FDA Publishes Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions and GRAS Notices

FDA Publishes Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions and GRAS Notices

February 14, 2020, Covington Alert

On February 13, 2020, the Food and Drug Administration (FDA) issued a draft guidance document describing the pre-submission consultation process for food additive petitions (FAPs) and generally recognized as safe (GRAS) notices for ingredients used in animal feed/pet food, and describing what to include in food use authorization (FUA) requests. The Animal Drug and Animal Generic Drug User Fee Amendments of 2018 required that FDA develop this guidance by today, February 14, 2020, and finalize it one year after the close of the draft guidance comment period. FDA requests electronic or written comments concerning the draft guidance be submitted to the docket by April 13, 2020.

FDA encourages pre-petition or pre-notification consultations with FDA for FAPs and GRAS notices, and recommends that you contact FDA early in the development process. A pre-submission consultation may be used to, among other things:

• Discuss your proposed intended use of a substance, the best avenue for approval (FAP or GRAS notice) and whether existing information is likely to meet FDA’s requirements;
• Address how to establish safe conditions of use;
• Consult with FDA about data interpretation and recommendations on proposed studies and research methodologies; and
• Determine what additional data and information may be needed.

Investigational Food Additive (IFA) File for Animal Food

In addition to pre-submission consultation meetings and general correspondence requests, the draft guidance discusses the Investigational Food Additive (IFA) file, through which sponsors can communicate confidentially with FDA regarding data and information while conducting pre-submission studies. This information can include reviews of study protocols and of the adequacy of existing data from a completed study. Although FDA has no hard-and-fast deadlines for such review, the draft guidance says FDA will try to adhere to the following review times, all calculated from the date FDA receives the submission:

• Study protocol without method validation or preliminary data: 50 days
• Study protocol with method validation or preliminary data: 130 days
• Analytical method development and validation: 130 days
• Adequacy of existing data from a completed study: 180 days

Sponsors can also use an IFA to submit FUA requests. FDA seeks to provide a response letter 130 days from the date of receipt.

Establishing an IFA File

An IFA file should include:

• The common or usual name of the substance you intend to investigate;
• The proposed intended use of the substance;
• The target animal species for the substance’s proposed use; and
• An Environmental Assessment or a request for a Categorical Exclusion (CE) from preparation of an Environmental Assessment.

FDA’s draft guidance summarizes the information that must be included in each type of submission to an established IFA file:

• In Appendix 2 to the draft guidance, FDA describes the recommended content and format for a request to review a study protocol.
• FUA Requests should include information about the investigational substance, its composition, the form in which it will be fed, the maximum use rate, the route of delivery, the target animal, the study design, the duration of administration and the hold time prior to slaughter, among other information.
• A Request for Review of the Adequacy of Study Data should be submitted to FDA in the form of a final study report, which should be formatted in accordance with Appendix 3.

Submitting Information to an IFA File and FDA’s Response

Sponsors can establish an IFA file or add documents to an existing one through the Center for Veterinary Medicine eSubmitter Application using FDA’s secure Electronic Submission Gateway. For detailed explanations on how to submit information through the eSubmitter tool, FDA refers users to its website, “Electronic Submissions,” and Guidance For Industry #108, “Registering with CVM’s Electronic Submission System.”

FDA will convey comments from its review in a letter to the requester, and will notify the requester if the review of a study protocol without accompanying data is expected to exceed 50 days.

Environmental Assessments

FDA is required under the National Environmental Policy Act (NEPA) to consider the environmental impact of its regulatory actions, including those relating to the investigational use of a substance. In accordance with 21 CFR 25.20(i), approval of an FAP and approval of a request for an exemption for investigational use of a substance are both actions that normally require preparation of at least an Environmental Assessment, unless the action is of a class that qualifies for categorical exclusion.

 If you have any questions concerning the material discussed in this client alert, please contact the following members of our Animal Food and Drug practice.