Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 23, 2003 FBO #0478
SOURCES SOUGHT

A -- Identification of Immunotoxic Drugs Using Standard Nonclinical Toxicology Studies

Notice Date

3/21/2003
 

Notice Type

Sources Sought
 

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-D87951
 

Archive Date

4/16/2003
 

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. D87951. 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 7389 and the North American Classification System (NAICS) Code is 541710. The FDA intends to issue a purchase order for the following project. The contractor will catalog the clinical immune effects of selected drugs, including any indication of allergenicity and increased incidence of infections, and collect parametric data from nonclinical studies that might indicate adverse immune effects from the selected drugs. Nonclinical parameters that will be analyzed include increased incidence of infections, routine hematology, routine clinical chemistry (e.g. changes in total protein levels and composition), body weight and weight and histology of all lymphoid tissues (e.g. bone marrow, lymph nodes, spleen and thymus), gross necropsy evaluations and histopathology of lymphoid organs, and carcinogenicity. For each selected drug, the contractor will collect data that will be used to evaluate the potential of the selected nonclincial parameters to predict adverse clinical immune effects. The type of analysis will depend upon the quality of the data obtained and it may or may not include generating correlation coefficients between nonclinical parameters and clinical immunotoxic effects. The contractor will also aid in the preparation of the data for presentation to CDER and its stakeholders. The principal investigator and co-investigators will advise and assist the contractor in all aspects of the project. A learning curve is expected and the expected time frame for the first couple of drug is 3 to 4 weeks per drug. After that it is expected that each drug will take approximately two weeks to complete. The final month will be used to compile data into a final report, write a draft paper and potentially design a poster for the FDA Science Forum. The contractor will have to work on-site in space provided by the FDA. Period of Performance: One year from date of award or 2000 hours from date of award. Requirements: The contractor should have an interest in immunology and drug development. Minimum requirements include a BS with a minimum of 30 credit hours of science, of which at least 15 hours must be in a relevant biological field. Preference will be given to candidates with graduate training in immunology, pathology and/or histology. Should also have good computer and organizational skills. The contractor shall obtain FDA security clearance prior to beginning work and sign a confidentiality agreement as well. Please include a Curriculum Vitae in your application. The following FAR Clauses shall apply to this solicitation: 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 will be issued to the contractor offering the best value to the government. FAR provisions can be found at the following website: http://www/arnet.gov.
 

Place of Performance

Address: DHHS/FDA/CDER/OND/ODEIII/DRUDP, 5600 Fishers Lane, HFD-580, Rockville, Maryland

Zip Code: 20857

Country: USA
 

Record

SN00284907-W 20030323/030321213321 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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