PRESOL | A | The Synthesis and Preclinical Studies of New Treatments for Neurodegenerative Disease, Diabetes Mellitus, Congestive Heart Failure, Oncologic and Immunologic Disease.

FBO DAILY ISSUE OF JULY 09, 2009 FBO #2782
SOLICITATION NOTICE

A -- The Synthesis and Preclinical Studies of New Treatments for Neurodegenerative Disease, Diabetes Mellitus, Congestive Heart Failure, Oncologic and Immunologic Disease.

Notice Date: 7/7/2009
Notice Type: Presolicitation
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: HHS-NIH-NIDA(AG)-RFP-09-006
Point of Contact: Drake Russell, Phone: 301-443-0212, Teresa A. Baughman, Phone: (301) 443-1193
E-Mail Address: russeldr@mail.nih.gov, baughmat@nida.nih.gov
(russeldr@mail.nih.gov, baughmat@nida.nih.gov)
Small Business Set-Aside: N/A
Description: PRESOLICITATION NOTICE 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 Internationa, Inc. under NIA Contract HHSN260200400010C (N01-AG-40010). This procurement is being competed under full and open competitive procedures under NAICS 541711. 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 4 FTEs annually. The contract will provide drug discovery support to NIA Investigators. The contract will provide NIA investigators with 1) full characterization of the interaction with the target receptor(s) and systems; 2) identification of potential "off-target" interactions; 3) the determination of the absorption, distribution, metabolism, excretion and toxicity of the potential drug candidate (the ADMET stage of drug discovery); 4) lead optimization involving the synthesis of a series of related compounds, the establishment of quantitative structure-activity relationships (QSAR), followed by selection of "second generation" lead compounds and ADMET studies of these compounds; 5) synthesis of material for toxicology studies including the development of a "good manufacturing process" synthesis of the drug candidate including proof of chemical and microbiological purity; 6) determination of the toxicology profiles of the drug candidate; 7) formulation of the drug candidate; 8) preparation of the documents required for Food and Drug Administration (FDA) approval. Listed below are mandatory qualification criteria. THE OFFEROR SHALL INCLUDE ALL INFORMATION WHICH DOCUMENTS AND/OR SUPPORTS THE QUALIFICATION CRITERIA IN ONE CLEARLY MARKED SECTION OF ITS PROPOSAL. 1) The following qualification criteria establish conditions that must be met at the time of receipt of initial proposals by the Contracting Officer in order for your proposal to be considered any further for award: a. The 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. Compliance is documented in an FDA inspection report. A copy of the two (2) 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. b. The Laboratory Facility must be in compliance with the Food and Drug Administration's (FDA) Good Manufacturing Processes (GMP) as published in the http://www.fda.gov/CDRH/DEVADVICE/32.html#introduction and the http://www.fda.gov/cdrh/comp/gmp.html. GMP Regulations Questions and Answers are available at http://www.fda.gov/cdrh/devadvice/16.html and http://www.fda.gov/cdrh/devadvice/ide/faq.shtml. A copy of the two (2) most recent FDA GMP inspection reports must be included in the proposal. If only one (1) report exists, it is acceptable to include only that one (1) report. c. 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 http://grants.nih.gov/grants/olaw/references/phspol.htm and http://grants.nih.gov/grants/olaw/olaw.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 Drake Russell, Contract Specialist, Phone: 301-443-0212 Email: russeldr@mail.nih.gov Teresa A. Baughman, Contracting Officer, Phone 301-443-1193, Email baughmat@nida.nih.gov
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-RFP-09-006/listing.html)
Place of Performance: Address: N/A, United States
Record: SN01867242-W 20090709/090708000657-0729b5aa67ebb54190b1c68b33715699 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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A -- The Synthesis and Preclinical Studies of New Treatments for Neurodegenerative Disease, Diabetes Mellitus, Congestive Heart Failure, Oncologic and Immunologic Disease.