Liver Toxicity Test Services

Added: Aug 06, 2010 6:51 pm 1) What are the three specific enzymatic assays that need to be tested?

Three cytotoxicity endpoints are cytoplasmic enzyme release, cellular ATP content, and caspase activation. The enzymes to be analyzed in cytoplasmic enzyme release are the ones commonly measured in clinical and preclinical studies to reflect liver toxicity, including ALT, ALP, AST, TBL and LDH.

2) Do the assays need to be validated, or are the results being used for only research purposes? GLP or not ( it is mentioned that it's subject to FDA approval)

Non GLP, research only, thus no validation is required as long as the company has a good track record in this line of business,

3) Are all 25 drugs to test on hepatocytes being sent at once?

Yes

4) Who is providing hepatocytes and should we create a cell bank?

The company should have the source of hepatocytes for this experiment. We only provide the drugs.

5) Is there a protocol (conc., time etc.) for this toxicity study already available or would the contractor develop it?

The contractor will develop a protocol that will be reviewed by the FDA.

6) What should be done with RNA after extraction?

Put in the Pax-gene tube and send to FDA.

7) When is the anticipated award date? What is the period of performance?

The Anticipated award date is September. The work shall be completed within 10 weeks from receipt of government provided compounds. We do not know how long IRB approval may take. The government will not send the compounds until IRB approval is issued.

8) Are there any proposal instructions?

Proposal instructions are contained in the solicitation. A firm should provide technical, past performance and price information as instructed in the solicitation. Technical proposal should be as detailed as possible for the government to determine technical acceptability and provide reference for similar work that may be contacted by the government.

Added: Aug 06, 2010 10:30 am

Question: What are the specific cystoplasmic enzyme(s) on which the requestor wants release dose response curves?

Answer: The enzymes to be analyzed are the ones commonly measured in clinical and preclinical studies to reflect liver toxicity: ALT, ALP, AST, TBL and LDH.

Added: Jul 28, 2010 11:32 am This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR 13.5 Test Program for Certain Commercial Items, as applicable. The solicitation number is 10-223-SOL-00268. This solicitation is issued as a Request for Quote (RFQ) and is set-aside for small business concerns.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-44.

The associated North American Industry Classification System (NAICS) Code is-541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees.

The Food and Drug Administration is soliciting for a contractor to conduct in vitro assay for 25 human drugs using human hepatocytes. Cryopreserved human hepatocytes are preferred for this application. FDA will provide the 25 drugs for testing. The drugs need to be tested on each of three donors in triplicates with 5 concentrations plus negative (solvent control) at 4 different time points.

Deliverable:
(1) Dose response toxicity curves and raw image files for three cytotoxicity endpoints (i.e., cytoplasmic enzyme release, cellular ATP content, and caspase activation) measured at different time points for each donor.
(2) The contractor shall deliver sufficient amount of purified and frozen RNA samples in the Pax-gene tube from each donor at each combination of concentration and time point.

Period of Performance: The work shall be completed within 10 weeks from receipt of government provided compounds. This study is subject to FDA IRB approval after the selection of the apparent successful offeror before performance of the contract shall begin.

Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized.

FOB Point destination. FOB Point of Delivery for deliverables will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR. Payment terms net 30 days.

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 is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows:

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

(i) Technical capability/experience of the items/services offered to meet the Government's requirement.
(ii) Past Performance
(iii) Price.

Technical and past performance; when combined, are significantly more important when compared to price.

Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the offeror has the capability to perform the required services which demonstrates knowledge and technical approach to accomplish the work called for in this solicitation. The offeror must provide a detailed study design.

Past Performance
Identify federal, state, local government, or private contracts for which the offeror has performed work similar to the SOW in this solicitation (include contracts within the last three years, point of contact, and telephone numbers).

The government reserves the right to make an award without discussions.

The government 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 material necessary for the government to determine whether the product and/or service meets the technical requirements.

The Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following agenda has been attached to the clause.

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

52.212-4 (j). Paragraph (j) of the clause is changed to the following:
Risk of loss. Risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
Delivery of the supplies to the Government at the destination specified in the contract.

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 alt I, 52.204-10, 52.219-6, 52.219-8, 52.219-14, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-1, 52.225-13, and 52.232-33. The following additional provisions and/or clauses apply: 52.204-4 and 52.204-7. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov/far/

The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm

352.202-1 Definitions (January 2006)
352.203-70 Anti-lobbying (January 2006)
352.222-70 Contractor cooperation in equal employment opportunity investigations (January 2010)
352.223-70 Safety and health. (January 2006)
352.270-6 Restriction on use of human subjects. (January 2006)

Other Solicitation Provisions that apply:
352.270-4 Protection of human subjects. Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (January 2006)

CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov.

The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 10-223-SOL-00268. The Offers are due in person, by postal mail, fax or email to the point of contact listed below on or before August 11, 2010 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.

For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.