
[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83552-83554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4095]


Using Relative Supersaturation To Support ``Urinary Tract 
Health'' Claims for Adult Maintenance Cat Food; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a draft guidance for industry #284 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 This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by February 28, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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

[[Page 83553]]

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-2023-D-4095 for ``Using Relative Supersaturation to Support 
``Urinary Tract Health'' Claims for Adult Maintenance Cat Food.'' 
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 (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Karen Donnelly, Center for Veterinary 
Medicine (HFV-227), Food and Drug Administration, 12225 Wilkins Avenue, 
Rockville, MD 20852, 240-402-9802, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#284 entitled ``Using Relative Supersaturation to Support ``Urinary 
Tract Health'' Claims for Adult Maintenance Cat Food.'' RSS methodology 
is a measurement that estimates the potential for crystal formation and 
bladder stone (urolith) growth, which is a common affliction in cats. 
One of the primary conditions for urolith formation in any species is 
oversaturation of the urine with dissolved substances (solutes) that 
have the potential to precipitate out of solution and form crystals. 
These crystals can eventually grow into uroliths. The two most common 
types of uroliths in cats are magnesium ammonium phosphate (struvite) 
and calcium oxalate (CaOx).
    Based on concerns about uroliths, pet food manufacturers use 
various formulation strategies to make adult maintenance cat food, with 
general structure or function claims, that support urinary tract health 
(UTH cat food). Historically, manufacturers of UTH cat food restricted 
the magnesium content and/or formulated their cat food to produce 
slightly acidic urine (pH of 5.9 to 6.4). The slight acidity and low 
magnesium content create a urinary environment that is unfavorable for 
struvite crystallization and urolith growth but may be favorable for 
CaOx urolith growth in predisposed cats. Formulating cat food based on 
RSS methodology is a more recent dietary strategy that some pet food 
manufacturers use to create UTH cat food. RSS provides a numerical 
measurement of the degree of saturation of a specific urolith-forming 
substance, and thus a quantitative method to evaluate the risk of 
urolith formation. The principles of RSS apply to all urolith types, so 
UTH cat food based on RSS methodology has the potential to help protect 
cats from both struvite and CaOx uroliths.
    In response to requests from pet food manufacturers, CVM has 
evaluated the use of RSS methodology to support urinary tract health 
claims for certain adult maintenance cat food. This draft guidance 
provides recommendations for how a cat food manufacturer 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. This draft 
guidance also includes information we recommend the manufacturer 
submits to us to ensure the urinary tract health claim is 
substantiated.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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 tentatively concludes that this draft 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 draft guidance 
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.


[[Page 83554]]


    Dated: November 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26306 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P


