This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Parts 12.6 and 13. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation; NAICS code 541711, Research and Development in Biotechnology RFQ #1088502 is to notify contractors that the government intends to award a Firm Fixed-Price Contract in accordance with FAR Part 13.106 for the following under simplified acquisition procedures. This requirement is a 100% Small Business Set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this RFQ.

General Information

A. Introduction

The FDA requires services to determine the ability of antibodies in serum to protect mice against a lethal dose of influenza virus

B. Background

Animal models to study immunity against influenza usually challenge mice by inoculation of liquid drops into the nares. It has therefore not been established that immunized animals will be protected against aerosolized influenza, a form that delivers virus as very small droplets directly into the lower respiratory tract. The experiments in this proposal will determine the ability of neuraminidase-specific antibodies to protect against aerosol challenge.

C. Scope

Two experiments will be conducted: (1) an experiment to establish the lethal dose of influenza virus X-31 in DBA/2 mice; (2) an experiment to evaluate the ability of neuraminidase-specific antibodies to protect mice against a lethal X-31 challenge. The data will establish whether antibodies to NA can protect mice against aerosol challenge.

Work Requirements

A. Technical Requirements

1. Contractor to determine inhalation LD50 of X31 virus in DBA/2 mice
a. The contractor shall be approved to expose mice to live influenza virus in a facility that is AALAC approved
b. The contractor may exposure animals to aerosol by either whole body or nose-only route. If whole body exposure is performed in experiment 2, it will be advantageous to determine LD50 by both delivery methods
c. The study shall use female DBA/2 mice
d. The study shall use 6 groups of no more than 8 DBA/2 mice per group; dilutions of virus in the nebulizer will contain 0 virus, 10e6 TCID50/ml, 10e5 TCID50/ml, 10e4 TCID50/ml, 10e3 TCID50/ml, 10e2 TCID50/ml. The virus for this study, X-31, shall be provided by the FDA investigator.
e. Nebulizer and impinger samples shall be collected and stored at -80C until shipped to the FDA investigator.
f. On a daily basis, mice shall be weighed and number of deaths recorded.
g. All surviving mice shall be sacrificed on day 14.

2. Contractor to determine protective capacity of immune sera antibodies against aerosolized influenza virus
a. The study shall use female DBA/2 mice
b. The study shall comprise of 4 groups: 10 mice in Groups A and D; 15 mice in Groups B and C.
c. Six hours before virus challenge group A will be treated with serum 1, Group B with serum 2, group C with serum 3, and group D with serum 4; Serum preparations shall be provided by the FDA investigator; 0.2 ml of serum shall be delivered by intraperitoneal injection.
d. Virus challenge shall be performed at a dose of aerosol 10 LD50
e. Nebulizer and impinger samples shall be collected and stored at -80C until shipped to the FDA investigator.
f. On day 7 post virus challenge, 5 mice in each group shall be sacrificed and lungs removed. The lungs shall be snap-frozen on dry ice in a sterile cryovial and stored at -80 C.
g. Mouse weight and survival must be recorded on a daily basis up to day 14, when surviving mice will be sacrificed.

B. Deliverables

• Nebulizer, impinger and mouse lungs should be shipped to the FDA investigator no later than 7 days post collection
• Raw data shall be provided to the investigator no later than 1 week after the end of each experiment
• A written report providing a summary of the experiment shall be provided no later than 4 weeks after the end of the experiment
• The contractor shall not share or publish this data without consent of the FDA investigator

Period of Performance

Experiments shall be performed no later than 4 weeks after receipt of required raw materials (X-31 and/or serum).

Technical Evaluation Elements:

1. The Offeror shall demonstrate the ability to meet all technical performance requirements.

2. The Offeror shall demonstrate their relevant experience in regards to this requirement.

3. The Offeror shall demonstrate the ability to provide past performance for similar services.

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 Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors.

CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to http://www.ccr.gov. You will need your Duns & Bradstreet number and banking information.

QUOTATIONS DUE: All quotations are due, via email to: [email protected] no later than 12:00pm, EST on Tuesday September 6, 2011.

ANTICIPATED AWARD DATE: The anticipated award date is on or about September 8, 2011, however, all dates in this announcement are subject to change.

PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items. FAR 52.212-3, Offeror Representations and Certifications Commercial Items, FAR 52.212-4, Contract Terms and Conditions, Commercial Items, FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items, FAR 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to [email protected] No Phone Calls Will Be Accepted.