Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments, 51814-51815 [2012-20945]
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51814
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Notices
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaewon Hong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 866–405–5367 or 301–796–6707.
SUPPLEMENTARY INFORMATION:
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20946 Filed 8–22–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
Draft Guidance for Industry on Generic
Drug User Fee Amendments of 2012:
Questions and Answers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Generic
Drug User Fee Amendments of 2012:
Questions and Answers.’’ The Generic
Drug User Fee Amendments of 2012
(GDUFA) is designed to speed the
delivery of safe and effective generic
drugs to the public and reduce costs to
industry. GDUFA enables FDA to assess
user fees to support critical and
measurable enhancements to FDA’s
generic drugs program. GDUFA also
requires that generic drug facilities,
sites, and organizations located around
the world provide identification
information annually to FDA. This
guidance is intended to provide answers
to common questions from the generic
drug industry and other interested
parties involved in the development
and/or testing of generic drug products
regarding the requirements and
commitments of GDUFA.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 26,
2012.
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
ADDRESSES:
VerDate Mar<15>2010
15:04 Aug 24, 2012
Jkt 226001
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Generic Drug User Fee Amendments of
2012: Questions and Answers.’’ GDUFA
(Pub. L. 112–144, Title III) was signed
into law by the President on July 9,
2012. GDUFA is designed to speed the
delivery of safe and effective generic
drugs to the public and reduce costs to
industry. GDUFA enables FDA to assess
user fees to support critical and
measurable enhancements to FDA’s
generic drugs program.
GDUFA establishes fees for
abbreviated new drug applications
(ANDAs), prior approval supplements
(PASs) to ANDAs, and drug master files
(DMFs), annual facility fees, and a onetime fee for original ANDAs pending
with FDA on October 1, 2012 (backlog
fees). Fees will be incurred for ANDAs
and PASs submitted on or after October
1, 2012. An application fee will also be
incurred the first time a DMF is
referenced in an ANDA or PAS
submitted on or after October 1, 2012.
FDA plans to publish the fee amounts
for ANDAs, PASs, DMFs, and the
backlog fee in the Federal Register on
or before October 31, 2012.
The amount of the annual user fees
for generic drug facilities will be
determined after GDUFA program
launch. Under GDUFA, facilities, sites,
and organizations are first required to
self-identify. Fees will be determined
after the self-identification process has
been completed, providing FDA
information about the number of
facilities that will be required to pay
user fees. These include facilities
manufacturing, or intending to
manufacture, active pharmaceutical
ingredients of human generic drugs and/
or finished dosage form human generic
drugs.
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Frm 00067
Fmt 4703
Sfmt 4703
This draft guidance is intended to
provide answers to common questions
from generic drug industry participants
and other interested parties involved in
the development and/or testing of
generic drug products regarding FDA’s
plans for implementing GDUFA. This
draft guidance is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
the Agency’s current thinking on
generic drug user fee amendments of
2012. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20944 Filed 8–22–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0882]
Generic Drug User Fee Amendments of
2012; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
SUMMARY:
E:\FR\FM\27AUN1.SGM
27AUN1
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Notices
SUPPLEMENTARY INFORMATION:
Comments: Submission of comments
before the meeting is strongly
encouraged. Regardless of attendance at
the public meeting, interested persons
may submit either electronic or written
comments. Submit electronic comments
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
The deadline for submitting comments
is October 12, 2012.
Attendance and Registration: If you
wish to attend and/or present at the
meeting, please register for the meeting
and/or make a request for oral
presentation by email to
GDUFA_Meeting@fda.hhs.gov by
September 14, 2012. Your email should
contain complete contact information
for each attendee, including name, title,
affiliation, address, email address, and
telephone number. Registration is free
and will be on a first-come, first-served
basis. Early registration is recommended
because seating is limited. (FDA may
limit the number of participants from
each organization, as well as the total
number of participants, based on space
limitations.) Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meeting will be based on the
availability of space.
