Supporting Statement A_v2

Healthcare Response and Prevention Training Curriculum for Health Departments

Request for OMB approval of a New Information

August 16, 2023

Supporting Statement A

Contact:

Rudith Vice

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

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 3

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

5. Impact on Small Businesses or Other Small Entities 4

6. Consequences of Collecting the Information Less Frequently 4

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 4

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 4

9. Explanation of Any Payment or Gift to Respondents 4

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 5

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 5

12. Estimates of Annualized Burden Hours and Costs 5

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 6

14. Annualized Cost to the Government 6

15. Explanation for Program Changes or Adjustments 6

16. Plans for Tabulation and Publication and Project Time Schedule 6

17. Reason(s) Display of OMB Expiration Date is Inappropriate 7

18. Exceptions to Certification for Paperwork Reduction Act Submissions 7

Attachments 7

• Goal of the study: CDC funds Healthcare-Associated Infection and Antibiotic Resistance (HAI/AR) programs in 64 state, local and territorial health departments. Funding is awarded through the Epidemiology and Laboratory cooperative agreements (ELC). Funds are intended to provide critical resources to recipients in support of a broad range of healthcare infection prevention and control and epidemiologic surveillance activities to detect, monitor, mitigate, and prevent the spread of HAI/AR in healthcare settings. HAI/AR programs have experienced an increase in program size and scope through COVID-19 supplemental funds. To better support the growing programs, CDC has developed high-priority trainings requested by the health department programs with the goal of strengthening public health workforce capacity to prevent and respond to HAI/AR outbreaks in healthcare settings, including preventing the spread of SARS-CoV. A training evaluation will be used to assess whether the CDC-developed trainings are reaching the intended audience and achieving the intended goals.

• Intended use of the resulting data: Data collection will be used to improve future training resources. CDC will summarize data and may use findings to inform future trainings and to demonstrate accomplishments, successes, and challenges. PII will not be included in any report-outs.

• Methods to be used to collect: Training evaluation data will be collected electronically using standardized forms in CDC’s REDCap project or CDC TRAIN. Trainees will complete the registration and pre-assessment prior to the training, the post-assessment immediately after the training. The public health program impact of training data will be requested from HAI/AR program leads once per year.

• The subpopulation to be studied: The public health workforce at state, local, and territorial health departments focused on responding to and preventing healthcare-associate infections.

• How data will be analyzed: Descriptive statistics (i.e., number, percentage) will be used to describe the results of the training evaluation. A review of statistical methods is not required for this initiative as it’s intended uses are for training evaluation and improvement. Sample size calculations are not required because the training evaluation includes the entire universe of trainees (estimated: 500 trainees per year) and HAI/AR Program leads (64 total).

1. Circumstances Making the Collection of Information Necessary

This is a new Information Collection Request. We are requesting an extension approval for a period of 3 years. Data collection for these training evaluations were approved under the COVID-19 Public Health Emergency Waiver.

CDC funds Healthcare-Associated Infections and Antibiotic Resistance (HAI/AR) Programs in 64 state, local, and territorial health departments through the American Rescue Plan Act of 2021 (ARP), P.L. 117-2 (https://www.congress.gov/bill/117th-congress/house-bill/1319/text).A supplemental funding award was issued to Epidemiology and Laboratory Capacity cooperative agreement (ELC) recipients as program-initiated component funding under Project E: Emerging Issues of CK19-1904: ‘Strengthening HAI/AR Program Capacity’ (SHARP). This award is intended to strengthen and expand health department capacity to prevent and respond to COVID-19 and other Healthcare-Associated Infections and Antibiotic Resistance (HAI/AR) threats in healthcare facilities. In addition, 59 of the 64 programs are also funded through Project G: Healthcare-associated Infections & Antibiotic Resistance Programs. This award is intended to build and sustain a public health department program that can prevent and respond to HAI/AR threats in healthcare facilities.

