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U.S. Department of Health and Human Services

Drugs

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Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on establishing a list of qualifying pathogens (i.e., those that have the potential to pose a serious threat to public health), as required under the Food and Drug Administration Safety and Innovation Act (FDASIA). This public hearing is being held to obtain comments from the public to determine the methodology that should be used in developing the list of qualifying pathogens, and to elicit suggestions for adding specific pathogens to the list.

Date:   December 18, 2012, from 9:00 a.m. to 5:00 p.m.

Location:   FDA White Oak campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503, Silver Spring, MD 20993 (Note - Entrance for public meeting attendants (non-FDA Employees) is through Bldg 1.)

Registration:  The public hearing is free, and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register. If you wish to make an oral presentation during the hearing, you must register by submitting either an electronic or written request by close of business on Monday, December 3, 2012 to CDER-GAINPublicMtg@fda.hhs.gov.

For further information contact: Lee Lemley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-7563, FAX: 301-847-8753, e-mail: CDER-GAINPublicMtg@fda.hhs.gov.

Webcast

 A live webcast of this public hearing will be viewable at the following Web address: https://collaboration.fda.gov/gain121812/