GUIDANCE DOCUMENT

Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Adminstration Amendments Act of 2007 - Appendix September 2009

Final

Docket Number:: FDA-2009-D-0260
Issued by:: Guidance Issuing Office

Center for Food Safety and Applied Nutrition

Contains Nonbinding Recommendations

September 2009

V. Appendix: Instructions for Completing the Reportable Food Registry Report

Return to Main Guidance Document or to the Reportable Food Registry home page

OVERVIEW

This document is intended to provide step-by-step instructions to responsible parties and public health officials on how to submit reports regarding instances of reportable food to FDA via the Reportable Food electronic portal in order to comply with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085, section 1005).

The Reportable Food electronic portal collects information in six sections, as described below:

Introduction - questions regarding the type of report you are submitting.
Responsible Party Information - questions regarding the identity of the Responsible Party and the identity of the individual submitting the report.
Location of Reportable Food - questions regarding the facility where the reportable food problem was first identified, as well as contact information for individuals and entities that can provide additional information about the reportable food.
Problem Origination Site - questions about the location that is the suspected or known source of the problem. The Problem Origination Site may or may not be a facility owned by your firm. You will see this section if you indicate that you know where the problem originated. If you indicate that you know where the problem originated and that the Problem Origination Site is the same as the Location of Reportable Food, this information will be pre-populated for you.
Product Problem - questions about the reportable food and its supply chain, where applicable:
- Description of the Problem - questions about the discovery of the reportable food problem and description of the problem.
- Received Product Information - if you indicate that you received reportable food, you will see questions about reportable food you received and its supplier(s).
- Distributed Product Information - if you indicate that you distributed reportable food, you will see questions about outbound shipments of reportable food you distributed and its recipient(s).
- Product Information - if you indicate that you are not ready or required to report supply chain information, you will see questions about reportable food you manufactured, processed, packed, or held.
Submit Report and Confirmation - this section provides an opportunity to review your report before submission, instructions for attaching supplemental information to accompany your report, and assigns an FDA-issued unique identifier number (also known as an Individual Case Safety Report number (ICSR), or ICSR number) with which to identify your report.

FDA wants to be sure we have all the necessary information to follow up on the reportable food instance you are reporting. Although optional information is not required for report submission, we encourage you to provide as much information as you can to assist in our investigation of the problem.

You can move back and forth between sections of the electronic portal, however, you must complete all required fields on each page to proceed. The ‘Return to Previous Page' button allows you to navigate backwards without having to fill in the required fields. There is no save function in this application and the system will time-out if it sits idle for more than 30 (thirty) minutes.

All required questions in all sections must be answered prior to submitting the report.

SECTION 1: Introduction

(Note: Asterisk, *, beside a question or sub-question indicates a required field)

The questions in the Introduction section enable us to generate the correct set of questions for your reporting situation.

1.1 Are you required by law to submit a report about a reportable food? *

If you are a Responsible Party (a person who submits a facility registration under section 415(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d] who is required by law to submit a report regarding an instance of reportable food to FDA through the electronic portal), select "Yes." If you are a Federal, State, or local public health official submitting a voluntary report, select "No." If you do not fall into one of these two categories, you should not submit a reportable food report through the electronic portal. Instead, please contact the FDA District Office consumer complaint coordinator serving your geographic area to report a problem.

Note that if you are a Federal, State, or local public health official, on the following screens you will see a report that differs in some ways from the mandatory report. For example, you will not see some questions and/or sections of the report described here, and some questions will appear but will be worded differently. Federal, State, and local public health officials may choose not to complete any question, even those questions marked with an asterisk. For example, for an asterisked question requesting a text response, you could answer "NA," "Information not available," or a similar response. If you are unable to proceed through the report because you cannot answer a required question, please contact your local FDA District Office for assistance.

1.2 Type of Submission *

Indicate whether this is your initial report or an amended report. If you indicate that this is an amended report, questions 2a, 2b, and 2c on your screen also apply to you.

