83552 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Temporary Marketing Permit 

Applications—21 CFR 130.17(c) and (i) 

OMB Control Number 0910–0133— 

Extension 

This information collection request 

supports FDA regulations found in 21 

CFR 130.17 (section 130.17). Section 

401 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

341) directs FDA to issue regulations 

establishing definitions and standards of 

identity (SOIs) for food. Under section 

403(g) of the FD&C Act (21 U.S.C. 

343(g)), a food that is subject to a 

definition and SOI prescribed by 

regulation is misbranded if it does not 

conform to such definition and SOI. 

Section 130.17 provides for the issuance 

by FDA of temporary marketing permits 

(TMPs) that enable the food industry to 

test consumer acceptance and measure 

the technological and commercial 

feasibility in interstate commerce of 

experimental packs of food that deviate 

from applicable definitions and SOIs. 

Section 130.17(c) enables the Agency to 

monitor the manufacture, labeling, and 

distribution of experimental packs of 

food that deviate from applicable 

definitions and SOIs. The information 

so obtained can be used in support of 

a petition to establish or amend the 

applicable definition or SOI to provide 

for the variations. Section 130.17(i) 

specifies the information that a firm 

must submit to FDA to obtain an 

extension of a TMP. To assist 

respondents with the TMP process, we 

have developed guidance entitled 

‘‘Temporary Permits for Interstate 

Shipment of Experimental Packs of 

Food Varying from the Requirements of 

Definitions and Standards of Identity: 

Guidance for Industry’’ (November 

2021). This resource can be found on 

our website https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/guidanceindustry-temporary-permits-interstateshipment-experimental-packs-foodvarying-requirements. 

Description of Respondents: 

Respondents to this collection of 

information include private sector 

businesses including institutional and/ 

or industrial customers and food 

industry members such as 

manufacturers, packers, or distributors 

desiring to apply for a TMP or TMP 

extension. 

In the Federal Register of July 17, 

2023 (88 FR 45431), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

130.17(c); Request for TMP ................................................ 13 2 26 25 650 

130.17(i); Request for TMP extension ................................. 1 2 2 2 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 654 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: November 24, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26300 Filed 11–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 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 selfaddressed 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, 

karen.donnelly2@fda.hhs.gov. 

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/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 


khammond on DSKJM1Z7X2PROD with NOTICES
83554 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2459] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Product 

Jurisdiction and Combination 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 2, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0523. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Product Jurisdiction and Combination 

Products—21 CFR Parts 3 and 4 

OMB Control Number 0910–0523— 

Extension 

This information collection helps 

support implementation of statutory 

requirements that govern product 

jurisdiction and combination products. 

Congress expressly directed FDA to 

assign combination products to the 

appropriate Agency component for 

regulation as set forth in section 503(g) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 353(g)). 

Congress also expressly directed FDA to 

determine the classification of a product 

as a drug, biological product, device, or 

combination product, or the component 

of the Agency that will regulate the 

product, as applicable, in response to a 

request submitted under section 563 of 

the FD&C Act (21 U.S.C. 360bbb–2). 

Regulations in 21 CFR part 3 provide 

for product classification 

determinations and FDA designation on 

which Agency component will have 

primary jurisdiction for any drug, 

device, biological, or combination 

product, where such jurisdiction is 

unclear or in dispute. These 

determinations are made by our Office 

of Combination Products (OCP) upon 

receiving Requests for Designation 

(RFDs). We maintain a web page that 

includes contact and resource 

information pertaining to the RFDs 

process at https://www.fda.gov/ 

combination-products/jurisdictionalinformation. As communicated on our 

web page, FDA welcomes comments 

from interested stakeholders on issues 

pertaining to OCP and encourages 

medical product developers to contact 

us if they are uncertain about the 

classification or assignment of their 

products and with questions regarding 

premarket or postmarket considerations 

for combination products. A dedicated 

mailbox is established at combination@

fda.hhs.gov. 

Similar to the RFD process, we have 

established the Pre-RFD process for 

sponsors to obtain preliminary, 

nonbinding feedback regarding medical 

product classification and assignment. 

Although Forms FDA 5003, 5004, and 

5005 (pre-request and request for 

designation forms) were previously 

developed to facilitate information 

collection for Pre-RFDs and RFDs, we 

have more recently issued the following 

Agency guidance documents to provide 

instruction and recommendations to 

respondents regarding the submission of 

RFDs and Pre-RFDs. 

• The guidance document entitled, 

‘‘How to Write a Request for 

Designation’’ (April 2011), provides 

instruction regarding the information 

that needs to be submitted to OCP in an 

RFD as described in 21 CFR 3.7. The 

guidance is available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/howwrite-request-designation-rfd. 

• The guidance document entitled 

‘‘How to Prepare a Pre-Request for 

Designation,’’ (February 2018) was 

developed to assist sponsors in 

obtaining a preliminary, non-binding 

assessment regarding the classification 

and assignment of products from OCP 

through the Pre-RFD process. The 

guidance explains the Pre-RFD process 

and helps a sponsor understand the type 

of information to provide in a Pre-RFD 

submission. The guidance is available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/how-prepare-pre-requestdesignation-pre-rfd. 

• This information collection also 

includes burden associated with 

Combination Product Agreement 

Meetings (CPAM) requests. The 

guidance document entitled, 

‘‘Requesting FDA Feedback on 

Combination Products,’’ (December 

2020) was developed to discuss ways in 

which combination product sponsors 

can obtain feedback from FDA on 

scientific and regulatory questions and 

to describe best practices for FDA and 

sponsors when interacting on these 

topics. The guidance is available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/requesting-fda-feedbackcombination-products. 

The guidance documents were issued 

consistent with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

The information collection also 

includes regulations in 21 CFR part 4 

that govern current good manufacturing 

practice requirements and 

postmarketing safety requirements for 

combination products. We expect, 

however, that burden attendant to the 

associated recordkeeping, reporting, 

and/or disclosure activities is already 

accounted for in approved information 

collections that apply to drug, device, 

and/or biologic products specifically 

and respectively. Therefore, we do not 

ascribe separate burden in this 

information collection request for the 

activities generated by these 

requirements. 

Respondents to the information 

collection are sponsors of medical 

products, including combination 

products. Based on submissions 

received by OCP during fiscal years 

2020, 2021, and 2022, we account for 

135 respondents annually. 

In the Federal Register of July 31, 

2023 (88 FR 49467), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. One 

comment was received expressing 

interest in combination product 


khammond on DSKJM1Z7X2PROD with NOTICES