Revised SSA - Emergency Zika Migrant Ag Workers_21 July 2016_OMB_GMTF

Emergency Zika Information Collection Request:

US-based Migrant Farm Workers’ Understanding and Use of Measures to Prevent Zika Transmission

Request for OMB approval of an Emergency ICR

January 23, 2021

Supporting Statement A

Contact:

Lee Samuel

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404) 718-1616

Email: [email protected]

Table of Contents

1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of Information Collection 3

3. Use of Improved Information Technology and Burden Reduction 4

4. Efforts to Identify Duplication and Use of Similar Information 5

5. Impact on Small Businesses or Other Small Entities 5

6. Consequences of Collecting the Information Less Frequently 5

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

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 5

9. Explanation of Any Payment or Gift to Respondents 6

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 6

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 6

12. Estimates of Annualized Burden Hours and Costs 7

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 7

14. Annualized Cost to the Government 8

15. Explanation for Program Changes or Adjustments 9

16. Plans for Tabulation and Publication and Project Time Schedule 9

17. Reason(s) Display of OMB Expiration Date is Inappropriate 9

18. Exceptions to Certification for Paperwork Reduction Act Submissions 9

Attachments 9

1. Public Health Service Act (42 USC 241)

2. Draft 60-Day FRN

3. Attachment C Key Informant Interview Field Guide - English

4. Attachment D Key Informant Interview Field Guide - Spanish

5. Attachment E Focus Group Discussion Field Guide - English

6. Attachment F Focus Group Discussion Field Guide – Spanish

7. Attachment G Verbal consent form Key Informant Interview – English

8. Attachment H Verbal consent form Key Informant Interview – Spanish

9. Attachment I Verbal consent form Focus Group Discussion – English

10. Attachment J Verbal consent form Focus Group Discussion – Spanish

11. Attachment K IRB Review

• Goal of the study: To collect scientifically valid, current information to better describe farm migrant workers’ understanding of Zika virus and Zika communication messages and their access and willingness to use public health interventions (such as insect repellents and condoms) to prevent the spread of Zika.

• Intended use of the resulting data: To inform culturally appropriate health communication materials for this particular at risk population.

• Methods: A qualitative rapid assessment will triangulate data from three different methods: focus group discussions (FGDs), key informant interviews (KIIs), and an observational checklist for assessing use of screens in housing areas when access is granted.

• The subpopulation to be studied: This project focuses on migrant farm workers in four states (FL, GA, TX and CA).

• How data will be analyzed: Using the approach of content analysis, relevant themes that address the key areas of concern will be identified. Data will be coded manually or a qualitative software package may be used, such as NVivo.

This is a request for emergency OMB approval of the information collection, “US-based Migrant Farm Workers Understanding and Use of Measures to Prevent Zika Transmission.” CDC requests six months of OMB clearance. Information collection is not expected to require more than six months. If more than six months are needed to complete this information collection, CDC will pursue a formal ICR.

Authorizing Legislation for this information collection comes from Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment A).

1. Circumstances Making the Collection of Information Necessary

Zika is an emerging arboviral disease transmitted by Aedes aegypti and Aedes albopictus, the mosquitoes that spread dengue and chikungunya. First identified in 1947 in a monkey in Uganda, most people infected with the virus have experienced mild illness. However, in 2015, Zika virus was detected in the Americas and outbreaks spread rapidly. A major public health concern is the association of Zika with microcephaly, along with an increase in neurological syndromes that coincided with Zika virus outbreaks (WHO, 2016). In February 2016, the World Health Organization (WHO) declared Zika a global public health emergency and stressed the need to improve surveillance, work with communities to communicate risks, and increase the use of preventive measures, and to provide care for those suffering from the Zika virus (WHO, 2016).

As of 1 July 2016, the United States (US) has had a total of 865 laboratory-confirmed cases reported to ArboNET by a state or territory but no reported locally acquired vector-borne cases to date. Preventing local transmission through use of appropriate vector control and personal protective measures, as well as providing risk reduction information in culturally appropriate ways, are key elements in reducing the risk of locally acquired vector-borne cases of Zika. It is imperative that ‘at-risk’ populations for both transmitting Zika virus to the US and acquiring the infection be identified. Migrant farm workers in the US are an example of a vulnerable, at-risk population.

