30 Day FRN

Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-XXXX] (30Day-22-CDC#)

Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Generic Clearance for Lyme and other Tickborne Diseases Knowledge, Attitudes, and Practices Surveys to the Office of Management and budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on [insert Month Day, Year] to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(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 [email protected]. Direct written comments and/or suggestions regarding the items contained in this notice to:

Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Lyme and other Tickborne Diseases Knowledge, Attitudes, and Practices Surveys (OMB Control Number, Expiration Date if applicable) – Revision to a Generic Clearance – National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) Division of Vector-Borne Diseases (DVBD) and other programs working on tickborne diseases (TBDs) are requesting a revision to a previously approved generic clearance to conduct TBD prevention studies to include knowledge, attitudes, and practices (KAP) surveys regarding ticks and tickborne diseases (TBDs) among residents and businesses offering pest control services in Lyme disease endemic areas of the United States. The data collection for which approval is sought will allow DVBD to use survey results to inform implementation of future TBD prevention interventions. The revision involves a broadening of the secondary target population from owners and employees of pest control companies to stakeholders of local entities affected by TBDs (e.g., leaders in local public health or local government; owners or employees of pest control companies, landscaping companies, or other at-risk occupations; non-governmental organizations serving at-risk populations; and/or clinicians serving at-risk populations).

TBDs are a substantial and growing public health problem in the United States. From 2004-2016, over 490,000 cases of TBDs were reported to CDC, including cases of anaplasmosis, babesiosis, ehrlichiosis, Lyme disease, Rocky Mountain spotted fever, and tularemia (CDC, 2018). Lyme disease accounted for 82% of all TBDs, with over 400,000 cases reported during this time period. Recent studies estimate nearly 500,000 cases of Lyme disease are diagnosed annually in the United States (Kugeler et al, 2021). In addition, several novel tickborne pathogens have recently been found to cause human disease in the United States. Factors driving the emergence of TBDs are not well defined and current prevention methods have been insufficient to curb the increase in cases. Data is lacking on how often certain prevention measures are used by individuals at risk as well as what the barriers to using certain prevention measure are.

The primary target population for these data collections are individuals and their household members who are at risk for TBDs associated with I.scapularis ticks and who may be exposed to these ticks residentially, recreationally, and/or occupationally. The secondary target population includes stakeholders of local entities affected by TBDs (e.g., leaders in local public health or local government; owners or employees of pest control companies, landscaping companies, or other at-risk occupations; non-governmental organizations serving at-risk populations; and/or clinicians serving at-risk populations) in areas where I. scapularis ticks transmit diseases to humans. Specifically, these target populations include those residing or working in the 15 highest incidence states for Lyme disease (CT, DE, ME, MD, MA, MN, NH, NJ, NY, PA, RI, VT, VA, WI and WV). We anticipate conducting one to two surveys per year, for a maximum of six surveys conducted over a three-year period. Depending on the survey, we aim to enroll 500-10,000 participants per study. It is expected that we will need to target recruitment to about twice as many people as we intend to enroll. Surveys may be conducted daily, weekly, monthly, or bi-monthly per participant for a defined period (whether by phone or web survey), depending on the survey or study. The surveys will range in duration from approximately 5-30 minutes. Each participant may be surveyed 1-64 times in one year; this variance is due to differences in the type of information collected for a given survey. Specific burden estimates for each study and each information collection instrument will be provided with each individual project submission for OMB review. The maximum estimated, annualized burden hours are 98,830 hours. There is no cost to respondents other than their time.

Insights gained from KAP surveys will aid in prioritizing which prevention methods should be evaluated in future randomized, controlled trials and ultimately help target promotion of proven prevention methods that could yield substantial reductions in TBD incidence.

The total estimated annualized burden is 98,830 hours.

Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
General public, individuals or households	Screening instrument (Attachment 1)	20,000	1	0.25	5,000
	Consent form (Attachment 2)	10,000	1	0.33	3,330
	Introductory Surveys (Attachment 3)	10,000	1	0.5	5,000
	Monthly surveys (Attachment 4)	10,000	12	0.25	30,000
	Final surveys (Attachment 5)	10,000	1	0.5	5,000
	Daily surveys (Attachment 6)	10,000	60	0.083	50,000
Stakeholders of local entities affected by TBDs	Stakeholder Survey (Attachment 7)	1,000	1	0.5	500

__________________________________

Jeffrey M. Zirger, Ph.D.,

Lead,

Information Collection Review Office,

Office of Scientific Integrity,

Office of Science,

Centers for Disease Control and Prevention.

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