Drug Testing for Clinical Trials

Notice Number: NOT-DA-09-027

RFP Available: N01DA-09-8882

Key Dates
Release Date: March 11, 2009
Proposal Due Date: May 11, 2009

Issued by
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov )

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having in-house capability to perform the following tasks: (a) automated qualitative screening and quantitative measurement of illicit drugs in urine samples to assess illicit drug use in clinical trials and (b) acquisition and distribution supplies (urine collection cups and on-site multi-panel drug test cards) and (c) shipping and handling of urine specimens. The data obtained will be used by the NIDA to support clinical development of new medications for treatment of drug addiction. NIDA anticipates a 2-year Firm Fixed Price type contract with options to extend for 3 additional years and option quantities. One contract will be awarded. 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. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations.

The pertinent FDA's guidelines/guidance shall be followed. RFP No. N01DA-09-8882 will be available electronically on or about March 25, 2009. You can access the RFP through the FedBizOpps http://www.fbo.gov or through the NIDA website at the following address: http://www.nida.nih.gov/RFP/RFPList.html. The electronic RFP contains all information needed to submit a proposal. 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 y 11, 2009.

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.

Inquiries

Amy Sheib, Contract Specialist
Contracts Management Branch
National Institute on Drug Abuse, NIH
NIDA R&D Contracts Management Branch
6101 Executive Blvd., Room 260, MSC 8402
Bethesda, Maryland 20892-8402
E-mail: sheiba@nida.nih.gov
Telephone: (301) 443-6677
Fax: (301) 443-7595