MODIFICATION
A -- Toxicological Evaluation of Potential Medications to Treat Drug Addiction
- Notice Date
- 2/13/2008
- Notice Type
- Modification
- 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
- 20892
- Solicitation Number
- N01DA-8-8880
- Response Due
- 2/28/2008
- Point of Contact
- Robin Jeffries, Contract Specialist, NIDA R&D Contracts Management Branch, Phone 301.443.6677, Fax 301.443.6677
- E-Mail Address
-
jeffriesr@nida.nih.gov
- Description
- This modification, to the synopsis posted on February 13, 2008, revises the period in which the RFP will be due to be received (see 4th paragraph below). The National Institute on Drug Abuse plans to solicit proposals from qualified offerors with the in-house capacity to conduct systematic preclinical toxicology studies and preclinical cardiovascular safety studies that support the development of potential pharmacotherapies for the treatment of drug addiction. The preclinical studies shall adhere to Good Laboratory Practices (GLP) guidelines as set forth by relevant Food and Drug Administration (FDA) guidance and regulations (e.g. CFR Title 21). Offerors must have on-site in vivo toxicology (rodent, canine and nonhuman primate) and in vivo cardiovascular safety testing facilities with telemetric recording (dog and nonhuman primate), access to state-of-the-art equipment for performing in vitro tests on cardiac muscle (hERG channel assays and APD tests) and access to state-of-the-art equipment for performing analytical testing of dosing solutions and verification of identity of the bulk substance (HPLC, GC/LC-MS, IR and NMR). Offerors must show experience in preparing reports in acceptable format for submission to the FDA. 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 offerors must comply with NIH guidelines on the care and use of laboratory animals. We anticipate the award of one cost reimbursement contract for a period of five years with additional annual option quantities. NIDA anticipates release of this solicitation (RFP No. N01DA-8-8880) on or about March 13, 2008, with responses due to be received in the NIDA R&D Contracts Management Branch 45 calendar days thereafter. You can access the RFP through the FedBizOpps website (URL: http://www.fedbizopps.gov) or through the NIDA website (URL: http://www.nida.nih.gov/funding/rfplist.html). Award of this contract is anticipated on or about September 1, 2008. NIDA will consider proposals submitted by all responsible offerors. This advertisement does not commit the Government to award a contract. See Note 26. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (13-FEB-2008). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 25-MAR-2008, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01DA-8-8880/listing.html)
- Place of Performance
- Address: NIDA R&D Contracts Management Branch, OPRM, NIDA/NIH 6101 Executive Boulevard, Room 260, MSC 8402 Bethesda, MD
- Zip Code: 20892-8402
- Country: UNITED STATES
- Zip Code: 20892-8402
- Record
- SN01541608-F 20080327/080325230847 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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