GenIC Request

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-1071)

TITLE OF INFORMATION COLLECTION: LLS Class of 2016 Laboratory Quality Survey

PURPOSE: To solicit feedback from the CDC laboratory community on their knowledge and perception of Laboratory Quality Management Systems (LQMS), capabilities and barriers to LQMS implementation, and preferred training delivery methods to help inform the development of a LQMS training curriculum.

LQMS is a formalized and documented system of processes, procedures, resources, and qualified technical personnel that consistently, efficiently, and effectively generates accurate, precise, and reproducible laboratory data. The LQMS defines laboratory management responsibilities at all levels of the agency for achieving agency quality objectives, maintaining compliance with regulatory requirements, meeting applicable quality standards, and promoting continual quality improvement.

DESCRIPTION OF RESPONDENTS: Anyone who is directly involved in research activities, as well as, those who work to support research operations at CDC. This includes FTEs and non-FTEs.

We estimate the maximum number of survey participants to be 1,000. Of those 1,000, we estimate 60% (600) of the respondents will be non-FTEs.

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:__Justine M. Pompey______________________________________________

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 [ ] 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

Category of Respondent	No. of Respondents	Participation Time	Burden
Individuals	600	10 min	100 hrs
Totals			100 hrs

FEDERAL COST: The estimated annual cost to the Federal government is $4,800. This represents the wages of eight LLS fellows (20 hours each; $30/hour) to design, administer, and analyze results of the survey.

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

The LLS Class of 2016 reached out to the Office of the Associate Director for Laboratory Science and Safety (OADLSS), Office of Laboratory Science (OLSci) to request assistance in identifying Quality Managers and/or quality point of contacts (POCs) located across the agency. OLSci provided the contact information for 37 individuals leading laboratory Quality Management efforts within their respective CIOs.

The LLS Class of 2016 scheduled individual meetings/calls with the quality POCs to solicit assistance in identifying research scientist and research support personnel in their CIOs. Out of the 37 quality POCs, 30 agreed in participating in the project. The 30 quality POCs represent NIOSH, NCHHSTP, NCZEID, NCIRD, NCBDDD, CSELS, and CGH and eight CDC campuses across the U.S. The quality POCs provided either a list or a total number of research scientist and research support staff as potential survey participants. This information was used to estimate the potential number of respondents.

We estimate the maximum number of survey participants to be 1,000. Of those 1,000, we estimate 60% (600) of the respondents will be non-FTEs.

Survey Monkey was the survey tool selected for data collection. A link to the survey will be forwarded to the quality POCs via e-mail for survey deployment and distribution. In addition, we will target respondents through the CDC Today Announcement and the Lab Links newsletter. We hope to achieve a high survey response rates by having the quality POCs distribute the survey directly to their own colleagues. The data collected will be quantified and analyzed used SAS.

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.

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