7190 Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 

1https://www.fda.gov/medical-devices/howstudy-and-market-your-device/device-registrationand-listing. 

registered. If an owner or operator 

changes, the new owner or operator 

creates a new owner or operator account 

and transfers the ownership of the 

establishment to their owner or operator 

account. Once they create an owner or 

operator account, they use the account 

for as long as the company is registered. 

Under § 807.22(b)(4), changes to listing 

information may be made at times 

outside of the annual listing 

requirement period, such as when a 

change is made to a previously listed 

device. 

The draft guidance document entitled 

‘‘Transfer of a Premarket Notification 

(510(k)) Clearance—Questions and 

Answers’’ (December 2014), which 

contained instructions for the proposed 

voluntary information collection, has 

recently been withdrawn. While 

notification of transfer of ownership 

information is not currently required, 

our medical device registration and 

listing website 1 communicates 

procedures for notifying FDA of the 

transfer of a premarket notification 

(510(k)) clearance from one person to 

another. The notification is used to 

ensure public information in FDA’s 

databases about the current 510(k) 

holder for a specific device(s) is 

accurate and up to date. Although 

submission of information regarding the 

transfer of a 510(k) clearance is not 

required under the regulations, we 

regularly receive such notifications from 

respondents. 

FDA estimates that annually 78 

percent of 510(k)s may be initially listed 

or updated outside of the annual 

registration requirement (about 4,080 

510(k)s per year). FDA estimates that it 

will take approximately 15 minutes for 

each listing, for a total reporting burden 

of 1,020 hours. 

FDA estimates it will have 2,033 

instances of more than one party 

claiming to be a 510(k) holder for a 

specific device as part of annual 

registration and listing. FDA reached 

this estimate by identifying the average 

number of unique 510(k) device listings 

entered in FURLS between fiscal years 

2017 and 2019 that conflict with a 

listing already entered by another party 

(5,304), dividing that number by the 

number of years (3) and multiplying by 

the average number of parties claiming 

to be the 510(k) holder when there is a 

conflict in the current FURLS database 

(2.3), then dividing the result by 2 

(because only one company per listing 

will submit the appropriate 

documentation to show that they are the 

current 510(k) holder). 

The registration and listing website 

identifies potential documentation a 

party could submit to FDA to establish 

the transfer of a 510(k) clearance to a 

new owner or operator. Based on the 

amount of time to locate the 

information, copy it, and submit a copy, 

FDA estimates it will take respondents 

approximately 4 hours to establish the 

transfer of a 510(k) clearance. 

The estimate for § 807.25(d) in table 2 

of this document (recordkeeping 

burden) reflects the requirement that 

owners or operators maintain a 

historical file containing the labeling 

and advertisements in use. The estimate 

for § 807.26 reflects the requirement that 

owners or operators keep a list of 

officers, directors, and partners for each 

establishment. Owners or operators will 

need to provide this information only 

when requested by FDA. However, it is 

assumed that some effort will need to be 

expended to keep such records current. 

The recurring burden for the data 

collection under § 807.41 (importrelated information provided by foreign 

companies exporting to the United 

States) was estimated based on data 

from previous years. Foreign companies 

identify one importer and one person 

who imports or offers for import with 

readily available contact information at 

the time of registration. After 

completing their initial registration, 

they are required to review the importer 

information annually. When they 

review the importer information 

annually, they simply verify the 

importer information is accurate. If it is 

and no changes are needed, the foreign 

establishment’s official correspondent 

checks the certification and submits the 

annual registration. If they need to make 

changes to the importer information, 

they can do so at any time and use a 

spreadsheet to update more than one 

importer at a time to their registration. 

The use of the spreadsheet reduces the 

burden to the official correspondent of 

the foreign establishment. 

Our estimated burden for the 

information collection reflects an 

overall increase of 10,880 hours and a 

corresponding increase of 28,430 

responses/records. We attribute this 

adjustment to an increase in the number 

of submissions we received over the last 

few years. Additionally, we have 

included non-substantive changes, 

incorporating the burden previously 

approved under OMB control number 

0910–0852 into OMB control number 

0910–0625, as approved by OMB in May 

2021. 

Dated: February 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02600 Filed 2–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0294] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 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 March 10, 

2022. 

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 0910–0495. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 7191 

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. The forms are 

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

food-ingredients-packaging/packagingfood-contact-substances-fcs. To open 

field fillable forms, they must be 

downloaded and then opened from your 

local computer (not from a web 

browser). 

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/ 

GuidanceRegulation/ 

GuidanceDocuments

RegulatoryInformation/ 

IngredientsAdditivesGRASPackaging/ 

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. 

In the Federal Register of September 

15, 2021 (86 FR 51358), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited. 

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
7192 Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / 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: February 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02620 Filed 2–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on the National Health Service 

Corps 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Council on the National 

Health Service Corps (NACNHSC) will 

hold public meetings for the 2022 

calendar year (CY). Information about 

NACNHSC, agendas, and materials for 

these meetings can be found on the 

NACNHSC website at: https://

www.hrsa.gov/advisory-committees/ 

national-health-service-corps. 

DATES: NACNHSC meetings will be held 

on: 

• March 29, 2022, 9:00 a.m.–5:00 p.m. 

Eastern Time (ET) and March 30, 2022, 

9:00 a.m.–2:00 p.m. ET; 

• June 28, 2022, 9:00 a.m.–5:00 p.m. 

ET and June 29, 2022, 9:00 a.m.–2:00 

p.m. ET; and 

• November 15, 2022, 9:00 a.m.–5:00 

p.m. ET and November 16, 2022, 9:00 

a.m.–2:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or 

ZOOM. For updates on how meetings 

will be held, visit the NACNHSC 

website 30 business days before the date 

of the meeting, where instructions for 

joining meetings either in-person or 

remotely will be posted. In-person 

NACNHSC meetings will be held at 

5600 Fishers Lane, Rockville, Maryland 

20857. For meeting information 

updates, go to the meetings page on the 

NACNHSC website at https://

www.hrsa.gov/advisory-committees/ 

national-health-service-corps/meetings. 

FOR FURTHER INFORMATION CONTACT: 

Diane Fabiyi-King, Designated Federal 

Official, Division of National Health 

Service Corps, HRSA, 5600 Fishers 

Lane, Rockville, Maryland 20857; phone 

(301) 443–3609; or 

NHSCAdvisoryCouncil@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

NACNHSC consults with, advises, and 

makes recommendations to the 

Secretary of Health and Human Services 

with respect to the Secretary’s 

responsibilities in carrying out Subpart 

II, Part D of Title III of the Public Health 

Service Act (42 U.S.C. 254d–254k), as 

amended, including the designation of 

areas of the United States with health 

professional shortages and assignment 

of National Health Service Corps 

(NHSC) clinicians to improve the 

delivery of health services in health 

professional shortage areas. Since 

priorities dictate meeting times, be 

advised that start times, end times, and 

agenda items are subject to change. 

Refer to the meeting website listed 

above for any meeting updates. 

For CY 2022 meetings, agenda items 

may include, but are not limited to, the 

identification of NHSC priorities for 

future program issues and concerns; 

proposed policy changes by using the 

varying levels of expertise represented 

on the NACNHSC to advise on specific 

program areas; updates from clinician 

workforce experts; and education and 


khammond on DSKJM1Z7X2PROD with NOTICES