12690 Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 

Center for Food Safety and Applied 

Nutrition (CFSAN). Form FDA 3666 is 

entitled ‘‘Early Food Safety Evaluation 

of a New Non-Pesticidal Protein 

Produced by a New Plant Variety (New 

Protein Consultation)’’ and may be used 

in lieu of a cover letter for a New 

Protein Consultation (NPC). The form 

may be accessed at FDA’s web page for 

forms (https://www.fda.gov/about-fda/ 

reports-manuals-forms/forms) using the 

search term ‘‘3666.’’ To enable fieldfillable functionality of FDA forms, they 

must be downloaded. Form FDA 3666 

prompts a submitter to include certain 

elements of an NPC in a standard format 

and helps the respondent organize their 

submission to focus on the information 

needed for our safety review. The form, 

and elements prepared as attachments 

to the form, may be prepared using the 

CFSAN Online Submission Module 

(https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/ 

cfsan-online-submission-module-cosm). 

Once the submission is prepared, it may 

be submitted in electronic format via the 

Electronic Submissions Gateway 

(https://www.fda.gov/industry/ 

electronic-submissions-gateway), paper 

format, or as electronic files on physical 

media with paper signature page. We 

use this information to evaluate the food 

safety of a specific new protein 

produced by a new plant variety. 

Description of Respondents: The 

respondents to this collection of 

information are developers of new plant 

varieties intended for food use. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

GFI section VI: Format for submission Form FDA No. Number of 

responses 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

First four data components ...................... 3666 6 1 6 4 24 

Two other data components .................... 3666 6 1 6 16 96 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 120 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. The 

estimated number of annual responses 

and average burden per response are 

based on our experience with early food 

safety evaluations. Completing an early 

food safety evaluation for a new protein 

from a new plant variety is a one-time 

burden (one evaluation per new 

protein). Many developers of novel 

plants may choose not to submit an 

evaluation because the field testing of a 

plant containing a new protein is 

conducted in such a way (e.g., on such 

a small scale, or in such isolated 

conditions, etc.) that cross-pollination 

with traditional crops or commingling 

of plant material is not likely to be an 

issue. Also, other developers may have 

previously communicated with us about 

the food safety of a new plant protein, 

for example, when the same protein was 

expressed in a different crop. 

We estimate the annual number of 

NPCs submitted by developers will be 

six or fewer. The early food safety 

evaluation for new proteins includes six 

main data components. Four of these 

data components, having to do with the 

identity and source of the protein, are 

easily and quickly obtainable. We 

estimate that completing these data 

components will take about 4 hours per 

NPC. 

Two data components ask for original 

data to be generated. One data 

component consists of a bioinformatics 

analysis that can be performed using 

publicly available databases. The other 

data component involves ‘‘wet’’ lab 

work to assess the new protein’s 

stability and the resistance of the 

protein to enzymatic degradation using 

appropriate in vitro assays (protein 

digestibility study). The paperwork 

burden of these two data components 

consists of the time it takes the company 

to assemble the information on these 

two data components and include it in 

an NPC. We estimate that completing 

these data components will take about 

16 hours per NPC. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04448 Filed 3–3–21; 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; Proposed Collection; 

Comment Request; Animal Food 

Labeling; Declaration of Certified and 

Non-Certified Color Additives 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of FDA regulations 

requiring the declaration of color 

additives on animal food labels. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 3, 2021. 

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 May 3, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 3, 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 


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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 12691 

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– 

2009–N–0025 for ‘‘Animal Food 

Labeling; Declaration of Certified and 

Non-Certified Color Additives.’’ 

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 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: 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Animal Food Labeling; Declaration of 

Certified and Non-Certified Color 

Additives—21 CFR 501.22(k) 

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. 

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: 


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12692 Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 

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. 

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: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04461 Filed 3–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3077] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Obtaining Information To Understand 

and Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a collection of 

information entitled ‘‘Obtaining 

Information to Understand and 

Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 18, 2020, the Agency 

submitted a proposed collection of 

information entitled ‘‘Obtaining 

Information to Understand and 

Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0883. The approval expires on 

January 31, 2022. A copy of the 

supporting statement for this 

information collection is available on 

the internet at https://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04470 Filed 3–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1228] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Study of Multiple 

Indications in Direct-to-Consumer 

Television Advertisements 

AGENCY: Food and Drug Administration, 

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 April 5, 

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 title 

of this information collection is ‘‘Study 

of Multiple Indications in Direct-toConsumer Television Advertisements.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Study of Multiple Indications in Directto-Consumer Television Advertisements 

OMB Control Number 0910–NEW 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes the FDA to 

conduct research relating to health 

information. Section 1003(d)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 393(d)(2)(C)) 

authorizes FDA to conduct research 

relating to drugs and other FDA 

regulated products in carrying out the 

provisions of the FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have 

consistently conducted research to 

evaluate the aspects of prescription drug 

promotion that are most central to our 

mission, focusing in particular on three 

main topic areas: (1) Advertising 

features, including content and format; 

(2) target populations; and (3) research 

quality. Through the evaluation of 

advertising features, we assess how 

elements such as graphics, format, and 

disease and product characteristics 

impact the communication and 


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