To better understand health department needs associated with this funding, CDC conducted a training needs assessment in April 2022. Funded health departments requested CDC develop and deliver trainings to strengthen public health workforce capacity to prevent and respond to COVID-19 and other healthcare outbreaks. To meet this need, CDC has developed the following training curriculum: Healthcare Outbreak Prevention and Response Curriculum for Health Departments. This includes 3 trainings: (1) Healthcare Outbreak Response Training – Didactic Curriculum, (2) Healthcare Outbreak Response Training – Case-based learning, and (3) Healthcare Infection Prevention and Control (IPC): Foundational Training – Didactic Curriculum. Each training will consist of a course registration form and a pre- and post-training assessment (Attachments 1A-1C). Additionally, a Public Health program impact of trainings assessment will be delivered annually at the program level (Attachment 1D). The proposed training evaluation will be used to assess whether the CDC-developed trainings are reaching the intended audience and achieving the intended goal of strengthening public health workforce capacity to prevent and respond to HAI/AR outbreaks, including COVID-19 at the individual trainee and program level.

This data collection is authorized by the Public Health Service Act (Section 301) (Attachment 2).

2. Purpose and Use of Information Collection

The proposed training evaluation will be used to assess whether the CDC-developed trainings are reaching the intended audience and achieving the intended goal of strengthening public health workforce capacity to prevent and respond to HAI/AR outbreaks, including COVID-19, at the individual trainee and program level. Additionally, the evaluation data collection will be used to improve future training resources. CDC will summarize data and may use findings to inform future trainings and to demonstrate accomplishments, successes, and challenges. PII will not be included in any report-outs.

3. Use of Improved Information Technology and Burden Reduction

Electronic data collection will occur for 100% of responses. Data will be collected electronically using standardized forms in CDC’s REDCap project or CDC TRAIN. We have collected prior training evaluation data before electronically through REDCap and the HAI/AR program staff (respondents) are comfortable with using this format to provide feedback.

We have designed the data collection instruments to reduce burden by asking a minimum number of actionable questions that will allow us to better assess our trainings to meet their staff needs.

4. Efforts to Identify Duplication and Use of Similar Information

As the technical monitors for the CK19-1904 CoAg, The Division of Healthcare Quality Promotion is the primary CDC collaborator with Public Health HAI/AR Program staff. We continuously work with other teams in the division to avoid duplication of data collection. In addition, we collaborate with their project officers in CDC’s Division of Preparedness and Emerging Infections to streamline communications and data collection. We reviewed existing HAI/AR Program data collection by other teams in the division and collaborating centers at CDC (e.g., performance measures, annual progress report, milestones) to ensure that these data are not being collected through any other source to avoid duplication. CDC works closely with other organizations that support the HAI/AR programs and there are no duplicate data collections conducted by other organizations outside of CDC. Additionally, where possible, existing CDC program evaluation questions were utilized (https://www.cdc.gov/evaluation/index.htm).

5. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.

6. Consequences of Collecting the Information Less Frequently

The annual collection provides necessary data for CDC to evaluate our efforts in meeting program needs. Less frequent data collection could result in CDC providing unnecessary trainings.

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

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

A. A 60-day Federal Register Notice was published in the Federal Register on JUNE 16, 2023, vol. 88, No. 116, pp. 39437 & 39438 (Attachment 3). CDC received one non-substantive public comment related to this notice (Attachment 7).

B. No consultations outside of CDC occurred.

9. Explanation of Any Payment or Gift to Respondents

Respondents will not receive any incentives.

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

CDC’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does apply. A Privacy Impact Assessment is included as part of this submission (Attachment 4).

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

Institutional Review Board (IRB)

NCEZID’s Human Subjects Advisor has determined that information collection is not research involving human subjects. IRB approval is not required (Attachment 5)

Justification for Sensitive Questions

There are no planned sensitive questions.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

Estimates below include aggregated estimates of annual burden per response and total burden hours for staff from public health staff (including trainees from CDC-funded HAI/AR Programs and other trainees) and HAI/AR Program leads.

Public Health Trainees:

For each training, public health trainees will be asked to complete a registration, a pre-test and a post-test.