It is estimated that there are approximately 1.5 million migrant farm workers¹ in the US. These migrants can follow the crops state to state or reside in a primary location from which they travel less than 75 miles in order to harvest the crops (referred to as ‘shuttler’). Migrant farm work is low-paid, with the median wage only 55% that of all full-time wage and salary workers. In addition, the work may be temporary and seasonal and agricultural work is considered the most dangerous industrial sector in the US (Legal Services Corporation, 2015). Recent data from the Legal Services Corporation indicate that migrant farm workers are 76% more likely to be Latino/Hispanic than the total US population, 27% report that they cannot speak English and 33% report speaking English ‘well,’ and only 39% of this population have schooling beyond the ninth grade (Legal Services Corporation, 2015; USDA, https://www.doleta.gov/agworker/naws.cfm#d-files).

Many of these individuals migrate from Zika-affected countries in Central America, with 74% of the agricultural workers surveyed in 2009-2010 reporting Mexico as their country of birth (USDA, National Agricultural Worker Survey). They represent a vulnerable population in terms of Zika transmission due to multiple factors, such as working outside during the period in which the vector bites (daylight hours), living in sub-standard housing with minimal screens, limited to no English proficiency, and having an illegal status in the US that may prevent them from seeking health care services if symptomatic. Migrant farm workers often work in isolated areas with little access to transportation – their only source of transportation may be that provided by farm labor contractors or other employers, which may limit their access to health care or stores where they could purchase preventive measures such as insect repellent. Approximately only 33% of farm workers reported having health insurance in 2009-2010, which represents yet another barrier for poorly paid workers in receiving health care (USDA, National Agricultural Worker Survey. https://naws.jbsinternational.com/7/7.php).

2. Purpose and Use of Information Collection

The Global Migration Task Force, in collaboration with the US Mexico Unit (USMU)/Division of Global Migration and Quarantine (DGMQ) proposes to do a rapid qualitative assessment of migrant farm workers in four states (FL, GA, TX and CA) in order to better describe farm migrant workers’ understanding of Zika virus and Zika communication messages and their access and willingness to use public health interventions (such as insect repellents and condoms) to prevent the spread of Zika. Information will also be gathered about use of health care services and major concerns related to Zika. Questions, posed during key informant interviews (Attachment C (English), Attachment D (Spanish)) and focus groups discussions (Attachment E (English), Attachment F (Spanish)) will be directed toward understanding what information is needed to better understand the virus and its implications on health, particularly in regard to pregnancy, as well as the best approaches to providing health education and risk reduction communication to this vulnerable, at-risk population. Information will be gathered to assess the following:

• General knowledge and understanding of Zika virus and risk of Zika transmission

• Concerns in relation to Zika infection and transmission

• Knowledge about Zika prevention

• Willingness to use preventive measures or to seek health care if sick

• Access to preventive measures and health care

• Gaps in knowledge that indicate additional or more culturally appropriate health communication is needed

This qualitative assessment will use a data-to-action framework, with an emphasis on rapid data analysis in order to provide data that can inform health and risk reduction communications that are most appropriate to this particular at-risk population. These findings will be shared with State and Local Health Departments, as well as their partner migrant farm work organizations. Following the focus group discussions and individual interviews, cleared CDC Zika communication literature translated to Spanish can be shared with the migrant farm workers, as well as with employers, which will broaden the population base that receives Zika health communication. The materials shared with the migrant workers will be CDC-cleared materials to provide basic information about Zika to a highly vulnerable population. However, these materials are generic in nature and do not address any specific concerns that this population may have. Findings will help partner agencies and local and state health departments to identify issues that are specific to a vulnerable, often temporary population that come from Zika affected countries and who are both at risk for transmitting Zika, as well as at risk for acquiring Zika due to environmental exposures of being outside, daytime workers who generally live in sub-standard housing. The findings will illuminate any special concerns of these workers and may help employers in understanding the risk to their labor force. Emergency clearance is necessary due to the timing of harvesting season in the summer, particularly for the Eastern southern states.

