SOLICITATION NOTICE
A -- Topical Drug Cream Development for Leishmaniasis, Manufacture and FDA Submission Approval.
- Notice Date
- 1/13/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-05-R-0003
- Response Due
- 1/28/2005
- Archive Date
- 3/29/2005
- Small Business Set-Aside
- N/A
- Description
- Solicitation No. W81XWH-05-R-0003 will be ISSUED ON OR ABOUT 28 Jan 2005 and proposals will be due in accordance with block 9 of the Request for Proposal (RFP). No hard copies of the solicitation will be issued by the contracting office. All intere sted parties can view, download and print a copy of the solicitation and any resulting amendments at the following website: www.usamraa.army.mil, click on Products, then Solicitations. Scope of Work: The requirement is for drug development, submission of a New Drug Application (NDA) to the FDA for approval of Paromomycin Sulfate plus Gentamicin Sulfate in Aquaphilic (referred to hereafter as Topical Paromomycin) for use as a topical agent that can be applied directly to the cutaneous leishmaniasis lesion o n human skin, and provide for production options post-FDA approval. Upon award, the government will provide OTSG IND batch production records for the Topical Paromomycin and the historical regulatory submissions to FDA as government furnished material. T he contractor shall be responsible for manufacturing batches of the subject drug for required pre-NDA batches and NDA batches for clinical trials and stability testing requirements. All offers must provide a written technical proposal discussing specific technical evaluation factors and a business cost proposal, with costs identified per fiscal year. Proposal will be evaluated on a Best Value basis. It is anticipated that the resulting contract will be issued as a Cost Plus Fixed-Fee Award, for a period that includes a Four Year Base and Two Option Years. In accordance with DFARS 252.204-7004, all contractors wishing to do business with the Department of Defense must be registered in the Central Contractor Registration (CCR) database. CCR registration can be accomplished at the following website: www.ccr. gov or by calling (888)227-2423. This procurement is UNRESTRICTED. The North American Industry Classification System (NAICS) code for this procurement is 541710 with a size standard of $34,145,927 million in average annual receipts.
- 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
- SN00734696-W 20050115/050113212200 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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