Supporting Statement A

Formative Assessment of the Information Needs to Prevent Skin Cancer Among Spanish speaking Outdoor Workers

Supporting Statement-Section A

OMB No. 0920-1154

Contents

1. Circumstances making the collection of information necessary 3

2. Purpose and Use of the Information Collection 4

3. Use of Improved Information Technology and Burden Reduction 4

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

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 Guidance of 5 CFR1320.5 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 5

10. Assurance of Confidentiality Provided to Respondents 5

11. Justification for Sensitive Questions 5

12. Estimated of Annualized Burden Hours and Costs 6

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keeping 6

14. Annualized Cost to the Government 7

15. Explanation for Program Changes or Adjustments 7

16. Plans for Tabulation and Publication and Project Time Schedule 7

17. Reason(s) Display of OMB Expiration Date is Inappropriate 8

18. Exceptions to Certification for Paperwork Reduction Act Submissions 8

List of Attachments

1. Authorizing Act

2. Signed NIOSH IRB Determination Form

3. Focus Group Guide (English and Spanish)

4. Consent Form

• Goals of the project: To collect preliminary information to inform the development of communication products to prevent skin cancer among Spanish speaking outdoor workers.

• Intended use of the resulting data: Internal use to develop communication products on skin cancer and sun exposure prevention for Spanish speaking outdoor workers.

• Methods to be used to collect data: Focus Group

• The subpopulation to be studied: Spanish speaking outdoor workers

• How data will be analyzed: Qualitative analysis will be performed to examine themes and major topics mentioned by focus group participants.

Section A-Justification

1. Circumstances making the collection of information necessary

Background

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) seeks approval from the Office of Management and Budget (OMB) to conduct formative research focus groups with Spanish speaking outdoor workers who are at risk for sun exposure and skin cancer. These focus group discussions will be conducted by a contractor for the National Institute for Occupational Safety and Health (NIOSH).

The Office of the Surgeon General reports that skin cancer is the most commonly diagnosed cancer in the United States (DHHS, 2014). Each year, nearly 5 million people are treated for all forms of skin cancer combined. Nearly 13,000 people die annually from the two most deadly forms of skin cancer (i.e., melanoma and squamous cell carcinoma). It is estimated that the annual cost for treatment of skin cancer is $8.1 billion.¹ In 2014, The Surgeon General’s Call for Action to Prevent Skin Cancer recommended a focus on the protection of outdoor workers, with particular attention paid to issues related to language and culture.² Research indicates that although Hispanics develop skin cancer at lower rates than White workers, mortality rates for Hispanics are higher due to the skin cancer typically being diagnosed at later stages when the prognosis is worse. This health disparity is due in large part to a lack of awareness and understanding of skin cancer among Hispanics. NIOSH estimates that there are nearly 13 million workers in the industry sectors Construction and Agriculture, Forestry and Fisheries, which are considered high risk sectors by NIOSH and which typically require workers to spend large portions of the workday outdoors (NIOSH, 2004). Nearly 16% of construction workers are Hispanic, as are over 20% of the workers in agriculture. In order to produce effective and culturally tailored communication materials and tools, it is important to understand the unique occupational safety and health (OSH) needs and challenges of Spanish speaking immigrant outdoor workers.

This data collection is being conducted using the Generic Information Collection OMB No. 0920-1154. A private contractor (Communidades Unidas), working with NIOSH researchers, will recruit focus group participants, conduct the focus groups, and provide information to NIOSH that summarizes major findings.

2. Purpose and Use of the Information Collection

The purpose of conducting these formative research focus groups is to improve the researchers’ understanding of Spanish speaking outdoor workers’ (e.g., construction, landscaping, agriculture, etc.) knowledge of work-related sun exposure prevention and skin cancer risk. This information will be used internally to inform the development of draft educational materials and resources for Spanish speaking outdoor workers.

Potential respondents will be identified from among the contractor’s members/clients. The contractor will determine interest in participating in a focus group discussion as well as the individual’s eligibility as it pertains to this study. Approximately 5-7 respondents will be recruited for each of the 4 focus groups.

Questions in the focus group guide ask participants to provide feedback on the following: (1) knowledge about skin cancer, (2) sun protection and skin cancer communication resources, (3) perceived importance and barriers to communication, (4) communication information and resources, and (5) communication tool review.

3. Use of Improved Information Technology and Burden Reduction

The focus groups will include Spanish speaking outdoor workers. A contractor will recruit workers for focus group participation. Individuals who would like to volunteer will be selected based on the eligibility criteria of the focus group (native language and occupation). The contractor will recruit potential participants from pre-existing lists; therefore, no personally identifiable information (PII) will be collected nor will be provided to NIOSH. All the information collected will be used internally for product development and improvement purposes.

4. Efforts to Identify Duplication and Use of Similar Information

No similar information has been gathered by or maintained by NIOSH or other Federal agencies and are not available from other known sources.

5. Impact on small Businesses or other small entities

Workers from small business or other small entities may be involved in these efforts but the contractor will minimize the burden on them during information collections by scheduling focus groups dates and times that work for participants, asking for readily available information, and using short, easy-to-complete information collection instruments. The burden on respondents has been reduced and minimized by the use of an efficient and effective focus group guide.

6. Consequences of collecting the information less frequently

This request is for a one-time data collection. There are no legal obstacles to reducing the burden. This formative research will aid in the understanding of the information needs to prevent sun exposure and skin cancer in Spanish speaking outdoor workers. Data will be used to inform the development of draft educational products to aid in awareness and prevention. Without this focus group data, knowledge gaps will not be identified and researchers will not have adequate information to develop effective educational materials for Spanish speaking outdoor workers.

7. Special Circumstances Relating to the Guidance of 5 CFR1320.5

There are no special circumstances with this information collection package. This request fully complies with the regulation 5 CFR 1320.5.

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

The Federal Register Notice was published for this collection on July 18, 2016, Vol. 81, No. 137, pp. 46680. No public comments were received.

B. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and record keeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

This project builds upon a recent NIOSH collaboration with the American Academy of Dermatology (AAD) and the Ventanillas de Salud (VDS) program, a health promotion program of the Mexican Department of Health and operates in all 50 Mexican consulates across the US serving 1.5 million individuals annually.  This collaboration provided free skin cancer screenings to nearly 2000 individuals seeking services at their local consulate. Interviews with participants revealed a high level of misinformation about skin cancer and misunderstanding of critical prevention behaviors, such as the use of sunscreen. The AAD has approached NIOSH researchers to develop educational materials that will increase skin cancer awareness and knowledge among Hispanics.

9. Explanation of Any Payment or Gift to Respondents

Focus group participants will be provided remuneration of $40 cash as an incentive to encourage participation.

10. Assurance of Confidentiality Provided to Respondents

The NIOSH Information Systems Security Officer reviewed this submission and determined that Privacy Act does not apply because no personal identifiable information will be collected. This data collection was determined to be not research involving human subjects by the NIOSH Division of Science Integration Associate Director of Science.

Participation in the focus groups is voluntary. Participants will be provided with an informed consent form prior to the start of focus group and will be allowed to ask questions about the project before deciding whether to participate or not. The consent form describes the purpose of the project, how the information they provide will be used and describes protections for the participant’s privacy and confidentiality. The contractor will recruit potential participants from pre-existing lists of personnel; therefore, no new personally identifiable information (PII) will be collected.

11. Justification for Sensitive Questions

No information will be collected that is of a personal or sensitive nature. The proposed data collection was determined by the NIOSH Division of Science Integration Associate Director for Science to be a non-research project and does not need further IRB review. Please see the attached NIOSH IRB determination form (Attachment I).

12. Estimates of Annualized Burden Hours and Costs

Each focus group will be of 90 minutes and will have up to 7 participants.

Table A.12.A Annualized Burden Hours

Category of Respondent	Form Name	No. of Respondents	Participation Time	Burden
Outdoor Workers (Spanish speaking outdoor workers)	Focus Group Guide	28	1.5 hr	42

Activity	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
Focus Group	42	$28.09	$1179.78

Estimated Annualized Costs

No costs are anticipated.

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

There are no other costs to focus group participants or record keepers. There will be no direct cost to the focus group participants other than their time to participate in the data collection activity.

14. Annualized Costs to the Government

    Expense Type	Expense Explanation	Annual Costs ($)
    Direct Costs to the Federal Government
    	CDC Project Officer (GS-13, 0.05 FTE)	$6,935
    	CDC Project Officer (GS-14, 0.02 FTE)	$3,333
    	Subtotal, Direct costs	$10,268
    Cooperative Agreement or Contract	Contracts	$22,400
    	TOTAL COST TO THE GOVERNMENT	$32,668

15. Explanation for Program Changes or Adjustments

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

16. Plans for Tabulation and Publication and Project Time Schedule

    Date	Item Description
    December 2019	Receive OMB approval.
    January 2020	Task 1: Project plan that includes steps contractor will take to complete each task and a project timeline the contractor and NIOSH PO will mutually agree on.
    February 2020	Task 2: Draft and final protocol for each of the focus group sessions (with input from NIOSH PO).
    March 2020	Task 3: Collect data
    June2020	Task 4: Brief summary of the findings from each focus group.
    October 2020	Task 5: Summary report of the key findings from all focus groups.

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. These activities comply with the requirements in 5 CFR 1320.9.

1 Medical Expenditure Panel Survey. Rockville, MD: Agency for Healthcare Research and Quality. http://meps.ahrq.gov/mepsweb/data_stats/download_data_files.jsp. Accessed January 2014.

2 US Department of Health and Human Services. (2014). The Surgeon General's call to action to prevent skin cancer.