Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User Fee Act of 2012 Reauthorization; Request for Notification of Regulated Industry Organization Intention To Participate, 58738 [2015-24815]
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58738
Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Notices
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.
Notice; request for notification
of participation.
ACTION:
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:27 Sep 29, 2015
Jkt 235001
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.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–0281–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
revision of the approved information
collection assigned OMB control
number 0990–0281, scheduled to expire
on November 30, 2015. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before October 30, 2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUMMARY:
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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
