Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43243 

submission by the sponsor of an IND 

describing an investigation that FDA 

determines is intended to support a 

biosimilar biological product 

application. 

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 Web site 

(http://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 

http://www.pay.gov, a web-based 

payment application, for online 

electronic payment. The Pay.gov feature 

is available on FDA’s Web site after 

completing the Biosimilar 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 it payable to the 

Food and Drug Administration. Your 

payment can be mailed to: Food and 

Drug Administration, P.O. Box 979108, 

St. Louis, MO 63197–9000. To send a 

check by a courier such as Federal 

Express or United Parcel Service, the 

courier must deliver the check and 

printed copy of the cover sheet 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. 

Contact U.S. Bank at 314–418–4013 if 

you have any questions concerning 

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 Treasury, 

TREAS NYC, 33 Liberty St., New York, 

NY 10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33, 

Beneficiary: FDA, 8455 Colesville Rd., 

14th Floor, Silver Spring, MD 20993– 

0002. If needed, FDA’s tax identification 

number is 53–0196965. 

B. Annual BPD and Program Fees 

FDA will issue invoices for annual 

BPD and program fees for FY 2018 

under the new fee schedule in 

September 2017. Payment instructions 

will be included in the invoices, 

including payment due dates. If 

sponsors join the BPD program after the 

annual BPD invoices have been issued 

in September 2017, FDA will issue 

invoices in December 2017 to firms 

subject to fees for FY 2018 that qualify 

for the annual BPD fee after the 

September 2017 billing. FDA will issue 

invoices in December 2017 for any 

annual program fees for FY 2018 that 

qualify for fee assessments and were not 

issued in September 2017. 

Dated: September 8, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19493 Filed 9–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0594] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Focus Groups as 

Used by the Food and Drug 

Administration (All Food and Drug 

Administration-Regulated Products) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 16, 

2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0497. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. Focus Groups as 

Used by the Food and Drug 

Administration (All FDA-Regulated 

Products), OMB Control Number 0910– 

0497. 

FDA conducts voluntary focus group 

interviews on a variety of topics 

involving FDA-regulated products, 

including drugs, biologics, devices, 

food, tobacco, and veterinary medicine. 

Focus groups provide an important 

role in gathering information because 

they allow for a more in-depth 

understanding of patients’ and 

consumers’ attitudes, beliefs, 

motivations, and feelings than do 

quantitative studies. Focus groups serve 

the narrowly defined need for direct and 

informal opinion on a specific topic and 

as a qualitative research tool have three 

major purposes: 

• To obtain patient and consumer 

information that is useful for developing 

variables and measures for quantitative 

studies, 

• To better understand patients’ and 

consumers’ attitudes and emotions in 

response to topics and concepts, and 

• To further explore findings 

obtained from quantitative studies. 

FDA will use focus group findings to 

test and refine their ideas, but will 

generally conduct further research 

before making important decisions such 

as adopting new policies and allocating 

or redirecting significant resources to 

support these policies. 

In the Federal Register of April 21, 

2017 (82 FR 18763), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
43244 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Focus Group Interviews ....................................................... 8,800 1 8,800 1.75 15,400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: September 8, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19492 Filed 9–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Prescription Drug 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 

rates for prescription drug user fees for 

fiscal year (FY) 2018. The Federal Food, 

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

as amended by the Prescription Drug 

User Fee Amendments of 2017 (PDUFA 

VI), authorizes FDA to collect 

application fees for certain applications 

for the review of human drug and 

biological products, and prescription 

drug program fees for certain approved 

products. This notice establishes the fee 

rates for FY 2018. 

FOR FURTHER INFORMATION CONTACT: 

Robert J. 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 

Sections 735 and 736 of the FD&C Act 

(21 U.S.C. 379g and 379h, respectively) 

establish two different kinds of user 

fees. Fees are assessed on the following: 

(1) Application fees are assessed on 

certain types of applications for the 

review of human drug and biological 

products; and (2) prescription drug 

program fees are assessed on certain 

approved products (section 736(a) of the 

FD&C Act). When specific conditions 

are met, FDA may waive or reduce fees 

(section 736(d) of the FD&C Act). 

For FY 2018 through FY 2022, the 

base revenue amounts for the total 

revenues from all PDUFA fees are 

established by PDUFA VI. The base 

revenue amount for FY 2018 is 

$878,590,000. The FY 2018 base 

revenue amount is to be adjusted for 

inflation and for the resource capacity 

needs for the process for the review of 

human drug applications (the capacity 

planning adjustment). An additional 

dollar amount specified in the statute 

(see section 736(b)(1)(F) of the FD&C 

Act) is then added to provide for 

additional full-time equivalent (FTE) 

positions to support PDUFA VI 

initiatives. The FY 2018 revenue 

amount may be adjusted further, if 

necessary, to provide for sufficient 

operating reserves of carryover user fees. 

Finally, the amount is adjusted to 

provide for additional direct costs to 

fund PDUFA VI initiatives. Fee amounts 

are to be established each year so that 

revenues from application fees provide 

20 percent of the total revenue, and 

prescription drug program fees provide 

80 percent of the total revenue. 

This document provides fee rates for 

FY 2018 for an application requiring 

clinical data ($2,421,495), for an 

application not requiring clinical data 

($1,210,748), and for the prescription 

drug program fee ($304,162). These fees 

are effective on October 1, 2017, and 

will remain in effect through September 

30, 2018. For applications that are 

submitted on or after October 1, 2017, 

the new fee schedule must be used. 

II. Fee Revenue Amount for FY 2018 

The base revenue amount for FY 2018 

is $878,590,000 prior to adjustments for 

inflation, capacity planning, additional 

FTE, operating reserve, and additional 

direct costs (see section 736(b)(1) of the 

FD&C Act). 

A. FY 2018 Statutory Fee Revenue 

Adjustments for Inflation 

PDUFA VI specifies that the 

$878,590,000 is to be adjusted for 

inflation increases for FY 2018 using 

two separate adjustments—one for 

personnel compensation and benefits 

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

section 736(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 FTE 

positions at FDA for the first three of the 

preceding four FYs, multiplied by the 

proportion of PC&B costs to total FDA 

costs of the process for the review of 

human drug applications for the first 

three of the preceding four FYs (see 

section 736(c)(1)(A) and (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 three of the four 

FYs preceding FY 2018. The 3-year 

average is 2.2354 percent. 

TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES

Fiscal year 2014 2015 2016 3-year 

average 

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

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

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

Percent Change From Previous Year ..................................... 2.3451 2.1136 2.2474 2.2354 


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