[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30741-30742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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: Fax written comments on the collection of information by July 
30, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0721.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 30742]]

collection of information to OMB for review and clearance.

Animal Food Labeling; Declaration of Certifiable Color Additives

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. In the Federal Register of February 20, 2018 (83 FR 7198), 
FDA published a 60-day notice requesting public comment on the proposed 
collection of information.
    (Comment) One comment was received that supported FDA's need for 
the information collection and characterized the burden of the 
information collection as low compared to the importance of informative 
food labels. The comment did not suggest revising our estimate of the 
burden. However, it suggested we should provide greater detail about 
how we estimated the number of respondents and the flow of new 
products.
    (Response) We based our estimate of the number of respondents on 
the number of pet food manufacturers subject to this regulation. The 
figure of 3,120 used in table 1 was derived from the number of 
establishments listed under North American Industrial Classification 
System codes 311111 and 311119, including very small establishments. As 
noted in the 60-day notice, we based our estimate of the flow of new 
products on A.C. Nielsen data for the number of animal food product 
units for sale (for which sales of the products are greater than zero) 
in the latest year for which data is available, stated to be 25,874. 
Then, we assumed that the flow of new products would be 10 percent per 
year, for a figure of 2,587 new products per year. That figure was used 
in table 1 as our estimate of the total annual disclosures. 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 per    Total annual         Average burden per disclosure         Total hours
                                             respondents       respondent        disclosures
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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.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The requirement became effective November 18, 2013; thus, we 
estimate that the burden associated with the labeling requirements 
under Sec.  501.22(k) applies 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 (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: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14059 Filed 6-28-18; 8:45 am]
BILLING CODE 4164-01-P