Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43241 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ORR–5 Form ................................................................................................... 50 1 22 1,100 

Estimated Total Annual Burden 

Hours: 1,100. 

Additional Information: 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. 2017–19467 Filed 9–13–17; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Biosimilar 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 biosimilar user fees for fiscal 

year (FY) 2018. The Federal Food, Drug, 

and Cosmetic Act (the 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 

program fees for such year. These fees 

apply to the period from October 1, 

2017, through September 30, 2018. 

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), authorizes the 

program 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. 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 (sections 744H(a)(2) and 

744H(a)(3) of the FD&C Act). Under 

certain conditions, FDA may 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, the fee revenue amount 

is $45,000,000, adjusted as needed to 

reflect an updated assessment of the 

workload for the process for the review 

of biosimilar biological product 

applications. FDA is adjusting the FY 

2018 revenue amount to $40,214,000 

(rounded to the nearest thousand 

dollars) reflecting its updated 

assessment of the likely workload for 

the BsUFA program in FY 2018. 

This document provides fee rates for 

FY 2018 for the initial and annual BPD 

fee ($227,213), for the reactivation fee 

($454,426), 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 apply to the 

period from October 1, 2017, through 

September 30, 2018. For applications 

that are submitted for this period, this 

FY 2018 fee schedule must be used. 

II. Fee Revenue Amount for FY 2018 

The fee revenue amount for FY 2018 

is $45,000,000 adjusted for updated 

workload estimates (see sections 

744H(b)(1) and 744H(c)(4) of the FD&C 

Act). 

A. Statutory Fee Revenue Adjustments 

for Inflation 

BsUFA II specifies that the annual fee 

revenue amount is to be further adjusted 

for inflation increases for FY 2019 

through FY 2022 using two separate 

adjustments—one for personnel 


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43242 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

compensation and benefits (PC&B) and 

one for non-PC&B costs (see section 

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

the adjustment for inflation does not 

take effect until FY 2019, FDA will not 

adjust the FY 2018 fee revenue amount 

for inflation. 

B. FY 2018 Statutory Fee Revenue 

Adjustment for Workload 

BsUFA II specifies that for FY 2018, 

the fee revenue amount includes an 

adjustment to reflect an updated 

assessment of the workload for the 

process for the review of biosimilar 

biological product applications (see 

section 744H(c)(4) of the FD&C Act). 

In considering the appropriate FY 

2018 fee revenue adjustment, FDA 

considered a range of factors including 

its best estimated level of submissions 

and activities (including forecasts of 

new BPDs, new 351(k)s, resubmitted 

351(k)s, advisory committee meetings, 

interchangeability supplements, 

industry meetings, inspection activity, 

science and research activities, policy 

work, and other activities). Considering 

the totality of work forecasted for FY 

2018 (and recognizing the inherent 

uncertainty of any forecast), FDA has 

determined that the appropriate 

adjusted level of the FY 2018 BsUFA fee 

revenue amount to be $40,214,000 

(rounded to the nearest thousand 

dollars). FDA will use this amount as 

the target revenue amount for FY 2018. 

III. Fee Amounts for FY 2018 

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 first year of BsUFA II, 

FDA considered how best to balance the 

fee allocation to provide stable funding 

and reasonable fee amounts, and 

utilized benchmarks as described below. 

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 2018, FDA estimated the 

total number of fee-paying full 

applications equivalents (FAEs) it 

expects to receive in FY 2018. A full 

original 351(k) submission requiring 

clinical data counts as one FAE. An 

original 351(k) application not requiring 

clinical data counts as one-half of an 

FAE. An application that is withdrawn 

before filing, or refused for filing, counts 

as one-fourth of an FAE if the applicant 

initially paid a full application fee. An 

application that is withdrawn, or 

refused for filing, counts as one-eighth 

of an FAE if the applicant initially paid 

one-half of the full application fee. 

FDA considered the likelihood of 

submissions based on various indicators 

including a survey of sponsors on their 

intention to submit a 351(k) application. 

Based on the available information, FDA 

estimates it may receive 13 351(k) 

applications in FY 2018. 

FDA has determined that the amount 

of the biosimilar biological product 

application fee for FY 2018 is 

$1,746,745, which is estimated to 

provide a total of $22,707,685, 

representing 56 percent (rounded to the 

nearest one) of the FY 2018 target 

revenue amount. 

B. Biosimilar Biological Product 

Program Fee 

BsUFA II renamed the product fee as 

the biosimilar biological product 

program fee (‘‘program fee’’); in 

addition, BsUFA II introduced a 

limitation that a person who is named 

as an applicant in a 351(k) application 

shall not be assessed more than five 

program fees for a fiscal year for 

biosimilar biological products identified 

in each 351(k) application (see FD&C 

Act section 744H(a)(3)(D)). The program 

fee was also modified so that applicants 

are assessed a program fee only for 

biosimilar biological products identified 

in a biosimilar biological product 

application approved as of October 1 of 

such fiscal year. 

FDA estimates up to nine program 

fees will be invoiced in FY 2018, 

including currently approved products 

and products with the potential to be 

approved in pending applications with 

goal dates in FY 2017. For products 

invoiced in the FY 2018 regular billing 

cycle, FDA anticipates that zero 

program fees will be refunded. This 

prediction is based on observations 

dating to 2015, when the first biosimilar 

product was approved. 

FDA has determined that the amount 

of the biosimilar biological product 

program fee for FY 2018 is $304,162, 

which is estimated to provide a total of 

$2,737,458, representing 7 percent 

(rounded to the nearest one) of the FY 

2018 target revenue amount. 

C. Initial and Annual BPD Fees, 

Reactivation Fees 

To estimate the number of 

participants in the BPD program in FY 

2018, 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, a survey of BPD 

sponsors, market sales data on reference 

products, and expected reference 

product expiration dates to estimate the 

total number of participants in the BPD 

program. FDA estimates 10 participants 

entering the BPD program, zero 

reactivations, and 55 participants to be 

invoiced for the annual BPD fee for a 

total of 65 participants in the BPD 

program in FY 2018. 

The remainder of the target revenue of 

$14,768,857, or 37 percent (rounded to 

the nearest one), is to be collected from 

the BPD fees. Dividing this amount by 

the estimated 65 BPD fees to be paid 

equals a BPD fee amount of $227,213. 

The reactivation fee is set at twice the 

initial/annual BPD amount at $454,426. 

FDA estimates zero reactivation fees 

will be paid, as none have yet been paid 

in the history of the BsUFA program. 

IV. Fee Schedule for FY 2018 

The fee rates for FY 2018 are provided 

in table 1. 

TABLE 1—FEE SCHEDULE FOR FY 

2018 

Fee category 

Fee rates 

for FY 2018 

($) 

Initial BPD ............................. 227,213 

Annual BPD .......................... 227,213 

Reactivation .......................... 454,426 

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 2018, i.e., the 

period from October 1, 2017, through 

September 30, 2018. 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 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 


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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 


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