SOLICITATION NOTICE
A -- GMP Synthesis of Bulk Drug Substances
- Notice Date
- 3/6/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Blvd. Room #3105, Bethesda, MD, 20892-9543
- ZIP Code
- 20892-8402
- Solicitation Number
- N01DA-3-8840
- Response Due
- 5/12/2003
- Point of Contact
- Diane Loeb, Contract Specialist, NIDA/NIH, Phone 301 443-6677, Fax 301 443-7595, - Nikki Zangwill, Contracting Officer, National Institute on Drug Abuse, NIH, Phone (301) 443-6677, Fax (301)443-7595,
- E-Mail Address
-
dloeb@nida.nih.gov, nz2f@nih.gov
- Description
- The National Institute of Drug Abuse (NIDA) has a requirement for qualified organizations to manufacture bulk drug substances under Good Manufacturing Practices (GMP). The regulations and guidelines are in the Code of Federal Regulations, Food and Drugs, 21, Part 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals". 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 2 three-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 March 26, 2003 and interested sources may access it through the Internet at: www.fedbizopps.gov or through the NIDA website address: 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 12, 2003. Following proposal submission and the initial review, the Contracting Officer may require additional documentation from offerors in the competitive range. This advertisement does not commit the Government to award a contract. See Note 26. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (06-MAR-2003). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 19-DEC-2003. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIDA/N01DA-3-8840/listing.html)
- Record
- SN00493605-F 20031221/031219215524 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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