RFI_SS Path.pdf

SOURCES SOUGHT/REQUEST FOR INFORMATION (RFI):

Pathology Support for the National Institute of Environmental Health Sciences

1 INTRODUCTION

THIS IS A COMBINED REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT NOTICE ONLY. This Request for Information (“RFI”) is issued by the National Institutes of Health’s (“NIH”) National Institute of Environmental Health Sciences (“NIEHS” or “the Government”) in accordance with FAR Part 15.201(e) ‐ Exchanges with Industry. It is solely issued for market research information and planning purposes. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This RFI does not commit the Government to contract for any supply or service whatsoever. Further, NIEHS is not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised that NIEHS will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it may be synopsized on the SAM.gov website or issued through any number of existing Government contract vehicles determined by the Government to be the best procurement approach (e.g., GSA Federal Supply Schedule (FSS), Government Wide Acquisition Vehicles (GWACs), etc.). It is the responsibility of the potential offerors to monitor any related solicitation sites used by the Government for additional information pertaining to this requirement.

2 BACKGROUND

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 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.

The NIEHS is issuing this SS/RFI to accomplish five (5) goals:

1) Facilitate early (pre‐Request for Proposal [RFP]) engagement with industry, in accordance with FAR

15.201(e).

2) Improve NIEHS’s understanding of market capabilities and current vendor offerings for provision of the services as outlined in the Statement of Objectives (See Attachment 1).

3) Collect input and build knowledge on the vendors’ capabilities to provide the services outlined in the

Statement of Objectives.

4) Provide the specifications and set expectations with industry to support NIH’s commitment to fair competition, in accordance with FAR 5.401.

5) Determine if there are small businesses capable of fulfilling the requirement.

NAICS Code and Size Standard In the event that a Request for Proposal (RFP) is issued, North American Industry Classification System (NAICS) code 541715 ‐ Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) with a size standard of 1,000 employees is being considered.

Anticipated Period of Performance The anticipated Period of Performance is ten (10) years with an estimated start date of July 2025.

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. The offeror must further certify that the accounting system is currently in full operation.

2.1 CAPABILITIES SOUGHT

The NIEHS seeks information on contract support to provide the capabilities in Attachment 1 the

Statement of Objectives. It is anticipated that this solicitation may result in up to three awards. The awards will be a cost‐plus fixed fee level of effort type contract with the anticipated period of performance for ten (10) years for each contract. The total estimated level of effort for all awards is anticipated to be between 20,000 and 60,000 labor hours per year, including options, depending on the needs of the NIEHS.

The purpose of the Pathology Support Contract is to provide a broad range of pathology support for studies conducted by the CROs and by in‐house investigators at NIEHS. Support includes peer review and assessment of pathology evaluations and 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. See Attachment 1, Statement of Objectives for more information.

3 REQUESTED INFORMATION/RESPONSES

All interested parties are hereby invited to submit a capability statement in accordance with the following constraints:

Maximum of 15 pages in length submitted in Adobe Portable Document Format (.pdf), using the numbered format below (Items 1‐8).

Times New Roman font no smaller than 12‐point with one‐inch margins.

Electronic file submissions must be less than 30 megabytes in size.

Additionally, the Government will review each capability statement based on the interested party's demonstrated qualifications, capabilities, expertise, experience and past performance in each of the areas. More specifically, capability statements should provide the following information and address the following questions as appropriate and as applicable:

1. Company Information:

Company Name:

Point of Contact:

Address:

Phone #:

E‐mail address:

Cage Code:

UEI:

NAICS Code:

Small Business Status: (“8(a)” Program, Women‐Owned Small Business concern (WOSB), Economically Disadvantaged Women‐Owned Small Business concern (EDWOSB), HUBZone Small Business concern (HUBZoneSB), Veteran‐Owned Small Business concern (VOSB), Service‐ Disabled Veteran‐Owned Small Business concern (SDVOSB), Small Business, Large Business, Other)

2. Is your company currently capable of providing 100% of the requirements and objectives of the subject requirement? (Explain)

