51358 Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0294] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Contact 

Substance Notification Program 

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 associated with the Food 

Contact Substance Notification Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 15, 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 November 15, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 15, 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– 

2012–N–0294 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Contact Substance Notification 

Program.’’ 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 


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Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Notices 51359 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Food Contact Substance Notification 

Program—21 CFR 170.101, 170.106, 

and 171.1 

OMB Control Number 0910–0495— 

Extension 

This information collection supports 

FDA regulations regarding Food Contact 

Substance Notification, as well as 

associated guidance and accompanying 

forms. Section 409(h) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 348(h)) establishes a 

premarket notification process for food 

contact substances. Section 409(h)(6) of 

the FD&C Act defines a ‘‘food contact 

substance’’ as ‘‘any substance intended 

for use as a component of materials used 

in manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food.’’ Section 409(h)(3) of 

the FD&C Act requires that the 

notification process be used for 

authorizing the marketing of food 

contact substances except when: (1) We 

determine that the submission and 

premarket review of a food additive 

petition (FAP) under section 409(b) of 

the FD&C Act is necessary to provide 

adequate assurance of safety or (2) we 

and the manufacturer or supplier agree 

that an FAP should be submitted. 

Section 409(h)(1) of the FD&C Act 

requires that a notification include: (1) 

Information on the identity and the 

intended use of the food contact 

substance and (2) the basis for the 

manufacturer’s or supplier’s 

determination that the food contact 

substance is safe under the intended 

conditions of use. 

Sections 170.101 and 170.106 of 

FDA’s regulations (21 CFR 170.101 and 

170.106) specify the information that a 

notification must contain and require 

that: (1) A food contact substance 

notification (FCN) includes Form FDA 

3480 and (2) a notification for a food 

contact substance formulation includes 

Form FDA 3479. These forms serve to 

summarize pertinent information in the 

notification. The forms facilitate both 

preparation and review of notifications 

because the forms will serve to organize 

information necessary to support the 

safety of the use of the food contact 

substance. The burden of filling out the 

appropriate form has been included in 

the burden estimate for the notification. 

Currently, interested persons transmit 

an FCN submission to the Office of Food 

Additive Safety in the Center for Food 

Safety and Applied Nutrition using 

Form FDA 3480 whether it is submitted 

in electronic or paper format. We 

estimate that the amount of time for 

respondents to complete Form FDA 

3480 will continue to be the same. 

In addition to its required use with 

FCNs, Form FDA 3480 is recommended 

to be used to organize information 

within a Pre-notification Consultation or 

Master File submitted in support of an 

FCN according to the items listed on the 

form. Master Files can be used as 

repositories for information that can be 

referenced in multiple submissions to 

FDA, thus minimizing paperwork 

burden for food contact substance 

authorizations. We estimate that the 

amount of time for respondents to 

complete the Form FDA 3480 for these 

types of submissions is 0.5 hours. 

FDA recommends using Form FDA 

3480A for each submission of additional 

information (i.e., amendment) to an FCN 

submission of Pre-notification 

Consultation currently under Agency 

review, as well as for Master Files. Form 

FDA 3480A helps the respondent 

organize the submission to focus on the 

information needed for FDA’s safety 

review. We estimate that the amount of 

time for respondents to complete the 

Form FDA 3480A for these types of 

submissions is 0.5 hours. 

FDA’s guidance documents entitled: 

(1) ‘‘Preparation of Food Contact 

Notifications: Administrative,’’ (2) 

‘‘Preparation of Food Contact 

Notifications and Food Additive 

Petitions for Food Contact Substances: 

Chemistry Recommendations,’’ and (3) 

‘‘Preparation of Food Contact 

Notifications for Food Contact 

Substances: Toxicology 

Recommendations’’ provide assistance 

to industry regarding the preparation of 

an FCN and a petition for food contact 

substances (FCSs). FDA also issued a 

guidance entitled, ‘‘Preparation of Food 

Contact Notifications for Food Contact 

Substances in Contact with Infant 

Formula and/or Human Milk.’’ The 

guidance provides assistance to industry 

regarding the preparation of an FCN for 

FDA review and evaluation of the safety 

of FCSs used in contact with infant 

formula and/or human milk. These 

guidances are available at https://

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/Ingredients

AdditivesGRASPackaging/default.htm. 

Section 171.1 of FDA’s regulations (21 

CFR 171.1) specifies the information 

that a petitioner must submit in order 

to: (1) Establish that the proposed use of 

an indirect food additive is safe and (2) 

secure the publication of an indirect 

food additive regulation in parts 175 

through 178 (21 CFR parts 175 through 

178). Parts 175 through 178 describe the 

conditions under which the additive 

may be safely used. 

In addition, FDA’s guidance entitled 

‘‘Use of Recycled Plastics in Food 

Packaging: Chemistry Considerations,’’ 

provides assistance to manufacturers of 

food packaging in evaluating processes 

for producing packaging from postconsumer recycled plastic. The 

recommendations in the guidance 

address the process by which 

manufacturers certify to FDA that their 

plastic products are safe for food 

contact. 

Description of Respondents: The 

respondents to this information 

collection are manufacturers of food 

contact substances sold in the United 

States. Respondents are from the private 

sector. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

170.106 2 (Category A) ....................... 3479 10 2 20 2 ......................... 40 

170.101 3 7 (Category B) ..................... 3480 6 1 6 25 ....................... 150 

170.101 4 7 (Category C) ..................... 3480 6 2 12 120 ..................... 1,440 

170.101 5 7 (Category D) ..................... 3480 42 2 84 150 ..................... 12,600 

170.101 6 7 (Category E) ..................... 3480 38 1 38 150 ..................... 5,700 

Pre-notification Consultation or Master 

File (concerning a food contact substance) 8.

3480 150 1 150 0.5 (30 minutes) 75 


khammond on DSKJM1Z7X2PROD with NOTICES
51360 Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section; activity Form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

Amendment to an existing notification 

(170.101), amendment to a Pre-notification Consultation, or amendment to a Master File (concerning a 

food contact substance) 9.

3480A 80 1 80 0.5 (30 minutes) 40 

171.1; Indirect Food Additive Petitions N/A 1 1 1 10,995 ................ 10,995 

Use of Recycled Plastics in Food 

Packaging: Chemistry Considerations.

N/A 65 1 65 25 ....................... 1,625 

Preparation of Food Contact Notifications for Food Contact Substances 

in Contact with Infant Formula and/ 

or Human Milk.

........................ 2 1 2 5 ......................... 10 

Total ............................................. ........................ ........................ ........................ ........................ ............................ 32,675 

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

2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479 

(‘‘Notification for a Food Contact Substance Formulation’’) only. 3 Duplicate notifications for uses of food contact substances. 

4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 

5 Notifications for uses that are the subject of moderately complex food additive petitions. 

6 Notifications for uses that are the subject of very complex food additive petitions. 

7These notifications require the submission of Form FDA 3480. 

8These notifications recommend the submission of Form FDA 3480. 

9These notifications recommend the submission of Form FDA 3480A. 

Based on a review of the information 

collection since our last request for 

OMB approval, we made adjustments to 

our burden estimate. The estimates are 

based on our current experience with 

the Food Contact Substance Notification 

Program and informal communication 

with industry. 

Our estimated burden for the 

information collection reflects an 

overall increase of 1,345 hours and a 

corresponding decrease of 5 responses. 

We attribute this adjustment to a 

decrease in Pre-Notification 

Consultations or Master Files by 40 

responses, a subsequent decrease of 

amendments to Pre-Notification 

Consultations or Master Files by 20 

responses, and an increase of 55 

respondents using the recommendations 

in the guidance document entitled, ‘‘Use 

of Recycled Plastics in Food Packaging: 

Chemistry Considerations.’’ As the 

average burden for preparing recycling 

submissions is higher than for Prenotification Consultations or Master 

Files, this results in an overall increase 

in total burden even with an overall 

decrease in responses. 

Dated: September 9, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19925 Filed 9–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Biobehavioral Regulation, Learning 

and Ethology Study Section. 

Date: October 7, 2021. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Sara Louise Hargrave, 

Ph.D. Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3170, 

Bethesda, MD 20892, (301) 443–7193, 

hargravesl@mail.nih.gov. 

Name of Committee: Population Sciences 

and Epidemiology Integrated Review Group; 

Kidney, Nutrition, Obesity and Diabetes 

Study Section. 

Date: October 7–8, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Steven Michael Frenk, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3141, 

Bethesda, MD 20892, (301) 480–8665 

frenksm@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; High-end 

and Shared Instrumentation Grants. 

Date: October 12, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jonathan Arias, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5170, 

MSC 7840, Bethesda, MD 20892, (301) 435– 

2406, ariasj@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience; Integrated Review 

Group; Developmental Brain Disorders Study 

Section. 

Date: October 13–15, 2021. 

Time: 11:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


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