Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Notices 36937 

thresholds for certain data items to 

reduce reporting burden. The comment 

period expired June 29, 2018. 

Detailed Discussion of Public 

Comments 

The Federal Reserve received one 

comment from a banking association. 

The commenter noted several 

inconsistencies on the FR Y–9C report 

form and one inconsistency on the 

instructions when compared to the Call 

Report pertaining to Schedule HC–Q 

Memoranda items 4.b and 4.d, column 

A and Schedule HC–S Column G 

instructions and requested clarification 

on the proper reporting. The draft report 

form was inadvertently updated to 

reflect the removal of items 4.b and 4.d 

and a line item reference on the 

instructions for Schedule HC–S Column 

G was also inadvertently struck through. 

The Board has revised these items so 

that both the report form and 

instructions align with the Call Report. 

Additionally, the commenter noted an 

inconsistency between the caption on 

the report form and the caption on the 

instructions pertaining to Equity 

investments without readily 

determinable fair values on Schedule 

HC–F line item 4 on the FR Y–9C report. 

The Board has updated the instructions 

so that the report form and instructions 

align. 

The revisions will be implemented as 

proposed, with the modifications 

described above, effective for the June 

30, 2018, report date. 

Board of Governors of the Federal Reserve 

System, July 25, 2018. 

Michele Taylor Fennell, 

Assistant Secretary of the Board. 

[FR Doc. 2018–16265 Filed 7–30–18; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: 

Voluntary Relinquishment From 

Diagnostic Quality Assurance 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), Department of 

Health and Human Services (HHS). 

ACTION: Notice of delisting. 

SUMMARY: The Patient Safety Rule 

authorizes AHRQ, on behalf of the 

Secretary of HHS, to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ by 

the Secretary if it is found to no longer 

meet the requirements of the Patient 

Safety Act and Patient Safety Rule, 

when a PSO chooses to voluntarily 

relinquish its status as a PSO for any 

reason, or when a PSO’s listing expires. 

AHRQ has accepted a notification of 

voluntary relinquishment from 

Diagnostic Quality Assurance of its 

status as a PSO, and has delisted the 

PSO accordingly. Diagnostic Quality 

Assurance, PSO number P0170, 

submitted this request for voluntary 

relinquishment after receiving a Notice 

of Preliminary Finding of Deficiency. 

DATES: The directories for both listed 

and delisted PSOs are ongoing and 

reviewed weekly by AHRQ. The 

delisting was effective at 12:00 Midnight 

ET (2400) on July 1, 2018. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS website: http://www.pso.ahrq.gov/ 

listed. 

FOR FURTHER INFORMATION CONTACT: 

Eileen Hogan, Center for Quality 

Improvement and Patient Safety, AHRQ, 

5600 Fishers Lane, Room 06N94B, 

Rockville, MD 20857; Telephone (toll 

free): (866) 403–3697; Telephone (local): 

(301) 427–1111; TTY (toll free): (866) 

438–7231; TTY (local): (301) 427–1130; 

Email: pso@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety and Quality 

Improvement Act of 2005, 42 U.S.C. 

299b–21 to b–26, (Patient Safety Act) 

and the related Patient Safety and 

Quality Improvement Final Rule, 42 

CFR part 3 (Patient Safety Rule), 

published in the Federal Register on 

November 21, 2008, 73 FR 70732– 

70814, establish a framework by which 

hospitals, doctors, and other health care 

providers may voluntarily report 

information to Patient Safety 

Organizations (PSOs), on a privileged 

and confidential basis, for the 

aggregation and analysis of patient 

safety events. 

The Patient Safety Act authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity are to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule relating to the listing and operation 

of PSOs. The Patient Safety Rule 

authorizes AHRQ to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ if 

it is found to no longer meet the 

requirements of the Patient Safety Act 

and Patient Safety Rule, when a PSO 

chooses to voluntarily relinquish its 

status as a PSO for any reason, or when 

a PSO’s listing expires. Section 3.108(d) 

of the Patient Safety Rule requires 

AHRQ to provide public notice when it 

removes an organization from the list of 

federally approved PSOs. 

AHRQ has accepted a notification 

from Diagnostic Quality Assurance, a 

component entity of Quality Star, LLC, 

to voluntarily relinquish its status as a 

PSO. Accordingly, Diagnostic Quality 

Assurance was delisted effective at 

12:00 Midnight ET (2400) on July 1, 

2018. AHRQ notes that that Diagnostic 

Quality Assurance submitted this 

request for voluntary relinquishment 

following receipt of the Notice of 

Preliminary Finding of Deficiency sent 

on April 10, 2018. 

More information on PSOs can be 

obtained through AHRQ’s PSO website 

at http://www.pso.ahrq.gov. 

Francis D. Chesley, Jr., 

Acting Deputy Director. 

[FR Doc. 2018–16327 Filed 7–30–18; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Biosimilar 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 

rates for biosimilar user fees for fiscal 

year (FY) 2019. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the Biosimilar User Fee 

Amendments of 2017 (BsUFA II), 

authorizes FDA to assess and collect 

user fees for certain activities in 

connection with biosimilar biological 

product development; review of certain 

applications for approval of biosimilar 

biological products; and each biosimilar 

biological product approved in a 

biosimilar biological product 

application. 

BsUFA II directs FDA to establish, 

before the beginning of each fiscal year, 

the amount of initial and annual 

biosimilar biological product 

development (BPD) fees, the 

reactivation fee, and the biosimilar 

biological product application and 


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program fees for such year. These fees 

apply to the period from October 1, 

2018, through September 30, 2019. 

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 744G, 744H, and 744I of the 

FD&C Act (21 U.S.C. 379j–51, 379j–52, 

and 379j–53), as amended by BsUFA II 

(title IV of the FDA Reauthorization Act 

of 2017, Pub. L. 115–52), authorize the 

collection of fees for biosimilar 

biological products. Under section 

744H(a)(1)(A) of the FD&C Act, the 

initial BPD fee for a product is due 

when the sponsor submits an 

investigational new drug (IND) 

application that FDA determines is 

intended to support a biosimilar 

biological product application or within 

5 calendar days after FDA grants the 

first BPD meeting, whichever occurs 

first. A sponsor who has paid the initial 

BPD fee is considered to be participating 

in FDA’s BPD program for that product. 

Under section 744H(a)(1)(B) of the 

FD&C Act, once a sponsor has paid the 

initial BPD fee for a product, the annual 

BPD fee is assessed beginning with the 

next fiscal year. The annual BPD fee is 

assessed for the product each fiscal year 

until the sponsor submits a marketing 

application for the product that is 

accepted for filing or discontinues 

participation in FDA’s BPD program. 

Under section 744H(a)(1)(D) of the 

FD&C Act, if a sponsor has discontinued 

participation in FDA’s BPD program and 

wants to re-engage with FDA on 

development of the product, the sponsor 

must pay a reactivation fee to resume 

participation in the program. The 

sponsor must pay the reactivation fee by 

the earlier of the following dates: No 

later than 5 calendar days after FDA 

grants the sponsor’s request for a BPD 

meeting for that product or upon the 

date of submission by the sponsor of an 

IND describing an investigation that 

FDA determines is intended to support 

a biosimilar biological product 

application for that product. The 

sponsor will be assessed an annual BPD 

fee beginning with the first fiscal year 

after payment of the reactivation fee. 

BsUFA II also authorizes fees for 

certain biosimilar biological product 

applications and for each biosimilar 

biological product identified in an 

approved biosimilar biological product 

application (section 744H(a)(2) and (3) 

of the FD&C Act). Under certain 

conditions, FDA will grant a small 

business a waiver from its first 

biosimilar biological product 

application fee (section 744H(d)(1) of 

the FD&C Act). 

For FY 2018 through FY 2022, the 

base revenue amounts for the total 

revenues from all BsUFA fees are 

established by BsUFA II. For FY 2019, 

the base revenue amount is the FY 2018 

inflation adjusted fee revenue amount of 

$40,214,000. The FY 2019 base revenue 

amount is to be adjusted for inflation 

and may be reduced, as appropriate, for 

long-term financial planning purposes. 

This document provides fee rates for 

FY 2019 for the initial and annual BPD 

fee ($185,409), for the reactivation fee 

($370,818), for an application requiring 

clinical data ($1,746,745), for an 

application not requiring clinical data 

($873,373), and for the program fee 

($304,162). These fees are effective on 

October 1, 2018, and will remain in 

effect through September 30, 2019. For 

applications that are submitted on or 

after October 1, 2018, the new fee 

schedule must be used. 

II. Fee Revenue Amount for FY 2019 

The base revenue amount for FY 2019 

is $40,214,000 prior to adjustments for 

inflation and operating reserves (see 

section 744H(c)(1) and (3) of the FD&C 

Act). 

A. FY 2019 Statutory Fee Revenue 

Adjustments for Inflation 

BsUFA II specifies that the 

$40,214,000 is to be adjusted for 

inflation increases for FY 2019 using 

two separate adjustments—one for 

personnel compensation and benefits 

(PC&B) and one for non-PC&B costs (see 

section 744H(c)(1) of the FD&C Act). 

The component of the inflation 

adjustment for payroll costs shall be one 

plus the average annual percent change 

in the cost of all PC&B paid per full-time 

equivalent (FTE) positions at FDA for 

the first 3 of the preceding 4 FYs, 

multiplied by the proportion of PC&B 

costs to total FDA costs of the process 

for the review of biosimilar biological 

product applications for the first 3 of the 

preceding 4 FYs (see section 

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

Table 1 summarizes the actual cost 

and FTE data for the specified FYs and 

provides the percent changes from the 

previous FYs and the average percent 

changes over the first 3 of the 4 FYs 

preceding FY 2019. The 3-year average 

is 2.4152 percent. 

TABLE 1—FDA PC&B EACH YEAR AND PERCENT CHANGES

Fiscal year 2015 2016 2017 3-year 

average 

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

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 statute specifies that this 2.4152 

percent be multiplied by the proportion 

of PC&B costs to the total FDA costs of 

the process for the review of biosimilar 

biological product applications. Table 2 

shows the PC&B and the total 

obligations for the process for the 

review of biosimilar biological product 

applications for the first 3 of the 

preceding 4 FYs. 

TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF BIOSIMILAR BIOLOGICAL

PRODUCT APPLICATIONS

Fiscal year 2015 2016 2017 3-year 

average 

Total PC&B .......................................................................................... $23,265,434 $26,775,674 $30,707,050 ........................

Total Costs ........................................................................................... 34,817,217 45,569,430 55,814,043 ........................


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Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Notices 36939 

TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF BIOSIMILAR BIOLOGICAL

PRODUCT APPLICATIONS—Continued 

Fiscal year 2015 2016 2017 3-year 

average 

PC&B Percent ...................................................................................... 66.8216 58.7580 55.0167 60.1988 

The payroll adjustment is 2.4152 

percent from table 1 multiplied by 

60.1988 percent (or 1.4539 percent). 

The statute specifies that the portion 

of the inflation adjustment for nonpayroll costs is the average annual 

percent change that occurred in the 

Consumer Price Index (CPI) for urban 

consumers (Washington-Baltimore, DC– 

MD–VA–WV; not seasonally adjusted; 

all items; annual index) for the first 3 

years of the preceding 4 years of 

available data multiplied by the 

proportion of all costs other than PC&B 

costs to total costs of the process for the 

review of biosimilar biological product 

applications for the first 3 years of the 

preceding 4 FYs (see section 

744H(c)(1)(B) of the FD&C Act). Table 3 

provides the summary data for the 

percent changes in the specified CPI for 

the Washington-Baltimore area. The 

data are published by the Bureau of 

Labor Statistics and can be found on its 

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

SurveyOutputServlet?data_tool=

dropmap&series_id=CUURA311SA0,

CUUSA311SA0. 

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

Year 2015 2016 2017 3-year 

average 

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

Annual Percent Change ...................................................................... 0.3268 1.1760 1.2864 0.9297 

The statute specifies that this 0.9297 

percent be multiplied by the proportion 

of all costs other than PC&B to total 

costs of the process for the review of 

biosimilar biological product 

applications obligated. Since 60.1988 

percent was obligated for PC&B (as 

shown in table 2), 39.8012 percent is the 

portion of costs other than PC&B (100 

percent minus 60.1988 percent equals 

39.8012 percent). The non-payroll 

adjustment is 0.9297 percent times 

39.8012 percent, 0.3700 percent. 

Next, we add the payroll adjustment 

(1.4539 percent) to the non-payroll 

adjustment (0.3700 percent), for a total 

inflation adjustment of 1.8239 percent 

(rounded) for FY 2019. 

We then multiply the base revenue 

amount for FY 2019 ($40,214,000) by 

one plus the inflation adjustment 

percentage (1.018239), yielding an 

inflation-adjusted amount of 

$40,947,463. 

B. FY 2019 Statutory Fee Revenue 

Adjustments for Operating Reserve 

BsUFA II provides for an operating 

reserve adjustment to allow FDA to 

adjust the fee revenue and fees for any 

given fiscal year during BsUFA II, after 

FY 2018, to maintain an appropriate 

operating reserve of carryover user fees. 

Beginning in FY 2019, FDA may reduce 

the fee revenue and fees for long-term 

financial planning purposes. Once the 

capacity planning adjustment is 

effective (see section 744H(c)(2) of the 

FD&C Act), which FDA expects to occur 

in FY 2021, FDA also may, if necessary, 

increase the fee revenue and fees to 

maintain not more than 21 weeks of 

operating reserve of carryover user fees. 

As described in the BsUFA II 

commitment letter, Biosimilar Biological 

Product Reauthorization Goals and 

Procedures Fiscal Years 2018 Through 

2022, FDA is committed to reducing the 

BsUFA carryover reserve to an amount 

no greater than 21 weeks of operating 

reserve of carryover user fees by the end 

of FY 2022. In support of this 

commitment, FDA has determined that 

it shall apply an operating reserve 

adjustment to lower the FY 2019 target 

revenue amount by $2,100,000. This 

would establish an adjusted FY 2019 

BsUFA fee revenue amount of 

$38,847,000 (rounded to the nearest 

thousand dollars). 

III. Fee Amounts for FY 2019 

Under section 744H(b)(3)(A) of the 

FD&C Act, FDA must determine the 

percentage of the total revenue amount 

for a fiscal year to be derived from: (1) 

Initial and annual BPD fees and 

reactivation fees; (2) biosimilar 

biological product application fees; and 

(3) biosimilar biological product 

program fees. In establishing the fee 

amounts for the second year of BsUFA 

II, FDA considered how best to balance 

the fee allocation to provide stable 

funding and reasonable fee amounts. In 

future years, FDA will consider the most 

appropriate means of allocating the fee 

amounts to collect the adjusted target 

revenue amount, subject to the relevant 

statutory provisions. 

A. Application Fees 

In establishing the biosimilar 

biological product application fee 

amount for FY 2019, FDA considered 

historical program information as well 

as input from an annual industry 

survey. Based on the available 

information, FDA estimates it will 

receive nine biosimilar biological 

product applications requiring clinical 

data for approval in FY 2019. 

FDA will maintain the biosimilar 

biological product application fee for FY 

2019 at the same level as FY 2018, 

which is $1,746,745. This is estimated 

to provide a total of $15,720,705 

representing 40 percent (rounded to the 

nearest whole number) of the FY 2019 

target revenue amount. 

B. Biosimilar Biological Product 

Program Fee 

Under BsUFA II, FDA assesses 

biosimilar biological product program 

fees (‘‘program fees’’). An applicant in a 

biosimilar biological product 

application shall not be assessed more 

than five program fees for a fiscal year 

for biosimilar biological products 

identified in a single biosimilar 

biological product application (see 

FD&C Act section 744H(a)(3)(D)). 

Applicants are assessed a program fee 

for a fiscal year only for biosimilar 

biological products identified in a 

biosimilar biological product 

application approved as of October 1 of 

such fiscal year. 

Based on available information, FDA 

estimates that 23 program fees will be 


daltland on DSKBBV9HB2PROD with NOTICES
36940 Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Notices 

invoiced for FY 2019, including 

currently approved products and 

products with the potential to be 

approved in pending applications with 

goal dates in FY 2018. For products 

invoiced in the FY 2019 regular billing 

cycle, FDA anticipates that zero 

program fees will be refunded. This is 

based on observations dating to 2015, 

when the first biosimilar product was 

approved. 

FDA will maintain the biosimilar 

biological product program fee for FY 

2019 at the same level as FY 2018, 

which is $304,162. This is estimated to 

provide a total of $6,995,726, 

representing 18 percent (rounded to the 

nearest whole number) of the FY 2019 

target revenue amount. 

C. Initial and Annual BPD Fees, 

Reactivation Fees 

To estimate the number of 

participants in the BPD program in FY 

2019, FDA must consider the number of 

new participants in the BPD program 

(initial BPD), the number of current 

participants (annual BPD), and the 

number of participants who will reenter the BPD program (reactivation). 

FDA uses internal data and a survey 

of BPD sponsors to estimate the total 

number of participants in the BPD 

program. In FY 2019, FDA estimates 24 

participants entering the BPD program, 

zero reactivations, and 63 participants 

to be invoiced for the annual BPD fee for 

a total of 87 participants in the BPD 

program in FY 2019. 

The remainder of the target revenue of 

$16,130,569, or 42 percent (rounded to 

the nearest whole number), is to be 

collected from the BPD fees. Dividing 

this amount by the estimated 87 BPD 

fees to be paid equals a BPD fee amount 

of $185,409. The reactivation fee is set 

at twice the initial/annual BPD amount 

at $370,818. This represents a reduction 

of the BPD fee from the FY 2018 levels. 

IV. Fee Schedule for FY 2019 

The fee rates for FY 2019 are 

displayed in table 4. 

TABLE 4—FEE SCHEDULE FOR FY 

2019 

Fee category Fee rates for 

FY 2019 

Initial BPD ............................. $185,409 

Annual BPD .......................... 185,409 

Reactivation .......................... 370,818 

Applications: 

Requiring clinical data ....... 1,746,745 

Not requiring clinical data 873,373 

Program ............................ 304,162 

V. Fee Payment Options and 

Procedures 

A. Initial BPD, Reactivation, and 

Application Fees 

The fees established in the new fee 

schedule apply to FY 2019, i.e., the 

period from October 1, 2018, through 

September 30, 2019. The initial BPD fee 

for a product is due when the sponsor 

submits an IND that FDA determines is 

intended to support a biosimilar 

biological product application for the 

product or within 5 calendar days after 

FDA grants the first BPD meeting for the 

product, whichever occurs first. 

Sponsors who have discontinued 

participation in the BPD program for a 

product and seek to resume 

participation in such program must pay 

the reactivation fee by the earlier of the 

following dates: No later than 5 calendar 

days after FDA grants the sponsor’s 

request for a BPD meeting for that 

product or upon the date of submission 

by the sponsor of an IND describing an 

investigation that FDA determines is 

intended to support a biosimilar 

biological product application for that 

product. 

The application fee for a biosimilar 

biological product is due upon 

submission of the application (see 

section 744H(a)(2)(C) of the FD&C Act). 

To make a payment of the initial BPD, 

reactivation, or application fee, 

complete the Biosimilar User Fee Cover 

Sheet, available on FDA’s website 

(https://www.fda.gov/bsufa) and 

generate a user fee identification (ID) 

number. Payment must be made in U.S. 

currency by electronic check, check, 

bank draft, U.S. postal money order, or 

wire transfer. 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). 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, click ‘‘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. 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after the 

user fee ID number is generated. 

Please include the user fee ID number 

on your check, bank draft, or postal 

money order. Mail your payment to: 

Food and Drug Administration, P.O. 

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

If a check, bank draft, or money order 

is to be sent by a courier that requests 

a street address, the courier should 

deliver your payment 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 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 the transfer. 

The originating financial institution 

may charge a wire transfer fee. Please 

ask your financial institution about the 

fee and include it with your payment to 

ensure that your fee is fully paid. The 

account information for wire transfers is 

as follows: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Acct. No.: 

75060099, Routing No.: 021030004, 

SWIFT: FRNYUS33. If needed, FDA’s 

tax identification number is 53– 

0196965. 

B. Annual BPD and Program Fees 

FDA will issue invoices with payment 

instructions for FY 2019 annual BPD 

and program fees under the new fee 

schedule in August 2018. Payment will 

be due on October 1, 2018. If sponsors 

join the BPD program after the annual 

BPD invoices have been issued in 

August 2018, FDA will issue invoices in 

December 2018 to firms subject to fees 

for FY 2019 that qualify for the annual 

BPD fee after the August 2018 billing. 

FDA will issue invoices in December 

2018 for any annual program fees for FY 

2019 that qualify for fee assessments 

and were not issued in August 2018. 

Dated: July 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16312 Filed 7–30–18; 8:45 am] 

BILLING CODE 4164–01–P 


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