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A -- Investigational New Drug Toxicology for Drugs to Treat Alzheimer’s Disease and Other Aging-Related Diseases

Notice Date
Notice Type
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 Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
ZIP Code
Solicitation Number
Point of Contact
Teresa A. Baughman, Phone: (301) 443-1193, Tawanda Haynes, Phone: (301) 443-2848
E-Mail Address
baughmat@nida.nih.gov, haynest@mail.nih.gov
(baughmat@nida.nih.gov, haynest@mail.nih.gov)
Small Business Set-Aside
The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (DHHS intends to recompete a requirement currently being performed by SRI International, Inc. under NIA Contract HHSN260200400010C (N01-AG-40010). This procurement is being competed under full and open competitive procedures under NAICS 541712. It is anticipated that a single cost reimbursement, term type contract will be awarded for a 5-year period of performance beginning on or about February 1, 2010, with an anticipated level of effort of approximately 3.4 FTEs annually, to provide toxicology resources to academic and small business investigators who believe they have promising compounds for the treatment or prevention of Alzheimer's disease or other aging-related diseases or have PET imaging agents but who do not have the resources to perform the required toxicology studies. The contract shall provide investigators access to toxicological evaluations that are required by the Food and Drug Administration (FDA) when requesting an Investigational New Drug (IND) designation for clinical studies. This preclinical drug-development program expands the potential range of drug therapies and imaging agents for Alzheimer's disease and other aging-related diseases by making these resources available to a larger and more diverse group of investigators. The contract will also provide services in the following four general categories: (1) analytical chemistry, (2) pharmacokinetics and bioavailability, (3) preliminary toxicity screens, and (4) IND-directed toxicology studies including safety pharmacology. The species to be used in the in vivo studies shall include rodents (rats or mice), dogs (purpose bred Beagle dogs), rabbits, non-human primates, and other animal models as appropriate. In addition, the following types of studies may be performed: (1) Single-dose and 7-day dose range finding toxicity studies in rats and dogs; (2) Expanded acute intravenous toxicity studies in rats and dogs; (3) Functional observation battery evaluations of neurobehavioral effects in rats; (4) Safety pharmacology in rats and dogs; (5) 30-day toxicity studies in rats and dogs; (6) 90-day toxicity studies in rats and dogs; (7) Acute vascular irritation study in rabbits; (8) Cardiopulmonary evaluation by intravenous administration in dogs; (9) In vitro mutagenicity, genotoxicity, and microsomal studies; (10) Pharmacokinetics and bioavailability studies in rats and dogs; (11) Immunotoxicity studies in rats; (12) Single intravenous dose study in rabbits; and (13) Preparation of IND package for submission to the FDA. Depending on the specific protocol, the The contract will also perform hematological and clinical chemistry parameters, urinalysis, ophthalmological examination, necropsy, microscopic examination of tissues, and pharmacokinetic analyses. One mandatory qualification criterion which must be met at the time of initial proposal submission is that the Contractor’s laboratory must be in compliance with the FDA’s 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. Compliance is documented in a FDA inspection report. A copy of the two most recent FDA GLP inspection reports must be included in the proposal. If only one (1) report exists, it is acceptable to include only that one (1) report. In addition, one other mandatory qualification criterion which must be met at the time of receipt of Final Proposal Revisions (FPRs) is that the Contractor'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 Contractor 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://grants.nih.gov/grants/olaw/references/phspol.htm All responsible sources may submit a proposal which will be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. Points of Contact: Stephanie Powell, Contract Specialist, Phone 301-443-6162, Fax 301-443-0501, Email spowel1@nida.nih.gov Teresa A. Baughman, Contracting Officer, Phone 301-443-1193, Fax 301- 301-443-0501, Email baughmat@nida.nih.gov
Web Link
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