1.2.1 ICSR number from initial report *

Enter the ICSR number that was provided to you when you submitted your initial report.
1.2.2 Is this amended report in response to an FDA request for additional information?

Indicate Yes, No, or I don't know.
1.2.3 Reason for amended report:

Select all the reasons why you are submitting an amended report. You may select more than one option. You should select "additional information" if you are submitting new information not included in your initial report; "correction" if you are submitting information that is different from what was included in your initial report; "nullification" if you are indicating that your initial report was submitted in error; and/or "product evaluation" if you are submitting additional information based on research or analysis to confirm or identify a product problem.

Click the "Continue" button to begin your report. As you proceed through the report, you can click the "Continue" button to proceed to the next page or "Return to the Previous Page" if you want to go back. When you click the "Continue" button any required information that is missing will be flagged.

SECTION 2: Responsible Party Information

2.1 Responsible Party's Organization Name

2.1.1 Responsible Party's Organization Name*

This is the organizational name of the responsible party. For Federal, State, and local public health officials, this question appears as Reporter's Organization Name and should be completed with the name of your own organization.
2.1.2 Registration/Identifier Type and ID

The required registration/identifier type is your Food Facility Registration Number (FFRN). More information on how to register for this number is available at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006832.htm
- Food Facility Registration Number*
If you have additional identifier numbers of the types listed below, please provide the corresponding ID number in the space provided. These additional numbers are not required.
- Federal Establishment Inventory Number (FEI)
- Data Universal Numbering System (DUNS) Number
- Food Canning Establishment Number
2.1.3 Type of Organization

Select the various establishment types which apply to your organization.
2.1.4 Country Location of Responsible Party*

Select the Responsible Party's country from the drop down list of countries. For Federal, State, and local public health officials, this question appears as Reporter's Country and should be completed with your own country.

2.2 Responsible Party Information

2.2.1 Street Address

Enter the number and street name of the Responsible Party's physical address, and other information as necessary. Do not enter Post Office Box address information in this field. For Federal, State, and local public health officials, this question refers to the reporter's street address and should be completed with your own address.
2.2.2 City/Town *

Enter the city/town of the Responsible Party's physical address. For Federal, State, and local public health officials, this question refers to the reporter's city/town and should be completed with your own city/town.
2.2.3 State (State/Province if not in the United States)*

Select the Responsible Party's state from the drop down list. If you are not located in the United States, this question will appear as State/Province. For Federal, State, and local public health officials, this question refers to the reporter's state and should be completed with your own state.
2.2.4 ZIP Code (Postal Code if not in the United States)*

Enter the ZIP Code of the Responsible Party's physical address. If you are not located in the United States, your question will appear as Postal Code. If your country does not use postal codes, enter "NA" in this field. For Federal, State, and local public health officials, this question refers to the reporter's ZIP code and should be completed with your own ZIP code.
2.2.5 First Name of the Individual Submitting this Report

Enter your first name.
2.2.6 Last Name of the Individual Submitting this Report

Enter your last name.
2.2.7 Email Address

Enter your email address, or if different, the email address of the Responsible Party's primary contact person, and re-enter the same email address to confirm that it is correct. Federal, State, or local public health officials should enter their own email address. FDA will use the email address entered in response to this question to send you an electronic copy of your reportable food report and to contact you, if necessary.
2.2.8 Primary Phone

Enter your primary telephone number, or if different, the primary telephone number (and extension, if applicable) for the Responsible Party's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact you. Federal, State, and local public health officials should enter their own primary telephone number.
2.2.9 Other Phone

Enter a secondary telephone number and extension for you, or if different, the Responsible Party's primary contact person, if applicable. Federal, State, and local public health officials should enter their own secondary telephone number.
2.2.10 Fax

Enter a fax number for you, or if different, the Responsible Party's primary contact person. Federal, State, and local public health officials should enter their own fax number.
2.2.11 Is this location the same as the Location of Reportable Food? * (The Location of Reportable Food is the location of the reportable food within the responsible party's organization or company.)

