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This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on August 3, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Pharmacology and Toxicology for Therapeutics Program (PTTP) IDIQ Contracts

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75N98026R00138Federal

Contract Overview

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Coordinating Center for National Resource Network for the Study of Human Auditory and Vestibular Disorders (U24 Clinical Trial Not Allowed)
Solicitation # RFA-DC-28-002
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Solicitation # RFA-DC-28-001
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The National Institute on Neurological Disorders and Stroke plans to extend the ordering period of four existing multiple-award Indefinite Quantity Indefinite Delivery contracts under the Pharmacology and Toxicology for Therapeutics Program by two years, from September 12, 2026, to September 12, 2028. These contracts are held by SRI International, Southern Research, IIT Research Institute, and the University of Illinois Chicago, and they support critical preclinical pharmacology and toxicology studies essential for advancing therapeutic candidates toward FDA Investigational New Drug applications. The work includes in vivo pharmacokinetics, acute and chronic toxicity evaluations, safety pharmacology, genotoxicity and carcinogenicity assessments, and in vitro ADMET assays, serving both the NIH Blueprint Neurotherapeutics Network and external NIH-funded projects. The modification is authorized under 41 U.S.C. 3304(a)(1) and follows RFO procedures for sole-source actions, as no other sources are deemed capable of meeting the agency’s requirements. The effort is classified under NAICS code 541715 with a size standard of 1,000 employees and is governed by Executive Order 14275 and OMB Memorandum M-25-26. Interested parties may submit capability statements, express interest, or lodge objections by August 18, 2026, at 3:00 p.m. Eastern Time, electronically to Sneha Singh at sneha.singh@nih.gov, referencing solicitation number 75N98026R00138. All respondents must have an active SAM registration with a valid Unique Entity Identifier and Taxpayer Identification Number, along with a certified business size statement. The government will evaluate submissions to determine whether to proceed with the non-competitive modification or initiate a new competitive procurement. No formal competitive bidding is being requested, and the decision to extend the contracts rests entirely at the discretion of the government. The requirement is not being fulfilled under commercial item acquisition authorities, but responders may still indicate if they can satisfy the need with commercial solutions.

General Info

Extend four sole-source contracts for preclinical pharmacology and toxicology studies through September 2028.

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Bethesda, MD, USA

Set-Aside

NONE

Documents

1

Notice of Intent to Award Modifications for PTTP Contract Extension

PDF, High priority: read this firstpresolicitation
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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida
Contacts1 person available
OfficeBethesda, MD, 20892, USA
Office AddressBethesda, MD, 20892, USA
Contacts

Full Description

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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 of supporting efforts to advance compounds successfully through Phase I


clinical testing. Projects may utilize some or all of the BPN infrastructure. The


PTTP contract will support all preclinical pharmacology and toxicology testing


needed to inform lead discovery, the selection of a clinical candidate, and


comprehensive studies needed for regulatory filings, such as an Investigational


New Drug (IND) application to the FDA, to allow for clinical evaluation of the


candidates. This contract will serve as part of the NIH Blueprint Neurotherapeutics


Network and will also be utilized for individual development projects outside of the


Blueprint Network.



Scope and Objectives


The goal of the PTTP is to assess the pharmacokinetics, toxicology and safety of


promising candidates to support their eventual use as therapeutics. It is anticipated


that NIH-approved samples will be submitted from a variety of sources including


NIH-funded research programs, pharmaceutical companies, biotechnology


companies, or other sources. Pharmacology, toxicology and safety data generated


from this program may be used by investigators in support of an Investigational


New Drug (IND) application.



Studies to be performed may include, but are not limited to:


• Development and validation of the analytical methods for quantitating


drug/biologic concentrations in dosing solutions, biological fluids, and


tissues, as required


• In vivo pharmacokinetic studies through various routes of administration


• Preclinical acute toxicity evaluations on lead compounds or therapeutics


• Subacute, subchronic, and/or long-term toxicity evaluations in rodents


and non-rodent species


• Safety Pharmacology Studies in rodent and non-rodent species (e.g.,


cardiovascular, pulmonary, CNS)


• Genotoxicity assessments using a battery of appropriate assays and


carcinogenicity assessments


• In vitro predictive ADMET assays, including metabolic stability studies,


hepatotoxicity, permeability studies, cytochrome P450 assays, plasma


protein binding, and cytotoxicity assay



Period of Performance


As a result of this modification, the ordering period of the IDIQ will be extended by two (2) years, from September 12, 2026, to September 12, 2028.


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, or submitting objections to the proposed contract modification.  The government will consider responses, however, a determination by the government to proceed with the proposed contract modification is solely within the discretion of the government. 


Any potential offeror must have an active registration in the System for Award Management (SAM), housed at www.sam.gov. In addition, the Unique Entity Identifier (UEI), 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 requirements 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 for determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.


Based upon market research, the government is not using RFO Part 12, Acquisition of Commercial Products and Commercial Services, to fulfill this requirement.  However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government’s requirement with a commercial item within 15 days of this notice. 


All responses must be received by August 18, 2026, at 3:00 pm Eastern Time.  Responses must be submitted electronically to Sneha Singh, Contacting Officer, at sneha.singh@nih.gov.  Please reference notice, 75N98026R00138 in any responses or inquiries. 


More opportunities from Department Of Health And Human Services → National Institutes Of Health Nida

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Solicitation # OLAO-SSD-SOAR-NOI
The National Institutes of Health (NIH) intends to negotiate and award non-competitive modifications to extend the Scientific, Operations and Administrative Resources (SOAR) contract program. This program consists of five indefinite-delivery, indefinite-quantity (IDIQ) contracts held by Axle Informatics LLC, Gap Solutions Inc., Kelly Services Inc., Guidehouse Digital LLC, and 22nd Century Technologies Inc. The primary objective is to ensure continuity of specialized scientific professional services across 29 NIH organizations, including the Office of the Director, 27 Institutes and Centers, and ARPA-H, while the agency finalizes a strategic procurement consolidation effort and a competitive follow-on acquisition. The proposed extension includes a basic ordering period from June 22, 2026, to June 21, 2027, with two optional six-month extensions extending through June 21, 2028. Additionally, the government seeks to revise FAR 52.216-22 to allow task orders to extend up to 36 months beyond the parent contract end date. While the combined maximum contract ordering value remains unchanged at $3,600,713,546, the estimated total dollar value for orders through the end of the extension is $2,174,615,674. The government projects the award of these modifications in April 2026. The SOAR program provides critical scientific staffing, such as bioinformatics scientists and molecular biologists, to support biomedical research and public health missions. The NIH has cited a critical need for these specific contract holders to avoid disruptions to ongoing research and patient diagnostics. Interested parties may submit capability statements and pricing information by March 5, 2027, although the government currently intends to proceed on a non-competitive basis with the existing holders.
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