83 FR 30746 - Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

Page Range		30746-30748
FR Document		2018-14057

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.

Federal Register, Volume 83 Issue 126 (Friday, June 29, 2018)

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30746-30748]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14057]


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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

[[Page 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.thefederalregister.org/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, 
[email protected].

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

[[Page 30748]]

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/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf.
    We estimate the burden of this collection of information as 
follows:

                                                  Table 1--Estimated Annual Reporting Burden[thinsp]\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
        Information collection title             Number of     responses per   Total annual      Average burden per response  (hours)       Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosimilar User Fee Cover Sheet; Form FDA                 35               1              35  0.5 (30 minutes)..........................            17.5
 3792.
Annual Survey...............................              35               1              35  1.........................................              35
Request for discontinuation from BPD program               2               1               2  1.........................................               2
Request to move products to discontinued                   5               1               5  0.5 (30 minutes)..........................             2.5
 section of the biosimilar list.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................              57
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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

30748 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices

submit payments. The draft guidance list. Finally, the draft guidance provides www.fda.gov/downloads/Drugs/
also explains how respondents can information on the consequences of GuidanceComplianceRegulatory
request discontinuation from the BPD failing to pay BsUFA II fees, as well as Information/Guidances/
program as well as how respondents can processes for submitting reconsideration UCM584984.pdf.
request to move products to the and appeal requests. The draft guidance We estimate the burden of this
discontinued section of the biosimilar is available on our website at https:// collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average burden per
Number of Total annual
Information collection title responses per response Total hours
respondents responses
respondent (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 5 1 5 0.5 (30 minutes) ........ 2.5
of the biosimilar list.

Total .................................................................. ........................ ........................ ........................ .................................... 57
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We have increased our estimate by an establishments, contract manufacturing implementation of a modern, risk-based
additional 15 respondents since last organizations, over-the-counter (OTC) pharmaceutical quality assessment
OMB approval of the information monograph products establishments, or system. As part of this initiative, and in
collection. This estimated increase is marketed unapproved finished drug recognition of the increasing complexity
based on our expectation that products establishments). Participation of pharmaceutical manufacturing, FDA
participation in the BPD program will in either of these efforts is voluntary and developed a 21st century vision for
continue to grow, consistent with our the programs are intended to foster the manufacturing and quality with input
experience since establishment of the joint efforts of FDA and stakeholders to from academia and industry. The
information collection in 2012. further develop an FDA Quality Metrics desired state was described as follows:
Dated: June 26, 2018. Program. The FDA Quality Metrics ‘‘A maximally efficient, agile, flexible
Leslie Kux, Program aims to evaluate a new pharmaceutical manufacturing sector
approach for regulatory oversight of that reliably produces high-quality drug
Associate Commissioner for Policy.
pharmaceutical products through the products without extensive regulatory
[FR Doc. 2018–14057 Filed 6–28–18; 8:45 am]
collection of certain quality information oversight.’’ 1
BILLING CODE 4164–01–P There has been significant progress
developed and maintained in the course
of manufacturing drugs under current toward this vision in the intervening
good manufacturing practices. FDA years, as evidenced by programs and
DEPARTMENT OF HEALTH AND guidance from FDA around major
HUMAN SERVICES intends to use quality metrics data to
further develop the Agency’s risk-based initiatives such as pharmaceutical
Food and Drug Administration inspection scheduling (e.g., decreased development and quality by design,
surveillance inspection frequency for quality risk management and
[Docket No. FDA–2018–N–1903] pharmaceutical quality systems, process
certain establishments) to improve the
efficiency and effectiveness of validation, and process analytical
Modernizing Pharmaceutical Quality technology, among other initiatives.
Systems; Studying Quality Metrics and establishment inspections, improve
FDA’s evaluation of drug manufacturing These programs and guidances are
Quality Culture; Quality Metrics intended to promote effective use of the
Feedback Program and control operations, and identify
situations in which there may be a risk most current pharmaceutical science
AGENCY: Food and Drug Administration, for drug supply disruption. and engineering principles and
HHS. knowledge throughout the life cycle of
DATES: Submit a written request to
ACTION: Notice. a product.
participate in the program by July 29, While much progress has been made,
SUMMARY: The Food and Drug 2019. See sections II and III.B of this we have not fully realized our 21st
Administration (FDA, Agency, or we) notice for information to include in century vision for manufacturing and
Center for Drug Evaluation and Research such requests. FDA will start accepting quality. Rather than focusing on use of
(CDER) is announcing two new efforts to requests beginning July 30, 2018. science- and risk-based principles as
gather feedback on the use of quality FOR FURTHER INFORMATION CONTACT: Tara described in current good
metrics to modernize pharmaceutical Gooen Bizjak, Center for Drug manufacturing practices, many
quality systems and advance innovation Evaluation and Research, Food and establishments continue to focus on
based on stakeholder feedback. These Drug Administration, 10903 New minimum requirements (e.g., check-box
efforts include Type C formal meeting Hampshire Ave., Bldg. 51, Rm. 2109, approach). Recalls and drug shortages,
sradovich on DSK3GMQ082PROD with NOTICES

requests and pre-abbreviated new drug Silver Spring, MD 20993, 301–796– which are often indications of serious
application (pre-ANDA) meeting 3257, Tara.Gooen@fda.hhs.gov. product quality defects caused by drug
requests, and a pilot study to gain SUPPLEMENTARY INFORMATION:
1 See ‘‘FDA Pharmaceutical Quality Oversight:
feedback from those establishments for
which Type C formal meetings or pre- I. Background One Quality Voice’’ at https://www.fda.gov/
downloads/AboutFDA/CentersOffices/Officeof
ANDA meetings do not apply (e.g., More than a decade ago, FDA MedicalProductsandTobacco/CDER/
active pharmaceutical ingredients (API) launched an initiative to encourage the UCM442666.pdf.

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Document Created: 2018-06-29 01:13:44
Document Modified: 2018-06-29 01:13:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 28, 2018.
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, [email protected]
FR Citation		83 FR 30746

83 FR 30746 - Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration