[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Proposed Rules]
[Pages 32384-32386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 80

[Docket No. FDA-2022-N-1635]
RIN 0910-AI69


Color Additive Certification; Increase in Fees for Certification 
Services; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the proposed rule, ``Color Additive Certification; 
Increase in Fees for Certification Services,'' which published in the 
Federal Register of November 2, 2022. We are taking this action to add 
supporting information to the administrative record and to adjust the 
record to reflect the same cost and benefits figures that were 
published in the preliminary regulatory impact analysis. We are 
reopening the comment period for 30 days specifically to invite public 
comments on the new information being added to the administrative 
record.

DATES: FDA is reopening the comment period on the proposed rule ``Color 
Additive Certification; Increase in Fees for Certification Services,'' 
which published in the Federal Register on November 2, 2022 (87 FR 
66116). Either electronic or written comments must be submitted by May 
28, 2024.

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 May 28, 2024. 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-2022-N-1635 for ``Color Additive Certification; Increase in Fees 
for Certification Services; Reopening of the

[[Page 32385]]

Comment Period.'' 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.'' We will review 
this copy, including the claimed confidential information, in our 
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: Bryan Bowes, Office of Cosmetics and 
Colors (HFS-105), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1122; or Carrol Bascus, Center for Food Safety and Applied 
Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 2, 2022 
(87 FR 66116), FDA published a proposed rule to amend the color 
additive regulations to increase the fee for certification services. 
The change in fees would allow FDA to continue to maintain an adequate 
color certification program as required by the Federal Food, Drug, and 
Cosmetic Act. The fees are intended to recover the full costs of 
operation of FDA's color certification program. We originally gave 
interested persons until January 3, 2023, to provide comments on the 
proposed rule. On January 24, 2023, in response to a stakeholder 
request, we reopened the comment period for an additional 45 days to 
allow interested parties more time to collect, analyze, and incorporate 
data and submit comments to the proposed rule.
    Subsequently, we determined that additional supporting information 
should be included in the administrative record. Therefore, we are 
adding a Color Certification Fee Study (March 2024) to the 
administrative record that further explains the basis for the proposed 
rule. The fee study documents the need for increased fees and outlines 
the basis on which we developed the fee schedule in the proposed rule. 
We are adding the fee study to the administrative record and reopening 
the comment period for 30 days to provide the public an opportunity to 
comment on the document. Comments are invited, and will be considered, 
only to the extent they are focused on the information being newly 
added to the record.
    Additionally, for transparency, we are adjusting the Preliminary 
Economic Analysis of Impacts, in Section V. B. Summary of Costs and 
Benefits (87 FR 66116 at 66118). The proposed rule did not include the 
same estimates that were published in the Preliminary Regulatory Impact 
Analysis (PRIA) listed in the reference section (87 FR 66116 at 66119). 
The PRIA, entitled ``Color Additive Certification; Increase in Fees for 
Certification Services'' Preliminary Regulatory Impact Analysis, 
Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act 
Analysis, and available at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria describes the estimates of the 
costs and benefits of the proposed rule.
    Consistent with the published PRIA, Section V.B. Summary of Costs 
and Benefits should read as follows:
    This proposed rule, if finalized, would amend existing color 
additive regulations by increasing fees for certification services. The 
fee schedule for color additive certification, as provided for in this 
proposed regulation, is designed to cover all the costs of operation of 
FDA's color certification program. This includes both the cost of 
specific tests required by the regulations and the general costs 
associated with the certification program, such as the costs of 
accounting, reviewing data, issuing certificates, conducting research, 
inspecting establishments, and purchasing and maintaining equipment. 
The fee for certification services of straight colors including lakes 
would increase from $0.35 per pound to $0.45 per pound, with the 
minimum fee increasing from $224 to $288. The fees for repacks of 
certified color additives and color additive mixtures would increase 
from $35 for 100 pounds or less to $45 for 100 pounds or less. The fee 
for repacks of certified color additives and color additive mixtures 
over 100 pounds, but not over 1,000 pounds would increase from $35 plus 
$0.06 for each pound over 100 pounds to $45 plus $0.08 for each pound 
over 100 pounds. The fee for repacks of certified color additives and 
color additive mixtures over 1,000 pounds would increase from $89 plus 
$0.02 for each pound over 1,000 pounds to $114 plus $0.03 for each 
pound over 1,000 pounds.
    The economic burdens of this proposed rule, if finalized, would 
accrue to color additive manufacturers. We estimate a one-time cost to 
read and understand the rule for all color additive manufacturers. The 
present value of this cost is approximately $2,307 at a 3 percent rate 
of discount, and $2,221 at a 7 percent rate of discount. The annualized 
value of these costs estimates is approximately $270 at a 3 percent 
discount rate and $316 at a 7 percent discount rate. Because the value 
of these impacts is small relative to manufacturer revenues, we assume 
that the supply of color additives would not be affected by this 
proposed rule. Consequently, we estimate no other impacts associated 
with this proposed rule.
    As noted in the preamble, the fees are intended to recover the full 
costs of operation of FDA's color certification program. Since 2005, 
the costs of the certification program significantly increased as a 
result of escalating staff payroll, rent and facility charges, as well 
as general operational expenses including purchasing and maintaining 
equipment. As the increase in fees is not associated with any change in 
the FDA certification program, no economic benefits are expected to 
result from the proposed rule. Similarly, the impact of

