Quality Assessment Support for the National Institute of Environmental Health Sciences

Pre-solicitation Notice - 75N96025R00002

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

This notice announces the intended release of solicitation number 75N96025R00002.

DESCRIPTION

This pre-solicitation notice follows a Sources Sought notice that was released on September 07, 2023, under notice number QA_RFI_SSN_NIEHS2023.

The acquisition will support and assist the Division of Translational Toxicology (DTT) and the National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS). The objective of this contract is to conduct assessments of the accuracy, consistency, and completeness of various aspects of DTT/NIEHS or NTP products and their components, including data, and provide reports that identify areas in the conduct and documentation of studies that merit attention, correction, or improvement. The activities carried out by this contract will address five requirement areas for quality assessment, including Pathology Tables, Laboratory Reports, Manuscripts, DTT/NIEHS or NTP Reports, Monographs, Literature-Based Products, and Electronic Information (data, data management pipelines, pdf tables, bioinformatics, etc.).

The outputs from this requirement will directly feed into the mission of the Department of Health & Human Services (HHS) by fostering sound sustained advances in the sciences underlying medicine, public health, and social services. This requirement and these services are necessary to support each of the four focus areas within DTT: (1) exposure-based research programs, (2) health effects innovation programs, (3) responsive research programs, and (4) strengthening capabilities platforms.

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: 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. 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.

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. The program manager shall manage all aspects of the contract (including planning, coordination of effort, scope of the task assignments, and cost analysis), serve as the primary contact for communications with the DTT COR, and serve as an active participant in performance of assessments. The remaining staff should be an appropriate mix of professional and technical personnel with education, training, and/or experience necessary to conduct retrospective assessments that evaluate whether summary data and reports from toxicology studies and literature evaluations accurately reflect the study designs, records, and documentation.

Personnel to Support Required Capabilities:  Each requirement described in this SOW shall be performed by an appropriate mix of professional and technical staff. Because there is potential for real and perceived conflicts of interest, neither the organization nor personnel assigned to this contract, including subcontractors or consultants, shall be involved in DTT contracts associated with activities that involve the generation, analysis, and/or reporting of DTT data, as these activities are likely to require assessment under this contract. Personnel assigned to this contract with access to federal IT resources may be required to pass a security investigation. The Contractor shall ensure that all Contractor personnel are adequately trained, possess the required credentials, and are fully qualified and skilled to perform the activities outlined in this SOW. The Contractor shall be responsible for all costs associated with training and necessary travel to ensure that staff maintain required certifications and proficiency to perform assigned duties.

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 one (1) award to the offeror 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 September 2025 for a base period of one-year, plus nine (9) successive one-year option periods.  The proposed contract will be a small business set-aside. 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: adam.muhsin@nih.gov. Please reference the solicitation number #75N96025R00002 and project title on your written request. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED.