Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 41029 

preferred payment method is online 

using electronic check (Automated 

Clearing House (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 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. 

FDA has partnered with the U.S. 

Department of the Treasury to utilize 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA Web site after 

completing the Generic Drug User Fee 

Cover Sheet and generating the user fee 

ID number. 

Please include the user fee ID number 

on your check, bank draft, or postal 

money order and make payable to the 

order of the Food and Drug 

Administration. Your payment can be 

mailed to: Food and Drug 

Administration, P.O. Box 979108, St. 

Louis, MO 63197–9000. If checks are to 

be sent by a courier that requests a street 

address, the courier can deliver checks 

to: U.S. Bank, Attention: 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 the 

U.S. Bank at 314–418–4013. This 

telephone number is only for questions 

about courier delivery). Please make 

sure that the FDA post office box 

number (P.O. Box 979108) is written on 

the check, bank draft, or postal money 

order. 

If paying by wire transfer, please 

reference your unique user fee ID 

number when completing your transfer. 

Without your unique user fee ID 

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. Please ask your financial 

institution about the wire transfer fee 

and include it with your payment to 

ensure that your fee is fully paid. Use 

the following account information when 

sending a payment by wire transfer: U.S. 

Department of Treasury, TREAS NYC, 

33 Liberty St., New York, NY 10045, 

account number: 75060099, routing 

number: 021030004, SWIFT: 

FRNYUS33, Beneficiary: FDA, 8455 

Colesville Rd., 14th Floor, Silver Spring, 

MD 20993–0002. If needed, FDA’s tax 

identification number is 53–0196965. 

Dated: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18377 Filed 8–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Medical Device User Fee Rates for 

Fiscal Year 2018 

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) 2018. The Federal Food, Drug, and 

Cosmetic Act (the 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 2018, which apply from 

October 1, 2017, through September 30, 

2018. 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 fee 

you must pay is the fee that is in effect 

on the later of the date that your 

application is received by FDA or the 

date your fee payment is recognized by 

the U.S. Treasury. If you want to pay a 

reduced small business fee, you must 

qualify as a small business before 

making your submission to FDA; if you 

do not qualify as a small business before 

making your submission to FDA, you 

will have to pay the higher standard fee. 

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 2018, you should not 

submit a FY 2018 Small Business 

Qualification and Certification request. 

This document provides information on 

how the fees for FY 2018 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: Visit FDA’s Web site at 

https://www.fda.gov/ForIndustry/ 

UserFees/MedicalDeviceUserFee/ 

ucm20081521.htm. 

For questions relating to this notice: 

Robert Marcarelli, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd. 

(COLE–14202F), Silver Spring, MD 

20993–0002, 301–796–7223. 

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 statutorilydefined 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 2018 is $294,000. 

From this starting point, this document 

establishes FY 2018 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 2018 is $4,375. 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 2018 

The total revenue amount for FY 2018 

is $183,280,756, as set forth in the 


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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 2018 are 

described in this document. 

Inflation Adjustment 

MDUFA specifies that the 

$183,280,756 is to be adjusted for 

inflation increases for FY 2018 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 2018 is the 

sum of one plus these 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 three of the four 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 2018. The 3-year average 

is 2.2354 percent (rounded). 

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

Fiscal year 2014 2015 2016 3-year 

average 

Total PC&B .......................................................................................... $2,054,937,000 $2,232,304,000 $2,414,728,159 ........................

Total FTE ............................................................................................. 14,555 15,484 16,381 ........................

PC&B per FTE ..................................................................................... $141,184 $144,168 $147,408 ........................

Percent change from previous year .................................................... 2.3451% 2.1136% 2.2474% 2.2354% 

The payroll adjustment is 2.2354 

percent multiplied by 60 percent, or 

1.3412 percent. 

The statute specifies that the 

component of the inflation adjustment 

for non-payroll costs for FY 2018 is the 

average annual percent change that 

occurred in the Consumer Price Index 

(CPI) for urban consumers (WashingtonBaltimore, DC-MD-VA-WV; 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)). 

