SOLICITATION NOTICE
B -- Assay Novel Compounds
- Notice Date
- 1/22/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting 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, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-16-147
- Archive Date
- 2/16/2016
- Point of Contact
- Farrin Stanton,
- E-Mail Address
-
farrin.stanton@nih.gov
(farrin.stanton@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a combined synopsis/solicitation for commercial services 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. This acquisition is being conducted in accordance with the procedures of FAR Part 12.6--Acquisition of Commercial Items. The Solicitation Number for this acquisition is HHS-NIH-NIDA-SSSA-CSS-16-147 and the solicitation is being issued as a Request for Proposal (RFP). THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. SET ASIDE STATUS This is an unrestrictive solicitation. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The North American Industry Classification System (NAICS) Code for this procurement is 541690 Other scientific and technical consulting services and the Small Business Size Standard is 15.0 million. ACQUISITION AUTHORITY 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 and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-84, dated September 3, 2015. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT Background The mission of the Intramural Research Program (IRP) of the National Institute on Drug Abuse is to conduct state-of-the-art research on basic mechanisms that underlie drug abuse and addiction, and to develop new methods for the treatment of drug abuse and addiction. Research is supported at the molecular, genetic, cellular, animal, and clinical levels and is conceptually integrated, highly innovative, and focused on major problems in the field. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of drug abuse and addiction (and associated diseases), and to translate this knowledge into improved strategies for preventing, treating, and reducing the negative consequences for the individual and for society caused by drug abuse and addiction. The Drug Design and Synthesis Section (DDSS) major research direction is the elucidation of the structure and function of neurotransmitter systems in the mammalian central nervous system (CNS) in normal, drug-altered, and pathological states and the molecular mechanism of action of CNS active drugs. Organic/medicinal chemistry is the foundation of the multidisciplinary approach utilized in these studies that requires the rational design and chemical synthesis of novel agonists, antagonists, imaging agents, affinity ligands, and other drugs for particular applications. Our principal focus is the application of these techniques to study the mechanism of action of abused drugs and the development of medications for the treatment and prevention of drug abuse. The DDSS needs the services of a Contractor to assay novel compounds that have been synthesized in house for specific opioid receptors. Project Requirements: The experiments the contractor will analyze are run in duplicate and repeated a minimum of three-times. Specifically, the contractor shall provide the following services: 1) Examine submitted compounds for their agonist or antagonist activity at three opioid receptors, mu, delta and kappa. a. Pure compounds (approx. 5 mg) will be supplied by the NIDA IRP's DDSS as coded compounds such that analysis is blinded. b. Compounds will have been previously pre-screened for binding affinity and only compounds with an affinity of ≥ 100nM will be supplied. 2) Evaluate the submitted compounds for opioid efficacy using the [35S]GTPγS (guanosine-5'-O-(3-thio)triphosphate) assay as follows: a. Membrane homogenates from cloned cell lines expressing mu, delta or kappa receptors will be used. Membrane proteins (10 g) are incubated for 1 h at 25ºC in buffer (50mM Tris pH 7.4, 100mM NaCl, 5mM MgCl2, 1mM EDTA] with 0.1nM [35S]GTPγS, 30 μM GDP (guanosine 5'-diphosphate) and test compound. An internal standard at 10µM (DAMGO for Mu, SNC80 for delta, U69593 for kappa) is used to define maximal activation. The assays are terminated by rapid filtration through GF/C filters, washed and [35S]GTPγS bound determined by scintillation counting. 3) Evaluate compounds at all three opioid receptors as follows: a. Agonist activity: An initial screen will be performed at 10 M drug concentration. Compounds showing agonist activity will be then studied across a range of 8 doses to determine if they are full or partial agonists and their potency, compared to standard accepted full agonists at each receptor - Mu (DAMGO), Delta, (SNC80) and kappa (U69593). b. Compounds showing no agonism (<10% of standard) will be examined as antagonists. Concentration-response curves for the standard agonists will be performed over 8 concentrations in the presence or absence of test compound added at10-times its receptor binding affinity. Antagonist activity will be compared to standard known antagonists - Mu (CTOP), Delta (Naltrindole) and kappa (nor-Binaltorphimine) as well as naloxone as a standard non-selective antagonist. c. Concentration response curves will be analyzed using GraphPad Prism® ( La Jolla, CA) to provide potency values (EC50) for each compound and maximal stimulation compared to the full standard agonists at each receptor as stated above. Compounds showing less than 90% of the effect of the appropriate full agonist will be designated as partial agonists. d. For antagonists the ability to shift the concentration-effect curves for agonists will be analyzed to provide antagonist affinity constants (Ke values), that will be compared to the standard known antagonists listed above plus naloxone as a standard non-selective antagonist. 4) It is estimated that 75 assays can be run per month. This equates to full concentration responses curves, repeated three times, for 25 compounds at a single receptor or 8 compounds at all three receptors. Only half as many antagonist compounds can be evaluated. This is because of the need for two concentration-response curves for each antagonist (agonist curves with and without antagonist). 5) Data Submission: the Contactor will perform analyses of data to provide Potency (EC50) and Maximal Effect (% of standard agonist) and/or Antagonist Dissociation Constants (Ke) and this data submitted to the NIDA IRP. The data will be in table form with statistical analysis, appropriate for publication in high impact Medicinal Chemistry/Organic Chemistry journals. If requested graphical representations of the data will be provided 6)Questions: the Contractor will be available to answer any queries that arise from material submitted to DDSS, or questions from reviewers or publishers of scientific journals. Contract Type The Government intends to issue a firm fixed price contract for this requirement. Period of Performance: The base period of performance shall be 1 year from notice of award. APPLICABLE CLAUSES AND PROVISIONS The following FAR clauses and provisions shall apply to this solicitation: 1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (May 2015) apply to this acquisition. 5. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 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." EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and 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 on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: Factor 1: Technical Approach (70 points) The Offeror shall detail in its technical proposal how it meets each of the project requirements and objectives set forth in the requirement. Factor 2: Capabilities (30 Points) The Offer shall detail in its proposal describe previous experience in this field of assay development. The Offer shall provide a CV or Resume outlining specific experience in evaluation of functional activity at opioid receptors. AWARD CRITERIA a. The acceptability of the technical portion of each contract offer will be evaluated by a technical review committee. The committee will evaluate each offer in strict conformity with the evaluation criteria of the solicitation. The committee may suggest that the Contracting Officer request clarifying information from an offeror. b. The business portion of each contract offer will be evaluated for reasonableness of the Offeror's firm to supply the services required. c. The selection for award will be based on the offer that proposes the best value to the Government. Potential for Award Without Discussions The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary. Contracting Officer's Representative A Contracting Officer's Representative (COR) will be identified 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 for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Government may unilaterally change its COTR designation. Reporting Matters Involving Fraud, Waste and Abuse Anyone who becomes aware of the existence or apparent fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector general's Office in writing or the Inspector general's hotline. The toll free number is 1-800-HHS- TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is Htips@os.dhhs.gov and the mailing address is: Office of the Inspector general Department of Health and Human Services TIPS HOTLINE PO Box 23489 Washington, DC 20026 RESPONSE FORMAT 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. The offeror must submit 1) a technical response and 2) a separate price quotation. The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to ten-sided pages. The price quotation must include the requirements listed above as well as associated pricing. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." NOTE Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. CLOSING STATEMENT All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-147. Responses shall be submitted electronically via email to Farrin Stanton, Contract Specialist, at Farrin.Stanton@nih.gov.
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