On August 14, 2018, President Trump signed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, reauthorizing the U.S. Food and Drug Administration’s user fee programs for pioneer and generic new animal drugs. These amendments mandated important changes to the process for submitting new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), applications for conditional approval (CNADA) and related information. These changes took effect October 1, 2018. FDA developed several training resources to help drug sponsors understand the recent changes to the submission process.
The two user fee programs for new animal drugs are authorized by the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. Among other things, these laws authorize FDA to collect fees from drug sponsors for certain applications in support of the review of animal drugs.
Required Use of eSubmitter
FDA’s Center for Veterinary Medicine (CVM) has moved toward 100% electronic submission of all (A)NADA applications and related information. As of October 1, 2018, drug sponsors are required to submit all information supporting drug approval using CVM’s eSubmitter program. This program is an electronic, question-based tool for submitting information electronically through the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS).
eSubmitter Webinar Series
This three-part webinar series provides an overview of the electronic submission process, explains how to register for FDA ESG and CVM ESS, and explains how to use eSubmitter:
Webinar 1: FDA ESG and CVM ESS Registration Process (May 23, 2018)
Webinar 2: How to Use the eSubmitter Tool (August 22, 2018)
Webinar 3: Follow-up Question and Answer Session (September 19, 2018)
Reviewing an Original NADA for an ADAA Feed-Use Combination Drug in 60 Days
This webinar describes how FDA evaluates and processes an original new animal drug application (NADA) for a feed-use combination drug that may qualify for a 60-day review timeline under the Animal Drug Availability Act of 1996 (ADAA). An original NADA is the first application submitted to FDA for approval of a drug for a specific use in a specific animal species (or group of animal species). For qualifying applications, the usual 180-day review timeline will be reduced to 60 days.
Certain feed-use combination drugs are regulated under the Animal Drug Availability Act of 1996, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and gave FDA some flexibility in the way the agency regulates medicated feed for animals. If multiple new animal drugs are approved for use in the same medicated feed, the product is called a feed-use combination drug. To be eligible for an approval as a feed-use combination drug (also referred to as an ADAA combination drug), the ADAA requires each drug in the combination to be previously and separately approved (under section 512(b)(1) of the FD&C Act) prior to the submission of an NADA for the feed-use combination drug itself.
The webinar discusses:
- How FDA determines if an original NADA for an ADAA feed-use combination drug is eligible for the new 60-day review timeline;
- Which actions the drug sponsor needs to initiate under the investigational new animal drug (INAD) file before submitting the original NADA;
- Which documents the drug sponsor is required to submit in the original NADA;
- What happens when the review timeline is lengthened to 100 days for an original NADA that initially qualified for a 60-day review timeline, but later required a minor amendment to address FDA’s concerns; and
- What happens when the original NADA does not qualify for the 60-day review timeline and the 180-day review timeline applies.
- Presentation recording: 60-Day Review of Eligible Original Animal Drug Availability Act of 1996 (ADAA) Feed Use Combination NADA Applications
- Presentation Recording Transcript
Reopening a Completed Environmental Impact Technical Section and Reviewing a Categorical Exclusion in 60 Days
This webinar informs drug sponsors about FDA’s process for reopening an Environmental Impact technical section when there has been a change in the proposed conditions of use for the drug after the technical section was completed. This process only applies when a drug sponsor has submitted all technical sections for the pending approval.
The Environmental Impact technical section is a major technical section required for all (A)NADAs. Under the National Environmental Policy Act of 1969, FDA must consider how the environment will be affected if the agency approves an animal drug. To do this, the agency requires that drug sponsors prepare an environmental assessment (EA). This assessment describes how much drug is expected to get into the environment and its potential direct and indirect environmental effects. Instead of submitting an EA, the drug sponsor can ask FDA for a categorical exclusion (CE). A CE means that the drug approval is unlikely to have a significant effect on the environment.
The webinar discusses:
- The types of changes that would result in reopening a completed Environmental Impact technical section;
- Which submissions qualify for a 60-day review timeline;
- The administrative process for communicating and documenting the reopened Environmental Impact technical section; and
- How to resubmit a CE claim through eSubmitter.
- Presentation Recording: Reopening a Completed Environmental Impact Technical Section and Reviewing a Categorical Exclusion in 60 Days
- Presentation Recording Transcript
Tissue Residue Method
FDA has put in place processes to ensure that method demonstrations for analytical methods for residues of new animal drugs take place within 120 days of FDA’s determination that the method is adequately validated.
For new animal drugs intended for use in a food-producing animal, FDA requires a practicable analytical method to identify unsafe drug residues in the edible tissues of the animal. The analytical method is validated by the drug sponsor, then undergoes a method transfer trial to show that the method can be transferred to a new laboratory with a naïve analyst. The method demonstration is a step in the acceptance of the practicable method where the drug sponsor’s laboratory staff demonstrates performance of the method at CVM’s Office of Research for other participants in the method transfer trial.
The slide presentation discusses:
- The submissions related to the practicable method that are expected prior to the method demonstration;
- Changes at CVM to meet the timeline; and
- How to request the method demonstration meeting through eSubmitter.