Pre-Clinical Consulting Services
ID: 75N95025Q00127Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

NAICS

Other Scientific and Technical Consulting Services (541690)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)
Timeline
  1. 1
    Posted Jan 15, 2025, 12:00 AM UTC
  2. 2
    Updated Jan 15, 2025, 12:00 AM UTC
  3. 3
    Due Jan 17, 2025, 2:00 PM UTC
Description

The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified vendors to provide Pre-Clinical Consulting Services as part of a Sources Sought Notice (Solicitation Number: 75N95025Q00127). The objective is to identify capable sources that can support the Clinical Trials Unit (CTU) in areas such as clinical research regulatory compliance and gene therapy, enhancing the CTU's ability to manage over 120 clinical research programs effectively. This consulting expertise is vital for the CTU's role in pre-clinical development, particularly in relation to investigational new drug (IND) and investigational device exemption (IDE) processes. Interested firms must submit a capability statement by January 17, 2025, detailing their qualifications and experience, and can contact Frederick Weddington at frederick.weddington@nih.gov or 301-594-6835 for further information.

Point(s) of Contact
Files
Title
Posted
Jan 15, 2025, 4:05 PM UTC
The government issued a Sources Sought Notice (Solicitation Number: 75N95025Q00127) to gather information on qualified sources capable of providing Pre-Clinical Consulting Services. This notice aims to assess the availability and capability of vendors in compliance with specific requirements related to the Clinical Trials Unit (CTU) and associated stakeholders, particularly in areas including clinical research regulatory and gene-therapy domains. Companies interested in responding must submit a capability statement detailing their qualifications, including workforce size and experience, along with relevant military or government acquisition contracts. Responses should identify the business type, applicable NAICS Code, and size standard, while avoiding proprietary information. There is no obligation for the government to award a contract based on this notice, and responses are due by January 17, 2025. Interested firms must follow specific formatting guidelines for submission and provide comprehensive details to support their qualification claims. The document underscores the government’s effort to enhance its consulting capabilities and resources while ensuring compliance with legal and technical standards.
Jan 15, 2025, 4:05 PM UTC
The National Institute of Neurological Disorders and Stroke (NINDS) aims to enhance clinical research through its Clinical Trials Unit (CTU). The CTU offers support for over 120 clinical research programs by managing all protocol phases, including development, execution, and data analysis. To maintain high-quality practices, the CTU collaborates with various stakeholders, providing education and training to research teams while promoting innovative clinical trial methodologies. To further its mission, the CTU seeks consultant expertise in areas relevant to investigational new drug (IND) and investigational device exemption (IDE)-enabling pre-clinical development. This expertise is crucial for the CTU's role as a sponsor, engaging with diverse organizations such as the pharmaceutical industry and academic institutions. Services will be conducted virtually at the NINDS Intramural Clinical Neurosciences Program in Bethesda, MD, leveraging NINDS IT resources, with the timing to be determined. The designated contacts for this service are Dr. Lauren Reoma and Mr. Bradley Alvarez. Overall, this RFP emphasizes the need for specialized knowledge to support and advance clinical trials at NINDS.
Lifecycle
Title
Type
Sources Sought
Similar Opportunities
75N93025R00013 - Medical Residents for NIH's Clinical Center
Buyer not available
The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for the provision of Medical Residents at its Clinical Center in Bethesda, Maryland, under RFP No. 75N93025R00013. The contract aims to enhance clinical care for adult and pediatric inpatients involved in NIH research, requiring contractors to supply postgraduate medical residents who will deliver primary medical care and respond on-site within an hour when called. This initiative is crucial for bolstering healthcare services at the NIH, ensuring compliance with federal regulations, and maintaining high standards of patient care. Interested offerors must submit their proposals by April 14, 2025, and can direct inquiries to primary contact Sevag Kasparian at Sevag.Kasparian@nih.gov or secondary contact Maya Joseph at Maya.Joseph@nih.gov.
iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for the procurement of iNDI ALFAtag cell lines as part of the iPSC Neurodegenerative Disease Initiative (iNDI) project. The objective is to generate up to 230 isogenic iPSC cell lines, including fluorescent ALFAtags for visualization, adhering to established quality control standards for research on Alzheimer's disease and related dementias. This initiative is crucial for advancing scientific understanding of neurodegenerative diseases and creating a publicly accessible cell repository. Interested vendors must submit their proposals by April 15, 2025, at 12:00 PM Eastern Time, to Andrea Clay at amcgee@nih.gov, referencing solicitation number 75N95025Q00078.
Purchase of Lab Supplies
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified vendors to provide various lab supplies, including cleaning and sanitation products, under solicitation number 75N98025Q00021. The procurement aims to ensure the NIH is equipped with essential supplies such as paper towels, disinfectant wipes, and hand soap, which are critical for maintaining hygiene and safety in healthcare environments. This opportunity includes a partial small business set-aside, encouraging participation from small businesses, including service-disabled veteran-owned and women-owned enterprises, with a focus on timely delivery within a 10-day timeframe. Interested vendors must submit their quotes via email by 4:30 PM Eastern Daylight Time on April 9, 2025, and can direct inquiries to Carol Hayden at haydenc@od.nih.gov.
Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits
Buyer not available
Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits The Department of Health and Human Services, Department of, National Institutes of Health, is planning to procure BD Rhapsody Single-Cell Analysis Reagent Kits. These kits are used for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy, and gene therapy conducted in the Clinical Center at the NIH. The procurement includes a standing order for multi-type sequencing kits and reagents with a short shelf life. The contractor will be responsible for shipping the sufficient reagents and kits following the scheduled delivery dates. The shelf life of the sequencing reagents should be at least 3 months, and the shelf life of library generation kits should be at least 6 months. The contractor is also required to provide technical support for all kits and reagents at no additional cost. The period of performance for this procurement is from 5/1/2024 to 8/30/2024. The delivery schedule is overnight delivery Monday through Thursday to the Center for Cellular Engineering (CCE) at NIH/CC in Bethesda, MD. The vendor will be responsible for ensuring the safe transport of cryopreserved patient cells and maintaining the temperature and other parameters during the shipment of reagents and kits. The contractor will be paid per product delivered and is required to provide hard copies of proofs of each product delivered. Interested parties can submit their capabilities to the Office of Purchasing and Contracts by May 1st, 9:00 AM EST. Please note that this is not a request for proposal.
Preventative Maintenance Agreement for Various Instruments in the Department of Laboratory Medicine
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a firm-fixed-price purchase order for a preventative maintenance agreement for various laboratory instruments located in the Department of Laboratory Medicine. The procurement involves maintenance services for specific proprietary instruments, including the 7500 FAST Real-Time PCR Systems and the 3500xL Genetic Analyzer, which are critical for the rapid detection of infectious agents from clinical samples. The performance period for this contract is set from May 1, 2025, to April 30, 2030, with a total funding amount not exceeding $250,000. Interested parties are encouraged to submit capability statements to Shasheshe Goolsby at shasheshe.goolsby@nih.gov by April 14, 2025, at 6:30 AM EST, as this is not a request for quotation.
Notice of Intent to Sole Source – TheraDoc subscription
Buyer not available
The National Institutes of Health (NIH) Clinical Center intends to award a firm fixed-price purchase order for subscription services related to the TheraDoc application, exclusively owned by Premier Healthcare LLC. This procurement aims to secure applications, support, maintenance, and training for the TheraDoc clinical surveillance solution, which is critical for enhancing healthcare delivery and patient safety. The acquisition will follow the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, allowing for a sole-source solicitation due to the unique nature of the services required. Interested parties may express their capabilities and submit comments to the NIH by November 21, 2024, with inquiries directed to Ryssa Nix at Ryssa.nix@nih.gov.
MAINTENANCE SERVICES FOR THERMOFISHER MANUFACTURED CENTRIFUGES & INCUBATORS
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through its National Institute of Allergy and Infectious Diseases (NIAID), is seeking maintenance services for 23 incubators and 16 centrifuges located in Bethesda, Maryland. The procurement requires priority onsite repair during business hours, annual preventive maintenance, rapid response for corrective repairs, and unlimited phone and email support, emphasizing the critical role of these laboratory instruments in health research. Interested vendors must provide OEM authorization to deliver these services and be registered in the System for Award Management (SAM), with quotes due by April 10, 2025, under solicitation number RFQ-NIAID-25-2257534. For further inquiries, vendors can contact Leah Hinson at leah.hinson@nih.gov.
Cisco Customer Experience Enterprise Agreement (CXEA)
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified vendors to participate in the Cisco Customer Experience Enterprise Agreement (CXEA) procurement. This opportunity is a total set-aside for Historically Underutilized Businesses (HUBZone) and is being conducted under the NIH Information Technology Acquisition and Assessment Center (NITAAC) vehicle. The services sought are related to IT and telecom service delivery management, which are crucial for enhancing the operational capabilities of the NIH. Interested vendors should direct their inquiries to Karen Miller at karen.miller@nih.gov or Temeka Mumford at temeka.mumford@nih.gov, with the notice being posted for seven days prior to solicitation.
SOURCES SOUGHT: Maintenance and Repair Service for an Automated Liquid Handling System
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide maintenance and repair services for a Microlab VANTAGE 1.3 Automated Liquid Handling System utilized by the National Institute on Aging (NIA) for neurodegenerative disease research. The procurement aims to ensure the system's continuous operation through preventative maintenance, repairs, and software updates, with a contract period spanning from June 17, 2025, to June 16, 2029, including options for extensions. This specialized maintenance support is critical for facilitating ongoing research efforts in Alzheimer's and related dementias, adhering to federal regulations and performance standards. Interested parties must submit their capability statements to Rashiid Cummins at rashiid.cummins@nih.gov by April 8, 2025, at 9:00 am Eastern Time.
NIAID High Containment Integrated Research Facility Fort Detrick, Frederick, MD (IRF-Frederick)
Buyer not available
The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking qualified small business sources to provide operational, scientific, and administrative support services at the Integrated Research Facility (IRF-Frederick) located at Fort Detrick, Maryland. The primary objective of this Sources Sought Notice is to enhance research capabilities focused on infectious diseases and biodefense, particularly in conducting high-containment studies and evaluating medical countermeasures. The anticipated contract will span one base year with six additional one-year options, emphasizing the need for continuous operation and emergency preparedness in a biosafety level 4 environment. Interested parties must submit their capability statements by April 11, 2025, detailing relevant experience and operational capacity, and can contact Matt Lear at matt.lear@nih.gov or Rosemary Gomes at Rosemary.Gomes@nih.gov for further information.