genIC Request for Approval

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: CDC/NIOSH/PMRD

PROJECT TITLE: Formative Research to Improve the Early Detection and Surveillance of Pneumoconiosis among U.S. Coal Miners

PURPOSE AND USE OF COLLECTION: Coal workers pneumoconiosis (CWP), commonly known as “black lung”, is a progressive occupational lung disease that can lead to disability and premature death. For more than two decades following the enactment of the 1969 Federal Coal Mine Health and Safety Act (Coal Act), CWP cases in the U.S. significantly declined. However, this trend unexpectedly shifted in the early 2000’s, despite established dust exposure limits, dust control methods and technologies, and medical surveillance programs. Since then, the prevalence of CWP, including progressive massive fibrosis (PMF)—a severe form of CWP, has steadily climbed.

The resurgence of CWP raises questions about disease detection and coal miners’ participation in the NIOSH Coal Workers’ Health Surveillance Program (NIOSH CWHSP). NIOSH CWHSP monitors pneumoconiosis (black lung) through voluntary screenings for surface, underground, and contract mineworkers conducted at approved clinics. Additionally, NIOSH CWHSP offers mobile units through its Enhanced Coal Workers’ Health Surveillance Program (ECWHSP). These units travel to and near mine sites to provide free and convenient screening options. Screenings offered through the NIOSH ECWHSP include spirometry (i.e., breathing test), work history questionnaire, chest radiograph, respiratory assessment, and a blood pressure screening.

Annual participation in the voluntary program is estimated at 25% to 40%. Some stakeholders argue that the low participation in medical surveillance programs is limiting researchers and clinicians understanding of recent changes in disease prevalence and severity. The primary aim of this research task is to conduct formative research to develop a theory-based intervention that could be implemented to increase mineworker participation in secondary prevention programs such as NIOSH CWHSP.

The research study has two primary objectives. First, to conduct elicitation interviews to better understand mineworkers’ attitudes, beliefs, and behaviors relative to voluntary health surveillance programs (i.e., black lung screenings). Results from this data will be used to develop data collection instruments for the next phase of the study. Second, to engage stakeholders and capture their perspectives on barriers to early detection and surveillance. This information will be used to determine priority areas for the intervention.

DESCRIPTION OF RESPONDENTS:

A maximum of 103 respondents will be recruited for this study. Respondents will participate in a focus group or interview and complete a demographic survey. Up to 40 coal miners will be recruited to participate in the elicitation interviews and 63 stakeholders will be recruited for the focus groups.

In 2018, U.S. coal mines employed 53,515 workers. Regarding ethnicity and gender identity, coal miners can be characterized as a homogeneous group. More than 95% of underground coal mineworkers identify as White males. Nearly 80% of coal miners have a high school education.

Coal Miners- In recent decades, the U.S. mining sector has made great strides in improving workplace safety. Neason claims that over the last 30 years, fatal mining injuries have decreased by more than 79%. As a result, coal miners may be motivated to participate in health and safety research.

Mining Stakeholders- Researchers will also recruit mining stakeholders to participate in focus groups. The stakeholder population is a broader and more diverse audience compared to mineworkers. The population includes individuals who work in or support the mining sector. These individuals may be employed by mining companies, industry associations, regulatory agencies, labor unions, suppliers, manufacturers, or academic institutions. Due to the job requirements and locations of many of these organizations, this population may have higher educational attainment, greater gender and ethnic diversity, and an increased knowledge or interest in mine health and safety. However, as a result of some organizations employing individuals with mining experience, many other characteristics of the mining stakeholder population may be comparable to the general mineworker population.

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. Information gathered will not be used to substantially inform influential policy decisions.

5. The study is not intended to produce results that can be generalized beyond its scope.

Name: _ LaTasha R. Swanson, PhD ___________________

To assist review, please answer the following questions:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [ X ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X ] No

BURDEN HOURS

Types of Respondents	Form Name	No. of Respondents	Average Burden per Response (in hours)	Total Burden (in hours)
Coal miners	INT Sign-Up Sheet	50	2/60	2
Coal miners	INT Demographic Survey	50	5/60	4
Coal miners	INT Protocol	50	1	50
Stakeholders	FG Demographic Survey	63	5/60	5
Stakeholders	FG Protocol	63	1	63
Total				124

FEDERAL COST: The estimated annual cost to the Federal government is $24,695.50

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [X] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

Interview and focus group participants will be recruited from mining conferences and events. These events include mine rescue competitions, health and safety conferences, and stakeholder meetings.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[ ] Telephone

[X] In-person

[ ] Mail

[] Other, Explain

2. Will interviewers or facilitators be used? [ ] Yes [ X ] No

Please make sure all instruments, instructions, and scripts are submitted with the request.

Instructions for completing genIC Request for Approval for

CDC/ATSDR Formative Research and Tool Development

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is requested.

PURPOSE and USE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Briefly describe the targeted group/groups for this collection.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households; (2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected.

Form: Provide the title of the information collection form.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group).

Burden in Minutes: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Estimate the annual cost to the Federal government for this collection.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

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