[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Page 58738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24815]



[[Page 58738]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]


Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User 
Fee Act of 2012 Reauthorization; Request for Notification of Regulated 
Industry Organization 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 industry trade associations, whose members include drug 
companies currently engaged in development or manufacture of biosimilar 
biological products in the U.S., or drug companies intending to engage 
in these activities during the period of FY 2018-2022, notify FDA of 
their intent to participate in industry stakeholder meetings in support 
of timely reauthorization of the Biosimilar User Fee Act of 2012 
(BsUFA). The statutory authority for BsUFA expires at the end of 
September 2017. At that time, new legislation will be required for FDA 
to continue collecting user fees to fund the biosimilar biological 
product review process. The Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) requires that FDA engage in negotiations with regulated 
industry to develop recommendations to present to Congress with respect 
to the reauthorization of BsUFA. The purpose of this request for 
notification is to ensure that qualifying industry organizations notify 
FDA of their intention to participate in the planned negotiation 
process.

DATES: Submit notification of intention to participate by October 30, 
2015.

ADDRESSES: Submit notification of intention to participate in FDA-
industry user fee negotiations by email to [email protected].

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796-
1042, FAX: 301-847-3529; [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting that industry trade 
associations, whose members include drug companies currently engaged in 
development or manufacture of biosimilar biological products in the 
U.S., or drug companies intending to engage in these activities during 
the period of FY 2018-2022, notify the Agency of their intent to 
participate in FDA-industry negotiations on the reauthorization of 
BsUFA. BsUFA authorizes FDA to collect fees from the biosimilar 
biological product industry for certain activities relating to 
biosimilar biological product development, for certain types of 
applications and supplements for approval of biosimilar biological 
products, on establishments where approved biosimilar biological 
products are made, and on biosimilar biological products after 
approval. BsUFA fees finance critical and measurable aspects of FDA's 
biosimilar biological product review program. The statutory authority 
for BsUFA expires at the end of September 2017. Without new 
legislation, FDA will no longer be able to collect user fees for future 
fiscal years to fund the biosimilar biological product review process. 
Section 744I(e) (21 U.S.C. 379j-53(e)) of the FD&C Act requires that 
FDA, in developing reauthorization recommendations to present to 
Congress, consult with a range of public and industry stakeholders 
including representatives from patient and consumer advocacy 
groups,health care professionals, scientific and academic experts, and 
the regulated industry. FDA will initiate this process on December 18, 
2015, by holding a public meeting at which these key stakeholders and 
other members of the public will be given an opportunity to present 
their views on reauthorization. The FD&C Act further requires that 
after negotiations with the regulated industry are concluded, FDA shall 
present those recommendations for public review and comment, and 
finally transmit recommendations to Congress, revised as necessary 
based on public input, not later than January 15, 2017.
    Consistent with FDA's approach to the Prescription Drug User Fee 
Act (PDUFA) industry stakeholder meetings, the BsUFA industry 
stakeholder meetings will include industry trade associations that 
represent biosimilar biological product manufacturers rather than 
individual companies. Accordingly, FDA is issuing this Federal Register 
notice to request that industry associations, whose members include 
drug companies currently engaged in the development or manufacture of 
biosimilar biological products in the U.S, or drug companies intending 
to engage in these activities during the period of FY 2018-2022, notify 
FDA of their intent to participate in the industry stakeholder meetings 
on BsUFA reauthorization.
    Please notify FDA if you are a trade association interested in 
participating in this process by providing an email to 
[email protected] by October 30, 2015. Your email should contain 
complete contact information, including name, title, organization 
affiliation, address, email address, telephone number, and notice of 
any special accommodations required because of disability. It is 
anticipated that the negotiation process will begin within the first 
quarter of calendar year 2016 in order to ensure that FDA-industry 
negotiations can be concluded and the subsequent public consultation 
process conducted in advance of the statutory deadline in January 2017.

    Dated: September 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24815 Filed 9-29-15; 8:45 am]
 BILLING CODE 4164-01-P