MODIFICATION
B -- Technical Support in the Interaction of Dietary Supplements on the Liver Toxicity, Biomarker Discovery of Liver Toxicity and Assessment of Cardiovascular Risk posed by Methylphenidte
- Notice Date
- 7/27/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1106397
- Archive Date
- 8/15/2012
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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. The solicitation number is 1106397. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-58 dated May 18, 2012. The associated North American Industry Classification System (NAICS) Code is- 541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $14 million and is issued as full and open competition. The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires technical expertise in the (1) interaction of dietary supplements on the liver toxicity caused by acetaminophen, (Tylenol), (2) Expertise in biomarker discovery of liver toxicity using state-of -the -art ‘Omics technologies, (genomics, Metabolomics and proteomics) and (3) assessment of the cardiovascular risk posed by methylphenidate (Ritalin) in non-human primates. 1. Background: The FDA's Commissioner has highlighted the need for Regulatory Science to underpin the FDA's decision-making. Solid scientific studies and communications arising from such are critical to support this mission. The work at NCTR embraces the needs of the multiple regulatory agencies within the FDA and these have very different focuses (e.g., dietary supplements, tobacco regulation). The NCTR Division of Systems Biology, Center of Innovative Safety and Technologies conducts research in biomarker discovery of liver toxicity, the interaction of dietary supplements on the liver toxicity caused by various drugs (presently studying the interaction with acetaminophen (Tylenol), and cardiovascular research within NCTR, across FDA Centers and in the larger toxicology community. Ultimately the goal is to publish the results in scientific journals to help inform the public and other scientists. 2. Objective: Assistance to the Center for Innovative Safety and Technologies researchers to provide technical expertise in the interaction of dietary supplements on the liver toxicity caused by acetaminophen (Tylenol). Expertise in biomarker discovery of liver toxicity using state-of -the -art ‘Omic technologies, (genomics, metabolomics and proteomics). Must be able to assess the cardiovascular risk posed by methylphenidate (Ritalin) in non-human primates. 3. Scope: Working in close coordination with the Division of Systems Biology Center for Innovative Safety and Technologies at the FDA's National Center for Toxicological Research at Jefferson, Arkansas the contractor shall provide scientific advice, direction, and support to NCTR staff conducting basic and applied research to answer questions of FDA importance. The contractor shall communicate via e-mail, phone calls and /or visits to the NCTR campus with the Division Director to make recommendations. This is further detailed in Paragraph 4, Specific Tasks. 4. Specific Tasks and deliverables: 4.1 Assist the Center of Innovative Safety and Technologies researchers in toxicogenomics and toxicology studies. The contractor shall provide toxicology/pharmacology expertise for the interaction of dietary supplements with drugs on liver toxicity. See Attachment 1 and Attachment 2 for protocol #: E07379.01 and E07379.11 respectively for background information. The specific deliverable will be drafting of at least 3 or more scientific papers for submission to a peer-reviewed journal that summarizes the results of the recently completed studies assessing the interaction of black cohosh, kava, and ginkgo biloba on the hepatotoxicity caused by acetaminophen. In addition, the contractor shall help design and oversee additional studies to determine if some dietary supplement exposure scenarios result in lower blood levels of acetaminophen. Based on the research results provide the Division Director with draft of proposed additional studies that may be needed for the interaction of dietary supplements with drugs on liver toxicity and biomarkers of hepatotoxicity. 4.2 The contractor shall also assist in the discovery of new biomarkers in liver toxicity by coordinating the processing of liver mRNA from recently completed biomarkers of hepatotoxicity studies in rats (See Attachment 3 for protocol #7322.01). The contractor shall assist in the publication of these findings once the mRNA Next-Generation sequencing results are obtained from the sequencing provider (being outsourced to a 3rd party vendor). The contractor will be required to visit the NCTR campus lab atleast one day per week to complete this task. The Contractor shall assist the Division in achieving biological qualification and public acceptance of biomarkers. In achieving biological qualification the contractor shall ensure that no erroneous results are produced in the data and that the research follow scientific protocol. The contractor shall be responsible for analyzing gene expression experiments, and other raw data reports with relevance to each experiment. Gene expression data, including miRNA levels, are being generated in several different sub-studies under protocol E07322.01 which are for 7 compounds. The contractor shall be responsible for coordinating and ensuring that the first set of samples of total RNA, including microRNA extracted from livers are processed and then sent to a 3rd party vendor for Next-Generation sequencing. The samples will be provided by the Government to the Contractor for processing by August 1, 2012. The contractor will begin analyzing the results using NCTR's ArrayTrack software. The specific deliverable will be drafting of at least one scientific paper for submission to a peer-reviewed journal that summarizes the results of drug-induced liver injury biomarkers. 