Source: https://www.federalregister.gov/documents/2013/05/09/2013-11007/generic-drug-user-fee-amendments-of-2012-regulatory-science-initiatives-public-hearing-request-for
Timestamp: 2017-08-22 07:53:11
Document Index: 749154655

Matched Legal Cases: ['art15', 'art15', 'art 15', 'art 15', '§\u200915', 'art 15', 'art 10', 'art 10', '§\u200910', '§\u200915', 'art 15', '§\u200915']

Federal Register :: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request for Comments
https://www.federalregister.gov/d/2013-11007 https://www.federalregister.gov/d/2013-11007
Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), 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.
Transcripts: Transcripts of the public meeting will be available for review at the Division of Dockets Management and on the Internet at: http://www.regulations.gov approximately 30 days after the public meeting. A live Webcast of this public meeting will be available at: https://collaboration.fda.gov/​regscipart15/​.
In July 2012, Congress passed GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public access to safe, high-quality generic drugs and to reduce costs to industry. To support this goal, FDA agreed in the GDUFA commitment letter to the FY 2013 Regulatory Science Plan, and to consult Start Printed Page 27114with industry and the public in order to create an annual list of regulatory science initiatives specific to research on generic drugs for each subsequent year covered by GDUFA. The FY 2013 Regulatory Science Plan consisted of the following research topics:
FDA will consider all comments made at this meeting or received through the docket (see section V, Request for Comments) as it develops its FY 2014 GDUFA Regulatory Science Plan. Additional information concerning GDUFA, including the text of the law and the letter in which the Agency describes its commitments may be found on the FDA Web site at http://www.fda.gov/​gdufa.
If you need special accommodations because of a disability, please contact Thushi Amini or Robert Lionberger (see Contact Persons) at least 7 days before the meeting. For those unable to attend in person, FDA will provide a Webcast to the meeting. To join the meeting via the Webcast, please go to: https://collaboration.fda.gov/​regscipart15/​.
FDA will try to accommodate all persons who wish to make a presentation. These individuals should identify the section and the number of each question they wish to address (see section II) in their presentation to help FDA organize the presentations. FDA will notify registered presenters of their scheduled presentation times. The time allotted for presentations will depend on the number of individuals who wish to speak. Persons registered to make an oral presentation should check in before the meeting and are encouraged to arrive early to ensure the designated order of presentation times. An agenda for the meeting and other background material will be made available 5 days before the meeting at http://www.fda.gov/​Drugs/​NewsEvents/​ucm344710.htm. Once FDA notifies registered presenters of their scheduled times, they should submit an electronic copy of their presentation to GDUFARegulatoryScience@fda.hhs.gov on or before June 14, 2013.
The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner and the Center for Drug Evaluation and Research. Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10, subpart C) (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see section VI). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).
Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may also be viewed at the Division of Dockets Management (see Comments). A transcript will also be made available in either hardcopy or on CD-ROM upon submission of a Freedom of Information Start Printed Page 27115request. 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.