SOLICITATION NOTICE
A -- GMP Synthesis of Bulk Drug Substances
- Notice Date
- 12/12/2008
- Notice Type
- Modification/Amendment
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Room 260 - MSC 8402, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- N01DA-09-8881
- Response Due
- 2/2/2009
- Point of Contact
- Rob Bowman,, Phone: 3014436677, Kenneth E Goodling,, Phone: (301)443-6677
- E-Mail Address
-
bowmanrv@mail.nih.gov, kg25d@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This Procurment is 100% set asaide for Small Businesses The National Institute of Drug Abuse (NIDA) intends to solicit for the manufacture of 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. 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 possess a current DEA registration for Schedules II-V substances, and demonstrate the capability to obtain DEA registration for Schedule I controlled substances. NIDA anticipates the award of two 3-year task order contracts, each with two 1-year options. RFP No. N01DA-9-8881 will be available electronically about November 17, 2008 and interested sources may access it through the Internet at: www.fbo.gov or through the NIDA website address: www.nida.nih.gov/RFP/RFPList.html. The electronic RFP contains all information needed to submit an offer. No printed version of the solicitation document or bidders list available. Proposals will be due about January 5, 2009. 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.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=192e3c7b3bdfc81471fc1a1bedebece4&tab=core&_cview=1)
- Record
- SN01718156-W 20081214/081212215411-192e3c7b3bdfc81471fc1a1bedebece4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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