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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice; request for notification of participation.

# 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 .                           ( print 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]

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