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FBO DAILY ISSUE OF AUGUST 19, 2010 FBO #3190
SOURCES SOUGHT

A -- Calibration of Rabbit and Mouse Spore Inhalation Challenge Models

Notice Date
8/17/2010
 
Notice Type
Sources Sought
 
NAICS
541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, NCTR-50 RM422 HFT-320, Jefferson, Arkansas, 72079, United States
 
ZIP Code
72079
 
Solicitation Number
1077467
 
Archive Date
9/4/2010
 
Point of Contact
Roy E. Mutch, Phone: 404-253-1258
 
E-Mail Address
roy.mutch@fda.hhs.gov
(roy.mutch@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged businesses and HUBZone firms, Veteran and Service-Disabled Veteran-Owned small businesses, and Women-Owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitations, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission the information being requested or reimburse expenses incurred to interested parties for responses to this Sources Sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any small business that can provide the following: Statement of Work: Objective 1: Generate rabbit reference antisera specific for B. anthracis Protective Antigen (PA), Lethal factor (LF) and the Loop Neutralizing Determinant (LND) of PA, Use these rabbit reference sera to determine therelationship between the PD50 in mice and rabbits subjected to aerosol spore challenge with B.anthracis Sterne or Ames strain, respectively. Deliverables: Standardized high titer antiseraagainst recombinant protective antigen (rPA) and against the loop-neutralizing determinant of PA (LND) Objective 2: Utilizing the mouse aerosol challenge model and the rabbit reference antisera, evaluate whether synergies exist between PA-, LF- and LND-specific antibody. Deliverable: Quantitative analysis of serum anti-PA and anti-LND antibody titers in all sera generated during challenge studies conducted at CBER. Technical Requirements: & # 61607; The contractor must either have sufficient quantities of rPA, LF and LND on-hand to immediately begin the vaccination of rabbits to generate reference serum or have immediate access to these reagents. & # 61607; The contractor must have the ability to provide the characterized rabbit reference serum against PA, LF and LND. The minimum quantity and titer of each serum needs to be as follows: Anti-PA antiserum: volume: 100 ml; ELISA titer on rPA: 1/10,000; TNA titer: 1/1,000 Anti-LF antiserum: volume: 100 ml; ELISA titer on rLF: 1/10,000; TNA titer: 1/1,000 Anti-LND antiserum: volume: 100 ml; ELISA titer on rPA: 1/10,000; TNA titer: 1/1,000 & # 61607; The ELISA and TNA titers of the reference sera must be determined by the contractor and that information must be provided upon delivery of the reference sera. & # 61607; The contractor will determine the anti-PA, anti-LF, and anti-LND ELISA and TNA titers of the mouse sera provided. Period of Performance Period of performance is not to exceed six months from date of award. The three rabbit reference sera and accompanying reports to be delivered to FDA within 15 weeks from the time funds are available to the contractor. Report to be included upon delivery of anti-sera specifying the amount of specific antibody present in each serum. The assay results on mouse sera to be provided to FDA within 10 business days of receipt of the samples. Bi-weekly teleconferences are to be held between contractor and CBER point of contact throughout the period of performance to provide updates on progress. Total performance should require no more than six (6) months: Objective 1: Months 1 - 4 Objective 2: Months 4 - 6 Interested small business potential offerors are encouraged to respond to this notice. However be advised that generic capabilities are not sufficient for effective evaluation of respondents capacity and capabilities to provide service for Calibration of Rabbit and Mouse Spore Inhalation Challenge Models. All offerors must be registered in the CCR located at http://www.ccr.gov. Respondents will not be notified of the results of this evaluation. The Government will not entertain questions regarding this Market Research. Interested contractors must submit their responses by email, fax or mail to Roy Mutch, Contract Specialist, 60 8th Street, NE, Atlanta, GA 30309 or roy.mutch@fda.hhs.gov, on or before August 20, 2010, 16:00pm EDT.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1077467/listing.html)
 
Place of Performance
Address: FDA/CBER, TOD J. MERKEL, Ph.D., BLDG 29, ROOM 207, 29 LINCOLN DRIVE, BETHESDA, Maryland, 20892, United States
Zip Code: 20892
 
Record
SN02243168-W 20100819/100817235103-a935cd7fc27ede3125bb00fa9a2d659d (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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