SOLICITATION NOTICE
L -- Expert Witness
- Notice Date
- 5/30/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-1015752
- Response Due
- 6/9/2006
- Archive Date
- 6/9/2006
- Small Business Set-Aside
- Total Small Business
- Description
- Notice of Intent: The Government intends to negotiate on a sole source basis with an outside expert, Hillring & Associates, Inc. located on Saint Charles Drive, Tampa, FL for a Quality System expert witness to prepare a summary of support for the complaint for injunctive relief against bioMerieux, Inc. This summary of support will be a Quality System regulation review and based on the documentation provided concerning the case. If necessary, the outside expert witness will prepare a declaration and be prepared to testify in court. This announcement constitutes the only solicitation; proposals/bids are not being requested and a written solicitation will not be issued. Center for Devices and Radiological Health (CDRH) requests the services of Ms. Annette Hillring of Hillring & Associates, Inc. as the outside Quality System expert witness for the injunction case against bioMerieux, Inc. bioMerieux manufactures designs, packages, stores, installs, labels and services several in vitro diagnostic devices that are regulated by Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). This case concerns bioMerieux's continuous failure to comply with the United States Food and Drug Administration's (FDA's) Quality System regulation as required by Title 21, Code of Federal Regulation, Part 820 (21 CFR 820). This award will be made 6 days after the date of this notice. The associated North American Industry Classification System (NAICS) Code is 541690 and the Business Size Standard is 6.5 Million dollars in assets. The FDA office building is located at 5600 Fishers Lane, Rockville, MD 20857. These justification and approval requirements are in accordance with FAR subparts 6.3. Acceptance shall be performed by the Food and Drug Administration (FDA) at the address listed above. Offers are due either in person or by fax on June 09, 2006, by 1400 hours eastern time, at Food and Drug Administration 5630 Fishers Lane, Rockville, MD 20857. For information regarding this solicitation, please contact Jeankite Joseph at (301) 827-5095, FAX (301) 827-7106 or email Jeankite.joseph@fda.hhs.gov.
- Place of Performance
- Address: 2098 Gaither Road,, Rockville, MD
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN01058911-W 20060601/060530220244 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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