ANALYTICAL CHEMISTRY AND STABILITY TESTING OF TREATMENT DRUGS RELEASE DATE: December 17, 2003 NOTICE: NOT-DA-04-020 PRE-SOLICITATION NO.: N01DA-4-8844 National Institute on Drug Abuse (NIDA) The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations having in-house capability to carry out the work for the development of analytical methods, carrying out quality control tests and performing stability studies for compounds and dosage forms to be used in the medications development program. The development of medications for the treatment of drug addiction is one of the major missions 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 (e.g., GBR-12909, tropane analogs, RPR 102681, etc.) and dosage forms (e.g., buprenorphine tablets, GBR- 12909 capsules, RPR 102681 capsules, etc.). 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. NIDA anticipates award of a three year incrementally funded completion type contract with options for two additional years and additional quantities. 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. If the offeror does not possess a DEA registration for controlled substances Schedules II through V, the proposal must indicate that application for such registration is in progress and assurance must be provided that such application will be successful (documentation to be provided of adequately secure storage facilities, etc.). RFP No. N01DA-4-8844 will be available electronically on or about January 12, 2004. You can access The RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (URL: http://www.nida.nih.gov/RFP/RFPList.html). Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, Deliverables, Reporting Requirements, Special Requirements, Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. However, all information required for the submission of an offer will be contained in or accessible through the streamlined electronic RFP package. Responses to the RFP will be due on or about February 26, 2004. This advertisement does not commit the Government to award a contract. See Note 26. Original Point of Contact Dawn Rabunsky, Contract Specialist, NIDA/NIH, Phone 301 443-6677, Fax 301 443-7595, Email dr23a@nih.gov - Nancy Hurd, Contracting Officer, Phone (301) 443-6677, Fax (301) 443-7595, Email nh31d@nih.gov
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