Development and Manufacture of Pharmaceutical Products for Addiction Treatment

This Procurement is a 100% Small Business Set-Aside. The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified Small Businesses (NAICS Code 541712) concerning the following: Having in-house capability 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. Qualifications include: 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). We anticipate the award of one cost reimbursement completion contract for a base period of one year plus four one year options. RFP No. N01DA-11-8899 will be available electronically on or about March 3, 2011. You will access the RFP through the FedBizOpps (URL: http://www.fbo.gov) or through the NIDA website: (URL: http://www.nida.nih.gov/RFP/RFPList.html). All information required for the submission of a proposal is contained in or accessible through the RFP package. Responses are due to be received in the Contracting Office on or about May 3, 2011. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.