LAAF; Reporting Requirements

U.S. Food and Drug Administration
Laboratory Accreditation for Analyses of Foods
(LAAF) Program Portal
Electronic User Guide
Step-by-Step Instructions for an Accreditation
Body to Apply for and Manage Recognition Status
in the Program

Document Version: 1.0
Last Updated: April 2024

Table of Contents
1

Introduction ............................................................................................................ 1
1.1 Overview of FDA Portals for Electronic Laboratory Accreditation for Analyses
of Foods Program Submissions ....................................................................... 1
1.2 Adding Attachments ......................................................................................... 1
1.3 Supported Browsers......................................................................................... 2
2 Access FDA FIS Electronic Portal ......................................................................... 3
2.1 Log in with an Existing Account........................................................................ 3
2.2 Create an Account ........................................................................................... 7
3 Access the Laboratory Accreditation for Analyses of Foods Program – AB ........ 18
4 Apply for Recognition as an Accreditation Body .................................................. 20
5 Application Returned for Action ........................................................................... 43
6 Application Decision by FDA ............................................................................... 48
6.1 Application Approval ...................................................................................... 48
6.2 Application Denial .......................................................................................... 50
7 Add or View Accredited Laboratories................................................................... 54
7.1 Accredited Laboratories Section .................................................................... 55
7.1.1 Search for the AL by FEI ............................................................................ 56
7.1.2 Search for the AL by Firm Name & Address .............................................. 62
7.2 Accreditation Information Section................................................................... 69
7.3 Certification Information Section .................................................................... 70
7.4 Disciplines, Analyses, and Test Methods Section .......................................... 72
8 Reports and Notifications ..................................................................................... 77
8.1 Notice of Addition or Removal of Test Methods for an AL .............................. 79
9 Submit Supplemental Documentation.................................................................. 88
10 Contact Us........................................................................................................... 94
APPENDIX ................................................................................................................. 97
Abbreviations .......................................................................................................... 97
Icon Behavior .......................................................................................................... 97

1 Introduction
This document is intended for Accreditation Bodies (ABs) or persons who are
authorized to act on their behalf, who are applying or seeking renewal for recognition
in FDA’s Laboratory Accreditation for Analyses of Foods (LAAF) Program. If approved
by FDA, ABs can manage their profiles, including the Accredited Laboratories (ALs).
This document provides detailed instructions regarding how an AB can use FDA’s
electronic portal for the following:
Submit an application
Manage an AB profile
Add and manage ALs
Communicate with FDA

1.1 Overview of FDA Portals for Electronic Laboratory
Accreditation for Analyses of Foods Program
Submissions
FDA Industry Systems (FIS)
FDA Industry Systems (FIS) is an electronic portal which facilitates making
submissions to FDA; it includes registration, listing, and other notifications. FIS is
available 24 hours a day, seven days a week. It provides general entry to a series of
systems which allow electronic submissions to FDA.
FDA’s Unified Registration and Listing System (FURLS)
FDA’s Unified Registration and Listing System (FURLS) is a specific component of
FIS. Persons with an FDA account ID and password for the FIS electronic portal can
use systems within the FURLS components to exchange information with the
Agency. The FURLS system described in this document is for the Laboratory
Accreditation for Analyses of Foods Program

1.2 Adding Attachments
Users of the system may need to provide additional information to the Agency while
working in the portal. Additional documentation can be provided by attaching an
electronic file (e.g., reports, schematics, or other supporting information).
The electronic LAAF Program system supports attachments of the following
document types: .pdf, .png, .jpeg, .gif, .bmp, .jpg, .jpe, .jfif, tif, .tiff, .doc, .docx, .ppt,
.xls, .xlsx, .txt, .pptx, and .rtf. The maximum file size allowed is 50 MB. Relevant
sections of this document will identify opportunities for adding attachments.

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1.3 Supported Browsers
FURLS may be accessed using Microsoft Edge, Google Chrome, or Firefox. Please
visit the “Systems Requirements” section of the FURLS page for a list of approved
browsers and browser versions. The “Systems Requirements” section can be found
by navigating to Access.fda.gov.
Obtain an FDA Account through the FDA FIS Electronic Portal.
Each person who uses this system needs a personal FDA Account ID and password.
To access the FIS electronic portal, they can go to the OAA site. They can click the
“Create New Account” button near the bottom of the page, in the New User section
and then follow the instructions for obtaining an FDA Account ID and password
below. Once the account has been created, the user will be able to log into the
“Online Account Administration” (OAA) system.

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2 Access FDA FIS Electronic Portal
An Accreditation Body (AB) seeking recognition by FDA is required to create an online
account first. Once the account has been created, the applicant can then log into the
FURLS “OAA” page with valid account credentials to apply for recognition by FDA.
The AB user should navigate to Access.fda.gov and click the “Log-In” or “Create
Account” button, depending on which is applicable to the user (Figure 2.1).

Figure 2.1: FDA Industry Systems Page

2.1 Log in with an Existing Account
If the AB user has previously created an FIS account, they should click the “Log-In”
button on the “FDA Industry Systems” page (Figure 2.2).

Figure 2.2 Log-In Button

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The user will be directed to the Online Account Administration (OAA) “Login” page.
The user can log into the FDA “OAA” page. This is the same page used to begin the
process of creating a new OAA account (Figure 2.3).
The user will use the account ID and password from the account creation process for
the “Account ID” and “Password” fields. The user should click the “I understand”
checkbox, and then click the “Login” button.

Figure 2.3: OAA Login

Once logged into the FDA “OAA” site, the user will be prompted to enter a verification
code (Figure 2.4). The verification code will be sent to the e-mail address entered on
the “Account Information” page. If the user does not receive the verification code
within 10 minutes, they will click the “Resend verification code” link on the page. Once
the user has received the code, they will enter it in the box labeled “Enter Verification
Code,” then click the “Verify” button.
Note: Users will be prompted to enter a verification code each time they log in.

