Document ID: FDA-2011-N-0326-0001
Agency: fda
Document Type: Notice
Title: Biologics Price Competition and Innovation Act of 2009: Options for User Fee Program for Biosimilar and Interchangeable Biological Product Applications, etc.
Posted Date: 2011-05-10T04:00Z

[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27062-27067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11348]

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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; Options 
for a User Fee Program for Biosimilar and Interchangeable Biological 
Product Applications for Fiscal Years 2013 Through 2017; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
issuing this document to request comments relating to the development 
of a user fee program for biosimilar and interchangeable biological 
product (351(k)) applications submitted under the Public Health Service 
Act (PHS Act). FDA is requesting input on the identified principles for 
development of a 351(k) user fee program, FDA's proposed structure for 
a 351(k) user fee program that would adhere to these principles, and 
performance goals for this program. FDA plans to review the comments 
submitted to the docket, hold meetings with public stakeholders, and 
hold industry stakeholder meetings to develop proposed recommendations 
for a user fee program for 351(k) applications for fiscal years (FYs) 
2013 through 2017.

DATES: Submit either electronic or written comments by June 9, 2011. 
Submit notification of interest in participating in public stakeholder 
meetings or industry stakeholder meetings on or before June 3, 2011.

ADDRESSES: 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. Public and industry stakeholders who have not yet 
notified FDA of their interest in participating in these meetings 
should e-mail complete contact information to 
BiosimilarsUserFeeProgram@fda.hhs.gov. (See sections VI.B and VI.C of 
this document for additional information.)

FOR FURTHER INFORMATION CONTACT: Sunanda Bahl, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-
796-3584, FAX: 301-847-8443, e-mail: sunanda.bahl@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    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 PHS Act and other statutes to create an 
abbreviated approval pathway for biological products shown to be highly 
similar (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 amends section 735 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C 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 FD&C 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

[[Page 27063]]

under the new 351(k) approval pathway or the preexisting 351(a) 
approval pathway.
    The authority conferred by the FD&C Act's prescription drug user 
fee provisions expires in September 2012. The BPCI Act directs FDA to 
develop recommendations for a user fee program for 351(k) applications 
for FYs 2013 through 2017. (See section 7002(f)(1) of the Affordable 
Care Act.) In developing recommendations for a biosimilar and 
interchangeable biological products user fee program, FDA is required 
to consult with a range of groups, including scientific and academic 
experts, health care professionals, representatives of patient and 
consumer advocacy groups, and regulated industry. The recommendations 
must be presented to Congress by January 15, 2012. (See section 
7002(f)(1) of the Affordable Care Act.)
    Developing a user fee program for 351(k) applications presents 
unique challenges as compared to other medical product user fee 
programs. One key consideration in developing a user fee program is the 
state of the regulated industry. For example, when the Prescription 
Drug User Fee Act (PDUFA) program was first implemented in FY 1993, the 
biopharmaceutical industry was relatively mature. FDA had a record of 
more than 2,000 drug and biological products already on the market, 
more than 200 establishments were involved in the manufacturing of 
these products, and approximately 120 new drug marketing applications 
were submitted each year for FDA review. The number of participants in 
the industry and the volume of anticipated annual applications allowed 
FDA to generate significant revenue from user fees tied to marketing 
application submissions and currently marketed products (product and 
establishment fees). In contrast, given that the biosimilar and 
interchangeable biological product approval pathway did not exist prior 
to March 2010, the biosimilar and interchangeable biological product 
market is just forming. Although FDA has met with sponsors who are 
interested in developing biosimilar and interchangeable biological 
products, no products have been approved for marketing under section 
351(k) of the PHS Act. As such, although the PDUFA program is a useful 
model, FDA believes that a user fee program for 351(k) applications 
will need to include different elements to ensure an equitable program 
that generates adequate revenue.
    In this document, FDA describes the principles it proposes to use 
to develop a biosimilars user fee program, a proposed structure for the 
program based on these principles, and proposed performance goals. FDA 
is requesting public comment on each of these proposals, and is also 
posing several questions for public input on some unresolved issues 
associated with developing performance goals for this new user fee 
program.

