B -- PREPARATION OF INVESTIGATIONAL NEW DRUG (IND) APPLICATIONS

Notice Date

October 24, 2001

Contracting Office

Acquisition Management Department, Building 54, National Naval Medical Center, Bethesda, MD 20889-5600

ZIP Code

20889-5600

Solicitation Number

N00168-02-T-4048

Response Due

November 2, 2001

Point of Contact

Ms Donna Smith on 301, 295-0548, Fax 301, 295-0286, E mail: DRSmith@bethesda.med.navy.mil

Description

The Acquisition Management Department, National Naval Medical Center (NNMC) Bethesda, MD 20889 has a requirement for the Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, MD 20910. NNMC intends to award a sole-sourced procurement to Biologics Consulting, Inc., 1407 King Street, Alexandria, VA 22314. The contractor must prepare Investigational New Drug (IND) applications oral and intranasal Campylobacter flagellin and E. Coli heatlabile toxin LT (R192G) for submission to the Food and Drug Administration. Contractor will review records and data supporting preclinical testing (pharmacology/toxicology), manufacturing, and analytical methods characterizing the vaccine product. Based on the review, provide recommendations for presenting existing information to CBER and recommend additional studies/testing when necessary. Contractor will produce the final IND document, including structure and formatting of IND text, organization of all attachments and appendices, and copying and collating of final docuemnt into binder for submission to CBER. Should you desire a copy of the solicitation, please contact the above. Award will be based on the Federal Acquisition Regulation.

Record

Loren Data Corp. 20011026/BSOL001.HTM (W-297 SN5114F2)