Introductory Letter

ICR ATTACHMENT D

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
Food and Drug Administration

[Date]
Dear Owner/Manager:
Your facility has been randomly selected as part of a nationwide research project designed to assess food
preparation procedures and practices specific to the various segments of the retail food industry. The
U.S. Food and Drug Administration (FDA) will use this research for identifying best practices within the
industry and directing limited resources to areas that will provide the most significant public health
benefits.
This is not a regulatory visit. Your participation is voluntary. No inspection report will be left with your
facility. This is a research project designed to focus on the implementation of food safety procedures
and practices within the retail food industry that are designed to protect the public health. The expected
length of the data collection will be 90-120 minutes. Approximate 30 minutes of the data collection will
focus on obtaining information on the nature of your operation.
Should an observation be made of a food safety procedure or practice that poses a significant public
health risk, every effort will be made to work with you to ensure that the appropriate corrective action is
taken to alleviate the hazard. Should a situation arise where a significant public health risk cannot be
resolved during the data collection, the regulatory authority that has issued your permit will be contacted
to work with you to ensure corrective action is taken.
An exit briefing will be provided at the end of the visit to discuss significant findings that may assist you
in enhancing the effectiveness of your food safety system. If significant food safety issues are
identified, they will be brought to the attention of the person-in-charge or responsible employee to
determine the appropriate corrective action based on the current FDA Food Code. Your questions
regarding the data collection process or food safety issues in general are encouraged as part of the visit
to your facility.
Your facility’s name will not appear on any reports or public documents. The research project is
designed to protect the privacy of participating establishments to the extent the law permits. The data
collected is tabulated using broad industry segments and is not associated with any specific
establishment.
FDA is responsible for providing technical assistance to approximately 75 state and territorial agencies
and more than 2,300 local departments that assume primary responsibility for working with the industry
on preventing foodborne illnesses. Beginning in 1998, FDA began collecting data related to direct
observations made of food safety practices within institutional foodservice, restaurant, and retail food
segments of the industry. From the data collected, FDA provides guidance to regulatory and industry
food safety professionals to assist them in addressing food safety issues that have the most significant
impact on protecting the public health.
FDA’s previous research studies can be accessed and downloaded from the following web link:
http://www.fda.gov/retailfoodriskfactorstudy

Public Reporting burden of this collection of information is estimated to average 180 minutes per
response for the person in charge of a Retail Food Store facility and 30 minutes for the program director
(or designated individual) of the regulatory authority. This includes the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a currently valid OMB control
number. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden to: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint, 11601 Landsdown St., North Bethesda, MD 20852
PRAStaff@fda.hhs.gov. OMB # 0910-0799 expires on August 30, 2021
Thank you for your willingness to cooperate in this important endeavor. It is through this type of
cooperative effort that government and the food service industry seek to provide safe and wholesome
food to the consuming public.
In the future, should you have any questions regarding this study or other food safety issues, please do
not hesitate to contact me at [Specialist’s phone number].
Sincerely,

Regional Retail Food Specialist