Table 2 provides the summary data 

and the 3-year average percent change 

in the specified CPI for the BaltimoreWashington area. These data are 

published by the Bureau of Labor 

Statistics and can be found on their Web 

site at https://data.bls.gov/cgi-bin/ 

surveymost?cu by checking the box 

marked ‘‘Washington-Baltimore All 

Items, November 1996 = 

100¥CUURA311SA0’’ and then 

clicking on the ‘‘Retrieve Data’’ button. 

TABLE 2—ANNUAL AND THREE-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI 

Fiscal year 2014 2015 2016 3-year 

average 

Annual CPI ........................................................................................... 154.847 155.353 157.180 ........................

Annual Percent Change ...................................................................... 1.5390% 0.3268% 1.1760% ........................

3-Year Avg. Percent Change in CPI ................................................... ............................ ............................ ............................ 1.0139% 

The non-pay adjustment is 1.0139 

percent multiplied by 40 percent, or 

0.4056 percent. 

Next, the payroll adjustment (1.3412 

percent or 0.013412) is added to the 

non-payroll adjustment (0.4056 percent 

or 0.004056), for a total of 1.7468 

percent (or 0.017468). To complete the 

inflation adjustment, 1 (100 percent or 

1.0) is added for a total base inflation 

adjustment of 1.017468 for FY 2018. 

MDUFA IV provides for this inflation 

adjustment to be compounded for FY 

2018 and each subsequent fiscal year 

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

inflation adjustment for FY 2018 

(1.017468) is compounded by 

multiplying it by the compounded 

applicable inflation factors from FY 

2016 and FY 2017 (1.020416 times 

1.015774 or 1.036512). To complete the 

compounded inflation adjustment for 

FY 2018, the FY 2016 and FY 2017 

compounded adjustment (1.036512) is 

multiplied by the FY 2018 base inflation 

adjustment (1.017468) to reach the 

applicable inflation adjustment of 

1.054618 (rounded) for FY 2018. We 

then multiply the total revenue amount 

for FY 2018 ($183,280,756) by 1.054618, 

yielding an inflation adjusted total 

revenue amount of $193,291,000 

(rounded to the nearest thousand 

dollars). 

III. Fees for FY 2018 

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 

$294,000 (premarket application) and 

$4,375 (establishment registration) are 

to be adjusted for inflation for FY 2018 

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 these base fees by the 

compounded inflation adjustment of 

1.054618 yields inflation adjusted base 

fees of $310,058 (premarket application) 

and $4,614 (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 

2018. Most of the fee-paying submission 


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counts are published in the MDUFA 

Financial Report to Congress each year. 

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

Application type FY 2014 

actual 

FY 2015 

actual 

FY 2016 

actual 

3-year 

average 

Full Fee Applications ....................................................................................... 25 42 41 36 

Small Business ......................................................................................... 5 7 10 7 

Panel-Track Supplement ................................................................................. 12 22 18 17 

Small Business ......................................................................................... 3 3 1 2 

De Novo Classification Request 1 .................................................................... ........................ ........................ ........................ 40 

Small Business 1 ....................................................................................... ........................ ........................ ........................ 10 

180-Day Supplements ..................................................................................... 122 143 139 135 

Small Business ......................................................................................... 24 15 18 19 

Real-Time Supplements .................................................................................. 192 204 202 199 

Small Business ......................................................................................... 19 28 29 25 

510(k)s ............................................................................................................. 3,034 2,768 2,784 2,862 

Small Business ......................................................................................... 1,037 1,037 1,046 1,040 

30-Day Notice .................................................................................................. 934 920 1,029 961 

Small Business ......................................................................................... 91 71 80 81 

513(g) (21 U.S.C. 360c(g)) Request for Classification Information ................ 69 75 69 71 

Small Business ......................................................................................... 31 33 47 37 

Annual Fee for Periodic Reporting 2 ................................................................ 668 554 576 599 

Small Business 2 ....................................................................................... 74 73 74 74 

Establishment Registration .............................................................................. 24,626 25,363 26,222 25,404 

1Three-year average for De Novo is based on estimate used during MDUFA IV negotiations. 

