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
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30747 

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– 

2018–N–1967 for ‘‘Biosimilars User Fee 

Program.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements for members of the 

public when submitting reports, keeping 

records, or providing information to a 

third party. Section 3506(c)(2)(A) of the 

PRA (44 U.S.C. 3506(c)(2)(A)) requires 

federal agencies to provide a 60-day 

notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, FDA is 

publishing notice of the proposed 

collection of information set forth in 

this document. 

With respect to the following 

collection of information, 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. 

Biosimilars User Fee Program 

OMB Control Number 0910–0718— 

Extension 

This information collection supports 

FDA’s Biosimilars User Fee Program. 

The Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act), 

amended the Public Health Service Act 

(PHS Act) by adding section 351(k) (42 

U.S.C. 262(k)) to create an abbreviated 

approval pathway for biological 

products shown to be biosimilar to or 

interchangeable with an FDA-licensed 

reference biological product. This 

allows a company to apply for licensure 

of a biosimilar or interchangeable 

biological product (351(k) application). 

The BPCI Act also amended section 735 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379g) to include 351(k) 

applications as a type of application 

under ‘‘human drug application’’ for the 

purposes of the prescription drug user 

fee provisions. 

The Biosimilar User Fee Act of 2012 

(BsUFA) authorized FDA to assess and 

collect user fees for certain activities in 

connection with biosimilar biological 

product development (BPD). BsUFA 

was reauthorized for an additional 5 

years in August 2017 (BsUFA II). FDA’s 

biosimilar biological product user fee 

program requires FDA to assess and 

collect user fees for certain meetings 

concerning biosimilar BPD (BPD 

meetings), investigational new drug 

applications (INDs) intended to support 

a biosimilar biological product 

application, and biosimilar biologic 

license applications (BLAs). 

Form FDA 3792, entitled ‘‘Biosimilars 

User Fee Cover Sheet’’, is submitted by 

each new BPD entrant (identified via a 

new meeting request or IND submission) 

and new BLAs. Form FDA 3792 requests 

the minimum necessary information to 

identify the request and determine the 

amount of the fee to be assessed, and to 

account for and track user fees. The 

form provides a cross-reference of the 

fees submitted for an activity with the 

actual submission or activity by using a 

unique number tracking system. The 

information collected is used by FDA’s 

Center for Drug Evaluation and Research 

and Center for Biologics Evaluation and 

Research to initiate the administrative 

screening of biosimilar biological 

product INDs, and BLAs, and to account 

for and track user fees associated with 

BPD meetings. 

In addition to the Biosimilars User 

Fee Cover Sheet, the information 

collection includes an annual survey of 

all BsUFA II participants designed to 

provide information to FDA of 

anticipated BsUFA II activity in the 

upcoming fiscal year. This information 

helps FDA set appropriate annual 

BsUFA II fees. 

FDA has also developed the draft 

guidance entitled, ‘‘Assessing User Fees 

Under the Biosimilar User Fee 

Amendments of 2017’’ to assist industry 

in understanding when fees are incurred 

and the process by which applicants can 


sradovich on DSK3GMQ082PROD with NOTICES
30748 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

1See ‘‘FDA Pharmaceutical Quality Oversight: 

One Quality Voice’’ at https://www.fda.gov/ 

downloads/AboutFDA/CentersOffices/Officeof

MedicalProductsandTobacco/CDER/ 

UCM442666.pdf. 

submit payments. The draft guidance 

also explains how respondents can 

request discontinuation from the BPD 

program as well as how respondents can 

request to move products to the 

discontinued section of the biosimilar 

list. Finally, the draft guidance provides 

information on the consequences of 

failing to pay BsUFA II fees, as well as 

processes for submitting reconsideration 

and appeal requests. The draft guidance 

is available on our website at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM584984.pdf. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collection title Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

(hours) 

Total hours 

Biosimilar User Fee Cover Sheet; Form FDA 3792 35 1 35 0.5 (30 minutes) ........ 17.5 

Annual Survey .......................................................... 35 1 35 1 ................................ 35 

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 

Total .................................................................. ........................ ........................ ........................ .................................... 57 

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

We have increased our estimate by an 

additional 15 respondents since last 

OMB approval of the information 

collection. This estimated increase is 

based on our expectation that 

participation in the BPD program will 

continue to grow, consistent with our 

experience since establishment of the 

information collection in 2012. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14057 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–1903] 

Modernizing Pharmaceutical Quality 

Systems; Studying Quality Metrics and 

Quality Culture; Quality Metrics 

Feedback Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

Center for Drug Evaluation and Research 

(CDER) is announcing two new efforts to 

gather feedback on the use of quality 

metrics to modernize pharmaceutical 

quality systems and advance innovation 

based on stakeholder feedback. These 

efforts include Type C formal meeting 

requests and pre-abbreviated new drug 

application (pre-ANDA) meeting 

requests, and a pilot study to gain 

feedback from those establishments for 

which Type C formal meetings or preANDA meetings do not apply (e.g., 

active pharmaceutical ingredients (API) 

establishments, contract manufacturing 

organizations, over-the-counter (OTC) 

monograph products establishments, or 

marketed unapproved finished drug 

products establishments). Participation 

in either of these efforts is voluntary and 

the programs are intended to foster the 

joint efforts of FDA and stakeholders to 

further develop an FDA Quality Metrics 

Program. The FDA Quality Metrics 

Program aims to evaluate a new 

approach for regulatory oversight of 

pharmaceutical products through the 

collection of certain quality information 

developed and maintained in the course 

of manufacturing drugs under current 

good manufacturing practices. FDA 

intends to use quality metrics data to 

further develop the Agency’s risk-based 

inspection scheduling (e.g., decreased 

surveillance inspection frequency for 

certain establishments) to improve the 

efficiency and effectiveness of 

establishment inspections, improve 

FDA’s evaluation of drug manufacturing 

and control operations, and identify 

situations in which there may be a risk 

for drug supply disruption. 

DATES: Submit a written request to 

participate in the program by July 29, 

2019. See sections II and III.B of this 

notice for information to include in 

such requests. FDA will start accepting 

requests beginning July 30, 2018. 

FOR FURTHER INFORMATION CONTACT: Tara 

Gooen Bizjak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2109, 

Silver Spring, MD 20993, 301–796– 

3257, Tara.Gooen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

More than a decade ago, FDA 

launched an initiative to encourage the 

implementation of a modern, risk-based 

pharmaceutical quality assessment 

system. As part of this initiative, and in 

recognition of the increasing complexity 

of pharmaceutical manufacturing, FDA 

developed a 21st century vision for 

manufacturing and quality with input 

from academia and industry. The 

desired state was described as follows: 

‘‘A maximally efficient, agile, flexible 

pharmaceutical manufacturing sector 

that reliably produces high-quality drug 

products without extensive regulatory 

oversight.’’ 1

There has been significant progress 

toward this vision in the intervening 

years, as evidenced by programs and 

guidance from FDA around major 

initiatives such as pharmaceutical 

development and quality by design, 

quality risk management and 

pharmaceutical quality systems, process 

validation, and process analytical 

technology, among other initiatives. 

These programs and guidances are 

intended to promote effective use of the 

most current pharmaceutical science 

and engineering principles and 

knowledge throughout the life cycle of 

a product. 

While much progress has been made, 

we have not fully realized our 21st 

century vision for manufacturing and 

quality. Rather than focusing on use of 

science- and risk-based principles as 

described in current good 

manufacturing practices, many 

establishments continue to focus on 

minimum requirements (e.g., check-box 

approach). Recalls and drug shortages, 

which are often indications of serious 

product quality defects caused by drug 


sradovich on DSK3GMQ082PROD with NOTICES