Rules and Regulations. Notice of availability
/register/2024/10/15/2024-23706·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-23706 · Docket No. FDA-2023-D-4095
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #284 entitled “Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food.” FDA's Center for Veterinary Medicine (CVM) has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health claims for certain adult maintenance cat food. RSS is a measurement that estimates the potential for crystal formation and bladder stone growth, which is a common affliction in cats. This guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.
Dates
The announcement of the guidance is published in the Federal Register on October 15, 2024.
Supplementary Information
I. Background In the Federal Register of November 30, 2023 (88 FR 83552), FDA published the notice of availability for a draft guidance entitled “Using Relative Supersaturation To Support Urinary Tract Health' Claims for Adult Maintenance Cat Food,” giving interested persons until February 28, 2024, to comment on the draft guidance. FDA received four comment submissions from industry and industry associations, with multiple comments each on the draft guidance. Comments include requests for more clarity in the recommended study design and parameters, more opportunity to develop studies in consultation with FDA, shorter mechanism of action statement for the label, and questions on the length of recommended studies. These comments were considered as the guidance was finalized. A summary of changes includes: We clarified the language describing the recommended minimum 40-day study for utility and safety, we removed the recommendation to keep animals on a study for up to 26 weeks while we review the submitted data, we shortened the recommended mechanism of action statement for the label and added language indicating that other versions may also be acceptable, we added clarifying language about the target values for demonstrating utility, and we removed conjugated bilirubin from the recommended analytes included in a serum chemistry panel as being redundant if total bilirubin is measured. In addition, editorial changes were made to improve clarity, including creating new headings for the “Combined Safety and Utility Study” and “Other Considerations” sections instead of having them under the “Target Animal Safety” heading. The guidance announced in this notice finalizes the draft guidance dated November 30, 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 “Using Relative Supersaturation To Support Urinary Tract Health' Claims for Adult Maintenance Cat Food.” 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 FDA concludes that this final guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the guidance at , , or . Dated: October 4, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024-23706 Filed 10-11-24; 8:45 am]`