SOLICITATION NOTICE
B -- QT Interval Prolongation in Isolated Rabbit Hearts
- Notice Date
- 8/11/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-D18224
- Response Due
- 8/26/2003
- Archive Date
- 9/10/2003
- Point of Contact
- Stephanie Hawk, Buyer, Phone 301-827-7886, Fax 301-594-2127,
- E-Mail Address
-
hawks@cder.fda.gov
- Description
- This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. D18224. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification (SIC) Code for this acquisition is B529 and the North American Classification System (NAICS) Code is 541710. The FDA intends to issue a purchase order on a sole source basis to Georgetown University Medical Center for the following service entitled: Determination of Drug-Induced QT Interval Prolongation in Isolated Rabbit Hearts. The purpose of this project is to evaluate the predictive power of the isolated rabbit heart in evaluating the potential of a new drug to prolong QT and induce torsade de pointes. Period of Performance is one year from date of award. Deliverables: On November 1, 2003 and May 1, 2004, the contractor must submit a brief one page typewritten summary of the progress of the project and a delineation of any problems encountered. Please include any abstracts, pre-prints or publications with the appropriate progress report. Within 30 days of project completion the contractor must submit a full typewritten final report to the Office of Women’s Health (OWH). The format for the final report will be that of a journal article including an introduction, materials and methods, and a discussion of the results. A journal article is acceptable if it contains all the information covered in the research proposal. OWH may request an interim report and conduct a site visit of your research. Any published papers or public presentations on this work will acknowledge in writing where applicable support from the FDA Office of Women's Health. The following FAR Clauses shall apply to this solicitation: 52.213-4 TERMS AND CONDITIONS-SIMPLIFIED ACQUISITIONS (OTHER THAN COMMERCIAL ITEMS) (JUNE 2003); and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. The award is being issued on a sole source basis because the Georgetown University laboratory is experienced with the isolated rabbit heart model and has been successful in previous collaborations with the Food and Drug Administration. This study compliments that previous work. The lab and investigators are internationally recognized for scientifically excellent investigations into the issue being researched. FAR provisions can be found on the following website: http://www/arnet.gov.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/FDA/DCPM/Reference-Number-D18224/listing.html)
- Place of Performance
- Address: FDA/CDER/OND 1451 Rockville Pike, HFD-110 Rockville, Maryland
- Zip Code: 20852
- Country: USA
- Zip Code: 20852
- Record
- SN00398191-F 20030813/030811223135 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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