2017-11018. 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 “Backyard Integrated Tick Management Project” which will evaluate the effectiveness of specific tick control methods used on single versus multiple adjacent properties to suppress host-seeking ticks infected with Lyme disease spirochetes and to reduce human tick bites, and help the CDC better understand human landscape use patterns and tick exposure locations.

DATES:

Written comments must be received on or before July 31, 2017.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2017-0036 by any of the following methods:

• Federal eRulemaking Portal: Regulations.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 Leroy Richardson, 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

Backyard Integrated Tick Management Project—Existing Collection in Use Without an OMB Control Number—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)

Background and Brief Description

The combined number of confirmed and probable Lyme disease cases have exceeded 30,000 in all years since 2008, and recent estimates suggest that the true number of Lyme disease cases may be 10-fold higher. There is no Lyme disease vaccine for use in humans and prevention of infection is therefore completely reliant on personal protective measures (avoiding tick habitat, use of repellent, tick checks or prompt tick removal, etc.) and methods to suppress vector ticks in the environment.

The primary goal of this project is to evaluate the effectiveness of specific tick/pathogen control methods used on single versus multiple adjacent properties on the risk of human exposure to ticks. The secondary goal is to better understand human landscape use patterns and tick exposure locations. The project was initiated in direct response to knowledge gaps, identified by CDC Subject Matter Experts (SMEs), for the use of integrated tick vector/rodent reservoir management to reduce human risk of exposure to Ixodes scapularis ticks, the sole vector of Lyme disease in the Northeast.

Resulting data is intended to be used to provide suggestions for improving tick/pathogen control methods used in the environment.

Information will be collected, under protocols approved by the institutional review boards (IRBs) at Western Connecticut State University (WCSU) and the University of Rhode Island (URI), from inhabitants of residential properties to (i) compare the effectiveness of an integrated tick management approach at single-treated residential properties vs. contiguously-treated residential properties to reduce human tick bites and (ii) increase the understanding of where people encounter ticks, both near their homes and in other outdoor settings.

Another potential positive outcome of the information collection is more effective targeting of tick control efforts to high risk areas, minimizing pesticide use. Not collecting the information would lead to inadequate evaluation of the implemented integrated tick management program (solely focusing on host-seeking ticks collected from the vegetation) as well as the unacceptable status quo for detailed knowledge of where people encounter ticks within their residential properties and on the residential properties versus elsewhere.

Information will be collected by WCSU and URI researchers from inhabitants (adults and children) of participating residential properties (freestanding homes with tick habitat on the property) located in Connecticut and Rhode Island. Consenting participants will complete one introductory survey by telephone, projected to last no more than 15 minutes. In May-August of Years 1-4, participants will also complete an emailed monthly tick encounter survey about the number of ticks found on each member of the household and each household member's tick-borne disease status, projected to take no more than 10 minutes per month to complete. An end-of-season survey will also be administered in March/April each year, projected to take no more than 10 minutes to complete.

In addition, participants will be asked to record location of daily activity on behalf of themselves and household members each day over the first week of June in a single year via emailed daily surveys, projected to take 70 minutes over the week of participation. Lastly, an end-of-study survey will be administered in September 2020, projected to take no more than 15 minutes. In total, we expect approximately two hours or less of total time spent on surveys by consented participants in each year of the study. All survey instruments have been approved by the IRBs at WCSU and URI.

The collection of information is conducted by WCSU, and its subcontractor, URI, as part of a Cooperative Agreement with the Centers for Disease Control and Prevention (CDC) (1U01CK0004912-01). The Cooperative Agreement was established based on WCSU competing successfully for CDC RFA-CK-16-002 (Spatially Scalable Integrated Tick Vector/Rodent Reservoir Management to Reduce Human Risk of Exposure to Ixodes scapularis Ticks Infected with Lyme Disease Spirochetes).

This study is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241).

There is no cost to respondents other than their time to participate.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Households or Individuals	Eligibility Survey	500	1	15/60	125
	Introductory Survey (including Consent Form)	230	1	30/60	115
	Monthly Surveys	230	4	10/60	154
	Daily Surveys	230	7	10/60	269
	Annual End of Year Survey	230	1	15/60	58
	Final Survey	230	1	15/60	58
Total					779

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.