SOURCES SOUGHT
A -- Investigational New Drug Toxicology for Drugs to Treat Alzheimer’s Disease and Other Aging-Related Diseases
- Notice Date
- 4/1/2009
- Notice Type
- Sources Sought
- 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 Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- NIH-AG-2009-054
- Point of Contact
- Stephanie Powell,, Phone: (301) 443-6162, Teresa A. Baughman,, Phone: (301) 443-1193
- E-Mail Address
-
spowel1@nida.nih.gov, baughmat@nida.nih.gov
- Small Business Set-Aside
- N/A
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. No solicitation is available at this time. The NAICS code is 541712 with a size standard of 500 employees. The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), is seeking small businesses with the capabilities 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 Contractor shall be required to 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 Contractor shall be able to 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. The Contractor shall also be capable of performing the following types of studies: (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 Contractor shall be able to perform hematological and clinical chemistry parameters, urinalysis, ophthalmological examination, necropsy, microscopic examination of tissues, and pharmacokinetic analyses. It is a mandatory qualification criterion 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, the other mandatory qualification criterion 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 It is estimated that approximately 3.4 FTEs will be required annually for the performance of this project over a five (5)-year period of performance. Small business concerns within this size standard that believe they possess the capability necessary to successfully undertake the work described in the Statement of Work should submit an original and three (3) copies of their capability statement tailored to this requirement to the address shown. Respondents may also submit their capability statements via e-mail or fax. Capability statements must identify the business status of the organization (i.e. small business, 8 (a), HUBZone, Service Disabled Veterans, etc.). No collect calls will be accepted.
- Web Link
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- Record
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