G
The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-69, 01 August 2013.
The associated North American Industry Classification System (NAICS) Code is- 541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees. This acquisition is set-aside 100% for small business concerns.
The US Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR) Division of Bioinformatics and Biostatisitcs requires a contractor with knowledge and expertise in cryopreserved human primary hepatocytes and in vitro toxicity screening. Expertise in the technology allowing for extended drug treatment to support the creation of FDA's Liver Toxicity Knowledge Base for empowering FDA's review process on new drug application with safety issues is especially significant.
The work accomplished under this contract utilizing compound toxicity assessment will develop potential biomarkers to predict severe Drug Induced Liver Injury Assessment (DILI) and propose an early hepatotoxicity screening scheme for pharmaceutical industries' drug development.
Background:
The Liver Toxicity Knowledge Base (LTKB) is an ongoing research project (E0721501) within the Division of Bioinformatics & Biostatistics. Drug-Induced Liver Injury (DILI), or Liver Toxicity, is the most common reason for an approved drug's withdrawal from the marketplace. Because of this, DILI has been identified by the FDA's Critical Path Initiatives as a key area of focus in a concerted effort to broaden the agency's knowledge base for better evaluation of tools and safety biomarkers.
The objective of LTKB is to develop content-rich resources to improve our basic understanding of liver toxicity at the mechanistic level and to provide a valuable tool for scientific researchers, the pharmaceutical industry, and regulatory bodies. This project involves the collection of diverse data (e.g., DILI mechanisms, drug metabolism, histopathology, therapeutic use, targets, side effects, etc.) associated with individual drugs, and the use of systems biology analysis to integrate these data for DILI assessment and prediction. Importantly, both conventional and high-throughput molecular biomarker assays will be conducted for selected drugs to develop novel biomarkers based on knowledge accumulated from this project.
The project contains three components (1) collecting diverse data (e.g., DILI mechanisms, drug metabolism, histopathology, therapeutic use, targets, side effects, etc) associated with individual drugs; (2) applying systems biology and network pharmacology approaches to integrate these data for DILI assessment and prediction; and (3) verifying the results using both conventional and high-throughput molecular biomarker assays for selected drugs to develop novel biomarkers. The proposed contract will fulfill the goal for the third component of the project.
Requirements:
Project Management
- The contractor shall provide overall project management to insure that the scope, schedule, and cost are controlled and consistent with the agreed upon contract.
- The contractor shall produce validation reports and Standard Operating Procedures (SOPs) on the proposed assays, maintain the raw data generated from the assays for auditing, and communicate any obstacles or issues associated with successful completion of the contract.
Deliverables
- Contractor shall provide freshly isolated human hepatocytes from one (1) donor with 85% viability
- Contractor shall provide a summary report accompanied with raw data generated from three (3) assays, ATP, ALT, and Urea, performed on human hepatocytes with 32 drugs at 8 concentrations, two (2) time points and technical triplicates.
- The government will provide the drugs to be tested in powdered form. The drugs will have blinded identities and will be delivered (at the expense of the government) in two batches of 16 compounds. The drugs to be tested are as follows:
amiloride lamivudine
aspirin leflunomide
bupropion leuprorelin
cefepime lisinopril
captopril lovastatin
carbamazepine moclobemide
chlormezanone norfloxacin
cimetidine omeprazole
enalapril pioglitazone
erythromycin pravastatin
etodolac ranitidine
fluconazole rofecoxib
fluorouracil rosiglitazone
gemfibrozil saquinavir
haloperidol tacrine
ketoconazole ticlopidine
Proposed Price Per Compound___________
Extended Price_________________
The Government's estimated delivery date for the initial batch of 16 compounds shall be approximately 30-days from the date of award. The Government's estimated delivery date for the subsequent batch of 16 compounds, shall be approximately 30-days of the contractor's delivery of reports and data associated with the initial batch of compounds.