II. Principles for Development of a Biosimilars User Fee Program

    FDA proposes to develop recommendations for the 351(k) user fee 
program that are guided by a set of key principles to support the 
development of a fair and adequate initial user fee program.\1\ These 
proposed principles are based on FDA's prior experience with elements 
that foster strong and successful user fee programs, as well as 
comments submitted to the docket by external stakeholders. FDA solicits 
comment on these proposed principles. The proposed principles are:
---------------------------------------------------------------------------

    \1\ As we expect the program to be reevaluated and reauthorized 
periodically as are all of FDA's other medical product user fee 
programs, our focus here is on the initial program.
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    (1) Biosimilar and interchangeable biologics represent a critical 
public health benefit to patients, with the potential to offer life-
saving or life-altering benefits at reduced costs to the patient. FDA 
needs sufficient review capacity to prevent unnecessary delays in the 
development and approval of these products.
    (2) At least for the initial 5-year authorization of the 351(k) 
user fee program, 351(k) user fees should remain comparable to 351(a) 
user fees. This aligns with the PDUFA standard for assessing human drug 
application fees for applications for which clinical data (other than 
bioavailability or bioequivalence studies) with respect to safety or 
effectiveness are required for approval. That is, under PDUFA, the fee 
for a new drug application (NDA) that is submitted under section 
505(b)(2) of the FD&C Act (21 U.S.C. 355(b)(2)) and that requires 
clinical data is the same as the fee for an NDA submitted under section 
505(b) that requires clinical data for approval, even though the 
505(b)(2) approval pathway allows an applicant to rely on studies not 
conducted by or for the applicant and for which the applicant has not 
obtained a right of reference or use. FDA believes a similar approach 
is appropriate for applications for biosimilar products because, at 
least initially, review to determine biosimilarity or 
interchangeability of a proposed product in a 351(k) application is 
expected to be comparably complex, technically demanding, and resource-
intensive as review of a proposed 351(a) application. For example, 
characterizing biological products for the purpose of determining 
biosimilarity or interchangeability is challenging because the 
molecules of biological products tend to be much larger and have a far 
more complex spatial structure than small-molecule drugs. However, FDA 
does not expect that review of the 351(k) applications will require 
more resources than review of 351(a) applications. Therefore, the level 
of user fees for biosimilars should not exceed the level of 351(a) user 
fees.
    (3) The 351(k) user fee program should provide funding to support 
activities that occur early in the biosimilar and interchangeable 
product development cycle. Given that the approval pathway for 
biosimilar and interchangeable biological products is new, FDA services 
are most critical for continued and successful development of 
biosimilar and interchangeable biological products during the 
investigational stage prior to submission of a marketing application. 
To date, most of FDA's work on biosimilars has been focused on 
development of regulatory standards, policy, and consultations with 
351(k) sponsors to support product development leading to a marketing 
application. As a result, in developing an effective 351(k) user fee 
program, FDA should consider fee structures that fund critical 
activities that support submission of a marketing application.
    (4) Innovator biologics represent a critical public health benefit 
to patients, often offering life-saving or life-altering therapies to 
treat previously unmet medical needs. The same expert scientific teams 
that conduct FDA's review of 351(a) applications will typically be 
involved in the review of 351(k) applications. The 351(k) user fee 
program should ensure adequate resources for the review of 351(k) 
applications, so that critical resources for 351(a) review are not 
redirected from innovator drug review to biosimilar products. 
Applications submitted under both section 351(a) and section 351(k) 
need adequate resourcing to ensure the best health outcomes for U.S. 
patients and fairness to all industry sponsors.

III. Proposal for 351(k) User Fee Program for FYs 2013 Through 2017

    FDA believes the proposed structure for a user fee program 
described in this section adheres to the proposed principles identified 
in section II of this document. The proposed structure would ensure 
sound funding for development of the scientific,

[[Page 27064]]

