2015-07036. 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 newly proposed information collection activities for enhanced surveillance of Coccidioidomycosis in low- and non-endemic states.

DATES:

Written comments must be received on or before May 26, 2015.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2015-0010 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

Enhanced Surveillance of Coccidioidomycosis in Low- and Non-Endemic States—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Coccidioidomycosis, also called “Valley fever,” is a nationally notifiable fungal infection caused by inhalation of soil-dwelling Coccidioides spp. In the United States, coccidioidomycosis is known to be endemic in the southwestern states, but new evidence suggests that the true endemic areas may be broader than previously recognized. Approximately 10,000 coccidioidomycosis cases are reported in the U.S. each year to the National Notifiable Disease Surveillance System (NNDSS), but this system captures limited clinical and epidemiological information about reported cases. Most cases occur in Arizona or California, so the epidemiology of this disease has been well-described for these states, but little is known about the features of cases in other states.

Enhanced surveillance in low- and non-endemic states will help determine which information is most important to collect during routine surveillance and will help assess the suitability of the Council of State and Territorial Epidemiologists (CSTE) case definition for coccidioidomycosis in these areas. Primary prevention strategies for coccidioidomycosis have not yet been proven to be effective, so public health efforts may be best aimed at promoting awareness of coccidioidomycosis among healthcare providers and the general public. Improved surveillance data are essential for identifying such opportunities to promote awareness about this disease and for determining its true public health burden.

For a period of one year, state health department personnel in participating low- and non-endemic states (Louisiana, Michigan, Minnesota, Missouri, Montana, Nevada, New Mexico, North Dakota, Ohio, Oregon, Pennsylvania, Utah, and Wyoming) will conduct telephone interviews with reported coccidioidomycosis cases that meet the CSTE case definition and will record responses on a standardized form. Information collected on the form will include demographics, underlying medical conditions, travel history, symptom type and duration, healthcare-seeking behaviors, diagnosis, treatment, and outcomes.

This interview activity is consistent with the state's existing authority to investigate reports of notifiable diseases for routine surveillance purposes; therefore, formal consent to participate in the surveillance is not required. However, cases may choose not to participate and may choose not to answer any question they do not wish to answer.

It will take state health department personnel 20 minutes to administer the questionnaire and 10 minutes to retrieve and record the diagnostic information from their state reportable disease database.

Participation is voluntary. There are no costs to the respondents other than their time. The total burden hours are 73 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.)
State Health Department Personnel	Case Report Form for Coccidioidomycosis (Valley Fever) Enhanced Surveillance	145	1	30/60	73
Total					73

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.