85642 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

products for compliance with the 

requirements of section 403(w)(1) of the 

FD&C Act, along with the time needed 

to make any needed modifications to the 

labels of those products. We believe 

firms have already redesigned their 

labels to comply with requirements 

under the Food Allergen Labeling and 

Consumer Protection Act of 2004. 

However, this estimate accounts for 

firms that will redesign their label to 

comply with requirements under the 

FASTER Act. Our estimated reporting 

burden is based on our past experience 

with these submissions. We have 

increased our cumulative estimate by 

12,552 hours and 776 responses 

annually to reflect the inclusion of 

sesame as a major food allergen. 

Dated: December 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27018 Filed 12–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2851] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Time and Extent 

Applications for Nonprescription Drug 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 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 8, 

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 0910–0688. 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. 

Time and Extent Applications for 

Nonprescription Drug Products 

OMB Control Number 0910–0688— 

Revision 

I. Background

This information collection supports

certain Agency regulations in part 330 

(21 CFR part 330) regarding over-thecounter (OTC) human drugs and 

associated guidance. Specifically, FDA 

regulations in §§ 330.14 and 330.15 (21 

CFR 330.14 and 330.15) establish 

additional criteria and procedures for 

classifying OTC drugs as generally 

recognized as safe and effective and not 

misbranded. These regulations provide 

that OTC drug products introduced into 

the U.S. market after the OTC drug 

review began in 1972 and OTC drug 

products without any marketing 

experience in the United States can be 

evaluated under the OTC monograph 

system if the conditions (e.g., active 

ingredients) meet certain ‘‘time and 

extent’’ criteria outlined in the 

regulations. The regulations in § 330.14 

allow a sponsor to submit certain 

information to the Agency in a time and 

extent application (TEA) for use to 

determine eligibility of a condition for 

consideration in the OTC monograph 

system. 

We developed the final guidance 

document entitled ‘‘Time and Extent 

Applications for Nonprescription Drug 

Products’’ (September 2011) (available 

from our website at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/timeand-extent-applicationsnonprescription-drug-products) to assist 

respondents with the information 

collection provisions found in the 

regulations. The guidance was issued 

consistent with our good guidance 

practice regulations at 21 CFR 10.115, 

which provide for comment at any time. 

The guidance explains what information 

an applicant should submit to the 

Agency to request that a drug product be 

included in the OTC drug monograph 

system. The guidance also discusses 

format and content elements, and the 

process for submitting information, 

consistent with the applicable 

regulations. 

II. OTC Monograph Reform in the

Coronavirus Aid, Relief, and Economic

Security Act

The Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act 

(Pub. L. 116–136, Stat. 281)) signed 

March 27, 2020, included provisions 

that govern the way certain OTC drugs 

are regulated in the United States. The 

CARES Act added section 505G to the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355h), which 

reforms and modernizes the OTC drug 

review process, including establishing 

new procedures for consideration of 

additions or changes to conditions 

covered in OTC monographs. As a result 

of these revised statutory provisions, we 

anticipate no submissions under 

§ 330.14. Our OTC Monographs@FDA

portal (https://dps.fda.gov/omuf)

provides additional information about

OTC monograph drugs and the OTC

drug review process.

Consistent with section 505G(k)(3) of 

the FD&C Act, we plan to withdraw the 

regulations supporting the TEA 

provisions in part 330 and discontinue 

the related guidance document. When 

these actions occur, we will also request 

discontinuation of the information 

collection approved under OMB control 

number 0910–0688. 

In the Federal Register of August 8, 

2023 (88 FR 53497), 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: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85643 

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 

§ 330.14(c) and (d); Time and extent application and 

submission of information.

§ 330.14(f) and (i); Submission of safety and effectiveness data, including data and information listed in 

§ 330.10(a)(2), a listing of all serious adverse drug 

experiences that may have occurred (§ 330.14(f)(2)), 

and an official or proposed compendial monograph 

(§ 330.14(i)).

§ 330.14(j) and (k); Submitter correspondence with 

FDA.

1 ∼1.29 1.29 861.78 hours 

(861 hours and 

47 minutes).

1,112 

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

As previously stated, as a result of the 

CARES Act statutory provisions 

described above, we anticipate no TEA 

submissions. For purposes of burden 

calculation, we assume one respondent 

as a placeholder. The burden we 

attribute to reporting activities is 

assumed to be distributed among the 

individual elements. 

Our estimated burden for the 

information collection reflects, as a 

result of statutory requirements, a 

program change decrease of 6,894 hours 

and a corresponding decrease of 8 

responses. 

Dated: December 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26985 Filed 12–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–E–5267] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Nuzyra Tablets (New Drug 

Application 209816) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) has determined the regulatory 

review period for Nuzyra Tablets (new 

drug application (NDA) 209816) and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by February 6, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 5, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 6, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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 

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– 

2019–E–5267 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; NUZYRA 

TABLETS (NDA 209816).’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 


khammond on DSKJM1Z7X2PROD with NOTICES