2 Includes collection of quarter four billing for FY 2016 during FY 2017. 

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 

2018 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, the collections 

would total $192,850,757, which is 

$440,243 lower than the statutory 

revenue limit. Accordingly, the next 

step in the fee setting process is to 

increase the base fee amounts on a 

uniform proportionate basis to generate 

the inflation adjusted total revenue 

amounts (see 21 U.S.C. 379j(c)(2)(D)(ii) 

and table 4, column three). Applying 

these further adjusted fee rates to the 3- 

year average of fee paying submissions 

results in the establishment registration 

fee rate being increased by $10 to 

determine the new establishment 

registration fee rate of $4,624 (see 21 

U.S.C. 379j(c)(3) and table 4, column 

three), leaving a total revenue shortfall 

of $12,278. The fees in the second 

column from the right are those we are 

establishing in FY 2018, which are the 

standard fees. 

TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2018 REVENUE TARGET

Application type 

FY 2018 statutory fees 

(base fees) 

FY 2018 

inflation 

adjusted 

statutory 

base fees 

Adjusted FY 

2018 fees 

to meet 

revenue 

target 

(standard fees) 

FY 2018 

revenue 

from adjusted 

fees 

Full Fee Applications ................................................................................... $294,000 $310,058 $310,764 $11,187,504 

Small Business ..................................................................................... 73,500 77,514 77,691 543,837

Panel-Track Supplement ............................................................................. 220,500 232,543 233,073 3,962,241 

Small Business ..................................................................................... 55,125 58,136 58,268 116,272

De Novo Classification Request .................................................................. 88,200 93,017 93,229 3,729,160 

Small Business ..................................................................................... 22,050 23,254 23,307 233,070

180-Day Supplements ................................................................................. 44,100 46,509 46,615 6,293,025 

Small Business ..................................................................................... 11,025 11,627 11,654 221,426

Real-Time Supplements .............................................................................. 20,580 21,704 21,753 4,328,847 

Small Business ..................................................................................... 5,145 5,426 5,438 135,950 

510(k)s ......................................................................................................... 9,996 10,542 10,566 30,239,892 

Small Business ..................................................................................... 2,499 2,635 2,642 2,747,680 

30-Day Notice .............................................................................................. 4,704 4,961 4,972 4,778,092 

Small Business ..................................................................................... 2,352 2,480 2,486 201,366 

513(g) Request for Classification Information ............................................. 3,969 4,186 4,195 297,845 

Small Business ..................................................................................... 1,985 2,093 2,098 77,626 

Annual Fee for Periodic Reporting .............................................................. 10,290 10,852 10,877 6,515,323 

Small Business ..................................................................................... 2,573 2,713 2,719 201,206 

Establishment Registration .......................................................................... 4,375 4,614 4,624 117,468,096 

Total ...................................................................................................... ........................ ........................ ............................ 193,278,722 


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The standard fee (adjusted base 

amount) for a premarket application, 

including a BLA, and for a premarket 

report and a BLA efficacy supplement, 

is $310,764 for FY 2018. 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 

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 

$4,624 for FY 2018. There is no small 

business rate for the annual 

establishment registration fee; all 

establishments pay the same fee. 

Table 5 summarizes the FY 2018 rates 

for all medical device fees. 

TABLE 5—MEDICAL DEVICE FEES FOR FY 2018 

Application fee type 

Standard fee 

(as a percent of the 

standard fee for a premarket application) 

FY 2018 

standard fee 

FY 2018 

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 

(21 U.S.C. 360e(f), 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.

