Document ID: FDA-2011-N-0326-0024
Agency: fda
Document Type: Notice
Title: Recommendations for User Fee Programs: Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Meeting
Posted Date: 2011-12-07T05:00Z

[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76424-76429]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31499]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0326]

Biologics Price Competition and Innovation Act of 2009; Proposed 
Recommendations for a User Fee Program for Biosimilar and 
Interchangeable Biological Product Applications for Fiscal Years 2013 
Through 2017; Notice of Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss the proposed recommendations for a user fee program 
for biosimilar biological products for fiscal years (FYs) 2013 through 
2017.

DATES: The public meeting will be held on Friday, December 16, 2011, 
from 9 a.m. to 1 p.m. Registration to attend the meeting must be 
received by December 14, 2011. See section III.B of this document for 
information on how to register for the meeting. Submit either 
electronic or written comments by January 6, 2012.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD, 20993-
0002. Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. All comments should be identified with the docket number found 
in brackets in the heading of this document.
    Transcripts of the meeting will be available for review at the 
Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the public meeting (see 
section III.C of this document).

FOR FURTHER INFORMATION CONTACT:  Rokhsana Safaai-Jazi, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1164, Silver Spring, MD 20993-0002, (301) 
796-4463, Fax: (301) 847-8443, Email: 
BiosimilarsUserFeeProgram@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a public meeting to discuss proposed 
recommendations for a user fee program for biosimilar biological 
products (biosimilars user fee program) for FYs 2013 through 2017. On 
March 23, 2010, President Obama signed into law the Affordable Care Act 
(Pub. L. 111-148). The Affordable Care Act contains a subtitle called 
the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) 
that amends the Public Health Service Act (PHS Act) and other statutes 
to create an abbreviated approval pathway for biological products shown 
to be biosimilar to or interchangeable with an FDA-licensed reference 
biological product. (See sections 7001 through 7003 of the Affordable 
Care Act.) Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by 
the BPCI Act, allows a company to submit an application for licensure 
of a biosimilar or interchangeable biological product.
    The BPCI Act also amends section 735 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the 
definition of ``human drug application'' for the purposes of the 
prescription drug user fee provisions. (See section 7002(f)(3)(A) of 
the Affordable Care Act.) Accordingly, under section 736 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h), the fee for a biologics 
license application (BLA) is currently the same regardless of whether 
the application is submitted under the new 351(k) approval pathway or 
the preexisting 351(a) approval pathway.
    The authority conferred by the Federal Food, Drug, and Cosmetic 
Act's prescription drug user fee provisions expires in September 2012. 
The BPCI Act directs FDA to develop recommendations for a biosimilars 
user fee program for FYs 2013 through 2017. (See section 7002(f)(1) of 
the Affordable Care Act.) The BPCI Act provides that FDA must consult 
with a range of groups, including scientific and academic experts, 
health care professionals, representatives of patient and consumer 
advocacy groups (public stakeholders), and regulated industry (industry 
stakeholders), in developing the recommendations. As described in 
section II of this document, FDA consulted with public and industry 
stakeholders from June 2011 through September 2011.
    The BPCI Act requires that FDA must publish the recommendations for 
a biosimilars user fee program in the Federal Register and provide a 
period of 30 days for the public to provide written comments on the 
recommendations.

[[Page 76425]]

FDA is also required to hold a meeting at which the public may present 
its views on such recommendations. After consideration of such public 
views and comments, FDA is to revise the recommendations as necessary 
and transmit them to Congress by January 15, 2012.
    This notice, the 30-day comment period, and the public meeting will 
satisfy certain of these requirements. After the public meeting, FDA 
will revise the recommendations as necessary and present them to 
Congress. (See section 7002(f)(1) of the Affordable Care Act.) 
Additional information is provided in this document to help potential 
meeting participants better understand the proposed recommendations.

