Therapeutic for treatment of Thrombocytopenia arising from H-ARS
Closed Solicitation Posted
- Solicitation number
- 75A50122R00021
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeks to procure up to 170,000 unit doses of an FDA-approved therapeutic for the treatment of thrombocytopenia arising from hematopoietic acute radiation syndrome over a period of up to 10 years. The initial procurement will be up to 51,000 doses over a 5-year base period, with additional quantities procured through five 1-year option periods to reach the total requirement. Offerors must demonstrate the ability to provide contractor-managed inventory with stock rotation and accurate inventory reporting. Deadlines for questions are August 12th and 16th, with proposals due by September 9th.
There is no set-aside designation. The NAICS code is 325412, with PSC code 6515. The procurement seeks up to 170,000 unit doses total to be delivered over 10 years, with 51,000 doses initially and additional quantities through the option periods. The contractor must maintain secure labeling, storage, distribution and transport programs, with inventory stored and accessible nationwide for emergency deployment. Negotiation of a quality agreement with ASPR is also required.
Notice text
The objectives of this contract are: 1) to acquire a U.S. Food and Drug Administration (FDA) approved treatment for use in a mass casualty event where thrombocytopenia or platelet loss is a major concern. The total procurement may be up to 170,000 unit doses. The initial procurement shall be up to 51,000 doses. In each option period additional pharmaceutical doses shall be procured to reach the 170,000 level. The product selected will be procured in stages (i.e., initial purchase of up to 51,000 unit doses, plus up to five additional potential deliveries all over a 10-year period to build towards the requirement need-based quantity); and 2) for the Contractor to provide, as part of the annualized acquisition, a contractor-managed inventory (e.g., VMI) with rotation of stock to control product expiry. The inventory management plan shall also include a plan to provide the SNS with an accurate inventory of product as well as location(s) should the U.S. Government (USG) have an immediate need for product in an emergency situation. The Contractor's plan to deliver the product as needed by the government, the Quality Agreement with the Assistant Secretary of Preparedness and Response (ASPR), shall be negotiated to align with the USG’s specific product use during a mass casualty event.
In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled.
Files
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Solicitation | |
| Therapeutic for treatment of Thrombocytopenia arising from H-ARS | Pre-Solicitation |
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