0920-0260_Supporting Statement A

Health Hazard Evaluation/Technical Assistance and Emerging Problems

Revision Package: OMB 0920-0260

Section A

Project Officer: James Couch, PhD, CIH, CSP, REHS/RS

Branch Chief

Hazard Evaluation and

Technical Assistance Branch

CDC-NIOSH-DFSE

Phone: 513-841-4318

Email: [email protected]

Date: November 7, 2023

Table of Contents

Section A: Justification

A1. Circumstances Making the Collection of Information Necessary

A2. Purpose and Use of the Information Collection

A3. Use of Improved Information Technology and Burden Reduction

A4. Efforts to Identify Duplication and Use of Similar Information

A5. Impact on Small Businesses or Other Small Entities

A6. Consequences of Collecting the Information Less Frequently

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A9. Explanation of Any Payment or Gift to Respondents

A10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

A11. Institutional Review Board (IRB) and Justification for Sensitive Questions

A12. Estimates of Annualized Burden Hours and Costs

1. Table 12A Estimate of Annualized Burden Hours

2. Table 12B Estimated Annualized Burden Costs

A13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

A14. Annualized Cost to the Federal Government

A15. Explanation for Program Changes or Adjustments

A16. Plans for Tabulation and Publication and Project Time Schedule

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

List of Attachments

Attachment A1: Occupational Safety and Health Act of 1970 and

Mine Safety and Health Act of 1970

Attachment A2: 42 CFR Parts 85 and 85a

Attachment A3: 60-day FRN

Attachment B1: Health Hazard Evaluation (HHE) Request Form – English

Attachment B2: Health Hazard Evaluation (HHE) Request Form – Spanish

Attachment C: Interview Example

Attachment D: Sample HHE Specific Worker Questionnaire

Attachment E: Medical Survey Informed Consent Example

Attachment F: Sample Employee Exposure Assessment Contact Information Postcard

Attachment G: Followback Initial Site Visit Survey Form

Attachment H: After Final Report Followback Survey Form

Attachment I: 1 Year Later After Final Report Followback Survey Form

Attachment J: Closeout Letter No Site Visit Followback Survey Form

Attachment K: 1 Year After Closeout Letter No HHE Site Visit Followback Survey Form

Attachment L: 1 Year Later No HHE Site Visit Followback Survey Cover Letter and Form

• Goal of the study: This information collection request (ICR) facilitates agency initiation and conduct of legislatively mandated (PL 91-596 & PL 91-973) investigations of chemical, biological, and physical workplace health hazards. Collection of information may help define or assess the magnitude of workplace health hazards. The ICR includes tools necessary to a) initiate the investigation and collect data, b) communicate investigation findings to employers and employees at investigated workplaces, c) obtain information on program impact and outcomes to inform continuous program improvement, and d) allow the program to address emerging problems including emergency response activities and small-scale field projects.

• Intended use of the resulting data: Investigation results document current and potential workplace health hazards of concern to employers and employees specific to their workplace. Findings support recommendations for corrective or preventive measures to eliminate hazards and prevent work-related injury and illness in the investigated workplace and similar workplaces. Findings also are used to identify future research needs.

• Methods to be used to collect: Nearly all investigations use cross-sectional methods to assess current exposures and health status. For some investigations retrospective exposure information also is collected (e.g., through record review). Investigations may draw upon medical, industrial hygiene, epidemiologic, organizational and industrial psychology, ergonomic, engineering, toxicologic, and communication expertise.

• The subpopulation studied: NIOSH serves employees in the United States of America and its territories at all levels, industries, occupations, and workplaces.

• How data will be analyzed: Data will be analyzed using professionally accepted best practice and state-of-the-art methods where appropriate. Evaluation of occupational exposure conditions and health outcomes is used to address the occupational health concerns that prompted employers and employees or their representatives to request an investigation. Investigation determinations are made based on the data collected for the workplace under investigation and are consistent with current best public health practices.

This is a request for a revision to Health Hazard Evaluation/Technical Assistance and Emerging Problems 0920-0260 (exp. March 31, 2024) from the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). This revision is for an ongoing activity for a 3-year period. This data collection is authorized by the Occupational Safety and Health Act of 1970 and the Federal Mine Safety and Health Act of 1977 (Attachment A1).

Annualized burden hour estimates are associated with responding to an estimated 250 HHE requests including 15 emerging problem investigations (from burden tables on pages 15 and 16). These burden estimates are consistent with the HHE program’s recent experience. The proposed burden changes are:

• HHE specific interviews +60 hrs

• HHE specific questionnaires +400 hrs

• HHE specific medical survey informed consent +45 hrs

• Employee Contact Postcard +17 hrs

• Total ICR burden hour change from 2020 OMB renewal: + 522 hrs

The total annualized burden hour estimate for all forms is 2,267 hours. Note that in the calculation of hours rounding has been used per standard custom.

1. Justification

1. Circumstances Making the Collection of Information Necessary

NIOSH responds to requests for Health Hazard Evaluations to evaluate health concerns involving chemical, biological, or physical hazards in workplaces throughout the United States. Section 20(a)(6) of the Occupational Safety and Health Act of 1970 and Section 501(a)(11) of the Federal Mine Safety and Health Act of 1970 [Attachment A1] mandate NIOSH respond to these requests. Each year, NIOSH receives approximately 250 such requests. NIOSH conducts approximately 78 short-term field evaluations each year to identify potential chemical, biological, or physical hazards in a given workplace. For the remaining requests, NIOSH responds by letter or telephone. This authority forms the basis for the NIOSH “Health Hazard Evaluation” program. NIOSH uses its public health authority found in Section 20(a)(4), 20(a)(6), and 20(a)(7) of the Occupational Safety and Health Act and Sections 301(a) and 501(a)(5) of the Federal Mine Safety and Health Act (Attachment A1) to respond to requests for similar investigations from other federal agencies, and state and local institutions – i.e., “technical assistance” and to perform self-initiated short term studies of “emerging problems.”

Requirements in these two Acts

1. Provide a practical means to assure that workers exposed to the thousands of substances for which standards have not yet been developed are properly protected, and

2. Obtain information on health hazards at current workplace exposure levels. This information may indicate the need for changes in existing health standards or identify emerging hazards previously unevaluated.

Since 1970, NIOSH has responded to over 17,300 Health Hazard Evaluation requests. The main purpose of a Health Hazard Evaluation is to help employers and employees identify and eliminate work hazards. Nearly all Health Hazard Evaluations are in response to specific requests for assistance by employers, employees, employee representatives, other federal agencies, and state and local agencies. In the three years from FY 2020 – FY 2022, NIOSH received and responded to 557 Health Hazard Evaluation requests from a variety of workplaces including health care facilities, industrial settings, and non-industrial indoor environments. Each year NIOSH initiates evaluations in response to new information obtained by NIOSH regarding chemical, biological, or physical agent hazards and for which NIOSH needs to assess the feasibility of conducting a long-term research investigation. In these situations, a relatively small respondent burden is involved, using environmental and medical investigative procedures that are highly specific to the hazard and workers involved. The program may also be requested to participate in emergency response activities utilizing these same techniques.

NIOSH continues the agency’s outreach to its partners and customers through the National Occupational Research Agenda or NORA (http://www.cdc.gov/niosh/nora/). Based on a program review completed by an expert panel of the National Academies, the HHE Program continues to promote awareness of the program. It also continues to conduct followback evaluations for completed investigations, and continues to conduct a small number of emerging issue Health Hazard Evaluations. Two examples of emerging issues for which the Health Hazard Evaluation program are actively involved are per- and polyfluorinated substances (commonly known as PFAS) and occupational exposures to illicit drugs (police, emergency responders, crime laboratories, etc.).

Because of the number of investigations conducted each year, the need for rapid response by NIOSH to requests for assistance, and the unpredictable and changing nature of the investigations, consolidated clearance is requested for data collection activities related to Health Hazard Evaluations. The implementing regulations for these programs are 42 CFR Parts 85 and 85a (Attachment A2).