$310,764 $77,691 

Premarket report (submitted under section 515(c)(2) of the FD&C Act) .................... 100 ................................. 310,764 77,691 

Efficacy supplement (to an approved BLA under section 351 of the PHS Act) ......... 100 ................................. 310,764 77,691 

Panel-track supplement ............................................................................................... 75 ................................... 233,073 58,268 

De novo classification request .................................................................................... 30 ................................... 93,229 23,307 

180-day supplement .................................................................................................... 15 ................................... 46,615 11,654 

Real-time supplement ................................................................................................. 7 ..................................... 21,753 5,438 

510(k) premarket notification submission ................................................................... 3.40 ................................ 10,566 2,642 

30-day notice ............................................................................................................... 1.60 ................................ 4,972 2,486 

513(g) request for classification information ............................................................... 1.35 ................................ 4,195 2,098 

Annual Fee Type ......................................................................................................... ........................................ ........................ ........................

Annual fee for periodic reporting on a class III device ............................................... 3.50 ................................ 10,877 2,719 

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(13)).

Base fee specified in 

statute.

4,624 4,624 

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. 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 2017, your status as a 

small business will expire at the close 

of business on September 30, 2017. You 

must re-qualify for FY 2018 in order to 

pay small business fees during FY 2018. 

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

and wish to qualify as a small business 

for FY 2018, you must submit the 

following to FDA: 

1. A completed FY 2018 MDUFA 

Small Business Qualification 

Certification (Form FDA 3602). This 

form is provided in FDA’s guidance 

document, ‘‘FY 2018 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

Web site at https://www.fda.gov/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/ 

default.htm. 

2. A certified copy of your Federal 

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

recent tax year. The most recent tax year 

will be 2017, except: 

If you submit your FY 2018 MDUFA 

Small Business Qualification before 

April 15, 2018, and you have not yet 

filed your return for 2017, you may use 

tax year 2016. 

If you submit your FY 2018 MDUFA 

Small Business Qualification on or after 

April 15, 2018, and have not yet filed 

your 2017 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 certified 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 


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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 applicant must also 

submit a statement signed by the head 

of the applicant’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 applicant has no 

affiliates. 

If you are a foreign business, and wish 

to qualify as a small business for FY 

2018, you must submit the following: 

1. A completed FY 2018 MDUFA 

Foreign Small Business Qualification 

Certification (Form FDA 3602A). This 

form is provided in FDA’s guidance 

document, ‘‘FY 2018 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

Web site at https://www.fda.gov/ 

MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/ 

default.htm. 

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 certified copy of the affiliate’s 

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

most recent tax year (2017 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 applicant must also submit a statement 

signed by the head of the applicant’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 applicant 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, 

2017, and September 30, 2018, you must 

pay the fee in effect for FY 2018. 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 

2017 or FY 2018 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, 2017. 

One choice is for applications and fees 

that will be received on or before 

September 30, 2017, which are subject 

to FY 2017 fee rates. A second choice 

is for applications and fees received on 

or after October 1, 2017, which are 

subject to FY 2018 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 Treasury, 

TREAS NYC, 33 Liberty St., New York, 

NY 10045, Acct. No. 75060099, Routing 


sradovich on DSK3GMQ082PROD with NOTICES
41034 Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 

No. 021030004, SWIFT: FRNYUS33, 

Beneficiary: FDA, 8455 Colesville Road, 

14th Floor, Silver Spring, MD 20993– 

0002. 

FDA records the official application 

receipt date as the later of the following: 

(1) The date the application was 

received by an FDA Document Control 

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/cdrh

submissionaddress. 

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, Beneficiary: FDA, 

8455 Colesville Rd., 14th Floor, Silver 

Spring, MD 20993–0002. 