Average burden per response:

Registration=0.083 hrs. (5/60 min)

Pre-test=0.083 hrs. (5/60 min)

Post-test=0.083 hrs. (5/60 min)

The number of trainees is estimated based off the number of HAI/AR program staff (target audience) in the 64 CDC-funded HAI/AR programs and historical number of trainees who have attended previous CDC led trainings. Estimates below assume that each trainee attends and completes training registration and evaluations for two training per year. We are estimating that 500 respondents attend the trainings each year of the three-year ICR approval.

Other public health staff and may access the trainings. We anticipate the number of trainees to be limited but acknowledge that others may take and complete the evaluations. Estimate a total of 100 other trainees may take one training annually and participate in the evaluations.

This ICR submission includes three evaluation components for three related trainings: a 5-minute registration, a 5-minute pre-test and a 5-minute post-test.

Total burden hours per year for registration:

600 respondents x 2 responses (2 trainings per year) x 0.083 hours (5/60) per response = 100 hours per year

Total burden hours per year for pre-test:

600 respondents x 2 responses (2 trainings per year) x 0.083 hours (5/60) per response = 100 hours per year

Total burden hours per year for post-test:

600 respondents x 2 (2 trainings per year) x 0.083 hours (5/60) per response = 100 hours per year

HAI/AR Program Leads (CoAg Recipients):

HAI/AR program leads will be asked to provide information to help CDC assess the public health program training impact.

Average burden per response:

Public Health program impact of trainings =0.25 hours (15/60 min)

Average burden per response and Total burden hours per year:

64 respondents x 1 response per year x 0.25 hours (15/50) = 16 hours per year

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
Public Health Trainees	Registration	600	2	5/60	100
Public Health Trainees	Pre-Test	600	2	5/60	100
Public Health Trainees	Post-Assessment	600	2	5/60	100
HAI/AR Program Leads	Public Health program impact of trainings	64	1	15/60	16
Total					316

B. Estimated Annualized Burden Costs

The cost to respondents was calculated using the May 2022 National Occupational Employment and Wages Estimates United States data from the Bureau of Labor Statistics (Department of Labor website). The Epidemiology, Industry state Government hourly mean wage of $35.89 per hour was used. The total estimated respondent cost is $11,341.25. Detailed cost calculations are below.

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Public Health Trainees	Registration	100	$35.89	$3,589.00
Public Health Trainees	Pre-Test	100	$35.89	$3,589.00
Public Health Trainees	Post-Assessment	100	$35.89	$3,589.00
HAI/AR Program Leads	Public Health program impact of trainings	16	$35.89	$574.24
Total				$11,341.24

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

These evaluations are part of CDC staffs’ duty assignments. All evaluations are conducting electronically using software packages that are already available to CDC.

Estimated Annualized Cost to the Government per Activity
Cost Category	% Time	Annual Salary	Estimated Annualized Cost
1 CDC Staff GS-12	10	$71,000	Cost to Government = $7,100
1 CDC Staff GS-13	10	$85,000	Cost to Government = $8,500
Total Estimated annualized cost to the Government = $15,600

15. Explanation for Program Changes or Adjustments

This is a new request. Previously, the training evaluations were approved under the COVID-19 Public Health Emergency waiver.

16. Plans for Tabulation and Publication and Project Time Schedule

Project Time Schedule
Activity	Time Schedule
Data collected through the training evaluations approved may be used for publication. We estimate that if we publish it will take up to two years post data collection. We are requesting a 3-year approval, so we estimate any publication will occur by December of 2028. There should be no complex analytical techniques used to analyze data collected.	Data Collection Start to publication: December 2023 – December 2028.

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

The display of the OMB Expiration date is not inappropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

1. Information Collection instrument

   1. Pre-Test

   2. Post-Test

   3. Registration

   4. Public Health Program Impact of Trainings

2. Authorizing Legislation

3. 60-Day FRN

4. Privacy Impact Assessment

5. Human Subjects Determination

6. Additional attachments (IRB, scripts, consent forms, etc.)

   1. Pre-evaluation Reminder Email

   2. Post-evaluation Reminder Email

7. Public Comment and Response

10