2. Purpose and Use of the Information Collection

The Health Hazard Evaluation program provides individual work sites with a resource for determining if toxic substances, biological materials, or harmful physical agents are present in the environment and pose a health hazard to employees. Health Hazard Evaluations are essential to NIOSH for meeting its legislated function to determine the toxic or hazardous effects of substances or physical agents found in places of employment. Information collected is integral to identifying potential hazards in the workplace. Defining health impacts the workforce may be experiencing also requires this information. Identifiable information is used to ensure the integrity of data collected and that it is not comingled with other workers’ information within the same study. Additionally, this information is used to verify that health effects experienced by workers are occurring among workers encountering the workplace hazard of concern. Similarly, collection of workplace exposure monitoring requires that it be linkable with workers where the exposure may occur. NIOSH staff and NIOSH contractors responsible for doing the Health Hazard Evaluation use the collected information to complete the requested workplace investigations. Health Hazard Evaluation reports presenting the study findings use only de-identified data to report results.

Current information collection methods facilitate NIOSH investigators’ ability to obtain the required information for requested workplace investigations to determine the existence and magnitude of workplace hazards. NIOSH Health Hazard Evaluation findings presented in a report to employer and employees of the facility evaluated answer workplace health concerns identified in the Health Hazard Evaluation request. Health Hazard Evaluation results may be used by employers and employees to identify and reduce or eliminate hazardous workplace exposures; assess their need to improve or implement workplace health and safety programs; obtain input on the effectiveness of their workplace health and safety; or obtain specific assistance to solve a workplace related health concern.

Followback information collection provides the NIOSH Health Hazard Evaluation program with a mechanism for obtaining feedback on the effectiveness of the program. Employers and employee representatives may provide input to NIOSH from their perspective about what worked well and any suggestions that might improve the Health Hazard Evaluation program. NIOSH uses feedback to evaluate the usefulness of the program to employers and employees. NIOSH periodically reviews responses to help identify program areas that may be improved.

In addition to the direct benefit to the specific establishment studied, the majority of field investigations done in response to Health Hazard Evaluation requests result in a report that is deemed of sufficient general interest that the report is made available to a wider audience through the internet. Reports may also be obtained by calling the CDC-NIOSH toll-free assistance number (1-800 CDC INFO), using the CDC INFO webpage (https://www.cdc.gov/cdc-info/) or down loading a digital copy from the NIOSH Health Hazard Evaluation webpage (https://www.cdc.gov/niosh/hhe/default.html). Reports may be requested directly from the Health Hazard Evaluation Program office through the website, by e-mail, or by written request. These reports also become the basis for additional dissemination efforts such as publishing findings in scientific and trade publications or through presentations to professional and stakeholder groups.

3. Use of Improved Information Technology and Burden Reduction

Questionnaires are designed to collect only the minimal information necessary to address the issues of concern. A routine part of the initial site visit is to gather industrial hygiene, medical, and epidemiological data that are germane to the issues. Available data, collected by consultants and the employer, are utilized when possible to avoid collecting redundant information. Interviews are conducted to be as unobtrusive as possible and to minimize employees’ time away from the job. There are no legal obstacles to reduce the burden. Use of electronic surveys is not feasible in the workplace setting of most Health Hazard Evaluations. The Program is considering the development of an online version of the followback questionnaires (which do not collect personally identifiable information). The content of the online questionnaires will mirror that on the paper versions included with this document and the burden will remain the same. Information from past mailed survey respondents indicates the need, however, to retain a mailed, paper version as a respondent option to ensure the greatest response rate.

4. Efforts to Identify Duplication and Use of Similar Information

Previous information is used whenever appropriate to a Health Hazard Evaluation. Some Health Hazard Evaluation requests that involve issues of compliance with OSHA and MSHA standards are referred to those agencies. Before initiating a field investigation, local OSHA or MSHA offices are contacted to determine if a relevant investigation is ongoing or has recently been completed at the establishment and identification of an ongoing investigation is asked for during the initial request (Attachment B1 and B2). In addition, state health departments are informed of the Health Hazard Evaluation request and asked to contact NIOSH if they have relevant information about the establishment. It is important to note that the NIOSH Health Hazard Evaluation program is not primarily oriented to assisting employers to comply with OSHA or MSHA regulations and, unlike the compliance assistance, consultation, or alliance programs of those agencies, is authorized to respond to requests from employees and their representatives, as well as employers.

5. Impact on Small Businesses or Other Small Entities

Every effort is made to minimize the burden on all employers (including small businesses) when collecting information. The dates for the investigation are set in consultation with the employer. NIOSH investigators work closely with employers to establish the logistics of the visit. Employee interviews and questionnaires are designed to be as brief as possible while still obtaining the essential information needed for the evaluation. Paragraph (e) in Section 85.7 of 42CFR85 requires the conduct of Health Hazard Evaluations shall be such as to preclude unreasonable disruption of the operations of the employer's establishment.

6. Consequences of Collecting the Information Less Frequently

Responses to Health Hazard Evaluations are initiated only upon receipt of a Health Hazard Evaluation request. Typically, respondents reply only one time during the field investigation. For the followback surveys, respondents may be asked to complete two questionnaires within a one-year period. This is needed to ensure that feedback is timely and information is accurate, and permits the assessment of changes over time. There are no legal obstacles to reduce the burden.

The consequences to the agency of not collecting the information needed to validate and conduct Health Hazard Evaluations is that NIOSH will not be able to initiate and complete evaluations. Section 20(a)(6) of the Occupational Safety and Health Act of 1970 and Section 501(a)(11) of the Federal Mine Safety and Health Act of 1970 require NIOSH to determine whether any agent or process normally found in the place of employment has potentially toxic effects in such concentrations as used or found following a request for a Health Hazard Evaluation.

Eliminating the collection of privacy act information required during a workplace Health Hazard Evaluation would substantially reduce the ability to independently verify and evaluate reported and potential health hazards in the workplace. Omitting contact information would impede the ability of NIOSH to meet ethical and legislative obligations for notifying employers and affected employees of investigation findings. It would further reduce the ability of the program to determine program impact and outcomes.

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

There are no special circumstances associated with this data collection activity.

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

   1. A 60-day Federal Register Notice was published in the Federal Register on August 1, 2023, Volume 88, No. 146, Page(s) 50155-50156. No comments were received.

2. Because most of these evaluations are relatively small-scale efforts requiring a timely response, it is not always practical to obtain outside consultations. However, local OSHA and MSHA staff are contacted to determine if they have relevant information or activities relating to the Health Hazard Evaluation request. As noted above, the state health department is also asked to provide similar information to NIOSH. Project review is conducted with persons outside NIOSH as needed. Prior to or during a particular investigation, it may be necessary to contact individuals in academia (as recognized experts in specific scientific areas) for consultation. When Health Hazard Evaluation Program activities meet the legal criteria for research, procedures for human subjects review are followed, including statistical and peer review. For most investigations involving questionnaires or medical exams/tests, statistical consultation is provided by NIOSH subject matter experts.

9. Explanation of Any Payment or Gift to Respondents

Remuneration of respondents is not provided.

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

ISSO determined in conjunction with the CDC Privacy Office that the Privacy Act is applicable. The collection contains PII data elements with demographic information in the interviews (i.e., Name, Medical History).

Information Collection Instrument Questionnaire and the NIOSH HETAB MUST drive. Share drive includes the in-place technical, physical, or administrative controls (safeguards). Access is limited to NIOSH personnel with a bona-fide need for the data to perform their official duties. System Security Plan (SSP) defines the process for handling security incidents. The system’s team and the Cybersecurity Program Office (CSPO) share the responsibilities for event monitoring and incident response. Direct reports of suspicious security or adverse privacy related events to the component’s Information Systems Security Officer (ISSO), CDC helpdesk, or to the CDC Security Incident Response Team (CSIRT). The CDC CSPO reports to the HHS Computer Security Incident Response Center (CSIRC), which reports incidents to US-CERT as appropriate.”

Full names are collected because interviews (Attachment C) and questionnaires (Attachment D) are often required; medical histories, testing, and physical examinations are frequently determined to be a necessary part of the investigation of possible work hazards; and names are needed to enable NIOSH to notify individual employees of their own medical test and exposure monitoring results. Data will be covered under CDC Privacy Act System Notice Number 09‑20-0147, Occupational Health Epidemiological Studies and Energy Employees Occupational Illness Compensation Program Act (EEOICPA) Program Records and World Trade Center (WTC) Health Program Records. Respondents are assured that information received will be maintained in accordance with the Privacy Act (5 USC 522a) and the Department’s regulations under that law contained in Title 45, Part 5b of the Code of Federal Regulations.

