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FBO DAILY ISSUE OF JANUARY 26, 2003 FBO #0420
SOLICITATION NOTICE

B -- Migration of Legacy Data and Documentation for Drug Substance Registration System

Notice Date
1/24/2003
 
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-D36050
 
Archive Date
2/23/2003
 
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. D36050. 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 7379 and the North American Classification System (NAICS) Code is 541512. The FDA intends to issue a purchase order on a sole source basis to the Cygnus Corporation for the following service entitled: Migration of Legacy Data and Documentation of Drawing Rules for Drug Substance Registration System. The contractor will review the legacy substances of the Center for Drug Evaluation and Research and will identify those that need to be represented as mixtures, i.e., as combinations of distinct structures. Working with CDER?s registration staff, the contractor will enter structure and related data for these mixtures and will validate these data. Additional tasks to be completed by the contractor include: (1) In collaboration with CDER?s drug registration staff, prepare a document summarizing rules for drawing structures for CDER?s molecular registration system. This document will be used as guidance for future registration operations; (2) Conduct the migration of newly entered and validated structure data into the registration system database; (3) Assist in planning and implementing the linkage with systems of the National Library of Medicine. The work will assist CDER personnel in implementing an operational registration system utilizing ISIS molecular registration software provided by MDL Information Systems. The contractor will provide brief, monthly reports detailing accomplishments during prior month, contract resources expended and remaining, and plans for remainder of project. The final product will be a registration database containing CDER?s legacy substances, in the format required by MDL?s registration software along with appropriate documentation. Period of performance is six months from the date of the award. The following FAR Clauses shall apply to this solicitation: 52.212-1 Instructions to Offerors-Commercial; 52.212-4 Contract Terms and Conditions-Commercial Items; 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 Cygnus Corporation has worked on similar information management systems using ISIS technology and has worked with CDER in analyzing National Library of Medicine requirements to interface with CDER?s registration system. They are uniquely familiar with the rule set for the registration system and issues involved in defining it. Cygnus qualifications include experience with and understanding of CDER requirements for chemical compound registration. Their qualifications will reduce the cost of the project and will provide assurance of implementing the registration system in a timely manner. FAR provisions can be found on the following website: http://www/arnet.gov.
 
Place of Performance
Address: FDA/CDER/OPS, 1451 Rockville Pike, Rockville, Maryland
Zip Code: 20852
Country: USA
 
Record
SN00246279-W 20030126/030124213757 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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