0910-0721 Supporting Statement _05_14_2021

United States Food and Drug Administration
Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
OMB Control No. 0910-0721
SUPPORTING STATEMENT
Terms of Clearance: None
Part A: Justification:
1. Circumstances Making the Collection of Information Necessary
FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue
regulations concerning animal food. Specifically, section 403(i) of the FD&C Act (21 U.S.C.
343(i)) requires that certified color additives used in or on a food must be declared by their
common or usual names and not be designated by the collective term “colorings.” Our regulations
in part 501 (21 CFR part 501) set forth the requirements for animal food labeling. Under §
501.22(k) (21 CFR 501.22(k)), animal food manufacturers must declare on the animal food label
the presence of certified and noncertified color additives in their animal food products. Our
animal food labeling regulation at § 501.22(k) is consistent with the regulations requiring the
declaration of color additives on human food labels
We therefore request extension of OMB approval of the information collection provisions found in
21 CFR 501.22(k) as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The purpose of the labeling is 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.
3. Use of Improved Information Technology and Burden Reduction
In the majority of cases (>90%), animal feed companies revise their product labels without
sending their draft labels to FDA for review. 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.
For the small number of companies that will be sending their draft labels to FDA for review, about
90% will be by e-mail and 10% by mail.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
There is no exemption from section 403(i) of the FD&C Act for small businesses. We believe that
our requirements for the declaration of certifiable color additives in animal food labeling impose
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the minimal burden necessary while still allowing us to comply with the FD&C Act. We assist
small businesses to meet the requirements of the FD&C Act through our Regional Small Business
Representatives and through the scientific and administrative staff within the Center. We estimate
that approximately 3,050 respondents are small businesses.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. This information is collected and updated only when a
product label is changed. If this information is not collected, FDA would not be able to ensure the
safety of the regulated products entering the marketplace.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a 60-day notice for public comment in the Federal Register of March 4, 2021 (86
FR 12690). We received 22 comments expressing the importance of color additive information on
pet food labeling, along with other ingredient disclosures. FDA appreciates these comments; at
this time, we are not revising the regulations found at § 501.22(k) related to color additive
information on the labeling of animal food.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate
identification and handling of information collected.
This ICR collects personally identifiable information (PII). PII is collected in the context of the
subject individuals’ professional capacity and the FDA-related work they perform for their
employer (e.g., point of contact at a regulated entity). The PII submitted is name and employer
address. This information collection is to provide labeling so animal owners can have information
on the color additives used in animal food. Through appropriate guidance, FDA limited
submission fields and minimized the PII collected to protect the privacy of the individuals.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to
government documents. However, FOIA provides certain exemptions from mandatory public
disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest possible
disclosure of records to the public, consistent with the rights of individuals to privacy, the property
rights of persons in trade and confidential commercial or financial information.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.

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12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Third-Party Disclosure Burden1
21 CFR Section; Activity
No. of
No. of
Total
Average
Respondents Disclosures
Annual
Burden per
per
Disclosures Disclosure
Respondent
501.22(k); labeling of color
3,120
0.8292
2,587
0.25
additive or lake of color
(15
additive; labeling of color
minutes).
additives not subject to
certification

Total
Hours
647

12b. Annualized Cost Burden Estimate
Type of Respondent
Industrial Production Manager

Total Burden
Hours
647

Hourly Wage
Rate
$73.871

Total Respondent
Costs
$47,793.89

May 2020 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor Statistics
and including 30% for benefits (https://www.bls.gov/oes/current/oes113051.htm).
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13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
FDA estimates the cost to the Federal Government for this collection to be $1,253.40. This
estimate was calculated by multiplying the time the agency expends to review product labeling
(approximately 30 hours) by the hourly wage of a GS-12 employee in the locality pay area of
Washington-Baltimore-Arlington in 2021 ($41.78).
15. Explanation for Program Changes or Adjustments*
The were no changes to the burden since the last renewal.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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