75N96025R00003 Presolicitation Notice Pathology.docx

This pre-solictation notice was updated on 12/2/2024. Changes are in red. Strikethrough font indicates deletion; red font indicated addition.

Pre-solicitation Notice - 75N96024R00006 75N96025R00003

Pathology Support for the National Institute of Environmental Health Sciences (NIEHS)

This notice announces the intended release of solicitation number 75N96024R00006 75N96025R00003.

DESCRIPTION

This pre-solicitation notice follows a Sources Sought notice that was released on September 15, 2023, under notice number Pathology_RFI_SSN_NIEHS2023.

The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH) includes two intramural divisions, the Division of Translational Toxicology (DTT) and the Division of Intramural Research (DIR). DTT uses traditional and cutting‐edge approaches to better understand how factors in our environment may impact human health. DIR conducts in‐house research that contributes to the understanding of biological and chemical processes, the role(s) of environmental agents in human disease and dysfunction, underlying mechanisms of environmentally associated diseases, and how intervention and prevention strategies can reduce the effects of exposures to environmental agents.

The contractor shall provide a broad range of pathology support for studies conducted by the Contract Research Organizations (CROs) and by in‐house investigators at NIEHS. Support includes peer review and assessment of pathology evaluations, technical support of these efforts, histopathological interpretation these studies, histology, specialized procedures and emerging technologies, professional and technical personnel, and preparation of material for publication and outreach.

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

Mandatory Requirement: Conformance to Section 508 Standards Electronic documents and reports are anticipated to be included in the deliverables of the resultant contract. When acquiring Electronic and Information Technology (EIT), the government is obligated to meet the accessibility standards at 36 CFR Part 1194 and Section 508 of the Rehabilitation Act of 1973. Section 508 service requirements for Information Content are applicable for this requirement and must address 36 CFR Part 1194, Subpart D, Information, Documentation and Support Conformance to Section 508 Standards. Information about Section 508 is available at http://www.section508.gov/. Organizations submitting proposals will be required to demonstrate compliance with the established EIT accessibility standards by preparing an HHS Section 508 Product Assessment Template.

Mandatory Requirement: Location of Contractor Facilities The prospective contractor must have or demonstrate the ability to establish offices, equipment, and technical facilities including laboratory facilities, within 30 miles of NIEHS, Research Triangle Park, North Carolina, 27709, for the duration of the contract performance period. This requirement will not be changed or modified under any circumstances. Establishment of such offices shall occur within 60 days of award of a contract and be subject to approval by the COR as to suitability and adequacy.

Mandatory Requirement: GLP Compliance Many DTT studies are to be conducted in compliance with FDA GLP regulations as specified in Part 58 “Good Laboratory Practices for Non-clinical Laboratory Studies”. All laboratories (including proposed subcontractors) performing core work as defined in the Statement of Work are required to meet this mandatory qualification criterion.

OTHER IMPORTANT CONSIDERATIONS

Key Personnel: The Principal Investigator (PI) and Program Manager (PM) are considered key personnel and shall be employees of the prime contractor.

Personnel to Support Required Capabilities: Toxicologic Pathologist(s), Toxicologic Pathologist(s) for the Global Toxicologic Pathology Training Program, Immunohistochemistry Pathologist(s), Imaging Sciences Research Associate, Histologists/Histotechnologists, Immunohistochemistry Technicians.

Personnel to Support Elective Options: Electron Microscopist, Veterinary Anatomic Pathologist- Mouse Embryology, Biology Research Associate, Laboratory Animal Veterinarian, Medical or Veterinary Technologist, Laboratory Animal Medicine Technical Support Specialist.

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 may 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 30 days after the solicitation release date.

The solicitation is anticipated to result in up to three (3) awards to offerors capable of performing all aspects of the work described in the SOW. This contract is expected to be a cost-plus-fixed-fee contract for research and development services. It is anticipated that award will be on or before July 2025 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 competitive procedures. 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 solicitation 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 solicitation package. It is the offeror’s responsibility to monitor the above website for the release of this solicitation 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: sue.mckenzie@nih.gov. Please reference the solicitation number #75N96024R00006 75N96025R00003 and project title on your written request. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED.