
[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76472-76473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0602]


Biologics Price Competition and Innovation Act of 2009; Meetings 
on User Fee Program for Biosimilar and Interchangeable Biological 
Product Applications; Request for Notification of Stakeholder Intention 
To Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of participation.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this 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 relating to the development of a user fee program for 
biosimilar and interchangeable biological product applications 
submitted under the Public Health Service Act (PHS Act). FDA is holding 
these consultation meetings to satisfy the requirement in the Patient 
Protection and Affordable Care Act that FDA consult with such public 
stakeholders regarding the development of recommendations to present to 
Congress with respect to the goals, and plans for meeting the goals, 
for the process for the review of biosimilar and interchangeable 
biological product applications for fiscal years (FYs) 2013 through 
2017. To ensure continuity and to support the development of 
recommendations for establishing a user fee program for biosimilars and 
interchangeable products, the Agency requests stakeholder 
representation throughout this consultation process.

DATES: Submit notification of intention to participate by January 10, 
2011. Stakeholder discussions with FDA will occur during negotiations 
with the regulated industry.

ADDRESSES: Submit notification of intention to participate in 
stakeholder meetings by e-mail to 
BiosimilarsUserFeeProgram@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Sunanda Bahl, Food and Drug 
Administration, Center for Drug Evaluation and Research, 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 Patient 
Protection and Affordable Care Act (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 BPCI 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 for biosimilar or interchangeable biological products 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 BPCI Act.) 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 
biosimilar and biological product applications for FYs 2013 through 
2017. (See section 7002(f)(1) of the BPCI Act.)

II. FDA Consultation With Stakeholders

    FDA is required to develop recommendations to present to Congress 
by January 15, 2012, that address the goals, and plans for meeting the 
goals, for the process for the review of biosimilar and interchangeable 
biological product applications for FYs 2013 through 2017. (See section 
7002(f)(1) of the BPCI Act.) In developing such recommendations, FDA 
must consult with a range of groups, including scientific and academic 
experts; health care professionals; representatives of patient and 
consumer advocacy groups; and regulated industry. (See section 
7002(f)(1) of the BPCI Act.) FDA initiated this 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. To facilitate identification of regulated industry, in 
the Federal Register notice that announced the November 2010 public 
hearing, FDA requested that comments identify companies that would be 
affected by a user fee program for biosimilar or interchangeable 
biological products, as well as industry associations representing such 
companies. (See 75 FR 61497, October 5, 2010.)
    FDA is issuing this Federal Register notice to request that other 
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. FDA believes that 
consistent stakeholder representation at these consultation meetings 
will be important to ensure progress in the discussions. If you wish to 
participate in this process, please designate one or more 
representatives from your organization who will commit to attending 
these meetings and preparing for the discussions as needed. 
Stakeholders who identify themselves through this notice will be 
included in future stakeholder discussions as FDA negotiates with 
regulated industry. These discussions will satisfy the requirement for 
consultation with public stakeholders in section 7002(f)(1) of the BPCI 
Act.

III. 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 notice that announced the November 2 
and 3, 2010, public hearing and requested public comments is available 
at http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf.

[[Page 76473]]

     Comments submitted in response to the November 2010 public 
hearing notice can be found at http://www.regulations.gov using Docket 
No. FDA-2010-N-0477.
     Additional information regarding implementation of the 
BPCI Act is available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031.

IV. Notification of Intent To Participate in Consultation Meetings

    If you intend to participate in stakeholder consultation meetings 
regarding the development of recommendations for a user fee program for 
biosimilar and interchangeable biological product applications for FYs 
2013 through 2017, please provide notification by e-mail to 
BiosimilarsUserFeeProgram@fda.hhs.gov by January 10, 2011. Your e-mail 
should contain complete contact information, including name, title, 
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.

    Dated: December 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30713 Filed 12-7-10; 8:45 am]
BILLING CODE 4160-01-P


