PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS DEVELOPED FOR CANCER, 
AIDS AND AIDS-RELATED ILLNESSES

RELEASE DATE:  June 23, 2003

NOTICE:  NOT-CA-03-033

National Cancer Institute (NCI)
 (http://www.nci.nih.gov)

The Developmental Therapeutics Program (DTP) of the Division of Cancer 
Treatment, Diagnosis and Centers (DCTD) of the National Cancer 
Institute (NCI) is seeking organizations to carry out pharmacology and 
toxicology studies, the data from which must be suitable for filing 
with the Food and Drug Administration as part of Investigational New 
Drug Applications.  The organizations should have the facilities and 
staff to carry out such studies and the management expertise to analyze 
and evaluate the data. Proposals must meet the Mandatory Qualification 
Criterion at the time of submission of initial proposals. As a minimum 
requirement, the contractors must perform all toxicology studies in 
accord with the FDA's current Good Laboratory Practice Regulations 
(GLPs).  Contractors must also indicate their willingness to sign a 
confidentiality of information statement.  Multiple contracts will be 
awarded and each will be administered on a work assignment managed 
basis.  Work assignments will be issued under the "funded cost-
reimbursement completion" contracts resulting from this solicitation.  
Assignments are estimated to involve two to three chemical agents 
annually per contract.  Offerors are required to propose two levels of 
effort (64,015 and 127,960 hours over a 7 year period). The objectives 
of the work assignments in relative order of importance are: 1) 
assessment of acute and subacute toxicity in rodents, dogs, non-human 
primates (NHPs) and other animal models including determination of a 
maximum tolerated dose (MTD), dose limiting toxicities (DLT), schedule-
dependent toxicity, the reversibility of adverse effects and of a safe 
clinical starting dose; 2) validation of analytical methodology to 
quantitate plasma drug levels in preclinical animal models and to 
measure plasma drug levels in animal models treated with the agent 
under study; 3) determination of bioavailability of drug after 
parenteral and/or oral administration, if efficacious drug levels can 
be attained in plasma in vivo and if the drug crosses the blood-brain 
barrier; 4) the use of pharmacokinetic information to permit 
extrapolation of toxic effects across species by relating plasma drug 
levels to the time of appearance and severity of toxicity; and to 
establish the safety of potentially efficacious doses. The Principal 
Investigator should have a doctoral degree in pharmacology/ toxicology 
plus at least five years experience in directing, implementing, and 
evaluating drug toxicity studies in experimental animals.  The 
Pathologist, Pharmacokineticist, and Analytical Chemist should likewise 
have credentials, which illustrate their competence and accomplishments 
in serving as critical team members in the conduct of such studies. The 
government anticipates multiple awards on an incremental funded basis.  
Each increment will be for one year and the total contract will be 
awarded for a seven year period on or about February 28, 2004. All 
responsive offers will be considered.   The solicitation is scheduled 
for electronic release approximately July 17, 2003.  The proposals will 
be due approximately 65 days following the actual date of RFP issuance.  
The RFP may be accessed through the Research Contracts Branch Home Page 
by using the following internet address: http://rcb.nci.nih.gov.  It's 
the offeror's responsibility to monitor the above Internet site for the 
release of this solicitation and amendments, if any.  Potential 
offerors will be responsible for downloading their own copy of the 
solicitation and amendments.  No collect calls will be accepted.

INQUIRIES

For further information contact:

Diane H. Stalder
Contract Specialist
Treatment, Biology, and Sciences Section, RCB
6120 Executive Blvd.
Rockville, MD 20892-7193
Telephone: 301-435-3822
Fax: 301-402-6699
E-mail: ds88b@nih.gov

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