Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intention To Participate, 31602-31603 [2015-13465]
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31602
Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0785. The
approval expires on May 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–13472 Filed 6–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–13473 Filed 6–2–15; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2012–N–0882]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Generic Drug User Fees; Stakeholder
Meetings on Generic Drug User Fee
Amendments of 2012 Reauthorization;
Request for Notification of Stakeholder
Intention To Participate
Food and Drug Administration
[Docket No. FDA–2014–D–0313]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry, Researchers,
Patient Groups, and FDA Staff on
Meetings With the Office of Orphan
Products Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Guidance for Industry, Researchers,
Patient Groups, and FDA Staff on
Meetings with the Office of Orphan
Products Development’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
4, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Guidance for Industry,
Researchers, Patient Groups, and FDA
Staff on Meetings with the Office of
Orphan Products Development’’ to OMB
for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0787. The
approval expires on May 31, 2018. A
copy of the supporting statement for this
information collection is available on
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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18:57 Jun 02, 2015
Jkt 235001
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 public
stakeholders, including patient and
consumer advocacy groups, health care
professionals, and scientific and
academic experts, notify FDA of their
intent to participate in periodic
consultation meetings on the
reauthorization of the Generic Drug User
Fee Amendments of 2012 (GDUFA). The
statutory authority for GDUFA expires
at the end of September 2017. At that
time, new legislation will be required
for FDA to continue collecting user fees
for the generic drug program. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) requires that FDA
consult with a range of stakeholders in
developing recommendations for the
next GDUFA program. The FD&C Act
also requires that FDA hold continued
discussions with patient and consumer
advocacy groups at least monthly during
FDA’s negotiations with the regulated
industry. The purpose of this request for
notification is to ensure continuity and
progress in these monthly discussions
by establishing consistent stakeholder
representation.
SUMMARY:
Submit notification of intention
to participate by August 14, 2015.
ADDRESSES: Submit notification of
intention to participate in monthly
stakeholder meetings by email to
GenericDrugPolicy@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Connie Wisner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1718,
DATES:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Silver Spring, MD 20993–0002, 240–
402–7946, Connie.Wisner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is requesting that public
stakeholders, including patient and
consumer advocacy groups, health care
professionals, and scientific and
academic experts, notify the Agency of
their intent to participate in periodic
consultation meetings on the
reauthorization of GDUFA. GDUFA
authorizes FDA to collect fees from drug
companies that submit marketing
applications for certain generic human
drug applications, certain drug master
files, and certain facilities. GDUFA
requires that generic drug manufacturers
pay user fees to finance critical and
measurable generic drug program
enhancements. The statutory authority
for GDUFA 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 human generic drug review
process. Section 744C(d) (21 U.S.C.
379j–43(d)) of the FD&C Act requires
that FDA consult with a range of
stakeholders in developing
recommendations for the next GDUFA
program, including representatives from
patient and consumer groups, health
care professionals, and scientific and
academic experts. FDA will initiate this
process on June 15, 2015, by holding a
public meeting at which stakeholders
and other members of the public will be
given an opportunity to present their
views on reauthorization (80 FR 22204).
The FD&C Act further requires that FDA
continue meeting with these
stakeholders at least once every month
during negotiations with the regulated
industry to continue discussions of
stakeholder views on the
reauthorization.
FDA is issuing this Federal Register
notice to request that stakeholder
representatives from patient and
consumer groups, health care
professional associations, as well as
scientific and academic experts notify
FDA of their intent to participate in
periodic consultation meetings on
GDUFA reauthorization. FDA believes
that consistent stakeholder
representation at these meetings will be
important to ensuring progress in these
discussions. If you wish to participate in
this part of the reauthorization 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
E:\FR\FM\03JNN1.SGM
03JNN1
Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices
notice will be included in all
stakeholder discussions while FDA
negotiates with the regulated industry.
Stakeholders who decide to participate
in these monthly meetings at a later
time may still participate in remaining
monthly meetings by notifying FDA (see
ADDRESSES). These stakeholder
discussions will satisfy the requirement
in section 744C(d)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Consultation Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding GDUFA
reauthorization, please provide
notification by email to
GenericDrugPolicy@fda.hhs.gov by
August 14, 2015. Your email should
contain complete contact information,
including name, title, affiliation,
address, email address, phone 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: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Biosimilars User Fee Cover Sheet; Form
FDA 3792
[FR Doc. 2015–13465 Filed 6–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0194]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biosimilars User
Fee Cover Sheet; Form FDA 3792
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 6,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0718. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
OMB Control Number 0910–0718—
Extension
The Patient Protection and Affordable
Care Act (Pub. L. 111–148) contains a
subtitle called the Biologics Price
Competition and Innovation Act of 2009
(Title VII Subtitle A) (BPCI Act) that
amends the Public Health Service Act
(42 U.S.C. 262) (PHS Act) and other
statutes to create an abbreviated
approval pathway for biological
products shown to be biosimilar to or
interchangeable with an FDA-licensed
reference biological product. Section
351(k) of the PHS Act, added by the
BPCI Act, allows a company to submit
an application for licensure of a
biosimilar or interchangeable biological
product. The BPCI Act also amends
section 735 of the Federal Food, Drug,
31603
and Cosmetic Act (21 U.S.C. 379g) to
include 351(k) applications in the
definition of ‘‘human drug application’’
for the purposes of the prescription drug
user fee provisions. The BPCI Act
directs FDA to develop
recommendations for a biosimilar
biological product user fee program for
fiscal years 2013 through 2017. FDA’s
recommendations for a biosimilar
biological product user fee program
were submitted to Congress on January
13, 2012.
