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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
of the RFPs. The responses to the RFPs were directed in the HHS Notice and in the RFP for Personal Prescription Drug Importation issued on September 24, 2020, and revised on January 13, 2021, to be submitted to an HHS email address: import@hhs.gov, while the RFP
for Insulin Reimportation Programs issued on September 24, 2020, and revised on January 13, 2021, directed that responses be sent to import@
hhs.gov and to the Director of the FDA
Import Division in the region of the intended port of entry. The Department is not aware that any proposals were received in response to the HHS Notice or RFPs. The HHS Notice, RFPs, and FAQs are withdrawn. All website statements and other informal issuances with respect to the HHS Notice and RFPs are also withdrawn. Accordingly, no proposals submitted to HHS or FDA
in response to the HHS Notice or RFPs on or after July 9, 2021 will be considered by HHS or FDA. HHS
intends to consider alternatives to the RFPs.
Dated: June 11, 2021.
Janet Woodcock, Acting Commissioner of Food and Drugs.
Dated: June 28, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202114637 Filed 7821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Notice.

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: Submit written comments including recommendations on the collection of information by August 9, 2021.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting Currently under ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100721. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601 Landsdown St., North Bethesda, MD 20852, 301796
3794, 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.
SUMMARY:

Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
Food and Drug Administration Docket No. FDA2009N0025

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives Food and Drug Administration, Health and Human Services HHS.

AGENCY:

ACTION:

OMB Control Number 09100721
Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act FD&C Act to issue regulations concerning animal food. Specifically, section 403i of the FD&C Act 21
U.S.C. 343i 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 501.22k21 CFR 501.22k, 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 501.22k is consistent with the regulations requiring the declaration of color additives on human food labels.
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.
In the Federal Register of March 4, 2021 86 FR 12690, FDA published a 60-day notice requesting public comment on the proposed collection of information. 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 501.22k related to color additive information on the labeling of animal food.
FDA estimates the burden of this collection of information as follows:
Description of Respondents:
Respondents to this collection of information are manufacturers of pet food products that contain color additives.
FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of respondents
jbell on DSKJLSW7X2PROD with NOTICES

21 CFR section; activity 501.22k; labeling of color additive or lake of color additive; labeling of color additives not subject to certification.
1 There
Number of disclosures per respondent
3,120

0.8292

Total annual disclosures 2,587

Average burden per disclosure 0.25 15 minutes

are no capital costs or operating and maintenance costs associated with this collection of information.

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