Inactive

INTRODUCTION PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF IN... INTRODUCTION PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT 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). There are more than 6,500 identified rare and neglected diseases, yet only about 250 treatments are available for these conditions. The limited numbers of patients can make gathering information and designing drug studies difficult. As a result, scientists often know little about the symptoms and biology of these conditions. Also, some private companies may find it difficult to justify the cost of developing drugs for such small rare disease markets. The National Center for Advancing Translational Sciences (NCATS) Therapeutics for Rare and Neglected Diseases (TRND) program is designed to combat these challenges. Its mission is to encourage and speed the development of new treatments for diseases with high unmet medical needs. TRND stimulates therapeutic development research collaborations among NIH and academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies working on rare and neglected illnesses. The program provides expertise and resources, working with research partners to move therapeutics through preclinical testing, including plans for clinical trials and submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). These efforts effectively “de-risk” therapeutic candidates and make them more attractive for adoption by outside business partners. The TRND program aims to encourage and speed the development of new treatments for rare and neglected diseases. The program is designed to advance the entire field of therapeutic development by encouraging scientific and technological innovations to improve success rates in the crucial preclinical stage of development. The National Institute on Drug Abuse (NIDA) Office of Acquisition, on behalf of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), intends to negotiate and award modifications to the following multiple award indefinite-delivery, indefinite-quantity (IDIQ) contracts for the following TRND programs: CRO Support for NCATS Drug Substance Development and Manufacture (Drug Substance). The CROs provide Chemistry, Manufacturing, and Control (CMC) services to ensure NCATS receives Active Pharmaceutical Ingredients and formulated Drug Product of sufficient quality and quantity to support IND-enabling, pre-clinical, and clinical studies. The following IDIQ contracts were awarded under Solicitation No. N01TR-17-2001: Contract No. HHSN271201700005I (Curia Global, Inc.) Contract No. HHSN271201700006I (MRIGlobal) Contract No. HHSN271201700007I (Southwest Research Institute) Contract No. HHSN271201700008I (The Regents of the University of Minnesota) Contract No. HHSN271201700009I (Bachem Americas, Inc.) Contract No. HHSN271201700010I (Advanced Bioscience Laboratories) Contract No. HHSN271201700026I (University of Massachusetts) These modifications would extend the ordering period of the above IDIQ contracts by two years, through March 31, 2024. There are no other changes to the contracts. CRO Support for NCATS In Vitro and In Vivo Toxicology Studies (Toxicology). The CROs conduct safety assessments necessary for 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 following IDIQ contracts were awarded under Solicitation No. N01TR-17-2002: Contract No. HHSN271201700014I (SRI International) Contract No. HHSN271201700015I (Battelle Memorial Institute) Contract No. HHSN271201700016I (IIT Research Institute) Contract No. HHSN271201700017I (Lovelace Biomedical & Environmental Research Institute) These modifications would extend the ordering period of the above IDIQ contracts by two years, through April 20, 2024. There are no other changes to the contracts. CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies (Drug Product). The CROs provide services related to the development, manufacture, and conduct of stability studies for non-sterile and sterile pharmaceutical dosage forms. The following IDIQ contracts were awarded under Solicitation No. N01TR-17-2003: Contract No. HHSN271201700019I (University of Iowa Pharmaceuticals) Contract No. HHSN271201700020I (IriSys LLC) Contract No. HHSN271201700021I (Murty Pharmaceuticals LLC) Contract No. HHSN271201700022I (Purdue University) These modifications would extend the ordering period of the above IDIQ contracts by two years, through July 31, 2024. There are no other changes to the contracts. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE Drug Substance: The intended procurement is classified under NAICS code 325411 with a small business size standard of 1,000 employees. Toxicology: The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees. Drug Product: The intended procurement is classified under NAICS code 325412 with a small business size standard of 1,250 employees. REGULATORY AUTHORITY The resultant modifications will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through the current Federal Acquisition Circular (FAC). 