Supporting Statement A FINAL 3_15_12-2

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 approval of a new “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 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 A) 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.

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 B) and Section 325 of the Public Health Service Act (Attachment C). These regulations are codified in 42 CFR Part 34, 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 will allow 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.

Privacy Impact Assessment Information

Overview of Data Collection System

DGMQ staff proposes the following data collection methods for this package: interviews, focus groups, group discussions, surveys, and pre-post tests. 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.

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.

Identification of Websites and Website Content directed at Children under 13 Years of Age

No website content will be specifically directed to children under 13 years of age.

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.

Privacy Impact Assessment Information

DGMQ and contractors will follow procedures for assuring and maintaining privacy 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.

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.

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. DGMQ staff and contractors will collect and evaluate the research data.

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

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, being able to assess a lack of understanding of the term “H1N1 flu” amongst refugee populations during the recent pandemic would have helped communicators develop materials that were understandable for this vulnerable population.

Evaluation is also important in the health communication process because it can reveal why specific activities occur as planned. These insights can facilitate program improvement and ensure best allocation of resources. For example, being able to gather information on how many of the 10 million printed Travel Health Alert Notices during the H1N1 response were actually received and read by departing travelers could help save the government on printing costs, provide for better estimates for future emergencies, and improve distribution processes.

Evaluation is equally important because it provides accountability to stakeholders for DGMQ’s activities by demonstrating the effectiveness and the impact of the communication, training, and educational activities. Evaluation can also help to improve the effectiveness and efficiency of existing programs, and support the most effective distribution of resources. For example, knowing whether travelers understood that they should consider postponing their travel after seeing DGMQ’s Travelers Health 2009 H1N1 Flu Campaign messages would help DGMQ better understand the outcome of the campaign and what may or may not be effective for future campaigns.

There are no legal obstacles to reducing the burden.

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

Various data collection activities may be conducted under the auspices of this request.

Each activity is anticipated to be a one-time collection, with the exception of pre-post tests. The activities outlined in this package fully comply with all guidelines of 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 August 10, 2011(Attachment D). One non-substantive comment was received, and CDC’s standard response was sent to address the comment.

A.8.b Consultation

The following agencies and organizations outside of CDC have been 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 on infectious diseases was identified in 2009. This organization also recognized the need to gather information from refugees to help develop these communication materials.

Jennifer Cochran, Chair
Phone: 617.983.6596

E-mail: jennifer.cochran@state.ma.us

In consultation with the United States Olympic Committee, the need to educate Olympic athletes, coaches, and support staff on travel health was identified in 2008.

Margaret Hunt, MS, ATC

Manager, Medical Network

Phone: 719-866-4612

E-mail: Margaret.hunt@usoc.org

In consultation, with the National Association of State EMS Officials, the need for gathering information from EMS providers to help understand their training and education needs for responding to public health events was identified in 2007.

Leslee Stein-Spencer, Policy Advisor

Phone: 773-640-0649

E-mail: lesleess@aol.com

In consultation with the International Panel Physician Association , the need for conducting training and education assessments with panel physicians to help improve panel physician understanding and implementation of U.S. medical screening requirements was identified in 2010.

Ruth Abrahamson, CMP, Executive Director

Phone: 416-494-1440 x 231

E-mail: executivedirector@panelphysicians.org

In consultation with the American Academy of Pediatrics (AAP) Early Education and Child Care Initiatives, the need for CDC to collect information about child care and early childhood programs in order to refine communication materials and guidance about community measures to slow the spread of flu was identified in 2009. Constituents felt that it was important to identify the appropriate channels for reaching child care and early childhood programs and to promote rapid communication during a public health emergency.

Jeanne VanOrsdal, Manager, Early Education and Child Care Initiatives

Phone: 847-434-7638

E-mail: Jvanorsdal@aap.org

In consultation with the American Academy of Pediatrics (AAP) Disaster Preparedness Initiatives, the need for CDC to collect information on pediatric health care professionals' perspectives (including pediatricians in private practice, as well as those who work in community or children's hospitals). This is important, as pediatricians are viewed as trusted advisors by families and they can help the CDC to communicate to others about the need for infection control methods as well as the importance of influenza vaccine. There is a need for communication to occur between the CDC and the health professionals who care for children as well as between the CDC and the public. Including pediatricians in discussions about effective communication will greatly improve the CDC's ability to enhance its messaging.

Laura Aird, Manager, Disaster Preparedness and Response

Phone: 847-434-7132

E-mail: laird@aap.org

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

A cash stipend will be offered to the evaluation research participants as a token of appreciation for a respondent’s time and interest in the project. Amounts and justifications will be determined on an individual project basis. 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 remuneration to respondents. However, some respondents may receive remuneration 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. It is typical for recruitment companies to provide remuneration to users as part of their practices. The amount of remuneration is based on pay scales these companies follow for evaluation research. DGMQ will pay a fixed price to a recruitment company for their services and not specifically for any set remuneration.

A.10. Assurance of Confidentiality Provided to Respondents

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

This information collection request has been reviewed by the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), and determined that the Privacy Act does not apply. Individuals responding to this request are doing so voluntarily.

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 confidentiality. 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 confidentiality, particularly as it relates to handling requests for information from respondents, and in providing assurance to respondents about the protection of their responses.

