Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification, 71872-71873 [2023-22971]

Download as PDF 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 We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness.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. 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:01 Oct 17, 2023 Jkt 262001 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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. E:\FR\FM\18OCN1.SGM 18OCN1 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 Number of respondents 21 CFR Section; activity 80.21 and 80.22; Request for certification accompanied by sample. 1 There Number of responses per respondent 67 112 Average burden per response Total annual responses 7,504 0.22 (13 minutes) .......... Total hours 1,651 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section; activity 80.39; Record of distribution ................................ 1 There 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 Food and Drug Administration, ddrumheller on DSK120RN23PROD with NOTICES1 HHS. ACTION: 67 Average burden per recordkeeping Total annual records 112 7,504 0.25 (15 minutes) ......... Total hours 1,876 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. AGENCY: Number of records per recordkeeper Notice of availability. 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 SUMMARY: VerDate Sep<11>2014 18:01 Oct 17, 2023 Jkt 262001 ‘‘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, PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 E:\FR\FM\18OCN1.SGM 18OCN1

Agencies

[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71872-71873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22971]


-----------------------------------------------------------------------

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, 
[email protected].

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 (Sec. Sec.  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 FDA-regulated 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 [email protected]. 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.

[[Page 71873]]

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   21 CFR Section; activity        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
80.21 and 80.22; Request for                67             112           7,504  0.22 (13                   1,651
 certification accompanied by                                                    minutes).
 sample.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
   21 CFR Section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
80.39; Record of distribution.              67             112           7,504  0.25 (15                   1,876
                                                                                 minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There 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

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