Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41477 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 15, 2021. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 16, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Moon Hee V. 

Choi (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: July 27, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16356 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0659] 

Medical Device User Fee Rates for 

Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2022. The Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended 

by the Medical Device User Fee 

Amendments of 2017 (MDUFA IV), 

authorizes FDA to collect user fees for 

certain medical device submissions and 

annual fees both for certain periodic 

reports and for establishments subject to 

registration. This notice establishes the 

fee rates for FY 2022, which apply from 

October 1, 2021, through September 30, 

2022, and provides information on how 

the fees for FY 2022 were determined, 

the payment procedures you should 

follow, and how you may qualify for 

reduced small business fees. 

FOR FURTHER INFORMATION CONTACT:

For information on Medical Device 

User Fees: https://www.fda.gov/ 

industry/fda-user-fee-programs/ 

medical-device-user-fee-amendmentsmdufa. 

For questions relating to the MDUFA 

Small Business Program, please visit the 

Center for Devices and Radiological 

Health’s website: https://www.fda.gov/ 

medical-devices/premarketsubmissions/reduced-medical-deviceuser-fees-small-business-determinationsbd-program. 

For questions relating to this notice: 

Andrew Bank, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 62019A, Beltsville, MD 20705, 301– 

796–0292. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the FD&C Act (21 

U.S.C. 379j) establishes fees for certain 

medical device applications, 

submissions, supplements, notices, and 

requests (for simplicity, this document 

refers to these collectively as 

‘‘submissions’’ or ‘‘applications’’); for 

periodic reporting on class III devices; 

and for the registration of certain 

establishments. Under statutorily 

defined conditions, a qualified 

applicant may receive a fee waiver or 

may pay a lower small business fee (see 

21 U.S.C. 379j(d) and (e)). 

Under the FD&C Act, the fee rate for 

each type of submission is set at a 

specified percentage of the standard fee 

for a premarket application (a premarket 

application is a premarket approval 

application (PMA), a product 

development protocol (PDP), or a 

biologics license application (BLA)). 

The FD&C Act specifies the base fee for 

a premarket application for each year 

from FY 2018 through FY 2022; the base 

fee for a premarket application received 

by FDA during FY 2022 is $329,000. 

From this starting point, this document 

establishes FY 2022 fee rates for certain 

types of submissions, and for periodic 

reporting, by applying criteria specified 

in the FD&C Act. 

The FD&C Act specifies the base fee 

for establishment registration for each 

year from FY 2018 through FY 2022; the 

base fee for an establishment 

registration in FY 2022 is $4,978. There 

is no reduction in the registration fee for 

small businesses. Each establishment 

that is registered (or is required to 

register) with the Secretary of Health 

and Human Services under section 510 

of the FD&C Act (21 U.S.C. 360) because 

such establishment is engaged in the 

manufacture, preparation, propagation, 

compounding, or processing of a device 

is required to pay the annual fee for 

establishment registration. 

II. Revenue Amount for FY 2022 

The total revenue amount for FY 2022 

is $213,687,660, as set forth in the 

statute prior to the inflation adjustment 

(see 21 U.S.C. 379j(b)(3)). MDUFA 

directs FDA to use the yearly total 

revenue amount as a starting point to set 

the standard fee rates for each fee type. 

The fee calculations for FY 2022 are 

described in this document. 

Inflation Adjustment 

MDUFA specifies that the 

$213,687,660 is to be adjusted for 

inflation increases for FY 2022 using 

two separate adjustments—one for 

payroll costs and one for non-payroll 

costs (see 21 U.S.C. 379j(c)(2)). The base 

inflation adjustment for FY 2022 is the 

sum of one plus the two separate 

adjustments and is compounded as 

specified in the statute (see 21 U.S.C. 

379j(c)(2)(C) and 379j(c)(2)(B)). 

The component of the inflation 

adjustment for payroll costs is the 

average annual percent change in the 

cost of all personnel compensation and 

benefits (PC&B) paid per full-time 

equivalent position (FTE) at FDA for the 

first 3 of the 4 preceding FYs, 

multiplied by 0.60, or 60 percent (see 21 

U.S.C. 379j(c)(2)(C)). 

Table 1 summarizes the actual cost 

and FTE data for the specified FYs, and 

provides the percent change from the 

previous FY and the average percent 

change over the first 3 of the 4 FYs 

preceding FY 2022. The 3-year average 

is 2.7383 percent (rounded). 


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1The Bureau of Labor Statistics’ Announcement 

of the geographical revision can be viewed at 

https://www.bls.gov/cpi/additional-resources/ 

geographic-revision-2018.htm. 

