SOLICITATION NOTICE
A -- Commercial Services to performa 14-day toxicity study in dogs. Study to include dose ranging, sample analysis validation and telemetry
- Notice Date
- 7/3/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- DAMD17-03-R-0023
- Response Due
- 7/9/2003
- Archive Date
- 9/7/2003
- Point of Contact
- Shelley Marken, 301-619-2268
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shelley.marken@amedd.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- NA This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are b eing requested and a written solicitation will not be issued. The U.S. Army Medical Research Acquisition Activity (USAMRAA) has a request for proposals under DAMD17-03-R-0023. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with add itional information included in this notice. This will be a fixed-price contract. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular. The solicitation has been set aside for small businesses and is associated with NAICS code 541710 under small business code standard is 500 employees. The statement of wo rk is as follows. BACKGROUND: The Severe Malaria Drug project has been involved in the selection an development of artemisinin analogs. Currently artesunate, a member of the artemisinin family of analogs is entering formal development according to GLP/GMP production standards so that Investigational New Drug application can be filed. SCOPE OF WORK: Work will be the performance of a GLP compliant 14 day dog toxicology study as requested by the Food & Drug Administration (FDA) for an Investigational New Drug application for an intravenous treatment of severe malaria. The work will be conducted by a contractor who has extensive drug development and regulatory experience. The contractor will work independently with assigned project areas detailed in the scope o f work as summarized above. The work will be performed for the Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Spring, MD 20910. The contractor will comply with all specified guidelines regarding standard operating pr ocedures. There will be no experimental or clinical work. At the completion of each task, the contractor will submit a summary of the results to the point of contact in the form of an electronic report or through a hardcopy of the data. The contractor wor king under this proposal must be capable of asessing drug development activities and communicating changes to meet regulatory agencies requirements. The period of performance shall be four months from the effective date of the contract. The FOB shall be de stination. Payment will be made upon completion of each of the following tasks. Task 1. Perform a GLP compliant 14 day dog dose ranging study for the Investigational New Drug application of intravenous injectable artesunate. Task 2. Perform a GLP compliant 14 day toxicology study for the Investigational New Drug application of intravenous injectable artesunate. Task 3.Perform a GLP compliant 14 day dog cardio-respiratory telemetric monitoring study for the Investigational New Drug application of intravenous injectable artesunate. Task 4.Provide a GLP compliant final study report for the Investigational New Drug applicaton of intravenous injectable artesunate. The Federal Acquisition Regulation (FAR) 52.212-1, Instruction to Offerors-Commercial, applies to this acquisition. There are no addendments to this clause. The FAR clause 52.212-2 Evaluation-Commercial Items is applicable and is included as follows: (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers and are included in the relative order of importance: Technical Evaluation, Past Performance and Price. Technical Evaulation is 40%, Past Performance is 40% and Price is 20% which equals 100%. All offerors must include a completed copy of the provisions at FAR 52.212-3, Offerors Representation and Certifications-Commercial Items. FAR 52.212-4 Contract Terms and Conditions-Commercial Items apply to this acquisition and there ar e no addendments. FAR 52.212-5 Contract Terms and Conditions, Required to Implement Statues or Executive Orders-Commercial Items applies to this acquisition and the following clauses are applicable to this acquisition: 52.219-8 Utilization of Small Busines s Concerns; 52.222.21 Prohibition of Segregated Facilities; 52.222-26 Equal Opportunity, 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration. There are no additional contract requirements or terms and conditions determined by the contracting offier to be necessary for this acquisition and consistent with customary commercial practices. All offers are due by 2:00 p.m. on 9 July 2003 at USAMRAA, Attn: MCMR-AAA-R, 820 Chandler Street, Fort Detrick, MD. 21702-5014. All questions shoul d be directed by e-mail to shelley.marken@amedd.army.mil.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/USA/USAMRAA/DAMD17/DAMD17-03-R-0023/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Country: US
- Zip Code: 21702-5014
- Record
- SN00364262-F 20030705/030703221910 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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