SOURCES SOUGHT
A -- Radiation/Nuclear Medical Countermeasure Product Development Support Services Contract
- Notice Date
- 7/13/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-09-079
- Archive Date
- 8/12/2009
- Point of Contact
- Deborah J Blyveis, Phone: 301-594-7211, David T Lisle, Phone: 301-451-2617
- E-Mail Address
-
blyveisd@niaid.nih.gov, dlisle@niaid.nih.gov
(blyveisd@niaid.nih.gov, dlisle@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. ALL SMALL BUSINESSES ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 employees. The National Institute of Allergy and Infectious Diseases is conducting a market survey to determine the availability of sources and potential technical capability to perform a contract entitled "Radiation/Nuclear Medical Countermeasure Product Development Support Services." The NIAID plans to enter into a single 5-year work assignment-based, Cost-Reimbursement Contract to develop radiation/nuclear medical countermeasures (MCMs) suitable for use in a mass casualty incident for 1) the mitigation or treatment of the acute radiation syndromes (ARS) and delayed effects of acute radiation exposure (DEARES); and 2) the decorporation of internalized radionuclides. NIAID anticipates that research and development studies supported by this RFP will advance candidate MCMs toward eventual FDA approval or licensure for ARS/DEARE and radionuclide contamination. It is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs or biologics that are already licensed or approved for other indications). The Contractor will collaborate with NIAID and, under the direction of NIAID, with organizations that have developed MCMs and with other federal authorities, including the FDA. It is anticipated that the work to be performed by the Contractor under the Base Contract will consist of efficacy testing to fulfill the requirements of the FDA "Animal Rule" and will also include animal model development and refinement. Other tasks related to drug development (chemistry, manufacture and control, non-clinical safety testing, human safety studies) will be covered by Options to be exercised at the discretion of the Government. Potential sources must demonstrate and document the following in their capability statements: GLP-compliant facilities that can perform radiation exposure and internal radionuclide contamination studies in large animals (non-human primates, dogs) and rodents. Faculties capable of manufacturing MCM candidates under cGMP conditions. GLP-compliant facilities capable of performing non-clinical safety testing. GCP-compliant facilities capable of performing human safety studies. Capability statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: The performance of GLP efficacy studies for hematopoietic and gastrointestinal acute radiation syndromes in rodents and large animals (non-human primates, dogs). Development and refinement of rodent and large animal (non-human primates, dogs) models for hematopoietic and gastrointestinal acute radiation syndromes and lung models for radiation injury. The performance of internal radionuclide contamination and decorporation experiments in rodents and large animals (non-human primates, dogs.) Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by July 28, 2009. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID(AI)-SBSS-09-079/listing.html)
- Record
- SN01873161-W 20090715/090713235306-455db384bc5647a06900449fb1db6445 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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