83948 Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Programs of AllInclusive Care for the Elderly (PACE) 

PACE Quality Data Monitoring and 

Reporting; Use: The Programs of AllInclusive Care for the Elderly (PACE) 

program is a unique model of managed 

care service delivery for the frail elderly, 

most of whom are dually-eligible for 

Medicare and Medicaid benefits. To be 

eligible to enroll in PACE, an individual 

must: be 55 or older, live in the service 

area of a PACE organization (PO), need 

a nursing home-level of care (as certified 

by the state in which he or she lives), 

and be able to live safely in the 

community with assistance from PACE. 

PACE organizations are responsible 

for providing all required Medicare and 

Medicaid covered services, and any 

other service that the interdisciplinary 

team (IDT) determines necessary to 

improve and maintain a participant’s 

overall health condition (42 CFR 

460.92). POs must also comply with the 

quality monitoring and reporting 

requirements outlined in §§ 460.140, 

460.200(b)(1), 460.200(c) and 460.202. 

POs are also required to report certain 

unusual incidents to other Federal and 

State agencies consistent with 

applicable statutory or regulatory 

requirements (see 42 CFR 460.136(a)(5)). 

Form Number: CMS–10525 (OMB 

control number: 0938–1264); Frequency: 

Occasion; Affected Public: Business or 

other for-profits, Not-for-profits 

institutions; Number of Respondents: 

152; Total Annual Responses: 1,279; 

Total Annual Hours: 1,471. (For policy 

questions regarding this collection 

contact Donna Williamson at 410 786 

4647.) 

Dated: November 28, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–26444 Filed 11–30–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1051] 

Modified Risk Tobacco Product 

Application: Renewal Applications for 

General Snus Smokeless Tobacco 

Products Submitted by Swedish Match 

U.S.A., Inc. 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity to provide 

public comment on modified risk 

tobacco product applications (MRTPAs). 

The applications are for renewal of 

existing modified risk tobacco product 

(MRTP) orders for General Snus 

smokeless tobacco products submitted 

by Swedish Match U.S.A., Inc. 

DATES: Electronic or written comments 

on the application may be submitted 

beginning December 1, 2023. FDA will 

establish a closing date for the comment 

period as described in section I. 

ADDRESSES: You may submit comments 

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 

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– 

2014–N–1051 for ‘‘Modified Risk 

Tobacco Product Applications: Renewal 

applications for General Snus smokeless 

tobacco products submitted by Swedish 

Match U.S.A., Inc.’’ 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 the background documents or 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 83949 

1The notice of availability for the General Snus 

MRTPAs that received a modified risk granted order 

appeared in the Federal Register on August 27, 

2014 (79 FR 51183) and the docket containing 

notices and public comments, FDA–2014–N–1051, 

is accessible at: https://www.regulations.gov/. 

‘‘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. 

FOR FURTHER INFORMATION CONTACT: 

Dhanya John or Adrian Mixon, Office of 

Regulations, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G335, Silver Spring, 

MD 20993–0002, 1–877–287–1373, 

email: CTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 911 of the Federal Food, Drug, 

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

387k) addresses the marketing and 

distribution of MRTPs. MRTPs are 

tobacco products that are sold or 

distributed for use to reduce harm or the 

risk of tobacco-related disease 

associated with commercially marketed 

tobacco products. Section 911(a) of the 

FD&C Act prohibits the introduction or 

delivery for introduction into interstate 

commerce of any MRTP unless an order 

issued by FDA pursuant to section 

911(g) of the FD&C Act is effective with 

respect to such product. 

Section 911(d) of the FD&C Act 

describes the information that must be 

included in a MRTPA, which must be 

filed and evaluated by FDA before an 

applicant can receive an order from 

FDA. FDA is required by section 911(e) 

of the FD&C Act to make a MRTPA 

available to the public (except for 

matters in the application that are trade 

secrets or otherwise confidential 

commercial information) and to request 

comments by interested persons on the 

information contained in the 

application and on the label, labeling, 

and advertising accompanying the 

application. The determination of 

whether an order is appropriate under 

section 911 of the FD&C Act is based on 

the scientific information submitted by 

the applicant as well as the scientific 

evidence and other information that is 

made available to the Agency, including 

through public comments. 

