SOLICITATION NOTICE
R -- Bioanalysis Testing Services
- Notice Date
- 8/24/2015
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-2015-787
- Archive Date
- 9/15/2015
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- (i)This is a combined synopsis/solicitation for commercial items prepared in accordance with the 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. (ii)The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2015-787 and the solicitation is issued as a Request for Quotation (RFQ) on a competitive basis with no set-aside restriction. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is NOT expected to exceed the simplified acquisition threshold. (iii)The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83-1 dated July 2, 2015. This requirement is solicited as full and open with no socio-economic small business restrictions. The contract type is a fixed price type of contract. (iv)The North American Industry Classification System (NAICS) code applicable to this procurement is 541990 - All Other Professional, Scientific and Technical Services with associated business size standard 15.0 million Dollars. (v)Bioanalysis Testing Services (vi)Background: The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) was officially established in fiscal year 2012 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS, one of 27 Institutes and Centers (ICs) at NIH, strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. The mission of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS Division of Pre-Clinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. The DPI plans, conducts and collaborates on research to develop new methods and technologies to enhance pre-clinical processes. The DPI Chemistry Thymine team is developing the compound ML246 (metarrestin) as a therapy targeted against metastasis or the spread of cancer from its primary site. The compound has shown very good efficacy without toxicity after dosing for 7 weeks in a pancreatic mouse model. Statement of Work: Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the bioanalysis testing services as described herein. Specifically, the Contractor shall test the compound ML246 (metarrestin) as a therapy targeted against metastasis or the spread of cancer from its primary site by performing analytical method qualification, plasma sample analysis, and toxicokinentics modeling. The compound testing shall be performed as follows: (1) Experimental Design: Animals will be dosed daily for 14 days at doses as described; Dose Route/Frequency: Oral (gavage)/Once daily for 14 consecutive days; (2) Study design: 7 day dosing (N=10 male, N=10 female) at 25, 75, 250 mg/kg by oral gavage (subject to change depending on final selection and observation); (3) Observation: visual, body weight, food consumption, clinical; Observations: Twice daily (mortality/moribundity); Clinical Observations: Daily; Body Weights: Twice Weekly; Food Consumption: Twice Weekly; (4) Clinical Pathology: Hematology and clinical chemistry evaluations on 5 mice/sex/group (hematology) and 5 mice/sex/group (clinical chemistry) at termination on Day 15; (5) Necropsy: All animals sacrificed on Day 15, with collection of full set of tissues; (6) Histopathology: Heart, liver, kidneys, brain, spleen, lungs, thymus, stomach from 5 mice/sex from control and high dose groups; and (7) Toxicokinetics (Optional): Day 1; 6 time points post-dose (30, 60 min., 2, 4, 8 and 24 hrs.); 3 mice/sex/time point; 36 samples; TK modeling (Cmax, Tmax, AUC, t½). Deliverables and Reporting requirements: Delivery of the results of the sample analysis samples shall occur within 6 weeks from the receipt of the samples from the Government. The delivery of the sample analysis results and other reports as requested by the Government must be submitted to the COR as an attached file in electronic format. Government's responsibilities: NCATS will provide samples as needed. The contractor will not be reimbursed for any travel. Contracting Officer's Representative: The Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract and will be specified 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 Government may unilaterally change it's COR designation at any time throughout the performance period of this contract. The COR will be determined at time of award. (vii)The anticipated Period of Performance of any resulting contract is a one year performance period effective on or around September 8, 2015 for all requirements and a 6 week delivery time from the receipt of samples from the Government. Any deliveries shall be made FOB destination at 9800 Medical Drive, Rockville, MD 20850. The anticipated place of performance shall include the contractor's place of work. (viii)The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix)The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. (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. Technical and past performance when combined is significantly more important when compared to price. The following factors shall be used to evaluate offers: (1)Technical Approach, knowledge, and experience. Contractor shall clearly indicate possessing the infrastructure or ability to obtain the infrastructure necessary to complete this requirement. That Offeror shall include applicable Curriculum Vitae of key identified personnel. Offerors shall also submit documented evidence of published manuscripts in peer-reviewed journals for work related to the Statement of Work described in this solicitation; (2) Past Performance. The offeror must submit with their proposal a list of the last three (3) contracts completed during the past two (2) years and / or contracts awarded currently in process that are similar in nature to the work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. For each contract, subcontract, or reference include: (i) Name of Contracting Organization; (ii) Contract Number (for subcontracts, provide the prime contract number and the subcontract number); (iii) Contract Type; (iv) Total Contract Value; (v) Description of Requirement; (vi) Contracting Officer's Name and Telephone Number; (vii) Program Manager's Name and Telephone Number; and (viii) North American Industry Classification System(NAICS) Code. The offeror may provide information on problems encountered on the identified contracts and the corrective actions, if any. Offerors will be evaluated on its performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the offeror. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror's past performance; (3) Price. Basic cost and price information in the Offeror's business proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services with an estimate of the number of hours required, breakdown and rationale for any other direct costs or materials, and the total amount. Responses to this solicitation must include clear and convincing evidence of the Offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. Offerors may respond with a technical proposal indicating their ability to provide the technical specifications stated in this solicitation and an itemized price-cost proposal. Responses will be evaluated based on contractor's ability to meet the government's essential requirements stated in this notice and on ability to deliver required services and supplies. x.The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. xi.The provision at FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. xii.The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. FAR Clauses 52.217-7 Option for Increased Quantity-Separately Priced Line Item and 52.217-8 Option to Extend Services are applicable to any resulting contract as a result of this solicitation. xiii.There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. xiv.The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. xv.In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responses must be received no later than August 31, 2015, 4:30 PM, Eastern Time, as specified in this announcement. Responses to this RFQ must not exceed a combined 25 pages in length, exclusive of appendices and Curriculum Vitae, and be submitted in Microsoft Word or searchable PDF format in a font size of 11 or 12 point and font type of Arial or Times New Romans. Margins must be 1-inch wide (top, bottom, left, and right). Responses must references this solicitation number and include the name of the contractor. Pages in excess of the specified page limit will not be considered or evaluated. Late responses will not be accepted. All responses must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-2015-787. Responses must be submitted electronically to hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at 301-435-8780.
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