Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food; Guidance for Industry; Availability, 83017-83018 [2024-23706]

Download as PDF Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices khammond on DSKJM1Z7X2PROD with NOTICES the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and AllInclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities, 89 FR 59186 (July 22, 2024) (hereinafter referred to as the ‘‘July 2024 Proposed Rule’’). 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ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application for KISQALI (ribociclib), approved September 17, 2024, meets the criteria for redeeming a priority review voucher. SUMMARY: FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1394, email: Cathryn.Lee@ fda.hhs.gov. FDA is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the supplemental application (Supplement18) for KISQALI (ribociclib) meets the redemption criteria. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about KISQALI (ribociclib), go to the ‘‘Drugs@FDA’’ website at https://www.accessdata. fda.gov/scripts/cder/daf/. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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, E:\FR\FM\15OCN1.SGM 15OCN1 83018 Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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– 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 VerDate Sep<11>2014 16:35 Oct 11, 2024 Jkt 265001 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-201509-18/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, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Karen Donnelly, Center for Veterinary Medicine, Food and Drug Administration, 12225 Wilkins Ave., Rockville, MD 20852, 240–402–9802, karen.donnelly2@fda.hhs.gov. 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. 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] BILLING CODE 4164–01–P E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83017-83018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23706]


-----------------------------------------------------------------------

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; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

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.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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,

[[Page 83018]]

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-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, 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 guidance document.

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

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 
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: October 4, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23706 Filed 10-11-24; 8:45 am]
BILLING CODE 4164-01-P

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