
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54329-54331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17173]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2986]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Color Additive Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish 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 notice solicits comments on the information collection 
provisions of FDA's regulations governing batch certification of color 
additives manufactured for use in foods, drugs, cosmetics, or medical 
devices in the United States.

DATES: Either electronic or written comments on the collection of 
information must be submitted by October 10, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 10, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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-N-2986 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Color Additive Certification.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), 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 
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. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical

[[Page 54330]]

utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (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 through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Color Additive Certification--21 CFR Part 80

OMB Control Number 0910-0216--Extension

    This information collection helps support 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 part 80 (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 us. 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).
    We estimate 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 per response         Total hours
                                                 respondents       respondent       responses
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80.21 and 80.22; Request for certification                 67              112            7,504   0.22 (13 minutes)....................           1,651
 accompanied by 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
           21 CFR Section; activity               Number of       records per      Total annual      Average burden per recordkeeping      Total hours
                                                recordkeepers     recordkeeper       records
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80.39; Record of distribution................              67              112            7,504   0.25 (15 minutes)....................           1,876
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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.


[[Page 54331]]


    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17173 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P