We will try to accommodate all
persons who wish to make a
presentation. Those making oral
presentations at the meeting should
submit to the docket a brief summary of
the presentation (or questions),
including the discussion topic(s) that
will be addressed and the approximate
time requested for your presentation.
The time allotted for presentations will
depend on the number of persons who
wish to speak. If you need special
accommodations because of a disability,
please contact Mary Gross or Randi
Clark (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
meeting.
For those unable to attend in person,
FDA will provide a Webcast and a
telephone audio link to the meeting. To
join the meeting via the Webcast, please
go to https://collaboration.fda.gov/
gdufa91012. If you have never attended
a Connect Pro meeting, you may wish to
test your connection by going to https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm.
I. Background
On July 9, 2012, GDUFA (Pub. L. 112–
144, Title III) was signed into law by the
President. Designed to speed access to
safe and effective generic drugs to the
public and reduce costs to industry,
GDUFA requires that generic drug
manufacturers pay user fees to finance
critical and measurable generic drug
program enhancements. GDUFA also
requires that generic drug facilities,
sites, and organizations located around
the world provide identification
information annually to FDA.
Additional information concerning
GDUFA, including the text of the law
and the letter in which FDA describes
commitments it is making for
improvements in the process, may be
public meeting to discuss
implementation of the Generic Drug
User Fee Amendments of 2012
(GDUFA). GDUFA requires that generic
drug manufacturers pay user fees to
finance critical and measurable generic
drug program enhancements and also
requires that generic drug facilities,
sites, and organizations around the
world provide identification
information annually to FDA. The
purpose of the public meeting is to
discuss recent communications
concerning GDUFA implementation and
to provide an opportunity for the public
to present views on these materials.
DATES: The public meeting will be held
on September 21, 2012, from 9 a.m. to
1 p.m.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 2,
Rm. 2047, Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
pmangrum on DSK3VPTVN1PROD with NOTICES
Mary Gross, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6178, Silver Spring,
MD 20993, 301–796–3519, email:
Mary.Gross@fda.hhs.gov; or Randi
Clark, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6166, Silver Spring,
MD 20993, 301–796–4287, email:
Randi.Clark@fda.hhs.gov.
VerDate Mar<15>2010
15:04 Aug 24, 2012
Jkt 226001
PO 00000
Frm 00068
Fmt 4703
Sfmt 9990
51815
found on the FDA Web site at https://
www.fda.gov/gdufa.
The purpose of this meeting is to
discuss recent communications that
provide greater detail on FDA’s GDUFA
implementation plans. These
communications are published
elsewhere in this issue of the Federal
Register and include the following:
• Draft Guidance for Industry Generic
Drug User Fee Amendments of 2012:
Questions and Answers (available at
https://www.fda.gov/gdufa)
• Draft Guidance for Industry SelfIdentification of Generic Drug Facilities,
Sites, and Organizations (available at
https://www.fda.gov/gdufa)
• Federal Register Notice of
Opportunity To Withdraw Abbreviated
New Drug Applications To Avoid
Backlog Fee Obligations (available at
https://www.fda.gov/gdufa)
The meeting will provide an overview
of these communications and an
opportunity for public input.
II. Meeting Organization
In general, the meeting format will
include presentations by FDA, a panel
discussion with stakeholder groups,
individual public testimony, and an
opportunity for questions and answers
from the audience. The amount of time
available for public testimony will be
determined by the number of people
who register to provide testimony. An
agenda and other background for the
public meeting will be posted at https://
www.fda.gov/gdufa at least 2 days in
advance of the meeting.
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations
.gov. It may be viewed at the Division
of Dockets Management (see
Comments). A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. Written requests
are to be sent to the Division of Freedom
of Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
Dated August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20945 Filed 8–22–12; 11:15 am]
BILLING CODE 4160–01–P
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Notices]
[Pages 51814-51815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20945]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0882]
Generic Drug User Fee Amendments of 2012; Public Meeting; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
[[Page 51815]]
public meeting to discuss implementation of the Generic Drug User Fee
Amendments of 2012 (GDUFA). GDUFA requires that generic drug
manufacturers pay user fees to finance critical and measurable generic
drug program enhancements and also requires that generic drug
facilities, sites, and organizations around the world provide
identification information annually to FDA. The purpose of the public
meeting is to discuss recent communications concerning GDUFA
implementation and to provide an opportunity for the public to present
views on these materials.
DATES: The public meeting will be held on September 21, 2012, from 9
a.m. to 1 p.m.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 2, Rm. 2047, Silver Spring, MD 20993.
Entrance for the public meeting participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Mary Gross, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6178, Silver Spring, MD 20993, 301-796-3519, email:
Mary.Gross@fda.hhs.gov; or Randi Clark, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6166, Silver Spring, MD 20993, 301-796-4287, email:
Randi.Clark@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Comments: Submission of comments before the meeting is strongly
encouraged. Regardless of attendance at the public meeting, interested
persons may submit either electronic or written comments. Submit
electronic comments to https://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is
only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. The deadline for
submitting comments is October 12, 2012.
Attendance and Registration: If you wish to attend and/or present
at the meeting, please register for the meeting and/or make a request
for oral presentation by email to GDUFA_Meeting@fda.hhs.gov by
September 14, 2012. Your email should contain complete contact
information for each attendee, including name, title, affiliation,
address, email address, and telephone number. Registration is free and
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited. (FDA may limit the number of
participants from each organization, as well as the total number of
participants, based on space limitations.) Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on the availability of space.
We will try to accommodate all persons who wish to make a
presentation. Those making oral presentations at the meeting should
submit to the docket a brief summary of the presentation (or
questions), including the discussion topic(s) that will be addressed
and the approximate time requested for your presentation. The time
allotted for presentations will depend on the number of persons who
wish to speak. If you need special accommodations because of a
disability, please contact Mary Gross or Randi Clark (see FOR FURTHER
INFORMATION CONTACT) at least 7 days before the meeting.
For those unable to attend in person, FDA will provide a Webcast
and a telephone audio link to the meeting. To join the meeting via the
Webcast, please go to https://collaboration.fda.gov/gdufa91012. If you
have never attended a Connect Pro meeting, you may wish to test your
connection by going to https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
I. Background
On July 9, 2012, GDUFA (Pub. L. 112-144, Title III) was signed into
law by the President. Designed to speed access to safe and effective
generic drugs to the public and reduce costs to industry, GDUFA
requires that generic drug manufacturers pay user fees to finance
critical and measurable generic drug program enhancements. GDUFA also
requires that generic drug facilities, sites, and organizations located
around the world provide identification information annually to FDA.
Additional information concerning GDUFA, including the text of the law
and the letter in which FDA describes commitments it is making for
improvements in the process, may be found on the FDA Web site at https://www.fda.gov/gdufa.
The purpose of this meeting is to discuss recent communications
that provide greater detail on FDA's GDUFA implementation plans. These
communications are published elsewhere in this issue of the Federal
Register and include the following:
Draft Guidance for Industry Generic Drug User Fee
Amendments of 2012: Questions and Answers (available at https://www.fda.gov/gdufa)
Draft Guidance for Industry Self-Identification of Generic
Drug Facilities, Sites, and Organizations (available at https://www.fda.gov/gdufa)
Federal Register Notice of Opportunity To Withdraw
Abbreviated New Drug Applications To Avoid Backlog Fee Obligations
(available at https://www.fda.gov/gdufa)
The meeting will provide an overview of these communications and an
opportunity for public input.
II. Meeting Organization
In general, the meeting format will include presentations by FDA, a
panel discussion with stakeholder groups, individual public testimony,
and an opportunity for questions and answers from the audience. The
amount of time available for public testimony will be determined by the
number of people who register to provide testimony. An agenda and other
background for the public meeting will be posted at https://www.fda.gov/gdufa at least 2 days in advance of the meeting.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Comments). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20945 Filed 8-22-12; 11:15 am]
BILLING CODE 4160-01-P
