Notice Number: Number Here

Key Dates
Release Date: February 13, 2015

Issued by
National Cancer Institute (NCI)

Purpose

The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) announces the release of a Request for Proposals (RFP) on "Preclinical Prevent Cancer Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers."

This RFP (RFP N01CN55003-47) is available on the web site of the Office of Acquisitions (OA), NCI, at http://ncioa.cancer.gov/oa-internet/appl/rfp/55003/toc.pdf, with instructions for submission of proposals and evaluation criteria. For the complete solicitation package posted on Federal Business Opportunities site (www.fbo.gov), go to https://www.fbo.gov/index?s=opportunity&mode=form&id=9b0cfcc7158f823cca4cb5957840eb07&tab=core&_cview=1.

It is expected that multiple contracts will be awarded under this RFP. The contracts under RFP N01CN55003-47 shall support the development of potential cancer preventive agents or vaccines employing detailed preclinical efficacy studies and determining pharmacodynamics efficacy, and biomarkers, which parallel the effectiveness of a given agent. The primary endpoint of the efficacy studies shall be to prevent the development of invasive cancers whereas the biomarker studies will identify endpoints which correlate with the effectiveness of a given preventive agent or vaccine. These endpoints might be measured in body fluids, in normal or at-risk tissue from the target, or in histopathologically altered tissue from the target organ(s).

The Successful Contractor shall be able to perform work in these Task Areas as outlined in each Task Order:

1. TASK AREA 1 - CHEMOPREVENTIVE EFFICACY EVALUATION OF CHEMO-PREVENTIVE AGENTS BY ANIMAL BIOASSAYS. The Contractor shall use animal models for cancer prevention testing including bladder, lung, skin, esophagus, colon/intestinal tract, prostate, melanoma, trachea/bronchus, head and neck, brain, pancreas, ovary, and hematopoietic systems.

1. Breed, maintain rodent colonies.
2. Procure, analyze chemopreventive agent for purity, homogeneity, stability in administering vehicles.
3. Administer carcinogens, promoters, hormones, chemopreventive agents.
4. Conduct studies monitoring tumorigenesis, body weight, vital signs, vaccine-mediated humoral and cellular immune responses.

2. TASK AREA 2 - EVALUATION AND VALIDATION OF INTERMEDIATE ENDPOINTS. The Contractor shall conduct intermediate endpoint assays in rodent tissues and perform studies utilizing NCI-supplied de-identified human samples examining relevant intermediate endpoints.

1. Genomic, proteomic and metabolomic assays performed on tissues, serum, or urine.
2. Quantitative levels of specific genes or proteins (e.g., RT-PCR, quantitative IHC, Western Blotting) involved in the molecular mechanism of a given agent.
3. Pharmacokinetic endpoints.
4. Immunologic assays.

3. MANDATORY QUALIFICATION CRITERIA. The following conditions must be met at the time of receipt of Proposals to be considered any further for award.

1. Current Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) (or equivalent) accreditation.
2. Approved Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH).
3. Documented participation of an American College of Laboratory Animal Medicine (ACLAM) certified veterinarian.

Inquiries

Please direct all inquiries to:

Mandie S. White
National Cancer Institute (NCI)
Telephone: 301-624-8756
Email: whitems@mail.nih.gov