SOLICITATION NOTICE
A -- Science Policy Advisor to the CDRH's Transmissible Spongiform Encelphalopathies Working Group
- Notice Date
- 6/16/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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-B4280404
- Response Due
- 7/1/2004
- Archive Date
- 7/16/2004
- Point of Contact
- Barbara Kennedy, Contract Specialist, Phone 301-827-7166, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
barbara.kennedy@oc.fda.gov, hbrown@oc.fda.gov
- Description
- The Food and Drug Administration intends to issue a non-competitive, sole source purchase order to Dr. KiKi Hellman of Clarksburg, MD. Dr. Hellman shall serve as the Transmissible Spongiform encephalopathies/bonne spongiform encephalopathy (TSE/BSE) science policy advisor to CDRH (CDRH TSE Working Group) Dr. Hellman shall complete a Draft White Paper on TSE Science and Risk Analysis and provide advise on CDRH TSE Action Plan issues including a comprehensive plan to address TSE decontamination approaches for device, equipment, and facilities, draft Standard Operating Procedure (SOP) for device-related TSE inquiries, review/update of 1998 CDRH BSE Guidance Document, a TSE state-of-science assessment and identification of appropriate research to fill in formation gaps, and a comprehensive plan for cooperation with FDA Centers and other agencies/groups on TSE issues. Finally, Dr. Hellman shall develop follow-up approach (es) to address recommendations of the FDA TSE Advisory Committee at its July 2004 Public Meeting on TSE decontamination approaches for regulated devices, including surgical instruments, facilities and equipment. Dr. KiKi Hellman is an internationally renowned senior scientist with extensive experience in infectious diseases, including TSEs, by virtue of her formal training as a microbiologist/virologist and over thirty years? research and regulatory science and policy career. This has enabled her to address the public health issues of emerging diseases, such as BSE and other TSEs, and to formulate needed preventive actions. She has interfaced with the FDA TSE Advisory Committee, as well as other Federal agencies (NIH, CDC, USDA) and other national )PhARMA, and AdvaMed) and international (WHO) group to identify science gaps, address TSE risks, and develop appropriate TSE prevention programs and policies. Dr. Hellman is internationally recognized as an expert and chaired several international public workshops on TSE risks, inactivation, and diagnosis and made presentations to numerous and diverse international audiences. The period of performance is for 6 weeks. This is not a request for quotes. However other bidders/offers who believe they posses the capabilities and expertise to perform this work must respond to the responsible contract specialist prior to the response due date. The FDA?s evaluation/award will be based on the technically acceptable quote that offers the best value to the Government. The sole source procurement will be awarded as a simplified acquisition in accordance with FAR 13.5.
- Record
- SN00604347-W 20040618/040616211839 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |