GMP SYNTHESIS OF BULK DRUG SUBSTANCES RELEASE DATE: April 4, 2003 NOTICE: NOT-DA-03-024 RFP AVAILABLE: N01DA-3-8840 National Institute on Drug Abuse (NIDA) The National Institute of Drug Abuse (NIDA) has a requirement for qualified organizations to manufacture bulk drug substances under Good Manufacturing Practices (GMP). These bulk drug substances support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials. This is a follow-on procurement to contract number N01DA-8- 8091 with Albany Molecular Research. Offerors must be experienced in producing GMP drug substance in batch sizes of at least one kilogram or larger, able to store GMP materials, and be in good standing with the FDA. Offerors must have immediate access to state-of-the-art equipment for analytical testing such as HPLC, GC/MS, IR, NMR. In order to handle substances under the Controlled Substances Act of 1970, the successful offeror must indicate possession of a current DEA registration for Schedules II-V substances prior to award, and demonstrate the capability to obtain DEA registration for Schedule I controlled substances. NIDA expects that two 3-year task order contracts, each with two options to extend the period of performance for one year, will result from this solicitation. RFP No. N01DA-3-8840 will be available electronically about April 7, 2003 and interested sources may access it through the Internet at: http://www.fedbizopps.gov or through the NIDA website address: http://www.nida.nih.gov/RFP/RFPList.html. The streamlined RFP for this acquisition includes only the Work Statement, Deliverables and Reporting Requirements, Special Requirements and Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. The electronic RFP contains all information needed to submit an offer. No printed version of the solicitation document or bidders list available. All responsible offerors may submit a proposal for the government's consideration. Proposals will be due about May 20, 2003. This advertisement does not commit the Government to award a contract. Point of Contact: Diane M. Loeb, Contract Specialist National Institute on Drug Abuse, NIH Contracts Management Branch, OPRM 6001 Executive Boulevard Room 3105, MSC 9543 Bethesda, Maryland 20892-9543 Electronic Mail Address: dl294p@nih.gov Telephone: (301) 443-6677 Fax: (301) 443-7595
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