Presolicitation_Notice.pdf

PRE-SOLICITATION NOTICE OF INTENT

NON-COMPETITIVE

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A

PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD

A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME).

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) intends to negotiate and award an increase to the ceiling of four (4) multiple award indefinite delivery, indefinite quantity (IDIQ) contracts that were awarded under Solicitation No. N01TR-17-2002 by $20 million from $19,961,960 to $39,961,960 for the five (5) year ordering period from 2017 to 2022. The four (4) IDIQ contracts are:

1. Contract Number HHSN271201700014I with SRI International,

2. Contract Number HHSN271201700015I with Battelle Memorial Institute,

3. Contract Number HHSN271201700016I with IIT Research Institute, and

4. Contract Number HHSN271201700017I with Lovelace Biomedical &

Environmental Research Institute

These four (4) IDIQ contracts were awarded to provide (1) exploratory and genetic toxicology and (2) in-vivo toxicity testing services for the Division of Preclinical Innovation (DPI) at NCATS. The overall goal of DPI and this project is to bring new drugs to market faster that are safe, effective treatments for patients.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees. Note: the NAICS code for Solicitation No.

N01TR-17-2002 under which these IDIQ contracts were awarded was 541712 and is not a valid 2017 NAICS code.

REGULATORY AUTHORITY

The resultant modifications will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-05 with effective date 03-30-2020.

STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C.

3304(a)(1) under provisions of the statutory authority of FAR Subpart 6.302-1.

DESCRIPTION

Background Researchers nationwide and across the globe face common barriers in translational research that can delay the development of new interventions for patients in need. The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases. Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Contracted organizations provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to DPI to assist with probe and assay development, lead selection and optimization, and lnvestigational New Drug (IND)-, New Drug Application (NDA)-, and Biologic License Application (BLA)-directed studies.

Goals and Objectives Safety assessment of therapeutics and diagnostics is an important component of the drug and device discovery and development efforts in DPI. These assessments play a pivotal role in determining and evaluating therapeutic targets; selecting and optimizing leads; and establishing first in human starting doses, dose limiting toxicities, safety/pharmacodynamic biomarkers and therapeutic indexes.

The overall goal of this project is to support safety evaluations that are of interest to NCATS and other NIH institutes/centers by conducting various toxicology studies.

Through the issuance of Task Orders, (TO) Contractors will be required to help identify, develop, and perform in-vitro and in-vivo IND/NDA/BLA-enabling safety studies for small and large molecules. In addition, in-vitro tests and in-vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis.

Therapeutic modalities may include new and repurposed chemical entities and biological products (e.g. monoclonal antibodies, enzymes, gene vectors, etc.).

The project includes the following tasks:

Administrative Reporting Requirements: The Contractor shall perform activities related to the overall administration of the contract. Specific services to be performed under this Technical Area include the fulfillment of administrative reporting and deliverable requirements.

Exploratory and Genetic Toxicology: The Contractor shall perform efforts associated with planning, conducting and reporting on in-vitro toxicity testing (GLP and non-GLP) with limited in-vivo capabilities as described by each individual TO in accordance with approved protocols. At the direction of the COR, the Contractor shall perform toxicity evaluations in two areas including, but not limited to, the following:

In-vitro assays: Mitochondrial toxicity, Phospholipidosis and steatosis assay, Hemolysis assay, Lysosomal Trapping assay (to assess the test-article effect of lysosomotropism), Membrane integrity assay, Oxidative stress assay, Apoptosis assay, hERG assay, Ames assay, Mouse lymphoma assay, Chromosomal aberration assay.

In-vivo assays: Micronucleus Assay and Single Cell Gel Electrophoresis assay (COMET) assays. In-vivo studies under this technical area may include: animal dosing;

formulation and biological fluid analysis; clinical observations; clinical pathology; and histopathology evaluations. As needed, Contractors may be asked to complete only a portion or full studies, e.g. biological sample and histopathology analysis.

In-Vivo Toxicity Testing: The Contractor shall perform efforts associated with planning, conducting, and reporting on approved in vivo toxicology studies (GLP and non-GLP), as directed by each individual TO in accordance with approved protocols. At the direction of the COR, the Contractor shall perform toxicity evaluations, including but not limited to, the following:

a. In-vivo general toxicology and safety pharmacology studies (via oral, IM, IV, SC, IT, ocular, IP, etc.) for IND/NDA/BLA-enabling toxicology packages

i. Non-GLP range finding studies in rodent and non-rodent species

ii. GLP studies in rodent (with FOB and Micronucleus/comet assays either built-in or conducted stand-alone) and non-rodent species

iii. Single-dose safety pharmacology studies (pulmonary, cardiovascular) in relevant species

iv. Reproductive toxicology studies

v. Carcinogenesis studies in rodent and non-rodent

b. In-vivo exploratory assays: Common non-GLP exploratory toxicology studies in rodent and non-rodent species to aid therapeutic target evaluation, lead optimization and compound selection.

In-vivo studies under this technical area will include, but not be limited to: animal dosing;

formulation and biological fluid analysis; clinical observations; clinical pathology; and histopathology evaluations. As needed, Contractors may be asked to complete only a portion or full studies, e.g. biological sample and histopathology analysis.

Period of Performance The IDIQ contracts proposed for modification have an ordering period of April 21, 2017 to April 20, 2022.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement.. However, interested parties may respond by identifying their interest, submitting capability statements, and or submitting objections to the proposed contract modifications. The Government will consider responses; however, a determination by the Government to proceed with the proposed IDIQ contract modifications is solely within the discretion of the Government.

All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.

A determination by the Government not to compete these proposed IDIQ contracts based upon responses to this notice is solely within the discretion of the Government.

The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by 12:00 p.m. Eastern Daylight Time, Wednesday, April 22, 2020, and reference notice number 75N95020R00025. Responses must be submitted electronically to Mark McNally, Contract Specialist, at mark.mcnally@nih.gov.

Fax responses will not be accepted.

http://www.sam.gov/ mailto:mark.mcnally@nih.gov

Contracting Office Address:

National Institutes of Health National Institute on Drug Abuse Office of Acquisitions c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

All responsible sources may submit a capability statement which shall be considered by the agency.