2022-00475. Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public hearing; request for comments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed.

DATES:

The public hearing will be held virtually on March 10, 2022, from 1 p.m. to 5 p.m., Eastern Time. Persons interested in attending this public hearing must register no later than 11:59 p.m. Eastern Time on March 9, 2022. Persons interested in making oral presentations and comments at the public hearing must submit requests by February 18, 2022. Submit either electronic or written comments on this hearing by April 11, 2022. See the SUPPLEMENTARY INFORMATION section for registration dates and information.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 11, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 11, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2021-N-1326 for “Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Kelly Covington, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, [e-mail], 240-402-5661.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose of Hearing

Under the Delaney Clause (section 512(d)(1)(I) (21 U.S.C. 360b(d)(1)(I)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), FDA generally cannot approve a new animal drug application (NADA) if the drug that is the subject of that application induces cancer in humans or animals. 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 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 (section 512(d)(1)(I) of the FD&C Act).

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. (85 FR 43853, July 20, 2020; Docket No. FDA-2020-N-0955, “Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method.”) The currently approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of the residue of carcinogenic concern. (Determination of Carbadox (as Quinoxaline-2-Carboxylic [QCA]) Residues in Swine Liver and Muscle Tissues After Drug Withdrawal, https://www.fda.gov/​about-fda/​center-veterinary-medicine/​cvm-foia-electronic-reading-room. ) The proposal to revoke the approved method for carbadox is based on CVM's determination that the method is inadequate to monitor residue of carcinogenic concern in compliance with FDA's regulations in part 500, subpart E (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.

II. Notice of Hearing Under 21 CFR Part 15

This public hearing will be held in accordance with part 15 (21 CFR part 15). Pursuant to § 15.1(a) and authority delegated from the Commissioner of Food and Drugs as referenced in the FDA Staff Manual Guide 1410.21(1)(B)(6) and (1)(D), the FDA Acting Chief Scientist concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on this matter. The hearing will be conducted by a presiding officer, who will be accompanied by other United States Government employees serving as a panel in conducting the hearing. Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. Only the presiding officer and panel members can pose questions; they can question any person during or at the conclusion of each presentation. To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).

III. Topics for the Public Hearing

We encourage public comments and presentations at the public hearing. We are particularly interested in receiving comments, data, and information about the topics listed below. In submitting comments, data, and information to the docket, please identify available references for the data and information, as well as the specific item number listed below, if applicable. Please reference, but do not resubmit, any information already contained in Docket No. FDA-2020-N-0955, “Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method.”

1. Data to inform our knowledge of the residue of carcinogenic concern not summarized in the Freedom of Information summary for the 1998 supplemental approvals, including additional data regarding the fraction of noncarcinogenic residues in the total radiolabeled residues of carbadox.

2. For any given concentration of a marker residue, the corresponding concentration of the residue of carcinogenic concern.

3. Additional information not already contained in Docket 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.

4. Any method, other than the current approved method, that demonstrates “no residue” for the new animal drug carbadox in conformance with part 500, Subpart E.

5. 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.

IV. Participating in the Public Hearing

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; Public Hearing; Request for Comments” please register at https://fda.zoomgov.com/​j/​1600135012?​pwd=​MFdjMW9FRXg4RGllc3FHWVhkWVAyZz09 by March 9, 2022. If you have any questions, you can contact [e-mail] (See DATES and ADDRESSES ). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Request 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). If you decide you wish to make a presentation after registering online, you may submit a request to [e-mail]. All requests to make presentations must be received by February 18, 2022. 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 [e-mail] 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. An agenda for the hearing and any other background materials will be made available no later than 5 days before the hearing at https://www.fda.gov/​animal-veterinary/​workshops-conferences-meetings/​part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new.

Transcripts: Please be advised that as soon as a transcript of the public hearing is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the Agency's website at https://www.fda.gov/​animal-veterinary/​workshops-conferences-meetings/​part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new.

Dated: January 7, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.