Analytical Services Center for Medications Development

This is a Small Business Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. 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 preparing any information sent for the Government's use. Any proprietary information should be so marked. 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. The applicable NAICS code for this acquisition is 541715 with a size standard of 1,000 employees. An organization that is not considered a small business under this NAICS code should not submit a response to this notice. PROJECT REQUIREMENTS The National Institute on Drug Abuse (NIDA) seeks capability statements from small businesses having the in-house capability to act as a centralized laboratory to carry out validated quantitative and/or qualitative assays for a variety of compounds in biological specimens collected from pre-clinical and clinical studies. The data obtained will be used by NIDA to support the development of new medications for the treatment of substance use disorders. Specifically, the project requires the following tasks: (1) Develop, validate, and perform quantitative assays for samples collected from metabolic, pharmacokinetic, and/or toxicokinetic studies - Samples may be collected from preclinical metabolic and pharmacokinetic/toxicokinetic studies, as well as all phases of clinical studies - Analytes include, but are not limited to, potential therapeutic compounds and their metabolites, abused drugs and their metabolites, concomitant medications or compounds, and endogenous substances (e.g. proteins, enzymes etc.) - Sample matrices include biological fluids (plasma, urine, saliva, etc.) and tissues (liver, brain, hair etc.) - Analytes may appear at concentrations of low ng/mL or subnanogram/mL - Assays may require various analytical methods including gas chromatography-mass spectrometry (GC-MS), high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), liquid chromatography-mass Spectrometry-mass spectrometry (LC-MS-MS) and immunoassays (2) Perform assays for surrogate outcome measure and/or molecular biomarkers (protein, enzymes, etc.) - Perform assays for surrogate outcome measures and/molecular biomarkers for the assessment of efficacy and safety of study medications in clinical trials - Perform monitoring of abused drugs in biological fluids for assessing drug use in clinical trials - Utilize automated qualitative/semi-quantitative immunoassays for screening of abused drugs in biological fluids - Utilize immunoassays for quantitative assay of molecular biomarkers - Utilize validated quantitative methods using GC-MS or LC-MS for samples which showed positive for screening - Abused drugs include, but are not limited to: cocaine, benzoylecgonine (a cocaine metabolite), methamphetamine, amphetamine, morphine (or morphine-glucuronide), cannabinoids, and benzodiazepines. (3) Clinical site supplies - Supply clinical sites with sample collection and shipping containers - Supply clinical sites with on-site test devices for screening of abused drugs Additional Requirements: - Quantitative assay methods must be validated for reproducibility, accuracy, sensitivity, and specificity at the concentration ranges required for the preclinical and clinical studies - Validations must follow appropriate FDA guidance - Assays must be completed in compliance with current Good Laboratory Practices regulations - Automated equipment for sample preparation and injection is required - Data acquisition and report generation must be supported by adequate software - The ability to achieve high throughput of samples is required - Storage areas for biological samples must be appropriately secured - Computerized systems for tracking samples must be secured In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Registration for Chemical Analysis or a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. CAPABILITY STATEMENT/INFORMATION SOUGHT: Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: 1) Experience: An outline of previous similar projects in the areas specified above and work in the field of drug abuse; 2) Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions; 3) Mandatory Qualifications: Ability to handle Schedules II to V and potentially Schedule I controlled substances in accordance with the Controlled Substances Act of 1970; and, 4) Facilities: Availability and description of facilities and equipment required to conduct this type of work. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. All capability statements must provide the following: 1) company name, address and DUNS number; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as. Written capability statements must be received NO LATER THAN 14 December 2017 at 3:00 PM local time to the primary point of contact. Hard copy capability statements should be mailed to the Contracting Office Address below. Electronic capability statements will be accepted by the primary point of contact at lisa.bielen@nih.gov in the form of a single PDF file with the subject line: "Capability Statement N01DA-18-8938." Contracting Office Address: NIDA R&D Contracts Management Branch ATTN: Lisa Bielen 6001 Executive Blvd, Suite 4211, MSC 9559 Bethesda, MD 20892-9559* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery Primary Point of Contact: Lisa Bielen Contract Specialist lisa.bielen@nih.gov 301-443-6677 Secondary Point of Contact: Andrew R. Hotaling Contracting Officer andrew.hotaling@nih.gov 301-443-6677 THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to the subsequent solicitation.