Place of Performance:
Work shall be performed on the contractor's site
Period of Performance:
The period of performance shall commence upon receipt of compounds and shall not
exceeed 90-days.
Shipping Information:
US Food and Drug Administration
National Center for Toxicological Research
3900 NCTR Road, 53C - 109A
Jefferson, AR 72079
Solicitation Provisions
Contract Type: Commercial Item-Firm Fixed Price.
The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (JULY 2013) applies to this solicitation. The following addenda have been added to this provision:
Contract Clauses
The following clauses are incorporated by reference and are available in full text at http://www.acquistion.gov/far and http://www.hhs.gov/regulations/hhsar. Far Clauses are current through Federal Acquisition Circular 2005-69 dated August 01, 2013.
FAR 52.204-7 System for Award Management
FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper
The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been added:
FAR 52.232-99 Providing Accelerated Payment to Small Business Subcontractors (Deviation)
FAR 52.217-8 Option to Extend Services
The Contracting Officer may exercise the option by written notice to the Contractor within 5-days . . . .
The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm
352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009
352.223-70 Safety and Health JAN 2006
352.231-71 Pricing of Adjustments JAN 2001
The Contract Specialist is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:
(1) Direct or negotiate any changes in the statement of work;
(2) Modify or extend the period of performance;
(3) change the delivery schedule;
(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or
(5) Otherwise change any terms and conditions of this contract.
The Contract Specialist for this order is:
Sondea Blair, Contracting Specialist
3900 NCTR Rd
HFT-320, Room 421
Jefferson, AR. 72079
Phone: (870) 543-7469
Email: [email protected]
The COR is responsible for:
(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
(2) Interpreting the statement of work and any other technical performance requirements;
(3) Performing technical evaluation as required;
(4) Performing technical inspections and acceptances required by this contract; and
(5) Assisting in the resolution of technical problems encountered during performance.
The COR for this order is: shall be completed at time of award.
Invoice Submission
Invoices shall be submitted to the attention of the designated Contract Specialist identified above and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.
I. An original and two (2) copies shall be submitted to:
FDA/OC/OA/OFO/OFS
Attn: Division of Payment Services
3900 NCTR Road, HFT-324
Building 50, 6th floor, suite 616
Jefferson, AR 72079
Phone: (870) 543-7446
Fax 870-543-7224
An electronic invoice can be emailed to the following address:
[email protected]
II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked as: Courtesy Copy Only:
To be completed at time of award.
Questions regarding invoice payments should be directed to the FDA payment office at phone or email: 870.543.7446 or [email protected].
The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2013), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-3, 52.225-13, 52.232-33.
Solicitation Provisions:
Contract Type: Commercial Item-Firm Fixed Price.
Addendum to Paragraph (b)(8) Representations and Certifications- In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48.
Note: This solicitation is being issued under the premise that the Contractor will certify that the combination of equipment/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 05-2033 (Rev.-12): http://www.wdol.gov/wdol/scafiles/archive/sca/05-2033.r12
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 of the items/services offered to meet or exceed the Government's requirement
(ii) Price
Technical Acceptability: Technical acceptability will be determined by review of information submitted by the quoter who must provide sufficient descriptive literature that unequivocally demonstrates that offered services meet the requirements as stated herein.
Pricing: Offerors shall provide pricing using the above format. Prices shall be firm-fixed-price and shall not be subject to any further economic price increase beyond the initial price offered.
The government is not responsible for locating or securing any information, which is not identified in the proposal however, 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 Government reserves the right to make an award without discussions.
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 complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.
Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 10:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on August 28, 2013 to [email protected], Fax (870) 543-7990, or mail to the U.S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Sondea Blair, 3900 NCTR Road, Building 50, Room 421 Jefferson, AR 72079-9502.
PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below.
When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time.
For information regarding this solicitation, please contact Sondea Blair by e-mail at [email protected]. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 10:00 AM CST on August 22, 2013.