Supporting Statement A_Social Distancing2_OMB-Response_Followup_051917cl...

Goal of the study: Identify social distancing strategies to reduce person-to-person contact among students and staff in K-12 schools that are implementable without causing major detrimental effects to ongoing education activities.
Intended use of the resulting data: Develop knowledge base for the Pre-pandemic Community Mitigation Guidance and inform further study that will evaluate effectiveness of social distancing measures in K-12 schools.
Methods to be used to collect information: Focus group discussions.
Subpopulation to be studies: Senior education officials from schools, school districts and local and state education agencies from all 10 HHS regions; senior health officials in charge of statewide pandemic planning; and representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association.
How data will be analyzed: Summarizing common themes, most frequently mentioned social distancing measures and reasons for feasibility/non-feasibility to implement social distancing measures in K-12 schools, describing obstacles to implementing certain measures, and options of alternative format learning currently available at schools.

Information Collection on Feasibility of Social Distancing Measures in K-12 Schools in the United States

1. Circumstances Making the Collection of Information Necessary

This is a request for a new information collection. CDC is requesting a 1-year approval to collect information using focus groups.

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 information collection on Feasibility of Social Distancing in K-12 Schools in the United States for a period of 1 year. This information collection using focus groups aims to identify potential social distancing strategies to reduce person-to-person contact among students and staff in K-12 schools that are implementable without causing major detrimental effects to ongoing education activities. Insights gained from this information collection will be used to strengthen the evidence-base of CDC’s Pre-Pandemic Community Mitigation Guidance.

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 one state or possession into any other state or possession. These regulations are codified in 42 Code of Federal Regulations (CFR) Part 70 (Attachment A2). CDC is authorized to collect these data under the Public Health Service Act (42 USC 241), Section 301 (Attachment A3). The information collection for which approval is sought is in accordance with DGMQ’s mission to prevent the introduction, transmission, or spread of communicable diseases within the United States.

School-aged children are often the main introducers and an important transmission source of influenza and other respiratory viruses in their families, and school-based outbreaks frequently pre-date wide-spread influenza transmission in the surrounding communities. Therefore, infection control measures undertaken to reduce virus transmission among children at schools may also help prevent or postpone influenza outbreaks in communities. In respiratory transmission of influenza, proximity to the person with influenza plays a significant role: when droplets are produced during a sneeze or cough, a cloud of infectious particles is expelled, resulting in the potential exposure of susceptible persons. Studies conducted in healthcare settings suggest that people can be exposed to an infectious disease of influenza virus within 6 feet radius, while the greatest concentrations of the virus-containing aerosols are found within 3ft radius (1). Influenza virus can also be transmitted directly through touching contaminated surfaces or objects, which is an important transmission route to consider in school settings.

To slow down virus transmission in schools and surrounding communities during influenza pandemics, pre-emptive school closures are recommended by CDC as a community mitigation strategy during severe influenza pandemics based on the scientific evidence of their effectiveness and feasibility (2). However, during the early stages of increasing influenza activity, or during mild and moderate influenza pandemics, school closures may be too costly and premature to implement. Additionally, school closures of prolonged duration may have unintended adverse social and economic consequences for student families (such as lost access to subsidized school meals or lost pay for parents as a result of missing work while staying home with children). Therefore, there is a need to research alternative social distancing strategies that can help reduce influenza transmission in schools while minimizing social and economic burden on the community. Strategies that increase physical distance between students and/or reduce the duration of person to person contact in school settings may, theoretically, be effective in slowing influenza transmission. However, before assessing effectiveness in robust epidemiologic studies, it is necessary to explore the feasibility of implementing various social distancing measures. This allows us to prioritize which measures to formally evaluate and recommend in guidance. Information on potential social distancing measures for prevention of influenza and other respiratory infections that are feasible and infeasible to implement in K-12 schools will inform further studies evaluating effectiveness of school-based infection control and prevention measures.

