80_FR_10695 80 FR 10656 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review

80 FR 10656 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 39 (February 27, 2015)

Page Range10656-10658
FR Document2015-04169

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.

Federal Register, Volume 80 Issue 39 (Friday, February 27, 2015)
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Proposed Rules]
[Pages 10656-10658]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04169]


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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

[[Page 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 Sec.  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 Sec.  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/

[[Page 10658]]

publications/bmbl5/BMBL5_sect_VIII_d.pdf.
4. D. Raoult, J.B. Ndihokubwayo, H. Tissot-Dupont, 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



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

                                                Wynkoop Street, Denver, Colorado                        Agents and Toxins) of Public Law 107–                   B. Rickettsia prowazekii
                                                80202–1129, 303–312–6145,                               188 (June 12, 2002) (the Bioterrorism                   C. Bacillus anthracis Pasteur strain
                                                morrison.kendra@epa.gov.                                Response Act), the Centers for Disease                  D. Brucella abortus, B. melitensis, and B.
                                                                                                        Control and Prevention (CDC) located                       suis
                                                SUPPLEMENTARY INFORMATION: In the                                                                             IV. References
                                                ‘‘Rules and Regulations’’ section of this               within the Department of Health and
                                                Federal Register, EPA is publishing                     Human Services (HHS) has initiated the                I. Public Participation
                                                these negative declarations as a direct                 review of the HHS list of biological                     Interested persons or organizations
                                                final rule without prior proposal                       agents and toxins that have the potential             are invited to participate in this
                                                because the Agency views this as a                      to pose a severe threat to public health              rulemaking by submitting written views,
                                                noncontroversial action and anticipates                 and safety. We are considering whether                recommendations, and data. Comments
                                                no adverse comments. A detailed                         to propose amending the HHS list by                   are invited on any topic related to this
                                                rationale for publication is set forth in               removing six biological agents.                       rulemaking.
                                                the preamble to the direct final rule. If               DATES: Comments should be received on                    In addition, HHS/CDC invites
                                                EPA receives no adverse comments,                       or before April 28, 2015.                             comments specifically as to whether
                                                EPA will not take further action on this                ADDRESSES: You may submit comments,                   there are biological agents or toxins that
                                                proposed rule. If EPA receives adverse                  identified by Regulation Identifier                   should be added or removed from the
                                                comments, EPA will withdraw the                         Number (RIN), 0920–AA59 or Docket                     HHS list of select agents and toxins
                                                direct final rule and it will not take                  Number CDC–2015–0006 in the heading                   based on the following criteria, or any
                                                effect. EPA will address all public                     of this document by any of the following              other appropriate criteria:
                                                comments in a subsequent final rule                     methods:                                                 (1) The effect on human health of
                                                based on this proposed rule. EPA will                     • Federal eRulemaking Portal: http://               exposure to the agent or toxin;
                                                not institute a second comment period                   www.regulations.gov. Follow the                          (2) The degree of contagiousness of
                                                on this action. Any parties interested in               instructions for submitting comments.                 the agent or toxin and the methods by
                                                commenting must do so at this time.                       • Mail: Centers for Disease Control                 which the agent or toxin is transferred
                                                Please note that if EPA receives adverse                and Prevention, Select Agent Program,                 to humans; and
                                                comment on an amendment, paragraph,                     1600 Clifton Road NE., Mailstop A–46,                    (3) The availability and effectiveness
                                                or section of this rule and if that                     Atlanta, Georgia 30329, ATTN: RIN                     of pharmacotherapies and
                                                provision may be severed from the                       0920–AAxx.                                            immunizations to treat and prevent any
                                                remainder of the rule, EPA may adopt                      Instructions: All submissions received              illness resulting from infection by the
                                                as final those provisions of the rule that              must include the agency name and RIN                  agent or exposure to the toxin.
                                                are not the subject of an adverse                       for this rulemaking. All relevant                        (4) The needs of children and other
                                                comment. See the information provided                   comments received will be posted                      vulnerable populations.
                                                in the Direct Final action of the same                  without change to http://                                Comments received, including
                                                title which is located in the Rules and                 www.regulations.gov, including any                    attachments and other supporting
                                                Regulations Section of this Federal                     personal information provided.                        materials, are part of the public record
                                                Register.                                                 Docket Access: For access to the                    and subject to public disclosure. Do not
                                                   Authority: 42 U.S.C. 7401 et seq.                    docket to read background documents                   include any information in your
                                                                                                        or comments received or to download                   comment or supporting materials that
                                                  Dated: January 30, 2015.                              an electronic version of the ANPRM, go                you consider confidential or
                                                Debra H. Thomas,                                        to http://www.regulations.gov.                        inappropriate for public disclosure.
                                                Acting Regional Administrator, Region 8.                Comments will be available for public                 HHS/CDC will carefully consider all
                                                [FR Doc. 2015–03921 Filed 2–26–15; 8:45 am]             inspection Monday through Friday,                     comments submitted in preparation of a
                                                BILLING CODE 6560–50–P                                  except for legal holidays, from 9 a.m.                proposed final rule.
                                                                                                        until 5 p.m. at 1600 Clifton Road NE.,
                                                                                                        Atlanta, GA 30329. Please call ahead to               II. Background
                                                DEPARTMENT OF HEALTH AND                                1–866–694–4867 and ask for a                             The Bioterrorism Response Act
                                                HUMAN SERVICES                                          representative in the Division of Select              requires the HHS Secretary to establish
                                                                                                        Agents and Toxins to schedule your                    by regulation a list of biological agents
                                                42 CFR Part 73                                          visit. Please be aware that comments                  and toxins that have the potential to
                                                [Docket No. CDC–2015–0006]
                                                                                                        and other submissions from members of                 pose a severe threat to public health and
                                                                                                        the public are made available for public              safety. In determining whether to
                                                RIN 0920–AA59                                           viewing without changes.                              include an agent or toxin on the list, the
                                                                                                        FOR FURTHER INFORMATION CONTACT:                      HHS Secretary considers criteria such as
                                                Possession, Use, and Transfer of
                                                                                                        Robbin Weyant, Director, Division of                  the effect on human health of exposure
                                                Select Agents and Toxins; Biennial
                                                                                                        Select Agents and Toxins, Centers for                 to an agent or toxin; the degree of
                                                Review
                                                                                                        Disease Control and Prevention, 1600                  contagiousness of the agent and the
                                                AGENCY: Centers for Disease Control and                 Clifton Road NE., Mailstop A–46,                      methods by which the agent or toxin is
                                                Prevention (CDC), Department of Health                  Atlanta, Georgia 30329. Telephone:                    transferred to humans; the availability
                                                and Human Services (HHS).                               (404) 718–2000.                                       and effectiveness of pharmacotherapies
                                                ACTION: Advance notice of proposed                      SUPPLEMENTARY INFORMATION: The                        and immunizations to treat and prevent
tkelley on DSK3SPTVN1PROD with PROPOSALS




