Supporting Statement A 20MAR2018

Message Testing for Tobacco Communication Activities (MTTCA)

(OMB No. 0920-0910)

Supporting Statement: Part A

Program Official/Contact

Michelle O’Hegarty, PhD

Office on Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

4770 Buford Highway, NE MS F-79

Atlanta, Georgia 30341

770-488-5582

FAX:770-488-5939

Email: mohegarty@cdc.gov

February 20, 2018

TABLE OF CONTENTS

1. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

8. Comments in Response to the Federal Register Notice & Efforts to Consult Outside Agency

9. Explanation of Any Payment or Gift to Respondents 10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

13. Estimates of Other Annual Cost Burden to Respondents and Record Keepers

14. Annualized Cost to the Federal Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

17. Reason(s) Display of OMB Expiration Date is Inappropriate

18. Exceptions to Certification for Paperwork Reduction Act Submissions

LIST OF ATTACHMENTS

Attachment 1: Public Health Service Act

Attachment 2: Overview of Planned Information Collections

Attachment 3a: Example Data Collection Instrument – Rough Cut Testing Survey Screener

Attachment 3b: Example Data Collection Instrument – Rough Cut Testing Survey

Attachment 3c: Example Data Collection Instrument – Creative Concepts Survey Screener

Attachment 3d: Example Data Collection Instrument – Creative Concepts Survey

Attachment 3e: Example Data Collection Instrument – Creative Concepts Focus Group Screener

Attachment 3f: Example Data Collection Instrument – Creative Concepts Focus Group

Moderator’s Guide

Attachment 4: Example Informed Consent Form

Attachment 5: 60 Day Published FRN

Attachment 6: Institutional Review Board Approval Notification or exemption determination

• Goal of the Extension: The primary purpose and use of information collected under MTTCA is to inform the development and pretesting of materials for the Office on Smoking and Health’s (OSH) ongoing national tobacco education campaign (NTEC). The MTTCA clearance is also used to develop other health messages that are not specifically associated with NTEC (e.g. Surgeon General’s Reports, etc.)

• Intended use of the resulting data: OSH will continue to use the MTTCA clearance to develop and test messages and materials for NTEC, as well as OSH’s ongoing programmatic initiatives including, but not limited to, the Media Campaign Resource Center, reports from the Office of the Surgeon General, and other communication efforts and materials.

• Methods to be used to collect data: A variety of qualitative and quantitative information collection strategies are supported through this mechanism, including in-depth interviews; in-person focus groups; online focus groups; computer-assisted, in-person, or telephone interviews; and online surveys.

• Populations to be studied: The study population will be adult smokers 18-54 years old. The existing clearance also includes youth 13-17 years old. There are no proposed changes to the populations of interest from the last revision request to MTTCA.

• How data will be analyzed: Quantitative data will be analyzed using aggregate measures such as percentages and means. The qualitative data will be analyzed using thematic analysis. Focus group responses will be completely transcribed and read thoroughly, and codes will be created manually to identify themes and patterns of response.

A. Justification

A.1. Circumstances Making the Collection of Information Necessary

Significant improvements have been made in reducing the smoking rate in the United States since the first Surgeon General’s Report came out more than 50 years ago; the prevalence of cigarette smoking among adults has declined from 42% in 1965 to 15% in 2015 (U.S. Department of Health and Human Services (HHS), 2014; CDC 2016). Yet cigarette smoking is still the leading cause of preventable disease and death in the United States, accounting for more than 480,000 deaths every year, or one of every five deaths (HHS, 2014). In addition, more than 16 million Americans live with a smoking-related disease (HHS, 2014).

In 2012, the Centers for Disease Control and Prevention’s Office on Smoking and Health (CDC/OSH) obtained OMB approval of a generic clearance that established a unified information collection framework for the development of tobacco-related health messages, including messages related to the national tobacco education campaign (Message Testing

for Tobacco Communication Activities (MTTCA), OMB No. 0920-0910, exp. 1/31/2015). OSH is authorized to conduct information collection supporting these activities under the Public Health Service Act (41USC 241) Section 301 (see Attachment 1). The MTTCA clearance was initially approved with the following estimates: 5,775 annualized burden hours and 14,974 annualized responses. In 2014, OSH obtained approval for a revision to MTTCA that granted a three-year extension until 3/31/2018 and increased the estimated annualized burden hours to 10,998 and the annualized number of responses to 44,216.

