A DEVELOPMENT AND MANUFACTURE OF PHARMACEUTICAL PRODUCTS FOR ADDICTION TREATMENT Release Date: January 31, 2001 NOTICE: NOT-DA-01-022 RFC No. N01DA-1-8813 National Institute on Drug Abuse The development of medications for the treatment of drug addiction is a major mission of the National Institute on Drug Abuse (NIDA). The Institute prepares potential treatment drugs for use in preclinical toxicology evaluation, pharmacological studies and clinical trials. The treatment drugs include both bulk drug substances (e.g., GBR-12909, tropane analogs, RPR-102681, etc.) and dosage forms (e.g., GBR-12909 capsules, RPR-102681, etc.). These drugs are acquired by the Government from private industry, Government contractors/grantees or independent investigators. As for the dosage forms to be used in preclinical and clinical studies, the Government has relied on contractors to develop and manufacture stable dosage forms under Good Manufacturing Practice (GMP). Proposals are being soliciting from qualified organizations having the capability to carry out tasks of collecting and analyzing preformulation data on drug substances, developing and manufacturing dosage forms, packaging the dosage forms, developing and validating analytical methods, carrying out stability studies, adequate storage of controlled drug substances and their finished dosage forms and preparation and submission of Chemistry, Manufacturing and Control section of DMFs, INDs or NDAs. In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. Further, all offerors must have adequate GMP manufacturing facilities. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of three years with two additional option years. The contract will also include options for additional quantities. RFP No. N01DA-1-8813 will be available electronically on or about March 5, 2001, and may be accessed through the NIDA website. Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, Deliverables and Reporting Requirements, Special Requirements and Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. All information required for the submission of an offer will be contained in or accessible through the electronic RFP package. This advertisement does not commit the Government to award a contract. This acquisition is a 100% Small Business Set-Aside. Point of Contact: David T. Lisle, Contracts Specialist Contracts Management Branch, OPRM National Institute on Drug Abuse, NIH 6001 Executive Boulevard Room 3105, MSC 9543 Bethesda, MD 20892-9543 Email: DL115q@nih.gov Telephone: (301) 443-6677 Fax: (301) 443-7595
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