Select Yes, No, or Unknown. The Location of Reportable Food may or may not be same as the location of the Responsible Party, but it is a location within the Responsible Party's organization/company. For example, for a large food company, corporate headquarters may be the Responsible Party, but the Location of Reportable Food may be a different facility that manufactured, processed, packed, or held the food. If the Responsible Party still has the reportable food, the Location of Reportable Food is the physical location of the reportable food at this time. If the Responsible Party has distributed all of the Reportable Food, the Location of Reportable Food is the physical location of the reportable food when it was within the control of the Responsible Party.
2.2.12 Is the contact person for the Location of Reportable Food the same as the Responsible Party contact person?

Select Yes or No.

SECTION 3: Location of Reportable Food

The Location of Reportable Food is the location of the reportable food within the responsible party's organization or company.

3.1 Location of Reportable Food (first screen)

3.1.1 Location of Reportable Food Site Name: *

This is the organizational name of the food or feed facility for which the Responsible Party is submitting a report. The Location of Reportable Food may or may not be same as the location of the Responsible Party, but it is a location within the Responsible Party's organization/company. For example, for a large food company, corporate headquarters may be the Responsible Party, but the Location of Reportable Food may be a different facility that manufactured, processed, packed, or held the food. If the Responsible Party still has the reportable food, the Location of Reportable Food is the physical location of the reportable food at this time. If the Responsible Party has distributed all of the Reportable Food, the Location of Reportable Food is the physical location of the reportable food when it was within the control of the Responsible Party.

For Federal, State, and local public health officials, the Location of Reportable Food is the entity that is the current manufacturer, processor, packer or holder of the food to the best of your knowledge.
3.1.2 Registration/Identifier Type and ID

The required registration/identifier type is the Location of Reportable Food's Food Facility Registration Number (FFRN). More information on how to register for this number is available at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006832.htm
- Food Facility Registration Number*
If the Location of Reportable Food has additional identifier numbers of the types listed below, please provide the corresponding ID number in the space provided. These additional numbers are not required.
- Federal Establishment Inventory Number (FEI)
- Data Universal Numbering System (DUNS) Number
- Food Canning Establishment Number
3.1.3 Type of Organization

Select the various establishment types which apply to the Location of Reportable Food.
3.1.4 Location of Reportable Food Country*

Select the country of the Location of Reportable Food from the drop down list of countries.

3.2 Location of Reportable Food (second screen)

3.2.1 Street Address

Enter the number and street name of the Location of Reportable Food's physical address, and other information as necessary. Do not enter Post Office Box address information in this field.
3.2.2 City/Town *

Enter the city/town of the physical address of the Location of Reportable Food.
3.2.3 State (State/Province if not in the United States) *

Select the state of the Location of Reportable Food from the drop down list. If the Location of Reportable Food is not in the United States, this question will appear as State/Province.
3.2.4 ZIP Code (Postal Code if not in the United States)*

Enter the ZIP Code of the physical address of the Location of Reportable Food. If the Location of Reportable Food is not in the United States, this question will appear as Postal Code.
3.2.5 Title of the Site Contact Person (Title of the Site US Agent if not in the United States)

Enter the organizational title of the Location of Reportable Food's primary contact person. If the Location of Reportable food is not located in the United States, this question will appear as Title of the Site US Agent.
3.2.6 First Name of the Site Contact Person (First Name of US Agent if not in the United States)

Enter the first name of the Location of Reportable Food's primary contact person. If the Location of Reportable Food is not located in the United States, this question will appear as First Name of US Agent.
3.2.7 Last Name of the Site Contact Person (Last Name of US Agent if not in the United States)

Enter the last name of the Location of Reportable Food's primary contact person. If the Location of Reportable Food is not located in the United States, this question will appear as Last Name of US Agent.
3.2.8 Email Address

Enter the email address of the Location of Reportable Food's primary contact person, and re-enter the same email address to confirm that it is correct.
3.2.9 Primary Phone

Enter the primary telephone number (and extension, if applicable) for the Location of Reportable Food's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the Location of Reportable Food.
3.2.10 Other Phone

Enter a secondary telephone number for the Location of Reportable Food's primary contact person, if applicable.
3.2.11 Fax

Enter a fax number for the Location of Reportable Food's primary contact person.
3.2.12 Do you know where the problem originated? *

This question asks whether you know or suspect where the reportable food problem initially started. This site may be within your organization or outside your organization. Select Yes, No, or Unknown.

