[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56277-56279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22045]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1022]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reporting Associated With Food Additive Petitions, 
Investigational Food Additive Files Exemptions, and Declaration of 
Color Additives on Animal Food Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, 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 associated with food additive petitions, investigational 
food additive files exemptions, and declaration of color additives on 
animal food labels.

DATES: Submit either electronic or written comments on the collection 
of information by December 7, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 7, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 7, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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-2021-N-1022 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reporting Associated with Food 
Additive Petitions, Investigational Food Additive Files Exemptions, and 
Declaration of Color Additives on Animal Food Labels.'' 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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

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of FDA's functions, including whether the information will have 
practical 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.

Reporting Associated With Food Additive Petitions, Investigational Food 
Additive Files Exemptions, and Declaration of Color Additives on Animal 
Food Labels--21 CFR 501.22(k), 570.17, 571.1, and 571.6

OMB Control Number 0910-0546--Extension

    This information collection supports FDA regulations as discussed 
below. In this notice, we are combining all reporting burden associated 
with FDA's regulations Sec. Sec.  501.22(k), 570.17, 571.1, and 571.6 
(21 CFR 501.22(k), 570.17, 571.1, and 571.6) into one collection and 
are consolidating the burden for OMB control numbers 0910-0546 and OMB 
control number 0910-0721. Upon approval of the consolidated collection 
OMB control number 0910-0546, we will ask OMB to discontinue OMB 
control number 0910-0721. The information collection provisions 
approved under OMB control numbers 0910-0546, and 0910-0721 are similar 
in that they support FDA's regulations Sec. Sec.  501.22(k), 570.17, 
571.1, and 571.6. Thus, with this notice, FDA proposes to consolidate 
these collections of information into one OMB control number for 
government efficiency and to allow the public to look to one OMB 
control number for all reporting associated with FDA's regulations 
Sec. Sec.  501.22(k), 570.17, 571.1, and 571.6.

Food Additive Petitions and Investigational Food Additive Files 
Exemptions

    Section 409(a) of the Federal Food, Drug and Cosmetic Act (FD&C 
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed 
to be unsafe unless its use is permitted by a regulation which 
prescribes the condition(s) under which it may safely be used, or 
unless it is exempted by regulation for investigational use. Section 
409(b) of FD&C Act specifies the information that must be submitted by 
a petitioner in order to establish the safety of a food additive and to 
secure the issuance of a regulation permitting its use.
    To implement the provisions of section 409 of the FD&C Act, we 
issued procedural regulations under 21 CFR part 571. These procedural 
regulations are designed to specify more thoroughly the information 
that must be submitted to meet the requirement set down in broader 
terms by the FD&C Act. The regulations add no substantive requirements 
to those indicated in the FD&C Act but attempt to explain these 
requirements and provide a standard format for submission to speed 
processing of the food additive petition. Labeling requirements for 
food additives intended for animal consumption are also set forth in 
various regulations contained in parts 501, 573, and 579 (21 CFR parts 
501, 573, and 579). The labeling regulations are considered by FDA to 
be cross-referenced to Sec.  571.1, which is the subject of this same 
OMB clearance for food additive petitions.
    Regarding the investigational use of food additives, section 409(j) 
of the FD&C Act provides that any food additive or any food bearing or 
containing such an additive may be exempted from the requirements of 
this section if intended solely for investigational use by qualified 
experts. Investigational use of a food additive is typically to address 
the safety and/or intended physical or technical effect of the 
additive. To implement the provisions of section 409(j) of the FD&C 
Act, we issued regulations under Sec.  570.17. These regulations are 
designed to specify more thoroughly the information that must be 
submitted to meet the requirement set down in broad terms by the FD&C 
Act. Labeling requirements for investigational food additive files are 
also set forth in various regulations contained in part 501. The 
labeling regulations are considered by FDA to be cross-referenced to 
Sec.  570.17, which is the subject of this same OMB clearance for 
investigational food additive files.
    The information collected is necessary to protect the public 
health. We use the information submitted by food manufacturers or food 
additive manufacturers to ascertain whether the data establish the 
identity of the substance, justify its intended effect in/on the food, 
and establish that its intended use in/on food is safe.

Animal Food Labeling; Declaration of Certified and Non-Certified Color 
Additives

    FDA has the authority under the FD&C Act to issue regulations 
concerning animal food. Specifically, section 403(i) of the FD&C Act 
(21 U.S.C. 343(i)) requires that certified color additives used in or 
on a food must be declared by their common or usual names and not be 
designated by the collective term ``colorings.'' Our regulations in 
part 501 set forth the requirements for animal food labeling. Under 
Sec.  501.22(k), animal food manufacturers must declare on the animal 
food label the presence of certified and noncertified color additives 
in their animal food products. Our animal food labeling regulation at 
Sec.  501.22(k) is consistent with the regulations requiring the 
declaration of color additives on human food labels. The purpose of the 
labeling is to provide animal owners with information on the color 
additives used in animal food. Animal owners use the information to 
become knowledgeable about the foods they purchase for their animals.
    Description of Respondents: Respondents to this collection of 
information are manufacturers of animal food products that contain 
color additives or are manufacturers of food additives.
    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             Number of     responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses      per response
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                                             Food Additive Petitions
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571.1(c) Moderate Category.....               6               1               6            3,000          18,000
571.1(c) Complex Category......               5               1               5           10,000          50,000
571.6 Amendment of Petition....               5               1               5            1,300           6,500
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                                       Investigational Food Additive Files
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570.17 Moderate Category.......               6               1               6            1,500           9,000
570.17 Complex Category........               7               1               7            5,000          35,000
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                                                 Color Additives
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501.22(k); labeling of color              3,120          0.8292           2,587           * 0.25             647
 additive or lake of color
 additive; labeling of color
 additives not subject to
 certification.................
                                --------------------------------------------------------------------------------
    Total Hours................  ..............  ..............  ..............  ...............         119,147
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (15 minutes).

    For the purpose of this consolidation, we base our estimate of the 
total annual responses on submissions received during fiscal years 2019 
and 2020. We base our estimate of the hours per response on our 
experience with the labeling, food additive petition, and filing 
processes.
    The information collection reflects a net decrease of 70,453 hours 
(189,600 OMB approved hours--119,147 estimated hours). We also 
experienced a net increase of 2,587 responses from 35 OMB approved 
annual responses to 2,616 estimated annual responses. These changes 
were due to the consolidating of the information collection covered by 
OMB control number 0910-0721 and due to estimated changes of the number 
of respondents for food additive petitions and investigational food 
additive files.
    Section 571.1(c) Moderate Category: The estimated time requirement 
per food additive petition remains at approximately 3,000 hours; 
however, we now estimate that the number of annual respondents has 
decreased from 12 to 6 respondents for a total of 18,000 hours.
    Section 571.1(c) Complex Category: The estimated time requirement 
per food additive petition remains at approximately 10,000 hours; 
however, we now estimate that the number of annual respondents has 
decreased from 12 to 5 respondents for a total of 50,000 hours.
    Section 571.6 Amendment of Petition: We estimated that the number 
of annual respondents that will submit an amendment has increased from 
two to five respondents who will each submit one amendment for a total 
of 6,500 hours. This is an increase of three respondents and 3,900 
hours from the burden approved by OMB.
    Section 570.17 Moderate Category: We estimated that the number of 
annual respondents for investigational food additive files has 
increased from four to six respondents who will each submit one file 
for a total of 9,000 hours. This is an increase of two respondents and 
3,000 hours from the burden approved by OMB.
    Section 570.17 Complex Category: We estimated that the number of 
annual respondents for investigational food additive files has 
increased from five to seven respondents who will each submit one such 
file, for a total of 35,000 hours. This is an increase of 10,000 hour 
from the burden approved by OMB.
    Section 501.22(k) Labeling of Color Additive or Lake of Color 
Additive; Labeling of Color Additives Not Subject to Certification: The 
information collection reflects an adjustment in burden by 647 hours 
and 2,587 responses. We attribute this adjustment due to the 
consolidation of OMB control number 0910-0546 and OMB control number 
0910-0721.

    Dated: October 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22045 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P