Document ID: FDA-2010-N-0381-0041
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee; Public Meeting; Request for Comments
Posted Date: 2011-04-29T04:00Z

[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24035-24036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0381]

Generic Drug User Fee; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting to provide a public update and to gather additional stakeholder 
input on the development of a generic drug user fee program. A user fee 
program could provide necessary supplemental funding, in addition to 
current Congressional appropriations, to facilitate the timely review 
of human generic drug applications by FDA, and FDA is currently in 
negotiations with the regulated industry aimed at providing a consensus 
proposal for congressional consideration. In the interest of 
transparency, and to assure that all interested stakeholders' views are 
heard and considered, whether they are present at the negotiations or 
not, FDA is holding a public meeting to

[[Page 24036]]

provide an update on the current process and to gather additional input 
on such a program.
    Date and Time: The public meeting will be held on May 10, 2011, 
from 2 p.m. to 3:30 p.m.
    Location: The public meeting will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103, 
and 4105, Silver Spring, MD 20993-0002.
    Contact Person: Mari Long, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 
4237, Silver Spring, MD 20993-0002, 301-796-7574, Fax 301-847-3541, 
mari.long@fda.hhs.gov; or
    Peter C. Beckerman, Office of Policy, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, rm. 4238, Silver Spring, MD 20993-
0002, 301-796-4830, Fax 301-847-3541, peter.beckerman@fda.hhs.gov.
    Registration and Requests for Oral Presentations: If you wish to 
attend and/or present at the meeting, please e-mail your registration 
information to GDUFA_Meeting2@fda.hhs.gov by May 3, 2011. Your e-mail 
should contain complete contact information for each attendee, 
including name, title, affiliation, address, e-mail 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 space availability. We will try to accommodate all persons who 
wish to make a presentation. The time allotted for presentations may 
depend on the number of persons who wish to speak, and if the entire 
meeting time is not needed for presentations, FDA reserves the right to 
terminate the meeting early.
    If you need special accommodations because of disability, please 
contact Mari Long or Peter Beckerman (see Contact Person) at least 7 
days before the meeting.
    Comments: Regardless of attendance at the public meeting, 
interested persons may submit either electronic or written comments 
regarding this document by June 10, 2011. To ensure consideration, all 
comments must be received by June 10, 2011. Submission of comments 
prior to the meeting is strongly encouraged. Submit any comments that 
you plan to present at the public meeting to the docket by the date of 
the public meeting, but note that either electronic or written comments 
generally may be submitted until June 10, 2011.
    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. It is no 
longer necessary to send two copies of mailed 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing its intention to hold a public meeting related to 
generic drug user fees. The Agency continues to solicit comment on 
whether to seek a user fee program that would provide additional 
resources for the review of human generic drug applications, as well as 
what such a program should look like. New legislation would be required 
for FDA to establish and collect user fees for generic drugs, and FDA 
is currently engaged in negotiations with industry over aspects of a 
joint proposal for a generic drug user fee program, including fees and 
performance goals. Because FDA can only negotiate with trade 
organizations, not individual companies, but remains interested in 
hearing from non-affiliated companies in addition to patient and 
consumer stakeholders, the Agency will hold a public meeting. The 
public meeting will provide a status update and seek input from 
stakeholders on generic drug user fees. In addition, FDA continues to 
encourage all interested stakeholders to submit either electronic or 
written comments to the docket (see Comments).

II. What information should you know about the public meeting, when and 
where will the public meeting occur, and what format will FDA use?

    Through this notice, we are announcing a public meeting to update 
stakeholders and hear stakeholder views on what features FDA should 
propose for a generic drug user fee program. We will conduct the 
meeting on May 10, 2011, from 2 p.m. to 3:30 p.m. at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103, 
and 4105, Silver Spring, MD 20993-0002. In general, the meeting format 
will include a presentation by FDA and presentations by stakeholders 
and members of the public who have registered in advance to present at 
the meeting. The amount of time available for presentations will be 
determined by the number of people who register to make a presentation. 
We will also provide an opportunity for organizations and individuals 
to submit either electronic or written comments to the docket after the 
meeting (see Comments). FDA policy issues are beyond the scope of this 
initiative. Accordingly, the presentations should focus on process and 
funding issues, and not focus on policy.

    Dated: April 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10382 Filed 4-28-11; 8:45 am]
BILLING CODE 4160-01-P