41026 Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 

Designees under 45 CFR 400.301(c), and 

Wilson-Fish Grantees (State 2 Agencies) 

administering or supervising the 

administration of programs under Title 

IV of the Act. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ORR–1, Cash and Medical Assistance Program Estimates ........................... 55 1 0.60 33 

Estimated Total Annual Burden 

Hours: 33. 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW., 

Washington, DC 20201. Attention 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–18254 Filed 8–28–17; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0007] 

Generic Drug User Fee Rates for Fiscal 

Year 2018 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), as 

amended by the Generic Drug User Fee 

Amendments of 2017 (GDUFA II), 

authorizes FDA to assess and collect 

fees for abbreviated new drug 

applications (ANDAs), drug master files 

(DMFs), generic drug active 

pharmaceutical ingredient (API) 

facilities, finished dosage form (FDF) 

facilities, contract manufacturing 

organization (CMO) facilities, and 

generic drug applicant program user 

fees. In this document the Food and 

Drug Administration (FDA or Agency) is 

announcing fiscal year (FY) 2018 rates 

for GDUFA fees. 

FOR FURTHER INFORMATION CONTACT: 

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 

Sections 744A and 744B of the FD&C 

Act (21 U.S.C. 379j–41 and 379j–42) 

establish fees associated with human 

generic drug products. Fees are assessed 

on: (1) Certain types of applications for 

human generic drug products; (2) 

certain facilities where APIs and FDFs 

are produced; (3) certain DMFs 

associated with human generic drug 

products; and (4) the generic drug 

applicant program (see section 

744B(a)(1)–(5) of the FD&C Act). 

GDUFA II fees vary greatly from those 

in GDUFA I because of two fundamental 

adjustments to the fee structure: 

(1) The revenue base for GDUFA II is 

$493.6 million versus $323 million in 

the final year of GDUFA I—ANDAs are 

the primary workload driver of the 

program. GDUFA I was built on the 

assumption that FDA would receive 750 

ANDAs per year. Over the first 4 years 

of GDUFA I, ANDA receipts have 

averaged approximately 1,000 per year. 

To address the increased workload, FDA 

hired additional staff and is projected to 

spend about $430 million in the final 

year of GDUFA I. To maintain FDA’s 

current productivity and implement 

negotiated improvements, GDUFA II 

stipulates that user fees should total 

$493.6 million annually adjusted each 

year for inflation. 

(2) GDUFA II will for the first time 

rely on annual program fees—GDUFA II 

shifts the fee burden somewhat from 

facility fees. 

For FY 2018, the generic drug fee 

rates are: ANDA ($171,823), DMF 

($47,829), domestic API facility 

($45,367), foreign API facility ($60,367), 

domestic FDF facility ($211,087), 

foreign FDF facility ($226,087), 

domestic CMO facility ($70,362), foreign 

CMO facility ($85,362), large size 

operation generic drug applicant 

program ($1,590,792), medium size 

operation drug applicant program 

($636,317), and small business generic 

drug applicant program ($159,079). 

These fees are effective on October 1, 

2017, and will remain in effect through 

September 30, 2018. 

II. Fee Revenue Amount for FY 2018 

The base revenue amount for FY 2018 

is $493,600,000, as set in the statute (see 

section 744B(b)(1) of the FD&C Act). 

GDUFA II directs FDA to use the yearly 

revenue amount as a starting point to set 

the fee rates for each fee type. For more 

information about GDUFA II, please 

refer to the FDA Web site (http://

www.fda.gov/gdufa). The ANDA, DMF, 

API facility, FDF facility, CMO facility, 

and generic drug applicant program fee 

(GDUFA Program Fee) calculations for 

FY 2018 are described in this document. 

GDUFA II specifies that the 

$493,600,000 is to be adjusted for 

inflation increases for FY 2019 through 

FY 2022 using two separate 

adjustments—one for personnel 

compensation and benefits (PC&B) and 

one for non-PC&B costs (see section 

744B(c)(1) of the FD&C Act). Because 

the adjustment for inflation does not 

take effect until FY 2019, FDA will not 

adjust the base revenue amount for 

inflation in FY 2018. 

III. ANDA Fee 

Under GDUFA II, the FY 2018 ANDA 

fee is owed by each applicant that 

submits an ANDA on or after October 1, 

2017. This fee is due on the receipt date 

of the ANDA. Section 744B(b)(2)(B) 

specifies that the ANDA fee will make 

up 33 percent of the $493,600,000, 

which is $162,888,000. 

To calculate the ANDA fee, FDA 

estimated the number of full application 

equivalents (FAEs) that will be 

submitted in FY 2018. An ANDA counts 

as one FAE; however, 75 percent of the 


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fee paid for an ANDA shall be refunded 

according to GDUFA II if (1) the ANDA 

is refused for a cause other than failure 

to pay fees or (2) the ANDA has been 

withdrawn prior to receipt (section 

744B(a)(2)(D)(i) of the FD&C Act). 

Therefore, an ANDA that is considered 

not to have been received by FDA due 

to reasons other than failure to pay fees 

or withdrawn prior to receipt counts as 

one-fourth of an FAE if the applicant 

initially paid a full application fee. One 

hundred percent of the fee paid for an 

ANDA shall be refunded if FDA initially 

receives the ANDA and subsequent to 

initial receipt, FDA determines that 

exclusivity should have prevented 

receipt of the ANDA, and thus FDA 

determines that the ANDA is no longer 

received (section 744B(a)(2)(D))(ii) of 

the FD&C Act). 

FDA utilized data from ANDAs 

submitted from October 1, 2013, to 

April 30, 2017, to estimate the number 

of new original ANDAs that will incur 

filing fees in FY 2018. For FY 2018, the 

Agency estimates that approximately 

938 new original ANDAs will be 

submitted and incur filing fees. Not all 

of the new original ANDAs will be 

received by the Agency and some of 

those not received will be resubmitted 

in the same fiscal year. Therefore, the 

Agency expects that the FAE count for 

ANDAs will be 948 for FY 2018. 

The FY 2018 application fee is 

estimated by dividing the number of 

FAEs that will pay the fee in FY 2018 

(948) into the fee revenue amount to be 

derived from ANDA application fees in 

FY 2018 ($162,888,000). The result, 

rounded to the nearest dollar, is a fee of 

$171,823 per ANDA. 

The statute provides that those 

ANDAs that include information about 

the production of active pharmaceutical 

ingredients other than by reference to a 

DMF will pay an additional fee that is 

based on the number of such active 

pharmaceutical ingredients and the 

number of facilities proposed to 

produce those ingredients (see section 

744B(a)(3)(F) of the FD&C Act). FDA 

considers that this additional fee is 

unlikely to be assessed often; therefore, 

FDA has not included projections 

concerning the amount of this fee in 

calculating the fees for ANDAs. 

IV. DMF Fee 

Under GDUFA II, the DMF fee is 

owed by each person that owns a type 

II active pharmaceutical ingredient DMF 

that is referenced, on or after October 1, 

2012, in a generic drug submission by 

an initial letter of authorization. This is 

a one-time fee for each DMF. This fee is 

due on the earlier of the date on which 

the first generic drug submission is 

submitted that references the associated 

DMF or the date on which the drug 

master file holder requests the initial 

completeness assessment. Under section 

744B(a)(2)(D)(iii) of the FD&C Act, if a 

DMF has successfully undergone an 

initial completeness assessment and the 

fee is paid, the DMF will be placed on 

a publicly available list documenting 

DMFs available for reference. 

To calculate the DMF fee, FDA 

assessed the volume of DMF 

submissions over time. The Agency 

assessed DMFs from October 1, 2015, to 

April 30, 2017, and concluded that 

averaging the number of fee-paying 

DMFs provided the most accurate model 

for predicting fee-paying DMFs for FY 

2018. FDA is estimating 516 fee-paying 

DMFs for FY 2018. 