3. Please describe capabilities and experience in the following areas below:

1. Pathology peer review

2. DTT and DIR pathology reporting

3. Pathology evaluation

4. Necropsy

5. Histology

6. Optical and digital imaging

7. Electron microscopy

8. Publication support and outreach

9. Clinical pathology

10. Investigative/Mechanistic

11. Preferred capabilities: whole slide scanning, imaging science technologies

4. What is the feasibility of solutions to accomplish the requirements detailed in the draft SOW?

Identify any barrier(s) that exist(s). Please include only items that are related to the requirement as described in the DRAFT SOW documents.

5. Describe your experience in a complex scientific research environment with respect working with various stakeholders, including toxicology contract research organizations, toxicologists, and laboratory investigators.

6. Provide up to three examples of projects of similar scope, and complexity to the NIEHS requirement described herein—preferably with the Federal Government. Briefly describe the scope of work, solutions designed/implemented, project management methodology, and best practices/lessons learned. Please be sure to describe any commercial business practices that are unique to your industry (if applicable).

7. Vendors are invited to submit comments on the Draft Statement of Objectives (SOO). The comments should identify any gaps in the SOO including areas requiring clarification, missing or ambiguous requirements, staffing considerations and any other general comments or concerns.

Vendors may also provide specific comments and suggestions for refining the SOO to reflect clear guidance to industry and industry best practices, as well as provide additional information that they think is relevant for developing the acquisition strategy for this requirement.

8. Vendors are invited to submit comments on the anticipated NAICS code, period of performance and anticipated contract type.

Standard product brochures will not be considered a sufficient response to this RFI. Any additional comments that are not responsive to a particular RFI requirement/question should be separated labeled as “Additional Comments” and included at the end of the response.

NIEHS reserves the right to use any and all information submitted by, or obtained from, an interested party in any manner NIEHS determines is appropriate including, but not limited to, the creation of a competitive solicitation. An interested party should avoid including any business confidential and/or proprietary information in its response. However, if an interested party must submit such information, the information must be clearly marked accordingly, and the interested party must provide enough justification as to why such information is business confidential and/or proprietary.

NIEHS will review said information and safeguard it appropriately.

4 RESPONSE SUBMISSION INSTRUCTIONS

All capability statements/responses shall be submitted electronically no later than 2:00 p.m. Eastern Time (ET) on October 2, 2023 to Erica Kitzmiller, Contract Specialist, at the following e‐mail address:

erica.kitzmiller@nih.gov.

All questions in regards to this notice should be directed to Erica Kitzmiller at erica.kitzmiller@nih.gov.

NIEHS personnel may contact firms responding to this RFI to clarify a Responder’s capabilities and other matters as part of this market research process.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to Responders with respect to any information submitted.

THIS IS A REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE (SSN) ONLY to identify sources that can provide the services described herein. The information provided in the RFI/SSN is subject to change and is not binding on the Government.

NIEHS has not made a commitment to procure any of the equipment, commodities, and services listed herein, and release of this RFI/SSN shall not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned.

Reference Links:

Specifications for the Conduct of Toxicity Studies by the Division of Translational Toxicology at NIEHS (DTT Specifications) https://doi.org/10.22427/NIEHS‐00

List of NTP products https://ntp.niehs.nih.gov/publications

List of NIEHS products https://www.niehs.nih.gov/research/atni ehs/dtt/assoc/reports/niehs‐ reports/index.cfm

NTP Immunotoxicity Study Pathology Specifications https://ntp.niehs.nih.gov/ntp/htdocs/leve ls/finalntpitoxspecs_508.pdf

NTP public website http://ntp.niehs.nih.gov

Chemical Effects in Biological Systems (CEBS) http://cebs.niehs.nih.gov

Non‐Neoplastic Lesion Atlas https://ntp.niehs.nih.gov/atlas/nnl

Rat and Mouse Proliferative Lesions Guides https://www.toxpath.org/inhand.asp#pubg