Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-13921 · Docket No. FDA-2023-D-3740

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #283 entitled “Priority Zoonotic Animal Drug Designation and Review Process.” This guidance is intended to assist sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. This guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process for PZADs.

Dates

The announcement of the guidance is published in the Federal Register on June 26, 2024.

Supplementary Information

I. Background In the Federal Register of December 18, 2023 (88 FR 87433), FDA published the notice of availability for a draft GFI #283 entitled “Priority Zoonotic Animal Drug Designation and Review Process” giving interested persons until February 16, 2024, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Changes to the final guidance include the following: providing examples of preliminary clinical evidence for the purposes of PZAD designation; confirming that PZAD indications may appear on the same product labeling as non-PZAD indications; and confirming that PZAD designation does not impact potential qualification for other review incentive programs within or outside of the Center for Veterinary Medicine. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated December 2023. This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the Priority Zoonotic Animal Drug Designation and Review Process. 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 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 21 CFR part 514 have been approved under OMB control number 0910-0032; the collections of information in 21 CFR 511.1 have been approved under OMB control number 0910-0117. III. Electronic Access Persons with access to the internet may obtain the guidance at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Dated: June 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13921 Filed 6-25-24; 8:45 am]