Participants are informed that NIOSH is authorized to collect their personal information and will protect it to the extent allowed by law. They are notified that there are conditions under the Privacy Act where their information may be released to collaborators or contractors, health departments or disease registries, to the Departments of Justice or Labor, or to Congressional offices.

Participants are notified during investigations that their participation is voluntary and that they may withdraw from participating at any time. Consent forms are used for participants involved in medical testing (Attachment E– presents a sample form, with text that can be used or adapted as needed). Participants are notified that their participation is voluntary and that they may withdraw from participating at any time. They are also notified that their information will be protected to the extent permitted by law. Questionnaires used for medical evaluations (Attachment D) notify participants on the first page that their participation is voluntary and that the information will be protected to the extent permitted by law. (Note that although the sample questionnaire indicates a burden of 10 minutes per respondent, we have continued to use an estimate of 30 minutes for consistency with HHE program experience in general.)The safeguarding measures that will be in effect to protect the records include locked files in locked rooms in a restricted access facility, password protection for computer files, and access being restricted to NIOSH personnel with a bona fide need for the data in order to perform their official duties. A new system of records will not be created for this project, since it is covered under the CDC Privacy Act System Notice Number 09-20-0147.

While an HHE evaluation is ongoing the personal information is kept in a locked file cabinet and/or restricted access internal electronic data management systems, accessible to NIOSH staff involved in the data collection activities. All NIOSH staff are required to maintain and protect private information according to the 2011 NIOSH Sensitive Data Security Program. Results of an individual’s medical tests, examinations, and exposure monitoring are shared with that individual. These results may also be provided to the employee’s personal physician upon the employee’s written request.

A statement detailing the impact the proposed collection will have on the respondent’s privacy: To minimize the risk of loss of privacy, NIOSH investigators use identification numbers and do not put names on specimens or medical questionnaires. The intent of the HHE program is not to impact the privacy of individuals. NIOSH investigators are required to follow the 2011 NIOSH Sensitive Data Security Program and current Agency guidance.

The HHE Program is included in a system that has an approved Security Assessment and Authorization (SA&A). The SA&A is to verify that the system is operating with proper security measures in place. The SA&A includes a Privacy Impact Assessment that reflects the activities of the HHE Program.

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

1. IRB Approval

Health Hazard Evaluations are a public health activity, not research, and do not undergo review by an institutional review board. If a proposed Health Hazard Evaluation were to meet specific criteria of a research study, that Health Hazard Evaluation would be individually required to go through an institutional review board review. This has not occurred in the last three years.

2. Justification for Sensitive Questions

With very few exceptions, Health Hazard Evaluations do not involve sensitive questions. When included, however, these questions relate to the objectives of the evaluation of work-related health concerns. The respondents are informed that participation is voluntary and that they may choose not to respond to specific questions.

12. Estimates of Annualized Burden Hours and Costs

The number of Health Hazard Evaluation requests received in a given year cannot be known in advance. Over the last four years, the numbers have ranged from 132 to 270. NIOSH anticipates that the number of requests received will continue to fluctuate, particularly in newer areas (such as “green” industries) where occupational health hazards have not been well evaluated. Considering this, and looking at previous trends, the average number of Health Hazard Evaluation requests for FY 2023 and beyond is estimated to be 250. Table 12A, Row1 shows that at an estimate of 12 minutes for completing and submitting a Health Hazard Evaluation request, the result is an estimated 50 burden hours.

Based on prior experience, NIOSH assumes that 25% of the 250 requests will require a site evaluation. In addition, 15 additional onsite evaluations will be done for emerging issue evaluations. A total of 78 on-site evaluations are used to calculate the burden of specific activities. The number of participants and time for completion described below are based on average experience in recent years.

Of the 78 onsite evaluations, NIOSH estimates that 57 (73%) will involve an initial site visit that includes informal interviews to gather information on exposures and health effects. Although these interviews (which are akin to a discussion between a doctor and patient) do not entail use of a questionnaire, we include them in our burden estimates. An example of what may be covered in these interviews is provided in Attachment C. This de-identified interview form was used for an evaluation of microbial exposure among warehouse and distribution employees. The interview form is used by the NIOSH investigator to maintain consistency across interviews and is not distributed to individuals. The estimated time for an interview is 15 minutes. Assuming that 30 employees are interviewed at each of the 57 work sites, the burden from this activity is 428 hours.

Of the 78 onsite evaluations, NIOSH estimates that 29 (37%) will involve employee questionnaires. As noted previously, the same questionnaire is not used in different evaluations; rather, questionnaires based on standard medical and epidemiologic approaches are developed to fit the unique needs of each situation. An example of a questionnaire used in an investigation addressing potential exposures and health effects among workers in a state crime laboratory is provided in Attachment D. Based on experience, the estimated time for completion of most questionnaires is 30 minutes. Assuming that 100 employees complete a questionnaire at each of the 29 work sites, the burden from this activity is 1,450 hours.

Of the 78 onsite evaluations, NIOSH estimates that 57 (73%) will involve personal exposure monitoring of employees. Employees who agree to be monitored are asked to complete a contact information postcard (Attachment F), which enables NIOSH to provide them with their individual results. The estimated time to complete the postcard is 5 minutes. Assuming that 25 employees are monitored at each of the 57 work sites, the burden from this activity is 119 hours.

During the HHE and after the report is issued, NIOSH will distribute followback questionnaires to the involved parties to assess the effectiveness of the HHE. With the estimated 78 onsite evaluations including 15 emerging hazards, only about 50% of the emerging hazards will be appropriate for the followback evaluations due to the emerging hazard and/or emergency response aspects of the evaluation. Therefore, approximately 70 onsite evaluations will be included in the followback evaluation estimations. Followback evaluations will be done for approximately 70 onsite evaluations with two respondents per evaluation. Based on 140 respondents completing one 10- and one 20-minute questionnaire in the first year (Attachments G and H) and one 15-minute questionnaire in the second year (Attachment I), this estimated burden is 70 (23 and 47) hours in the first year and 35 hours in the second year.

Followback evaluations will be done with the primary requestors for a sample of the HHE requests where there was no on-site evaluation. A 50% sample is selected by choosing every other request. Not including emerging problems and based on a total of 250 HHE requests (with 63 [25%] of the requests leading to on-site evaluation), approximately 94 of these followbacks will be done, with one respondent for each. Based on respondents completing one 10-minute questionnaire in the first year (Attachment J), and one 15-minute questionnaire in the second year (Attachment K), this equates to approximately 16 and 24 burden hours, respectively.

The total annualized burden hours are 2,267 hours, an addition of 522 hours.

Table 12A

Estimate of Annualized Burden Hours

Type of Respondent (row numbers referred to in text)	Form	No. of respondents	No. of responses per respondent	Average burden per response in minutes	Total Burden Hours
1) Employees/ employee representatives/ or employers*	HHE Request Form Attachment B1 or B2	250	1	12/60	50
2) Employees	HHE specific interview example Attachment C†	1,710	1	15/60	428
3) Employees	HHE specific questionnaire example Attachment D†	2,900	1	30/60	1,450
4) Employees	HHE specific medical survey informed consent form Attachment E	150	1	30/60	75
5) Employees	Employee Contact Postcard Attachment F	1,425	1	5/60	119
6) Followback for onsite evaluations – employer & employee representative Year 1	Initial Site Visit Followback Survey form Attachment G and H	140	1	10/60	23
7) - employer & employee representative Year 1	Closeout for HHE Followback Survey with site visit Attachment I	140	1	20/60	47
8) – employer & employee representative Year 2	1 Year Later for HHE Followback Survey with site visit Attachment J	140	1	15/60	35
9) Followback for evaluations without onsite – employee representative Year 1	Closeout for HHE without site visit Attachment K	94	1	10/60	16
10) Employee representative Year 2	1 Year Later for HHE without site visit Attachment L	94	1	15/60	24
Total Estimate of Annual Burden Hours					2,267

^* Includes government, other, and joint requests.