3.2.12.1 If yes, did the problem originate at the Location of Reportable Food? *

If you selected Yes in response to the previous question (12), select Yes or No in response to this question (12a).

SECTION 4: Problem Origination Site

The Problem Origination Site is the site at which the reportable food problem originated. You will see this section if you indicated that you know where the problem originated. If you indicated that you know where the problem originated and that this location is the same as the Location of Reportable Food, the fields will be pre-populated with information that you previously entered regarding the Location of Reportable Food.

Please provide any additional information you might have about the Problem Origination Site to help the FDA respond to this reportable food report.

4.1 Problem Origination Site (first screen)

4.1.1 Problem Origination Site Name

Enter the organizational name of the site at which the problem originated or is suspected to have originated.
4.1.2 Type of Organization

Select the various establishment types which apply to the Problem Origination Site.
4.1.3 Problem Origination Site Country

Select the Problem Origination Site's country from the drop down list of countries.

4.2 Problem Origination Site (second screen)

4.2.1 Street Address

Enter the number and street name of the Problem Origination Site's physical address, and additional information as necessary. Do not enter Post Office Box address information in this field.
4.2.2 City/Town

Enter the city/town of the physical address of the Problem Origination Site.
4.2.3 State

Select the state of the Problem Origination Site from the drop down list. If the Problem Origination Site is not in the United States, this question will appear as State/Province.
4.2.4 ZIP Code

Enter the ZIP Code of the physical address of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as Postal Code.
4.2.5 Title of the Site Contact Person

Enter the organizational title of the primary contact person of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as Title of the Site U.S. Agent.
4.2.6 First Name of Site Contact Person

Enter the first name of the primary contact person of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as First Name of Site U.S. Agent.
4.2.7 Last Name of Site Contact Person

Enter the last name of the primary contact person of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as Last Name of Site U.S. Agent.
4.2.8 Email Address

Enter the email address of the Problem Origination Site's primary contact person, and re-enter the same email address to confirm that it is correct.
4.2.9 Primary Phone

Enter the primary telephone number (and extension, if applicable) for the Problem Origination Site's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the Problem Origination Site.
4.2.10 Other Phone

Enter a secondary telephone number for the Problem Origination Site's primary contact person, if applicable.
4.2.11 Fax

Enter a fax number for the Problem Origination Site's primary contact person.

SECTION 5: Product Problem

In this section, you will provide a description of the product problem, including how it happened and when you learned of the problem. You will be asked to provide information about the origination and distribution of the reportable food. You will also be asked to provide additional details to enable FDA to fully understand the problem and investigate the report.

If you do not have all the details at this time, you may submit an amended report as soon as you have more information using the FDA-supplied ICSR number you will receive after submitting this report.

5.1 Product Problem (first screen)

5.1.1 Does your organization have an internal identifier corresponding to this reportable food report?

Please enter your organization's assigned number or code used to identify this report internally, if applicable.
5.1.2 Date the article of food was determined to be a reportable food. *

Enter the date you determined that the food was a reportable food. The date format is MM/DD/YYYY. For Federal, State, and local public health officials, enter the date you suspected the food to be a reportable food.
5.1.3 How the Location of Reportable Food first learned about the problem. *

Please select one of the two options that determine how the Location of Reportable Food first learned about the product problem. You should select "Notification by another firm in the supply chain" if a responsible party who is registered under section 415(a) of the Federal Food, Drug, and Cosmetic Act and has previously filed a reportable food report contacted you and provided you with an FDA-issued ICSR number for linkage to a previous report(s). You should select "Self discovery or other" if you learned about the problem in any other way.
1. 5.1.3.1 If you select "Notified by another firm in the supply chain," you will be prompted to provide answers to the questions below.Who notified you?
  