VII. Procedures for Paying Annual 

Establishment Registration Fees 

To pay the annual establishment 

registration fee, firms must access the 

Device Facility User Fee (DFUF) Web 

site at https://userfees.fda.gov/OA_

HTML/furls.jsp. (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site 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 2018 until it has completed the 

steps below to register and pay any 

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

Web site listed previously in this 

section. After creating a user name and 

password, log into the Establishment 

Registration User Fee FY 2018 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 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 41035 

1For the reasons explained in the third-party 

certification final rule (80 FR 74570 at 74578– 

74579, November 27, 2015), and for consistency 

with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11, 

and 16, this notice uses the term ‘‘third-party 

certification body’’ rather than the term ‘‘third-party 

auditor’’ used in section 808(a)(3) of the FD&C Act. 

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 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Acct. No. 

75060099, Routing No. 021030004, 

SWIFT: FRNYUS33, Beneficiary: FDA, 

8455 Colesville Rd., 14th Floor, Silver 

Spring, MD 20993–0002. If needed, 

FDA’s tax identification number is 53– 

0196965. 

C. Complete the Information Online To 

Update Your Establishment’s Annual 

Registration for FY 2018, or To Register 

a New Establishment for FY 2018 

Go to the Center for Devices and 

Radiological Health’s Web site at 

https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/Howto

MarketYourDevice/Registrationand

Listing/default.htm 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 2017. Manufacturers of licensed 

biologics should register in the BER 

system at https://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Establishment

Registration/BloodEstablishment

Registration/default.htm. 

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: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18378 Filed 8–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–4119] 

Food Safety Modernization Act ThirdParty Certification Program User Fee 

Rate for Fiscal Year 2018 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2018 annual fee rate for 

recognized accreditation bodies and 

accredited certification bodies, and the 

fee rate for accreditation bodies 

applying to be recognized in the thirdparty certification program that is 

authorized by the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), as 

amended by the FDA Food Safety 

Modernization Act (FSMA). 

FOR FURTHER INFORMATION CONTACT: 

Donald Prater, Office of Foods and 

Veterinary Medicine, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3234, Silver Spring, 

MD 20993, 301–348–3007. 

DATES: This fee is effective October 1, 

2017. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 307 of FSMA, Accreditation 

of Third-Party Auditors, amended the 

FD&C Act to create a new provision, 

section 808, under the same name. 

Section 808 of the FD&C Act (21 U.S.C. 

384d) directs FDA to establish a 

program for accreditation of third-party 

certification bodies 1 conducting food 

safety audits and issuing food and 

facility certifications to eligible foreign 

entities (including registered foreign 

food facilities) that meet our applicable 

requirements. Under this provision, we 

established a system for FDA to 

recognize accreditation bodies to 

accredit certification bodies, except for 

limited circumstances in which we may 

directly accredit certification bodies to 

participate in the third-party 

certification program. 

Section 808(c)(8) of the FD&C Act 

directs FDA to establish a 

reimbursement (user fee) program by 

which we assess fees and require 

reimbursement for the work FDA 

performs to establish and administer the 

third-party certification program under 

section 808 of the FD&C Act. The user 

fee program for the third-party 

certification program was established by 

a final rule entitled ‘‘Amendments to 

Accreditation of Third-Party 

Certification Bodies to Conduct Food 

Safety Audits and To Issue 

Certifications to Provide for the User 

Fee Program’’ (81 FR 90186, December 

14, 2016). 

The FSMA FY 2018 third-party 

certification program user fee rate 

announced in this notice is effective on 

October 1, 2017, and will remain in 

effect through September 30, 2018. 

II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2018 

In each year, the costs of salary (or 

personnel compensation) and benefits 

for FDA employees account for between 

50 and 60 percent of the funds available 

to, and used by, FDA. Almost all of the 

remaining funds (operating funds) 

available to FDA are used to support 

FDA employees for paying rent, travel, 

utility, information technology, and 

other operating costs. 

A. Estimating the Full Cost per Direct 

Work Hour in FY 2018 

Full-time Equivalent (FTE) reflects the 

total number of regular straight-time 

hours—not including overtime or 

holiday hours—worked by employees, 


sradovich on DSK3GMQ082PROD with NOTICES