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 State Tobacco Compliance Check Inspection Training Program and FDA/Center for Tobacco Products/Annual Program Coordinators’ Conference

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

To determine the effectiveness of training provided to state contractors performing inspections for FDA tobacco retailer program and 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 are two similar training program surveys which will be administered. Respondents to the FDA State Tobacco Compliance Check Inspection Training Program Survey are state contractors commissioned by FDA to oversee and perform tobacco retailer inspections for the FDA program. 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 State Tobacco Compliance Check Inspection Training Program will be conducted at the end of each training session, from August 2011 thorough August 2012, as state contractors are commissioned by FDA to oversee and perform tobacco retail inspections for the FDA program.

Surveys for the FDA/Center for Tobacco Products Annual Program Coordinators’ Conference will be conducted at the end of the conference in September, 2011.

5. How the Information is being collected:

Surveys for the FDA State Tobacco Compliance Check Inspection Training Program will be provided to participants upon completion of training and six months after beginning inspections either in person or electronically.

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

6. Confidentiality of Respondents:

In both surveys, 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.”

7. Amount and justification for any proposed incentive

There is no incentive being offered for completing this voluntary survey.

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

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

9. Description of Statistical Methods

The sample size for the FDA State Tobacco Compliance Check Inspection Training Program was based on the number of state contractors who may be participating in the program as submitted in the contract. The surveys will be sent out to the contractors approximately 4 months after they’ve started performing inspections to determine if the training was retained and effective for the inspectors to do their job. FDA will send this survey to all inspectors who have completed the training; however, it is anticipated that only 75% of the inspectors will respond.

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 State Tobacco Compliance Check Inspection Training Program – State Contractors	600	25	250
FDA/CTP Annual Program Coordinators’ Conference – State Contractor	45	15	11
Total	645		261

REQUESTED APPROVAL DATE: August 1, 2011

NAME OF PRA ANALYST & PROGRAM CONTACT:

PRA Analyst Daniel Gittleson

301-796-5156

[email protected]

Program Contact Shawnte Adams

301-796-7277

[email protected]

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

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