4.3 Draft a scientific paper for submission to a peer-reviewed journal describing the cardiovascular assessments that were conducted in non-human primates chronically exposed to methylphenidate (Ritalin). The study was conducted at NCTR in July/August 2011. The paper shall be based on those sample analysis results and will be provided to the contractor upon award. Reference Attachment 4 titled "Biopsy of Non-Human Primate Hearts" for background information. As part of this process, the Contractor shall review and analyze the data and shall coordinate with the University of Miami on the data they analyzed for inclusion in the paper. 5. Deliverable Schedule: The written tasks identified above shall be completed within 3 months of award. The draft publications for submission to peer-reviewed journals will be reviewed by the Division Director and the NCTR publication review process for acceptability. The contractor shall allow the Government a minimum of 3 weeks for review and comments of drafts papers for incorporation into the final document. The contractor shall provide a weekly report to the Division Director outlining the progress made in coordinating studies and 3rd party work, writing papers, and general oversight of projects identified above. Government provided equipment: The contractor will have access to Government equipment such as routine molecular biology laboratory instruments used to prepare, analyze and label the samples required to complete the tasks. FOB Point Destination. FOB Point of Delivery for Services and Supplies will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR 72079. Payment terms net 30 days after government acceptance of the supplies/services. Period of Performance: Three months from time of award. Schedule of Items: 1. Scientific support, data analysis and deliverables identified above, the government will pay the contractor the firm fixed price of $__________. Contract clauses- The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been attached to the clause. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ 52.204-4 Printed or Copied Double-Sided on Recycled Paper.(MAY 2011) 52.204-7 Central Contractor Registration. (FEB 2012) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions JAN 2006 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 352.223-70 Safety and Health JAN 2006 352.224-70 Privacy Act JAN 2006 352.227-70 Publications and publicity JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.242-71 Tobacco-Free Facilities JAN 2006 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. The COR for this order is: to be completed at time of award. 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 Contracting Officer 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 government reserves the right to increase or decrease the actual quantity ordered at time of award. Invoice Submission Invoices shall be submitted to the attention of the designated Contract Specialist identified below 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: Food and Drug Administration Nick Sartain 3900 NCTR Road Building 50, Room 422 Jefferson, AR 72079 Or electronically at nick.sartain@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only: To be completed at time of award. Questions regarding invoice payments should be directed to the FDA payment office at a telephone number provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAY 2012) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 204-10, 209-6,, 52.209-10, 52.219-4, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3, 52.225-13, and 52.232-33. Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been attached to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) 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 services offered to meet or exceed the Government's requirement. (ii) Price. Technical is significantly more important when compared to price in determining the best value to the government. Technical capability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above. Offerors shall specifically address each performance requirements stated above to demonstrate that the proposal meets the technical requirements. Offerors can provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. Proposed qualifications for proposed personnel: • Project Management Certification (PMP), for overseeing complex projects involving the conduct and coordination of many different toxicology studies. • Documented ability in preparing a research protocol. • Proven publication record on potential biomarkers of hepatotoxicity including miRNA. • Experience as a Principle Investigator of regulatory toxicology studies in either a pharmaceutical or contract research organization. • Expertise in preclinical toxicology studies in species including rodents and non-human primates. • Experienced Toxicologist with a DABT, (Diplomat of the American Board of Toxicology) certificate. • Documented knowledge in gene expression profile and database mining Price proposal: The contractor shall provide a detailed price proposal for the tasks identified above with amount of labor hours and fully burdened labor rates. 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. Include the firms DUNS number with quote. (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 government reserves the right to make an award without discussions. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2012), 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. CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made. 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 complete the 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 1106397. The offers are due in person, by postal mail or email to the point of contact listed below on or before July 31, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1106397/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02818201-W 20120729/120728000043-4b21b1328f2120291eb4724c68f1a6b1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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