SOLICITATION NOTICE
A -- Preclinical Toxicology & Pharmacology of Drugs Developed for Cancer, AIDS and AIDS RELTED ILLNESSES
- Notice Date
- 6/10/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N01-CM-37039-19
- Response Due
- 9/17/2003
- Point of Contact
- Diane Stalder, Contract Specialist, Phone (301) 435-3822, Fax (301) 402-6699, - MaryAnne Golling, Contracting Officer, Phone (301) 435-3819, Fax (301) 402-6699,
- E-Mail Address
-
ds88b@nih.gov, mg345x@nih.gov
- Description
- 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 both 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 a 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 responsible offerors will be considered. The solicitation is scheduled for electronic release approximately July 17, 2003. The proposals will be due approximately 60 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. Point of contact: Diane Stalder, Contract Specialist at e-mail: ds88b@nih.gov; FAX: 301-402-6699; Telephone: 301-435-3822. No collect calls will be accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (10-JUN-2003). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 07-APR-2004, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N01-CM-37039-19/listing.html)
- Record
- SN00562158-F 20040409/040407214447 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |