Preclinical Pharmacology and Toxicology Studies

Contracting Office Address

Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, 6120 Executive Boulevard, Suite 600, Room 6012, Bethesda, MD 20892-7195.

Description

The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) has a requirement to support the conduct of toxicological and pharmacological evaluations of potential cancer preventive agents for Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for phase 0, 1-3 clinical studies; New Drug Applications (NDA) to the FDA; and, to determine appropriate first-in-human (FIH) doses.

I. TASK AREAS

1. TASK AREA 1 - GENOTOXICITY TESTING. The Contractor shall determine the homogeneity, concentration, and stability of the test substance/test substance mixture under the conditions of use, as appropriate.
A. Bacterial Reverse Mutation Test
B. An In Vitro Test with Cytogenetic Evaluation of Chromosomal Damage with Mammalian Cells
C. An In Vivo Test for Chromosomal Damage Using Mouse or Rat Hematopoietic Cells

2. TASK AREA 2 - GENERAL TOXICOLOGY IN EXPERIMENTAL ANIMALS.
A. Acute Oral Toxicity in Rodents
B. Twenty-Eight Day Study in Rodents and Dogs
C. Ninety Day, Oral Toxicity Study in Rodents and Dogs
D. Six Month Rodent and Nine Month Dog Chronic Toxicity Studies
E. Carcinogenicity Studies in Rodents

3. TASK AREA 3 - REPRODUCTIVE TOXICITY STUDIES IN RODENTS AND RABBITS.
A. Segment II Teratogenicity Studies
B. Two Generation Reproduction Studies in Rodents

4. TASK AREA 4 - SPECIALIZED STUDIES.
A. Bioanalytical Methodology Studies
B. Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Studies
C. Bioavailability and Bioequivalence Studies
D. Drug Metabolism/Drug Interaction Studies
E. Specific Safety Studies
F. Genomics/Proteomics/Metabolomics
G. Computational (Predictive) Pharmacology/Toxicology

II. GENERAL PROCEDURES include compliances for

A. Animal Facility
B. Good Laboratory Practice (GLP) Regulations
C. Pathology procedures
D. Assay of Test Material and Formulations

The Contractor shall be required to conduct studies under the Food and Drug Administration Good Laboratory Practice Regulations (as published in the Federal Register CFR Title 21, Part 58).
It is anticipated that an Indefinite Delivery Indefinite Quantity (IDIQ) type contract will be awarded for a 2-year period of performance beginning on or about September 7, 2012. Request for Proposal Number N01CN25000-26 will be available on or about October 24, 2011, and may be accessed through the FedBizOpps website and the National Cancer Institute home page at http://rcb.cancer.gov/rcb-internet/index.jsp The NAICS Code is 541711. All responsible sources may submit a proposal, which shall 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.

POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND ANY POSSIBLE AMENDMENTS. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACT SPECIALIST LISTED AS THE POINT OF CONTRACT HEREIN.

Point of Contact

Kathleen Sears, Contract Specialist, Phone 301-451-5804, Fax 301-402-8579, searsky@mail.nih.gov

Alternate Point of Contact

Virginia DeSeau, Contracting Officer, Phone 301-435-3778, FAX 301-402-8579, Email deseauv@mail.nih.gov