SOLICITATION NOTICE
A -- Calibration of Rabbit and Mouse Spore Inhalation Challenge Models
- Notice Date
- 8/12/2010
- Notice Type
- Combined Synopsis/Solicitation
- 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
- FDA-10-223-SOL-00300
- Archive Date
- 9/2/2010
- 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
- The Food and Drug Administration intends to award a Purchase Order for the Calibration of Rabbit and Mouse Spore Inhalation Challenge Models. The requirements will be awarded using Simplified Acquisition Procedures in accordance with FAR 13.5. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the solicitation: Proposals are being requested and a written solicitation will not be issued. The solicitation number is FDA-10-223-SOL-00300. This solicitation is issued as Request for Quote (RFQ). The associated North American Industry Classification System (NAICS) is 541712. Contract Type: Commercial Item-Firm Fixed Price. All responsible sources may submit a quote which shall be considered. The Food and Drug Administration is soliciting 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 FOB: Shipping Point - Destination. Company must be registered in Central Contractor Registration (CCR) before an award could be made to them. If the company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The provision at FAR 52.212-1 Instructions to Offeror-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. The provision a FAR 52.212-2 Evaluation-Commercial Item is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of this provision are as follows: (i) Technical capability described to "Meet or Exceed the Requirement", (ii) Price. The Government will award a Purchase Order resulting from this solicitation to the responsible offeror whose offer comforming to the solicitation will be the most advantageous to the Government. Technical factors and price considered. The Govenment is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive materials necessary for the Government to determine whether their instrument meets the technical requirements. The Government reserves the right to make an award without discussions. The provision at FAR 52.212-3, Offeror Representation and Certification-Commercial Items, applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Excutive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this solicitation are applicable: 52.222-3; 52.222-19; 52.222.21; 52.222-26; 52.222.36; 52.225-1; 52.232-13; and 52.232-34. Clauses and provision can be obtained at http://www.acquisition.gov. Offers are due in person, by postal mail, by email or fax on or before August 18, 2010, 15:00pm Eastern Daylight Saving Time. Local Prevailing Time in Atlanta, GA at Food and Drug Administration OSS/PB, Attn: Roy E. Mutch, 60 8th Street, NE, Atlanta, GA 30309. For information regarding this solicitation, please contact Roy E. Mutch @ (404) 253-1258, or email roy.mutch@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-10-223-SOL-00300/listing.html)
- Place of Performance
- Address: FDA/CBER, TOD J. MERKEL, Ph.D., c/o GLORIA LEE, BLDG 29, ROOM 207, 29 LINCOLN DRIVE, BETHESDA, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02238771-W 20100814/100812235721-120ea694af1888b0fa4bb69d34b02df5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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