[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7198-7199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0025]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Food Labeling; Declaration of Certifiable Color 
Additives

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 of FDA regulations requiring the declaration of color 
additives on animal food labels.

DATES: Submit either electronic or written comments on the collection 
of information by April 23, 2018.

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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 23, 2018. 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-2009-N-0025 for ``Animal Food Labeling; Declaration of Certifiable 
Color Additives.'' 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.
     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.gpo.gov/fdsys/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.

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. 3501-3520), 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 
utility; (2) the accuracy of FDA's

[[Page 7199]]

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.

Animal Food Labeling; Declaration of Certifiable Color Additives--21 
CFR 501.22(k)

OMB Control Number 0910-0721--Extension

    This information collection is associated with requirements under 
Sec.  501.22(k) (21 CFR 501.22(k)) in which animal food manufacturers 
must declare the presence of certified and noncertified color additives 
in their animal food products on the product label. We issued this 
regulation in response to the Nutrition Labeling and Education Act of 
1990 (Pub. L. 101-535) to make animal food regulations consistent with 
the regulations regarding the declaration of color additives on human 
food labels and 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. 
Color additive information enables a consumer to comparison shop and to 
avoid substances to which their animals may be sensitive.
    Description of Respondents: Respondents to this collection of 
information are manufacturers of pet food products that contain color 
additives.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                      Number of
             21 CFR Section/activity                 Number of       disclosures      Total annual     Average  burden per  disclosure     Total hours
                                                    respondents    per  respondent    disclosures
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501.22(k); labeling of color additive or lake of           3,120           0.8292            2,587   0.25 (15 minutes).................             647
 color additive; labeling of color additives not
 subject to certification.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Having become effective November 18, 2013, we estimate that the 
burden associated with the labeling requirements under Sec.  501.22(k) 
apply only to new product labels. Because the vast majority of animal 
food products that contain certified color additives are pet foods, we 
limit our burden estimate to reviewing labels for the use of certified 
color additives to pet food manufacturers subject to this regulation. 
Based on A.C. Nielsen Data, we estimate that the number of animal food 
product units subject to Sec.  501.22(k) for which sales of the 
products are greater than zero is 25,874. Assuming that the flow of new 
products is 10 percent per year, then 2,587 new animal food products 
subject to Sec.  501.22(k) will become available on the market each 
year. We also estimate that there are approximately 3,120 manufacturers 
of pet food subject to either Sec.  501.22(k)(1) or (k)(2). Assuming 
the approximately 2,587 new products are split equally among the firms, 
then each firm would prepare labels for approximately 0.8292 new 
products per year (2,587 new products/3,120 firms is approximately 
0.8292 labels per firm). We expect that firms prepare the required 
labeling for their products in a manner that takes into account at one 
time all information required to be disclosed on their product labels. 
Based on our experience with reviewing pet food labeling, we estimate 
that firms would require less than 0.25 hour (15 minutes) per product 
to comply with the requirement to include the color additive 
information pursuant to Sec.  501.22(k). The total burden of this 
activity is 647 hours (2,587 labels x 0.25 hour/label is approximately 
647 hours). The burden for this information collection has not changed 
since the last OMB approval.

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03339 Filed 2-16-18; 8:45 am]
 BILLING CODE 4164-01-P