Preclinical PREVENT Cancer Program for Preclinical Efficacy and Intermediate Endpoint Biomarkers

Contracting Office Address Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, Riverside Five, Suite 400, 8490 Progress Drive, Room 4036, Frederick, MD 21701-4998. Note: This synopsis follows a Sources Sought notice that was released on July 25, 2014 under HHS-NIH-NCI-SBSS-PCPSB-45011-64. Description The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) is planning to award multiple contracts under the, Preclinical PREVENT Cancer Program for Preclinical Efficacy and Intermediate Endpoint Biomarkers. These contracts 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, normal or at risk tissue from the target or in histopathlogically 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. A. Breed, maintain rodent colonies. B. Procure, analyze chemopreventive agent for purity, homogeneity, stability in administering vehicles. C. Administer carcinogens, promoters, hormones, chemopreventive agents. D. 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. A. Genomic, proteomic and metabolomic assays performed on tissues, serum or urine. B. Quantitative levels of specific genes or proteins (e.g. RT-PCR, quantitative IHC, Western Blotting) involved in the molecular mechanism of a given agent. ? C. Pharmacokinetic endpoints D. 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. A. Current Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) (or equivalent) accreditation. B. Approved Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH). C. Documented participation of an American College of Laboratory Animal Medicine (ACLAM) certified veterinarian. It is anticipated that up to six (6) Indefinite Delivery Indefinite Quantity (IDIQ) type contracts will be awarded for a 3-year period of performance beginning on or about September 15, 2015. Request for Proposal Number N01CN55003-47 will be available on or about January 7, 2015, 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 CONTRACTING OFFICER LISTED AS THE POINT OF CONTRACT HEREIN. Point of Contact: Mandie S. White, Contracting Officer; Phone +1 (555) 000-0000; Fax +1 (555) 000-0000; email contact@example.gov