[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]
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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.
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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 http://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 http://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 http://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 http://www.fda.gov/gdufa)
Draft Guidance for Industry Self-Identification of Generic
Drug Facilities, Sites, and Organizations (available at http://www.fda.gov/gdufa)
Federal Register Notice of Opportunity To Withdraw
Abbreviated New Drug Applications To Avoid Backlog Fee Obligations
(available at http://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 http://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 http://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