Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71869 

in PowerPoint presentation format, not 

PDF. We will not play videos or 

animations during the public meeting 

sessions and request the speakers to 

exclude these materials from their 

PowerPoint presentation and instead 

submit any relevant video or animation 

materials along with the written 

comments. We request the speakers to 

ensure that the presentation does not 

include any inappropriate content 

before submission. 

Every primary speaker must declare at 

the beginning of their presentation at 

the meeting, as well as in their written 

summary, whether they have any 

financial involvement with the 

manufacturer of the item that is the 

subject of the HCPCS application that 

the primary speaker presented, or any 

competitors of that manufacturer with 

respect to the item. This includes any 

payment, salary, remuneration, or 

benefit provided to that speaker by the 

applicant. 

2. 5-Minute Speakers

Any individual related to the public

meeting agenda item, including but not 

limited to, an employee, stakeholder, 

competitor, insurer, public consumer, 

etc., may register and speak as a 5- 

minute speaker. The deadline for 

registering to be a 5-minute speaker is 

5 p.m., EST, Tuesday, November 14, 

2023. 

Every 5-minute speaker must declare 

at the beginning of their presentation at 

the meeting, as well as in their written 

summary, whether they have any 

financial involvement with the 

manufacturer of the item that is the 

subject of the HCPCS code application 

or agenda item that the 5-minute 

speaker presented, or any competitors of 

that manufacturer with respect to the 

item. This includes any payment, salary, 

remuneration, or benefit provided to 

that speaker by the applicant. We will 

not accept any other written materials, 

outside of the written comments, from 

a 5-minute speaker. 

3. All Other Attendees

All individuals who plan to attend the

virtual public meetings to listen and do 

not plan to speak, may access the virtual 

public meeting using the Zoom link 

posted on the HCPCS website at https:// 

www.cms.gov/Medicare/Coding/ 

MedHCPCSGenInfo after the speaker 

registration closes on Tuesday, 

November 14, 2023. 

Individuals who require special 

assistance must register and request 

special assistance services by 5 p.m. 

EST, Tuesday, November 14, 2023. 

IV. Written Comments

The primary and 5-minute speaker(s)

must email a brief, written summary 

(one paragraph) of their comments and 

conclusions. Written comments from 

anyone, including the primary and 5- 

minute speaker(s), will only be accepted 

when emailed to: HCPCS@cms.hhs.gov 

before 5 p.m., EST on the date of the 

virtual public meeting at which the 

HCPCS code application that is the 

subject of the comments is discussed. 

V. Additional Information

The HCPCS section of the CMS

website also includes details regarding 

the public meeting process for new 

revisions to the HCPCS code set, 

including information on how to join 

the meeting remotely, and guidelines for 

an effective presentation. The HCPCS 

section of the CMS website also 

contains a document titled ‘‘Healthcare 

Common Procedure Coding System 

(HCPCS) Level II Coding Procedures,’’ 

which is a description of the HCPCS 

coding process, including a detailed 

explanation of the procedures CMS uses 

to make HCPCS coding determinations. 

When CMS refers to HCPCS code or 

HCPCS coding application above, CMS 

may also be referring to circumstances 

when a HCPCS code has already been 

issued, but a Medicare benefit category 

and/or payment has not been 

determined. CMS is working diligently 

to address Medicare benefit category 

and payment determinations for new 

items and services that may be DME, 

prosthetic devices, orthotics and 

prosthetics, therapeutic shoes and 

inserts, surgical dressings, or splints, 

casts, and other devices used for 

reductions of fractures and dislocations 

under Medicare Part B. Please check the 

CMS website listed above for the final 

agenda. 

VI. Collection of Information

Requirements

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Administrator of CMS, Chiquita 

Brooks-LaSure, having reviewed and 

approved this document, authorizes 

Chyana Woodyard, who is the Federal 

Register Liaison, to electronically sign 

this document for purposes of 

publication in the Federal Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–22953 Filed 10–17–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities: Proposed Collection; Public 

Comment Request; ACL Generic for 

Administration on Aging Formula 

Grant Programs OMB Control Number 

0985–New 

AGENCY: Administration for Community 

Living, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

an opportunity for the public to 

comment on the proposed collection of 

information listed above. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This new information collection 

solicits comments on the information 

collection requirements relating to the 

ACL Generic for Administration on 

Aging Formula Grant Programs. 

DATES: Comments on the collection of 

information must be submitted 

electronically by 11:59 p.m. (EST) or 

postmarked by December 18, 2023. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: Adam Mosey, 

Adam.Mosey@acl.hhs.gov. Submit 

written comments on the collection of 

information to Administration for 

Community Living, 330 C Street SW, 

Washington, DC 20201, Attention: 

Adam Mosey. 

