Draft 60d FRN

BILLING CODE: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-xxxx]

[Docket No. CDC-2016-xxxx]

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 Knowledge, Attitudes, and Practices related to a Domestic Readiness Initiative on Zika Virus Disease. This project consists of telephone interviews with participants in Puerto Rico and the domestic U.S.

DATES: Written comments must be received on or before [INSERT DATE 60 DAYS AFTER PUBLICATION DATE IN THE FEDERAL REGISTER].

ADDRESSES: You may submit comments, identified by Docket No. CDC-201x-xxxx 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, N.E., 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, N.E., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; E-mail: [email protected].

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

Knowledge, Attitudes, and Practices related to a Domestic Readiness Initiative on Zika Virus Disease – National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Since late 2015, Zika has rapidly spread through Puerto Rico. As of July 2016, there have been 7,286 confirmed cases of Zika in Puerto Rico, with 788 cases among pregnant women and 23 cases of Guillain-Barré caused by Zika. In the continental United States, there have been 1,658 travel-associated cases of Zika. And as of August 2^nd, there have been 14 locally-acquired Zika cases in Miami, Florida. Due to the urgent nature of this public health emergency, CDC is implementing a Zika prevention communication and education initiative in the continental United States and Puerto Rico.

The Centers for Disease Control and Prevention (CDC) requests approval from the Office of Management and Budget (OMB) to conduct an assessment of a domestic U.S. and Puerto Rico-based communication and education initiative aimed at encouraging at-risk populations to prepare and protect themselves and their families from Zika virus infection. As part of the mission of CDC’s Domestic Readiness Initiative on the Zika Virus Disease, CDC will assess the following communication and education objectives: 1) determine the reach and saturation of the initiative’s messages in Puerto Rico and 20 U.S. states and Washington, DC; 2) measure the extent to which messages were communicated clearly across multiple channels to advance knowledge and counter misinformation; and 3) monitor individual and community-level awareness, attitudes and intention to follow recommended behaviors.

This ICR is for data collection over the next six months related to Zika prevention efforts that have been and will be implemented in Puerto Rico and the domestic U.S. Specifically, CDC needs this assessment to ensure that Zika prevention campaigns effectively reach target audiences to educate individuals regarding Zika prevention behaviors. On-going evaluation is an important part of this program because it can inform awareness of campaign activities, how people perceive Zika as a health risk, and assess their uptake of recommended health behaviors after the campaign has been implemented.

These interviews can help articulate motivations for and against engaging in Zika prevention behaviors that are critical for preventing Zika-associated birth defects and morbidities. Implementing changes based on results from this assessment is expected to facilitate program improvement and ensure the most efficient allocation of resources for this public health emergency.

The goal of this project is to determine knowledge, attitudes, and practices related to a new Domestic Readiness Initiative on Zika Virus Disease being launched in the United States (U.S.) mainland and Puerto Rico.

Findings will be used to improve planning, implementation, refinements, and demonstrate outcomes of a Zika Domestic Readiness Initiative communication and education effort. The plan is to conduct up to 2,400 interviews (1,200 in the domestic U.S. and 1,200 in Puerto Rico) after the initial campaign is launched. An additional 2,400 (1,200 in the domestic U.S. and 1,200 in Puerto Rico) interviews will be conducted three months after the campaign is launched. As each phase of data is collected, researchers will analyze the data, and generate a report for leaders of the response to offer insights on the delivery of the communication campaign. The information will be used to make recommendations for improving communication and education regarding the prevention and spread of the Zika virus. Information may also be used to develop presentations, reports, and manuscripts to document the communication effort and lessons learned in order to inform future similar communication efforts.

The purpose of this assessment is to assess core components of CDC’s Zika response in communicating prevention behaviors and risk messages to the public about vector control services.

The following factors will be assessed:

• Knowledge about Zika virus and related prevention behaviors

• Self-efficacy in engaging in Zika prevention behaviors

• Engagement in Zika prevention behaviors (e.g, protective clothing use, condom use, and standing water removal)

• Risk perceptions of Zika

CDC will conduct telephone interviews with a mix of closed-ended and open-ended questions with individuals domestically in the US and in Puerto Rico. We estimate 4,800 individuals will participate in the project over a six month period.

Results of this project will have limited generalizability. However, results of this evaluation should provide information that can be used to enhance and revise the existing program as well as offer lessons learned to inform infectious disease control programs that use education materials.

Authorizing legislation comes from Section 301 of the Public Health Service Act (42 USC 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 Hours
U.S. Domestic Adults	Zika Readiness Initiative Survey	3600	1	12/60	720
Puerto Rico Adults	Zika Readiness Initiative Survey	3600	1	12/60	720
TOTAL		7200			1,440

Dated: September 1, 2016

__________________________________

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

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