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Withdrawn From Sale for Reasons of 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75mg/10mL, were not withdrawn from 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


ddrumheller on DSK120RN23PROD with NOTICES1
71872 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that these 

drug products were not withdrawn from 

sale for reasons of safety or 

effectiveness. 

Accordingly, the Agency will 

continue to list Naropin (ropivacaine 

hydrochloride) solution, 50mg/10mL 

and 75mg/10mL, in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to Naropin 

(ropivacaine hydrochloride) solution, 

50mg/10mL and 75mg/10mL, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for these drug products should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22960 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2986] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Color Additive 

Certification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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 November 

17, 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 0910–0216. 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. 

Color Additive Certification 

OMB Control Number 0910–0216— 

Extension 

This information collection supports 

FDA regulations governing certification 

for color additives used in foods, drugs, 

cosmetics, and medical devices. All 

color additives must have FDA-approval 

for their intended use and be listed in 

the color additive regulations before 

they are permitted for use in food, 

drugs, cosmetics, and many medical 

devices. Some color additives have an 

additional requirement: they are 

permitted only if they are from batches 

that FDA has certified under section 

721(a) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379e(a)). This 

means that FDA chemists have analyzed 

a sample from the batch and have found 

that it meets the requirements for 

composition and purity stated in the 

regulation, called a ‘‘listing regulation,’’ 

for that color additive. We list color 

additives that have been shown to be 

safe for their intended uses in Title 21 

of the Code of Federal Regulations 

(CFR). We require batch certification for 

all color additives listed in 21 CFR part 

74 and for all color additives 

provisionally listed in 21 CFR part 82. 

Color additives listed in 21 CFR part 73 

are exempted from certification. 

The requirements for color additive 

certification are established in 21 CFR 

part 80. Procedures for color additive 

certification are set forth in part 80, 

subpart B (§§ 80.21 through 80.39) and 

communicate required data elements for 

requests for certification, limitations of 

certificates, exemptions from 

certification for color additive mixtures, 

treatment of batches pending and after 

certification, and recordkeeping 

requirements for respondents to whom 

a certificate is issued. During the batch 

certification procedure, a manufacturer 

of color additives must submit a 

‘‘request for certification’’ that provides 

information about the batch, 

accompanied by a representative sample 

of a new batch of color additive, to 

FDA’s Office of Cosmetics and Colors. 

FDA personnel perform chemical and 

other analyses of the representative 

sample and, providing the sample 

satisfies all certification requirements, 

issue a certificate that contains a 

certification lot number for the batch. 

The batch can then be used in FDAregulated products marketed in the 

United States, in compliance with the 

uses and restrictions in that color 

additive’s listing regulation. If the 

sample does not meet the requirements, 

the batch will be rejected. We require 

manufacturers to keep complete records 

showing disposal of all of the color 

additive covered by the certification. 

FDA’s web-based color certification 

information system is available for 

respondents to request color 

certification online, track their 

submissions, and obtain account status 

information. Prior to submitting a 

request for certification, the 

manufacturer must open a color 

certification account by sending a letter, 

as an email attachment, signed by 

responsible company representative, to 

FDA’s Office of Cosmetics and Colors at 

color.cert@fda.hhs.gov. System 

certification results are returned 

electronically, allowing submitters to 

sell their certified color before receiving 

hard copy certificates. 

We charge a fee for certification based 

on the batch weight and require 

manufacturers to keep records of the 

batch pending and after certification. 

The user fees support FDA’s color 

certification program. Additional 

information about color additive 

certification is available at: https://

www.fda.gov/industry/color-additives/ 

color-certification. 

The purpose for collecting this 

information is to help the Agency assure 

that only safe color additives will be 

used in foods, drugs, cosmetics, and 

medical devices sold in the United 

States. 

Description of Respondents: The 

respondents include businesses engaged 

in the manufacture of color additives 

used in FDA-regulated foods, drugs, 

cosmetics, and medical devices. 

Respondents are from the private sector 

(for-profit businesses). 

In the Federal Register of August 10, 

2023 (88 FR 54329), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 


ddrumheller on DSK120RN23PROD with NOTICES1