GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
OMB Control No. 0920-1154
Expiration Date: 04/30/2026
CDC OneLab REACH Formative Evaluation
Contact: Breyanna Mikel
Health Scientist (Program Evaluator)
Division of Laboratory Systems
Centers for Laboratory Systems and Response (CLSR)
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Phone: (404) 498-4095
Email: [email protected]
A.1. Circumstances Making the Collection of Information Necessary 3
A.2. Purpose and Use of Information Collection 4
A.3. Use of Improved Information Technology and Burden Reduction 5
A.4. Efforts to Identify Duplication and Use of Similar Information 5
A.5. Impact on Small Businesses or Other Small Entities 5
A.6. Consequences of Collecting the Information Less Frequently 6
A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 6
A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside 6
A.9. Explanation of Any Payment or Gift to Respondents 6
A.10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 6
A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions 6
A.12. Estimates of Annualized Burden Hours and Costs 6
A.13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 7
A.14. Annualized Cost to the Government 7
A.15. Explanation for Program Changes or Adjustments 8
A.16. Plans for Tabulation and Publication and Project Time Schedule 8
A.17. Reason(s) Display of OMB Expiration Date is Inappropriate 8
A.18. Exceptions to Certification for Paperwork Reduction Act Submissions 8
List of Attachments 9
Goal of the data
collection: Explore how OneLab REACH increases access to
laboratory trainings among laboratory professionals and the testing
community in order to better meet the laboratory and testing
communities’ needs as well as identify opportunities
to improve the OneLab REACH learning management system as a
platform that houses laboratory trainings.
Intended
use of the resulting data: Better understand the users
(learners) of OneLab REACH, their needs and gather feedback on
available tools, resources, and trainings. Methods to be used to
collect data: Surveys that will collect qualitative as well as
semi-quantitative data. The subpopulation to be
studied: Clinical and public health laboratory professionals,
representatives with the responsibility for education and training
within major laboratory organizations and members of the testing
community
How data will be analyzed:
Qualitative analysis (and
additional quantitative analyses where appropriate)
CDC requests approval for a new GenIC OneLab REACH Evaluation under OMB Control No. 0920-1154.
Information collection activities are limited to formative work that will result in overall program improvement for CDC OneLab REACH.
CDC OneLab REACH is a targeted and customized learning management system (LMS) specifically for laboratory and testing professionals. OneLab™ REACH offers free public health emergency response relevant education and trainings resources, Continuing Education Units (including P.A.C.E.®), and downloadable materials. OneLab REACH learning management system provides trainings and workforce development resources (e.g., OneLab Network live events and webinars, OneLab Virtual Reality (VR) trainings and simulations, OneLab Test community of practice events, and OneLab REACH training courses, job aids, and microlearning materials and resources) to laboratory professionals that work in communities that are underserved, work with people who are part of minority groups and populations, and work within communities that have very limited access to timely, relevant, and accurate resources. OneLab REACH has the short-term goal of strengthening interconnections between clinical, public health, and CDC laboratory education and training professionals to collectively support rapid, large-scale responses (e.g., MPox, COVID-19, etc.). Further, it has the long-term goal of establishing a sustainable learning community to equip the public health and clinical laboratory workforce with necessary tools, resources, and networks. The evaluation of OneLab REACH aims to assess how well the LMS system is performing, how the resources and materials are accessed and used by laboratory and testing professionals, and whether OneLab REACH is meeting both the short-term and long-term goals.
The purpose of this formative evaluation is to gather information to:
Assess how well the OneLab REACH LMS system is performing by:
gaining additional knowledge and insight about learners’ knowledge, skills, attitudes, and behaviors around accessing and using the platform for training and workforce development needs
determining the effectiveness of OneLab REACH and the continuous quality improvement of OneLab REACH
Assess representation from laboratories of various settings (e.g., hospital labs, commercial labs, etc.) to improve access to timely and relevant resources
Assess learners’ critical training needs and how well they are addressed by OneLab REACH
Improve the ability of OneLab REACH to support the timely development and dissemination of training and education resources for laboratory professionals during future response to public health emergencies.
The anticipated number of respondents and cadence for each data collection component are described below. All surveys will be voluntary and anonymous and will be programmed and administered to respondents on CDC’s LMS platform, OneLab REACH.
Single Sign-Up Survey (SSU) (10,000 respondents): The anonymous SSU Survey will only be taken once by each learner to assess their demographic information. This voluntary survey is estimated to include up to 10,000 respondents based on annual registration volume. The demographic section of the SSU is up to 15 questions long; however, the length of the survey may vary based on the skip logic of questions and how learners respond to the survey. For example, if the learner is a student, performs diagnostic testing, or performs point-of-care testing, then they will be asked several more questions related to the specific type of work that they do. We estimate that on average this survey will incur no more than 20 minutes for each respondent to complete.
