{"database": "openregs", "table": "federal_register", "rows": [["2010-19537", "Generic Drug User Fee; Public Meeting; Request for Comments", "Notice", "The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for generic drug applications have increased in recent years. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President's Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program. As FDA begins negotiations with the regulated industry about generic drug user fees, FDA will hold a public meeting to gather the public's input on such a program. Date and Time: The public meeting will be held on September 17, 2010, from 9 a.m. to 5 p.m. Location: The meeting will be held at the Hilton Washington DC/ Rockville and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Persons: Mary C. 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, FAX: 301-847-8753, e-mail: mary.gross@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, 301-796-4830, FAX: 301-847-3541, e-mail: peter.beckerman@fda.hhs.gov. Registration and Requests for Oral Presentations: If you wish to attend and/or present at the meeting, please register by September 9, 2010. Please e-mail your registration information to GDUFA_ Meeting@fda.hhs.gov. Those without e-mail access may register by contacting one of the persons listed in the Contact Persons section of the document. Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail address, and phone 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 due to a disability, please contact Mary Gross or Peter Beckerman (see Contact Persons) at least 7 days before the meeting. Comments: Regardless of attendance at the public meeting, interested persons may submit either electronic or written comments by October 17, 2010. 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. Submission of comments prior to the meeting is strongly encouraged.", "2010-08-09", 2010, 8, "https://www.federalregister.gov/documents/2010/08/09/2010-19537/generic-drug-user-fee-public-meeting-request-for-comments", "https://www.govinfo.gov/content/pkg/FR-2010-08-09/pdf/2010-19537.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2010-19537"], "units": {}, "query_ms": 0.522407004609704, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}