This is a Market Search for certified and qualified small business firms. The FDA Office of DSFM Silver Springs, MD has a requirement for human female cadaver spines. All firms responding to this notice must submit qualification statments of their firm, indicating the number of years experience and past experience with the type of project described. Statement must also include references (for whom work was provided): (1) provide contract number, (2) type of contract,(3) description of work performed. The requirements needed for human spine tissue are as follows: A maximum of 32 female cadaver spines ages 25-45 (qty. 16) and 60-85 (qty 16) WITHOUT the following conditions: Long term use (.>2 year) of bisphosphonates such as alendronate, risedronate, zoledronic acid, raloxifene, calcitonin, teriparatide, and estrogen/hormone therapy. • Metaboloc bone diseases such as Pagets disease, osteomalacia, rickets, premenapausal osteoporosis, hyperparathyroidism, osteogensis imperfecta. • Any prior history of vertebral compression fractures, spinal implants (vertebroplasty, spinal fusion, etc.) or cancers that metastasize to the bone. Spine sections must be from at least the first thoracic vertebrae (T1) through the fifth lumbar vertebrae (L5). For all spine sections, serological testing for bloodborne pathogens (HIV1, HIV2, HBV, HCV, RPR/syphilis) is required. Spiones must be harvested fresh and frozen at -80 degrees C less than 24 hours after death. Delivery of spine sections will be on going as spines that qualify will be identified and shipped on a continuing basis.

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