SB Sources Sought Notice.pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE (SSN)

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

NIEHS

Agency: NIH/National Institute of Environmental Health Sciences (NIIEHS)

Office: Office of Acquisitions (OA)

SSN Document #: NICEATM_RFI‐SS_NIEHS_2023

1 PURPOSE

This announcement constitutes a Sources Sought Notice (SSN) in accordance with FAR Part 15.201(e) – Exchanges with Industry. THIS SSN DOES NOT CONSTITUTE A SOLICITATION (e.g., Invitation for Bids (IFB), Request for Proposal (RFP), Request for Quotation (RFQ), etc.) nor is it to be construed as a commitment by the Government. The information requested may be used as market research for planning purposes and to facilitate decision making (i.e., acquisition strategy determinations, availability of capable small business concerns, etc.). The information submitted will not be disclosed outside the Government. Proprietary information submitted shall be appropriately marked (see SSN Section 6 – Other SSN Administrative Information for additional information relating to Contractor proprietary information).

This Small Business Sources Sought (SSN) encourages responses from capable small businesses, to include all the socioeconomic categories.

NOTE: The Government will not be responsible for any costs incurred by interested parties in responding to this SSN (or any possible Government follow‐up questions / meetings relating to this SSN).

Not responding to this SSN does not preclude participation in any potential future solicitation.

2 DESCRIPTION

The National Institutes of Health (NIH), National Institute of Environmental Health Sciences (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.

The DRAFT Statement of Work (SOW) has been attached for reference purposes and includes additional requirement details.

PLACE OF PERFORMANCE

TBD

ESTIMATED PERIODS OF PERFORMANCE

The anticipated Period of Performance is ten (10) years (a base year with nine (9) option years) with an estimated start date of November 2025. The contract will also include an optional 6‐month extension in accordance with FAR 52.217‐8.

3 BACKGROUND

3.1 PROGRAM INFORMATION

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 (NIH).

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 Translational Toxicology (DTT) is an intramural division of the NIEHS, NIH. DTT uses traditional and cutting‐edge approaches to better understand how factors in the environment may impact human health. Such approaches include using scientific expertise to identify, collect, analyze, and interpret diverse types of information relevant to the effects of environmental exposures on human health. Information from the fields of toxicology, epidemiology, chemistry, pathology, and other disciplines is used in the design of research programs; in literature based health assessments; and in the development of new tools and methodologies.

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.

3.2 CURRENT CONTRACT

This is not a new requirement. The current contract (No. HHSN273201500010C) was awarded in 2015 to Integrated Laboratory Systems, Inc, as a R&D Cost Plus Fixed Fee Level of Effort contract, procured as a small business set‐aside. This award includes a base period, multiple option periods, and an optional 6‐ month extension in accordance with FAR 52.217‐8, for a total contract period of performance of 10.5 years.

4 INFORMATION REQUESTED

Interested Parties in assisting NIEHS with this market research are requested to submit the following information electronically to: megan.bang@nih.gov.

Generic capability statements will not be provided to the requirements team for review.

Interested Parties shall provide the following information:

I. COMPANY INFORMATION

a. Company Name

b. CAGE Code

c. Point of Contract Name, Phone Number, and E‐mail Address

d. Company Website

e. ALL government contract vehicles under which the Company holds contracts (e.g., GSA

Federal Supply Schedule (FSS), NITAAC, OASIS, etc.)

II. BUSINESS SIZE

a. The anticipated NAICS for this effort is 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The Small Business Administration (SBA) small business size standard for this NAICS code is 1000 employees.

b. Based on the NAICS 541715, identify your business size as Small or Large.

c. If a small business concern, identify which, if any, of the below small business socio‐ economic categories are applicable:

Small Disadvantaged Business (SDB

Woman‐Owned Small Business (WOSB)

Economically Disadvantaged Woman‐Owned Small Business (EDWOSB)

Veteran‐Owned Small Business (VOSB)

Service‐Disabled Veteran‐Owned Small Business (SDVOSB)

HUBZone Small Business (HZ)

d. If your company is an Other Than Small Business (OTSB) concern (i.e., large business), have you partnered or subcontracted with small business concerns to provide the same or similar services as this requirement?

