Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices 36283 

product information, particularly for 

applications that include multiple 

products. 

All information is entered using 

electronic Forms FDA 3613d, 3613e, 

and 3613k and used to evaluate 

certificate requests. The eCATS Module 

is Form FDA 3613k, where Form FDA 

3613e is the Certificate of Free Sale 

(https://www.fda.gov/food/food-exportcertificates/online-applications-exportcertificates-food). All ‘‘forms’’ are 

electronic and part of the eCATS or CAP 

portal accessed via https://

www.access.fda.gov. To view 

representations of the forms, you have 

to download the instructions, which are 

accessible from the following links: 

https://www.fda.gov/cosmetics/ 

cosmetics-exporters/onlineapplications-export-certificatescosmetics and https://www.fda.gov/ 

food/food-export-certificates/onlineapplications-export-certificates-food. 

While burden associated with 

information collection activities for 

export certificates issued for other FDAregulated products is approved under 

OMB control number 0910–0498, this 

collection specifically supports export 

certificates issued by CFSAN. Also, 

because we have eliminated paperbased forms, respondents who require 

assistance with completing export 

certificate applications online may 

contact CFSAN directly by email 

(CFSANExportCertification@

fda.hhs.gov) or telephone (240–402– 

2307). Instructions for requesting export 

certificates for cosmetics (Form FDA 

3613d) are available online at https://

www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-cosmetics and instructions 

for requesting export certificates for 

food (Forms FDA 3613e and 3613k) are 

available online at https://www.fda.gov/ 

food/food-export-certificates/onlineapplications-export-certificates-food. 

Description of Respondents: The 

respondents to this collection of 

information are firms interested in 

exporting U.S.-manufactured human 

food and cosmetic products to foreign 

countries that require export certificates. 

In the Federal Register of March 16, 

2021 (86 FR 14452), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. We received one comment 

offering general support for our 

cosmetic export certificate program. The 

comment also recommended FDA 

consider providing certificates that 

allow exporters to use an exemption 

from requirements in China for animal 

testing for certain imported cosmetic 

products. We appreciate the comment 

and continue to seek ways to increase 

the utility of the information collection 

as our limited resources permit. At the 

same time, the comment did not suggest 

we revise the burden we attribute to the 

associated information collection 

activity. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent Form No. 2 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

(in hours) 

Total hours 

Cosmetics ..................... FDA 3613d .................. 113 3 339 0.5 (30 minutes) .......... 170 

Food ............................. FDA 3613e, 3613k ...... 468 9 4,212 0.5 (30 minutes) .......... 2,106 

Total ...................... ..................................... ........................ ........................ ........................ ..................................... 2,276 

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

2All forms are submitted electronically via FDA Industry Systems. 

Based on a review of the information 

collection since our last OMB approval, 

we have reduced our burden estimate. 

The burden estimate has been lowered 

due to a reduced number of 

respondents. We base our estimates on 

our experience with certificate 

applications received in the past 3 fiscal 

years. 

Dated: July 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14650 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–2021–Z–0025] 

Requests for Proposals for Insulin 

Reimportation and Personal 

Prescription Drug Importation; 

Withdrawal 

AGENCY: Food and Drug Administration 

(FDA), Department of Health and 

Human Services (HHS). 

ACTION: Notice; withdrawal. 

SUMMARY: The Department of Health and 

Human Services (Department or HHS) is 

announcing the withdrawal of a notice 

published in the Federal Register on 

January 21, 2021, entitled ‘‘Requests for 

Proposals for Insulin Reimportation and 

Personal Prescription Drug 

Importation.’’ HHS also withdraws the 

requests for proposals issued on its 

website on September 24, 2020, and 

revised on January 13, 2021, and ends 

the period for submission of proposals 

in response to the requests for 

proposals. 

DATES: The notice published in the 

Federal Register on January 21, 2021, at 

86 FR 6343, is withdrawn as of July 9, 

2021. 

FOR FURTHER INFORMATION CONTACT: 

Katelyn Mineo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6222, 

Silver Spring, MD 20993, 301–796– 

1054. 

SUPPLEMENTARY INFORMATION: On 

September 24, 2020, HHS issued two 

requests for proposals for the 

reimportation of insulin and the 

personal importation of prescription 

drugs (collectively, the RFPs) and 

posted related ‘‘Frequently Asked 

Questions’’ documents (FAQs) on its 

website. On January 21, 2021, HHS 

published a notice in the Federal 

Register entitled ‘‘Requests for 

Proposals for Insulin Reimportation and 

Personal Prescription Drug Importation’’ 

(the HHS Notice) (86 FR 6343). The 

HHS Notice referred to revised versions 


jbell on DSKJLSW7X2PROD with NOTICES
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. 


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