  Please enter the name of the other firm in the supply chain that notified you about the reportable food.
2. 5.1.3.2 Date notified.
  
  Please enter the date (in MM/DD/YYYY format) on which the other firm notified you about the reportable food.
3. 5.1.3.3 What is the FDA-issued ICSR number for this product problem provided by the site that notified you? *
  
  Enter the FDA-issued ICSR number that you received from the firm that notified you about the reportable food.

5.2 Product Problem Narrative (second screen)

On this screen, you should describe the sequence of events that have occurred in connection with this instance of reportable food, including, as applicable: a detailed description of the discovery, investigation (if any), and disposition of the reportable food. This description should answer the questions "who, what, where, when, and how," regarding the instance of reportable food, and should include anything else FDA should know that was not asked for elsewhere. Four open text boxes have been provided. You must enter information in at least one of the four text boxes. If you do not have information to enter in the other boxes, please enter "NA".

5.2.1 Describe the problem *

Enter a clear description of the problem that includes the "who, what, where, when, and how" of what happened. If known, include what the problem is, how it happened, any contributing factors, and how long the problem has been occurring. If known, specify if the problem involves biological, physical, radiological or chemical adulteration.
5.2.2 Describe any investigations in progress and any available investigation results *

Enter information about the ongoing investigation and any results or conclusions at this point.
5.2.3 Describe the current status *

Provide a description of the current status of the instance of reportable food, including what is being done to contain or dispose of any affected products.
5.2.4 Other relevant details *

Provide any other relevant details you believe will assist the FDA in responding to this instance of reportable food.
5.2.5 Do you believe the problem was intentionally caused? *

Select Yes, No, or Unknown.
5.2.6 Has a human adverse event(s) been reported? *

Select Yes, No, or Unknown.

If yes, please provide a narrative including, if known, the number of affected individuals, symptoms, lab results, and date/time of onset relative to product consumption. To protect patient privacy, do not provide personally-identifiable information; instead, the responsible party should assign a code (e.g., the patient's initials) to each adverse event. The assigned code will permit the responsible party to cross-reference identifying information and contact information for the patient in the event that the responsible party needs to follow up.
5.2.7 Has an animal adverse event(s) been reported? *

Select Yes, No, or Unknown.

If yes, please provide a narrative including, if known, the number of affected animals, symptoms, lab results, and date/time of onset relative to product consumption.

5.3 Product Problem - Supply Chain Information

5.3.1 Select one site in the supply chain for the reportable food. What is your relationship to the site? *

Your answer to this question describes the relationship between your facility and the other firm/site. You can either choose to describe your relationship with firms in the supply chain by indicating that you receive or distribute products to those firm(s) or you can indicate that you are not ready or required to report supply chain information. Select one of the following:
- You received reportable food from the other firm/site. If you select this option, you should specify the supplier firm and the product in the next two questions. Then you will see additional questions regarding the received product and your supplier(s).
- You distributed reportable food to the other firm/site. If you select this option, you should specify the recipient firm and the product in the next two questions. Then you will see additional questions regarding the distributed product and your recipient(s).
- You are not ready to report supply chain information or are not required to report this information. If you select this option, you must still identify the product, but you will not need to report supplier or recipient information in order to complete your report.
5.3.2 Organization Name

Please enter the organizational name of the firm/site from which you received products or to which you distributed products.
5.3.3 Product Name *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself.

If you indicated that you received products from a site, you will see the following screens and questions in section 5:

5.4 Received Product Information

5.4.1 Name of Received Product *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself. This portal only collects data for one site/product at a time. If there is more than one site from which you have received reportable food, you will be given the opportunity to add information after completing this entry.
5.4.2 Received From

Enter the name of the organization that supplied the product to you.
5.4.3 Did the company entered in question 2 (4.4.1.2) notify you of this product problem?

