0360 ss 6-20-08

Customer/Partner Customer Satisfaction Service Surveys

OMB Control Number -- 0910-0360

SUPPORTING STATEMENT

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Food and Drug Administration (FDA) is requesting that the Office of Management and Budget (OMB) extend the approval of a generic clearance that implements Executive Order 12862. This request covers:

• customer service surveys of any regulated entities such as Food Processors, Cosmetic, Drug, Biologic and Medical Device manufacturers, consumers and health professionals, and State and local governments;

• web-based, remote-user feedback surveys to assess and improve the quality of information services that FDA provides through its website.

Executive Order 12862 directs agencies that “provide significant services directly to the public” to “survey customers to determine the kind and quality of services they want their level of satisfaction with existing services.” FDA provides a wide range of services to the public and to the regulated industries.

There are two objectives for these surveys in seeking ideas from respondents on (1) their current level of satisfaction with the services and information provided by FDA and (2) their recommendations on how to improve services and information provided by FDA.

According to OMB guidelines for generic clearances for voluntary customer/partner service surveys, FDA will establish an independent review process to assure the development and implementation of high quality customer/partner service surveys within FDA. FDA will provide OMB a copy of the survey instrument for review, approval, and inclusion in the public docket.

2. Purpose and Use of the Information Collection

FDA will collect and use information gathered through this vehicle to identify strengths and weaknesses in current service provisions, including FDA’s website, and to make improvements that are practical and feasible. Information from these customer service surveys and website usability surveys will be used to plan and redirect resources and efforts to improve or maintain a high quality of service to affected publics. FDA’s website provides a variety of services to the general public, health professionals, drug and biologics companies, consumer advocates, students, medical professionals, and journalists. Website usability will be surveyed on a regular basis on different parts of FDA’s website. Information gathered from surveying website users will enable the agency to provide an effective, efficient, and satisfying experience. Timeliness, appropriateness, accuracy of information, courtesy, or problem resolution will be assessed in individual programs. If this information is not collected, vital feedback regarding customers’ satisfaction or dissatisfaction with various aspects of FDA program services, including FDA’s website, will be unavailable.

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. Customer satisfaction surveys approved under the generic clearance will only be used to obtain information for general service improvement, not for publication or for the purpose of informing significant policy or resource allocation decisions. In addition, individual collections will concern subject matter and methods that are not controversial. FDA website usability data will be collected to ensure that we have the valuable data needed to routinely revise content and reorganize important online health and consumer information in a way that is most easily understood and useful to by the website visitors.

3. Use of Improved Information Technology and Burden Reduction

As appropriate, automated information technology will be used to collect and process information for these surveys to reduce the burden on the public. Surveys will be simple with short questions.

Customer satisfaction surveys can involve written to brief questionnaires; however, website usability will be surveyed through web-based, remote user access.

For most website usability surveys the respondent will click a “radio button” or checkbox that corresponds to their response. For open-ended questions the respondent will be told to enter their answer in the provided text box. Website usability surveys will include no more than 22 questions, including no more than 4 open-ended questions.

4. Efforts to Identify Duplication and Use of Similar Information

Only limited information on customer satisfaction with FDA services, including the FDA website, has been collected in the past. In order to completely fulfill the mission of the agency, implementation of E.O. 12862 will represent collection of new information for new purposes.

5. Impact on Small Businesses or Other Small Entities

Small businesses or other small entities may be involved in these efforts, but FDA will keep the burden on them to a minimum by sampling, asking for opinions on a strictly voluntary basis, and the questionnaires will be short, user friendly and take a relatively short time to complete. Therefore, these customer satisfaction surveys will not have a significant impact on small business or other small entities.

6. Consequences of Collecting the Information Less Frequently

FDA will conduct customer satisfaction surveys only at intervals considered appropriate to measure the impact of changes because of initial satisfaction surveys and to monitor the continued level of performance. Usually, the Agency likely will conduct a satisfaction survey annually after the establishment of a baseline. Collection on a less frequent basis than annually would reduce the practical utility of the information and inhibit the programs’ ability to monitor changes.

