Conduct of Toxicological Evaluations for the Division of Translational Toxicology (DTT)   3

This notice announces the intended release of solicitation number 75N96023R00009.

DESCRIPTION
This pre-solicitation notice follows a Sources Sought notice that was released on December 23, 2022 under notice number NIEHS2022-ToxDTT.

The Division of Translational Toxicology (DTT) is an intramural division of the National Institute of Environmental Health Sciences, National Institutes of Health. DTT uses traditional and cutting- edge approaches to better understand how factors in our environment may impact human health. Such approaches include the conduct of toxicology studies on chemical, physical, and biological agents, as well as non-chemical stressors, using in vitro and in vivo models of health and disease.

The National Institute of Environmental Health Sciences (NIEHS) intends to negotiate and award a contract to support and assist the National Institute of Environmental Health Sciences and the and the Division of Translational Toxicology (DTT) by conducting ongoing and recurring evaluations of the toxic and carcinogenic potential of chemical, biological and physical agents that may pose a health hazard to humans. Services and support related to toxicology testing include, but are not limited to, the following: 1) customized, fit-for-purpose study designs (2) refinement of requirements after study initiation and (3) specific data collection requirements. The Contractor will conduct in vitro studies and short-term and long-term in vivo studies on a diverse array of agents by various routes of exposure.

MANDATORY QUALIFICATION CRITERIA
Mandatory qualification criteria will apply to this requirement. The qualification criteria establish conditions that must be met at the time of receipt of Final Proposal Revisions (FPRs) by the Contracting Officer in order for the proposal to be considered any further for award. The following Mandatory Qualification Criteria apply to this requirement:

Mandatory Requirement 1: SMALL BUSINESS SUBCONTRACTING PLAN
In accordance with FAR 19.7, all other than small businesses shall submit a Small Business Subcontracting Plan.

Mandatory Requirement 2: GLP COMPLIANCE
The DTT requires that selected work (as directed by the COR) shall be conducted in compliance with FDA GLP regulations as specified in Part 58 Good Laboratory Practices for Non-clinical Laboratory Studies .

Mandatory Requirement 3: ANIMAL REQUIREMENTS
The contract must be conducted in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the AWRs, the current edition of the Guide for the Care and Use of Laboratory Animals (the Guide), and all local, state, or federal regulations. The contractor must be accredited by AAALAC International.

Mandatory Requirement 4: CONFORMANCE TO SECTION 508 STANDARDS
Electronic documents and reports are anticipated to be included in the deliverables of the resultant contract. Requirements for accessibility based on Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220) will apply to this procurement. Products, platforms, and services delivered as part of this work statement that are identified as Information and Communication Technology (ICT), or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 & Apps. A, C & D, and available at 508 Standards and Guidelines. Additional information on Section 508 including NIH's 508 policy can be found at https://ocio.nih.gov/ITGovPolicy/NIH508/Pages/default.aspx .

OTHER IMPORTANT CONSIDERATIONS

Key Personnel: The principal investigator (PI) and program manager (PM) are considered key personnel and shall be employees of the contractor.

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.

NOTICE TO OFFERORS

This notice is not a Request for Proposals and does not commit the Government to award a contract.

A solicitation may or not be issued. The estimated issue date of the solicitation is 15 days from the date of this notice. Proposals will be due on or about 45 days after the solicitation release date.

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. This contract is expected to consist of a single award, cost-plus-fixed-fee contract for research and development services. It is anticipated that award will be on or before September 2024 for a base period of one-year, plus nine (9) successive one-year option periods. The proposed contract is anticipated to be issued using full and open competition. The North American Industry Classification System (NAICS) code for this procurement is 541715 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.

The RFP will only be available electronically and must be accessed through the Sam.gov website (www.sam.gov). All information required for submission of a proposal will be contained in the electronic RFP package. It is the offeror's responsibility to monitor the above Website for the release of this RFP and amendments, if any. All responsible sources may submit a proposal, which shall be considered by the agency. Proposals must be submitted through the NIH electronic Contract Proposal Submission (eCPS) system. Detailed submission instructions will be provided upon issuance of the solicitation. All questions regarding this acquisition shall be submitted in writing via email to: filardok@niehs.nih.gov. Please reference the solicitation number RFP#75N96023R00009 and project title on your written request. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED.