Analytical Chemistry & Stability Testing of Treatment Drugs

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 under the task categories defined below; (2) whether the capable organizations 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(s), including whether a set-aside in a specific category is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Institute on Drug Abuse 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 the National Institute on Drug Abuse (NIDA). The Institute 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. 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. Organizations should also possess DEA registrations to distribute, import and export controlled substances. In addition, please provide information on any available computerized shipment tracking system. The established NAICS code is 541712. 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 area(s) 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; and 3) Facilities: Availability and description of facilities and equipment required to conduct the type of work required under a specific task area. 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 under these task areas. 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. 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 preparing any information sent for the Government's use. Any proprietary information should be so marked. 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 to provide feedback to respondents with respect to any information submitted. Interested organizations presenting a capability statement 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) the capability information in response to the requirement and qualification identified in this notice; and 7) small business classification. Please submit written capability statements by November 13, 2013 to the NIDA Contracting Officer.