III. CAPABILITIES

a. Generally, describe your company’s capabilities in fulfilling the requirements of the attached draft Statement of Work.

b. Specifically, address the information in subparagraphs i. through iv. below:

i. Concisely describe your company’s ability to perform the work described in the below areas. Include supporting information which demonstrates your company’s knowledge / capability to meet the requirements of the DRAFT SOW tasks. Supporting information shall not reiterate the language of the tasks provided in the DRAFT SOW;

rather it shall provide details regarding your company’s knowledge/capability to execute these tasks. NIEHS is not asking for disclosure of specific or detailed innovative solutions; however, specific examples would assist the Government with this SSN.

If your company does not have direct experience, please explain how you would perform tasks utilizing experienced subcontractors, through a proposed contract teaming arrangement (CTA) or hiring qualified personnel.

The specific areas are the following:

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).

ii. Has your company performed work of the same or similar scope as this requirement within the last three (3) years? Please explain.

For any contracts or projects for the same or similar work performed by your company within the last three (3) years, please provide the following information relating (no more than three (3) examples; government or commercial contracts):

Brief Description of the Contract/Project

Contract Number

Period of Performance

Contract Type(s) (e.g., FFP, T&M, Labor‐Hour (LH), etc.)

Commercial or Non‐Commercial Requirement?

Was your company a prime or subcontractor?

Contract/Project Dollar Value

Scope of the portion of the effort your company supported

iii. Provide additional relevant experience/ information that demonstrate your company’s capabilities relevant to the scope of work.

5 SSN SUBMISSION INSTRUCTIONS

5.1 QUESTIONS

Questions regarding this SSN shall be received no later than 2:00 PM Eastern Time (ET) on 22 November 2024. Questions received by the due date/time will be answered and provided to all respondents in the form of an SSN Amendment. Questions received after the due date/time may not be answered.

Questions shall be submitted in writing via e‐mail to Megan Bang at megan.bang@nih.gov and Erica Kitzmiller at erica.kitzmiller@nih.gov, and shall reference this SSN.

5.2 SSN RESPONSES

Responses to this SSN shall be received no later than 4:00 PM Eastern Time (ET) on 29 November 2024 as identified the SSN’s online SAM.gov (formerly FBO) posting. (If there is a difference in SSN response date/time between this document and the online posting, the online posting shall take precedence.)

Responses shall be submitted electronically via e‐mail to all parties listed below in Section 5.3 ‐ SSN Points of Contact and shall reference this SSN.

All SSN responses will be reviewed and utilized for market research.

5.3 SSN POINTS OF CONTACT

Contract Specialist: Megan Bang @ megan.bang@nih.gov

Contracting Officer: Erica Kitzmiller @ erica.kitzmiller@nih.gov

6 OTHER SSN ADMINISTRATIVE INFORMATION

All information received in response to this notice that is marked “Proprietary” will be handled accordingly. The Government reserves the right to use any non‐proprietary information submitted by, or obtained from, a Respondent in any manner NIEHS determines is appropriate including, but not limited to, the creation of a competitive solicitation. Any proprietary data that is included in the response must be marked appropriately at the paragraph level (or at a more granular level as required; page level is acceptable for full page table, graphs, etc.). Any response marked proprietary at the document level will not be considered.

NIEHS personnel may contact any company responding to this SSN to clarify its capabilities/product/ other matters as part of its market research.

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.

Responses to this notice will not be returned.

7 ATTACHMENT(S)

DRAFT Statement of Work (SOW)

8 FAR PROVISIONS

The following provision is applicable to this notice and is hereby incorporated by reference:

FAR 52.215‐3: Request for Information or Solicitation for Planning Purposes (Oct 1997).

The full text of this provision is available at: https://www.acquisition.gov/far/52.215‐3.