In Vitro Metabolism and Metabolite Quantification

This is a SOURCES SOUGHT NOTICE to determine the availability of SMALL BUSINESSES (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having the capability to provide analytical services and in vitro metabolism and disposition studies for test materials from the medications development program of NIDA. Pertinent Food and Drug Administration (FDA) guidance and regulations (e.g. Good Laboratory Practice regulations) must be followed. In vitro metabolism and disposition studies may include: permeability studies to evaluate passive absorption across biological membranes (e.g., intestinal, blood-brain barrier) using appropriate cell lines; interactions with and inhibition of membrane transporters (e.g., P-glycoprotein, organic anion or cation transporters (OAT, OCT)); metabolic stability in the presence of liver fractions (e.g., microsomes, S9, hepatocytes) or recombinant enzymes (e.g., cytochrome P450 enzymes (CYP), UDP-glucuronosyltransferase (UGT)); enzyme/reaction phenotyping; enzyme inhibition; enzyme induction; identification and structural characterization of metabolites using nuclear magnetic resonance (NMR) and/or high-resolution mass spectrometry; and protein binding. Other analytical services may include the development of sensitive and specific assays for a drug (or drug candidate) and its metabolites in biological matrices using methods such as high-performance liquid chromatography with UV/Visible detection (HPLC), liquid chromatography-mass spectrometry or tandem mass spectrometry (LC-MS or LC-MS/MS), and gas chromatography-mass spectrometry (GC-MS). NIDA and NIDA sponsored investigators use the data obtained for submissions to the FDA. The reports shall be adequate in format and substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) applications. Mandatory Criteria In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. All offerors must be in compliance with the FDA's Good Laboratory Practices Program. Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers, and technical personnel who may be assigned as principal investigator and/or project director; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, including security: (4) Compliance with the Mandatory Criteria specified above. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted should be provided. 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 the interrelated tasks in an effective and timely manner. Documentation may include, but not limited to, contracts both Government and commercial that the organization has performed, references, i.e., names, titles, telephone numbers and any other information which would serve to document the organizations capability, e.g., awards, commendations, etc. 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. This is not a request for proposals. The Government neither intends to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information submitted for the Government's use. Any proprietary information should be so marked. Interested organizations submitting a capability statement in response to this sources sought announcement must provide the following: 1) company name and address; 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 7) type of small 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). Small business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Alexander Beraud at Alexander.Beraud@nih.gov, NO LATER THAN 4:00 p.m. EST on November 5th, 2019. The Subject line for the submission should include this Small Business Sources Sought Number. NIDA will not accept paper or faxed capability statements. Primary Point of Contact: Alexander Beraud, Contract Specialist Alexander.Beraud@nih.gov Phone: (301) 827-6857 Fax: (301) 443-7595 Secondary Point of Contact: Andrew R. Hotaling, Contracting Officer Hotalingar@nida.nih.gov Phone: (301) 443-6677 Fax: (301) 443-7595