30744 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

If you need special accommodations 

due to a disability, please contact Jessica 

Barnes or Lori Benner (see FOR FURTHER

INFORMATION CONTACT) no later than 

August 13, 2018. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session or participate 

in a specific session, and which topic(s) 

you wish to address. We will do our 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations or request time for a joint 

presentation. Following the close of 

registration, we will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

August 10, 2018. All requests to make 

oral presentations must be received by 

the close of registration on August 6, 

2018. If selected for presentation, any 

presentation materials must be emailed 

to NonTraditionalTherapiesWorkshop

2018@fda.hhs.gov no later than August 

14, 2018. No commercial or promotional 

material will be permitted to be 

presented or distributed at the public 

workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast at the following site: 

https://collaboration.fda.gov/dcontpfbi/. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm606052.htm. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14048 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6209] 

Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017.’’ This guidance concerns FDA’s 

implementation of the Biosimilar User 

Fee Amendments of 2017 (BsUFA II) 

and certain changes in policies and 

procedures surrounding its application. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 29, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6209 for ‘‘Assessing User Fees 

Under the Biosimilar User Fee 

Amendments of 2017.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30745 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Beena Alex, Division of User Fee 

Management and Budget Formulation, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Rm. 2185, Silver Spring, MD 

20993, 301–796–7900, 

CDERCollections@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017.’’ This guidance concerns the 

implementation of BsUFA II, including 

an explanation about the new fee 

structure and types of fees for which 

entities are responsible. BsUFA II 

extends FDA’s authority to collect user 

fees from fiscal year (FY) 2018 to 2022 

and introduces a number of technical 

revisions that affect what fees are 

collected and how fees are collected. 

Fees authorized by this legislation help 

fund the process for the review of 

biosimilar biological product 

applications and have played an 

important role in expediting the review 

and approval process. 

BsUFA II authorizes biosimilar 

biological product development 

program fees (BPD fees), biosimilar 

biological product application fees, and 

biosimilar biological product program 

fees. This guidance describes when 

these fees are incurred and the process 

by which applicants can submit 

payments. The guidance also provides 

information on consequences of failing 

to pay BsUFA II fees and the processes 

for submitting reconsideration and 

appeal requests. 

In the Federal Register of November 

16, 2017 (82 FR 53505), FDA announced 

the availability of a draft version of this 

guidance and provided interested 

parties an opportunity to submit 

comments. We have reviewed the 

comment submitted to the docket. This 

guidance does not include any 

substantive changes from the draft 

guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance, when finalized, will 

represent the current thinking of FDA 

on assessing user fees under the 

biosimilar user fee amendments of 2017. 

It does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This guidance is not subject 

to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The title, description, and 

respondent description of the 

information collection are given under 

this section with an estimate of the 

annual reporting burden. Included in 

the estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

With respect to the collection of 

information associated with this 

document, FDA invites comments on 

these topics: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017: Guidance for Industry. 

Description: This guidance provides 

information on the assessment of 

biosimilar biological product user fees, 

describes the types of user fees 

authorized, the process for submitting 

payments to FDA, and consequences for 

failing to pay BsUFA fees. The guidance 

also describes how FDA determines 

which products are subject to a fee and 

the changes to certain FDA policies 

regarding BsUFA fees. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Biosimilar User 

Fee Act of 2012 and recently renewed 

in 2017 (BsUFA) under the FDA 

Reauthorization Act of 2017, authorizes 

FDA to assess and collect user fees from 

companies that produce biosimilar 

biological products in conjunction with 

the review of biosimilar biological 

product applications. The guidance 

includes processing and policies for the 

initial and the annual biosimilar 

biological product development (BPD) 

fees; the BPD discontinuation process 

requirements and BPD reactivation fees; 

process and policies for biosimilar 

biological product application fees 

including exceptions to the application 

fees and refund of fees; process and 

policies for the small business waiver of 

the biosimilar application fee; and 

implementation of the biosimilar 

biological product program fee. 

The burdens associated with 

requesting a small business waiver of 

BsUFA fees and the associated burdens 

for new activities as noted in the 

guidance are listed in table 1. 

FDA estimates the annual burden of 

these new collections of information as 

follows: 


sradovich on DSK3GMQ082PROD with NOTICES
30746 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

(hours) 

Total hours 

Request for discontinuation from BPD 

program.

2 1 2 1 ................................ 2 

Request to move products to discontinued section of the biosimilar list.5 1 5 0.5 (30 minutes) ........ 2.5 

Small business waiver of the BsUFA application fee.1 1 1 16 .............................. 16 

Small business waiver reconsiderations .. 1 1 1 24 .............................. 24 

Small business waiver appeals ............... 1 1 1 12 .............................. 12 

Annual Fee Determination Survey ........... 35 1 35 1 ................................ 35 

Annual BsUFA fees correspondence ...... 35 1 35 2 ................................ 70 

Total .................................................. ............................ ............................ ............................ .................................... 161.5 

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

This guidance also refers to 

previously approved collections of 

information found in FDA forms 

developed to support its user fee 

program. Specifically, the guidance 

refers to Form FDA 3792; Forms FDA 

3913 and 3914; and Form FDA 3971, 

which have been approved under OMB 

control numbers 0910–0718, 0910–0719, 

0910–0805, and 0910–0693, 

respectively. The guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 312 are currently approved 

under OMB control number 0910–0014; 

the collections of information regarding 

new drug applications under the FD&C 

Act are approved under OMB control 

number 0910–0001; and biologics 

license applications under sections 

351(a) or 351(k) of the Public Health 

Service Act are approved under OMB 

control numbers 0910–0338 and 0910– 

0719, respectively. 

This final guidance contains 

information collection provisions 

subject to review by OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). Except for the 

provisions listed in table 1, the 

information collections already have 

been approved. The applicable 

provisions are shaded in the guidance to 

identify those for which OMB approval 

has not yet been obtained. When 

approval of these provisions has been 

received, FDA will provide notice. 

BsUFA II provides the statutory 

authority to collect user fees from FY 

2018 through FY 2022. Consistent with 

the statutory requirements of BsUFA II, 

FDA is issuing this guidance to facilitate 

understanding and enhancing 

implementation of the policies and 

processes in the assessment of 

biosimilar user fees in upcoming fiscal 

years. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14049 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1967] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biosimilars User 

Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection supporting the Agency’s 

Biosimilars User Fee Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 28, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 28, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of August 28, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 


sradovich on DSK3GMQ082PROD with NOTICES