This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 13-223-SOL-00112. This solicitation is issued as a Request for Quotation (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-18 dated July 5, 2007.

The associated North American Industry Classification System (NAICS) Code is 325414 - Biological Product Manufacturing

DHHS FDA Office of Acquisitions and Grants Services requires the following:

Prepare a concentrated and purified Reovirus stock with characterization.

The company will prepare a purified and concentrated stock of Reovirus. They will also perform additional characterization of the custom designed stock, including the protein concentration, virus particle count, genome copy number and infectivity titer (TCID50).

A.Technical Requirements

•The company shall use a characterized viral seed (they will provide their own) to prepare a custom purified and concentrated viral stock of Reovirus.
•After concentration and purification, the company shall provide a stock containing a minimum of 10mg protein concentration.
•Virus stock should be aliquoted prior to freeze down in either 0.25ml or 0.5ml aliquots, upon investigator's request after company determines the infectivity titer.
•They shall determine the protein concentration, virus particle count, genome copy number and infectivity titer (TCID50) of the final product.
•Production details and all data pertaining to the characterization of the virus stock shall be provided in a clear report.
•The company must employ high levels of quality control (QC) techniques and testing, including sterility, hemagglutination assay and mycoplasma testing during production and of the final product.
•The company should provide the investigator with updates during the production of the custom Reovirus stock.
•Deliverables should be provided within 10-12 weeks of order placement.

B. Deliverables
- A concentrated and purified stock of Reovirus aliquoted into either 0.25ml or 0.5ml vials (minimum total of 10mg protein after purification and concentration)
- A clear report containing production details and virus stock characterization data

Sample preparation, assaying, and data analysis will all be completed at the company site
Deliverables will be shipped to:

Deliverables should be shipped to:
Food and Drug Administration
8800 Rockville Pike
Bethesda, MD 20892

Period of Performance:
24 months from the effective date of contract award

An official authorized to bind the offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None

The provision at FAR 52.212-2 Evaluation - Commercial Items

Evaluation-Commercial Items (Jan 1999)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(i)Technical capability of the item offered to meet the Government requirement
(ii) price.
(iii) past performance

Technical and past performance when combined are more important than price. Award will be made to the party whose quote meet the required technical requirements and the best value to the Government. The Government may award this purchase order to other than the lowest price technically acceptable quote. Technical factors are significantly more important than price.
(b) Options: not applicable
(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The provision at FAR 52.212-3. Offeror Representations and Certifications - Commercial Items applies to this acquisition. If offerors are not registered via the ORCA website at http//orca.bpn.gov, offerors shall complete and return a copy of the provision at FAR 52.212-3 with their offer.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following agenda have been attached to the clause. None.

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 additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-1.52.225-13, 52.232-33 and 52.232-34 Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov.

SAM Requirement - All interested parties must be registered on System for Award Management (SAM) before an award could be made to them. To obtain registration information, go to the internet website at at http://www.sam.gov.

All responsible sources may submit a quotation, which shall be considered. The quotation must reference solicitation number 13-223-SOL-00112. The Offers are due in person, by mail or fax on or before July 12, 2013 by 14:00 hours Eastern Standard Time at FDA Philadelphia District Office, Food and Drug Administration, 200 Chestnut Street, Rm 900, U.S. Customhouse, Philadelphia, PA 19106/Fax (215)597-6649/Email: [email protected]

An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.