II. Proposed Biosimilars User Fee Program Recommendations

    In developing proposed recommendations for a biosimilars user fee 
program, FDA has conducted discussions with regulated industry and 
consulted with public stakeholders, as required by the law. FDA 
initiated the public consultation process on November 2 and 3, 2010, by 
holding a public hearing at which stakeholders and other members of the 
public were given an opportunity to present their views on issues 
associated with the implementation of the BPCI Act. (See 75 FR 61497, 
October 5, 2010.) \1\ Among other issues relating to the implementation 
of the BPCI Act, FDA solicited public comment on the following 
questions related to a biosimilars user fee program:
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    \1\ http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf.
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     If the existing fee structure under the Prescription Drug 
User Fee Act (PDUFA) were to be considered as a model in establishing a 
user fee structure for applications and supplements for proposed 
biosimilar and interchangeable biological products, what factors and 
changes should FDA take into consideration, and why?
     What factors should FDA take into account when considering 
whether to recommend that user fees for biosimilar and interchangeable 
biological products should also be used to monitor safety after 
approval?
    In the Federal Register of May 10, 2011 (76 FR 27062),\2\ FDA 
published a notice requesting public input on FDA's proposed principles 
for development of a biosimilars user fee program, FDA's proposed 
structure for a biosimilars user fee program that would adhere to these 
principles, and proposed performance goals for this program.
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    \2\ http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf.
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    From June 2011 through September 2011, FDA conducted negotiations 
with regulated industry, and consultation meetings with public 
stakeholders, concerning development of recommendations for a 
biosimilars user fee program. FDA posted minutes of these meetings on 
its Web site at http://www.fda.gov/ForIndustry/UserFees/ucm268124.htm.
    The proposed biosimilars user fee program for FYs 2013 through 2017 
addresses many of the top priorities identified by public and industry 
stakeholders, and the most important challenges identified within FDA. 
The proposed biosimilars user fee program is similar to the PDUFA 
program in that it includes fees for marketing applications, 
manufacturing establishments, and products. However, there are some 
differences because of the nascent state of the biosimilars industry in 
the United States. For example, there are no currently marketed 
biosimilar biological products; accordingly, the recommended 
biosimilars user fee program includes fees for products in the 
development phase in order to generate fee revenue in the near-term and 
to enable sponsors to have meetings with FDA early in the development 
of biosimilar biological product candidates.
    As in all of FDA's other medical product user fee programs, under 
the proposed biosimilars user fee program, user fee funding would 
supplement dedicated non-user fee funding to ensure sufficient 
resources for the Agency's biosimilars review program. In each fiscal 
year, in order to spend biosimilars user fees, FDA would be required to 
have available and allocate at least $20 million, adjusted for 
inflation, in non-user fee money for biosimilars review activities.
    Under the proposed biosimilars user fee program, FDA would be 
authorized to spend biosimilars user fees on Agency activities related 
to the review of submissions in connection with biosimilar biological 
product development, biosimilar biological product applications, and 
supplements. This would include activities related to biosimilar 
biological product development meetings and investigational new drug 
applications (INDs). It would also include development of the 
scientific, regulatory, and policy infrastructure necessary for review 
of biosimilar biological product applications, such as regulation and 
policy development related to the review of biosimilar biological 
product applications, and development of standards for products subject 
to review and evaluation. It would cover FDA activities at the 
application stage, such as review of advertising and labeling prior to 
approval of a biosimilar biological product application or supplement; 
review of required postmarketing studies and postmarketing studies that 
have been agreed to by sponsors as a condition of approval; the 
issuance of action letters that communicate decisions on biosimilar 
biological product applications; and inspection of biosimilar 
biological product establishments and other facilities undertaken as 
part of FDA's review of pending biosimilar biological product 
applications and supplements (but not inspections unrelated to the 
review of biosimilar biological product applications and supplements). 
Finally, it would include some activities at the post-approval stage, 
such as postmarketing safety activities with respect to biologics 
approved under biosimilar biological product applications or 
supplements.

A. Proposed Fees

    The four types of fees under the proposed biosimilars user fee 
program are summarized in this section II.A.
1. Biosimilar Product Development Fees
    FDA's proposed biosimilars user fee program includes initial and 
annual biosimilar product development (BPD) fees for biosimilar 
biological products in development. The initial BPD fee would be due 
upon the date of submission of an IND describing an investigation that 
FDA determines is intended to support a biosimilar biological 
application for a product, or within 5 days after FDA grants a request 
for a ``biosimilar biological product development meeting'' (BPD 
Meeting) for a product. (BPD Meetings are further described in section 
II.B.7 of this document.)
    Additionally, under the proposed BPD program, if FDA determines 
that an IND is intended to support a biosimilar biological product 
application for a product, each person that has submitted an IND before 
the date of enactment of the legislation authorizing the biosimilars 
user fee program would also be subject to the initial BPD fee. A 
sponsor would be assessed only one initial BPD fee per product. 
Regardless of the number of proposed indications for the biosimilar 
biological product, the sponsor would pay one BPD fee per product. The 
initial BPD fee for each of the FYs 2013 through 2017 would be equal to 
10 percent of the fee established for a human drug