3. Use of Improved Information Technology and Burden Reduction

The particular population or respondents is highly mobile, difficult to reach, and with expected low levels of literacy so IT solutions is problematic. Therefore, one hundred percent of the focus groups and interviews will take place in person through the use of a translator.

4. Efforts to Identify Duplication and Use of Similar Information

CDC has received emergency approval to collect information from pregnant women, individuals in Puerto Rico (i.e., message testing for pregnant women, travelers, and community leaders) and adult Zika-infected men in the US. This study targets a unique group of vulnerable, binational populations that may be in the United States on a temporary basis. Findings will provide information that will inform specific communication messages and other preventive measures for this population that can be developed by partner organizations that work with migrant populations in the United States, as well as local and state health departments. This broadens our reach to populations that have risk factors for both transmission and acquisition of Zika.

5. Impact on Small Businesses or Other Small Entities

The collection of information does not primarily involve small business or other small entities, it is concerned with collecting individual workers’ opinions. However, for the individuals involved, the burdens imposed by CDC’s information collection requirements have been reduced to the minimum necessary for CDC to meet its statutory and public health responsibilities.

6. Consequences of Collecting the Information Less Frequently

This is a one-time information collection to assess various aspects of migrant farm worker’s knowledge of Zika virus, their access to health resources, and their willingness to use public health interventions to prevent the spread of Zika.

Collecting information less frequently than the CDC recommendations would interfere with the public health actions required to contain and respond to Zika virus transmission and to do everything possible to limit, if not stop, deaths and birth defects due to this disease.

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

The activities outlined in this package fully comply with all guidelines of 5 CFR 1320.5. 

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

A) Because this is a request for an emergency clearance, CDC asks that the 60-day comment period be waived. A 60-day Federal Register Notice was drafted (Attachment B).

B) There was no consultation outside of the Agency.

9. Explanation of Any Payment or Gift to Respondents

A cash incentive will be provided to participants to defray any costs associated with participation in this information collection, e.g. lost wages or transportation. Each participant, whether in a key informant interview or focus group discussion, will be given $20 dollars and/or a gift card.

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

The Privacy Act is not applicable.

No personal identifying information, such as names or addresses, will be collected during the interviews for the assessment. For descriptive purposes only, the number of participants in each FGD will be recorded. Sex of participant will also be recorded in key informant interviews and focus group discussions in order to discern any gender-related differences in the data. No other demographic data will be collected, other than the state in which the interview was conducted.

Participation is voluntary in the key informant interviews and focus group discussions and individuals will be consented prior to participation (key informant interviews: Attachments G (English), Attachment H (Spanish); focus group discussion: Attachment I (English), Attachment J (Spanish). Participants will be informed that they do not have to answer any question that they do not wish to answer, respond “I don’t know” and are free to leave at any point. Once informed of this information, participant’s agreement to participate in the interview will be their consent to participate in the interview. They will also give consent for manually recording notes and for use of the digital recorder. Key informant interviews and focus group discussions will be conducted with only those that chose to participate. Consent will be verbal and will be asked in Spanish.

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

IRB Approval

This protocol was submitted for Human Subjects Protection review on 7/18/16 and received a non-research determination (Attachment K).

Justification for Sensitive Questions

There are no physical, social or psychological risks anticipated due to participation in this research. Mosquito-borne diseases are not known to result in social stigmatization, and it is not believed that participation in an interview or discussion regarding this topic places the participants at risk for negative social stigma. Participants may be fearful that their immigration status may be questioned. All participants will be first approached by someone outside of CDC (local/state health department staff and/or representative from a partner organization) to explain that no personal identifiers will be collected, including country of origin and immigration status. Any person that does not want to participate is free to refuse without repercussions of any type.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

The information collection will be accomplished through focus group discussions and key informant interviews.

Ten focus groups discussions with approximately 8-12 participants will be held in the four states; 4 focus groups in two sites in CA (San Diego and Ventura Counties), and two focus groups in a location in each of the other three states: Texas, Florida, and Georgia. Each focus group is expected to last 60 minutes. The maximum total expected burden is approximately 120 hours.

