36598 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

FoodborneIllnessRiskFactorReduction/ 

ucm224321.htm. 

4. FDA National Retail Food Team. ‘‘FDA 

Trend Analysis Report on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Institutional 

Foodservice, Restaurant, and Retail Food 

Store Facility Types (1998–2008).’’ 

Available at: https://wayback.archiveit.org/7993/20170406022950/https://

www.fda.gov/Food/GuidanceRegulation/ 

RetailFoodProtection/FoodborneIllness

RiskFactorReduction/ucm223293.htm. 

5. ‘‘FDA Food Code.’’ Available at: https://

www.fda.gov/FoodCode. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16189 Filed 7–27–18; 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 2019 

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) 2019. 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 2019, which apply from 

October 1, 2018, through September 30, 

2019. 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 2019, you should not 

submit a Small Business Certification 

Request. This document provides 

information on how the fees for FY 2019 

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 website at: 

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

UserFees/MedicalDeviceUserFee/ 

ucm20081521.htm. 

For questions relating to the MDUFA 

Small Business Program, please visit 

CDRH’s website: https://www.fda.gov/ 

medicaldevices/deviceregulation

andguidance/howtomarketyourdevice/ 

premarketsubmissions/ucm577696.htm. 

For questions relating to this notice: 

David Haas, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd. 

(COLE–14202I), Silver Spring, MD 

20993–0002, 240–402–9845. 

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 2019 is $300,000. 

From this starting point, this document 

establishes FY 2019 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 2019 is $4,548. 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 2019 

The total revenue amount for FY 2019 

is $190,654,875, 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 2019 are 

described in this document. 

Inflation Adjustment 

MDUFA specifies that the 

$190,654,875 is to be adjusted for 

inflation increases for FY 2019 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 2019 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 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 2019. The 3-year average 

is 2.4152 percent (rounded). 

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

Fiscal year 2015 2016 2017 3-Year average 

Total PC&B .............................................................................................. $2,232,304,000 $2,414,728,159 $2,581,551,000 ..........................


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

Fiscal year 2015 2016 2017 3-Year average 

Total FTE ................................................................................................. 15,484 16,381 17,022 ..........................

PC&B per FTE ......................................................................................... $144,168 $147,408 $151,660 ..........................

Percent change from previous year ........................................................ 2.1136 2.2474 2.8845 2.4152 

The payroll adjustment is 2.4152 

percent multiplied by 60 percent, or 

1.4491 percent. 

The statute specifies that the 

component of the inflation adjustment 

for non-payroll costs for FY 2019 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 

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

SurveyOutputServlet?data_

tool=dropmap&series_

id=CUURA311SA0,CUUSA311SA0. 

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

Fiscal year 2015 2016 2017 3-Year average 

Annual CPI ............................................................................................... 155.353 157.180 159.202 ..........................

Annual Percent Change .......................................................................... 0.3268 1.1760 1.2864 ..........................

3-Year Average Percent Change in CPI ................................................. .......................... .......................... .......................... 0.9297 

The non-pay adjustment is 0.9297 

percent multiplied by 40 percent, or 

0.3719 percent. 

Next, the payroll adjustment (1.4491 

percent or 0.014491) is added to the 

non-payroll adjustment (0.3719 percent 

or 0.003719), for a total of 1.8210 

percent (or 0.018210). To complete the 

inflation adjustment, 1 (100 percent or 

1.0) is added for a total base inflation 

adjustment of 1.018210 for FY 2019. 

MDUFA IV provides for this inflation 

adjustment to be compounded for FY 

2019 and each subsequent fiscal year 

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

inflation adjustment for FY 2019 

(1.018210) is compounded by 

multiplying it by the compounded 

applicable inflation factor from FY 2018 

(1.054618). To complete the 

compounded inflation adjustment for 

FY 2019, the FY 2018 compounded 

adjustment (1.054618) is multiplied by 

the FY 2019 base inflation adjustment 

(1.018210) to reach the applicable 

inflation adjustment of 1.073823 

(rounded) for FY 2019. We then 

multiply the total revenue amount for 

FY 2019 ($190,654,875) by 1.073823, 

yielding an inflation adjusted total 

revenue amount of $204,730,000 

(rounded to the nearest thousand 

dollars). 

III. Fees for FY 2019 

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 

$300,000 (premarket application) and 

$4,548 (establishment registration) are 

to be adjusted for FY 2019 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 

1.073823 yields inflation adjusted base 

fees of $322,147 (premarket application) 

and $4,884 (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 

2019. Most of the fee-paying submission 

counts are published in the MDUFA 

Financial Report to Congress each year. 

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

Application type FY 2015 actual FY 2016 actual FY 2017 actual 3-Year average 

Full Fee Applications ....................................................... 42 37 40 40 

Small Business ......................................................... 7 10 7 8 

Panel-Track Supplement ................................................. 22 17 27 22 

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

De Novo Classification Request 1 .................................... ................................ ................................ 24 24 

Small Business 1 ....................................................... ................................ ................................ 31 31 

180-Day Supplements ..................................................... 143 116 184 148 

Small Business ......................................................... 15 16 36 22 

Real-Time Supplements .................................................. 204 179 195 193 

Small Business ......................................................... 28 27 20 25 

510(k)s ............................................................................. 2,768 2,599 3,141 2,836 

Small Business ......................................................... 1,037 1,005 1,125 1,056 


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

Application type FY 2015 actual FY 2016 actual FY 2017 actual 3-Year average 

30-Day Notice .................................................................. 920 929 1,080 976 

Small Business ......................................................... 71 76 82 76 

513(g) (21 U.S.C. 360c(g)) Request for Classification 

Information ................................................................... 75 68 98 80 

Small Business ......................................................... 33 46 41 40 

Annual Fee for Periodic Reporting 2 ................................ 554 582 429 522 

Small Business 2 ....................................................... 73 75 37 62 

Establishment Registration .............................................. 25,363 26,046 27,268 26,226 

1Three-year average for De Novo is based on estimate for FY 2019. 

2 Includes collection of quarter 4 billing for FY 2017 during FY 2018. 

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 

2019 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 $207,708,611, which is 

$2,978,611 higher than the inflation 

adjusted total revenue amount. The fees 

in column two are those we are 

establishing in FY 2019, which are the 

standard fees. 

TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2019 REVENUE TARGET

Application type 

FY 2019 

statutory fees 

(base fees) 

FY 2019 

inflation 

adjusted 

statutory base fees 

(standard fees) 

FY 2019 

revenue from 

adjusted fees 

Full Fee Applications ........................................................................................... $300,000 $322,147 $12,885,880 

Small Business ............................................................................................. 75,000 80,537 644,296 

Panel-Track Supplement ..................................................................................... 225,000 241,610 5,315,420 

Small Business ............................................................................................. 56,250 60,403 120,806 

De Novo Classification Request .......................................................................... 90,000 96,644 2,319,456

Small Business ............................................................................................. 22,500 24,161 748,991 

180-Day Supplements ......................................................................................... 45,000 48,322 7,151,656 

Small Business ............................................................................................. 11,250 12,081 265,782 

Real-Time Supplements ...................................................................................... 21,000 22,550 4,352,150 

Small Business ............................................................................................. 5,250 5,638 140,950 

510(k)s ................................................................................................................. 10,200 10,953 31,062,708 

Small Business ............................................................................................. 2,550 2,738 2,891,328 

30-Day Notice ...................................................................................................... 4,800 5,154 5,030,304 

Small Business ............................................................................................. 2,400 2,577 195,852 

513(g) Request for Classification Information ..................................................... 4,050 4,349 347,920 

Small Business ............................................................................................. 2,025 2,175 87,000 

Annual Fee for Periodic Reporting ...................................................................... 10,500 11,275 5,885,550 

Small Business ............................................................................................. 2,625 2,819 174,778 

Establishment Registration .................................................................................. 4,548 4,884 128,087,784 

Total .............................................................................................................. ................................ ................................ 207,708,611 

The standard fee (adjusted base 

amount) for a premarket application, 

including a BLA, and for a premarket 

report and a BLA efficacy supplement, 

is $322,147 for FY 2019. 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 

$4,884 for FY 2019. There is no small 

business rate for the annual 

establishment registration fee; all 

establishments pay the same fee. 

Table 5 summarizes the FY 2019 rates 

for all medical device fees. 


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TABLE 5—MEDICAL DEVICE FEES FOR FY 2019 

Application fee type 

Standard fee 

(as a percent 

of the standard 

fee for a premarket 

application) 

FY 2019 

standard fee 

FY 2019 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.

$322,147 $80,537 

Premarket report (submitted under section 515(c)(2) of the FD&C Act) ............ 100 ......................... 322,147 80,537 

Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100 ......................... 322,147 80,537 

Panel-track supplement ....................................................................................... 75 ........................... 241,610 60,403 

De novo classification request ............................................................................ 30 ........................... 96,644 24,161 

180-day supplement ............................................................................................ 15 ........................... 48,322 12,081 

Real-time supplement ......................................................................................... 7 ............................. 22,550 5,638 

510(k) premarket notification submission ........................................................... 3.40 ........................ 10,953 2,738 

30-day notice ....................................................................................................... 1.60 ........................ 5,154 2,577 

513(g) request for classification information ....................................................... 1.35 ........................ 4,349 2,175 

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

Annual fee for periodic reporting on a class III device ....................................... 3.50 ........................ 11,275 2,819 

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.

4,884 4,884 

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 2018, your status as a 

small business will expire at the close 

of business on September 30, 2018. You 

must re-qualify for FY 2019 in order to 

pay small business fees during FY 2019. 

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

and wish to qualify as a small business 

for FY 2019, you must submit the 

following to FDA: 

1. A completed MDUFA Small 

Business Certification Request For a 

Business Headquartered in the U.S. 

(Form FDA 3602). Form FDA 3602 is 

provided in the FDA Forms database: 

https://www.fda.gov/downloads/ 

AboutFDA/ReportsManualsForms/ 

Forms/UCM573420.pdf. 

2. A signed certified copy of your 

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

most recent tax year. The most recent 

tax year will be 2018, except: 

If you submit your MDUFA Small 

Business Certification Request for FY 

2019 before April 15, 2019, and you 

have not yet filed your return for 2018, 

you may use tax year 2017. 

If you submit your MDUFA Small 

Business Certification Request for FY 

2019 on or after April 15, 2019, and 

have not yet filed your 2018 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 

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. 

If you are a foreign business, and wish 

to qualify as a small business for FY 

2019, you must 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. 

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 

(2018 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 


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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, 

2018, and September 30, 2019, you must 

pay the fee in effect for FY 2019. 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 

2018 or FY 2019 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, 2018. 

One choice is for applications and fees 

that will be received on or before 

September 30, 2018, which are subject 

to FY 2018 fee rates. A second choice 

is for applications and fees received on 

or after October 1, 2018, which are 

subject to FY 2019 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 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. 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36603 

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 2019 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 

website listed previously in this section. 

After creating a user name and 

password, log into the Establishment 

Registration User Fee FY 2019 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 

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. If needed, FDA’s 

tax identification number is 53– 

0196965. 

C. Complete the Information Online To 

Update Your Establishment’s Annual 

Registration for FY 2019, or To Register 

a New Establishment for FY 2019 

Go to the Center for Devices and 

Radiological Health’s website at https:// 

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

HowtoMarketYourDevice/ 

RegistrationandListing/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 2018. Manufacturers of licensed 

biologics should register in the BER 

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

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Establishmen

tRegistration/BloodEstablishment

Registration/default.htm. 

Enter your existing account ID and 

password to log into FURLS. From the 

FURLS/FDA Industry Systems menu, 


daltland on DSKBBV9HB2PROD with NOTICES
36604 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

1On April 30, 2018, Bayer filed a submission 

titled ‘‘Request for Clarification of FDA Granting of 

a Petition for Stay of Action.’’ Bayer requested that 

FDA clarify that the stay allowed new 

manufacturing only until May 2, 2018, with 

shipment of product permitted until November 2, 

2018. Breckenridge/Nexgen responded to Bayer’s 

request for clarification and argued that Bayer’s 

submission should have been a petition for 

reconsideration and that it failed to meet the 

standards required for reconsideration. Regardless 

of whether Bayer’s submission should have been a 

petition for reconsideration, FDA’s letter granting 

the stay provides that the order is stayed until 

November 2, 2018, without the limitations Bayer 

now requests. 

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 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16178 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0549] 

Prescription Polyethylene Glycol 3350; 

Denial of a Hearing and Order 

Withdrawing Approval of Abbreviated 

New Drug Applications; Temporary 

Stay of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice that the effective date of an April 

2, 2018, order denying requests for a 

hearing and withdrawing approval of 

abbreviated new drug applications 

(ANDAs) for certain prescription 

laxatives with the active ingredient 

polyethylene glycol 3350 (PEG 3350) is 

stayed until November 2, 2018. 

DATES: FDA is staying the effective date 

of the April 2, 2018, order withdrawing 

approval of ANDAs for certain 

prescription laxatives with the active 

ingredient PEG 3350 until November 2, 

2018. 

ADDRESSES: For access to the docket, go 

to https://www.regulations.gov and 

insert the docket number, found in 

brackets in the heading of this 

document, into the ‘‘Search’’ box and 

follow the prompts and/or go to the 

Dockets Management Staff, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

between 9 a.m. and 4 p.m., Monday 

through Friday. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: Julie 

Finegan, Office of Scientific Integrity, 

Office of the Chief Scientist, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 4218, 

Silver Spring, MD 20993–0002, 301– 

796–8618. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 2, 2018 (83 FR 

13994), FDA denied requests for hearing 

and issued an order withdrawing 

approval of ANDAs for certain 

prescription laxatives with the active 

ingredient PEG 3350. The effective date 

of the order was May 2, 2018. Between 

April 6, 2018, and April 13, 2018, FDA 

received petitions for stay under § 10.35 

(21 CFR 10.35) on behalf of four ANDA 

holders: Breckenridge Pharmaceutical, 

Inc. and Nexgen Pharma, Inc. (hereafter 

Breckenridge/Nexgen) who submitted a 

joint petition; Lannett Company, Inc.; 

and Paddock Laboratories, Inc. 

(collectively the ANDA holders). 

Breckenridge/Nexgen, Lannett, and 

Paddock petitioned FDA to stay its 

order withdrawing the approval of their 

ANDAs for prescription PEG 3350 and 

argued that all four criteria for a 

mandatory stay under § 10.35(e) were 

met. Bayer Healthcare, LLC, (Bayer) 

which holds an approved New Drug 

Application for MiraLAX, an over-thecounter laxative containing PEG 3350, 

responded. Bayer argued that the 

petitioners failed to meet any of the 

factors in § 10.35(e).1

By a letter dated April 16, 2018, the 

Acting Chief Scientist, pursuant to 

authority delegated by the 

Commissioner, concluded that the 

ANDA holders had not met the criteria 

for a mandatory stay under § 10.35(e). 

The Acting Chief Scientist granted a 

temporary, discretionary stay of the 

effective date of the order until 

November 2, 2018. As described in the 

April 16, 2018, letter, based upon 

information submitted by the ANDA 

holders and not disputed by Bayer, it 

would likely be difficult for 

manufacturers of OTC PEG 3350 

products to compensate for the removal 

of prescription PEG 3350 products 

within 30 days. The letter explained 

that public health interests would not be 

served should the 30-day effective date 

negatively impact the availability of 

PEG 3350, particularly given that the 

basis of the withdrawal of the ANDA 

products is not an issue of safety or 

efficacy. The April 16, 2018, letter 

additionally noted that FDA has 

provided lengthier time frames to phase 

out manufacturing and distribution of 

affected products in other cases. While 

the Acting Chief Scientist rejected the 

petitioners’ arguments that financial 

hardship and harm to reputation 

resulting from the withdrawal order rise 

to the level of irreparable injury 

necessary for a mandatory stay under 

§ 10.35(e), she agreed that there may 

some validity to the petitioner’s 

concerns of harm to their business 

interests as a result of the 30-day 

effective date. The Acting Chief 

Scientist concluded that it is in the 

public interest and in the interest of 

justice to stay the effective date of the 

April 2, 2018, order until November 2, 

2018. 

The parties’ submissions and the 

Agency’s orders are available at https:// 

www.regulations.gov and with the 

Dockets Management Staff (see 

ADDRESSES). 

FDA is providing notice of the 

decision to grant a temporary stay in 

accordance with § 10.35(f). 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16148 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 


daltland on DSKBBV9HB2PROD with NOTICES