AOAC INTERNATIONAL AOAC PERFORMANCE TESTED METHODS (PTM) AOAC OFFICIAL METHODS OF ANALYSIS (OMA)

AOAC INTERNATIONAL AOAC PERFORMANCE TESTED METHODS (PTM)

APPLICATION FOR PTM METHOD SUBMISSION
PART I - AUTHORIZED METHOD SUBMITTER

CONTACT INFORMATION

PTM applications ONLY

Please note that this application must be completed and submitted by the contact that is authorized by the organization to pursue and obtain validation and/or the development of protocols. All correspondence in relation to this application will be directed to the contact listed in this section.
First Name *
Last Name *
Organization *
Title *
Address *
City/Town, State/Country, Postal Code *
Telephone *
Email Address *
LEGAL NAME OF METHOD: *
Date of Submission: *

Month Day Year
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PART I.A. - FINANCIAL CONTACT INFORMATION

Please provide the contact iinformation for the person within your organization that will be responsible for receiving and processing the payments for invoicing.
Financial Contact: First Name *
Financial Contact: Last Name *

Address

Street Address
Street Address Line 2
City	State / Province
Postal / Zip Code	Country

Telephone *
E-mail

PART II - TERMS & CONDITIONS

Please read all Terms and Conditions ( Certain Terms and Conditions are subject to change ).
AOAC INTERNATIONAL Policy Documents
AOAC Research Institute Fee Schedule
AOAC Research Institute Fee Schedule
I HAVE READ AND AGREE TO THE TERMS AND CONDITIONS.

Accept Decline

PART III- METHOD REVIEW
Please select the type of method review program to which you wish to apply. *

AOAC Performance Tested Method (PTM) Harmonized AOAC Performance Tested (PTM) and AFNOR Harmonized AOAC Performance Tested (PTM) and MICROVAL Harmonized AOAC Performance Tested (PTM) and NORDVAL Harmonized AOAC PTM to Official Methods of Analysis (OMA)*
* Please note, following the PTM review Method Developers' will need to submit an OMA application to advance to the OMA program.

PART IV - METHOD AUTHOR CONTACT INFORMATION

The method or study author is the person who will be primary contact for the method submission, including correspondence regarding method reports and reviews.
Method Author Contact Information *
Co-Method Author Contact Information
PART V- METHOD INFORMATION
Legal Name of Method/Product: *
Catalog Number(s) - (if applicable)
Briefly describe Sample Preparation Procedure
Briefly describe analyte isolation procedures (Enrichment, Extraction procedures - if available)
Briefly describe method of detection/ determination/identification
Briefly describe any method confirmation, if applicable
State Matrices to be reviewed: *
Method Applicability and Intended Use *
PTM Reviews: Please attach package inserts/user instructions.
PRODUCT INSERT REQUIREMENTS: The test kit insert should include the following items, when applicable: Intended User - Specify the intended user, such as farmer, milk processor, analytical laboratory, etc. Environmental Factors - In what environment should the test be conducted? Laboratory? Office? Hot or cold? Good ventilation? Applicability - Identify the analyte, mode of measurement (e.g., detection or quantitation) and matrices (e.g., specific foods or feeds, specific beverages, specific environmental surfaces, waste water, etc.) for which the kit has been validated. Include precautionary statements on potential interferences and other known limitations of the test. Instructions - Include complete instructions on how to conduct the test from sample preparation to data interpretation. Describe the use of any internal or external quality control features. Shelf Life - What is the shelf life of the test kit? What are the required storage conditions for the kit? Detection Limit and Limit of Quantitation - Express in concentration (parts per million, percent, mg/kg, CFU/g, etc.) the limits of detection and quantitation as defined under "Data Package." These statements should agree with the supporting data. Precautions - Provide warnings of safety concerns, disposal instructions, and potentially hazardous steps or components. Technical Assistance - Provide information (email, internet, telephone and FAX numbers) where the user can obtain technical assistance.
Please attach a copy of packaging. *
Please attach QA/QC synopsis for manufacturing location. *
Comments:
INDEPENDENT LABORATORY RECOMMENDATIONS

Please recommend at least three independent laboratories from which bids can be solicited. Please be sure that the three laboratories are different. The AOAC-RI reserves the right to choose additional laboratories from which to solicit independent laboratory bids.
Potential Independent Laboratory #1 *
Potential Independent Laboratory #2 *
Potential Independent Laboratory #3 *
I UNDERSTAND THAT THE METHOD DEVELOPER AGREES TO PAY THE AOAC RESEARCH INSTITUTE THE ESTIMATED COSTS PER THE ACCEPTED BID OF THE INDEPENDENT LABORATORY FOR THE INDEPENDENT VALIDATION EVALUATION. AFTER THE INDEPENDENT EVALUATION IS COMPLETE, AOAC RESEARCH INSTITUTE WILL PROVIDE THE METHOD DEVELOPER AN INVOICE FOR ACTUAL FEES. AMOUNTS WILL BE RECONCILED IF ESTIMATED COSTS DIFFER FROM ACTUAL COSTS. THE INDEPENDENT LABORATORY REPORT MAY NOT BE RELEASED UNTIL ALL INDIEPENDENT LABORATORY FEES HAVE BEEN REMITTED TO THE AOAC RESEARCH INSTITUTE. ADDITIONAL INDEPENDENT TESTING REQUIRING AN INCREASE IN COSTS WILL NOT BE PERFORMED WITHOUT THE WRITTEN APPROVAL OF THE METHOD DEVELOPER. *

I AGREE I DISAGREE

I UNDERSTAND THAT APPLICATION FEES MUST BE REMITTED PRIOR TO THE COMPLETION OF THE METHOD REVIEW TO RECEIVE COMPLETED DATA FOR FINAL REVIEW *

YES NO
I CERTIFY THAT THE RESPONSES IN THIS APPLICATION ARE ACCURATE TO THE BEST OF MY KNOWLEDGE. *

YES NO
I CERTIFY THAT I AM AUTHORIZED TO SUBMIT THIS APPLICATION. *

YES NO
I understand that as a requirement of AOACRI PTM approval, submission of a Certificate of Authenticity is required for multi-lingual inserts/guides if the method is approved. Please print this form for future use.
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