Pharmacology and Toxicology for Therapeutics Program (PTTP) IDIQ Contracts

Solicitation description

INTRODUCTION PURSUANT TO RFO SUBPART 5.101- PRESOLICITATION NOTICE, THIS IS A NOTICE OF A PROPOSED CONTRACT ACTION. THIS IS A NOTICE OF INTENT TO AWARD MODIFICATIONS TO EXTEND THE ORDERING PERIOD BY TWO (2) YEARS UNDER THE FOLLOWING CONTRACT NOS: HHSN271201600006i - SRI International HHSN27120160007i - Southern Research 75N95021D00026 - IIT Research Institute (IITRI) 75N95022D00026 - University of Illinois Chicago The National Institute on Neurological Disorders and Stroke (NINDS) intends to modify the multiple-award Indefinite Quantity Indefinite Delivery (IDIQ) contracts under the Pharmacology and Toxicology for Therapeutics Program (PTTP). These contracts serve as part of the NIH Blueprint Neurotherapeutics Network (BPN) and are also utilized for individual development projects outside of the Blueprint Network. These services are a critical component of the BPN drug development infrastructure, supporting all preclinical pharmacology and toxicology testing needed to inform lead discovery and the selection of a clinical candidate, as well as comprehensive studies needed for regulatory filings such as FDA Investigational New Drug (IND) applications to allow for clinical evaluation of the candidates. This modification will extend the ordering period as denoted in IDIQ contract clause FAR 52.216-18, Ordering (AUG 2020), to be extended September 12, 2026, to September 12, 2028. The extension will allow the four existing IDIQ holders to continue supporting BPN and other NINDS initiatives - including pharmacokinetic (PK), non-GLP, and GLP-IND-enabling studies - while the PTTP requirement is recompeted and a new IDIQ contract is awarded. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The requirement is classified under NAICS code is 541715: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), with a size standard of 1,000 employees. REGULATORY AUTHORITY The resultant modification will include all the applicable provisions and clauses of the RFO initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26. STATUTORY AUTHORITY This modification is conducted under the authority of 41 U.S.C. 3304(a)(1) and in accordance with RFO – FAR 6.103-1- Only one responsible source and no other supplies or services will satisfy agency requirements. DESCRIPTION Background The National Institute of Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) have established a ‘virtual pharma’ network of contract service providers and consultants with extensive industry experience to enable therapeutic (e.g., small molecule, peptide, biologic) development in the NIH research community. The Network, similar NINDS and NIH programs offer researchers access to a range of industry style therapeutic development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase I clinical trial infrastructure, with the goal...

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