Abbreviated Supporting Statement

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: CDRH Customer Satisfaction Survey

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

One of CDRH’s 2014/2015 Strategic Priorities is to Provide Excellent Customer Service.  We developed our “Standards of Excellence” and are working to assure all of CDRH understands and interacts with our stakeholders with these standards in mind.  CDRH needs a tool to gather satisfaction levels of our stakeholders both inside FDA/CDRH and external, including the medical device industry, academia, patient groups, health professionals, consumers and anyone else that interacts with CDRH.  A voluntary Customer Satisfaction Survey will allow us to collect data to 1) determine existing customer satisfaction; 2) track trends around specific areas of satisfaction or dissatisfaction, 3) gather feedback on our processes allowing us to assess and improve them and 4) to determine the areas where we need to educate our staff on how to provide excellent Customer Service.

Attached is a link to CDRH’s 2014/2015 Strategic Priorities, specifically “Provide Excellent Customer Service” which is posted on the FDA internet site:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/ucm384132.htm#service

Also attached is a link to the CDRH Customer Service Standards of Excellence:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm384176.htm

               

2. Intended use of information:

CDRH will collect data from our internal and external stakeholders to 1) determine existing customer satisfaction; 2) track trends around specific areas of satisfaction or dissatisfaction, 3) gather feedback on our processes allowing us to assess and improve them and 4) to determine the areas where we need to educate our staff on how to provide excellent Customer Service.  We will share the “overall” CDRH customer satisfaction level with our staff on a monthly basis and with the public every 6 months via the FDA website.  

3. Description of respondents:

Respondents would volunteer to take the survey and would include stakeholders both internal and external to CDRH/FDA, including the medical device industry, academia, patient groups, health professionals, consumers, other federal agencies and anyone else that interacts with CDRH and wants to provide feedback about our customer service performance via our survey tool on the web.

4. Date(s) to be Conducted:

Beginning April 2014 and ongoing thereafter

5. How the Information is being collected:

The information will be electronically collected based on business interactions conducted with CDRH. We will use an electronic survey (Survey Monkey).  It will be made available on the FDA.Gov website, on email salutations of CDRH staff, on CDRH meeting agendas, posted in CDRH conference rooms, added to CDRH Staff Presentations to the public and included in selected CDRH public communications.

6. Confidentiality of Respondents:

All information collected by CDRH will be kept confidential. In instances where respondent identity is provided by the respondent (e.g., for follow-up of non-respondents), this information collection will fully comply with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.

CDRH will include the following statement on the survey instrument and/or instructions:

“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

None

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

None

9. Description of Statistical Methods

The information will be electronically collected based on business interactions conducted with CDRH. We will use an electronic survey (Survey Monkey).  It will be made available on the FDA.Gov website, on email salutations of CDRH staff, on CDRH meeting agendas, posted in CDRH conference rooms, added to CDRH Staff Presentations to the public and included in selected CDRH public communications.

Given this type of voluntary customer initiated satisfaction survey, statistical methodology such as Sampling Methods and Methods to Maximize Response Rates and Non-response were not considered. However CDRH did pretest the survey instrument with CDRH staff.

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

We anticipate receiving about 1,500 surveys annually from internal CDRH Staff and 6,000 surveys annually from external stakeholders for a total of 7,500 surveys a year. There are 9 questions in the survey and we expect it to take approximately 10 minutes to take.

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
Individuals or households, Private Sector State, Local, or Tribal Governments, Federal Government Business or other for-profits, Not-for-profit institutions	7,500	10	1,250

REQUESTED APPROVAL DATE: March 31, 2014

NAME OF PRA ANALYST & PROGRAM CONTACT: John Burke and Lynne Rice

FDA CENTER: CDRH

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