Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 7187 

operational improvements associated 

with PDUFA implementation. The 

commitment goals provide for the 

development and issuance of topicspecific guidance. We maintain a 

searchable guidance database on our 

website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents. In publishing the 

respective notices of availability for 

each guidance document, we include an 

analysis under the PRA and invite 

public comment on the associated 

information collection 

recommendations. In addition, all 

Agency guidance documents are issued 

in accordance with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

In the Federal Register of November 

30, 2021 (86 FR 67958), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Prescription drug user fee activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Sections 735 and 736 of the FD&C Act (PDUFA waivers, 

not including small business waivers) .............................. 112 1.68 189 17 3,213 

Section 736(d)(1)(C) of the FD&C Act and Form FDA 

3971 (small business waivers) ......................................... 37 1 37 2 74 

Reconsideration Requests ................................................... 6 1.67 10 24 240 

Appeal Requests .................................................................. 1 1 1 12 12 

User Fee Cover Sheet Form FDA 3397 .............................. 174 1 174 0.5 (30 

minutes) 

87 

Total .............................................................................. ........................ ........................ 411 ........................ 3626 

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

Based on a review of Agency records, 

we estimate that the number of initial 

waiver requests submitted annually 

(excluding small business waiver 

requests under section 736(d)(1)(C)) of 

the FD&C Act) will be 189, submitted by 

112 different applicants; and that 37 

respondents annually will each submit 

a small business waiver request. We 

have included in the burden estimate 

the time for preparation and submission 

of application fee waivers for small 

businesses, including completion of 

Form FDA 3971. Small businesses 

requesting a waiver must submit 

documentation to FDA, including the 

number of their employees, as well as 

information that the application is the 

first human drug application, within the 

meaning of the FD&C Act, to be 

submitted to the Agency for approval. 

We estimate receiving 10 requests for 

reconsideration annually (including 

small business waiver reconsiderations) 

and assume the average burden for 

preparing and submitting each request 

is 24 hours. In addition, we estimate 

receiving 1 request annually for appeal 

of user fee waiver determination, and 

assume the time needed to prepare an 

appeal is 12 hours. We have included in 

this estimate both the time needed to 

prepare the request for appeal to the 

Chief Scientist and User Fee Appeals 

Officer within the Office of the 

Commissioner, and the time needed to 

create and send a copy of the request for 

an appeal to the Director Division of 

User Fee Management within the Office 

of Management at FDA’s Center for Drug 

Evaluation and Research. 

We assume 87 hours of burden for 

completing and submitting Form FDA 

3397 (Prescription Drug User Fee 

Coversheet) for submission of a new 

drug application or biologics license 

application. 

The information collection reflects an 

overall increase since our last request 

for OMB review and approval. We 

attribute this to expected fluctuations in 

submissions to the Agency. 

Dated: February 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02617 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–2015–N–3815] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Establishment 

Registration and Device Listing for 

Manufacturers and Importers of 

Devices 

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 information 

collection associated with establishment 

registration and device listing for 

manufacturers and importers of devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 11, 2022. 

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 April 11, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 11, 2022. 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. 


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7188 Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 

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– 

2015–N–3815 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Establishment Registration and Device 

Listing for Manufacturers and Importers 

of Devices.’’ 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: 

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: 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. 

Establishment Registration and Device 

Listing for Manufacturers and 

Importers of Devices—21 CFR Part 807, 

Subparts A Through D 

OMB Control Number 0910–0625— 

Extension 

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360) and part 807, 

subparts A through D (21 CFR part 807, 

subparts A through D), medical device 

establishment owners and operators are 

required to electronically submit 

establishment registration and device 

listing information. 

Complete and accurate registration 

and listing information is necessary to 

accomplish a number of statutory and 

regulatory objectives, such as: (1) 

Identification of establishments 

producing marketed medical devices, 

(2) identification of establishments 

producing a specific device when that 

device is in short supply or is needed 

for national emergency, (3) facilitation 

of recalls for devices marketed by 

owners and operators of device 

establishments, (4) identification and 

cataloging of marketed devices, (5) 

administering postmarketing 

surveillance programs for devices, (6) 

identification of devices marketed in 

violation of the law, (7) identification 

and control of devices imported into the 

country from foreign establishments, 

and (8) scheduling and planning 

inspections of registered establishments 

under section 704 of the FD&C Act (21 

U.S.C. 374). 

