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Notice

Generic Drug User Fee; Public Meeting; Request for Comments

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

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.

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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 Start Printed Page 44015meeting 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.

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Dated: July 19, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

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[FR Doc. 2011-18591 Filed 7-21-11; 8:45 am]

BILLING CODE 4160-01-P