                                                rulemaking and request for comments.                    Preamble to this notice of proposed                   illnesses resulting from an agent or
                                                                                                        rulemaking is organized as follows:                   toxin; and the needs of children and
                                                SUMMARY:  In accordance with the Public                                                                       other vulnerable populations. The
                                                                                                        I. Public Participation
                                                Health Security and Bioterrorism                        II. Background
                                                                                                                                                              current list of HHS select agents and
                                                Preparedness and Response Act of 2002,                  III. Changes to 42 CFR Part 73, Modifications         toxins can be found at 42 CFR 73.3
                                                Subtitle A (Department of Health and                          to the List of Select Agents and Toxins         (HHS select agents and toxins) and 42
                                                Human Services) of Title II (Enhancing                        Being Considered                                CFR 73.4 (Overlap select agents and
                                                Controls on Dangerous Biological                           A. Coxiella burnetii                               toxins). The list of HHS and Overlap


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                                                                        Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules                                         10657

                                                select agents and toxins is available at:               III. Proposed Changes to 42 CFR Part                  C. Bacillus anthracis Pasteur Strain
                                                http://www.selectagents.gov/                            73, Modifications to the List of Select                  Bacillus anthracis is the bacterium
                                                Select%20Agents%20and%20Toxins                          Agents and Toxins Being Considered                    that causes anthrax, an acute disease in
                                                %20List.html.                                                                                                 animals and humans. However,
                                                                                                          The purpose of this advanced notice
                                                   The HHS Secretary last republished                   of proposed rulemaking is to seek public              different strains of B. anthracis have
                                                the list of HHS select agents and toxins                comment on the appropriateness of the                 different abilities to cause disease. The
                                                in the Federal Register on October 5,                   current list of HHS and Overlap select                Pasteur strain, for example, is unable to
                                                2012 (77 FR 61084). The list of HHS                     agents and toxins. Specifically, we are               produce toxic factors and is not
                                                select agents and toxins is divided into                providing an opportunity for interested               considered harmful to humans. Should
                                                two sections. The select agents and                     persons to submit comments, research                  B. anthracis Pasteur strain be removed
                                                toxins listed in § 73.3 (HHS select agents              data, and other information that will                 or retained as an Overlap select agent?
                                                and toxins) are those regulated only by                 better inform us as to whether: (1) There             Are there other reasons or research data
                                                HHS under the authority of the                          are any other biological agents or toxins             to support the removal besides the
                                                Bioterrorism Response Act (42 U.S.C.                    that should be added to the list because              following reasons?
                                                262a). The select agents and toxins                     they have the potential to pose a severe                 • B. anthracis Pasteur strain lacks the
                                                listed in § 73.4 (Overlap select agents                 threat to public health and safety; (2)               plasmid that encodes the toxin genes
                                                                                                        there are any other biological agents or              causing disease (6);
                                                and toxins) are those regulated by HHS
                                                                                                        toxins currently on the list that should                 • B. anthracis Sterne strain, which
                                                under the authority of the Bioterrorism
                                                                                                        be removed because they no longer have                lacks the plasmid that encodes for the
                                                Response Act and regulated by the U.S.                                                                        capsule, was excluded from the
                                                Department of Agriculture under the                     the potential to pose a severe threat to
                                                                                                        public health and safety, and/or (3) the              requirements of the regulations effective
                                                authority of the Agricultural                                                                                 on February 27, 2003 (7–8); and
                                                Bioterrorism Protection Act of 2002                     biological agents specifically listed in
                                                                                                        the following paragraphs should be                       • Historically, the B. anthracis
                                                (7 U.S.C. 8401).                                                                                              Pasteur strain has been retained as a
                                                                                                        removed or remain on the list.
                                                   The Bioterrorism Response Act                                                                              select agent to allow for continued
                                                                                                          HHS/CDC is also seeking comments                    oversight of laboratories in which the