Each proposed evaluation project will submit an application for IRB review and approval, which will outline their procedure for participant consent. However, prior to participating in the information collection, most prospective respondents will receive information such as sponsorship of the evaluation project, their rights as participants, risks and benefits in participating, and contacts for more information about the 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.

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

The surveys, tests, discussion and interview guides for each information collection activity will be submitted for OMB review. The average burden for each respondent depending on the specific data collection and type of respondent will range from 10-90 minutes.

Similarly, potential respondents may be screened for interest and eligibility using a customizable screening form. 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.

The estimated burden to respondents is summarized in Table A.12-A below.

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/Healthcare Professionals Focus Groups	Screening form	3,000	1	10/60	500
General Public/Healthcare Professionals Focus Groups	Focus Groups	1,500	1	1.5	2,250
General Public/Healthcare Professionals Interviews	Screening Form	2,000	1	10/60	333
General Public/Healthcare Professionals Interviews	Interviews	1,000	1	1	1,000
General Public/Healthcare Professionals Large Group Discussions	Screening Forms	2,000	1	10/60	333
	Large Group Discussion	1,000	1	1.5	1,500
General Public/Healthcare Professionals Surveys	Screening Forms	15,000	1	10/60	2,500
General Public/Healthcare Professionals Surveys	Surveys	7,500	1	45/60	5,625
General Public/Healthcare Professionals Pre/post tests	Screening Forms	15,000	1	10/60	2,500
General Public/Healthcare Professionals Pre/post tests	Pre/Post Tests	7,500	1	45/60	5,625
TOTAL	22,166

Information will be collected 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 22,166 hours.

Approximately 70% of respondents will be members of the general public and 30% of respondents will be health care professionals. 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, specifically originating from the 2009 National Compensation Survey. The total estimated annualized respondent cost (including the screening form) is $880,265.

Table A.12-B: Estimated Annualized Cost 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)	Average Hourly Wage Rate	Total Cost
Healthcare Provider Focus Groups	Screening Form	900	1	10/60	150	$83.59	$12,539
Healthcare Provider Focus Groups	Research Activity	450	1	1.5	675	$83.59	$56,423
Healthcare Provider Interviews	Screening Form	600	1	10/60	100	$83.59	$8,359
Healthcare Provider Interviews	Research Activity	300	1	1	300	$83.59	$25,077
Healthcare Provider Group Discussion	Screening Form	600	1	10/60	100	$83.59	$8,359
Healthcare Provider Group Discussion	Research Activity	300	1	1.5	450	$83.59	$37,616
Healthcare Provider Survey	Screening Form	4,500	1	10/60	750	$83.59	$62,693
Healthcare Provider Survey	Research Activity	2,250	1	45/60	1,688	$83.59	$141,100
Healthcare Provider Pre/Post tests	Screening Form	4,500	1	10/60	750	$83.59	$62,693
Healthcare Provider Pre/Post tests	Research Activity	2,250	1	45/60	1,688	$83.59	$141,100
General Public Focus Groups	Screening Form	2,100	1	10/60	350	$20.90	$7,315
General Public Focus Groups	Research Activity	1,050	1	1.5	1,575	$20.90	$32,918
General Public Interviews	Screening Form	1,400	1	10/60	233	$20.90	$4,870
General Public Interviews	Research Activity	700	1	1	700	$20.90	$14,630
General Public Group Discussions	Screening Form	1,400	1	10/60	233	$20.90	$4,870
General Public Group Discussions	Research Activity	700	1	1.5	1,050	$20.90	$21,945
General Public Surveys	Screening Form	10,500	1	10/60	1,750	$20.90	$36,575
General Public Surveys	Research Activity	5,250	1	45/60	3,938	$20.90	$82,304
General Public Pre/post tests	Screening Form	10,500	1	10/60	1,750	$20.90	$36,575
General Public Pre/post tests	Research Activity	5,250	1	45/60	3,938	$20.90	$82,304
Total						$880,265

*Healthcare wages from http://www.bls.gov/oes/current/oes291069.htm

*Public wages from 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 $467,000. 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/oca/09tables/html/atl_h.asp). The hourly rate for a GS-13 in metro Atlanta is $40.11 per hour, which is about $83,500 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 $150,000.

Table A.13-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 $83,500/year)	$83,500
Contractual costs for an information collection (e.g. facility rental, moderator/interviewer, participant recruitment, transcriptions and report on findings)	$150,000
Cost per information collection	$233,500
Total cost of 20 information collections	$467,000

A.15. Explanation for Program Changes or Adjustments

This is a new information collection.

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

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.
Legislative Authority: Section 212(a)(1)(A) of the Immigration and Nationality Act
Legislative Authority: Section 325 of the Public Health Service Act.
60-Day Federal Register Notice
Example of a Focus Group Guide
Example of an Interview Guide
Example of a Survey

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
Author	wernerk
File Modified	0000-00-00
File Created	2021-01-31

Supporting Statement A FINAL 3_15_12-2

Supporting Statement A FINAL 3_15_12-2.docx

Data Collection for Evaluation of Education, Communication, and Training Activities

OMB: 0920-0932

Contents

PART A. JUSTIFICATION

REFERENCES

ATTACHMENTS