Analytical Services Center for Medications Development Program

The Government is seeking Capability Statements on behalf of The National Institute on Drug Abuse (NIDA) from Small Business organizations under the North American Industry Classification System (NAICS) code 541715. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a

set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.Background:The National Institute on Drug Abuse (NIDA), Division of Therapeutics and Medical Consequences (DTMC) supports research and development of new medications for the treatment of substance use disorders (SUDs).Purpose and Objectives:The Government is seeking Capability Statements from qualified vendors to provide bioanalytical chemistry resources to support NIDA's medications development program. Capable Vendors will serve as a centralized bioanalytical facility to support the preclinical PK/toxicokinetic studies, clinical pharmacology/PK studies and clinical trials for assessing the efficacy and safety of the study medications. Capable Offerors shall carry out qualitative and/or quantitative assays for a variety of compounds in biological specimens collected from preclinical and clinical studies using validated analytical methods. The analytes include, but are not limited to, new medications and/or their metabolites, abused drugs/metabolites, potential concomitant medications/compounds, and surrogate outcome measures and/molecular biomarkers (small molecules, peptides, proteins, enzymes, etc). Capable Vendors shall also develop and validate new assay methods for medications/compounds for which established assays do not exist. The data generated by this contract will be utilized by the NIDA Division of Therapeutics and Medical Consequences (DTMC) in the evaluation of new medications under development for the treatment of SUDs. The data will generally be integral to Investigational New Drug (IND) and New Drug Application (NDA) submissions for the Medications Development program and as such must abide by published/appropriate procedures and in a format suitable for this purpose.Requirements:MANDATORY REQUIREMENTS:Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970 at the time of submission of the proposal. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule 1 controlled substances prior to awarding the contract.Offeror must be able to provide proof that it can and has conducted analytical services under GLP conditions.PROGRAM REQUIREMENTS:Capable vendors must demonstrate their understanding and experience to perform quantitative and/or qualitative determination of a variety of compounds, including but are not limited to, new medications and/or their metabolites, abused drugs/metabolites, potential concomitant medications/compounds, and molecular biomarkers (small molecules, peptides and proteins, etc.) in biological specimens collected from preclinical and clinical studies. Capable vendors must demonstrate their experience to develop and validate new quantitative assay methods for medications/compounds for which no established methods exist. These compounds may appear in biological specimens at concentrations of low nanogram/mL (ng/mL) or subnanogram/ml and therefore require the use of state of the art analytical methods including mass spectrometric methods and immunoassays. Tasks to be performed:Task A. Assay Development and Validation;Task B. Quantitative Assays;Task C. Qualitative Screening and Quantitative Assay of Abused Drugs in Biological Samples Collected from Clinical Trials;Task D. Acquisition and Distribution of On-site Testing Devices;Task E. Supplies for Sample Collection/Storage and Shipment for Clinical Trials;Task F. Results and Database Maintenance; andTask G. Archival Maintenance of Records.Interested organizations must demonstrate and document, in the capability statement submitted, extensive experience in the technical area under consideration. Send information relevant and specific, on each of the following qualifications:1) expertise in evaluation and personnel with the knowledge of, and experience in a) developing and validating new quantitative assay methods; b) state-of-the-art assay methodologies; 2) equipment, instrumentation, facility, and personnel to perform the Tasks; 3) DEA Research Registration for Schedules II to V with the potential to apply for Schedule I if required; 4) Offeror must be able to provide proof that it can and has conducted analytical services under GLP conditions.Capability Statement:Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist.THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contract, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) types(s) of business, if any (e.g.,: small, Veteran-owned, service-disabled Veteran-owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone).Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non­ responsive. When submitting this information, please reference the solicitation notice number.All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Alexander Beraud, Contract Specialist, at Alexander.Beraud@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered.PLEASE SEE ATTACHED SMALL BUSINESS SOURCES SOUGHT NOTICE FOR ALL RELEVANT DETAILS