Twenty key informant interviews will be held. It is anticipated that each interview will last 60 minutes. The total estimated burden to respondents who participate in the interviews is 20 hours.

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Migrant Farm Worker	Focus Group Discussion	120	1	60/60	120
Migrant Farm Worker	Key Informant Interview	20	1	60/60	20
Total					140

B. Estimated Annualized Burden Costs

There will be no anticipated costs to respondents other than time.

The average annual response burden cost is estimated to be $1489.60. The hourly wage estimates are based on the Bureau of Labor Statistics May 2015 National Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/oes_nat.htm). The mean hourly wage rate for 45-2092 Farmworkers and Laborers, Crop, Nursery, and Greenhouse was used. Currently, this wage is $10.64 per hour.

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Migrant Farm Worker	Focus Group Discussion	120	$10.64	$1276.80
Migrant Farm Worker	Key Informant Interview	20	$10.64	$212.80
Total				$1489.60

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

There are no costs to respondents other than their time to participate.

14. Annualized Cost to the Government

The total estimated cost to the government is $45,521.96. The table below breaks down how many CDC employees will be working on this project, what percentage of their time will be devoted to this project multiplied by wages (Atlanta or San Diego locality). Additional costs for travel, lodging, meals and incidentals, and incentives are included below.

Staffing

# of Staff	GS Level or Equivalent	Hourly Wage	Total Hours	Total Cost
2	14	$52.15	224	$11,681.60
2	13	$42.31	384	$16,247.04
1	13 (San Diego)	$44.13	48	$2,118.24
1	12	$35.58	72	$2,561.76
1 non-FTE contractor	9	$25.59	48	$1,228.32
Total				$33,836.96

Other costs:

Cost category	Total
Travel	$4,585.50
Lodging	$2847
Staff Meals and Incidentals	$1,252.50
Incentives	$2800
Total	$11,485

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2016/ATL_h.pdf.

15. Explanation for Program Changes or Adjustments

This is a new information collection request, therefore program changes and adjustments do not apply at this time. 

16. Plans for Tabulation and Publication and Project Time Schedule

During the approximate weeks of July 25^th and Aug 1^st, training of the field staff will occur. It is anticipated that data collection will occur starting the week of Aug 8^th. Pilot testing of the instruments will occur prior to data collection.

Each site will take 2-3 days and East and West Coast data collections can occur simultaneously. It is anticipated that all data collection will be completed by August 31st with a two-week period allotted for data analysis. By end of September, a preliminary report of key findings will be developed and shared with state/local health departments, relevant partners and CDC response staff.

Given the time sensitivity of this in relation to seasonal harvesting, data will be shared as quickly as possible with state and local health departments, as well as partner organizations. At the end of the FGDs and KIIs, participants will receive information about how to prevent Zika infection. CDC-cleared printed materials will be shared. If appropriate and desired, the field team can also provide informal health education to employers for how to prevent Zika infections in their laborers. Insights from the data will help the Office of Minority Health and Health Equity as they prepare a workshop for upcoming Migrant Health Forums. The PI and Co-PI expect to share findings at public health conferences and/or to publish findings in a peer reviewed journal.

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

The OMB Expiration Date will be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

1. Public Health Service Act (42 USC 241)

2. Draft 60-Day FRN

3. Attachment C Key Informant Interview Field Guide - English

4. Attachment D Key Informant Interview Field Guide - Spanish

5. Attachment E Focus Group Discussion Field Guide - English

6. Attachment F Focus Group Discussion Field Guide – Spanish

7. Attachment G Verbal consent form Key Informant Interview – English

8. Attachment H Verbal consent form Key Informant Interview – Spanish

9. Attachment I Verbal consent form Focus Group Discussion – English

10. Attachment J Verbal consent form Focus Group Discussion – Spanish

11. Attachment K IRB Review

1 For the purposes of this proposal, ‘migrant farm worker’ will encompass seasonal crop workers, migrant agricultural workers, migrant laborers that follow the crops state-to-state, as well as those that live and work within a set vicinity, approximately 75 miles from their place of residence.