Notice of Request for Proposals for a Contract for Absorption, Distribution, Metabolism, and Excretion (ADME) Studies of Chemical Disposition in Mammals

Notice Number: NOT-ES-06-011

Key Dates
Release Date: March 31, 2006

Issued by
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

The purpose of this notice is to announce a request for proposal (RFP NIH-ES-06-01) (http://www.niehs.nih.gov/dert/rcb/rfp.htm).  The National Institute of Environmental Health Sciences (NIEHS) is seeking contract proposals that study the Absorption, Distribution, Metabolism, and Excretion (ADME) Disposition of Chemicals in Mammals.The purpose of the project is to obtain detailed chemical disposition data from 3 to 6 studies ofselected environmental contaminants or model compounds per year. Most of these studies will be required in laboratory rats (Fischer 344) and/or mice (B6C3F1); however, some studies may require other laboratory animals (other rodent species or dogs).  Most of the studies will address the disposition of organic chemicals or environmental contaminants; however, studies of inorganic chemicals may also be requestedIndividual studies may vary in complexity from preliminary investigations of chemical absorption to detailed studies of all phases of chemical disposition, toxicokinetics, and metabolism.  The immediate goal of these studies is to determine more accurately the doses for National Toxicology Program (NTP) bioassay studies.  The long range goal is the accumulation of data that will permit a better assessment of structure-activity for chemical absorption, metabolism and disposition in laboratory animals and to better interpret the significance of these data to man. A study shall consist of the determination of absorption, distribution, metabolism and excretion of a selected compound in a given species.Identification of unknown metabolites may be complex enough to be considered a separate study. Estimation of toxicokinetic parameters may be requested for selected chemicals.  One or more studies per year may be requested to investigate the comparative metabolism of chemicals in human and rat liver microsomes or hepatocytes in vitro. The compounds for study shall be selected and provided by the Project Officer.  Unless a satisfactory analytical procedure is available for unlabeled compounds and both parties agree to its use, radio labeled compounds shall be provided to facilitate the assay. In most instances, the initial studies shall be performed in male rats; however, the Project Officer shall reserve the right to require studies in female rats or additional species.  Male animals are studied initially to avoid the influence of estrogenic hormones on xenobiotic metabolizing enzymes. The protocol for the study shall be developed by the Principal Investigator in cooperation with the Project Officer.  The government estimates that the project will require the work of 2 professional and 3 technical/administrative personnel in each contract year.  The estimated level of effort is 9,980 labor hours per year.  The Principal Investigator and Co-Principal Investigator shall have a minimum of 5 years Post-Doctoral Degree experience.  The Principal Investigator and Co-Principal Investigator shall demonstrate experience in specific areas by manuscripts or publications as described in the evaluation criteria. Award of two cost-reimbursement, term form contracts (the work on the contract involves continuous activity with no clearly defined end point)on an open competition basis is contemplated as a result of this solicitation.The contracts obtained under this solicitation will continue the work of two similar contracts.  The period of performance for the contract is five years, beginning on or about March 1, 2007 through February 28, 2012.  Five (5) one-year options extending the performance of the contract beyond the fifth base year are planned. Should a study using dogs be initiated it will be included as an option. Interested organizations should fax a request for RFP NIH-ES-06-01 to the attention of Mr. David Sedgley, Contract Specialist at (919) 541-2712 or send an e-mail request to sedgley@niehs.nih.gov.   The electronic version of the Fed Biz Ops synopsis will be available on the Internet at:  http://www.niehs.nih.gov/dert/rcb/rfp.htm.  An electronic copy of the RFP (without the Attachments) with instructions for submission of proposals and evaluation criteria will be posted to this site on or about April 6, 2006.  All responsible sources may submit a proposal which shall be considered by the Agency.  Expected release date of the RFP is April 6, 2006 with proposals due May 24, 2006.  This requirement is unrestricted.  NAICS Code is 541710. 

Inquiries

Written requests should reference RFP NIH-ES-06-01 and should be forwarded to:

National Institute of Environmental Health Sciences
Office of Acquisition, Office of Management
ATTN: David C. Sedgley, Contract Specialist
79 T.W. Alexander Drive, 4401 Building
P. O. Box 12874, EC-02
Research Triangle Park, NC  27709
Phone: (919) 541-4027
Fax:  (919) 541-2712
E-mail: sedgley@niehs.nih.gov


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