The FY 2018 DMF fee is determined 

by dividing the DMF target revenue by 

the estimated number of fee-paying 

DMFs in FY 2018. Section 744B(b)(2)(A) 

specifies that the DMF fees will make 

up five percent of the $493,600,000, 

which is $24,680,000. Dividing the DMF 

revenue amount ($24,680,000) by the 

estimated fee-paying DMFs (516), and 

rounding to the nearest dollar, yields a 

DMF fee of $47,829 for FY 2018. 

V. Foreign Facility Fee Differential 

Under GDUFA II, the fee for a facility 

located outside the United States and its 

territories and possessions shall be 

$15,000 higher than the amount of the 

fee for a facility located in the United 

States and its territories and 

possessions. The basis for this 

differential is the extra cost incurred by 

conducting an inspection outside the 

United States and its territories and 

possessions. 

VI. FDF and CMO Facility Fees 

Under GDUFA II, the annual FDF 

facility fee is owed by each person who 

owns an FDF facility that is identified 

in at least one approved generic drug 

submission owned by that person or his 

affiliates. The CMO facility fee is owed 

by each person who owns an FDF 

facility that is identified in at least one 

approved ANDA but is not identified in 

an approved ANDA held by the owner 

of that facility or its affiliates. These fees 

are due no later than the first business 

day on or after October 1 of each such 

year. Section 744B(b)(2)(C) of the FD&C 

Act specifies that the FDF and CMO 

facility fee revenue will make up 20 

percent of the $493,600,000, which is 

$98,720,000. 

To calculate the fees, data from FDA’s 

Integrity Services (IS) were utilized as 

the primary source of facility 

information for determining the 

denominators of each facility fee type. 

IS is the master data steward for all 

facility information provided in generic 

drug submissions received by FDA. A 

facility’s reference status in an approved 

generic drug submission is extracted 

directly from submission data rather 

than relying on data from selfidentification. This information 

provided the number of facilities 

referenced as FDF manufacturers in at 

least one approved generic drug 

submission. Based on FDA’s IS data for 

FY 2018, the FDF and CMO facility 

denominators are 182 FDF domestic, 

208 FDF foreign, 71 CMO domestic, and 

97 CMO foreign facilities. 

GDUFA II specifies that the CMO 

facility fee is to be equal to one-third the 

amount of the FDF facility fee. 

Therefore, to generate the target 

collection revenue amount from FDF 

and CMO facility fees ($98,720,000), 

FDA must weight a CMO facility as onethird of an FDF facility. FDA set fees 

based on the estimate of 182 FDF 

domestic, 208 FDF foreign, 23.67 CMO 

domestic (71 multiplied by one-third), 

and 32.33 CMO foreign facilities (97 

multiplied by one-third), which equals 

446 total weighted FDF and CMO 

facilities for FY 2018. 

To calculate the fee for domestic 

facilities, FDA first determines the total 

fee revenue that will result from the 

foreign facility differential by 

subtracting the fee revenue resulting 

from the foreign facility fee differential 

from the target collection revenue 

amount ($98,720,000) as follows. The 

foreign facility fee differential revenue 

equals the foreign facility fee differential 

($15,000) multiplied by the number of 

FDF foreign facilities (208) plus the 

foreign facility fee differential ($15,000) 

multiplied by the number of CMO 

foreign facilities (97), totaling 

$4,575,000. This results in foreign fee 

differential revenue of $4,575,000 from 

the total FDF and CMO facility fee target 

collection revenue. Subtracting the 

foreign facility differential fee revenue 

($4,575,000) from the total FDF and 

CMO facility target collection revenue 

($98,720,000) results in a remaining 

facility fee revenue balance of 

$94,145,000. To determine the domestic 

FDF facility fee, FDA divides the 

$94,145,000 by the total weighted 

number of FDF and CMO facilities 

(446), which results in a domestic FDF 

facility fee of $211,087. The foreign FDF 

facility fee is $15,000 more than the 

domestic FDF facility fee, or $226,087. 