Overview of Data Collection System

This information collection will be implemented in collaboration with a contractor and will target senior education officials, senior health officials, and representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association to collect information on feasibility of social distancing in K-12 schools (Attachment C1- Protocol, Attachment C2 - Informed Consent Form). The researchers will strive for diversity in representation of schools and school districts in terms of HHS region, urbanicity, and socio-economic level. Within each of the ten HHS regions, two states will be selected at random. The contractor will identify potential participants through steering committee recommendations as well as snowball sampling in a phased approach that starts with authority figures or organizations with the broadest scope (e.g., start with state education agency officials and ask for recommendations for urban and rural districts with varying socioeconomic levels, and then move to the next level such as local education agency). When possible, the contractor will work with national organizations/associations and ask for their help in tapping into standing committees or workgroups with members from across the U.S. In those cases, the contractor will invite workgroups to participate, directing each participant to the appropriate focus group based on his/her region. The recruitment script is provided in Attachment C6. The contractor will conduct three to four focus group discussions in each of 10 HHS regions. Each focus group will include an average of 8 persons, and each discussion will last for 1.5-2 hours. Focus groups will occur on weekdays during business hours via webinar and conference call. A standard focus group interview guide (semi-structured questionnaire) will be used to facilitate each focus group discussion (Attachment C3-Focus Group Interview Guide). Focus group discussions will be conducted via webinar and conference call.

Items of Information to be Collected

Data collection efforts will engage senior educators and other relevant persons (e.g. school principals, superintendents, teachers, senior leaders from state agencies, etc.). Below we have outlined the information that will be collected during the qualitative field study focus groups:

Current knowledge, attitudes and potential practices for organizing and delivering K-12 student instruction in ways that help increase physical distance among students and/or reduce duration of in-person instruction at schools (including use of distance learning options), while preserving the normal education process

Facilitating and inhibiting factors for implementing and sustaining the social distancing options in emergencies as an alternative to the complete student dismissal in K-12 schools

2. Purpose and Use of the Information Collection

The purpose of this new information collection is to identify social distancing strategies reducing person-to-person contact among students and staff in K-12 schools that are implementable without causing major detrimental effects to ongoing education activities. Insights gained from this information collection will strengthen the evidence-base for CDC’s Pre-Pandemic Community Mitigation Guidance on school-related mitigation measures.

Due to the congregation of children at schools and their susceptibility to many infectious diseases, school-based infectious disease outbreaks frequently precede disease transmission in the wider community. There is a need to research social distancing strategies that can help reduce influenza transmission in schools while minimizing social and economic burden on the community. Strategies that increase physical distance between students and/or reduce the duration of person to person contact in school settings may, theoretically, be effective in slowing influenza transmission. However, there have been no evaluations to date of feasibility of implementation of social distancing measures other than school closures. The project described in this information collection request aims to address this knowledge gap. CDC will use insights from this information collection to identify and prioritize school practices that should be evaluated for effectiveness (i.e., through epidemiologic studies).

3. Use of Improved Information Technology and Burden Reduction

When feasible, the contractor organization will employ electronic technology (e.g. video- or tele-conferencing) for conducting focus group discussions and reduce respondent burden. Particular emphasis will be placed on compliance with the Government Paperwork Elimination Act (GPEA), Public Law 105-277, title XVII. The number of questions posed has been held to the minimum required in order to elicit the necessary information.

4. Efforts to Identify Duplication and Use of Similar Information

DGMQ’s public health mission involves strengthening the evidence-base on school measures and updating CDC’s Pre-Pandemic Community Mitigation Guidance, as outlined in Section A1. As such, it is not expected that any of the information collected under this package is duplicative or is already in the possession of the federal government or other organizations that study or promote school-related mitigation measures. Retrospective review of the U.S. government response to the 2009 pandemic identified a limited evidence-base on where, when or for how long to implement school-related mitigation measures, supporting the need for this information collection. DGMQ will make all reasonable effort to ensure that the information collection does not overlap with other projects on infectious disease control measures in school settings. This project originates from DGMQ’s Community Interventions for Infection Control Unit (CI-ICU) that is the core of the Community Mitigation Task Force for pandemic preparedness and response. We have discussed with other offices in CDC and the Department of Education. We have also formed a steering committee for technical oversight of this project that includes representation from CDC’s DGMQ/CI-ICU, Division of Adolescent and School Health, School Health Branch in the Division of Population Health, and the Department of Education.

5. Impact on Small Businesses or Other Small Entities

Small entities, including small governments (i.e. county and local public health and school officials), will be included in the proposed information collection. A small government is defined as a government jurisdiction of a city, county, town, township, school district, or special district with a population of less than 50,000. Questions will be held to the absolute minimum required for the intended use when participants could include officials representing small government offices. The maximum time commitment for each participant is 2 hours.

6. Consequences of Collecting the Information Less Frequently

The proposed information collection is required for DGMQ to strengthen the evidence-base for influenza epidemic mitigation measures in school settings. The lack of information on feasibility of social distancing measures in schools may result in studies on effectiveness of social distancing that evaluate measures not feasible to implement in school settings in the US. Burden to individuals participating in the study will be minimized and only necessary questions are included in the collection instruments.

This information collection will inform the timely implementation of appropriate disease prevention and control measures in school settings. Findings from this information collection will be used to identify a comprehensive menu of school-based strategies, refine current strategies if needed, and inform decision-making regarding which strategies to pursue, in what order. For example, the barriers, facilitators, and feasibility of implementing distance learning for a prolonged period during a pandemic will likely be different for elementary schools than for high schools. .

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

Information collection in each of the 10 HHS Regions will be conducted under the auspices of this request. Individual respondents will not be asked to respond to investigators more than once. All materials related to this information collection are included in this package as specified in regulation 5 CFR 1320.5.

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

8a. A 60-day Federal Register notice was published in the Federal Register on August 10, 2016, Vol 81, No. 154, pages 52872-52873 (Attachment B). No comments were received.

8b. 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 information collection:

In consultation with University of Wisconsin-Madison on the need for and process of data collection with the audiences described in this package:

Jonathan Temte, MD, PhD, Professor

Phone: 608-577-5846

E-mail: Jon.Temte@fammed.wisc.edu

In consultation with the U.S. Department of Education on the need for and process of data collection with the audiences described in this package:

Madeline Sullivan, MA, Office of Safe and Healthy Students

Phone: 202-453-6705

Email: Madeline.Sullivan@ed.gov

In consultation with University of Pittsburgh the need for additional school-related research was identified in 2013:

Charles Vukotich, MS, Senior Program Manager
Phone: 412-383-2882

E-mail: charlesv@pitt.edu

9. Explanation of Any Payment or Gift to Respondents

DGMQ will not directly offer cash incentives to the participants targeted in this information collection. However, the contractor organizations will provide small, tangible tokens of appreciation for participants’ time. In each of the 10 HHS regions, each participant will receive $50 gift card after the focus group discussion is completed if they are allowed to accept it.

In cases where potential participants are contacted directly (rather than through an employer), the contractor will ask each participant whether he/she is permitted to accept an incentive. This question will be included as part of standard correspondence in the recruitment and scheduling process. If the participant does not know whether accepting an incentive is permitted, he/she will be instructed to review any relevant organizational policies and/or consult a supervisor. Only those participants who indicate that they can receive an incentive will be sent an incentive after the focus group has concluded. In cases where the participant does not confirm that he/she can receive in incentive, an incentive will not be dispensed.

In cases where a larger organization or employer recommends potential participants for inclusion in the study, we will first ask the employer whether incentives are permitted. We will only offer incentives to individual participants associated with a particular employer in cases where the employer indicates that this is acceptable.

The Need for Incentives

Incorporating modest incentives to aid in recruitment for information collection is standard practice among commercial market researchers. First, participants are losing time from work to participate, as focus groups occur during the work day. This may require them to work additional hours without compensation from their employer. Second, some teachers and other school staff are likely to be on summer vacation during the data collection period. We are concerned that it may be difficult to recruit participants who may be out of the office during June, July, and August without an incentive.

