Supporting Statement A 0932 revision 03092015

Data Collection for Evaluation of Education, Communication, and Training Activities for the Division of Global Migration and Quarantine (0920-0932)

Request for Revision of a “Generic Clearance” Data Collection

March 9, 2015

Statement A

Contact:

Amy McMillen

Office of Policy and Planning

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E., MS D76

Atlanta, Georgia 30333

Phone: (404) 639-1045

Fax: (404) 248-4146

Email: [email protected]

Contents

PART A. JUSTIFICATION 3

A.1. Circumstances Making the Collection of Information Necessary 3

A.2. Purpose and Use of Information Collection 4

A.3. Use of Improved Information Technology and Burden Reduction 6

A.4. Efforts to Identify Duplication and Use of Similar Information 6

A.5. Impact on Small Businesses or Other Small Entities 6

A.6. Consequences of Collecting the Information Less Frequently 6

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

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

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

A.10. Assurance of Confidentiality Provided to Respondents 10

A.11. Justification for Sensitive Questions 11

A.12. Estimates of Annualized Burden Hours and Costs 12

Table A.12-A: Estimated Annualized Burden to Respondents 12

Table A.12-B: Estimated Annualized Cost to Respondents 14

A.13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 15

A.14. Annualized Cost to the Government 15

Table A.13-A: Estimated Annualized Cost to the Government per Activity and Total 16

A.15. Explanation for Program Changes or Adjustments 16

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

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate 16

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions 16

REFERENCES 17

ATTACHMENTS 18

A. Legislative Authority: Section 361 of the Public Health Service (PHS) Act (42 USC 264). These regulations are codified in 42 Code of Federal Regulations (CFR) Parts 70 and 71.

B. Legislative Authority: Section 212(a)(1)(A) of the Immigration and Nationality Act

C. Legislative Authority: Section 325 of the Public Health Service Act.

D. 60-Day Federal Register Notice

E. Example of a Focus Group Guide

F. Example of an Interview Guide

G. Example of a Survey

Data Collection for Evaluation of Education, Communication, and Training Activities for the Division of Global Migration and Quarantine (0920-0932)

Request for Revision of a “Generic Clearance” Data Collection

• The goal of the generic information collection request is to evaluate the effectiveness of CDC’s communication, training, and education materials that are focused on mobile populations.

• Intended use of the resulting information is to identify ways to improve planning, implementation, refinements, and demonstrate outcome and impact of health communication, education, and training activities focused on mobile populations.

• The methods of information collection will include focus groups, interviews, surveys, and pre/post-tests. Both purposive and probabilistic samples will be employed for these information collections.

• The populations covered under this generic include refugees, immigrants, migrants, expatriates, international travelers, travel industry partners, emergency responders, healthcare providers, non-profit agencies, importers, school officials and staff, business owners and employers, customs brokers and forwarders, childcare providers, state and local health department staff, and the general public. Due to the broad populations, two respondent classes are outlined in the burden tables: general public and health care providers. This was done to provide a range of respondent monetary costs we believe will be present in the projects conducted under this generic.

• Data will be analyzed depending on the method and purpose of collection. For example, qualitative analysis of focus groups or interviews, software such as NVivo, AtlasTi, MaxQDA may be used to look at trends in terminology or content elicited during information collection.

CDC is requesting a revision of a currently approved generic clearance, Data Collection for Evaluation of Education, Communication, and Training Activities for the Division of Global Migration and Quarantine (0920-0932). This request is for 3 years and includes changes that result in a decrease in requested burden. These changes are as follows:

• CDC is no longer requesting Screeners for Large Group Discussions, or Large Group Discussions, as information collections, and CDC is no longer requesting Screeners for Pre/Post Tests. This results in 4331 fewer hours in this revision.

• Respondent costs are being updated to reflect current wage data from 2013.

The total reduction in burden requested for this revision is 4331 hours. The total burden requested for this generic information collection is 17,835 hours from 37,500 respondents.

PART A. JUSTIFICATION

A.1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ), requests a revision of a “generic clearance” to conduct evaluation research in order to plan, implement, and demonstrate outcome and impact of health communication, education, and training activities. These activities may include communicating with international travelers and other mobile populations, training healthcare providers and educating public health departments.

The information collection for which approval is sought is in accordance with DGMQ’s mission to reduce morbidity and mortality among immigrants, refugees, travelers, expatriates, and other globally mobile populations, and to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. This mission is supported by delegated legal authorities.

Section 361 of the Public Health Service (PHS) Act (42 USC 264) (Attachment A1) authorizes the Secretary of Health and Human Services (HHS) to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries or possessions into the United States and from one state or possession into any other state or possession. These regulations are codified in 42 Code of Federal Regulations (CFR) Parts 70 and 71 (Attachment A2 and A3)

The Secretary of Health and Human Services also has the legal authority to establish regulations outlining the requirements for the medical examination of aliens before they may be admitted into the United States. This authority is provided under Section 212(a)(1)(A) of the Immigration and Nationality Act (8 U.S.C. § 1182(a)(1)(A)) (Attachment A4) and Section 325 of the Public Health Service Act (Attachment A5). These regulations are codified in 42 CFR Part 34 (Attachment A6), which establish requirements that determine whether aliens can be admitted into the United States.

Successful implementation of DGMQ’s regulatory authority and public health mission requires a variety of communication, training, and/or educational activities with staff, partners, mobile populations and the general public. DGMQ conducts many communication and education activities to convey health information to key audiences. Data collection is needed to successfully plan, implement and evaluate health communication, education, and training activities related to DGMQ’s public health mission.

This generic OMB clearance allows DGMQ to quickly collect information about the knowledge, attitudes, and behaviors from key audiences (such as refugees, immigrants, migrants, international travelers, travel industry partners, healthcare providers, non-profit agencies, customs brokers and forwarders, schools, state and local health departments) to help improve and inform these activities during routine and emergency public health events. This generic OMB clearance will also help DGMQ continue to refine these efforts in a timely manner, and will be especially valuable for communication activities that must occur quickly.

CDC has submitted five Gen IC’s during the last three years: (1) Evaluation of the TravAlert Electronic Messaging System, (2) Evaluating the Effectiveness of Quick Response Codes in Educating Panel Physicians, (3) Evaluation of Adapted Health Education Materials for LEP Spanish-Speakers and Indigenous Migrants, (4) Evaluating the Effectiveness of Ebola CARE Program, and (5) Assessment of Travelers and the Ebola CARE Plus Program.

A.2. Purpose and Use of Information Collection

The purpose of this generic clearance request is to conduct timely evaluations of DGMQ’s communication, education, and training activities. These evaluation activities will allow DGMQ to provide clear, effective, and appropriate training, education, and communication to key audiences. The information collected will be used by DGMQ staff to appropriately plan, implement, and demonstrate outcomes and impact of communication, education, and training activities. This generic OMB clearance will support conducting evaluation for communication, education, and training activities.

Since receiving approval for this generic, DGMQ has conducted five information collections. These information collections were in support of an Evaluation of Adapted Health Education Materials for LEP Spanish Speakers and Indigenous Migrants, an Evaluation of the TravAlert Electronic Messaging System, a project entitled Scan This: Effectiveness of Quick Response Codes for Engaging International Panel Physicians, and two information collections concerning the Check and Report Ebola (CARE) program (The second of the two CARE program collections is not completed at this time, and so only the title and a brief summary is provided below). Summaries of the projects, as well as outcomes, lessons learned, and a description of how these lessons will be incorporated into future information collections using this generic are included below.

Evaluation of Adapted Health Education Materials for LEP Spanish Speakers and Indigenous Migrants

• Summary: This project aimed to improve CDC and the Division of Global Migration and Quarantine’s communication efforts for limited English proficient (LEP) Spanish-speaking and indigenous audiences. Existing health communication materials on infectious disease topics were catalogued, evaluated, translated, and adapted for cultural and linguistic relevance. New materials were field tested with the target audience in Oregon and Southern California. Materials were revised based on feedback from testing.

• Outcome: Created two new posters in Spanish plain language, one on tuberculosis and another on queso fresco. Translated and culturally adapted an audio public service announcement about TB into a Mexican indigenous language. Developed a recommended process to produce culturally and linguistically appropriate health communication materials.

• Lessons Learned: It is important and feasible for CDC to test health education materials for cultural and linguistic appropriateness of materials, especially if translated. Plain language efforts to create materials are often lost during translation, and must be re-assessed after translation to ensure they are understandable by audiences with lower literacy levels. LEP, Spanish-speaking and indigenous audiences prefer health communication materials that use bold colors, contain images to which they can relate and that explain the content, limited words, and focus on family support of healthy behaviors.

• How lessons will be incorporated in the future: CDC will use elements of the new process to develop, adapt, and translate health communication materials into other languages.

Evaluation of the TravAlert Electronic Messaging System

• Summary: Evaluation of the implementation of the TravAlert electronic public health messaging system and the public comprehension of these messages.

• Outcome: Data were collected and a draft report has been submitted to CDC for review and edits.

• Lessons Learned: With respect to the overall performance of the monitors, the results then suggest that while a relatively low proportion of travelers attended to the monitors, those that did were able to recall at least one key message point. If this assessment is accurate, a primary means of improving the overall performance of the monitors is to increase the extent to which the monitors get the attention of travelers. Observation of travelers near the monitors may provide insight into any environmental obstacles or issues with foot traffic flow that may exist.

• How lessons will be incorporated in the future: The results will be used to determine if the public health messages displayed on monitors in airports by CDC are effective in reaching the priority population, are understandable, and are effective in influencing the priority population’s behavior. Additionally, it may prove useful to follow travelers from the jet bridge to see where they stop and what they look at after leaving the airplane. Electronic data collection may be useful if there could be a way to do this without increasing the cost of data collection significantly. Work with data collectors to determine financial feasibility of electronic data collection.

Scan This: Effectiveness of Quick Response Codes for Engaging International Panel Physicians

• Summary: The purpose of the QR code project is to provide panel physicians with immediate access to current US policies regarding medical screening and treatment requirements for US-bound immigrants and refugees. This pilot project introduced QR codes on the laminated Technical Instruction reference guides.  DGMQ evaluated the effectiveness of QR codes as a vehicle to connect panel physicians to DGMQ medical exam guidelines.

• Outcome: Participants reported they would be more likely to use QR codes if they were easier to scan and if it were easier to read documents on a small screen. Lack of use was also attributable to slow mobile internet connection, preference for old-fashioned print methods, lack of training on how to use QR codes, more convenient to use computer, and not having access to a smart phone device. The majority of respondents indicated they used the Panel Physician Portal to access the Technical Instructions (TI).  Referencing hard copies of the TI was also a common method. The most referenced resources by panel physicians included the mental health TI FAQS, the panel physician index laminated reference guide and the vaccination TIs.

• Lessons Learned: In general, QR codes have not been successful in fields other than marketing/advertising, and this was reflected in the result that QR codes are not considered a necessity by the panel physicians, nor were they considered an impediment to their work. DGMQ concluded that a more targeted approach with certain populations of panel physicians may be useful, e.g., physicians who work in refugee camps who do not have regular access to computers. Additionally, the creation of a mobile site for the Panel Physician Port may enhance the use of QR codes. Finally, additional training on the use and benefits of QR codes may be considered.

• How lessons will be incorporated in the future: An enhanced awareness of the technological and logistical variance in capabilities among panel physician sites can inform how to better survey this population, as well as inform what kinds of tools for information dissemination will be useful.

Evaluating the Effectiveness of Ebola CARE Program

• Summary: A baseline evaluation of the screening and education process that travelers from Ebola-affected countries experienced before more intensive interventions (e.g., social workers) were implemented.

• Outcome: Data were collected and a draft report has been submitted to Ebola response teams for review and action.

• Lessons Learned: Travelers were very willing to participate in intercept interviews and follow-up phone interviews to respond to questions about the screening process, educational materials received, perceptions of risk, knowledge of Ebola signs and symptoms, knowledge, intention, and ability to comply with Ebola self-monitoring requirements, as well as challenges they’ve experienced and suggestions for improvement. Travelers believe Ebola is a very serious disease and that efforts under way are necessary for public health. They are very knowledgeable of Ebola signs and symptoms as well as key aspects of prevention, transmission, and self-monitoring behaviors (i.e., take temperature twice a day, look for and log Ebola signs and symptoms, and report to health department per their requirements). Two areas for improvement have been identified for immediate action: (1) clarifying for travelers whether public health authorities will be calling them or whether they should be calling the public health authorities and (2) clarifying who they should contact if Ebola signs and symptoms emerge. The Check and Report Ebola (CARE) kit the travelers’ received as part of their entry screening process was received and opened by almost all travelers. Specific feedback on the clarity and usefulness of the materials, especially the temperature and symptom tracking log, was very favorable with many travelers expressing gratitude for the government providing them with these materials.

• How lesson will be incorporated in the future: The preliminary findings are being shared with the DGMQ communications team to use for revising the CARE kit to address specific feedback received, especially information pertaining to who calls who for what and when. In addition, the findings are being used to develop the next phase of evaluation activities which will look at the CARE Plus program which involves trained social workers providing the information currently provided in the CARE kit (which has to be read by the traveler) as an interpersonal, one-on-one encounter with the traveler. Face-to face encounters ensure exposure to critical health information whereas providing information that may or may not be reviewed by travelers does not ensure exposure to critical information. To date, travelers have opened and used the materials, but as the outbreak is contained, there is the possibility that travelers could be less vigilant. Insights from the baseline evaluation will be incorporated into the data collection instruments for the next phase of evaluation which is being planned right now.

Assessment of Travelers and the Ebola CARE Plus Program

• Summary: CDC is conducting this information collection to assess travelers’ knowledge, attitudes, beliefs, and behaviors related to Ebola active monitoring and reporting requirements in a way that considers (1) factors that affect traveler experience and compliance (see previous lists of concepts); (2) cultural competence of educational materials; and (3) program implementation over time (process evaluation). CDC needs this assessment to ensure that the CARE Plus program effectively educates, equips, and encourages mobile populations who may be at increased public health risk to fulfill Ebola monitoring and reporting requirements. On-going evaluation is important part of this program because it can reveal reasons why expected actions of program staff and travelers occur, or do not occur, and help identify alternate or supplemental strategies that can be used with them to support delivery of the program as intended in a way that results in the program’s intended effects.

DGMQ was limited to five projects in the last three years for several reasons. Since 2012, DGMQ has been involved in several high profile emergency responses that pulled staff away from long-term evaluation projects to focus on the immediate needs of these responses, ultimately delaying the timeline for the evaluation projects. These responses included H7N9 influenza in 2013, Middle East Respiratory Syndrome in 2013, Middle East Respiratory Syndrome in 2014, and Unaccompanied Children at US borders in 2014. The timeline and resources for these responses did not allow for evaluation activities while addressing immediate public health needs. Another contributing factor was the need to redirect evaluation funds for additional material/project development. Complications with funding and staffing resources also prevented DGMQ from submitting additional projects as part of this Generic Information Collection. As a result of the limited number of projects completed under this Generic Information Collection since 2012, we will be decreasing the total number of burden hours requested in this revision.

Ideas for Evaluation Projects for Education, Communication, and Training Activities in the following three years

The following ideas have been proposed for evaluation projects for the next three years.

• Ebola Emergency Response Evaluation: The intention for this evaluation is to use the package to evaluate communication and education activities with travelers arriving from countries affected by Ebola. The investigators want to find out about the messaging and information they recall about Ebola, the preferences they have for communication formats, ideas that will help motivate them to monitor for symptoms, and if they understand the information that is being provided. The investigators also may use the package to gather feedback from other audiences (such as foreign-born community members, business travelers, humanitarian aid workers) on the targeted advertising materials that we will be developing on Ebola and travel.

• Mobile Applications Evaluation: This project will evaluate mobile applications developed for travelers to assess how they are used, where and when they are used, and how they can be improved to help travelers follow travel recommendations.

• Data Visualization Evaluation: This project is an evaluation of visual communication methods by comparing data visualizations with other types of communication to determine which is more effective and likely for people to remember around messages that convey the value of work DGMQ does.

• VIP Packet and DGMQ Stories Evaluation: This evaluation will ask key target audience members (partners, public health leaders, etc.) to help make improvements and refine messaging to the materials about DGMQ.

• DGMQ Website Evaluation: The DGMQ website is an important tool to inform audiences about the work the Division does. This evaluation will help inform website redesign.

• Quarantine and Isolation Airline Website Evaluation: This evaluation will include asking airline partners to help inform the redesign of the airline pages and possibility the Quarantine and Isolation website.

• Refugee Health Museum Exhibit Evaluation: Gather feedback from visitors to a Refugee Health Museum exhibit to determine how to improve exhibit design for future use in other locations.

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

Whenever possible, DGMQ staff will employ electronic technology to collect and process data in order to reduce respondent burden and aid in data processing and reporting efficiency. Particular emphasis will be placed on compliance with the Government Paperwork Elimination Act (GPEA), Public Law 105-277, title XVII.

Data collection will be conducted using the most current modes, including computer-assisted methods, web-based surveys, web-based focus groups, or other modes as necessary to reach the intended audience. Though these technologies will be used by many of the individual projects in this data collection, the nature of many of these proposed activities typically requires direct interaction between respondents and project staff, especially in the case of qualitative focus group discussions. Also, in cases when respondents do not have access to electronic means of communication, a paper-based data collection will be implemented on a limited basis. Each proposed evaluation project will submit the tools used for data collection, including screenshots of web-based surveys, in the statement provided to OMB.

In all information collections, the number of questions posed will be held to the minimum required in order to elicit the necessary data.

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

Because DGMQ’s public heath mission is supported by regulatory responsibilities, as outlined in Section A1, it is not expected that any of the information collected under this proposed generic clearance is duplicative or is already in the possession of the federal government. The proposed generic clearance will allow DGMQ to significantly improve its ability to develop, refine and evaluate communication, education, and training activities. The results and final products from these activities may be used by multiple government and non-profit agencies.

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

Communication, training, and educational activities frequently include healthcare providers in the target population. When research with this audience is required, CDC works through established medical and professional societies and research contractors to gain access and obtain the necessary participants. Evaluation research efforts will be carefully planned to minimize the burden on healthcare provider practices and other small entities.

A.6. Consequences of Collecting the Information Less Frequently

If this information is not collected, DGMQ’s ability to effectively communicate messages to mobile populations who may be at increased public health risk will be compromised. According to the CDC’s Introduction to Program Evaluation for Public Health Programs: A Self-Study Guide (1), evaluation is critical for engaging in scientifically sound communication, training, and educational efforts. Communications evaluation, often encompassing concept, message, and materials testing activities, is essential in pre-testing materials to evaluate a wide variety of dimensions that include, but are not limited to, appeal, saliency, clarity, cultural appropriateness, and readability/understandability. If a concept and/or a message is not tested, then resources could be expended without evidence that the activity is appropriate or effective. For example, without the use of this generic information collection approval, CDC wouldn’t have been able to get timely evaluations of CDC’s CARE Ambassador program. This baseline evaluation resulted in the recognition that the program needed to provide increased clarity surrounding CDC messages concerned with travelers making contact with public health authorities after coming back to the United States from the Ebola affected countries. This is a critical piece of the follow-up program to ensure that if people become ill during their 21-day active monitoring period, they are connected with the appropriate public health authorities.

There are no legal obstacles to reducing the burden.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A.8a. A 60-day Federal Register notice was published in the Federal Register on 12/17/2014. Vol. 79, p. 75155. (Attachment B).  One non-substantive comment was received (Attachment B1) and CDC’s standard response was sent.

A.8.b Consultation

The following agencies and organizations outside of CDC have been updated and consulted on the need for data collection with the audiences, and for the purposes, described in this generic clearance package:

• In consultation with the Association of Refugee Health Coordinators, the need for clear, culturally, and linguistically appropriate information for refugees and the refugee health community on infectious diseases was identified. This organization also recognized the need to gather information from refugees and the refugee health community to help develop these communication materials.

Liz Edghill, BA, RN, BSN

Chair, The Association of Refugee Health Coordinators

Family Health Centers- Americana

4805 Southside Dr.

Louisville, KY 40214

(cell) 502-468-6589 (fax) 502-363-7704

[email protected]

• In consultation with the National Public Health Information Coalition, the need for clear, culturally, and linguistically appropriate information for the public on infectious diseases was identified. This organization also recognized the need to gather information from the public to help develop these communication materials.

Bill Walker, Emergency Preparedness Project Director

Phone: 770-509-5555 ext. 128

E-mail: [email protected]

• In consultation with the Society for Human Resource Management, the need for clear, culturally, and linguistically appropriate information for businesses on infectious diseases was identified. This organization also recognized the need to gather information from businesses to help develop these communication materials.

Evren Esen, SPHR, Director, Survey Programs

Phone: 703-535-6287

E-mail: [email protected]

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

A cash stipend or other gift may be offered to the evaluation research participants as a token of appreciation for a respondent’s time and interest in the project, but the use of incentives will not be the default practice. Amounts and justifications for any incentives will be determined on an individual project basis and will be supported by research indicating that incentives are useful for the particular population participating in the information collection. This information will be included in the statement provided to OMB for each information collection to be conducted by DGMQ.

The Need for Incentives

Incorporating modest incentives to aid in recruitment for evaluation research is standard practice among commercial market researchers. For a number of reasons, this practice is also appropriate for information collections covered by this generic package.

The most important aspect of an incentive plan may be its potential for reducing response bias, underreporting bias, and similar sources of error. Findings from the National Survey of Family Growth (a study in which childbearing and family planning patterns are collected from young women) demonstrated that incentives not only had positive effects on response rates, but they also increased the accuracy of reporting (2). Incentives are necessary for testing in order to ensure that those who are willing to participate are as representative as possible of the wider public. Failure to provide a basic incentive is likely to bias samples in the direction of well-educated individuals who are generally predisposed to be helpful.

In the National Adult Literacy Survey by Berlin and colleagues (3), a $20 incentive resulted in not only higher response rates from the sample cohort, but also lower costs per completed case than the comparison group. Importantly, the incentives provided higher response rates from adults with lower-than-average levels of education and basic literacy and numeracy skills.

Empirical evidence suggests that motivation is increased when an incentive is present for research. Krueger (4) cautions that without providing minimal levels of monetary compensation, insufficient numbers of participants will attend and results will not be useful. In addition, there is substantial evidence that monetary incentives increase response rates to surveys. In a meta-analysis of 38 experiments and quasi-experiments, Church (5) found that nonmonetary gifts were significantly less effective than cash in generating survey responses, and noted that offering pre-paid monetary incentives yielded an average increase of 19.1 percentage points over comparison groups.

Level of Incentive Payment

Under the terms of the subject OMB package, DGMQ will not directly provide incentives or gifts to respondents. However, some respondents may receive a token of appreciation through recruitment companies contracted to obtain participants. DGMQ may use these recruitment companies to find participants for larger surveys or when it is difficult to find specific types of audiences willing to participate, e.g., healthcare providers or hard to read or marginalized populations. It is typical for recruitment companies to provide incentives to users as part of their practices. The amount of incentive is based on pay scales these companies follow for evaluation research, and the type of gift may also be based on the age demographic participating in the information collection. DGMQ will pay a fixed price to a recruitment company for their services and not specifically for any set incentive or gift.

A.10. Assurance of Confidentiality Provided to Respondents

NCEZID has reviewed and stated that the Privacy Act may apply depending on the information collection. DGMQ and contractors will follow procedures for assuring and maintaining security during all stages of data collection. Respondents will be recruited using established record systems such as proprietary databases of professional organizations (e.g., the American Medical Association), commercial focus group companies, and other sources.

Respondents will be informed that information collected may be recorded and transcribed, and that any multimedia recordings will be destroyed after completion of each report on findings. DGMQ staff, in conjunction with the contractor, will collect and evaluate the research data.

All information provided by respondents will be treated in a secure manner and will not be disclosed unless otherwise compelled by law. Respondents will be informed prior to participation that their responses will be treated in a secure manner. An application for IRB review and approval will be submitted for each proposed evaluation project, which will outline their procedure for participant consent.

Privacy Impact Assessment Information

1. Overview of Data Collection System

DGMQ staff proposes the following data collection methods for this package: focus groups (Attachment C), interviews (Attachment D), surveys (Attachments E), and pre-post tests (Attachment F1 and F2). Depending on the information collected, data collection methods may be conducted either in-person, by telephone, on paper, or online. Data may be collected in quantitative and/or qualitative forms. Each proposed evaluation project will submit the tools used for data collection, including screenshots of web-based surveys, in the statement provided to OMB.

2. Items of Information to be Collected

Numerous audience variables will be assessed under the auspices of this generic OMB clearance. These include, but are not limited to, knowledge, attitudes, beliefs, behavioral intentions, practices, behaviors, skills, self-efficacy, and information needs and sources. Insights gained from evaluation research will assist in the development, refinement, implementation, and evaluation of communication, education, and training activities.

3. A description of how the information will be shared and for what purpose

Any information shared as a result of this collection will be shared in aggregate with personal identifiers removed. Sharing of any information in this way is intended to help improve program activities, help CDC and partners learn about the audiences and their communication, education, and training needs, and guide future efforts in reaching these populations. Some information may be submitted to peer-reviewed journals to help expand knowledge and understanding. All information provided by respondents will be treated in a secure manner and will not be disclosed unless otherwise compelled by law. Respondents will be informed prior to participation that their responses will be treated in a secure manner.

4. A statement detailing the impact the proposed collection will have on the respondent’s privacy

The proposed data collection will have little or no effect on the respondent’s privacy.

DGMQ and contractors will follow procedures for assuring and maintaining security during all stages of data collection. Respondents will be recruited using established record systems such as proprietary databases of professional organizations (e.g., the American Medical Association), commercial focus group companies, and other sources. Each proposed evaluation project will submit information about record systems, any demographic information retained for purposes of analysis, and will reference the appropriate Systems of Records Notice for the data as it applies to the project.

Only DGMQ staff and contractors will collect and evaluate the research data. Participants will be informed that evaluation research may be recorded and transcribed, and that multimedia recordings will be destroyed after completion of each report on findings.

5. Whether individuals are informed that providing the information is voluntary or mandatory

Each proposed activity will submit an application for IRB review and approval, which will outline their procedure for consent. However, prior to participating in the information collection, most prospective respondents will receive information such as the sponsorship of the evaluation project, their rights as participants, risks and benefits in participating, and contacts for more information about the evaluation project. Prior to the beginning of the information collection, a staff member will address any questions the participants have about the evaluation project.

Respondents will be advised of the nature of the information collection activity, the length of time it will require, and that participation is purely voluntary. Respondents will be assured that no penalties will occur if they wish not to respond to the information collection as a whole or to any specific questions. These procedures conform to ethical practices for collecting data from human participants.

6. Opportunities to consent, if any, to sharing and submission of information;

Prior to each information collection, the participants will be provided information on the intent of the project and will be given an opportunity to consent to the sharing and submission of information

7. How the information will be secured

All data will be stored in secured electronic files at CDC’s and/or a contractor’s office and will be accessible only to staff directly involved in the project. All members of the project will be required to sign a statement pledging their personal commitment to guard the confidentiality of data. Data files will be retained for a period of no more than three years and then destroyed. After the three years, the documents and multimedia recordings will be deleted.

Online data collections will conform totally 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 have comprehensive, written plans to maintain security of personal information. This plan will include having all personnel who will have access to individual identifiers sign confidentiality agreements. They will also be trained in the meaning of maintaining the security of personal information, particularly as it relates to handling requests for information from respondents, and in providing assurance to respondents about the protection of their responses.

8. Whether a system of records is being created under the Privacy Act.

Each information collection submitted under this generic will be evaluated to determine if a system of records is being created. CDC does not anticipate that the collection of PII will be commonly needed in the information collections submitted under this generic. Any PII collected will only be retained for potential follow-up questions, and will be destroyed in a manner specified in each information collection.

A.11. Justification for Sensitive Questions

The majority of questions asked will not be of a sensitive nature. However, some respondents (namely the general public) may find thinking about and discussing a disease unpleasant. A portion of respondents could consider questions about race, ethnicity, or other demographic characteristics to be sensitive, although such questions are unlikely to be highly sensitive. Where relevant to the information collection, race and ethnicity data will be collected consistent with HHS policy and standard OMB classifications.

Additionally, some respondents may feel uncomfortable answering particular questions about their individual experiences, level of disease awareness, and/or adopted preventative behaviors (or lack thereof) associated with various diseases. Such questions, if asked, would be necessary for the purposes of a targeted communication, training or education activity and thus to the information collection. To minimize psychological distress, the moderator or data collection instrument instructions will inform participants that they do not have to respond to any questions they do not want to answer and they may stop participating at any time. In addition, a subject matter expert from DGMQ or delegated organization will be present during the information collection to answer questions from participants at the end of the information collection activity.

A.12. Estimates of Annualized Burden Hours and Costs

1. The focus group and interview guides, surveys tools, and tests for each information collection activity will be submitted for OMB review. The average burden for each respondent depending on the specific data collection will range from 45-90 minutes. CDC is proposing to collect information from two types of respondents: the general public and healthcare practitioners. CDC estimates that approximately 70% of respondents contacted over the course of the requested three years will be general public, with the remaining 30% comprised of healthcare practitioners.

Similarly, potential respondents may be screened for interest and eligibility using a customizable screening form (Attachment G) designed for focus groups, interviews, and surveys. No screening forms will be used for pre/post tests. These screening forms will request an estimated 10 minutes per respondent. Screening forms for each information collection will be submitted for OMB review. Based on experience recruiting participants from master lists of eligible or interested persons, it is estimated that twice the number of respondents needed must be screened in order to yield the desired number of respondents.

Information collections will be requested over a three year time period. There are no costs to respondents except their time to participate in the research activities. The total annualized burden to respondents is 17,835 hours. Hours in Total Burden column are rounded to the nearest hour.

Table A.12-A: Estimated Annualized Burden to Respondents

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
General Public	Focus Groups Screening form	2100	1	10/60	350
Healthcare Professionals	Focus Groups Screening form	900	1	10/60	150
General Public	Focus Group Guide	1050	1	90/60	1575
Healthcare Professionals	Focus Group Guide	450	1	90/60	675
General Public	Interview Screening Form	1400	1	10/60	233
Healthcare Professionals	Interview Screening Form	600	1	10/60	100
General Public	Interview Guide	700	1	1	700
Healthcare Professionals Interviews	Interview Guide	300	1	1	300
General Public	Survey Screening Forms	10500	1	10/60	1750
Healthcare Professionals	Survey Screening Forms	4500	1	10/60	750
General Public	Surveys	5250	1	45/60	3938
Healthcare Professionals	Surveys	2250	1	45/60	1688
General Public	Pre/Post Tests	5250	1	45/60	3938
Healthcare Professionals	Pre/Post Tests	2250	1	45/60	1688
TOTAL		37500			17,835

2. Table A.12-B presents the calculations for cost of respondents’ time using two categories of mean hourly wages, one for the general public and one for health care providers. Hourly mean wage information is from the U.S. Department of Labor's Bureau of Labor Statistics website for 2013 wages. The total estimated reduction in respondent cost requested for this revision is $119,907. The total annualized respondent cost (including the screening forms) is $760,358. Total costs are rounded to the nearest dollar.

Table A.12-B: Estimated Annualized Cost to Respondents

Type of Respondents	Form Name	Total Burden (in hours)	Average Hourly Wage	Total Cost
General Public	Focus Groups Screening form	350	$22.33	$7,816
Healthcare Professionals	Focus Groups Screening form	150	$90.00	$13,500
General Public	Focus Group Guide	1575	$22.33	$35,170
Healthcare Professionals	Focus Group Guide	675	$90.00	$60,750
General Public	Interview Screening Form	233	$22.33	$5,203
Healthcare Professionals	Interview Screening Form	100	$90.00	$9,000
General Public	Interview Guide	700	$22.33	$15,631
Healthcare Professionals Interviews	Interview Guide	300	$90.00	$27,000
General Public	Survey Screening Forms	1750	$22.33	$39,078
Healthcare Professionals	Survey Screening Forms	750	$90.00	$67,500
General Public	Surveys	3938	$22.33	$87,936
Healthcare Professionals	Surveys	1688	$90.00	$151,920
General Public	Pre/Post Tests	3938	$22.33	$87,936
Healthcare Professionals	Pre/Post Tests	1688	$90.00	$151,920
TOTAL		17835		$760,358

*Healthcare wages from Physicians and Surgeons, All Other http://www.bls.gov/oes/current/oes291069.htm

*General Public wages from All Occupations: http://www.bls.gov/oes/current/oes_nat.htm#00-0000

A.13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

None.

