SPECIAL NOTICE
K -- FDA Industry Day - Statement of Priorities
- Notice Date
- 2/3/2016
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- IndustryDay-1160698
- Point of Contact
- Christopher R. McGucken, Phone: (240) 402-7599, Priscilla V. Harrison, Phone: 2404027609
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov, priscilla.harrison@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov, priscilla.harrison@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Specifications and images of the current device. This is a description of the objectives for the next generation device. Industry Day Announcement The Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA) is interested in the further development of an FDA patented device used to detect counterfeit drugs. In an effort to introduce the device to industry, receive feedback from interested parties, and identify capable sources, FDA will be hosting an Industry Day on March 3, 2016. The Industry Day will consist of presentations describing the current state of the device, the proposed next generation of the device and a demonstration of current device performance. Attached to this notice are documents (Statement of Priorities.pdf and Specifications.pdf) that describe the current state of the device as well as descriptions of what the next generation device must be capable of upon completion of the targeted objectives. Registration Interested parties have the option to attend the Industry Day in-person or via webcast. The limit to how many individuals may attend the event in-person is three (3) representatives per organization with a maximum capacity of 80 individuals. Registration for in-person attendees will be closed when capacity is reached or by February 24, 2016, 3:30 PM ET, whichever occurs first. The webcast will be hosted using WebEx and a link to the meeting will be sent to all registered attendees prior to the meeting. Pre-registration for this event is required for in-person attendees as well as webcast attendees. Please send e-mails requesting attendance to: Priscilla.Harrison@fda.hhs.gov with a copy to Christopher.Mcgucken@fda.hhs.gov. Registration e-mails must identify the following: Subject Line: Registration for Industry Day March 3, 2016 Name Position Affiliated Organization/Company Affiliated Organization/Company business size Affiliated Organization/Company Address In-person or webcast Email Phone Number The location of the Industry Day presentations will be held at: FDA's Forensic Chemistry Center, 6751 Steger Drive, Cincinnati, OH 45237 Questions Attendees are encouraged to submit questions prior to the Industry Day so that Government officials may have information on topics of interest to address in the presentations. Upon review of the attached documents technical questions must be submitted via email to Priscilla.Harrison@fda.hhs.gov no later than February 24, 2016 3:30 ET. Note: there will be an opportunity for questions and answers following the presentations and demonstration on March 3. This will be available for both online and in-person attendees. Conference Attendance Please arrive at 9:00 AM EST. Security Process: •Drive to the front of the building at 6751 Steger Dr., Cincinnati, OH 45237 •Enter through front door and push doorbell. Security guards will provide entry through the second door •Show either a state or federal photo ID, preferably a driver's license •Sign into building and onto the Industry Day log and receive a visitor badge •Walk through a security scanner (have minimal items in your pockets) •You will then be taken to the Industry Day location Directions: From the Airport, (South) -(CVG) Greater Cincinnati Northern Kentucky International Airport 30 - 45 minutes I-275 East to I-75 North (Cincinnati) Exit Towne Street (exit 8) bear right Turn left at light onto Paddock Road At next light, turn right onto Edison Drive At stop sign, turn right onto Steger Drive Turn right into (2nd driveway), you will see the Food and Drug Administration sign Follow driveway to the front of the building Enter through lobby where the guards will greet you
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/IndustryDay-1160698/listing.html)
- Place of Performance
- Address: 6751 Steger Drive, Cincinatti, Ohio, 45237, United States
- Zip Code: 45237
- Zip Code: 45237
- Record
- SN04008720-W 20160205/160203234407-6ce335dffb5549569a3386848d59b7f0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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