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, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. DESCRIPTION OF REQUIREMENT FOR EACH TRND PROGRAM DRUG SUBSTANCE 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. Purpose and Objectives: Chemistry, Manufacturing, and Control (CMC) services are an important component of the drug discovery and development efforts in DPI. DPI continues to need Active Pharmaceutical Ingredients and formulated Drug Product of sufficient quality and quantity to support IND-enabling, pre-clinical, and clinical studies. Through the issuance of task orders, the contractors will be required to perform some or all of the following services: 1. Administrative Reporting Requirements. This includes activities related to the overall administration of the contract. Specific services to be performed include the fulfillment of administrative reporting and deliverable requirements. 2. Manufacture and Analysis of Small Molecules. This includes activities related to the synthesis and analysis of small molecule as described by each individual task order and in accordance with an approved project plan. Examples of activities include conducting process research and development to identify reliable, scalable and commercially viable processes; manufacturing non-GMP and cGMP Active Pharmaceutical Ingredients (API); performing release testing of non-GMP and GMP API; performing synthesis and characterization of Reference Standard material; and conducting polymorph screening. 3. Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Substances. This includes activities related to the manufacture and analysis of synthetic peptides, oligonucleotides, and related substances as described by each individual task order and in accordance with an approved project plan. Examples of activities include conducting process research and development to identify reproducible synthesis and purification processes; performing process demonstration runs; manufacturing non-GMP and cGMP Active Pharmaceutical Ingredients (API); synthesizing and characterizing Reference Standard material; developing and validating analytical methods; and performing release testing of non-GMP and cGMP API. 4. Manufacture and Analysis of Biopharmaceuticals. This includes activities related to the synthesis and analysis of biopharmaceuticals as described by each individual task order and in accordance with an approved project plan. Examples of activities include performing construction of expression vectors; producing Development Cell Bank (DCB), cGMP Master Cell Bank (MCB), and/or Working Cell Bank (WCB); developing robust upstream processes and scalable downstream purification processes; developing analytical methods, including stability-indicating methods, for In-Process Control (IPC), Bulk Drug Substance (BDS) release, Drug Product (DP) release and stability evaluation; manufacturing non-GMP and GMP lots of BDS; generating and characterizing Reference Standard (RS) material; and performing stability evaluations of RS, BDS and DP. TOXICOLOGY 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. Purpose 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.). Through the issuance of task orders, the contractors will be required to perform some or all of the following services: Administrative Reporting Requirements: This includes 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: This includes efforts associated with planning, conducting, and reporting on in vitro toxicity testing, including those utilizing Good Laboratory Practice (GLP) and Non-Good Laboratory Practice (Non-GLP), with limited in vivo capabilities in accordance with approved protocols. This includes toxicity evaluations in two areas: a. 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. b. 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. These may require completing only a portion or full studies, e.g. biological sample and histopathology analysis. In Vivo Toxicity Testing: This includes efforts associated with planning, conducting, and reporting on approved in vivo toxicology studies, including those utilizing GLP and Non-GLP, in accordance with approved protocols. This includes the following toxicity evaluations: In vivo general toxicology and safety pharmacology studies (via oral, IM, IV, SC, IT, ocular, IP, etc.) for IND/NDA/BLA-enabling toxicology packages including: (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 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. These may require completing only a portion or full studies, e.g. biological sample and histopathology analysis. DRUG PRODUCT 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. Purpose and Objectives: The objective of this contract is to support the DPI drug development programs by providing services related to the development, manufacture, and conduct of stability studies for non-sterile and sterile pharmaceutical dosage forms. Through the issuance of task orders, the contractors will be required to perform some or all of the following services: 1. Administrative Reporting Requirements. This includes activities related to the overall administration of the contract. Specific services to be performed include the fulfillment of administrative reporting and deliverable requirements. 2. Non-Sterile Dosage Forms. This includes oral formulations and/or topical formulations. Anticipated oral dosage forms include, but are not limited to, solid formulations (i.e. capsule and tablet dosage forms and sustained release drug products) and liquid forms (i.e. solutions and suspensions). This may include the following activities: a. Development of Non-sterile Dosage Forms. b. Manufacture of Non-sterile Dosage Forms. c. Stability Studies on Non-sterile Dosage Forms. 3. Sterile Dosage Forms. This includes sterile liquid or lyophilized dosage forms; formulations will be primarily sterilized by 0.22 ?m filtration, but may require aqueous solutions sterilized by autoclaving or aseptically processed non-aqueous solutions; dosage forms are anticipated to primarily be for immediate release , but also may include sustained release or liposomal formulations; and administration routes to include intravenous, subcutaneous, intramuscular, ophthalmic, and inhalation. This may include the following activities: a. Development of Sterile Dosage Forms. b. Manufacture of Sterile Dosage Forms. c. Stability Studies on Sterile Dosage Forms. Period of Performance The ordering periods for the IDIQ contracts under each of the three TRND programs are as follows: Drug Substance: April 1, 2017 - March 31, 2022 (five years) This proposed modification will extend the ordering period through March 31, 2024. Toxicology: April 21, 2017 - April 20, 2022 (five years) This proposed modification will extend the ordering periods through April 20, 2024. Drug Product: August 1, 2017 - July 31, 2022 (five years) This proposed modification will extend the ordering periods through July 31, 2024. Contract Type Task orders awarded under these IDIQ contracts for each TRND program will be Firm-Fixed-Price or Cost-Plus-Fixed-Fee, in accordance with the contract terms and conditions of the IDIQ contracts. REASON FOR THE NON-COMPETITIVE ACTION The above IDIQ contracts for the three TRND programs were originally awarded based on full and open competition. FAR Part 15 source selection procedures were used during the pre-award process, including: an independent peer review, an internal review by NCATS of both the technical and cost proposals submitted, and discussions with the Offerors regarding their proposals. Drug Substance: The seven (7) aforementioned IDIQ Contracts under Drug Substance were awarded on March 30-31, 2017 and include a five-year ordering period which will end on March 31, 2022. Toxicology: The four (4) IDIQ Contracts under Toxicology were awarded on April 20, 2017 and include a five-year ordering period which will end on April 20, 2022. Drug Product: The four (4) IDIQ Contracts under Drug Product were awarded between July 26 and August 1, 2017 and include a five-year ordering period which will end on July 31, 2022. Modifying the aforementioned IDIQ contracts for each TRND program specified herein to extend the ordering period is the only efficient and effective way to ensure continuation of these services. NCATS is actively planning and preparing for a new acquisition for these services, but due to changes in requirements, it was not possible to have the new acquisition begin with sufficient time to avoid a gap in the ordering periods. The mission of the NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions, with the goal of getting more treatments to more patients more quickly. The TRND program advances the mission of NCATS by encouraging and accelerating the development of new treatments for diseases with high unmet medical needs. The services performed under the above IDIQ contracts are vital to the TRND program and advancing the mission of NCATS, and a gap in the ordering periods would severely impact both. The contractors listed in the Introduction above have specific qualifications to provide the services for these requirements and are the only organizations that can perform this specific work at this time without unacceptable delays. For the time period contemplated for these actions, modifications to extend the ordering periods are the only way to avoid lapses in the ordering periods and a lapse in NCATS’ ability to obtain these critical services in a timely fashion. CLOSING STATEMENT This notice of intent is NOT a request for competitive proposals; however, interested parties may identify their interest and capability to respond to this notice. Responses to this notice must contain sufficient information to establish the interested parties’ bona-fide capability of fulfilling the requirements described herein. The statement must also include the contractor’s Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), and its certification of business size. All offerors must have an active registration in the System for Award Management (SAM), which can be accessed at www.sam.gov. A determination by the Government not to compete these proposed contract actions 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 for these three TRND programs. The determination whether to proceed with the proposed IDIQ contract modifications for these three TRND programs is solely within the discretion of the Government. All responses must be received by 5:00 PM Eastern Time, February 11, 2022 and reference Notice No. 75N95022R00022. Responses shall be emailed to the following: Drug Substance: All responses must be emailed to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov. Toxicology: All responses must be emailed to Mark McNally, Contract Specialist, at mark.mcnally@nih.gov. Drug Product: All responses must be emailed to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.