Request for Approval

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-0974)

TITLE OF INFORMATION COLLECTION:

Good Laboratory Practices for Biochemical Genetic Testing Preanalytic Phase eLearning Course Learner Feedback Survey

PURPOSE:

The Division of Laboratory Systems (DLS) at the Centers for Disease Control and Prevention (CDC) developed a basic-intermediate level elearning course with educational content relevant

to laboratory scientists working in biochemical genetic testing or reference laboratories, and healthcare professionals who order biochemical genetic tests. This eLearning course is offered free of charge and hosted on CDC TRAIN.

An email invitation to complete the Good Laboratory Practices for Biochemical Genetic Testing Preanalytic Phase eLearning Course Learner Feedback voluntary survey will be sent to learners designated by CDC TRAIN as having completed all components the course during FY2018. The email invitation will include clickable links to either proceed to the survey or unsubscribe (opt out.) Learners may also opt out by not responding to the email. If learners click the link to begin the survey in the email, they will link to a Survey Monkey webpage housing the survey.

The information to be collected aims to understand to what extent the learners are able to use the content of the courses in their work settings. The survey questions will take approximately 10 minutes to complete. Responses will be anonymous and no unique identifying information will be sought or kept. The feedback we receive will be used by our program in aggregate only. The learner feedback will help the continuous quality assurance of our instructional design process and inform updates to these courses in alignment with learner’ needs. Learner feedback will provide valuable insight on the instructional design of this eLearning course, which includes relevance and applicability of content.

DESCRIPTION OF RESPONDENTS:

This is a voluntary survey to collect information from the learners who completed the Good Laboratory Practices for Biochemical Genetic Testing eLearning Course. These learners included laboratory scientists working in laboratory scientists working in biochemical genetic testing or reference laboratories, and healthcare professionals who order biochemical genetic tests.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ x ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[ ] Focus Group [ ] Other: ______________________

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. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name:____Collette Leaumont Fitzgerald, PhD ____________________________________

To assist review, please provide answers to the following question:

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 [X ] (No Not Applicable)

Gifts or Payments:

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

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time	Burden
Individuals and households	0
Private sector	140	10/60	23.3
State, local, tribal government
Federal government	0
Totals	140	10/60	23.3

FEDERAL COST: The estimated annual cost to the Federal government is $300_________

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?

[x ] Yes [] 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?

• This is a voluntary follow-up user feedback survey to be sent to learners who completed all required components for the Good Laboratory Practices for Biochemical Genetic Testing Preanalytic Phase eLearning Course. Completion status is assigned by CDC TRAIN when all components have been accomplished. We anticipate that these learners include healthcare providers and laboratory scientists from clinical, reference, university and public health settings. These learners will voluntarily participate in the survey administered through Survey Monkey. Responses will be anonymous and no unique identifying information will be sought or kept.

Administration of the Instrument

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

[ x] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

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

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

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the request. (e.g., Comment card for soliciting feedback on xxxx)

PURPOSE: 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: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

TYPE OF COLLECTION: Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

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.

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: Provide the Annual burden hours: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Provide an estimate of the annual cost to the Federal government.

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.

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

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