Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date, 48325 [2015-19768]
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Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices
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will be posted to the docket at https://
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III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–19740 Filed 8–11–15; 8:45 am]
BILLING CODE 4164–01–P
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
Intent To Participate; Extension of
Closing Date
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of intent to participate; extension of
closing date.
ACTION:
The Food and Drug
Administration (FDA) is extending the
closing date for the document that
appeared in the Federal Register of June
3, 2015. In that document, FDA
requested 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 the request for
notification is to ensure continuity and
progress in these monthly discussions
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:16 Aug 11, 2015
Jkt 235001
by establishing consistent stakeholder
representation.
DATES: FDA is extending the closing
date in the notice published June 3,
2015 (80 FR 31602). Submit notification
of intent to participate by April 30,
2016.
ADDRESSES: Submit notification of
intent 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 initiated this
process on June 15, 2015, by holding a
public meeting at which stakeholders
and other members of the public were
given an opportunity to present their
views on reauthorization (April 21,
2015, 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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
48325
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
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
April 30, 2016. 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: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–19768 Filed 8–11–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Page 48325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19768]
-----------------------------------------------------------------------
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 Intent To Participate; Extension of Closing Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of intent to participate;
extension of closing date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the
closing date for the document that appeared in the Federal Register of
June 3, 2015. In that document, FDA requested 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 the request for notification is to ensure continuity and
progress in these monthly discussions by establishing consistent
stakeholder representation.
DATES: FDA is extending the closing date in the notice published June
3, 2015 (80 FR 31602). Submit notification of intent to participate by
April 30, 2016.
ADDRESSES: Submit notification of intent 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 initiated this process on June 15, 2015, by holding a
public meeting at which stakeholders and other members of the public
were given an opportunity to present their views on reauthorization
(April 21, 2015, 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 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 April 30,
2016. 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: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19768 Filed 8-11-15; 8:45 am]
BILLING CODE 4164-01-P
