SOLICITATION NOTICE
A -- Development and Manufacture of Pharmaceutical Products for Addiction Treatment
- Notice Date
- 1/31/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, MD, 20892
- ZIP Code
- 20892
- Solicitation Number
- N01DA-6-8866
- Response Due
- 4/15/2006
- Archive Date
- 4/30/2006
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institute on Drug Abuse plans to procure services from a qualified organization having the capability to develop and manufacture pharmaceutical products for addiction treatment. This is a 100% Small Business Set-aside procurement (NAICS 541710 ? 500 employees). This includes, but is not limited to, conducting preformulation studies on drug substances, developing and manufacturing dosage forms, developing and validating analytical methods for dosage forms, carrying out stability studies, packaging and delivery of the pharmaceutical products to NIDA designated sites. Qualified organizations must also be able to provide adequate facilities for the storage of bulk drug substances, including controlled substances, and their finished dosage forms as directed by the NIDA Project Officer. The organizations shall have appropriate DEA Registrations for Schedules II-V Controlled Substances in order to use the controlled substances in research and manufacture of dosage forms under the Controlled Substance Act of 1970, and must either possess or demonstrate the ability to obtain DEA Registrations for Schedule I Controlled Substances should the research and manufacture of the Schedule I drugs be required. The organizations shall be able to carry out the tasks in compliance with the Food and Drug Administration's (FDA's) current Good Manufacturing Practice regulations (cGMP) and/or Good Laboratory Practices (GLP). The data and documentation prepared should be in a format acceptable to the Food and Drug Administration (FDA) for inclusion in Drug Master Files (DMF), Investigational New Drugs (IND) or New Drug Applications (NDA). NIDA expects to award a 3-year contract with two one-year options. Additional quantity options for manufacture of drug products will also be included. RFP No. N01DA-6-8866 will be available electronically on or about February 15, 2006 and may be accessed through the Internet at: www.fedbizopps.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 source list is available. NIDA will consider proposals submitted by any responsible offeror. Proposals will be due on or about April 15, 2006. Following proposal submission and the initial review, the Contracting Officer may require additional documentation. This advertisement does not commit the Government to award a contract. See Notes 1 and 26.
- Record
- SN00976613-W 20060202/060131211757 (fbodaily.com)
- Source
-
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