CMO fees are as follows. According to 

GDUFA II, the domestic CMO fee is 

calculated as one-third the amount of 

the domestic FDF facility fee. Therefore, 

the domestic CMO fee is $70,362, 

rounded to the nearest dollar. The 


sradovich on DSK3GMQ082PROD with NOTICES
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foreign CMO fee is calculated as the 

domestic CMO fee plus the foreign fee 

differential of $15,000. Therefore, the 

foreign CMO fee is $85,362. 

VII. API Facility Fee 

Under GDUFA II, the annual API 

facility fee is owed by each person who 

owns a facility that is identified in (1) 

at least one approved generic drug 

submission or (2) in a Type II API DMF 

referenced in at least one approved 

generic drug submission. These fees are 

due no later than the first business day 

on or after October 1 of each such year. 

Section 744B(b)(2)(D) of the FD&C Act 

specifies the API facility fee will make 

up seven percent of $493,600,000 in fee 

revenue, which is $34,552,000. 

To calculate the API facility fee, data 

from FDA’s IS were utilized as the 

primary source of facility information 

for determining the denominator. As 

stated above, IS is the master data 

steward for all facility information 

provided in generic drug submissions 

received by FDA. A facility’s reference 

status in an approved generic drug 

submission is extracted directly from 

submission data rather than relying on 

data from self-identification. This 

information provided the number of 

facilities referenced as API 

manufacturers in at least one approved 

generic drug submission. 

The total number of API facilities 

identified was 592. Of the total facilities 

identified as API facilities, there were 

79 domestic facilities and 513 foreign 

facilities. The foreign facility differential 

is $15,000. To calculate the fee for 

domestic facilities, FDA must first 

subtract the fee revenue that will result 

from the foreign facility fee differential. 

FDA takes the foreign facility 

differential ($15,000) and multiplies it 

by the number of foreign facilities (513) 

to determine the total fee revenue that 

will result from the foreign facility 

differential. As a result of that 

calculation, the foreign fee differential 

revenue will make up $7,695,000 of the 

total API fee revenue. Subtracting the 

foreign facility differential fee revenue 

($7,695,000) from the total API facility 

target revenue ($34,552,000) results in a 

remaining balance of $26,857,000. To 

determine the domestic API facility fee, 

we divide the $26,857,000 by the total 

number of facilities (592), which gives 

us a domestic API facility fee of 

$45,367. The foreign API facility fee is 

$15,000 more than the domestic API 

facility fee, or $60,367. 

VIII. Generic Drug Applicant Program 

Fee 

Under GDUFA II, if a person and its 

affiliates own at least one but not more 

than five approved ANDAs on October 

1, 2017, the person and its affiliates 

shall owe a small business GDUFA 

Program Fee. If a person and its 

affiliates own at least 6 but not more 

than 19 approved ANDAs, the person 

and its affiliates shall owe a medium 

size operation GDUFA Program Fee. If a 

person and its affiliates own at least 20 

approved ANDAs, the person and its 

affiliates shall owe a large size operation 

GDUFA Program Fee. These fees are due 

no later than the first business day on 

or after October 1 of each such year. 

Section 744B(b)(2)(E) of the FD&C Act 

specifies the GDUFA Program Fee will 

make up 35 percent of $493,600,000 in 

fee revenue, which is $172,760,000. 

To determine the appropriate number 

of applicants for each tier, the Agency 

has posted lists of approved ANDAs on 

the FDA Web site (http://www.fda.gov/ 

gdufa) and asked applicants on the list 

to claim which ANDAs and affiliates 

belong to the parent company. The 

original list of approved ANDAs came 

from the Agency’s Document Archiving, 

Reporting, and Regulatory Tracking 

System (DARRTS), which included all 

ANDAs with the status of ‘‘approved’’ as 

of April 30, 2017. 

In determining the appropriate 

number of approved ANDAs, the 

Agency has factored in a number of 

variables that could affect the collection 

of the target revenue: (1) Inactive 

ANDAs—applicants who have not 

submitted an annual report for one or 

more of their approved applications 

within the past 2 years; (2) unclaimed 

affiliations—a risk of undercollecting 

the target revenue if companies do not 

claim their ANDAs and their affiliates 

before the Program Fee is calculated; 

and (3) potential portfolio adjustment— 

applicants may choose to withdraw 

some of their approved ANDAs in order 

to move to a lower tier and reduce their 

fee exposure. The list of original 

approved ANDAs from the DARRTS 

database as of April 30, 2017, shows 339 

applicants in the small business tier, 74 

applicants in the medium size tier, and 

65 applicants in the large size tier. This 

list also takes into account all the 

withdrawals, consolidations, and 

transfer of ownerships from industry as 

of April 30, 2017. Factoring in all the 

variables for the first year of GDUFA II, 

the Agency estimates there will be 258 

applicants in the small business tier, 52 

applicants in the medium size tier, and 

62 applicants in the large size tier for FY 

2018. 

To calculate the GDUFA Program Fee, 

GDUFA II provides that large size 

operation generic drug applicants pay 

the full fee, medium size operation 

applicants pay two-fifths of the full fee, 

and small business applicants pay onetenth of the full fee. To generate the 

target collection revenue amount from 

GDUFA Program Fees ($172,760,000), 

we must weigh medium and small 

tiered applicants as a subset of a large 

size operation generic drug applicant. 

FDA will set fees based on the weighted 

estimate of 25.8 applicants in the small 

business tier (258 multiplied by 10 

percent), 20.8 applicants in the medium 

size tier (52 multiplied by 40 percent), 

and 62 applicants in the large size tier, 

arriving at 108.6 total weighted 

applicants for FY 2018. 

To generate the large size operation 

GDUFA Program Fee, FDA divides the 

target revenue amount of $172,760,000 

by 108.6, which equals $1,590,792. The 

medium size operation GDUFA Program 

Fee is 40 percent of the full fee 

($636,317), and the small business 

operation GDUFA Program Fee is 10 

percent of the full fee ($159,079). 

IX. Fee Schedule for FY 2018 

The fee rates for FY 2018 are set out 

in table 1. 

TABLE 1—FEE SCHEDULE FOR FY 

2018 

Fee category 

Fee rates 

for FY 

2018 

Applications: 

Abbreviated New Drug Application 

(ANDA) ......................................... $171,823 

Drug Master File (DMF) ................... 47,829 

Facilities: 

Active Pharmaceutical Ingredient 

(API)—Domestic .......................... 45,367 

API—Foreign ................................... 60,367 

Finished Dosage Form (FDF)—Domestic ........................................... 211,087 

FDF—Foreign .................................. 226,087 

Contract Manufacturing Organization (CMO)—Domestic ................. 70,362 

CMO—Foreign ................................. 85,362 

GDUFA Program: 

Large size operation generic drug 

applicant ....................................... 1,590,792 

Medium size operation generic drug 

applicant ....................................... 636,317 

Small business operation generic 

drug applicant .............................. 159,079 

X. Fee Payment Options and 

Procedures 

The new fee rates are effective 

October 1, 2017. To pay the ANDA, 

DMF, API facility, FDF facility, CMO 

facility, and GDUFA Program Fee, you 

must complete a Generic Drug User Fee 

Cover Sheet, available through https://

www.fda.gov/gdufa and at https://

userfees.fda.gov/OA_HTML/gdufaCAcd

Login.jsp, and generate a user fee 

identification (ID) number. Payment 

must be made in U.S. currency drawn 

on a U.S. bank by electronic check, 

check, bank draft, U.S. postal money 

order, credit card, or wire transfer. The 


sradovich on DSK3GMQ082PROD with NOTICES
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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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