Agency Forms Undergoing Paperwork Reduction Act Review

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Federal RegisterSep 16, 2015
80 Fed. Reg. 55631 (Sep. 16, 2015)

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

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 139 hours.

Estimated Annualized Burden Hours

Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hrs.)
Veterinary diagnostic laboratory staff Burden of Canine Brucellosis Information Collection 119 1 1
Non-responders (over estimation) Telephone script 119 1 5/60
Other laboratories Burden of Canine Brucellosis Information Collection 10 1 1
Total

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. 2015-23226 Filed 9-15-15; 8:45 am]

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