[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17445-17446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07420]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 burden hours associated with 
the animal food industry declaring the presence of certified and 
noncertified color additives in their animal food products on the 
animal food label.

DATES: Submit either electronic or written comments on the collection 
of information by June 1, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, [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,

[[Page 17446]]

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 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. The Agency issued 
this regulation in response to the Nutrition Labeling and Education Act 
of 1990 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.  501.22(k)(1) and 
(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.
    FDA estimates the burden for 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    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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501.22(k); labeling of color additive or lake of color additive;              3,120             0.83            2,587             0.25              647
 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.

    Because Sec.  501.22(k) became effective November 18, 2013, the 
Agency estimates 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, 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 
under 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: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07420 Filed 3-31-15; 8:45 am]
 BILLING CODE 4164-01-P