                                                requires the HHS Secretary to review
                                                                                                        on the following considerations                       accidental (or intentional) combination
                                                and republish the list of select agents
                                                                                                        regarding the list of HHS and Overlap                 of this strain with the Sterne strain
                                                and toxins on at least a biennial basis.                select agents:
                                                Using government subject matter                                                                               could occur to produce de novo the
                                                experts, HHS/CDC conducts the                           A. Coxiella burnetii                                  wild type phenotype B. anthracis.
                                                biennial review process in consultation                                                                       However, a recent study indicates that
                                                                                                           Coxiella burnetii causes a disease                 bacterial transformation of B. subtilis
                                                with the HHS/CDC Intragovernmental                      called Q fever. Q fever is an acute febrile
                                                Select Agents and Toxins Technical                                                                            with plasmid DNA (e.g. pXO1 into
                                                                                                        rickettsial disease that varies in severity           Bacillus anthracis Pasteur strain) is
                                                Advisory Committee (ISATTAC). The                       and duration. Should Coxiella burnetii
                                                ISATTAC recommends changes to the                                                                             inefficient; indicating that
                                                                                                        be removed or retained as a HHS select                transformation with bacteria such as B.
                                                list of HHS select agents and toxins. The               agent? Are there other reasons or
                                                ISATTAC is comprised of Federal                                                                               anthracis would also be inefficient (9).
                                                                                                        research data to support the removal
                                                government employees from CDC,                          besides the following reasons?                        D. Brucella abortus, B. melitensis, and
                                                Biomedical Advanced Research and                           • It is not easily transmitted from                B. suis
                                                Development Authority (BARDA)                           person to person (1);                        Brucella abortus, B. melitensis, and B.
                                                within the Office of the Assistant
                                                Secretary for Preparedness and                             • It has a low mortality rate with     suis bacteria cause brucellosis, a disease
                                                                                                        antibiotic treatment (2); and             that can spread from animals to
                                                Response, the National Institutes of                                                              humans. Should B. abortus, B.
                                                Health (NIH), the Food and Drug                            • There is an investigational new
                                                                                                        drug (IND) vaccine available for at-risk  melitensis, and B. suis be removed or
                                                Administration (FDA), the Department                                                              retained as select agents? Are there
                                                of Homeland Security (DHS), the                         personnel (3).
                                                                                                                                                  other reasons or research data to support
                                                Department of Defense (DOD), the                        B. Rickettsia prowazekii                  the removal besides the following
                                                USDA/Animal and Plant Health                                                                      reasons?
                                                                                                           Rickettsia prowazekii causes epidemic
                                                Inspection Service (APHIS), USDA/                                                                    • B. abortus has a low human
                                                Agricultural Research Service (ARS),                    typhus. Epidemic typhus is a potentially
                                                                                                                                                  mortality rate (10);
                                                and USDA/CVB (Center for Veterinary                     lethal, louse-borne, disease caused by R.    • B. abortus, B. melitensis, and B.
                                                Biologics). Based on the criteria                       prowazekii. Should Rickettsia             suis are readily treatable with
                                                outlined in the Bioterrorism Response                   prowazekii be removed or retained as a    antibiotics (10); and
                                                Act, the ISATTAC used the following                     HHS select agent? Are there other            • Human-to-human transmission is
                                                measures in its review: the degree of                   reasons or research data to support the   extremely rare, and wildlife carriers in
                                                pathogenicity (ability of an organism to                removal besides the following reasons?    the United States often come into
                                                cause disease), communicability (ability                   • It is readily treatable with         contact with humans without significant
                                                to spread from infected to susceptible                  antibiotics (4);                          transmission (10).
                                                hosts), ease of dissemination, route of                    • The risk of mass casualties is low
                                                                                                                                                  IV. References
                                                exposure, environmental stability, ease                 because R. prowazekii can be treated
tkelley on DSK3SPTVN1PROD with PROPOSALS




                                                of production, ability to genetically                   with a single dose of doxycycline when    1. T.J. Marrie. Q fever. In: Marrie TJ, editor.
                                                manipulate or alter, long-term health                   symptoms are present (4); and                  Q fever. Vol. 1. Boca Raton, FL: CRC
                                                                                                                                                       Press; 1990. (The disease).
                                                effects, acute morbidity (illness), acute                  • Transmissibility from person to      2. M. Maurin and D. Raoult. Q fever. Clin
                                                mortality (death), available treatment,                 person is low due to the fact that R.          Microbiol Rev. Oct. 1999;12(4):518–53.
                                                status of host immunity, vulnerability of               prowazekii is usually transmitted via     3. Biosafety in Microbiological and
                                                special populations, and the burden or                  blood, although it can be spread through       Biomedical Laboratories (BMBL) 5th
                                                impact on the health care system.                       inhalation of louse feces.                     Edition, http://www.cdc.gov/biosafety/



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                                                10658                    Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules

                                                     publications/bmbl5/BMBL5_sect_VIII_                ADDRESSES:    You may submit comments,                requirements for recipients of funding
                                                     d.pdf.                                             identified by WC Docket Nos. 10–90 and                awarded through the Phase II
                                                4. D. Raoult, J.B. Ndihokubwayo, H. Tissot-             14–259, by any of the following                       competitive bidding process. Thus,
                                                     Dupont, V. Roux, B. Faugere, R.                    methods:                                              during the comment period established,
                                                     Abegbinni, and R.J. Birtles. Outbreak of
                                                     epidemic typhus associated with trench
                                                                                                           • Electronic Filers: Comments may be               the Bureau encourages parties to
                                                     fever in Burundi. The Lancet. Aug. 1998;           filed electronically using the Internet by            comment on the petitions’ LOC
                                                     352 (3125):353–358.                                accessing the ECFS: http://                           proposals more generally and their
                                                5. D. Raoult, T. Woodward, and J.S. Dumler.             fjallfoss.fcc.gov/ecfs2/.                             potential applicability to the Phase II
                                                     The history of epidemic typhus. Infect                • People with Disabilities: Contact the            competitive bidding process.
                                                     Dis Clin N Am. Mar. 2004; 18(1):127–               FCC to request reasonable                               3. In order to develop a complete
                                                     140.                                               accommodations (accessible format                     record on the issues presented in the
                                                6. B.E. Ivins, J.W. Ezzell, J. Jemski, K.W.             documents, sign language interpreters,                waiver petition, the request for more
                                                     Hedlund, J.D. Ristroph, and S.H. Leppla.           CART, etc.) by email: FCC504@fcc.gov                  general comment will be treated, for ex
                                                     Immunization Studies with Attenuated                                                                     parte purposes, as ‘‘permit-but-disclose’’
                                                     Strains of Bacillus anthracis. Infection
                                                                                                        or phone: 202–418–0530 or TTY: 202–
                                                                                                        418–0432.                                             in accordance with section 1.1200(a) of
                                                     and Immunity. May 1986; 52(2):454–458.
                                                7. Centers for Disease Control and                         For detailed instructions for                      the Commission’s rules, subject to the
                                                     Prevention, National Center for Emerging           submitting comments and additional                    requirements under section 1.1206(b).
                                                     and Zoonotic Infectious Diseases                   information on the rulemaking process,                II. Procedural Matters
                                                     ‘‘Anthrax Sterne strain (34F2) of Bacillus         see the SUPPLEMENTARY INFORMATION
                                                     anthracis,’’ http://www.cdc.gov/nczved/            section of this document.                             1. Initial Regulatory Flexibility Act
                                                     divisions/dfbmd/diseases/anthrax_
                                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                              Analysis
                                                     sterne/.
                                                                                                        Heidi Lankau, Wireline Competition                       4. The USF/ICC Transformation Order
                                                8. Federal Select Agent Program, ‘‘Select
                                                     Agents and Toxins Exclusions,’’ http://            Bureau at (202) 418–7400 or TTY (202)                 and FNPRM included an Initial
                                                     www.selectagents.gov/                              418–0484.                                             Regulatory Flexibility Analysis (IRFA)
                                                     SelectAgentsandToxinsExclusions.html.              SUPPLEMENTARY INFORMATION: This is a                  pursuant to 5 U.S.C. 603, exploring the
                                                9. C. Johnston, B. Martin, G. Fichant, P.               synopsis of the Wireline Competition                  potential impact on small entities of the
                                                     Polard, and J.P. Claverys. Bacterial               Bureau’s Public Notices (Notices) in WC               Commission’s proposal. We invite
                                                     transformation: distribution, shared                                                                     parties to file comments on the IRFA in
                                                                                                        Docket No. 10–90, 14–259; DA 15–140,
                                                     mechanisms and divergent control.                                                                        light of this additional notice.
                                                     Nature Rev. Microbiol. 2014; 12: 181–              released January 30, 2015 and DA 15–
                                                     196.                                               158, released February 4, 2015. The                   2. Initial Paperwork Reduction Act of
                                                10. Center for Food Security and Public                 complete text of these documents are                  1995 Analysis
                                                     Health, ‘‘Brucellosis Technical fact               available for inspection and copying                     5. This document seeks comment on
                                                     sheet,’’ http://www.cfsph.iastate.edu/             during normal business hours in the                   a potential new or revised information
                                                     Factsheets/pdfs/brucellosis.pdf.                   FCC Reference Information Center,                     collection requirement. If the
                                                  Dated: February 5, 2015.                              Portals II, 445 12th Street SW., Room                 Commission adopts a new or revised
                                                Sylvia M. Burwell,                                      CY–A257, Washington, DC 20554. The                    information collection requirement, the
                                                Secretary.                                              document may also be purchased from                   Commission will publish a separate
                                                                                                        the Commission’s duplicating                          notice in the Federal Register inviting
                                                [FR Doc. 2015–04169 Filed 2–26–15; 8:45 am]
                                                                                                        contractor, Best Copy and Printing, Inc.,             the public to comment on the
                                                BILLING CODE 4163–18–P
                                                                                                        445 12th Street SW., Room CY–B402,                    requirement, as required by the
                                                                                                        Washington, DC 20554, telephone (800)                 Paperwork Reduction Act of 1995,
                                                                                                        378–3160 or (202) 863–2893, facsimile                 Public Law 104–13 (44 U.S.C. 3501–
                                                FEDERAL COMMUNICATIONS                                  (202) 863–2898, or via Internet at                    3520). In addition, pursuant to the
                                                COMMISSION                                              http://www.bcpiweb.com.                               Small Business Paperwork Relief Act of
                                                47 CFR Part 54                                          I. Introduction                                       2002, Public Law 107–198, see 44 U.S.C.
                                                                                                                                                              3506(c)(4), the Commission seeks
                                                                                                           1. On January 27, 2015, the Alliance               specific comment on how it might
                                                [WC Docket No. 10–90, 14–259; DA 15–140;
                                                                                                        of Rural Broadband Applicants filed a                 ‘‘further reduce the information
                                                DA 15–158]
                                                                                                        petition for limited waiver of certain                collection burden for small business
                                                Wireline Competition Bureau Seeks                       letter of credit (LOC) requirements                   concerns with fewer than 25
                                                Comment More Generally on Letter of                     applicable to the rural broadband                     employees.’’
                                                Credit Proposals for Connect America                    experiments. On February 3, 2015,
                                                Phase II Competitive Bidding Process                    NTCA—The Rural Broadband                              3. Filing Requirements
                                                                                                        Association filed an emergency petition                  6. Pursuant to §§ 1.415 and 1.419 of
                                                AGENCY:  Federal Communications                         for limited waiver of the LOC bank                    the Commission’s rules, 47 CFR 1.415,
                                                Commission.                                             eligibility requirements applicable to                1.419, interested parties may file
                                                ACTION: Proposed rule.                                  the rural broadband experiments. On                   comments and reply comments on or
                                                                                                        January 21, 2015, the National Rural                  before the dates indicated on the first
                                                SUMMARY:   In these documents, the                      Utilities Cooperative Finance                         page of this document. Comments may
                                                Wireline Competition Bureau seeks                       Corporation and its affiliate, the Rural              be filed using the Commission’s
                                                comment more generally on letter of
tkelley on DSK3SPTVN1PROD with PROPOSALS




                                                                                                        Telephone Finance Cooperative, also                   Electronic Comment Filing System
                                                credit proposals raised by several                      filed a petition for waiver of one aspect             (ECFS). See Electronic Filing of
                                                petitions for waiver and their potential                of the Commission’s LOC bank                          Documents in Rulemaking Proceedings,
                                                applicability to the Phase II competitive               eligibility requirements.                             63 FR 24121 (1998).
                                                bidding process.                                           2. The Bureau notes that these                        • Electronic Filers: Comments may be
                                                DATES: Comments are due on or before                    petitions for waiver raise issues that                filed electronically using the Internet by
                                                March 30, 2015 and reply comments are                   may be relevant to broader pending                    accessing the ECFS: http://
                                                due on or before April 13, 2015.                        questions regarding possible LOC                      fjallfoss.fcc.gov/ecfs2/.


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Document Created: 2015-12-18 13:14:14
Document Modified: 2015-12-18 13:14:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionAdvance notice of proposed rulemaking and request for comments.
DatesComments should be received on or before April 28, 2015.
ContactRobbin 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.
FR Citation80 FR 10656 
RIN Number0920-AA59

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