Small Business Sources Sought Notice.pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE (SSN)

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

Division of Translational Toxicology (DTT)

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

Office: Office of Acquisitions (OA)

SSN Document #: NIH‐NIEHS‐2024‐CHEM

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 National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS) is seeking sources that possess a broad range of chemistry R&D services needed to support the diverse range of test articles, dose formulations, and internal dose metrics found in studies performed as part of the DTT and/or National Toxicology Program’s testing and research programs. The test articles can vary from a single chemical to a complex mixture with a wide variety of physical and chemical properties. To obtain meaningful results, the test articles used in these studies must be well characterized. In fact, the precise definition of the chemical nature of the test materials is one of the cornerstones of toxicity testing in vitro or in vivo. In addition, it is necessary that the studies be carried out with dose formulations that are of known composition and stability. Analysis of this broad range of materials requires input from highly trained personnel with a broad theoretical background including experience with sophisticated analytical instrumentation. The chemistry support required includes chemical procurement and synthesis, purity characterization and identification of chemicals and test articles, dose formulation and analysis, analysis of biological matrices for test articles and metabolites, omics analyses of biological and environmental matrices, in vitro assays toxicokinetic studies to determine internal dose and kinetics. Detailed requirements for each support area can be found in the DTT Chemistry Specifications (https://ntp.niehs.nih.gov/go/SS_chemistryspecs). These contracts will supply both information and materials needed to conduct DTT research.

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

Period Period Length

Period Start Date

Period End Date

Base Period 12‐months 1/18/2027 1/17/2028

Option Period 1 12‐months 1/18/2028 1/17/2029

Option Period 2 12‐months 1/18/2029 1/17/2030

Option Period 3 12‐months 1/18/2030 1/17/2031

Option Period 4 12‐months 1/18/2031 1/17/2032

Option Period 5 12‐months 1/18/2032 1/17/2033

Option Period 6 12‐months 1/18/2033 1/17/2034

Option Period 7 12‐months 1/18/2034 1/17/2035

Option Period 8 12‐months 1/18/2035 1/17/2036

Option Period 9 12‐months 1/18/2036 1/17/2037

Optional 6‐Month Extension 6‐months 1/18/2037 7/17/2037

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. 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 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. Such approaches include the conduct of toxicology studies on chemical, physical and biological agents, as well as non‐chemical stressors, using in vitro and in vivo models of health and disease. Chemistry related activities, including chemical characterization, formulation support, biosample analysis, ADME/TK and in vitro ADME studies, Omics, and support for medium to high throughput toxicology studies are required for the successful execution of these studies.

3.2 CURRENT CONTRACT

This is not a new requirement. This requirement has been in place for over 40 years with three

(3) contracts currently in place for performance of the requirement which include:

MRIGlobal (Contract Number HHSN273201400020C) Contract Amount: $62,971,920 (Total Base+All Option Periods+All Optional Studies) Contract Period of Performance: 7/18/2014 – 1/17/2025 (will be extended through January 2027 as discussed below)

RTI International (Contract Number HHSN273201400022C) Contract Amount: $69,006,799 (Total Base+All Option Periods+All Optional Studies) Period of Performance: 7/30/2014 – 1/31/2025 (will be extended through January 2027 as discussed below)

Battelle (Contract Number HHSN273201400027C) Contract Amount: $72,865,113 (Total Base+All Option Periods+All Optional Studies) Period of Performance: 7/25/2014 – 1/24/2025 (will be extended through January 2027 as discussed below)

These awards are R&D Cost Plus Fixed Fee contracts, procured under full and open competition.

These awards include 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 for each contract. Currently, Justification and Approvals have been approved to add an additional two years to these contracts, which will extend each contract into January 2027.

4 INFORMATION REQUESTED

Interested Parties in assisting NIEHS with this market research are requested to submit the following information electronically to: mikel.outen@nih.gov and erica.kitzmiller@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 questions below:

Note: The questions are intended to provide the Government with feedback about the feasibility of the requirement and broaden the knowledge of vendor capabilities.

Please answer the questions below that describe capabilities and current capacity in the following areas:

1. Do you have experience with the conduct of chemistry activities in the areas of:

o Chemical handling, including handling of hazardous / controlled substances?

o Chemical characterization?

o Formulation development and analysis, including method validation?

o Biosample analysis, including method development and validation?

o Omics analyses?

o Chemical handling, characterization, and formulation in support of medium to high throughput toxicology studies?

2. Does your organization perform ADME/TK studies?

3. Does your organization conduct in vitro ADME assays?

4. Does your organization have experience in the following:

a. Design and problem assessment for non‐targeted analysis of complex mixtures, e.g., botanicals, including use of literature to develop analytical approaches and use of data obtained to plan future work needed?

b. Low‐cost, high‐volume analysis methods to handle and characterize substances used in medium to high throughput toxicology studies?

c. Cheminformatics for maintaining large numbers of chemicals for use in medium to high throughput toxicology studies.

5. Does your organization have a testing laboratory that is in compliance with Food and Drug

Administration Good Laboratory Practices for Nonclinical Laboratory Studies—as outlined in the provisions of 21 CFR 58?

6. Is your organization accredited by the Association for Assessment & Accreditation of Laboratory

Animal Care International (AAALAC)?

7. Does your organization have an approved animal welfare assurance statement on file with the

NIH Office of Laboratory Animal Welfare (OLAW)?

5 SSN SUBMISSION INSTRUCTIONS

5.1 QUESTIONS

Questions regarding this SSN shall be received no later than 2:00 PM Eastern Time (ET) on 15 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 Mikel Outen at mikel.outen@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 ET on 22 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: Mikel Outen @ mikel.outen@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.