Please select either Yes or No. If yes, provide the date you were notified of the reportable food by the other company. The date format is MM/DD/YYYY.
5.4.4 Universal Product Code (UPC)

Enter the actual UPC code on the package here.
5.4.5 Product Group *

Select the product group from the drop down list.
5.4.6 Intended Product Use *

Select the intended product use from the drop down list.
5.4.7 Was product imported?

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted to select the Country of Origin and the Port of Entry from their respective drop down lists.
5.4.8 Was the product recalled? *

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted for the FDA Recall Number, if known.
5.4.9 Package Category

Select the food package category: Bulk, Retail, or Institutional.
5.4.10 Container Type

Please select the container type from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.
5.4.11 Container Size

Please enter the container size and select the unit of measure from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.
5.4.12 Number of Lots or Batches of Reportable Food Received

Enter the total number of lots or batches of the reportable food that you received from the organization that distributed the product to you.

5.5 Supplier Information (Continued) (first screen)

5.5.1 Supplier Type of Site

Select the various establishment types which apply to your supplier's site.
5.5.2 Supplier's Country

Select the supplier's country from the drop down list of countries. The United States is the default country.

5.6 Supplier Information (Continued) (second screen)

5.6.1 Supplier's Street Address

Enter the number and street name of the supplier's physical address, and other information as necessary. Do not enter Post Office Box address information in this field.
5.6.2 Supplier's City/Town

Enter the city/town of the supplier's physical address.
5.6.3 Supplier's State

Select the supplier's state from the drop down list. If the supplier is not in the United States, this question will appear as Supplier's State/Province.
5.6.4 Supplier's ZIP Code

Enter the ZIP Code of the supplier's physical address. If the supplier is not in the United States, this question will appear as Supplier's Postal Code.
5.6.5 Contact Person Title

Enter the organizational title of the supplier's primary contact person.
5.6.6 Contact First Name

Enter the first name of the supplier's primary contact person.
5.6.7 Contact Last Name

Enter the last name of the supplier's primary contact person.
5.6.8 Email Address

Enter the email address of the supplier's primary contact person.
5.6.9 Primary Phone

Enter the primary telephone number (and extension, if applicable) for the supplier's contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the supplier.
5.6.10 Other Phone

Enter a secondary telephone number and extension for the supplier's primary contact person, if applicable.
5.6.11 Fax

Enter fax number for the supplier's primary contact person.

5.7 Received Product Information (Continued)

Additional Information About Reportable Foods Received

This screen uses your answer to the question "Number of Lots or Batches of Reportable Food Received" to generate question sets by lot or batch. Please complete the questions regarding each individual lot or batch.

5.7.1 Lot Number or ID

Enter the lot number or ID of the batch.
5.7.2 Expiration/Use-by Date

Enter the expiration or use-by month, day, and year that is on the reportable food container. The date format is MM/DD/YYYY.
5.7.3 Number of Containers Received

Enter the number of containers received from the supplier.
5.7.4 Total Amount Received

Enter the total amount of the reportable food received from the supplier and select the unit of measure associated with the product.
5.7.5 First Receipt Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you first received the reportable food from the supplier.
5.7.6 Last Receipt Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you last received the reportable food from the supplier.
5.7.7 Did you dispose of any of the received product? *

Select either Yes, No, or Unknown. If you select "Yes", you will be prompted for the additional information below.
1. 5.7.7.1 Disposal Date
  
  Enter the month, day, and year, in the MM/DD/YYYY format, that you disposed of the reportable food.
2. 5.7.7.2 Number of Containers Disposed
  
  Enter the number of containers disposed of.
3. 5.7.7.3 Total Amount Disposed
  
  Enter the total amount of the reportable food that was disposed of on the Disposal Date and select the unit of measure associated with the product.
4. 5.7.7.4 Method of Disposal
  
  Select the method of disposal. Check all that apply.

5.8 Supplier & Distribution Summary

A summary of all the supplier and/or recipient sites and products that you have entered will be displayed in this section. If you would like to add additional sites or products, click the appropriate add button and enter the additional information. If you have entered all the supplier and recipient sites and products associated with this product problem (or if you have entered all of the sites you plan to enter manually and you are planning to send the rest of your sites to FDA using an email attachment), click the "Continue" button.

If you indicated that you distributed products to a site, you will see the following screens and questions in Section 5:

5.9 Distributed Product Information

5.9.1 Name of Distributed Product *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself. This portal only collects data for one site/product at a time. If there is more than one site to which you have distributed reportable food, you will be given the opportunity to add information after completing this entry.
5.9.2 Universal Product Code (UPC)

Enter the actual UPC code on the package here.
5.9.3 Product Group *

Select the product group from the drop down list.
5.9.4 Intended Product Use *

Select the intended product use from the drop down list.
5.9.5 Was the product imported?

Please select either YES, NO, or Unknown. If you select "Yes", you will be prompted to select the Country of Origin and the Port of Entry from their respective drop down lists.
5.9.6 Was the product recalled? *

Please select either YES, NO, or Unknown. If you select "Yes", you will be prompted for the FDA recall number. Please enter the FDA recall number, if known.
5.9.7 Package Category

Select the food package category: Bulk, Retail, or Institutional.
5.9.8 Container Type

Please select the container type from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.
5.9.9 Container Size

Please enter the container size and select the unit of measure from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.
5.9.10 Number of Lots or Batches of Reportable Food Distributed

Enter the total number of lots or batches of the reportable food that you distributed and select the unit of measure from the drop down list of values.
5.9.11 Number of Sites Distributed To

Enter the total number of sites to which you distributed the reportable food.

5.10 Distributed Product Information (Continued)

Additional Information About Reportable Foods Distributed

This screen uses your answer to the question "Number of Lots or Batches of Reportable Food Distributed" to generate question sets by lot or batch. Please complete the questions regarding each individual lot or batch.

5.10.1 Lot Number or ID

Enter the lot number or ID of the batch.
5.10.2 Expiration/Use-by Date

Enter the expiration or use-by month, day, and year that is on the reportable food container. The date format is MM/DD/YYYY.
5.10.3 Number of Containers Distributed

Enter the number of containers distributed by your site.
5.10.4 Total Amount Distributed

Enter the total amount of the reportable food that was distributed by you and select the unit of measure associated with the product.
5.10.5 Did you dispose of any of the Product? *

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted for additional information below.
1. 5.10.5.1 Disposal Date
  
  Enter the month, day, and year, in the MM/DD/YYYY format, that you disposed of the reportable food.
2. 5.10.5.2 Number of Containers Disposed
  
  Enter the number of containers disposed of.
3. 5.10.5.3 Total Amount Disposed
  
  Enter the total amount of the reportable food that was disposed of by you and select the unit of measure associated with the product.
4. 5.10.5.4 Method of Disposal
  
  Select the method of disposal. Check all that apply.

5.11 Distribution Information

This screen uses your answer to the question "Number of Sites Distributed To" to generate question sets by recipient. Please complete the questions regarding each recipient.

5.11.1 Organization Type

Select the various establishment types which apply to your recipient.
5.11.2 Name of Recipient Site

Enter the name of the recipient to which you distributed the reportable food.
1. 5.11.2.1 Have you notified this site of the product problem?
  
  Please select either Yes or No. If yes, provide the date you notified this recipient of the reportable food.
5.11.3 Container Quantity Distributed

Enter the number of containers of the reportable food you distributed to this recipient.
5.11.4 Total Amount Distributed

Enter the total amount of the reportable food that was distributed to this recipient and select the unit of measure associated with the product.
5.11.5 First Distributed Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you first distributed the reportable food to this recipient.
5.11.6 Last Distributed Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you last distributed the reportable food to this recipient.
5.11.7 Country

Select the recipient's country from the drop down list of countries. The United States is the default country.
5.11.8 Street Address

Enter the number and street name of the recipient's physical address, and other information as necessary. Do not enter Post Office Box address information in this field.
5.11.9 City/Town

Enter the city/town of the recipient's physical address.
5.11.10 State/Province

Select the state or province of the recipient from the drop down list.
5.11.11 ZIP or Postal Code

