OMB Justification

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE

OF CUSTOMER SATISFACTION SURVEYS (0910-0360)

The generic clearance will only be used for customer satisfaction and website usability surveys where FDA seeks to gather information that is planned for internal use only, and can provide a justification for qualitative or anecdotal collections that may nonetheless produce useful information for program and service improvement.

TITLE OF INFORMATION COLLECTION: FDA/CTP Training Program Surveys for FDA’s Center for Tobacco Products Office of Compliance and Inspection 2012 Annual Training Conference

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

To determine the effectiveness of training provided to state contractors attending the annual conference hosted by FDA/CTP.

2. Intended use of information:

This information will be used to assess the effectiveness of the training provided by FDA and identify training areas that require improvement.

3. Description of respondents:

There is one training program survey which will be administered. Respondents to the FDA/Center for Tobacco Products Annual Program Coordinators’ Conference Survey are state contractors commissioned by FDA to oversee the tobacco retailer inspections program for the FDA.

4. Date(s) to be Conducted:

Surveys for the FDA/Center for Tobacco Products Annual Program Coordinators’ Conference will be conducted at the end of the conference in September, 2012. Tentative dates for this survey are September 12^th and 13^th, and alternative dates are September 19^th and 20^th if FDA has problems securing the initial date choices.

5. How the Information is being collected:

6. Surveys for the FDA/Center for Tobacco Products Annual Program Coordinators’ Conference will be provided during the training event, held annually.

7. Confidentiality of Respondents:

In the survey, the following statement will be provided on the survey instrument: “Your participation / nonparticipation is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.”

8. Amount and justification for any proposed incentive

N/A. There is no proposed incentive being offered for completing this voluntary survey.

9. Questions of a Sensitive Nature (Data will be kept private to the extent allowed by the law)

N/A. There are no questions of a sensitive nature being asked on either survey.

10. Description of Statistical Methods

The sample size for the FDA/Center for Tobacco Products Annual Program Coordinators’ Conference was based on the number of people expected to attend the conference. FDA will be providing the surveys to all attendees prior to the end of the conference, but expects that approximately 75% of the attendees will complete and return the surveys.

BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours):

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
FDA/CTP Annual Program Coordinators’ Conference – State Contractor	86	15	21.5
Total	86		21.5

REQUESTED APPROVAL DATE: August 6, 2012

NAME OF PRA ANALYST & PROGRAM CONTACT:

PRA Analyst Daniel Gittleson

301-796-5156

[email protected]

Program Contact Sandra Magera

301-796-9102

[email protected]

FDA CENTER: Center for Tobacco Products (FDA/CTP)

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