Post-Course Evaluation Survey (14,000 respondents): The anonymous post-course evaluation survey will capture information about the effectiveness and relevancy of the course to the learner. Answers are not linked to individual LMS Profiles. The anticipated number of learners that will complete the post-course evaluation will be 14,000 based on the 2,000 current registrants who on average take 7 of OneLab REACH courses in a year. This survey will take approximately 15 minutes to complete.
User Experience Survey (3,000 respondents): This is an optional and anonymous survey where learners provide feedback about their experience using OneLab REACH. Answers are not linked to individual LMS Profiles. This survey will be administered on a rolling basis once a month to up to 3,000 learners. The survey will take approximately 5 minutes to complete.
P.A.C.E.® and non-P.A.C.E.® Evaluation Survey (20,000 respondents): This voluntary survey is offered to learners attending OneLab live events (e.g., OneLab REACH or TEST webinars) or trainings (e.g., OneLab Virtual Reality (VR) training). Skip logic is programmed within this survey based on the webinar, post-event or training a leaner attended., For the P.A.C.E® evaluation surveys, learners will provide feedback about their experience completing a OneLab REACH training, OneLab VR training, OneLab Network live event, or OneLab TEST live event for P.A.C.E.® credit. The non- P.A.C.E. ® evaluation survey will be offered to learners who attend recordings and live webinars that are hosted on OneLab REACH, OneLab Network, and OneLab TEST to provide feedback on the quality of the content and speakers of the event. We estimate that the 2,000 current OneLab registrants on average participate in up to 10 OneLab live events per person in a year, for a subtotal of 20,000 respondents in this evaluation component.
Mini Lesson and Job Aids Surveys (3,000 respondents): This voluntary survey is offered to up to 3,000 learners after taking a mini lesson or using a job aid on the OneLab REACH platform, to assess the mini lesson’s and/or job aid’s content, its helpfulness, and its usefulness. This survey will take approximately 5 minutes to complete.
Project results will be reported publicly in anonymized, aggregated summary form to inform CDC and other public health and clinical laboratory partners to address gaps identified. The user experience survey will primarily be shared with and used internally in CDC to inform areas of improvement for the OneLab REACH platform; the aggregated data will also be shared with users to inform them that their feedback is being utilized for program improvement.
Participation in all data collection activities will be voluntary. All data from OneLab REACH surveys will be collected via OneLab REACH in anonymous and deidentified manners.
Demographic information will be collected through OneLab REACH’s sign-up survey when learners initially sign-up to use the LMS. The respondents to the OneLab REACH single sign-up survey will include clinical and public health laboratory professionals as well as professionals from the testing community. Upon initially signing up for OneLab REACH, respondents will complete this one-time survey that will capture demographic data and background characteristics to better tailor their OneLab REACH experience. All evaluation components are built-in surveys programmed in and administered via the OneLab REACH LMS platform, and the data will live secured and encrypted in the LMS.
All Survey questions were reviewed by evaluation experts and pilot tested to collect the minimum information necessary for the purposes of this formative evaluation. Skip patterns are used so that respondents only answer the minimum applicable questions based on previous answers.
CDC is not aware of the availability of any similar information. OneLab REACH was established by CDC/DLS as a one-of-a-kind innovative program that has not been previously evaluated. Therefore, no duplicate or similar information evaluating the program exists.
This data collection will not involve small businesses.
The single sign-up survey is only completed one time when learners initially sign up for OneLab REACH and/or want to opt into other OneLab elements. The other data collection instruments will be distributed upon the completion of a course, attendance of a live or recorded, or on random basis for the mini lessons and job aid survey and user experience survey. If CDC does not collect data from participants after each course or, on a random basis, access of a mini lesson or job aid, then the utility of OneLab REACH across the participant communities will not be fully characterized.
This request fully complies with the regulation 5 CFR 1320.5.
A. A Federal Register notice was published for this generic package on August 23, 2019, Vol. 87, No. 140, pp. 43860. No public comments were received.
B. “No consultations outside of CDC occurred.”
N/A
CDC is not collecting information in identifiable form (IIF) and will not be retrieving the data by IIF data elements.
This project was reviewed by CLSR human subjects contact and determined to not meet the definition of research under 45 CFR §46.102(l). IRB review is not required (Attachment 9).
Exhibit A.12. Estimated Annualized Burden Hours
The length of time for participants to complete the Single-Sign Up Survey is estimated to be 20 minutes per individual. It is expected that up to 10,000 respondents per year will complete the SSU. For the Post-Course Evaluation Survey, it estimated up to 14,000 respondents will take this survey with up to 15 minutes to complete per response on average. Up to 3,000 respondents will complete the 5-minute user experience survey. Approximately 20,000 respondents will complete the 15-minute P.A.C.E.® and non-P.A.C.E.® Evaluation Survey. Up to 3,000 respondents will complete the 5-minute Mini Lesson and Job Aid Survey. There is no cost to participants beyond the participation burden time. The table below provides the burden estimates for this study.
Type of Respondent |
Form Name |
No. of Respondents |
No. Responses per Respondent |
Avg. Burden per response (in hrs.) |
Total Burden (in hrs.) |
Individuals and household |
Single Sign-Up Survey |
10,000 |
1 |
20/60 |
3,333 |
Individuals and household |
Post-Course Evaluation Survey |
14,000 |
1 |
15/60 |
3,500 |
Individuals and household |
User Experience Survey |
3,000 |
1 |
5/60 |
250 |
Individuals and household |
P.A.C.E.® and non-P.A.C.E.® Evaluation Survey |
20,000 |
1 |
15/60 |
5,000 |
Individuals and household |
Mini Lesson and Job Aid Survey |
3,000 |
1 |
5/60 |
250 |
Total |
|
50,000 |
|
|
12,333 |
Exhibit B.12. Estimated Annualized Burden Costs
The estimates of the annualized cost to respondents for the burden hours for the collection of information is derived from the 2022 mean hourly wage of $28.43 for Clinical laboratory technologists and technicians (#29-2010), per the Department of Labor website. This estimate will be used as a proxy to provide the total respondent cost for other participants (such as public health laboratories, large commercial laboratories, and manufacturers).
Type of Respondent |
Form Name |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
Individuals and household |
Single Sign-Up Survey |
3,333 |
$28.43 |
$ 94,757.19 |
Individuals and household |
Post Course Evaluation Survey |
3,500 |
$28.43 |
$99,505.00 |
Individuals and household |
User Experience Survey |
250 |
$28.43 |
$ 7,107.50 |
Individuals and household |
P.A.C.E.® and non-P.A.C.E.® Evaluation Survey |
5,000 |
$28.43 |
$142,150.00 |
Individual and household |
Mini Lesson and Job Aid Survey |
250 |
$28.43 |
$ 7,107.50 |
Total |
|
12,333 |
|
$350,627.19 |
There are no costs to respondents other than their time to participate.
The cost to prepare for, administer, and report the results of the single sign-up survey, post-course evaluation survey, user experience survey, P.A.C.E.® and non-P.A.C.E.® Evaluation Survey and mini lesson and job aid survey is $71,600.00. This cost includes salaried labor for contractor staff and other direct costs associated with planning and execution of the single sign-up survey, post-course evaluation survey, user experience survey, P.A.C.E.® and non-P.A.C.E.® Evaluation Survey, and mini lesson and job aid survey. Federal staff responsibilities include overall management and oversight of the project, provision of data collection instruments, oversight of the project, and overseeing all data analyses and dissemination activities.
Cost Category |
Estimated Annualized Cost |
||
Contractor labor |
$30,000.00 |
||
Other direct costs (recruitment, incentives, transcripts, online platform) |
-- |
||
Federal Government Personnel Costs |
CDC Health Scientist (GS-13) |
20% time |
$20,800.00 |
CDC Health Scientist (GS-13) |
20% time |
$20,800.00 |
|
Total Annualized Cost to Government |
$71,600.00 |
No change in burden is requested as this is a new information collection.
Project Time Schedule |
|
Activity |
Time Schedule |
Single Sign-Up Survey |
|
Obtain LMS Profile list |
Immediately after OMB approval |
Administer Single Sign-Up Survey |
Immediately after OMB approval |
Analyze data and produce summary report |
1 month after OMB approval |
**Please note that this process will be repeated on a monthly basis |
|
Post-Course Evaluation Survey |
|
Obtain OneLab REACH course registration and completion lists |
Immediately after OMB approval |
Administer Post-Course Evaluation Survey |
Immediately after OMB approval |
Analyze data and produce summary report |
1 month after OMB approval |
**Please note that this process will be repeated on a monthly basis |
|
User Experience Survey |
|
Obtain OneLab REACH active accounts list |
Immediately after OMB approval |
Administer User Experience Survey |
Immediately after OMB approval |
Analyze data and produce summary report |
1 month after OMB approval |
**Please note that this process will be repeated on a monthly basis |
|
P.A.C.E.® and non-P.A.C.E.® Evaluation Survey |
|
Obtain OneLab REACH registration and attendance lists |
Immediately after OMB approval |
Administer P.A.C.E.® and non-P.A.C.E.® Evaluation Survey |
Immediately after OMB approval |
Analyze data and produce summary report |
1 month after OMB approval |
**Please note that this process will be repeated on a monthly basis |
|
Mini Lesson and Job Aid Survey |
|
Obtain OneLab REACH active accounts list |
Immediately after OMB approval |
Administer Mini Lesson and Job Aid Survey |
Immediately after OMB approval |
Analyze data and produce summary report |
1 month after OMB approval |
**Please note that this process will be repeated on a monthly basis |
|
The display of the OMB Expiration date is not inappropriate.
There are no exceptions to the certification.
Attachment 2: OneLab REACH Post-Course Evaluation Survey
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Samuel, Lee (CDC/OID/NCEZID) |
File Modified | 0000-00-00 |
File Created | 2025-05-19 |