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, 36284-36285 [2021-14655]

Download as PDF 36284 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 The HHS Notice, RFPs, and FAQs are withdrawn. All website statements and other informal issuances with respect to the HHS Notice and RFPs are also withdrawn.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. 2021–14637 Filed 7–8–21; 8:45 am] BILLING CODE 4164–01–P 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 Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0721. 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, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 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. FDA–2009–N–0025] 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 0910–0721— Extension 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. 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 § 501.22(k) 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 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents jbell on DSKJLSW7X2PROD with NOTICES 21 CFR section; activity 501.22(k); 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. VerDate Sep<11>2014 17:01 Jul 08, 2021 Jkt 253001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM 09JYN1 Total hours 647 Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: July 2, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14655 Filed 7–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–E–1944] Determination of Regulatory Review Period for Purposes of Patent Extension; AJOVY AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AJOVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by September 7, 2021. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 5, 2022. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 7, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 7, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:01 Jul 08, 2021 Jkt 253001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–E–1944 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; AJOVY.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 36285 information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36284-36285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14655]


-----------------------------------------------------------------------

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 Certified and Non-Certified Color Additives

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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: 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 Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0721. 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, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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 Certified and Non-Certified Color 
Additives

OMB Control Number 0910-0721--Extension

    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 Sec.  
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 Sec.  501.22(k) 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 Sec.  501.22(k) 
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 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR section; activity               Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
501.22(k); labeling of color additive or               3,120          0.8292           2,587  0.25 (15 minutes).........................             647
 lake of color additive; labeling of color
 additives not subject to certification.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 36285]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14655 Filed 7-8-21; 8:45 am]
BILLING CODE 4164-01-P