Conduct of Studies to Evaluate the Toxicologic Potential of Selected Test Agents for the National Toxicology Program (NTP)

This solicitation notice follows a Sources Sought notice that was released on May 31, 2016 under notice number HHS-NIH-NIEHS-16-531 and a Presolicitation notice released on September 21, 2016 under notice number NIEHS-2016-531-0921.

The National Institute of Environmental Health Sciences (NIEHS) intends to negotiate and award a contract to provide support to the NTP in conducting studies which will assist the NTP in the toxicologic characterization of chemicals/test agents. The purpose of this contract is to provide support to conduct short term and long term studies, including but not limited to 5-day, 2-week, 90-day or longer, toxicogenomic, mechanistic, in vitro and in vivo studies on a variety of test articles by various routes of exposure. The project is designed to study diverse agents that may include environmental chemicals, food additives, colorants, flavorings, pharmaceuticals, herbal remedies, pesticides, ingredients found in a variety of consumer products such as soaps, lotions or cosmetics, detergents, cleaners; or other agents not specified at this time.

The NIEHS seeks a qualified contractor to furnish all the necessary services, qualified personnel, procedures, materials, equipment, and facilities not otherwise provided by the Government as needed to perform the work set forth in the draft Statement of work attached and dated December 28, 2015.

Mandatory Requirements: (1) all studies must be conducted in compliance with FDA GLP regulations as specified in Part 58 "Good Laboratory Practices for Non-clinical Laboratory Studies" and the contractor must demonstrate current compliance with the provisions of 21 CFR 58; (2) the contractor must have an AAALAC-accredited animal facility and demonstrate their compliance with the NIH Guide for Care and Use of Laboratory Animals; and (3) the contractor must have a PHS Assurance from the NIH Office of Laboratory Animal Welfare (OLAW) and the assurance number shall be obtained and on file with OLAW prior to contract award. These minimum mandatory requirements must be met in order to be considered for award.

Contract Type and Contractor's Accounting System: It is anticipated that the resultant contract will be a cost reimbursement type contract. Therefore, to be considered for an award under the resultant solicitation, the offeror's accounting system and practices must be adequate and suitable for accumulating costs under government contracts. Offerors will be required to provide evidence of the accounting system being adequate and the proposal shall include a certification that the offeror's accounting system meets all of the specifications outlined in the solicitation for an adequate accounting system, in accordance with FAR 16.301-3, 16.403-1, and in compliance with FAR Part 31.

Solicitation Details:

The solicitation is anticipated to result in one (1) award to an offeror capable of performing all aspects of the work described in the SOW. It is anticipated that a single award, cost-plus-fixed-fee contract will be awarded on or before May 1, 2017 for a base period of one-year, plus nine (9) successive one-year option periods, as well as an option for an additional level of effort each year. The proposed contract will be issued using full and open competition. The North American Industry Classification System (NAICS) code for this procurement is 541712 with a corresponding size standard of 1,000 employees. The Government intends to make an award using the procedures for competitive negotiated acquisitions as authorized in FAR Part 15.

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.