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GEN IC REQUEST TEMPLATE FOR
Customer/Partner Service Surveys
OMB Control Number 0910-0360


BEFORE SUBMISSION

Ensure that your Gen IC meets the requirements of the umbrella generic. This generic facilitates FDA’s ability to conduct customer satisfaction surveys and gain important feedback from all FDA-regulated industries. Feedback from these collections is intended to provide insights into customer or stakeholder perceptions, experiences, and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services.

All documents submitted with this gen IC should indicate FDA sponsorship and display the current OMB approval expiration date.

HOW TO USE THIS TEMPLATE

This template utilizes fill-in enabled text form fields. Simply click on the shaded text and enter your narrative.

United States Food and Drug Administration
Generic Clearance: Customer Satisfaction Surveys
OMB Control Number 0910-0360
Gen IC Request for Approval

Title of Gen IC: Provide the name of the collection of information that is the subject of the request followed by your center in parentheses.
    1. Statement of Need
Provide a brief description of the purpose of this collection.

    2. Intended Use of the Information

Indicate how the information will be used.
    3. Description of Respondents

Describe participants/respondents. 

    4. How the Information is Collected

Describe the method of collection (e.g., web-based, telephone, social media) and who (e.g., contractor) will conduct.

    5. Confidentiality of Respondents

Describe any assurance of confidentiality provided to respondents.

[You may provide this statement on your survey instrument]: “Your participation / nonparticipation is completely voluntary, and your responses will not affect your eligibility to receive 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.”

    6. Amount and Justification for Proposed Incentive

This generic allows for an incentive of up to $40 for in-person interviews or hard to reach respondents. Please provide justification if an incentive is requested. 

    7. Questions of a Sensitive Nature

Describe and provide justification.

    8. Description of Statistical Methods

Describe sample size and method of selection.

    9.  Burden

    10. Replace the content of the example table below with the estimated burden for this gen IC.

Participation time may be in the format of hours or minutes (use a decimal) and indicated in the heading. 

Burden Hour Computation: Number of Respondents multiplied by participation time = total burden hours. Data in all fields of the table must be entered, including totals. 

Generally we do not screen respondents for customer satisfaction surveys. However, if your gen IC employs a screener be sure not to double count respondents. A screened respondent and the respondent completing the survey is counted as 1 because they are the same person. Round up to whole numbers for the total burden hours; do not use decimals. Delete this italicized instruction prior to submission.

Example:

Type of information collection/Category of Respondent
No. of Respondents
Participation Time (minutes)
Total Burden (hours)
Website Satisfaction Survey
1,000
5 (.08)
80
Email Communication Survey
500
5 (.08)
40
Total
1,500
---
120

    11. Date(s) to be Conducted

Insert date(s) and locations, if applicable.

    12. Requested Approval Date

Insert date if shorter than 10 day turn-around time as noted in the SSA. Otherwise use the month and year, only, allowing for a 30 day review time at APRA.

    13. FDA Contacts

Program Office Contact
FDA PRA Contact
Insert name, email
Enter program office
Enter center
Insert name, email
Paperwork Reduction Act Staff
Office of Enterprise Management Services
Office of Operations