SOLICITATION NOTICE
A -- ANALYTICAL CHEMISTRY AND STABILITY TESTING OF TREATMENT DRUGS
- Notice Date
- 11/24/2008
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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-9-8890-RFP
- Point of Contact
- Diane M Loeb,, Phone: 301 443-6677, Craig D Sager,, Phone: (301) 443-6677
- E-Mail Address
-
dloeb@nida.nih.gov, cs591t@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Drug Abuse is soliciting proposals from qualified organizations having the capability to carry out the work for the development and validation of analytical methods, preparation of reference standards, carrying out quality control tests, storage and distribution of drug substances and drug products, and performing stability studies for the compounds and dosage forms to be used in the medications development program. The development of medications for the treatment of drug addiction is a major mission 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 including new molecular entities and dosage forms. 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. The objectives of this requirement are: (1) development and validation of analytical methods for drug substances and/or finished dosage forms; (2) preparation of reference standards; (3) physical and chemical characterizations and quality control tests of drug substances and/or drug products; (4) determination of stability of drug substances and/or finished dosage forms under accelerated and long-term storage; (5) keeping an adequate storage facility for the drug substances and/or finished dosage forms; (6) shipment of drug substances and dosage forms to NIDA designated sites; and (7) keeping a database to track the shipment and storage of the drug substances and the finished dosage forms. The NIDA Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC) will use the data produced by this acquisition in the preparation of Drug Master File (DMF), Investigational New Drug (IND) or New Drug Application (NDA) submitted by NIDA or NIDA supported investigators to the FDA. MANDATORY REQUIREMENTS: 1) DEA REGISTRATIONS: 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 for both narcotics and non-narcotics, and demonstrate the capability to obtain DEA Registration for Schedule I controlled substances. In addition, the successful offeror must also possess DEA registrations for distribution, importation and exportation of controlled substances. 2) DEA APPROVED VAULT: The offeror must have a vault for Schedules I and II and Schedules III-V raw materials and finished products that meets standards described in 21 CFR Part 1301.72. The vault should have a minimum of 300 square feet in area and refrigerators and freezers located inside the vault. 3) COMPUTERIZED SHIPMENT TRACKING SYSTEM: The offeror must have a computerized shipment tracking system. NIDA anticipates the award of a 3-year contract, with two 1-year options. RFP No. N01DA-9-8890 will be available electronically on or about December 15, 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 are available. Proposals will be due on or about February 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=c387f5a9527efc3865246879eb2698c1&tab=core&_cview=1)
- Record
- SN01709579-W 20081126/081124214946-c387f5a9527efc3865246879eb2698c1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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