Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

Q -- COMPARATIVE BIOAVAILABILITY STUDY OF PYRIDOSTIGMINE BROMIDE TABLETS SOL DAMD17-00-R-0016 DUE 072500 POC B.C. Baker III (301) 619-2035 E-MAIL: Mike.Younkins@det.amedd.army.mil, BC.Baker@det.amedd.army.mil. The U.S. Army Medical Research Acquisition Activity (USAMRAA) anticipates awarding a contract to provide clinical comparative Bioavailability study of ICN-and Roche-Manufactured 30 Mg Pyridostigmine Bromide Tablets. The contract shall be awarded for a base period of 1 year. This is a combined synopsis/solicitation for commercial items, prepared IAW the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested & a written solicitation will not be issued. This is a request for proposal (RFP) & the solicitation document & incorporated provisions & clauses are those in effect through Federal Acquisition Circular (FAC) 97-3. The contractor shall develop a protocol and then conduct a Clinical Study. Specifically, the contractor shall: a. Prepare a draft protocol for a double-blind randomized cross-over design study with 24 subjects that shall include experimental detailsto include experimental design, oral dosing procedures, time periods for collection of blood samples, procedures for shipment of samples for pyridostigmine analyses to an off-site contractor, a Case Report Form, an Informed Consent Form, a statement of consent to audit by USAMMDA QAU at periodic intervals (two visits for a civilian contractor and three for a military facility). and a statement that the contractor shall prepare a Phamacokinetic Report from the Analytical Report on Blood Levels provided by the off-site contractor. Contractor shall address all Government-provided comments on the draft Protocol in the finalized Protocol. b. Prepare a draft Final Report for Government review. The Final Report shall incorporate all Government-provided comments on the draft Final Report. The Final Report shall be acceptable for submission to the FDA. c. Have the Government-approved Protocol approved by the contractor's local Human Subjects Research Review Board before submission to the Command's Human Subjects Research Review Board (HSRRB) for approval. Approval of the HSRRB shall be obtained before study start. The clinical study will be done under Army's IND 23509 for Pyridostigmine Bromide and shall be conducted in accordance with all applicable federal, state, local and Army regulations. Availability of ICN-manufactured PB is projected for July 2000. Conduct of study can not begin before that date but all preliminary work can be done. The Government shall provide the Roche- and ICN-manufactured 30 mg pyridostigmine bromide tablets. The contractor shall provide a Gantt chart for the Study that shall have day 1 being the receipt of the Roche- and the ICN-manufactured pyridostigmine tablets by the contractor. FAR 52.212-1, Instruction to Offerors Commercial Items (Oct 1995) is incorporated by reference. Applicable is FAR 52.212-2 Evaluation Commercial Items: The Government will award a contract resulting from this synopsis/solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous, representing the best value to the Government, price and other factors considered. Evaluation of offers shall be based on the following factors: (1) Past Performance on Work of Similar Nature; (2) Personnel; (3) Contract Management and Technical Approach; (4) Cost. Factors are listed in their relative order of importance. The technical proposal shall include any information the offeror deems relevant & pertinent to these requirements. As a minimum, the offeror shall include their understanding of the requirement, their corporate structure & how they will manage the study. Identify a minimum of 3 Federal, State, local Government, or private contracts for which the offeror has performed the same or similar services within the last 3 years, including name, address & current phone telephone number, Point of Contacts, contract number, date and amount of award. Offerors are reminded to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The following clauses are incorporated into this solicitation: FAR 52.212-4, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items. FAR clauses 52.204-6, 52.216-18, 52.216-19, 52.216-22, 52.217-8, 52.217-9, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-41, 52.222-42, (The DOL Wage Determination No. 94-2167 rev 10, applies), 52.222-46, 52.224-1, 52.232-19, 52.232-33, 52.237-2, 52.242-15, and 52.242-17 apply, as well as DFARS clauses at 252.205-7000,252.212-7001, 252.227-7015, 252.227-7037, and 252.232-7007 and the USAMRAA local clause at 52.0027-4004-Safeguarding Proprietary Information. Questions are due by 2:30 PM EST, 18 July 2000. Proposals are due by 2:30 PM EST 25 July 2000 via email (Microsoft Word and Excel format requested) to USAMRAA, ATTN: MCMR-AAA-V, 820 Chandler Street, Fort Detrick, MD 21702-5014. The full SOW can be obtained by contacting the POC to request a copy via email. POC is B.C. Baker III (301) 619-2035, fax (301) 619-2505 and email BC.Baker@det.amedd.army.mil. Posted 07/05/00 (W-SN471397). (0187)

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