NICEATM_RFI-SS_NIEHS_2023.pdf

SOURCES SOUGHT/REQUEST FOR INFORMATION (RFI):

Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the

NIEHS

Notice ID: NICEATM_RFI-SS_NIEHS_2023

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), located in the Research Triangle Park, North Carolina, is one of the 27 Institutes and Centers comprising the National Institutes of Health. The NIEHS is a multidisciplinary research institution with the primary mission of conducting research to discover how the environment influences the development and progression of human disease in order to promote healthier lives. NIEHS focuses on basic science, disease-oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

The Division of the 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 the environment may impact human health. One of DTT's goals is to lead the transformation of toxicology through the development and application of innovative tools and strategies. This effort includes the development, validation, and application of alternatives for toxicity testing in partnership via the interagency Tox21 Program1 and/or the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)2. ICCVAM is a permanent committee of NIEHS under the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)3. ICCVAM was formally established in 2000 by the ICCVAM Authorization Act (42 U.S.C. 285l-3)4 to promote the research, development, validation, evaluation, acceptance, and use of new and alternative testing methods and strategies that are more predictive of human health and ecological effects than currently available methods and strategies. Such efforts are further refined in U.S. Strategic Roadmap document5. NICEATM is an office within DTT focused on the development and evaluation of alternatives to animal use for chemical safety testing. In addition to performing independent research and development (R&D) activities to provide bioinformatics and computational toxicology support for DTT/NIEHS research, NICEATM also carries out ICCVAM’s mission by providing technical and scientific support for ICCVAM and ICCVAM workgroup activities, reviewing proposed test methods, organizing workshops, etc.

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 Draft Statement of Work (See Attachment 1).

3) Collect input and build knowledge on the vendors’ capabilities to provide the services outlined in the Draft Statement of Work.

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 May 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 scientific and administrative support for the activities of DTT/NIEHS and ICCVAM to develop, validate, and utilize a variety of new approach methodologies (NAMs) to predict human health effects more accurately while also replacing, reducing, or refining the use of animals in toxicity testing as detailed in the Draft Statement of Work (Attachment 1). Award of a cost-reimbursement, level of effort type contract is contemplated with the anticipated period of performance for ten (10) years. The total estimated level of effort is anticipated to be between 30,000 to 60,000 labor hours per year, including options, depending on the needs of the NIEHS.

In brief, the NIEHS is interested in acquiring and applying new and existing scientific knowledge to develop, evaluate, and validate novel computational approaches that can be used for the toxicological studies including but not limited to chemical prioritization, hazard identification, read-across prediction, and risk assessment in the context of human health. Data development, analysis, and evaluation represent a large portion of the daily work conducted under this requirement. These approaches include, but are not limited to: Exposure assessment and modeling, Adverse Outcome Pathways (AOPs), Physiologically based pharmacokinetic/pharmacodynamic modeling, In vitro-to-in vivo extrapolation (IVIVE) modeling, Quantitative Structure-Activity Relationship modeling (QSAR) and comparisons, Analysis of quantitative high throughput screening and high content data, Development of novel Integrated Approaches to Testing and Assessment (IATA) using in vivo, in vitro, and/or in silico data sets, Database development and maintenance, etc.

Additionally, the work related to develop, evaluate, and utilize alternative methods in toxicological studies may include but is not limited to cross validations on protocols, interlaboratory data, bioactivity indication, bioreactivity screening, database searching, exposure assessment, in silico modeling of physiochemical structure and hazard, in vitro high-throughput screening, dose-response assessment, transcriptomic signatures, analysis of cell-based biological processes and/or toxicity pathways, kinetics and dose extrapolation, etc.

The DTT/NIEHS also seeks support on meetings deemed necessary to carry out the goals and objectives of DTT/NIEHS and ICCVAM in in-person, virtual, or a combination of in-person and virtual environments.

These meetings include but are not limited to ICCVAM monthly meetings, ICCVAM Public Forums, ICCVAM workgroup meetings, workshops, webinars, the International Cooperation on Alternative Test Methods (ICATM) meetings, and national and/or international professional meetings (e.g., Society of Toxicology Annual Meeting and World Congress).

DTT/NIEHS has established several databases and model tools, carrying high-quality curated toxicological data to support development and evaluation of new, revised, and alternative methods, such as ICE and OPERA. The DTT/NIEHS seeks support on the maintenance of existing and/or the development of new databases and tools by incorporating supporting dataset, identifying changes in data and endpoint level, data curation, updating database and associated websites, organizing, and providing training event on the use of tools, etc.

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:

1) Conduct of computational toxicology studies, such as chem/bioinformatics-based model development, hazard identification, read-across prediction, quantitative analysis, etc.

2) Demonstration of performance for developing and validating in vitro and alternative methods, such as bioreactivity screening, complex in vitro, high-throughput screening and high-content data management, etc.

3) Integration of in vitro and in vivo toxicology data for use in translation to human health.

4) The familiarity of activities associated with OECD Test Guidelines Programme, the interagency Tox21 Program and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

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 to problem-solving and working with various stakeholders, such as Investigators, Systems Administrators, and Application Developers.

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 Work (SOW). The comments should identify any gaps in the SOW 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 SOW 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 June 26, 2023 to Sue McKenzie, Contract Specialist, at the following e-mail address:

sue.mckenzie@nih.gov.

All questions in regards to this notice should be directed to Sue McKenzie at sue.mckenzie@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:

1. Interagency Tox21 Program (Tox21), https://ntp.niehs.nih.gov/go/tox21

2. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), https://ntp.niehs.nih.gov/go/iccvam

3. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), https://ntp.niehs.nih.gov/go/niceatm

4. ICCVAM Authorization Act (42 U.S.C. 285l-3), https://ntp.niehs.nih.gov/iccvam/docs/about_docs/pl106545.pdf

5. A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and

Medical Products in the United States, https://ntp.niehs.nih.gov/go/natl-strategy mailto:sue.mckenzie@nih.gov mailto:sue.mckenzie@nih.gov https://ntp.niehs.nih.gov/go/tox21 https://ntp.niehs.nih.gov/go/iccvam https://ntp.niehs.nih.gov/go/niceatm https://ntp.niehs.nih.gov/iccvam/docs/about_docs/pl106545.pdf https://ntp.niehs.nih.gov/go/natl-strategy