[[Page 32386]]

the increase in certification fees on color additive manufacturers is 
considered a transfer, rather than an economic cost. Accordingly, we do 
not estimate economic benefits associated with this proposed rule, and 
the impact of the increase in color certification fees is estimated as 
an ongoing transfer from manufacturers of color additives to the 
federal government. Our estimates are summarized in Table 1, below.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
                                                  [Millions of 2020 dollars over 10-year time horizon]
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                                                                                               Units
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                 Category                     Primary       Low        High                               Period                    Notes
                                             estimate    estimate    estimate      Year      Discount     covered
                                                                                  dollars    rate (%)     (years)
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Benefits:
    Annualized............................  ..........  ..........  ..........  ..........           7  ..........  ....................................
    Monetized $/year......................  ..........  ..........  ..........  ..........           3  ..........  ....................................
    Annualized............................  ..........  ..........  ..........  ..........           7  ..........  ....................................
    Quantified............................  ..........  ..........  ..........  ..........           3  ..........  ....................................
    Qualitative...........................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
Costs:
    Annualized............................    $0.00032  ..........  ..........        2020           7          10  ....................................
    Monetized $/year......................    $0.00027  ..........  ..........        2020           3          10  ....................................
    Annualized............................  ..........  ..........  ..........  ..........           7  ..........  ....................................
    Quantified............................  ..........  ..........  ..........  ..........           3  ..........  ....................................
    Qualitative...........................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
Transfers:
    Federal...............................       $2.46  ..........  ..........        2020           7          10  ....................................
    Annualized............................       $2.46  ..........  ..........        2020           3          10  ....................................
    Monetized $/year......................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
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    From/To...............................  From: Manufacturers of color
                                            additives
                                            To: Federal Government              ..........
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    Other Annualized......................  ..........  ..........  ..........  ..........           7  ..........  ....................................
    Monetized $/year......................  ..........  ..........  ..........  ..........           3  ..........  ....................................
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From/To...................................  From:
                                            To:                                 ..........
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Effects:
    State, Local or Tribal Government: No effect........................................................................................................
    Small Business: The proposed rule, if finalized, would generate costs to small businesses, as well as transfers from small businesses to FDA that we
     treat as costs from the perspective of the small business. On average, these costs amount to approximately 0.2733% of annual average revenues of
     the small firms in the affected industry..
    Wages: No effect....................................................................................................................................
    Growth: No effect...................................................................................................................................
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    Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08950 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P