FDA’s biosimilar biological product
user fee program requires FDA to assess
and collect user fees for certain
meetings concerning biosimilar
biological product development (BPD
meetings), investigational new drug
applications (INDs) intended to support
a biosimilar biological product
application, and biosimilar biological
product applications and supplements.
Form FDA 3792, the Biosimilars User
Fee Cover Sheet, requests the minimum
necessary information to determine the
amount of the fee required, and to
account for and track user fees. The
form provides a cross-reference of the
fees submitted for a submission with the
actual submission by using a unique
number tracking system. The
information collected is used by FDA’s
Center for Drug Evaluation and Research
and Center for Biologics Evaluation and
Research to initiate the administrative
screening of biosimilar biological
product INDs, applications, and
supplements, and to account for and
track user fees associated with BPD
meetings.
In the Federal Register of January 27,
2015 (80 FR 4272), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
Respondents to this collection of
information are manufacturers of
biosimilar biological product
candidates. Based on the number of
Form FDA 3792s we have received, we
estimate the burden of this collection of
information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
tkelley on DSK3SPTVN1PROD with NOTICES
FDA form No.
Biosimilars User Fee Cover Sheet; Form FDA
3792 ..................................................................
1 There
No. of
responses per
respondent
20
1
Total annual
responses
20
Average burden
per response
0.50 (30 minutes)
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
10
]]>Agencies
[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Pages 31602-31603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13465]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0882]
Generic Drug User Fees; Stakeholder Meetings on Generic Drug User
Fee Amendments of 2012 Reauthorization; Request for Notification of
Stakeholder 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 public stakeholders, including patient and consumer
advocacy groups, health care professionals, and scientific and academic
experts, notify FDA of their intent to participate in periodic
consultation meetings on the reauthorization of the Generic Drug User
Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA
expires at the end of September 2017. At that time, new legislation
will be required for FDA to continue collecting user fees for the
generic drug program. The Federal Food, Drug, and Cosmetic Act (the
FD&C Act) requires that FDA consult with a range of stakeholders in
developing recommendations for the next GDUFA program. The FD&C Act
also requires that FDA hold continued discussions with patient and
consumer advocacy groups at least monthly during FDA's negotiations
with the regulated industry. The purpose of this request for
notification is to ensure continuity and progress in these monthly
discussions by establishing consistent stakeholder representation.
DATES: Submit notification of intention to participate by August 14,
2015.
ADDRESSES: Submit notification of intention to participate in monthly
stakeholder meetings by email to GenericDrugPolicy@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993-0002, 240-
402-7946, Connie.Wisner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is requesting that public stakeholders, including patient and
consumer advocacy groups, health care professionals, and scientific and
academic experts, notify the Agency of their intent to participate in
periodic consultation meetings on the reauthorization of GDUFA. GDUFA
authorizes FDA to collect fees from drug companies that submit
marketing applications for certain generic human drug applications,
certain drug master files, and certain facilities. GDUFA requires that
generic drug manufacturers pay user fees to finance critical and
measurable generic drug program enhancements. The statutory authority
for GDUFA 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 human generic drug review process. Section
744C(d) (21 U.S.C. 379j-43(d)) of the FD&C Act requires that FDA
consult with a range of stakeholders in developing recommendations for
the next GDUFA program, including representatives from patient and
consumer groups, health care professionals, and scientific and academic
experts. FDA will initiate this process on June 15, 2015, by holding a
public meeting at which stakeholders and other members of the public
will be given an opportunity to present their views on reauthorization
(80 FR 22204). The FD&C Act further requires that FDA continue meeting
with these stakeholders at least once every month during negotiations
with the regulated industry to continue discussions of stakeholder
views on the reauthorization.
FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer groups, health
care professional associations, as well as scientific and academic
experts notify FDA of their intent to participate in periodic
consultation meetings on GDUFA reauthorization. FDA believes that
consistent stakeholder representation at these meetings will be
important to ensuring progress in these discussions. If you wish to
participate in this part of the reauthorization 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
[[Page 31603]]
notice will be included in all stakeholder discussions while FDA
negotiates with the regulated industry. Stakeholders who decide to
participate in these monthly meetings at a later time may still
participate in remaining monthly meetings by notifying FDA (see
ADDRESSES). These stakeholder discussions will satisfy the requirement
in section 744C(d)(3) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Consultation
Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding GDUFA reauthorization, please provide
notification by email to GenericDrugPolicy@fda.hhs.gov by August 14,
2015. Your email should contain complete contact information, including
name, title, affiliation, address, email address, phone 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: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13465 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P
