NOT-DA-01-022: A DEVELOPMENT AND MANUFACTURE OF PHARMACEUTICAL PRODUCTS FOR ADDICTION TREATMENT

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®


A DEVELOPMENT AND MANUFACTURE OF PHARMACEUTICAL PRODUCTS FOR ADDICTION TREATMENT

Release Date:  January 31, 2001

NOTICE:  NOT-DA-01-022

RFC No. N01DA-1-8813

National Institute on Drug Abuse

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.  
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.  
This advertisement does not commit the Government to award a contract.  
This acquisition is a 100% Small Business Set-Aside.

Point of Contact:

David T. Lisle, Contracts Specialist
Contracts Management Branch, OPRM
National Institute on Drug Abuse, NIH
6001 Executive Boulevard
Room 3105, MSC 9543
Bethesda, MD  20892-9543
Email:  [email protected]
Telephone:  (301) 443-6677
Fax:  (301) 443-7595
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices