70--The US Army Medical Research Acquisition Activity intends to procure Dell Poweredge 4600 servers and 18 GB Hard Drives under the FAR authority 6.302-1(c), under a brand name justification and approval.

The Defense Blood Standard System (DBSS) v3.04 is a Blood Established Computer Software (BECS) that is required by law to be sustained under the Code of Federal Regulations (CFR), Title 21, Series 800 to 899. The Food and Drug Administration (FDA) requires compliance to current Good Manufacturing Practices by qualified medical device suppliers to meet industry standards of care. The computer hardware as well as the software application are part of the medical device as regulated by the FDA and cannot be modified without prior FDA approval. The current FDA approved hardware configuration is the Dell PowerEdge 4600 server. Purchase of any other manufacturer's hardware or even a different Dell server would violate CFR, Title 21, Series 800 to 900 without prior FDA approval including a significant system testing and validation effort by the DBS Project Office. Market research has indicated that these items are no longer manufactured and must be procured as used/refurbished. Several vendors have been identified that can provide the products. No solicitation document exists. Any firm that believes it can provide the the Dell PowerEdge 4600 Servers and 18GB Hard Drives is invited to submit written notification to the Contracting Officer within 5 calendar days from the date of publication of this notice. Supporting evidence must be furnished in sufficient detail to demonstrate the firm's ability to provide the products. Information can be sent to: USAMRAA, ATTN: MCMR-AAA-P (Jodi Cardoza), 820 Chandler Street, Frederick, MD 21702-5014. No telephone requests will be accepted. Responses received will be evaluated; however, a determination by the government not to compete the procurement as a brand name only is solely within the discretion of the government.