Support of the Research Effort to Evaluate the Toxic and Carcinogenic Potential of Test Agents in Laboratory Animals for the National Toxicology Program (NTP)

General Information:
This notice synopsizes and announces the release of solicitation number NIHES2013160. The National Institute of Environmental Health Sciences (NIEHS) is soliciting proposals for conducting toxicology studies for the National Toxicology Program (NTP). These studies will support and assist the NTP research effort to evaluate the toxic and carcinogenic potential of test agents in laboratory animals for the NTP.

Key Date: Proposals due September 5, 2013, 4:00pm Eastern time

Background:
The National Toxicology Program (NTP) was established within the Department of Health and Human Services and charged with coordinating toxicological testing programs within the Public Health Service of the Department. The NTP, as part of the National Institute of Environmental Health Sciences (NIEHS), is responsible for evaluating the toxic and carcinogenic potential of environmental agents that may pose a health hazard to citizens of the United States. The NTP requires support for the conduct of short- and long-term toxicity and carcinogenicity studies following exposure to a variety of test agents by various routes of exposure. This requirement is designed to study diverse agents that may include: environmental chemicals; chemicals used in manufacturing or industrial settings; naturally occurring chemicals; food additives, preservatives, colorants or flavorings; pharmaceuticals, botanically- and non botanically-based dietary supplements; herbicides, fungicides, and pesticides; ingredients found in a wide variety of consumer products including soaps, lotions, perfumes and cosmetics; chemicals used in detergents and cleaners, etc.; naturally occurring and synthetic fibers, nanomaterials including carbon nanotubes; metals; plasticizers; flame retardants; mold or mold components; or other agents not specified at this time.

Project Details:
Ongoing and recurring evaluations shall be conducted to evaluate the toxicity and carcinogenicity of test agents by various routes of exposure. For each test agent a detailed protocol outline will be provided by the Government to the testing laboratory. The design of studies assigned to the contract will vary as needed depending on the individual test agents, route(s) of exposure, and endpoints to be evaluated. Studies will typically utilize Harlan Sprague Dawley rats and B6C3F1/N mice; however, other stocks/strains or other species may be utilized. Study duration may be from a few days up to 2-years or lifetime; exposure may begin in utero or in young animals; the route of administration may be inhalation (whole body or nose only), oral (dosed feed, dosed water, gavage), dermal or parenteral (intraperitoneal, subcutaneous, intravenous, intratracheal). Endpoints to be evaluated may include signs of toxicity in life (survival, body weight, food/water consumption, clinical observations), clinical pathology (hematology and clinical chemistry), organ weights, gross and histopathology, and determination of concentration of the test article blood, tissues and excreta). Test agents will typically be provided to the contractor. For inhalation studies, the contractor shall develop methods for characterizing identity and purity to be conducted prior to the start and during the course of the studies. In addition, methods for exposure generation and monitoring of chamber concentrations shall be developed and validated by the contractor. For routes other than inhalation, chemical reanalysis (identity and purity) and dose formulation and analysis methods will typically be provided to the contractor, and test agents will typically have been evaluated for identity and purity (for routes other than inhalation) prior to shipment to the contractor. The contractor will be required to demonstrate method performance prior to starting the studies. Details for typical study designs and for individual routes of administration are found in the Specifications for the Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological and Physical Agents in Laboratory Animals for the National Toxicology Program dated January 2011 and any subsequent revisions (http://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ToxCarSpecsJan2011.pdf).

Award of a cost-reimbursement, level of effort type contract is contemplated. The total estimated level of effort is anticipated to be between 50,000 to 100,000 labor hours per year, including options, depending on the needs of the NTP. The laboratory would be anticipated to provide support to the NTP toxicity and carcinogenicity testing effort by conducting approximately 2-4 prechronic toxicity studies and 2-4 chronic toxicity and carcinogenicity studies per year. The mix of routes and study types may change from year to year.

Mandatory Qualification Criteria:
The Contractor shall have the ability to conduct studies that are compliant with Good Laboratory Practice (GLP) regulations and have an AAALAC accredited laboratory and demonstrate compliance with the NIH guide for Care and Use of Laboratory Animals by the time of proposal submission. In addition, the Contractor shall have a PHS Assurance from the NIH Office of Laboratory Animal Welfare (OLAW) by the time of contract award. See Section M of the RFP package for detailed information on these requirements.

Anticipated Period of Performance:
The anticipated period of performance is a 1-year base contract with nine (9) 1-year options for a total period of performance of ten (10) years. The estimated award date is January 31, 2014.

Disclaimer and Important Notes:
This solicitation is being released under full and open competition. All details and necessary information have been attached herein and made a part of this synopsis/solicitation. The due date for proposals shall be September 5, 2013 at 4:00 pm Eastern time (45 calendar days after release of this notice). All questions related to this solicitation must be submitted no later than August 19, 2013 at 3:00 pm Eastern time.  Interested firms who are unable to access the solicitation files via the FedBizOpps website may request a copy of the solicitation by contacting the Contract Specialist listed herein. Please reference the solicitation number RFP# NIHES2013160 in your written request. All questions regarding this acquisition shall be submitted in writing via email to smithj3@niehs.nih.gov. Telephone inquiries will not be accepted.