Amendment 2 - SB Sources Sought Notice (ITOX).pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE (SSN)

Assessment of Immunotoxicity – In Vitro and In Vivo Assessment of Immune Function for the National Institute of Environmental

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

Office: Office of Acquisitions (OA)

SSN Document #: mmunotox_RFI_SSN_NIEHS_2023

1 PURPOSE

This announcement constitutes a Small Business 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 Division of Transitional Toxicology (DTT) is an intramural division of NIEHS within the National Institutes of Health (NIH). DTT uses traditional and cutting‐edge approaches to better understand how factors in our environment may impact human health. Such approaches include the conduct of immunotoxicology studies on chemical, physical, and biological agents, as well as non‐chemical stressors, using in vitro and in vivo models of health and disease.

Specific research activities include: The development and establishment of methods with predictive value for potentially immunotoxic chemicals. Examination of selected agents employing a defined panel of immune function tests and observational measures.

Immunotoxicity is used to describe the potential of an agent to alter the normal structure and/or function of the immune system as determined by established immunological techniques. In cases of immunomodulation, a chemical or physical agent may alter hematopoietic or immunological function in humans and animals, resulting in changes in the ability to recognize and eliminate threats such as self‐reactive or cancerous cells. When immune responses are suppressed, increased rates of infection and certain cancers may occur.

Conversely, when the immune system is stimulated and uncontrolled, chronic inflammation or autoimmune disease may manifest. In cases of hypersensitivity, the immune system responds to chemically modified ("non‐self") compounds (haptens) as part of a "specific" immune response. The most likely health consequences include respiratory tract allergies (e.g., asthma, rhinitis) or allergic contact dermatitis.

With the increasing awareness of the need for translational toxicology and to reduce the use of animals, the main objectives in DTT’s research efforts to examine altered immunity resulting from chemical exposures will be using in vitro methods to evaluate immune function. The focus of this requirement will be to provide DTT with a mechanism to evaluate the complete scope of chemical induced immunotoxicity by determining: 1) whether chemical or therapeutic agents can modulate the immune response using a battery of in vitro tests to measure immune suppression or stimulation in response to relevant antigens; 2) whether chemical agents have the potential to induce allergic responses using in chemico and in vitro Organisation for Economic Co‐operation and Development (OECD) guideline test methods for skin sensitization as part of an integrated panel of tests; 3) evaluate the potential of a test agent to modulate immune function using a comprehensive in vivo testing panel that evaluates the major components of the immune system in the developing rat and/or adult mice or rats; and 4) because immunology is a developing science, it is expected that new and improved methodology will be required to maintain "state of the art" evaluation. As an additional activity, in consultation with the Contracting Officer's Representative (COR), the Contractor shall identify research gaps and conduct methods development and validation.

PLACE OF PERFORMANCE

Contractor’s Facility

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 February 2026. 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 to promote healthier lives. NIEHS focuses on basic science, disease‐oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

DTT is an intramural division of NIEHS within the National Institutes of Health (NIH). DTT uses traditional and cutting‐edge approaches to better understand how factors in our environment may impact human health. Such approaches include the conduct of immunotoxicology studies on chemical, physical, and biological agents, as well as non‐chemical stressors, using in vitro and in vivo models of health and disease.

3.2 CURRENT CONTRACT

This is not a new requirement. The current contract (No. HHSN273201400017C) was awarded in 2014 to Burleson Research Technologies, Inc., as a R&D Cost Plus Fixed Fee Level of Effort contract. 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 11.5 years.

4 INFORMATION REQUESTED

Interested Parties in assisting NIEHS with this market research are requested to submit the following information in the format of a White Paper outlined below. The response should be concise (no more than 20 pages), 11 pt Calibri font, and address only the information requested below. Bulleted lists and summaries are acceptable. (Note: title pages, cover letters, etc., will not count against the total page limit).

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:

Evaluation of the Potential to Modulate Immune Function Using In Vitro Assays The Contractor shall have the capability to assess chemical modulation of immune function in primary human cells using in vitro screening methods and a panel of assays that provide functional and quantitative information on humoral, cell‐ mediated, and innate immunity.

Evaluation of the Potential to Induce Hypersensitivity Using In Vitro Assays The Contractor shall have the capability to assess the potential for chemical agents to induce hypersensitivity using in chemico or in vitro models. To achieve this objective, research must be performed in accordance with OECD Guideline Test

Methods as referenced in Section Error! Reference source not found. of this

Statement of Work (SOW) entitled “Applicable Publications.”

