AOAC STANDARDS & METHODS ORIENTATION E-BOOK

AOAC INTERNATIONAL - Official Methods of Analysis SM Program (OMA) HOWTOSUBMITAMETHOD

AOAC INTERNATIONAL’S PREMIER METHODS PROGRAM AOAC Official Methods SM program allows for submissions for all proprietary, single and sole source methods. Methods submitted through the PTM-OMA harmonized process also will be reviewed through the Official Methods of Analysis SM (OMA) program. The program evaluates chemistry, microbiology, and molecular biology methods. It also evaluates traditional benchtop methods, instrumental methods, and proprietary, commercial, and/or alternative methods. All methods in the AOAC Official Methods SM program are now reviewed by Expert Review Panels for First Action AOAC Official Methods of Analysis SM status, continuance, repeal, and/or to recommend for AOAC Final Action Official Methods status. HOW TO SUBMIT YOUR METHOD  Method Submission Deadlines The Expert Review Panel (ERP) will meet in person a minimum of two (2) to four (4) times per year: *AOAC Mid‐ Year meeting (DC metro area) * AOAC Annual Meeting * Two (2) additional designated times for proprietary method Organizational Affiliates. Please refer to our OMA Submission Deadlines .  Call for Methods AOAC INTERNATIONAL invites method authors and developers to submit relevant methods that may meet the AOAC Standard Method Performance Requirements (SMPR®). For methods submitted through an open Call for Methods, please see the Standards Development submission deadlines. For a specific open Call for Methods or more detailed information, please visit www.aoac.org . APPLICATION PROCESS Method Author or Champion Submits Consulting Service Application and Remittance • Section 1: Organization and Applicant Information • Section2: AOAC Terms & Conditions • Section 3: Submission and Method Information Application will include Method applicability statement including target analyte(s), Matrix combinations, method instructions, and relevant method safety information. • Section 4: Application Fees and Payment

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Required application documentation: • Method manuscript in OMA format • Package insert or user manual, (if rapid method or test kit) • Safety checklist • Validation protocols ( not required if AOAC Consulting Service is used ) $35,000.00 USD per method for Non-Organizational Affiliates • $20,000.00 USD per method for Organizational Affiliate • $15,000.00 USD per method for Organizational Affiliate for joint/ harmonized methods (e.g., PTM-OMA, etc.) • $10,000.00 USD AOAC Organizational Affiliate Membership. AOAC EXPERT REVIEW PANEL PROCESS The AOAC Expert Review Panels (ERPs) adopt candidate methods as First Action Official Methods and recommend adoption of these methods to Final Action Official Methods status. The composition of the ERP must be fulfilled with qualified subject matter experts representing various perspectives. All methods are reviewed under the following criteria, technical evaluation, general comments, editorial criteria, and recommendation status. Methods are reviewed against their collaborative study protocols and/or Standard Method Performance Requirements (SMPR®). Method author(s) are invited to attend and present their method during the Expert Review Panel session and to respond to the comments of the ERP. At the conclusion of the review of the method, the ERP will render a decision to either grant or not to grant the method with an AOAC First Action Official Methods SM status. OPTIONAL CONSULTING SERVICES  AOAC’s Consulting service is an optional service that allows method developers to quickly organize your study to collect the exact data needed to evaluate and validate a method. *Use of the service does not guarantee or infer a method approval. • OMA Program Fees • To apply, visit www.aoac.org >Official Methods Program

For more information visit www.aoac.org > Official Methods of Analysis Program 2275 Research Blvd., Suite 300 * Rockville, MD 20850 USA * Telephone: +1-301-924-7077 x129 * Fax: +1-301-924-7089 Internet e-mail: aoacri@aoac.org * World Wide Web Site: http://www.aoac.org. © 2019 Copyright AOAC INTERNATIONAL.