80_FR_58927 80 FR 58738 - Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User Fee Act of 2012 Reauthorization; Request for Notification of Regulated Industry Organization Intention To Participate

80 FR 58738 - Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User Fee Act of 2012 Reauthorization; Request for Notification of Regulated Industry Organization Intention To Participate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 189 (September 30, 2015)

Page Range58738-58738
FR Document2015-24815

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.

Federal Register, Volume 80 Issue 189 (Wednesday, September 30, 2015) 
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Page 58738]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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 biosimilars@fda.hhs.gov.

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; sandra.benton@fda.hhs.gov.

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 
biosimilars@fda.hhs.gov 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

58738 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Notices DEPARTMENT OF HEALTH AND engage in these activities during the Please notify FDA if you are a trade HUMAN SERVICES period of FY 2018–2022, notify the association interested in participating in Agency of their intent to participate in this process by providing an email to Food and Drug Administration FDA-industry negotiations on the biosimilars@fda.hhs.gov by October 30, [Docket No. FDA–2015–N–0007] reauthorization of BsUFA. BsUFA 2015. Your email should contain authorizes FDA to collect fees from the complete contact information, including Biosimilar User Fee Act; Stakeholder biosimilar biological product industry name, title, organization affiliation, Meetings on Biosimilar User Fee Act of for certain activities relating to address, email address, telephone 2012 Reauthorization; Request for biosimilar biological product number, and notice of any special Notification of Regulated Industry development, for certain types of accommodations required because of Organization Intention To Participate applications and supplements for disability. It is anticipated that the approval of biosimilar biological negotiation process will begin within AGENCY: Food and Drug Administration, products, on establishments where the first quarter of calendar year 2016 in HHS. approved biosimilar biological products order to ensure that FDA-industry ACTION: Notice; request for notification are made, and on biosimilar biological negotiations can be concluded and the of participation. products after approval. BsUFA fees subsequent public consultation process finance critical and measurable aspects conducted in advance of the statutory SUMMARY: The Food and Drug of FDA’s biosimilar biological product deadline in January 2017. Administration (FDA) is issuing this review program. The statutory authority notice to request that industry trade Dated: September 24, 2015. for BsUFA expires at the end of Leslie Kux, associations, whose members include September 2017. Without new drug companies currently engaged in legislation, FDA will no longer be able Associate Commissioner for Policy. development or manufacture of to collect user fees for future fiscal years [FR Doc. 2015–24815 Filed 9–29–15; 8:45 am] biosimilar biological products in the to fund the biosimilar biological product BILLING CODE 4164–01–P U.S., or drug companies intending to review process. Section 744I(e) (21 engage in these activities during the U.S.C. 379j–53(e)) of the FD&C Act period of FY 2018–2022, notify FDA of requires that FDA, in developing DEPARTMENT OF HEALTH AND their intent to participate in industry reauthorization recommendations to HUMAN SERVICES stakeholder meetings in support of present to Congress, consult with a timely reauthorization of the Biosimilar Office of the Secretary range of public and industry User Fee Act of 2012 (BsUFA). The stakeholders including representatives statutory authority for BsUFA expires at [Document Identifier: HHS–OS–0990–0281– from patient and consumer advocacy 30D] the end of September 2017. At that time, groups,health care professionals, new legislation will be required for FDA scientific and academic experts, and the Agency Information Collection to continue collecting user fees to fund regulated industry. FDA will initiate Activities; Submission to OMB for the biosimilar biological product review this process on December 18, 2015, by Review and Approval; Public Comment process. The Federal Food, Drug, and holding a public meeting at which these Request Cosmetic Act (the FD&C Act) requires key stakeholders and other members of that FDA engage in negotiations with the public will be given an opportunity AGENCY: Office of the Secretary, HHS. regulated industry to develop to present their views on ACTION: Notice. recommendations to present to Congress reauthorization. The FD&C Act further with respect to the reauthorization of requires that after negotiations with the SUMMARY: In compliance with section BsUFA. The purpose of this request for regulated industry are concluded, FDA 3507(a)(1)(D) of the Paperwork notification is to ensure that qualifying shall present those recommendations for Reduction Act of 1995, the Office of the industry organizations notify FDA of public review and comment, and finally Secretary (OS), Department of Health their intention to participate in the transmit recommendations to Congress, and Human Services, has submitted an planned negotiation process. revised as necessary based on public Information Collection Request (ICR), DATES: Submit notification of intention input, not later than January 15, 2017. described below, to the Office of to participate by October 30, 2015. Management and Budget (OMB) for Consistent with FDA’s approach to review and approval. The ICR is for ADDRESSES: Submit notification of the Prescription Drug User Fee Act intention to participate in FDA-industry revision of the approved information (PDUFA) industry stakeholder meetings, collection assigned OMB control user fee negotiations by email to the BsUFA industry stakeholder biosimilars@fda.hhs.gov. number 0990–0281, scheduled to expire meetings will include industry trade on November 30, 2015. Comments FOR FURTHER INFORMATION CONTACT: associations that represent biosimilar Sandra Benton, Food and Drug submitted during the first public review biological product manufacturers rather of this ICR will be provided to OMB. Administration, Center for Drug than individual companies. Evaluation and Research, 10903 New OMB will accept further comments from Accordingly, FDA is issuing this the public on this ICR during the review Hampshire Ave., Bldg. 51, Rm. 6340, Federal Register notice to request that Silver Spring, MD 20993, 301–796– and approval period. industry associations, whose members 1042, FAX: 301–847–3529; DATES: Comments on the ICR must be include drug companies currently sandra.benton@fda.hhs.gov. received on or before October 30, 2015. mstockstill on DSK4VPTVN1PROD with NOTICES engaged in the development or SUPPLEMENTARY INFORMATION: FDA is manufacture of biosimilar biological ADDRESSES: Submit your comments to requesting that industry trade products in the U.S, or drug companies OIRA_submission@omb.eop.gov or via associations, whose members include intending to engage in these activities facsimile to (202) 395–5806. drug companies currently engaged in during the period of FY 2018–2022, FOR FURTHER INFORMATION CONTACT: development or manufacture of notify FDA of their intent to participate Information Collection Clearance staff, biosimilar biological products in the in the industry stakeholder meetings on Information.CollectionClearance@ U.S., or drug companies intending to BsUFA reauthorization. hhs.gov or (202) 690–6162. 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Document Created: 2015-12-15 09:31:36
Document Modified: 2015-12-15 09:31:36
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for notification of participation.
DatesSubmit notification of intention to participate by October 30, 2015.
ContactSandra 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]
FR Citation80 FR 58738 
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