OMB Approval Memo

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: User Fee Website Survey

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

The Food and Drug Administration (FDA)’s Office of Financial Management (OFM), Division of User Fees (DUF), is requesting Office of Management and Budget extend the approval of a generic clearance 0910-0360 to conduct an online customer satisfaction survey of the User Fee Website (https://userfees.fda.gov/OA_HTML/fdaCCtdMinisites.jsp).

The purpose of the survey is to gauge the current level of customer satisfaction and elicit recommendations on how to improve services and information provided. Survey feedback received will help DUF identify improvement areas to optimize services to industry customers and enhance the usability of the Website.

If this information is not collected, feedback regarding customers’ satisfaction or dissatisfaction with the User Fee Website and helpdesk will be unavailable.

2. Intended use of information:

Survey data provides insights needed to improve business processes, enhance the user’s experience with the User Fee Website and increase customer satisfaction. When feasible, improvements are implemented based on feedback and comments collected in the survey.

3. Description of respondents:

Survey respondents include domestic and foreign pharmaceutical and medical device firms who use the User Fee Website to submit a cover sheet (which is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required and to help FDA track payments).

4. Date(s) to be Conducted:

Beginning October 2018

5. How the Information is being collected:

Participation in the survey is completely voluntary. Users may click on a link to initiate the survey from the User Fee Website. An online survey software, SurveyMonkey, is utilized to collect the data.

6. Confidentiality of Respondents:

Participation/non-participation is completely voluntary, and responses will not influence a respondent’s eligibility for receipt of any FDA services. All respondents, identification, and information are kept secure to the extent provided by law and will be anonymous, unless otherwise indicated. In instances where respondent identity is needed, this information collection fully complies with all aspects of the Privacy Act.

7. Amount and justification for any proposed incentive

No remuneration will be provided to survey respondents.

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

Survey respondents may voluntarily provide their name, email address and phone number at the end of the survey if they would like FDA to follow-up on the responses.

9. Description of Statistical Methods

On a weekly basis, survey data is compiled and analyzed from SurveyMonkey. Data includes the number of survey respondents and levels of satisfaction across various dimensions (Website, helpdesk and frequently asked questions).

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)
Domestic and Foreign Pharmaceutical and Medical Device Firms	829	.08	66.32

REQUESTED APPROVAL DATE: October, 2018

NAME OF PRA ANALYST & PROGRAM CONTACT:

Ila S. Mizrachi

Paperwork Reduction Act Staff

Ila.Mizrachi@fda.hhs.gov

301-796-7726

David Miller

Office of the Commissioner

Office of Financial Operations

David.Miller@fda.hhs.gov

301-796-7103

FDA CENTER: Office of the Commissioner (FDA/OC)

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