Sample Rapid Response Survey as submitted in the previous clearance

OMB Number 0910-0XXX

Expiration Date: XX/XX/XX

Sample A

RAPID RESPONSE SURVEY

Dear Colleague,

The Food and Drug Administration (FDA) needs your help. This survey is designed to assist FDA in understanding more fully a potentially serious medical product problem.

{SYNOPSIS OF PROBLEM GOES HERE}

(You) (Your facility) (have been) (has been) selected for this survey because (you) (your facility) (are) (is) likely to have experience using this product.

Your participation in this survey is critical. FDA believes there may be a potentially serious public health hazard and FDA must have additional information as quickly as possible. Because the number of respondents is small, each survey is vitally important in providing critical information.

Your participation in this survey is voluntary and your responses are anonymous. There is no identifying information on the survey form; therefore, your responses to the survey questions cannot be linked to the respondent list. The survey sample list will be destroyed one month following the completion date of the survey.

If you have any questions about this survey, please do not hesitate to call:

____________________________________ at (301) _____________________ Please do not identify yourself by name.

We are extremely appreciative of the time and effort involved in your participation in this important information collection. Your efforts will provide critical public health information.

Please respond by: _____________. Respondents are requested to route the survey questions and responses through the process improvement/quality improvement process in their facility to ensure the maximum input into this process.

Please feel free to respond by:

Telephone: _________________ Identify yourself as only “a respondent to the survey sent __________ date;

Fax: _________________ Do not send your institution’s cover sheet. The Office Director’s secretary will remove any identifiers your fax machine automatically assigns to the forms before giving the forms to the analysis team.

Mail: ____________________________ Use the enclosed stamped, addressed return envelope for your convenience. All return envelopes are addressed to the Office Director’s secretary. Surveys will be removed and the envelope destroyed before the results are given to the analysis team.

Questions:

A.

B.

C.

D.

Page 2 – Attachment A (Survey Form)

Please fell free to provide any other information about this topic that you believe may be useful to FDA’s analysis of the problem:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Thank you for your time and energy in aiding FDA to understand more fully this issue!

Sincerely yours,

John Q. Fed, Ph.D.

Director, Office of Postmarketing Surveillance

Center for XXXXX XXXXX xxx XXXXXXXXXX

Food and Drug Administration

Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching data sources, gathering and maintaining the data needed, and completing/reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Director, Office of Postmarketing Surveillance

HFX-XXX

5600 Fishers Lane

Rockville, MD 20857

An agency may not conduct or sponsor, and a person is not required to, a collection of information unless it displays a currently valid OMB control number. Form Approved: OMB Number 0910-0XXX, expires XX-XX-05.