Inactive Total Small Business Set-Aside (FAR 19.5)

DESCRIPTION: The National Institute on Drug Abuse (NIDA) is seeking Capability Statements from Small Business organizations to provide the Government support for analytical chemistry and stability tes... DESCRIPTION: The National Institute on Drug Abuse (NIDA) is seeking Capability Statements from Small Business organizations to provide the Government support for analytical chemistry and stability testing of treatment drugs for substance use disorders. This is a 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 business sources; (2) the availability of capable 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 established NAICS code is 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The U.S. Small Business Administration establishes a size standard for 541715 as 1,000 employees or less. BACKGROUND INFORMATION AND OBJECTIVE: Drug development to improve the prevention and treatment of substance use disorders is a major mission of the National Institute on Drug Abuse (NIDA). The Institute provides investigational drugs to investigators for use in preclinical toxicology evaluations, pharmacological studies and clinical trials. The investigational drugs include both bulk drug substances (e.g., Almitrine, AZD2207, Cannabidiol, Nalmefene, Naloxone, etc.) and dosage forms (e.g., Buprenorphine sublingual tablets, Cannabidiol capsules, Lorcarserin capsules, Dronabinol capsules, etc.). The Government acquires these drugs from private industries, Government contractors/grantees or independent investigators. The Government has been performing quality control tests to ensure acceptable identity, strength, quality and purity of the investigational drugs before distributing them to the research community. Capable vendors shall demonstrate their ability, experience, and expertise to develop and validate analytical methods, perform quality control tests, prepare reference standards, and perform stability studies of drug substances and products. In addition, capable vendors shall demonstrate their ability, experience, and expertise to provide satisfactory facilities for the storage of drug substances and finished dosage forms. Capable vendors shall demonstrate their ability, experience, and expertise to make a limited number of shipments of drug substances and dosage forms to the sites designated by the NIDA. Capable vendors shall demonstrate their ability, experience, and expertise to manage an up-to-date tracking system to track the status of all drug substances and drug products being studied under this contract. It is also necessary for Capable vendors to demonstrate their ability, experience, and expertise to track all drug products and drug substances in various stages of stability testing. Capable vendors should demonstrate their ability, experience, and expertise to carry out the tests in compliance with Food and Drug Administration (FDA) current Good Manufacturing Practice regulations (cGMP) and Good Laboratory Practices (GLP). The data and documents prepared must adequately support Drug Master File (DMF), Investigational New Drug (IND) or New Drug Application (NDA) submitted by NIDA or investigators supported by the NIDA to the FDA. PROJECT REQUIREMENTS: The National Institute on Drug Abuse (NIDA) is seeking capability statements from qualified organizations having the capability to carry out the work for the development and validation of analytical methods, preparation of reference standards, carrying out quality control tests, storage and distribution of drug substances and drug products, and performing stability studies for the compounds and dosage forms to be used in the medications development program. The development of medications for the treatment of drug addiction is a major mission of NIDA. NIDA has been providing potential treatment drugs to investigators for use in preclinical toxicology evaluation, pharmacological studies and clinical trials. The treatment drugs include both bulk drug substances including new molecular entities and dosage forms. These drugs are acquired by the Government from private industry, Government contractors/grantees or independent investigators. In order to assure the identity, strength, quality and purity of these materials, the Government has been performing quality control tests before distributing them to the research community. The preparation of data and documents will support Drug Master File (DMF), Investigational New Drug (IND) or New Drug Application (NDA) submitted by NIDA or NIDA supported investigators to the FDA. MANDATORY REQUIREMENTS: NIDA and NIDA sponsored investigators use the data obtained for submission to the FDA. The reports shall be acceptable in format and substance for submission to the FDA in support of IND and NDA procedures. To handle substances under the Controlled Substances Act of 1970, it is mandatory that the organizations possess a Drug Enforcement Agency (DEA) Research Registration for Schedules II to V. Also, organizations must demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. Capable vendors must demonstrate their ability to obtain and possess DEA registrations to distribute, import and export controlled substances. In addition, please provide information on any available computerized shipment tracking system, availability of DEA approved vault securely to store controlled drug substances/products, and cGMP-compliance of the proposed facility. INSTRUCTIONS: Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) 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. The established NAICS code is 541715. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; and (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. 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. 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. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required. Any 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, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 4:00 p.m. EST on June 30, 2023. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements. THIS NOTICE 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 notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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 on SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. 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).