SOLICITATION NOTICE
A -- Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Other Aging Related Diseases
- Notice Date
- 1/21/2004
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Division of Research Acquisition, 6100 Executive Boulevard, Room 6E01, MSC 7540, Bethesda, MD, 20892-7540
- ZIP Code
- 20892-7540
- Solicitation Number
- AG-260-04-05
- Point of Contact
- Teresa Baughman, Contracting Officer, Phone 301-496-4487, Fax 301-402-0178,
- E-Mail Address
-
tb14j@nih.gov
- Description
- The National Institute on Aging (NIA), National Institutes of Health (NIH), has a requirement to evaluate acute and chronic toxicity in rodents, dogs, and rabbits of drugs which are proposed to have potential use in the treatment of Alzheimer's disease and other aging-related diseases. The data generated from those studies will be used as part of the filing of an Investigational New Drug Application to the Food and Drug Administration in order to receive approval to use the drugs in humans. The work to be performed includes toxicity evaluations using fully audited Good Laboratory Practices (GLP) in studies such as: single-dose and 7-day dose range finding oral toxicity study in rats; single-dose and 7-day dose range finding oral toxicity study in dogs; expanded acute intravenous toxicity study in rats; expanded acute intravenous toxicity study in dogs; functional observation battery evaluations of neurobehavioral effects in rats; 30 day oral toxicity study in rats; 30 day oral toxicity study in dogs; 90 day oral toxicity study in rats; 90 day oral toxicity study in dogs; acute vascular irritation study in rabbits; cardiopulmonary evaluation by intravenous administration in dogs; and other ancillary studies (e.g. in vitro mutation assays). The following qualification criteria must be met at the time a proposal is submitted: (1) The Offeror’s laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in the December 22, 1978 Federal Register (Volume 43, No. 247, pp. 59986-60025). GLP Regulations are available on the World Wide Web (WWW) at www.fda.gov/ora/compliance_ref/bimo/glp/87finalrule.htm and GLP Regulations Questions and Answers are available at www.fda.gov/cder/guidance/old004fn.pdf. A copy of the most recent FDA GLP inspection report must be included in the proposal; and, (2) The Offeror's animal facilities must be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as indicated by providing the latest accreditation report. Information about AAALAC accreditation is available on the WWW at www.aaalac.org. The Offeror must also provide an animal welfare assurance indicating compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, information for which is available on the WWW at http://ohrp.osophs.dhhs.gov/index.htm and http://grants.nih.gov/grants/olaw/olaw.htm. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. It will be available on this website on or about 15 calendar days from the date of the publication of this synopsis. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal which shall be considered. No collect calls will be accepted.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/OLAO-DRA/AG-260-04-05/listing.html)
- Record
- SN00507651-F 20040123/040121213742 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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