Guidance: Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication

Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability

DATES:

The announcement of the guidance is published in the Federal Register on October 16, 2025.

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-2025-D-4500 for "Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication." Received comments 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 its 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.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the guidance to the Policy and Regulations Staff, Center for Veterinary Medicine, 5100 Campus Drive, College Park, MD 20740-3840. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of guidance for industry #299 entitled "Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication." We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without initially seeking prior public comment because we have determined that prior public participation is not feasible or appropriate (see § 10.115(g)(2)). We made this determination in light of the significant potential for a public health emergency associated with New World Screwworm, Cochliomyia hominivorax, (NWS).

NWS is a parasitic fly that lays eggs in and on open wounds and mucous membranes of warm-blooded animals. NWS can infest livestock, pets, wildlife, occasionally birds, and in rare cases, people. Although eradicated from North America and Central America decades ago, NWS has progressed north since 2022 and is approaching the U.S. border with Mexico. This parasite poses an emerging threat to livestock and food security, with potential impacts on both national security and animal health. In order to respond effectively and efficiently to this threat, FDA must act expeditiously to review and, where appropriate, approve or authorize animal drugs for NWS myiasis. ⁽¹⁾ Such approvals may include conditional approvals under section 571 of the FD&C Act for new indications for products that are currently approved for a different indication(s) under section 512 of the FD&C Act.

Section 571(f)(2) of the FD&C Act permits the agency, through regulation or guidance, to determine under what conditions an intended use that is the subject of a conditional approval may be included in the same product label with any intended use approved under section 512 of the FD&C Act, i.e., a full approval. The guidance document refers to this practice as "dual labeling." While FDA intends to issue guidance in the future to more broadly address conditions under which it would consider dual labeling appropriate, FDA is issuing this guidance concerning products with indications for NWS at this time due to the particular need to act quickly and efficiently to address the imminent health threat of NWS.

Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation.

The guidance represents the current thinking of FDA on "Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication." It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in sections 512 and 571 of the FD&C Act (21 U.S.C. 360b) have been approved under 0910-0032. The collections of information in 21 CFR 514.80 have been approved under 0910-0284.

III. Electronic Access

Persons with access to the internet may obtain the document at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

⁽¹⁾  We note that this guidance document is relevant to new animal drugs with approved and conditionally approved claims. Emergency Use Authorizations under section 564 of the FD&C Act are outside the scope of this guidance.