Clinical Research Operations Core

Project ID: 75N93025R00019 FederalOpportunitiesPresolicitation

Overview

Agency	National Institutes of Health
Deadline	02/27/26
Posted	01/13/26
Estimated Value	Not Provided
Set Aside	None
NAICS	541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
PSC	AN12 - Health R&D Services; Health Care Services; Applied Research
Location	Rockville, MD United States

Description

Primary Latest Change

The purpose of this pending solicitation is to provide the resources and services needed to implement clinical research in support of NIAID's mission. This will allow NIAID to respond to public health needs including public health emergencies and produce high quality data supporting regulatory and policy decisions. These services are intended to support: A wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and support Phase I/II clinical studies. NIAID priority activities including manufacture and characterization of reagents and products to support government supported clinical trials such as those supported by IDCRC. Manufacture of critical reagents and clinical trial material to support the wider scientific community and non-government sponsored projects. NIAID has implemented a Determination of Exceptional Circumstances in accordance with 37 C.F.R. 401.3(e) (see Advanced Understandings) for NIAID's preclinical service contracts that include Vaccine (and Other Biologic) Manufacturing Services for Infectious Diseases. Consequently, all contractors are required to operate under a fee-for-service model, and the contractor may be required to assign any intellectual property they file on third part material of information ( Provider Materials ), or new processes, and products relating to Provider Materials they develop and manufacture. The contractor will also be required to delay any public release of results until NIAID and Provider have a chance to review and file patents of their own. The contractors may propose the use of reagents and processes that are proprietary or under license. However, NIAID and the Provider reserve the right to reject the use of these alternative materials and processes.

Summary (Newest Update)

Background The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) under the Department of Health and Human Services (DHHS), is dedicated to supporting research aimed at understanding, treating, and preventing infectious, immunologic, and allergic diseases. This solicitation aims to provide resources and services necessary for implementing clinical research that aligns with NIAID's mission to address public health needs, including emergencies, while generating high-quality data for regulatory and policy decisions. Work Details The services required under this contract include: 1. Supporting a diverse range of investigators in various scientific fields to obtain critical data for funding acquisition, partnership development for Phase I/II trials, fulfilling regulatory requirements, and supporting Phase I/II clinical studies. 2. Engaging in NIAID priority activities such as the manufacture and characterization of reagents and products to support government-sponsored clinical trials. 3. Manufacturing critical reagents and clinical trial materials for both the scientific community and non-government sponsored projects. 4. Operating under a fee-for-service model with potential requirements for contractors to assign intellectual property rights related to third-party materials or new processes developed during the contract. 5. Delaying public release of results until NIAID has reviewed them for patent filing opportunities. 6. Supporting countermeasures against diseases caused by pathogens on the NIAID Category A, B, and C Priority Pathogens list, as well as emerging infectious diseases, antimicrobial resistant infections, and other significant health threats. Period of Performance The anticipated period of performance is structured as an Indefinite Delivery Indefinite Quantity (IDIQ) contract with a seven-year ordering period and a ten-year completion timeframe for Task Area A. The expected start date is on or about July 16, 2026. Place of Performance The specific place of performance is currently unknown; however, it will be determined based on the requirements of the tasks outlined in the solicitation.

Contacts

Contact name	Cindy Hargett
Contact email	cindy.hargett@nih.gov
Contact phone	None
Secondary contact name	Ignacio Reyes, Contracting Officer
Secondary contact email	ignacio.reyes@nih.gov
Secondary contact phone	(301) 435-7574