Level of Incentive Payment

DGMQ will not directly provide remuneration to project participants. However, the contractor will provide small tokens of appreciation to focus group participants ($50 gift card). To account for differences in local culture and socioeconomic factors, project investigators will work with the contractor to ensure that incentive type is appropriate and does not have the effect of coercing individuals to participate.

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

The National Center for Emerging and Zoonotic Infectious Diseases determined that the Privacy Act is not applicable to this information collection. No information can be retrieved by name of the respondent. Individuals will be responding to the information collection completely voluntarily. Personal identifiable information will be deleted by the contractor and de-identified data will be received by DGMQ.

DGMQ, contractors, and the contractor organizations will follow procedures for securing and maintaining privacy during all stages of information collection. Participants will be recruited from each of the 10 HHS regions and all participants who are recruited will give consent using Attachment C2 Informed Consent form. Recruitment will also be done using the language in the consent form. The contractor will collect and analyze the project specific data. DGMQ will provide technical assistance in the design, implementation, and analysis of the project but will not be in contact with project participants (and will only have access to de-identified data). All information provided by participants will be treated in a secure manner and will not be disclosed unless otherwise compelled by law. Participants will be informed prior to participation that their responses will be treated in a secure manner.

Privacy Impact Assessment Information

1. Participants will be advised of the nature of the information collection activity, the length of time it will require, and that participation is purely voluntary. Participants 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 subjects.

2. The proposed information collection has been reviewed and approved by the contractor’s IRB. CDC human subjects approval has been obtained. Prospective participants will receive information on the purpose and rationale of the project, explanation of what their participation will involve and how their confidentiality will be protected. Prior to the beginning of the information collection, a staff member will address any questions the participants have about the project.

3. All data will be stored in secure electronic files maintained by the contractor 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 guarding the security of collected information. Online information collections will conform completely to federal regulations [the Hawkins-Stafford Amendments of 1988 (P.L. 100-297) and the Computer Security Act of 1987]; all information will be maintained in a password protected secure location. Stored transcripts will not contain personally identifiable information.

4. No system of records is being created for this information collection. No personal identifiable information will be retained.

5. The proposed information collection will not involve collecting or sharing respondents’ personal identification or place of residence with persons outside of the project coordinating organization (the identified contractor). Information collected including potentially personal identifiable information include affiliation and position title. No personal identifiable information will be retained.

6. The proposed collection will not impact the respondents’ privacy. All collected information will remain secure. Collected information including focus group discussion transcripts will be entered into appropriate data management systems, and all personal identifying information will be deleted following information verification and cleaning. Final de-identified electronic data (discussion transcripts and summary reports) will be maintained by DGMQ. Analysis and resulting publications will not include any personal identifying information regarding participants.

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

IRB Approval

The protocols and tools included in this information collection request have been reviewed and approved by the IRB at the contractor organization, and CDC human subjects review has deemed the project to be exempt research. IRB approval letter from the contractor institution and CDC’s human subjects approval notice are included in the attachments (Attachment C4 Contractor IRB approval and Attachment C5 CDC human subjects approval).

Justification for Sensitive Questions

Mitigation measure research typically does not involve questions of a sensitive nature. Some participants may feel uncomfortable answering particular questions about their individual experiences, and/or adopted practices (or lack thereof) related to their work duties. Such questions, when asked, are necessary for the purposes of this information collection. To minimize psychological distress, the moderator and information collection instructions will inform participants that they do not have to respond to any questions they do not want to answer and that they may stop participating at any time. In addition, a subject matter expert from the contractor will be available to answer questions from participants following the information collection activity.

12. Estimates of Annualized Burden Hours and Costs

This information collection using focus groups will be implemented in collaboration with the contractor and will include senior educators (e.g. school principals, superintendents, teachers, senior leaders from state agencies, etc.) from all 10 HHS regions; senior health officials in charge of statewide pandemic planning; and representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association. Information will be collected on the feasibility of social distancing measures in K-12 schools in the United States as previously described.

We outline the estimated burden hours for the proposed project in Table 12A. The burden table provides estimated annualized burden hours and costs across the different project locations.

