[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