A -- A -- DEVELOPMENT AND MANUFACTURE OF PHARMACEUTICAL PRODUCTS FOR ADDICTION TREATMENT

Notice Date

January 29, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Blvd, Rm 3105 (MSC 9543), Bethesda, MD, 20892-9543

ZIP Code

20892-9543

Solicitation Number

N01DA-1-8813

Response Due

April 19, 2001

Point of Contact

John Hamill, Chief Contracting Officer, NIDA, Phone (301) 443-6677, Fax (301) 443-7595, Email jh148m@nih.gov

E-Mail Address

John Hamill (jh148m@nih.gov)

Description

The development of medications for the treatment of drug addiction is a major mission of the National Institute on Drug Abuse (NIDA). The Institute prepares potential treatment drugs for use in preclinical toxicology evaluation, pharmacological studies and clinical trials. The treatment drugs include both bulk drug substances (e.g., GBR-12909, tropane analogs, RPR-102681, etc.) and dosage forms (e.g., GBR-12909 capsules, RPR-102681, etc.). These drugs are acquired by the Government from private industry, Government contractors/grantees or independent investigators. As for the dosage forms to be used in preclinical and clinical studies, the Government has relied on contractors to develop and manufacture stable dosage forms under Good Manufacturing Practice (GMP). Proposals are being soliciting from qualified organizations having the capability to carry out tasks of collecting and analyzing preformulation data on drug substances, developing and manufacturing dosage forms, packaging the dosage forms, developing and validating analytical methods, carrying out stability studies, adequate storage of controlled drug substances and their finished dosage forms and preparation and submission of Chemistry, Manufacturing and Control section of DMFs, INDs or NDAs. In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. Further, all offerors must have adequate GMP manufacturing facilities. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of three years with two additional option years. The contract will also include options for additional quantities. RFP No. N01DA-1-8813 will be available electronically on or about March 5, 2001, and may be accessed through the NIDA website at the following address: (URL: http://www.nida.nih.gov/RFP/RFPList.html) Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, Deliverables and Reporting Requirements, Special Requirements and Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. All information required for the submission of an offer will be contained in or accessible through the electronic RFP package. Response to the RFP will be due on or about April 19, 2001. This advertisement does not commit the Government to award a contract. See Note 1 and Note 26.

Web Link

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Record

Loren Data Corp. 20010131/ASOL004.HTM (D-029 SN50C1C8)