Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 83551 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, Nuzyra Injection 

(NDA 209817) (omadacycline). Nuzyra 

Injection (NDA 209817) is indicated for 

the treatment of adult patients with the 

following infections caused by 

susceptible microorganisms: 

• Community-acquired bacterial 

pneumonia, and 

• Acute bacterial skin and skin 

structure infections. 

Subsequent to this approval, the 

USPTO received a patent term 

restoration application for Nuzyra 

Injection (NDA 209817) (U.S. Patent No. 

7,553,828) from Paratek 

Pharmaceuticals, Inc., and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

December 23, 2019, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of Nuzyra 

Injection (NDA 209817) and Nuzyra 

Tablets (NDA 209816) represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

USPTO requested that FDA determine 

the products’ regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Nuzyra Injection (NDA 209817) is 4,361 

days. Of this time, 4,118 days occurred 

during the testing phase of the 

regulatory review period, while 243 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

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

355(i)) became effective: October 26, 

2006. The applicant claims September 

26, 2006, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

October 26, 2006, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: February 2, 2018. FDA 

has verified the applicant’s claim that 

the NDA for Nuzyra Injection (NDA 

209817) was initially submitted on 

February 2, 2018. 

3. The date the application was 

approved: October 2, 2018. FDA has 

verified the applicant’s claim that NDA 

209817 was approved on October 2, 

2018. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,812 days of patent 

term extension. 

Note: We have determined that the 

regulatory review period for the human drug 

product, NUZYRA, approved under NDA 

209817 is the same as the regulatory review 

period determined for the human drug 

product, NUZYRA, approved under NDA 

209816. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: November 27, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26363 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–2562] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Temporary 

Marketing Permit Applications 

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 0910–0133. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 


khammond on DSKJM1Z7X2PROD with NOTICES
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