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE

Fiscal year 2018 2019 2020 3-Year average 

Total PC&B ...................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ................................

Total FTE ......................................................................... 17,023 17,144 17,535 ................................

PC&B per FTE ................................................................. $158,061 $152,826 $163,992 ................................

Percent change from previous year ................................ 4.2206% ¥3.3120% 7.3063% 2.7383% 

The payroll adjustment is 2.7383 

percent multiplied by 60 percent, or 

1.6430 percent. The statute specifies 

that the component of the inflation 

adjustment for non-payroll costs for FY 

2022 is the average annual percent 

change that occurred in the Consumer 

Price Index (CPI) for urban consumers 

(Washington-Baltimore, DC-MD-VAWV; Not Seasonally Adjusted; All Items; 

Annual Index) for the first 3 of the 

preceding 4 years of available data 

multiplied by 0.40, or 40 percent (see 21 

U.S.C. 379j(c)(2)(C)). As a result of a 

geographical revision made by the 

Bureau of Labor and Statistics in 

January 2018,1 the ‘‘WashingtonBaltimore, DC-MD-VA-WV’’ index was 

discontinued and replaced with two 

separate indices (i.e., ‘‘WashingtonArlington-Alexandria, DC-VA-MD-WV’’ 

and ‘‘Baltimore-Columbia-Towson, 

MD’’). In order to continue applying a 

CPI that best reflects the geographic 

region in which FDA is headquartered 

and that provides the most current data 

available, the Washington-ArlingtonAlexandria index has been used since 

FY 2020 and will be used in calculating 

the relevant adjustment factors for FY 

2022 and subsequent years. 

Table 2 provides the summary data 

and the 3-year average percent change 

in the specified CPI for the WashingtonArlington-Alexandria area. These data 

are published by the Bureau of Labor 

Statistics and can be found on their 

website under series Id CUURS35ASA0 

at: https://data.bls.gov/pdq/Survey

OutputServlet?data_

tool=dropmap&series_

id=CUURS35ASA0,CUUSS35ASA0. 

TABLE 2—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN WASHINGTON-ARLINGTON-ALEXANDRIA AREA CPI 

Fiscal year 2018 2019 2020 3-Year average 

Annual CPI ....................................................................... 261.445 264.777 267.157 ................................

Annual Percent Change .................................................. 2.0389% 1.2745% 0.8989% ................................

3-Year Average Percent Change in CPI ......................... ................................ ................................ ................................ 1.4041% 

The non-payroll adjustment is 1.4041 

percent multiplied by 40 percent, or 

0.5616 percent. Next, the payroll 

adjustment (1.6430 percent or 0.016430) 

is added to the non-payroll adjustment 

(0.5616 percent or .005616), for a total 

of 2.2046 percent (or 0.022046). To 

complete the inflation adjustment, 1 

(100 percent or 1.0) is added for a total 

base inflation adjustment of 1.022046 

for FY 2022. 

MDUFA IV provides for this inflation 

adjustment to be compounded for FY 

2022 and each subsequent fiscal year 

(see 21 U.S.C. 379j(c)(2)(B)(ii)). To 

complete the compounded inflation 

adjustment for FY 2022, the FY 2021 

compounded adjustment (1.114808) is 

multiplied by the FY 2022 base inflation 

adjustment (1.022046) to reach the 

applicable inflation adjustment of 

1.139385 (rounded) for FY 2022. We 

then multiply the total revenue amount 

for FY 2022 ($213,687,660) by 1.139385, 

yielding an inflation adjusted total 

revenue amount of $243,473,000 

(rounded to the nearest thousand 

dollars). 

III. Fees for FY 2022 

Under the FD&C Act, all submission 

fees and the periodic reporting fee are 

set as a percent of the standard (full) fee 

for a premarket application (see 21 

U.S.C. 379j(a)(2)(A)). 

A. Inflation Adjustment 

MDUFA specifies that the base fees of 

$329,000 (premarket application) and 

$4,978 (establishment registration) are 

to be adjusted for FY 2022 using the 

same methodology as that for the total 

revenue inflation adjustment in section 

II (see 21 U.S.C. 379j(c)(2)(D)(i)). 

Multiplying the base fees by the 

compounded inflation adjustment of 

1.139385 yields inflation adjusted base 

fees of $374,858 (premarket application) 

and $5,672 (establishment registration). 

B. Further Adjustments 

After the applicable inflation 

adjustment to fees is done, FDA may 

increase, if necessary to achieve the 

inflation adjusted total revenue amount, 

the base fee amounts on a uniform 

proportionate basis (see 21 U.S.C. 

379j(c)(2)(D)(ii)). If necessary, after this 

adjustment, FDA may further increase 

the base establishment registration fees 

to generate the inflation adjusted total 

revenue amount (see 21 U.S.C. 

379j(c)(3)). 

C. Calculation of Fee Rates 

Table 3 provides the last 3 years of 

fee-paying submission counts and the 3- 

year average. These numbers are used to 

project the fee-paying submission 

counts that FDA will receive in FY 

2022. 

TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS

Application type FY 2018 

actual 

FY 2019 

actual 

FY 2020 

actual 

3-Year 

average 

Full Fee Applications ....................................................................................... 38 32 30 33 

Small Business ......................................................................................... 7 8 6 7 

Panel-Track Supplement ................................................................................. 23 14 22 20 


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TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS—Continued 

Application type FY 2018 

actual 

FY 2019 

actual 

FY 2020 

actual 

3-Year 

average 

Small Business ......................................................................................... 5 4 6 5 

De Novo Classification Request ...................................................................... 27 12 11 17 

Small Business ......................................................................................... 29 37 18 28 

180-Day Supplements ..................................................................................... 133 124 126 128 

Small Business ......................................................................................... 27 23 21 24 

Real-Time Supplements .................................................................................. 169 213 175 186 

Small Business ......................................................................................... 34 43 29 35 

510(k)s ............................................................................................................. 2,122 2,069 2,049 2,080 

Small Business ......................................................................................... 1,385 1,558 1,667 1,537 

30-Day Notice .................................................................................................. 1,058 925 867 950 

Small Business ......................................................................................... 98 111 105 105 

513(g) (21 U.S.C. 360c(g)) Request for Classification Information ................ 84 75 96 85 

Small Business ......................................................................................... 33 54 57 48 

Annual Fee for Periodic Reporting .................................................................. 624 629 420 558 

Small Business 2 ....................................................................................... 74 96 68 79 

Establishment Registration .............................................................................. 27,544 27,734 41,409 32,229 

The information in table 3 is 

necessary to estimate the amount of 

revenue that will be collected based on 

the fee amounts. Table 4 displays the FY 

2022 base fees set in statute (column 

one) and the inflation adjusted base fees 

(per calculations in section III.A.) 

(column two). Using the inflation 

adjusted fees and the 3-year averages of 

fee-paying submissions, collections are 

projected to total $262,694,460, which is 

$19,221,460 higher than the inflation 

adjusted total revenue amount (in 

section II). The fees in column two are 

those we are establishing in FY 2022, 

which are the standard fees. 

TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2022 REVENUE TARGET

Application type 

FY 2022 

statutory fees 

(base fees) 

FY 2022 

Inflation adjusted 

statutory 

base fees 

(standard fees) 

3-Year 

average of 

fee-paying 

submissions 

FY 2022 

revenue from 

adjusted fees 

Full Fee Applications ..................................................................... $329,000 $374,858 33 $12,370,303 

Small Business ....................................................................... 82,250 93,714 7 656,001 

Panel-Track Supplement ............................................................... 246,750 281,143 20 5,622,865 

Small Business ....................................................................... 61,688 70,286 5 351,429 

De Novo Classification Request .................................................... 98,700 112,457 17 1,911,774 

Small Business ....................................................................... 24,675 28,114 28 787,201 

180-Day Supplements ................................................................... 49,350 56,229 128 7,197,267 

Small Business ....................................................................... 12,338 14,057 24 337,372 

Real-Time Supplements ................................................................ 23,030 26,240 186 4,880,647 

Small Business ....................................................................... 5,758 6,560 35 229,600 

510(k)s ........................................................................................... 11,186 12,745 2,080 26,509,934 

Small Business ....................................................................... 2,797 3,186 1,537 4,897,328 

30-Day Notice ................................................................................ 5,264 5,998 950 5,697,837 

Small Business ....................................................................... 2,632 2,999 105 314,880 

513(g) Request for Classification Information ............................... 4,442 5,061 85 430,149 

Small Business ....................................................................... 2,221 2,530 48 121,454 

Annual Fee for Periodic Reporting ................................................ 11,515 13,120 558 7,320,970 

Small Business ....................................................................... 2,879 3,280 79 259,120 

Establishment Registration ............................................................ 4,978 5,672 32,229 182,798,329 

Total ................................................................................. .............................. .............................. ........................ 262,694,460 

