Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Notices 83417 

3. The date the application was 

approved: July 9, 2021. FDA has verified 

the applicant’s claim that NDA 215341 

was approved on July 9, 2021. 

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 1,597 days of patent 

term extension. 

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 24, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26251 Filed 11–28–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2707] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Petitions for 

Exemption From Preemption 

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 December 

29, 2023. 

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 0910–0277. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

State Petitions for Exemption From 

Preemption 

OMB Control Number 0910–0277— 

Extension 

This information collection supports 

FDA regulations. Under section 403A(b) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 343–1(b)), 

States may petition FDA for exemption 

from Federal preemption of State food 

labeling and standard-of-identity 

requirements. Section 100.1(c) (21 CFR 

100.1(c)) provides prerequisites a 

petition must satisfy for an exemption 

from preemption. Section 100.1(d) sets 

forth the information a State is required 

to submit in such a petition. The 

petition must be submitted to the 

Dockets Management Staff. The 

information required under § 100.1 

enables FDA to determine whether the 

State food labeling or standard-ofidentity requirement satisfies the 

criteria of section 403A(b) of the FD&C 

Act for granting exemption from Federal 

preemption. 

In the Federal Register of July 31, 

2023 (88 FR 49469), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four information collection topics 

solicited. 

Description of Respondents: The 

respondents to this collection of 

information are State and local 

governments who regulate food labeling 

and standards-of-identity. 

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 

100.1; petition for exemption from preemption .................... 1 1 1 40 40 

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

The reporting burden for § 100.1 is 

minimal because petitions for 

exemption from preemption are seldom 

submitted by States. In the next 3 years, 

we estimate that one or fewer petitions 

will be submitted annually. 

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. 2023–26250 Filed 11–28–23; 8:45 am] 

BILLING CODE 4164–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1