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Figure 2.4: Enter Verification Code

Users will be directed to the FURLS “Account Management” page after the verification
code has been verified (Figure 2.5).

Figure 2.5: Account Management Page

On the FURLS “Account Management” page click the “Update System Access” link
from the upper left-hand corner of the OAA “Account Management” page (Figure 2.6).
The page will display instructions to select the system(s) the AB user will need to
access. The user will click on the checkbox for “Laboratory Accreditation for Analyses
of Foods Program – Accreditation Body”, and then click the “Submit” button.

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Figure 2.6: Update System Access

The system will display a message confirming the user’s access was successfully
updated (Figure 2.7).

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Figure 2.7: Successful Update Message

2.2 Create an Account
If the AB user has not previously created a FIS account, they should click the “Create
Account” button on the FIS page (Figure 2.8).

Figure 2.8: Create Account Button

The user will be directed to the OAA “Login” page (Figure 2.9). The AB can sign up for
an account by clicking the “Create New Account” button on the “FDA Industry
Systems” (FIS) Online Account Administration (OAA) page.

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Figure 2.9: FIS OAA Page

The system will display the “Create New Account” page (Figure 2.10).
Two radio buttons will display at the top of the page, “Yes” and “No;” “No” is selected
by default.
Note: The radio buttons should remain in their default state. Selecting “Yes” will direct
users to a program which is not part of the scope of this document.
The system will display the various programs available in OAA.

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Figure 2.10: Create New Account Page

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The AB user will select the “Laboratory Accreditation for Analyses of Foods Program –
Accreditation Body" checkbox under “FSMA Program(s),” and click the “Continue”
button to continue to the next step (Figure 2.11).

Figure 2.11: Laboratory Accreditation for Analyses of Foods Program – Accreditation Body Link

The system will display the “Step 1a: Enter Verification Code for Account Creation”
screen. The user will receive a system-generated e-mail containing the verification
code, once the accrediting AB submits the laboratory accreditation via FURLS.
The user will enter the verification code in the field and click the “Verify” button. After
the code is verified, the user will be able to create an account for accessing the AL
Portal (Figure 2.12).

Figure 2.12: Step 1a: Enter Verification Code for Account Creation

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The system will display the “Step 2: Enter Your Account Information” section, where
the accrediting AB will provide Point of Contact information, account information, and
the account holder’s physical address (Figure 2.13). They must also provide additional
information (i.e., passwords, secret questions and answers, and an alternate mailing
address,) if applicable. The user may edit any of the existing information.
Note: The account holder’s physical address may include a street address and/or
Post Office Box.

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Figure 2.13: Create New Account Page

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Step 2: Enter Your Account Information
The data fields in the “Step 2A: Point of Contact Information” section include:
First Name – The first name of the Point of Contact
Middle Initial (Optional field) – The first letter of the Point of Contact’s middle
name
Last Name/Surname – The last name of the Point of Contact
Job Title – The job title of the Point of Contact
Company Name – The name of the company the Point of Contact represents
Web Address (Optional field) – The URL of the company
Phone Number (Country/Area/Phone Number/Extension) – The telephone
number of the Point of Contact
o “Country” is the country code.
o “Area” is the area code.
o “Phone Number” is the phone number.
o “Extension” is the local phone extension to dial the Point of Contact, if
applicable.
Fax Number (Country/Area/Fax Number) (Optional field) – The fax number of
the Point of Contact
o “Country” is the country code.
o “Area” is the area code.
o “Fax Number” is the fax number.
E-mail Address – The e-mail address of the Point of Contact.
Confirm E-mail Address – The re-entry of the Point of Contact’s e-mail
address
*The entry must match the “E-mail Address” field.
The data fields in Step 2B: Account Information include:
Password – The field to create password for the AB’s account. This password
will be used every time the AB user logs into the system.
Confirm Password – The field to enter password created in the “Password”
field. The entry must match the “Password” field.
Secret Question 1 – This is the first secret question used to protect the
account. Select a question from the dropdown list.
Secret Answer 1 – This is the answer to the first secret question. Enter your
response to the question selected in “Secret Question 1.”
Secret Question 2 – The second secret question used to protect the account.
Select a question from the dropdown list.
Secret Answer 2 – This is the answer to the second secret question. Enter
your response to the question selected in “Secret Question 2.”
Secret Question 3 – This is the third secret question used to protect the
account. Select a question from the dropdown list.
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Secret Answer 3 – This is the answer to the third secret question. Enter your
response to the question selected in “Secret Question 3.”
The data fields in “Step 2C: Physical Address (Business) of Account Holder” include:
Country/Area – The country/area where the business is located
Select a country/area from the dropdown list.
Address Line 1 – The address where the business is physically located
This includes the number, street, quadrant, etc.
Address Line 2 (Optional field) – The field to enter additional information
about the physical location of the company.
This may include a suite or apartment number, if applicable.
City – The city where the business is physically located.
State/Province/Territory – The state/province/territory where the business is
physically located.
Zip Code (Postal Code) – The zip code (domestic) or postal code (foreign)
where the business is physically located.
DUNS Identifier (Optional field) – The firm’s DUNS number.
Do you have preferred mailing address other than the physical address
mentioned above? – The “Yes” and “No” radio buttons provided to answer this
question:
o If “No” is selected, the physical address will be used as the mailing
address.
o If “Yes” selected, the system will display “Step 2D: Preferred Mailing
Address” which must be completed (Figure 2.11). The address entered
in Step 2D will be used as the mailing address.

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Figure 2.14: Step 2D: Preferred Mailing Address

After completing all mandatory fields, the AB applicant must click the “I understand”
checkbox and the “Continue” button at the bottom of the page. The system will display
the “Account Review” page (Figure 2.15).
The AB user can then click the “Submit” button to finalize the account creation or, click
the “Modify” button to edit the profile information.

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Figure 2.15: Account Review Page

When the AB user clicks the “Submit” button, the system will display a page with a
message stating their account was created successfully. The message will also
display the account ID the user will use to log in and submit an application for
recognition as an AB (Figure 2.16).

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Figure 2.16: Account Created Successfully Message and Account ID

Once the AB user has created an account, they will receive an e-mail notification
containing the account ID, which will be sent to the e-mail address entered on the
“Create New Account” page.

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3 Access the Laboratory Accreditation for Analyses of
Foods Program – AB
After the AB user logs into the FDA “OAA” page, the FURLS “Account Management”
page will display. The AB user will select the “Laboratory Accreditation for Analyses of
Foods Program – Accreditation Body" checkbox under “FSMA Program(s),” and
continue to the next step (Figure 3.1).

Figure 3.1: Account Management Page

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This system will navigate the user to the “AB Home” page with the “LAAF Accreditation Body (AB) Program” banner (Figure 3.2).

Figure 3.2: AB Home Page

Each screen in the AB electronic submission process has the banner “LAAF –
Accreditation Body (AB) Program.” The “FURLS Home” link (on the right side of the
banner) will navigate them to the “Account Management” page, where the AB user is
able to log out of the system.

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4 Apply for Recognition as an Accreditation Body
To create a new application for recognition as an Accreditation Body, the AB user can
select the “Apply for Recognition” link from the navigation menu on the “AB Home”
page (Figure 4.1).

Figure 4.1: Navigation Menu

The system will navigate to the first page of the application, “Applicant Information”
(Figure 4.2). This page displays read-only information from the AB user’s profile
submitted while creating the account in OAA.

Figure 4.2: Applicant Information Page

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The “AB Home” link will navigate the AB user to the main menu on the “AB Home”
page.
The system allows navigation between the pages of the application using the
“Previous” and “Next” buttons or, by selecting the tab of the desired page directly.
The “Program Requirements” page allows the AB user to enter information and attach
files for the following regulatory requirements:
Eligibility
Competency and Capacity
Conflict of Interest
Oversight Requirements
Reports and Notifications
Records
The regulatory requirements are listed on the left side of the page. The “Eligibility”
regulatory requirement is expanded by default upon navigating to the page (Figure
4.3).

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Figure 4.3: Program Requirements Page

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The definition of the regulatory requirement is displayed when the AB user clicks on
its heading; (Figure 4.4 shows an example for “Eligibility”).

Figure 4.4: Definition of Eligibility

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Each regulatory requirement has regulation text displayed when expanded.
When the AB user clicks on the element for “Eligibility” (i.e., “1.1113(a), (b), and (c)”)
the system displays three accordion sections, containing the following data fields
(Figure 4.5):
1) “Eligibility” section:
Regulatory Requirement and Criteria to Demonstrate – Contain(s)
read-only information
User Response – Text entry field, which allows up to 4,000 characters
Additional Information – Optional text entry field, which allows up to
4,000 characters
2) “Certificate Attachments” section:
Attachments button – To provide the ability to upload certification
documents
Table of attachments (empty by default) – Any uploaded documents
related to certificates will be listed here.
Evaluation Date – Date field for the accreditation evaluation date listed
in the certificate attachment, which will display once a file has been
uploaded to this section
Expiration Date – Optional date field for the expiration of the
accreditation as listed in the certificate attachment, which will display
once a file has been uploaded to this section
3) “Other Supporting Documents” section – Optional section, which contains the
following:
Attachments button – To provide file upload functionality for documents
not related to certification
Table of attachments (empty by default) – Any documents uploaded in
this section will be listed here.

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Figure 4.5: Eligibility Section

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Each element is red flagged by default for all of the regulatory requirements, indicating
the required field of the element has not been completed (Figure 4.5). The system will
remove the red flag when the AB user provides a response in the “User Response”
field.
All other regulatory requirements (other than “Eligibility”) contain the following two
accordion sections. Figure 4.6 shows an example for “Records”:
“”:
o Regulatory Requirement and Criteria to Demonstrate – Contain(s)
read-only information
o User Response – Text entry field which allows up to 4,000 characters
o Additional Information – Optional text entry field, which allows up to
4,000 characters
“Attachments” – Optional section, which contains the following:
o Attachments button – To provide file upload functionality for
documents not related to certificates.
o Table of attachments (empty by default) – Any uploaded files
uploaded in this section will be listed here.

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Figure 4.6: Records Section

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Attachments may be uploaded with each response using the “Attachments” button.
Figure 4.7 shows an example for the regulatory “Eligibility” requirement.

Figure 4.7: Attachments Button

To upload an attachment, the AB applicant will click the “Attachments” button. The
system will display the “Attachments” pop-up window which contains the following
(Figure 4.8):

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Upload instructions:
o Step 1: Click “Browse” to find the document(s) you want to upload
o Step 2: Click “Upload”
o Step 3: Click “Close”
Browse, Upload, Cancel, and Close buttons
Manage Attachments table with three columns:
o File Name
o Date of Upload
o Action
Note: File types permitted are .pdf, .png, .jpeg, .gif, .bmp, .jpg, .jpe, .jfif, .tif, .tiff, .doc,
.docx, .ppt, .xls, .xlsx, .txt, .pptx, and .rtf.
The maximum file size allowed is 50 MB.
The AB applicant will select a file using the “Browse” button. After a file has been
selected, the “Upload” and “Cancel” buttons will be enabled.

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Figure 4.8: Attachments Pop-up Window

The AB user can click the “Upload” button to complete the upload or, click the
“Cancel” button to cancel the upload process.
Upon successful upload, the system will disable all three buttons and post a
confirmation message with the file name displayed in the “Attachments” window and
on the main page (Figure 4.9).

