Document ID: FDA-2010-N-0381-0046
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee; Request for Comments
Posted Date: 2011-07-22T04:00Z

[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44014-44015]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18591]

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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. FDA has been 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 fourth public meeting on this topic to provide an update and 
to gather additional input on such a program.
    Date and Time: The public meeting will be held on August 25, 2011, 
from 2 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, Office of Policy, 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_Meeting3@fda.hhs.gov by August 18, 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. To ensure consideration, all comments must be 
received by September 26, 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 September 26, 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. New legislation would be required for FDA to 
establish and collect user fees for generic drugs, and FDA has been 
engaged in negotiations with industry over aspects of a joint proposal 
for a generic drug user fee program, including fees and performance 
goals, for several months. The Agency has held three prior public 
meetings on the topic before and during this process. 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 is holding an 
additional public meeting. The 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 August 25, 2011, from 2 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

[[Page 44015]]

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: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18591 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P