Section 911(g) of the FD&C Act 

describes the demonstrations applicants 

must make to obtain an order from FDA 

under either section 911(g)(1) or (g)(2). 

The applicant, Swedish Match U.S.A., 

Inc., is seeking a renewal of the order 

under section 911(g)(1) of the FD&C Act. 

FDA may issue an order under 

Section 911(g)(1) of the FD&C Act, if 

FDA has determined that the applicant 

has demonstrated that the proposed 

MRTP, as it is actually used by 

consumers, will: 

• Significantly reduce harm and the 

risk of tobacco-related disease to 

individual tobacco users; and 

• Benefit the health of the population 

as a whole taking into account both 

users of tobacco products and persons 

who do not currently use tobacco 

products. 

Section 911(g)(4) of the FD&C Act 

describes factors that FDA must take 

into account in evaluating whether a 

tobacco product benefits the health of 

individuals and the population as a 

whole. 

FDA is issuing this notice to inform 

the public that renewal MRTPAs 

submitted by Swedish Match U.S.A. Inc. 

for the following products (identified by 

FDA Submission Tracking Numbers 

(STN) (MR0000256.PD1— 

MR0000256.PD9)) have been filed and 

are being made available for public 

comment: 

• MR0000256.PD1: General Loose 

• MR0000256.PD2: General Dry Mint 

Portion Original Mini 

• MR0000256.PD3: General Portion 

Original Large 

• MR0000256.PD4: General Classic 

Blend Portion White Large-12 ct 

• MR0000256.PD5: General Mint 

Portion White Large 

• MR0000256.PD7: General Nordic 

Mint Portion White Large- 12 ct 

• MR0000256.PD8: General Portion 

White Large 

• MR0000256.PD9: General 

Wintergreen Portion White Large 

The applicant is seeking renewal of 

the authorization to market General 

Loose, General Dry Mint Portion 

Original Mini, General Portion Original 

Large, General Classic Blend Portion 

White Large—12ct, General Mint Portion 

White Large, General Nordic Mint 

Portion White Large—12ct, General 

Portion White Large, and General 

Wintergreen Portion White Large 

Smokeless Tobacco Products (category)/ 

Loose Snus and Portioned Snus 

(subcategories) as MRTPs under section 

911(g)(1) of the FD&C Act.1 These 

products previously received such 

authorization in October 2019, and the 

applicant is including information from 

the previous MRTPAs by crossreference. 

FDA will post the application 

documents, including any amendments, 

to its website for the MRTPAs (see 

section II) for public comment on a 

rolling basis as they are redacted in 

accordance with applicable laws. In this 

document, FDA is announcing the 

availability of the first batch of 

application documents for public 

comment. FDA intends to establish a 

closing date for the comment period that 

is both at least 180 days after the date 

of this notice and at least 30 days after 

the final documents from the 

application are made available for 

public comment. FDA will announce 

the closing date at least 30 days in 

advance. FDA believes that this 

comment period is appropriate given 

the volume and complexity of the 

applications being posted. 

FDA will notify the public about the 

availability of additional application 

documents and comment period closing 

date via the Agency’s web page for the 

MRTPAs (see section II) and by other 

means of public communication, such 

as by email to individuals who have 

signed up to receive email alerts. To 

receive email alerts, visit FDA’s email 

subscription service management 

website (https://www.fda.gov/about-fda/ 

contact-fda/get-email-updates), provide 

an email address, scroll down to the 

‘‘Tobacco’’ heading, select ‘‘Modified 

Risk Tobacco Product Application 

Update’’, and click ‘‘Submit’’. To 

encourage public participation 

consistent with section 911(e) of the 

FD&C Act, FDA is making the redacted 

MRTPAs that are the subject of this 

notice available electronically (see 

section II). 

II. Electronic Access 

Persons with access to the internet 

may obtain the document(s) at https:// 

www.fda.gov/tobacco-products/ 

advertising-and-promotion/swedishmatch-usa-inc-mrtp-applications. 

Dated: November 28, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26498 Filed 11–30–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3007] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Human Drug Compounding 

Outsourcing Facilities Under the 

Federal Food, Drug, and Cosmetic Act 

and Associated Fees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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