1995 Analysis 

5. This document seeks comment on 

a potential new or revised information 

collection requirement. If the 

Commission adopts a new or revised 

information collection requirement, the 

Commission will publish a separate 

notice in the Federal Register inviting 

the public to comment on the 

requirement, as required by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13 (44 U.S.C. 3501– 

3520). In addition, pursuant to the 

Small Business Paperwork Relief Act of 

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

3506(c)(4), the Commission seeks 

specific comment on how it might 

‘‘further reduce the information 

collection burden for small business 

concerns with fewer than 25 

employees.’’ 

3. Filing Requirements 

6. Pursuant to §§ 1.415 and 1.419 of 

the Commission’s rules, 47 CFR 1.415, 

1.419, interested parties may file 

comments and reply comments on or 

before the dates indicated on the first 

page of this document. Comments may 

be filed using the Commission’s 

Electronic Comment Filing System 

(ECFS). See Electronic Filing of 

Documents in Rulemaking Proceedings, 

63 FR 24121 (1998). 

• Electronic Filers: Comments may be 

filed electronically using the Internet by 

accessing the ECFS: http://

fjallfoss.fcc.gov/ecfs2/. 


tkelley on DSK3SPTVN1PROD with PROPOSALS