Document ID: FDA-2023-N-2986-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification
Posted Date: 2023-10-18T04:00Z

[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]

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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.

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

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                   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).
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\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