[[Page 76426]]

application under PDUFA for that fiscal year.
    Beginning in the next fiscal year after a sponsor has paid the 
initial BPD fee for a product, the sponsor would pay an annual BPD fee 
on or before October 1 of each year, until the sponsor submits a 
marketing application for the product that is accepted for filing, or 
discontinues participation in the BPD program for the product. A 
sponsor that has not submitted an IND for the product may discontinue 
participation in the BPD program by submitting a written declaration to 
FDA affirming that the sponsor has no present intention of further 
developing the product as a biosimilar biological product. A sponsor 
that has submitted an IND for the product would be able to effectuate 
the discontinuation only after withdrawing the IND as specified in 21 
CFR part 312. A sponsor must discontinue participation in the BPD 
program by August 1 of the year of discontinuation to avoid incurring 
the fee that otherwise would be due on October 1. A sponsor that 
maintains an IND for the product after submitting a marketing 
application for the product that was accepted for filing would not pay 
the annual BPD fee for that product.
    A sponsor that has discontinued participation in the BPD program 
for a product would be required to pay a reactivation fee in order to 
resume participation in the BPD program for that product. The 
reactivation fee would be equal to twice the initial BPD fee for that 
fiscal year. The reactivation fee would be due within 5 days after FDA 
grants a request for a BPD Meeting for the product, or upon the date of 
submission of an IND describing an investigation that FDA determines is 
intended to support a biosimilar biological product application for 
that product, whichever is earlier. A sponsor that pays a reactivation 
fee for a product would be required to pay the annual BPD fee for the 
product beginning in the next fiscal year.
    If a sponsor has failed to pay the initial BPD fee, annual BPD fee, 
or reactivation fee as required, FDA would not provide a BPD Meeting 
relating to the biosimilar biological product for which the fees are 
owed. Also, except in extraordinary circumstances, if a sponsor that 
owes BPD fees submits an IND that FDA determines is intended to support 
a biosimilar biological product application, FDA would not consider the 
sponsor's IND to have been received under section 505(i)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(2)). In 
addition, if a sponsor that owes BPD fees has an existing IND that FDA 
determines is intended to support a biosimilar biological product 
application, FDA would prohibit the sponsor from continuing the 
investigation (this action would be referred to as ``financial hold''). 
Finally, if a sponsor has failed to pay BPD fees as required, then any 
biosimilar biological product application or supplement submitted by 
that sponsor would be considered incomplete and would not be accepted 
for filing until all fees owed by the sponsor have been paid.
2. Marketing Application Fee
    FDA estimates that the cost of reviewing an application for 
licensure of a biosimilar biological product will be comparable to the 
cost of reviewing an application for licensure of a biological product 
under section 351(a) of the PHS Act. FDA therefore proposes to set the 
marketing application fee for a biosimilar biological product equal to 
the fee established for a human drug application under PDUFA, minus the 
cumulative amount of any BPD fees (including any reactivation fees) 
paid for the product that is the subject of the application. The 
feedback and consultation that FDA expects to provide to sponsors 
during the biosimilar biological product development phase is expected 
to improve the efficiency of the biosimilar biological product 
development process and the quality of submitted marketing 
applications. Therefore, FDA considers the BPD phase fees, and the 
deduction of paid BPD fees from the associated marketing application 
fee payment, to be a reasonable approach to shift resources forward to 
the point in development where FDA review is currently being sought by 
sponsors.
3. Establishment Fees and Product Fees
    Because the complexity and level of effort required for FDA 
oversight of manufacturing and postmarketing safety issues for products 
licensed under section 351(k) of the PHS Act is expected to be 
comparable to that required for products licensed under section 351(a), 
FDA proposes setting biosimilar biological product establishment and 
product fees equal to the establishment and product fees under PDUFA 
for any fiscal year. FDA anticipates a modest level of funding from 
these sources initially because only biosimilar biological products 
that are approved for marketing would be subject to these fees.

B. Proposed Performance Goals and Procedures

    The full description of the proposed performance goals and 
procedures for the biosimilars user fee program can be found in the 
draft biosimilars user fee commitment letter (draft commitment letter) 
posted on FDA's Web site at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf. The proposed performance goals and procedures are 
described in this section II.B with reference to the section of the 
draft commitment letter where more detailed information can be found.
1. Review Performance Goals
    The proposed biosimilars review program would include review 
performance goals for biosimilar biological product application 
submissions and resubmissions, supplements with clinical data, and 
original manufacturing supplements. Further information concerning 
these review performance goals can be found in section I of the draft 
commitment letter. The review performance goals are summarized in 
tables 1 and 2 of this document.:

              Table 1--Performance Goals for Original and Resubmitted Applications and Supplements
----------------------------------------------------------------------------------------------------------------
                                                                 Performance goal
        Submission cohort        -------------------------------------------------------------------------------
                                      FY 2013         FY 2014         FY 2015         FY 2016         FY 2017
----------------------------------------------------------------------------------------------------------------
                                      Within 10 Months of the Receipt Date
----------------------------------------------------------------------------------------------------------------
Original Biosimilar Biological               70%             70%             80%             85%             90%
 Product Application Submissions
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[[Page 76427]]

 
                                       Within 6 Months of the Receipt Date
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Resubmitted Original Biosimilar              70%             70%             80%             85%             90%
 Biological Product Applications
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                       Table 2--Performance Goals for Original and Resubmitted Supplements
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               Submission                                            Performance goal
----------------------------------------------------------------------------------------------------------------
Original Supplements with Clinical Data  90% Within 10 Months of the Receipt Date.
Resubmitted Supplements with Clinical    90% Within 6 Months of the Receipt Date.
 Data.
Manufacturing Supplements..............  90% Within 6 Months of the Receipt Date.
----------------------------------------------------------------------------------------------------------------

2. First Cycle Performance Goals
    The proposed biosimilars review program includes first cycle review 
performance goals for original biosimilar biological product 
applications and supplements with clinical data. For 90 percent of 
applications and supplements with clinical data, FDA's goal would be to 
inform the applicant of any substantive review issues identified during 
the initial filing review within 74 calendar days of the receipt date. 
In addition, for 90 percent of applications and supplements with 
clinical data, FDA's goal would be to inform the applicant of the 
planned review timeline for the application within 74 calendar days of 
the receipt date. Section II of the draft commitment letter contains 
further information concerning these performance goals.
3. Review of Proprietary Names To Reduce Medication Errors
    The proposed biosimilars review program includes proprietary name 
review performance goals. For proprietary names submitted during the 
biosimilar biological product development phase, FDA's goal would be to 
review 90 percent within 180 days of receipt. For proprietary names 
submitted with the biosimilar biological product application, FDA's 
goal would be to review 90 percent within 90 days of receipt. Section 
III of the draft commitment letter contains further information 
concerning these performance goals.
4. Major Dispute Resolution
    The proposed biosimilars review program includes a major dispute 
resolution performance goal. For procedural or scientific matters 
involving the review of biosimilar biological product applications and 
supplements that cannot be resolved at the signatory authority level, 
FDA's goal would be to respond to 90 percent of decision appeals within 
30 calendar days of FDA's receipt of the written appeal, provided that 
certain conditions are met. Section IV of the draft commitment letter 
contains further information concerning this performance goal.
5. Clinical Holds
    The proposed biosimilars review program includes a clinical hold 
performance goal. FDA's goal would be to respond to 90 percent of 
sponsors' complete responses to a clinical hold within 30 days of FDA's 
receipt of the complete response submission. Section V of the draft 
commitment letter contains further information concerning this 
performance goal.
6. Special Protocol Assessment
    The proposed biosimilars review program includes procedures and 
performance goals for special protocol assessments. Under the proposed 
program, provided that certain conditions are met, upon specific 
request by a sponsor, the Agency would evaluate certain protocols and 
related issues to assess whether the design is adequate to meet 
scientific and regulatory requirements identified by the sponsor. FDA's 
goal would be to provide a written response to the sponsor that 
includes a succinct assessment of the protocol and answers to the 
questions posed by the sponsor. For FYs 2013 and 2014, FDA's goal would 
be to respond to 70 percent of the requests within 45 days of FDA's 
receipt of the protocol and specific questions. For FY 2015, FDA's goal 
would be to respond to 80 percent of the requests within the 45-day 
time frame; for FY 2016, 85 percent, and for FY 2017, 90 percent. 
Section VI of the draft commitment letter contains further information 
concerning this performance goal.
7. Meeting Management Goals
    FDA proposes performance goals and procedures regarding meetings 
related to sponsors' biosimilar biological product development 
programs. Further information concerning these goals can be found in 
section VII of the draft commitment letter. These goals and procedures 
would apply to Biosimilar Initial Advisory Meetings and BPD Meetings. 
Under the proposed program, a Biosimilar Initial Advisory Meeting is an 
initial assessment limited to a general discussion regarding whether 
licensure under section 351(k) of the PHS Act may be feasible for a 
particular product, and, if so, general advice on the expected content 
of the development program. It does not include any meeting that 
involves substantive review of summary data or full study reports. A 
BPD Meeting is any meeting, other than a Biosimilar Initial Advisory 
Meeting, regarding the content of a development program, including a 
proposed design for, or data from, a study intended to support a 
biosimilar biological product application. The four types of BPD 
Meetings are as follows:
     A BPD Type 1 Meeting is a meeting that is necessary for an 
otherwise stalled drug development program to proceed (e.g., meeting to 
discuss clinical holds, dispute resolution meeting), a special protocol 
assessment meeting, or a meeting to address an important safety issue.
     A BPD Type 2 Meeting is a meeting to discuss a specific 
issue (e.g., proposed study design or endpoints) or questions where FDA 
will provide targeted advice regarding an ongoing biosimilar biological 
product development program. BPD Type 2 Meetings include substantive 
review of

[[Page 76428]]

summary data, but does not include review of full study reports.
     A BPD Type 3 Meeting is an in-depth data review and advice 
meeting regarding an ongoing biosimilar biological product development 
program. This type of meeting includes substantive review of full study 
reports, FDA advice regarding the similarity between the proposed 
biosimilar biological product and the reference product, and FDA advice 
regarding additional studies, including design and analysis.
     A BPD Type 4 Meeting is a meeting to discuss the format 
and content of a biosimilar biological product application or 
supplement submitted under section 351(k) of the PHS Act.
    The proposed review program includes performance goals for 
responses to meeting requests. Specifically, for 90 percent of BPD Type 
1 Meeting requests, FDA's goal would be to notify the requester in 
writing of the date, time, place, and format for the meeting, as well 
as expected Center participants, within 14 calendar days of FDA's 
receipt of the request and meeting package. For 90 percent of BPD Type 
2, 3, and 4 Meeting requests and Biosimilar Initial Advisory Meeting 
requests, FDA's goal would be to notify the requester in writing of the 
date, time, place, and format for the meeting, as well as expected 
Center participants, within 21 calendar days of FDA's receipt of the 
request and meeting package.
    The proposed review program also includes performance goals for 
scheduling meetings within target time frames. The target time frames 
for each of the five meeting types are as follows:

              Table 3--Target Time Frames for Meeting Types
------------------------------------------------------------------------
                                   Timeframe after receipt of meeting
         Meeting type                 request and meeting package
------------------------------------------------------------------------
Biosimilar Initial Advisory    Meeting should occur within 90 calendar
 Meeting.                       days of FDA receipt.
BPD Type 1 Meeting...........  Meeting should occur within 30 calendar
                                days of FDA receipt.
BPD Type 2 Meeting...........  Meeting should occur within 75 calendar
                                days of FDA receipt.
BPD Type 3 Meeting...........  Meeting should occur within 120 calendar
                                days of FDA receipt.
BPD Type 4 Meeting...........  Meeting should occur within 60 calendar
                                days of FDA receipt.
------------------------------------------------------------------------

