Notice2023-17173
Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification
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Published
August 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54329-54331]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#8fdfddcedcfbeee9e9cfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="6f3f3d2e3c1b0e09092f090b0e4107071c41080019">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#7c1f1310130e521f190e083c1a181d5214140f521b130a"><span class="__cf_email__" data-cfemail="a7c4c8cbc8d589c4c2d5d3e7c1c3c689cfcfd489c0c8d1">[email protected]</span></a>. 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: <a href="https://www.fda.gov/industry/color-additives/color-certification">https://www.fda.gov/industry/color-additives/color-certification</a>.
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
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