The standard fee (adjusted base 

amount) for a premarket application, 

including a BLA, and for a premarket 

report and a BLA efficacy supplement, 

is $374,858 for FY 2022. The fees set by 

reference to the standard fee for a 

premarket application are: 

• For a panel-track supplement, 75 

percent of the standard fee; 

• For a de novo classification request, 

30 percent of the standard fee; 

• For a 180-day supplement, 15 

percent of the standard fee; 

• For a real-time supplement, 7 

percent of the standard fee; 

• For an annual fee for periodic 

reporting concerning a class III device, 

3.5 percent of the standard fee; 

• For a 510(k) premarket notification, 

3.4 percent of the standard fee; 

• For a 30-day notice, 1.6 percent of 

the standard fee; and 

• For a 513(g) request for 

classification information, 1.35 percent 

of the standard fee. 

For all submissions other than a 30- 

day notice and a 513(g) request for 

classification information, the small 

business fee is 25 percent of the 

standard (full) fee for the submission 

(see 21 U.S.C. 379j(d)(2)(C) and 

(e)(2)(C)). For a 30-day notice and a 

513(g) request for classification 

information, the small business fee is 50 


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percent of the standard (full) fee for the 

submission (see 21 U.S.C. 379j(d)(2)(C)). 

The annual fee for establishment 

registration, after adjustment, is set at 

$5,672 for FY 2022. There is no small 

business rate for the annual 

establishment registration fee; all 

establishments pay the same fee. 

Table 5 summarizes the FY 2022 rates 

for all medical device fees. 

TABLE 5—MEDICAL DEVICE FEES FOR FY 2022 

Application fee type 

Standard fee 

(as a percent of the standard 

fee for a premarket 

application) 

FY 2022 

standard fee 

FY 2022 

small business 

fee 

Premarket application (a PMA submitted under section 515(c)(1) of the 

FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of 

the FD&C Act, or a BLA submitted under section 351 of the Public Health 

Service Act (the PHS Act) (42 U.S.C. 262)).

Base fee specified in statute .. $374,858 $93,714 

Premarket report (submitted under section 515(c)(2) of the FD&C Act) .......... 100 .......................................... 374,858 93,714 

Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100 .......................................... 374,858 93,714 

Panel-track supplement ..................................................................................... 75 ............................................ 281,143 70,286 

De novo classification request ........................................................................... 30 ............................................ 112,457 28,114 

180-day supplement ........................................................................................... 15 ............................................ 56,229 14,057 

Real-time supplement ........................................................................................ 7 .............................................. 26,240 6,560 

510(k) premarket notification submission .......................................................... 3.40 ......................................... 12,745 3,186 

30-day notice ...................................................................................................... 1.60 ......................................... 5,998 2,999 

513(g) request for classification information ...................................................... 1.35 ......................................... 5,061 2,530 

Annual Fee Type 

Annual fee for periodic reporting on a class III device ............................... 3.50 ......................................... 13,120 3,280 

Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or 

processing of a device, as defined by 21 U.S.C. 379i(14)).

Base fee specified in statute .. 5,672 5,672 

IV. How To Qualify as a Small Business 

for Purposes of Medical Device Fees 

If your business, including your 

affiliates, has gross receipts or sales of 

no more than $100 million for the most 

recent tax year, you may qualify for 

reduced small business fees. If your 

business, including your affiliates, has 

gross sales or receipts of no more than 

$30 million, you may also qualify for a 

waiver of the fee for your first premarket 

application (i.e. PMA, PDP, or BLA) or 

premarket report. If you want to pay the 

small business fee rate for a submission 

or you want to receive a waiver of the 

fee for your first premarket application 

or premarket report, you should submit 

the materials showing you qualify as a 

small business at least 60 days before 

you send your submission to FDA. 

Please note that the establishment 

registration fee is not eligible for a 

reduced small business fee. As a result, 

if the establishment registration fee is 

the only medical device user fee that 

you will pay in FY 2022, you should not 

submit a Small Business Certification 

Request. FDA will review your 

information and determine whether you 

qualify as a small business eligible for 

the reduced fee and/or fee waiver. If you 

make a submission before FDA finds 

that you qualify as a small business, you 

must pay the standard (full) fee for that 

submission. 

If your business qualified as a small 

business for FY 2021, your status as a 

small business will expire at the close 

of business on September 30, 2021. You 

must re-qualify for FY 2022 in order to 

pay small business fees during FY 2022. 

A. Domestic (U.S.) Businesses 

If you are a domestic (U.S.) business 

and wish to qualify as a small business 

for FY 2022, submit the following to 

FDA: 

1. A completed MDUFA Small 

Business Certification Request For a 

Business Headquartered in the United 

States (Form FDA 3602). Form FDA 

3602 is provided in the FDA Forms 

database: https://www.fda.gov/ 

downloads/AboutFDA/Reports

ManualsForms/Forms/UCM573420.pdf. 

2. A signed copy of your Federal 

(U.S.) Income Tax Return for the most 

recent tax year. The most recent tax year 

will be 2021, except: 

If you submit your MDUFA Small 

Business Certification Request for FY 

2022 before April 15, 2022, and you 

have not yet filed your return for 2021, 

you may use tax year 2020. 

If you submit your MDUFA Small 

Business Certification Request for FY 

2022 on or after April 15, 2022, and 

have not yet filed your 2021 return 

because you obtained an extension, you 

may submit your most recent return 

filed prior to the extension. 

3. For each of your affiliates, either: 

• If the affiliate is a domestic (U.S.) 

business, a signed copy of the affiliate’s 

Federal (U.S.) Income Tax Return for the 

most recent tax year, or 

• If the affiliate is a foreign business 

and cannot submit a Federal (U.S.) 

Income Tax Return, a National Taxing 

Authority Certification completed by, 

and bearing the official seal of, the 

National Taxing Authority of the 

country in which the firm is 

headquartered. The National Taxing 

Authority is the foreign equivalent of 

the U.S. Internal Revenue Service. This 

certification must show the amount of 

gross receipts or sales for the most 

recent tax year, in both U.S. dollars and 

the local currency of the country, the 

exchange rate used in converting the 

local currency to U.S. dollars, and the 

dates of the gross receipts or sales 

collected. The business must also 

submit a statement signed by the head 

of the business’s firm or by its chief 

financial officer that the business has 

submitted certifications for all of its 

affiliates, identifying the name of each 

affiliate, or that the business has no 

affiliates. 

B. Foreign Businesses 

If you are a foreign business, and wish 

to qualify as a small business for FY 

2022, submit the following: 

1. A completed MDUFA Foreign 

Small Business Certification Request 

For a Business Headquartered Outside 

the United States (Form FDA 3602A). 

Form FDA 3602A is provided in the 

FDA Forms database: https://

www.fda.gov/downloads/AboutFDA/ 

ReportsManualsForms/Forms/ 

UCM573423.pdf. 


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2. A National Taxing Authority 

Certification, completed by, and bearing 

the official seal of, the National Taxing 

Authority of the country in which the 

firm is headquartered. This certification 

must show the amount of gross receipts 

or sales for the most recent tax year, in 

both U.S. dollars and the local currency 

of the country, the exchange rate used 

in converting the local currency to U.S. 

dollars, and the dates of the gross 

receipts or sales collected. 

3. For each of your affiliates, either: 

• If the affiliate is a domestic (U.S.) 

business, a signed copy of the affiliate’s 

Federal (U.S.) Income Tax Return for the 

most recent tax year (2021 or later), or 

• If the affiliate is a foreign business 

and cannot submit a Federal (U.S.) 

Income Tax Return, a National Taxing 

Authority Certification completed by, 

and bearing the official seal of, the 

National Taxing Authority of the 

country in which the firm is 

headquartered. The National Taxing 

Authority is the foreign equivalent of 

the U.S. Internal Revenue Service. This 

certification must show the amount of 

gross receipts or sales for the most 

recent tax year, in both U.S. dollars and 

the local currency of the country, the 

exchange rate used in converting the 

local currency to U.S. dollars, and the 

dates for the gross receipts or sales 

collected. The business must also 

submit a statement signed by the head 

of the business’s firm or by its chief 

financial officer that the applicant has 

submitted certifications for all of its 

affiliates, identifying the name of each 

affiliate, or that the business has no 

affiliates. 

V. Procedures for Paying Application 

Fees 

If your application or submission is 

subject to a fee and your payment is 

received by FDA between October 1, 

2021, and September 30, 2022, you must 

pay the fee in effect for FY 2022. To 

avoid delay in the review of your 

application, you should pay the 

application fee before or at the time you 

submit your application to FDA. The 

later of the date that the application is 

received in the reviewing center’s 

document room or the date the U.S. 

Treasury recognizes the payment 

determines whether the fee rates for FY 

2021 or FY 2022 apply. FDA must 

receive the correct fee at the time that 

an application is submitted, or the 

application will not be accepted for 

filing or review. 

FDA requests that you follow the 

steps below before submitting a medical 

device application subject to a fee to 

ensure that FDA links the fee with the 

correct application. (Note: Do not send 

your user fee check to FDA with the 

application.) 

A. Secure a Payment Identification 

Number (PIN) and Medical Device User 

Fee Cover Sheet From FDA Before 

Submitting Either the Application or the 

Payment 

Log into the User Fee System at: 

https://userfees.fda.gov/OA_HTML/ 

mdufmaCAcdLogin.jsp. Complete the 

Medical Device User Fee cover sheet. Be 

sure you choose the correct application 

submission date range. (Two choices 

will be offered until October 1, 2021. 

One choice is for applications and fees 

that will be received on or before 

September 30, 2021, which are subject 

to FY 2021 fee rates. A second choice 

is for applications and fees received on 

or after October 1, 2021, which are 

subject to FY 2022 fee rates.) After 

completing data entry, print a copy of 

the Medical Device User Fee cover sheet 

and note the unique PIN located in the 

upper right-hand corner of the printed 

cover sheet. 

B. Electronically Transmit a Copy of the 

Printed Cover Sheet With the PIN 

When you are satisfied that the data 

on the cover sheet is accurate, 

electronically transmit that data to FDA 

according to instructions on the screen. 

Applicants are required to set up a user 

account and password to assure data 

security in the creation and electronic 

submission of cover sheets. 

C. Submit Payment for the Completed 

Medical Device User Fee Cover Sheet 

1. The preferred payment method is 

online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). FDA has partnered with the 

U.S. Department of the Treasury to 

utilize Pay.gov, a web-based payment 

system, for online electronic payment. 

You may make a payment via electronic 

check or credit card after submitting 

your cover sheet. Secure electronic 

payments can be submitted using the 

User Fees Payment Portal at https://

userfees.fda.gov/pay. Note: only full 

payments are accepted. No partial 

payments can be made online. Once you 

search for your invoice, select ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S bank accounts as well as U.S. credit 

cards. 

2. If paying with a paper check: 

• All paper checks must be in U.S. 

currency from a U.S. bank and made 

payable to the Food and Drug 

Administration. If needed, FDA’s tax 

identification number is 53–0196965. 

• Please write your application’s 

unique PIN (from the upper right-hand 

corner of your completed Medical 

Device User Fee cover sheet) on your 

check. 

• Mail the paper check and a copy of 

the completed cover sheet to: Food and 

Drug Administration, P.O. Box 979033, 

St. Louis, MO 63197–9000. (Please note 

that this address is for payments of 

application and annual report fees only 

and is not to be used for payment of 

annual establishment registration fees.) 

If you prefer to send a check by a 

courier, the courier may deliver the 

check to: U.S. Bank, Attn: Government 

Lockbox 979033, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. If you have any questions 

concerning courier delivery contact U.S. 

Bank at 314–418–4013. This telephone 

number is only for questions about 

courier delivery.) 

3. If paying with a wire transfer: 

• Please include your application’s 

unique PIN (from the upper right-hand 

corner of your completed Medical 

Device User Fee cover sheet) in your 

wire transfer. Without the PIN, your 

payment may not be applied to your 

cover sheet and review of your 

application may be delayed. 

• The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee it is required that you add 

that amount to the payment to ensure 

that the invoice is paid in full. 

Use the following account 

information when sending a wire 

transfer: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Acct. No. 

75060099, Routing No. 021030004, 

SWIFT: FRNYUS33. 

FDA records the official application 

receipt date as the later of the following: 

(1) The date the application was 

received by the FDA Document Control 

Center for the reviewing Center or (2) 

the date the U.S. Treasury recognizes 

the payment. It is helpful if the fee 

arrives at the bank at least 1 day before 

the application arrives at FDA. 

D. Submit Your Application to FDA 

With a Copy of the Completed Medical 

Device User Fee Cover Sheet 

Please submit your application and a 

copy of the completed Medical Device 

User Fee cover sheet to the address 

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

cdrhsubmissionaddress. 


khammond on DSKJM1Z7X2PROD with NOTICES
41482 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

VI. Procedures for Paying the Annual 

Fee for Periodic Reporting 

You will be invoiced at the end of the 

quarter in which your PMA Periodic 

Report is due. Invoices will be sent 

based on the details included on your 

PMA file. You are responsible for 

ensuring FDA has your current billing 

information, and you may update your 

contact information for the PMA by 

submitting an amendment to the 

pending PMA or a supplement to the 

approved PMA. 

1. The preferred payment method is 

online using electronic check (ACH also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). Secure electronic payments 

can be submitted using the User Fees 

Payment Portal at https://

userfees.fda.gov/pay (Note: only full 

payments are accepted. No partial 

payments can be made online). Once 

you search for your invoice, select ‘‘Pay 

Now’’ to be redirected to Pay.gov. Note 

that electronic payment options are 

based on the balance due. Payment by 

credit card is available for balances that 

are less than $25,000. If the balance 

exceeds this amount, only the ACH 

option is available. Payments must be 

made using U.S. bank accounts as well 

as U.S. credit cards. 

2. If paying with a paper check: 

The check must be in U.S. currency 

from a U.S. bank and made payable to 

the Food and Drug Administration. If 

needed, FDA’s tax identification 

number is 53–0196965. 

• Please write your invoice number 

on the check. 

• Mail the paper check and a copy of 

the invoice to: Food and Drug 

Administration, P.O. Box 979033, St. 

Louis, MO 63197–9000. (Please note 

that this address is for payments of 

application and annual report fees only 

and is not to be used for payment of 

annual establishment registration fees.) 

To send a check by a courier, the 

courier must deliver the check and 

printed copy of the cover sheet to: U.S. 

Bank, Attn: Government Lockbox 

979033, 1005 Convention Plaza, St. 

Louis, MO 63101. (Note: This U.S. Bank 

address is for courier delivery only. If 

you have any questions concerning 

courier delivery, contact U.S. Bank at 

314–418–4013. This telephone number 

is only for questions about courier 

delivery). 

3. When paying by a wire transfer, it 

is required that the invoice number is 

included; without the invoice number 

the payment may not be applied. If the 

payment amount is not applied, the 

invoice amount would be referred to 

collections. The originating financial 

institution may charge a wire transfer 

fee. If the financial institution charges a 

wire transfer fee, it is required that you 

add that amount to the payment to 

ensure that the invoice is paid in full. 

Use the following account 

information when sending a wire 

transfer: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Acct. No. 

75060099, Routing No. 021030004, 

SWIFT: FRNYUS33. 

VII. Procedures for Paying Annual 

Establishment Registration Fees 

To pay the annual establishment 

registration fee, firms must access the 

Device Facility User Fee (DFUF) website 

at https://userfees.fda.gov/OA_HTML/ 

furls.jsp. (FDA has verified the website 

address, but FDA is not responsible for 

any subsequent changes to the website 

address after this document publishes in 

the Federal Register.) Create a DFUF 

order and you will be issued a PIN 

when you place your order. After 

payment has been processed, you will 

be issued a payment confirmation 

number (PCN). You will not be able to 

register your establishment if you do not 

have a PIN and a PCN. An establishment 

required to pay an annual establishment 

registration fee is not legally registered 

in FY 2022 until it has completed the 

steps below to register and pay any 

applicable fee (see 21 U.S.C. 379j(f)(2)). 

Companies that do not manufacture 

any product other than a licensed 

biologic are required to register in the 

Blood Establishment Registration (BER) 

system. FDA’s Center for Biologics 

Evaluation and Research (CBER) will 

send establishment registration fee 

invoices annually to these companies. 

A. Submit a DFUF Order With a PIN 

From FDA Before Registering or 

Submitting Payment 

To submit a DFUF Order, you must 

create or have previously created a user 

account and password for the user fee 

website listed previously in this section. 

After creating a user name and 

password, log into the Establishment 

Registration User Fee FY 2022 store. 

Complete the DFUF order by entering 

the number of establishments you are 

registering that require payment. When 

you are satisfied that the information in 

the order is accurate, electronically 

transmit that data to FDA according to 

instructions on the screen. Print a copy 

of the final DFUF order and note the 

unique PIN located in the upper righthand corner of the printed order. 

B. Pay for Your DFUF Order 

Unless paying by U.S. credit card, all 

payments must be in U. S. currency and 

drawn on a U.S. bank. 

1. If paying by credit card or 

electronic check (ACH or eCheck): 

The DFUF order will include payment 

information, including details on how 

you can pay online using a credit card 

or electronic check. Follow the 

instructions provided to make an 

electronic payment. 

2. If paying with a paper check: 

The check must be in U.S. currency 

and drawn on a U.S. bank, and mailed 

to: Food and Drug Administration, P.O. 

Box 979108, St. Louis, MO 63197–9000. 

(Note: This address is different from the 

address for payments of application and 

annual report fees and is to be used only 

for payment of annual establishment 

registration fees.) 

If a check is sent by a courier that 

requests a street address, the courier can 

deliver the check to: U.S. Bank, Attn: 

Government Lockbox 979108, 1005 

Convention Plaza, St. Louis, MO 63101. 

(Note: This U.S. Bank address is for 

courier delivery only. If you have any 

questions concerning courier delivery, 

contact U.S. Bank at 314–418–4013. 

This telephone number is only for 

questions about courier delivery.) 

Please make sure that both of the 

following are written on your check: (1) 

The FDA post office box number (P.O. 

Box 979108) and (2) the PIN that is 

printed on your order. Include a copy of 

your printed order when you mail your 

check. 

3. If paying with a wire transfer: 

Wire transfers may also be used to pay 

annual establishment registration fees. 

To send a wire transfer, please read and 

comply with the following information: 

Include your order’s unique PIN (in 

the upper right-hand corner of your 

completed DFUF order) in your wire 

transfer. Without the PIN, your payment 

may not be applied to your facility and 

your registration may be delayed. 

The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee, it is required that you add 

that amount to the payment to ensure 

that the invoice is paid in full. Use the 

following account information when 

sending a wire transfer: U.S. Dept. of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Acct. No. 

75060099, Routing No. 021030004, 

SWIFT: FRNYUS33. If needed, FDA’s 

tax identification number is 53– 

0196965. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41483 

C. Complete the Information Online To 

Update Your Establishment’s Annual 

Registration for FY 2022, or To Register 

a New Establishment for FY 2022 

Go to the Center for Devices and 

Radiological Health’s website at https:// 

www.fda.gov/medical-devices/howstudy-and-market-your-device/deviceregistration-and-listing and click the 

‘‘Access Electronic Registration’’ link on 

the left side of the page. This opens up 

a new page with important information 

about the FDA Unified Registration and 

Listing System (FURLS). After reading 

this information, click on the ‘‘Access 

Electronic Registration’’ link in the 

middle of the page. This link takes you 

to an FDA Industry Systems page with 

tutorials that demonstrate how to create 

a new FURLS user account, if your 

establishment did not create an account 

in FY 2021. Manufacturers of licensed 

biologics should register in the BER 

system at https://www.fda.gov/vaccinesblood-biologics/guidance-complianceregulatory-information-biologics/ 

biologics-establishment-registration. 

Enter your existing account ID and 

password to log into FURLS. From the 

FURLS/FDA Industry Systems menu, 

click on the Device Registration and 

Listing Module (DRLM) of FURLS 

button. New establishments will need to 

register and existing establishments will 

update their annual registration using 

choices on the DRLM menu. When you 

choose to register or update your annual 

registration, the system will prompt you 

through the entry of information about 

your establishment and your devices. If 

you have any problems with this 

process, email: reglist@cdrh.fda.gov or 

call 301–796–7400 for assistance. (Note: 

This email address and this telephone 

number are for assistance with 

establishment registration only; they are 

not to be used for questions related to 

other aspects of medical device user 

fees.) Problems with the BER system 

should be directed to https://

www.accessdata.fda.gov/scripts/email/ 

cber/bldregcontact.cfm or call 240–402– 

8360. 

D. Enter Your DFUF Order PIN and PCN 

After completing your annual or 

initial registration and device listing, 

you will be prompted to enter your 

DFUF order PIN and PCN, when 

applicable. This process does not apply 

to establishments engaged only in the 

manufacture, preparation, propagation, 

compounding, or processing of licensed 

biologic devices. CBER will send 

invoices for payment of the 

establishment registration fee to such 

establishments. 

Dated: July 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16408 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0658] 

Vithal K. Patel; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a 

request for a hearing submitted by 

Vithal K. Patel (Mr. Patel) and issuing 

an order under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) debarring 

Mr. Patel for 1 year from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. FDA bases this 

order on a finding that Mr. Patel was 

convicted of conspiracy to commit a 

felony under Federal law for conduct 

relating to the regulation of drug 

products under the FD&C Act and that 

the type of conduct underlying the 

conviction undermined the process for 

the regulation of drugs. In determining 

the appropriateness and period of Mr. 

Patel’s debarment, FDA considered the 

relevant factors listed in the FD&C Act. 

Mr. Patel has failed to file with the 

Agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: This order is applicable August 

2, 2021. 

ADDRESSES: Any application for 

termination of debarment by Mr. Patel 

under section 306(d) of the FD&C Act 

(application) may be submitted as 

follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked, and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All applications must 

include the Docket No. FDA–2011–N– 

0658. Received applications 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 an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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 application and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 


khammond on DSKJM1Z7X2PROD with NOTICES