    The performance goals for each meeting type are as follows:
     For FY 2013, 70 percent of Biosimilar Initial Advisory 
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the 
target time frame.
     For FY 2014, 70 percent of Biosimilar Initial Advisory 
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the 
target time frame.
     For FY 2015, 80 percent of Biosimilar Initial Advisory 
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the 
target time frame.
     For FY 2016, 85 percent of Biosimilar Initial Advisory 
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the 
target time frame.
     For FY 2017, 90 percent of Biosimilar Initial Advisory 
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the 
target time frame.
    Under the proposed program, in order for a meeting to qualify for 
these performance goals, certain conditions would need to be met. 
First, the meeting request and meeting package must include the 
information outlined in the draft commitment letter. Second, FDA must 
concur that the meeting will serve a useful purpose (i.e., it is not 
premature or clearly unnecessary). If FDA determines that a different 
type of meeting is more appropriate, it may grant a meeting of a 
different type than requested, which may require the payment of a BPD 
fee before the meeting will be provided. If a BPD fee is required and 
the sponsor does not pay the fee within the required time frame, the 
meeting will be cancelled. If the sponsor pays the BPD fee after the 
meeting has been cancelled because of non-payment, the target time 
frame for the meeting will be calculated from the date on which FDA 
received the payment, not the date on which the sponsor originally 
submitted the meeting request.
    FDA's goal would be to provide meeting minutes within 30 days of 
the date of the meeting for 90 percent of Biosimilar Initial Advisory 
Meetings and BPD Type 1, 2, 3, and 4 Meetings. Finally, FDA's goal 
would be to develop and publish for comment draft guidance on 
Biosimilar Initial Advisory Meetings and BPD Type 1, 2, 3, and 4 
Meetings by the end of the second quarter of FY 2014.

III. What information should you know about the public meeting?

A. When and where will the public meeting occur? What format will FDA 
use?

    We will convene a public meeting to hear the public's views on the 
proposed recommendations for a biosimilars user fee program. We will 
conduct the meeting on December 16, 2011, at FDA's White Oak Campus 
(see ADDRESSES). The meeting will include a presentation by FDA and a 
series of panels representing different stakeholder groups identified 
in the statute (such as patient advocacy groups, consumer advocacy 
groups, health professionals, and regulated industry) to provide input 
on the proposed recommendations. We will also provide an opportunity 
for other organizations and individuals to make presentations at the 
meeting or to submit written comments to the docket before the meeting.

B. How do you register for the public meeting or submit comments?

    If you wish to attend this meeting, please register by email at: 
BiosimilarsUserFeeProgram@fda.hhs.gov by December 14, 2011. Your email 
should contain complete contact information for each attendee, 
including: Name title, affiliation, address, email, address, and phone 
number. Registration is free and will be on a first-come, first-served 
basis. Early registration is recommended because seating is limited. 
FDA may limit the number of participants from each organization based 
on space limitations. Registrants will receive confirmation once they 
have been accepted. On-site registration on the day of the meeting will 
be based on space availability. We will try to accommodate all persons 
who wish to make a presentation. If you need special accommodations 
because of disability, please notify FDA by email to 
BiosimilarsUserFeeProgram@fda.hhs.gov or Rokhsana Safaai-Jazi (see FOR 
FURTHER INFORMATION CONTACT) at least 4 days before the meeting.
    In addition, interested persons may submit to the Division of 
Dockets Management (see ADDRESSES) either electronic or written 
comments regarding this document. It is only necessary to send one set 
of comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be

[[Page 76429]]

seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday. To ensure consideration, all comments must be 
received by January 6, 2012.

C. Will meeting transcripts be available?

    As soon as a transcript is available, it will be accessible at 
http://www.regulations.gov and http://www.fda.gov. It may be viewed at 
the Division of Dockets Management (see ADDRESSES). A transcript will 
also be made available in either hard copy or on CD-ROM, after 
submission of a Freedom of Information request. Written requests are to 
be sent to Division of Freedom of Information (ELEM-1029), Food and 
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 
20857.

IV. Additional Information on the BPCI Act

    The following sources of information on FDA's Web site may serve as 
useful information:
     The Federal Register document that announced the November 
2010 public hearing and requested public comments is available at 
http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf. (FDA has 
verified the Web site address, but FDA is not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)
     Comments submitted in response to the November 2010 public 
hearing document can be found at http://www.regulations.gov using 
Docket No. FDA-2010-N-0477.
     The Federal Register notice document that requested 
notification of stakeholder intention to participate in consultation 
meetings in December 2010 is available at http://edocket.access.gpo.gov/2010/pdf/2010-30713.pdf.
     The Federal Register notice that requested input on the 
comments relating to the development of a user fee program for 
biosimilar and interchangeable biological product applications in May 
2010 is available at http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf. Additional information regarding implementation of the 
BPCI Act is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031.

    Dated: December 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31499 Filed 12-5-11; 4:15 p.m.]
BILLING CODE 4160-01-P