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Figure 4.9: Confirmation of Successful Upload

To remove the attachment, the AB applicant can click the trash/delete icon in the
“Action” column. The system will display a confirmation message (Figure 4.10).
The AB user can click the “Close” button to close the “Attachments” window.

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Figure 4.10: Confirmation of Successful Deletion

Important: The user must click the “Save” button upon completion of all the
regulatory requirements.
The AB applicant can proceed to the “Attachments” page, where the AB user can
upload additional documents to include with the application submission. The user can
follow the instructions listed on the “Attachments” page. This page is optional (Figure
4.11).

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Figure 4.11: Attachments Page

The AB user will make a selection from the “Type of Attachment” menu. If “Other” is
selected, the text field “Additional Description” will display and must be completed to
proceed to the next page of the application (Figure 4.12). The “Browse” button will
become enabled, allowing them to search for a file to upload.

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Figure 4.12: Attachments Page

When a file has been selected, the “Upload” and “Cancel” buttons will become
enabled. Clicking the “Upload” button will complete the upload; clicking the “Cancel”
button will cancel the upload process.

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Upon a successful upload, the system will disable all three buttons. A confirmation
message will display the file name in the table with the following four columns (Figure
4.13):
File Name
Type
Date of Upload
Action

Figure 4.13: Confirmation of Successful Upload

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To remove the attachment, the AB applicant can click the trash/delete icon in the
“Action” column of the table. The system will display a confirmation message (Figure
4.14).

Figure 4.14: Confirmation of Successful Deletion

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After all the files have been uploaded, the AB applicant can click the “Save” button.
The applicant will then click the “Next” button or the “Summary” tab to proceed to the
“Summary” page.
The “Summary” page allows the AB applicant to review all application data for
accuracy prior to its submission (Figure 4.15).

Figure 4.15: Summary Page

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After reviewing the “Summary” page, the AB applicant will click the “Next” button. The
system will validate all the information entered. If the validation fails, the system will
display error message(s) (Figure 4.16).

Figure 4.16: Error Messages on Summary Page

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The AB applicant must correct any identified issue(s) to be able to submit the
application.
After correcting the error(s,) the applicant will click the “Save” button to preserve the
changes made.
If the system validation on the “Summary” page is successful, the system will navigate
to the “e-Signature” page (Figure 4.17).
The applicant will follow the directions provided on the “e-Signature” page, complete
the following user entry fields, and then click the “Submit” button:
Checkbox (unchecked by default) – “I certify that the information in the
submission is true and accurate and that I am authorized to submit the
information to FDA. Further, I certify that the accreditation body will comply with
all requirements for recognized accreditation bodies under 21 CFR part 1,
subpart R while recognized.”
Name of Submitter – The first and last name of the submitter.
Title of Submitter – The title of the submitter.

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Figure 4.17: e-Signature Page

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The system will display a confirmation message on the page after the application has
been submitted (Figure 4.18).

Figure 4.18: Confirmation Message

If the AB user wishes to view the status of their application, they can select the
“View/Edit my application for recognition” link from the navigation menu on the “AB
Home” page (Figure 4.19).

Figure 4.19: Navigation Menu

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The system will display the “Application Information” page. The application status will
update from “Pending,” to “Transmitting,” to “Submitted” (Figure 4.20).
Pending – Interim status to indicate the application is undergoing a virus scan
of any attachments
Transmitting – Interim status to indicate the application has passed the virus
scan and is in the process of being downloaded/transmitted to FDA
Submitted – Indicates the application has been successfully
downloaded/transmitted to FDA
Note: “Pending” and “Transmitting” statuses may remain for up to (approximately) 15
minutes each before updating to the "Submitted" status.

Figure 4.20: Application Status

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5 Application Returned for Action
FDA may return an application if it determines additional information is needed. FDA
will notify the applicant of any insufficiencies and information needed to address the
insufficiencies.
Note: The AB user must submit the requested information before FDA will continue
the application review process. When the application has been returned with
additional information, the application status will display on the “Application
Information” page as “In-Process”.
The submission status will be displayed as follows:
Returned for Action – For regulatory requirements in question
Under Review – For all other regulatory requirements
The status of all other program requirements criteria will display as “Under Review”
(Figure 5.1).

Figure 5.1: Application In-Process/Returned for Action Submission Statuses

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To address the information request from FDA, the AB user will click the pencil/edit
icon in the “Action” column on the “Application Information” page (Figure 5.2).

Figure 5.2: Edit Icon

The system will open the “Program Requirements” page (Figure 5.3). “Program
Requirements” criteria displayed with red flags indicate a response is needed. The AB
user will navigate to the red-flagged regulatory requirement(s) to provide the required
answers, information, and/or attachments.
The AB user will click on the dropdown to expand the section. The user will then click
on the element under the flagged regulatory requirement to view the question(s) from
FDA in the “Review Comments” section.

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Figure 5.3: Eligibility Element with a Question from FDA

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After answering all of the questions on the “Program Requirements” page, the AB
applicant can add more documents on the “Attachments” page, if needed. They may
then proceed to the “Summary” page to review and verify the information entered
before the application’s resubmission.
When AB users select the regulatory requirement(s) for re-submission and click the
“Next” button on the “Summary” page, the system will validate the information. If all
system validations pass, the system will navigate to the “e-Signature” page (Figure
5.4). If the validation fails, the system will post error message(s) relevant to the
issue(s) in need of correction before the application can be resubmitted.

Figure 5.4: e-Signature Page

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Once the user clicks “Submit” from the “e-Signature” page, the system will display a
“Confirmation” message (Figure 5.5). The applicant will also receive an e-mail
confirmation.

Figure 5.5: Confirmation Message

After the application has been resubmitted, the “Application Status” will remain “InProcess” until FDA has made a decision regarding the application.

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6 Application Decision by FDA
When FDA has made a decision regarding the AB’s application an e-mail notification
will be sent to the AB applicant, notifying them of the decision.

6.1 Application Approval
If FDA approves the application, the AB applicant will receive the following e-mail
notification (Figure 6.1):
Subject: FDA's Laboratory Accreditation for Analyses of Foods Program - Recognition Approved
We are pleased to inform you that you have been accepted into FDA's Laboratory Accreditation for
Analyses of Foods Program and are now a recognized Accreditation Body (AB) with FDA.
Your acceptance into the program is valid from DEC 10, 2021. Any work you perform under this
recognition is subject to the requirements under 21 CFR Part 1, Subpart R. All notifications must be
made through your FDA Online Account Administration (OAA) account.
We look forward to working with you, thank you for your participation in FDA's Laboratory
Accreditation for Analyses of Foods Program.
For other questions please contact us at [email protected].
Laboratory Accreditation for Analyses of Foods Program
U.S. Food and Drug Administration
DO NOT REPLY TO THIS EMAIL
Figure 6.1: Application Approval Email from FDA

The “Recognition Status and Application Status will display on the “Application
Information” page will display as “Recognized” (Figure 6.2).

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Figure 6.2: Application Recognized Status

Once recognized, the applicant will have the full privileges of a recognized AB,
including the ability to add a LAAF-Accredited Laboratory (AL), and submit
supplemental documents to FDA. The related features items will display on the “AB
Home” page (Figure 6.3).

Figure 6.3: Additional Features Displayed to Recognized AB

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6.2 Application Denial
If FDA denies the application for recognition, the AB applicant will receive the
following e-mail notification from FDA (Figure 6.4):

Figure 6.4: Application Denial Email from FDA

The “Application Status” will display on the “Application Information” page as “Denied”
(Figure 6.5).

Figure 6.5: Application Denied Status

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As stated in the e-mail notification, the applicant can create new application and
submit it to FDA. When the AB user logs into the LAAF AB system, (after receiving the
application denial notification from FDA), the system will display the “Apply for
Recognition” menu option from the navigation menu on the “AB Home” page (Figure
6.6).

Figure 6.6: Navigation Menu

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When the AB user clicks the “Apply for Recognition” link, the system will display the
“Application Pre-fill Option” for a new application with “Yes” and “No” radio buttons
(Figure 6.7).
If the AB user selects “Yes,” the system will navigate to the “Applicant Information”
page of a new application. When the AB user proceeds to the “Program
Requirements” page, all of the responses provided in the previous application will be
pre-filled in the new application.
Note: All pre-filled responses are editable. Any attachments (either from the “Program
Requirements” or “Attachments” pages), will be pre-filled from the previous application
as well.

Figure 6.7: Application Pre-fill Option

The AB user can delete any pre-filled attachments they do not wish to submit in the
new application by clicking the trash/delete icon where the attachment is listed (Figure
6.8).

Figure 6.8: Trash/Delete Icon

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The AB applicant will follow the “Apply for Recognition” workflow described in Chapter
4 – Apply for Recognition as an Accreditation Body (AB), to complete and submit the
new application.
If the AB user selects the radio button for “No,” the AB user will click the “Next” button
from the “Application Pre-fill Option” page and navigate to the “Applicant Information”
page of the application (Figure 6.9). When the AB user proceeds to the “Program
Requirements” and “Attachments” pages, no data will be pre-filled.

Figure 6.9: New Application Pages

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7 Add or View Accredited Laboratories
A recognized AB can add a LAAF AL. To add and accredit an AL, the AB user will
select the “Add or View my Accredited Laboratories (AL)” link from the navigation
menu on the “AB Home page”.
The system will navigate to the “Add or View my Accredited Laboratories (AL)” page
with the following page elements displayed (Figure 7.1):
Instructional text to add or view an Accredited Lab
Table of existing Accredited Labs (displays the message “No records found” if
there are no existing ALs under the AB user)
“Previous” and “Add AL” buttons

Figure 7.1: Add or View My Accredited Laboratories (AL) Page

To add an AL, the AB user will click the “Add AL” button.
The system will display the “Add Accredited Laboratories (AL)” page and display
instructions regarding how to add an AL (Figure 7.2). The instructional text can be
expanded and collapsed using the “…more/less” link.
The page contains four sections within accordion panels, which can be expanded to
display their content:
Accredited Laboratories (AL) (expanded by default)
Accreditation Information
Certification Information
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Disciplines, Analyses, and Test Methods
There are two navigational buttons at the bottom of the page, “Previous” and “Next”.

Figure 7.2: Add Accredited Laboratories (AL) Page

7.1 Accredited Laboratories Section
The “Accredited Laboratories” section contains instructional text and radio buttons for
“FEI Number” and “Firm Name & Address” to allow the AB user to select one of the
two possible methods to search for an AL (Figure 7.3).
**Important: LAAF accreditation is based on individual lab location, not by a parent or
corporate lab. If a lab has more than one location, the AB user should enter the FEI
number or name and address of the physical location to be accredited.

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Figure 7.3: Accredited Laboratories (AL) Section

Note: The AB user can change their selection by selecting the radio button for the
alternate option. If the AB user changes their selection at any point, the system will
display a warning message in a pop-up window (Figure 7.4).
If the user selects “Yes” from the pop-up, the system will dismiss the warning and
change to the new selection. If the user selects “No,” the pop-up will be dismissed.
The original selection will be maintained.

Figure 7.4: Warning Pop-Up Message

7.1.1

Search for the AL by FEI

To search an AL by its FEI Number, the AB user will select the radio button for “FEI
Number” in the “Accredited Laboratories (AL)” section. The system will display a user
input field and a “Search” button (Figure 7.5).

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Figure 7.5: Search by FEI Number

The AB user will enter the FEI number in the input field and click the “Search“ button.
If the system finds a match for the FEI number that was searched, the AL’s
information will be displayed in the fields from the left-hand column within the
“Accredited Laboratories (AL)” accordion section (Figure 7.6).
Additional fields will be displayed in the right column for the AB user to provide
the AL’s contact information.

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Figure 7.6: FEI Number Search Result

If the system returns a match for the FEI number searched, which belongs to an AL
that is already accredited by another AB, the system will pre-fill the AL’s information in
both the left and right columns within the section. It will also post a message at the top
of the page: “The system has the information below for the AL whose FEI number or
Firm Name and Address you searched. If you disagree with the information, please
contact the AL. The AL may have to update its account profile” (Figure 7.7).
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Figure 7.7: FEI Number Search Result of an AL Accredited by another AB

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If the system does not find a match for the FEI number which was searched, the
system will display a message at the top of the page: “FEI number is
invalid.” (Figure 7.8).

Figure 7.8: Invalid FEI Number Message

If the AB user wishes to execute a new FEI Number search, they can click the “Clear”
button at the bottom of the “Accredited Laboratories (AL)” section and remove all data
displayed in the fields. The system will post the warning message: “WARNING! You
are about to clear all data in this section. Are you sure you want to proceed?” Users
may respond by clicking either the “Yes” or “No” buttons (Figure 7.9).
If the user selects “Yes,” the system will remove all data returned from the search
results and display the user input field. A “Search” button will display. The AB user
can execute a new search by an FEI number.
If the user selects “No,” the system returns to the “Add Accredited Laboratories (AL)”
page and maintains the results of the FEI number search.

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Figure 7.9: Warning Message

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7.1.2

Search for the AL by Firm Name & Address

To search an AL by its Firm Name & Address, the AB user will select the “Firm Name
& Address” button. The system will display the following user input fields, and a
“Search” button (Figure 7.10):
Firm Name – The name of the firm
Address Line 1 – The address where the firm is physically located – this
includes the number, street, quadrant, etc.
Address Line 2 – The field to enter additional information about the physical
location of the firm, such as a suite or building number; this field is optional.
City – The city where the firm is physically located
Country/Area – The country/area where the firm is physically located
State/Province/Territory – The state/province/territory where the firm is
physically located
Zip Code (Postal Code) – The zip code (domestic) or postal code (foreign)
where the firm is physically located
Note: “Zip Code” is only required for U.S. addresses. However, including the postal
code may help refine the search results.
Once the AB user has entered the information in the search fields, they can click the
“Search” button.

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Figure 7.10: Search by Firm Name and Address

The system will perform a search from the FDA Firm Inventory database for the
information provided. If the system does not return a match for the searched firm
information, the system will display the firm information in the left column – which will
remain editable – as well as additional user input fields in the right column (Figure
7.11).
Note: The “Country” code of the phone number will be automatically prefilled when
the user selects a country in the “Country/Area” dropdown.

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Figure 7.11: No Result Returned for the AL Name and Address

If the system returns a single match from its search for the AL’s information, the
system will display the AL’s read-only information in both the left and right columns,
with the message “The system has the information below for the AL whose FEI
number or Firm Name and Address you searched. If you disagree with the
information, please contact the AL.

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The AL may have to update its account profile.” (Figure 7.12).

Figure 7.12: Single Match Returned

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The system will perform a search from the “FDA Firm Inventory” database for the
information provided. If the system returns multiple results for the AL information
search the system will display the results in a pop-up window. The AB user will click
the “Select & Continue” button to select the correct match (Figure 7.13).
Alternatively, the AB can click the “Return to Search” button to return to the “Add
Accredited Laboratories (AL)” page – without selecting a record – to execute a new
search.

Figure 7.13: Multiple Results Pop-up

Once the AB user selects a result, the system will dismiss the pop-up and display the
read-only firm name and address for the selected result on the “Add Accredited
Laboratories (AL)” page. The additional fields will remain blank and editable (Figure
7.14).

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Figure 7.14: Result Selected from Multiple Matches

If desired, the AB can clear all data using the “Clear” button and restart the process.
If the user enters the same e-mail address associated with another AL, the system will
display a warning at the top of the page: “The email you entered is associated with
another accredited lab in the system. Please enter a different email address.” (Figure
7.15).
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Figure 7.15: Warning Message Displays when Same Email Address is Used

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To complete the process of adding an AL, the AB user must complete the three
remaining accordion sections:
Accreditation Information
Certification Information
Disciplines, Analyses, and Test Methods

7.2 Accreditation Information Section
The “Accreditation Information” section contains the following mandatory date fields
(Figure 7.16):
Accreditation Date – The date of the AL’s LAAF accreditation by the AB user
Expiration Date – The expiration date of the AL’s accreditation by the AB user
Note: Each date field allows the user to pick a date from the calendar or enter a date
manually in “YYYY-MM-DD” format.

Figure 7.16: Additional Information Section

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7.3 Certification Information Section
The “Certification Information” section contains the following elements related to the
lab’s LAAF accreditation (Figure 7.17):
Instructional text – How to upload the certificate
Certificate Number – Required text field; accepts 15 alphanumeric characters
Date of Issuance – Optional date field
Certificate Expiration Date – Required date field
Note: Each date field allows the user to pick a date from the calendar or enter a date
manually in “YYYY-MM-DD” format.

Figure 7.17: Certification Information Section

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When the AB user enters the “Certificate Number” and “Certificate Expiration Date,”
the system will allow the user to upload documents related to the certificate by
displaying the “Browse,” “Upload,” and “Cancel” buttons (Figure 7.18).
Note: The AB user can upload more than one certificate.

Figure 7.18: Browse, Upload, and Cancel Buttons

The table at the bottom of the “Certification Information” section will be populated
once the AB user completes the data input fields and uploads a file (Figure 7.19). The
AB user can click the trash/delete icon in the “Action” column of the attachment table
to remove a file.

