[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4614-4615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 February 28, 2022.

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 0910-0546. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
<a href="/cdn-cgi/l/email-protection#e6b6b4a7b592878080a6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="87d7d5c6d4f3e6e1e1c7e1e3e6a9efeff4a9e0e8f1">[email protected]</span></a>.

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.

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 at 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 
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 at 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 at 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

[[Page 4615]]

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.
    In the Federal Register of October 8, 2021 (86 FR 56277), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although three comments were received, they 
were not responsive to the four collection of information topics 
solicited and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual          Average burden  per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petitions:
    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
Investigational Food Additive Files:
    570.17; Moderate Category...............               6               1               6  1,500.....................................           9,000
    570.17; Complex Category................               7               1               7  5,000.....................................          35,000
Color Additives:
    501.22(k); labeling of color additive or           3,120          0.8292           2,587  0.25 (15 minutes).........................             647
     lake of color additive; labeling of
     color additives not subject to
     certification.
                                             -----------------------------------------------------------------------------------------------------------
        Total...............................  ..............  ..............  ..............  ..........................................         119,147
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 hours 
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 numbers 0910-0546 and 0910-0721.

    Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01792 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


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