Evaluation of the Potential to Induce Immunotoxicity Using In Vivo Rodent Models The Contractor shall have the capability to conduct research studies in adult mice, adult rats, and/or developing rats, and to evaluate specific measures of immune function including:

a) Clinical Pathology

b) Humoral Mediated Immunity

c) Cell Mediated Immunity

d) Quantification of Leukocyte Subpopulations

e) Non‐Specific Immunity

Research studies shall be conducted using the assays described in Section Error!

Reference source not found.. The exposure regimen for adult mice or rats shall normally (but not always) consist of daily dosing for 28 days by a route of exposure specified in a research outline. For studies including perinatal exposure, the exposure regimen shall normally (but not always) consist of daily dosing of time‐ mated female rats beginning on day 6 of gestation (GD 6) and continuing through postnatal day (PND) 4. Offspring (F1) may continue to be dosed daily until PND 42 or other age as specified by the COR.

Development and Evaluation of Novel Tools and Methods to Assess Immunotoxicity The Contractor shall have the capability to assess novel methods that may be used to determine the potential for chemical agents to induce immune modulation or hypersensitivity with a focus on in vitro models. Assessment of new strategies to evaluate immune perturbations in the developing immune system should also be a priority. Studies to help establish cellular and/or molecular mechanisms of action for immune perturbations observed during the conduct of activities described in Sections

Error! Reference source not found., Error! Reference source not found., and Error!

Reference source not found. may be appropriate. Development of novel screening strategies including the use of molecular techniques such as analysis of gene expression to assess xenobiotic‐induced immunologic alterations would be also desirable.

a. Test facilities shall be accredited by AAALAC International and shall have an approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW).

b. Test facilities shall comply with Public Health Service (PHS) Policy, the Animal Welfare Act and regulations, the current edition of the Guide for the Care and Use of Laboratory Animals, and all local, state, or federal regulations.

c. If animal species regulated by the U.S. Department of Agriculture (USDA) are involved, the Contractor shall be registered with the Secretary of Agriculture of the United States in accordance with 7 U.S.C 2136 and 9 Code of Federal Regulations (CFR) sections 2.25 through 2.28.

d. Animal experimental protocols, approved by the Contractor’s Institutional Animal Care and Use Committee (IACUC), shall be delivered electronically via PDF to the NIEHS COR prior to the commencement of a study. These Contractor‐approved protocols shall also be available to the NIEHS Animal Care and Use Committee (ACUC). The Contractor shall have an animal disease‐screening program that complies with the DTT Specifications, Chapter 6 (see below).

For in vitro studies:

a. The Contractor shall reference and utilize the Guidance Document on Good In Vitro

Method Practices (https://www.oecd.org/env/guidance‐document‐on‐good‐in‐vitro‐ method‐practices‐givimp‐9789264304796‐en.htm) for the conduct of in vitro work.

For all studies:

a. Studies shall be conducted in accordance with the Specifications for the Conduct of Toxicity Studies by the Division of Translational Toxicology at NIEHS (https://doi.org/10.22427/NIEHS‐00), referred to hereafter as the DTT Specifications.

Specifically, Chapters 2, 3, 4, 6, 7, 8, 11, and 12 of the DTT Specifications are applicable to the activities outlined in this SOW. Any exceptions shall be reviewed and approved by the COR prior to study conduct.

b. When specified by the research outline, the study shall be performed in accordance with the Good Laboratory Practice (GLP) regulations established by the U.S. Food and Drug Administration (FDA) for Non‐clinical Laboratory Studies (21 CFR 58;

https://www.ecfr.gov/current/title‐21/chapter‐I/subchapter‐A/part‐58) or as most recently updated. The Government reserves the right to ensure compliance with FDA GLP regulations as specified in Part 58 “Good Laboratory Practices for Non‐Clinical

Studies” (Federal Register, Friday, December 22, 1978, Part II, and any later interpretations published by the FDA) and to conduct Quality Assurance (QA) audits.

c. The Contractor shall have in place a Quality Management Plan. Information on quality management plans can be found at https://www.epa.gov/quality/epa‐qar‐2‐epa‐ requirements‐quality‐management‐plans.

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.

5 SSN SUBMISSION INSTRUCTIONS

5.1 QUESTIONS

Questions regarding this SSN shall be received no later than Nov. 29th, at 5:00 PM Eastern Standard Time. 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 (Name of CO/CS) at adam.muhsin@nih.gov and shall reference this SSN.

5.2 SSN RESPONSES

Responses to this SSN shall be received no later than December 6th, at 5:00 PM EST 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 Adam Muhsin at adam.muhsin@nih.gov, and shall reference this SSN.

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

5.3 SSN POINTS OF CONTACT

Contract Specialist: Adam Muhsin ‐ adam.muhsin@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)

Attachment 1: 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.