Respondents to this information 

collection are owners or operators of 

establishments that engage in the 

manufacturing, preparation, 

propagation, compounding, or 

processing of a device or devices, who 

must register their establishments and 

submit listing information for each of 

their devices in commercial 

distribution. Notwithstanding certain 


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Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 7189 

exceptions, foreign device 

establishments that manufacture, 

prepare, propagate, compound, or 

process a device that is imported or 

offered for import into the United States 

must also comply with the registration 

and listing requirements. The number of 

respondents is based on data from the 

FDA Unified Registration and Listing 

System (FURLS). Burden estimates are 

based on recent experience with the 

medical device registration and listing 

program, electronic system operating 

experience, and previous data estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 2

807.20(a)(5) 3 Initial submittal of manufacturer information 

by initial importers ............................................................ 4,125 1 4,125 1.75 7,219 

807.20(a)(5) 4 Annual submittal of manufacturer information by initial importers ..................................................... 4,125 1 4,125 0.1 413 

807.21(a) 3 Creation of electronic system account .............. 5,355 1 5,355 0.5 2,678 

807.21(b) 4 Annual request for waiver from electronic registration & listing ............................................................... 1 1 1 1 1 

807.21(b) 3 Initial request for waiver from electronic registration & listing ............................................................... 1 1 1 1 1 

807.22(a) 3 Initial registration & listing ................................. 5,355 1 5,355 1 5,355 

807.22(b)(1) 4 Annual registration ........................................ 28,496 1 28,496 0.5 14,248 

807.22(b)(2) 4 Other updates of registration ........................ 2,671 1 2,671 0.5 1,336 

807.22(b)(3) 4 Annual update of listing information ............. 26,871 1 26,871 0.5 13,436 

807.22(b)(4) Changes to listing information (outside of annual listing requirement period) 

Voluntary reporting of transfer of 510(k) clearance 

(outside of annual listing requirement period) .......... 4,080 1 4,080 0.25 1,020 

Submission of 510(k) transfer documentation when 

more than one party lists the same 510(k) ............... 2,033 1 2,033 4 8,132 

807.26(e) 4 Labeling & advertisement submitted at FDA request ................................................................................. 9 1 9 1 9 

807.34(a) 3 Initial registration & listing when electronic filing waiver granted ............................................................ 1 1 1 1 1 

807.34(a) 4 Annual registration & listing when electronic filing waiver granted ............................................................ 1 1 1 1 1 

807.40(b)(3) 4 Annual update of U.S. agent information ..... 6,101 1 6,101 0.5 3,051 

807.40(b)(2) 4 U.S. agent responses to FDA requests for 

information ........................................................................ 1,535 1 1,535 0.25 384 

807.41(a) 4 Identification by foreign establishments of importers, defined in 21 CFR 807.3, of the establishment’s 

devices ............................................................................. 14,017 1 14,017 0.5 7,009 

807.41(b) 4 Identification of other importers (defined in 21 

CFR 807.3(x) and (y)) that facilitate import by foreign 

establishments .................................................................. 14,017 1 14,017 0.5 7,009 

Total one-time burden .................................................. ........................ ........................ ........................ ........................ ........................

Total recurring burden ........................................... ........................ ........................ ........................ ........................ ........................

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

2Totals are rounded to the nearest whole number. 

3One-Time Burden—Firm only provides initially. 

4 Recurring Burden—Firm is required to review annually. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

respondents 

Annual 

frequency 

per 

recordkeeper 

Total annual 

records 

Hours per 

record Total hours 

807.25(d) 2 Labeling & advertisements available for review 17,032 4 68,128 .5 34,064 

807.26 2 List of officers, directors & partners ...................... 33,851 1 33,851 .25 8,463 

Total .............................................................................. ........................ ........................ ........................ ........................ 42,527 

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

2 Recurring burden—Firm is required to keep records. 

The estimates for creation of new user 

accounts under § 807.21(a) are based on 

the recent number of owners or 

operators. An owner or operator only 

creates an account one time when they 

register for the first time (initial 

registration). Once the account is 

created, the owner or operator uses the 

account as long as the establishment is 


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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 


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