FOR FURTHER INFORMATION CONTACT: 

Adam Mosey (202) 795–7631 or 

Adam.Mosey@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 


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71870 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

The PRA requires Federal agencies to 

provide a 60-day notice in the Federal 

Register concerning each proposed 

collection of information, including 

each proposed extension of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, ACL invites 

comments on our burden estimates or 

any other aspect of this collection of 

information, including: 

(1) whether the proposed collection of 

information is necessary for the proper 

performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) ways to minimize the burden of 

the collection of information on 

respondents, including using automated 

collection techniques when appropriate, 

and other forms of information 

technology; 

(5) ACL issued a Notice of Proposed 

Rulemaking (NPRM) to modify the 

implementing regulations of the Older 

Americans Act of 1965 (‘‘the Act’’ or 

OAA) to add a new subpart (Subpart D) 

related to Adult Protective Services 

(APS) RIN 0985–AA18. 0985–New is 

referenced in 88 FR 62503 pages 62503– 

62522 published on September 12, 

2023. Comments associated with this 

proposed Generic Information 

Collection (Gen IC) should be submitted 

separately to the above listed program 

contact. 

As a unit of the Administration for 

Community Living, the Administration 

on Aging (AoA) provides expertise on 

program development, advocacy, and 

initiatives for older Americans and their 

caregivers and families. Working with 

State agencies, local agencies, grantees, 

and community providers, AoA directs 

programs authorized by the OAA, Elder 

Justice Act (EJA), and other legislation 

that supports older adults. Through 

these programs multi-year State Plans 

and assurances, and other financial 

forms are needed to provide approval 

and oversight of grant recipients. 

ACL is seeking OMB approval to add 

a new Gen IC to ACL’s Paperwork 

inventory. This Gen IC will cover AoA 

formula grant programs for State Plans 

on Aging and assurances, State Plans on 

Adult Protective Services and 

assurances, and other financial forms 

associated with Aging formula grant 

management. Adding a Gen IC will 

allow for the collection of data across 

programmatic and financial 

management of the Aging and APS 

formula grants. 

Statutory Background 

In 1965, Congress originally passed 

the Older Americans Act (OAA) in 

response to concerns by policymakers 

about a lack of community social 

services for older adults. The original 

legislation established authority for 

grants to States for community planning 

and social services, research and 

development projects, and personnel 

training in the field of aging. Changes to 

the OAA were made through the 

Supporting Older Americans Act of 

2020 (Pub. L. 116–131). This legislation 

reauthorized the OAA and its programs 

from Federal fiscal year (FFY) 2020 

through 2024. The OAA provides the 

foundation for the National aging 

Network, which includes the 

Administration on Aging (AoA), State 

Units on Aging (SUA), Area Agencies on 

Aging (AAA), tribal organizations, 

service providers, and volunteers. SUAs 

are an integral part of the network 

responsible for developing and 

administering a multi-year State plan 

that advocates for and aids older 

residents, their families, their 

caregivers, and, in many States, for 

adults with disabilities. 

The Elder Justice Act, passed in 2010, 

is the first comprehensive legislation to 

address the abuse, neglect, and 

exploitation of older adults at the 

Federal level. The law authorized a 

variety of programs and initiatives to 

better coordinate Federal responses to 

elder abuse, promote elder justice 

research and innovation, support Adult 

Protective Services systems, and 

provide additional protections for 

residents of long-term care facilities. 

The importance of these services at the 

State-level and local-level is 

demonstrated by the fact that States 

significantly leverage OAA funds to 

obtain other funding for these activities. 

The Coronavirus Response and Relief 

Supplemental Appropriations Act of 

2021 and the American Rescue Plan Act 

provided two years of Federal funding 

($188 million in each year) to support, 

for the first time, the nationwide APS 

formula grant program authorized by the 

Elder Justice Act of 2010. That funding 

was used by States to expand or develop 

a variety of capabilities that were 

necessary to meet increased needs due 

to the public health pandemic, and 

ongoing funding is necessary to 

maintain the improved reach and 

effectiveness of APS systems beyond the 

pandemic. 

The FY 2023 Omnibus 

Appropriations Bill provided, for the 

first time, an annual appropriation of 

$15 million to continue providing 

Federal formula grants to State APS 

programs. This will be the first time 

State entities are required to develop 

and submit State plans on Adult 

Protective Services under Section 2042 

of the Elder Justice Act, 42 U.S.C. 

1397m–1(b). However, States have 

developed spending plans for the 

formula funding received to date, 

consistent with 45 CFR 75.206(d), and 

to update those every three to five years. 

This new Gen IC is for programmatic 

and financial management of the Aging 

and APS formula grants. The purpose of 

the State Plans and assurances is to 

document and provide the opportunity 

for public comment of achievements 

and planned activities for the multi-year 

plan period. A wide range of 

constituents use or will use the State 

Plans to coordinate, monitor, evaluate, 

and improve Aging Network and APS 

support services by using the State 

Plans as a blueprint for service planning 

and delivery. 

Additionally, ACL leverages State 

Plans to understand the numerous 

services older adults use, and to utilize 

the information for advocating for the 

needs of older adults and those who use 

APS and for requesting additional 

funding. The purpose of the other 

financial forms that are a part of this 

Gen IC is to facilitate OAA formula 

grant management. 

Financial forms provide statutorily 

required information regarding each 

State’s contribution to programs to 

ensure compliance with legislative 

requirements, pertinent Federal 

regulations, and other applicable 

instructions and guidelines issued by 

ACL. This information will be used for 

Federal oversight of the Aging Programs. 

Based on ACL’s extensive experience 

working with APS systems and OAA 

grantees on their State plans, ACL does 

not anticipate a significantly greater 

level of detail for the development of 

State plans for APS. 

Since a new Gen IC does not permit 

the public to examine the details of each 

individual collection, the ACL Generic 

for Administration on Aging Formula 

Grant Programs 0985–New Proposed 

Gen IC Plan can be found on the ACL 

website for review and comment at: 


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Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71871 

https://www.acl.gov/about-acl/publicinput. 

In accordance with the PRA 44 U.S.C. 

3506(c)(2)(A); 44 U.S.C. 3507(a)(1)(D) 

ACL details the proposed Gen IC 

pertaining to: 

• the method of collection;

• the category (or categories) of

respondents; 

• the estimated maximum number of

burden hours (per year) for the specific 

information collections, and against 

which burden will be charged for each 

collection actually used; 

• ACL’s plans for how it will use the

information collected; and 

• ACL’s internal procedures to ensure

that the specific collections comply 

with the PRA, applicable regulations, 

and the terms of the generic clearance. 

Estimated Program Burden: ACL 

estimates the burden of this collection 

of information as follows: 

ESTIMATED ANNUALIZED BURDEN TABLE

Respondent/data collection activity Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

State Unit on Aging (SUA) ................ State Plan on Aging ......................... 14.7 1 80 1,176 

State Entity for APS .......................... State Plan on APS ........................... 56 1 6 336 

State Entity for APS .......................... Required Assurances for APS (4) ... 56 3 10 1,680 

State Unit on Aging (SUA) ................ Financial Forms ................................ 56 5 1 280 

Total Estimated Burden ............. ........................................................... ........................ ........................ ........................ 3,472 

Dated: October 12, 2023. 

Alison Barkoff, 

Senior official performing the duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2023–22956 Filed 10–17–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–1323] 

Determination That NAROPIN 

(Ropivacaine Hydrochloride) Solution, 

50 Milligrams/10 Milliliters and 75 

Milligrams/10 Milliliters, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that Naropin 

(ropivacaine hydrochloride) solution, 50 

milligrams (mg)/10 milliliters (mL) and 

75mg/10mL, were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to these drug products as long as 

they meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Alexander Poonai, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6213, 

Silver Spring, MD 20993–0002, 301– 

796–3600, Alexander.Poonai@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

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

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

Naropin (ropivacaine hydrochloride) 

solution, 50mg/10mL and 75mg/10mL, 

are the subject of NDA 020533, held by 

Fresenius Kabi USA LLC, and initially 

approved on May 1, 1998. Naropin is 

indicated for the production of local or 

regional anesthesia for surgery and for 

acute pain management. 

Naropin (ropivacaine hydrochloride) 

solution, 50mg/10mL and 75mg/10mL, 

are currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated 

December 15, 2021 (Docket No. FDA– 

2021–P–1323), under 21 CFR 10.30, 

requesting that the Agency determine 

whether Naropin (ropivacaine 

hydrochloride) solution, 50mg/10mL 

and 75mg/10mL, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that Naropin (ropivacaine

hydrochloride) solution, 50mg/10mL

and 75mg/10mL, were not withdrawn

for reasons of safety or effectiveness.

The petitioner has identified no data or

other information suggesting that these

drug products were withdrawn for

reasons of safety or effectiveness. We

have carefully reviewed our files for

records concerning the withdrawal of

Naropin (ropivacaine hydrochloride)

solution, 50mg/10mL and 75mg/10mL,

from sale. We have also independently


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