Loren Data's SAM Daily™

fbodaily.com
Home Today's SAM Search Archives Numbered Notes CBD Archives Subscribe
FBO DAILY ISSUE OF JULY 15, 2009 FBO #2788
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
(may not be valid after Archive Date)

FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |
ECGrid: EDI VAN Interconnect ECGridOS: EDI Web Services Interconnect API Government Data Publications CBDDisk Subscribers
 Privacy Policy  Jenny in Wanderland!  © 1994-2024, Loren Data Corp.