
[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Rules and Regulations]
[Pages 59624-59625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 501

[Docket No. FDA-2013-D-1088]


Guidance for Industry 223: Small Entity Compliance 
Guide--Declaring Color Additives in Animal Foods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availabilty.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry 223 entitled ``Small 
Entity Compliance Guide--Declaring Color Additives in Animal Foods.'' 
This small entity compliance guide (SECG) aids industry in complying 
with the requirements of the final rule that published in the Federal 
Register of November 17, 2011. FDA issued the regulation in response to 
the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), 
which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
Specifically, FDA amended its regulations regarding the declaration of 
certified color additives on the labels of animal food including animal 
feeds and pet foods.

DATES: The guidance is effective September 27, 2013. Submit either 
electronic or written comments on the SECG at any time.

ADDRESSES: Submit requests for single copies of the SECG to the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the SECG.
    Submit electronic comments on the SECG to http://www.regulations.gov. Submit written comments to the

[[Page 59625]]

Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Charlotte Conway, Center for 
Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-8649; email: 
charlotte.conway@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of an SECG entitled ``Small 
Entity Compliance Guide--Declaring Color Additives in Animal Foods.'' 
This SECG aids industry in complying with the requirements of the final 
rule published in the Federal Register of November 17, 2011 (76 FR 
71248).
    FDA has prepared this SECG in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). 
This document is intended to provide guidance to small businesses on 
the requirements of the final rule, which implements a portion of the 
1990 amendments. The 1990 amendments, among other things, provided for 
the declaration of certified color additives on the labels of human and 
animal food, including animal feeds and pet foods. The 1990 amendments 
also provided for the listing on food labels of the common or usual 
names of all color additives required to be certified by FDA. This 
regulation deals with the requirements associated with animal food 
only.
    Before passage of the 1990 amendments, the FD&C Act provided that 
colorings could be declared collectively on food product labels using 
the term ``colorings.'' The 2011 regulation requires that certified 
color additives be declared on labeling of animal food by their common 
or usual name, but color additives exempt from certification (e.g., 
caramel, paprika, and beet juice) may still be declared collectively. 
The rule makes these animal food regulations consistent with the 
regulations regarding the declaration of certified color additives on 
the labels of human food. The rule also suggests appropriate 
terminology for the declaration of noncertified color additives on the 
labels of animal food.

II. Significance of Guidance

    FDA is issuing this SECG as a level 2 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The guidance 
represents the Agency's current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    This SECG refers to previously approved collections of information 
found in FDA regulations. These collections of information are subject 
to review by the Office of Management and Budget under the Paperwork 
Reduction Act (44 U.S.C. 3501-3520.) The collections of information in 
the regulation ``Animal Food Labeling; Declaration of Certifiable Color 
Additives'' (21 CFR 501.22(k)(1) and (2)) have been approved under OMB 
control number 0910-0721.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the SECG at either 
http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: September 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23560 Filed 9-26-13; 8:45 am]
BILLING CODE 4160-01-P


