Development and Manfacture of Pharmaceutical Products for Addiction Treatment

Small Business Sources Sought Announcement This is a SMALL BUSINESS 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 in-house capability to demonstrate an ability to develop medications for the treatment of drug addiction. This contract is to provide the Government a resource for the development and manufacture of stable dosage forms for use in preclinical and clinical studies. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: 1) Have the ability to conduct preformulation studies on drug substances, developing and manufacturing dosage forms, developing and validating analytical methods for dosage forms, carrying out stability studies, packaging and delivery of the pharmaceutical products to NIDA designated sites. 2) Provide adequate facilities for the storage of bulk drug substances, including controlled substances, and their finished dosage forms. 3) Contractor shall have appropriate DEA Registrations for Schedules II-V Controlled Substances in order to use the controlled substances in research and manufacture of dosage forms under the Controlled Substance Act of 1970. 4) Contractor must either possess or demonstrate the ability to obtain DEA Registrations for Schedule I Controlled Substances should the research and manufacture of the Schedule I drugs be required. 5) Contractor shall carry out the tasks in compliance with the Food and Drug Administration's (FDA's) current Good Manufacturing Practice regulations (cGMP) and/or Good Laboratory Practices (GLP). 6) The data and documentation prepared should be in a format acceptable to the Food and Drug Administration (FDA) for inclusion in Drug Master Files (DMF), Investigational New Drugs (IND) or New Drug Applications (NDA). Associated with each of the six main components are activities that require demonstrated experience and expertise to manage this project, including high level organizational and management support. 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. 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 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. Interested organizations presenting a capability statement 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, and 6) capability information in response to the requirement; and 6) type of small business your organization classifies itself as. Please submit written capability statements by November 10, 2010 to the NIDA Contracting Officer.