NIH GUIDE, Volume 25, Number 34, October 11, 1996




P.T. 34







National Cancer Institute


The National Cancer Institute (NCI), Division of Cancer Treatment,

Diagnosis and Centers (DCTDC), Development Therapeutics Program (DTP)

anticipates the award of five cost-reimbursement contracts, for a

five year period beginning August 30, 1997.  As a minimum

requirement, the contractors must perform all toxicology studies in

accordance with the FDA's current Good Laboratory Practice (GLP).

Contractors must also indicate their willingness to sign a

confidentiality of information statement.  The proposed awarded

contracts will be administered on a work assignment managed basis.

Offerors are required to proposed levels of effort for both levels:

Level A: 46,875 labor hours, and Level B: 93,750 labor hours over a

five year period.  DTP is seeking organizations to carry out

pharmacology and toxicology studies, the data from which must be

suitable for filing with the FDA as part of Investigational New Drug

Applications Offerors should have the facilities and staff to carry

out such studies and the management expertise to analyze and evaluate

the data.  Work assignments are estimated to involve two or three

chemical agents annually per contract.  The objectives of the

assignments in relative order of importance are: (1) assessment or

acute and subacute toxicity in rodents and dogs including

determination of a maximum  tolerated dose (MTD), of dose limiting

toxicities (DLT), schedule-dependent toxicity, of 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

rodents, dogs, and/or non-human primates treated with the agents

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 is 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, pharmacokinetics and analytical chemist should likewise

have credentials which illustrate their competence and accomplishment

in service as critical team members in the conduct of such studies.

This is a recompetition of a group of 5 contractors currently

performing these activities.


The Request for Proposal will be available on or about October 18,

1996.  No collect calls accepted.  Requests for the RFP may be

directed to:


Elsa B. Carlton

Research Contracts Branch

National Cancer Institute

6120 Executive Boulevard, Room 603 - MSC 7220

Bethesda, MD  20892-7220

Telephone:  (301) 496-8620



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