A.14. Annualized Cost to the Government

The estimated average annual cost to the federal government for the proposed information collection activities is $2,863,550. This figure encompasses 50% FTE of two GS-13 employees and information collection contract costs. The average hourly rate was obtained from the Office of Personnel Management’s website (http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/14Tables/html/ATL.aspx). The hourly rate for a GS-13 in metro Atlanta is $40.11 per hour, which is about $86,355 per year.

The contractual cost for an information collection (e.g. the development of a screener and instrument, participant recruitment, incentive payments, facility rental (when applicable), transcriptions, and final reports) is estimated at $200,000.

Table A.14-A: Estimated Annualized Cost to the Government per Activity and Total

Estimated Annualized Cost to the Government per Activity and Total
Cost Category	Estimated Annualized Cost
Federal employee costs, per information collection (50% FTE of two GS-13 at $86,355/year)	$86,355
Contractual costs for an information collection (e.g. facility rental, moderator/interviewer, participant recruitment, transcriptions and report on findings)	$200,000
Cost per information collection	$286,355
Total cost of 10 information collections	$2,863,550

A.15. Explanation for Program Changes or Adjustments

CDC is requesting a revision of a currently approved generic clearance, Data Collection for Evaluation of Education, Communication, and Training Activities for the Division of Global Migration and Quarantine (0920-0932). This request is for 3 years and includes changes that result in a decrease in requested burden. These changes are as follows:

• CDC is no longer requesting Screeners for Large Group Discussions, or Large Group Discussions, as information collections, and CDC is no longer requesting Screeners for Pre/Post Tests. This results in 4331-4333 fewer hours in this revision, subject to rounding.

• Respondent costs are being updated to reflect current wage data from 2013.

The total reduction in burden requested for this revision is 4331 hours. The total burden requested for this generic information collection is 17,835 hours from 37,500 respondents.

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

Project Time Schedule

In some cases, the results of information collection will not be published; instead, the information will be used to inform communication, training and/or education activities across DGMQ. In other cases, results will be presented at professional conferences and in peer-reviewed journals. Project timelines will vary, depending on the program requirements and the activity itself. The project timeline will be dependent on the nature of the data collection.

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

The display of the OMB expiration date is not inappropriate.

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

Not applicable. No certification exemption is being sought.

REFERENCES

1. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Office of the Director, Office of Strategy and Innovation. Introduction to program evaluation for public health programs: A self-study guide. Atlanta: Centers for Disease Control and Prevention; 2005.

2. Mosher WD. Design and operation of the 1995 National Survey of Family Growth. Family Planning Perspectives 1998:30(1).

3. Berlin M, Mohadjer L, Waksberg J, Kolstad A, Kirsch I, Rock D, Yamamoto K. An experiment in monetary incentives. In: American Statistical Association, editor. Proceedings of the American Statistical Association Section on Survey Research Methods. Alexandria (VA): American Statistical Association;1992, p. 393-398.

4. Krueger RA. Focus groups: a practical guide for applied research. 2nd ed. Thousand Oaks, CA: Sage Publications; 1994.

5. Church AH . Estimating the Effect of Incentives on Mail Survey Response Rates: A Meta Analysis. Pub Opin Q 1993:57: 62 79.

ATTACHMENTS

Attachment A1 - Section 361 of the Public Health Service (PHS) Act (42 USC 264).

Attachment A2 - 42 Code of Federal Regulations part 70

Attachment A3 - 42 Code of Federal Regulations part 71.

Attachment A4 - Section 212(a)(1)(A) of the Immigration and Nationality Act

Attachment A5 - Section 325 of the Public Health Service Act.

Attachment A6 - 42 Code of Federal Regulations part 34

Attachment B - 60 Day Federal Register Notice

Attachment B1 – Comment on Federal Register Notice

Attachment C - Sample of a Focus Group Guide

Attachment D - Sample of an Interview Guide

Attachment E - Sample of a Survey

Attachment F1 – Sample of a Pre-Test

Attachment F2 – Sample of Post-Test

Attachment G - Sample of a Screening Tool

26