SOLICITATION NOTICE
A -- NIMH Toxicological Evaluation of Novel Ligands Program
- Notice Date
- 2/5/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch 6001 Executive Blvd, Rm 6107, MSC 9603, Bethesda, MD, 20892-9603
- ZIP Code
- 20892-9603
- Solicitation Number
- NIMH-02-DB-0005
- Response Due
- 4/23/2002
- Archive Date
- 5/8/2002
- Point of Contact
- Bruce Anderson, Contracting Officer, Phone 301-443-2234, Fax 301-443-0501, - David Eskenazi, Contracting Officer, Chief, Contracts Management Branch, Phone 301-443-2696, Fax 301-443-0501,
- E-Mail Address
-
ba9i@nih.gov, de5d@nih.gov
- Description
- The National Institute of Mental Health (NIMH) proposes to issue a Request for Proposals (RFP) No. NIMH-02-DB-0005 entitled NIMH Toxicological Evaluation of Novel Ligands Program under Full and Open Competition. The objective of resultant contract is to evaluate the acute toxicity and safety of central nervous system (CNS) compounds submitted for testing in animal model and in vitro test systems. Compounds may include, but are not limited to, unlabeled CNS radioligands, target-selective compounds, novel chemical entities, and structural analogs of Food and Drug Administration (FDA)-approved drugs. Assays may include: acute, single dose toxicity studies in rodents, rabbits, dogs, and/or primates; toxicokinetic studies; and safety studies (e.g., cardiovascular function) in dogs. In some cases, compounds will be evaluated for toxicity and safety under conditions of repeated administration, including mutagenicity and genotoxicity studies. The primary requirements are: (1) to develop experimental protocols for toxicology and safety studies in accordance with current FDA GLP regulations for nonclinical laboratory studies (21 CFR Part 58) http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html) and International Conference on Harmonisation (ICH) Guidelines; (2) to conduct studies in rodents, rabbits, beagle dogs, or rhesus monkeys using established techniques, study parameters, and statistical methods of data analysis; and (3) to prepare Technical Reports structured according to the currently accepted requirements (style and content) necessary for documentation submitted in support of an IND, RDRC, or NDA application. The Contractor is required to have an AAALAC accredited animal facility and to perform most of the assays under GLP - FDA regulations (e.g., the current FDA draft guidance document "Developing Medical Imaging Drugs and Biological Products" dated June 2000 http://www.fda.gov/cder/guidance/3646dft.htm) and ICH Guidelines. A three (3) year base contract with two (2), one (1) year options is contemplated. One (1) contract award is anticipated on or about September 30, 2002. RFP No. NIMH-02-DB-0005 will be available on or about February 22, 2002 and the receipt date of proposals on or about April 23, 2002. The RFP may be accessed through http://www.fedbizopps.gov or the NIMH home page by using the following instructions: access the home page at http://www.nimh.nih.gov, first select Funding Opportunities, then Contracts, then NIMH Requests for Proposals. Please note that the RFP for this requirement will include the Statement of Work, Deliverables and Reporting Requirements, the Technical Evaluation Criteria, and other proposal preparation instructions. All information required for the submission of a proposal will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range may be requested to provide additional documentation to the Contracting Officer. All responsible sources are encouraged to submit a proposal to be considered by the NIMH. This advertisement does not commit the Government to award a contract.
- Place of Performance
- Address: At offeror's location
- Record
- SN20020207/00022716-020205213131-W (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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