Since 2012, OSH has successfully planned, implemented, and evaluated a national tobacco education campaign (NTEC), which includes health messages for the target audience (adults ages 18-54 years old) and a number of messages that are tailored to specific audience segments (e.g. smokers versus nonsmokers). The existing clearance also includes youth ages 13-17 years old. The campaign is delivered through a variety of media channels and formats, including television ads, radio ads, digital ads, out-of-home, and print materials. To keep the target audience engaged and ensure continued effectiveness of the campaign, new ads must be developed. For this reason, OSH is submitting a three-year extension request to the 0920-0910 MTTCA clearance so OSH can continue to test messages and materials for NTEC, the Media Campaign Resource Center, reports from the Office of the Surgeon General, and other communication efforts. There are no proposed changes to the information collection activities, methodology, populations of interest, or burden. Attachment 2 provides an overview of projected program needs during the time period of March 31, 2018 through March 31, 2021, including estimated burden to respondents.

A.2. Purposes and Use of Information Collection

The primary purpose and use of information collection under MTTCA will be to inform the development and pretesting of materials for OSH’s ongoing NTEC. Since approval of the revision to MTTCA in January 2014, this mechanism has been used to support message platform testing, creative concept testing, and rough cut testing of television, print, digital, out-of-home, and radio ads for NTEC. In addition, MTTCA has supported the development of health messages that are not specifically associated with NTEC (e.g. Public Service Announcements released as part of the 2016 Surgeon General’s Report on E-Cigarette Use Among Youth and Young Adults).

To date, NTEC has had a significant impact on cessation behaviors among U.S. adult smokers over time because of the continued use of graphic, hard-hitting, emotional ads (Davis, Patel, Shafer, Duke, Glover-Kudon, Ridgeway, & Cox, 2017). For example, the 2012 campaign motivated an estimated 1.64 million smokers to make a quit attempt (McAfee, Davis, Alexander, Pechacek, & Bunnell, 2013) and more than 100,000 smokers are estimated to have remained quit. Following the launch of the nine-week Phase 2 2014 campaign, an estimated 1.83 million smokers attempted to quit smoking, 1.73 million additional smokers intended to quit within six months, and an estimated 104,000 smokers were able to stay quit for at least 6 months (CDC, 2016). The campaign has also been associated with increased knowledge of tobacco-related health risks (Huang, Thrasher, Abad, Cummings, Bansal-Travers, Brown, & Nagelhout, 2015.). In addition, in the first year of the campaign alone, an estimated 6 million nonsmokers talked with friends and family about the dangers of smoking. More information about the impact of the campaign can be found at the website cdc.gov/tips under the heading Tips^® Impact and Results.

The MTTCA generic clearance is founded on a strategic and systematic approach to the design and testing of high-quality health messages, campaigns, and programs, and employs accepted methods of health message development, including input from public health partners, and pre-testing with target audiences. (Figure 1) (National Cancer Institute, 2002). In Figure 1 below, step three would also include implementing the program/campaign (e.g., NTEC).

Figure 1. Health Communication Program Cycle

This approach is outlined below:

1. Planning and Strategy Development. This step can occur via formal needs assessments with partners and intended users (i.e., the target audience) and a review of published literature and epidemiological data related to a specific health problem. A needs assessment can be accomplished by conducting surveys, for example, to determine pressing health needs or concerns of the target audience. Next, OSH must understand a target audience’s current behaviors, beliefs, attitudes, and knowledge about tobacco-related issues to effectively design health messages, programs, and campaigns. This information can be gained with focus groups, interviews, and/or surveys. These will guide selection and application of behavioral theories to a program’s strategies and messages and audience segmentation (Fishbein & Yzer, 2003; Noar, 2006; Thackeray & Neiger, 2000).

2. Developing and Pretesting Concepts, Messages, and Materials. In this second step, OSH designs draft messages that must be tested with members of the target audience. Audience feedback, in the form of interviews, focus groups or surveys, is incorporated into subsequent revisions. Audience testing informs the final development of messages, materials or advertisements and is essential for ensuring that federal dollars are expended appropriately on health messages that are effective.

