[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28615-28617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15AIS; Docket No. CDC-2015-0037]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

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

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
information collection entitled CDC Burden of Canine Brucellosis 
Information Collection. This information collection will help to 
estimate canine brucellosis disease burden in dogs, which will aid in 
the determination of the public health importance of human B. canis 
infections, and the potential for zoonotic transmission.

DATES: Written comments must be received on or before July 20, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0037 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and

[[Page 28616]]

instruments, contact the Information Collection Review Office, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, 
Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    CDC Burden of Canine Brucellosis Information Collection--New--
National Center for Emerging and Zoonotic Infectious Diseases, Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Canine brucellosis is a bacterial infection caused by the organism 
Brucella canis. Few seroprevalence studies have been done to estimate 
the prevalence of canine brucellosis, most of which were conducted over 
25 years ago. Two recent reports from Oklahoma and Wisconsin describe 
increasing prevalence in dogs; however, the national burden is not 
known. B. canis is also pathogenic to humans, although human infections 
are thought to be rare in the United States.
    Unlike Brucella abortus, B. melitensis, and B. suis, B. canis is 
not classified as a select agent. As a result, laboratory 
identification of the organism in humans does not require reporting to 
the Laboratory Response Network. Brucella species-specific data are not 
collected in the Nationally Notifiable Disease Surveillance System at 
CDC, and there are no validated Brucella canis serological tests to 
diagnose disease in humans. For these reasons, there are no national 
estimates of B. canis prevalence in humans or canines.
    Additionally, canine infections with other Brucella species have 
been reported in the literature. Zoonotic transmission is a concern 
with all Brucella species pathogenic to humans, and at least one human 
infection with B. suis related to canine contact has been reported. 
Neither the prevalence of canine brucellosis nor the potential risk of 
zoonotic spread to humans is known.
    There has been interest in human brucellosis caused by B. canis 
among the public health community. However, the degree of public health 
importance of human B. canis infections has not yet been ascertained. 
The Council of State and Territorial Epidemiologists approved a 
position statement in 2012 that recommends increased focus on B. canis, 
and urges CDC to support the development of a human diagnostic assay.
    The purpose of this information collection request is to estimate 
the burden of canine brucellosis in the United States, which will aid 
in the determination of the level of public health importance of human 
B. canis infections, and the potential for transmission of brucellosis 
from dogs. An estimate of disease burden in dogs will provide an idea 
of potential transmission between dogs and humans, and determine the 
need for future human public health studies, which is critical during 
this time of scarce resources.
    Veterinary diagnostic laboratories throughout the United States 
will be solicited to provide information on the quantity of test 
requests and positive results for Brucella spp. in canines, outsourcing 
of clinical testing, state-wide policies for reporting of positive 
results, and policies for human exposure to clinical specimens or 
isolates.
    The laboratories were identified through multiple sources: A review 
of the Animal and Plant Health Inspection Service-approved Brucella 
diagnostic laboratories, the National Animal Health Laboratory Network 
laboratories, the American Association of Veterinary Laboratory 
Diagnosticians (AAVLD), and an Internet search.
    The outcomes of this information collection are to assess the 
burden of disease in the animal host (dogs, in this case), as well as 
evaluate the knowledge and practices of occupational exposures to the 
organism. The information collected will be used to guide a longer term 
strategy for identification of human cases, understanding risk factors 
and activities associated with zoonotic transmission, and eventually 
validation of a human diagnostic assay. These strategies will be 
implemented using other mechanisms.
    The total annual burden is 129 hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Veterinary diagnostic           Burden of Canine             119               1               1             119
 laboratory staff.               Brucellosis
                                 Information
                                 Collection.
Other laboratories............  Burden of Canine              10               1               1              10
                                 Brucellosis
                                 Information
                                 Collection.
                                                 ---------------------------------------------------------------

[[Page 28617]]

 
    Total.....................  ................  ..............  ..............  ..............             129
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-12094 Filed 5-18-15; 8:45 am]
 BILLING CODE 4163-18-P