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FBO DAILY ISSUE OF AUGUST 30, 2009 FBO #2836
SOLICITATION NOTICE

A -- Develop a Rapid Assay Prototype for the Detection of HIV, P24 Antigen

Notice Date

8/28/2009
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-09-1060835
 

Point of Contact

Karen R. Petty, Phone: 301-827-8774
 

E-Mail Address

karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541511, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for Full and Open competition for a firm fixed-price purchase order. Any small business firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the second (2nd) calendar day following the appearance of this announcement. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to develop a rapid assay prototype for the detection of HIV, P24 antigen. SOW The Laboratory of Molecular Virology is interested in developing portable, rapid diagnostics against HIV in pursuit of FDA’s mission of bringing more rapid, sensitive diagnostic tests to practical use. Our lab would provide the necessary reagents and would provide the service in trying to show proof-of-concept that a lateral-flow device would be feasible as a tool to detect p24, an antigen that is a critical biomarker in HIV-positive patients. The service would be broken down into Phases, and each phase would be evaluated before deciding on whether to continue or not. We have worked to assemble the device with all the best parts, and now it is time to run additional phases to test, optimize, and see if the devices actually work satisfactorily. Task •Development of a rapid assay prototype for detecting HIV, P24 antigen in format of a rapid test design incorporating gold labeled monoclonal p24 antibodies and polyclonal p24 antibodies immobilized to solid phase. •Prototype production to include membrane stripping, conjugate preparation, test card lamination, test strip cutting and assembly into cassettes. •Optimize test construction •Testing of Test devices •Provide Assay feasibility Study Report Deliverables Data generated from the studies shall be sent to us on a continuing basis to assess progress. EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price. Technical Capability is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 31, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before September 3, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 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 Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1060835/listing.html)
 

Place of Performance

Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN01932536-W 20090830/090829010852-7dde76e05609c45c1aa4150e505310a1 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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