Justification 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: Evaluation of the 20.88 Single Signature Long-Term Information Sharing Agreement

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

The 20.88 Single Signature Long-Term Food Information Sharing Agreement is a five year confidentiality agreement between State/local authorities and FDA that facilitates the rapid exchange of non-public food information (including feed and cosmetics). Efficient information-sharing between FDA and State/local governments is a critical component in protecting and promoting public health. An evaluation of the 20.88 Single Signature Food Agreement following one year of implementation is necessary in order to assess utilization and satisfaction among participating State/local agencies.

The solicitation of feedback will target areas such as: difficulty with sign up process, appropriateness of content, and efficiency of service delivery. Responses will be assessed and used internally to improve or maintain the quality of the information sharing service offered. If this information is not collected, vital feedback on the success and utilization of the agreement after one year will be unavailable as the agreement continues in the future, expiring in 2019.

2. Intended use of information:

Since the implementation of the 20.88 Single Signature Food Agreement in July 2014, no feedback from the participating State/local agencies has been obtained. To address this need, a customer satisfaction survey was created to ensure these services continue to fulfill the State/local agency’s needs as well as identify any opportunities for improvement.

3. Description of respondents:

Current state/local agencies that are signatories to 20.88 Single Signature Long-Term Food Agreements as found on FDA’s intranet site: Inside.FDA - Single Signature FOOD will be surveyed. Since the agency contact listed on the site may not be the most appropriate survey participant, the agency contact will be asked to forward the survey to the most appropriate contact in their state or region that is heavily involved in making information sharing requests to FDA. Respondents’ positions within their State/local agency and the type of agency surveyed will vary (i.e. state health agency, university, agricultural agency).

4. Date(s) to be Conducted:

Pending OMB clearance, it is anticipated that the survey will be opened sometime in the next several weeks and remain open for 3 weeks.

5. How the Information is being collected:

The Program Evaluation Branch (PEB) of FDA’s Office of Regulatory Affairs (ORA), Division of Planning, Evaluation, and Management (DPEM) will email the survey link to participating State/local agencies. The survey will be administered electronically using SurveyMonkey. Survey Monkey will also be used to analyze the data collected in the survey. A reminder email will be sent to agencies after one week of survey availability to increase the survey’s response rate.

6. Confidentiality of Respondents:

PEB will survey current signatories of 20.88 Single Signature Long-Term Food Agreements. As the agencies who participate in this agreement are not listed on FDA’s public page, the participants will be kept anonymous from each other as well as within data reporting. Survey participation and any resulting responses will not have an effect on future receipt of any FDA services. PEB will not collect respondent identity (name, contact info).

We will include this statement in our survey instrument:

“Your participation / nonparticipation is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services.” 

7. Amount and justification for any proposed incentive

FDA/ORA/DPEM/PEB will not provide payment or other incentives to participants.

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

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

The survey will ask for demographic information (e.g. position title, location [state] of agency). The survey will not ask for respondent’s name or contact information. Survey will ask for information concerning the 20.88 request process and satisfaction with information delivered from FDA. Survey participation is voluntary and any information provided by respondents will be kept private and anonymous, except as otherwise required by law.

9. Description of Statistical Methods

PEB intends to use Survey Monkey (www.surveymonkey.com) to analyze survey results. Analysis will include frequency distributions and summary statistics.

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)
Web-based surveys	100	.17 (10 minutes)	16.7

REQUESTED APPROVAL DATE: 12/4/15

NAME OF PRA ANALYST & PROGRAM CONTACT:

Ila S. Mizrachi

Paperwork Reduction Act Staff

[email protected]

(301) 796-7726

Christina Czabaranek

Program Evaluation Branch

[email protected]

(240) 402-3440

Lacreisha Ejike-King

Program Evaluation Branch

[email protected]

(240) 402-2633

FDA CENTER: Office of Regulatory Affairs | Office of Policy and Risk Management | Division of Planning, Evaluation, and Management | Program Evaluation Branch

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