2015-12094. 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.

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

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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Veterinary diagnostic laboratory staff	Burden of Canine Brucellosis Information Collection	119	1	1	119
Other laboratories	Burden of Canine Brucellosis Information Collection	10	1	1	10
Total					129

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.