Part 15 Public Hearing: Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox
Date: March 10, 2022, 1:00 p.m. – 5:00 p.m. ET
On This Page:
- Background
- Part 15 Hearing Information
- Registration
- Requests for Oral Presentations
- Submitting Electronic or Written Comments
- Transcript
The Food and Drug Administration will hold a public hearing on Thursday, March 10, 2022, from 1pm – 5 pm Eastern Time, on Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox. The hearing, which will be held virtually, will provide an opportunity for stakeholders to share data and information on this topic with the FDA.
Background
Under the Delaney Clause (section 512(d)(1)(I)) of the Food, Drug, and Cosmetic Act (FD&C Act), the FDA generally cannot approve an application for a carcinogenic new animal drug. An exception to this general rule is commonly known as the Diethylstilbestrol “DES” Proviso, which allows for the approval of a carcinogenic new animal drug where the FDA finds that under the approved conditions of use: (1) The drug will not adversely affect the animals treated with the drug; and, (2) no residues of the drug will be found by an approved regulatory method in any edible tissues of, or in any foods yielded by, the animal.
On July 20, 2020, the Agency published a notice in the Federal Register proposing an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. The currently approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of the residue of carcinogenic concern. The proposal to revoke the approved method for carbadox is based on CVM’s determination that the method is inadequate to monitor the residue of carcinogenic concern in compliance with FDA's regulations (21 CFR part 500, subpart E). These regulations set out the requirements for demonstrating that no residues of the drug will be found by an approved regulatory method in any edible tissues of or in any foods obtained from the animal, as required to meet the requirements of the DES Proviso. The purpose of the public hearing is to gather additional data and information related to the residue of carcinogenic concern for the new animal drug carbadox.
The hearing will be conducted by a presiding officer, who will be accompanied by other employees of the United States government serving as a panel in conducting the hearing. Dr. Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs, FDA, will serve as the presiding officer for the hearing. The panelists for the hearing will be:
- Dr. Donald Prater, Associate Commissioner for Imported Food Safety, Office of Food Policy and Response, FDA;
- Dr. Louis Bluhm, Director, Laboratory Quality Assurance, Response, and Coordination Staff; Food Safety and Inspection Service (FSIS), USDA;
- Dr. Meredith Egger, Animal Scientist, Office of New Animal Drug Evaluation, FDA’s Center for Veterinary Medicine; and
- Dr. Jonathan Greene, Biologist, Office of New Animal Drug Evaluation, FDA’s Center for Veterinary Medicine.
Part 15 Hearing Information
FDA encourages public comments and presentations at the public hearing. We are particularly interested in receiving comments, data, and information about the topics listed below:
- Data to inform our knowledge of the residue of carcinogenic concern not summarized in the FOI summary for the 1998 supplemental approvals, including additional data regarding the fraction of noncarcinogenic residues in the total radiolabeled residues of carbadox.
- For any given concentration of a marker residue, the corresponding concentration of the residue of carcinogenic concern.
- Additional information not already contained in Docket No. No. FDA-2020-N-0955, “Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method” related to the adequacy of the current approved method to measure QCA as a marker residue for the residue of carcinogenic concern for the new animal drug carbadox.
- Any method, other than the current approved method, that demonstrates “no residue” for the new animal drug carbadox in conformance with 21 CFR part 500, Subpart E.
- Detailed information on the conduct and quality of studies providing data to support the points above, including information on the extraction process and the stability of residues being analyzed.
Registration
To register to attend the virtual public hearing on ‘‘Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox,’’ please register at https://fda.zoomgov.com/j/1600135012?pwd=MFdjMW9FRXg4RGllc3FHWVhkWVAyZz09 by March 9, 2022. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.
Requests for Oral Presentations
During online registration, you may indicate if you wish to make a formal presentation (with accompanying slide deck) or present oral comments during the public hearing session (with no slide deck) and which topic(s) you would like to address. If you decide you wish to make a presentation after registering online, you may submit a request to [email protected]. All requests to make presentations must be received by February 18, 2022.
The FDA will do its best to accommodate requests to make public presentations. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations. FDA will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin and will select and notify participants by February 23, 2022.
If selected for a formal oral presentation (with a slide deck), each presenter must submit an electronic copy of their presentation (PowerPoint or PDF) to [email protected] with the subject line “Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments” on or before March 4, 2022. No commercial or promotional material will be permitted to be presented or distributed at the public hearing.
Persons notified that they will be presenters are encouraged to be online early. Actual presentation times may vary based on how the hearing progresses in real time.
Presentations from the Part 15 hearing can be found at https://www.regulations.gov/document/FDA-2021-N-1326-1568.
Submitting Electronic or Written Comments
The FDA has opened a docket and is accepting electronic or written comments. Interested persons were originally given until April 11, 2022, to comment on this hearing. The FDA has received a request to allow interested persons additional time to comment and is now extending the comment period until June 10, 2022. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2021-N-1326 in the search box.
To submit comments to the docket by mail, follow the instructions in the Federal Register Notice.
Transcript
A transcript of the Part 15 hearing is available at https://www.regulations.gov/document/FDA-2021-N-1326-1567. You can also view a video recording of the hearing at the following link: Part 15 Hearing - Zoom (zoomgov.com).