12688 Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 

4https://www.cbp.gov/travel/travel-industrypersonnel/apis/eapis-transmission-system 

CDC or CBP may issue additional 

operational guidance to aircraft 

operators regarding the collection and 

transmission of the designated 

information, including for those who are 

unable submit data in the manner 

specified or to meet the deadline of 

technical compliance. 

Any airline that fails to comply with 

section 1 may be subject to criminal 

penalties under, inter alia, 42 U.S.C. 271 

and 42 CFR 71.2, in conjunction with 18 

U.S.C. 3559 and 3571. 

2. This section applies to all other 

aircraft operators not covered in section 

1 above. Beginning 11:59 p.m. Eastern 

Standard Time on March 4, 2021, for 

each passenger flight transporting 

passengers destined for the United 

States from international last points of 

departure who have been in DRC or 

Guinea within 21 days prior to the date 

of entry or attempted entry into the 

United States, all airlines or aircraft 

operators shall — 

(a) Collect the designated information 

for all passengers who are departing 

from, or were otherwise present in, DRC 

or Guinea within the 21 days prior to 

their entry or attempted entry into the 

United States. When collecting the 

designated information, aircraft 

operators shall notify passengers that 

the obligation to provide the 

information is a United States 

Government requirement. 

(b) Transmit the designated passenger 

information to CBP or CDC through one 

of the following means: 

(1) Electronic Advance Passenger 

Information System; 4 or 

(2) Other means meeting minimum 

standards deemed acceptable to CDC in 

consultation with CBP. 

(c) For all crew members, upon 

request from the CDC Director, transmit 

the designated information through 

encrypted email or other means 

approved by CDC within 24 hours. 

CDC or CBP may issue additional 

operational guidance to aircraft 

operators regarding the collection and 

transmission of the designated 

information, including for those who are 

unable submit data in the manner 

specified or to meet the deadline of 

technical compliance. 

Any entities covered under section 2 

that fail to comply with section 2 may 

be subject to criminal penalties under, 

inter alia, 42 U.S.C. 271 and 42 CFR 

71.2, in conjunction with 18 U.S.C. 3559 

and 3571. 

3. Requirements for Passengers: 

Beginning 11:59 p.m. Eastern 

Standard Time on March 4, 2021, any 

passenger destined for the United States 

on a flight covered under sections 1 or 

2 who is departing from, or was 

otherwise present in, DRC or Guinea 

within 21 days prior to entry, or 

attempted entry, into the United States 

shall provide the designated 

information, as instructed by the airline 

or aircraft operator, insofar as the 

information exists for the passenger. 

Authorized representatives (for 

example, immediate family member, 

legal guardian, or travel agent) may 

provide the designated information on 

behalf of passengers, including on 

behalf of minors or other passengers 

who are unable to do so on their own 

behalf), but the information must be 

specific to the individual passenger 

(e.g.agents may not put one number for 

an entire group of unrelated persons). 

Any passenger who fails to comply 

with the requirements of section 3 may 

be subject to criminal penalties under, 

inter alia, 42 U.S.C. 271 and 42 CFR 

71.2, in conjunction with 18 U.S.C. 3559 

and 3571. 

CDC and CBP will maintain the 

designated information within their 

respective systems in accordance with 

Federal law, including the Privacy Act 

of 1974 (5 U.S.C. 552a). Identifiable 

information may be used and shared 

only for lawful purposes, including with 

authorized personnel of the United 

States Department of Health and Human 

Services; the United States Department 

of Homeland Security; state, local, 

tribal, and territorial public health 

departments; and other cooperating 

authorities, as authorized by law. CDC 

and CBP will retain, use, delete, or 

otherwise destroy the designated 

information in accordance with the 

Federal Records Act, applicable Privacy 

Act System of Records Notices, and 

other applicable law. 

CDC may modify this Order by an 

updated publication in the Federal 

Register or by posting an advisory to 

follow at www.cdc.gov. 

Authority 

The CDC Director is issuing this Order 

pursuant to Sections 361 and 365 of the 

Public Health Service (PHS) Act, 42 

U.S.C. 264 and 268, and implementing 

regulations at 42 CFR 71.4, 71.20, 71.31, 

and 71.32. 

Dated: March 2, 2021. 

Sherri Berger, 

Acting Chief of Staff, Centers for Disease 

Control and Prevention. 

[FR Doc. 2021–04625 Filed 3–2–21; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0438] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Early Food Safety 

Evaluation of New Non-Pesticidal 

Proteins Produced by New Plant 

Varieties Intended for Food Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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’s 

procedures for early food safety 

evaluation of new non-pesticidal 

proteins produced by new plant 

varieties intended for food use, 

including bioengineered food plants. 

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 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 


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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 12689 

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– 

2012–N–0438 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Early 

Food Safety Evaluation of New NonPesticidal Proteins Produced by New 

Plant Varieties Intended for Food Use.’’ 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by 

New Plant Varieties Intended for Food 

Use 

OMB Control Number 0910–0583— 

Extension 

This information collection supports 

FDA regulations. Since May 29, 1992, 

when we issued a policy statement on 

foods derived from new plant varieties, 

including those varieties that are 

developed through biotechnology, we 

have encouraged developers of new 

plant varieties to consult with us early 

in the development process to discuss 

possible scientific and regulatory issues 

that might arise (57 FR 22984). The 

guidance, entitled ‘‘Recommendations 

for the Early Food Safety Evaluation of 

New Non-Pesticidal Proteins Produced 

by New Plant Varieties Intended for 

Food Use’’ (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/guidanceindustry-recommendations-early-foodsafety-evaluation-new-non-pesticidalproteins-produced), continues to foster 

early communication by encouraging 

developers to submit to us their 

evaluation of the food safety of their 

new proteins. Such communication 

helps to ensure that any potential food 

safety issues regarding a new protein in 

a new plant variety are resolved early in 

development, prior to any possible 

inadvertent introduction into the food 

supply of the new protein. 

We believe that any food safety 

concern related to such material 

entering the food supply would be 

limited to the potential that a new 

protein in food from the plant variety 

could cause an allergic reaction in 

susceptible individuals or could be a 

toxin. The guidance describes the 

procedures for early food safety 

evaluation of new proteins produced by 

new plant varieties, including 

bioengineered food plants, and the 

procedures for communicating with us 

about the safety evaluation. 

Interested persons may use Form FDA 

3666 to transmit their submission to the 

Office of Food Additive Safety in the 


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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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