Enter the ZIP Code or Postal Code of the recipient's physical address.
5.11.12 Contact Person Title

Enter the organizational title of the recipient's primary contact person.
5.11.13 Contact First Name

Enter the first name of the recipient's primary contact person.
5.11.14 Contact Last Name

Enter the last name of the recipient's primary contact person.
5.11.15 Email Address

Enter the email address of the recipient's primary contact person.
5.11.16 Primary Phone

Enter the primary telephone number for the recipient's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the recipient.
5.11.17 Other Phone

Enter the secondary telephone number for the recipient's primary contact person, if applicable.
5.11.18 Fax

Enter a fax number for the recipient's primary contact person.

5.12 Supplier & Distribution Summary

If you indicated that you were not ready or required to report supply chain information, you will see the following screens and questions in section 5. Federal, State, and local public health officials will see some but not all of the following questions in section 5.

5.13 Product Information

5.13.1 Name of Product *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself. This portal only collects data for one product at a time. If there is more than product associated with the reportable food, you will be given the opportunity to add information after completing this entry.
5.13.2 Product Manufacturer

Enter the name of the organization that manufactures the product.
5.13.3 Did the company entered in the previous question notify you of this product problem?

Please select either Yes or No. If yes, provide the date you were notified of the reportable food by the company. The date format is MM/DD/YYYY.
5.13.4 Universal Product Code (UPC)

Enter the actual UPC code on the package here.
5.13.5 Product Group *

Select the product group from the drop down list.
5.13.6 Intended Product Use *

Select the intended product use from the drop down list.
5.13.7 Was product imported?

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted to select the Country of Origin and the Port of Entry from their respective drop down lists.
5.13.8 Was the product recalled? *

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted for the FDA recall number, if known.
5.13.9 Package Category

Select the food package category: Bulk, Retail, or Institutional.
5.13.10 Container Type

Please select the container type from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.
5.13.11 Container Size

Please enter the container size and select the unit of measure from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.
5.13.12 Total Containers Manufactured, Processed, Packed, or Held

Enter the number of containers of the reportable food that you manufactured, processed, packed, or held. Federal, State, and local public health officials should answer regarding the total number of containers of the reportable food manufactured, processed, packed or held by the Location of Reportable Food, if known.
5.13.13 Total Amount Manufactured, Processed, Packed, or Held

Enter the total amount of the reportable food that you manufactured, processed, packed, or held and select the unit of measure from the drop down list of values. Federal, State, and local public health officials should answer regarding the total amount of reportable food manufactured, processed, packed or held by the Location of Reportable Food, if known.
5.13.14 Number of Lots or Batches of Product Manufactured, Processed, Packed, or Held

Enter the total number of lots or batches of the reportable food that you manufactured, processed, packed, or held. Federal, State, and local public health officials should answer regarding the total number of lots or batches of reportable food manufactured, processed, packed or held by the Location of Reportable Food, if known.

5.14 Product Summary

A summary of all the products for which you entered information but indicated that you were not ready or required to report supply chain information will be displayed in this section. If you would like to add additional products, click the "Add another Product" button and enter the product information associated with this reportable food. If you have entered all the products associated with the reportable food, click the "Continue" button.

SECTION 6: Submit Report and Confirmation

Please review your information to ensure it is correct and complete. We appreciate any optional information you can provide at this time even though it is not required for initial report submission. Click the link "Click to review your report" to review your report. Upon submission of your report, you will immediately receive a confirmation page with an FDA-assigned Individual Case Safety Report (ICSR) number. It is important that you use this ICSR number if you submit amended reports and/or consult with the FDA regarding this instance of reportable food. Depending on the circumstances, you may also need to use this ICSR number if you notify immediate previous sources or immediate subsequent recipients of the reportable food. If you have additional documents to submit, the confirmation page also provides an FDA email address, FDAReportableFoods@fda.hhs.gov, or a button ("Send Supplemental Report Information to FDA") that you can click to email the related files to the FDA. If you send any additional documents to FDA by email, please include your ICSR number in the subject line of the email.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0260.