SOLICITATION NOTICE
A -- Analytical Services Center for Medications Development
- Notice Date
- 12/10/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard Room 260 - MSC 8402, Bethesda, MD, 20892, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- N01DA-8-8875
- Archive Date
- 1/4/2008
- Point of Contact
- Amy Pasciak, Contract Specialist, NIDA/NIH, Phone 301.443.6677, Fax 301.443.7595, - Kenneth Goodling, Contracting Officer, Phone (301)443-6677, Fax (301)443-7595
- E-Mail Address
-
ap370t@nih.gov, kg25d@nih.gov
- Description
- The National Institute on Drug Abuse (NIDA) 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 cost 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. 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. 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. 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-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. See note 26.
- Record
- SN01466779-W 20071212/071210223239 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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