
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37269-37270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16022]


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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, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of

[[Page 37270]]

Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 
202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0721. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

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 
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. The Agency 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 colors used 
in animal food.
    Respondents to this collection are manufacturers of pet food that 
contain color additives. Manufacturers of certain food or food 
ingredients do not have products that contain color additives requiring 
certification (e.g., food for chickens, fish, and some other species, 
including some pet foods) and would thus be minimally affected by Sec.  
501.22(k)(1). However, since we cannot rule out the possibility that 
they may at some point use a color additive requiring certification, we 
have consolidated the burden estimates for Sec. Sec.  501.22(k)(1) and 
501.22(k)(2). Additionally, we believe that this burden is more 
accurately characterized as a third-party disclosure burden because FDA 
does not require routine submission of pet food labeling to the Agency.
    In the Federal Register of April 1, 2015 (80 FR 17445), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but did not respond 
to any of the four information collection topics solicited and is 
therefore not addressed by the Agency.
    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 make             3,120             0.83            2,587   .25                                             647
 of color additive; labeling of color additives                                                     (15 minutes)
 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, the Agency estimates 
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, FDA estimates 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 come on the market each year. FDA also 
estimates that there are about 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 0.83 new products per year 
(2,587 new products/3,120 firms is approximately 0.83 labels per firm).
    The Agency expects 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, FDA estimates 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).

    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16022 Filed 6-29-15; 8:45 am]
 BILLING CODE 4164-01-P


