RFI_SS QA_Final.pdf

SOURCES SOUGHT/REQUEST FOR INFORMATION (RFI):

Quality Assessment 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), 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. DTT offers a unique venue for the testing, research, and analysis of agents of concern to identify toxic and biological effects, provide information that strengthens the science base in toxicology, and inform decisions by health regulatory and research agencies to safeguard public health. Many of these studies are conducted in support of the interagency National Toxicology Program (NTP), which evaluates the potential toxicity and carcinogenicity of environmental agents that may pose a health hazard to citizens of the United States. The DTT, NIEHS, and NTP produce numerous types of reports on their activities.

Products include, but are not limited to, technical reports on toxicity and carcinogenicity studies;

literature reviews and assessments of potential hazards to human health; manuscripts; and data via websites and databases. These products are multidisciplinary compilations, and development of each product may encompass findings from multiple laboratory study reports, ancillary activity reports, and results of peer reviews of data. Development of these products occurs over several years and may involve input from DTT and NIEHS personnel as well as personnel from multiple contractors, including those supporting the NTP and DTT in analytical chemistry, toxicology, genetic toxicology, absorption, distribution, metabolism, and excretion (ADME) and toxicokinetics (TK), pathology, technical report preparation, archiving, data collection and management, and others. The purpose of the Quality Assessment Support Contract is to conduct assessments of the accuracy, consistency, and completeness of various aspects of DTT/NIEHS/NTP products and their components, including data, and provide reports that identify areas in the conduct and documentation of studies that merit attention, correction, or improvement. Findings from these assessments will be communicated to DTT staff and management so they may be addressed; this process will aid the DTT in managing the overall quality of DTT or NTP studies, records, data, and reports. This contract is not intended to perform the function of a quality assurance unit in a Good Laboratory Practice environment.

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 April 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 quality assessment support to conduct assessments of the accuracy, consistency, and completeness of various aspects of DTT/NIEHS/NTP products and their components, including data, and provide reports that identify areas in the conduct and documentation of studies that merit attention, correction, or improvement as defined in the Draft

Statement of Work (Attachment 1). Award of a cost‐plus fixed fee 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 6,000 to 10,000 labor hours per year, including options, depending on the needs of the NIEHS.

1 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. The purpose of the Quality Assessment Support Contract is to conduct assessments of the accuracy, consistency, and completeness of various aspects of DTT/NIEHS/NTP products and their components, including data, and provide reports that identify areas in the conduct and documentation of studies that merit attention, correction, or improvement. Example products include the following six elements below. Please describe capabilities and experience in the following areas below:

1) Pathology Tables

2) NTP and NIEHS Reports

3) Laboratory Reports

4) Electronic Information

5) Manuscripts

6) Monographs and other literature review products

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.

3 RESPONSE SUBMISSION INSTRUCTIONS

All capability statements/responses shall be submitted electronically no later than 2:00 p.m. Eastern Time (ET) on September 22, 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

GLP Regulations for Non‐clinical Laboratory Studies https://www.ecfr.gov/current/title‐ 21/chapter‐I/subchapter‐A/part‐58

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

Cancer Health Effects https://ntp.niehs.nih.gov/whatwestudy/a ssessments/cancer

Non‐Cancer Health Effects https://ntp.niehs.nih.gov/go/noncancer

Government Monographs https://ntp.niehs.nih.gov/go/monographs