FDA will conduct website usability surveys for specific sites on an on-going basis initially. Once a site is established, the surveys will be instituted at intervals considered appropriate to measure the impact of changes to FDA’s website, and to monitor level of performance. Without this routine collection of information FDA could experience less frequent visitors to the website. This could result in the display of information that is not useful to the user; missing vital feedback from our target audience; and a decrease in the effectiveness of dissemination of important information. We expect only one-time responses from respondents. Therefore, it is not possible to ask participants to complete the survey less frequently.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances for the collection of the information.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency

FDA programs will use routine contacts with customers and partners and other qualitative information collection activities to identify areas of interest and concern to customers and partners. FDA will utilize in-house statistical staff and the staff of contractors in developing survey plans. As needed, FDA may also utilize the statistical resources of the National Center for Health Statistics, which has a questionnaire design laboratory. As appropriate, centers will establish panels of outside experts to help in design and implementation of the surveys.

In accordance with 5 CFR 1320.8(d), on January 24, 2008 (73 FR 4234), a 60-day notice for public comment was published in the FEDERAL REGISTER. No comments were received from the public.

9. Explanation of Any Payments or Gift to Respondents

No payment or gift will be provided to survey respondents.

10. Assurance of Confidentiality Provided to Respondents

The confidentiality of respondent identification and information will be assured to the maximum extent allowed by law. Participation will be fully voluntary and, to the extent possible, responses will be anonymous. In instances where we need respondent identity (e.g., for following up of non-respondents), the information collection will fully comply with all aspects of the Privacy Act. A data collection contractor will generally maintain any identifying information, and they will not give it to the agency. Respondents will be assured that neither their participation/non-participation nor any responses to items will affect their eligibility for or receipt of any FDA receipt.

11. Justification for Sensitive Questions

No questions will be asked that are of a personal or sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

The total annual estimated burden imposed by this collection of information is 4,500 hours annually.

Estimated Annual Reporting Burden
Type of Survey	No. of Respondents	Annual Frequency per Response	Hours per Responses	Total Hours
Mail, telephone, in person, fax and web-based surveys and questionnaires	15,000	1	.30	4,500
Website usability surveys	10,000	1	.14	1,400

The total annual estimated burden imposed by this collection of information is 4,500 hours annually. FDA projects 10 customer and/or partner surveys per year, with 600 respondents per survey on average, requiring an average of 18 minutes for review/completion per respondent. Some of these surveys will be repeats of earlier surveys for purposes of monitoring customer/partner service and developing long-term data. We have allowed burden for unplanned surveys to be completed so as not to restrict the agency's ability to obtain feedback on its performance in fulfilling its mission.

It is virtually impossible to estimate how many people will respond to a request to provide voluntary feedback about their interaction with a particular FDA Web site. While FDA’s Web site, as a whole, gets [hundreds of thousands] of visitors, we have no experience with what percentage of such visitors would provide feedback. Once we have some experience with getting feedback on a specific site we will be able to extrapolate a little more confidently. At present, we intend to request feedback on one particular site that has not yet been launched. We estimate that it will take a maximum of 8 ½ minutes to complete the survey, assuming a full minute for each of 4 open-ended questions. The number of respondents is a guess at 10,000.

13. Costs to Respondents

There are no capital costs or operating and maintenance costs associated with this collection.

14. Costs to Federal Government

The postage paid postal response cards would cost the agency approximately $7,200, annually.

15. Reason for Change

FDA is requesting an increase in the number of respondents and total burden hours to accommodate a survey directed at subscribers of the publication, “FDA Consumer” and users of the FDA website.

16. Statistical Reporting

There are no tabulated results for this information collection. Customer satisfaction surveys approved under this generic clearance will not yield meaningful quantitative findings; they can provide useful customer input, but they do not yield data about customer opinions that can be generalized. Finding will be used to obtain information for general service improvement, not for publication or for the purpose of informing significant policy or resource allocation decisions.

17. Display of OMB Approval Date

We are requesting no exemption.

18. Exceptions to “Certification for Paperwork Reduction Act Submissions”

n/a

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