Pre-Sol_Notice.pdf

SYNOPSIS

N02-CM-47001-42

“PRECLINICAL TOXICOLOGY OF DRUGS DEVELOPED FOR CANCER

PATIENTS”

Background

The Development Therapeutics Program (DTP) of the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is soliciting preclinical toxicology of drugs developed for cancer patients. Investigations that profile and characterize the toxicological risk of these compounds to healthy organs are essential to the preclinical development phase for potential new drugs. Data generated from these studies are evaluated in light of potential human toxicity risk and additionally, form a major portion of the information required by the Food and

Drug Administration for an Investigational New Drug Application (IND). Such laboratory investigations comprise the primary responsibility of this concept and of the Toxicology &

Pharmacology Branch (TPB) within the DTP.

Toxicology studies conducted under these contracts are designed to meet this objective by providing: characterization of dose limiting toxicities (DLT); determination of schedule-dependent toxicity; determination of the reversibility of adverse effects; determination of a safe clinical starting dose via a margin of safety determination. Toxicology studies conducted under these contracts are designed to meet this objective by providing: characterization of dose limiting toxicities (DLT); determination of schedule-dependent toxicity; determination of the reversibility of adverse effects; determination of a safe clinical starting dose via a margin of safety determination.

Project Requirements:

A Statement of Work (SOW) is attached to this notice

A. Analytical Phase: Drug identity analysis (e.g., IR, NMR, MP, MS, or other emergent assay methodology designated by the Contracting Officer’s Representative (COR).)

B. Pharmacokinetic Phase: Plasma elimination kinetics shall be determined in one or more of the following species: dogs, rodents and non-human primates after single intravenous doses of drugs.

C. Screening and Preliminary Phase: For each drug, establish a maximum tolerated dose

(MTD) and dose limiting toxicities (DLT).

D. IND-Directed Toxicology Assessment Phase: For each drug, establish toxicity and safety in relation to drug plasma concentrations or area-under-the-curve.

Solicitation Date:

The solicitation is scheduled for electronic release on or about April 23, 2014. The RFP may be accessed through the NCI Office of Acquisitions, NCI homepage by using the following address:

http://rcb.cancer.gov/rcb-internet/index.jsp; or through FedBizOpps.gov https://www.fbo.gov/.

It is the offeror’s responsibility to monitor the above internet sites for the release of this solicitation and amendments if any. ALL OFFERORS WILL BE RESONSIBLE FOR

DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN

ADDITION, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO FAX

SUBMISSIONS WILL BE ACCEPTED. NO COLLECT CALLS WILL BE ACCEPTED.

Other Important Considerations:

Data obtained from resulting contract(s) may 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agencies, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting.

The contract type is multiple award, five (5) year, Indefinite Delivery Indefinite Quantity (IDIQ)

(FAR 16.5) type contracts. Task Orders will be either cost reimbursement completion, fixed price completion, or a combination of both. Offerors will be invited to submit a sample task order with their proposal. The sample task will be detailed in the solicitation. This acquisition will be full and open due to the responses that were received from a small business sources sought notice that was posted on August 1, 2013.

NAICS Code and Size Standard: The North American Industry Classification System (NAICS) code that will be used is 541690 with a size standard of $14,000,000.

Accreditation by the American Association for Accreditation of Laboratory Animal Care

(AAALAC) is desirable. Documentation of a lack of findings from one or more ALLAC inspections may also be provided.

Under governing policy, federal funds administered by the Public Health Service (PHS) shall not be expended for research involving live vertebrate animals without prior approval by the Office of Laboratory Animal Welfare (OLAW). An assurance to comply with the PHS policy on humane care and use of laboratory animals and/or a valid Institutional Animal Care and Use

Committee (IACUC) approval must be submitted before a contract award can be made. This restriction applies to all performance sites (e.g. collaborating institutions, subcontractors, subgrantees) without OLAW-Approved Assurances, whether domestic or foreign.

DISCLAIMER AND IMPORANT NOTES: This notice does not obligate the Government to award a contract. Interested parties are advised that the Government is under no obligation to acknowledge receipt of any information received or provide feedback to interested parties with respect to any information submitted.

http://rcb.cancer.gov/rcb-internet/index.jsp https://www.fbo.gov/

Main Point of Contact: MaryAnne Golling, Contracting Officer gollingm@mail.nih.gov

Riverside Five, Suite 400, Room 4045

8490 Progress Drive

Frederick, MD 21701

Phone: 301-624-8746

Secondary Point of Contact: Andrew May, Contracting Officer

Andrew.May@nih.gov

Riverside Five, Suite 400, Room 4041

8490 Progress Drive

Frederick, MD 21701

Phone: 301-624-8755