regulatory, and policy infrastructure necessary for review of 351(k) 
applications, including resources for critical development-phase FDA 
consultation and review work, while charging no more for review of a 
351(k) application than would be paid by applicants seeking review of a 
351(a) marketing application. The level and timing of the proposed fee 
funding is also expected to minimize the risk of redirection of 351(a) 
review resources to biosimilars review work.
    FDA's proposed structure for a 351(k) user fee program has some 
features that would be similar to the current PDUFA structure. First, 
because FDA expects that marketing application review, preapproval 
facility inspections, and safety issues will be comparably complex for 
351(k) and 351(a) applications, for the initial 5-year authorization, 
the Agency proposes to maintain the PDUFA fee levels for 351(k) 
marketing applications, manufacturing establishments, and products. 
However, the Agency proposes to modify this structure to provide 
resources in the near-term because, as noted in section I of this 
document, there is no existing inventory of marketed products that 
would generate fees.
    Sponsors are currently submitting requests for FDA meetings and 
consultations during the biosimilar product development phase. Given 
that sponsors have limited experience utilizing the novel 351(k) 
pathway, FDA expects that sponsors will continue to require significant 
advice and support throughout this phase. As a result, the Agency is 
proposing a 351(k) user fee structure that would shift payment for FDA 
review to the earlier stage of development where FDA activities 
currently are in greatest demand and increased review capacity is 
needed.
    The proposed 351(k) user fee program would consist of the 
following:
For an Application in the Premarket Phases
     Biosimilar Product Development fee, paid upon submission 
of an investigational new drug application (IND) and annually 
thereafter for a biosimilar or interchangeable product (molecule) under 
active development that is intended for submission in a single 351(k) 
marketing application.
     351(k) Marketing Application fee, paid for each submitted 
351(k) marketing application. This fee would be set equal to a 351(a) 
marketing application fee, less the sum of all of the previously paid 
annual Biosimilar Product Development fees associated with the 
biosimilar product that is the subject of the 351(k) application.
For Marketed 351(k) Products, the Annual Fees Would Include
     Establishment fee, paid annually for each biosimilar and 
interchangeable biological product establishment listed in an approved 
351(k) application. The establishment fee is assessed for each 
biosimilar and interchangeable biological product that is assessed a 
product fee--unless the establishment listed in the application does 
not manufacture the product during the FY.
     Product fee, paid annually for each eligible approved 
biosimilar and interchangeable biological product.

    These fees are described in more detail. (See sections III.A and 
B.)

A. Description of Proposed Fees

1. Biosimilar Product Development Fee
    FDA proposes an annual 351(k) Biosimilar Product Development fee 
for each distinct biosimilar or interchangeable product (molecule) 
under active development. The sponsor would pay this fee at IND 
submission and annually thereafter for the duration of the active 
development phase. The sponsor would be required to declare that the 
development program is intended to support a 351(k) marketing 
application upon IND submission. During the development phase, if the 
sponsor changes the approval pathway from 351(k) to another, such as 
the 351(a) approval pathway, then the sponsor would stop paying the 
Biosimilar Product Development fee. Similarly, if a sponsor changes the 
development program for an existing IND from the 351(a) pathway to the 
351(k) pathway, the sponsor would be required to begin paying the 
Biosimilar Product Development fee. Failure to pay the Biosimilar 
Product Development fee on initial IND submission or annually as 
required would result in the IND being placed on Full Clinical Hold. 
When the applicant submits the associated 351(k) marketing application, 
the sum of the previously paid annual Biosimilar Product Development 
fees would be deducted from the 351(k) marketing application fee.
    This annual Biosimilar Product Development fee would support the 
ongoing scientific, technical, and other regulatory activities 
associated with 351(k) biosimilar development, including milestone 
meetings and the application data reviews required to provide advice 
for the next steps in development. These fees are essential to enable 
the staffing capacity to handle the workload associated with activities 
that support 351(k) product development programs. FDA estimates that 
the annual activities in this phase may be comparable to, or greater 
than, 351(a) IND application activities. These activities can include 
FDA review of study protocols; review of clinical, safety and other 
data; and providing sponsors with timely feedback and advice for their 
351(k) development program. FDA anticipates that the FY 2013 annual 
Biosimilar Product Development fee amount would be on the order of 
$150,000.
2. 351(k) Marketing Application Fee
    FDA estimates that the cost of reviewing a 351(k) marketing 
application will be comparable to the cost of reviewing a 351(a) 
marketing application. FDA therefore proposes to set the marketing 
application fee for a 351(k) submission equal to that of a 351(a) 
submission. The feedback and consultation that FDA expects to provide 
for active 351(k) INDs is expected to improve the efficiency of the 
351(k) product development process and the quality of submitted 351(k) 
marketing applications. Therefore, FDA considers the deduction of the 
Biosimilar Product Development fee payments from the associated 
marketing application fee payment is a reasonable approach to shift 
resources forward to the point in development where FDA review is 
currently being sought by sponsors. When a 351(k) marketing application 
is submitted, the applicant would pay the 351(k) application fee less 
the sum of any associated paid annual Biosimilar Product Development 
fees. For example, if the IND sponsor paid a total of $450,000 in 
Biosimilar Product Development annual fees, upon submission of the 
351(k) marketing application, the applicant would pay the prevailing 
351(k) marketing application fee (set equal to the 351(a) marketing 
application fee) less $450,000.
3. Annual Establishment and Product Fees for Marketed 351(k) Products
    Because the complexity and level of effort required for FDA 
oversight of manufacturing and postmarket safety issues for products 
licensed under 351(k) is expected to be comparable to that required for 
products licensed under 351(a), FDA also proposes setting the 
establishment and product fee rates equal to the comparable PDUFA rates 
for any FY. FDA anticipates a modest level of funding from these 
sources because only biosimilar biological products already approved 
for marketing would be subject to these fees.

[[Page 27065]]

B. Summary of Proposed 351(k) User Fee Program

    The intent of the proposed 351(k) user fee program is to provide 
FDA with adequate funding throughout each stage in the development of a 
biosimilar or interchangeable biological product, ensuring efficiency 
in FDA's review and approval of these important therapies without 
compromising review quality or approval standards. Table 1 of this 
document contains a summary of the proposed recommendations for the 
351(k) user fee program.

                Table 1--Proposed 351(k) User Fee Program
------------------------------------------------------------------------
                                                         Estimated fee
          Fee category            Fee administration   rates for FY 2013
------------------------------------------------------------------------
                    Pre 351(k) Market Approval Phase
------------------------------------------------------------------------
Biosimilar Product Development    Annual for each     Based on the
 Fee.                              351(k) IND, for     annual estimated
                                   duration of IND     cost of IND
                                   phase.              activities per
                                                       year per IND.
                                                       Estimated to be
                                                       $150,000.
Application Fee.................  For each 351(k)     Set equal to PDUFA
                                   marketing           original NDA/BLA
                                   application at      fee, less sum of
                                   time of             payments of
                                   application         Biosimilar
                                   submission.         Product
                                                       Development fees.
------------------------------------------------------------------------
                      Marketed 351(k) Applications
------------------------------------------------------------------------
Establishment Fee...............  Annual............  Set equal to PDUFA
                                                       establishment
                                                       fee.
Product Fee.....................  Annual............  Set equal to PDUFA
                                                       product fee.
------------------------------------------------------------------------

IV. Proposed Performance Goals for 351(k) Applications for FYs 2013 
Through 2017

    Under section 351(k)(7) of the PHS Act, a 351(k) application may 
not be submitted to the Secretary of Health and Human Services (the 
Secretary) until 4 years after the reference product was first licensed 
under section 351(a); however, the Secretary may not make approval of a 
351(k) application effective until 12 years after the reference product 
was first licensed. Accordingly, in proposing performance goals for 
351(k) applications for FYs 2013 through 2017, FDA must take into 
account the fact that two different categories of 351(k) applications 
may be submitted. In the first category are applications that are 
submitted 10 or more years after the date of first licensure of the 
reference product. Such applications would be eligible for approval in 
2 years or less, depending on the relevant filing dates. For these 
applications, performance goals similar to those for 351(a) 
applications may be appropriate. Like the initial PDUFA review 
performance goals, FDA is proposing that the goals be phased in over 
the first 5 years of the program so that an increasing percentage of 
applications would be expected to be reviewed within the goal each 
year.
    In the second category are applications submitted between 4 and 10 
years after the date of first licensure of the reference product. Under 
section 351(k)(7) of the PHS Act, such applications would not be 
eligible for approval for more than 2 years and perhaps for as long as 
8 years. For this second category of applications, FDA is concerned 
about committing resources to meet performance goals that might ready 
an application for approval years before it could be approved, 
necessitating updating of the application, new reviews, and new 
inspections of facilities shortly before the application becomes 
eligible for approval under the section 351(k)(7). Accordingly, FDA is 
proposing performance goals for applications in the first category and 
soliciting public input on several questions relating to establishing 
performance goals for applications in the second category.
    For 351(k) applications that are submitted 10 or more years after 
the date of first licensure of the reference product, FDA recommends 
the following proposed review performance goals for FYs 2013 through 
2017:

FY 2013

     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 50 percent of original 351(k) 
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 50 percent of original 
351(k) submissions for interchangeability determination within 10 
months of the 60-day filing date.
     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 50 percent of 351(k) resubmissions in 
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 50 percent of 351(k) 
resubmissions in response to a complete response action within 6 months 
of receipt.

FY 2014

     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 60 percent of original 351(k) 
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 60 percent of original 
351(k) submissions for interchangeability determination within 10 
months of the 60-day filing date.
     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 60 percent of 351(k) resubmissions in 
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 60 percent of 351(k) 
resubmissions in response to a complete response action within 6 months 
of receipt.

FY 2015

     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 70 percent of original 351(k) 
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 70 percent of original 
351(k) submissions for interchangeability determination within 10 
months of the 60-day filing date.
     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 70 percent of 351(k) resubmissions in 
response to a complete response action within 6 months of receipt.

[[Page 27066]]

     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 70 percent of 351(k) 
resubmissions in response to a complete response action within 6 months 
of receipt.

FY 2016

     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 80 percent of original 351(k) 
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 80 percent of original 
351(k) submissions for interchangeability determination within 10 
months of the 60-day filing date.
     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 80 percent of 351(k) resubmissions in 
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 80 percent of 351(k) 
resubmissions in response to a complete response action within 6 months 
of receipt.

FY 2017

     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 90 percent of original 351(k) 
submissions within 10 months of the 60-day filing date.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 90 percent of original 
351(k) submissions for interchangeability determination within 10 
months of the 60-day filing date.
     For applications requesting a biosimilarity determination, 
FDA proposes to review and act on 90 percent of 351(k) resubmissions in 
response to a complete response action within 6 months of receipt.
     For applications requesting an interchangeability 
determination, FDA proposes to review and act on 90 percent of 351(k) 
resubmissions in response to a complete response action within 6 months 
of receipt.

    To help the Agency develop performance goals for 351(k) 
applications that are submitted earlier than 10 years after first 
licensure of the reference product (i.e., between year four and year 
ten), FDA requests comment on the following questions:
    Question IV.1: What factors should the Agency consider in 
determining appropriate performance goals for 351(k) applications that 
are filed earlier than 2 years prior to the date on which a 351(k) 
application would be eligible for approval (i.e., 12 years after the 
date of first licensure of the reference product)? For example, how 
should the Agency address issues relating to review of critical quality 
attributes of the 351(k) product, technological developments, facility 
changes, and other issues that arise during the period of time between 
the filing of a 351(k) application (as early as 4 years after the date 
of first licensure of the reference product) and the date on which a 
351(k) application would be eligible for approval (12 years after the 
date of first licensure of the reference product)?
    Question IV.2: How should the performance goals take into account 
readiness for inspection? For example, should the performance goal (or 
user fee) structure take into account such factors as whether the 
product that is the subject of a 351(k) is already in commercial 
production for sale in another country? In such a case, if the sponsor 
proposes to use the same manufacturing facility for the 351(k) product, 
FDA could conduct an inspection at the facility and actually observe 
the production process. If the product is not being produced in another 
country, there may not be a facility ready for preapproval inspection, 
or even built yet. How should the performance goals take this into 
account?
    Question IV.3: What other factors relating to the unique 
characteristics of the 351(k) approval pathway should the Agency 
consider when setting performance goals for 351(k) applications?

V. Stakeholder Meetings

A. Public Stakeholder Meetings

    In the Federal Register of December 8, 2010 (75 FR 76472) (December 
2010 notice), FDA issued a notice to request that public stakeholders, 
including patient and consumer advocacy groups, health care 
professionals, and scientific and academic experts, notify FDA of their 
intent to participate in consultation meetings related to the 
development of recommendations for a user fee program for biosimilar 
and interchangeable biological product applications. Public 
stakeholders who identified themselves in response to the December 2010 
notice will be notified and invited to participate in future public 
stakeholder meetings that will be held over the same period when FDA is 
holding industry stakeholder meetings. (See section V.B of this 
document.) FDA regulatory policy issues are beyond the scope of the 
proposed stakeholder discussions. Accordingly, stakeholder 
presentations and discussions will focus on the structure of the 351(k) 
user fee program, and not policy issues.

B. Industry Stakeholder Meetings

    The BPCI Act requires FDA to consult with ``regulated industry'' in 
developing recommendations for the 351(k) user fee program. 
Acknowledging the nascent state of the biosimilar biologics industry, 
FDA proposes to hold a series of industry stakeholder meetings to 
comply with this requirement.
    Given that no approval pathway for biosimilar biological products 
existed prior to the BPCI Act, it is not clear which companies comprise 
``regulated industry'' for biosimilar and interchangeable biological 
products. Accordingly, in the Federal Register document that announced 
the November 2 and 3, 2010, public hearing (November 2010 public 
hearing document) on the implementation of the BPCI Act, FDA sought 
comments relating to user fees and requested that those who submitted 
comments identify companies that would be affected by a 351(k) user fee 
program, as well as industry associations representing such companies. 
(See 75 FR 61497, October 5, 2010.) Based on comments submitted to the 
docket, FDA anticipates that companies that principally manufacture 
innovator drugs and companies that principally manufacture generic 
drugs will pursue biosimilar and interchangeable product development 
programs. Given the potential competing interests of the affected 
stakeholders, and given that no industry association exists to 
expressly represent the interests of 351(k) sponsors, FDA concludes 
that it will need to follow a different process for the 351(k) user fee 
program than for its other medical product user fee programs.
    Specifically, FDA proposes to conduct a series of industry-
stakeholder meetings over a period of 2 to 3 months in 2011, with the 
hope that this process will lead to a package of proposed 
recommendations with which all parties can align. All industry 
associations who have expressed interest, and individual industry 
sponsors who have identified their interest and intention to develop 
biosimilar biological products, will be invited to participate in the 
industry-stakeholder meetings. The industry stakeholder meetings will 
address the following:
     Review and discussion of key principles and criteria for 
design of a fair and adequate 351(k) user fee program.

[[Page 27067]]

     Review and discussion of FDA's proposed 351(k) user fee 
program structure and any alternative structures submitted to the 
public docket in response to this document that would also meet the key 
design principles and criteria.
     Review and discussion of FDA's proposed performance goals 
for 351(k) applications. FDA will review and analyze the industry 
stakeholder input obtained through this process. FDA will take this 
information into account, as well as information obtained from public 
stakeholder consultation meetings, in developing the proposed set of 
recommendations that will be presented to Congressional Committee 
staff, published in the Federal Register for public review and comment, 
and presented at a public meeting to obtain public input. After the 
public meeting, the proposed recommendations would be revised as 
necessary before transmittal to Congress by January 15, 2012.

VI. Next Steps

A. Comments

    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 seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    FDA encourages members of the public to submit comments to the 
docket on the following topics:
    Question VI.1: FDA-proposed principles for a fair and adequate 
351(k) user fee program (section II of this document),
    Question VI.2: FDA-proposed structure for a 351(k) user fee program 
that aligns with these principles (section III of this document), and
    Question VI.3: FDA-proposed performance goals for a 351(k) user fee 
program for FYs 2013 through 2017 (section IV of this document).

    FDA also encourages the public to submit comments to the docket 
concerning any potential alternative 351(k) user fee structures that 
would align with the proposed principles. When you submit comments to 
the docket, identify the section of this document and the number of 
each question you address. FDA plans to review the comments submitted 
to the docket, hold consultation meetings with public stakeholder 
groups, and hold industry stakeholder meetings, to refine the proposed 
recommendations for a 351(k) user fee program for FYs 2013 through 
2017.

B. Public Stakeholder Identification

    Public stakeholders who have not yet notified FDA that they wish to 
participate in these consultation meetings should notify FDA by e-mail 
to BiosimilarsUserFeeProgram@fda.hhs.gov on or before June 3, 2011. 
Your e-mail should contain complete contact information, including 
name, title, organization affiliation, address, e-mail address, 
telephone number, and notice of any special accommodations required 
because of disability. Stakeholders will receive confirmation and 
additional information about the first meeting once FDA receives their 
notification.

C. Industry Stakeholder Identification

    FDA is requesting that industry stakeholders, including industry 
associations with relevant interests and individual companies with 
ongoing efforts or interest in developing biosimilar and 
interchangeable biological products, identify their interest in 
participating in industry stakeholder meetings. The purpose of these 
industry stakeholder meetings is to hold a series of discussions to 
develop proposed recommendations for a user fee program for biosimilar 
and interchangeable biological product applications for FYs 2013 
through 2017.
    If you have not yet notified FDA that you are a company or trade 
association that would be affected by a 351(k) user fee program, please 
provide notification by e-mail to BiosimilarsUserFeeProgram@fda.hhs.gov on or before June 3, 2011. Your e-mail should contain 
complete contact information, including name, title, organization 
affiliation, address, e-mail address, telephone number, and notice of 
any special accommodations required because of disability.

VII. Additional Information on the BPCI Act

    There are several sources of information on FDA's Web site that may 
serve as useful resources for stakeholders intending to participate in 
consultation meetings:
     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 that requested notification of 
stakeholder intention to participate in consultation meetings is 
available at http://edocket.access.gpo.gov/2010/pdf/2010-30713.pdf.
     Additional information regarding implementation of the 
BPCI Act is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031.

    Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11348 Filed 5-9-11; 8:45 am]
BILLING CODE 4160-01-P