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RG-1 Regulatory Guidance:
Chapter 8 - Pre-submission consultation procedures for livestock feed

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Introduction

To obtain an approval and/or registration, applicants must provide a pre-market submission to the Animal Feed Division (AFD) of the CFIA. The specific data requirements for pre-market submissions are dependent on the nature of the feed in question. The CFIA provides guidance to stakeholders on how to meet the data requirements for the assessment process through workshops, and the publication of regulatory guidance documents. The Animal Feed Division also provides the option of pre-submission consultations with applicants which can provide even more detailed regulatory interpretation and guidance.

This document provides information on how to request a pre-submission consultation meeting with subject matter experts from the AFD. To make the pre-submission consultation meetings most useful, it is best that the consultation follows a standardized process; the following guidelines have been developed.

Applicants must consult with the RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards regarding all administrative and data requirements prior to requesting a pre-submission consultation meeting. Many questions regarding the application process or data requirements may be clarified by consulting the guidance documents or by requesting a clarification via e-mail with the AFD. If the applicant has additional clarifications after reviewing the RG-1 or requesting information by e-mail, the applicant may then request a pre-submission meeting with the AFD. A meeting or teleconference may be scheduled depending upon the nature of the clarification request. Questions related to pre-market submissions can be sent to the AFD generic mailbox at cfia.afp-paa.acia@inspection.gc.ca

Purpose and scope of the pre-submission consultation and this guidance document

The purpose of this document is to formalize the process for a specific type of consultation: the pre-submission consultation for livestock feeds. Focus of the consultation is related to the specific livestock feed ingredient or product to be submitted for pre-market assessment and the preparation for a complete submission package that clearly details all of the necessary requirements for safety and/or efficacy assessments.

Description of pre-submission consultations

A pre-submission consultation is a voluntary process that occurs between applicants and the AFD to address potential questions related to the assessment criteria of a specific livestock feed ingredient or product before the official pre-market submission is submitted for assessment. The consultation allows applicants to seek clarification on pre-market submission regulatory requirements and consult on information that may or may not be included in their pre-market submissions. It is intended to provide a mechanism for the AFD to provide the applicant with thorough and aligned guidance and to assist the applicant in providing a high quality pre-market submission.

The goal of a pre-submission consultation is to improve predictability of the pre-market assessment process and the overall quality of pre-market submissions. Pre-submission consultations also allow the AFD to provide valuable guidance to applicants who have less experience with the regulatory process and submission preparation.

The AFD can provide considerations and input regarding the completeness of the proposed pre-market submission and respond to applicants' questions with respect to their proposed submission. This process often reduces the number of additional information requests required to complete an assessment and reach a decision. Please note that all pre-market submissions, whether they were subject to a pre-submission consultation or not, are reviewed in the order that they are received and successfully screened in.

With regard to the specific feed being discussed, pre-submission consultations usually can include:

Pre-submission consultations will not include:

Roles and responsibilities

Applicant

Animal Feed Division

Procedure

1. Applicant requests a pre-submission consultation at least four (4) weeks prior to the desired pre-submission consultation

A meeting request should be made by an applicant (example, registrant, importer, manufacturer, Canadian Agent, etc.) in writing at least four (4) weeks ahead of the desired time frame of the proposed pre-submission consultation.

The applicant sends an email message to cfia.afp-paa.acia@inspection.gc.ca indicating that a request for a pre-submission consultation is being made, and include the following information:

The AFD acknowledges receipt of the request within one week of receiving the email request and will be responsible for organizing the pre-submission consultation.

2. Applicant provides relevant information package to AFD minimum of two (2) weeks prior to the pre-submission consultation

Applicants are to submit electronic copies of the relevant information that they wish to discuss, including any specific questions that they would like the AFD to address, in sufficient detail at least two (2) weeks prior to the scheduled pre-submission consultation. In addition to providing enough time for logistical planning, this lead time will allow all subject matter experts to review the information and prepare for the consultation in order to provide meaningful advice during the pre-submission consultation. The applicant is encouraged to provide sufficient information on the product to enable the AFD to identify product-specific issues that may need to be addressed at the pre-submission consultation and, if applicable, provide specific questions for which answers are required from the AFD at the time of the pre-submission consultation.

In the event that insufficient information is provided, or if information or questions are not provided at least two weeks prior to the scheduled consultation, the AFD may not be able to provide valuable feedback. In this case, the AFD lead may postpone the consultation and will reschedule it for a later date after the complete pre-submission consultation information package has been received.

The information package should include the following:

This information package can be in the form of documents, slides or presentation material that may be used at the pre-submission consultation by the applicant.

3. Applicant provides an agenda two (2) weeks prior to the pre-submission consultation meeting

It is requested that the applicant begin the development of the agenda. There is no agenda template; however pre-submission consultations commonly follow this format:

The applicant should ensure that all topics for discussion are listed on the agenda, as well as a list of specific questions to be addressed by the AFD during the pre-submission consultation. The AFD will contribute to the agenda as necessary and finalize it in conjunction with the applicant, where needed.

During the pre-submission consultation

During the meeting, the applicant is invited to present a brief overview of the product, ask any questions or points of discussion originally submitted in their consultation request/agenda as well as record minutes of the meeting. The role of the minute recorder has been assigned to the company representative to ensure that the information they deem important and relevant is captured.

The AFD will provide advice and guidance in response to the questions under discussion. The AFD may or may not be able to immediately address additional questions that develop from the discussion (i.e., not provided in advance with the pre-submission consultation information package). Questions that were not answered at the meeting will be noted and will be addressed separately through email.

Following the pre-submission consultation

The information provided by the applicant prior to the pre-submission consultation, together with the information package material, will be retained and filed accordingly by the AFD.

Any information identified as confidential business information in the applicant's file and/or discussed at the pre-submission consultation will be treated as such and in accordance with the provisions of the Access to Information Act and the Privacy Act. Access to the file will be restricted to the applicant or person(s) granted signing authority by the applicant.

Disclaimer

The advice and/or conclusions resulting from a pre-submission consultation should be considered applicable for an indeterminate period, except in the event of any new information becoming available about the product, or in the event of any legislative, regulatory, or policy changes that would affect the guidance. To account for such possibilities, the following disclaimer will be included in all consultation summary documents:

The above advice/conclusions provided by the AFD are based on current policy and the quality and accuracy of the information supplied by the applicant. There may be subsequent legislative or regulatory policy changes, or significant new information may come to the attention of the AFD, which could affect the guidance resulting from this consultation. It is the sole responsibility of the applicant/company to maintain current knowledge of any policy or legislation changes that may alter or impact this guidance. It must be recognized that the guidance provided by the AFD is not intended to alter or qualify in any way CFIA's authority and responsibility to evaluate and decide on the acceptability of a product in accordance with the Feeds Act and Regulations.

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