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drug products were not withdrawn from 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
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71873 

FDA estimates 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 

80.21 and 80.22; Request for certification accompanied by sample.67 112 7,504 0.22 (13 minutes) .......... 1,651 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

80.39; Record of distribution ................................ 67 112 7,504 0.25 (15 minutes) ......... 1,876 

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

We base our estimate on our review 

of the certification requests received 

over the past 3 years. Using information 

from industry personnel, we estimate 

that an average of 0.22 hour per 

response is required for reporting 

(preparing certification requests and 

accompanying samples) and an average 

of 0.25 hour per response is required for 

recordkeeping. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have slightly 

decreased our burden estimate based on 

our experience with this program. As a 

result, although the number of 

respondents increased, the number of 

responses per respondent decreased. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22971 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–D–4128] 

Guidance Documents Referencing PreExisting Tobacco Products; Guidance 

for Industry; Availability; Withdrawal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of revised final guidances 

for industry entitled ‘‘Demonstrating the 

Substantial Equivalence of a New 

Tobacco Product: Responses to 

Frequently Asked Questions,’’ and 

‘‘Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007.’’ 

Following the issuance of the final rules 

entitled ‘‘Content and Format of 

Substantial Equivalence Reports; Food 

and Drug Administration Actions on 

Substantial Equivalence Reports’’ (SE) 

and ‘‘Premarket Tobacco Product 

Applications and Recordkeeping 

Requirements’’ (PMTA), FDA has made 

minor updates to these guidances for 

consistency with the terminology used 

in those rules. FDA is also announcing 

the withdrawal of the final guidances 

entitled ‘‘Section 905(j) Reports: 

Demonstrating Substantial Equivalence 

for Tobacco Products,’’ and 

‘‘Investigational Use of Deemed, 

Finished Tobacco Products That Were 

on the U.S. Market on August 8, 2016, 

During the Deeming Compliance 

Periods,’’ and a draft guidance entitled 

‘‘Substantial Equivalence Reports: 

Manufacturer Requests for Extensions or 

to Change the Predicate Tobacco 

Product,’’ which are obsolete due to the 

issuance of the SE final rule or the end 

of the compliance period for deemed, 

finished tobacco products that were on 

the U.S. market on August 8, 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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– 

2023–D–4128 for ‘‘Guidance Documents 

Referencing Pre-Existing Tobacco 

Products.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 


ddrumheller on DSK120RN23PROD with NOTICES1