^†Each interview/questionnaire is specific to a work site evaluation and its hazard and health concerns. No specific interview form is distributed, questions pertain to concerns expressed in the HHE request and are asked in an open-ended manner. An HHE-specific sample of what may be asked in the interviews is provided. An HHE-specific questionnaire from another HHE is provided as an example of the questionnaire employees may complete as a part of the on-site investigation.

Data collection for a Health Hazard Evaluation generally occurs during a respondent’s usual work hours. Assuming an average civilian hourly wage (total compensation) in the US of $ 29.76 (National employment and wage data from the Occupational Employment and Wage Statistics survey by occupation, May 2022), from the Bureau of Labor Statistics, Economic News Release Table 1 [Table 1. National employment and wage data from the Occupational Employment and Wage Statistics survey by occupation, May 2022 - 2022 A01 Results (bls.gov). Accessed May 2023]. The annualized respondent cost is $67,466 ($29.76 x 2,267 burden hours).

Table 12B

Estimated Annualized Burden Costs

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Employees/employee representatives/ employers	50	$29.76	$1,488
Employees (interview)	428	$29.76	$12,737
Employees (questionnaire)	1,450	$29.76	$43,152
Employees (informed consent medical)	75	$29.76	$2,232
Employees (contact postcard)	119	$29.76	$3,541
Followback for onsite evaluations Year 1 (Attachment H) Year 1 (Attachment I) Year 2 (Attachment J)	23 47 35	$29.76 $29.76 $29.76	$684 $1,399 $1,042
Followback for evaluations without onsite Year 1 (Attachment K) Year 2 (Attachment L)	16 24	$29.76 $29.76	$476 $714
TOTAL	2,267	N/A	$67,465*
*Total does not match direct calculation ($29.76 x 2,267=$67,466) due to rounding

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

None

14. Annualized Cost to the Federal Government

The annual cost to the government for operating the Health Hazard Evaluation and Technical Assistance program is approximately 5.7 million dollars, which covers $5.1 million for 37 FTEs in FY 2022 and $600,000 in discretionary costs. The estimated cost for preparing, administering, and processing questionnaires related to this program is $450,000 (which covers both FTE expenses and discretionary expenses and is included in the total annual funding of 6.3 million dollars).

15. Explanation for Program Changes or Adjustments

One new form has been added to this submission (Attachment E HHE-specific informed consent). The HHE Request Forms (Attachment B1 and B2 English and Spanish) were updated to clarify information requested. Due to an increase in emerging problems or hazards including emergency response activities in previous years, an additional 15 onsite evaluations were added. Because of these changes the amount of estimated burden hours was increased by 552 hours. The increase in estimated hours also increased the annualized respondent cost by approximately $16,000 than the previous years.

Followback forms were revised to remove redundant questions, improve clarity for questions where previous versions often lacked a response from participants, and based on external feedback to inquire about specific recommendations that were adopted after an HHE. With both removal and addition of questions to followback forms, the estimated burden hours per document remained the same.

No additional changes were made to the submission from previous years.

16. Plans for Tabulation and Publication and Project Time Schedule

Typically, NIOSH investigators arrange to visit the establishment within 6-10 weeks following a request. Preliminary observations are reported at the end of the initial site visit; when needed, interim results may be reported before a final report is completed. Environmental and medical data collection efforts for studies that require additional evaluation usually take about six months. Individual medical test and individual workplace exposure monitoring results are usually available and distributed two to three months after testing. The median time to complete the evaluation after the initial visit for Fiscal years 2020-2022 was 8 months. Completion times vary according to the time to receive analytical results for environmental or biological samples, medical reports from consulting specialists, complexity of the data analysis, and competing demands on staff time.

A report of each Health Hazard Evaluation is prepared. Medical results are presented in summary fashion; personal identifiers are never included. The report is distributed to employee and employer representatives, OSHA or MSHA as appropriate, and other government agencies, as needed. Reports are available to the public through the NIOSH web site and the NIOSH HHE Branch office. Findings may be published in scientific and trade journals. Reports often are cited in other NIOSH publications and trade journals, furthering their dissemination.

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

No exemption is requested.

17. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions are requested.

HHE 2023 OMB 0920-0260 ICR