A minimum of 210 and a maximum of 320 participants will be enrolled in the project led by the contractor: three to four focus groups in each of 10 HHS regions (for a maximum total of 40 focus groups), with a range of 7-8 participants in each focus group. While we will aim to have 8 participants in each focus group, we will run a given focus group as long as five individuals confirm for a particular time. We estimate that each focus group will last about 1.5 to 2 hours and the maximum total burden for participants is estimated at 640 hours.

Table 12-A: Estimated Annualized Burden to Participants for example projects

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Senior educators; senior health officials; representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association	Focus Group Interview Guide (semi-structured questionnaire)	320	1	2	640
TOTAL		640

Type of Respondent

Form Name

No. of Respondents

No. of Responses per Respondent

Average Burden per Response (in hours)

Total Burden Hours

Senior educators; senior health officials; representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association

Focus Group Interview Guide (semi-structured questionnaire)

320

640

TOTAL

640

Table A.12-B presents the calculations for cost of respondents’ time using hourly mean wage information from the U.S. Department of Labor's Bureau of Labor Statistics website, specifically originating from the 2015 National Occupational Employment and Wage Estimates for the United States (http://www.bls.gov/oes/current/oes_nat.htm). The mean wage for Education Administrators ($43.74) was used to estimate cost burden.

The overall cost of participants’ time for the example information collections is estimated to be a maximum of $27,994.

The total respondent costs are summarized below in Table A.12-B.

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

Type of Respondents	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Senior educators; senior health officials; representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association	Focus Group Interview Guide	640	$43.74	$27,994
TOTAL		$27,994

Type of Respondents

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Senior educators; senior health officials; representatives from the National Association of School Nurses, school safety organizations/law enforcement, and National Distance Learning Association

Focus Group Interview Guide

640

$43.74

$27,994

TOTAL

$27,994

*Public wages from http://www.bls.gov/oes/current/oes_nat.htm

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

There is no cost or burden to respondents other than their time.

14. Annualized Cost to the Government

There is no equipment or overhead costs. The cost to the federal government would be the salary of CDC staff supporting the data collection activities and associated contractual costs.

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 (15% FTE of two GS-14 at $120,000/year)	$36,000
Contractual costs for an information collection (e.g. facility rental, moderator/interviewer, participant recruitment, translations, transcriptions and final reports)	$348,000
Cost per information collection	$384,000
Total cost for annualized information collections	$384,000

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

In collaboration with the contractor, DGMQ anticipates starting the qualitative field study focus groups in April 2017 after OMB approval is obtained. DGMQ expects to receive a comprehensive report and focus group transcripts from the contractor by September 2017 and potentially publish the results from this information collection upon completion of the project in late 2017. The report will summarize the key findings and common themes nationally and for each of the 10 HHS regions separately.

The responses from the ranking exercise will be aggregated so that we will report top three strategies for each focus group. For example, a strategy mentioned as “most feasible” by a respondent will get three points, whereas “second most feasible” will get two points. We will add up all points, and present the top three strategies across all respondents in a given group. We can then compare top strategies within and across regions.

We do not aim to generalize results obtained from the project covered by this information collection.

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

No exemption is requested.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

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

A2. 42 Code of Federal Regulations Part 70 Interstate Quarantine

A3. Section 301 of the Public Health Service Act (42 USC 241)

B. 60-Day Federal Register Notice

C1. Contractor – Protocol

C2. Contractor – Consent/Assent form

C3. Contractor – Focus Group Interview Guide

C4. Contractor – IRB Approval

C5. CDC – Human Subjects Approval Notice

C6. Contractor – Recruitment Script

References

Exposure to Influenza Virus Aerosols During Routine Patient Care. Werner E. Bischoff, Katrina Swett, Iris Leng, and Timothy R. Peters . JID 2013;207:1037-46.
Centers for Disease Control and Prevention. Guide to Community Preventive Services. Emergency preparedness: school dismissals to reduce transmission of pandemic influenza [Internet]. Emerg. Prep. Response Sch. Dismissals to Reduce Transm. Pandemic Influ. 2012;Available from: http://www.thecommunityguide.org/emergencypreparedness/RRschooldismissals.html

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