Figure 7.19: Table of Certificate Attachments

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7.4 Disciplines, Analyses, and Test Methods Section
The “Disciplines, Analyses, and Test Methods” section contains instructions on how to
select value(s) from the “List of Available Disciplines, Analyses, and Test Methods”
table.
The table is paginated and contains read-only information in three searchable
columns:
Discipline
Analysis
Test Method
The value(s) selected by the user will be added to (and displayed in) the second table,
“List of Selected Disciplines, Analyses, and Test Methods” located at the bottom of the
section. This table displays the text “No Records Added” by default, and contains the
following columns (Figure 7.20):
Discipline
Analysis
Test Method
Action

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Figure 7.20: Disciplines, Analyses, and Test Methods Section

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The AB user will click the “Next” button to navigate to the “e-Signature” page. The
system will validate the data entered in the four accordion sections of the “Add
Accredited Laboratories (AL)” page. If any of the system validations fail, the system
will post the appropriate error message at the top of the page. The AB user must
address the error before submitting the AL accreditation information.
If the validation was successful, the system will navigate to the “e-Signature” page.
The AB user will complete all fields on the page and click the “Submit” button to send
the information to FDA (Figure 7.21).

Figure 7.21: e-Signature Page

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The system will display the “Confirmation” page (Figure 7.22).

Figure 7.22: Confirmation Page

The AB user can view the details for its ALs by navigating to the “Add or View my
Accredited Laboratories (AL)” page. The ALs will display in the table on the page.
To view the details for an AL, the AB user can click the “View” icon from the “Action”
column of the table (Figure 7.23).

Figure 7.23: View Icon

The system will display the AL’s read-only accreditation details for the AB user on a
new page: “Accredited LAB Information” (Figure 7.24).

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Figure 7.24: AL Accreditation Details

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8 Reports and Notifications
The “Reports and Notifications” feature allows the user to (electronically) notify FDA of
events or updates.
To access the “Reports and Notifications” feature, the user will click the “Reports and
Notifications” link from the navigation menu on the “AB Home” page (Figure 8.1).

Figure 8.1: Navigation Menu

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The system will display the “Reports and Notifications” page with the following reports
and notifications available (Figure 8.2):
Notice of Addition or Removal of Test Methods for an Accredited
Laboratory (AL) – Generates a notice to FDA when an AB submits a Notice of
Addition or Removal of Test Methods for an Accredited Laboratory.

Figure 8.2: Reports and Notifications Page

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8.1 Notice of Addition or Removal of Test Methods for an
AL
To notify FDA of any addition or removal of test methods, the user will click the
“Notice of Addition or Removal of Test Methods for an Accredited Laboratory (AL)” link
on the “Reports and Notifications” page (Figure 8.3).
The user may click the “Previous” button to return to the “AB Home” page.

Figure 8.3: Notice Link and Previous Button

The system will display the “Notice of Addition or Removal of Test Methods for an
Accredited Laboratory (AL)” page (Figure 8.4).
When AB doesn't have at least one AL, system will display the below message to the
user: “Before notifying the Laboratory Accreditation for Analyses of Foods Program about
your accreditation of an AL, you must first add the AL to the system. To add an AL to
the system, select the Add or View my Accredited Laboratories (AL) menu option on
the Home page. After the AL is added, return to this page to submit the notice of
accreditation of AL.”
Note: The user can click the “Previous” button at the bottom of the notice to return to
the “AB Home” page.

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Figure 8.4: Message displayed when no AL added

When at least one AL is added, the system will display the “List of Available
Disciplines, Analyses, and Test Methods” (Figure 8.5) and “List of Current Accredited
or Selected Disciplines, Analyses, and Test Methods” (Figure 8.6).

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Figure 8.5: Notice of Addition or Removal of Test Methods for an AL

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Figure 8.6: Notice of Addition or Removal of Test Methods for an AL Page

The user will select the AL from the “Accredited Laboratory” dropdown menu (Figure
8.7). If the AL is only accredited by one AB, the “AL Name” field will be pre-filled.

Figure 8.7: Accredited Laboratory Dropdown Menu

The system displays the “List of available Disciplines, Analyses and Test Methods”
table which lists all the test methods. (Figure 8.8).

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The system displays the “List of Current Accredited or Selected Disciplines, Analyses
and Test Methods” table, displaying those accredited by the AB (Figure 8.8).

Figure 8.8: List of Available Disciplines, Analyses, and Test Methods

When the user selects test methods from the “List of available Disciplines, Analyses,
and Test Methods” table, the selected test methods will display under the table “List of
Current Accredited or Selected Disciplines, Analyses and Test Methods”. The newly
added test methods display an accreditation status of “Selected”. Users can delete
any test methods from “List of Current Accredited or Selected Disciplines, Analyses,
and Test Methods” table by clicking the trash can/delete icon under the “Action”
column.
The system displays the “List of Current Accredited or Selected Disciplines, Analyses
and Test Methods” table, displaying those accredited by the AB (Figure 8.9).

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Figure 8.9: List of Current Accredited or Selected Disciplines, Analyses, and Test Methods

Note: The “Certificate Upload (Optional)” section functionality is the same as that
which is noted in Section 7.3 Certification Information Section.

Figure 8.10: Additional Information (Optional).

The user can enter additional information in the “Please provide any additional
information that is relevant to this notification (Optional)” field (Figure 8.11). This is a
free-type optional field which allows a maximum of 4,000 characters.

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Figure 8.11: Additional Information (Optional).

After completion of the notice, the user will click the “Next” button. The system will
navigate them to the “e-Signature” page (Figure 8.12).
The user will follow the directions provided on the “e-Signature” page, complete the
following user entry fields, then click the “Submit” button:
Checkbox (unchecked by default) – “I certify that the information in the
submission is true and accurate and that I am authorized to submit the
information to FDA.”
Name of Submitter – The first and last name of the submitter.
Title of Submitter – The title of the submitter.

Figure 8.12: e-Signature Page

Upon successful submission, the system will post a message on the “Confirmation”
page (Figure 8.13).
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Figure 8.13: Confirmation Message

The user may click the “AB Home” link on the top of the banner (or from the
breadcrumb) to return to the “AB Home” page (Figure 8.13).
The system will send the user an e-mail indicating the notice was received by FDA
(Figure 8.14).
Note: The image (below) only depicts the e-mail notification text.

Figure 8.14: Email Confirmation

Once the notice is submitted successfully, the newly added/deleted test methods and
certificate updates will show up on the “Accredited Lab Information” page (Figure
8.15).

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Figure 8.15: Accredited Lab Information Page

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9 Submit Supplemental Documentation
The “Supplemental Documentation” feature allows the AB user to perform two main
functions related to supplemental documents:
Uploading and submitting documents to FDA
Viewing documents submitted to FDA
To upload new documents or view documents already submitted to FDA, the AB user
will click the “Supplemental Documentation” link from the navigation menu on the “AB
Home” page (Figure 9.1).

Figure 9.1: Navigation Menu

The system will display the “Supplemental Documentation” page (Figure 9.2). Any
document(s) previously submitted to FDA will display in a table at the bottom of the
page. The AB user can click on the hyperlinked document name in the “File Name”
column to view the document.
The AB user will follow Steps 1 - 5 from the “Instructions” section of the page to
upload attachments.
Note: The AB user will click the “Previous” button at the bottom of the “Supplemental
Documentation” page to return to the “AB Home” page.

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Figure 9.2: Supplemental Documentation Page

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The AB user will select a document description from the list displayed in the “Type of
Attachment” dropdown menu (Figure 9.3).
The complete list of values in the “Type of Attachment” menu is as follows:
AB Corrective Action Plan
Add or Manage Laboratories
Internal Audit Results
Laboratory Corrective Action Plan
Notice of Change in AB Recognition
Notice of Records Custodian
Notice of Records Custodian of Lab
Notice to Voluntarily Relinquish Accreditation
Notice to Voluntarily Relinquish Recognition
Request for Regulatory Hearing
Submit Internal Audit Results
Other

Figure 9.3: Type of Attachment Menu

Note: A text box labeled “Additional Description” will display if the AB user selects
“Other” from the list (Figure 9.4).
The AB user will enter a detailed description of the document type in the “Additional
Description” field, which allows a maximum of 200 characters.
The user must enter a description in the “Additional Description” field to proceed to the
next step.

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Figure 9.4: “Other” Attachment Type

A pop-up window will appear, prompting the AB user to access their file system.
The AB user will select one or more file attachments. The “Upload” and “Cancel”
buttons will be enabled after a file is chosen (Figure 9.5). The system will close the
browsing window.
The AB user can click the “Upload” button to complete the attachment upload or, click
the “Cancel” button to discard the attachment upload.

Figure 9.5: Upload and Cancel Buttons

Attachments must be configured as a document type supported by the system.
Note: The system supports the following document types: .pdf, .png, .jpeg, .gif, .bmp,
.jpg, .jpe, .jfif, .tif, .tiff, .doc, .docx, .ppt, .xls, .xlsx, .txt, .pptx, or .rtf.
The maximum file size allowed is 50 MB.
Once the upload is complete, a confirmation message indicating a successful upload
(along with the file name) will display at the top of the page (Figure 9.6).
The system will display uploaded files in the table at the bottom of the page.

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Figure 9.6: Successful Upload Message

To remove the attachment from the table at the bottom of the page, the AB user can
click the trash/delete icon in the “Action” column (Figure 9.7).

Figure 9.7: Trash/Delete Icon

After the additional files have been uploaded, the AB user will click the “Save” button
(Figure 9.8).
**Important: Uploaded files cannot be deleted once “Save” is clicked. The AB user
must click the “Save” button to complete file transmission to FDA.

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Figure 9.8: Save Attachment

Once a file has been uploaded and added to the “Attachments” table, the file name
will become hyperlinked. If the AB user clicks on the hyperlinked file name, they will
be prompted to open or save the file (Figure 9.9).

Figure 9.9: Hyperlinked File Name

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10 Contact Us
The “Contact Us” feature allows the AB user to contact the LAAF program by e-mail.
To access the feature, the AB user will click the “Contact Us” link from the navigation
menu on the “AB Home” page (Figure 10.1). This feature is available to the AB upon
account creation.

Figure 10.1: Navigation Menu

The system will display the “Contact Us” page in an e-mail template format, with a
“Subject” field allowing up to 150 characters and a “Message” field allowing up to
4,000 characters (Figure 10.2). Once the AB user has completed the “Subject” and
“Message” fields, they will click the “Send” button to send the e-mail.

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Figure 10.2: Contact Us Page

The system will display a confirmation message on the “AB Home” page stating the
message has been sent (Figure 10.3).

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Figure 10.3: Email Sent Successfully

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APPENDIX
Abbreviations
Acronyms

Definitions

AB

Accreditation Body

AL

Accredited Laboratory

CFSAN

Center for Food Safety and Applied Nutrition

CVM

Center for Veterinary Medicine

FDA

U.S. Food and Drug Administration

LAAF

Laboratory Accreditation for Analyses of Foods

OAA

Online Account Administration

ORA

Office of Regulatory Affairs

Icon Behavior
Standardized icons are used throughout the system. Each icon performs a specific
system function. The icon description and system function are described below:
Icon Description
Magnifying Glass

Icon

System Function
View the associated item.

Pencil

Edit the associated item.

Trash Can

Delete the associated item.

Printer

Print the associated item.

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