Justification Memo - FDA

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0910-0697)

TITLE OF INFORMATION COLLECTION:

Request for Qualitative Feedback Generic Clearance about FDA.gov Web Site Customer Service.

PURPOSE:

In accordance with Executive Order 12862, and in order to improve service delivery to public users of FDA.gov’s website, the Food and Drug Administration (FDA), Office of the Commissioner, Office of External Affairs, Web Communications seeks to obtain Office of Management and Budget (OMB) approval for a Generic Clearance for the collection of qualitative feedback of FDA.gov service delivery. Focus groups will be used to gather qualitative feedback on target audiences’ experience with the FDA.gov web site. This information will help improve customer service and provide insights on audience perceptions and opinions related to FDA web communications.

This collection of information is necessary to enable FDA to garner customer and stakeholder feedback in an efficient, timely manner in accordance with our commitment to improving service delivery. Obtaining feedback will help ensure that our customers have an effective, efficient, and satisfying experience with FDA.gov, highlighting any issues with service or focus attention on areas where changes to the web site might improve delivery of services. The information obtained will allow for ongoing, collaborative and actionable communications between FDA and its customers.

The feedback will be used to:

• improve content delivery to our target audiences

• suggest ways to make customer top tasks easier and more efficient

• Evaluate how well the current FDA.gov meets customer needs

• Identify potential improvements to increase customer satisfaction

Without these types of feedback about its service delivery, FDA will not have timely information to modify FDA.gov to meet customer needs. Specifically, without this data there would be:

• No customer service information to include in website design changes to ensure that the customer experience on our site is efficient, effective, and enjoyable.

• Vital feedback regarding customer and/or partner satisfaction with various aspects of FDA.gov will be unavailable.

DESCRIPTION OF RESPONDENTS:

Focus group participants will be representative members of the FDA.gov landing page target audiences: (1) Regulated Industry; (2) Consumers; (3) Scientists & Researchers; (4) Healthcare Professionals; and (5) Media & Press.

Information provided by respondents will be kept private and anonymous, except as otherwise required by law. This will be communicated to respondents prior to and at the beginning of the discussions. Respondents also will be advised of the following: the nature of the activity; the purpose and use of the data collected; FDA sponsorship (when appropriate); and the fact that participation is voluntary at all times. Because responses are voluntary, respondents will be assured that there will be no penalties if they decide not to respond, either to the information collection as a whole or to any particular questions.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[X] Focus Group [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name:____Dan Luxenberg___________________________

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [X] No

2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Yes, has an up-to-date System of Records Notice (SORN) been published? [ ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ X ] Yes [ ] No

The amount of compensation that it takes to incentivize a participant to attend a data collection session is directly proportional to his/her earning power. People drawn from more highly compensated occupations need to be paid a higher incentive. For focus groups, as opposed to individual sessions, it is typical to compensate participants at a slightly higher rate because the participants have fewer choices for session times.

The typical compensation for an average consumer would be $75 for a one hour data collection session. Healthcare professionals, legal professionals, engineers and the like would typically command twice these amounts or more.

We are planning external focus groups that will each last approximately one hour. As a result, we are proposing compensation for participants as follows:

Audience Group	Proposed Incentive
Industry	$125-$200
Consumers	$75
Health Professionals	$125-$200
Science and Research	$100
Press and Media	$75

The incentives being proposed for the present audience groups are typical of those being charged for similar user profiles industry-wide, including federal government projects. The Usability.gov website, which offers guidance on a number of aspects for planning user research projects, shows an incentive of $100 per participant for an example statement of work that calls for the recruitment of participants for both usability test sessions and focus groups. Our sub contractor, UserWorks, has a long history of recruiting participants for government projects from the above audience groups. They have recruited, screened, and scheduled thousands of participants for hundreds of federal government projects, both their own and on behalf of third parties. The participant incentive rates being proposed here for the present project are typical of those that have been approved and paid by numerous HHS agencies, including AHRQ, HRSA, the Office of the National Coordinator, CDC, NHTSA, 7 of the NIH institutes, the NIH Library, and several NIH Centers and programs, as well as past FDA projects.

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time	Burden
(1) Individuals or Households, who are target audience users of FDA.gov	39	1 hours	39 hours
(2) Private Sector, who are target audience users of FDA.gov	167	1 hours	167 hours
TOTAL			206 hours

FEDERAL COST: The estimated annual cost to the Federal government is $47,575.05

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [X] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

Respondent Universe and Sampling Methods

Data from the American Customer Satisfaction Index (ACSI) showed that FDA.gov site visitors self-identify into five main audience groups: (1) Regulated Industry; (2) Consumers; (3) Scientists & Researchers; (4) Healthcare Professionals; and (5) Media & Press. To gain a better perspective on these target audiences, FDA met with internal agency stakeholders and asked them to provide a list of external contacts for these target audiences.

Participants will be identified in several ways:

• Recruited from lists of contacts, which are aligned to the target audiences, provided by FDA staff.

• Recruited from lists drawn from appropriate professional, trade, and consumer organizations, which are aligned to the target audiences.

• Recruited from existing FDA email lists aimed at specific target audiences (GovDelivery).

Participants will be selected if they meet the following criteria:

• Self identified as a member of one of the target audiences

• Has visited FDA.gov within the past three months

• Uses FDA.gov more than twice a year

The pools of respondents will be broken out by audience type and level of experience with the site and divided into focus group participants according to those groupings.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[X] Telephone

[X] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X] Yes [ ] No

Trained facilitators will moderate the focus group in accordance with the guidance set forth in the Moderators Guide (see attached)

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Attached: Focus Group Moderator’s Guide (Appendix A below)

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