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FAQs are withdrawn.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RFPs are also withdrawn.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 

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, 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. 

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 

§ 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

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

501.22(k); labeling of color additive or lake of color 

additive; labeling of color additives not subject to 

certification.

3,120 0.8292 2,587 0.25 (15 minutes) ...... 647 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices 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 

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. 

SUMMARY: 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. 

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 

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-2015- 

09-18/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 


jbell on DSKJLSW7X2PROD with NOTICES