NOT-DA-03-024: GMP SYNTHESIS OF BULK DRUG SUBSTANCES

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

GMP SYNTHESIS OF BULK DRUG SUBSTANCES

RELEASE DATE:  April 4, 2003

NOTICE:   NOT-DA-03-024

RFP AVAILABLE:  N01DA-3-8840

National Institute on Drug Abuse (NIDA)

The National Institute of Drug Abuse (NIDA) has a requirement for 
qualified organizations to manufacture bulk drug substances under Good 
Manufacturing Practices (GMP).  These bulk drug substances support NIDA 
preclinical safety testing and subsequent safety and efficacy clinical 
trials.   This is a follow-on procurement to contract number N01DA-8-
8091 with Albany Molecular Research.  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 indicate possession of a current DEA registration for 
Schedules II-V substances prior to award, and demonstrate the capability 
to obtain DEA registration for Schedule I controlled substances.   NIDA 
expects that two 3-year task order contracts, each with two options to 
extend the period of performance for one year, will result from this 
solicitation.  RFP No. N01DA-3-8840 will be available electronically 
about April 7, 2003 and interested sources may access it through the 
Internet at: http://www.fedbizopps.gov or through the NIDA website address: 
http://www.nida.nih.gov/RFP/RFPList.html.  The streamlined RFP for this 
acquisition includes only the Work Statement, Deliverables and Reporting 
Requirements, Special Requirements and Mandatory Qualifications, 
Technical Evaluation Criteria, and other necessary Proposal Preparation 
Instructions.  The electronic RFP contains all information needed to 
submit an offer.  No printed version of the solicitation document or 
bidders list available.  All responsible offerors may submit a proposal 
for the government's consideration.  Proposals will be due about May 20, 
2003.  This advertisement does not commit the Government to award a 
contract. 

Point of Contact:

Diane M. Loeb, Contract Specialist
National Institute on Drug Abuse, NIH
Contracts Management Branch, OPRM
6001 Executive Boulevard
Room 3105, MSC 9543
Bethesda, Maryland  20892-9543
Electronic Mail Address: [email protected]
Telephone:  (301) 443-6677
Fax:  (301) 443-7595
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices