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NOT-DA-08-022: Analytical Services Center for Medications Development Analytical Services Center for Medications Development

Notice Number: NOT-DA-08-022

Key Dates
Release Date: December 11, 2007

Issued by
National Institute on Drug Abuse (NIDA) (www.nida.nih.gov)

The National Institute on Drug Abuse (NIA) is soliciting proposals from qualified organizations having in-house capability to perform the following tasks: (a) quantitative analyses of new medications and their metabolites, illicit drugs, and endogenous substances in biological specimens primarily in plasma and bioanalytical method development and validation for these assays in support of pharmacokinetic studies  (b) automated qualitative screening and quantitative measurement of illicit drugs in biological specimens primarily in urine to assess illicit drug use in clinical trials and (c) shipping and handling of biological specimens.  The data obtained will be used by the NIDA to support preclinical and clinical development of new medications for treatment of drug addiction.   The study reports generated shall be adequate in format and substance for submission to the FDA in support of IND and NDA applications.  NIDA anticipates a 3-year const reimbursement type contract with options to extend for 2 additional years. Additional quantity options will also be included. The solicitation is divided into two Parts.  Part A requires the performance of tasks (a) and (c).  Part B requires the performance of tasks (b) and (c).  The offeror can respond to either one of the two Parts or both Parts. Two separate contracts, one for either Part, or one contract for both Parts will be awarded. Because some compounds may be scheduled under the Controlled Substances Act, proper DEA registration and adequate security is required. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. To handle substances under the Controlled Substances Act of 1970, DEA Research Registration for Schedules II to V will be required.     NIDA may also require a DEA registration for Schedule I controlled substances. In addition, the offeror for Part B should be certified by SAMHSA, state government, or other government agencies for conducting illicit drug testing for the work place. The pertinent FDA's guidelines/guidance shall be followed. RFP No. N01DA-8-8875 will be available electronically on or about January 4, 2008. You can access the RFP through the FedBizOpps http://www.fedbizopps.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 on or about February 21, 2008. This advertisement does not commit the Government to award a contract.


Amy Sheib, Contract Specialist
National Institute on Drug Abuse, NIH
Contracts Management Branch, OPRM
6101 Executive Blvd., Room 260, MSC 8402
Bethesda, Maryland  20892-8402
E-mail: ap370t@nih.gov
Telephone: (301) 443-6677
Fax:  (301) 443-7595

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