3. Implementing the Program/Campaign. OSH implements the campaign and conducts process evaluation to ascertain to what extent the campaign was implemented as planned and under what conditions. This information helps campaign developers identify areas for improvement.

4. Assessing Effectiveness and Making Refinements. OSH must conduct outcome evaluation of the campaign to assess the degree to which the campaign was effective. This process also captures lessons learned for improving subsequent iterations of the program and for similar future efforts. Information collection for campaign assessment and evaluation activities has been approved in a separate but related information collection request (OMB No. 0920-1083, exp. 09/30/2017, Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign).

MTTCA provides a unified clearance framework for a variety of tobacco-related communication activities primarily related to steps 1-3 described above, which may occur on an as-needed basis, or in the context of a planned series utilizing a variety of methodologies. In the initial generic clearance period, we outlined the following purposes and uses of information to be collected. We plan to continue using the MTTCA clearance in these ways:

• Provide critical knowledge about specific target audiences for tobacco communication activities conducted by OSH.

• Understand individuals’ attitudes, knowledge and beliefs around tobacco use and quitting behaviors and how this may influence perception of messages.

• Develop and refine message concepts and pretest draft materials for clarity, salience, appeal, and persuasiveness to target audiences.

• Ensure quality of health information and prevent ineffective and wasteful message dissemination by OSH to the public.

• Allow for the collection of health and other employment-specific information from individuals who apply to be spokespersons for the campaign.

OSH will request OMB approval for each data collection activity through submission of a specific Information Collection Request that describes its purpose, use, methodology, and impact on affected respondents. Given that every data collection instrument will be based upon specific data collection needs for different stages of health communication planning and implementation, it is not possible to develop one instrument for use in all instances. Attachments 3a-3f provide illustrative examples of previously OMB approved instruments that could be used for a variety of information collections. Future instruments are not expected to have any extensive revisions from those used previously under this clearance.

A.3. Use of Improved Information Technology and Burden Reduction

Whenever possible and appropriate, information collections submitted for approval under this generic clearance will use advanced technology to collect and process data in order to reduce respondent burden and to make data processing and reporting maximally efficient. Particular emphasis will be placed on compliance with the Paperwork Reduction Act. As computer technology has continued to improve and become more widespread, opportunities to pretest messages on the Internet using either web-based surveys or online focus groups have increased. Using computer-assisted information technology to transmit data collection instruments and/or collect responses will continue to reduce the burden on respondents. Wherever possible, OSH will make use of web-based data collection methods. Further, in all message, concept, material, and ad testing, the number of questions will be held to the absolute minimum required for the intended use of the data and trained interviews and moderators will lead the discussions, where appropriate, to ensure that time is used in the most efficient and productive manner. Following are examples of the types of technology that may be used to reduce burden and that have been used successfully by OSH in the past to collect information; evolving technologies may also be employed.

Online Interviews, Focus Groups, Bulletin Boards, and Surveys: Online systems are ideal because of the ease of presenting visual stimuli (e.g., the concepts or advertisements) to respondents and recording their feedback. Online methods for focus groups, bulletin boards and surveys can also minimize burden because they can be completed in the respondent’s home or workplace, at the respondent’s convenience and, in some cases, do not require the presence of an interviewer. They are less burdensome than mailed questionnaires in that they eliminate the need to handle and return paper copies (Stempel III & Stewart, 2000).

A web-enabled panel approach uses online technology to collect data from households that participate in an ongoing panel. The panels are very large, allowing quick selection from the overall pool and the rapid identification of several potential respondents from extremely small subgroups of the population. Samples from these panels are not designed to generate nationally representative samples or precise population parameters but rather are used as a highly efficient, low cost, and low burden method of data collection for formative message testing. A web-enabled or online panel approach also allows for the immediate turnaround of transcripts from online focus groups and data from online surveys.

For online bulletin boards, respondents can respond to a pre-loaded discussion guide at their own convenience while a trained, live moderator monitors responses throughout the duration of the bulletin board. Web-based surveys are an especially convenient option for eliciting feedback on visual stimuli. With web-based surveys, respondents view an ad, complete an online survey and then submit the data electronically and securely over the Internet. Online methods for bulletin boards and surveys are described in more detail in Part B. Relative to less technically advanced methods, these data collection approaches have the advantages of speed, cost, access and reduced burden.

Other Surveys: Some surveys will be conducted via mail, or emergent technologies, similar to those described in the previous section. Other surveys will be conducted by telephone and will consist of quantitative closed-ended questions. When most interview items response alternatives are “closed ended,” as in a survey, a Computer-Assisted Telephone Interview will be utilized to help phone interviewers move quickly and accurately through items and skip patterns, reducing response burden.

A.4. Efforts to Identify Duplication and Use of Similar Information

To prepare for data collection, OSH reviewed existing published literature, and unpublished qualitative pretesting reports (e.g., the findings from previous formative testing) when they were available. OSH also consults with outside experts to identify information that could facilitate message development. Health messages developed by OSH are unique in their mix of intended audience, health behavior, concept, and execution. Therefore, there are no similar data available.

To help prevent redundancy, OSH collaborates with other federal government agencies that sponsor or endorse health communication projects, such as the U.S. Food and Drug Administration’s Center for Tobacco Products (FDA CTP). For example, FDA CTP is investing in a number of public education campaigns aimed at youth and young adults, such as The Real Cost, Fresh Empire, and This Free Life, to educate them about the dangers of regulated tobacco products. Additionally FDA CTP is planning a new campaign focused at the point of purchase which aims to prevent a relapse or get smokers who may have slipped to try and quit again. Rooted in science, these efforts are directly linked to their authority to regulate the marketing and sales of tobacco products.

OSH and FDA CTP are coordinating and collaborating closely on tobacco information collections and material development to avoid duplication of efforts and to support respective campaign messaging. Regularly scheduled conference calls are held to review plans and share research findings of mutual interest. These collaborations serve as information channels, help prevent redundancy, and promote use of consistent measures of effectiveness. Coordination activities include the review of data collection instruments and other support materials for testing purposes. Relevant communications will be documented in each information collection request submitted to OMB for approval under MTTCA. OSH will share with FDA CTP all future findings from the formative work that will be submitted to OMB under this revised package to ensure that future duplication of efforts is preempted.

Points of contact for this coordination are:

• OSH: Brian Armour, Associate Director for Science, Office of the Associate Director for Science, telephone (404) 498-3014, email bka9@cdc.gov

• OSH: Israel Agaku, Senior Service Fellow, Office of the Associate Director for Science, telephone (770) 488-5138, email wgn9@cdc.gov

• OSH: Satomi Odani, Oak Ridge Institute for Science and Education Fellow, Office of the Associate Director for Science, telephone (404) 649-2586, email lpu7@cdc.gov

• OSH: Diane Beistle, Chief, Health Communications Branch, telephone (770) 488-5066, email zgv1@cdc.gov

• OSH: Lauren Boyle-Estheimer, Scientist, Health Communications Branch, telephone (404) 498-228, email yjw7cdc.gov

• CDC: Lindsey McCarter, Team Lead, Campaign Development, Health Communications Branch, telephone (770) 488-4239, email lpq4@cdc.gov

• OSH: Michelle O’Hegarty, Health Communications Specialist, Campaign Development, Health Communications Branch, telephone (770) 488-5582, email mohegarty@cdc.gov

A.5. Impact on Small Businesses or Other Small Entities

Information collection requests will not involve small businesses or other small entities.

A.6. Consequences of Collecting the Information Less Frequently

This package supports the essential steps of conducting needs assessments, assessing target audience awareness, attitudes, knowledge, beliefs, and behaviors; and testing messages on dimensions such as clarity, salience, appeal, and persuasiveness (i.e., the ability to influence behavioral intention). Skipping these steps has a high potential cost. A program designed without a clear understanding of the issue or message from the target audience’s perspective can be minimally effective, at best. Untested messages can waste communication resources and opportunities because the messages may be perceived as unclear or irrelevant. Untested messages can also have unintended consequences, such as jeopardizing the credibility of federal health agencies.

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances that require data collection to be conducted in a manner inconsistent with 5 CFR 1320.5 (d) (2). The information collection fully complies with the guidelines in 5 CFR 1320.5.

A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A.8.a PUBLIC NOTICE

• A 60-Day Federal Register Notice was published in the Federal Register, on December 13, 2017, vol. 82, No. 238, pg. 58609-611 (see Att 5). CDC did not receive public comments related to this notice.

A.8.b Consultations

CDC consulted with FDA CTP on this extension request to 0920-0910 as part of our ongoing coordination and collaboration on tobacco information collections.

Chaunetta Jones

FDA, Center for Tobacco Products

9200 Corporate Boulevard

Rockville, MD 20850

Phone: 240-402-0427

Email: Chaunetta.Jones@fda.hhs.gov

Rashetta Fairnot

FDA, Center for Tobacco Products

9200 Corporate Boulevard

Rockville, MD 20850

Phone: 240-402-4092

Email: Rashetta.Fairnot@fda.hhs.gov

Matthew Walker

FDA, Center for Tobacco Products

9200 Corporate Boulevard

Rockville, MD 20850

Phone: 240-402-3824

Email: Matthew.Walker@fda.hhs.gov

A.9. Explanation of Any Payment or Gift to Respondents

Participation in certain data collections will be requested on a voluntary basis without specific incentives. However, OSH may request OMB approval to offer incentives in some circumstances, when a) information is needed from respondents who are difficult to reach or recruit, or b) information collection is time-sensitive and recruitment must be accelerated. Each request to offer an incentive will be appropriately justified on a case-by-case basis and will describe the type of incentive to be offered (cash, gift card, or reward “points”) and the amount. Reviewed literature reveals that the payment of incentives can provide significant advantages to the government, such as an increase in response rates (Church, 1993; Greenbaum, 2000; Haveman, 2010).

A.10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

For prior rounds of testing under this clearance, submissions were reviewed by staff in CDC’s National Center for Chronic Disease Prevention and Health Promotion, who determined that the Privacy Act does not apply. While the OSH data collection contractors may have access to personally identifiable information (PII), no PII will be shared with OSH or any agencies. All data collected and delivered to OSH from contractors will be in the aggregate only. Further, the information that will be reported to and maintained by OSH is not considered a record as defined by the Privacy Act: it will not include individuals’ education, financial transactions, medical history, criminal or employment history, name, or the identifying number, symbol, or other identifier assigned to any individual, such as a finger or voice print or a photograph.

OSH anticipates that participation in all data collection under this generic clearance will be voluntary. Each project-specific data collection request submitted to OMB for review and approval will include 1) a description of the applicable privacy safeguards, 2) a project-specific Privacy Act determination, and 3) a project-specific IRB approval, if required.

Overview of information collection

Although personal information (e.g., gender, age, and race) may be gathered for screening or in interviews and focus group-type activities to describe an audience segment, no personal identifiers (e.g., full name, address or phone number, social security number, etc.) will be collected or maintained. For online surveys, online data collections will conform to federal regulations [the Hawkins-Stafford Amendments of 1988 (P.L. 100-297) and the Computer Security Act of 1987] and will be required to comply with comprehensive, written plans to maintain security. Information will be collected electronically through self-administered survey instruments hosted in secure, online, web-based data collection systems. Data will be separated from any identifying information, including the email address of the respondent. There is no online content being planned that will be directed at children younger than 13 years of age.

Respondents will be informed prior to participation that their responses will be treated in a secure manner. All data provided by respondents will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. All electronic file transmissions will be encrypted and password protected.

Overview of how information will be shared and for what purpose

Information will be collected and evaluated by OSH personnel and/or OSH’s data collection contractors. OSH will collaborate with its data collection contractors on instrument development, analysis, interpretation, and implementation of the results from the data. OSH will not have direct contact with participants nor will OSH have access to any personal identifying information about the panelists. The data collection contractors, in collaboration with OSH, plan to analyze data on measures such as perceived effectiveness, comprehension, and believability of the tested advertisements, as well as demographic characteristics, such as state of residence, and smoking status.

Overview of voluntary participation

Independent of the data collection system, all potential respondents will be advised of the nature of the activity, the length of time it will require, and that participation is voluntary. The appropriate advisements on voluntary participation will also be provided to respondents, generally during the recruitment, consent and/or screening process (Attachment 4 includes an example Informed Consent form). These procedures conform to ethical practices for collecting data from human participants.

Overview of data security

All information will be stored on password-protected databases to which only contractors working on this project have access. When data are collected by means of paper questionnaires (e.g., questionnaires to complement in-person focus group data), the questionnaires will be kept in locked filing cabinets in the offices of project staff employed by OSH contractors. When the data have been coded into electronic files and cleaned, the paper records will be destroyed.

OSH contractors will keep the data in non-aggregate form for six months after data collection has been completed, and then the observation-level data will be deleted from the password-protected databases. Contractors will provide OSH with de-identified data, to be used for analyses. OSH will handle the de-identified data in accordance with the record control schedule (maintained at least six years, but no longer than ten years). No desktop or laptop computer will contain any PII. OSH will retain and destroy records in accordance with the applicable CDC Records Control Schedule. Data management procedures have not changed since previous approval.

A.11 Institutional Review Board (IRB) and Justification for Sensitive Questions

IRB Approval

All procedures will be developed in accordance with federal, state, and local guidelines to ensure that the rights and privacy of participants are protected and maintained. When applicable, IRB approval will be obtained. Participants will be provided with a phone number and email for the principal investigator and for the IRB, should they have any questions or concerns about the study or their rights as a study participant.

Sensitive Questions

The majority of questions asked will not be of a sensitive nature. There will be no requests for a respondent’s Social Security Number. Questions asked during the screening about tobacco use and some demographic information (e.g., age) could be considered sensitive, although these items would not generally be considered highly sensitive. It may also be necessary to ask some questions considered to be sensitive in order to assess individuals’ attitudes and behaviors about tobacco products and to test ads about the specific health behavior of cigarette smoking. These items are not generally considered highly sensitive either. To avoid fear of disclosure of potentially sensitive information, participants will be informed of the applicable privacy safeguards. Sensitive information will only be requested when necessary to describe sample characteristics (e.g., age); such questions will include a “prefer not to answer” option. In addition, to avoid negative reactions to potentially sensitive questions, several steps may be taken:

• Respondents will be informed that they do not have to answer any question that makes them feel uncomfortable or that they simply do not wish to answer.

• Where possible, use of touch-screen methodology or other self-directed techniques will provide privacy; not having to verbalize a response may increase comfort.

• When such numbers are available and appropriate, participants will be provided with specific agency hotline numbers to call in case they have a question or concern about the sensitive issue.

• Interviewers will be trained to ask questions in a sensitive manner and to handle any subsequent discussion skillfully. Where appropriate, interviewers and respondents will be matched for gender and other demographic criteria (e.g., age, preferred language use).

• If specific health information is obtained from medical professionals, informed consent will be obtained.

Sensitive information will only be requested when necessary for specific project objectives.

A.12. Estimates of Annualized Burden Hours and Cost

Information will be collected through methods including, but not limited to:

• Screening to ensure proper selection of participants. The estimated burden is two minutes per response.

• In-depth interviews, including interviews conducted with key informants. Interviews will typically be conducted in-person. The estimated burden is 60 minutes per response.

• In-person/Online focus groups, primarily for creative concept testing and social media concept testing. The estimated burden is 60-90 minutes per response.

• Short surveys conducted online or through bulletin boards, for message platform testing, message validation, rough cut testing and final revised cut testing. The estimated burden is 10-15 minutes per response.

• Medium-length surveys conducted online for quantitative social media concept testing, and validation of advertisements and Surgeon General Report materials. The estimated burden is 25-40 minutes per response.

• In-depth surveys for in-depth formative testing of message concepts, etc. The estimated burden is 60 minutes per response.

• Questionnaires conducted by mail, email or by telephone interview to identify individuals who may be featured in ads developed for OSH’s media campaigns or materials. The estimated burden is 10 minutes per response.

The distribution of OSH’s needs for information collection through screening, surveys, interviews, and focus groups may change over time. The existing clearance was granted, approval for a total of 132,648 respondents and 32,994 burden hours over a three-year period.  To date, there have been 63,475 respondents and 11,737 burden hours used in this clearance over three years, leaving a balance of 69,173 respondents and 21,257 burden hours. Thus, the existing clearance has adequate respondents and burden remaining to cover all currently anticipated information collection requests over a three-year extension (e.g. three information collection requests for rough cut testing of ads for NTEC). We propose to contact 69,171 respondents (annualized to 23,057 per year for three years), using 21,210 burden hours (annualized to 7,070 hours).

An approximate distribution is described in Table A.2 below, which shows the estimated annualized number of respondents for the requested extension as 23,057 and the estimated annualized burden as 7,070. Over the course of the three-year extension, the data collection methods may differ from the two anticipated methods indicated below, but the number of responses/respondents and total burden hours will be itemized in each request submitted to OMB for approval under the MTTCA generic clearance.

Table A.2. Estimated Annualized Burden to Respondents

Type of Respondents	Data Collection Method	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in minutes)	Total Burden (in hours)
General Public and Special Populations	Screening	23,057	1	2/60	769
	Short Surveys/Questionnaires/qualitative studies (e.g., focus groups and key informant interviews), employment application (Online, Bulletin Board, etc.)	13,224	1	10/60	2,204
	Medium Surveys (Online)	9,833	1	25/60	4,097
	Total	46,114			7,070

Because the time required for responding to a survey or interview, and to participate in a focus group has a monetary value, Table A.3. estimates the total annual cost to the respondents for all activities and breaks the total figure down by the principal data collection strategies that may occur over a one-year period. To calculate this cost, we used the mean hourly wage of $24, which represents the Department of Labor estimated mean for state, local, and private industry earnings (Bureau of Labor Statistics, 2016). The total annualized burden cost is estimated at $169,680 per year.

Table A.3. Estimated Annualized Burden Costs

Type of Respondents	Data Collection Method	Total Burden (in hours)	Average Hourly Wage	Total Cost
	Screening	769	$24	$18,456
Public and Special Populations	Short Surveys/Questionnaires (Online, Bulletin Board, etc.)	2,204	$24	$52,896
Public and Special Populations	Medium Surveys (Online)	4,097	$24	$98,328
	Total			$169,680

A.13. Estimate of Other Annual Cost Burden to Respondents and Record Keepers

No respondent capital and maintenance costs are anticipated.

A.14. Annualized Cost to the Federal Government

Approximately 20% of one full-time equivalent (FTE) staff and 5% of one senior manager FTE will be required to oversee this generic clearance and associated information collection requests. Additional responsibilities will include internal coordination of a specific Information Collection Requests and maintaining proper accounting of burden hours. The total average annualized cost to the government for CDC oversight is $29,922 (Table A.4.). The majority of data collections will be conducted by contractors on CDC’s behalf. The costs of each information collection activity will be itemized in the project-specific request submitted for approval under this generic clearance.

Table A.4. Estimated Annualized Cost to the Federal Government

Government Personnel	Time Commitment	Average Annual Salary	Total
GS-13	20%	$ 111,027	$22,205
GS-15	5%	$ 154,332	$7,717
Total			$29,922

A.15. Explanation for Program Changes or Adjustments

This package is a three-year renewal request to the 0920-0910 MTTCA clearance. No modification is requested for information collection activities, methodology, respondents, or burden shown in the current inventory.

A.16. Plans for Tabulation and Publication and Project Time Schedule

Results of the information collections conducted under this generic clearance will be used primarily to inform programmatic efforts, specifically the NTEC. Information collections may include rough cut testing (i.e., online surveys) related to the development of messages and materials for the NTEC. Quantitative data will be analyzed using conventional tabulation techniques. Qualitative data will be analyzed using thematic analysis. The data will be read thoroughly and initial codes will be created manually, identifying themes and patterns of responses.

Publication and Dissemination Plans

The information collected under this generic clearance will be used primarily for NTEC, and to inform programmatic efforts. Results that may be of interest to health communicators may be disseminated through presentations at professional meetings and publications.

Project Time Schedule

Table A.5 is an example of a project time schedule for an information collection request for rough cut testing.

Table A.5 Project Time Schedule

Activity	Time Schedule
Email invitations sent to respondents for quantitative testing	1-30 days after OMB approval
Online data collection	1-30 days after OMB approval
Complete field work	30-45 days after OMB approval
Validation	45-55 days after OMB approval
Data analysis	55-65 days after OMB approval
Report writing	65-150 days after OMB approval

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate

An exemption to this requirement is not being requested. The expiration date of OMB approval will be displayed on all information collection instruments.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

References

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